TrialPanorama/Dataset huggingface dataset:
Please select the outcome measures that correspond to the clinical trial below.
Title: Varenicline Treatment for Smoking Cessation in Patients With Bipolar Disorder
Brief Summary: The investigators' hypothesis is that add-on varenicline will be effective (versus placebo) in initiating abstinence from smoking in subjects with stable, euthymic bipolar disorder who are motivated to quit smoking within four weeks. This primary outcome will be assessed from randomization to 12 weeks or end of the treatment phase of the study. Secondarily, the investigators also hypothesize that varenicline will prevent relapse in the subsequent 12-weeks follow-up non-treatment phase. Furthermore, the investigators plan to test the effectiveness of varenicline in reducing nicotine withdrawal symptoms or urges to smoke, as well as its safety for use in stable bipolar patients when used as an add-on treatment for smoking cessation.

The investigators plan to test these hypotheses by conducting a randomized, placebo-controlled add-on treatment trial of Chantix with 60 recruited subjects diagnosed with DSM-IV bipolar disorder for a period of three months. The investigators will follow-up with them three months later to evaluate extended abstinence.


Options:
A: Primary result is percent not using NRT and not smoking at 12 weeks (point prevalence last 7 days) verified by self-declaration combined with a CO < 8 ppm and a p-cotinine < 15 ng/ml (12 weeks +/- 1 week)
B: Pharmacokinetic parameters: Population mean estimate for apparent plasma clearance (CL/F), central volume of distribution (V2/F) and steady-state volume of distribution (Vss/F).
C: Average Number of Cigarettes Smoked Between the Varenicline and Placebo Groups for Completers Through Week 12. (Weeks 1-12)
D: 7-day Prevalence of Abstinence From Cigarette Smoking at 12 Weeks (12 weeks); 7 Day Prevalence of Abstinence From Cigarette Smoking at 24 Weeks (24 weeks)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: Varenicline Treatment for Smoking Cessation in Patients With Bipolar Disorder
Brief Summary: The investigators' hypothesis is that add-on varenicline will be effective (versus placebo) in initiating abstinence from smoking in subjects with stable, euthymic bipolar disorder who are motivated to quit smoking within four weeks. This primary outcome will be assessed from randomization to 12 weeks or end of the treatment phase of the study. Secondarily, the investigators also hypothesize that varenicline will prevent relapse in the subsequent 12-weeks follow-up non-treatment phase. Furthermore, the investigators plan to test the effectiveness of varenicline in reducing nicotine withdrawal symptoms or urges to smoke, as well as its safety for use in stable bipolar patients when used as an add-on treatment for smoking cessation.

The investigators plan to test these hypotheses by conducting a randomized, placebo-controlled add-on treatment trial of Chantix with 60 recruited subjects diagnosed with DSM-IV bipolar disorder for a period of three months. The investigators will follow-up with them three months later to evaluate extended abstinence.


Options:
A: Seven-day point prevalence smoking abstinence at end of trial (abstinence based on self-reported smoking abstinence verified by CO levels < 10 ppm) (9 weeks)
B: Primary efficacy and Safety endpoint: (within 12 month from enrollment)
C: 7 Day Point Prevalence Abstinence From All Forms of Tobacco (4 weeks after beginning study)
D: 7-day Prevalence of Abstinence From Cigarette Smoking at 12 Weeks (12 weeks); 7 Day Prevalence of Abstinence From Cigarette Smoking at 24 Weeks (24 weeks)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: Varenicline Treatment for Smoking Cessation in Patients With Bipolar Disorder
Brief Summary: The investigators' hypothesis is that add-on varenicline will be effective (versus placebo) in initiating abstinence from smoking in subjects with stable, euthymic bipolar disorder who are motivated to quit smoking within four weeks. This primary outcome will be assessed from randomization to 12 weeks or end of the treatment phase of the study. Secondarily, the investigators also hypothesize that varenicline will prevent relapse in the subsequent 12-weeks follow-up non-treatment phase. Furthermore, the investigators plan to test the effectiveness of varenicline in reducing nicotine withdrawal symptoms or urges to smoke, as well as its safety for use in stable bipolar patients when used as an add-on treatment for smoking cessation.

The investigators plan to test these hypotheses by conducting a randomized, placebo-controlled add-on treatment trial of Chantix with 60 recruited subjects diagnosed with DSM-IV bipolar disorder for a period of three months. The investigators will follow-up with them three months later to evaluate extended abstinence.


Options:
A: biologically verified smoking cessation or reduction (8 weeks and delivery)
B: 7-day Prevalence of Abstinence From Cigarette Smoking at 12 Weeks (12 weeks); 7 Day Prevalence of Abstinence From Cigarