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{
"NCT_ID" : "NCT02753712",
"Brief_Title" : "A Study to Evaluate the Effect of Fluticasone/Formoterol Breath Actuated Inhaler (BAI) or Relvar® Ellipta® DPI on Ventilation Heterogeneity in Asthma",
"Official_title" : "A Two-arm, Randomised, Assessor-blind, Parallel Group Study to Evaluate the Effect of Fluticasone/Formoterol Breath Actuated Inhaler (BAI) and Relvar® Ellipta® DPI on Ventilation Heterogeneity in Subjects With Partially Controlled or Uncontrolled Asthma",
"Conditions" : ["Asthma"],
"Interventions" : ["Drug: Fluticasone/Formoterol BAI", "Drug: Fluticasone/Vilanterol DPI (Relvar Ellipta DPI)"],
"Location_Countries" : ["Sweden", "Australia", "United Kingdom", "Slovakia", "New Zealand"],
"Study_Design" : {
"Study_Type" : "INTERVENTIONAL",
"Phase" : ["PHASE3"],
"Primary_Purpose" : "TREATMENT",
"Allocation" : "RANDOMIZED",
"Interventional_Model" : "PARALLEL",
"Masking" : "SINGLE"
},
"Recruitment_Information" : {
"Study_Start_Date(Actual)" : "2016-06-15",
"Primary_Completion_Date(Actual)(Final_data_collection_date_for_primary_outcome_measure)" : "2017-08-14",
"Study_Completion_Date(Actual)" : "2017-08-14},
"Study_Record_Dates" : {
""Study_Registration_Dates" : {
"First_Submitted" : 2016-04-11",
"First_Posted(Estimated)" : 2016-04-28"
},
"Study_Record_Updates" : {
"Last_Updated_that_Met_QC_Criteria" : 2016-04-27",
"Last_Update_Posted(Estimated)" : 2018-10-23",
"Last_Verified" : 2018-10"
}
}}
|
#Study Description
Brief Summary
The purpose of this study is to demonstrate improvement of peripheral airway resistance (R5-R20) from baseline with fluticasone/formoterol breath actuated inhaler (BAI).
#Intervention
- DRUG : Fluticasone/Formoterol BAI
- DRUG : Fluticasone/Vilanterol DPI (Relvar Ellipta DPI)
|
#Eligibility Criteria:
Inclusion Criteria for subjects on Seretide Accuhaler 250/50 µg at screening:
* Male and female subjects >=18 years.
* Adequate contraception
* Documented clinical history of asthma for >=6 months prior to screening visit
* Using Seretide Accuhaler at a stable dose of 250/50 μg BID at screening for >= 8 weeks.
* uncontrolled asthma as defined by Asthma Control Questionnaire (ACQ-6) score >= 1.0
* R5-R20 >= 0.10 kPa/L/s as measured on impulse oscillometry during the screening visit.
* Historical evidence (within 24 months) of eosinophilic airways disease evidenced by sputum eosinophil count >= 3% and/or FeNO 35 ppb.
Inclusion criteria for subjects on equivalent /higher dose or other ICS-LABAs or higher dose of Seretide at screening:
* Male and female subjects >=18 years.
* Adequate contraception
* Documented clinical history of asthma for >=6 months prior to screening visit
* R5-R20 >=0.07 kPa/L/s as measured on impulse oscillometry during the screening visit.
* 5. Historical evidence (within past 24 months) of eosinophilic airways disease, evidenced by sputum eosinophil count >=3% and/or FeNo >=35 ppb.
Exclusion Criteria for all subjects:
* Any severe chronic respiratory disease other than asthma.
* Subject has a smoking history >=10 'pack years' (i.e., at least 1 pack of 20 cigarettes/day for 10 years or 10 packs/day for 1 year, etc.)
* Current smoking history within 12 months prior to the screening visit
* Near fatal or life-threatening (including intubation) asthma within the past year.
* Known history of systemic (injectable or oral) corticosteroid medication within 1 month of visit 1.
* Evidence of a clinically unstable disease as determined by medical history or physical examination that, in the investigator's opinion, precludes entry into the study. 'Clinically unstable' is defined as any disease that, in the opinion of the Investigator, would put the subject at risk through study participation, or which would affect the outcome of the study.
* In the investigator's opinion a clinically significant upper or lower respiratory infection within 4 weeks prior to visit 1.
* Current evidence or known history of alcohol and/or substance abuse within 12 months prior to the screening visit.
* Subject has taken β-blocking agents, tricyclic antidepressants, monoamine oxidase inhibitors, astemizole, quinidine type antiarrhythmics, or potent CYP 3A4 inhibitors such as ketoconazole within 1 week prior to screening visit.
* Current use of bronchodilators / anti-inflammatory agents other than those specified in the protocol.
* Known or suspected sensitivity to study drug or excipients.
* Participation in a clinical drug study within 30 days of the screening visit.
* Current participation in a clinical study.
Exclusion Criteria for subset of subjects undergoing OR-MRI and HD-CT
* Contraindication for MRI scanning (as assessed by local MRI safety questionnaire), which includes, but is not limited to: presence of non-MRI compatible artificial heart valves, hydrocephalus shunts, intracranial aneurysm clips, joint replacements or metal implants, pacemakers or other cardiac rhythm management devices, claustrophobia, history of metal in the eye, presence of shrapnel from a war injury, callipers or braces, dentures, dental plates or hearing aids that include metal and cannot be removed, history of epilepsy or black-outs, ear implants, piercings cannot be removed, intrauterine contraceptive device or coil.
* Inability to stay in the supine position for the duration of the scanning procedure
* Obesity (body weight >140kg).
Sex :
ALL
Ages :
- Minimum Age : 18 Years
- Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : ADULT, OLDER_ADULT
Accepts Healthy Volunteers:
No
|
NCT02753712
| 78,096 |
{
"NCT_ID" : "NCT00857272",
"Brief_Title" : "F38-27: An Evaluation of 2 Different Bowel Cleansing Preparations in Adult Subjects",
"Official_title" : "F38-27: An Evaluation of 2 Different Bowel Cleansing Preparations in Adult Subjects",
"Conditions" : ["Colonoscopy"],
"Interventions" : ["Drug: PEG electrolyte lavage solution + bisacodyl", "Drug: PEG electrolyte lavage solution + bisacodyl - reformulation"],
"Location_Countries" : ["United States"],
"Study_Design" : {
"Study_Type" : "INTERVENTIONAL",
"Phase" : ["PHASE4"],
"Primary_Purpose" : "TREATMENT",
"Allocation" : "RANDOMIZED",
"Interventional_Model" : "PARALLEL",
"Masking" : "SINGLE"
},
"Recruitment_Information" : {
"Study_Start_Date(Actual)" : "2009-02",
"Primary_Completion_Date(Actual)(Final_data_collection_date_for_primary_outcome_measure)" : "2009-05",
},
"Study_Record_Dates" : {
""Study_Registration_Dates" : {
"First_Submitted" : 2009-03-05",
"First_Submitted_that_Met_QC_Criteria" : 2010-09-08",
"First_Posted(Estimated)" : 2009-03-06"
},
"Study_Record_Updates" : {
"Last_Updated_that_Met_QC_Criteria" : 2009-03-05",
"Last_Update_Posted(Estimated)" : 2010-10-05",
"Last_Verified" : 2010-09"
}
}}
|
#Study Description
Brief Summary
To compare the safety and efficacy of 2 different bowel cleansing preparations prior to colonoscopy in adult subjects.
#Intervention
- DRUG : PEG electrolyte lavage solution + bisacodyl - reformulation
- multi dose formulation (tablet/solution) for oral administration prior to colonoscopy
- DRUG : PEG electrolyte lavage solution + bisacodyl
- multi dose preparation (tablet/solution) for oral administration prior to colonoscopy
|
#Eligibility Criteria:
Inclusion Criteria:
* Male or female outpatients who are undergoing colonoscopy for a routinely accepted indications:
* At least 18 years
* Otherwise in good health, as determined by physical exam and medical history
* If female, and of child-bearing potential, is using an acceptable form of birth control
* Negative urine pregnancy test at screening, if applicable
* In the Investigator's judgment, subject is mentally competent to provide informed consent to participate in the study
Exclusion Criteria:
* Subjects with known or suspected ileus, gastrointestinal obstruction, gastric retention, bowel perforation, toxic colitis, or toxic megacolon
* Subjects with impaired consciousness that predisposes them to pulmonary aspiration
* Subjects who are undergoing colonoscopy for foreign body removal and decompression
* Subjects with pre-existing electrolyte disturbances, such as dehydration, or those secondary to the use of diuretics
* Subjects who are taking drugs that may affect electrolyte levels with the exception of routine diuretics
* Subjects with known clinically significant electrolyte abnormalities such as hypernatremia, hyperphosphatemia, hypokalemia, or hypocalcemia
* Subjects who are pregnant or lactating, or intending to become pregnant during the study
* Subjects of childbearing potential who refuse a pregnancy test
* Subjects who are allergic to any preparation components
* Subjects who, in the opinion of the Investigator, should not be included in the study for any reason, including inability to follow study procedures
* Subjects who have participated in an investigational clinical, surgical, drug, or device study within the past 30 days
Sex :
ALL
Ages :
- Minimum Age : 18 Years
- Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : ADULT, OLDER_ADULT
Accepts Healthy Volunteers:
No
|
NCT00857272
| 114,683 |
{
"NCT_ID" : "NCT03789968",
"Brief_Title" : "The Incidence and Severity of Drug Interactions Before and After Switching Antiretroviral Therapy to Bictegravir/Emtricitabine/Tenofovir Alafenamide in Treatment Experienced Patients",
"Official_title" : "The Incidence and Severity of Drug Interactions Before and After Switching Antiretroviral Therapy to Bictegravir/Emtricitabine/Tenofovir Alafenamide in Treatment Experienced Patients",
"Conditions" : ["HIV/AIDS"],
"Location_Countries" : ["United States"],
"Study_Design" : {
"Study_Type" : "OBSERVATIONAL",
},
"Recruitment_Information" : {
"Study_Start_Date(Actual)" : "2019-09-01",
"Primary_Completion_Date(Actual)(Final_data_collection_date_for_primary_outcome_measure)" : "2020-09-05",
"Study_Completion_Date(Actual)" : "2020-10-05},
"Study_Record_Dates" : {
""Study_Registration_Dates" : {
"First_Submitted" : 2018-12-26",
"First_Posted(Estimated)" : 2018-12-31"
},
"Study_Record_Updates" : {
"Last_Updated_that_Met_QC_Criteria" : 2018-12-26",
"Last_Update_Posted(Estimated)" : 2020-10-08",
"Last_Verified" : 2020-10"
}
}}
|
#Study Description
Brief Summary
This study will assess changes in the incidence and severity of drug interactions before and after switching antiretroviral therapy to bictegravir/emtricitabine/tenofovir alafenamide-based regimens in treatment experienced patients living with HIV infection.
Detailed Description
Simple, safe and effective antiretroviral therapy (ART) can provide optimal treatment outcomes for people living with HIV infection (PLWH) \[1\]. Increasingly complex and poorly tolerated regimens, on the other hand often limit ART adherence, while drug-drug interactions (DDIs) and safety concerns with individual ART agents can limit treatment selection \[2-4\]. Fortunately, recent advances in ART have included the emergence of several highly effective, safe and well tolerated regimens with limited DDIs. In clinical trials, integrase strand transfer inhibitors (INSTIs) such as raltegravir, elvitegravir, dolutegravir and bictegravir are consistently as effective or more effective than comparator agents and often superior in terms of tolerability \[5-10\]. Due to their efficacy, safety, and tolerability, INSTI-based regimens are now routinely used in treatment naïve patients and emerging data suggests that several may be used to simplify therapy for selected patients with treatment experience \[11, 12\].
Among the INSTIs, bictegravir is the newest agent in the class \[13\]. Similar to dolutegravir and raltegravir and in contrast to elvitegravir, it has few significant drug-drug interactions. Unlike dolutegravir and raltegravir, bictegravir is available as part of a single-tablet, once-daily regimen that includes tenofovir alafenamide and emtricitabine (BIC/TAF/FTC). Raltegravir is not available within a single tablet regimen, while dolutegravir is available as part of a single-tablet regimen, but it includes abacavir, which has been linked to an increased cardiovascular disease risk. As a result, BIC/TAF/FTC is currently among the most effective, safe, well-tolerated treatment options with limited drug-drug interactions.
With several new treatment options available, particularly in the INSTI class, current guidelines advocate switching ART when possible in virologically suppressed, ART experienced patients \[1\]. Switching ART can simplify treatment, improve tolerability, eliminate toxicity, and mitigate drug-drug interactions. When switching ART for any reason, it is critical to review a patient's full HIV treatment history, including virologic responses, past ART-associated toxicities, and cumulative resistance before selecting a new regimen \[1\].
Drug-drug interaction assessments with a patient's concomitant medications should also be performed prior to switching ART. More than 70% of the HIV population will be above the age of 50 by the year 2020 and many are receiving 5 or more medications for common chronic conditions in addition to being ART experienced \[14, 15\]. Cardiovascular disease, hepatic and renal disease, osteoporosis, insulin resistance, metabolic disorders, and cancers are among the conditions that can occur more commonly in PLWH and at times earlier in life in comparison to their HIV negative counterparts \[16\]. Drug-drug interactions between medications needed to treat or prevent these comorbid conditions can often interact with ART. Switching ART, in many circumstances can reduce the number drug interactions with medications for comorbid conditions. Conversely, switching can also lead to new interactions requiring intervention to avoid toxicities or prevent ineffective treatment.
Multiple studies have confirmed that switching HIV treatment can improve patient adherence and quality of life \[17\]. Several studies have also confirmed that clinically significant drug-drug interactions are common in patients living with HIV, but none have assessed changes in the incidence and severity of drug-drug interactions in the setting of ART switches \[18-20\]. The primary objective of this study is to assess changes in the incidence and severity of drug interactions before and after switching ART to BIC/TAF/FTC -based regimens in treatment experienced patients.
Null Hypothesis:
There is no difference in the incidence and severity of drug-drug interactions between ART and concomitant medications before and after switching to a BIC/TAF/FTC-based ART regimen in treatment experienced patients.
Alternative Hypothesis:
The incidence and severity of drug-drug interactions between ART and concomitant medications is reduced after switching to a BIC/TAF/FTC-based ART regimen in treatment experienced patients.
Data Collection Subjects from the Jefferson Infectious Diseases Associates outpatient HIV Clinic will be evaluated for study inclusion. Co-investigators at six partner institutions will also evaluate patients at their HIV clinics for study inclusion. The following information will be collected for patients meeting the study criteria: age, gender, race, duration of HIV infection, duration of ART treatment, number of previous ART regimens, CD4+ cell count and HIV RNA directly prior to switching to a BIC/TAF/FTC-based ART regimen, and the reason for switching ART to a BIC/TAF/FTC-based regimen. Additionally, all concomitant medication names at the time of the ART switch will be collected.
Scoring System To assess the combined incidence and severity of drug interactions with concomitant medications (CM) prior to and following each patient's ART switch, a DDI incidence and severity score was developed. The score is based upon results obtained when entering medications into the University of Liverpool's HIV Drug Interaction Checker (ULHDIC) database \[21\]. Each ART-CM pair is given one of the following scores: 'do not co-administer' is assigned a score of 2, 'potential interaction' a score of 1, and 'potential weak interaction' or 'no interaction' a score of 0. For those interactions that have 'no clear data,' or for those medications that are not listed in the drug database, the Department of Health and Human Services HIV treatment guidelines will be consulted along with the FDA product labeling.
Score Validation A separate analysis (data not provided here) was completed by study investigators to validate the use of the ULDIC severity ranking. The medication profiles of a random, representative sample of the study's population were selected for analysis. Drug interaction scores using the aforementioned ULHDIC were compared with drug interaction scores determined manually using the Department of Health and Human Services HIV treatment guidelines and FDA product labeling. No statistical difference in drug interaction scores between methods was observed.
Primary Endpoint The primary endpoint of the study will be to measure the change in mean total drug interaction scores pre and post ART switch to a BIC/TAF/FTC-based ART regimen. The total drug interaction scores for each patient pre- and post-switch will be calculated. The average pre-switch and post-switch scores will then be determined and analyzed for statistical differences using a two-sided paired t-test (normal distribution) with an alpha level of 0.05 or a Wilcoxon Ranked Sum test (non-normal distribution).
Secondary Endpoints The secondary endpoint of the study will be to identify predictors of achieving drug interaction score reductions after switching to a BIC/TAF/FTC-based ART regimen. Predictors for achieving drug interaction score reductions will be examined using a multivariable linear regression model. Initial models will include all a priori determined variables and all variables will be examined for multi-collinearity. Models will be fit using a backwards selection procedure. Candidate predictors will be eliminated individually by comparing the log likelihood ratio test for each model step and using the 5% significance level.
#Intervention
- DRUG : bictegravir/emtricitabine/tenofovir alafenamide
- Treatment experienced patients with HIV infection that switched to a bictegravir/emtricitabine/tenofovir alafenamide-based ART regimen
|
#Eligibility Criteria:
Inclusion Criteria:
* HIV diagnosis
* 18 years or older
* Receiving ART for at least 3 months
* ART is switched to bictegravir/emtricitabine/tenofovir alafenamide between 2/7/2018 and 3/30/2019
* Patient is receiving at least one chronic or as needed non-ART medication at the time of the switch
Exclusion Criteria:
*
Sex :
ALL
Ages :
- Minimum Age : 18 Years
- Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : ADULT, OLDER_ADULT
Accepts Healthy Volunteers:
Yes
|
NCT03789968
| 113,099 |
{
"NCT_ID" : "NCT03684798",
"Brief_Title" : "Mental Contrasting With Implementation Intentions for Alcohol Use Disorders",
"Official_title" : "Applying Mental Contrasting With Implementation Intentions to Prevent Relapse and Drop-out in Patients With Alcohol Use Disorders",
"Conditions" : ["Alcohol Use Disorder"],
"Interventions" : ["Other: Treatment as usual", "Other: MCII"],
"Location_Countries" : ["Switzerland"],
"Study_Design" : {
"Study_Type" : "INTERVENTIONAL",
"Phase" : ["NA"],
"Primary_Purpose" : "TREATMENT",
"Allocation" : "RANDOMIZED",
"Interventional_Model" : "PARALLEL",
"Masking" : "SINGLE"
},
"Recruitment_Information" : {
"Study_Start_Date(Actual)" : "2017-08-14",
"Primary_Completion_Date(Actual)(Final_data_collection_date_for_primary_outcome_measure)" : "2019-03-04",
"Study_Completion_Date(Actual)" : "2019-03-04},
"Study_Record_Dates" : {
""Study_Registration_Dates" : {
"First_Submitted" : 2018-08-31",
"First_Posted(Estimated)" : 2018-09-26"
},
"Study_Record_Updates" : {
"Last_Updated_that_Met_QC_Criteria" : 2018-09-24",
"Last_Update_Posted(Estimated)" : 2020-02-05",
"Last_Verified" : 2020-02"
}
}}
|
#Study Description
Brief Summary
Mental Contrasting (MC) consists of imaging a desired future and comparing it with obstacles of the present reality in order to increase goal commitment when expectations of success are high. The study aims to investigate the effects of a motivational training (Mental Contrasting with Implementation Interventions; MCII) as a therapeutic add-on to standard treatment in inpatients with Alcohol Use Disorders.
Detailed Description
Today's elaborated therapeutic interventions do not ensure sustainability of therapeutic success in alcohol-dependent patients. Thus, it is to develop and implement new therapeutic methods in order to increase regular treatment termination and continuous abstinence during treatment. Mental Contrasting (MC) consists of imaging a desired future and comparing it with obstacles of the present reality in order to increase goal commitment when expectations of success are high.
In the study, MCII is implemented as an add-on intervention in order to reduce the risk of a relapse during treatment and to decrease drop-outs from treatment in alcohol-dependent inpatients. Therefore, inpatients with alcohol use disorder (AUD) are randomly assigned to one of two groups. The experimental group does receive MCII, the control group an exercise from treatment as usual. In addition, patients undergo brief motivational screenings in form of self-report questionnaires at the beginning and during treatment in order to assess motivational mediation of treatment effects and drinking events. The effect of the MCII training will be examined on primary (drinking during treatment) and secondary outcome variables (early treatment termination, motivational changes after drinking events).
The Primary Outcome is return to drinking during treatment defined as any violation of total abstinence. Drinking is assumed if either a drinking event is reported by the patient or a Breathalyzer tests is positive.
Participants are allocated to the groups using randomisation with emphasis on equal group sizes in control and experimental group. The list of randomisation was generated with the online tool 'Research Randomizer'.
The investigator's a priori calculation of the required sample size is based on the primary outcome, i.e. return to any drinking during treatment. Given α=0.05 and 1-β=0.80 a one-sided z-test then yields a required sample size of 122 participants, i.e. 61 subjects in the intervention group and 61 subjects in the control group.
All randomized subjects will be included in the analyses, regardless of whether they terminate the study regularly or not. Analyses will be done according to the intention-to-treat method (ITT).
#Intervention
- OTHER : MCII
- In this study, the research staff will work through the MCII approach with the participant as an interactive, face-to-face training. The desired future consists of imaging an abstinent life and comparing it with personally relevant obstacles. Afterwards, the most relevant obstacle will be chosen and an if-then-plan will be formed, that refers to this obstacle.
- OTHER : Treatment as usual
- The patients in the control group will receive a 2 x 2 contingency table about the disadvantages and advantages of being abstinent and of drinking. In addition, abstinence intentions of patients in the control group will also be supported and risk situations and relapse events since the last trainings will be reappraised, but without the use of MCII.
|
#Eligibility Criteria:
Inclusion Criteria:
* Diagnosis of alcohol use disorder according to DSM 5 (Diagnostic and Statistical Manual)
* Age: >=18 years
Exclusion Criteria:
* Cognitive deficits that limit the patients' ability to provide informed consent
* Inability to follow the procedures of the study
* Acute suicidality
* Acute psychosis
Sex :
ALL
Ages :
- Minimum Age : 18 Years
- Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : ADULT, OLDER_ADULT
Accepts Healthy Volunteers:
No
|
NCT03684798
| 268,882 |
{
"NCT_ID" : "NCT00866502",
"Brief_Title" : "A Safety and Tolerability Study of Intracerebroventricular Administration of sNN0031 to Patients With Parkinson's Disease",
"Official_title" : "A Randomized, Double-blind, Placebo Controlled, Safety and Tolerability Study of Intracerebroventricular Administration of sNN0031 to Patients With Idiopathic Parkinson's Disease (PD) of Moderate Severity, Using an Implanted Catheter and a SynchroMed® II Pump.",
"Conditions" : ["Parkinson's Disease"],
"Interventions" : ["Drug: Placebo", "Drug: sNN0031"],
"Location_Countries" : ["Sweden"],
"Study_Design" : {
"Study_Type" : "INTERVENTIONAL",
"Phase" : ["PHASE1", "PHASE2"],
"Primary_Purpose" : "TREATMENT",
"Allocation" : "RANDOMIZED",
"Interventional_Model" : "PARALLEL",
"Masking" : "QUADRUPLE"
},
"Recruitment_Information" : {
"Study_Start_Date(Actual)" : "2009-03",
"Primary_Completion_Date(Actual)(Final_data_collection_date_for_primary_outcome_measure)" : "2011-03",
"Study_Completion_Date(Actual)" : "2011-03},
"Study_Record_Dates" : {
""Study_Registration_Dates" : {
"First_Submitted" : 2009-03-18",
"First_Posted(Estimated)" : 2009-03-20"
},
"Study_Record_Updates" : {
"Last_Updated_that_Met_QC_Criteria" : 2009-03-18",
"Last_Update_Posted(Estimated)" : 2015-01-12",
"Last_Verified" : 2015-01"
}
}}
|
#Study Description
Brief Summary
This study is conducted to evaluate the safety and tolerability of the drug product sNN0031, containing Platelet Derived Growth Factor (PDGF), when administered directly into one of the fluid filled cavities in the brain using an implanted catheter and an implanted SynchroMed® II pump. Patients with a diagnosis of Parkinson's disease will be enrolled.
Detailed Description
Tremor, rigidity, slow movement, poor balance, and difficulty walking are characteristic symptoms of Parkinson's disease (PD) that are associated with degeneration of dopamine-producing nerve cells in the brain. Administration of growth factors that stimulate neuronal stem and progenitor cells is one possible approach to restore the dopaminergic activity. The drug product sNN0031 containing the endogenous growth factor PDGF has been demonstrated to reduce the typical symptoms in animal models of PD.
NeuroNova intends to investigate whether intracerebroventricular administration of PDGF in the form of the drug product sNN0031 can improve motor function in patients with PD. In this first study the safety and tolerability of treatment for 2 weeks followed by 10 weeks follow-up will be evaluated.
#Intervention
- DRUG : sNN0031
- Continuous ICV infusion for two weeks
- Other Names :
- PDGF
- DRUG : Placebo
- Continous ICV infusion
- Other Names :
- Artificial CSF
|
#Eligibility Criteria:
Inclusion Criteria:
* Male or female. Females should either be post-menopausal (at least 12 months of spontaneous amenorrhea or 6 months of spontaneous amenorrhea with FSH levels >40 mIU/mL), be surgically sterilized (bilateral oophorectomy w/o hysterectomy), or use adequate contraception (oral contraceptives, intrauterine device or double barrier contraception, i.e., condom + diaphragm, condom or diaphragm + spermicidal gel or foam.) during the duration of the study.
* Diagnosis of idiopathic Parkinson's disease (PD) of moderate severity (modified Hoehn & Yahr Stage IIb-III).
* Effect duration of oral L-dopa dose intake <=4 hours
* Score >=30 on motor part (part III) of UPDRS at defined off (>12 hours after last dose intake)
* Dopaminergic responsiveness with at least 33% decrease in the UPDRS part III score after administration of L-dopa
* Disease duration at least 5 years
* Age 30 <= age <= 75
* Stable anti-Parkinson treatment for at least 3 months
* Ophthalmologic examination with normal findings regarding vascular structure and function
* MRI examination of the brain and cervical spinal cord within 3 months before anticipated implantation of the device with no findings of tumors or potential sources of pathological bleedings, or abnormality that may interfere with the assessments of safety or efficacy or would, in the judgment of the investigator, represent a surgical risk to the subject.
* Values of coagulation parameters including platelet count, normalized prothrombin complex (PK-INR), activated partial thromboplastin time (APTT) within normal ranges.
* The subject is medically able to undergo the surgery required for stereotactic implantation of the catheter and infusion pump.
* Has been given written and verbal information, has had opportunity to ask questions about the study, and understands time and procedural commitments
* Signed consent (written) to participate in the study
Exclusion Criteria:
* Atypical form of PD including repeated head trauma, drug- or toxin-induced PD, and other neurological conditions including Shy-Drager syndrome (multiple system atrophy), progressive supranuclear palsy, Wilson's disease, Huntington's disease, Hallervorden-Spatz syndrome, Alzheimer's disease, Creutzfeldt-Jakob disease, olivopontocerebellar atrophy, and post-traumatic encephalopathy
* Concurrent dementia with a score of 20 or lower on the MMT rating scale
* Concurrent clinically significant depression with a score of 16 or higher on the MADRS rating scale, equivalent to moderate or severe depression.
* Exposure to neuroleptic drugs blocking dopamine receptors within 6 months
* History of structural brain disease including tumors and hyperplasia
* History of increased intracranial pressure
* Prior surgical procedures or implantation of device for the treatment of PD
* Prior exposure to any formulation of PDGF-BB (including topical)
* Uncontrolled hypertension with blood pressure >160 mmHg systolic or >90 mmHg diastolic.
* Any disorder that precludes a surgical procedure (eg, signs of sepsis or inadequately treated infection), alters wound healing (e.g. including bleeding disorders), or renders chronic ICV delivery or device implants medically unsuitable.
* Presence of risk for increased or uncontrolled bleeding and/or risk of bleeding that is not managed optimally. Physicians should specifically investigate anatomical factors at or near the implant site (e.g., vascular abnormalities, neoplasms, or other abnormalities), underlying disorders of the coagulation cascade, platelet function, or platelet count (e.g., hemophilia, Von Willebrand's disease, liver disease, or other medical conditions), and the administration of any antiplatelet or anticoagulant medication (e.g., aspirin, Plavix, NSAIDs) in the pre- or perioperative period. Any of those conditions or drugs could place a patient at an increased risk for intraoperative or postoperative bleeding.
* Presence of an implanted shunt for the drainage of cerebrospinal fluid (CSF) or an implanted central nervous system (CNS) catheter.
* Presence of cardiac pacemakers, spinal cord stimulators, implantable programmable intraspinal drug pumps, or any other device that may interfere or interact with the programmer, without prior approval by Medtronic.
* Clinically significant abnormalities in hematology or clinical chemistry parameters as assessed by the investigator
* Ongoing medical condition that according to the investigator would interfere with the conduct and assessments in the study. Examples are medical disability (eg, severe degenerative arthritis, compromised nutritional state, peripheral neuropathy) that would interfere with the assessment of safety and efficacy of investigational product or device performance, or would compromise the ability of the subject to undergo study procedures (eg, MRI, PET), or to give informed consent.
* Participation in another clinical trial with an investigational drug or device within 3 months prior to Screening visit.
Sex :
ALL
Ages :
- Minimum Age : 30 Years
- Maximum Age : 75 Years
- Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : ADULT, OLDER_ADULT
Accepts Healthy Volunteers:
No
|
NCT00866502
| 175,008 |
{
"NCT_ID" : "NCT01690676",
"Brief_Title" : "Effect of an Apple Polyphenol Extract on Brachial Artery Flow-mediated Vasodilatory Function",
"Official_title" : "The Effect of an Apple Polyphenol Extract Rich in Epicatechin and Flavan-3-ol Oligomers (Evesse™ EPC) on Brachial Artery Flow-mediated Vasodilatory Function (FMD)in Volunteer Subjects",
"Conditions" : ["Borderline Hypertension"],
"Interventions" : ["Dietary Supplement: Microcrystalline cellulose", "Dietary Supplement: Epicatechin"],
"Location_Countries" : ["Finland"],
"Study_Design" : {
"Study_Type" : "INTERVENTIONAL",
"Phase" : ["PHASE2"],
"Primary_Purpose" : "SUPPORTIVE_CARE",
"Allocation" : "RANDOMIZED",
"Interventional_Model" : "CROSSOVER",
"Masking" : "TRIPLE"
},
"Recruitment_Information" : {
"Study_Start_Date(Actual)" : "2012-08",
"Primary_Completion_Date(Actual)(Final_data_collection_date_for_primary_outcome_measure)" : "2013-05",
"Study_Completion_Date(Actual)" : "2013-05},
"Study_Record_Dates" : {
""Study_Registration_Dates" : {
"First_Submitted" : 2012-09-14",
"First_Posted(Estimated)" : 2012-09-24"
},
"Study_Record_Updates" : {
"Last_Updated_that_Met_QC_Criteria" : 2012-09-19",
"Last_Update_Posted(Estimated)" : 2014-04-08",
"Last_Verified" : 2014-04"
}
}}
|
#Study Description
Brief Summary
Effect of apple polyphenols on FMD.
Detailed Description
The aim of this single centre, repeated-dose, double-blind, placebo-controlled, crossover study is to test the hypothesis that an orally ingested apple polyphenol extract rich in epicatechin and flavan-3-ol oligomers improves brachial artery endothelium-dependent vasodilation function (FMD) in volunteer subjects with borderline hypertension. FMD and endothelium-independent nitrate-mediated vasodilatation (NMD) of the left brachial artery will be investigated with ultrasonography at the start and end of both treatment periods. Biomarkers of vascular function and epicatechin (and metabolite) concentrations will be determined from blood samples taken at the start and end of both treatment periods. Diet diary data will be collected for the evaluation of the possible effects of diet on the study results. Adverse events data will be collected throughout the study. Safety laboratory determinations will be performed at the last visit of both treatment periods.
#Intervention
- DIETARY_SUPPLEMENT : Epicatechin
- DIETARY_SUPPLEMENT : Microcrystalline cellulose
|
#Eligibility Criteria:
Inclusion Criteria:
* Borderline hypertension
* Otherwise healthy
* Aged 40 <= age <= 65 years (inclusive)
* Not consuming high amounts (over 20 mg daily) of flavonoids
Exclusion Criteria:
* BMI >32 kg/m2
* Total serum cholesterol >= 8 mmol/l
* Any abnormal safety laboratory parameter or abnormal finding in ECG evaluated to be clinically significant
* Coronary artery disease
* Pregnancy or lactating
* Alcohol abuse as evaluated by medical history
* Regular smoking/using nicotine products
* Diabetes mellitus
* Apple allergy
* Use of lipid lowering medications
* Regular use of any medication that is known or believed to affect endothelial function or blood vessel constriction
* Any other condition or medication that in the opinion of the investigator would interfere with the evaluation of the study results or constitute a health risk for the subject
* High consumption of vitamin products, herbal remedies or products containing flavonoids
Sex :
ALL
Ages :
- Minimum Age : 40 Years
- Maximum Age : 65 Years
- Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : ADULT, OLDER_ADULT
Accepts Healthy Volunteers:
Yes
|
NCT01690676
| 2,672 |
{
"NCT_ID" : "NCT00643734",
"Brief_Title" : "A Multicenter, Randomized, Double-Blind, Double-Dummy Trial of Azithromycin SR Compared With Levofloxacin for the Treatment of Mild to Moderate Pneumonia in Adult Patients",
"Official_title" : "A Multicenter, Randomized, Double-Blind, Double-Dummy Comparative Trial of Azithromycin SR Versus Levofloxacin for the Treatment of Mild to Moderate Community-Acquired Pneumonia in Adults",
"Conditions" : ["Pneumonia"],
"Interventions" : ["Drug: levofloxacin", "Other: placebo", "Drug: azithromycin sustained release"],
"Location_Countries" : ["India", "Lithuania", "United States", "Mexico", "Chile", "Canada", "Peru", "Russian Federation"],
"Study_Design" : {
"Study_Type" : "INTERVENTIONAL",
"Phase" : ["PHASE3"],
"Primary_Purpose" : "TREATMENT",
"Allocation" : "RANDOMIZED",
"Interventional_Model" : "PARALLEL",
"Masking" : "DOUBLE"
},
"Recruitment_Information" : {
"Study_Start_Date(Actual)" : "2003-04",
"Study_Completion_Date(Actual)" : "2004-04},
"Study_Record_Dates" : {
""Study_Registration_Dates" : {
"First_Submitted" : 2008-03-19",
"First_Posted(Estimated)" : 2008-03-26"
},
"Study_Record_Updates" : {
"Last_Updated_that_Met_QC_Criteria" : 2008-03-19",
"Last_Update_Posted(Estimated)" : 2008-03-26",
"Last_Verified" : 2008-03"
}
}}
|
#Study Description
Brief Summary
The study was performed to see if a single, 2.0-g oral dose of azithromycin sustained release (SR) was at least as effective as a 7-day regimen of levofloxacin (500 mg once daily) for the treatment of mild to moderate community-acquired pneumonia, and to assess the efficacy and safety of both treatment regimens.
#Intervention
- DRUG : azithromycin sustained release
- azithromycin SR 2.0 g by mouth in the form of a slurry for 1 dose
- OTHER : placebo
- placebo
- DRUG : levofloxacin
- 500 mg (two 250 mg capsules) by mouth once daily for 7 days
- OTHER : placebo
- placebo
|
#Eligibility Criteria:
Inclusion Criteria:
Patients with clinical evidence of mild to moderate community-acquired pneumonia, including cough productive of sputum and a diagnosis of pneumonia, were included.
Exclusion Criteria:
Key exclusion criteria were treatment with any systemic antibiotic of greater than one dose or one combination dose within the previous 7 days, previously diagnosed conditions which tend to mimic or complicate the course and the evaluation of the evaluation process (e.g., bronchiectasis, lung abscess or empyema, active tuberculosis, pulmonary malignancy, cystic fibrosis, post-obstructive pneumonia), hospitalization in the previous 14 days or infection acquired in the hospital, and residents of a long-term care facility.
Sex :
ALL
Ages :
- Minimum Age : 18 Years
- Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : ADULT, OLDER_ADULT
Accepts Healthy Volunteers:
No
|
NCT00643734
| 100,607 |
{
"NCT_ID" : "NCT03956186",
"Brief_Title" : "Can Right Toe Perfusion Index or Pleth Variability Index Predict Spinal Anesthesia Induced Hypotension?",
"Official_title" : "Can we Predict Predict Spinal Anesthesia Induced Hypotension During Caesarean Section Using Right Toe Perfusion Index or Pleth Variability Index?",
"Conditions" : ["Cesarean Section Complications", "Hypotension", "Spinal Anesthesia", "Perfusion Index", "Pleth Variability Index"],
"Location_Countries" : ["Turkey"],
"Study_Design" : {
"Study_Type" : "OBSERVATIONAL",
},
"Recruitment_Information" : {
"Study_Start_Date(Actual)" : "2019-05-21",
"Primary_Completion_Date(Actual)(Final_data_collection_date_for_primary_outcome_measure)" : "2019-07-11",
"Study_Completion_Date(Actual)" : "2019-07-11},
"Study_Record_Dates" : {
""Study_Registration_Dates" : {
"First_Submitted" : 2019-05-16",
"First_Posted(Estimated)" : 2019-05-20"
},
"Study_Record_Updates" : {
"Last_Updated_that_Met_QC_Criteria" : 2019-05-17",
"Last_Update_Posted(Estimated)" : 2019-07-24",
"Last_Verified" : 2019-07"
}
}}
|
#Study Description
Brief Summary
Spinal anesthesia for caesarean section is associated with a decrease in systemic vascular resistance and cardiac output and may cause hypotension in a significant portion of the parturients. Hypotension during delivery may cause maternal and fetal complications. If parturients who are likely to develop hypotension after spinal anesthesia can be identified before surgery, anesthesiologists would have opportunity to take measures such as prophylactic vasopressor administration. Perfusion index (PI) measured by pulse oximetry reflects vasomotor tone which affects the degree of hypotension after spinal anesthesia. This is a non-invasive method of assessing the relative vascular tone with the use of pulse oximeter which calculates the ratio of pulsatile versus the non-pulsatile component of the blood flow. A lower PI indicates greater peripheral vasomotor tone. Pleth variability index (PVI) is calculated using maximum and minimum values of perfusion index during respiratory cycles. PVI is one of the dynamic indices that can predict fluid responsiveness. There are several studies investigating the predictive value of finger PI and PVI on hypotension after spinal anesthesia. However the aortocaval compression by the gravid uterus directly effects the lower extremity perfusion. So, in this study we aimed to investigate whether the right toe PI and PVI values at supine and left lateral positions can predict hypotension during caesarean section.
|
#Eligibility Criteria:
Inclusion Criteria:
* singleton parturient
* planned for elective LSCS under spinal anesthesia
Exclusion Criteria:
* gestational age < 36 weeks
* emergency cases
* placenta previa, pre-eclampsia
* BMI>40
* Reynauld disease
* patient refusal
* cardiovascular disease
Sex :
ALL
Ages :
- Minimum Age : 18 Years
- Maximum Age : 45 Years
- Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : ADULT
Accepts Healthy Volunteers:
No
|
NCT03956186
| 81,008 |
{
"NCT_ID" : "NCT01448317",
"Brief_Title" : "Ascending Dose Study of the Safety and Tolerability of Alirocumab (SAR236553/REGN727) in Japanese Healthy Volunteers",
"Official_title" : "A Randomized, Double-Blind, Placebo-Controlled, Ascending Single-Dose Study of the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of Subcutaneously Administered SAR236553 in Japanese Healthy Male Subjects",
"Conditions" : ["Hypercholesterolemia"],
"Interventions" : ["Drug: Alirocumab (Solution)", "Drug: Placebo (Lyophilized formulation)", "Drug: Alirocumab (Lyophilized formulation)", "Drug: Placebo (Solution)"],
"Location_Countries" : ["Japan"],
"Study_Design" : {
"Study_Type" : "INTERVENTIONAL",
"Phase" : ["PHASE1"],
"Primary_Purpose" : "TREATMENT",
"Allocation" : "RANDOMIZED",
"Interventional_Model" : "PARALLEL",
"Masking" : "DOUBLE"
},
"Recruitment_Information" : {
"Study_Start_Date(Actual)" : "2011-05",
"Primary_Completion_Date(Actual)(Final_data_collection_date_for_primary_outcome_measure)" : "2012-01",
"Study_Completion_Date(Actual)" : "2012-01},
"Study_Record_Dates" : {
""Study_Registration_Dates" : {
"First_Submitted" : 2011-09-21",
"First_Posted(Estimated)" : 2011-10-07"
},
"Study_Record_Updates" : {
"Last_Updated_that_Met_QC_Criteria" : 2011-10-05",
"Last_Update_Posted(Estimated)" : 2016-09-28",
"Last_Verified" : 2016-09"
}
}}
|
#Study Description
Brief Summary
Primary Objective:
To assess the safety and tolerability of ascending single doses of subcutaneously (SC) administered alirocumab (SAR236553/REGN727) in Japanese healthy male subjects.
Secondary Objectives:
* To assess the pharmacodynamics effect of a single SC dose of alirocumab on serum low-density lipoprotein cholesterol (LDL-C) and other lipids and apolipoproteins such as total cholesterol, high-density lipoprotein cholesterol (HDL-C), non-high-density lipoprotein cholesterol, very low-density lipoprotein cholesterol, Triglycerides, Apolipoprotein B, Apolipoprotein A1 and Lipoprotein(a).
* To assess the Pharmacokinetic profile of a single SC dose of alirocumab.
* To assess the immunogenicity of a single SC dose of alirocumab.
Detailed Description
4 sequential dose cohorts. Single dose followed by a total observation period of 15 weeks (106 days) for each participant.
#Intervention
- DRUG : Alirocumab (Solution)
- Pharmaceutical form: solution
Route of administration: subcutaneous
- Other Names :
- SAR236553, REGN727
- DRUG : Alirocumab (Lyophilized formulation)
- Pharmaceutical form: lyophilized formulation
Route of administration: subcutaneous
- Other Names :
- SAR236553, REGN727
- DRUG : Placebo (Solution)
- Pharmaceutical form: solution
Route of administration: subcutaneous
- DRUG : Placebo (Lyophilized formulation)
- Pharmaceutical form: lyophilized formulation
Route of administration: Subcutaneous
|
#Eligibility Criteria:
Inclusion Criteria:
* Healthy male subject, between 20 and 65 years inclusive.
* Body weight between 50.0 and 95.0 kg inclusive, body mass index between 18.0 and 30.0 kg/m² inclusive.
* Serum LDL-C levels >100 mg/dL
Exclusion Criteria:
* Subject indicated for the use of statins according to criteria in Adult Treatment Panel (ATP) III Guidelines as updated in 2004
* Significant concomitant illness or history of significant illness such as cardiac, renal, neurological, endocrinological, dermatological, metabolic or lymphatic disease, or any other illness or condition that would adversely affect the subject's participation in this study.
* History or presence of drug or alcohol abuse
* Smoking more than 5 cigarettes or equivalent in any 24 hour period.
* Any medication (including St John's Wort) within 14 days before the inclusion or within 5 times the elimination half-life or pharmacodynamic (PD) half-life of that drug, whichever the longest; any vaccination within the last 28 days.
* Positive reaction to any of the following tests: hepatitis B surface (HBs Ag) antigen, anti-hepatitis B core antibodies (anti-HBc Ab), anti-hepatitis C virus (anti-HCV) antibodies, human immunodeficiency virus (HIV) antigen and antibodies, syphilis.
* Elevated cholesterol due to a secondary cause such as hypothyroidism or alcohol.
* Presence or history of drug hypersensitivity
* Initiation of a new exercise routine or major change to a previous exercise routine within 4 weeks prior to Screening.
* Initiation of a new diet or major change to a previous diet within 4 weeks prior to Screening.
The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.
Sex :
MALE
Ages :
- Minimum Age : 20 Years
- Maximum Age : 65 Years
- Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : ADULT, OLDER_ADULT
Accepts Healthy Volunteers:
Yes
|
NCT01448317
| 260,869 |
{
"NCT_ID" : "NCT04490616",
"Brief_Title" : "TMS Treatment of Social Cognition Skills in Mild Cognitive Impairment",
"Official_title" : "EFFECTS of RTMS TREATMENT on SOCIAL COGNITION DYSFUNCTIONS in MILD COGNITIVE IMPAIRMENT: an PROSPECTIVE, DOUBLE-BINDING, RANDOMIZED, SINGLE CENTRE, EXPLORATIVE STUDY",
"Conditions" : ["Mild Cognitive Impairment"],
"Interventions" : ["Other: rTMS treatment"],
"Location_Countries" : ["Switzerland"],
"Study_Design" : {
"Study_Type" : "INTERVENTIONAL",
"Phase" : ["NA"],
"Primary_Purpose" : "TREATMENT",
"Allocation" : "RANDOMIZED",
"Interventional_Model" : "CROSSOVER",
"Masking" : "DOUBLE"
},
"Recruitment_Information" : {
"Study_Start_Date(Actual)" : "2021-02-11",
"Primary_Completion_Date(Actual)(Final_data_collection_date_for_primary_outcome_measure)" : "2024-02-28",
"Study_Completion_Date(Actual)" : "2024-03-31},
"Study_Record_Dates" : {
""Study_Registration_Dates" : {
"First_Submitted" : 2020-07-10",
"First_Posted(Estimated)" : 2020-07-29"
},
"Study_Record_Updates" : {
"Last_Updated_that_Met_QC_Criteria" : 2020-07-24",
"Last_Update_Posted(Estimated)" : 2025-03-20",
"Last_Verified" : 2023-10"
}
}}
|
#Study Description
Brief Summary
Social cognitive abilities are impaired in around 17% of subjects with mild cognitive impairment (MCI), and might not reflect upon functional status. Compared to healthy controls, MCI showed impairments in theory of mind (ToM) and facial emotion recognition. Moreover, in amnesic MCI patients, reduced ToM ability appears to be correlated with worse performances at several cognitive performances. These findings, in agreement with previous evidence, confirm that impaired social cognition might occur prior to dementia: typically elderly start to show impairment in the complex ToM levels, which is found also in MCI patients and proceeds further in AD patients. Thus, the treatment of these aspects has the potential to influence the trajectory of neurodegeneration. In the last decade, it has been increasingly evident the effectiveness of active stimulation of brain regions with repetitive transcranial magnetic stimulation (rTMS), to improve cognitive and functional performances in patients with dementia.
On the other hand, brain imaging techniques and TMS stimulations have identified two main areas responsible for human social cognition- the medial prefrontal cortex (MPFC) and the right temporo-parietal junction (RTPJ).
In this project, we hypothesized that an improvement of social cognition skills may be obtained in MCI patients by using the rTMS on two main areas responsible for human social cognition- the medial prefrontal cortex (MPFC) and the right temporoparietal junction (RTPJ). Moreover, it expects that rTMS treatment may also contribute to improving cognitive abilities and neuropsychiatric aspects partially modulated by the same networks stimulated.
Detailed Description
This is a prospective, double-binding, cross-sectional, randomized, sham-controlled, and single-center project aimed to investigate the effect of rTMS treatment of social cognition abilities in MCI subjects at 2 and 4 weeks, and after 8 weeks from baseline.
All patients will be recruited at Clinical Neuroscience Institute, Department of Neurology, Regional Civic Hospital, Lugan; Department of Geriatric Italian Hospital Viganello; and Department of Geriatric, Beata Vergine Hospital Mendrisio; Southern Switzerland, Switzerland.
Primary objective:
1. To investigate whether the application of high-frequency rTMS, for 2 or 4 weeks, to the RPTJ and MPFC resulted in social cognitive improvements.
Secondary objectives:
1. To verify whether the social cognition benefits previously recorded might persist after 8 weeks the end of the stimulation, with a major benefit with a longer rTMS application (4 weeks).
2. To investigate whether the application of high-frequency rTMS, at 2 weeks or 4 weeks, to the RPTJ and MPFC contributes to improve cognitive functions as well as neuropsychiatric (depression) and functional aspects.
3. To verify whether the cognitive functions, neuropsychiatric aspect, and functional benefits previously recorded persist after the end of the rTMS stimulation.
Primary analysis: To investigate the behavioral effects induced by the rTMS protocol after 2 and 4 weeks of daily stimulation on social cognition skills, executive/attentive functions, neuropsychiatric and functional aspects will be used a mixed-model ANOVA, considering the group as a between-subjects factor, and time as a within-subject factor.
Secondary Analyses: To investigate the direct or mediated rTMS effect on social cognition skills, a multivariate linear regression analysis will be done for each social cognition measure (ToM, empathy, social perception, social behavior) changes after rTMS treatment at 2 and 4 weeks as the dependent factor, separately, and appropriate screening/baseline dependent variables and rTMS groups as independent factors.
The evaluation and treatment of social cognition alterations in subjects with MCI can be useful for two main aspects: first, the mild cognitive and behavior impairment of these subjects favor a better answer at the treatment, both at the behavioral level and in terms of brain structural and functional response; second, treatment of these abilities in MCI population might retard the conversion to dementia. More importantly, the detection of predominant social cognition alteration in early phases of cognitive decline might be potentially helpful to differentiate individuals who will develop frontotemporal dementia. Therefore, it is important to investigate and define a treatment protocol to limit social cognition disturbances in MCI.
#Intervention
- OTHER : rTMS treatment
- A two-site rTMS stimulation delivered by a Magstim unit featuring a double 70 mm cooled coil will be applied.
MCI patients will be randomly assigned to one of the two study groups:
1. RR-Gr will receive 4 weeks of rTMS stimulation of the right temporo-parietal junction (RTPJ) and medial prefrontal cortex (MPFC);
2. PL-Gr will receive sham stimulation of the RTPJ and MPFC during the first 2 weeks followed by 2 weeks of real stimulation. Each week of rTMS treatment will consist of five sessions (50 min, one per day).
For each area target, a total of 2000 pulses at 20Hz, 3-s train duration, and 28-s inter-train interval at 100% motor threshold (MT) will be delivered per session. A fixed intensity of MT will ensure a more consistent spatial spread of TMS effects in subjects' brains not influenced by differences in individual MT. In the sham condition, a sham coil will be used.
Each session lasted for about 60 min including time for set up and 50 min of stimulation.
|
#Eligibility Criteria:
Inclusion Criteria:
* Subjects aged 50 <= age <= 85 old, inclusive, at the time of informed consent;
* Must have at least 5 years of education or work experience to exclude mental deficits other than MCI;
* Must meet Petersen's criteria for mild cognitive impairment, and must have:
* Clinical dementia rating global score of 0.5;
* Mini-Mental State Examination score between 24 and 30;
* Must have a score >= 26.5 at Token test to ensure that subjects have the ability to understand the instructions and procedures;
* Must have a score < 29 at Beck Depression Inventory to exclude major depression that could compromise the patient's ability to engage in the study;
* Apart from a clinical diagnosis of MCI, the subject must be in good health;
* Must be on stable dose of antidepressant (if applicable) for at least 2 months prior to the enrolment.
Exclusion Criteria:
* Any uncontrolled medical or neurological/neurodegenerative condition (other than MCI);
* Clinical significant unstable psychiatric illness requiring treatment with neuroleptic;
* Transient ischemic attack, stroke, or any unexplained loss of consciousness or severe ongoing stressor within 1 year prior to screening;
* History of seizure within10 years prior to screening;
* Recent history of alcohol or substance abuse or use of cannabinoids;
* Any other medical conditions that are not stable or controlled, or could affect the subject's safety or interfere with the study assessments and treatment;
* Contraindication to having TMS treatment;
* Inability to understand the purpose of the study or to comply with study requirements.
Sex :
ALL
Ages :
- Minimum Age : 50 Years
- Maximum Age : 80 Years
- Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : ADULT, OLDER_ADULT
Accepts Healthy Volunteers:
No
|
NCT04490616
| 95,986 |
{
"NCT_ID" : "NCT01711034",
"Brief_Title" : "A Phase 1, Open-label, Multiple Dose Escalation Trial to Determine Safety and Tolerability of Once Daily OPB-111077 in Subjects With Advanced Cancer",
"Official_title" : "A Phase 1, Open-label, Multiple Dose Escalation Trial to Determine Safety and Tolerability of Once Daily OPB-111077 in Subjects With Advanced Cancer",
"Conditions" : ["Solid Tumors"],
"Interventions" : ["Drug: OPB-111077"],
"Location_Countries" : ["United States"],
"Study_Design" : {
"Study_Type" : "INTERVENTIONAL",
"Phase" : ["PHASE1"],
"Primary_Purpose" : "TREATMENT",
"Allocation" : "NA",
"Interventional_Model" : "SINGLE_GROUP",
"Masking" : "NONE"
},
"Recruitment_Information" : {
"Study_Start_Date(Actual)" : "2012-06",
"Primary_Completion_Date(Actual)(Final_data_collection_date_for_primary_outcome_measure)" : "2015-12",
"Study_Completion_Date(Actual)" : "2015-12},
"Study_Record_Dates" : {
""Study_Registration_Dates" : {
"First_Submitted" : 2012-10-12",
"First_Posted(Estimated)" : 2012-10-22"
},
"Study_Record_Updates" : {
"Last_Updated_that_Met_QC_Criteria" : 2012-10-17",
"Last_Update_Posted(Estimated)" : 2016-04-05",
"Last_Verified" : 2016-04"
}
}}
|
#Study Description
Brief Summary
The primary objective of this study is to determine the safe and tolerable dose level of OPB-111077 for patients with advanced cancer.
Detailed Description
The secondary objective of this study is to investigate the pharmacokinetic properties of OPB-111077; the pharmacodynamic effects of OPB-111077; the antitumor activity of OPB-111077 as assessed by RECIST or IMWG Uniform Response Criteria; and to explore whether PET responses correlate with other measures of clinical response.
#Intervention
- DRUG : OPB-111077
- Dose escalation phase starting with dose of 100mg tablets on Day 1 and 4, and all remaining days of each 28 day cycle until disease progression or toxicity develops.
Dose expansion phase starting with daily dosing of 250mg for 28 day consecutive day cycles.
|
#Eligibility Criteria:
Inclusion Criteria:
* Pathologically and/or cytologically confirmed advanced malignancy that is refractory to standard therapy or for which there are no standard treatment options available
* For oral or intravenous anticancer therapies, at least 4 weeks or 5 half-lives, whichever is shorter, need to have elapsed since the last dose
* Recovery from adverse effects of prior therapy at time of enrollment to
o <= Grade 1 (excluding alopecia)
* Agreement to forego any other chemotherapy, immunotherapy, radiotherapy, or investigational drug while enrolled on this trial except hormonal therapy for prostate cancer or radiotherapy for symptomatic bone metastases known to be present at Screening
* Male or female subjects aged >= 18 years
* ECOG performance status <= 2
* Adequate organ function
* Life expectancy of >= 3 months following trial entry
* For women of childbearing potential, a negative serum pregnancy test result at Screening
* For women of childbearing potential or men whose sexual partners are women of childbearing potential, agreement to use 2 methods of adequate contraception prior to trial entry, for the duration of the trial, and for 90 days after the last dose of trial medication
* Signed and dated IRB-approved informed consent prior to any performance of protocol-specific screening procedures
Exclusion Criteria:
* Uncontrolled concurrent illness, including but not limited to: ongoing or active infection; uncontrolled heart, liver, kidney, or endocrine disorder
* Altered mental status, psychiatric illness, or social situation that would limit compliance with trial requirements and/or obscure trial results
* Immunocompromised state
* Known or evidence of chronic viral hepatitis (hepatitis B or C virus)
* Untreated or symptomatic brain metastasis, or subjects with leptomeningeal disease
* Inability to swallow oral meds or gastrointestinal disorder that might interfere with absorption of oral drugs
* Major surgery within 28 days of first receipt of trial drug
* Nursing or pregnant women
* >= Grade 1 neuropathy with pain or > Grade 2 neuropathy without pain (subjects with neuropathy caused by a previous regimen that is recovered to <= Grade 2 and stable without pain may be included)
* Food-effect sub-study (Part B) only: Pathologies or medical histories that might impair absorption and elimination.
* PET scan sub-study (Part C) only: Uncontrollable blood glucose or intolerance to PET scan procedures.
Sex :
ALL
Ages :
- Minimum Age : 18 Years
- Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : ADULT, OLDER_ADULT
Accepts Healthy Volunteers:
No
|
NCT01711034
| 101,028 |
{
"NCT_ID" : "NCT00304239",
"Brief_Title" : "Metvix PDT Versus Vehicle PDT With Aktilite CL128 Lamp in Patients With Actinic Keratosis on the Face and Scalp",
"Official_title" : "A Multicenter, Double Blind, Vehicle-controlled, Randomized Study of Photodynamic Therapy (PDT) With Metvix 160 mg/g Cream and Aktilite CL128 LED Light in Patients With Multiple Actinic Keratosis on the Face and/or Scalp",
"Conditions" : ["Actinic Keratosis"],
"Interventions" : ["Combination Product: Vehicle-PDT", "Combination Product: Metvix-PDT"],
"Location_Countries" : ["Germany", "United States"],
"Study_Design" : {
"Study_Type" : "INTERVENTIONAL",
"Phase" : ["PHASE3"],
"Primary_Purpose" : "TREATMENT",
"Allocation" : "RANDOMIZED",
"Interventional_Model" : "PARALLEL",
"Masking" : "DOUBLE"
},
"Recruitment_Information" : {
"Study_Start_Date(Actual)" : "2006-03-13",
"Primary_Completion_Date(Actual)(Final_data_collection_date_for_primary_outcome_measure)" : "2007-01-23",
"Study_Completion_Date(Actual)" : "2007-01-23},
"Study_Record_Dates" : {
""Study_Registration_Dates" : {
"First_Submitted" : 2006-03-16",
"First_Submitted_that_Met_QC_Criteria" : 2022-08-03",
"First_Posted(Estimated)" : 2006-03-17"
},
"Study_Record_Updates" : {
"Last_Updated_that_Met_QC_Criteria" : 2006-03-16",
"Last_Update_Posted(Estimated)" : 2023-07-03",
"Last_Verified" : 2022-08"
}
}}
|
#Study Description
Brief Summary
The purpose of this study was to compare the efficacy of Photodynamic Therapy (PDT) with methyl aminolevulinate (MAL) cream to PDT with vehicle cream, using the Light-emitting diode (LED) light source Aktilite CL128, in treatment of participants with multiple actinic keratosis (sun-damaged skin) on the face and/or scalp.
Detailed Description
Actinic keratoses are pre-malignant skin lesions, which may develop to squamous cell carcinomas (SCC). They are usually small, thin, erythematous, de-squamating lesions on light exposed atrophic skin and the lesions are often multiple.
Photodynamic therapy (PDT) is the selective destruction of abnormal cells through light activation of a photosensitiser in the presence of oxygen. These cells accumulate more photosensitiser than normal cells. The photosensitiser generates reactive oxygen species upon illumination.
For skin diseases, such as actinic keratosis (AK), there has been an increasing interest in using topically applied precursors of the photoactive porphyrins (PAP). The most commonly used precursors have been 5-aminolevulinic acid (ALA) and its derivatives. The present test drug contains methyl aminolevulinate, which penetrates the lesions well and shows high lesion selectivity.
Different light sources (i.e. CureLight, Aktilite CL16 and Aktilite CL128) had been used for the activation of PAP, which absorbs light in the range of 400-700 nanometer (nm). The present study used the Aktilite CL 128 lamp. Aktilite 128 was based on LED technology and emits a narrow red light spectrum with an average wavelength of 630 (+/-5) nm. This study was similar to two other studies performed, on which the U.S. approval of Metvixia cream was based except for the light source used. This study was one of two studies performed to document the safety and efficacy of the Aktilite CL 128 lamp when used in combination with Metvixia cream.
Previous studies have shown that the risks attributed to Metvixia PDT are few and related mainly to transient pain and local erythema during and shortly after treatment. These reactions are part of the expected local phototoxicity reaction. PDT offers an advantage to other treatment modalities for actinic keratosis, being a non-invasive treatment available on an outpatient basis. Several separate lesions can be treated simultaneously and the same lesion(s) can be treated repeatedly with success. There are no known systemic toxicity or interaction with other medication. The treatment is also lesion selective, leaving the surrounding tissue intact and functional, also allowing excellent cosmetic results after treatment.
#Intervention
- COMBINATION_PRODUCT : Metvix-PDT
- Metvix 160 mg/g Cream was applied for 3 hours with occlusive dressing, and illumination with non-coherent red light using the Aktilite CL128 lamp, with a total light dose 37 Joule/square centimeter (J/cm²). All eligible lesions on the participant were treated twice with an interval of 1 week between treatments.
- COMBINATION_PRODUCT : Vehicle-PDT
- Vehicle Cream was applied for 3 hours with occlusive dressing, and illumination with non-coherent red light using the Aktilite CL128 lamp, with a total light dose 37 J/cm². All eligible lesions on the participant were treated twice with an interval of 1 week between treatments.
|
#Eligibility Criteria:
Inclusion Criteria:
* Clinical diagnosis of 4 <= age <= 10 previously untreated, not pigmented, non-hyperkeratotic AK lesions of 3 mm or more diameter of Grade 1 and/or 2 of the face and/or scalp where other therapies are unacceptable or considered medically less appropriate.
* Males or females above 18 years.
* Written informed consent.
Exclusion Criteria:
* Participants with porphyria.
* Participants immunosuppressed for idiopathic, disease specific or therapeutic reasons.
* Known allergy to MAL, a similar PDT compound or excipients of the cream.
* Participants with history of hypersensitivity to nut products or other known protein antigens.
* Participation in other clinical studies either currently or within the last 30 days.
* Participants receiving local treatment (including cryotherapy and curretage) in face / scalp area within the last 30 days.
* Participants receiving topical treatment (including imiquimod, 5-FU and diclofenac) in face / scalp area within the last 3 months.
* Pregnant or breast-feeding: All women of child-bearing potential must use adequate contraception (oral contraceptives, intrauterine device, contraceptive skin patch, etc) during the treatment period and one month thereafter. In addition, they must have a negative pregnancy test prior to treatment.
* Any conditions that may be associated with a risk of poor protocol compliance.
* Participants currently receiving regular ultraviolet radiation therapy.
Sex :
ALL
Ages :
- Minimum Age : 18 Years
- Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : ADULT, OLDER_ADULT
Accepts Healthy Volunteers:
No
|
NCT00304239
| 102,603 |
{
"NCT_ID" : "NCT03249038",
"Brief_Title" : "Estimated Blood Loss: Novel Model for Estimating Surgical Blood Loss.",
"Official_title" : "Estimated Blood Loss: Novel Model for Estimating Surgical Blood Loss.",
"Conditions" : ["Blood Loss, Surgical", "Blood Loss", "Blood Loss, Postoperative"],
"Study_Design" : {
"Study_Type" : "OBSERVATIONAL",
},
"Recruitment_Information" : {
"Study_Start_Date(Actual)" : "2017-01-01",
"Primary_Completion_Date(Actual)(Final_data_collection_date_for_primary_outcome_measure)" : "2017-08-01",
"Study_Completion_Date(Actual)" : "2017-09-01},
"Study_Record_Dates" : {
""Study_Registration_Dates" : {
"First_Submitted" : 2017-08-10",
"First_Posted(Estimated)" : 2017-08-15"
},
"Study_Record_Updates" : {
"Last_Updated_that_Met_QC_Criteria" : 2017-08-10",
"Last_Update_Posted(Estimated)" : 2024-10-29",
"Last_Verified" : 2024-10"
}
}}
|
#Study Description
Brief Summary
Estimated blood loss is an important parameter recognized as a standard practice in anesthesiology and others medical specialties, with relevant clinical and research applications. Currently is no model capable of accurately estimate blood loss. The purpose of this study is to evaluate the accuracy of a novel model.
#Intervention
- OTHER : Measurement of external blood loss
- DIAGNOSTIC_TEST : Serum Hemoglobin concentration
|
#Eligibility Criteria:
Inclusion Criteria:
* Patients scheduled for elective urologic laparoscopy surgery.
Exclusion Criteria:
* Patient with suspected or confirmed heart failure, severe hypertension, hepatic cirrhosis, chronic kidney disease on dialysis, coagulopathy, as well as patient receiving diuretics, anticoagulant or antiplatelet agents.
* Cases in which surgical gauzes were used, including conversion to open surgical technique. - Patients who have received transfusions of RBCs during the perioperative period.
* Patients who have showed postoperative bleeding, defined by an amount greater than 50 ml in surgical drains, or any other type of blood loss.
Sex :
ALL
Ages :
- Minimum Age : 18 Years
- Maximum Age : 100 Years
- Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : ADULT, OLDER_ADULT
Accepts Healthy Volunteers:
No
|
NCT03249038
| 188,427 |
{
"NCT_ID" : "NCT01393340",
"Brief_Title" : "Clinical and Biological Effects of Anti-IgE (Omalizumab) in Patients With Bilateral Nasal Polyposis and Asthma",
"Official_title" : "Clinical and Biological Effects of Anti-IgE (Omalizumab) in Patients With Bilateral Nasal Polyposis and Asthma",
"Conditions" : ["Nasal Polyposis", "Asthma"],
"Interventions" : ["Drug: Placebo", "Drug: Omalizumab"],
"Location_Countries" : ["Belgium"],
"Study_Design" : {
"Study_Type" : "INTERVENTIONAL",
"Phase" : ["PHASE2"],
"Primary_Purpose" : "TREATMENT",
"Allocation" : "RANDOMIZED",
"Interventional_Model" : "PARALLEL",
"Masking" : "TRIPLE"
},
"Recruitment_Information" : {
"Study_Start_Date(Actual)" : "2006-12",
"Primary_Completion_Date(Actual)(Final_data_collection_date_for_primary_outcome_measure)" : "2008-10",
"Study_Completion_Date(Actual)" : "2009-12},
"Study_Record_Dates" : {
""Study_Registration_Dates" : {
"First_Submitted" : 2011-07-07",
"First_Posted(Estimated)" : 2011-07-13"
},
"Study_Record_Updates" : {
"Last_Updated_that_Met_QC_Criteria" : 2011-07-11",
"Last_Update_Posted(Estimated)" : 2011-07-13",
"Last_Verified" : 2011-07"
}
}}
|
#Study Description
Brief Summary
This pilot study is a double-blinded, randomized controlled, two-centre trial in which subjects will receive 4 to 8 (subcutaneous administered) doses of medication (Omalizumab or placebo) (dose and dosing interval calculated on body weight and baseline total serum IgE). During the treatment period and follow-up, the clinical efficacy of the treatment will be assessed by evaluation of symptoms, Quality of Life questionnaire, morning Peak Expiratory Flow measurement, smell test, nasal endoscopy, CT-scan, peak nasal inspiratory flow and spirometry. Biological activity will be evaluated by measuring peripheral and local (in serum, in nasal secretions, biopsies) markers of inflammation.
Study hypothesis
1. Evaluation of the efficacy and safety of anti-IgE (Omalizumab) in patients with nasal polyposis and comorbid asthma.
2. Exploration of anti-IgE effects on local and systemic metabolism of IgE in nasal polyposis
3. Clinical assessment of the IgE theory in the pathogenesis of nasal polyps
#Intervention
- DRUG : Omalizumab
- Omalizumab (Xolair(R)) is a recombinant DNA-derived humanized IgG1 monoclonal antibody that selectively binds to human IgE. Molecular weight is approximately 149 kilodaltons. Xolair(R) is a sterile, white, preservative-free, lyophilized powder contained in a single-use vial, reconstituted with Sterile Water For Injection (SWFI), and administered as subcutaneous (SC) injection.
Xolair(R) will be administered subcutaneously in a dose of 75 to 375mg every 2 to 4 weeks. Doses (mg) and dosing frequency are determined by total serum IgE level (IU/ml) measured at the start of treatment and body weight (kg). During this 20-week during trial patients will receive 4 or 8 doses of omalizumab.
- DRUG : Placebo
- Placebo
|
#Eligibility Criteria:
Inclusion Criteria:
* Subjects must be at least 18 years, of either gender and any race.
* Subjects must have a diagnosis of bilateral nasal polyps at screening and baseline that have recurred after surgical resection or nasal polyps that are grades 3 or 4 in both nares using the scoring system described in table 5. Bilateral nasal polyposis is defined as sinus symptoms for more than 3 months, bilateral opacity on CT-scan imaging and visible nasal polyps at endoscopy.
Subjects must have a diagnosis of asthma for more than 2 years. Subjects must be in good health, free of any clinically significant disease that would interfere with the study schedule or procedures or compromise his/her safety.
* Subjects must be willing to give informed consent and adhere to visit schedules, medication restrictions, and agree to perform daily diary entries.
* Subjects must be free of any upper respiratory tract infection within two weeks prior to inclusion.
* Clinical laboratory tests must be within normal limits or clinically acceptable for the investigator.
* Non-pregnant women of childbearing potential must use a medically acceptable, adequate form of birth control. This includes: a) hormonal contraceptive as prescribed by a physician (eg, oral combined, hormonal implant, depot injectable); b) medically prescribed Intra-Uterine Device (IUD); c) condom in combination with a spermicide; d) monogamous relationship with a male partner who has had a vasectomy or is using a condom plus spermicide during the study. They must have started this birth control method at least three months prior to screening (with the exception of condom in combination with a spermicide), and they must agree to continue its use for at least 3 months after last dosing. Women of childbearing potential who are not currently sexually active must agree and consent to using a double-barrier method should they become sexually active during the course of this study. Women who are surgically sterilized or are at least one year postmenopausal are considered not to be of childbearing potential. However, all female subjects must have a urine pregnancy test prior to treatment, which must be negative. A monthly-control pregnancy test is requested.
* Male subjects must agree to use an adequate form of birth control from first dosing to at least 3 months after last dosing. They must either agree to use a condom with spermicide or agree to have sexual relations only with women using medically acceptable forms of birth control as described above.
Exclusion Criteria:
* Women must not be pregnant, breast feeding, or premenarcheal.
* Patients younger than 18 years.
* Subjects with history of systemic reactions to the study medication.
* Subjects with prohibited medication at screening without full wash-out period.
* Subjects with acute sinusitis, concurrent nasal infection, or subjects who have had a nasal or upper respiratory tract infection within two weeks of the inclusion are excluded.
* Subjects with cystic fibrosis, primary ciliary's dysfunction or Kartagener's syndrome by history are excluded.
* Subjects must not have ever been diagnosed with a parasitic infection.
* Subjects must not have ever been diagnosed with cancer
* Subjects must not have a medical history of Human Immunodeficiency Virus (HIV) or hepatitis B or C. Testing will not be done at screening.
* Subjects must not have had an acute asthmatic attack requiring admission to a hospital (excluding emergency room visits which resulted in direct discharge without hospitalization) within the four weeks prior to screening.
* Subjects must not have received specific immunotherapy within the previous three months.
Sex :
ALL
Ages :
- Minimum Age : 18 Years
- Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : ADULT, OLDER_ADULT
Accepts Healthy Volunteers:
No
|
NCT01393340
| 65,078 |
{
"NCT_ID" : "NCT02184091",
"Brief_Title" : "Study to Evaluate the Effects of Underlying Renal or Hepatic Dysfunction on the Pharmacokinetics of Nevirapine",
"Official_title" : "An Open-Label, Single Dose Study to Evaluate the Effects of Underlying Renal or Hepatic Dysfunction on the Pharmacokinetics of Nevirapine (VIRAMUNE®)",
"Conditions" : ["Renal Insufficiency", "Hepatic Insufficiency"],
"Interventions" : ["Drug: Nevirapine"],
"Study_Design" : {
"Study_Type" : "INTERVENTIONAL",
"Phase" : ["PHASE1"],
"Primary_Purpose" : "TREATMENT",
"Allocation" : "NON_RANDOMIZED",
"Interventional_Model" : "SINGLE_GROUP",
"Masking" : "NONE"
},
"Recruitment_Information" : {
"Study_Start_Date(Actual)" : "1999-01",
"Primary_Completion_Date(Actual)(Final_data_collection_date_for_primary_outcome_measure)" : "1999-07",
},
"Study_Record_Dates" : {
""Study_Registration_Dates" : {
"First_Submitted" : 2014-07-08",
"First_Posted(Estimated)" : 2014-07-09"
},
"Study_Record_Updates" : {
"Last_Updated_that_Met_QC_Criteria" : 2014-07-08",
"Last_Update_Posted(Estimated)" : 2014-07-14",
"Last_Verified" : 2014-07"
}
}}
|
#Study Description
Brief Summary
Study to assess the effects of varying degrees of renal dysfunction and hepatic insufficiency on the single-dose pharmacokinetics of nevirapine and nevirapine metabolites in order to establish an appropriate dose and/or dosing frequency for renally- and hepatically-impaired patients
#Intervention
- DRUG : Nevirapine
|
#Eligibility Criteria:
Inclusion Criteria:
* Male or female patients of any race between the ages of 18 and 75 years with weight within 30% of normal for gender, height and frame as specified by the Metropolitan Life Insurance Table
* For patients in the renal group: stable creatinine clearance based on two estimations taken at least 3 days apart, corresponding to one of four groups:
* Group 1 (mild dysfunction) = 50 ml/min <= Creatinine Clearance (CLcr) < 80 ml/min
* Group 2 (moderate dysfunction) = 30 ml/min <= CLcr < 50 ml/min
* Group 3 (severe dysfunction) = CLcr < 30 ml/min and
* Group 4 = end-stage renal disease (ESRD) requiring dialysis
* For patients in the hepatic group
* Two baseline creatinine clearances (taken at least 3 days apart) > 80 ml/min
* clinically diagnosed with hepatic insufficiency and Class A or B liver disease according to Child-Pugh's Classification; subjects must have a Child-Pugh score of 5 <= age <= 9 points
* For patients in the normal group, i.e. normal with respect to hepatic and renal function
* matched with hepatic group regarding gender, age (+- 10 years), weight (+- 30 pounds) and smoking history
* Two baseline creatinine clearances (taken at least 3 days apart) > 80 ml/min
* No abnormalities on clinical or laboratory evaluations
* Female patients of childbearing potential must be willing to use a reliable form of contraception which must include a medically approved form of barrier contraception
* Patients who are able to provide written consent and comply with study requirements
Exclusion Criteria:
* Female patients who are pregnant or breast-feeding
* Seated systolic blood pressure either < 100 mmHg or > 150 mmHg and/or heart rate either < 50 beats/min or > 90 beats/min
* History of any illness or drug allergy that in the opinion of the investigator might confound the results of the study or pose additional risk in administering nevirapine to the subject
* Patients who have had an acute illness or hospitalization other than for routine dialysis within 2 weeks prior to study initiation
* Patients who are currently taking any over-the-counter drug within 3 days prior to study initiation, or who are currently taking any prescription drug that in the opinion of the investigator in consultation with Boehringer Ingelheim Pharmaceuticals Incorporated (BIPI) medical monitor and pharmacokineticist might interfere with the absorption, distribution or metabolism on the test drug
* Significant electrocardiogram (ECG) abnormalities
Sex :
ALL
Ages :
- Minimum Age : 18 Years
- Maximum Age : 75 Years
- Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : ADULT, OLDER_ADULT
Accepts Healthy Volunteers:
No
|
NCT02184091
| 46,930 |
{
"NCT_ID" : "NCT05575687",
"Brief_Title" : "Brain and Glycemic Responses to Sweet Soft Drinks",
"Official_title" : "Brain and Glycemic Responses to Soft Drinks With Different Sweeteners",
"Conditions" : ["Normal Physiological Response to Sweet Drinks"],
"Interventions" : ["Other: Monk fruit", "Other: Allulose + stevia", "Other: Sucrose", "Other: Water (reference)", "Other: Sucralose", "Other: Stevia"],
"Location_Countries" : ["Netherlands"],
"Study_Design" : {
"Study_Type" : "INTERVENTIONAL",
"Phase" : ["NA"],
"Primary_Purpose" : "BASIC_SCIENCE",
"Allocation" : "RANDOMIZED",
"Interventional_Model" : "CROSSOVER",
"Masking" : "TRIPLE"
},
"Recruitment_Information" : {
"Study_Start_Date(Actual)" : "2023-01-09",
"Primary_Completion_Date(Actual)(Final_data_collection_date_for_primary_outcome_measure)" : "2024-03-15",
"Study_Completion_Date(Actual)" : "2024-03-15},
"Study_Record_Dates" : {
""Study_Registration_Dates" : {
"First_Submitted" : 2022-10-04",
"First_Posted(Estimated)" : 2022-10-12"
},
"Study_Record_Updates" : {
"Last_Updated_that_Met_QC_Criteria" : 2022-10-07",
"Last_Update_Posted(Estimated)" : 2024-04-01",
"Last_Verified" : 2024-03"
}
}}
|
#Study Description
Brief Summary
The goal of this observational study is to determine changes in brain activity and blood sugar in response to the ingestion of flavored waters sweetened with either the nutritive sugar sucrose or different low-caloric sweeteners in healthy normal-weight individuals aged between 18 and 30 years.
The main question it aims to answer is in how far brain and glycemic responses differ between a sugar-sweetened drink and drinks sweetened with different low-caloric sweeteners.
Participants will visit after an overnight fast six times and then have an MRI brain scan before and after consumption of 500 ml of one of the study drinks (beverage sweetened with sucrose or one of four non-caloric sweeteners, or water).
Detailed Description
Rationale: The brain is crucial in the regulation of energy intake and maintaining homeostasis which is subserved by an interaction of homeostatic and reward-related brain areas. These brain areas integrate multiple neural and hormonal signals related to energy content such as sweet taste and food reward in the form of ingested energy. Sugar-sweetened soft drinks have been shown to contribute to overconsumption and obesity. Therefore, there is great consumer interest in drinks with low-caloric sweeteners because they do not contribute to energy intake while still providing the hedonic experience of sweet taste. However, different low-caloric sweeteners may have differential effects on the brain because of (subliminal) taste difference and their different metabolic fate. We hypothesize that the brain and glycemic responses to drinks sweetened with sugar and different low-caloric sweeteners will be different. This may have implications for their reward value.
Objective: To determine changes in brain activity in response to the ingestion of flavored waters sweetened with either the nutritive sugar sucrose or different low-caloric sweeteners.
Study design: Randomized crossover design with six treatments. Study population: 30 healthy, non-smoking, normal-weight individuals, aged between 18 and 30 years.
Intervention: Participants will be scanned using MRI before and after consumption of six 500-ml drinks: water; water + sucrose; water + sucralose; water + stevia extract; water + allulose + stevia; water + monk fruit extract. Regional cerebral blood flow (rCBF) and resting state functional MRI (rsfMRI) scans will be made at baseline and at t=5 and t=30 min. Additionally, gastric emptying of the drinks will be examined through gastric MRI at t=15, 25 and 45 min. Blood samples will be collected to measure changes in insulin and glucose levels at baseline and at t=5, 15, 30, 45 and 60 min for all sweet treatments. Participants will rate their appetite and thirst at baseline and at t=15, 25, 30, 45 and 60 min.
#Intervention
- OTHER : Water (reference)
- Ingestion of 500 ml mineral water
- OTHER : Sucrose
- Ingestion of 500 ml of a flavored mineral water sweetened with sucrose
- OTHER : Sucralose
- Ingestion of 500 ml of a flavored mineral water sweetened with sucralose
- OTHER : Stevia
- Ingestion of 500 ml of a flavored mineral water sweetened with stevia extract
- OTHER : Monk fruit
- Ingestion of 500 ml of a flavored mineral water sweetened with monk fruit extract
- OTHER : Allulose + stevia
- Ingestion of 500 ml of a flavored mineral water sweetened with allulose and stevia extract
|
#Eligibility Criteria:
Inclusion Criteria:
* Age between 18 and 30 years
* BMI between 18.5 and 25 kg/m2
* Apparently healthy (self-reported)
* Right-handed (because brain responses may differ between right- and left handed individuals)
* Sufficient blood hemoglobin (Hb) levels (women > 7,5; men > 8.5 g/dl) and having antecubital veins suitable for blood sampling via a catheter
* Willing to comply with the study procedures
* Willing to be informed about incidental findings of pathology and consenting to informing their general practitioner about this.
Exclusion Criteria:
* Having disturbances of glucose metabolism such as being prediabetic or diabetic
* Use of medication that could influence study results including insulin/metformin/proton pump inhibitors, antacids, anti-depressants
* Allergy or intolerance for any of the study products/compounds (sucrose, sucralose, stevia extract, allulose, monk fruit extract)
* Being a regular smoker (smoking more than one cigarette or e-cigarette with nicotin per day)
* Drinking more than 14 glasses of alcohol a week
* Having genetic, psychiatric or neurological diseases affecting the brain
* Gastric disorders or regular gastric complaints (more than once per week), for example heart burn
* Having renal or hepatic disease
* Using recreational drugs more than once per week (e.g. marihuana, XTC, GHB, laughing gas)
* Having given a blood donation in the past two months
* Being pregnant, lactating or planning on becoming pregnant during the study
* Currently following or having followed calorie-restricted diet in the past two months
* Participating in other research during the study period
* Not having a general practitioner
* Being an employee or student of the Division of Human Nutrition and Health
* Having a contra-indication to MRI scanning
Sex :
ALL
Ages :
- Minimum Age : 18 Years
- Maximum Age : 30 Years
- Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : ADULT
Accepts Healthy Volunteers:
Yes
|
NCT05575687
| 217,327 |
{
"NCT_ID" : "NCT00781092",
"Brief_Title" : "A Prospective, Randomized, Double-Masked, Single Center, Clinical Comparison of the Use of Systane Ultra in the Management of Dry Eyes in Bilateral Eyes",
"Official_title" : "A Prospective, Randomized, Double-Masked, Single Center, Clinical Comparison of the Use of Systane Ultra in the Management of Dry Eyes in Bilateral Eyes",
"Conditions" : ["Dry Eye"],
"Interventions" : ["Other: Bausch and Lomb Sensitive Eyes", "Other: Systane Ultra"],
"Study_Design" : {
"Study_Type" : "INTERVENTIONAL",
"Phase" : ["PHASE4"],
"Primary_Purpose" : "TREATMENT",
"Allocation" : "RANDOMIZED",
"Interventional_Model" : "PARALLEL",
"Masking" : "DOUBLE"
},
"Recruitment_Information" : {
"Study_Start_Date(Actual)" : "2008-10",
"Primary_Completion_Date(Actual)(Final_data_collection_date_for_primary_outcome_measure)" : "2009-03",
"Study_Completion_Date(Actual)" : "2009-03},
"Study_Record_Dates" : {
""Study_Registration_Dates" : {
"First_Submitted" : 2008-10-27",
"First_Posted(Estimated)" : 2008-10-28"
},
"Study_Record_Updates" : {
"Last_Updated_that_Met_QC_Criteria" : 2008-10-27",
"Last_Update_Posted(Estimated)" : 2012-09-20",
"Last_Verified" : 2012-09"
}
}}
|
#Study Description
Brief Summary
The primary objective of this study is to compare two post operative drop regimens for the management of dry eye and control of healing using FDA-approved ophthalmic solutions.
Detailed Description
This comparison will be made between bilateral eyes of the same patient following excimer laser ablation using the FDA-approved LADARVision 4000 Excimer Laser System or the WaveLight ALLEGRETTO WAVE™ Excimer Laser System. Post operative questionnaires regarding the use of the drops will be compared. Tear osmolarity and tear breakup time will be evaluated using Tear Lab and OQAS II.
#Intervention
- OTHER : Systane Ultra
- Ophthalmic Solution, 1 gtt, three times daily to both eyes for 1 month post operative
- Other Names :
- Natural Tears
- OTHER : Bausch and Lomb Sensitive Eyes
- Ophthalmic Solution, 1 gtt, three times a day in both eyes for 1 month after LASIK
- Other Names :
- Saline Solution
|
#Eligibility Criteria:
Inclusion Criteria:
* Subjects must be a suitable candidate for FDA Approved LASIK.
* Subjects must have a stable refraction as documented by previous clinical records.
* Subjects who wear soft contact lenses must discontinue wear at least 3 days prior to preoperative exam or surgery.
* Subjects who wear gas permeable contact lenses must discontinue wear at least 3 weeks prior to preoperative exam or surgery.
* Subjects must be at least 18 years.
* Subjects must be willing and able to return for scheduled follow up examinations each day after surgery at the specified time.
* Subjects must sign and be given a copy of the written Informed Consent form.
Exclusion Criteria:
* Subjects for whom either eyes do not meet all inclusion criteria and either eye meets any exclusion criteria.
* Subjects with clinically significant dry eye syndrome or clinically significant blepharitis in either eye.
* Subjects with clinically significant anterior segment pathology, including clinically significant cataracts, corneal scarring or neovascularization in either eye.
* Subjects who have undergone previous intraocular or corneal surgery of any kind, including any type of surgery for either refractive or therapeutic purposes in either eye.
* Subjects who have a history of Herpes zoster or Herpes simplex keratitis.
* Subjects on chronic systemic corticosteroid or other immunosuppressive therapy that may affect wound healing, any immunocompromised subjects, and subjects with clinically significant atopic disease, connective tissue disease, or uncontrolled diabetes.
* Subjects with a history of steroid-responsive rise in intraocular pressure, glaucoma, or preoperative IOP>25 mm Hg in either eye.
* Subjects with macular pathology in either eye.
* Subjects who are pregnant, lactating, or planning to be pregnant during the course of the study.
* Subjects with known sensitivity to planned study concomitant medications.
* Subjects participating in any other ophthalmic drug or device clinical trial during the time of this clinical investigation.
* Use of ocular drugs, other than study medications, during the study and within 30 days prior to study entry or any other ocular medication.
Sex :
ALL
Ages :
- Minimum Age : 18 Years
- Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : ADULT, OLDER_ADULT
Accepts Healthy Volunteers:
Yes
|
NCT00781092
| 74,892 |
{
"NCT_ID" : "NCT02700009",
"Brief_Title" : "Computer-assisted Cognitive-Behavior Therapy for Depression in Primary Care",
"Official_title" : "Dissemination of Computer-assisted Cognitive-behavior Therapy for Depression in Primary Care",
"Conditions" : ["Depression"],
"Interventions" : ["Other: Treatment as Usual (TAU)", "Behavioral: Computer-assisted CBT (CCBT)"],
"Location_Countries" : ["United States"],
"Study_Design" : {
"Study_Type" : "INTERVENTIONAL",
"Phase" : ["NA"],
"Primary_Purpose" : "TREATMENT",
"Allocation" : "RANDOMIZED",
"Interventional_Model" : "PARALLEL",
"Masking" : "NONE"
},
"Recruitment_Information" : {
"Study_Start_Date(Actual)" : "2016-05",
"Primary_Completion_Date(Actual)(Final_data_collection_date_for_primary_outcome_measure)" : "2020-12",
"Study_Completion_Date(Actual)" : "2020-12},
"Study_Record_Dates" : {
""Study_Registration_Dates" : {
"First_Submitted" : 2016-02-25",
"First_Posted(Estimated)" : 2016-03-07"
},
"Study_Record_Updates" : {
"Last_Updated_that_Met_QC_Criteria" : 2016-03-01",
"Last_Update_Posted(Estimated)" : 2025-03-17",
"Last_Verified" : 2025-03"
}
}}
|
#Study Description
Brief Summary
Computer-assisted cognitive-behavior therapy, a treatment that has been shown to be effective in previous studies in psychiatric settings, will be disseminated into primary care - a health care setting where there are significant problems in receiving adequate treatment for depression. Computer-assisted cognitive-behavior therapy will feature a low-cost method of delivering therapy designed to be replicated and sustained in other primary care settings. Feasibility and effectiveness will be tested by randomly assigning 320 primary care patients with depression to receive either computer-assisted cognitive-behavior therapy or treatment as usual.
Detailed Description
Computer-assisted cognitive-behavior therapy (CCBT) for depression in primary care will be evaluated in a trial with 320 patients randomly assigned to CCBT or treatment as usual (TAU). The study will disseminate a therapy method found to be effective in psychiatric settings into primary care - a setting where there have been significant problems in delivery of adequate, evidence-based treatment for depression. The study will include a high percentage of disadvantaged patients - a population that has been largely ignored in previous research in CCBT. There have been no previous studies of CCBT for depression in primary care that have enrolled large numbers of disadvantaged patients. The form of CCBT used in this study is designed to increase access to effective therapy, provide a cost-effective method, and be a sustainable model for wide-spread use in primary care.
In order to deliver therapy in a practical manner that can be replicated in other primary care practices, patients with significant symptoms of depression will receive treatment with an empirically supported computer program that builds cognitive-behavior therapy skills. Support for CCBT will be provided by telephone and/or e-mail contact with a care coordinator instead of the face-to-face treatment with a cognitive-behavior therapist that has been a part of CCBT delivery in mental health settings. Novel features of this treatment program include: 1) fully detailed and replicable method for integrating clinician support with CCBT in primary care; 2) delivery of CCBT to a population with high percentage of disadvantaged patients; 3) integration of CCBT into the primary care delivery model; 4) highly interactive, multimedia computer program with adaptations for persons who may have lower levels of education or computer experience; 5) advanced cost-benefit analysis including data on actual health care utilization and costs; 6) exploration of moderators and predictors of treatment outcome.
Outcome will be assessed by measuring CCBT completion rate, comprehension of CBT concepts, and satisfaction with treatment; in addition to ratings of depressive symptoms, negative thoughts, and quality of life. The cost-effectiveness analysis and exploration of possible predictors of outcome should help clinicians, health care organizations, and others plan further dissemination of CCBT in primary care.
#Intervention
- BEHAVIORAL : Computer-assisted CBT (CCBT)
- Computer-assisted psychotherapy for depression using a computer program plus clinician support
- OTHER : Treatment as Usual (TAU)
- Ordinary treatment for depression in primary care setting
|
#Eligibility Criteria:
Inclusion Criteria:
* Patient Health Questionnaire score of 10 or above
* Age 18 or above
Exclusion Criteria:
* Refusal to provide informed consent
* Inability to read English text on computer screen
* Significant suicidal thoughts, intent, plan, or behavior reported on Columbia Suicide Severity Rating Scale
* Severe or poorly controlled medical disorders that would interfere with participation in CCBT (e.g., liver failure, terminal cancer)
* Dementia or other organic brain disorders that would prevent participation in CCBT
* Diagnosis of any psychotic disorder or bipolar disorder.
Sex :
ALL
Ages :
- Minimum Age : 18 Years
- Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : ADULT, OLDER_ADULT
Accepts Healthy Volunteers:
No
|
NCT02700009
| 211,106 |
{
"NCT_ID" : "NCT04139811",
"Brief_Title" : "Evaluation of Visual Functions After Pars Plana Vitrectomy With and Without Internal Limiting Membrane Peeling in RRD",
"Official_title" : "Evaluation of Primary Internal Limiting Membrane Peeling in Cases of Rhegmatogenous Retinal Detachment",
"Conditions" : ["Retinal Detachment"],
"Interventions" : ["Other: Pars Plana Vitrectomy"],
"Location_Countries" : ["Egypt"],
"Study_Design" : {
"Study_Type" : "INTERVENTIONAL",
"Phase" : ["NA"],
"Primary_Purpose" : "TREATMENT",
"Allocation" : "NON_RANDOMIZED",
"Interventional_Model" : "PARALLEL",
"Masking" : "SINGLE"
},
"Recruitment_Information" : {
"Study_Start_Date(Actual)" : "2017-03-15",
"Primary_Completion_Date(Actual)(Final_data_collection_date_for_primary_outcome_measure)" : "2019-07-15",
"Study_Completion_Date(Actual)" : "2019-08-15},
"Study_Record_Dates" : {
""Study_Registration_Dates" : {
"First_Submitted" : 2019-09-24",
"First_Posted(Estimated)" : 2019-10-25"
},
"Study_Record_Updates" : {
"Last_Updated_that_Met_QC_Criteria" : 2019-10-23",
"Last_Update_Posted(Estimated)" : 2019-10-25",
"Last_Verified" : 2019-10"
}
}}
|
#Study Description
Brief Summary
Internal limiting membrane peeling is performed during vitrectomy for macular diseases such as macular holes, macular edema due to diabetic retinopathy and retinal vein occlusion.
The incidence of epiretinal membrane formation after vitrectomy for rhegmatogenous detachment has been reported to range from 4.4% to 12.8%.
In this study, the efficacy and safety of internal limiting membrane peeling will be studied in vitrectomy for rhegmatogenous retinal detachment and if it is essential to peel it in those cases or not.
Detailed Description
interventional observational study comparing vitrectomy with versus without internal limiting membrane peeling in cases of rhegmatogenous retinal detachment.
#Intervention
- OTHER : Pars Plana Vitrectomy
- vitrectomy with and without ILM peeling
|
#Eligibility Criteria:
Inclusion Criteria:
* All eyes with recent macula-off rhegmatogenous retinal detachment (RRD).
Exclusion Criteria:
* Complicated cases with advanced proliferative vitreoretinopathy (PVR).
* Patients with retinal vascular disorders and other macular disorders.
* Combined tractional and rhegmatogenous detachment.
* Previous retinal reattachment surgery or Intravitreal injections.
* Glaucomatous patients.
* Patients with corneal opacity which impairs good visualization.
Sex :
ALL
Ages :
- Minimum Age : 20 Years
- Maximum Age : 73 Years
- Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : ADULT, OLDER_ADULT
Accepts Healthy Volunteers:
No
|
NCT04139811
| 257,686 |
{
"NCT_ID" : "NCT04593095",
"Brief_Title" : "Nurturing and Quiet Intervention: NeuroN-QI",
"Official_title" : "Nurturing and Quiet Intervention (NeuroN-QI) on Preterm Infants' Neurodevelopment and Maternal Stress and Anxiety: Protocol of a Pilot Randomized Clinical Trial",
"Conditions" : ["Neurodevelopment"],
"Interventions" : ["Other: NeuroN-QI"],
"Location_Countries" : ["Canada"],
"Study_Design" : {
"Study_Type" : "INTERVENTIONAL",
"Phase" : ["NA"],
"Primary_Purpose" : "OTHER",
"Allocation" : "RANDOMIZED",
"Interventional_Model" : "PARALLEL",
"Masking" : "DOUBLE"
},
"Recruitment_Information" : {
"Study_Start_Date(Actual)" : "2021-06-01",
"Primary_Completion_Date(Actual)(Final_data_collection_date_for_primary_outcome_measure)" : "2024-06-01",
"Study_Completion_Date(Actual)" : "2024-06-01},
"Study_Record_Dates" : {
""Study_Registration_Dates" : {
"First_Submitted" : 2020-08-25",
"First_Posted(Estimated)" : 2020-10-19"
},
"Study_Record_Updates" : {
"Last_Updated_that_Met_QC_Criteria" : 2020-10-13",
"Last_Update_Posted(Estimated)" : 2025-03-20",
"Last_Verified" : 2023-11"
}
}}
|
#Study Description
Brief Summary
The current state of knowledge reveals that the development of the brain of preterm infants is influenced by specific neonatal experiences during hospitalization, such as environmental sensory stimulation (light and noise), as well as physical and emotional proximity to mothers. However, there is a lack of evidence regarding the benefits that could be associated with the combination of care interventions to improve the health outcomes of preterm infants and their mothers, and in particular the development of the brain of infants during their hospitalization in the neonatal unit. The aim of this pilot study is to assess the feasibility and acceptability of a developmental care intervention including periods of nurturing between mothers and their infant (skin-to-skin contact and auditory stimulation) to promote physical and emotional proximity and a quiet period (controlled light and noise levels and olfactory stimulation in incubators) and to estimate the effect of this intervention on infants' neurodevelopment as well as on maternal stress and anxiety.
#Intervention
- OTHER : NeuroN-QI
- SSC session lasting 2-hr during the day 4 times/wk including a 15-min of auditory stimulation with maternal voice and controlled levels of NICU light and noise followed by a 1-hr quiet period where infants will rest in their incubator/crib with olfactory stimulation and where the control of light and noise levels will be continued.
|
#Eligibility Criteria:
Inclusion Criteria:
Infants:
* born between 26 and 316/7 WGA.
Mothers
* agree to do 4 SSC sessions/week with a 15-minutes period of auditory (reading) stimulation;
* express breast milk for their infant;
* speak, read, or write French or English.
Nurses:
* have at least 6 months of work experience in a NICU;
* speak and read French or English.
Exclusion Criteria:
Infants:
* have birth defects or genetic disorders;
* have an intraventricular hemorrhage > grade II;
* receive nasal respiratory support;
* have been transferred from another hospital.
Mothers:
* are <18 years;
* had a multiparous birth;
* have a physical condition that does not allow SSC;
* abuse substances or alcohol;
* do not intend to breastfeed or give breastmilk.
Sex :
ALL
Ages :
- Minimum Age : 26 Weeks
- Maximum Age : 32 Weeks
- Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : CHILD
Accepts Healthy Volunteers:
Yes
|
NCT04593095
| 125,683 |
{
"NCT_ID" : "NCT05977010",
"Brief_Title" : "Evaluation of GeneXpert HIV-1 as The Gold Standard Test for HIV-1 Viral Load Count",
"Official_title" : "Evaluation of GeneXpert HIV-1 as The Gold Standard Test for HIV-1 Viral Load Count",
"Conditions" : ["HIV"],
"Location_Countries" : ["Indonesia"],
"Study_Design" : {
"Study_Type" : "OBSERVATIONAL",
},
"Recruitment_Information" : {
"Study_Start_Date(Actual)" : "2018-01-08",
"Primary_Completion_Date(Actual)(Final_data_collection_date_for_primary_outcome_measure)" : "2018-01-10",
"Study_Completion_Date(Actual)" : "2018-01-15},
"Study_Record_Dates" : {
""Study_Registration_Dates" : {
"First_Submitted" : 2018-01-11",
"First_Posted(Estimated)" : 2023-08-04"
},
"Study_Record_Updates" : {
"Last_Updated_that_Met_QC_Criteria" : 2023-07-27",
"Last_Update_Posted(Estimated)" : 2023-08-04",
"Last_Verified" : 2023-07"
}
}}
|
#Study Description
Brief Summary
This is a cohort study on HIV-1 patients treated in outpatient and inpatient wards of Tangerang District Hospital. The participant will be interviewed and retrieved for their demographics, treatment history, CD4 and viral load history. Blood will be drawn for HIV-1 viral load examination using Xpert® HIV-1 Viral Load \[Cepheid\], in-house qRT-PCR, and REALTIME HIV-1 VIRAL LOAD \[Abbott\]
Detailed Description
Participant candidate will be screened at Tangerang District Hospital's outpatient and inpatient units. The purpose is to get various VL values from participants with various clinical conditions (light-heavy). If a participant is willing to participate and has signed the Informed Consent Form (ICF), he/she will be interviewed for demographic data and case history (age, gender, first HIV diagnosis). After that, the participant will be physically examined (height, weight, and vital signs). Other information, such as current HIV clinical stage, current ART regimen, Viral Load value (final and highest), and CD4 (final and lowest) are collected from participant's medical records.
The participant's blood will be drawn as much as 9 ml and will be processed to obtain plasma. Plasma will be aliquoted into 3 vials for VL test using 3 devices: 1 ml using Xpert HIV-1, 1 ml using PCR (Abbott) at Dharmais Hospital, and 1 ml or leftover plasma using PCR (ABI7500) at INA-RESPOND's reference laboratory. The process follows the manufacturer's manual or the standard of sample preparation procedure and the operation of the devices at each hospital.
The result of viral load measurement will be informed to the participant via the attending physician during the participant's routine HIV treatment visit to the hospital.
|
#Eligibility Criteria:
Inclusion Criteria:
* HIV positive patient by the HIV Diagnoses Guideline in the Tangerang District Hospital.
* Patient older than 18 years and above.
* Willing and signed the informed consent (ICF).
* Willing to comply with the study procedures.
Exclusion Criteria:
* Suffered from a disease or having condition that could complicated the blood drawing process or increasing the risk of disease complications.
* Currently imprisoned.
Sex :
ALL
Ages :
- Minimum Age : 18 Years
- Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : ADULT, OLDER_ADULT
Accepts Healthy Volunteers:
No
|
NCT05977010
| 8,125 |
{
"NCT_ID" : "NCT05433233",
"Brief_Title" : "Effects of Lifestyle Walking on Blood Pressure in Older Adults With Hypertension",
"Official_title" : "Effects of Lifestyle Walking on Blood Pressure in Older Adults With Hypertension",
"Conditions" : ["Hypertension", "Aging"],
"Interventions" : ["Behavioral: Walking", "Other: HAPA Behavior Change Counseling"],
"Location_Countries" : ["United States"],
"Study_Design" : {
"Study_Type" : "INTERVENTIONAL",
"Phase" : ["NA"],
"Primary_Purpose" : "PREVENTION",
"Allocation" : "RANDOMIZED",
"Interventional_Model" : "PARALLEL",
"Masking" : "NONE"
},
"Recruitment_Information" : {
"Study_Start_Date(Actual)" : "2020-09-09",
"Primary_Completion_Date(Actual)(Final_data_collection_date_for_primary_outcome_measure)" : "2021-03-22",
"Study_Completion_Date(Actual)" : "2021-03-22},
"Study_Record_Dates" : {
""Study_Registration_Dates" : {
"First_Submitted" : 2022-06-21",
"First_Posted(Estimated)" : 2022-06-27"
},
"Study_Record_Updates" : {
"Last_Updated_that_Met_QC_Criteria" : 2022-06-21",
"Last_Update_Posted(Estimated)" : 2022-06-30",
"Last_Verified" : 2022-06"
}
}}
|
#Study Description
Brief Summary
Eight out of ten older adults have hypertension in the US, which is a strong risk factor for cardiovascular events. To manage hypertension, regular and structured exercise is effective and strongly recommended regardless of drug therapy. However, structured exercise is often performed in a health club, could be difficult, and warrants caution in older adults with chronic conditions. In contrast, the most common lifestyle physical activity in older adults is walking, which is inexpensive, easy, and safe. Recent technological advancement in activity monitoring provides reliable step counts and promotes lifestyle walking. Although one of the most popular public health goals is walking 10,000 steps/day, recent studies found that it is unrealistic and difficult to achieve. Further, there is very little evidence whether walking 10,000 steps/day is effective, specifically in older adults with hypertension. Walking 3,000 extra steps/day 5 days/week is equivalent to meeting the current aerobic physical activity guidelines, as it takes about 30 minutes each day, and is more realistic and achievable. Steps/day is easy to understand and captures most physical activities in older adults. However, there are no specific guidelines about how many daily steps are needed for older adults in the current physical activity guidelines. Thus, this project is aimed to provide pilot data to answer a simple, but unknown, question about physical activity in older adults: 'Can increasing lifestyle walking in older adults with hypertension reduce blood pressure? And can older adults maintain a lifestyle walking intervention on their own?'. This project will significantly contribute to developing more effective and easy physical activity guidelines for older adults.
Detailed Description
All participants will be prescribed a step goal to increase their walking by 3,000 steps/day on 5 days/week for 20 weeks. During the first 10 weeks, support will be provided by research personnel to actively help obtain these goals. During weeks 11-20, participants will be in a self-maintenance phase where no research personnel assistance will be provided to help maintain the extra walking. Participants will log their steps every day during the 20-weeks from a pedometer that they will wear daily. Participants will assess blood pressure and weight at baseline, 10 and 20 weeks.
#Intervention
- BEHAVIORAL : Walking
- Participants will perform 3,000 additional steps/day on 5 days/week.
- OTHER : HAPA Behavior Change Counseling
- Structured dialogue for initiating behavior change.
|
#Eligibility Criteria:
Inclusion Criteria:
* Men and women aged 65+
* Systolic/diastolic blood pressure of 130 <= age <= 159/80 <= age <= 99 mmHg. Participants will be allowed to be on blood pressure medication.
* Body mass index of 25 <= age <= 40 kg/m2
* Non-smokers
* Sedentary/inactive individuals: not meeting the current aerobic physical activity guidelines of 150 minutes per week over the past 3 months
* Baseline average daily step count <8,000 steps
Exclusion Criteria:
* Any significant mobility limitation because our intervention requires an increase in 3,000 steps per day, which needs to be achievable by the participant.
* A stroke, myocardial infarction (heart attack) or cancer diagnosis within the last 6 months.
Sex :
ALL
Ages :
- Minimum Age : 65 Years
- Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : OLDER_ADULT
Accepts Healthy Volunteers:
No
|
NCT05433233
| 230,127 |
{
"NCT_ID" : "NCT00165542",
"Brief_Title" : "A-protein Levels in Adult and Pediatric Brain Tumor Patients",
"Official_title" : "Determination of A-Protein Levels in Adult and Pediatric Brain Tumor Patients",
"Conditions" : ["Malignant Childhood Central Nervous System Neoplasm"],
"Interventions" : ["Other: A PROTEIN level"],
"Location_Countries" : ["United States"],
"Study_Design" : {
"Study_Type" : "OBSERVATIONAL",
},
"Recruitment_Information" : {
"Study_Start_Date(Actual)" : "1998-06",
"Primary_Completion_Date(Actual)(Final_data_collection_date_for_primary_outcome_measure)" : "2004-02",
"Study_Completion_Date(Actual)" : "2009-08},
"Study_Record_Dates" : {
""Study_Registration_Dates" : {
"First_Submitted" : 2005-09-12",
"First_Posted(Estimated)" : 2005-09-14"
},
"Study_Record_Updates" : {
"Last_Updated_that_Met_QC_Criteria" : 2005-09-12",
"Last_Update_Posted(Estimated)" : 2016-11-23",
"Last_Verified" : 2016-11"
}
}}
|
#Study Description
Brief Summary
The purpose of this study is to evaluate the sensitivity and specificity of 'A-PROTEIN' levels in patients with brain tumors. A-PROTEIN levels will be analyzed both pre and post treatment. Levels in blood and/or cerebrospinal fluid (CSF) will be analyzed and correlated with the underlying diagnosis and outcome.
Detailed Description
* Patients will be identified at the time of presentation to their neurologist, neurosurgeon or oncologist.
* Blood or cerebrospinal fluid will be collected for this study only when they are being collected for other reasons before and after each surgery. Samples will also be collected after any event such as significant change in symptoms or radiographic progression.
* Once the patients condition has been stabilized, samples will be take at regular intervals of \>= 1 month. The duration of this study is 24 months.
#Intervention
- OTHER : A PROTEIN level
|
#Eligibility Criteria:
Inclusion Criteria:
* All patients with possible malignant or benign lesions of the central nervous system will be included.
* There are no restrictions with respect to treatment protocols or prior therapy.
* Patients will be identified after presentation to the neurosurgical, neurological or oncologic services at participating centers. Any patient with evidence of a central nervous system tumor will be eligible. Individuals without evidence of CNS tumors are also eligible, in order to provide blinded controls.
* A signed informed consent will be requested and required for participation.
* There is no age, sex, or ethnic origin restrictions in this protocol. Patients who choose not to participate in the study will continue to have their regular care as defined by their treating team. Patients who speak foreign languages are eligible as long a translator can be found to ensure proper consent has been obtained.
Exclusion Criteria: There are no exclusion criteria for this study.
Sex :
ALL
Ages :
- Maximum Age : 77 Years
- Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : ADULT, OLDER_ADULT, CHILD
Accepts Healthy Volunteers:
No
|
NCT00165542
| 203,285 |
{
"NCT_ID" : "NCT05433519",
"Brief_Title" : "Diagnostic Accuracy of a Novel Machine Learning Algorithm to Estimate Gestational Age",
"Official_title" : "Z 32104 - Diagnostic Accuracy of a Novel Machine Learning Algorithm to Estimate Gestational Age",
"Conditions" : ["Gestational Age", "Machine Learning", "Pregnancy Related"],
"Location_Countries" : ["United States", "Zambia"],
"Study_Design" : {
"Study_Type" : "OBSERVATIONAL",
},
"Recruitment_Information" : {
"Study_Start_Date(Actual)" : "2022-07-27",
"Primary_Completion_Date(Actual)(Final_data_collection_date_for_primary_outcome_measure)" : "2023-05-31",
"Study_Completion_Date(Actual)" : "2023-11-13},
"Study_Record_Dates" : {
""Study_Registration_Dates" : {
"First_Submitted" : 2022-06-21",
"First_Posted(Estimated)" : 2022-06-27"
},
"Study_Record_Updates" : {
"Last_Updated_that_Met_QC_Criteria" : 2022-06-21",
"Last_Update_Posted(Estimated)" : 2024-05-08",
"Last_Verified" : 2023-12"
}
}}
|
#Study Description
Brief Summary
This is a prospective cohort study of women enrolled early in pregnancy, with randomization to determine the timing of three follow-up visits in the second and third trimester. At each of these follow-up visits, investigators will assess gestational age with the FAMLI technology and compare that estimate to the known gestational age established early in pregnancy.
Detailed Description
The primary purpose of this research is to assess the diagnostic accuracy of the FAMLI Technology, a novel machine learning-based tool for gestational age assessment that can run on a smart phone or tablet. Study staff will enroll 400 pregnant volunteers prior to 14 completed gestational weeks and obtain accurate 'ground truth' gestational age dating with standard ultrasound biometry, using the crown-rump length. These participants will then be asked to return for three follow-up visits, which will include a routine sonogram performed by a trained sonographer and the collection of a set of blind sweep cineloop videos using a low-cost, battery-operated device. The research will be conducted in Chapel Hill, North Carolina (at the University of North Carolina Hospital and/or sites associated with UNC OBGYN) and in Lusaka, Zambia (at the University Teaching Hospital or Kamwala District Health Centre). Approximately equal numbers of participants will be enrolled from each country.
|
#Eligibility Criteria:
Inclusion Criteria:
* 18 years or older
* viable intrauterine pregnancy at less than 14 0/7 weeks of gestation
* ability and willingness to provide written informed consent
* intent to remain in current geographical area of residence for the duration of study
* willingness to adhere to study procedures
Exclusion criteria:
* maternal body mass index = 40 kg/m^2
* multiple gestation (i.e., twins or higher order)
* major fetal malformation or anomaly
* any other condition (social or medical) that, in the opinion of the study staff, would make study participation unsafe or complicate data interpretation.
Sex :
FEMALE
Ages :
- Minimum Age : 18 Years
- Maximum Age : 59 Years
- Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : ADULT
Accepts Healthy Volunteers:
No
|
NCT05433519
| 189,490 |
{
"NCT_ID" : "NCT04068961",
"Brief_Title" : "New Strategies of Genetic Study of Patients With Oculocutaneous Albinism",
"Official_title" : "New Strategies of Genetic Study of Patients With Oculocutaneous Albinism",
"Conditions" : ["Oculocutaneous Albinism", "Mutation"],
"Study_Design" : {
"Study_Type" : "OBSERVATIONAL",
},
"Recruitment_Information" : {
"Study_Start_Date(Actual)" : "2010-09-15",
"Primary_Completion_Date(Actual)(Final_data_collection_date_for_primary_outcome_measure)" : "2010-10-31",
"Study_Completion_Date(Actual)" : "2010-10-31},
"Study_Record_Dates" : {
""Study_Registration_Dates" : {
"First_Submitted" : 2019-08-22",
"First_Posted(Estimated)" : 2019-08-28"
},
"Study_Record_Updates" : {
"Last_Updated_that_Met_QC_Criteria" : 2019-08-22",
"Last_Update_Posted(Estimated)" : 2019-08-28",
"Last_Verified" : 2019-08"
}
}}
|
#Study Description
Brief Summary
The oculocutaneous albinism is an autosomal recessive condition associated with mutations in 4 genes. In 20% of patients no mutation is identified. The optimization of genetic analysis methods and the search for new genes involved will help improve the diagnosis in these patients.
Detailed Description
The oculocutaneous albinism is an autosomal recessive condition associated with mutations in 4 genes. In 20% of patients no mutation is identified. The optimization of genetic analysis methods and the search for new genes involved will help improve the diagnosis in these patients.
.
#Intervention
- OTHER : Genetic analyzes
- Analysis by CGH array, homozygotic cartography and candidate gene sequencing
|
#Eligibility Criteria:
Inclusion Criteria:
*Oculocutaneous albinism (diagnosis validated by a clinician at the initial genetic consultation and did not show mutations of the TYR, OCA2, TYRP1, SLC45A2 genes)
Exclusion Criteria:
None
Sex :
ALL
Ages :
- Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : ADULT, OLDER_ADULT, CHILD
Accepts Healthy Volunteers:
No
|
NCT04068961
| 235,973 |
{
"NCT_ID" : "NCT03714100",
"Brief_Title" : "Use of Tele-Exercise for Translating an Evidence-Based Fall-Prevention Program for Older Adults in West Virginia",
"Official_title" : "Use of Tele-Exercise as an Alternative Delivery Channel for Translating an Evidence-Based Fall-Prevention Program Into Practice for Older Adults in West Virginia",
"Conditions" : ["Accidental Falls"],
"Interventions" : ["Behavioral: Tai Ji Quan: Moving for Better Balance"],
"Location_Countries" : ["United States"],
"Study_Design" : {
"Study_Type" : "INTERVENTIONAL",
"Phase" : ["NA"],
"Primary_Purpose" : "PREVENTION",
"Allocation" : "NA",
"Interventional_Model" : "SINGLE_GROUP",
"Masking" : "NONE"
},
"Recruitment_Information" : {
"Study_Start_Date(Actual)" : "2018-11-01",
"Primary_Completion_Date(Actual)(Final_data_collection_date_for_primary_outcome_measure)" : "2020-01-31",
"Study_Completion_Date(Actual)" : "2020-01-31},
"Study_Record_Dates" : {
""Study_Registration_Dates" : {
"First_Submitted" : 2018-10-11",
"First_Posted(Estimated)" : 2018-10-22"
},
"Study_Record_Updates" : {
"Last_Updated_that_Met_QC_Criteria" : 2018-10-18",
"Last_Update_Posted(Estimated)" : 2020-10-14",
"Last_Verified" : 2020-10"
}
}}
|
#Study Description
Brief Summary
West Virginia (WV) has a critical need for resources to reach more of its older adults with fall-prevention programming. The Tai Ji Quan: Moving for Better Balance® (TJQMBB) program is an evidence-based, Centers for Disease Control and Prevention (CDC)-approved, community-delivered, physical activity fall-prevention intervention for older adults. The program is efficacious and effective in reducing falls in older adults, and has been translated into clinical and community settings. Programs delivered in one setting; however, may not automatically translate to others.
Using telehealth technology to deliver exercise classes (i.e. tele-exercise) is one alternative to the traditional, face-to-face, group exercise classes where the instructor and participants are in the same room. We propose delivering tele-TJQMBB to older adults using a computer, television, and the internet. This delivery mode will allow us to recruit instructors from any location (e.g., urban areas), and with possibly more experience, yet still reach older adults in communities without instructors.
Detailed Description
West Virginia (WV) has a critical need for resources to reach more of its older adults with fall-prevention programming. The Tai Ji Quan: Moving for Better Balance® (TJQMBB) program is an evidence-based, CDC-approved, community-delivered, physical activity fall-prevention intervention for older adults. The program is efficacious and effective in reducing falls in older adults, and has been translated into clinical and community settings. Programs delivered in one setting; however, may not automatically translate to others. We recently completed a CDC-funded study which successfully translated a 16-week TJQMBB intervention into 20 faith-based organizations in 7 rural WV counties. In the maintenance phase of the study (i.e., post intervention), only 38% of classes continued despite the fact that 87% of participants expressed a desire to continue. The rate limiting factor for continuing classes in these rural areas was lack of instructors. Thus, there is a vital need to further translate TJQMBB into practice using alternative delivery channels to increase the reach and maintenance of the program, especially in rural areas where instructors are less available.
Using telehealth technology to deliver exercise classes (i.e. tele-exercise) is one alternative to the traditional, face-to-face, group exercise classes where the instructor and participants are in the same room. We propose delivering tele-TJQMBB to older adults using a computer, television, and the internet. This delivery mode will allow us to recruit instructors from any location (e.g., urban areas), and with possibly more experience, yet still reach older adults in communities without instructors.
The purpose of this translational study is to work with our injury control, technology, and wellness partners to: 1) implement a 16-week intervention of the tele-TJQMBB classes in 120 older adults at 12 community sites in 4 WV counties; 2) describe functional, self-reported, and fall/injury outcomes; and 3) evaluate the translation of tele-TJQMBB with respect to its Reach into the target population (number of participants), Effectiveness (participant outcomes), Adoption (number of sites, instructors, classes), Implementation (fidelity ratings), and Maintenance (satisfaction, continued participation) using the Re-aim Framework. Demonstrating that tele-TJQMBB is effective would provide an additional delivery channel for the program, help overcome the barrier of identifying instructors in rural areas, and in the future, allow for the number of classes to be expanded to reach more older adults, provide more community-based programs in which to refer older adults to, and enhance overall maintenance of the program. To our knowledge, this is the first study to translate an evidence-based, group, fall-prevention exercise program using an alternative delivery method in a priority population, and thus, may serve as a model for reaching other underserved older adults.
#Intervention
- BEHAVIORAL : Tai Ji Quan: Moving for Better Balance
- Participants will attend one-hour Tai Ji Quan: Moving for Better Balance classes twice a week for 16-weeks. Groups of participants will gather at a local community site that has videoconferencing capabilities. The instructor will be teaching the class from a different location via a live video feed.
- Other Names :
- Tai Chi, Physical Activity, Exercise
|
#Eligibility Criteria:
Inclusion Criteria:
* Adults age 55 and older
* Community-dwelling
* Able to attend 2, 1-hour Tai Ji Quan: Moving for Better Balance classes a week for 16 weeks
* Able to attend 2 testing sessions for data collection (Testing sessions will be scheduled the week before classes begin and the week after the classes end)
* Able to walk at least 2 city blocks with or without an assistive device
Exclusion Criteria:
* Lack reliable transportation
* Unable to speak English
Sex :
ALL
Ages :
- Minimum Age : 55 Years
- Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : ADULT, OLDER_ADULT
Accepts Healthy Volunteers:
Yes
|
NCT03714100
| 256,806 |
{
"NCT_ID" : "NCT03583060",
"Brief_Title" : "Interoceptive Engagement",
"Official_title" : "Interoceptive Engagement in Response to Mindful Awareness in Body-oriented Therapy: A Pilot Test Comparison",
"Conditions" : ["Stress"],
"Interventions" : ["Behavioral: Mindful Awareness in body-oriented therapy"],
"Location_Countries" : ["United States"],
"Study_Design" : {
"Study_Type" : "INTERVENTIONAL",
"Phase" : ["NA"],
"Primary_Purpose" : "BASIC_SCIENCE",
"Allocation" : "RANDOMIZED",
"Interventional_Model" : "PARALLEL",
"Masking" : "SINGLE"
},
"Recruitment_Information" : {
"Study_Start_Date(Actual)" : "2018-05-01",
"Primary_Completion_Date(Actual)(Final_data_collection_date_for_primary_outcome_measure)" : "2018-11-01",
"Study_Completion_Date(Actual)" : "2018-11-01},
"Study_Record_Dates" : {
""Study_Registration_Dates" : {
"First_Submitted" : 2018-06-26",
"First_Posted(Estimated)" : 2018-07-11"
},
"Study_Record_Updates" : {
"Last_Updated_that_Met_QC_Criteria" : 2018-07-09",
"Last_Update_Posted(Estimated)" : 2020-05-13",
"Last_Verified" : 2020-05"
}
}}
|
#Study Description
Brief Summary
The proposed project is the first pilot test to examine interoceptive function as a mechanistic biomarker underlying Mindful Awareness in Body-oriented Therapy (MABT). MABT, an empirically-validated and manualized protocol is explicitly designed to teach interoceptive awareness skills for emotion regulation and is thus an ideal intervention approach in which to address this gap in research. This study uses a two group, randomized design to examine neural and physiological biomarkers in response to MABT. Twenty-four individuals reporting moderate stress will be recruited from the community and randomized to 8-week MABT intervention or the control condition. The study aims are to: 1) evaluate whether interoceptive training improves interoceptive function in the MABT vs control condition, and 2) explore whether changes in interoceptive function correlate with improved health outcomes. Analyses will include within and between-group ANOVA of brain activity with symptom change as a covariate. This is the first study to test whether a clinical intervention aimed specifically at cultivating interoceptive awareness effects change on interoceptive biomarkers. The results will support larger NIH proposals to more comprehensively validate neuro and behavioral biomarkers of interoceptive training to enhance mental health, particularly targeting depression and substance use disorder that have identified interoceptive dysfunction and poor emotion regulation.
#Intervention
- BEHAVIORAL : Mindful Awareness in body-oriented therapy
- teaches interoceptive awareness skills for self care
|
#Eligibility Criteria:
Inclusion Criteria:
* adult (over 18)
* Perceived Stress Scale scores indicating moderate stress levels
* naive to mindfulness-based approaches (no prior experience)
* agrees to forgo (non-study) manual therapies (e.g., massage) and mind-body therapies (e.g., mindfulness meditation) for 3 months (baseline to post-test)
* fluent in English
* can attend MABT and assessment sessions
* right-handed (for uniformity of neuroimaging results)
Exclusion Criteria:
* lifetime diagnosis of mental health disorder
* unable to complete study participation (includes planned relocation, pending inpatient treatment, planned extensive surgical procedures, etc.)
* cognitive impairment, assessed by the Mini-Mental Status Exam (MMSE) if demonstrated difficulty comprehending the consent
* use of medications in the past 30 days that affect hemodynamic response
* lifetime head injuries or loss of consciousness longer than 5 min
* currently pregnant
* contraindications for MRI, e.g., claustrophobia, metal objects in body, etc.
Sex :
ALL
Ages :
- Minimum Age : 18 Years
- Maximum Age : 65 Years
- Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : ADULT, OLDER_ADULT
Accepts Healthy Volunteers:
Yes
|
NCT03583060
| 79,240 |
{
"NCT_ID" : "NCT00210470",
"Brief_Title" : "A Phase 2 Clinical Trial of the Safety and Effects of IRX-2 in Treating Patients With Operable Head and Neck Cancer",
"Official_title" : "A Phase 2, Open-label Trial of the Safety and Biological Effect of Subcutaneous IRX-2 (With Cyclophosphamide, Indomethacin, and Zinc) in Patients With Resectable Cancer of the Head and Neck",
"Conditions" : ["Squamous Cell Carcinoma of the Head and Neck"],
"Interventions" : ["Drug: Indomethacin", "Drug: Cyclophosphamide", "Biological: IRX-2", "Drug: Omeprazole", "Drug: Zinc"],
"Study_Design" : {
"Study_Type" : "INTERVENTIONAL",
"Phase" : ["PHASE2"],
"Primary_Purpose" : "TREATMENT",
"Allocation" : "NA",
"Interventional_Model" : "SINGLE_GROUP",
"Masking" : "NONE"
},
"Recruitment_Information" : {
"Study_Start_Date(Actual)" : "2005-07",
"Primary_Completion_Date(Actual)(Final_data_collection_date_for_primary_outcome_measure)" : "2010-12",
"Study_Completion_Date(Actual)" : "2012-03},
"Study_Record_Dates" : {
""Study_Registration_Dates" : {
"First_Submitted" : 2005-09-13",
"First_Submitted_that_Met_QC_Criteria" : 2012-01-06",
"First_Posted(Estimated)" : 2005-09-21"
},
"Study_Record_Updates" : {
"Last_Updated_that_Met_QC_Criteria" : 2005-09-13",
"Last_Update_Posted(Estimated)" : 2020-12-11",
"Last_Verified" : 2020-12"
}
}}
|
#Study Description
Brief Summary
This was a Phase 2a trial to investigate the safety and biological activity of the RIX-2 Regimen in patients with untreated, resectable squamous cell cancer of the head and neck (HNSCC).
Detailed Description
IRX-2 is a primary cell-derived biologic that reduces the immune suppression that is often seen in the cancer tumor micro-environment, restores immune function and activates a coordinated immune response against the tumor. IRX-2 is a complex proprietary therapeutic containing numerous active cytokine components, which restores and activates multiple immune cell types including T cells, dendritic cells, and natural killer cells to recognize and destroy tumors.
The present study administered the IRX-2 Regimen to 27 patients as a neoadjuvant (before surgery) therapy, and the main objective of the study was to determine the safety and tolerability of the IRX-2 regimen.
#Intervention
- BIOLOGICAL : IRX-2
- IRX-2 for 10 days (2 s.c. injections of 1 mL each day) into bilateral mastoid insertion regions.
- DRUG : Cyclophosphamide
- Single i.v. injection of low-dose (300 mg/m2) on Day 1
- Other Names :
- Cytoxan, cyclophosphane
- DRUG : Indomethacin
- 21 days of oral indomethacin, 25 mg. 3 times daily
- Other Names :
- Indocin, Indocid
- DRUG : Zinc
- 21 days of zinc gluconate (65 mg) as part of an oral multivitamin
- Other Names :
- zinc gluconate
- DRUG : Omeprazole
- 21 days of 20 mg. orally
- Other Names :
- Prilosec
|
#Eligibility Criteria:
Inclusion Criteria:
* Pathologically confirmed (histology) Squamous Cell Carcinoma of the oral cavity, oropharynx, hypopharynx, or larynx.
* No prior surgery, radiation therapy or chemotherapy of this tumor other than biopsy or emergency procedure required for supportive care.
* Clinically staged Stage II, III, or IVA cancer, assessed to be surgically resectable with curative intent.
* Life Expectancy of greater than 6 months
Exclusion Criteria:
* Stage IVB Squamous Cell Carcinoma
* Use of any investigational agent within the previous 30 days
* Uncontrolled cardiovascular disease
* Myocardial infarction within the last 3 months
* Abnormal hemoglobin, neutrophil, lymphocyte or platelet counts
* Positive for hepatitis B or C or HIV
* Evidence of distant metastases
* Clinical gastritis or peptic ulcer within the last 6 months
* Stroke within the last six months
Sex :
ALL
Ages :
- Minimum Age : 18 Years
- Maximum Age : 80 Years
- Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : ADULT, OLDER_ADULT
Accepts Healthy Volunteers:
No
|
NCT00210470
| 164,018 |
{
"NCT_ID" : "NCT01972711",
"Brief_Title" : "Study Assessing SEP-363856 in Male and Female Volunteers With High or Low Schizotype Characteristics",
"Official_title" : "A Randomized, Double-blind, Placebo-controlled, Single-dose, Study of the Effects of SEP 363856 and Amisulpride on BOLD-fMRI Signal in Healthy Male and Female Volunteers With High or Low Schizotype Characteristics.",
"Conditions" : ["Schizophrenia"],
"Interventions" : ["Drug: Placebo", "Drug: Amisulpride", "Drug: SEP-363856"],
"Location_Countries" : ["United Kingdom"],
"Study_Design" : {
"Study_Type" : "INTERVENTIONAL",
"Phase" : ["PHASE1"],
"Primary_Purpose" : "TREATMENT",
"Allocation" : "RANDOMIZED",
"Interventional_Model" : "PARALLEL",
"Masking" : "QUADRUPLE"
},
"Recruitment_Information" : {
"Study_Start_Date(Actual)" : "2014-03",
"Primary_Completion_Date(Actual)(Final_data_collection_date_for_primary_outcome_measure)" : "2015-07",
"Study_Completion_Date(Actual)" : "2015-07},
"Study_Record_Dates" : {
""Study_Registration_Dates" : {
"First_Submitted" : 2013-10-24",
"First_Posted(Estimated)" : 2013-10-30"
},
"Study_Record_Updates" : {
"Last_Updated_that_Met_QC_Criteria" : 2013-10-24",
"Last_Update_Posted(Estimated)" : 2024-06-26",
"Last_Verified" : 2024-06"
}
}}
|
#Study Description
Brief Summary
This study is designed to evaluate the effects of a single dose of SEP-363856 in healthy male and female volunteers with high or low schizotype characteristics.
Detailed Description
The study is a randomized, double-blind, placebo-controlled functional magnetic resonance imaging (fMRI) study of the effects of a single dose of SEP-363856 and amisulpride on blood oxygen level dependent (BOLD) signal in healthy male and female volunteers with high or low schizotype characteristics.
#Intervention
- DRUG : SEP-363856
- SEP-36385625 as a single oral dose of 50 mg
- DRUG : Amisulpride
- Amisulpride as a single oral dose of 400 mg
- DRUG : Placebo
- single oral dose placebo
|
#Eligibility Criteria:
Inclusion Criteria:
* Male or female aged 18 <= age <= 45, inclusive, at Day 1.
* Subject must be healthy as determined by the Investigator, based on a medical evaluation including medical history, physical examination, laboratory tests and cardiac monitoring within four weeks of randomisation. A subject with a clinical abnormality or laboratory parameters outside the reference range for the population being studied may be included only if the Investigator considers that the finding is unlikely to introduce additional risk factors and will not interfere with the study procedures.
* Subject must be normotensive with sitting (5 minutes) blood pressure between the range of 90 to 150 mm Hg systolic, inclusive, and 60 to 90 mm Hg diastolic, inclusive, at Screening.
* Subject must have sitting (5 minutes) heart rate >= 50 beats per minute at Screening.
* Subject must agree to use one of the following birth control/contraception methods from Screening until 90 days after receiving study drug.
* Female subject of child bearing potential (<= 65 years) should be surgically sterile or abstinent or, if sexually active, must use an adequate method of contraception in addition to their partner(s) using a barrier method.
* Male subject with female partner(s) of childbearing potential must take appropriate precautions to avoid fathering a child and use barrier contraception, in addition to their female partner(s) using another method.
* Male subject must not donate sperm.
* Acceptable forms of contraception are as follows:
* Barrier methods: condoms, diaphragms, cervical caps; with a spermicide foam, gel, film, cream or pessary.
* Non-hormone containing intrauterine methods: intrauterine devices or systems.
* Other: prescription oral contraceptives, contraceptive injections, contraceptive implant, contraceptive vaginal ring, hormonal intrauterine device, double-barrier method, contraceptive patch, or male partner sterilisation.
* Subject must have normal ECG results, including QTcF < 450msec (for men) or < 470 ms (for women) (based on the Fridericia correction where QTcF = QT/RR0.33) at Screening.
* Subject must be a completely fluent English speaker who, in the opinion of the Investigator, is capable of completing the fMRI and behavioural tasks.
* Subject must be right-handed.
* Subject must have acceptable weight as defined by BMI (weight [kg]/height [m]²) range of 18 to 35 kg/m², inclusive at Screening.
* Subject must be a non-smoker or light smoker (<= 10 cigarettes per day).
* Subject must have signed the informed consent form prior to the first study-related procedure indicating they understand the purpose of and procedures required for the study and are willing to participate in the study.
* Subject in the low schizotypy group must have an SPQ score < 10 at Screening.
* Subject in the high schizotypy group must have an SPQ score >43 at Screening
Exclusion Criteria:
* Subject with a history of alcohol or substance dependence within the last 12 months from Screening.
* Subject with a positive urine drug screen at Screening or Day 1. One re-test within 1 to 3 days is permitted if positive result is believed to be due to licenced opiate-based medication or ingestion of poppy seeds. In this event, re-test result will be used for assessing entry criterion and must be completed prior to randomisation.
* Subject with a positive alcohol breath test at Screening or Day 1.
* Female subject with a positive pregnancy test at Screening or Day 1.
* Female subject currently pregnant or trying to get pregnant or currently breast feeding.
* Subject who consumes large amounts of caffeinated drinks (more than 8 cups of standard caffeinated drinks (tea, instant coffee) or 6 cups of stronger coffee or other drinks containing methylxanthines such as coca cola or Red Bull per day).
* Subject with a relevant history, or presence upon clinical examination, of cardiac, ophthalmologic, pulmonary, endocrine (diabetes), blood disease, gastro-intestinal, hepatic or renal disease or other condition which in the opinion of the Investigator could interfere with the test procedures.
* Subject with a history of cancer, except for basal cell or Stage 1 squamous cell carcinoma of the skin which has been in remission for at least 5 years prior to Day 1.
* Subject meets the diagnostic criteria for schizophrenia, or any other psychotic disorder, as determined by the SCID-I at Screening
* Subject with a history of, or presents (in the opinion of the Investigator) with, significant neurological or psychiatric conditions (such as stroke, traumatic brain injury, depression, seizures, space occupying lesions, multiple sclerosis, Parkinson's disease, vascular dementia, transient ischemic attack, schizophrenia, blackouts requiring hospitalisation).
* Subject with a history of positive HIV test.
* Subject with a history of, or current condition of, migraine headaches or has undergone operations to the head.
* Subject with a significant hearing impairment which, in the opinion of the Investigator, may interfere with the performance of the behavioural tasks or fMRI tasks.
* Subject with a significant visual impairment including colour blindness, or history of ocular treatment including corrective laser eye surgery, or ongoing condition, which in the opinion of the Investigator may interfere with the performance of the behavioural tasks or fMRI tasks.
* Subject received prescribed medication within 28 days prior to Day 1 (apart from the contraceptive pill). Subjects who have taken prescription medication may still be entered into the study, if, in the opinion of the Investigator, the medication received will not interfere with the study procedures or compromise safety (see Section 10.2, Concomitant Medications).
* Subject received non-prescription medication, including supplements such as vitamins and herbal supplements within 48 hours prior to Day 1 (apart from paracetamol). Subjects who have taken non-prescription medication may still be entered into the study, if, in the opinion of the Investigator, the medication received will not interfere with the study procedures or compromise safety (see Section 10.2, Concomitant Medications).
* Subject received an experimental drug and / or used an experimental medical device within 30 days of randomisation or within a period less than 5 times the drug's half-life, whichever is longer.
* Subject with a known hypersensitivity to SEP-363856 or amisulpride or any of their excipients.
* Subject with a history of severe drug allergy or hypersensitivity.
* Subject who is unable or unwilling to comply with study procedures, including study prohibitions and restrictions (see Section 10.2, Concomitant Medications and Section 10.3, Restrictions).
* Subject with previous experience with the ETB.
* Subject with a diagnosis of dyslexia.
* Subject with a history of claustrophobia or inability to tolerate scanner environment.
* Subject who fulfills any of the MRI contraindications on the standard site radiography screening questionnaire (e.g. history of surgery involving metal implants).
* Subject with a clinically relevant structural brain abnormality as determined by prior MRI scan.
* Subject with planned medical treatment within the study period that might interfere with the study procedures.
* Subject who is unlikely to comply with the clinical study protocol or is unsuitable for any other reason, in the opinion of the Investigator.
* Subject is a staff member or the relative of a staff member, or is in a subordinate relationship with the Investigator.
* Subject answers 'yes' to 'Suicidal Ideation' Items 4 or 5 on the C-SSRS.
Sex :
ALL
Ages :
- Minimum Age : 18 Years
- Maximum Age : 45 Years
- Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : ADULT
Accepts Healthy Volunteers:
Yes
|
NCT01972711
| 228,836 |
{
"NCT_ID" : "NCT01447485",
"Brief_Title" : "Pharmacokinetics Following Single-dose of Valsartan in Japanese Pediatric Patients",
"Official_title" : "A Multicenter, Open-label, Single-dose Study to Evaluate the Pharmacokinetics of Valsartan in Japanese Pediatric Patients 6 to 14 Years of Age",
"Conditions" : ["Hypertension", "Chronic Kidney Disease", "Nephrotic Syndrome"],
"Interventions" : ["Drug: Valsartan (VAL489)"],
"Location_Countries" : ["Japan"],
"Study_Design" : {
"Study_Type" : "INTERVENTIONAL",
"Phase" : ["PHASE1"],
"Primary_Purpose" : "BASIC_SCIENCE",
"Allocation" : "NA",
"Interventional_Model" : "SINGLE_GROUP",
"Masking" : "NONE"
},
"Recruitment_Information" : {
"Study_Start_Date(Actual)" : "2011-08",
"Primary_Completion_Date(Actual)(Final_data_collection_date_for_primary_outcome_measure)" : "2011-10",
"Study_Completion_Date(Actual)" : "2011-10},
"Study_Record_Dates" : {
""Study_Registration_Dates" : {
"First_Submitted" : 2011-08-31",
"First_Posted(Estimated)" : 2011-10-06"
},
"Study_Record_Updates" : {
"Last_Updated_that_Met_QC_Criteria" : 2011-10-05",
"Last_Update_Posted(Estimated)" : 2020-12-21",
"Last_Verified" : 2012-05"
}
}}
|
#Study Description
Brief Summary
This study will assess the pharmacokinetics and safety following single dose of valsartan in Japanese pediatric patients with hypertension, chronic kidney disease, or nephrotic syndrome.
#Intervention
- DRUG : Valsartan (VAL489)
|
#Eligibility Criteria:
Inclusion Criteria:
* Japanese pediatric patients with hypertension, chronic kidney disease, or nephrotic syndrome
Exclusion Criteria:
* GFR < 30 mL/min/1.73 m2
* Inability to safely tolerate the temporary discontinuation of concomitant antihypertensive medications (expect amlodipine or atenolol) from 24 hours prior to study drug administration to study completion.
* Inability to safely tolerate the temporary discontinuation of any drug known or suspected to effect hepatic or renal clearance capacity from 24 hours prior to study drug administration to study completion (this includes drugs that are known to cause induction or inhibition of hepatic enzymes).
Other protocol-defined inclusion/exclusion criteria may apply
Sex :
ALL
Ages :
- Minimum Age : 6 Years
- Maximum Age : 14 Years
- Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : CHILD
Accepts Healthy Volunteers:
No
|
NCT01447485
| 207,057 |
{
"NCT_ID" : "NCT02551341",
"Brief_Title" : "Lung Protective Ventilation During Robotic Assisted Prostatectomy",
"Official_title" : "Randomized Study To Study the Effect of Lung Protective Ventilation (PEEP) Compared With Normal Ventilation (ZEEP) on Lung Function, Kidney Treatment of Sodium and Water, Vasoactive Hormones, Biomarkers of Nephrotoxicity and Haemodynamics in Patients Undergoing Robot-assisted Radical Prostatectomy",
"Conditions" : ["Prostate Cancer"],
"Interventions" : ["Procedure: higher PEEP ventilation"],
"Location_Countries" : ["Denmark"],
"Study_Design" : {
"Study_Type" : "INTERVENTIONAL",
"Phase" : ["PHASE3"],
"Primary_Purpose" : "TREATMENT",
"Allocation" : "RANDOMIZED",
"Interventional_Model" : "PARALLEL",
"Masking" : "NONE"
},
"Recruitment_Information" : {
"Study_Start_Date(Actual)" : "2015-09",
"Primary_Completion_Date(Actual)(Final_data_collection_date_for_primary_outcome_measure)" : "2017-01",
"Study_Completion_Date(Actual)" : "2017-02},
"Study_Record_Dates" : {
""Study_Registration_Dates" : {
"First_Submitted" : 2015-09-13",
"First_Posted(Estimated)" : 2015-09-16"
},
"Study_Record_Updates" : {
"Last_Updated_that_Met_QC_Criteria" : 2015-09-15",
"Last_Update_Posted(Estimated)" : 2018-11-16",
"Last_Verified" : 2018-11"
}
}}
|
#Study Description
Brief Summary
Randomized study investigating the effects of lung protective ventilation (PEEP), as compared with normal ventilation (ZEEP) on lung function, treatment of the renal sodium and water, vasoactive hormones, biomarkers of nephrotoxicity, and the circulation of patients undergoing assisted robotic radical prostatectomy
Detailed Description
Protocol Summary
Purpose:
The project will investigate whether a suspected lung protective ventilator therapy in connection with surgery for cancer of the prostate (prostate) have a relevant beneficial effects on lung function, renal function and circulation associated with keyhole surgery performed with surgical robot.
Trial method:
The trial is a randomized study (randomized controlled trials), which are drawn between normal and a suspected lung protective ventilator treatment in connection with the surgical removal of the prostate due to Cancers. Before the operation, collected urine and blood samples and that a study of lung function and circulation as a starting point. During the operation, and in the following two days collected urine and blood samples. Prepare Furthermore, new studies of lung function and circulation. Blood tests and lung function studied also in outpatient control about 1 week after surgery.
The two groups of patients (for respectively normal respiratory therapy and suspected lung protective) compared subsequent terms. Impact on lung function, renal function and circulation as well as the number and severity of any complications compared to assess whether the suspected lung protective ventilator therapy is safe and provides adequate beneficial effect to introduce as standard in the future.
Tissue sampling used in the form of blood tests or urine tests MHP research biobank in the experiment. This tissue will be used for analyzes in the specific project and the tissue will be destroyed after current guidelines for project completion.
Side effects and risks:
There are at every blood sampling a small risk of infection and bleeding. Using standard sterile technique. Blood volume removed by blood tests is max of 250 ml in total. Removing this amount of blood does not entail health risks in patients. There may be discomfort around the injection site, the needle drop is wrong in the arm, but using standard sterile technique and dropped down by experienced personnel. Blood samples for the experiment performed during routine blood sampling equipment as specified in the department's instructions.
For lung studies will in some cases could be detected a certain constriction of the small branches of the airways (bronchi). To determine whether this is a condition may require treatment given ally a spray to suck, which aims to expand the branches in order to improve lung function. This medication can cause slight transient dizziness and palpitations.
Disadvantages:
The additional lung examinations in the study will attempt established in connection with the patient's usual attendance and stay at the hospital to avoid extra visits. There must be calculated some extra time spent for outpatient visits in connection with participation in the trial. There is no economic disadvantages associated with the trial for the patient.
Economic conditions:
There is no economic disadvantages associated with the trial for the patient. Funding for the project will be done through a joint financing by the Urology Department D, Department of Anesthesiology and University Clinic for Kidney disease and high blood pressure, Hospital West and Aarhus University. Research funds will be sought from public and private funds.
Publication of trial results:
The results, both positive and negative findings, will be made published in internationally recognized scientific journal anonymously with no personally identifiable data.
Research Ethics statement:
The project reported to the Ethical Science Council at the Central Denmark Region. Database for the project must be approved by the Data Protection Agency by Region of Central. The project is started only after the approval of these two bodies. The project will comply with applicable GCP rules.
Recruitment of participants:
First contacting the patient about the project via the operator, Urology Department, at the information interview on operation. If the patient wants to get further information about the project handed out written information and project manager contacted.
The written information consists of: Participant Information, consent form, 'Information for subjects' and 'Your Rights as a test subject in a biomedical research.' The patient is informed both in writing and orally on the right and the opportunity to bring legal counsel to informed consent.
The project manager or his representative hold subsequent information interview about 7 days before surgery. This will last approximately 30 minutes. Information being conducted in consultation room at the clinic, where there is no other activity in the allocated room during the interview.
The anesthesia controller or his deputy hold right now usual anesthesia monitoring and ensuring written consent.
At the oral information, patients will be informed that there is a request to participate in a biomedical research. Patients are informed acc. the guidelines in 'Guidelines for review, etc. of a biomedical research for the ethics committee system 'from the Central Scientific Ethical Committee. Information is provided for the experiment, as listed in Annex 1 'Information for volunteers.' The subjects, who wish to participate are advised that, if they wish, can get consideration before submitting their written consent to participate in research is voluntary, and that they will always be able to draw a committed participation back .
The subjects were informed that they will receive information on the results achieved by research reporting on the project if they are interested in this.
Written informed consent given to the project manager or the anesthetic consultant or his deputy in the project in connection with the information interview, journal recording and anesthesia monitoring. The subjects signed concent- and proxy statement, which is kept by the Data Protection Agency guidelines. A copy provided to the subject.
#Intervention
- PROCEDURE : higher PEEP ventilation
|
#Eligibility Criteria:
Inclusion Criteria:
* Age> 18 years
* Men
* Indication for robot-assisted radical prostatectomy acc. the department's instructions
Exclusion Criteria:
* Lack of desire to participate
* EGFR <15 ml / min
* BMI> 35 kg / m2
* Former lung surgery
* Known requiring treatment lung disease
* Known heart disease svt NYHA Class III or higher
* Recent AMI within 12 months
* Known neuromuscular disease
Sex :
MALE
Ages :
- Minimum Age : 18 Years
- Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : ADULT, OLDER_ADULT
Accepts Healthy Volunteers:
No
|
NCT02551341
| 131,313 |
{
"NCT_ID" : "NCT02579954",
"Brief_Title" : "Cardiac Function and Exercise Capacity in Pulmonary Arterial Hypertension",
"Official_title" : "Cardiac Function and Exercise Capacity in Pulmonary Arterial Hypertension",
"Conditions" : ["Pulmonary Arterial Hypertension"],
"Interventions" : ["Behavioral: Rehabilitation"],
"Location_Countries" : ["France"],
"Study_Design" : {
"Study_Type" : "INTERVENTIONAL",
"Phase" : ["NA"],
"Primary_Purpose" : "TREATMENT",
"Allocation" : "RANDOMIZED",
"Interventional_Model" : "PARALLEL",
"Masking" : "SINGLE"
},
"Recruitment_Information" : {
"Study_Start_Date(Actual)" : "2015-08-06",
"Primary_Completion_Date(Actual)(Final_data_collection_date_for_primary_outcome_measure)" : "2022-12-05",
"Study_Completion_Date(Actual)" : "2024-01-24},
"Study_Record_Dates" : {
""Study_Registration_Dates" : {
"First_Submitted" : 2015-10-15",
"First_Posted(Estimated)" : 2015-10-20"
},
"Study_Record_Updates" : {
"Last_Updated_that_Met_QC_Criteria" : 2015-10-19",
"Last_Update_Posted(Estimated)" : 2024-06-25",
"Last_Verified" : 2024-06"
}
}}
|
#Study Description
Brief Summary
Pulmonary Arterial Hypertension is characterized by a progressive increase in pulmonary vascular resistance inducing shortness of breath and exercise intolerance. We aim to correlate cardiac function (evaluated at rest by right heart catheterism and RMN) to exercise capacity (evaluated by endurance time at 75% of maximal workout), in prevalent patients with pulmonary arterial hypertension, and their evolution at three and twelve months.
#Intervention
- BEHAVIORAL : Rehabilitation
- Other Names :
- Supervised rehabilitation
|
#Eligibility Criteria:
Inclusion Criteria:
* Adult patients
* Patients with Pulmonary Arterial Hypertension (idiopathic, heritable or due to anorexigens),
* Prevalent cases of pulmonary artery hypertension (>= 6 months) confirmed by right heart catheterism,
* Stable for at least 3 months,
* Written consent.
Exclusion Criteria:
* Patients unable to proceed with six-minute walk test or CPET, or with contra-indication to exercise evaluation (syncope, low cardiac index, etc).
* Exercise induced abnormality (evaluated during the initial CPET) precluding to further evaluation.
Sex :
ALL
Ages :
- Minimum Age : 18 Years
- Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : ADULT, OLDER_ADULT
Accepts Healthy Volunteers:
No
|
NCT02579954
| 276,317 |
{
"NCT_ID" : "NCT03154957",
"Brief_Title" : "Management of Acute Dislocation of Emergency in the University Hospital of Strasbourg Shoulder: Retrospective Evaluation of Practices and Proposal of a Clinical Path",
"Official_title" : "Management of Acute Dislocation of Emergency in the University Hospital of Strasbourg Shoulder: Retrospective Evaluation of Practices and Proposal of a Clinical Path",
"Conditions" : ["Shoulder Dislocation"],
"Location_Countries" : ["France"],
"Study_Design" : {
"Study_Type" : "OBSERVATIONAL",
},
"Recruitment_Information" : {
"Study_Start_Date(Actual)" : "2016-09",
"Primary_Completion_Date(Actual)(Final_data_collection_date_for_primary_outcome_measure)" : "2017-07",
"Study_Completion_Date(Actual)" : "2017-07},
"Study_Record_Dates" : {
""Study_Registration_Dates" : {
"First_Submitted" : 2017-05-11",
"First_Posted(Estimated)" : 2017-05-16"
},
"Study_Record_Updates" : {
"Last_Updated_that_Met_QC_Criteria" : 2017-05-14",
"Last_Update_Posted(Estimated)" : 2020-01-30",
"Last_Verified" : 2017-05"
}
}}
|
#Study Description
Brief Summary
The analysis of professional practices in the emergency department of the Strasbourg CHRU in the management of acute shoulder dislocations aims at proposing a clinical pathway of synthesis taking into account current practices and data from the literature. Thus, the objectives are twofold: first standardize care in emergency rooms and try to improve the weak points of this care.The Investigators will concentrate thier observation work on the medicinal analgesic methods proposed to these patients in order to minimize the pain induced by the external reduction maneuvers performed, in the majority of cases, in the emergencies. This work will ultimately have a real clinical impact on the management of these traumatized patients
|
#Eligibility Criteria:
Inclusion Criteria:
* Adult patient consulting for acute shoulder dislocation
Exclusion Criteria:
* Patient refusing to participate in the study
Sex :
ALL
Ages :
- Minimum Age : 18 Years
- Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : ADULT, OLDER_ADULT
Accepts Healthy Volunteers:
No
|
NCT03154957
| 57,856 |
{
"NCT_ID" : "NCT04633668",
"Brief_Title" : "Impact of Cognitive Behavioral Therapy on Parasomnias",
"Official_title" : "Pilot RCT of the Impact of Cognitive Behavioral Therapy on Parasomnias",
"Conditions" : ["Parasomnia"],
"Interventions" : ["Behavioral: Self-Monitoring", "Behavioral: CBT for parasomnias (CBT-p)"],
"Location_Countries" : ["Canada"],
"Study_Design" : {
"Study_Type" : "INTERVENTIONAL",
"Phase" : ["NA"],
"Primary_Purpose" : "TREATMENT",
"Allocation" : "RANDOMIZED",
"Interventional_Model" : "PARALLEL",
"Masking" : "SINGLE"
},
"Recruitment_Information" : {
"Study_Start_Date(Actual)" : "2021-01-01",
"Primary_Completion_Date(Actual)(Final_data_collection_date_for_primary_outcome_measure)" : "2022-04-30",
"Study_Completion_Date(Actual)" : "2022-04-30},
"Study_Record_Dates" : {
""Study_Registration_Dates" : {
"First_Submitted" : 2020-11-06",
"First_Posted(Estimated)" : 2020-11-18"
},
"Study_Record_Updates" : {
"Last_Updated_that_Met_QC_Criteria" : 2020-11-12",
"Last_Update_Posted(Estimated)" : 2022-05-17",
"Last_Verified" : 2022-05"
}
}}
|
#Study Description
Brief Summary
This research aims to determine whether cognitive behavioral therapy can effectively reduce parasomnias in a sample of 20 adult outpatients with Non-REM and REM parasomnias. A secondary objective is to assess whether treatment produces improvements in daytime energy, mood, and anxiety symptoms, as well as functional impairment (work/leisure activities).
Detailed Description
Sleep wake disorders are prevalent and impactful conditions often poorly assessed and sub-optimally treated in the clinical setting. Undiagnosed sleep disorders can masquerade as mental health conditions and worsen the outcomes associated with these conditions. Further, sleep disorders can develop from mental health conditions and the reverse is also true (particularly for mood disorders). Successful treatment of sleep disorders requires a targeted approach.
Parasomnias are unwanted physical or mental events that occur during sleep or during arousal from sleep. The states of wakefulness, NREM, and REM are normally distinct and occur in an organized and predictable pattern over the 24-hour period. However, in parasomnias, aspects of more than one state co-occur and intermix. There are four types of parasomnias identified by the Diagnostic and Statistical Manual of Mental Disorders ( DSM 5). These include two NREM parasomnias: sleepwalking and sleep terrors, and two REM parasomnias: nightmare disorder and REM sleep behaviour disorder (RSBD). Lifetime prevalence of these conditions ranges from 6.9% (sleepwalking) to 67% (nightmare disorder).
In general, NREM parasomnia events are primed by conditions that increase sleep pressure and triggered by sleep-disrupting factors. They are more likely to occur following sleep restriction or deprivation, when SWS rebounds. Immediate triggers of sleepwalking in adults are sleep disruptions associated with sleep-disordered breathing, periodic limb movements, noises and touch. Pilon et al. induced episodes in adult sleepwalkers, but not in non-sleepwalkers, with specific auditory stimuli and this effect was accentuated under conditions of prior sleep deprivation.
Currently accepted interventions for parasomnias include pharmacological and psychological treatments. Pharmacological interventions involve the use of sedating medications (benzodiazepines, tricyclic antidepressants) or alpha-1 blocker (Prazosin).
Cognitive Behavioral Therapy. Psychological treatments primarily rely on cognitive behavioral therapy to achieve better sleep hygiene, reduced hyperarousal, and to teach the ability to practice with reducing cognitive arousal during the sleep period through planned rehearsal and scheduled awakenings. There are no well elaborated and systematic treatment packages for Non-REM parasomnias and so this protocol will represent an innovation in this area. Therefore, the purpose of the study is to develop and test such a package.
Self-Monitoring of Sleep. Self-monitoring of disturbed sleep has been shown to produce small but significant positive impacts on some aspects of sleep (e.g., insomnia). As there is no widely accepted placebo for parasomnia treatment, this is viewed as an adequate control condition.
Objectives This research aims to determine whether cognitive behavioral therapy can effectively reduce parasomnias in a sample of 20 adult outpatients with Non-REM and REM parasomnias. A secondary objective is to assess whether treatment produces improvements in daytime energy, mood, and anxiety symptoms, as well as functional impairment (work/leisure activities). The hypotheses of the study are that participants who receive a 6-week program CBT-p therapy will report fewer episodes of parasomnia than those who self-monitor their sleep for 6 weeks, and will have objectively better sleep as measured by the prodigy and actigraphy at one-week (T2) post treatment and at two months post treatment (T3).
METHODS Trial Design This will be a single-blind randomized controlled trial with two conditions.
#Intervention
- BEHAVIORAL : CBT for parasomnias (CBT-p)
- Psychoeducation, sleep hygiene, imagery re-scripting, scheduled awakenings, safety planning, cognitive therapy, and stress management for 6 weeks
- BEHAVIORAL : Self-Monitoring
- Monitoring of sleep quality through sleep diary, actigraphy, nightmare experiences for 6 weeks
|
#Eligibility Criteria:
Inclusion Criteria:
* DSM 5 Parasomnia Disorder
* at least one parasomnia event per week
* daytime fatigue or sleepiness
* 6 months in duration
Exclusion Criteria:
* current use of agents known to triggers parasomnias such as Lithium carbonate, Thioridazine, Chlorpromazine, Perhphenazine, Methaqualone, or Amitriptyline,
* for participants taking benzodiazepines or Prazosin, a stable dose regime for the past 4 weeks,
* excessive alcohol consumption defined as the consumption of > 10 alcoholic beverages per week
Sex :
ALL
Ages :
- Minimum Age : 18 Years
- Maximum Age : 90 Years
- Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : ADULT, OLDER_ADULT
Accepts Healthy Volunteers:
No
|
NCT04633668
| 62,733 |
{
"NCT_ID" : "NCT04016480",
"Brief_Title" : "HFNC During Bronchoscopy for Bronchoalveolar Lavage",
"Official_title" : "High Flow Oxygen Therapy Through Nasal Cannula in Patients With Acute Respiratory Failure During Bronchoscopy for Bronchoalveolar Lavage",
"Conditions" : ["Acute Respiratory Failure", "Bronchoscopy", "Bronchoalveolar Lavage"],
"Interventions" : ["Device: High Flow Nasal Cannula", "Device: Conventional Oxygen Therapy"],
"Location_Countries" : ["Italy"],
"Study_Design" : {
"Study_Type" : "INTERVENTIONAL",
"Phase" : ["NA"],
"Primary_Purpose" : "TREATMENT",
"Allocation" : "RANDOMIZED",
"Interventional_Model" : "PARALLEL",
"Masking" : "NONE"
},
"Recruitment_Information" : {
"Study_Start_Date(Actual)" : "2019-09-12",
"Primary_Completion_Date(Actual)(Final_data_collection_date_for_primary_outcome_measure)" : "2020-02-28",
"Study_Completion_Date(Actual)" : "2020-02-28},
"Study_Record_Dates" : {
""Study_Registration_Dates" : {
"First_Submitted" : 2019-07-02",
"First_Posted(Estimated)" : 2019-07-11"
},
"Study_Record_Updates" : {
"Last_Updated_that_Met_QC_Criteria" : 2019-07-09",
"Last_Update_Posted(Estimated)" : 2020-12-04",
"Last_Verified" : 2020-12"
}
}}
|
#Study Description
Brief Summary
The execution of diagnostic-therapeutic investigations by bronchial endoscopy can expose the patient to acute respiratory failure (ARF). In particular, the risk of hypoxemia is greater during broncho-alveolar lavage (BAL). For this reason, oxygen therapy is administered at low or high flows during the course of bronchoscopic procedures, in order to avoid hypoxemia.
Few clinical studies have demonstrated the efficacy and safety of high flow oxygen through nasal cannula (HFNC) during BAL procedures, and no study has evaluated, during bronchial endoscopy, the effects of HFNC on diaphragmatic effort (assessed with ultrasound) and aeration and ventilation of the different lung regions (assessed with electrical impedance tomography).
Therefore, investigators conceived the present randomized controlled study to evaluate possible differences existing during bronchoscopy between oxygen therapy administered with HFNC and conventional (low-flow) oxygen therapy, delivered through nasal cannula.
Detailed Description
Patients with Acute Respiratory Failure may sometimes require a bronchial endoscopy for broncho-alveolar lavage (BAL).
During the procedure, hypoxemia may worsen and oxygen may be require to avoid desaturation.
In the recent years, High-Flow through Nasal Cannula (HFNC) has been introduced in the clinical practice. HFNC delivers to the patient heated humidified air-oxygen mixture, with an inspiratory fraction of oxygen (FiO2) ranging from 21 to 100% and a flow up to 60 L/min through a large bore nasal cannula.
HFNC has some potential advantages. First of all, HFNC provides heated (37°C) and humidified (44 mg/L) air-oxygen admixture to the patient, which avoids injuries to ciliary motion, reduces the inflammatory responses associated to dry and cold gases, epithelial cell cilia damage, and airway water loss, and keeps unmodified the water content of the bronchial secretions. Second, HFNC determines a wash out from carbon dioxide of the pharyngeal dead space. Third, HFNC generates small amount (up to 8 cmH2O) of pharyngeal pressure during expiration, which drops to zero during inspiration. Fourth, HFNC guarantees a more stable FiO2, as compared to conventional oxygen therapy. Whenever the inspiratory peak flow of a patient exceeds the flow provided by a Venturi mask, the patient inhaled also part of atmospheric air.
Electrical impedance tomography (EIT) is a noninvasive imaging technique providing instantaneous monitoring of variations in overall lung volume and regional distribution of ventilation, as determined by variations over time in intrathoracic impedance, which is increased by air and reduced by fluids and cells. EIT allows determining changes in end-expiratory lung impedance (EELI), a surrogate estimate of end-expiratory lung volume, assessing global and regional distribution of Vt, and obtaining indexes of spatial distribution of ventilation.
Diaphragm ultrasound is a bedside, radiation free technique to assess the contractility of the diaphragm and the respiratory effort.
In this study investigators aim to evaluate possible differences existing during bronchoscopy between oxygen therapy administered with HFNC and conventional (low-flow) oxygen therapy, delivered through nasal cannula in terms of respiratory effort (as assessed through diaphragm ultrasound), lung aeration and ventilation distribution (as assessed with EIT) and arterial blood gases.
#Intervention
- DEVICE : High Flow Nasal Cannula
- High Flow Nasal Cannula will be set at 60 liters per minute of air/oxygen admixture to reach a peripheral oxygen saturation equal or greater than 94%
- DEVICE : Conventional Oxygen Therapy
- Conventional Oxygen Therapy will be administered through nasal cannula with a oxygen flow set to achieve a peripheral oxygen saturation equal or greater than 94%
|
#Eligibility Criteria:
Inclusion Criteria:
* need for bronchial endoscopy for bronchoalveolar lavage
Exclusion Criteria:
* life-threatening cardiac aritmia or acute miocardical infarction within 6 weeks
* need for invasive or non invasive ventilation
* presence of pneumothorax or pulmonary enphisema or bullae
* recent (within 1 week) thoracic surgery
* presence of chest burns
* presence of tracheostomy
* pregnancy
* nasal or nasopharyngeal diseases
* dementia
* lack of consent or its withdrawal
Sex :
ALL
Ages :
- Minimum Age : 18 Years
- Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : ADULT, OLDER_ADULT
Accepts Healthy Volunteers:
No
|
NCT04016480
| 50,905 |
{
"NCT_ID" : "NCT06478654",
"Brief_Title" : "Modified Pectoral Nerve Block Vs Thoracic Erector Spinae Plane Block for Analgesia for Aesthetic Breast Surgeries",
"Official_title" : "Ultrasound Guided Bilateral Modified Pectoral Nerve (PECS II) Block Vs Bilateral Thoracic Erector Spinae Plane (ESP) Block for Postoperative Analgesia for Aesthetic Breast Surgeries",
"Conditions" : ["Postoperative Pain"],
"Interventions" : ["Procedure: Bilateral Modified Pectoral Nerve Block (PECS II).", "Procedure: Bilateral Thoracic Erector spinae plane block (ESPB)."],
"Location_Countries" : ["Egypt"],
"Study_Design" : {
"Study_Type" : "INTERVENTIONAL",
"Phase" : ["NA"],
"Primary_Purpose" : "OTHER",
"Allocation" : "RANDOMIZED",
"Interventional_Model" : "PARALLEL",
"Masking" : "SINGLE"
},
"Recruitment_Information" : {
"Study_Start_Date(Actual)" : "2024-03-01",
"Primary_Completion_Date(Actual)(Final_data_collection_date_for_primary_outcome_measure)" : "2024-09-01",
"Study_Completion_Date(Actual)" : "2024-10-01},
"Study_Record_Dates" : {
""Study_Registration_Dates" : {
"First_Submitted" : 2024-06-23",
"First_Posted(Estimated)" : 2024-06-27"
},
"Study_Record_Updates" : {
"Last_Updated_that_Met_QC_Criteria" : 2024-06-26",
"Last_Update_Posted(Estimated)" : 2024-12-03",
"Last_Verified" : 2024-02"
}
}}
|
#Study Description
Brief Summary
The aim of this study is to evaluate The Effectiveness of Ultrasound Guided Modified Pectoral Nerve Block (PECS II) versus Thoracic Erector Spinae Plane Block (ESPB) for postoperative Analgesia in cases of aesthetic breast surgeries.
Detailed Description
Preoperative settings:
All the patients will be fasting for solid food for at least 6 hours and for clear fluids for 4 hours before surgery and will be instructed about Numeric Rating Scale (NRS) and its interpretation.
Intravenous access will be inserted, premedication with midazolam 3 mg will be done. On arrival to operating room, routine monitoring including electrocardiography (ECG), non-invasive arterial blood pressure(NIBP) and pulse oximetry will be used. The mean arterial blood pressure (MAP)and heart rate (HR) will be recorded before induction of general anaesthesia (baseline).
Intraoperative \& postoperative settings :
A prophylactic antibiotic will be given after skin sensetivity test then General Intravenous anaesthesia induction will be done. Patient inductions by Propofol (2 mg/kg), Atracurium 0.5 mg/kg and Fentanyl 1 µg/kg. Endotracheal intubation will be settled then Patients will be mechanically ventilated and ventilator parameters will be set to keep end tidal CO2 between 30-35 mmHg guided by Capnogram. Anaesthesia will be maintained with Isoflurane 1,5 to 2 vol%. Patient will be given 50% oxygen/air mixture, and Incremental doses of fentanyl (0.5µg/kg) will be given every 1 hour. The depth of anaesthesia will be adjusted to keep changes of hemodynamics; (MAP) and (HR); within the range of ±20% of the baseline.
Under complete aseptic conditions, The blocks will be performed by a consultant anesthesiologist with a 5-year of experience in regional nerve blocks.
The blocks will be performed with a 20gauge, echogenic needle (Pajunk, 120mm, Germany).
The patients will be randomly divided into two groups,then the desired block will be done.
Surgical procedure will be started after performing the desired block.
At the end of surgery, Patients will be extubated after reversal of muscle relaxant by neostigmine 0.05 mg/kg with atropine 0.02 mg/kg. Patients will be transported to Post Anaesthesia care unit (PACU). HR, systolic, diastolic and mean pressures will be observed.
#Intervention
- PROCEDURE : Bilateral Modified Pectoral Nerve Block (PECS II).
- The procedure will be done bilateral with the patient lying in the supine position and the ipsilateral arm will be abducted and externally rotated, and the elbow flexed 90°.
The block will be managed by in-plane technique. After confirming the location of the needle with 2-3 mL of saline, 10 mL of 0.25% bupivacaine will be injected. Then, the needle will be advanced to the interfascial plane between the pectoralis minor and serratus anterior muscle, and 20 mL of 0.25% bupivacaine will be administered with the same procedure. The Block will be repeated on the other side using similar technique taking into consideration the toxic dose of bupivacaine
- PROCEDURE : Bilateral Thoracic Erector spinae plane block (ESPB).
- Under all aseptic precautions and sonar guided, ESP block will be managed at T4 or T5 bilateral using a high-frequency linear ultrasound probeWe will inject 20ml of bupivacaine 0.25% into interfacial plane below to erector spinae, a manifest linear pattern will be visualized uplifting the muscle. The Block will be repeated on the other side using similar technique taking into consideration the toxic dose of bupivacaine.
|
#Eligibility Criteria:
Inclusion Criteria:
* Females aged >=21 years' old.
* BMI <=35.
* Patients with ASA I & II.
* Scheduled for one of the aesthetic breast surgeries.
Exclusion Criteria:
* Patients refusal.
* Contraindications to regional anaesthesia as bleeding disorders, spine deformity and local infection.
* Patients with unstable cardiovascular disease.
* Emergency surgery.
* Patients with chronic pain.
* History of allergy to the medications used in the study.
Sex :
FEMALE
Ages :
- Minimum Age : 21 Years
- Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : ADULT, OLDER_ADULT
Accepts Healthy Volunteers:
Yes
|
NCT06478654
| 276,084 |
{
"NCT_ID" : "NCT00638079",
"Brief_Title" : "Evaluating the Effect of Food on Absorption of Megace ES",
"Official_title" : "Single-center, Randomized, Open-label, 2-way Crossover Bioavailability Study, Evaluating the Effect of Food on Megace ES (Megestrol Acetate 625 mg/5 mL Oral Suspension) Following a 625 mg Dose in Healthy Subjects",
"Conditions" : ["Pharmacokinetics", "Bioavailability", "Absorption"],
"Interventions" : ["Drug: Megestrol acetate oral suspension 625 mg/5 mL"],
"Location_Countries" : ["Canada"],
"Study_Design" : {
"Study_Type" : "INTERVENTIONAL",
"Phase" : ["PHASE1"],
"Allocation" : "RANDOMIZED",
"Interventional_Model" : "CROSSOVER",
"Masking" : "NONE"
},
"Recruitment_Information" : {
"Study_Start_Date(Actual)" : "2006-06",
"Primary_Completion_Date(Actual)(Final_data_collection_date_for_primary_outcome_measure)" : "2006-07",
"Study_Completion_Date(Actual)" : "2006-07},
"Study_Record_Dates" : {
""Study_Registration_Dates" : {
"First_Submitted" : 2008-03-11",
"First_Posted(Estimated)" : 2008-03-18"
},
"Study_Record_Updates" : {
"Last_Updated_that_Met_QC_Criteria" : 2008-03-11",
"Last_Update_Posted(Estimated)" : 2016-04-19",
"Last_Verified" : 2015-08"
}
}}
|
#Study Description
Brief Summary
To evaluate the effect of food on the rate and extent of absorption of megestrol acetate 625 mg/5 mL , and determine the safety and tolerability of megestrol acetate 625 mg/5 mL in healthy individuals.
#Intervention
- DRUG : Megestrol acetate oral suspension 625 mg/5 mL
- Megestrol acetate oral suspension 625 mg/5 mL. Single dose (5 mL) administered with a high fat meal
- Other Names :
- Megace ES
- DRUG : Megestrol acetate oral suspension 625 mg/5 mL
- Megestrol acetate oral suspension 625 mg/5 mL. Single dose (5 mL) administered following an overnight fast
- Other Names :
- Megace ES
|
#Eligibility Criteria:
Inclusion Criteria:
* Body weight ranging from 60 <= age <= 100 kg (132 <= age <= 220 lbs) and body mass index >=18 and <=32
* Healthy
Exclusion Criteria:
* History of or any current medical conditions that could interfere with drug consumption, absorption, distribution, metabolism (eg. CYP450 inducers or inhibitors), or excretion of study drug
* History of or any current medical conditions that could affect subject safety
* History of frequent nausea or emesis, regardless of etiology
* Participation in a clinical drug study during the 30 days preceding the initial dose
* Significant illness during the 4 weeks preceding study entry
* Use of any medication, including vitamins/herbal/mineral supplements, during the 7 days preceding the initial dose
* Refusal or inability to abstain from food 10 hours proceeding and 4 hours following study drug administration, to consume the FDA high fat meal as directed, and to abstain from caffeine- or xanthine-containing beverages entirely during each confinement
* Any history of or current drug or alcohol abuse
* Prior alcohol intake exceeding the equivalent of 14 units/week (12 oz beer = 4 oz wine = 1.5 oz shot = 1 unit) on average, or consumption of any alcoholic beverages within 48 hours of study drug administration
* History of smoking>25 cigarettes/day within 45 days of study drug administration
* Blood or blood products donated within 30 days prior to study drug administration, or anytime during the study, except as required by this protocol
* Positive results of urine drug screen, blood alcohol by a Breathalyzer test, hepatitis B surface antigen, hepatitis B surface antibody (unless immunized), or anti-HCV
Sex :
MALE
Ages :
- Minimum Age : 18 Years
- Maximum Age : 55 Years
- Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : ADULT
Accepts Healthy Volunteers:
Yes
|
NCT00638079
| 160,240 |
{
"NCT_ID" : "NCT00122447",
"Brief_Title" : "Cardiovascular Disease (CVD) Risk and Prevention in Early Glucose Intolerance",
"Official_title" : "CVD Risk and Prevention in Early Glucose Intolerance",
"Conditions" : ["Impaired Glucose Tolerance", "Prediabetic State"],
"Interventions" : ["Drug: Placebo", "Drug: Aspirin", "Drug: Olmesartan", "Drug: Alpha lipoic acid"],
"Location_Countries" : ["United States"],
"Study_Design" : {
"Study_Type" : "INTERVENTIONAL",
"Phase" : ["NA"],
"Primary_Purpose" : "PREVENTION",
"Allocation" : "RANDOMIZED",
"Interventional_Model" : "PARALLEL",
"Masking" : "QUADRUPLE"
},
"Recruitment_Information" : {
"Study_Start_Date(Actual)" : "2005-05",
"Primary_Completion_Date(Actual)(Final_data_collection_date_for_primary_outcome_measure)" : "2011-05",
"Study_Completion_Date(Actual)" : "2011-05},
"Study_Record_Dates" : {
""Study_Registration_Dates" : {
"First_Submitted" : 2005-07-21",
"First_Submitted_that_Met_QC_Criteria" : 2012-05-18",
"First_Posted(Estimated)" : 2005-07-22"
},
"Study_Record_Updates" : {
"Last_Updated_that_Met_QC_Criteria" : 2005-07-21",
"Last_Update_Posted(Estimated)" : 2013-12-05",
"Last_Verified" : 2013-11"
}
}}
|
#Study Description
Brief Summary
The purpose of this study is to determine whether cardiovascular disease (CVD) risk markers, β-cell function, and insulin sensitivity can be improved by targeting mechanisms of both diabetes and CVD - using an antioxidant, an angiotensin II receptor blocker (ARB), or an anti-inflammatory agent - in patients with impaired glucose tolerance (IGT) in a randomized, controlled trial.
Detailed Description
Diabetes is a common, major health problem in the United States, and it significantly increases the risk of developing heart disease, which is the leading cause of death. Research studies have shown that the risk of heart disease is increased, even in the 'pre-diabetes' or impaired glucose tolerance (IGT) stage, before the onset of true diabetes. While many studies have shown that aggressive management of diabetes lowers the risk of heart disease, at the present time, it is not known how best to treat patients with impaired glucose tolerance (pre-diabetes) to prevent the development of heart disease. It is also not known where in the range of blood sugar levels risk begins to increase. The purpose of this study is to determine:
* whether medications, which target pathways involved in the development of heart disease, can decrease the risk of heart disease in individuals with impaired glucose tolerance; and
* whether a 'high' blood sugar level measured one hour after drinking a standard high-sugar drink is associated with an increased risk of heart disease even in individuals who have no evidence of diabetes or pre-diabetes.
The purpose of Aim 1 of this study is to determine whether medications, which target pathways involved in the development of heart disease, can decrease the risk of heart disease in individuals with impaired glucose tolerance. One hundred-twenty volunteers with impaired glucose tolerance and 30 volunteers with normal glucose tolerance (normal blood sugars after ingesting a standard high-sugar drink) will be recruited from the 'Screening for Impaired Glucose Tolerance' (SIGT) study. The 30 volunteers with normal glucose tolerance will not take any study medication, but will undergo medical testing to determine their risk of heart disease at the beginning of the study, after which their participation in the study will be complete. The 120 volunteers with impaired glucose tolerance will be randomly assigned to one of four medications to be taken over a one-year period:
* alpha lipoic acid (an antioxidant, dietary supplement);
* olmesartan (a drug used to treat high blood pressure);
* aspirin (an anti-inflammatory drug); and
* placebo (an inactive, 'dummy' pill).
Subjects with impaired glucose tolerance will undergo medical testing to determine their risk of heart disease at the beginning of the study (before beginning study medications), after 3 months of intervention, and again at the end of the study (12 months after enrollment). Test results will be compared between the subjects taking each of the active medications and those taking placebo, to determine if the medications lead to a significant reduction in the risk for the development of heart disease. The medical tests used in this study are currently used in medical practice, and include blood and urine specimens, ultrasound testing of the artery at the arm, and an insulin sensitivity test (test of how effectively the body uses sugar). All visits and tests will be conducted in the General Clinical Research Centers of Emory University Hospital and Grady Memorial Hospital.
The purpose of Aim 2 of this study is to determine whether a 'high' blood sugar level measured one hour after drinking a standard high-sugar drink (1-hour blood sugar level) is associated with an increased risk of heart disease even in individuals who have no evidence of diabetes or pre-diabetes. Seventy-five volunteers with normal glucose tolerance (normal blood sugars after ingesting a standard high-sugar drink) will be recruited from the SIGT study, as well as 15 subjects with impaired glucose tolerance and 15 with diabetes. The subjects with normal glucose tolerance will be grouped into those with 'low', 'middle', and 'high' 1-hour blood sugar levels. All subjects will undergo medical testing (as in Aim 1 above) to determine their risk of heart disease. Test results of subjects with 'low', 'middle', and 'high' 1-hour blood sugar levels will be compared against one another, as well as against those of subjects with IGT and diabetes. If subjects with normal glucose tolerance but 'high' 1-hour blood sugar levels are found to have increased risk for heart disease compared to those with 'low' 1-hour blood sugar levels, then the 1-hour blood sugar levels may provide important information regarding an increased risk of heart disease even in individuals with normal glucose tolerance but 'high' 1-hour blood sugar levels - a population which otherwise would not be identified with the current standard tests used for the diagnosis of diabetes and pre-diabetes.
Over 40 million Americans have pre-diabetes (impaired glucose tolerance), which is associated with an increased risk of the development of both diabetes and heart disease. Findings from these studies will provide important insights into the pathways that lead to the development of heart disease related to pre-diabetes, prevention of heart disease in the pre-diabetic population, and identification of individuals at high risk for heart disease earlier in their natural history - even before the onset of pre-diabetes.
#Intervention
- DRUG : Aspirin
- 325 mg PO QD
- Other Names :
- Bayer aspirin
- DRUG : Alpha lipoic acid
- 600 mg PO BID
- DRUG : Olmesartan
- 40 mg PO QD
- Other Names :
- Benicar
- DRUG : Placebo
- Identical placebo for each active comparator:
placebo aspirin 325 mg PO QD; placebo for alpha lipoic acid 600 mg PO BID; placebo for olmesartan 40 mg PO QD
|
#Eligibility Criteria:
Inclusion Criteria:
* Impaired glucose tolerance
Exclusion Criteria:
* Diagnosis of diabetes
* Taking an ACE inhibitor (ACE-I), angiotensin II receptor blocker (ARB), or aspirin
* Have systolic blood pressure >140 mm Hg
* Have a chronic inflammatory disorder (i.e. rheumatoid arthritis, inflammatory bowel disease, sinusitis)
* Vascular disease (cardiac, peripheral, cerebral)
* Renal insufficiency or hepatic abnormalities
* Gastrointestinal bleeding (defined as gastric or duodenal ulcer, hematemesis, and/or blood in the stool) or significant other upper gastrointestinal problems (i.e. gastritis) within the previous 6 months
* Anemia or a history of bleeding disorder
* Have a history of ARB or aspirin allergy
* Have the syndrome of asthma, rhinitis, and nasal polyps
* Have other medical problems which would preclude taking potential study medications for 12 months
* Are pregnant or have a positive pregnancy test
* Are breast feeding
* Are unable or unwilling to tolerate having one catheter in each arm for 4 hours
* Have health status such that the envisioned blood sampling would confer a physiologic risk
* Have other physical, social, or behavioral problems which would decrease the likelihood that they would remain in the study for 12 months
* Do not appear capable of giving informed consent
Sex :
ALL
Ages :
- Minimum Age : 18 Years
- Maximum Age : 75 Years
- Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : ADULT, OLDER_ADULT
Accepts Healthy Volunteers:
Yes
|
NCT00122447
| 264,247 |
{
"NCT_ID" : "NCT01115504",
"Brief_Title" : "Thiamine Supplementation in Heart Failure Patients Receiving Full Medical Therapy",
"Official_title" : "Thiamine Supplementation in Heart Failure Patients Receiving Full Medical Therapy",
"Conditions" : ["Chronic Heart Failure"],
"Interventions" : ["Drug: Thiamine"],
"Location_Countries" : ["Iran, Islamic Republic of"],
"Study_Design" : {
"Study_Type" : "INTERVENTIONAL",
"Phase" : ["PHASE3"],
"Primary_Purpose" : "TREATMENT",
"Allocation" : "RANDOMIZED",
"Interventional_Model" : "SINGLE_GROUP",
"Masking" : "QUADRUPLE"
},
"Recruitment_Information" : {
"Study_Start_Date(Actual)" : "2010-05",
"Primary_Completion_Date(Actual)(Final_data_collection_date_for_primary_outcome_measure)" : "2010-11",
"Study_Completion_Date(Actual)" : "2010-12},
"Study_Record_Dates" : {
""Study_Registration_Dates" : {
"First_Submitted" : 2010-05-03",
"First_Posted(Estimated)" : 2010-05-04"
},
"Study_Record_Updates" : {
"Last_Updated_that_Met_QC_Criteria" : 2010-05-03",
"Last_Update_Posted(Estimated)" : 2010-12-23",
"Last_Verified" : 2010-11"
}
}}
|
#Study Description
Brief Summary
The study is performed to consider the effect of thiamine supplementation on symptoms and signs of patients with heart failure and systolic and diastolic function of left ventricle.
Detailed Description
The study is performed to consider the effect of thiamine supplementation versus placebo on symptoms and signs of patients with heart failure systolic and diastolic function of left ventricle.
Heart failure patients (left ventricular ejection fraction (LVEF ≤ 40%) are randomized to receive tablets of 300mg or placebo for 1 months in a double-blind fashion. All subjects will be on stable optimal medical therapy according to the present guidelines for at least 3 months before enrolment. At randomization and at study end, echocardiography by a single observer will be performed and assessment of symptoms and signs and quality of life based on self scoring system (from 1 to 7) and objective physical examinations will be done.
#Intervention
- DRUG : Thiamine
- 300 mg daily for 30 days
- Other Names :
- Thiamine: brand name: Thiamine Hakim
|
#Eligibility Criteria:
Inclusion Criteria:
* Heart failure patients (left ventricular ejection fraction (LVEF <= 40%)
* Optimal medical therapy according to the present guidelines for at least 3 months before enrollment.
Exclusion Criteria:
* Decompensated heart failure
* Renal failure
* COPD
* Asthma
* Uncontrolled hypertension
* Bradycardia or tachycardia which needs increase or decrease in medications
Sex :
ALL
Ages :
- Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : ADULT, OLDER_ADULT, CHILD
Accepts Healthy Volunteers:
No
|
NCT01115504
| 114,256 |
{
"NCT_ID" : "NCT01081353",
"Brief_Title" : "Pharmacokinetic Study Comparing Aspirin and Effervescent Aspirin",
"Official_title" : "An Open Label 4-Way Crossover Pharmacokinetic Trial of New Formula Aspirin Versus Effervescent Aspirin in Healthy Adult Subjects",
"Conditions" : ["Pharmacokinetics"],
"Interventions" : ["Drug: Alka Seltzer Extra Strength", "Drug: Aspirin Aspro", "Drug: Acetylsalicylic Acid (Aspirin BAY1019036)", "Drug: Aspirin Migraine"],
"Location_Countries" : ["United States"],
"Study_Design" : {
"Study_Type" : "INTERVENTIONAL",
"Phase" : ["PHASE1"],
"Primary_Purpose" : "TREATMENT",
"Allocation" : "RANDOMIZED",
"Interventional_Model" : "CROSSOVER",
"Masking" : "NONE"
},
"Recruitment_Information" : {
"Study_Start_Date(Actual)" : "2010-02",
"Primary_Completion_Date(Actual)(Final_data_collection_date_for_primary_outcome_measure)" : "2010-03",
"Study_Completion_Date(Actual)" : "2010-03},
"Study_Record_Dates" : {
""Study_Registration_Dates" : {
"First_Submitted" : 2010-03-04",
"First_Posted(Estimated)" : 2010-03-05"
},
"Study_Record_Updates" : {
"Last_Updated_that_Met_QC_Criteria" : 2010-03-04",
"Last_Update_Posted(Estimated)" : 2014-06-26",
"Last_Verified" : 2014-06"
}
}}
|
#Study Description
Brief Summary
To determine the bioequivalence of new formula of aspirin relative to the established commercial effervescent aspirin when taken orally by healthy adult subjects
#Intervention
- DRUG : Acetylsalicylic Acid (Aspirin BAY1019036)
- One tablet of new formula Aspirin under fasting conditions
- DRUG : Alka Seltzer Extra Strength
- One effervescent tablet under fasting conditions
- DRUG : Aspirin Migraine
- One effervescent tablet under fasting conditions
- DRUG : Aspirin Aspro
- One effervescent tablet under fasting conditions
|
#Eligibility Criteria:
Inclusion Criteria:
* Healthy male and female subjects between 18 <= age <= 55 of age inclusive with a Body Mass Index (BMI) of approximately 18 to 30 kg/m2; and a total body weight >50 kg (110 lbs)
* Results of screening and clinical laboratory tests are within normal range or considered not clinically significant by the Principal Investigator or Sponsor
* Female subjects of childbearing potential must be using a medically acceptable form of birth control for at least 1 month prior to screening (3 months on oral contraceptives), e.g., oral or patch contraceptives, intrauterine device, Depo-Provera, or a double barrier and have a negative pregnancy test at Screening and Day 0 for each Dosing Period. Female subjects of non-childbearing potential must be amenorrheic for at least 2 years or had a hysterectomy and/or bilateral oophorectomy
* Be willing to participate in all scheduled visits, treatment plan, laboratory tests and other trial procedures according to the clinical protocol
Exclusion Criteria:
* History of hypersensitivity to aspirin (ASA), Nonsteroidal Antiinflammatory Drugs (NSAIDs), acetaminophen and similar pharmacological agents or components of the products
* Eighteen to twenty year olds with a viral infection, with or without fever, at the time of dosing - Syndromes of asthma, rhinitis or nasal polyps
* Females who are pregnant or lactating
* Have taken ASA, ASA-containing products, acetaminophen or any other NSAID (Over the counter (OTC) or prescription) 7 days prior to dosing or during the treatment period, other than trial treatment
* Smokers or currently consuming any type of tobacco product(s) including any smoking cessation nicotine-containing product (e.g., nicotine patch, nicotine gum)
Sex :
ALL
Ages :
- Minimum Age : 18 Years
- Maximum Age : 55 Years
- Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : ADULT
Accepts Healthy Volunteers:
Yes
|
NCT01081353
| 274,623 |
{
"NCT_ID" : "NCT01530620",
"Brief_Title" : "Efficacy and Tolerability of Propiverine Hydrochloride in Patients With Neurogenic Detrusor Overactivity",
"Official_title" : "Efficacy and Tolerability of Propiverine Hydrochloride Extended Release (ER) Compared to Immediate Release (IR) in Patients With Neurogenic Detrusor Overactivity. A Randomized, Double Blind, Parallel Group, Multicenter Clinical Trial",
"Conditions" : ["Neurogenic Urinary Bladder Disorder", "Urinary Bladder, Neurogenic", "Bladder Disorder, Neurogenic", "Urinary Bladder Disorder, Neurogenic", "Neurogenic Bladder Disorder", "Urinary Bladder Neurogenic Dysfunction", "Urologic Diseases", "Overactive Detrusor Function", "Urinary Incontinence"],
"Interventions" : ["Drug: Propiverine hydrochloride IR (immediate release)", "Drug: Propiverine hydrochloride ER (extended release)"],
"Location_Countries" : ["Germany", "Austria", "Romania"],
"Study_Design" : {
"Study_Type" : "INTERVENTIONAL",
"Phase" : ["PHASE3"],
"Primary_Purpose" : "TREATMENT",
"Allocation" : "RANDOMIZED",
"Interventional_Model" : "PARALLEL",
"Masking" : "QUADRUPLE"
},
"Recruitment_Information" : {
"Study_Start_Date(Actual)" : "2004-12",
"Primary_Completion_Date(Actual)(Final_data_collection_date_for_primary_outcome_measure)" : "2005-06",
"Study_Completion_Date(Actual)" : "2006-07},
"Study_Record_Dates" : {
""Study_Registration_Dates" : {
"First_Submitted" : 2012-02-02",
"First_Posted(Estimated)" : 2012-02-10"
},
"Study_Record_Updates" : {
"Last_Updated_that_Met_QC_Criteria" : 2012-02-09",
"Last_Update_Posted(Estimated)" : 2012-02-10",
"Last_Verified" : 2012-02"
}
}}
|
#Study Description
Brief Summary
The purpose of this clinical study is to compare efficacy and safety of propiverine hydrochloride extended and immediate release formulations in patients suffering from neurogenic detrusor overactivity.
#Intervention
- DRUG : Propiverine hydrochloride ER (extended release)
- 45 mg capsule (1x1/d)
- Other Names :
- Mictonorm UNO 45, Detrunorm XL 45
- DRUG : Propiverine hydrochloride IR (immediate release)
- 15 mg tablet (3x1/d)
- Other Names :
- Mictonorm, Detrunorm
|
#Eligibility Criteria:
Inclusion Criteria:
* Male or female Caucasian patients aged >=18 and <=70 years
* Voluntarily signed informed consent
* Neurogenic detrusor overactivity with occurrence of reflex detrusor contractions
* Reflex volume of <=250 mL
* Intact reflex arcs in the area of segments S2-S4
Exclusion Criteria:
* Patients suffering from multiple sclerosis under unstable conditions
* Augmented reflex bladder
* Patients with increased residual urine (>=20 % of the maximum bladder capacity), in whom catheterization is not possible
* Acute urinary tract infection
* Electrostimulation therapy (within 4 weeks propir to Visit 1)
* Anomalies of the lower genitourinary tract (e.g. ectopic ureters, fistulas, urethral stenosis)
* Radiation bladder, interstitial cystitis, bladder calculi, bladder carcinoma
* Surgery of the lower genitourinary tract within the last 6 months (e.g. prostatectomy, hysterectomy, tumor surgery)
* Pre-existing medical contraindications for anticholinergics
* Cardiac insufficiency (NYHA stage III/ IV)
* Therapy with botulinum toxin within the last 12 months
* Evidence of severe renal, hepatic or metabolic disorders
* History of drug or alcohol abuse
* Concomitant medication known to have a potential to interfere with the trial medication
* Known hypersensitivity to Propiverine hydrochloride or excipients contained in the trial medication, respectively
* Pregnant or breast-feeding women, or women of childbearing potential without using any reliable contraceptive method
* Patients with impaired co-operation or who are unable to understand the nature, scope and possible consequences of the study
Sex :
ALL
Ages :
- Minimum Age : 18 Years
- Maximum Age : 70 Years
- Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : ADULT, OLDER_ADULT
Accepts Healthy Volunteers:
No
|
NCT01530620
| 5,099 |
{
"NCT_ID" : "NCT06306066",
"Brief_Title" : "Coronary Thermo-dilution Derived Flow-indices in Chronic Coronary Syndrome",
"Official_title" : "Coronary Microvascular Dysfunction in Chronic Coronary Syndrome - Invasive Assessment With Thermo-dilution Technique in the LAD and Biobanking in an All-comer Population",
"Conditions" : ["Coronary Artery Disease", "Microvascular Angina", "Coronary Microvascular Dysfunction"],
"Location_Countries" : ["Sweden"],
"Study_Design" : {
"Study_Type" : "OBSERVATIONAL",
},
"Recruitment_Information" : {
"Study_Start_Date(Actual)" : "2015-09-02",
"Primary_Completion_Date(Actual)(Final_data_collection_date_for_primary_outcome_measure)" : "2021-06-07",
"Study_Completion_Date(Actual)" : "2022-12-28},
"Study_Record_Dates" : {
""Study_Registration_Dates" : {
"First_Submitted" : 2024-02-27",
"First_Posted(Estimated)" : 2024-03-12"
},
"Study_Record_Updates" : {
"Last_Updated_that_Met_QC_Criteria" : 2024-03-07",
"Last_Update_Posted(Estimated)" : 2024-03-12",
"Last_Verified" : 2024-03"
}
}}
|
#Study Description
Brief Summary
Patients scheduled for elective coronary angiography due to chronic coronary syndrome are recruited at admission to hospital before the coronary anatomy is known. Immediately after coronary angiography measures thermo-dilution derived flow indices are obtained in the left left anterior descending artery (LAD). The patients are followed through telephone-calls and medical records at 1 and 2 years after inclusion and at completion of the study. The hypothesis is that elevated index of microcirculatory resistance (IMR),(\>25) is associated with all-cause death, myocardial infarction (MI) and hospitalization due to congestive heart failure (CHF).
The primary analysis is the relationship between IMR and the composite outcome all-cause death, MI and hospitalization due to CHF.
Detailed Description
Patients scheduled for elective coronary angiography due to chronic coronary syndrome are recruited at admission to hospital after written informed consent has been obtained and before the coronary anatomy is known. Blood sampling is performed from the arterial sheath before coronary angiography. The coronary angiography is done according to clinical practice. Immediately after coronary angiography measures thermo-dilution derived flow indices are obtained in the LAD (methods below). Interventions of epicardial lesions are then performed at the percutaneous coronary intervention (PCI)-operators discretion.
Fractional Flow Reserve (FFR), Coronary Flow Reserve(CFR) and IMR measurements
All indices FFR, CFR and IMR are measured in the left anterior descending artery (LAD). The flow measurements shall be obtained before PCI in the LAD. Further assessment of flow in LAD after PCI are optional. Flow measurements in the right coronary artery and circumflex lesions are optional.
Flow measurements:
A coronary guidewire with pressure and temperature sensors (PressurewireX, Abbott Inc, Calif., USA) is advanced in the LAD. The thermistor is placed \> 70 mm from the catheter-tip and three millilitres of cold saline is injected into the LAD three times through the guiding catheter and thermo-dilution resting curves in triplicate are obtained. The patient then receives an intravenous infusion of adenosine (167 µg/kg/min) during approximately two minutes to induce stable hyperaemia. Again, three millilitres of cold saline is injected into the LAD through the guiding catheter and hyperaemic thermos-dilution curves in triplicate are obtained.
FFR is calculated as the ratio of distal coronary pressure (Pd) to proximal coronary pressure (Pa) at hyperaemia. CFR will be calculated through as the ratio of mean transit time of resting thermo-dilution curves (Tmnbas) divided by mean transit time of hyperaemic thermos-dilution curves (Tmnhyp). IMR is calculated as the product of Pd and Tmnhyp during stable hyperaemia. If FFR is \<0.75 IMR can be overestimated and will be calculated differently (Yong et al.); Corrected index of microcirculatory resistance (IMRcorr) = Pa x Tmnhyp x (\[1.35 x Pd/Pa\] - 0.32).
Recordings of systolic blood pressure, diastolic blood pressure, Tmnbas, Tmnhyp, Pa, Pd, IMR, CFR will be saved and analysed off-line by a dedicated physician.
Follow-up The patients are followed through telephone-calls and medical records at 1 and 2 years and after inclusion and at completion of the study December 2022.
Patients with extensive atherosclerotic disease in the left main or the LAD with risk of complications when advancing a pressure wire making flow-measures not possible will be followed according to the protocol but excluded from the primary analysis. Patients with chronic total occlusions (CTO) in the LAD making flow-measures impossible in the LAD will be followed according to the protocol but excluded from the primary analysis.
Survival analysis The null hypothesis is that subjects with IMR \>25 have the same outcome (death, MI, and hospitalization due to CHF) as subjects with IMR≤25. Assumptions are that 30% of subjects have IMR \>25, the hazard ratio is 2.0, the event rate is 0.09 per year, censoring rate 0.3/year, average follow-up 3 years. With 395 subjects the power is 80% to reject the null hypothesis. α=0.05.
Biomarkers in relation to IMR Post-hoc power calculation; the null hypothesis is that no variables are associated with IMR. Assumptions; effect-size (R2) = 0.20; maximum variables in the regression analysis = 15; α = 0.05. With a power of 0.80 a sample size of 89 subjects are needed to reject the null hypothesis.
|
#Eligibility Criteria:
Inclusion Criteria:
* Subjects with stable angina pectoris or suspected angina pectoris who are scheduled for coronary angiography
* Age 18 years - 85 years
* Life expectancy >2 years
Exclusion Criteria:
* Acute coronary syndrome (ST-elevation myocardial infarction [STEMI], non-ST-elevation myocardial infarction [NSTEMI] and unstable angina pectoris)
* Known CHF
* Prior heart transplantation
* Prior coronary artery by-pass grafting
* Hypertrophic cardiomyopathy (Septum >15 mm)
* Valvular disease
* Not eligible for coronary angiogram
* Cancer within three years of admission
* Peri-myocarditis
* Atrial fibrillation with heart beats per minute >120
* Asthma
Sex :
ALL
Ages :
- Minimum Age : 18 Years
- Maximum Age : 85 Years
- Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : ADULT, OLDER_ADULT
Accepts Healthy Volunteers:
No
|
NCT06306066
| 21,636 |
{
"NCT_ID" : "NCT03911596",
"Brief_Title" : "Smart Autofocusing Eyeglasses",
"Official_title" : "Cyber Physical System for Smart Corrective Eyeglasses",
"Conditions" : ["Presbyopia"],
"Location_Countries" : ["United States"],
"Study_Design" : {
"Study_Type" : "OBSERVATIONAL",
},
"Recruitment_Information" : {
"Study_Start_Date(Actual)" : "2019-03-01",
"Primary_Completion_Date(Actual)(Final_data_collection_date_for_primary_outcome_measure)" : "2022-12-30",
"Study_Completion_Date(Actual)" : "2022-12-30},
"Study_Record_Dates" : {
""Study_Registration_Dates" : {
"First_Submitted" : 2019-04-09",
"First_Posted(Estimated)" : 2019-04-11"
},
"Study_Record_Updates" : {
"Last_Updated_that_Met_QC_Criteria" : 2019-04-09",
"Last_Update_Posted(Estimated)" : 2024-04-19",
"Last_Verified" : 2022-11"
}
}}
|
#Study Description
Brief Summary
A high-performance smart eyeglasses system with integrated sensing, actuation, control and data collection is being developed at the University of Utah. These smart eyeglasses use tunable lenses and integrated sensor technologies to correct blurred vision caused due to a major age-related condition called presbyopia.The objective of this study is to test this smart system on patients suffering from presbyopia aged 45 and above. The researchers intend to study the effect of these smart eyeglasses by qualitatively investigating the patient's visual acuity with this smart system. The results of this study and subsequent research have the potential to lead to major lifestyle improvements and better treatment for millions of presbyopic patients that are constrained by the limitation of current corrective eyeglass technologies. There are two main sources of fairly well understood problems that lead to presbyopia and loss of the eye focusing function. The adaptive eyeglasses used in these tests do not fix any of the internal eye problems. They just compensate externally for the loss of the eye focusing function caused by presbyopia. As such, the investigators intend to evaluate our system's effectiveness in terms of the sharpness of the perceived images.
Detailed Description
Eye defects occur when the eye cannot focus images from the outside world. This results in blurred vision, which sometimes is so severe that it causes visual impairment. Among the many vision defects, presbyopia is an inevitable, irreversible, universal age-related condition where the crystalline lens in the eye loses its accomodation orthe ability to change the optical power. This defect occurs as a natural result of aging and will ultimately affect any person reaching advanced enough age. It was estimated in 2005 that over 1 billion people worldwide suffered from presbyopia, with approximately 400 million suffering from near vision loss due to the lack of correction technologies.
The most inexpensive and commonly used tools to correct vision errors are fixed power eyeglasses, which haven't seen any improvement since the mid-1800s. Conventional eyeglasses are an ancient piece of technology which originated in Europe's middle ages. A major drawback of such eyeglasses is that they can only correct the lack of accomodation at a particular object distance, since they use fixed power lenses. As a result, conventional eyeglasses can produce sharp images for objects located either far away or near the observer but not both. Bifocal, multifocal and progressive lenses can partially alleviate vision defects, but at the expense of reduced and fragmented field of view. As an example, multifocal lenses have different lens powers in different regions of the lens. With such lenses, it is not possible to see objects clearly over the entire visual field. Further, the effectiveness of conventional eyeglasses is not monitored outside the optometrist's office.
The proposed smart eyeglasses system uses a combination of large-aperture fluidic lenses, ultra-light actuators, object distance sensors and embedded control, communications and computing electronics to continuously produce sharp and focused images at any object range. They can also collect the behaviour and characteristics of the observer's eyes to gauge the effectiveness of the technology and adapt to observer's visual degradation over age.
#Intervention
- DEVICE : Smart Autofocusing Eyeglasses
- The smart eyeglasses system is meant to be a next generation alternative technology which replaces the generic eyeglasses used for correction of refractory defects in human vision. These smart eyeglasses do not fix any internal eye problems. They just externally compensate for the loss of eye focusing functions caused by presbyopia. This system is a medical assistive device which is meant to improve the quality of life of presbyopic patients.
|
#Eligibility Criteria:
Inclusion Criteria:
* Presbyopic
* Less than 1.0 diopter astigmatism
* Eyeglass prescription between -2.5 and +2.5, correctable to 20/20
Exclusion Criteria:
* Artificial intraocular lens
* Any ocular pathology that would inhibit accommodation of the natural lens
Sex :
ALL
Ages :
- Minimum Age : 45 Years
- Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : ADULT, OLDER_ADULT
Accepts Healthy Volunteers:
No
|
NCT03911596
| 258,193 |
{
"NCT_ID" : "NCT04158713",
"Brief_Title" : "Improving PRegnancy Outcomes With PReVEntive Therapy in Africa-2 (IMPROVE-2)",
"Official_title" : "Chemoprevention With Monthly IPTp With Dihydroartemisinin-piperaquine for Malaria in HIV-infected Pregnant Participants on Daily Cotrimoxazole in Kenya and Malawi: a Multi-centre Placebo-controlled Trial",
"Conditions" : ["Pregnancy; HIV; Malaria"],
"Interventions" : ["Drug: Intermittent Preventive Therapy with Dihydroartemisinin-Piperaquine"],
"Location_Countries" : ["Kenya"],
"Study_Design" : {
"Study_Type" : "INTERVENTIONAL",
"Phase" : ["PHASE3"],
"Primary_Purpose" : "PREVENTION",
"Allocation" : "RANDOMIZED",
"Interventional_Model" : "PARALLEL",
"Masking" : "QUADRUPLE"
},
"Recruitment_Information" : {
"Study_Start_Date(Actual)" : "2019-11-11",
"Primary_Completion_Date(Actual)(Final_data_collection_date_for_primary_outcome_measure)" : "2022-04-15",
"Study_Completion_Date(Actual)" : "2022-08-30},
"Study_Record_Dates" : {
""Study_Registration_Dates" : {
"First_Submitted" : 2019-11-07",
"First_Posted(Estimated)" : 2019-11-12"
},
"Study_Record_Updates" : {
"Last_Updated_that_Met_QC_Criteria" : 2019-11-07",
"Last_Update_Posted(Estimated)" : 2023-08-22",
"Last_Verified" : 2023-08"
}
}}
|
#Study Description
Brief Summary
2.3.3 Short technical protocol summary Background: Pregnant women represent a vulnerable population for malaria. HIV-infected women are particularly at risk. In HIV-infected pregnant women, WHO recommends daily cotrimoxazole (CTX), an antifolate drug, for malaria chemoprevention and prophylaxis against opportunistic infection. However, there is cross-resistance with sulphadoxine-pyrimethamine (SP), and high levels of antifolate resistance threatens the antimalarial effect of CTX. Recent trials with intermittent preventive therapy (IPT) with mefloquine in HIV-infected women on daily CTX, suggested that chemoprevention with an effective antimalarial markedly improves the protection against malaria compared to daily CTX alone. However, mefloquine was not well tolerated.
The long-acting combination of dihydroartemisinin-piperaquine (DP) is well tolerated and has shown great promise as IPTp in HIV-negative women in East-Africa. Chemoprevention with monthly DP has also been explored in HIV-infected pregnant women on daily CTX in Uganda. Unfortunately, the study was inconclusive because malaria transmission was too low and a clinically relevant drug interaction with efavirenz (EFV) was found reducing the exposure to DP. WHO now recommends dolutegravir (DTG) based combination antiretroviral therapy (ARTs) as the preferred firstline regimen including for pregnant women in the 2nd and 3rd trimester of pregnancy for the prevention of mother-to-child transmission of HIV. As a result, many countries in Africa are now transitioning to DTG-based combination antiretroviral therapy (cARTs). No such drug-drug interaction is expected between DTG and DP. We will, therefore, assess the safety and efficacy of malaria chemoprevention with monthly DP in HIV-infected women on daily CTX and DTG-based cARTs.
Objectives and methods: This is a 2-arm, individually-randomized, multi-centre, placebo-controlled superiority trial comparing the safety and efficacy of daily CTX plus monthly DP ('CTX-DP') versus daily CTX plus monthly placebo-DP (i.e. 'CTX-alone', control arm) to reduce malaria and the adverse effects of malaria in 898 (449 per arm) HIV-infected pregnant women on DTG-based cARTs. The study will be conducted in 8 hospitals in Kenya and Malawi in high SP-resistance areas with a high prevalence of malaria. These are the same sites where the sister trial in HIV-uninfected women is being conducted in Kenya and Malawi (IMPROVE trial). Both the mother and baby will be followed for 6-8 weeks after delivery. The study is powered at 80% (alpha=0.05) to detect ≥50% relative risk reduction (RR=0.50) in the primary outcome (cumulative incidence of malaria infection) from 12% in the CTX-alone arm (control arm) to 6% in in the interventions arm allowing for 20% non-contributors. The trial includes a pharmacokinetic assessment, cardiac monitoring for safety, assessment of antimalarial drug and the impact on immune responses to malaria and other pathogens.
Detailed Description
2.3.4 Long technical protocol summary Title: Chemoprevention with monthly IPTp with dihydroartemisinin-piperaquine for malaria in HIV-infected pregnant participants on daily cotrimoxazole in Kenya and Malawi: a multi-centre placebo-controlled trial(IMPROVE-2).
Background and rationale: In malaria-endemic Africa, HIV and malaria conspire to increase the risks of adverse pregnancy outcomes. For HIV-infected pregnant women, WHO recommends daily cotrimoxazole (CTX) for chemoprevention for malaria and prophylaxis against opportunistic infection. However, there is cross-resistance with SP, and high levels of antifolate resistance threaten the antimalarial effect of CTX. Recent trials in HIV-infected pregnant women who received daily CTX plus IPTp with mefloquine, suggested that chemoprevention with an effective antimalarial markedly reduces the risk of malaria compared to daily CTX alone. However, mefloquine was not well tolerated. The long-acting combination of dihydroartemisinin-piperaquine (DP) is well tolerated and has shown great promise as IPTp in HIV-negative women in East-Africa. Chemoprevention with monthly DP has also been explored in HIV-infected women on daily CTX in Uganda. Unfortunately, the study was inconclusive as malaria transmission was too low. Furthermore, a clinically relevant drug-drug interaction between DP and efavirenz (EFV) was found to reduce DP drug levels. Following the recommendation from WHO, many countries in Africa are transitioning from EFV-based to dolutegravir (DTG) based combination antiretroviral therapy (cARTs). WHO now recommends DTG-based cARTS as the preferred first-line cART regimen in the 2nd and 3rd trimester of pregnancy. No such drug-drug interaction is expected between DTG and DP. We will therefore assess the safety and efficacy of malaria chemoprevention with monthly DP in HIV-infected women on daily CTX and DTG-based cARTs. We will therefore assess the safety and efficacy of malaria chemoprevention with monthly IPTp with DP in women on daily CTX and DTG-based cARTs and daily CTX.
Overall aim: To provide WHO with evidence on whether monthly IPTp-DP can improve current policies to control malaria in HIV-infected pregnant women on daily CTX in areas with high levels of parasite resistance and malaria in East and Southern Africa.
Primary objective: To determine if monthly IPTp-DP in HIV-infected pregnant women receiving daily CTX is safe and superior to daily CTX-alone for controlling malaria infection in areas with high antifolates resistance to SP and CTX in Malawi and Kenya.
Hypotheses: Monthly IPTp-DP in women receiving daily CTX is superior to daily CTX-alone in controlling malaria infection during pregnancy in HIV infected women on antiretroviral therapy.
Overview Study Design: This multi-centre trial will be conducted in antenatal clinics in 8 hospitals in Kenya and Malawi located in areas with high prevalence of HIV and malaria and with high anti-folate resistance of the malaria parasite. These are the same sites where the sister trial in HIV-uninfected women (all gravidae) is being conducted in Kenya and Malawi (IMPROVE trial: NCT03208179). Overall, 898 (449 per arm) HIV-infected pregnant women who are 16 to 28 weeks pregnant assessed by ultrasound dating, will be randomised to receive one of the two interventions. Permuted block randomisation stratified by site (i.e. hospital) and HIV-status (known-positive and newly-diagnosed) will be used. Allocation concealment will be ensured by using sequentially numbered, sealed, opaque envelopes. The study will include pharmacokinetic studies and cardiac monitoring in a sub group of women. Other components include molecular marker studies of antimalarial resistance. We will also look at the impact on biomarkers of placental function and trans-placental antibody transfer and multi-pathogen neonatal cell mediated immune responses.
Study Interventions: Daily CTX for all trial participants receiving cARTs in addition to: a) monthly-DP ('CTX-DP'), or b) monthly DP-placebo ('CTX-alone') (control).
Follow-up procedures: Monthly visits during pregnancy, and then at delivery. Mother and newborn follow-up at 7 days and 6-8 weeks post-partum.
Primary outcome: The cumulative incidence of malaria infection detected from 2 weeks after the first day of the first dose of the first course to delivery inclusive, defined as the presence of peripheral (maternal) or placental (maternal) Plasmodium infection detected by either molecular diagnostics (henceforth referred to as PCR), microscopy, RDT or placental histology (active infection).
Sample size: 898 (449 per arm), allowing for 20% loss to follow-up. Data Analysis: Log-binomial regression will be used to analyse the primary outcome, controlled for site and gravidity.
Primary partner institutions: KEMRI, Kenya; College of Medicine, University of Malawi, Malawi; Liverpool School of Tropical Medicine (LSTM); London School of Hygiene and Tropical Medicine (LSHTM); US Centers for Disease Control and Prevention (CDC); University of Bergen, Norway.
Funding: Joint Global Health Trials Scheme, Medical Research Council/Wellcome Trust/DFID, UK; and the European and Developing Countries Clinical Trials Partnership (EDCTP).
Sponsor: Liverpool School of Tropical Medicine (LSTM); Pembroke Place, Liverpool L3 5QA, UK, Phone: +44 0151 7053794; Email: lstmgov@lstmed.ac.uk.
#Intervention
- DRUG : Intermittent Preventive Therapy with Dihydroartemisinin-Piperaquine
- Monthly DP fixed dose of 3 tablets (40 mg of dihydroartemisinin and 320 mg of piperaquine) daily for three days until delivery. All participants will (continue to) receive daily cotrimoxazole (CTX) (one double-strength tablet of 160mg of sulfamethoxazole and 800mg of trimethoprim) and anti-retroviral drugs.
- Other Names :
- Monthly DP, D-artepp
|
#Eligibility Criteria:
Inclusion Criteria:
* HIV-infected pregnant women between 16 <= age <= 28 weeks' gestation
* Viable singleton pregnancy
* On or eligible for cARTs and CTX
* A resident of the study area
* Willing to adhere to scheduled and unscheduled study visit procedures
* Willing to deliver in a study clinic or hospital
* Provide written informed consent
Exclusion Criteria:
* Multiple pregnancies (i.e. twin/triplets)
* HIV-negative or HIV status unknown
* Known heart ailment
* Severe malformations or non-viable pregnancy if observed by ultrasound
* Participants with advanced HIV-disease at WHO clinical stage 3 and 4
* Confirmed or suspected TB infection,
* Unable to give consent
* Known allergy or contraindication to any of the study drugs
Sex :
FEMALE
Ages :
- Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : ADULT, OLDER_ADULT, CHILD
Accepts Healthy Volunteers:
Yes
|
NCT04158713
| 143,263 |
{
"NCT_ID" : "NCT03572985",
"Brief_Title" : "Development of Assessment Method for Driving Ability Using Driving Simulator in Healthy Volunteers #3",
"Official_title" : "Development of Assessment Method for Driving Ability Using Driving Simulator in Healthy Volunteers #3: Alcohol Calibration",
"Conditions" : ["Healthy Participants"],
"Interventions" : ["Other: Road-tracking test", "Other: Car-following test", "Other: Harsh-braking test"],
"Location_Countries" : ["Japan"],
"Study_Design" : {
"Study_Type" : "INTERVENTIONAL",
"Phase" : ["NA"],
"Primary_Purpose" : "OTHER",
"Allocation" : "RANDOMIZED",
"Interventional_Model" : "CROSSOVER",
"Masking" : "QUADRUPLE"
},
"Recruitment_Information" : {
"Study_Start_Date(Actual)" : "2018-06-27",
"Primary_Completion_Date(Actual)(Final_data_collection_date_for_primary_outcome_measure)" : "2019-01-31",
"Study_Completion_Date(Actual)" : "2019-01-31},
"Study_Record_Dates" : {
""Study_Registration_Dates" : {
"First_Submitted" : 2018-06-19",
"First_Posted(Estimated)" : 2018-06-28"
},
"Study_Record_Updates" : {
"Last_Updated_that_Met_QC_Criteria" : 2018-06-19",
"Last_Update_Posted(Estimated)" : 2025-02-28",
"Last_Verified" : 2019-11"
}
}}
|
#Study Description
Brief Summary
The purpose of this study is to collect alcohol calibration data for the driving simulator.
#Intervention
- OTHER : Road-tracking test
- Driving with simulator program for SDLP measurement
- OTHER : Car-following test
- Driving with simulator program for DCV measurement
- OTHER : Harsh-braking test
- Driving with simulator program for BRT measurement
|
#Eligibility Criteria:
Inclusion Criteria:
* Body mass index (BMI) >=18.5 and <25.0 kg/m^2 at screening inspection
* No visual impairment (enable to correct the vision with eyeglasses or contact lens)
* Receive a prior explanation on the study, able to accept its content, and capable to provide voluntary written consent for participation in this study
Exclusion Criteria:
* History of drug and food allergy
* Alcohol dependence, drug dependence or abnormal drunken (including past history)
* Inappropriate for enrollment in this study was judged by principal investigator or subinvestigator
Sex :
MALE
Ages :
- Minimum Age : 21 Years
- Maximum Age : 64 Years
- Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : ADULT
Accepts Healthy Volunteers:
Yes
|
NCT03572985
| 206,228 |
{
"NCT_ID" : "NCT01009606",
"Brief_Title" : "Cardiopulmonary Resuscitation Witnessing by a Relative",
"Official_title" : "Interest for a Relative of Seeing Himself Proposing to Witness Resuscitation of a Family Member Victim of a Cardiac Arrest",
"Conditions" : ["Cardiac Arrest"],
"Interventions" : ["Other: Modified strategy", "Other: Usual strategy"],
"Location_Countries" : ["France"],
"Study_Design" : {
"Study_Type" : "INTERVENTIONAL",
"Phase" : ["PHASE4"],
"Primary_Purpose" : "PREVENTION",
"Allocation" : "RANDOMIZED",
"Interventional_Model" : "PARALLEL",
"Masking" : "NONE"
},
"Recruitment_Information" : {
"Study_Start_Date(Actual)" : "2009-11",
"Primary_Completion_Date(Actual)(Final_data_collection_date_for_primary_outcome_measure)" : "2011-12",
"Study_Completion_Date(Actual)" : "2011-12},
"Study_Record_Dates" : {
""Study_Registration_Dates" : {
"First_Submitted" : 2009-11-06",
"First_Posted(Estimated)" : 2009-11-09"
},
"Study_Record_Updates" : {
"Last_Updated_that_Met_QC_Criteria" : 2009-11-06",
"Last_Update_Posted(Estimated)" : 2013-01-18",
"Last_Verified" : 2012-12"
}
}}
|
#Study Description
Brief Summary
The bereavement generated by the loss of a family member can induce pathological situations: depressive state, anxiety, post-traumatic stress disorder and complicated grief. These morbid factors can be influenced by the death circumstances and in particular by the possibility given to the family to attend the medical management of the patient. This clinical trial aims to evaluate the psychological consequences of bereavement on the relatives according to the possibility of witnessing the cardiopulmonary resuscitation of a family member. This possibility lies within the scope of a strategy of global management of the relatives.
Detailed Description
This clinical trial aims to compare the presence of post-traumatic stress disorder on a relative related to the death of a family member:
Test group: the medical team will propose to the relative to witness the cardiopulmonary resuscitation.
Control group: the medical team will not modify its usual management of care.
#Intervention
- OTHER : Usual strategy
- Usual strategy
- OTHER : Modified strategy
- Proposition to a relative to witness the cardiopulmonary resuscitation of a family member and debriefing ot the situation
|
#Eligibility Criteria:
Inclusion Criteria:
* Patient victim of a cardiac arrest and resuscitation initiated
* Occurrence of cardiac arrest at home
* Presence of a relative :
* husband or spouse
* father or mother
* son or daughter
* brother or sister
* Patient's age >= 18 years
* Relative's age >= 18 years
* Consent of the relative to the participation in the study
Exclusion Criteria:
* No understanding of the explanations (language problem, important agitation)
* Non-affiliated to social security
Sex :
ALL
Ages :
- Minimum Age : 18 Years
- Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : ADULT, OLDER_ADULT
Accepts Healthy Volunteers:
No
|
NCT01009606
| 135,457 |
{
"NCT_ID" : "NCT06524752",
"Brief_Title" : "Risk Factors for PONV in Patients Undergoing Hysteroscopic Surgery",
"Official_title" : "Risk Factors for Postoperative Nausea and Vomiting in Patients Undergoing Day-case Hysteroscopic Surgery",
"Conditions" : ["Gynecologic Nursing", "Postoperative Complications"],
"Interventions" : ["Other: The presence of nausea and vomiting within 24 hours after surgery", "Other: Non-existence of nausea and vomiting within 24 hours after surgery"],
"Location_Countries" : ["China"],
"Study_Design" : {
"Study_Type" : "OBSERVATIONAL",
},
"Recruitment_Information" : {
"Study_Start_Date(Actual)" : "2021-01-01",
"Primary_Completion_Date(Actual)(Final_data_collection_date_for_primary_outcome_measure)" : "2024-01-01",
"Study_Completion_Date(Actual)" : "2024-06-01},
"Study_Record_Dates" : {
""Study_Registration_Dates" : {
"First_Submitted" : 2024-07-22",
"First_Posted(Estimated)" : 2024-07-29"
},
"Study_Record_Updates" : {
"Last_Updated_that_Met_QC_Criteria" : 2024-07-26",
"Last_Update_Posted(Estimated)" : 2024-07-29",
"Last_Verified" : 2024-07"
}
}}
|
#Study Description
Brief Summary
The purpose of this study was to construct and validate a risk prediction model for PONV in patients undergoing hysteroscopic day-case surgery.
Detailed Description
This study predicted the risk of postoperative nausea and vomiting in patients undergoing day-case hysteroscopic surgery by constructing and validating a web-based dynamic nomogram.
#Intervention
- OTHER : The presence of nausea and vomiting within 24 hours after surgery
- This is a prospective risk prediction model building, thus there is no traditional definition of intervention.
- OTHER : Non-existence of nausea and vomiting within 24 hours after surgery
- This is a prospective risk prediction model building, thus there is no traditional definition of intervention.
|
#Eligibility Criteria:
Inclusion Criteria:
* Female patients undergoing hysteroscopic day-case surgery and aged 18 years.
Exclusion Criteria:
* Patients with intraoperative change of surgical method and unstable postoperative vital signs.
Sex :
FEMALE
Ages :
- Minimum Age : 18 Years
- Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : ADULT, OLDER_ADULT
Accepts Healthy Volunteers:
No
|
NCT06524752
| 168,608 |
{
"NCT_ID" : "NCT04716010",
"Brief_Title" : "Developing and Evaluating Product Messaging",
"Official_title" : "Developing and Evaluating Product Messaging",
"Conditions" : ["Cancer of Colon", "Cancer of Rectum"],
"Interventions" : ["Other: Warning Labels", "Other: Tax", "Other: Control", "Other: Combined Warning Labels and Tax"],
"Location_Countries" : ["United States"],
"Study_Design" : {
"Study_Type" : "INTERVENTIONAL",
"Phase" : ["NA"],
"Primary_Purpose" : "PREVENTION",
"Allocation" : "RANDOMIZED",
"Interventional_Model" : "PARALLEL",
"Masking" : "NONE"
},
"Recruitment_Information" : {
"Study_Start_Date(Actual)" : "2021-10-18",
"Primary_Completion_Date(Actual)(Final_data_collection_date_for_primary_outcome_measure)" : "2021-10-28",
"Study_Completion_Date(Actual)" : "2021-10-28},
"Study_Record_Dates" : {
""Study_Registration_Dates" : {
"First_Submitted" : 2021-01-14",
"First_Submitted_that_Met_QC_Criteria" : 2022-08-12",
"First_Posted(Estimated)" : 2021-01-20"
},
"Study_Record_Updates" : {
"Last_Updated_that_Met_QC_Criteria" : 2021-01-19",
"Last_Update_Posted(Estimated)" : 2023-08-18",
"Last_Verified" : 2021-08"
}
}}
|
#Study Description
Brief Summary
Purpose: To assess the impact of taxes, warnings, and a combination of taxes and warnings on US adults' decisions to purchase products that contain red meat in an online grocery store.
Procedures (methods): Participants will be recruited from Prime Panels (an online panel research company). Following online consent, participants will be assigned to one of four trial arms: 1) Control (no warning and no tax), 2) Warnings (all products that contain red meat have a health warning and environmental warning), 3) Tax (30% tax on products that contain red meat), and 4) Combined warning and tax (all products that contain red meat will have the two warnings and a 30% tax). Then, participant will enter an online grocery store reflecting their assigned arm. The participant will be instructed to complete a shopping task in the online grocery store. After completing the shopping task, participants will be redirected to an online survey and answer a series of questions about the shopping task, labels (excluding tax and control groups), and taxes (excluding warning and control groups). Questions will also include standard demographic and health related variables.
Detailed Description
Participants will be recruited from Prime Panels (an online panel research company). Following online consent, participants will be randomly assigned to one of four trial arms affecting the appearance of an online grocery store. Once in the online grocery store, participants will complete a shopping task. The participants will have 9 specified items to add to their shopping cart (1 pizza, 1 burrito, Burger patties \[meat or vegetarian\], Breakfast sausages \[meat or vegetarian\], 1 frozen individual meal, 1 loaf of bread, 1 sandwich filling \[for example, ham, turkey, or peanut butter\], 1 pack of tortillas, 1 taco filling \[for example, steak, chicken, or beans\]). Participants will be informed that they will not be spending any of their own money to complete the shopping task. After completing the shopping task, participants will be redirected to a survey. They will provide self-reported responses to survey questions (e.g. perceived healthfulness from eating red meat, perceived risk of cancer from eating red meat, thinking about the health/environmental harms of food products). Participants will also answer demographic and health related questions.
#Intervention
- OTHER : Control
- Participants will complete a shopping task in the online grocery store, and the products that contain red meat will not have warning labels or a 30% increase in price.
- OTHER : Warning Labels
- While completing the shopping task in the online grocery store, the health and environmental warning labels will appear next to the image of every product that contains red meat.
- OTHER : Tax
- While completing the shopping task in the online grocery store, all products containing red meat will have a 30% increase in price.
- OTHER : Combined Warning Labels and Tax
- While completing the shopping task in the online grocery store, all products containing red meat will have the health and environmental warning labels appear next to the product image and a 30% increase in price.
|
#Eligibility Criteria:
Inclusion Criteria:
* >= 18 years
* Consumes red meat at least once per week.
* Responsible for at least 50% of grocery shopping for the household.
* Lives in the United States
Exclusion Criteria:
* Individuals who have participated in research studies from previous aims of this research.
Sex :
ALL
Ages :
- Minimum Age : 18 Years
- Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : ADULT, OLDER_ADULT
Accepts Healthy Volunteers:
Yes
|
NCT04716010
| 117,578 |
{
"NCT_ID" : "NCT04082676",
"Brief_Title" : "Height Versus Height and Weight Based Spinal Bupivacaine on Maternal Haemodynamics for Elective Cesarean in Short Stature Patients",
"Official_title" : "Effect of Height Versus Height and Weight Based Intrathecal Bupivacaine Dose on Maternal Haemodynamics for Elective Caesarean Section in Short Stature Patients: A Randomized Trial",
"Conditions" : ["Maternal Hypotension After Spinal Anesthesia"],
"Interventions" : ["Drug: Hyperbaric bupivacaine spinal"],
"Location_Countries" : ["Nepal"],
"Study_Design" : {
"Study_Type" : "INTERVENTIONAL",
"Phase" : ["PHASE4"],
"Primary_Purpose" : "TREATMENT",
"Allocation" : "RANDOMIZED",
"Interventional_Model" : "PARALLEL",
"Masking" : "TRIPLE"
},
"Recruitment_Information" : {
"Study_Start_Date(Actual)" : "2019-11-30",
"Primary_Completion_Date(Actual)(Final_data_collection_date_for_primary_outcome_measure)" : "2021-09-01",
"Study_Completion_Date(Actual)" : "2021-09-01},
"Study_Record_Dates" : {
""Study_Registration_Dates" : {
"First_Submitted" : 2019-09-01",
"First_Posted(Estimated)" : 2019-09-09"
},
"Study_Record_Updates" : {
"Last_Updated_that_Met_QC_Criteria" : 2019-09-06",
"Last_Update_Posted(Estimated)" : 2022-03-22",
"Last_Verified" : 2022-03"
}
}}
|
#Study Description
Brief Summary
Doses of intrathecal bupivacaine based on patients either height or height and weight has shown to lower the risk of maternal hypotension with similar quality of anesthesia compared to conventional doses.
In clinical practice there is a tendency of reducing the dose of bupivacaine as either low fixed dose or using the doses based on either height and weight or height (0.06mg/cm) alone in parturient with short stature. However, there is lack of evidence regarding the appropriate dose required in this group of patients. Therefore, our aim is to compare the height versus height and weight based intrathecal bupivacaine dose for elective caesarean on maternal haemodynamics in short stature patients.
Detailed Description
Spinal induced hypotension in women undergoing caesarean section (CS) is the most common unwanted effect. The dose of intrathecal local anesthetic is the main determining factor that balances between successful block and an incidence of maternal hypotension. Although lowering the doses of intrathecal bupivacaine provides better maternal hemodynamic stability it compromises the quality of anesthesia. Moreover, there is no consensus regarding the cut-off at which the dose can be defined as low. Doses based on patients either height or height and weight has shown to lower the risk of maternal hypotension with similar quality of anesthesia compared to conventional doses.
In clinical practice there is a tendency of reducing the dose of bupivacaine as either low fixed dose or using the doses based on either height and weight or height (0.06mg/cm) alone in parturient with short stature. However, there is lack of evidence regarding the appropriate dose required in this group of patients.
Our aim is to compare the height versus height and weight based intrathecal bupivacaine dose for elective caesarean on maternal haemodynamics in short stature patients.
Doses of intrathecal bupivacaine for elective caesarean section based on Harten chart is available from the following reference- Harten JM, Boyne I, Hannah P, Varveris D, Brown A. Effects of a height and weight adjusted dose of local anaesthetic for spinal anaesthesia for elective Caesarean section. Anaesthesia 2005; 60: 348-53.
Consent for the participation in the study will be obtained during pre-anaesthetic assessment visits in the evening before surgery. The investigator will also educate the patients regarding the use of numeric rating scale scores. Preoperative anxiety will be recorded in numerical rating scale scores where 0 is no anxiety and 10 is maximum anxiety patient reported. The enrolled subjects will be randomly assigned to 2 equal groups (allocation ratio, 1:1) according to the codes generated from the website (www.sealedenvleop.com) using the variable block size of 4, 6 and 8. The group allocation will be concealed in sequentially numbered, sealed opaque envelopes that will be opened by the anaesthesia assistant not involved in the study only after the patient arrives in the operating room. The patient will be fasted for at least eight hours and will receive antibiotics, ranitidine 50 mg and metoclopramide 10 mg intravenously via 18-gauge cannula before transfer to the operation room. In the operating table patient will be laid supine with a wedge under right buttock and standard monitors (electrocardiography, pulse oximetry, and noninvasive BP) will be applied. Thereafter, successive three readings of heart rate (HR) and systolic blood pressure (SBP) will be taken at 2 minutes interval with difference not exceeding 10%. The average of these recordings will be documented by the investigators as baseline parameters. To maintain blinding, the investigator will leave the operating room and will return immediately once the spinal injection is initiated. Subarachnoid block will be performed by the attending anesthesiologist not involved in the study in the sitting position at the L3-L4 or L4-L5 vertebral interspace using a 25-gauge spinal needle via midline approach. The study solution will be administered according to the group allocated. In Group A the dose of heavy bupivacaine will be based on height and weight and in group B the dose will be based on patient's height (0.06 mg/cm). 10 microgram fentanyl will be added to bupivacaine in both groups.
#Intervention
- DRUG : Hyperbaric bupivacaine spinal
- In this group patient will receive intrathecal hyperbaric bupivacaine based on patients height and weight according to Harten chart with 10 μg of fentanyl (0.1 ml)
- DRUG : Hyperbaric bupivacaine spinal
- In this group will receive intrathecal hyperbaric bupivacaine based on patients height (0.06mg/cm) with 10 μg of fentanyl (0.1 ml)
|
#Eligibility Criteria:
Inclusion Criteria:
* Women with full-term gestation undergoing planned Caesarean section under spinal anesthesia
* Who provide consent .
* Height less than 150 cm
Exclusion Criteria:
* Patients with height <140 cm,
* Hypertensive disorders of pregnancy,
* Placental disorders,
* Body mass index >= 40 kg/m2,
* Diabetes mellitus
* Cardiovascular
* Cerebrovascular
* Hormonal disorder
* Renal disease
* Polyhydramnios
* Known case of bad obstetric history
* Fetal abnormalities
* Baseline systolic blood pressure (SBP) less than 100 mmHg
* Contraindication to spinal anaesthesia
* Allergy to any drug used in the study and
* Those unable to understand and sign the consent form
Sex :
FEMALE
Ages :
- Minimum Age : 18 Years
- Maximum Age : 40 Years
- Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : ADULT
Accepts Healthy Volunteers:
No
|
NCT04082676
| 2,375 |
{
"NCT_ID" : "NCT06981104",
"Brief_Title" : "Tear Film Stability and Improvement of Asthenopia: Efficacy Observation of 0.05% Cyclosporine in Dry Eye Patients With Short BUT",
"Official_title" : "A Randomized, Double-blind, Controlled Clinical Study on the Efficacy and Safety of 0.05% Cyclosporine Eye Drops in the Treatment of Mild to Moderate Dry Eye",
"Conditions" : ["Dry Eye Disease (DED)", "Asthenopia"],
"Interventions" : ["Drug: 0.05% cyclosporine eyedrops", "Drug: 0.1% sodium hyaluronate eye drop"],
"Location_Countries" : ["China"],
"Study_Design" : {
"Study_Type" : "INTERVENTIONAL",
"Phase" : ["NA"],
"Primary_Purpose" : "TREATMENT",
"Allocation" : "RANDOMIZED",
"Interventional_Model" : "PARALLEL",
"Masking" : "QUADRUPLE"
},
"Recruitment_Information" : {
"Study_Start_Date(Actual)" : "2024-11-18",
"Primary_Completion_Date(Actual)(Final_data_collection_date_for_primary_outcome_measure)" : "2025-02-14",
"Study_Completion_Date(Actual)" : "2025-02-14},
"Study_Record_Dates" : {
""Study_Registration_Dates" : {
"First_Submitted" : 2025-05-12",
"First_Posted(Estimated)" : 2025-05-20"
},
"Study_Record_Updates" : {
"Last_Updated_that_Met_QC_Criteria" : 2025-05-12",
"Last_Update_Posted(Estimated)" : 2025-05-20",
"Last_Verified" : 2024-11"
}
}}
|
#Study Description
Brief Summary
At present, research on cyclosporine mainly focuses on patients with moderate to severe dry eye. Based on the importance of the vicious cycle of inflammation in the pathogenesis of dry eye and the mechanism of cyclosporine, we believe that it may also have therapeutic effects in patients with mild to moderate dry eye, and may have certain advantages compared to traditional artificial tear therapy. In summary, this study intends to use a randomized, double-blind, parallel controlled trial to evaluate the therapeutic efficacy and safety of 0.05% cyclosporine eye drops in patients with mild to moderate dry eyes.
#Intervention
- DRUG : 0.05% cyclosporine eyedrops
- 0.05% cyclosporine, one drop each time, twice a day
- DRUG : 0.1% sodium hyaluronate eye drop
- 0.1% sodium hyaluronate, one drop each time, three times a day
|
#Eligibility Criteria:
Inclusion Criteria:
* 18 <= age <= 75 years (including 18 and 75 years), male or female;
* Meets the diagnostic criteria for dry eye syndrome in China (2020) and is mild dry eye 1) Dry Eye Questionnaire (OSDI) score >= 13 points; 2) BUT <= 10 seconds or Schirmer I <= 5mm/5 minutes 3) Corneal staining positive <= 5 points.
* At least one of OSDI, BUT, and Schirmer I meets the moderate standard OSDI >= 23 points; BUT<5 seconds; Schirmer I < 5mm/5min
* The subjects themselves signed an informed consent form and voluntarily participated in this study.
Exclusion Criteria:
* Women who are breastfeeding or pregnant, or men and women of childbearing age who are unable to use effective contraceptive methods during the study period;
* Those who need to wear contact lenses during treatment;
* Acute inflammation, infection, allergy, and trauma of the eyes;
* There are obvious scars or keratinization on the eyelid margin;
* Have undergone eye or eyelid surgery within the 6 months prior to enrollment;
* Diagnosed with facial nerve paralysis or ocular nerve paralysis within 6 months prior to enrollment;
* Currently using lacrimal duct embolization (permanent lacrimal plug or treatment with lacrimal plug within 6 months);
* I am currently taking medication that may affect dry eye syndrome.
Sex :
ALL
Ages :
- Minimum Age : 18 Years
- Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : ADULT, OLDER_ADULT
Accepts Healthy Volunteers:
No
|
NCT06981104
| 62,003 |
{
"NCT_ID" : "NCT01435343",
"Brief_Title" : "Treatment of Relapsed or Refractory Acute Myeloblastic Leukemia",
"Official_title" : "Multicenter, Prospective, Open-label, Single-arm, Phase I-II Clinical Trial to Analyze Induction Therapy With a Combination of Fludarabine, Idarubicin, Cytarabine, G-CSF and Plerixafor for the Treatment of Young Patients With Relapsed or Refractory AML",
"Conditions" : ["Acute Myeloblastic Leukemia"],
"Location_Countries" : ["Spain"],
"Study_Design" : {
"Study_Type" : "INTERVENTIONAL",
"Phase" : ["PHASE1", "PHASE2"],
"Primary_Purpose" : "TREATMENT",
"Allocation" : "NON_RANDOMIZED",
"Interventional_Model" : "SINGLE_GROUP",
"Masking" : "NONE"
},
"Recruitment_Information" : {
"Study_Start_Date(Actual)" : "2012-07",
"Primary_Completion_Date(Actual)(Final_data_collection_date_for_primary_outcome_measure)" : "2016-05",
"Study_Completion_Date(Actual)" : "2016-12},
"Study_Record_Dates" : {
""Study_Registration_Dates" : {
"First_Submitted" : 2011-09-14",
"First_Posted(Estimated)" : 2011-09-16"
},
"Study_Record_Updates" : {
"Last_Updated_that_Met_QC_Criteria" : 2011-09-15",
"Last_Update_Posted(Estimated)" : 2017-04-25",
"Last_Verified" : 2016-09"
}
}}
|
#Study Description
Brief Summary
Second-line induction therapy with fludarabine, idarubicin, cytarabine,Granulocyte colony-stimulating factor (G-CSF) and plerixafor, in patients with relapsed or refractory Acute Myeloblastic Leukemia (AML) aged 65 or younger.
Detailed Description
This protocol corresponds to a multicenter, open-label, non-randomized, Phase I-II study designed to determine the safety and efficacy of the combination of plerixafor with chemotherapy in young patients with relapsed or refractory AML.
The clinical trial is divided into pre-treatment and treatment periods (induction and consolidation cycle(s) and consists of two general phases: an initial Phase I in which escalating doses of plerixafor will be given to 4 groups, each with 3 patients; and a secondary Phase II in which an additional patient group will be treated with the maximum tolerated dose (MTD) from Phase I.
In the pre-treatment period, all patients who provide written informed consent will be screened and any patients who meet all the inclusion and none of the exclusion criteria will be eligible for treatment.
The patients who are finally included in the study should begin treatment within 7 days after signing the informed consent document (ICD). The pre-treatment period begins when the ICD is signed and enrollment occurs when the patient receives the first study drug of the treatment regimen (i.e., Day 1 of the induction cycle).
In this study, the induction cycle will consist of fludarabine 30 mg/m2/day intravenously on days 1 to 4, idarubicin 10 mg/m2/day intravenously on days 1 to 3, cytarabine 2 g/m2/day intravenously on days 1 to 4, G-CSF 5 μg/kg/day subcutaneously from days 1 to 4, and plerixafor intravenously from days 1 to 4. The dose of plerixafor will be escalated over 4 groups of three patients as follows: 240 μg/kg/day (120 μg/kg/12 h); 320 μg/kg/day (160 μg/kg/12 h); 400 μg/kg/day (200 μg/kg/12 h); and 480 μg/kg/day (240 μg/kg/12 h). If MTD is observed with the first treatment dose of plerixafor the dose will be progressively deescalated to 160 μg/kg/day (80μg/kg/12 h) on a first deescalating level or 240 μg/kg/day in a single daily dose on a second deescalating level if no twice a day (BID) dose is tolerated. Patient enrollment will be expanded to a total of 55 patients using MTD. If patients do not achieve CR after one induction cycle they will leave the study and be followed according to routine clinical practice. Patients who achieve complete response (CR) who are eligible for allogeneic hematopoietic stem cell transplantation (HSCT) and have a donor will leave the trial and receive allogeneic HSCT and will be followed according to routine clinical practice. Patients who achieve CR and are not eligible for allogeneic HSCT or do not have a donor will receive two consolidations with cytarabine at 3 g/m2/12 hours on days 1, 3 and 5 along with Granulocyte colony-stimulating factor (GCSF) at 5 μg/kg/day on days 1 to 5 and plerixafor at the same dose used in the induction cycle on days 1, 3 and 5, coinciding with the days that cytarabine is administered.
In the context of this protocol, a treatment cycle is defined as the first day of the study drug administration regimens (Day 1) up to and including the day before the first day of the treatment cycle immediately afterwards. The treatment cycles will begin after Day 28 but no later than Day 85, counting from Day 1 of the treatment cycle immediately before.
Patients will be assessed in the three days before each cycle (see Appendix A). Follow-up, outside the protocol in routine clinical practice, will be performed monthly during the first year and at least every three months during the second year; notwithstanding, visits may be more frequent at the discretion of each site or based on the clinical characteristics.
All treatment cycles will be administered while the patient is hospitalized. Clinical procedures for the care of patients with acute leukemia require flexibility. However, deviations from the study treatment defined in this section must be prospectively discussed with the coordinator.
#Intervention
- DRUG : fludarabine
- 30 mg/m2/day intravenously on days 1 to 4
- DRUG : Idarubicin
- 10 mg/m2/day intravenously on days 1 to 3
- DRUG : cytarabine
- 2 g/m2/day intravenously on days 1 to 4
- DRUG : G-CSF
- 5 μg/kg/day subcutaneously from days 1 to 4
- DRUG : plerixafor
- intravenously from days 1 to 4
|
#Eligibility Criteria:
Inclusion Criteria:
* Diagnosis of AML according to the WHO criteria
* Relapsed or refractory AML as defined below First relapse after standard treatment with duration of the first remission less than year
* Refractoriness to an induction cycle that includes cytarabine and anthracyclines
* Nonpromyelocytic leukemia (absence of t(15;17) or PML-RARα rearrangement and its variants)
* Peripheral blood blast cell count less than 50 x 109/L. Hydroxyurea and leukopheresis can be used to lower the blast count prior to beginning treatment
* Age <= 65 years and >= 18 years
* ECOG performance status of 0 <= age <= 2
* Provide signed written informed consent
* Be able to comply with study procedures and follow-up examinations
* Be nonfertile or agree to use birth control during the study through the end of last treatment visit
* Adequate renal and hepatic function as indicated by all of the following:
Total bilirubin <1.5 x Institutional Upper Limit of Normal (ULN); and AST and ALT <2.5 xULN; and Serum creatinine <1.0 mg/dL; if serum creatinine <1.0 mg/dL, then, the estimated glomerular filtration rate (GFR) must be <60 ml/min/1.73 m2 as calculated by the Modification of Diet in Renal Disease (MDRD) equation - Minimal impairment of cardiac function as measured by at least 1 of the following: Left ventricular ejection fraction (LVEF) >40% on multigated acquisition (MUGA) scan or radionuclide angiographic scan; or Left ventricular fractional shortening >22% on echocardiography exam;
Exclusion Criteria:
* Diagnosis of acute promyelocytic leukemia (APL, French-American-British [FAB] classification M3 or WHO classification of APL with t(15;17)(q22;q12), (PML/RARalfa and variants)
* AML secondary to previous treatment for myelodysplastic syndrome (MDS)
* Peripheral blood blast cell count >= 50 x 109/L. Hydroxyurea and leukopheresis can be used to lower the blast count prior to beginning treatment
* Prior investigational treatment within 30 days prior to the first dose of study drug. If any investigational treatment has been received prior to this time point, drug related toxicities must have recovered to Grade 1 or less prior to first dose of study drug
* Prior hematopoietic stem cell transplant (HSCT) (previous autologous hematopoietic stem cell transplant is allowed)
* Investigational agent received within 5 days prior to the first dose of study drug. If received any investigational agent prior to this time point, drug-related toxicities must have recovered to Grade 1 or less prior to first dose of study drug
* Impaired renal and liver function as indicated by the following:
Total bilirubin > 1.5 x upper limit of normal (ULN) provided that this is not attributable to AML itself; or AST and ALT > 2.5 xULN provided that this is not attributable to AML itself; or Serum creatinine > 1.0 mg/dL provided that the estimated glomerular filtration rate (GFR) is <= 60 mL/min/1.73 m2 as calculated by the Modification of Diet in Renal Disease (MDRD) equation
* Impaired cardiac function as measured by at least 1 of the following: Left ventricular ejection fraction (LVEF) < 40% on multigated acquisition (MUGA) scan or radionuclide angiographic scan; or Left ventricular fractional shortening < 22% on echocardiography exam;
* Poor overall condition ECOG 3 <= age <= 4
* Refusal to sign the informed consent
* Unable to comply with study procedures and follow-up examinations
* Psychiatric disorders that could interfere with consent, study participation or follow-up
* Systemic fungal, bacterial, viral, or other infection not controlled (defined as exhibiting ongoing signs/symptoms related to the infection and without improvement, despite appropriate antibiotics or other treatment)
* Diagnosis of another malignancy, unless the patient has been disease-free for at least 5 years following the completion of curative intent therapy with the following exceptions:
Patients with treated non-melanoma skin cancer, in situ carcinoma, or cervical intraepithelial neoplasia, regardless of the disease-free duration, are eligible for this study if definitive treatment for the condition has been completed Patients with organ-confined prostate cancer with no evidence of recurrent or progressive disease based on prostate-specific antigen (PSA) values are also eligible for this study if hormonal therapy has been initiated or a radical prostatectomy has been performed
* Clinical evidence suggestive of central nervous system (CNS) involvement with leukemia unless a lumbar puncture confirms the absence of leukemic blasts in the cerebrospinal fluid (CSF)
* Prior positive test for the human immunodeficiency virus (HIV)
* History of hypersensitivity to any of the study drugs
Sex :
ALL
Ages :
- Minimum Age : 18 Years
- Maximum Age : 65 Years
- Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : ADULT, OLDER_ADULT
Accepts Healthy Volunteers:
No
|
NCT01435343
| 146,097 |
{
"NCT_ID" : "NCT03104062",
"Brief_Title" : "Effect of Ticagrelor and Clopidogrel on Coronary Microcirculation in Patients With Acute Myocardial Infarction",
"Official_title" : "Effect of Ticagrelor and Clopidogrel on Coronary Microcirculation in Patients With Acute Myocardial Infarction",
"Conditions" : ["Coronary Microvascular Disease", "Ticagrelor", "Thrombolysis", "Microbubble Contrasted Echocardiography"],
"Interventions" : ["Diagnostic Test: Laboratory", "Diagnostic Test: Platelet Aggregability", "Diagnostic Test: Microbubble Contrasted Echocardiography"],
"Location_Countries" : ["Brazil"],
"Study_Design" : {
"Study_Type" : "INTERVENTIONAL",
"Phase" : ["NA"],
"Primary_Purpose" : "OTHER",
"Allocation" : "NON_RANDOMIZED",
"Interventional_Model" : "PARALLEL",
"Masking" : "NONE"
},
"Recruitment_Information" : {
"Study_Start_Date(Actual)" : "2016-10-01",
"Primary_Completion_Date(Actual)(Final_data_collection_date_for_primary_outcome_measure)" : "2018-02-01",
"Study_Completion_Date(Actual)" : "2018-02-01},
"Study_Record_Dates" : {
""Study_Registration_Dates" : {
"First_Submitted" : 2017-03-17",
"First_Posted(Estimated)" : 2017-04-07"
},
"Study_Record_Updates" : {
"Last_Updated_that_Met_QC_Criteria" : 2017-03-31",
"Last_Update_Posted(Estimated)" : 2018-05-18",
"Last_Verified" : 2018-05"
}
}}
|
#Study Description
Brief Summary
Of the patients diagnosed with ST-segment elevation myocardial infarction (STEMI) who underwent reperfusion therapy and have thrombolysis in myocardial infarction (TIMI) 3 flow, about 40% have flow alterations in the coronary microcirculation, which leads to worse remodeling of the left ventricle with a consequent increase in the mortality of this population. Clopidogrel is the only known antiplatelet medication that brings benefits to the coronary microcirculation. Ticagrelor is significantly superior to clopidogrel in terms of decreasing mortality.
The main objective of this study is to compare the effect of ticagrelor versus clopidogrel on the coronary microcirculation by the Myocardial Perfusion Score Index (MPSI) obtained using Microbubble Contrasted Echocardiography (MCE) in patients who have STEMI and treated with thrombolysis.
Detailed Description
The present project should prospectively include patients participating in the TREAT study, who are including individuals with Acute Myocardial Infarction (AMI) treated with fibrinolytic and openly randomized to ticagrelor or clopidogrel within 24 hours of the onset of symptoms. Patients will be submitted to coronary angiography within 4 (± 2) days of the onset of symptoms, and those who, at the end of coronary angiography, present residual obstruction in the culprit vessel of less than 50% and have TIMI 3 flow, regardless of have undergone percutaneous coronary intervention will be included.
Following, on day 2 (± 1) days after coronary angiography (therefore 6 ± 3 days from the onset of symptoms), they will be submitted to microcirculation perfusion evaluation by means of MPSI (myocardial perfusion score index) obtained by MCE (Microbubble contrasted echocardiography) - blood collection for evaluation of Platelet aggregability will be performed immediately prior to the start of MCE. Finally, in order to evaluate left ventricular remodeling, patients will undergo a new Echocardiography within 90 (± 10) days after discharge.
#Intervention
- DIAGNOSTIC_TEST : Microbubble Contrasted Echocardiography
- Myocardial Perfusion Score Index (MPSI) obtained using Microbubble Contrasted Echocardiography
- DIAGNOSTIC_TEST : Platelet Aggregability
- Obtained using Multiplate Analyzer
- DIAGNOSTIC_TEST : Laboratory
- it will be collected at patients arrival, Reative C-Protein, BNP, CK-mass, Troponine, interleukine-6, Creatinine.
|
#Eligibility Criteria:
Inclusion Criteria:
* age from 18 years to 75 years.
* Patients with a ST-segment elevation AMI with up to 24 hours duration, documented by ischemic symptoms due to atherosclerosis> 10 minutes at rest, treated with pharmacological thrombolysis, acetylsalicylic acid (ASA) and Clopidogrel or Ticagrelor.
* Cardiac catheterization performed within 4 (± 2) days of the onset of symptoms, which at the end of coronary angiography showed residual obstruction in the 'culprit' artery <50% with TIMI 3 flow regardless of whether or not the percutaneous coronary intervention was performed.
Exclusion Criteria:
* Previous infarction known from the same wall as the current one
* Any contraindication to the use of Clopidogrel or Ticagrelor
* Need for oral anticoagulation therapy or aspirin doses greater than 100mg per day.
* Concomitant oral or intravenous therapy with strong inhibitors of Cytochrome P450, family 3, subfamily A (CYP3A), Substrates of CYP3A with narrow therapeutic indices or strong inducers of CYP3A
* High risk of bradyarrhythmias
* Dialysis therapy
* Clinically important thrombocytopenia known
* Clinically Significant Anemia
* Pregnancy or lactation
* Contraindications to fibrinolytic therapy
Sex :
ALL
Ages :
- Minimum Age : 18 Years
- Maximum Age : 75 Years
- Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : ADULT, OLDER_ADULT
Accepts Healthy Volunteers:
No
|
NCT03104062
| 252,034 |
{
"NCT_ID" : "NCT02513641",
"Brief_Title" : "Effect of 2-Week Nightly Moderate Hypoxia on Glucose Tolerance in Individuals With Type 2 Diabetes",
"Official_title" : "Effect of 2-Week Nightly Moderate Hypoxia on Oral Glucose Tolerance in Individuals With Type 2 Diabetes",
"Conditions" : ["Type 2 Diabetes"],
"Interventions" : ["Device: Hypoxico Altitude Training Systems"],
"Location_Countries" : ["United States"],
"Study_Design" : {
"Study_Type" : "INTERVENTIONAL",
"Phase" : ["NA"],
"Primary_Purpose" : "TREATMENT",
"Allocation" : "NA",
"Interventional_Model" : "SINGLE_GROUP",
"Masking" : "NONE"
},
"Recruitment_Information" : {
"Study_Start_Date(Actual)" : "2015-12",
"Primary_Completion_Date(Actual)(Final_data_collection_date_for_primary_outcome_measure)" : "2018-04",
"Study_Completion_Date(Actual)" : "2020-09},
"Study_Record_Dates" : {
""Study_Registration_Dates" : {
"First_Submitted" : 2015-07-28",
"First_Submitted_that_Met_QC_Criteria" : 2019-10-11",
"First_Posted(Estimated)" : 2015-07-31"
},
"Study_Record_Updates" : {
"Last_Updated_that_Met_QC_Criteria" : 2015-07-30",
"Last_Update_Posted(Estimated)" : 2020-10-12",
"Last_Verified" : 2020-09"
}
}}
|
#Study Description
Brief Summary
The purpose of this study is to determine if 2 weeks of nightly exposure (7-12 hours per night) to moderate hypoxia (\~2,400 meters or 7,500 feet) improves glucose metabolism in people with type 2 diabetes.
Detailed Description
Exposure to hypoxia has been advocated as a possible therapeutic aid against obesity. Indeed, our laboratory has provided the first evidence that intermittent, nightly exposure to moderate hypoxia is beneficial in improving insulin sensitivity in healthy obese patients and, therefore, lowers the risk of developing type 2 diabetes. Benefits included reduced fasting glucose levels and improved whole-body (skeletal muscle) and hepatic insulin sensitivity. Whether such intermittent hypoxia improves glucose metabolism in people with type 2 diabetes is unknown.
#Intervention
- DEVICE : Hypoxico Altitude Training Systems
- Participants will sleep in a tent (which will fit his/her personal mattress) simulating an altitude of \~2,400 meters for 7-12 hours each night for a period of 14 days. Baseline testing measures will include a oral glucose tolerance test (OGTT) and body composition (iDXA). Post-treatment testing measures will include OGTT only.
|
#Eligibility Criteria:
INCLUSION CRITERIA:
* Aged 20 <= age <= 65 yrs
* Body mass index (BMI) < 55 kg/m2
* Body weight 450 lbs or less (to accommodate body composition assessment)
* Have either been diagnosed with type 2 diabetes, or fasting blood glucose between 125 and 200 mg/dL, or have a hemoglobin A1c >= 6.5%
* Non-smokers
* Weight stable over the previous 3 months (<3 kg fluctuation)
* Known diagnosis of sleep apnea and ownership of a continuous positive airway pressure (C-PAP) device that must be worn throughout the nights spent in the tent
* If no known presence of sleep apnea, be willing to spend one night in a sleep laboratory (Louisiana Sleep Foundation) to assess presence of sleep apnea
EXCLUSION CRITERIA:
* Diagnosed with T2DM >= 15 years ago
* Pregnant Women
* Current insulin treatment
* Treatment with sulfonylureas or glitinides
* Treatment with a GLP-1 agonist
* Any other diabetes medication other than an oral agent is exclusionary unless otherwise cleared by medical investigator.
* Chronic Obstructive Pulmonary Disease (COPD)
* Congestive heart failure
* Prior severe cardiovascular events such as stroke or myocardial infarction
* If treated for T2DM with other oral agent, no change in the treatment for 1 month before the study and the duration of the study
* Previously known diagnosis of sleep apnea without ownership of a continuous positive airway pressure (C-PAP) device or agreement to use owned CPAP device during the nights spent in the tent
* Presence of sleep apnea following a positive home sleep test (HST), or have unsafe oxyhemoglobin saturation levels (less than 78%) during a one night sleep monitoring assessment conducted at the Louisiana Sleep Foundation without ownership of a continuous positive airway pressure (C-PAP) device or agreement to use owned C-PAP device during the nights spent in the tent
* History of high altitude sickness
* History of altitude sickness
* Does not have access to a bed or sleeping surface equivalent to or smaller than a queen size mattress
Sex :
ALL
Ages :
- Minimum Age : 20 Years
- Maximum Age : 65 Years
- Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : ADULT, OLDER_ADULT
Accepts Healthy Volunteers:
Yes
|
NCT02513641
| 98,734 |
{
"NCT_ID" : "NCT05494827",
"Brief_Title" : "The Impact of a Regular Borjomi® Consumption on an Anaerobic Performance",
"Official_title" : "The Impact of a Regular Mineral Water With a High Content of Sodium Bicarbonate (Borjomi®) Consumption on Anaerobic Performance",
"Conditions" : ["Healthy"],
"Interventions" : ["Other: Regular consumption of still drinking water", "Other: Regular consumption of natural mineral water Borjomi® with high bicarbonate content", "Other: Regular consumption of processed drinking water Smart Spring®"],
"Location_Countries" : ["Russian Federation"],
"Study_Design" : {
"Study_Type" : "INTERVENTIONAL",
"Phase" : ["NA"],
"Primary_Purpose" : "BASIC_SCIENCE",
"Allocation" : "RANDOMIZED",
"Interventional_Model" : "PARALLEL",
"Masking" : "SINGLE"
},
"Recruitment_Information" : {
"Study_Start_Date(Actual)" : "2020-07-01",
"Primary_Completion_Date(Actual)(Final_data_collection_date_for_primary_outcome_measure)" : "2020-09-30",
"Study_Completion_Date(Actual)" : "2020-12-31},
"Study_Record_Dates" : {
""Study_Registration_Dates" : {
"First_Submitted" : 2022-08-08",
"First_Posted(Estimated)" : 2022-08-10"
},
"Study_Record_Updates" : {
"Last_Updated_that_Met_QC_Criteria" : 2022-08-08",
"Last_Update_Posted(Estimated)" : 2022-08-10",
"Last_Verified" : 2022-08"
}
}}
|
#Study Description
Brief Summary
The effects of 2 weeks 1000 ml daily mineral water Borjomy® consumption of anaerobic performance and acid-base balance in comparison with purified electrolite smart-water and still drinking water.
Detailed Description
Bicarbonate supplementation increases the efficiency of the body's buffer systems and improves anaerobic performance in athletes when taking bicarbonate just before training. In the course of studies, a similar effect was confirmed for professional swimmers at a distance of 200 meters freestyle, cyclists at distances up to 3 km and track and field athletes in steeplechase. However, these studies were conducted on professional male athletes, and it is interesting to compare the effects with non-athletes population.
Borjomi® is a natural bicarbonate sodium mineral water with high taste qualities. The effects of Borjomi® as bicarbonate source on physical performance are another research interest.
The aim of this study was to evaluate the comparative effectiveness of the regular use of bicarbonate-containing mineral water (Borjomi®) on anaerobic performance and acid-base balance during short-term physical activity of high intensity in comparison with purified electrolite smart-water and still drinking water.
#Intervention
- OTHER : Regular consumption of natural mineral water Borjomi® with high bicarbonate content
- Natural mineral water Borjomi® is a transparent mineral water with specific alkaline taste and smell. The chemical composition includes sodium hydrocarbonate (HCO2-) 3995 mg/l (3500-5000 mg/l), chlorides (Cl-) 360 mg/l (250-500 mg/l), and nitrites (NO2-) \<0.005 mg/l (up to 1 mg/l). The 'Borjomi' water was packaged into standardized unlabeled 500 ml bottles. Participants were prescribed with 2 bottles (1000 ml) of daily consumption for 14 days. In order to maintain their usual water regimen, the participants additionally consumed steal drinking water on demand. The day before testing, participants were asked to abstain from their routine training and other physical activities.
- Other Names :
- Borjomi
- OTHER : Regular consumption of processed drinking water Smart Spring®
- Processed drinking water Smart Spring® has no colour and smell with delicate specific taste. The chemical composition includes sodium (Na+) 33.6 mg/l, magnesium (Mg2+) 10.03 mg/l, calcium (Ca2+) 34.57 mg/l, chlorides (Cl-) 69.79 mg/l, sulfates (SO42-) 22.00 mg/l, and hydrocarbonates (HCO2-) 96.48 mg/l. The Smart Spring® water was packaged into standardized unlabeled 500 ml bottles. Participants were prescribed with 2 bottles (1000 ml) of daily consumption for 14 days. In order to maintain their usual water regimen, the participants additionally consumed steal drinking water on demand. The day before testing, participants were asked to abstain from their routine training and other physical activities.
- Other Names :
- Smart Spring®
- OTHER : Regular consumption of still drinking water
- Still drinking water Святой Источник®is a standard steal drinking water, that has no colour, taste, and smell. The Святой Источник® water was packaged into standardized unlabeled 500 ml bottles. Participants were prescribed with 2 bottles (1000 ml) of daily consumption for 14 days. In order to maintain their usual water regimen, the participants additionally consumed steal drinking water on demand. Participants were asked to abstain from mineral water consumption for the entire observation period.
- Other Names :
- Water
|
#Eligibility Criteria:
Inclusion Criteria:
* Normal body weight (BMI >=18 <= age <= 24.90 kg/m2).
* Regular physical activity - at least 150 minutes of exercise per week in 2 and more trainings.
Exclusion Criteria:
* Peak oxygen consumption less than 50% of the norm (adjusted for sex and age).
* Allergic reactions to latex.
* Smokers or quit-smokers (less than 6 month of withdrawal).
* Any vitamin, sport or food supplementation in 3 month prior to participation.
* Any low-limb trauma in 6 month prior to participation.
* Any chronic diseases on permanent treatment.
Sex :
ALL
Ages :
- Minimum Age : 18 Years
- Maximum Age : 45 Years
- Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : ADULT
Accepts Healthy Volunteers:
Yes
|
NCT05494827
| 34,013 |
{
"NCT_ID" : "NCT03386279",
"Brief_Title" : "A Study To Determine The Effect Of Single-dose PF-04965842 On QTc Interval In Healthy Volunteers Compared With Placebo and Moxifloxacin",
"Official_title" : "A PHASE 1, RANDOMIZED, PLACEBO-AND POSITIVE-CONTROLLED CROSSOVER STUDY TO DETERMINE THE EFFECT OF SINGLE-DOSE PF-04965842 ON QTC INTERVAL IN HEALTHY VOLUNTEERS",
"Conditions" : ["Healthy Volunteers"],
"Interventions" : ["Drug: Placebo", "Drug: PF-04965842", "Drug: Moxifloxacin"],
"Location_Countries" : ["Belgium"],
"Study_Design" : {
"Study_Type" : "INTERVENTIONAL",
"Phase" : ["PHASE1"],
"Primary_Purpose" : "OTHER",
"Allocation" : "RANDOMIZED",
"Interventional_Model" : "CROSSOVER",
"Masking" : "QUADRUPLE"
},
"Recruitment_Information" : {
"Study_Start_Date(Actual)" : "2018-07-02",
"Primary_Completion_Date(Actual)(Final_data_collection_date_for_primary_outcome_measure)" : "2018-10-01",
"Study_Completion_Date(Actual)" : "2018-10-01},
"Study_Record_Dates" : {
""Study_Registration_Dates" : {
"First_Submitted" : 2017-12-21",
"First_Posted(Estimated)" : 2017-12-29"
},
"Study_Record_Updates" : {
"Last_Updated_that_Met_QC_Criteria" : 2017-12-21",
"Last_Update_Posted(Estimated)" : 2019-10-14",
"Last_Verified" : 2019-10"
}
}}
|
#Study Description
Brief Summary
This is a Phase 1, single-dose, randomized, 3-treatment, 3-period cross-over, sponsor-open, placebo-and positive-controlled trial to be conducted in approximately 36 adult healthy volunteers. There will be 3 crossover treatments: PF-04965842 600 mg (A), placebo (B) and moxifloxacin 400 mg (C). Treatment assignments to PF-04965842 and placebo will be blinded to the subjects, investigator and Clinical Research Unit (CRU) staff (except pharmacist) but open to the sponsor. Moxifloxacin administration will be unblinded. Dosing in each of the 3 treatment periods will be separated by a washout period of at least 5 days
Screening evaluation will occur within the 28 days prior to dosing in the first treatment period. During each treatment period, eligible subjects who meet the entry criteria will be admitted on Day -1, prior to treatment administration on Day 1, and will reside in the CRU until completion of protocol assessments on Day 2. There will be a washout of at least 5 days between dose administrations in consecutive crossover treatment periods. After completion of the 3 study periods or upon withdrawal from the study, subjects will return for a follow-up visit approximately 7-14 days following last dose of investigational product. Further follow-up contact will be made at least 28 calendar days and up to 35 calendar days after the last administration of the investigational product to capture any potential AEs and concomitant treatments, and to confirm appropriate contraception usage, contact with the subject may be done via phone. For each subject, the duration of participation from Day 1 admission to follow-up visit will be approximately 10 weeks. The follow-up call will occur up to 4 weeks after the follow-up visit.
In each treatment period, the subject will be admitted to the CRU the day prior to dosing. Genotyping samples for CYP2C19 and CYP2C9 will be collected pre-dose in Period 1 only. The subject will receive a single dose of the assigned trial medication in the morning of Day 1. Triplicate 12-lead ECG measurements (approximately 2 minutes apart) will be performed on Days 1 and 2 of each treatment period as follows: -1, -0.5 and 0 hours pre-dose and at 0.25, 0.5, 1, 2, 3, 6, 12, and 24 hours post-dose. Blood samples will be collected following the 0 hour and post-dose ECG measurements at the same time-points to evaluate the PK of PF-04965842 and moxifloxacin (if needed). Clinical safety laboratory tests will be performed on Day -1 and at 24 hours on Day 2, and vital signs (supine pulse rate and BP) will be monitored pre-dose and at 2 and 6 hours post-dose on Day 1 and at 24 hours on Day 2. The subject will be discharged from the CRU after completing all trial procedures of the particular treatment period in the morning of Day 2 (24 hours post-dose).
#Intervention
- DRUG : PF-04965842
- one single dose of 600 mg by mouth
- DRUG : Moxifloxacin
- one single dose of 400 mg by mouth
- DRUG : Placebo
- one single dose by mouth
|
#Eligibility Criteria:
Inclusion Criteria:
* Healthy female subjects of nonchildbearing potential and/or male subjects who, at the time of screening, are between the ages of 18 and 55 years, inclusive. Healthy is defined as no clinically relevant abnormalities identified by a detailed medical history, full physical examination, including BP and pulse rate measurement, 12-lead
ECG, or clinical laboratory tests. Female subjects of nonchildbearing potential must meet at least 1 of the following criteria:
1. Achieved postmenopausal status, defined as follows: cessation of regular menses for at least 12 consecutive months with no alternative pathological or physiological cause; status may be confirmed with a serum follicle-stimulating hormone (FSH) level confirming the postmenopausal state;
2. Have undergone a documented hysterectomy and/or bilateral oophorectomy;
3. Have medically confirmed ovarian failure. All other female subjects (including female subjects with tubal ligations) are considered to be of childbearing potential.
* Body mass index (BMI) of 17.5 to 30.5 kg/m2; and a total body weight >50 kg (110 lb).
* Evidence of a personally signed and dated informed consent document indicating that the subject has been informed of all pertinent aspects of the study.
* Subjects who are willing and able to comply with all scheduled visits, treatment plan, laboratory tests, and other study procedures.
Exclusion Criteria:
* Evidence or history of clinically significant hematological, renal, endocrine, pulmonary, gastrointestinal, cardiovascular, hepatic (including alcoholic liver disease, nonalcoholic steatohepatitis (NASH), autoimmune hepatitis, and hereditary liver diseases), psychiatric, neurological, or allergic disease (including drug allergies, but excluding untreated, asymptomatic, seasonal allergies at the time of dosing).
* Evidence or history of clinically significant dermatological condition (eg, contact dermatitis or psoriasis) or visible rash present during physical examination.
* Subjects, who according to the product label for moxifloxacin, would be at increased risk if dosed with moxifloxacin (ie, including but not limited to subjects with history of myasthenia gravis, tendinitis/tendon rupture).
* Self-reported history or risk factors for QT prolongation or torsades de pointes (eg, organic heart disease, congestive heart failure, hypokalemia, hypomagnesaemia, congenital long QT syndrome, myocardial ischemia or infarction), congenital deafness, family history of sudden death, and family history of long QT syndrome.
* Any condition possibly affecting drug absorption (eg, gastrectomy).
* A positive urine drug test.
* History of regular alcohol consumption exceeding 14 drinks/week for female subjects or 21 drinks/week for male subjects (1 drink = 5 ounces [150 mL] of wine or 12 ounces [360 mL] of beer or 1.5 ounces [45 mL] of hard liquor) within 6 months before screening.
* Treatment with an investigational drug within 30 days (or as determined by the local requirement) or 5 half-lives preceding the first dose of investigational product (whichever is longer).
* Subjects with known prior participation (ie, randomized and received at least 1 dose of investigational product) in a trial involving PF-04965842.
* Screening supine systolic BP <90 mm Hg or <140 mm Hg following at least 5 minutes of supine rest OR Screening supine diastolic BP <50 mm Hg or <90 mm Hg following at least 5 minutes of supine rest. If a subject meets any of these criteria, the BP should be repeated 2 more times and the average of the 3 BP values should be used to determine the subject's eligibility.
* Screening supine 12-lead ECG demonstrating: QTcF >450 msec OR QRS interval >120 msec. If QTcF exceeds 450 msec, or QRS exceeds 120 msec, the ECG should be repeated 2 more times and the average of the 3 QTcF or QRS values should be used to determine the subject's eligibility.
* Subjects with ANY of the following abnormalities in clinical laboratory tests at screening, as assessed by the study-specific laboratory and confirmed by a single repeat test, if deemed necessary:
Aspartate aminotransferase (AST)/serum glutamic oxaloacetic transminase (SGOT) or alanine aminotransferase (ALT)/serum glutamic pyruvic transminase (SGPT) <1.5 × upper limit of normal (ULN).
Total bilirubin level 1.5 × ULN; subjects with a history of Gilbert's syndrome may have direct bilirubin measured and would be eligible for this study provided the direct bilirubin level is ULN.
* Known relevant history of elevated liver function tests (LFTs).
* History of tuberculosis (TB) or active or latent or inadequately treated infection.
* Fertile male subjects who are unwilling or unable to use a highly effective method of contraception as outlined in this protocol for the duration of the study and for at least 28 days after the last dose of investigational product.
* Use of prescription or nonprescription drugs and dietary supplements within 7 days or 5 half-lives (whichever is longer) prior to the first dose of investigational product. As an exception, acetaminophen/paracetamol may be used at doses of 1g/day. Limited use of nonprescription medications that are not believed to affect subject safety or the overall results of the study may be permitted on a case-by-case basis following approval by the sponsor. Herbal supplements and hormone replacement therapy must have been discontinued at least 28 days prior to the first dose of investigational product.
* Use of tobacco- or nicotine- containing products in excess of the equivalent of 5 cigarettes per day.
* Blood donation (excluding plasma donations) of approximately 1 pint (500 mL) or more within 60 days prior to dosing.
* History of hypersensitivity, allergy, severe adverse drug reaction or intolerance to quinolone antibiotics, including moxifloxacin.
* History of human immunodeficiency virus (HIV), hepatitis B, or hepatitis C; positive testing for HIV, hepatitis B surface antigen (HepBsAg), hepatitis B core antibody (HepBcAb), or hepatitis C antibody (HCVAb). As an exception, a positive hepatitis B surface antibody (HepBsAb) finding as a result of subject vaccination is permissible.
* Unwilling or unable to comply with the criteria in the Lifestyle Requirements section of this protocol.
* Subjects who are investigator site staff members directly involved in the conduct of the study and their family members, site staff members otherwise supervised by the investigator, or subjects who are Pfizer employees, including their family members, directly involved in the conduct of the study.
* Other acute or chronic medical or psychiatric condition including recent (within the past year) or active suicidal ideation or behavior or laboratory abnormality that may increase the risk associated with study participation or investigational product administration or may interfere with the interpretation of study results and, in the judgment of the investigator, would make the subject inappropriate for entry into this study.
Sex :
ALL
Ages :
- Minimum Age : 18 Years
- Maximum Age : 55 Years
- Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : ADULT
Accepts Healthy Volunteers:
Yes
|
NCT03386279
| 185,798 |
{
"NCT_ID" : "NCT00194688",
"Brief_Title" : "Breath Ammonia Method for H. Pylori Detection: Phase II",
"Official_title" : "Breath Ammonia Method for H. Pylori Detection: Phase II",
"Conditions" : ["Helicobacter Infections"],
"Location_Countries" : ["United States"],
"Study_Design" : {
"Study_Type" : "INTERVENTIONAL",
"Phase" : ["PHASE2"],
"Primary_Purpose" : "DIAGNOSTIC",
"Allocation" : "NON_RANDOMIZED",
"Interventional_Model" : "PARALLEL",
"Masking" : "SINGLE"
},
"Recruitment_Information" : {
"Study_Start_Date(Actual)" : "2003-03",
"Study_Completion_Date(Actual)" : "2005-06},
"Study_Record_Dates" : {
""Study_Registration_Dates" : {
"First_Submitted" : 2005-09-13",
"First_Posted(Estimated)" : 2005-09-19"
},
"Study_Record_Updates" : {
"Last_Updated_that_Met_QC_Criteria" : 2005-09-13",
"Last_Update_Posted(Estimated)" : 2008-01-11",
"Last_Verified" : 2008-01"
}
}}
|
#Study Description
Brief Summary
The objective is to evaluate the utility of a breath ammonia sensing device. In this study we will assess the effect of H. pylori infection on breath ammonia levels by measuring whether there is a change in the pattern or quantity of breath ammonia seen in H. pylori positive patients compared to H. pylori negative patients.
Detailed Description
Healthy volunteers will undergo testing for H. pylori infection using a 14-C urea breath test, and the results will be compared to an experimental ammonia breath test. The breath sample will be collected by an investigational device that the patient will be exposed to consisting of a plastic mouth-piece which is attached to a T-tubing section having a side-arm port through which a fiberoptic ammonia sensor is inserted inside the tube. To meet the Phase II specific aim, the scope of the clinical trials is expanded addressing the following specific objectives:
* Test refinements of the sensing system (hardware, software, \& breath test device)
* Determine whether a urea dose-response effect exists following urea ingestion,
* Define the optimal cutoff values for expired breath ammonia to allow optimal discrimination of H. pylori infected vs. uninfected persons.
* Determine the appropriate time interval for breath ammonia testing following urea ingestion.
* Determine whether there is a change in breath ammonia level after H. pylori treatment.
#Intervention
- DRUG : H. pylori treatment
|
#Eligibility Criteria:
Inclusion Criteria:
* Adult volunteers not meeting exclusion criteria
Exclusion Criteria:
* Known cirrhosis of the liver
* Renal insufficiency (BUN greater than 40 mg/dl, Creatinine greater than 2.0 mg/dl).
* Prior gastric resection
* Severe chronic obstructive pulmonary disease (Forced expiratory volume in 1 second less than 1.5 L)
* Patients unwilling or unable to discontinue proton pump inhibitors for 2 weeks prior to scheduled 14C or non-isotopic urea breath testing
* Patients who have received antibiotics or bismuth within the preceding month.
* Patients unwilling or unable to give informed consent
* Pregnant women (14C urea breath test is not approved for use in pregnant women)
* Age less than 21 years (14C urea breath test is not approved for use in children)
Sex :
ALL
Ages :
- Minimum Age : 21 Years
- Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : ADULT, OLDER_ADULT
Accepts Healthy Volunteers:
Yes
|
NCT00194688
| 215,258 |
{
"NCT_ID" : "NCT04672538",
"Brief_Title" : "Fontan Physiology Ventilation Strategy",
"Official_title" : "Impact of Fontan Ventilation Strategy on Cardiac Output: An Invasive Physiologic Cross-over Study",
"Conditions" : ["Anesthesia", "Congenital Heart Disease"],
"Interventions" : ["Procedure: Low Vt protocol", "Procedure: High Vt protocol"],
"Location_Countries" : ["United States"],
"Study_Design" : {
"Study_Type" : "INTERVENTIONAL",
"Phase" : ["NA"],
"Primary_Purpose" : "SUPPORTIVE_CARE",
"Allocation" : "RANDOMIZED",
"Interventional_Model" : "CROSSOVER",
"Masking" : "NONE"
},
"Recruitment_Information" : {
"Study_Start_Date(Actual)" : "2021-03-02",
"Primary_Completion_Date(Actual)(Final_data_collection_date_for_primary_outcome_measure)" : "2023-03-14",
"Study_Completion_Date(Actual)" : "2023-05-15},
"Study_Record_Dates" : {
""Study_Registration_Dates" : {
"First_Submitted" : 2020-12-08",
"First_Posted(Estimated)" : 2020-12-17"
},
"Study_Record_Updates" : {
"Last_Updated_that_Met_QC_Criteria" : 2020-12-16",
"Last_Update_Posted(Estimated)" : 2023-05-17",
"Last_Verified" : 2023-05"
}
}}
|
#Study Description
Brief Summary
This study will investigate the different tidal volume (Vt) strategies during a cardiac catheterization procedure to determine whether or not low or high Vt have an impact on cardiac output.
Research question: While maintaining the same minute ventilation/PaCO2, does higher Vt (10 cc/kg)/lower rate vs. lower Vt (6 cc/kg)/higher rate (maintaining consistent PEEP) result in improved cardiac output?
Detailed Description
The trial will be a randomized crossover design. The study cohort will be randomized (50/50) to begin with either low Vt or high Vt ventilation. After achieving steady state, initial cardiac output measurements will be made using a measured oxygen consumption (VO2) and the Fick principle, per routine clinical protocol. Following baseline assessment of cardiac output and hemodynamics (which is standard of care for all catheterization procedures), participants will be transitioned to the alternative ventilation modality (high Vt or low Vt). After a 5-minute equilibration period, oxygen saturations and VO2 measurements will be re-acquired, to determine cardiac output and hemodynamics in this second state.
#Intervention
- PROCEDURE : Low Vt protocol
- Low Vt protocol - tidal volumes (Vt) 6 ml/kg, respiratory rate required for end tidal carbon dioxide (EtCO2) of 36-38 mmHg, PEEP 5 centimeter of water (cm-H20) , I:E ratio 1:2
- PROCEDURE : High Vt protocol
- High Vt protocol - tidal volumes (Vt) 10 ml/kg, respiratory rate required for EtCO2 of 36-38 mm Hg, PEEP 5 cmH2O, I:E ratio 1:3.
|
#Eligibility Criteria:
Inclusion Criteria:
* Patients of UPMC Children's Hospital of Pittsburgh that have Fontan physiology (single heart ventricle) that are presenting as outpatients to undergo a cardiac catheterization with general endotracheal anesthesia for purpose of diagnosis or interventional cath.
* Parents and/or guardians willing to provide informed consent.
Exclusion Criteria:
* Those unwilling to give consent and those patients who do not have Fontan physiology.
* Any urgent/emergent catheterization procedure will be excluded.
* Any Fontan patient having a cardiac catheterization under monitored anesthesia care (as opposed to general endotracheal anesthesia) will not be eligible.
* Inability to undergo cardiac catheterization.
* Pregnant women will be excluded.
* < 6 weeks post-op from Fontan completion surgery
* Same hospitalization as Fontan completion surgery
* Intrinsic pulmonary disease which would be anticipated to impact study protocol / findings
* Fontan completion surgery performed at > 7 yearsyears
Sex :
ALL
Ages :
- Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : ADULT, OLDER_ADULT, CHILD
Accepts Healthy Volunteers:
No
|
NCT04672538
| 187,354 |
{
"NCT_ID" : "NCT02299128",
"Brief_Title" : "Effectiveness of Early Physical Therapy Intervention for Patients With Dizziness After a Sports-Related Concussion",
"Official_title" : "A Feasibility Study for a Randomized Controlled Trial on the Effectiveness of Early Physical Therapy Intervention for Patients With Dizziness After a Sports-Related Concussion",
"Conditions" : ["Brain Concussion", "Dizziness"],
"Interventions" : ["Other: Physical Therapy Treatment"],
"Location_Countries" : ["United States"],
"Study_Design" : {
"Study_Type" : "INTERVENTIONAL",
"Phase" : ["NA"],
"Primary_Purpose" : "TREATMENT",
"Allocation" : "RANDOMIZED",
"Interventional_Model" : "PARALLEL",
"Masking" : "TRIPLE"
},
"Recruitment_Information" : {
"Study_Start_Date(Actual)" : "2014-09",
"Primary_Completion_Date(Actual)(Final_data_collection_date_for_primary_outcome_measure)" : "2015-12",
"Study_Completion_Date(Actual)" : "2016-01},
"Study_Record_Dates" : {
""Study_Registration_Dates" : {
"First_Submitted" : 2014-11-17",
"First_Posted(Estimated)" : 2014-11-24"
},
"Study_Record_Updates" : {
"Last_Updated_that_Met_QC_Criteria" : 2014-11-21",
"Last_Update_Posted(Estimated)" : 2016-02-25",
"Last_Verified" : 2016-02"
}
}}
|
#Study Description
Brief Summary
Therefore, the purpose of this pilot study is to determine the feasibility of conducting a randomized clinical trial (RCT) on physical therapist treatment for dizziness after sports-related concussion. The specific research question for this pilot RCT is: What is the feasibility of conducting a RCT on athletes who have dizziness 10 or greater days after a sports-related concussion to explore the effectiveness of directed vestibular rehabilitation, neuromotor retraining, and/or manual physical therapy (PT) when compared to sham treatment? The findings of this study (for both feasibility and effect size) will be used to inform and direct revisions to the methods for a larger RCT on this population.
Primary Aims:
Specific Aim 1: Assess the feasibility of the following: recruitment and retention of participants, required resources for project management, and assessment of patient safety.
Specific Aim 2: Estimate the size of the effect between skilled physical therapist intervention and a sham treatment for the recovery rate for athletes with a concussion who have dizziness 10 - 14 days post-concussion.
Detailed Description
Study design: This study will be a pilot feasibility study of a RCT, randomized at the individual level.
Subjects:
The population of interest includes athletes who are seen by the physicians from a Sports Medicine Center (on site at Akron Children's Hospital (ACH) or at proxy locations, e.g. Walsh University or North Canton Children's Hospital Clinic) with a sports-related concussion. The specific population of interest is concussed patients who present for a medical assessment with dizziness as measured by the Post-Concussion Symptom Scale (PCS).
Sample Size and Sampling: Because this is a pilot study exploring the feasibility of the recruitment, retention and methods for a larger RCT, the sample is not intended to power a full scale study. It is standard for a pilot study to include at least 12 participants per arm of the study, however, because of the potential for loss to follow up the investigators plan to enroll 20 subjects per treatment group.
Study Subject Selection and Definitions: All patients who present to a Sports Medicine Center after an acute concussion (defined as any time between the event causing the concussion and up to 14 days after concussion) will complete the PCS. Within this 22 item scale, 7 items specify physical symptoms as components of the migraine cluster. These symptoms include: headaches, visual problems, dizziness, noise-light sensitivity, nausea/vomiting, balance problems, numbness/tingling. Although dizziness is the primary patient complaint being targeted, these other symptoms within the migraine cluster may also be present in addition to dizziness and may implicate a cervical, proprioceptive, and/or vestibular injury. For this reason, patients who report symptoms in the migraine cluster with one of the following criteria will be asked to enroll in the study at the initial assessment:
1. An initial score of at least 3 on the 7 point Likert scale for dizziness as a singular symptom OR
2. A score of 10 across the 7 items within the migraine cluster including a complaint of dizziness with at a score of at least 1 on the 7 point Likert scale OR
3. If findings from the objective assessment conducted by the physician indicate that postural/vestibular/ocular perception is abnormal.
Methods Allocation: At day10 after concussion, patients who enrolled in the study at their initial medical visit will be contacted by e-mail through Qualtrics and will be asked to complete the PCS a second time (if the patient sees the medical provider from Sports Medicine between day 10 and day 14, this will done on that same day). If at day 10 - 14 after the concussion was sustained, the patient continues to report dizziness with a score of at least 3 or a total score in the migraine cluster of at least 10 (including a score of at least 1 for dizziness) he/she will be randomized into one of the treatment groups using a random allocation sequence generator. If the patient does not meet the threshold of symptoms at day 10 - 14, they will receive standard medical care from the Sports Medicine physicians but will not be randomized into one of the PT treatment arms. One study investigator will be responsible for assignment into the treatment groups using a 1:1 allocation ratio.
Blinding: This study will be conducted as a double-blind trial whereby the physicians in the sports-medicine center, the patient participants, and their families will be blinded to the treatment allocation (sham or skilled) of patients throughout the study time. Blinding here is important to limit study bias because the physicians will determine one key outcome, the timeframe for return to play, and the athletes will report on the second key outcome, symptom severity on the PCS. The PTs performing the assessment and treatments will not be blinded to the allocation of the patients as they will be delivering the intervention. The same therapists will deliver both treatments (sham and skilled) based on allocation. Because the PTs cannot be blinded to the allocation of treatment, they will not determine the timeframe for return to play.
Patient follow-up: All patients allocated into one of the treatment arms will be followed for 4 consecutive weeks or until they are released for return to play by the sports medicine physician. All patients will continue to be followed by physicians in the sports medicine practice (as that is the standard of care).
Patient safety: Because this study is challenging the rest paradigm and using a progressive and active treatment to manage acute dizziness, it is not without risk. Patients will be carefully monitored during each visit to determine their response to treatment. Since the sham treatment incorporates no actual therapeutic activities, an exacerbation in symptoms is not expected. The skilled treatment group is pragmatic, allowing the treating therapists to determine the type and aggressiveness of each treatment session. This gives therapists the ability to modify the activity using their expert clinical judgment. For all subjects in the study, patient response between PT sessions will be monitored at the beginning of each PT treatment. If patient symptoms increase between therapy sessions, greater than the standard error of measure 6.3 points, treatment will be ceased and patients will be referred back to Sports Medicine for follow up. All adverse events will be recorded.
#Intervention
- OTHER : Physical Therapy Treatment
- Other Names :
- Vestibular rehabilitation, Manual Therapy, Neuromotor training
|
#Eligibility Criteria:
Inclusion Criteria:
* Patients age 10 - 23 who have sustained a sports-related concussion.
* Sports will include participation in any organized sporting activity (including club teams, recreational sports, or school teams).
* Patients with a history of learning disorders, use of medication (including psychotropics or narcotics) will be included.
Exclusion Criteria:
* Patients younger than >= 10 years than 23 years.
* If the patient has a concussion that was sustained during activities other than sports-related (bicycle accident, motor vehicle accident, or other non-sports related activities) they will not be enrolled in this study.
* Athletes with concussion who have symptoms but none of their complaints include dizziness or indicate a postural/vestibular/ocular or perceptual abnormality will be excluded.
* Finally, athletes who present to the sports-medicine physician for an initial assessment greater than 14 days after they sustained a concussion will be excluded.
Sex :
ALL
Ages :
- Minimum Age : 10 Years
- Maximum Age : 23 Years
- Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : ADULT, CHILD
Accepts Healthy Volunteers:
No
|
NCT02299128
| 237,232 |
{
"NCT_ID" : "NCT01019369",
"Brief_Title" : "Study of Self or Clinic Administration of DepoProvera",
"Official_title" : "Randomized Clinical Trial of Self Versus Clinical Administration of Depot Medroxyprogesterone Acetate",
"Conditions" : ["Contraception"],
"Interventions" : ["Drug: Medroxyprogesterone 17-Acetate"],
"Location_Countries" : ["United States"],
"Study_Design" : {
"Study_Type" : "INTERVENTIONAL",
"Phase" : ["NA"],
"Primary_Purpose" : "PREVENTION",
"Allocation" : "RANDOMIZED",
"Interventional_Model" : "PARALLEL",
"Masking" : "NONE"
},
"Recruitment_Information" : {
"Study_Start_Date(Actual)" : "2010-03",
"Primary_Completion_Date(Actual)(Final_data_collection_date_for_primary_outcome_measure)" : "2011-01",
"Study_Completion_Date(Actual)" : "2012-11},
"Study_Record_Dates" : {
""Study_Registration_Dates" : {
"First_Submitted" : 2009-11-18",
"First_Submitted_that_Met_QC_Criteria" : 2015-04-14",
"First_Posted(Estimated)" : 2009-11-25"
},
"Study_Record_Updates" : {
"Last_Updated_that_Met_QC_Criteria" : 2009-11-24",
"Last_Update_Posted(Estimated)" : 2019-05-07",
"Last_Verified" : 2019-04"
}
}}
|
#Study Description
Brief Summary
Depot medroxyprogesterone acetate (DepoProvera) is an acceptable form of contraception for many women. However, difficulty in access may cause many women to discontinue use, often without the use of another effective method of contraception, thereby leaving them vulnerable to unintended pregnancy. This study will randomly assign women who present for contraceptive services to two groups: self or clinic administered SC DMPA. The participants will be followed for one year to compare continuation rates, acceptability, cost effectiveness, evidence of skin changes, and need for continued support between the two groups.
Detailed Description
Unintended pregnancy remains a worldwide problem in both developed and developing countries. In 2001, 49% of pregnancies in the United States were unintended. Moreover, more than 6 million women annually are at high risk of becoming unintentionally pregnant because of a gap in contraceptive use, and disadvantaged women are more likely to have more difficulty than others with continuous method use. Multiple strategies have been explored and implemented to increase the effective usage of contraception, including promoting the use of longer acting reversible contraceptives.
Difficulty in access to depot medroxyprogesterone acetate (DMPA) remains a problem. With the advent of a subcutaneous formulation of DMPA, administration outside of the clinical setting is possible. The acceptability of self administered DMPA has also been reviewed, with favorable outcomes; however, the actual intervention has not been studied.
This study will recruit women presenting for abortion or contraceptive services at the Columbia University and New York Presbyterian affiliated Family Planning Clinic and Special Gynecology Services who desire DMPA for contraception. Women will be randomized to two groups: self administration of SC DMPA or clinic administration of SC DMPA. The primary objective of this study is to compare the continuation rates of SC DMPA between the self and clinic administration groups at 6 months. Secondary outcomes include participant satisfaction, cost effectiveness of self-injected use of DMPA, baseline predictors of method continuation or discontinuation, evidence of persistent skin changes following administration of SC DMPA, and need for continued clinical support.
#Intervention
- DRUG : Medroxyprogesterone 17-Acetate
- Depot medroxyprogesterone acetate, SC, every 12 weeks for 1 year
- Other Names :
- depo-subQ 104
- DRUG : Medroxyprogesterone 17-Acetate
- Depot medroxyprogesterone acetate, SC, every 12 weeks for 1 year
- Other Names :
- depo-subQ 104
|
#Eligibility Criteria:
Inclusion Criteria:
* age greater than or equal to 18 years
* seeking DMPA for contraception
* English or Spanish speaking
* consistent access to a working telephone
* availability for follow up for one year
Exclusion Criteria:
* suspected or continuing pregnancy
* undiagnosed vaginal bleeding
* known or suspected breast cancer
* acute liver disease
* known hypersensitivity to medroxyprogesterone acetate or any other components of DMPA
* desire for pregnancy within one year
Sex :
FEMALE
Ages :
- Minimum Age : 18 Years
- Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : ADULT, OLDER_ADULT
Accepts Healthy Volunteers:
Yes
|
NCT01019369
| 111,911 |
{
"NCT_ID" : "NCT00171977",
"Brief_Title" : "Post-Marketing Clinical Study of Postoperative Adjuvant Therapy With Imatinib Mesylate in Patients With Gastrointestinal Stromal Tumors (GIST)",
"Official_title" : "Post-Marketing Clinical Study of Postoperative Adjuvant Therapy With Imatinib Mesylate in Patients With Gastrointestinal Stromal Tumors (GIST)",
"Conditions" : ["Gastrointestinal Stromal Tumors"],
"Interventions" : ["Drug: Imatinib Mesylate"],
"Location_Countries" : ["Japan"],
"Study_Design" : {
"Study_Type" : "INTERVENTIONAL",
"Phase" : ["PHASE4"],
"Primary_Purpose" : "TREATMENT",
"Allocation" : "NA",
"Interventional_Model" : "SINGLE_GROUP",
"Masking" : "NONE"
},
"Recruitment_Information" : {
"Study_Start_Date(Actual)" : "2004-07",
"Primary_Completion_Date(Actual)(Final_data_collection_date_for_primary_outcome_measure)" : "2009-04",
},
"Study_Record_Dates" : {
""Study_Registration_Dates" : {
"First_Submitted" : 2005-09-13",
"First_Posted(Estimated)" : 2005-09-15"
},
"Study_Record_Updates" : {
"Last_Updated_that_Met_QC_Criteria" : 2005-09-14",
"Last_Update_Posted(Estimated)" : 2012-08-07",
"Last_Verified" : 2012-08"
}
}}
|
#Study Description
Brief Summary
This is a multicenter, post-marketing, clinical study evaluating the safety and efficacy of postoperative adjuvant therapy with Imatinib Mesylate in high-risk patients after curative resection of newly diagnosed GIST.Patients will be evaluated for relapse -free survival as measured by the confirmation of tumor recurrence and survival for 3 years after surgery for their primary tumors.
#Intervention
- DRUG : Imatinib Mesylate
- Other Names :
- Gleevec/Glivec, STI571
|
#Eligibility Criteria:
Inclusion Criteria:
* underwent macroscopically curative resection;
* immunohistochemically confirmed KIT (CD117)-positive tumors;
* judged as being high-risk according to the criteria for risk classification
Exclusion Criteria:
* synchronous double cancer or metachronous double cancer with a disease-free period of <=5 years;
* received therapy with Imatinib Mesylate prior to study entry;
* cardiac problem of Grade 3 or higher (New York Heart Association (NYHA) criteria)
Other protocol-defined inclusion / exclusion criteria may apply.
Sex :
ALL
Ages :
- Minimum Age : 20 Years
- Maximum Age : 74 Years
- Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : ADULT, OLDER_ADULT
Accepts Healthy Volunteers:
No
|
NCT00171977
| 245,996 |
{
"NCT_ID" : "NCT06139471",
"Brief_Title" : "Efficacy of a Virtual Reality-Enhanced Gagne's Instructional Model",
"Official_title" : "Exploring the Efficacy of a Virtual Reality-Enhanced Gagne's Instructional Model in Promoting Nursing Students' Aging Rejection and Willingness Towards Gerontological Care",
"Conditions" : ["Acceptance Processes", "Rejection, Psychology"],
"Interventions" : ["Behavioral: Virtual Reality-Enhanced Gagne's Instructional Model"],
"Location_Countries" : ["Egypt"],
"Study_Design" : {
"Study_Type" : "INTERVENTIONAL",
"Phase" : ["NA"],
"Primary_Purpose" : "OTHER",
"Allocation" : "RANDOMIZED",
"Interventional_Model" : "PARALLEL",
"Masking" : "NONE"
},
"Recruitment_Information" : {
"Study_Start_Date(Actual)" : "2023-02-01",
"Primary_Completion_Date(Actual)(Final_data_collection_date_for_primary_outcome_measure)" : "2023-04-30",
"Study_Completion_Date(Actual)" : "2023-06-30},
"Study_Record_Dates" : {
""Study_Registration_Dates" : {
"First_Submitted" : 2023-11-02",
"First_Posted(Estimated)" : 2023-11-18"
},
"Study_Record_Updates" : {
"Last_Updated_that_Met_QC_Criteria" : 2023-11-17",
"Last_Update_Posted(Estimated)" : 2023-11-18",
"Last_Verified" : 2023-11"
}
}}
|
#Study Description
Brief Summary
Gagne's conditions of instructional learning theory, it presumed that several learning levels was exist that require different instruction types, and external and internal environments, commonly referred to as 'conditions of learning'.
Detailed Description
According to Robert Gagne's conditions of instructional learning theory, it presumed that several learning levels was exist that require different instruction types, and external and internal environments, commonly referred to as 'conditions of learning', for every learning type. These internal conditions related to the learner's preexisting knowledge and external ones related to the instructions and teaching strategies provided by the instructor. The theory emphasizes the importance of both internal and external factors in creating a conducive learning environment that fosters effective learning outcomes According to this theorist, there are five primary knowledge categories, including verbal information, cognitive strategies, attitudes, and motor and intellectual skills.
#Intervention
- BEHAVIORAL : Virtual Reality-Enhanced Gagne's Instructional Model
- Virtual Reality-Enhanced Gagne's Instructional Model
|
#Eligibility Criteria:
Inclusion Criteria:
* Agreement to participate in this study.
* Have a Microsoft team's account and able to use it.
* No previous participation in any gerontological educational course either compulsory or elective.
exclusion Criteria: previous participation in any gerontological educational course either compulsory or elective.
Sex :
ALL
Ages :
- Minimum Age : 18 Years
- Maximum Age : 24 Years
- Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : ADULT
Accepts Healthy Volunteers:
No
|
NCT06139471
| 234,894 |
{
"NCT_ID" : "NCT02926027",
"Brief_Title" : "Effect of Vascepa on Improving Coronary Atherosclerosis in People With High Triglycerides Taking Statin Therapy",
"Official_title" : "Effect of Vascepa on Progression of Coronary Atherosclerosis in Persons With Elevated Triglycerides (200-499) on Statin Therapy",
"Conditions" : ["Hypertriglyceridemia"],
"Interventions" : ["Drug: placebo", "Drug: Vascepa"],
"Location_Countries" : ["United States"],
"Study_Design" : {
"Study_Type" : "INTERVENTIONAL",
"Phase" : ["PHASE4"],
"Primary_Purpose" : "TREATMENT",
"Allocation" : "RANDOMIZED",
"Interventional_Model" : "PARALLEL",
"Masking" : "DOUBLE"
},
"Recruitment_Information" : {
"Study_Start_Date(Actual)" : "2017-03-28",
"Primary_Completion_Date(Actual)(Final_data_collection_date_for_primary_outcome_measure)" : "2020-05-15",
"Study_Completion_Date(Actual)" : "2020-08-15},
"Study_Record_Dates" : {
""Study_Registration_Dates" : {
"First_Submitted" : 2016-09-28",
"First_Submitted_that_Met_QC_Criteria" : 2021-10-04",
"First_Posted(Estimated)" : 2016-10-06"
},
"Study_Record_Updates" : {
"Last_Updated_that_Met_QC_Criteria" : 2016-10-04",
"Last_Update_Posted(Estimated)" : 2023-02-21",
"Last_Verified" : 2023-02"
}
}}
|
#Study Description
Brief Summary
Effect of Vascepa on Progression of Coronary Atherosclerosis in Persons with Elevated Triglycerides (200-499) on Statin Therapy. The study is to determine progression rates of low attenuation plaque under influence of Vascepa as compared to placebo.
Detailed Description
Residual cardiovascular (CV) risk remains in dyslipidemic patients despite intensive statin therapy, underscoring the need for additional intervention. Eicosapentaenoic acid (EPA), an omega-3 polyunsaturated fatty acid, is incorporated into membrane phospholipids and atherosclerotic plaques and exerts beneficial effects on the pathophysiologic cascade from onset of plaque formation through rupture. EPA also improves atherogenic dyslipidemia characterized by reduction of triglycerides without raising low-density lipoprotein cholesterol. All of this data supports the biologic plausibility of EPA as an anti-atherosclerotic agent. The goal of this study is to evaluate whether treatment with Vascepa (4 grams) results in a greater change from baseline in low attenuation plaque than placebo in subjects with elevated triglycerides (200-499 mg/dl).
#Intervention
- DRUG : Vascepa
- Vascepa is a an Eicosapentaenoic acid (EPA), an omega-3 polyunsaturated fatty acid.
- Other Names :
- icosapent ethyl
- DRUG : placebo
- placebo
|
#Eligibility Criteria:
Inclusion Criteria:
* Elevated triglycerides (fasting value between 200 <= age <= 499 mg/dl) at qualifying or baseline visit.
* LDL-C <=115 mg/dL on appropriate statin therapy
* LDL-C >40 mg/dL
* Stable diet and exercise, as defined as the same pattern for the previous 4 weeks
* Stable treatment with a statin+/- ezetimibe for at least 4 weeks
* Patients with at least 1 angiographic stenosis with at least 20% narrowing by coronary computed tomography angiography (CTA).
* Willingness to be on birth control for women of childbearing age or established post-menopausal
Exclusion Criteria:
* A contraindication to fish or fish oils including: known hypersensitivity to drug or fish.
* Any unstable medical, psychiatric or substance abuse disorder that in the opinion of the investigator or principal investigator is likely to affect the subject's ability to complete the study or precludes the subject's participation in the study.
* Non-study lipid altering medications or supplements (ie - Niacin, PCSK9, fibrates, bile acid Sequestrants, dietary fish oil supplement capsules, orlistat [OTC (Alli®) as well as Rx (Xenical®)] or other drugs used for weight loss).
* Stable (same daily dose for the last 4 weeks) on medications that can affect lipids (retinoids, hormones, steroids, HIV medications, chemotherapy, thyroid medications).
* BMI > 40
* Bleeding disorder
* Uncontrolled hypertension (SBP>= 180 mmHg or DBP>=100 mmHg)
* History of known myocardial infarction, stroke or life-threatening arrhythmia within the prior six months.
* NYHA Class III- IV heart failure
* History of malignancy within the last 5 years (other than skin cancer) or evidence of active cancer which would require concomitant cancer chemotherapy.
* Serum creatinine > 1.4 mg/dl
* Drug or alcohol abuse, or current intake of more than 14 ounces of alcohol per week for men and 10 ounces for women
* Concurrent enrollment in another placebo-controlled trial or within 30 days of finishing another trial
* Partial ileal bypass or known gastrointestinal disease limiting drug absorption
* History of hypertensive encephalopathy or cerebrovascular accident
* Hematological or biochemical values at screening outside the reference ranges considered as clinically significant in the opinion of the investigator or PI
* Pregnancy
* Genetic mutations/polymorphisms having an effect on blood lipids
* History of coronary artery bypass surgery
* Allergy to contrast material
* Allergy to beta-blocker in subjects with resting heart rate >70 bpm
Sex :
ALL
Ages :
- Minimum Age : 30 Years
- Maximum Age : 85 Years
- Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : ADULT, OLDER_ADULT
Accepts Healthy Volunteers:
No
|
NCT02926027
| 33,873 |
{
"NCT_ID" : "NCT04773548",
"Brief_Title" : "Feasibility and Safety of a Virtual-Reality Based Job Interview Training Tool in Teenagers With High-Functioning Autism",
"Official_title" : "Feasibility and Safety of a Virtual-Reality Based Job Interview Training Tool in Teenagers With High-Functioning Autism",
"Conditions" : ["Autism Spectrum Disorder"],
"Interventions" : ["Other: VR-JIT"],
"Location_Countries" : ["United States"],
"Study_Design" : {
"Study_Type" : "INTERVENTIONAL",
"Phase" : ["NA"],
"Primary_Purpose" : "TREATMENT",
"Allocation" : "NA",
"Interventional_Model" : "SINGLE_GROUP",
"Masking" : "NONE"
},
"Recruitment_Information" : {
"Study_Start_Date(Actual)" : "2018-10-24",
"Primary_Completion_Date(Actual)(Final_data_collection_date_for_primary_outcome_measure)" : "2020-10-24",
"Study_Completion_Date(Actual)" : "2020-10-24},
"Study_Record_Dates" : {
""Study_Registration_Dates" : {
"First_Submitted" : 2021-02-25",
"First_Posted(Estimated)" : 2021-02-26"
},
"Study_Record_Updates" : {
"Last_Updated_that_Met_QC_Criteria" : 2021-02-25",
"Last_Update_Posted(Estimated)" : 2021-02-26",
"Last_Verified" : 2021-02"
}
}}
|
#Study Description
Brief Summary
The current project involves the application of a VR job training software. We propose to use an interactive VR job interview practice system, Virtual Reality Job Interview Training (VR-JIT), in youths with ASD at the highschool level. This system was developed to bolster job interview practice skills and to help reduce anxiety in adults with ASD. However, it has never before been used in individuals under the age of 18. Our hope is that if this program is utilized in individuals while they are still in highschool, we can target those persons before the window for which risk of unemployment appears to be highest for ASD youths, immediately after high school graduation.
#Intervention
- OTHER : VR-JIT
- Job interview with virtual interviewer
|
#Eligibility Criteria:
Inclusion Criteria:
* Be between the ages of 13 and 18
* Have a diagnosis of ASD or a typically developing child
* Be able to speak and read English fluently
Exclusion Criteria:
* I had a stroke, TBI, or neurologic injury or disease in the past
* I have a history of significant psychiatric illness (like bipolar, schizophrenia, or psychosis)
* I have uncontrolled seizures or other unstable medical complications
Sex :
ALL
Ages :
- Minimum Age : 13 Years
- Maximum Age : 18 Years
- Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : ADULT, CHILD
Accepts Healthy Volunteers:
Yes
|
NCT04773548
| 35,461 |
{
"NCT_ID" : "NCT04217122",
"Brief_Title" : "Effect of Strawberry Consumption on the Microbiome",
"Official_title" : "Effect of Strawberry Consumption on the Microbiome in Healthy Subjects: A Pilot Study",
"Conditions" : ["Microbiome"],
"Interventions" : ["Other: placebo powder", "Other: strawberry powder"],
"Location_Countries" : ["United States"],
"Study_Design" : {
"Study_Type" : "INTERVENTIONAL",
"Phase" : ["NA"],
"Primary_Purpose" : "OTHER",
"Allocation" : "RANDOMIZED",
"Interventional_Model" : "PARALLEL",
"Masking" : "SINGLE"
},
"Recruitment_Information" : {
"Study_Start_Date(Actual)" : "2018-09-11",
"Primary_Completion_Date(Actual)(Final_data_collection_date_for_primary_outcome_measure)" : "2019-02-21",
"Study_Completion_Date(Actual)" : "2019-12-19},
"Study_Record_Dates" : {
""Study_Registration_Dates" : {
"First_Submitted" : 2019-12-30",
"First_Posted(Estimated)" : 2020-01-03"
},
"Study_Record_Updates" : {
"Last_Updated_that_Met_QC_Criteria" : 2019-12-30",
"Last_Update_Posted(Estimated)" : 2020-01-07",
"Last_Verified" : 2020-01"
}
}}
|
#Study Description
Brief Summary
This pilot study will assess the ability of daily consumption of two servings of California strawberries to alter gut microbiome composition, leading to increased bile secretion and decreased plasma cholesterol in a free-living population.
Detailed Description
This will be a randomized, double-blinded, placebo controlled, parallel design. Thirty subjects will be randomized to consume two servings of standardized freeze-dried strawberry powder (2 x 13g) daily or placebo for 4 weeks, followed by 2 weeks of follow up with beige diet only to observe whether the effect can be sustained for 2 weeks. Blood will be collected at baseline (week 0), weeks 4 and week 6 after strawberry consumption. On the day prior to the study visits participants will collect a stool and a 24-hr urine sample and bring to the lab. In addition, body weight and composition will be determined and questionnaires and 3-day food record will be completed. Twenty-four hour urine content of pelargonidin glucuronide will be measured for compliance. Plasma and fecal cholesterol and bile acids will be determined at baseline (week 0) and weeks 4 and 6.
Subjects will be assigned an enrollment number after signing the informed consent form approved by the UCLA Medical Internal Review Board. Subjects will undergo a physical exam, complete medical history, and blood draw. A standard chem. panel will be performed at the UCLA clinical laboratory. Eligible subjects will be enrolled into the study upon completion of screening evaluations and will be randomized to the strawberry or placebo arm at their baseline visit.
The study will be conducted in healthy free-living subjects (18-55 years). Subjects consume 13 grams standard strawberry powder in the morning and afternoon/evening or placebo powder for 4 weeks. Subjects will be instructed to eat a beige diet (low fiber\<10g and low polyphenols \<3 servings of polyphenol rich fruit/vegetables per day) during the entire study period. 24 hr urine pelargonidin glucuronide will be measured at weeks 2 (baseline), 6 and 8 for compliance. In addition, pelargondin, ellagic acid, dimethylellagic acid glucuronide and urolithin glucuronide will be measured in plasma and urine to determine strawberry phytochemical bioavailability and intestinal/microbiome metabolic capacity. Participants will meet with the dietitian for assessment of habitual dietary pattern and instructions on maintain on a beige diet. A list of foods with high fiber and phenolic compounds will be provided and subjects are instructed to follow the diet during the entirety of the study.
A standardized freeze-dried strawberry powder and a strawberry placebo powder provided by the California Strawberry Commission will be used. Ten grams of freeze dried powder is equivalent to about 110 g fresh fruit. One serving of fresh strawberry (one cup) is estimated to weigh 144 g and therefore is equivalent to 13 g of freeze dried powder. Subjects will consume two packages of 13 g of strawberry powder per day. The powder can be mixed into beverages and consumed with breakfast and dinner.
Strawberry powder ingredients include Individually Quick Frozen (IQF) strawberries. Placebo powder ingredients include fructose, sucrose, dextrose, tapioca maltodextrin, modified food starch, erythritol, cellulose gum, citric acid (anhydrous), N-C Strawberry Flavor Natual WONF, xanthan gum, malic acid, sugar beet fiber, silicon dioxide, nat. strawberry-type flavor, FD\&C Red #40, FD\&C Yellow 6, FD\&C Blue 2.
#Intervention
- OTHER : strawberry powder
- Participants consume 2 packages of standard strawberry powder (13 g x 2) daily for 4 weeks
- OTHER : placebo powder
- Participants consume 2 packages of placebo powder (13 g x 2) daily for 4 weeks
|
#Eligibility Criteria:
Inclusion Criteria:
* Healthy human adults age 18 <= age <= 55 years (females have to be premenopausal)
* Typically consume low fiber/polyphenol diet (beige diet)
Exclusion Criteria:
* Eating a high fiber/polyphenol diet or taking any medication or dietary supplement which interfere with the absorption of polyphenols.
* History of gastrointestinal surgery, diabetes mellitus on medications, or other serious medical condition, such as chronic hepatic or renal disease, bleeding disorder, congestive heart disease, chronic diarrhea disorders, myocardial infarction, coronary artery bypass graft, angioplasty within 6 months prior to screening, current diagnosis of uncontrolled hypertension (defined as systolic BP >160mmHg, diastolic BP > 95mmHg), active or chronic gastrointestinal disorders, bulimia, anorexia, laxative abuse, or endocrine diseases (except thyroid disease requiring medication) as indicated by medical history or routine physical examination.
* Screening laboratory value outside of the laboratory normal range that is considered clinically significant for study participation by the investigator.
* Is known HIV positive (subjects who are HIV positive are known to have high evels of LDL cholesterol and generalized heart inflammation).
* Is unable or unwilling to comply with the study protocol.
* Using prebiotics, probiotics, yogurt, and/or any fiber supplements regularly
* Allergy or sensitivity to strawberries. Subjects will be excluded if there is a prior history of such sensitivity. Since these foods are commonly eaten and allergies are rare, subjects should be aware of this sensitivity prior to entering the study. To determine this, a positive affirmation by the subject of strawberry ingestion without incident will be requested. In addition, any subject with a history of allergy or anaphylaxis of any kind will be excluded.
* Taking antibiotics or laxatives within the past 3 months
* Any subject who demonstrate a risk of non-compliance with study procedure, or one who cannot read, understand or complete study - related materials in the opinion of the study investigator.
Sex :
ALL
Ages :
- Minimum Age : 18 Years
- Maximum Age : 55 Years
- Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : ADULT
Accepts Healthy Volunteers:
Yes
|
NCT04217122
| 54,329 |
{
"NCT_ID" : "NCT00607568",
"Brief_Title" : "Atomoxetine Effects in Humans",
"Official_title" : "Atomoxetine Effects in Humans",
"Conditions" : ["Physiological Stress"],
"Interventions" : ["Drug: Atomoxetine"],
"Study_Design" : {
"Study_Type" : "INTERVENTIONAL",
"Phase" : ["PHASE1", "PHASE2"],
"Primary_Purpose" : "TREATMENT",
"Allocation" : "RANDOMIZED",
"Interventional_Model" : "CROSSOVER",
"Masking" : "DOUBLE"
},
"Recruitment_Information" : {
"Study_Start_Date(Actual)" : "2006-06",
"Primary_Completion_Date(Actual)(Final_data_collection_date_for_primary_outcome_measure)" : "2007-08",
"Study_Completion_Date(Actual)" : "2009-09},
"Study_Record_Dates" : {
""Study_Registration_Dates" : {
"First_Submitted" : 2008-01-23",
"First_Posted(Estimated)" : 2008-02-05"
},
"Study_Record_Updates" : {
"Last_Updated_that_Met_QC_Criteria" : 2008-02-04",
"Last_Update_Posted(Estimated)" : 2011-12-12",
"Last_Verified" : 2011-12"
}
}}
|
#Study Description
Brief Summary
A total of 18 healthy volunteers will participate in this four-week, within-groups, double-blind, placebo-controlled study. The study has two phases separated by a 4 to 15-day washout period. Subjects will be randomly assigned to receive either 40 mg atomoxetine or placebo. For Phase I, subjects will be assigned to atomoxetine or placebo for 4 days. After receiving medication or placebo for three days, subjects will have a 6-hour laboratory session, where responses to physical and psychological stress of a 20 mg/70 kg (20 mg maximum) dose of d-amphetamine will be measured. Several physiological, hormonal, and subjective outcome measures will be obtained during the experimental sessions. Subjects will then have a 4-15 day washout period and will be crossed over to the alternative treatment for Phase II.
Detailed Description
This pilot study will examine the effects of a norepinephrine reuptake blocker, atomoxetine, on physiological and subjective responses to physical and psychological models of stress and oral amphetamine in healthy volunteers. The physical stress model will be the cold pressor test (CPT) and the psychological stress will be the paced auditory serial addition task (PASAT).
Our overall hypothesis is that atomoxetine treatment, compared to placebo, will attenuate the physiological and subjective responses to stress and d-amphetamine.
2. Research Design: Double-blind, placebo-controlled, within-groups, outpatient study.
3. Methodology: A total of 18 healthy volunteers will participate in this four-week, within-groups, double-blind, placebo-controlled study. The study has two phases separated by a 4 to 15-day washout period. Subjects will be randomly assigned to receive either 40 mg atomoxetine or placebo. For Phase I, subjects will be assigned to atomoxetine or placebo for 4 days. After receiving medication or placebo for three days, subjects will have a 6-hour laboratory session, where responses to physical and psychological stress of a 20 mg/70 kg (20 mg maximum) dose of d-amphetamine will be measured. Several physiological, hormonal, and subjective outcome measures will be obtained during the experimental sessions. Subjects will then have a 4-15 day washout period and will be crossed over to the alternative treatment for Phase II.
4. Findings: Since our last renewal, a total of 16 subjects signed the consent form. Among those, 6 subjects did not return after signing the consent form. An additional 2 subjects were randomized but did not complete the study. One subjects started 3 times was randomized 3 times therefore counted three times in enrollment. Currently still enrolling subjects. (2/7/07)
Have completed this study with 10 subjects, study was published. This study has been entered twice.
#Intervention
- DRUG : Atomoxetine
- atomoxetine 40mg per day or placebo
For Phase I, subjects will be assigned to atomoxetine or placebo for 4 days. Subjects will then have a 4-15 day washout period and will be crossed over to the alternative treatment for Phase II.
|
#Eligibility Criteria:
Inclusion Criteria:
* Female and males age 18 yrs to 45 yrs
* Current history of good health and normal ECG
* not pregnant , nor breast feeding
* using acceptable birth control methods
Exclusion Criteria:
* History of heart disease, hypertension, renal or hepatic diseases, glaucoma,hyperthyroidism,
* Current use of psychotropic medication
* Current dependence on alcohol or on drugs or treatments for drug or alcohol addiction within the past 5 years
Sex :
ALL
Ages :
- Minimum Age : 18 Years
- Maximum Age : 45 Years
- Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : ADULT
Accepts Healthy Volunteers:
Yes
|
NCT00607568
| 119,836 |
{
"NCT_ID" : "NCT06459739",
"Brief_Title" : "Effect of Sacral Erector Spinae Plane Block on Hemorrhoid and Pilonidal Sinus Surgery",
"Official_title" : "Effect of Sacral Erector Spinae Plane Block on Hemorrhoid and Pilonidal Sinus Surgery",
"Conditions" : ["Pain, Acute Post-Operative", "Pilonidal Sinus", "Hemorrhoids", "Anesthesia"],
"Interventions" : ["Procedure: sacral ESPB"],
"Location_Countries" : ["Turkey"],
"Study_Design" : {
"Study_Type" : "INTERVENTIONAL",
"Phase" : ["NA"],
"Primary_Purpose" : "SUPPORTIVE_CARE",
"Allocation" : "RANDOMIZED",
"Interventional_Model" : "PARALLEL",
"Masking" : "NONE"
},
"Recruitment_Information" : {
"Study_Start_Date(Actual)" : "2023-09-01",
"Primary_Completion_Date(Actual)(Final_data_collection_date_for_primary_outcome_measure)" : "2024-03-01",
"Study_Completion_Date(Actual)" : "2024-04-01},
"Study_Record_Dates" : {
""Study_Registration_Dates" : {
"First_Submitted" : 2024-06-05",
"First_Posted(Estimated)" : 2024-06-14"
},
"Study_Record_Updates" : {
"Last_Updated_that_Met_QC_Criteria" : 2024-06-10",
"Last_Update_Posted(Estimated)" : 2025-02-27",
"Last_Verified" : 2025-02"
}
}}
|
#Study Description
Brief Summary
Introduction: This study investigated the efficacy of sacral erector spinae plane block (ESPB) for managing postoperative pain and reducing opioid consumption in patients undergoing hemorrhoid and pilonidal sinus (PS) surgery.
Detailed Description
Introduction: This study investigated the efficacy of sacral erector spinae plane block (ESPB) for managing postoperative pain and reducing opioid consumption in patients undergoing hemorrhoid and pilonidal sinus (PS) surgery.
#Intervention
- PROCEDURE : sacral ESPB
- sacral ESPB
|
#Eligibility Criteria:
Inclusion Criteria:
* American Society of Anesthesiologists (ASA) I-II patients undergoing hemorrhoid and pilonidal sinus surgery
Exclusion Criteria:
* patients with coagulopathies, pregnant women, patients with significant cardiovascular, hepatic, or renal disease, patients who declined spinal anesthesia or were contraindicated for it, and patients who had previously undergone the same surgery
Sex :
ALL
Ages :
- Minimum Age : 18 Years
- Maximum Age : 70 Years
- Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : ADULT, OLDER_ADULT
Accepts Healthy Volunteers:
No
|
NCT06459739
| 55,477 |
{
"NCT_ID" : "NCT03239340",
"Brief_Title" : "A Molecular Profiling Study of Patients With EGFR Mutation-positive Locally Advanced or Metastatic NSCLC Treated With Osimertinib",
"Official_title" : "A Multicentre, Open-label, Single-arm, Molecular Profiling Study of Patients With EGFR Mutation-positive Locally Advanced or Metastatic NSCLC Treated With Osimertinib",
"Conditions" : ["EGFR Mutation Positive Locally Advanced or Metastatic Non-Small Cell Lung Cancer"],
"Interventions" : ["Drug: Osimertinib"],
"Location_Countries" : ["Spain", "United States", "Korea, Republic of", "Italy", "Malaysia"],
"Study_Design" : {
"Study_Type" : "INTERVENTIONAL",
"Phase" : ["PHASE2"],
"Primary_Purpose" : "TREATMENT",
"Allocation" : "NA",
"Interventional_Model" : "SINGLE_GROUP",
"Masking" : "NONE"
},
"Recruitment_Information" : {
"Study_Start_Date(Actual)" : "2018-05-30",
"Primary_Completion_Date(Actual)(Final_data_collection_date_for_primary_outcome_measure)" : "2023-09-19",
"Study_Completion_Date(Actual)" : "2023-09-19},
"Study_Record_Dates" : {
""Study_Registration_Dates" : {
"First_Submitted" : 2017-07-27",
"First_Submitted_that_Met_QC_Criteria" : 2024-08-21",
"First_Posted(Estimated)" : 2017-08-04"
},
"Study_Record_Updates" : {
"Last_Updated_that_Met_QC_Criteria" : 2017-08-01",
"Last_Update_Posted(Estimated)" : 2024-10-21",
"Last_Verified" : 2024-09"
}
}}
|
#Study Description
Brief Summary
A multicentre, open-label, single-arm, molecular profiling study of patients with EGFR mutation-positive locally advanced or metastatic NSCLC treated with osimertinib.
Detailed Description
Study design This is a phase II, open-label, single-arm tissue and plasma acquisition study assessing the efficacy, safety and underlying resistance mechanisms of osimertinib (80 mg orally, once daily) as first-line treatment in patients with locally advanced or metastatic EGFR mutation positive non-small cell lung cancer who are EGFR tyrosine kinase inhibitor treatment-naïve and eligible for first-line treatment. Participants with EGFR mutation-positive non-small cell lung cancer will be required to consent to 2 mandatory tumour biopsies to be considered for enrolment in this study. The first biopsy will be done prior to initiating treatment with osimertinib and the second biopsy will be obtained any time between Investigator assessed, Response Evaluation Criteria in Solid Tumours version 1.1 (RECIST 1.1)-defined progression and before the start of any new anticancer treatment. A third optional biopsy may be taken during the course of treatment at the Investigator's discretion if the patient consents and if clinically feasible. Tumour tissue and plasma samples will be collected and examined for genetic and non genetic aberrations that may be important in determining response and resistance to the treatment that participants will receive as a part of their cancer care. Patients should continue on osimertinib until progression or until other treatment discontinuation criteria are met. However, if patients continue to show clinical benefit to treatment as judged by the Investigator, patients may continue to receive osimertinib beyond RECIST 1.1-defined progression. Therefore, there is no maximum duration of treatment. Tumour assessments will be performed at baseline and then every 8 weeks from study enrolment until 3.5 years, and then every 10 weeks until RECIST 1.1-defined. Patients will be followed up for a period of 28 days following discontinuation of osimertinib. Target patient population Male and female patients aged 18 years and over with locally advanced or metastatic pathologically confirmed adenocarcinoma of the lung, not amenable to curative surgery or radiotherapy. Patients will have a tumour that harbours one of the EGFR mutations known to be associated with EGFR tyrosine kinase inhibitor sensitivity, either alone or in combination with other EGFR mutations (EGFR mutation status determined by a local laboratory). Patients must be EGFR tyrosine kinase inhibitor treatment-naïve and eligible to receive first line treatment with osimertinib. Osimertinib is an oral, potent, selective, irreversible inhibitor of both EGFR tyrosine kinase inhibitor sensitizing and resistance mutations in non-small cell lung cancer with a significant selectivity margin over wild type EGFR. Osimertinib (80 mg orally, once daily) will be administered. Doses may be reduced to 40 mg if needed.
#Intervention
- DRUG : Osimertinib
- Osimertinib is an oral, potent, selective, irreversible inhibitor of both EGFR-tyrosine kinase inhibitor sensitizing and resistance mutations in non-small cell lung cancer with a significant selectivity margin over wild type EGFR.
- Other Names :
- TAGRISSO, AZD9291
|
#Eligibility Criteria:
Inclusion Criteria:
* Provision of informed consent prior
* Patients aged >= 18 years
* Patients with histological confirmation of locally advanced or metastatic NSCLC
* Patients with M1 stage according to the Tumor, Node and Metastasis Classification of Malignant Tumours (TNM)
* Patients with an EGFR deletion or mutation known (from tumour biopsy or plasma) to be associated with EGFR TKI sensitivity
* Existence of measurable or evaluable disease (as per RECIST 1.1 criteria).
* Possibility of obtaining sufficient tissue sample, via a biopsy or surgical resection of the primary tumour or metastatic tumour tissue
* WHO performance status 0 <= age <= 1
* Life expectancy >=12 weeks
* Capacity to swallow
* Patients able to complete study and within geographical proximity allowing for adequate follow up
* Resolution of all acute toxic effects of previous anticancer therapy
* Female patients must be using highly effective contraceptive measures, and must have a negative pregnancy test prior to start of dosing if of childbearing potential
* Male patients must be willing to use barrier contraception
Exclusion Criteria:
* Locally advanced lung cancer candidate for curative treatment through radical surgery and/or radio(chemo)therapy
* Patients diagnosed with another lung cancer subtype
* Patients with an EGFR exon 20 insertion
* Patients with just one measurable or evaluable tumour lesion that has been resected or irradiated prior to their enrolment in the study
* Second active neoplasia
* Treatment with an investigational drug within five half-lives of the compound
* Participation in another clinical study with an investigational product (IP) during the last 3 weeks before the first day of study treatment
* Patients who have received prior immunotherapies
* Patients who have received prior EGFR treatments for lung cancer
* Patients who have received prior treatment with an EGFR TKI including in the adjuvant setting
* Patients who have received previous treatment for metastatic or stage IV disease
* Prior treatment with cytotoxic chemotherapy for advanced NSCLC
* Patients with a history of cancer that has been completely treated, with no evidence of malignant disease currently cannot be enrolled in the study if their chemotherapy was completed less than 6 months prior and/or have received a bone marrow transplant less than 2 years before the first day of study treatment
* Any unresolved toxicities from prior therapy greater than CTCAE grade 1 at the time of starting study treatment with the exception of alopecia and grade 2, prior platinum-therapy related neuropathy
* Any evidence of severe or uncontrolled systemic diseases, including uncontrolled hypertension and active bleeding diatheses or active infection (eg, patients receiving treatment for infection) including hepatitis C and human immunodeficiency virus (HIV), or active uncontrolled Hepatitis B virus (HBV) infection.
* Patients who have had a surgical procedure unrelated to the study within 14 days or major surgery within 1 month prior to the administration of the study drug
* Past medical history of interstitial lung disease (ILD), drug-induced ILD, radiation pneumonitis
* Any of the following cardiac criteria: Mean resting QT interval corrected for heart rate (QTc) more than 470 msec, obtained from 3 ECGs, using the screening clinic ECG machine derived QTc value. Any clinically important abnormalities in rhythm, conduction or morphology of resting ECG e.g. complete left bundle branch block, third degree heart block and second degree heart block. Any factors that increase the risk of QTc prolongation or risk of arrhythmic events such as heart failure, hypokalaemia, hypomagnesaemia, hypocalcaemia, congenital long QT syndrome, family history of long QT syndrome or unexplained sudden death under 40 years in first degree relatives or any concomitant medication known to prolong the QT interval
* Spinal cord compression, symptomatic and unstable brain metastases except for those patients who have completed definitive therapy, and have had a stable neurological status for at least 2 weeks after completion of definitive therapy. 20.Refractory nausea and vomiting, chronic gastrointestinal diseases, inability to swallow the formulated product or previous significant bowel resection that would preclude adequate absorption of osimertinib
*Inadequate bone marrow reserve or organ function 22.Female patients who are breastfeeding 23.Patients currently receiving medications or herbal supplements known to be potent inducers of cytochrome (CYP) 3A4.
*Patient unwilling to undergo a biopsy at the time of disease progression 25.History of hypersensitivity to active or inactive excipients of osimertinib or drugs with a similar chemical structure or class to osimertinib 26.Judgment by the Investigator that the patient should not participate in the study if the patient is unlikely to comply with study procedures, restrictions and requirements 27.Involvement in the planning and/or conduct of the study 28.Previous enrolment in the present study
Sex :
ALL
Ages :
- Minimum Age : 18 Years
- Maximum Age : 130 Years
- Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : ADULT, OLDER_ADULT
Accepts Healthy Volunteers:
No
|
NCT03239340
| 65,104 |
{
"NCT_ID" : "NCT01538225",
"Brief_Title" : "Neurophysiological Study of Sativex in Multiple Sclerosis (MS) Spasticity",
"Official_title" : "Neurophysiologic Study on Effects of Sativex® on Spasticity in Progressive Multiple Sclerosis",
"Conditions" : ["Multiple Sclerosis"],
"Interventions" : ["Drug: Sativex®", "Drug: Placebo"],
"Location_Countries" : ["Italy"],
"Study_Design" : {
"Study_Type" : "INTERVENTIONAL",
"Phase" : ["PHASE3"],
"Primary_Purpose" : "TREATMENT",
"Allocation" : "RANDOMIZED",
"Interventional_Model" : "CROSSOVER",
"Masking" : "DOUBLE"
},
"Recruitment_Information" : {
"Study_Start_Date(Actual)" : "2012-04",
"Primary_Completion_Date(Actual)(Final_data_collection_date_for_primary_outcome_measure)" : "2013-11",
"Study_Completion_Date(Actual)" : "2013-11},
"Study_Record_Dates" : {
""Study_Registration_Dates" : {
"First_Submitted" : 2012-02-20",
"First_Posted(Estimated)" : 2012-02-24"
},
"Study_Record_Updates" : {
"Last_Updated_that_Met_QC_Criteria" : 2012-02-23",
"Last_Update_Posted(Estimated)" : 2014-01-20",
"Last_Verified" : 2014-01"
}
}}
|
#Study Description
Brief Summary
Aim of this randomized, double-blind, placebo-controlled, cross-over study is to investigate cannabinoid-induced changes in neurophysiological parameters in a group of 40 patients with secondary or primary progressive Multiple Sclerosis (MS).
#Intervention
- DRUG : Sativex®
- THC:CBD 1:1 ratio oromucosal spray. A titration period is required to reach optimal dose. The number and timing of sprays may vary between patients.
Duration: 2 weeks
- DRUG : Placebo
- Placebo
Same frequency and dosage form as Sativex.
Duration: 2 weeks
|
#Eligibility Criteria:
Inclusion Criteria:
* Aged 18 years or above
* Willing and able to comply with the protocol for the duration of the study
* Diagnosis of Secondary-Progressive or Primary-Progressive MS from at least 12 months
* Relapse free from at least 3 months before screening visit
* Lower limb spasticity
* EDSS from > 3.0 and < 6.5
* Moderate to severe spasticity due to MS from at least 6 months and with stable drug treatment not able to relieve symptoms as a whole, deserving a specific add-on treatment
* Immunomodulatory or immunosuppressant therapies not modified during the study and 6 months before starting the study
* Stable doses of anti-spasticity agents from at least 2 months prior to screening visit
* Have given written informed consent
Exclusion Criteria:
* Any concomitant disease that may cause spasticity or that could interfere with subject's spasticity
* Botulinum Toxin injection for spasticity in the 4 months prior to screening visit
* Any known or suspected history of psychotic illness, alcohol or substance abuse, epilepsy, hypersensitivity to cannabinoids
* Significant cardiac, renal or hepatic disease
* Female subjects of child bearing potentials and male subjects whose partner is child bearing potential, unless willing to ensure that they or their partner use contraception during the study
* Female subjects who is pregnant lactating or planning pregnancy during the course of the study and for three months thereafter
* Sativex® SmPC contraindications
Sex :
ALL
Ages :
- Minimum Age : 18 Years
- Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : ADULT, OLDER_ADULT
Accepts Healthy Volunteers:
No
|
NCT01538225
| 27,924 |
{
"NCT_ID" : "NCT01864486",
"Brief_Title" : "Restoring Vision With the Intelligent Retinal Implant System (IRIS V1)in Patients With Retinal Dystrophy",
"Official_title" : "Restoring Vision With the Intelligent Retinal Implant System (IRIS V1)in Patients With Retinal Dystrophy (Title in France: Compensation of Vision With the Intelligent Retinal Implant System (IRIS V1) in Patients With Retinal Dystrophy)",
"Conditions" : ["Retinitis Pigmentosa", "Cone Rod Dystrophy", "Choroideremia"],
"Interventions" : ["Device: Intelligent Retinal Implant System"],
"Location_Countries" : ["Germany", "France", "Austria"],
"Study_Design" : {
"Study_Type" : "INTERVENTIONAL",
"Phase" : ["NA"],
"Primary_Purpose" : "TREATMENT",
"Allocation" : "NA",
"Interventional_Model" : "SINGLE_GROUP",
"Masking" : "NONE"
},
"Recruitment_Information" : {
"Study_Start_Date(Actual)" : "2013-04",
"Primary_Completion_Date(Actual)(Final_data_collection_date_for_primary_outcome_measure)" : "2017-10-13",
"Study_Completion_Date(Actual)" : "2017-10-13},
"Study_Record_Dates" : {
""Study_Registration_Dates" : {
"First_Submitted" : 2013-05-15",
"First_Posted(Estimated)" : 2013-05-29"
},
"Study_Record_Updates" : {
"Last_Updated_that_Met_QC_Criteria" : 2013-05-24",
"Last_Update_Posted(Estimated)" : 2017-10-17",
"Last_Verified" : 2017-10"
}
}}
|
#Study Description
Brief Summary
This study evaluates the safety and effectiveness of the Intelligent Retinal Implants System (IRIS V1)
#Intervention
- DEVICE : Intelligent Retinal Implant System
|
#Eligibility Criteria:
Inclusion Criteria:
* Is >= 25 years at the date of enrolment
* Has a confirmed diagnosis of retinitis pigmentosa, choroideremia or cone-rod dystrophy
* Has a visual acuity of logMAR 2.3 or worse in both the eyes as determined by a Square Grating scale.
* Has functional ganglion cells and optic nerve activity
* Has a memory of former useful form vision
* Understands and accepts the obligation to present for all schedule follow-up visits.
* Has AP eye dimensions that are appropriate with the dimensions of the implant(In Germany: Has an AP eye dimension between 20.5 and 25 mm)
* Has head dimensions that are appropriate for visual Interface.
Exclusion Criteria:
* Has a history of severe glaucoma, uveitis, optic neuropathy or any confirmed damage to the optic nerve and/or visual cortex,
* Has any disease (other than study allowed diseases) or condition that affects retinal function of the study eye (e.g., central retinal artery/vein occlusion, end-stage diabetic retinopathy, current or prior retinal detachment, infectious or inflammatory retinal disease, etc.),
* Has any disease or condition that prevents adequate visualization of the retina of the study eye including, but not limited to, corneal degeneration that cannot be resolved prior to implantation,
* Has any disease or condition of the anterior segment of the study eye that prevents adequate physical examination (e.g., ocular trauma, etc.),
* Has severe nystagmus,
* Has any ocular condition that leads him or her to eye rubbing,
* Has any disease or condition that precludes the understanding or communication of the informed consent, study requirements or test protocols (e.g., deafness , multiple sclerosis, amyotrophc lateral sclerosis, neuritis, etc),
* Has a history of epileptic seizure,
* Has a history of chronic or recurrent infection or inflammation that would preclude participation in the study,
* Has a known sensitivity to the contact materials of the implant,
* Presents with hypotony in the study eye,
* Presents with hypertony in the study eye,
* Is pregnant or lactating,
* Has another active implanted device (e.g. cochlear implant) or any form of metallic implant in the head (other than dental work) that may interfere with the device function,
* Has a diagnosis requiring an active implant (e.g., cardiac pacemaker, vagus nerve implant, etc.),
* Has active cancer or a history of intraocular, optic nerve or brain cancer and metastasis,
* Is an immune-suppressed subject (e.g., due to HIV positive diagnosis, etc.),
* Is carrier of multi-resistant germs,
* Requires the use of any of the following medications:
* Antimetabolites,
* Thrombocyte aggregation reducing therapies (10 days prior until 3 days after surgery),
* Oral anticoagulants (5 days before until 3 days after surgery),
* Is participating in another investigational drug or device study that may interfere with the proposed treatment or the ensuring follow-up schedule, (in Germany: Is participating in another investigational drug or device study)
* Has any health concern that makes general anaesthesia inadvisable, (in Germany: Patients with an ASA-Score of 3 or higher are excluded from the study)
* Is likely requiring MRI scans subsequent to implantation and prior to explantation,
* Is likely requiring therapeutic ultrasound subsequent to implantation and prior to explantation of the Retinal Implant
In Germany: - Patients with recurrent or chronic inflammations or infections are excluded from the study. Specifically patients with the following disorders are excluded:
* Common inflammation - severe chronic and consuming diseases that frequently associated with infection (e.g. Crohn disease, Whipple's disease)
* Chronic inflammation of the skin in the area of the eye (e.g. dermatitis, rosacea, infection of the skin, herpes zoster)
* Chronic inflammation in the area of the eye (e.g. herpes of cornea and/or conjunctiva, recurrent blepharoconjunctivitis, horedolum, chalazion) In Germany: - Has a severe psychological disorder. When in any doubt, an expert assessment needs to be arranged to clarify whether the patient's psychological health is suitable for the trial.
In Germany: - Has severe renal, cardiac, hepatic etc. organ diseases
Sex :
ALL
Ages :
- Minimum Age : 25 Years
- Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : ADULT, OLDER_ADULT
Accepts Healthy Volunteers:
No
|
NCT01864486
| 91,795 |
{
"NCT_ID" : "NCT03813459",
"Brief_Title" : "Subsyndromal Delirium in Intensive Care Unit",
"Official_title" : "Subsyndromal Delirium in Intensive Care Unit, a Multicenter Study",
"Conditions" : ["Delirium"],
"Location_Countries" : ["Portugal"],
"Study_Design" : {
"Study_Type" : "OBSERVATIONAL",
},
"Recruitment_Information" : {
"Study_Start_Date(Actual)" : "2018-08-01",
"Primary_Completion_Date(Actual)(Final_data_collection_date_for_primary_outcome_measure)" : "2019-09-01",
"Study_Completion_Date(Actual)" : "2020-03-31},
"Study_Record_Dates" : {
""Study_Registration_Dates" : {
"First_Submitted" : 2019-01-13",
"First_Posted(Estimated)" : 2019-01-23"
},
"Study_Record_Updates" : {
"Last_Updated_that_Met_QC_Criteria" : 2019-01-19",
"Last_Update_Posted(Estimated)" : 2021-12-14",
"Last_Verified" : 2021-12"
}
}}
|
#Study Description
Brief Summary
Subsyndromal delirium (SSD) is a condition characterized by a less severe cognitive impairment in comparison to delirium. To date there is no published consensus on SSD definitions and has been commonly reported as an intermediate stage between delirium and normal mental states.
SSD encompasses some of the delirium symptoms, and has been diagnosed with Intensive Care Delirium Screening Checklist scale (ICDSC) and Confusion Assessment Method-ICU (CAM-ICU).
The objective of this study is to identify subsyndromal delirium prevalence, the association between SSD and clinical outcomes and understanding the relationship between SSD and conversion to delirium.
The relevance of this study is understanding of subsyndromal delirium in ICU, namely the importance of early presentations of acute brain dysfunction in the patients outcome.
Detailed Description
SubSynD is a prospective, observational, multicenter clinical study, involving 400 patients in Intensive Care Units, to assess subsyndromal delirium.
A systematic screening for delirium and subsyndromal delirium (SSD) is done with Intensive Care Delirium Screening Checklist (ICDSC) and Confusion Assessment Method-ICU (CAM-ICU). Scales are applied once per day until ICU discharge or for up to 14 days of being in ICU.
The investigators access three different groups of patients: non-delirium, delirium and subsyndromal delirium. It is intended that either ICDSC or CAM-ICU, paired with a Richmond Agitation and Sedation Scale (RASS) be administered once per day (i.e. with first assessment in the morning). All patients with abnormal CAM-ICU or ICDSC features, beside the underlying cause of delirium and SSD are included. In addition, data regarding baseline demographic and clinical characteristics will be collected as well as data regarding the procedure performed (see Case Report Form (CRF)).
|
#Eligibility Criteria:
Inclusion Criteria:
* Age >= 18 years;
* Admission in Intensive care Unit
Exclusion Criteria:
* Primary neurological diagnosis, with Glasgow Coma Scale (GCS) <14 on ICU admission or in previous days;
* Blindness or deafness;
* Aphasia;
* Inability to communicate in the native language of the country where the study is enrolled;
* Death during the first 24 hours;
* Limitation of therapeutic efforts in the Intensive Care Unit admission;
* Refusal to participate;
* Previous diagnosis of dementia or psychiatric illness;
* Readmission in ICU;
Sex :
ALL
Ages :
- Minimum Age : 18 Years
- Maximum Age : 100 Years
- Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : ADULT, OLDER_ADULT
Accepts Healthy Volunteers:
No
|
NCT03813459
| 163,217 |
{
"NCT_ID" : "NCT02011295",
"Brief_Title" : "Bone Marrow Aspirate Concentrate (BMAC) Supplementation for Osteochondral Lesions",
"Official_title" : "Bone Marrow Aspirate Concentrate Supplementation to Microfracture in the Treatment of Osteochondral Lesions of the Talus",
"Conditions" : ["Osteochondral Lesions of Talus"],
"Interventions" : ["Other: Bone Marrow Aspirate injection", "Procedure: ankle arthroscopy with debridement and microfracture of the OLT"],
"Location_Countries" : ["United States"],
"Study_Design" : {
"Study_Type" : "INTERVENTIONAL",
"Phase" : ["NA"],
"Primary_Purpose" : "TREATMENT",
"Allocation" : "RANDOMIZED",
"Interventional_Model" : "PARALLEL",
"Masking" : "NONE"
},
"Recruitment_Information" : {
"Study_Start_Date(Actual)" : "2014-01-29",
"Primary_Completion_Date(Actual)(Final_data_collection_date_for_primary_outcome_measure)" : "2019-06-26",
"Study_Completion_Date(Actual)" : "2019-06-26},
"Study_Record_Dates" : {
""Study_Registration_Dates" : {
"First_Submitted" : 2013-12-10",
"First_Posted(Estimated)" : 2013-12-13"
},
"Study_Record_Updates" : {
"Last_Updated_that_Met_QC_Criteria" : 2013-12-12",
"Last_Update_Posted(Estimated)" : 2019-08-16",
"Last_Verified" : 2019-07"
}
}}
|
#Study Description
Brief Summary
The purpose of this study is to determine the clinical efficacy of the application of bone marrow aspirate concentrate (BMAC) as a supplement to microfracture in the treatment of osteochondral lesions of the talus (OLTs).
Detailed Description
After appropriate patient identification and consent, patients will be asked to complete a 100 mm visual analog pain scale, a Foot and Ankle Disability Index questionnaire, a Short Form-36 questionnaire, and a Short Musculoskeletal Function Assessment questionnaire. They will then be randomized to one of two groups: (1) microfracture alone or (2) microfracture plus injection of autologous BMAC.
At the time of surgery, all patients will undergo standard ankle arthroscopy with debridement and microfracture of the OLT. If randomized to the microfracture alone group, no further intervention will take place. If randomized to the microfracture + BMAC group, then, while the surgeon is performing the ankle arthroscopy, the surgical assistant will perform the iliac crest bone marrow aspiration. The ipsilateral iliac crest will undergo sterile preparation and draped into the surgical field. The iliac crest aspiration site will be injected with 2cc of 1% lidocaine for postoperative pain control. Through an approximate 4mm incision, approximately 2 cm posterior to the patient's ipsilateral anterior superior iliac spine, a Jamshidi® type trocar/cannula system will be placed through the incision and the medial and lateral borders of the pelvic brim will be palpated. Once centered, the needle will be malleted into the pelvis between the inner and outer tables to a depth of 2-3 cm. The sharp trocar will be switched for the blunt trocar and introduced another 2-3cm. The blunt trocar is used to prevent penetration of the cannula through the inner table cortex. Next, 60cc of iliac crest bone marrow will be aspirated. The needle will be withdrawn and the incision is closed with one 3-0 nylon suture. The iliac crest bone marrow aspirate is then passed through a filter to remove any bone spicules and then centrifuged using the Harvest SmartPReP 2 BMAC system (http://www.harvesttech.com). This device is approved for intra-operative point-of-care use for concentrating iliac crest bone marrow. Its use is approved at Duke. The process takes approximately 15 minutes and will be occurring simultaneous to the ankle arthroscopy, debridement, and microfracture of the OLT. Concentration of 60cc of iliac crest bone marrow aspirate typically yields 6-7cc of BMAC. Therefore, to provide a standard amount of BMAC across all cases, 5cc of the BMAC will be injected into the ankle joint through the arthroscopy incision prior to closure.
All patients will be placed in a postoperative splint and remain non-weightbearing for six weeks as a standard protocol for microfracture of OLTs. They will return for the first postoperative visit 2-3 weeks after the surgery and the sutures will be removed.
Additional post-surgical routine follow-up occurs at 3 months, 6 months, 1 year, and 2 years. These standard time-points will occur for all patients enrolled in this study. At each time-point, patients will be asked to complete a 100 mm visual analog pain scale, a Foot and Ankle Disability Index questionnaire, a Short Form-36 questionnaire, and a Short Musculoskeletal Function Assessment questionnaire. At the one-year time-point, patients will be scheduled for a repeat MRI.
#Intervention
- PROCEDURE : ankle arthroscopy with debridement and microfracture of the OLT
- ankle arthroscopy with debridement and microfracture of the OLT
- OTHER : Bone Marrow Aspirate injection
|
#Eligibility Criteria:
Inclusion Criteria:
* over age 18
* has an OLT that has not had previous surgical treatment
Exclusion Criteria:
* OLT greater than 1.5cm in diameter (these require more extensive treatment)
* more than one OLT
* radiographic evidence of widespread ankle joint arthritis
* any systemic inflammatory disease
* any ankle deformity
Sex :
ALL
Ages :
- Minimum Age : 18 Years
- Maximum Age : 95 Years
- Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : ADULT, OLDER_ADULT
Accepts Healthy Volunteers:
No
|
NCT02011295
| 125,898 |
{
"NCT_ID" : "NCT01971086",
"Brief_Title" : "Treatment With Rhinospray Plus in Patients With Acute Rhinitis in the Everyday Curative Routine in Hungary",
"Official_title" : "Treatment With Rhinospray Plus of Patients With Acute Rhinitis in the Everyday Curative Routine in Hungary",
"Conditions" : ["Rhinitis"],
"Location_Countries" : ["Hungary"],
"Study_Design" : {
"Study_Type" : "OBSERVATIONAL",
},
"Recruitment_Information" : {
"Study_Start_Date(Actual)" : "2013-10",
"Primary_Completion_Date(Actual)(Final_data_collection_date_for_primary_outcome_measure)" : "2014-03",
"Study_Completion_Date(Actual)" : "2014-03},
"Study_Record_Dates" : {
""Study_Registration_Dates" : {
"First_Submitted" : 2013-10-14",
"First_Submitted_that_Met_QC_Criteria" : 2015-03-13",
"First_Posted(Estimated)" : 2013-10-29"
},
"Study_Record_Updates" : {
"Last_Updated_that_Met_QC_Criteria" : 2013-10-23",
"Last_Update_Posted(Estimated)" : 2015-03-24",
"Last_Verified" : 2015-03"
}
}}
|
#Study Description
Brief Summary
Multi-centre, open-label, prospective, uncontrolled, single-arm, non-interventional study (NIS) with objective to collect and evaluate data concerning treatment with Rhinospray Plus in everyday curative routine treatment of acute rhinitis
Detailed Description
Study Design:
open, observational, single-arm, uncontrolled
|
#Eligibility Criteria:
Inclusion criteria:
* Patients who (or in case of 6 <= age <= 18 years whose legal representative) have signed the Informed Consent
* Male and female ambulatory outpatients being seen in a participating physicians office for routine care
* Patients with a clinical diagnosis of Rhinitis acuta
* Patient having the cognitive and functional abilities for answering the symptom specific questions
* Patients having expressed the willingness to participate in this observational study
* Patients at and above the age of 6
* Rhinospray Plus naive patients (patients who have not used Rhinospray Plus before)
Exclusion criteria:
* Uncooperative patients based on physicians judgement
* Patients with any conditions making the application of Rhinospray plus contraindicated
* Patients currently enrolled in any clinical trial which requires a change in medication for their respiratory problems
* Withdraw of Informed Consent
* Pregnancy or breast-feeding as stated in the Summary of Product Characteristic (SmPC)
* Patients with clinical diagnosis of allergic rhinitis
Sex :
ALL
Ages :
- Minimum Age : 6 Years
- Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : ADULT, OLDER_ADULT, CHILD
Accepts Healthy Volunteers:
No
|
NCT01971086
| 102,772 |
{
"NCT_ID" : "NCT00074386",
"Brief_Title" : "Kidney and Liver Transplantation in People With HIV",
"Official_title" : "Solid Organ Transplantation in HIV: Multi-Site Study",
"Conditions" : ["HIV Infections", "Kidney Disease", "Liver Disease"],
"Location_Countries" : ["United States"],
"Study_Design" : {
"Study_Type" : "OBSERVATIONAL",
},
"Recruitment_Information" : {
"Study_Start_Date(Actual)" : "2003-10",
"Primary_Completion_Date(Actual)(Final_data_collection_date_for_primary_outcome_measure)" : "2013-08",
"Study_Completion_Date(Actual)" : "2013-08},
"Study_Record_Dates" : {
""Study_Registration_Dates" : {
"First_Submitted" : 2003-12-11",
"First_Posted(Estimated)" : 2003-12-15"
},
"Study_Record_Updates" : {
"Last_Updated_that_Met_QC_Criteria" : 2003-12-12",
"Last_Update_Posted(Estimated)" : 2014-01-17",
"Last_Verified" : 2014-01"
}
}}
|
#Study Description
Brief Summary
With improved anti-HIV drug therapy, HIV infected patients are now living longer. These patients are at risk for liver and kidney failure and may need organ transplants. However, little is know about the safety and effectiveness of organ transplants in patients with HIV. This study will evaluate organ transplantation in HIV infected patients undergoing liver and kidney transplants.
Detailed Description
HIV infected people are at significant risk for end stage organ disease. Prior to the advent of highly active antiretroviral therapy (HAART), these people were often not considered transplant candidates based on concern about potential adverse effects of immunosuppressive drugs on HIV disease progression. However, with the use of HAART, HIV infected people have experienced significant improvements in morbidity and mortality. HIV infected people with end stage kidney and liver disease are now potential candidates for transplantation, yet patients and clinicians lack the necessary data to determine the safety and efficacy of transplantation and immunosuppression in this group. This lack of conclusive data has led to continued denial of care by many transplant centers and third party payers, resulting in frustration and confusion for both patients and their health care providers.
This study will evaluate the safety and efficacy of solid organ transplantation in people with HIV infection by following a prospective, multi-center cohort of HIV infected people who undergo kidney or liver transplantation. The long-term goals are: 1) to provide patients and clinicians with information regarding the HIV-specific risks of transplantation; 2) to provide clinicians with information necessary to manage immunosuppressive and HAART medications together; and 3) to understand underlying basic science mechanisms that explain patient outcomes so that clinical management can be adjusted to improve outcomes.
Approximately 150 kidney and 125 liver transplant patients will be enrolled in this study over a 3-year period at medical research centers throughout the United States. Participants will be enrolled in the study for five years from the day of the transplant.
|
#Eligibility Criteria:
Inclusion Criteria for All Participants:
* HIV infection
* Undetectable HIV viral load
* Meet all eligibility requirements for a transplant (same requirements that HIV uninfected patients must meet)
* Willing to take medication to prevent certain infections
* Willing to undergo frequent monitoring, including liver biopsies, and treatment, if participant has hepatitis B or C virus infection
* Willing to submit laboratory test results within 7 days of blood draw
* Willing to notify the transplant team before changing any medications
* If participant has a history of HIV-related cancers or opportunistic infections, some additional eligibility criteria must be met.
Inclusion Criteria for Patients Undergoing Kidney Transplant:
* CD4 count greater than 200 cells/mm3. CD4 count requirement for children will be based on child's age. Participant cannot have used the drugs IL-2 or GM-CSF in order to increase the CD4 count in the 6 months prior to transplant.
Inclusion Criteria for Patients Undergoing Liver Transplant:
* CD4 count greater than 100 cells/mm3. CD4 count requirement for children will be based on child's age. Some participants with certain HIV-related diseases must have a CD4 count that is greater than 200 cells/ml for the 6 months prior to study entry.
Exclusion Criteria for All Participants:
* Pregnancy
* Significant wasting or weight loss
Sex :
ALL
Ages :
- Minimum Age : 1 Year
- Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : ADULT, OLDER_ADULT, CHILD
Accepts Healthy Volunteers:
No
|
NCT00074386
| 89,411 |
{
"NCT_ID" : "NCT03793153",
"Brief_Title" : "A Novel Technique Of Uterine Cooling During Repeated Cesarean Section For Reducing Blood Loss",
"Official_title" : "A Novel Technique Of Uterine Cooling During Repeated Cesarean Section For Reducing Blood Loss",
"Conditions" : ["Cesarean Section Complications", "Intrapartum Hemorrhage", "Postpartum Hemorrhage", "Atony, Uterine"],
"Interventions" : ["Procedure: Uterine Cooling Technique"],
"Location_Countries" : ["Egypt"],
"Study_Design" : {
"Study_Type" : "INTERVENTIONAL",
"Phase" : ["NA"],
"Primary_Purpose" : "PREVENTION",
"Allocation" : "RANDOMIZED",
"Interventional_Model" : "PARALLEL",
"Masking" : "DOUBLE"
},
"Recruitment_Information" : {
"Study_Start_Date(Actual)" : "2018-12-19",
"Primary_Completion_Date(Actual)(Final_data_collection_date_for_primary_outcome_measure)" : "2019-03-20",
"Study_Completion_Date(Actual)" : "2019-03-25},
"Study_Record_Dates" : {
""Study_Registration_Dates" : {
"First_Submitted" : 2018-12-31",
"First_Posted(Estimated)" : 2019-01-04"
},
"Study_Record_Updates" : {
"Last_Updated_that_Met_QC_Criteria" : 2019-01-02",
"Last_Update_Posted(Estimated)" : 2019-04-09",
"Last_Verified" : 2019-04"
}
}}
|
#Study Description
Brief Summary
Study aim to evaluate the efficacy and safety of a novel technique of UTERINE COOLING during repeated cesarean section (CS) in reducing blood loss, and record any adverse effects following it.
Detailed Description
Bleeding during vaginal or operative delivery is always of prime concern. Despite significant progress in obstetric care 125,000 women die from obstetric hemorrhage annually in the world.
The incidence of caesarean delivery is increasing, and the average blood loss during caesarean delivery (1000 mL) is double the amount lost during vaginal delivery (500 mL).
Caesarean section (CS) rate as high as 25-30% in many areas of the world. In Egypt the CS rate is 27.6 %, in United States of America, from 1970-2009 the CS rate rose from 4.5-32.9%, and declined to 32.8% of all deliveries at 2010. In spite of the various measures to prevent blood loss during and after caesarean section, post-partum hemorrhage (PPH) continues to be the most common complication seen in almost 20% of the cases, and causes approximately 25% of maternal deaths worldwide, leading to increased maternal morbidity and mortality. Indeed we need to reduce the bleeding during and after caesarean sections aiming for reducing the morbidity and mortality rate due to obstetric hemorrhage, which can be life threatening.
The hematocrit level falls by 10% and blood transfusion is required in 6% of women undergoing caesarean delivery versus 4% of women who have a vaginal birth. Numerous methods for performing caesarean section exist targeting a safe delivery for the infant with minimum maternal morbidity. Operative morbidity includes hemorrhage, anemia, and blood products transfusion may be required associated with many risks and complications.
Women who undergo a caesarean delivery are much more likely to be delivered by a repeat operation in subsequent pregnancies. For women undergoing subsequent cesarean, the maternal risks are even greater like massive obstetric hemorrhage, hysterectomy, admission to an intensive care unit, or maternal death. Medications, such as oxytocin, misoprostol and prostaglandin F2α, have been used to control bleeding postoperatively.
The uterus is a smooth muscle whose contraction is modulated most directly by intrinsic or extrinsic oxytocin. During pregnancy the spiral arteries within the uterus and beneath the placenta enlarge to provide adequate perfusion to the placenta. After separation of the placenta the uterine smooth muscle cells contract in a pincer-like action to pinch the spiral arteries closed. When uterine contraction is inadequate (approximately 4-6% of normal pregnancies) the spiral arteries continue to bleed. If not addressed the bleeding can be excessive, even leading to maternal death. Approximately 5-8 out of 1,000 cesarean sections require hysterectomy to control bleeding.
Release of calcium ions from sarcoplasmic reticulum stores is the immediateinitiator of contraction, and calcium's diffusion from the muscle filaments andre-uptake by the sarcoplasmic reticulum results in relaxation of contraction. Insome smooth muscles cold enhances contraction; perhaps by slowing the re-uptake of calcium.
#Intervention
- PROCEDURE : Uterine Cooling Technique
- Standard LSCS will be done except immediatelyfollowing delivery of the fetus the uterus will beexternalized in the usual fashion and the body of theuterus cephalad to the hysterotomy incision will bewrapped in sterile surgical towels saturated in sterile,iced normal saline. These towels will come from asterile cooling pot set to 30 degrees Fahrenheit. Theskin of the abdomen will be draped to prevent contactwith the cold towels. Iced saline-soaked towels will bekept in place for a minimum of 5 minutes and replacedat the discretion of the attending obstetrician until thehysterotomy is closed and the uterus is replaced intothe patient's abdomen.
- Other Names :
- Hetta-UCT
|
#Eligibility Criteria:
Inclusion Criteria:
* Singleton pregnancy at term between 38±5 days and 40 weeks.
* Elective planned or emergency repeated lower segment cesarean sections(LSCS).
* Pregnant women who will accept to be in the study, and have giveninformed consent.
Exclusion Criteria:
Women who refuse to be in the study, and women who are unable to consentdue to emergent nature of the cesarean section will be excluded. Women whoare unable to understand the nature of the study due to mental illness, mentalretardation, medical condition, or other communication barrier will be excluded,or who with severe medical and surgical complications as any of the followingwill be excluded :
* Heart, liver, kidney, or brain diseases, and blood disorders.
* Abruptio placenta, and placental abnormalities or accrete syndromes.
* Polyhydraminos, macrosomia, or preeclampsia.
* History of thromboembolic disorders, or severe anemia.
Sex :
FEMALE
Ages :
- Minimum Age : 20 Years
- Maximum Age : 40 Years
- Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : ADULT
Accepts Healthy Volunteers:
Yes
|
NCT03793153
| 249,020 |
{
"NCT_ID" : "NCT00001251",
"Brief_Title" : "Phase I Study of Intrathecal Mafosfamide",
"Official_title" : "Phase I Study of Intrathecal Mafosfamide",
"Conditions" : ["Leukemia", "Lymphoma", "Meningeal Neoplasm"],
"Location_Countries" : ["United States"],
"Study_Design" : {
"Study_Type" : "INTERVENTIONAL",
"Phase" : ["PHASE1"],
"Primary_Purpose" : "TREATMENT",
},
"Recruitment_Information" : {
"Study_Start_Date(Actual)" : "1989-11",
"Study_Completion_Date(Actual)" : "2003-11},
"Study_Record_Dates" : {
""Study_Registration_Dates" : {
"First_Submitted" : 2006-07-07",
"First_Posted(Estimated)" : 1999-11-04"
},
"Study_Record_Updates" : {
"Last_Updated_that_Met_QC_Criteria" : 1999-11-03",
"Last_Update_Posted(Estimated)" : 2013-08-19",
"Last_Verified" : 2003-11"
}
}}
|
#Study Description
Brief Summary
The purpose of this study is to determine efficacy of intrathecal mafosfamide, a preactivated derivative of cyclophosphamide against meningeal malignancies refractory to conventional therapy (radiation therapy and chemotherapy). The maximally tolerated dose for intrathecal mafosfamide will be established in a limited dosage escalation schedule. The CSF pharmacokinetics of intrathecal mafosfamide will also be studied.
Mafosfamide will be administered intrathecally on a bi-weekly basis for four weeks, followed by twice monthly administration for four months and then monthly IT administration. A minimum of 9 patients will be studied in each disease category (leukemias, lymphomas, and other malignancies refractory to conventional therapy).
Detailed Description
The purpose of this study is to determine efficacy of intrathecal mafosfamide, a preactivated derivative of cyclophosphamide against meningeal malignancies refractory to conventional therapy (radiation therapy and chemotherapy). The maximally tolerated dose for intrathecal mafosfamide will be established in a limited dosage escalation schedule. The CSF pharmacokinetics of intrathecal mafosfamide will also be studied.
Mafosfamide will be administered intrathecally on a bi-weekly basis for four weeks, followed by twice monthly administration for four months and then monthly IT administration. A minimum of 9 patients will be studied in each disease category (leukemias, lymphomas, and other malignancies refractory to conventional therapy).
#Intervention
- DRUG : Mafosfamide
|
#Eligibility Criteria:
INCLUSION CRITERIA:
All patients > 3 years with meningeal malignancies that are progressive or refractory to conventional therapy will be eligible for this study. Patients with meningeal malignancies secondary to an underlying solid tumor are eligible at initial diagnosis if there is no conventional therapy.
Diagnosis: Patients with leukemia, lymphoma, or other solid tumor who also have overt meningeal involvement by their tumor. The definition of meningeal disease on this protocol includes:
Leukemia/Lymphoma - CSF cell count greater than or equal to 5/mm(3) AND evidence of blast cells on cytospin preparation or by cytology.
Solid tumors - Presence of tumor cells on cytospin preparation or cytology OR presence of measurable meningeal disease on CT or MRI scans.
Patients must have a life expectancy of at least 8 weeks and an ECOG performance status of 2 or better. Patients who are unable to walk because of paralysis, but who are up in a wheelchair will be considered ambulatory for the purposes of the performance score.
Patients and/or their parents must sign an informed consent indicating that they are aware of the investigational nature of this study.
Patients must have recovered from the acute toxic effects of all prior intrathecal chemotherapy, immunotherapy, or radiotherapy, prior to entering this study and must be without significant systemic illness (e.g. infection). Patients must not have received any CNS therapy within 1 week prior to starting treatment on this study or craniospinal irradiation within 8 weeks prior to starting treatment on this study. Patients must not have received intrathecal chemotherapy within 1 week (2 weeks if prior DTC101).
Patients must not have clinically significant abnormalities with regard to liver function, renal function or metabolic parameters (electrolytes, calcium and phosphorus).
A Durable Power of Attorney (DPA) must be offered to all patients greater than or equal to 18 years.
EXCLUSION CRITERIA:
Patients receiving other therapy (either intrathecal or systematic) designed specifically to treat their meningeal malignancy are not eligible for this study. However, patients receiving concomitant chemotherapy to control systemic or bulk CNS disease will be eligible, provided the systemic chemotherapy is not a phase I agent, an agent which significantly penetrates the CNS (e.g., high dose methotrexate, (greater than 1 gm/m(2)), thiotepa, high dose cytarabine, (greater than 2 gm/m(2) per day), 5-fluorouracil, intravenous 6-mercaptopurine or topotecan), or an agent known to have serious unpredictable CNS side effects. Careful documentation of systemic drugs being administered concurrently is required.
Patients with clinical evidence of obstructive hydrocephalus or compartmentalization of the CSF flow as documented by a radioisotope Indium(111) or Technitium(99) - DTPA flow study are not eligible for this protocol. If a CSF flow block or compartmentalization is demonstrated, focal radiotherapy to the site of the block to restore flow and a repeat CSF flow study showing clearing of the blockage is required for the patient to be eligible for the study.
Patients who have leukemia or lymphoma and a concomitant bone marrow relapse are not eligible for this study.
Women of childbearing age must not be pregnant or lactating.
Patients who have received any other systemic investigational agent within 14 days prior to, or during, study treatment. The 14 day period should be extended if the patient received any investigational agent which is known to have delayed toxicities after 14 days. Patients must not have received any other intrathecal investigational agent within 7 days prior to, or during, study treatment. The 7 day period should be extended if the patient received any investigational agent which is known to have delayed toxicities after 7 days or a prolonged half-life.
Sex :
ALL
Ages :
- Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : ADULT, OLDER_ADULT, CHILD
Accepts Healthy Volunteers:
No
|
NCT00001251
| 274,213 |
{
"NCT_ID" : "NCT04396197",
"Brief_Title" : "Physical Activity Levels in COVID-19 Patients Admitted to Intensive Care",
"Official_title" : "Physical Activity Levels in COVID-19 Patients Admitted to Intensive Care Requiring Invasive Ventilation: An Observational Study",
"Conditions" : ["COVID-19", "Critical Illness", "Ards", "ICU Acquired Weakness"],
"Interventions" : ["Other: Physiotherapy"],
"Location_Countries" : ["United Kingdom"],
"Study_Design" : {
"Study_Type" : "OBSERVATIONAL",
},
"Recruitment_Information" : {
"Study_Start_Date(Actual)" : "2020-03-01",
"Primary_Completion_Date(Actual)(Final_data_collection_date_for_primary_outcome_measure)" : "2020-05-08",
"Study_Completion_Date(Actual)" : "2020-05-08},
"Study_Record_Dates" : {
""Study_Registration_Dates" : {
"First_Submitted" : 2020-05-17",
"First_Posted(Estimated)" : 2020-05-20"
},
"Study_Record_Updates" : {
"Last_Updated_that_Met_QC_Criteria" : 2020-05-19",
"Last_Update_Posted(Estimated)" : 2020-05-20",
"Last_Verified" : 2020-05"
}
}}
|
#Study Description
Brief Summary
This is an observational study exploring the levels of mobility and rehabilitation in patients admitted to critical care with a confirmed diagnosis of COVID-19
Detailed Description
An admission to an intensive care unit (ICU) often results in significant muscle weakness and physical deconditioning, which can take many months or even years for recovery. Early and progressive programmes of rehabilitation are recommended to limit any muscle loss and support recovery as early as possible. Patients admitted to intensive care with COVID-19 have been found to require prolonged periods of mechanical ventilation, high sedation and neuromuscular blocking use and as a result require prolonged stays in the ICU. As yet no data exists to examine the specific physical impact this may have, or whether it is safe and feasible to commence this earlier rehabilitation within the ICU for patients with a diagnosis of COVID-19. Our study set out to evaluate the levels of rehabilitation which were delivered in a large acute NHS trust.
#Intervention
- OTHER : Physiotherapy
- Daily physiotherapy to include respiratory care and rehabilitation based on the individual therapists clinical reasoning
- Other Names :
- Rehabilitation
|
#Eligibility Criteria:
Inclusion Criteria:
* having a confirmed diagnosis of COVID-19
* being mechanically ventilated for at least 24 hours
* surviving to critical care discharge.
Exclusion Criteria:
* none
Sex :
ALL
Ages :
- Minimum Age : 18 Years
- Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : ADULT, OLDER_ADULT
Accepts Healthy Volunteers:
No
|
NCT04396197
| 240,356 |
{
"NCT_ID" : "NCT01622933",
"Brief_Title" : "Multiple Antigen-Engineered DC Vaccine for Melanoma",
"Official_title" : "A Phase I Trial Testing Multiple Antigen-Engineered DC Followed by IFNa2b Boost for Immunization of HLA-Unrestricted Melanoma Patients",
"Conditions" : ["Melanoma"],
"Interventions" : ["Biological: DC Vaccine + IFN", "Biological: AdVTMM2/DC Vaccination"],
"Location_Countries" : ["United States"],
"Study_Design" : {
"Study_Type" : "INTERVENTIONAL",
"Phase" : ["PHASE1"],
"Primary_Purpose" : "TREATMENT",
"Allocation" : "RANDOMIZED",
"Interventional_Model" : "PARALLEL",
"Masking" : "NONE"
},
"Recruitment_Information" : {
"Study_Start_Date(Actual)" : "2012-06",
"Primary_Completion_Date(Actual)(Final_data_collection_date_for_primary_outcome_measure)" : "2016-05",
"Study_Completion_Date(Actual)" : "2017-08},
"Study_Record_Dates" : {
""Study_Registration_Dates" : {
"First_Submitted" : 2012-06-14",
"First_Posted(Estimated)" : 2012-06-19"
},
"Study_Record_Updates" : {
"Last_Updated_that_Met_QC_Criteria" : 2012-06-18",
"Last_Update_Posted(Estimated)" : 2017-08-31",
"Last_Verified" : 2016-05"
}
}}
|
#Study Description
Brief Summary
This clinical trial is to determine if the addition of a standard of care drug, interferon-alfa 2b (IFN), with an investigation vaccine will have any affect on the immune system and/or your cancer. The investigational vaccine will be made with genes that are specific to melanoma and will be given intradermally (i.d.) every two weeks for a total of 3 vaccines.
After the vaccines, subjects will be randomized to either receive a boost of high dose IFN or no boost. IFN will be administered intravenously (into a vein) for 5 consecutive days (Monday through Friday) every week for 4 weeks. Administration will begin approximately 30 days (± 7 days) after the 3rd vaccine. The first dose of IFNα2b may begin within 10 business days of randomization. All subsequent procedure dates for Group A will be based on the date of the first dose of IFNα2b.
Detailed Description
This is a Phase I, single site study to evaluate the immunological effects of autologous DC transduced with the MART-1, tyrosinase and MAGE-A6 (melanoma associated antigens, MAA) genes in 30 subjects with recurrent, unresectable stage III, IV metastatic melanoma (M1a, M1b, M1c). AdVTMM2-transduced DC, 10e7, will be given intradermally (i.d.) every two weeks for a total of 3 vaccines.
After the DC vaccines, subjects will be randomized to either receive a boost of high dose IFNa2b or no boost.
Subjects randomized to receive the IFNa2b boost will receive Interferon-a2b, 20 MU/m2/d (rounded to the nearest 1 million units) administered intravenously for 5 consecutive days (Monday through Friday) every week for 4 weeks (induction). Administration will begin approximately 30 days (± 7 days) after the 3rd vaccine. The first dose of IFNα2b may begin within 10 business days of randomization. All subsequent procedure dates for Group A will be based on the date of the first dose of IFNα2b..
The end-points of this study are local and systemic toxicity, immunological response, generation of determinant spreading and anti-tumor immunity, and clinical response.
#Intervention
- BIOLOGICAL : DC Vaccine + IFN
- Vaccine: The dose target is 1x10e7 AdVTMM2/DC per intradermal injection, or lower dose per sponsor's discretion.
IFN: 20 MU/m²/d (rounded to the nearest 1.0 million unit) administered IV x 5 consecutive days out of 7 (M-F) every week x 4 weeks.
- Other Names :
- Interferon Alfa - 2b, Intron A, IFN-alpha 2b, NSC #377523, IFNα, AdVTMM2/DC Vaccination
- BIOLOGICAL : AdVTMM2/DC Vaccination
- Vaccine: The dose target is 1x10e7 AdVTMM2/DC per intradermal injection.If cell counts are below the target, as few as 5x10e6 AdVTMM2/DC may be administered. However, at the discretion of the sponsor and/or the treating physician, a lower dose of DC that fulfills all of the other criteria for release may be administered on a case by case basis. If this occurs a dose exception form will be completed by the IMCPL, signed by the treating physician and filed in the subjects research records.
|
#Eligibility Criteria:
Inclusion Criteria:
* Ability and willing to give consent
* Patients age 18 and older with recurrent, inoperable stage III, IV, M1a, b or c melanoma (any tumor thickness and any number of lymph node involvement, and in-transit metastases, or distant metastases) (AJCC).
Previously treated with any form of therapy (including chemotherapy, radiation therapy, immunotherapy or surgery) for either metastatic, relapsed, or primary melanoma are eligible for this trial, provided the previous treatment was completed > 30 days prior to enrollment.
* Patients should have at least 2 subcutaneous, intracutaneous, and accessible tumor deposits, lymph node or other site available for biopsy purposes.
* Both men and women may be enrolled. Premenopausal females must have a negative pregnancy test prior to treatment and lactating females will have to discontinue breast feeding to be eligible.
* ECOG Performance Status of 0 or 1.
* No previous evidence of class 3 or greater New York Heart Association cardiac insufficiency or coronary artery disease.
* No previous evidence of opportunistic infection.
* Adequate baseline hematological and organ function as assessed by the following laboratory values within 28 days prior to study entry:
Hemoglobin >=9 g/dL Granulocytes >=2,000/mm3 Lymphocytes >=1000/mm3 Platelets >100,000/mm3 Serum Creatinine <=1.5 X the ULN AST, ALT, GGT, CPK, LDH, Alk phos <=2.5 X the ULN Serum Bilirubin <=1.5 X ULN In addition to study entry, the above hematological and organ function lab values along with the ECOG PS must be met prior to starting IFNα treatment.
* Subjects must have normal coagulation parameters as measured by PT/PTT,unless the subject is on an anticoagulation therapy.
Exclusion Criteria:
* Females of child-bearing potential (pre-menopausal) must have a negative serum beta-HCG pregnancy test at screening.
* Subjects with acute infection: any acute viral, bacterial, or fungal infection which requires specific therapy. Acute therapy must have been completed more than 14 days prior to study treatment.
* Hep B & C and HIV-infected patients, due to concerns in the ability to stimulate an effective immune response (determined by historical medical data).
* Subjects with acute medical problems such as ischemic heart or lung disease that may be considered an unacceptable anesthetic or operative risk.
* Subjects with any underlying conditions which would contraindicate therapy with study treatment (or allergies to reagents).
* Subjects with organ allografts.
* Subjects must be free of known brain metastases by contrast-enhanced CT/MRI scans or have successfully-treated brain metastases and be asymptomatic for more than 1 month.
* Patients requiring immunosuppressive therapy for comorbid conditions.
* Concomitant Medication and Treatment: All allowed medications or treatments should be kept to a minimum and recorded. All questions regarding concomitant medications should be referred to the Investigator.
* Long term concurrent medications and/or treatments Not Allowed: Corticosteroids, chemotherapy, cyclosporin A. Short term (approximately 1 week) use of topical, low-dose or inhaled steroids may be allowed at the discretion of the investigator. Injectables not allowed.
Sex :
ALL
Ages :
- Minimum Age : 18 Years
- Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : ADULT, OLDER_ADULT
Accepts Healthy Volunteers:
No
|
NCT01622933
| 275,146 |
{
"NCT_ID" : "NCT01006057",
"Brief_Title" : "A Trial Investigating the NN1250 Concentration-time Curve in Subjects With Various Degrees of Renal Impairment and in Subjects With Normal Renal Function",
"Official_title" : "A Trial Investigating the Pharmacokinetic and Safety of NN1250 in Subjects With Various Degrees of Renal Impairment and in Subjects With Normal Renal Function",
"Conditions" : ["Diabetes", "Healthy"],
"Interventions" : ["Drug: insulin degludec"],
"Location_Countries" : ["Hungary"],
"Study_Design" : {
"Study_Type" : "INTERVENTIONAL",
"Phase" : ["PHASE1"],
"Primary_Purpose" : "TREATMENT",
"Allocation" : "NON_RANDOMIZED",
"Interventional_Model" : "PARALLEL",
"Masking" : "NONE"
},
"Recruitment_Information" : {
"Study_Start_Date(Actual)" : "2009-11",
"Primary_Completion_Date(Actual)(Final_data_collection_date_for_primary_outcome_measure)" : "2010-05",
"Study_Completion_Date(Actual)" : "2010-05},
"Study_Record_Dates" : {
""Study_Registration_Dates" : {
"First_Submitted" : 2009-10-30",
"First_Posted(Estimated)" : 2009-11-01"
},
"Study_Record_Updates" : {
"Last_Updated_that_Met_QC_Criteria" : 2009-10-30",
"Last_Update_Posted(Estimated)" : 2017-01-20",
"Last_Verified" : 2017-01"
}
}}
|
#Study Description
Brief Summary
This trial was conducted in Europe. The aim of this clinical trial was to evaluate if the NN1250 (insulin degludec/insulin 454) concentration-time curve is altered to such an extent that the dose should be adjusted in subjects with impaired renal function compared to the dose for subjects with normal renal function.
#Intervention
- DRUG : insulin degludec
- Single dose of 0.4 U/kg body weight injected s.c. (under the skin) in subjects with end stage renal disease
- DRUG : insulin degludec
- Single dose of 0.4 U/kg body weight injected s.c. (under the skin) in subjects with mild renal impairment
- DRUG : insulin degludec
- Single dose of 0.4 U/kg body weight injected s.c. (under the skin) in subjects with moderate renal impairment
- DRUG : insulin degludec
- Single dose of 0.4 U/kg body weight injected s.c. (under the skin) in healthy volunteers
- DRUG : insulin degludec
- Single dose of 0.4 U/kg body weight injected s.c. (under the skin) in subjects with severe renal impairment
|
#Eligibility Criteria:
Inclusion Criteria:
* Subject with normal renal function or renal impairment (mild, moderate, severe or end stage renal disease (ESRD) requiring haemodialysis)
* Body mass index maximum 40.0 kg/m^2
Exclusion Criteria:
* Subject with any disease or condition which the Investigator feels would interfere with the trial except for conditions associated with renal impairment in the group of subjects with compromised renal function. Diabetes mellitus can be accepted in the group of patients with renal impairment, but not in subjects with normal renal function
* Subject who has donated any blood or plasma in the past month or more than 500 mL within 3 months prior to screening
* Significant history of alcoholism or drug/chemical abuse
* Not able or willing to refrain from smoking during the inpatient period
Sex :
ALL
Ages :
- Minimum Age : 18 Years
- Maximum Age : 85 Years
- Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : ADULT, OLDER_ADULT
Accepts Healthy Volunteers:
No
|
NCT01006057
| 26,159 |
{
"NCT_ID" : "NCT03696056",
"Brief_Title" : "Improving Brain Function After Breast Cancer Study",
"Official_title" : "Improving Cognition in Breast Cancer Survivors Using Meditation: A Pilot Study",
"Conditions" : ["Breast Cancer Survivors"],
"Interventions" : ["Behavioral: Kirtan Kriya meditation", "Behavioral: Music listening program"],
"Location_Countries" : ["United States"],
"Study_Design" : {
"Study_Type" : "INTERVENTIONAL",
"Phase" : ["NA"],
"Primary_Purpose" : "PREVENTION",
"Allocation" : "RANDOMIZED",
"Interventional_Model" : "PARALLEL",
"Masking" : "NONE"
},
"Recruitment_Information" : {
"Study_Start_Date(Actual)" : "2018-09-28",
"Primary_Completion_Date(Actual)(Final_data_collection_date_for_primary_outcome_measure)" : "2020-01-01",
"Study_Completion_Date(Actual)" : "2020-01-30},
"Study_Record_Dates" : {
""Study_Registration_Dates" : {
"First_Submitted" : 2018-09-29",
"First_Posted(Estimated)" : 2018-10-04"
},
"Study_Record_Updates" : {
"Last_Updated_that_Met_QC_Criteria" : 2018-10-03",
"Last_Update_Posted(Estimated)" : 2020-11-09",
"Last_Verified" : 2020-11"
}
}}
|
#Study Description
Brief Summary
This study will explore the feasibility and potential effects of a simple, home-based daily meditation intervention on breast cancer survivors' cognitive and psychological functioning as well as inflammatory regulation.
Detailed Description
This study will compare two home based 8-week interventions (Kirtan Kriya meditation vs.
relaxing instrumental music listening) in 40 breast cancer survivors ages 21-75 who completed chemotherapy 3 months to 5 years prior.
#Intervention
- BEHAVIORAL : Kirtan Kriya meditation
- The program incorporates song with visualization and mudras, and is a multi-faceted, multisensory exercise that appears to engage several areas of the brain implicated in cognitive decline, yet is simple to learn and practice. The meditation includes a repeated Kirtan or song, a mudra or physical/motor component, and a visualization component. The meditation sound file will contain a user friendly introduction to the Kirtan Kriya meditation technique along with detailed instructions and meditation tracks. Three tracks will contain 12 minute guided meditations with the same female voice, and 2 with nature sounds, 2 without any additional sounds. Another 2 tracks will provide only the timing cues (1 with nature sounds, 1 without) so that the participant can conduct the meditation session without guidance if they chose.
- BEHAVIORAL : Music listening program
- The participants will receive audio files and an instruction sheet to facilitate their practice.
The audio tracks are 12 minutes in length and contain relaxing instrumental music from Mozart, Bach, Beethoven, Debussy, and Pachebel. Participants are instructed to sit comfortably with their eyes closed and listen to a track of their choice for 12 min daily, for 8 weeks and to record each session on their practice log.
|
#Eligibility Criteria:
Inclusion Criteria:
* Individuals with a history of non-inflammatory breast cancer (stages I-IV):
* Received chemotherapy as part of their treatment
* Completed chemotherapy treatment 3 months to 10 years prior to study enrollment
* Individuals who have report cognitive deficits
Exclusion Criteria:
* Breast cancer survivors with a history of metastases to the brain
* A physician diagnosis of: dementia, a learning disability, unmanaged major depression, psychosis, schizophrenia, bipolar, traumatic brain injury, cancer of the central nervous system, diabetes, arthritis
* Taking oral steroids within 30 days of enrolling
* A regular meditation practice (greater than 1 time per week)
* Currently taking immune modifying medications
Sex :
ALL
Ages :
- Minimum Age : 21 Years
- Maximum Age : 75 Years
- Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : ADULT, OLDER_ADULT
Accepts Healthy Volunteers:
No
|
NCT03696056
| 204,947 |
{
"NCT_ID" : "NCT01904331",
"Brief_Title" : "Breast Cancer Long-term Outcome of Cardiac Dysfunction",
"Official_title" : "Study of the Cardiovascular and Psychosocial Effects of the Treatment of Breast Cancer With Chemotherapy and/or Radiotherapy",
"Conditions" : ["Breast Neoplasms"],
"Location_Countries" : ["Netherlands"],
"Study_Design" : {
"Study_Type" : "OBSERVATIONAL",
},
"Recruitment_Information" : {
"Study_Start_Date(Actual)" : "2013-06",
"Primary_Completion_Date(Actual)(Final_data_collection_date_for_primary_outcome_measure)" : "2016-02-06",
"Study_Completion_Date(Actual)" : "2017-10-24},
"Study_Record_Dates" : {
""Study_Registration_Dates" : {
"First_Submitted" : 2013-07-11",
"First_Posted(Estimated)" : 2013-07-22"
},
"Study_Record_Updates" : {
"Last_Updated_that_Met_QC_Criteria" : 2013-07-17",
"Last_Update_Posted(Estimated)" : 2018-06-15",
"Last_Verified" : 2018-06"
}
}}
|
#Study Description
Brief Summary
The purpose of this study is to assess the prevalence of cardiac dysfunction and (undiagnosed) heart failure in women registered in general practice with a history of breast cancer who received chemotherapy and / or radiotherapy as compared to a matched female control population.
Detailed Description
Background:
Due to screening and progress in treatment the overall survival of women treated for breast cancer has increased over the last decades. Therefore, the long-term effects of breast cancer have emerged as an important topic. An increased mortality is seen within years post treatment due to an increased incidence of cardiac dysfunction among survivors of breast cancer. This increased mortality is related to long term side effects of treatment with chemotherapy and radiotherapy. Earlier studies into this topic have focused on specific patient groups and therefore these results are difficult to translate to the general population. Furthermore, most echo graphic studies have focused on the systolic dysfunction of the heart, which is a late stage of the cardiac deterioration. Detecting cardiotoxicity early on provides the opportunity for early treatment and might therewith prevent deterioration of cardiac function and improve the prognosis of patients
Objectives:
Primary objective
1. To assess the risk of a systolic and / or diastolic cardiac dysfunction at echocardiography of breast cancer patients compared to matched controls.
Secondary objective:
2. To assess the risk of heart failure( a combination of clinical complaints, objective measures at physical examination, laboratory examination or echocardiography) in breast cancer patients as compared to matched controls
3. To determine the value of patient characteristics, clinical complaints and signs in physical examination in diagnosing cardiac dysfunction as found of echocardiography
4. To determine the additional diagnostic value of biomarkers; N-terminal pro-hormone of brain natriuretic peptide (NT-pro-BNP) and high sensitive troponin T (hs-troponinT) in diagnosing cardiac dysfunction, as found on echocardiography
5. Genetic analysis
Study design and population:
This is a cross-sectional, observational study in women in general practice who have been curatively treated for breast cancer with chemo and / or radiotherapy at a minimum of 5 years ago and an age and general practitioner (GP) matched female control population. Patients must be 18 years or older, younger than 80 at the time of diagnosis, not been treated for other types of cancer with chemo- and/or radiotherapy and must be willing to give written informed consent Primary study parameters
1. Systolic and diastolic cardiac function of echocardiography
2. Hospital Anxiety and Depression Scale (HADS)
3. Multi dimensional Fatigue Inventory (MFI-20)
4. Cardiovascular Risk Management (CVRM)
5. Short physical examination: blood pressure, height, weight, waist circumference, electrocardiography, signs of edema, auscultation
6. Laboratory testing: Hemoglobin, hematocrit, leucocytes, creatinine , estimated glomerular filtration rate (GFR), cholesterol, triglycerides, High-density lipoprotein (HDL) cholesterol, Low-density lipoprotein (LDL) cholesterol, Cholesterol/HDL ratio, C-reactive protein (CRP),Thyroid stimulating hormone (TSH), glucose
7. Serum and plasma for biomarkers
8. ethylenediaminetetraacetic acid (EDTA) -tube for DeoxyriboNucleic Acid (DNA) analysis Outcomes
Primary outcome:
The cardiac dysfunction will be related to type of therapy and compared to the age-and general practice matched control group. Information on type of therapy will be gathered trough contacting the hospitals were patients were treated.
Secondary outcome:
Symptoms and signs of women with cardiac dysfunction will be compared with those without cardiac dysfunction. A comparison between women treated for breast cancer and women without breast cancer will be made.
The level of the biomarkers will be linked with the cardiac dysfunction. In women treated for breast cancer with chemo- and/or radiotherapy these will also be linked with type of therapy.
DNA analysis will be carried out to investigate if changes in candidate genes are related to the development of cardiac dysfunction.
Burden and risks associated with participation, benefit and group relatedness The minimal invasive tests will be performed if patient are willing to participate in de study after contact trough letters. As far as known no serious adverse events are linked to the described study procedures.
With this study we hope to get insight in the risk of cardiac dysfunction after chemo- and/or radiotherapy in women treated for breast cancer. And to determine possibly diagnostic measure to detect this deterioration. Eventually, this may contribute to the early detection of cardiac dysfunction in women treated with chemo- and/or radiotherapy for breast cancer to improve the prognosis for patients.
|
#Eligibility Criteria:
Inclusion Criteria:
* For breast cancer patients: minimum of 5 years after treatment for breast cancer with chemo- and/or radiotherapy and after 1970
* For breast cancer patients: younger than 80 at the time of diagnosis of breast cancer
* willing to sign an informed consent
* older than 18 at the time of inclusion
Exclusion Criteria:
* Treatment with chemo- and/or radiotherapy for other types of cancer besides breast cancer
* women who are unable to participate (e.g. terminally or mentally ill)
Sex :
FEMALE
Ages :
- Minimum Age : 18 Years
- Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : ADULT, OLDER_ADULT
Accepts Healthy Volunteers:
Yes
|
NCT01904331
| 11,476 |
{
"NCT_ID" : "NCT00260624",
"Brief_Title" : "Escitalopram Treatment of Patients With Agitated Dementia",
"Official_title" : "Escitalopram in the Treatment of Patients With Agitated Dementia",
"Conditions" : ["Alzheimer's Disease", "Psychomotor Agitation"],
"Location_Countries" : ["United States"],
"Study_Design" : {
"Study_Type" : "INTERVENTIONAL",
"Phase" : ["PHASE4"],
"Primary_Purpose" : "TREATMENT",
"Allocation" : "NON_RANDOMIZED",
"Interventional_Model" : "SINGLE_GROUP",
"Masking" : "NONE"
},
"Recruitment_Information" : {
"Study_Start_Date(Actual)" : "2003-02",
"Primary_Completion_Date(Actual)(Final_data_collection_date_for_primary_outcome_measure)" : "2006-12",
"Study_Completion_Date(Actual)" : "2006-12},
"Study_Record_Dates" : {
""Study_Registration_Dates" : {
"First_Submitted" : 2005-11-29",
"First_Posted(Estimated)" : 2005-12-01"
},
"Study_Record_Updates" : {
"Last_Updated_that_Met_QC_Criteria" : 2005-11-29",
"Last_Update_Posted(Estimated)" : 2012-02-24",
"Last_Verified" : 2012-02"
}
}}
|
#Study Description
Brief Summary
The purpose of this study is to determine the safety and efficacy of escitalopram (Lexapro) using 10 or 20 mg daily in patients with Alzheimer's disease who are also experiencing agitation.
Detailed Description
This study is designed for men and women over 60 who have an established diagnosis of mild to severe Alzheimer's disease and who also present behaviors of agitation such as restlessness, physical aggression, yelling and socially inappropriate interactions. While nonpharmacologic interventions are preferable, many times they are not effective alone. Each consented subject will be enrolled in a 12 week study with escitalopram, 10 or 20 mg per day. Each subject will be evaluated using rating scales designed for symptoms of Alzheimer's and agitated behavior. Each subject will also undergo physical and neurological examinations, laboratory tests and monitoring of side effects of escitalopram.
#Intervention
- DRUG : Escitalopram (Lexapro)
|
#Eligibility Criteria:
Inclusion Criteria:
* Dementia of Alzheimer's type with behavioral disturbance
* Mild to severe cognitive impairment
* Age over 60
* Medically stable
* Agitation present both at screening and baseline
* Agitation not responsive to simple nonpharmacologic interventions and lasting at least 2 weeks prior to enrollment.
* Available Health Care Proxy or other legal representative to give informed consent, and patient assent.
* No planned change in environment for duration of study
* At least one reliable caregiver
Exclusion Criteria:
* Any intercurrent medical problem that could explain the agitation
* History of major depression or bipolar preceding the onset of dementia
* Other major psychiatric illness preceding the onset of dementia or mental retardation
* Other dementias
* History of alcohol abuse or dependence in the last 2 years
* Delirium (or history of delirium in the last 8 weeks)
* Treatment with other psychotropic drugs except those permitted in the protocol. Patients already treated for agitation with psychotropic medication must be able to successfully discontinue it and tolerate a washout period of no less than 1 week.
* Treatment with non-psychotropic, centrally active drugs believed to contribute to patient's agitation.
* Severe psychiatric symptoms requiring psychiatric hospitalization or suicidal, homicidal potential.
* History of intolerance to citalopram
* Noncompliance with oral medication or inability to take oral medication
* Modified Hachinski score of 4 or greater
Sex :
ALL
Ages :
- Minimum Age : 61 Years
- Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : ADULT, OLDER_ADULT
Accepts Healthy Volunteers:
No
|
NCT00260624
| 105,638 |
{
"NCT_ID" : "NCT01037205",
"Brief_Title" : "Randomized, Double-blind, Placebo Controlled Phase II Study to Examine the Effects of DAS181 in Healthy Adult Subjects With Laboratory Confirmed Influenza",
"Conditions" : ["Influenza"],
"Interventions" : ["Drug: Respitose ML006 (DMV-Fonterra)", "Drug: DAS181 dry powder, formulation F02"],
"Location_Countries" : ["United States"],
"Study_Design" : {
"Study_Type" : "INTERVENTIONAL",
"Phase" : ["PHASE2"],
"Primary_Purpose" : "TREATMENT",
"Allocation" : "RANDOMIZED",
"Interventional_Model" : "SINGLE_GROUP",
"Masking" : "QUADRUPLE"
},
"Recruitment_Information" : {
"Study_Start_Date(Actual)" : "2009-12",
"Primary_Completion_Date(Actual)(Final_data_collection_date_for_primary_outcome_measure)" : "2011-09",
"Study_Completion_Date(Actual)" : "2011-09},
"Study_Record_Dates" : {
""Study_Registration_Dates" : {
"First_Submitted" : 2009-12-18",
"First_Posted(Estimated)" : 2009-12-22"
},
"Study_Record_Updates" : {
"Last_Updated_that_Met_QC_Criteria" : 2009-12-18",
"Last_Update_Posted(Estimated)" : 2014-04-08",
"Last_Verified" : 2013-07"
}
}}
|
#Study Description
Brief Summary
This protocol will seek to enroll adult otherwise healthy subjects presenting with influenza-like illness (ILI). Subjects will enter the study based on listed inclusion/exclusion criteria, including a positive diagnostic test for influenza virus (IFV).
Detailed Description
This protocol will seek to enroll adult otherwise healthy subjects presenting with influenza-like illness (ILI). Subjects will enter the study based on listed inclusion/exclusion criteria, including a positive diagnostic test for influenza virus (IFV).
Based upon a Rapid Diagnostic Test of IFV, subjects will be randomized into one of three groups: a single dose DAS181 10 mg group, a multiple dose DAS181 10 mg, 10 mg, 10 mg dose group or a placebo group.
The full analysis set will include subjects with confirmed influenza as documented with Rapid Diagnostic Testing. The set will be used for activity analysis and will include all randomized subjects with baseline and treatment data. Study staff may visit subjects outside the clinic. Per protocol, the safety analysis sets are described below in Statistical Methods.
Peripheral venous blood samples for pharmacokinetic (PK) and immunogenic analysis of DAS181 will be obtained on 10 subjects enrolled in each study arm.
#Intervention
- DRUG : DAS181 dry powder, formulation F02
- 10 mg delivered dose DAS181 in clear HPMC #3 Capsules
- DRUG : Respitose ML006 (DMV-Fonterra)
- Lactose monohydrate
|
#Eligibility Criteria:
Inclusion Criteria:
* Male and female subjects in generally good health in the opinion of the investigator as determined by vital signs, medical history, and a targeted physical exam based on medical history.
* Subjects must be able to verbalize understanding of the consent form, provide written informed consent and verbalize willingness to complete study procedures.
* Be 18 <= age <= 70 of age (inclusive).
* Subjects must weigh at least 55 kg and must have a Body Mass Index (BMI) of no greater than 35.99
* Febrile, oral temperature >100°F (37.8°C) and one or more of the following:
* Respiratory symptom (cough, sore throat, nasal symptoms)
* Constitutional symptom (headache, myalgia, sweat/chills, prostration)
* Positive rapid antigen test (RAT) for influenza performed using FDA-Cleared and CLIA-Waived commercially available rapid antigen test. A subject may be enrolled following a positive RAT of any manufacturer. Test may be conducted by a primary care physician prior to study enrollment if documentation of a positive RAT can be provided (documentation may consist of subjects medical records and must be included in subject documentation). A subject with a negative RAT result may still enroll if the sponsor and investigator agree that there is a known influenza outbreak circulating in the community. Blood pressure within normal limits (systolic 90 <= age <= 150 mmHg; diastolic 50 <= age <= 95 mmHg) and heart rate between 45 and 140 beats per minute.
* Blood pressure within normal limits (systolic 90 <= age <= 150 mmHg; diastolic 50 <= age <= 95 mmHg) and heart rate between 45 and 140 beats per minute.
* Onset of illness no more than 48 hours prior to diagnosis. Note: Time of onset of illness is defined as either (1) the time when the temperature was first measured as elevated (at least one degree (°C) of elevation temperature), OR (2) the time when the subject experienced the presence of at least one respiratory symptom or the presence of at least one constitutional symptom.
* Female subjects must be post-menopausal (one year or greater without menses), surgically incapable of childbearing, practicing abstinence or practicing two effective methods of birth control. Acceptable methods may include intrauterine device, spermicide, barrier and hormonal contraception. A female subject must agree to practice an acceptable method of birth control during study period and for 12 weeks after study terminates. All female subjects regardless of menopausal status or surgical history must have had a negative urine pregnancy test (urine betahuman chorionic gonadotropin [hCG]) during the screening visit. The urine pregnancy test must be sensitive to at least 50 mU/mL of beta-hCG.
* Male subjects must agree to use a medically accepted form of contraception from time of enrollment to 12 weeks after study termination.
Exclusion:
* Have received any investigational drug or vaccine within 8 weeks prior to study drug dosing.
* Have had a serious adverse reaction or hypersensitivity to any drug.
* Have received blood products within 6 months of study enrollment.
* Have concurrent cystic fibrosis, emphysema or previous episodes of anaphylaxis.
* Have sickle-cell disease.
* Allergy or history of allergy to milk or lactose.
* Any history of congenital or acquired bleeding abnormalities.
* Existence of any surgical, medical, or laboratory condition that, in the judgment of the clinical investigator, might interfere with the safety, distribution, metabolism or excretion of the drug.
* Use of antiviral influenza medications within 10 days prior to screening (subjects will be prohibited from taking antiviral influenza medications during the course of the trial).
* Current clinical evidence of a recognized or suspected uncontrolled non-influenza infectious illness with onset prior to screening.
* Known hypersensitivity to DAS181.
* Women who are pregnant (urine pregnancy test), who are attempting to become pregnant, or who are breast-feeding.
* Uncontrolled seizure disorder or history of seizure activity within 12 months prior to study participation.
* Any significant findings in the subject's medical history or physical examination that, in the opinion of the investigator, would affect subject safety or compliance with the dosing schedule.
* Documented infection other than IFV in past 2 weeks.
* Subjects with previous or current history of asthma or COPD requiring acute or chronic medication.
* Subjects with acute diagnosis of a chronic medical condition within the last 3 months.
* Subjects with a chronic medical condition that have initiated or changed dosing or regimen of prescription medications for their chronic medical condition within the last 3 months (any changes in chronic medications during the 28 day enrollment period will be captured in the source documentation under concomitant medications).
* Subjects with previous or current history of the following systemic disorders: immunological disorders, HBV, HCV or cirrhosis, transplant recipients, HIV infection, or other immunosuppressive illness.
* Subjects with cancer or history of hematologic malignancy. Cancer is defined as any active neoplastic diseases excluding noninvasive basal cell carcinoma.
* Subjects who have had or are scheduled to have surgery within 30 days of initiation of the study.
* Subjects who have donated or lost more than 500 mL of blood in the two months prior to screening.
* Psychiatric or cognitive illness or recreational drug/alcohol use that, in the opinion of the principal investigator, would affect subject safety and/or compliance.
Sex :
ALL
Ages :
- Minimum Age : 18 Years
- Maximum Age : 70 Years
- Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : ADULT, OLDER_ADULT
Accepts Healthy Volunteers:
No
|
NCT01037205
| 239,165 |
{
"NCT_ID" : "NCT01021748",
"Brief_Title" : "A Combination Therapy Study of MK-2206 and AZD6244 in Participants With Advanced Solid Tumors (MK-2206-010)",
"Official_title" : "A Phase I Study of Oral MK-2206 in Combination With Oral AZD6244 in Patients With Locally Advanced or Metastatic Solid Tumors",
"Conditions" : ["Locally Advanced or Metastatic Solid Tumors"],
"Interventions" : ["Drug: AZD6244", "Drug: MK-2206"],
"Study_Design" : {
"Study_Type" : "INTERVENTIONAL",
"Phase" : ["PHASE1"],
"Primary_Purpose" : "TREATMENT",
"Allocation" : "NON_RANDOMIZED",
"Interventional_Model" : "SINGLE_GROUP",
"Masking" : "NONE"
},
"Recruitment_Information" : {
"Study_Start_Date(Actual)" : "2009-11-23",
"Primary_Completion_Date(Actual)(Final_data_collection_date_for_primary_outcome_measure)" : "2012-11-26",
"Study_Completion_Date(Actual)" : "2014-07-16},
"Study_Record_Dates" : {
""Study_Registration_Dates" : {
"First_Submitted" : 2009-11-25",
"First_Submitted_that_Met_QC_Criteria" : 2017-11-03",
"First_Posted(Estimated)" : 2009-11-30"
},
"Study_Record_Updates" : {
"Last_Updated_that_Met_QC_Criteria" : 2009-11-25",
"Last_Update_Posted(Estimated)" : 2018-08-07",
"Last_Verified" : 2017-11"
}
}}
|
#Study Description
Brief Summary
This study will investigate the safety and tolerability of combination therapy with MK-2206 and AZD6244 (selumetinib) and determine the maximum tolerated dose (MTD) and recommended Phase 2 dose (RPTD) for this drug combination in the treatment of participants with locally advanced or metastatic solid tumors. Preliminary efficacy data will also be collected.
The primary hypotheses for this study are that: 1) the Dose-limiting Toxicities (DLTs) observed in participants with locally advanced or metastatic solid tumors after administration of combination therapy with MK-2206 and AZD6244 will be dose-dependent and allow for identification of the MTD, and 2) oral administration of combination therapy with MK-2206 and AZD6244 to participants with advanced solid tumors will be generally well-tolerated.
#Intervention
- DRUG : MK-2206
- Oral tablets
- DRUG : AZD6244
- Oral capsules
- Other Names :
- selumetinib
|
#Eligibility Criteria:
Inclusion Criteria:
* Participant has confirmed metastatic or locally advanced solid tumor that has failed to respond to standard therapy, progressed despite standard therapy, or therapies known to provide clinical benefit, or for whom efficacious standard therapy or any other therapy known to provide clinical benefit does not exist
* Participant has no history of prior cancer, except certain cervical, skin, or prostate cancers, or has undergone potentially curative therapy with no evidence of disease for 5 years
* At least 18 years
* Participant is able to swallow oral medications
* For participants enrolled in the MTD expansion cohorts, must have a diagnosis of Kirsten rat sarcoma viral oncogene homolog (KRAS) tumor-type non small-cell lung cancer (NSCLC). Additional tumor types (with specific mutations) may be added to the MTD expansion cohorts after discussion between Sponsor and Investigator
Exclusion Criteria:
* Participant has had chemotherapy, radiotherapy or biological therapy within 4 weeks of entering the study
* Participant is currently participating in or has participated in a study of an investigational compound or device within 30 days or 5x the compound's half-life of Cycle 1, Day 1
* Participant has known central nervous system metastases and/or carcinomatous meningitis
* Participant has a primary central nervous system tumor or spinal cord compression
* Participant is, at the time of signing informed consent, a regular user (including 'recreational use') of any illicit drugs or had a recent history (within the last year) of drug or alcohol abuse
* Participant is pregnant or breastfeeding or expecting to conceive or father children within the projected duration of the study
* Participant is human immunodeficiency virus (HIV) positive
* Participant is has history of hepatitis B or C or active hepatitis A
* Participant has a history or current evidence of heart disease
* Participant has uncontrolled high blood pressure
* Participant has poorly controlled diabetes
Sex :
ALL
Ages :
- Minimum Age : 18 Years
- Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : ADULT, OLDER_ADULT
Accepts Healthy Volunteers:
No
|
NCT01021748
| 26,232 |
{
"NCT_ID" : "NCT05853185",
"Brief_Title" : "Assessing Success of MTA and Pre-mixed Bioceramic in Mature Teeth With Irreversible Pulpitis With Full Pulpotomy.",
"Official_title" : "Assessing Success of MTA and Pre-mixed Bioceramic in Mature Teeth With Irreversible Pulpitis With Full Pulpotomy.",
"Conditions" : ["Pulpitis - Irreversible"],
"Interventions" : ["Drug: Pro Root MTA®", "Drug: EBRRM®"],
"Location_Countries" : ["Pakistan"],
"Study_Design" : {
"Study_Type" : "INTERVENTIONAL",
"Phase" : ["PHASE4"],
"Primary_Purpose" : "TREATMENT",
"Allocation" : "RANDOMIZED",
"Interventional_Model" : "PARALLEL",
"Masking" : "SINGLE"
},
"Recruitment_Information" : {
"Study_Start_Date(Actual)" : "2021-10-12",
"Primary_Completion_Date(Actual)(Final_data_collection_date_for_primary_outcome_measure)" : "2022-05-30",
"Study_Completion_Date(Actual)" : "2022-08-30},
"Study_Record_Dates" : {
""Study_Registration_Dates" : {
"First_Submitted" : 2023-03-25",
"First_Submitted_that_Met_QC_Criteria" : 2023-08-22",
"First_Posted(Estimated)" : 2023-05-10"
},
"Study_Record_Updates" : {
"Last_Updated_that_Met_QC_Criteria" : 2023-05-07",
"Last_Update_Posted(Estimated)" : 2023-08-24",
"Last_Verified" : 2023-08"
}
}}
|
#Study Description
Brief Summary
Although many pulpotomy agents are commercially available, there is a dearth of clinical research comparing the efficacy of these agents in treating individuals with irreversible pulpitis. Bioceramic and MTA both have similar clinical uses, but Bioceramic is distinguished from MTA by its superior chemical, physical, and biological properties. This study aims to address this knowledge deficit by assessing the performance of biocompatible materials in pulpotomy procedures for the treatment of symptomatic permanent teeth in adults with deep caries. For permanent teeth with a completed root and a diagnosis of irreversible pulpitis without apical periodontitis, this research will compare the success rates of MTA and EBRRM pulpotomy procedures in order to provide evidence-based clinical practice guidelines for the treatment of this disease.
Detailed Description
The goal of this observational study is to test and compare the success of full pulpotomy with Mineral Trioxide Aggregate (MTA) pre-mixed bioceramic in mature teeth with irreversible pulpitis. Participants in this study were patients with irreversible pulpitis without apical periodontal pathosis recruited from the waiting list at the School of Dentistry at Liaquat University of Medical and Health Sciences in Jamshoro. After obtaining informed consent, demographic information, clinical examination results, and binary variables were recorded pre- and intra-operatively. The study's primary aim was to assess postoperative pain, and secondary aims included assessing the presence of swelling, sinusitis, or fistula and detecting tooth mobility. Participants received either MTA or Endo Sequence Bioceramic Root Repair randomly allocated using a lottery system. Follow-up assessments were done initially, after 6 days, and after 6 months, and periapical radiography was done at 6 days and 6 months to detect radiolucency.
#Intervention
- DRUG : Pro Root MTA®
- Patients in this group will receive the pulpotomy with Pro Root MTA®.
- DRUG : EBRRM®
- Patients in this group will receive the pulpotomy with Endo Sequence Bioceramic Root Repair (EBRRM)®.
|
#Eligibility Criteria:
Inclusion Criteria:
* Patients with diagnosis of irreversible pulpitis without apical periodontitis
* Either gender
* Lower Age 10 Years - Upper Age 40 Years
Exclusion Criteria:
* Teeth displaying indications of resorption.
* Teeth that have not fully developed, characterized by open apices.
* Canals that are calcified or obstructed.
* Perforations that were caused by the dentist.
* Fractures in the root
* Teeth that cannot be restored
*
* Teeth that are unable to withstand frigid temperatures, have a sinus infection, or have swelling around them.
* There has been no pulp exposure despite the removal of carious lesion.
* Ten minutes after a pulpotomy, hemorrhage could not be stopped.
* Necrotic or partly necrotic pulp is indicated by insufficient bleeding after exposure.
Sex :
ALL
Ages :
- Minimum Age : 10 Years
- Maximum Age : 40 Years
- Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : ADULT, CHILD
Accepts Healthy Volunteers:
Yes
|
NCT05853185
| 207,188 |
{
"NCT_ID" : "NCT00946881",
"Brief_Title" : "Safety and Tolerability Study Using WST11 In Patients With Localized Prostate Cancer",
"Official_title" : "A Prospective, Multicenter Phase I/II Safety and Tolerability Study of Unilateral Vascular-Targeted Photodynamic Therapy Using WST11 in Patients With Localized Prostate Cancer",
"Conditions" : ["Prostate Cancer"],
"Interventions" : ["Drug: WST 11 -mediated -VTP"],
"Location_Countries" : ["United States"],
"Study_Design" : {
"Study_Type" : "INTERVENTIONAL",
"Phase" : ["PHASE1", "PHASE2"],
"Primary_Purpose" : "TREATMENT",
"Allocation" : "NA",
"Interventional_Model" : "SINGLE_GROUP",
"Masking" : "NONE"
},
"Recruitment_Information" : {
"Study_Start_Date(Actual)" : "2009-07",
"Primary_Completion_Date(Actual)(Final_data_collection_date_for_primary_outcome_measure)" : "2012-07",
"Study_Completion_Date(Actual)" : "2012-08},
"Study_Record_Dates" : {
""Study_Registration_Dates" : {
"First_Submitted" : 2009-07-24",
"First_Submitted_that_Met_QC_Criteria" : 2017-10-02",
"First_Posted(Estimated)" : 2009-07-27"
},
"Study_Record_Updates" : {
"Last_Updated_that_Met_QC_Criteria" : 2009-07-24",
"Last_Update_Posted(Estimated)" : 2024-02-07",
"Last_Verified" : 2017-10"
}
}}
|
#Study Description
Brief Summary
The aim of this study is to determine the optimal treatment conditions (WST11 dose and light energy dose) to achieve ablation in one lobe of the prostate and to evaluate the safety and quality of life of WST11 medicated Vascular-Targeted Photodynamic therapy (VTP) in men with localized prostate cancer.
Detailed Description
This study is designed as a multicenter, phase I/II, prospective, open-labeled, single intravenous (IV) dose, clinical trial in patients with localized prostate cancer.
The study population will be men who have been offered curative therapy (radical prostatectomy; cryotherapy; brachytherapy; External Beam RadioTherapy (EBRT), and refused. Patients must have already had a previous biopsy showing a histologically proven carcinoma of the prostate. The identification and the location of the tumor will be done using both dynamic contrast Magnetic resonance Imaging (MRI) and biopsy.
Only unilateral treatment with WST11-medicated VTP will be performed during the study. Treatment will consist of a single, 10 minute, IV administration of WST11 at doses of 2mg/kg, 4 mg/kg or 6 mg/kg, followed by either light activation delivered through transperineal interstitial optical fibers for 20 minutes using 753 nm laser light at escalating fixed energy doses of 200 J/cm or 300 J/cm by escalating power at each energy to 167 mW/cm or 250 mW/cm respectively. A brachytherapy-like template is used for the placement of the transparent implant catheters which are positioned in the prostate under transrectal ultrasound image guidance. The illumination fiber(s) are then inserted into the implant catheters.
If the safety profile for a given WST11 and light dose is acceptable, additional patients may be treated with multiple fibers at that WST11 treatment dose.
For cases where the Month 6 biopsy is positive, the patient will be offered the opportunity to be retreated with WST11
#Intervention
- DRUG : WST 11 -mediated -VTP
- The WST11-mediated VTP procedure will consist of a single, 10 min, IV administration of WST11 at doses of either 2mg/kg, 4 mg/kg or 6 mg/kg, followed by light activation delivered through one or more transperineal interstitial optical fibers for 20 minutes using 753 nm laser light at escalating fixed energy doses of 200 J/cm and 300 J/cm, by escalating power at each energy to 167 mW/cm and 250 mW/cm, respectively. A brachytherapy-like template is used for the placement of the optical fiber(s) that are positioned in the prostate areas of interest under trans-rectal ultrasound image guidance.
- Other Names :
- TOOKAD Soluble
|
#Eligibility Criteria:
Inclusion Criteria:
* At least 18 years
* Diagnosed with localized, prostate cancer and who have been offered curative therapy (radical prostatectomy; cryotherapy; brachytherapy; External Beam RadioTherapy (EBRT), and refused
* Localized prostate cancer stage T1C up to T2A based on biopsy performed at least 6 weeks prior to enrollment
* Gleason score <= 3+3 with <=50% of sampled cores positive, and each positive core having a tumour length of <=5 mm
* Prostate Specific Antigen (PSA) < 10 ng/mL
* No prior treatment for prostate cancer
* Signed Informed Consent Form
Exclusion Criteria:
* Any condition or history of illness or surgery that, in the opinion of the investigator and/or the Sponsor, might confound the results of the study or pose additional risks to the patient.
* All patients whose current pre-operative cardiac evaluation does not show their fitness for a procedure requiring general anesthesia;
* Patients with a prior history of viral or alcoholic hepatitis, and other patients felt to be at risk for hepatotoxicity including concomitant use of potentially hepatotoxic medications or dietary supplements;
* Patients with a history of inflammatory bowel disease or other factors which may increase the risk of fistula formation;
* Patients who have received any hormonal manipulation (excluding 5-alpha reductase inhibitors) or androgen supplements within the previous 6 months;
* Patients previously treated by radiation therapy (external therapy or brachytherapy) or chemotherapy or any therapy for prostate cancer;
* Patients who have received or are receiving chemotherapy for prostate carcinoma or other significant cancer;
* Patients who have undergone previous TURP (trans-urethral resection of the prostate);
* Patients with a history of urethral stricture disease
* Patients with a history of acute urinary retention
* Patients who are currently (within 10 days before the treatment procedure) receiving any medications having potential photosensitizing effects (e.g. tetracyclines, sulfonamides, phenothiazines, sulfonylurea hypoglycemic agents, thiazide diuretics and griseofulvin)
* Patients who are currently receiving anticoagulant drugs (within 10 days before the treatment procedure) (e.g.: coumadin, warfarin)
* Patient who stopped long term treatment of acetylsalicylic acid (aspirin) or other anti platelets agents within 10 days prior to the treatment procedure;
* Patient suspected of Disseminated Intravascular Coagulation (DIC) as defined by the presence of three out of the five following criteria: platelets decrease, increase of PT, increase of aPTT, fibrinogen decrease, D-Dimer increase; from the normal laboratory ranges;
* Patient with a history of vasculitis or collagen vascular disease;
* History of non compliance with medical therapy and medical recommendations or an unwillingness or inability to complete patient self-administered questionnaires;
* Participation in a clinical study or receipt of an investigational treatment within the past 3 months;
* A history of porphyria;
* A history of sun hypersensitivity or photosensitive dermatitis;
* Renal disorders (blood creatinine > 1.5 x ULN) or known post mictional residue > 150cc
* Hepatic disorders (transaminases > ULN, bilirubin > ULN, GGT > ULN). In case of slight abnormalities, another exam could be performed. If the results are within normal ranges, then the patient can be included;
* Hematological disorders (white cells < 2500/mm3, neutrophils < 1500/mm3, platelets, < 140.000/mm3, Hb <= 10 g/dL);
* Patients with contra-indication to MRI (such as pace maker, metal prosthesis, etc.).
Sex :
MALE
Ages :
- Minimum Age : 18 Years
- Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : ADULT, OLDER_ADULT
Accepts Healthy Volunteers:
No
|
NCT00946881
| 70,236 |
{
"NCT_ID" : "NCT00302172",
"Brief_Title" : "ARQ 197 in Subjects With Metastatic Solid Tumors",
"Official_title" : "A Phase 1 Dose Escalation Study of ARQ 197 in Adult Patients With Metastatic Solid Tumors",
"Conditions" : ["Cancer", "Tumor"],
"Interventions" : ["Drug: ARQ 197"],
"Location_Countries" : ["United States"],
"Study_Design" : {
"Study_Type" : "INTERVENTIONAL",
"Phase" : ["PHASE1"],
"Primary_Purpose" : "TREATMENT",
"Allocation" : "NON_RANDOMIZED",
"Interventional_Model" : "SINGLE_GROUP",
"Masking" : "NONE"
},
"Recruitment_Information" : {
"Study_Start_Date(Actual)" : "2006-01",
},
"Study_Record_Dates" : {
""Study_Registration_Dates" : {
"First_Submitted" : 2006-03-10",
"First_Posted(Estimated)" : 2006-03-14"
},
"Study_Record_Updates" : {
"Last_Updated_that_Met_QC_Criteria" : 2006-03-10",
"Last_Update_Posted(Estimated)" : 2009-08-26",
"Last_Verified" : 2009-08"
}
}}
|
#Study Description
Brief Summary
To determine the safety, tolerability and recommended Phase 2 dose (RP2D) of ARQ 197.
Detailed Description
To determine the safety, tolerability and recommended Phase 2 dose (RP2D) of ARQ 197 given orally. This is an open label, dose escalation study of ARQ 197 administered orally at a starting dose of 10 mg bid (20 mg/day).
#Intervention
- DRUG : ARQ 197
- Patients in this trial will receive ARQ 197 orally at dose levels specified for their respective dose cohorts. Dosing will begin at 20 mg/day (first cohort) and escalate until the RP2D or MTD is determined. Patients enrolled under a previous amendment will continue to receive ARQ 197 twice daily for 14 days followed by 7 days without therapy. Any patient enrolled under Amendment 3 will take ARQ 197 twice daily for 21 days where cycles will be repeated every three-weeks (21 days).
Patients enrolled under Amendment 4 will receive dose of 360 mg bid (720 mg daily) continuously for 21 days, and cycle will be repeated every three weeks.
All patients will remain on study until progression of disease, unacceptable toxicity, or another discontinuation criterion is met. In the case of toxicity, dose adjustment is permitted.
|
#Eligibility Criteria:
Inclusion Criteria:
* Signed written informed consent must be obtained and documented according to ICH GCP, the local regulatory requirements, and permission to use private health information in accordance with HIPPA prior to study-specific screening procedures
* A histologically or cytologically confirmed RCC or other c-Met expression tumors that is metastatic
* Patient must have available archival tumor tissue or accessible tumor that is safely amenable to tumor biopsy
* >= 18 years
* Measurable disease as defined by Response Evaluation Criteria in Solid Tumors
* Karnofsky performance status >= 70%
* Male or female patients of child-producing potential must agree to use contraception or avoidance of pregnancy measures during the study and for 30 days after the last ARQ 197 dose
* Females of childbearing potential must have a negative serum pregnancy test
* Aspartate transaminase (AST) and alanine transaminase (ALT) <= 2.5 × upper limit of normal (ULN) or <= 5.0 × ULN with metastatic liver disease.
* Hemoglobin (Hgb) >= 10 g/dl
* Total bilirubin <= 1.5 × ULN
* Creatinine <= 1.5 x ULN
* Absolute neutrophil count >= 1.5 x 10^9/L
* Platelets >= 100 x 10^9/L
Exclusion Criteria:
* Anti-cancer chemotherapy, radiotherapy, immunotherapy, or investigational agents within four weeks of first dose
* Surgery within 4 weeks prior to first dose
* Known brain metastases
* Pregnant or breastfeeding
* Significant gastrointestinal disorder(s), in the opinion of the Principal Investigator, (e.g., Crohn's disease, ulcerative colitis, extensive gastric resection)
* Unable or unwilling to swallow ARQ 197 capsules twice daily
* Uncontrolled intercurrent illness including, but not limited to ongoing or active infection, clinically significant non-healing or healing wounds, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, significant pulmonary disease (shortness of breath at rest or mild exertion), uncontrolled infection or psychiatric illness/social situations that would limit compliance with study requirements
* Bradycardia at baseline or known history of arrhythmia
Sex :
ALL
Ages :
- Minimum Age : 18 Years
- Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : ADULT, OLDER_ADULT
Accepts Healthy Volunteers:
No
|
NCT00302172
| 118,322 |
{
"NCT_ID" : "NCT06056778",
"Brief_Title" : "The Prevalence Evaluation of Systemic Lupus Erythematosus in Russian Patients With Reproductive Issues (PRISMA)",
"Official_title" : "The Prevalence Evaluation of Systemic Lupus Erythematosus in Russian Patients With Reproductive Issues (PRISMA)",
"Conditions" : ["Systemic Lupus Erythematosus"],
"Location_Countries" : ["Russian Federation"],
"Study_Design" : {
"Study_Type" : "OBSERVATIONAL",
},
"Recruitment_Information" : {
"Study_Start_Date(Actual)" : "2023-09-28",
"Primary_Completion_Date(Actual)(Final_data_collection_date_for_primary_outcome_measure)" : "2024-06-17",
"Study_Completion_Date(Actual)" : "2024-06-17},
"Study_Record_Dates" : {
""Study_Registration_Dates" : {
"First_Submitted" : 2023-09-21",
"First_Posted(Estimated)" : 2023-09-28"
},
"Study_Record_Updates" : {
"Last_Updated_that_Met_QC_Criteria" : 2023-09-21",
"Last_Update_Posted(Estimated)" : 2025-02-28",
"Last_Verified" : 2025-02"
}
}}
|
#Study Description
Brief Summary
This study will be a non-interventional prospective study. Assessment of parameters will be carried out as if the patient is treated in a real-life clinical setting. The patients should be enrolled into this project after evaluation of eligibility criteria by the investigator in clinical sites who have an experience in management of patients with SLE. No additional procedures besides those already used in the routine clinical practice will be applied to the patients.
The purpose of this study is to estimate prevalence of confirmed SLE in patients in rheumatological settings who has the reproductive issues and certain clinical and laboratory manifestations specific for immunoinflammatory diseases in Russia.
We will follow all the local regulatory requirements regarding adverse event reporting (pharmacovigilance).
It is planned to enrol 2000 patients in clinical sites in Russian Federation (N ≤ 15).
The study will include two visits. During the screening visit women who meet the inclusion/non-inclusion criteria will be offered to participate and sign the informed consent form (ICF). Initial patient's data input will be done retrospectively (case report forms \[CRF\] will be filled in, a patient's visit will be conducted in accordance with the routine practice and healthcare professionals (HCPs) recommendations on an individual basis). An experienced rheumatologist will collect the baseline patient's characteristics such as demographic data, clinical profile, detailed obstetric/reproductive history. Women who had pregnancies in the past will be asked about the course of all pregnancies and their outcomes. Women will be asked to provide the corresponding medical records or discharge summaries, if possible, in order to input the data from them into the CRFs (the documents will be given back to women at the same visit). The immunologic blood test will be conducted in the reference laboratory. According to clinical examination and laboratory test results (ANA, immunoassay for specific antibodies (anti-Sm, and-dsDNA), antiphospholipid antibodies (anticardiolipin antibodies, anti-β3GP1 antibodies, lupus anticoagulant, complement components C3, C4, etc.) SLE diagnosis will be made or rejected.
One follow-up visit will be conducted for those women who were referred to a laboratory testing for SLE. The visit will include the laboratory analyses assessment by an experienced rheumatologist with a subsequent confirmation or rejection of the SLE diagnosis.
The last date of enrolment - Dec 2023. Last patient last visit (approximately 4 months from the study start): patient's data input will be done for enrolled patients.
|
#Eligibility Criteria:
Inclusion Criteria:
* Women 18 <= age <= 45 years
* Patients with reproductive issues in the past (early or late miscarriages, unexplained infertility)
* Clinical manifestation of a suspected connective tissue disorder.
* Women who were referred to a rheumatological settings as a part of a routine practice.
* Provided written informed consent before any study-related procedures are performed.
Exclusion Criteria:
* Acute infectious disease or relapse of chronic infectious disease or other condition that can affect the immunological data accuracy according to physician decision,
* Previously confirmed by rheumatologist SLE or other immunoinflammatory disease including lupus nephritis and cutaneous or discoid lupus (acute or subacute).
Sex :
FEMALE
Ages :
- Minimum Age : 18 Years
- Maximum Age : 45 Years
- Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : ADULT
Accepts Healthy Volunteers:
No
|
NCT06056778
| 220,583 |
{
"NCT_ID" : "NCT01667068",
"Brief_Title" : "Cardiovascular Diseases in HIV-infected Patients HIV-HEART Study: 7.5 Years Follow-up",
"Official_title" : "HIV-HEART STUDY: A Prospective, Epidemiologic and Multicentre Trial to Determine the Cardiovascular Risk in HIV-infected Patients",
"Conditions" : ["Coronary Heart Disease", "Heart Failure", "HIV", "AIDS", "Metabolic Syndrome"],
"Interventions" : ["Other: Comprehensive non invasive cardiovascular examination"],
"Location_Countries" : ["Germany"],
"Study_Design" : {
"Study_Type" : "OBSERVATIONAL",
},
"Recruitment_Information" : {
"Study_Start_Date(Actual)" : "2012-04",
"Primary_Completion_Date(Actual)(Final_data_collection_date_for_primary_outcome_measure)" : "2014-04",
"Study_Completion_Date(Actual)" : "2014-10},
"Study_Record_Dates" : {
""Study_Registration_Dates" : {
"First_Submitted" : 2012-08-16",
"First_Posted(Estimated)" : 2012-08-17"
},
"Study_Record_Updates" : {
"Last_Updated_that_Met_QC_Criteria" : 2012-08-16",
"Last_Update_Posted(Estimated)" : 2014-10-28",
"Last_Verified" : 2014-10"
}
}}
|
#Study Description
Brief Summary
Since the introduction of antiretroviral therapy life expectancy of HIV-infected persons is rising. Different cohorts are observing an increased risk for cardiovascular diseases in this aging HIV-infected population. Traditional cardiovascular risk factors like smoking are more frequent in HIV-infected persons. For example chronic inflammation due to HIV-infection and metabolic disorders also caused by some antiretroviral substances as special non-traditional risk factors in HIV-infected persons can influence the development of cardiovascular diseases additionally. Therefore new research focus in special risk profile associated with HIV-infection or antiretroviral treatment and prevention for HIV-infected patients is developing.
This present study is an ongoing prospective regional multicenter trial that was conducted to analyse the incidence, prevalence and clinical course of cardiovacular disorders in HIV-infected out-patients.
Cardiac disorders witch are associated with HIV are pericarditis, pleural effusion, pulmonary hypertension, dilated cardiomyopathy, heart failure, myocarditis, bacterial endocarditis and heart valve disorders. In addition to previously stated disorders of the heart, the premature atherosclerosis of coronary arteries, a further even more important disease of the heart in this patient population, went into the focus of most HIV-researchers and physicians.
Detailed Description
A comprehensive detailed description of the study procedures had been previously published (European Journal of medical research 2007;12:243-248).
#Intervention
- OTHER : Comprehensive non invasive cardiovascular examination
- * Anamnesis with the participian
* File recherche,Physical examination
* Documentation of the carciovascular and antiretroviral medical therapy
* Electrocardiogram
* Transthoracic echocardiography
* Exercise electrocardiogram
* Measuring of the arterial media thickness
* Exercise Montreal Cognitive Assesment test
* Exercise the Grooved Pegboard test
* Blood collection
* Questionnaire to quality of life and health economics
|
#Eligibility Criteria:
Inclusion Criteria:
* Age > 18 years
* Known HIV-infection
* Written informed consent
Exclusion Criteria:
* Acute cardiovascular disease
* Unstable hemodynamic status in the three weeks before inclusion
* Pregnancy
Sex :
ALL
Ages :
- Minimum Age : 18 Years
- Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : ADULT, OLDER_ADULT
Accepts Healthy Volunteers:
No
|
NCT01667068
| 73,163 |
{
"NCT_ID" : "NCT02491203",
"Brief_Title" : "Post-stroke Upper Limb Rehabilitation Using Telerehabilitation Interactive Virtual Reality System in the Patient's Home",
"Official_title" : "Maximizing Post-stroke Upper Limb Rehabilitation Using a Novel Telerehabilitation Interactive Virtual Reality System in the Patient's Home",
"Conditions" : ["Stroke"],
"Interventions" : ["Other: Telerehabilitation system"],
"Location_Countries" : ["Canada"],
"Study_Design" : {
"Study_Type" : "INTERVENTIONAL",
"Phase" : ["NA"],
"Primary_Purpose" : "TREATMENT",
"Allocation" : "RANDOMIZED",
"Interventional_Model" : "PARALLEL",
"Masking" : "SINGLE"
},
"Recruitment_Information" : {
"Study_Start_Date(Actual)" : "2014-09",
"Primary_Completion_Date(Actual)(Final_data_collection_date_for_primary_outcome_measure)" : "2016-09",
"Study_Completion_Date(Actual)" : "2018-01},
"Study_Record_Dates" : {
""Study_Registration_Dates" : {
"First_Submitted" : 2015-06-13",
"First_Posted(Estimated)" : 2015-07-07"
},
"Study_Record_Updates" : {
"Last_Updated_that_Met_QC_Criteria" : 2015-07-06",
"Last_Update_Posted(Estimated)" : 2018-11-28",
"Last_Verified" : 2018-11"
}
}}
|
#Study Description
Brief Summary
Stroke is a leading cause of death and long-term disability worldwide and its incidence is on the rise. Importantly, loss of arm function occurs in up to 85% of stroke survivors, with a significant long-term impact on activities of daily living, leisure activities and work. The capacity for recovery following a stroke depends on several factors, including the extent of the initial neurological damage, spontaneous recovery and rehabilitation, with possible recovery even years after the stroke. Unfortunately, accessibility of much needed rehabilitation services poststroke often remains limited, both in terms of intensity and duration, as reported in a recent report on post-stroke rehabilitation services in Quebec (Richard, 2013) Recent evidence suggests that homebased telerehabilitation (TR) is a viable approach for upper limb training post-stroke when rehabilitation services are not available. Similarly, the Canadian Best Practice Recommendations for Stroke Care update for 2013 recommends home-based patient monitoring be used when frequent monitoring is needed and face-to-face visits are not available. Hence, The investigators have developed and propose to examine the use of a TR system that allows upper limb rehabilitation with ongoing off-line monitoring, to be used after usual poststroke rehabilitation is completed and services are no longer offered.
Detailed Description
More specifically, the objective of the proposed study is to assess the impact, in terms of motor recovery, function,quality of life, compliance, safety and cost, of a novel, patient-centered home-based tailored TR program using an affordable virtual reality system for upper-limb rehabilitation post-stroke. Such a system, combined with remote off-line monitoring could allow patients to take charge and pursue their rehabilitation beyond current services, maximizing their potential for recovery.
A single-blind two-arm randomized clinical trial (RCT) is proposed for this study with participants who have had a stroke randomly allocated to: (1) 4-week training with home-based tele-rehabilitation (TR) system (see intervention below).i.e. treatment group or (2) 4-week written home exercise program provided by a clinician, i.e. exercise control group.
#Intervention
- OTHER : Telerehabilitation system
- Usual care plus home-based virtual reality telerehabilitation system.
|
#Eligibility Criteria:
Inclusion Criteria:
* Ischemic or hemorrhagic stroke (does not have to be a first time stroke);
* Mild to moderate upper limb impairment (score 3 <= age <= 6 Chedoke-McMaster arm component or ability to perform VR tasks at least at the lowest setting according to clinician);
* At least 6 months post stroke;
* No longer receiving rehabilitation services; and (5) living in an area where high speed Internet access is available.
Exclusion Criteria:
* Being medically unstable;
* Severe cognitive or communication deficits;
* Visual impairments;
* Severe balance deficits limiting sitting safely independently;
* Shoulder pain;
* Previous upper limb impairment limiting potential recovery.
Sex :
ALL
Ages :
- Minimum Age : 18 Years
- Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : ADULT, OLDER_ADULT
Accepts Healthy Volunteers:
No
|
NCT02491203
| 172,824 |
{
"NCT_ID" : "NCT04377321",
"Brief_Title" : "Colchicine Has Anti-diabetic Effect",
"Official_title" : "Colchicine Has Anti-diabetic Effect and May be an Option for Type 2 Diabetes Management",
"Conditions" : ["Treatment Adherence"],
"Interventions" : ["Drug: Colchicine Tablets"],
"Location_Countries" : ["Egypt"],
"Study_Design" : {
"Study_Type" : "OBSERVATIONAL",
},
"Recruitment_Information" : {
"Study_Start_Date(Actual)" : "2019-10-10",
"Primary_Completion_Date(Actual)(Final_data_collection_date_for_primary_outcome_measure)" : "2020-05-01",
"Study_Completion_Date(Actual)" : "2020-05-02},
"Study_Record_Dates" : {
""Study_Registration_Dates" : {
"First_Submitted" : 2020-05-02",
"First_Posted(Estimated)" : 2020-05-06"
},
"Study_Record_Updates" : {
"Last_Updated_that_Met_QC_Criteria" : 2020-05-05",
"Last_Update_Posted(Estimated)" : 2020-05-06",
"Last_Verified" : 2020-05"
}
}}
|
#Study Description
Brief Summary
Colchicine has antidiabetic effect and may be an option for type 2 diabetes management
Detailed Description
Observational cohort prospective study with following of 150 newly diagnosed type 2 diabetes patients who were in 3 groups, had been monitored in a private clinic, each group 50 patients number, with 30 females and 20 males after written consent from all patients. The ages of all patients were between 35 and 55 years.
The aim of this study was to evaluate colchicine effect on A1C of newly diagnosed type2 diabetes compared to the metformin and control group on diet only.
The first group patients received colchicine 0.5twice daily for 6 months, the second group received metformin 1gm twice daily, the third group patients were on diet only. During the period of treatment, the investigators followed the patients if there were side effects of the drugs used. No side effects were monitored during the period of treatment except for gastric upset in some patients using metformin
#Intervention
- DRUG : Colchicine Tablets
- colchicine tabletes for 6 months
|
#Eligibility Criteria:
Inclusion Criteria:
* type 2 diabetes newly diagnosed age 35- 55 years
Exclusion Criteria:
* severe anemia hypothyroidism and hyperthyroidism moderate to severe liver or kidney disease
Sex :
ALL
Ages :
- Minimum Age : 35 Years
- Maximum Age : 55 Years
- Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : ADULT
Accepts Healthy Volunteers:
No
|
NCT04377321
| 179,402 |
{
"NCT_ID" : "NCT04128878",
"Brief_Title" : "Improvement in Endothelial Dysfunction After Initiation of Anti-arrhythmic Therapy in Atrial Fibrillation Patients",
"Official_title" : "Improvement in Endothelial Dysfunction After Initiation of Anti-arrhythmic Therapy in Atrial Fibrillation Patients",
"Conditions" : ["Atrial Fibrillation"],
"Interventions" : ["Drug: Dofetilide", "Drug: Sotalol"],
"Location_Countries" : ["United States"],
"Study_Design" : {
"Study_Type" : "OBSERVATIONAL",
},
"Recruitment_Information" : {
"Study_Start_Date(Actual)" : "2019-05-01",
"Primary_Completion_Date(Actual)(Final_data_collection_date_for_primary_outcome_measure)" : "2020-12-31",
"Study_Completion_Date(Actual)" : "2020-12-31},
"Study_Record_Dates" : {
""Study_Registration_Dates" : {
"First_Submitted" : 2019-10-14",
"First_Posted(Estimated)" : 2019-10-16"
},
"Study_Record_Updates" : {
"Last_Updated_that_Met_QC_Criteria" : 2019-10-14",
"Last_Update_Posted(Estimated)" : 2021-01-14",
"Last_Verified" : 2021-01"
}
}}
|
#Study Description
Brief Summary
This is a prospective, observational study that will examine endothelial dysfunction in atrial fibrillation before and after treatment with anti-arrhythmic agents and the extent to which baseline endothelial dysfunction improves after treatment.
Detailed Description
This will be a prospective, observational study and roughly 60 patients will be recruited based on strict inclusion/exclusion criteria. Goal population includes adult patients with a diagnosis of paroxysmal or persistent atrial fibrillation seen in the electrophysiology clinic and admitted to the UPMC Presbyterian electrophysiology service for initiation of anti-arrhythmic medications.
The primary goal of the study will be to evaluate the degree of endothelial function recovery seen after initiating anti-arrhythmic medical therapy. We will assess genetic markers, arterial stiffness and vasodilation in response to acetylcholine iontophoresis, nitroprusside iontophoresis, local thermal hyperemia and reactive hyperemia. Laser speckle contrast imaging will be employed to evaluate the microvasculature. SphygmoCor (arterial tonometry) will be used to assess macrovasculature. Testing will be performed at baseline prior to the 1st dose of anti- arrhythmic therapy and repeated again 1-3 months later at outpatient follow-up visit. Additionally, follow-up phone calls or office visits will take place at 6 and 12 months after the initial data collection visit to document recurrence rate of atrial fibrillation.
#Intervention
- DRUG : Sotalol
- The primary goal of the study will be to evaluate the change in endothelial function seen after initiating anti-arrhythmic medical therapy. Testing will be performed at baseline prior to the 1st dose of anti-arrhythmic therapy and again 1-3 months later at outpatient follow-up visit. We will record the resting flow (RF), biological zero (BZ) and peak flow (PF) as perfusion units (PU). Specifically, we will assess arterial stiffness and vasodilation in response to acetylcholine iontophoresis, nitroprusside iontophoresis, local thermal hyperemia and reactive hyperemia. Laser speckle contrast imaging will be employed to evaluate the microvasculature. SphygmoCor (arterial tonometry) will be used to assess macrovasculature.
- DRUG : Dofetilide
- Same as described above with sotalol.
|
#Eligibility Criteria:
Inclusion Criteria:
* Adult patients (18 <= age <= 75 years) with paroxysmal or persistent atrial fibrillation
* Patients who recovered from prior tachycardia induced cardiomyopathy will be allowed to enroll in the study.
Exclusion Criteria:
Exclusion criteria will include:
* age >75 years
* history of cardiomyopathy
* history of severe cardiac valvular disease
* history of coronary artery disease
* pulmonary artery hypertension
* congenital heart disease
* history of stroke
* chronic hypoxia
* recent worsening or flare up of obstructive or restrictive lung disease
* liver cirrhosis
* stage three or worse chronic kidney disease
* any major trauma or surgery within the preceding 3 months
* uncontrolled hyperthyroidism
* uncontrolled hypertension
* uncontrolled diabetes mellitus
* active malignancy
* poorly controlled connective tissue disease
* any acute or chronic inflammatory or infectious disease
* Patients who are already on class I or class III antiarrhythmic agents will be excluded from the study
* Patients on non-dihydropyridine calcium channel blockers and beta blockers will not be excluded from the study, as these agents are not considered anti-arrhythmics and are not hypothesized to affect endothelial function.
Sex :
ALL
Ages :
- Minimum Age : 18 Years
- Maximum Age : 75 Years
- Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : ADULT, OLDER_ADULT
Accepts Healthy Volunteers:
No
|
NCT04128878
| 220,430 |
{
"NCT_ID" : "NCT01745796",
"Brief_Title" : "Impact of the Contamination Mode on the Clinical Evolution During Pseudomonas Aeruginosa Ventilator Acquired Pneumonia (PYO GEN)",
"Official_title" : "Impact of the Contamination Mode on the Clinical Evolution During Pseudomonas Aeruginosa Ventilator Acquired Pneumonia",
"Conditions" : ["Pseudomonas Aeruginosa", "Ventilation Acquired Pneumonia"],
"Location_Countries" : ["France"],
"Study_Design" : {
"Study_Type" : "OBSERVATIONAL",
},
"Recruitment_Information" : {
"Study_Start_Date(Actual)" : "2013-07-03",
"Primary_Completion_Date(Actual)(Final_data_collection_date_for_primary_outcome_measure)" : "2015-06-02",
"Study_Completion_Date(Actual)" : "2015-06-02},
"Study_Record_Dates" : {
""Study_Registration_Dates" : {
"First_Submitted" : 2012-10-08",
"First_Posted(Estimated)" : 2012-12-10"
},
"Study_Record_Updates" : {
"Last_Updated_that_Met_QC_Criteria" : 2012-12-06",
"Last_Update_Posted(Estimated)" : 2022-11-08",
"Last_Verified" : 2022-05"
}
}}
|
#Study Description
Brief Summary
Pseudomonas aeruginosa is the main pathogen of nosocomial respiratory infections. Its increasing resistance to antibiotics requires the development of new strategies for prevention and control, demanding a better understanding of the modes of transmission and evolutionary dynamics of this bacteria. In patients under invasive mechanical ventilation, the main mode of contamination by Pseudomonas remains debated, with 3 modes of contamination (endogenous, crossed transmission between patients, or environmental origin) of varying importance, mainly depending on the endemic situation of the place of study.
The emergence of new genotyping technologies (DiversiLab) can now facilitate studies of molecular epidemiology. Thanks to the multidisciplinary collaboration and innovative techniques, the investigators wish to study the impact of the mode of contamination on the outcome of ICU patients, intubated and ventilated for more than 72 hours.
Detailed Description
The presence of environmental reservoirs can cause infections and multidrug-resistant P. aeruginosa colonization with P. aeruginosa is itself a prognostic factor, but the impact of the route of infection on the evolution of the history and future of the infectious patient is not established.
A second factor that may influence the evolution infectious is the degree of genetic heterogeneity of the bacterial population. Multiple exposure pathways could also influence the genetic diversity.
|
#Eligibility Criteria:
Inclusion Criteria:
* Patients> 18 years
* hospitalized in the intensive care unit
* with more than 72 hours of mechanical ventilation
* Presenting a positive bacteriological sample P. aeruginosa.
Exclusion Criteria:
* Minors.
* Pregnant or lactating women.
* Patients under guardianship, under judiciary placement, or hospitalized without their consent.
* Patients not affiliated to a social security scheme.
* Long-term corticosteroid therapy (> 2mg/kg or> 1 month before the onset of established infection suspected)
* Ongoing chemotherapy, AIDS, transplant patient under immunosuppressive drugs.
* Bedridden patient or therapeutic decision at ICU arrival
Sex :
ALL
Ages :
- Minimum Age : 18 Years
- Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : ADULT, OLDER_ADULT
Accepts Healthy Volunteers:
No
|
NCT01745796
| 95,276 |
{
"NCT_ID" : "NCT05448469",
"Brief_Title" : "Ultrasound-guided Erector Spinae Plane Block Versus Paravertebral Block for Perioperative Analgesia in Patients Undergoing Open Splenectomy",
"Official_title" : "Ultrasound-guided Erector Spinae Plane Block Versus Paravertebral Block for Perioperative Analgesia, a Randomized Double Blinded Controlled Trial",
"Conditions" : ["Analgesia"],
"Interventions" : ["Procedure: ultrasound guided erector spinae plane block", "Drug: conventional analgesia", "Procedure: ultrasound guided paravertebral block"],
"Location_Countries" : ["Egypt"],
"Study_Design" : {
"Study_Type" : "INTERVENTIONAL",
"Phase" : ["PHASE3"],
"Primary_Purpose" : "TREATMENT",
"Allocation" : "RANDOMIZED",
"Interventional_Model" : "PARALLEL",
"Masking" : "QUADRUPLE"
},
"Recruitment_Information" : {
"Study_Start_Date(Actual)" : "2022-07-10",
"Primary_Completion_Date(Actual)(Final_data_collection_date_for_primary_outcome_measure)" : "2022-12-10",
"Study_Completion_Date(Actual)" : "2022-12-10},
"Study_Record_Dates" : {
""Study_Registration_Dates" : {
"First_Submitted" : 2022-07-02",
"First_Posted(Estimated)" : 2022-07-07"
},
"Study_Record_Updates" : {
"Last_Updated_that_Met_QC_Criteria" : 2022-07-02",
"Last_Update_Posted(Estimated)" : 2022-12-23",
"Last_Verified" : 2022-12"
}
}}
|
#Study Description
Brief Summary
There are very few randomized controlled trials in open splenectomy surgery, which compare paravertebral block with ESP block. The purpose of this randomized controlled trial is to compare the efficacy of ultrasound-guided paravertebral block with ESP block for perioperative analgesia in open splenectomy .
#Intervention
- PROCEDURE : ultrasound guided erector spinae plane block
- patients will receive combined general anesthesia and ultrasound guided erector spinae plane block with 20 ml of bupivacaine 0.2 % at T9 level bilaterally.
- PROCEDURE : ultrasound guided paravertebral block
- patients will receive combined general anesthesia and ultrasound guided paravertebral block with 7 ml of bupivacaine 0.2 % at T8 and T10 bilaterally.
- DRUG : conventional analgesia
- patients will receive combined general anesthesia and conventional analgesia
|
#Eligibility Criteria:
Inclusion Criteria:
* patients who will be scheduled for indicated open splenectomy surgery in the supine position via left subcostal ,midline or letf subcostal with midline extention incisions
* physical status American Society of Anesthesiologists (ASA) II or III.
Exclusion Criteria:
* Patients who refuse to participate
* patients with body mass index (BMI) >35 kg/m2
* infection at the site of injection
* coagulopathy, severe thrombocytopenia <50×103
* spine deformity
* history of opioid dependence
* polytrauma patients with dorsal spine fracture
* urgent abdominal exploration for splenectomy in heamodynamically unstable patients
* history of allergy to opioids or local anesthetics
* history of allergy to opioids, or local anaesthetics.
Sex :
ALL
Ages :
- Minimum Age : 18 Years
- Maximum Age : 65 Years
- Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : ADULT, OLDER_ADULT
Accepts Healthy Volunteers:
No
|
NCT05448469
| 119,795 |
{
"NCT_ID" : "NCT05737966",
"Brief_Title" : "Evaluation of Case Management for First Episode Psychosis Using the PEPsy-CM Checklist",
"Official_title" : "Evaluation of Case Management for First Episode Psychosis Using the PEPsy-CM Checklist",
"Conditions" : ["First Episode Psychosis"],
"Location_Countries" : ["France"],
"Study_Design" : {
"Study_Type" : "OBSERVATIONAL",
},
"Recruitment_Information" : {
"Study_Start_Date(Actual)" : "2023-02-01",
"Primary_Completion_Date(Actual)(Final_data_collection_date_for_primary_outcome_measure)" : "2023-09-01",
"Study_Completion_Date(Actual)" : "2023-09-01},
"Study_Record_Dates" : {
""Study_Registration_Dates" : {
"First_Submitted" : 2022-12-22",
"First_Posted(Estimated)" : 2023-02-21"
},
"Study_Record_Updates" : {
"Last_Updated_that_Met_QC_Criteria" : 2023-02-17",
"Last_Update_Posted(Estimated)" : 2023-09-21",
"Last_Verified" : 2023-09"
}
}}
|
#Study Description
Brief Summary
Psychotic disorders are often chronic conditions that lead to impaired functioning, quality of life and social integration. Current research and recommendations for good practice are moving towards early detection and intervention. It is recognized that this leads to better adherence, alliance to care and knowledge of pathology for the patient, especially in young patients. For more than a decade, early intervention services (EIS) are opened in France over an increasingly large territory. Still too few studies assess the impact of these structures in France. These EIS offer a multimodal intervention (social, professional, psychotherapeutic). The intervention of case managers (or care coordinators in french) seems to be the core of EIS. The case manager has a fundamental role in the process of recovery in coordinating each individual's treatment and ensuring continuity of care.
The PEPsy-CM study aims to evaluate the effectiveness on the relapse rate of a 3 year Program for Early Psychosis based on Case Management (PEPsy-CM) compared to TAU in a population of young people with a FEP.
A qualitative evaluation of case management practice in EIS seems essential to assess the impact of case managers under real conditions.
Based on the Australian Good Practice Recommendations (EPICC integrity tools) and the case management practice manuals, the PEPsy-CM check-list questionnaire was developed to evaluate the practice of case management in the EIS in France. This check-list contains different 35 items. The final score between 1(poor) to 5 (good) is established to determine the quality of the case management. Qualitative data are also collected during the interview with the participants.
#Intervention
- OTHER : evaluation of professional practices
- Evaluation of professional practices : evaluation of the case management carried out in a program for early psychosis in France using a checklist according good practices guidelines
|
#Eligibility Criteria:
Inclusion Criteria:
* Professional working in an early intervention center treating first episodes of psychosis
* Professional involved in the organization/management of the center or practicing case management.
Exclusion Criteria:
* Professional not working in the early intervention center
* Professional working in the early intervention center but not having a role in the organization or management of the center or as case manager
* Professional who does not take charge of people who have had a first psychotic episode
Sex :
ALL
Ages :
- Minimum Age : 18 Years
- Maximum Age : 70 Years
- Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : ADULT, OLDER_ADULT
Accepts Healthy Volunteers:
No
|
NCT05737966
| 31,867 |
{
"NCT_ID" : "NCT01612013",
"Brief_Title" : "Intravenous High Dose NAC and Sodium Bicarbonate for the Prevention of Contrast-induced Acute Injury",
"Official_title" : "Intravenous High Dose of N-acetylcysteine and Sodium Bicarbonate for the Prevention of Contrast-induced Acute Injury: a Randomized Controlled Trial",
"Conditions" : ["Acute Renal Failure"],
"Interventions" : ["Drug: Saline", "Drug: Intravenous NAC plus saline", "Drug: Sodium bicarbonate plus saline", "Drug: NAC plus saline", "Drug: NAC plus sodium bicarbonate plus saline"],
"Location_Countries" : ["Brazil"],
"Study_Design" : {
"Study_Type" : "INTERVENTIONAL",
"Phase" : ["NA"],
"Primary_Purpose" : "PREVENTION",
"Allocation" : "RANDOMIZED",
"Interventional_Model" : "PARALLEL",
"Masking" : "NONE"
},
"Recruitment_Information" : {
"Study_Start_Date(Actual)" : "2005-05",
"Primary_Completion_Date(Actual)(Final_data_collection_date_for_primary_outcome_measure)" : "2009-05",
"Study_Completion_Date(Actual)" : "2009-12},
"Study_Record_Dates" : {
""Study_Registration_Dates" : {
"First_Submitted" : 2012-05-30",
"First_Posted(Estimated)" : 2012-06-05"
},
"Study_Record_Updates" : {
"Last_Updated_that_Met_QC_Criteria" : 2012-06-04",
"Last_Update_Posted(Estimated)" : 2012-06-05",
"Last_Verified" : 2012-06"
}
}}
|
#Study Description
Brief Summary
Contrast-induced acute kidney injury is a common cause of acquired in-hospital renal insufficiency and is associated with prolonged hospitalization and unfavorable early and late outcomes. The investigators sought to compare 4 different strategies (intravenous high-dose of N-acetylcysteine, sodium bicarbonate, the combination of both, and saline alone) in the prevention of contrast-induced acute kidney injury in patients undergoing coronary angiography using high-osmolar contrast media defined by creatinine and cystatin C serum levels.
#Intervention
- DRUG : Sodium bicarbonate plus saline
- Sodium bicarbonate solution (Sodium bicarbonate 8.4%, Equiplex, Brazil) was given by adding fifteen ampoules of sodium bicarbonate (150 mEq of sodium) to 1 L of 5% dextrose. Infusion in bolus began 60 min prior to the start of contrast administration at 3.5 ml/Kg/h, decreased to 1.18 ml/Kg/h during the contrast exposure and for the next 6 hours after the procedure. Saline (0.9 percent) was given IV at a rate of 1 ml/Kg/h over 60 min prior to the start of contrast administration and followed at the same rate during and for the next 6 hours after the procedure.
- DRUG : Intravenous NAC plus saline
- Acetylcysteine (Flucistein 100 mg/ml, Neo Química, Brazil) was given via IV bolus at a rate of 150 mg/kg in 500 ml dextrose 5% over 60 min immediately before contrast exposure and followed by 50 mg/kg in 500 ml dextrose 5% during the contrast exposure and for 6 hours after the procedure. Saline (0.9 percent) was given IV at a rate of 1 ml/Kg/h over 60 min prior to the start of contrast administration and followed at the same rate during and for the next 6 hours after the procedure.
- DRUG : NAC plus sodium bicarbonate plus saline
- Acetylcysteine was given intravenous at a rate of 150 mg/kg over 60 min before contrast exposure and followed by 50 mg/kg during the contrast exposure and for 6 hours after the procedure. Sodium bicarbonate solution(150 mEq of sodium) was began 60 min prior to the start of contrast administration at 3.5 ml/Kg/h, decreased to 1.18 ml/Kg/h during the contrast exposure and for the next 6 hours after the procedure. Saline was given intravenous at a rate of 1 ml/Kg/h over 60 min prior to the start of contrast administration and followed at the same rate during and for the next 6 hours after the procedure.
- DRUG : Saline
- Saline (0.9 percent) was given IV at a rate of 1 ml/Kg/h over 60 min prior to the start of contrast administration and followed at the same rate during and for the next 6 hours after the procedure.
- DRUG : NAC plus saline
- Acetylcysteine was given via intravenous bolus at a rate of 150 mg/kg over 60 min immediately before contrast exposure and followed by 50 mg/kg during and for 6 hours after the procedure. Saline (0.9 percent) was given intravenous at a rate of 1 ml/Kg/h over 60 min prior and followed at the same rate during and for the next 6 hours the procedure.
- DRUG : NAC plus sodium bicarbonate plus saline
- Acetylcysteine was given intravenous at a rate of 150 mg/kg over 60 min before contrast exposure and followed by 50 mg/kg during and for 6 hours after the procedure. Sodium bicarbonate solution (150 mEq/L of sodium) was given in bolus began 60 min before contrast administration at 3.5 ml/Kg/h, decreased to 1.18 ml/Kg/h during and for the next 6 hours of the procedure. Saline was given intravenous at a rate of 1 ml/Kg/h over 60 min prior to the start of contrast administration and followed at the same rate during and for the next 6 hours after the procedure.
|
#Eligibility Criteria:
Inclusion Criteria:
* eligible patients include individuals aged >= 18 years with normal renal function who were schedule to undergo cardiac catheterization. During the randomized study, consecutive eligible patients schedule for exposure to the ionic, high osmolality (2130 mOsm/Kg) contrast agent Ioxitalamato.
Exclusion Criteria:
* using metformin or nonsteroidal antiinflammatory drugs within the previous 48 hours
* intake of nephrotoxic drugs during the previous seven days
* pregnancy
* lactation
* intravascular administration of an iodinated contrast medium within the previous two days
* emergency catheterization
* pulmonary edema
* acutely decompensate congestive heart failure
* history of serious reactions to iodinated contrast mediums
* renal transplantation
* end-stage renal disease necessitating dialysis
Sex :
ALL
Ages :
- Minimum Age : 18 Years
- Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : ADULT, OLDER_ADULT
Accepts Healthy Volunteers:
Yes
|
NCT01612013
| 143,052 |
{
"NCT_ID" : "NCT06117072",
"Brief_Title" : "Hypertension DASH Diet and Salt Free Diet",
"Official_title" : "Which Is More Effective in Hypertension?: Salt-Free Diet vs. DASH Diet",
"Conditions" : ["Hypertension", "Nutritional Status", "Diet, Healthy", "Blood Pressure", "Salt; Deficit (or Low)"],
"Interventions" : ["Other: diet plan"],
"Location_Countries" : ["Turkey"],
"Study_Design" : {
"Study_Type" : "INTERVENTIONAL",
"Phase" : ["NA"],
"Primary_Purpose" : "PREVENTION",
"Allocation" : "NA",
"Interventional_Model" : "SINGLE_GROUP",
"Masking" : "NONE"
},
"Recruitment_Information" : {
"Study_Start_Date(Actual)" : "2019-07-01",
"Primary_Completion_Date(Actual)(Final_data_collection_date_for_primary_outcome_measure)" : "2020-03-15",
"Study_Completion_Date(Actual)" : "2020-03-15},
"Study_Record_Dates" : {
""Study_Registration_Dates" : {
"First_Submitted" : 2023-10-19",
"First_Posted(Estimated)" : 2023-11-03"
},
"Study_Record_Updates" : {
"Last_Updated_that_Met_QC_Criteria" : 2023-10-31",
"Last_Update_Posted(Estimated)" : 2023-11-03",
"Last_Verified" : 2023-10"
}
}}
|
#Study Description
Brief Summary
Background: In the management of hypertension lifestyle changes are recommended along with pharmacological treatment.
Aims: This randomized controlled intervention study aimed to compare the effects of a Dietary Approaches to Stop Hypertension (DASH) diet and a salt-free diet on blood pressure in hypertension patients. Methods: This study was conducted with 60 patients with primary hypertension. One group (n=30) was given an individualized DASH diet, the other group was given a salt-free diet (n=30), and the participants were followed for two months. The patients' blood pressures were monitored daily throughout the study, and their biochemical parameters were monitored at the beginning of the study, in the first and second months.
Detailed Description
This study, which was planned as a randomized controlled intervention study, was conducted to compare the effects of the Dietary Approaches to Stop Hypertension (DASH) and salt-free diet on blood pressure in patients with hypertension. The study was complited with the participation of 60 hypertensive individuals (46 females, 14 males) who applied to between July 2019 and March 2020. Patients with hypertension who were living in Kayseri province, at least elementary school graduate, in the 20-65 age group, able to communicate with the researcher face to face and by phone, diagnosed with hypertension at least 4 weeks ago, and whose medication did not change were included in the study. One group (n = 30) received the DASH diet and the other group received a salt-free diet (n = 30) and was followed for 2 months. Research data was repeated during application with the face-to-face interview method. Research data was collected through a questionnaire containing questions about the sociodemographic characteristics, nutritional habits, chronic diseases, and medications of the individuals. Anthropometric measurements of the patients were made and blood and urine samples were taken. Food consumption frequency was noted, DASH diet compliance scale and International Physical Activity Questionnaire (IPAQ) short form were applied.
#Intervention
- OTHER : diet plan
- One group (n = 30) received the DASH diet and the other group received a salt-free diet (n = 30) and was followed for 2 months
|
#Eligibility Criteria:
Inclusion Criteria:
* Hypertension at least four weeks prior and had not changed their drug regimen in the previous four weeks
* 20 <= age <= 65 age group
* At least primary school graduate
* Able to express himself verbally
* Volunteer to participate in the dietary intervention
* Able to communicate with the researcher face to face and by phone
Exclusion Criteria:
* Those with chronic diseases other than cardiovascular diseases (such as Type II diabetes, kidney disease, cancer disease)
* Using alcohol or smoking
Sex :
ALL
Ages :
- Minimum Age : 20 Years
- Maximum Age : 65 Years
- Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : ADULT, OLDER_ADULT
Accepts Healthy Volunteers:
Yes
|
NCT06117072
| 73,650 |
{
"NCT_ID" : "NCT02709915",
"Brief_Title" : "Effect of Meal Frequency and Timing on Insulin Dose and Clock Gene in Type 2 Diabetic Patients",
"Official_title" : "Effect of Meal Frequency and Timing on Glycemic Control, Daily Insulin Dose Requirements and Clock Gene Expression in Uncontrolled Type 2 Diabetic Patients",
"Conditions" : ["Type 2 Diabetes"],
"Interventions" : ["Other: Breakfast Diet (Bdiet)", "Other: 6Meal Diet (6Mdiet"],
"Location_Countries" : ["Israel"],
"Study_Design" : {
"Study_Type" : "INTERVENTIONAL",
"Phase" : ["NA"],
"Primary_Purpose" : "TREATMENT",
"Allocation" : "RANDOMIZED",
"Interventional_Model" : "PARALLEL",
"Masking" : "NONE"
},
"Recruitment_Information" : {
"Study_Start_Date(Actual)" : "2016-11",
"Primary_Completion_Date(Actual)(Final_data_collection_date_for_primary_outcome_measure)" : "2017-10",
"Study_Completion_Date(Actual)" : "2019-02},
"Study_Record_Dates" : {
""Study_Registration_Dates" : {
"First_Submitted" : 2016-03-07",
"First_Posted(Estimated)" : 2016-03-16"
},
"Study_Record_Updates" : {
"Last_Updated_that_Met_QC_Criteria" : 2016-03-15",
"Last_Update_Posted(Estimated)" : 2019-04-25",
"Last_Verified" : 2019-04"
}
}}
|
#Study Description
Brief Summary
This study is undertaken to explore in patients with uncontrolled T2D treated with insulin, whether a diet with large breakfast and lunch with small dinner (Bdiet) will enhance CG expression and will be more effective for weight loss and for achieving glycemic control and reduction of total daily insulin dose (first end point), compared to an isocaloric diet with 6 small meals distributed evenly along the day
Detailed Description
Obese patients with type 2 diabetes (T2D) and insulin resistance (IR), often require sequential increments of total daily insulin dose (TDID). This causes weight gain, worsens IR, leading to further increase of TDID and persistent hyperglycemia. In these patients, weight loss (WL) and reduction of IR are mandatory in order to achieve glucose control with less TDID. Impaired clock gene (CG) expression is linked to obesity and IR in T2D and it was shown in animals and T2D patients treated with oral anti-hyperglycemic drugs, that WL diet with restricted meal timing to specific hours, restored CG expression and was more effective for WL and for reduction of hyperglycemia compared to isocaloric WL diet, (commonly recommended for T2D), consisting of small meals randomly distributed along the day.
The investigators hypothesized that in patients with uncontrolled T2D treated with insulin, a diet with large breakfast and lunch with small dinner (Bdiet) will enhance CG expression and will be more effective for WL and for achieving glycemic control and reduction of TDID, compared to an isocaloric diet with 6 small meals distributed evenly along the day (6Mdiet).
This will be a randomized parallel, open label clinical study. Thirty overweight and obese insulin-treated T2D patients with HbA1c\>7.5% will be assigned to 12 weeks of 2 isocaloric diets: either Bdiet or 6Mdiet. HbA1c and CG mRNA expression in white blood cells and overall daily glycemia measured during 14 days, will be assessed before diet, after 14 days and at the end of the diet intervention. The TDID (first end point ) will be adjusted by physician, according to the results of self-monitoring of blood glucose on 3 consecutive days at baseline and before each of the visits.
#Intervention
- OTHER : Breakfast Diet (Bdiet)
- The Breakfast Ddiet consist of high-energy breakfast, medium-sized lunch and reduced in energy dinner, with distribution of calories: breakfast 50%, lunch 33% and dinner 17%. In this diet, the investigators will evaluate at baseline and at the end of 12 weeks of diet intervention, the diet efficacy on reducing HbA1c, the total daily insulin dose requirements (TDID), the efficacy on reducing body weight, fasting plasma glucose (FPG) and overall glycemic excursion assessed with continuous monitoring system. The investigators will assess also the Clock Genes mRNA expression in white blood cells. at baseline and after 12 weeks of diet intervention
- Other Names :
- Bdiet
- OTHER : 6Meal Diet (6Mdiet
- The 6meal diet (6Mdiet) will consist in the traditional antidiabetic diet, consuming 6 small meals: breakfast, lunch and dinner and 3 snacks, with caloric distribution: breakfast 20%, lunch 25%, dinner 25% and 10% each of the 3 snacks. In this diet, the investigators will evaluate at the beginning and at the end of the study (12 weeks), the diet effects on reducing HbA1c, total daily insulin dose requirements (TDID), and the diet efficacy on reducing body weight, fasting plasma glucose (FPG) and overall glycemic excursion, using continuous monitoring system, The investigators will assess also at baseline and at the end of the diet intervention the Clock Genes mRNA expression in white blood cells.
- Other Names :
- 6Mdiet
|
#Eligibility Criteria:
Inclusion Criteria:
* T2D patients with stable insulin treatment for at least 3 month preceding the study.
* HgA1c >7.5 %.
* Age > 30 years.
* BMI: 27 <= age <= 34 kg/m2.
* Treatment with antidiabetic drugs (i.e. metformin, DPP4 inhibitors, glinides) and GLP-1 analogs.
* Anti-hypertensive treatment will be allowed.
* Lipid-lowering medication.
Exclusion Criteria
* Type 1 diabetes.
* Major illnesses (liver, heart, kidney, infectious, neurological, psychiatric, immunological, active malignancy).
* Presently dieting.
* Change in weight of > 4.5 kg within 3 month prior to study onset.
* Night or rotating shift workers.
* Those who crossed more than 2 time zones during 2-week period prior to study onset.
Sex :
ALL
Ages :
- Minimum Age : 30 Years
- Maximum Age : 75 Years
- Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : ADULT, OLDER_ADULT
Accepts Healthy Volunteers:
No
|
NCT02709915
| 212,758 |
{
"NCT_ID" : "NCT00206336",
"Brief_Title" : "An Open-label Study to Determine the Efficacy and Safety of Topiramate in the Treatment of Tourette Syndrome.",
"Official_title" : "An Open-label Study to Determine the Efficacy and Safety of Topiramate in the Treatment of Tourette Syndrome (CAPSS-286)",
"Conditions" : ["Tourette Syndrome"],
"Interventions" : ["Drug: Topiramate (drug)"],
"Study_Design" : {
"Study_Type" : "INTERVENTIONAL",
"Phase" : ["PHASE3"],
"Primary_Purpose" : "TREATMENT",
"Allocation" : "NA",
"Interventional_Model" : "SINGLE_GROUP",
"Masking" : "NONE"
},
"Recruitment_Information" : {
"Study_Start_Date(Actual)" : "2004-10",
"Primary_Completion_Date(Actual)(Final_data_collection_date_for_primary_outcome_measure)" : "2008-12",
"Study_Completion_Date(Actual)" : "2008-12},
"Study_Record_Dates" : {
""Study_Registration_Dates" : {
"First_Submitted" : 2005-09-13",
"First_Submitted_that_Met_QC_Criteria" : 2017-10-05",
"First_Posted(Estimated)" : 2005-09-21"
},
"Study_Record_Updates" : {
"Last_Updated_that_Met_QC_Criteria" : 2005-09-13",
"Last_Update_Posted(Estimated)" : 2017-11-06",
"Last_Verified" : 2017-10"
}
}}
|
#Study Description
Brief Summary
Previous studies using topiramate in Tourette subjects have shown that with the use of this medication subjects report that their tics get better. The purpose of this study is to study if topiramate improves the symptoms of Tourette syndrome, such as motor tics, or other associated symptoms such as attention or obsessive-compulsive problems.
Detailed Description
In order to enroll in this study, you must have completed the Double-Blind phase of CAPSS-176 or discontinued the Double-Blind phase of CAPSS-176 after a minimum of 6 weeks because it has been determined that your symptoms of Tourette Syndrome were getting worse. You must also continue to meet the specific inclusion and exclusion criteria outlined in CAPSS-176.
The Titration/Maintenance Period: will last for 10 weeks, as it did during CAPSS-176. During the Titration and Maintenance Periods of the study, you will visit the study center 4 times. Visit 1 (Day 1) will be the same day as your final visit for CAPSS-176. You will have had a physical examination (including sitting blood pressure, pulse and weight), a urine pregnancy test if you are a female that is capable of having a child and been given the scale that measures the severity of your symptoms of Tourette Syndrome as part of the final visit procedures for CAPSS-176. This information will also be included as part of Visit 1.
During this visit, a blood sample will be taken (approximately 3 teaspoons) and tested to rule out any abnormalities and to make sure that your liver is working properly and your electrolytes are normal. You will also be asked to answer questions for the scale that measures your symptoms, if any, of attention deficit hyperactivity disorder (A-D/HD). If you have Bipolar II Disorder, you will be asked to answer questions for one scale that measures your symptoms of mania. If you have obsessive-compulsive disorder (OCD), you will be asked to answer questions for one scale that measures those symptoms. The study doctor or his staff will complete two scales that assess the severity of your condition.
If you continue to be eligible for the study, you will begin the Titration Period of the study by taking 1 tablet of commercial topiramate 25 mg in the evening. This will be Day 1 of the study. After one week of this phase of the study, your topiramate dose will be increased to 2 tablets of topiramate (50 mg total), one tablet in the morning and one in the evening. Your topiramate dose may continue to be increased until you have reached the dose level the study doctor determines to be appropriate for you, or, you are taking a maximum dose of 200 mgs per day of topiramate. Your study doctor may adjust your topiramate dose as necessary.
During the study, you will be expected to visit your study doctor or his staff again on Day 28 (Visit 2), Day 56 (Visit 3) and Day 70 (Visit 4) after beginning treatment. Extra visits may be scheduled at the discretion of your study doctor. At each visit, you will have your blood pressure, pulse and weight measured. You will be asked how you are feeling and if you have started taking any new medications or had changes in other medications you may be taking. All of the scales that were completed at Visit 1, and the scale that was completed at the final visit of CAPSS-176, will be completed again at each visit. You will have a urine pregnancy test performed at each visit if you are a female capable of having a child. The test must be negative to continue in the study. You will have blood drawn again (approximately three teaspoons) at Visits 2 and 4 to make sure that your liver is functioning properly and your electrolytes are normal.
You will be called between Visits 1 and 2 (Day 14 of the study) and Visits 2 and 3 (Day 42 of the study) on the telephone by one of the people working on this study. During these phone calls you will be asked how you are feeling, if you have had any changes in medications you are taking and how you are doing with topiramate.
Commercial topiramate will be provided in 25 mg tablets.Study medication is provided in child resistant bottles.All bottles should be returned(regardless of whether they are partial, empty or full) at each visit. It is important that you follow your study doctor or his staff's instructions on when and how to take the topiramate. At Visit 4 (Day 70), you will be given instructions about reducing your topiramate dose gradually for the next week. You will visit the study doctor or his staff again on Day 77 (Visit 5) after you have completely stopped taking the topiramate.
#Intervention
- DRUG : Topiramate (drug)
- Topiramate 25 mg to 200 mg
- Other Names :
- Topamax
|
#Eligibility Criteria:
Inclusion Criteria:
* Subjects must continue to meet the specific inclusion criteria outlined in either CAPSS-176 or CAPSS-198 to enroll in this protocol.
* Subjects must have completed the Double-Blind Phase or discontinued the Double-Blind Phase after a minimum of 6 weeks due to lack of efficacy (defined by a CGI improvement score of >6 [much worse or very much worse]) in either CAPSS-176 or CAPSS-198.
* Subjects or their parents/guardians, must be able to read and comprehend written instructions and willing to complete all scales and assessments required by this protocol.
* After full explanation of the study, subjects, or their parent/legally authorized representatives, must demonstrate their willingness to participate by signing an informed consent form. If applicable, pediatric subjects capable of giving assent must sign the assent form.
* Subjects must continue their current treatment for tics, treatment of comorbid symptoms or treatment of A-D/HD at the dose level established prior to entry in the Double-Blind Phase of CAPSS-176 or CAPSS-198.
Exclusion Criteria:
* Subjects must continue to meet the specific exclusion criteria outlined in either CAPSS-176 or CAPSS-198 to enroll in this protocol.
* Subjects who have SGOT and/or SGPT levels greater than 2 times the upper limit of the normal range from the last visit in either CAPSS-176 or CAPSS-198 will not be permitted to enroll in the current study.
Sex :
ALL
Ages :
- Minimum Age : 7 Years
- Maximum Age : 65 Years
- Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : ADULT, OLDER_ADULT, CHILD
Accepts Healthy Volunteers:
No
|
NCT00206336
| 133,095 |
{
"NCT_ID" : "NCT03039998",
"Brief_Title" : "Validity of Biological Material Sampling in Patients With Hospital-acquired Pneumonia",
"Official_title" : "Validity of Biological Material Sampling in Patients With Hospital-acquired Pneumonia",
"Conditions" : ["Hospital Acquired Pneumonia"],
"Study_Design" : {
"Study_Type" : "OBSERVATIONAL",
},
"Recruitment_Information" : {
"Study_Start_Date(Actual)" : "2013-03",
"Primary_Completion_Date(Actual)(Final_data_collection_date_for_primary_outcome_measure)" : "2014-12",
"Study_Completion_Date(Actual)" : "2015-12},
"Study_Record_Dates" : {
""Study_Registration_Dates" : {
"First_Submitted" : 2016-05-10",
"First_Posted(Estimated)" : 2017-02-01"
},
"Study_Record_Updates" : {
"Last_Updated_that_Met_QC_Criteria" : 2017-01-30",
"Last_Update_Posted(Estimated)" : 2017-02-01",
"Last_Verified" : 2017-01"
}
}}
|
#Study Description
Brief Summary
The main objective of project is to compare validity of sampling methods performed routinely (bronchial secretion, stomach content, oropharyngeal smear) for determination of etiological agent responsible for hospital-acquired pneumonia (HAP) in critically ill patients to bronchoscopy-assisted protected brush method. Evaluation of the present clinical praxis using bronchial secretion sampling in HAP diagnostics and detection of the most common etiological agents in patients with HAP are other priorities of the project. Aiming to confirm or exclude the diagnosis of HAP, determine the sources and possible routes of bacterial pathogens transmission molecular biology analysis of etiological agents is performed. Finally, percentage of HAP etiological agents resistant to initial empiric antibiotic therapy will be observed.
Detailed Description
The main objective of project will be comparing validity of sampling methods performed routinely (bronchial secretion, stomach content, oropharyngeal smear) for determination of etiological agent responsible for hospital-acquired pneumonia (HAP) in critically ill patients to bronchoscopy-assisted protected brush method. Obtained results of different methods will enable to determine if the bronchial secretion sample, stomach content sample or oropharyngeal smear are comparable to precise but technically difficult protected brush. Evaluation of the present clinical praxis using bronchial secretion sampling in HAP diagnostics and detection of the most common etiological agents in patients with HAP will be other priorities of the project. The role of atypical and fungal pathogens in HAP initiation will be discovered as well. Aiming to confirm or exclude the diagnosis of HAP, determine the sources and possible routes of bacterial pathogens transmission molecular biology analysis of etiological agents will be performed. Finally, percentage of HAP etiological agents resistant to initial empiric antibiotic therapy will be observed.
Project fulfills program objectives of molecular-biologic approaches and research support in infectious diseases domain. It will make contribution to faster and more precise HAP diagnosis and adequate antibiotic therapy.
|
#Eligibility Criteria:
Inclusion Criteria:
* clinical signs of HAP
* need for intubation and mechanical ventilation
Exclusion Criteria:
* inability to obtain samples in 24 hours after clinical diagnosis of HAP
Sex :
ALL
Ages :
- Minimum Age : 18 Years
- Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : ADULT, OLDER_ADULT
Accepts Healthy Volunteers:
No
|
NCT03039998
| 268,599 |
{
"NCT_ID" : "NCT02551510",
"Brief_Title" : "Comparison of Skin Adhesive to Subcuticular Suture Wound Closure After Port Placement",
"Official_title" : "Open, Randomized, Controlled Non-inferiority Trial to Compare Synthetic Tissue Adhesive and Skin Suture After Port Catheter Implantation With Reference to Cosmetic Result and Economy of Time at Equal Risk for Wound Infection",
"Conditions" : ["Wound Closure After Port Catheter Implantation"],
"Interventions" : ["Procedure: Suture", "Device: Experimental: Histoacryl®"],
"Location_Countries" : ["Germany"],
"Study_Design" : {
"Study_Type" : "INTERVENTIONAL",
"Phase" : ["NA"],
"Primary_Purpose" : "TREATMENT",
"Allocation" : "RANDOMIZED",
"Interventional_Model" : "PARALLEL",
"Masking" : "SINGLE"
},
"Recruitment_Information" : {
"Study_Start_Date(Actual)" : "2015-08",
"Primary_Completion_Date(Actual)(Final_data_collection_date_for_primary_outcome_measure)" : "2019-03",
"Study_Completion_Date(Actual)" : "2019-05},
"Study_Record_Dates" : {
""Study_Registration_Dates" : {
"First_Submitted" : 2015-08-17",
"First_Posted(Estimated)" : 2015-09-16"
},
"Study_Record_Updates" : {
"Last_Updated_that_Met_QC_Criteria" : 2015-09-15",
"Last_Update_Posted(Estimated)" : 2020-03-11",
"Last_Verified" : 2020-03"
}
}}
|
#Study Description
Brief Summary
Port Wound Closure compares synthetic tissue adhesives with seam for cutaneous wound closure to port plant in terms of cosmetic results and time savings at comparable risk for wound infection.
Detailed Description
Study patients who undergo a subcutaneous venous port implant procedure are randomized into control group (conventional sutures) or into interventional group (synthetic tissue adhesive). The intervention time is documented. Follow-up visit is performed 8 weeks after port implantation. It includes a photo documentation, quality of life questionnaire (EQ5D) and pain scala questionnaire (POSAS) by patient and by 3 independent observers as well as the documentation of complications.
#Intervention
- PROCEDURE : Suture
- Skin incision closure with standard subcuticular technique
- DEVICE : Experimental: Histoacryl®
- Skin incision closure with topic skin adhesive Histoacryl® Flexible (n-Butyl-2-Cyanoacrylate Monomer)
|
#Eligibility Criteria:
Inclusion Criteria:
* Medical indication for port catheter implantation because of chemotherapy or parenteral nutrition
Exclusion Criteria:
* Children and adolescents < 18 years
* Thrombocytes < 50/nl
* PTT <50%
* INR >1.5
* Systemic or local infection of the interventional location
* Known allergy to used material
* Known allergy to Histoacryl, Cyanoacrylate, D&C Violett or Formaldehyd
* General contraindication of port catheter implantation
Sex :
ALL
Ages :
- Minimum Age : 18 Years
- Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : ADULT, OLDER_ADULT
Accepts Healthy Volunteers:
No
|
NCT02551510
| 109,206 |
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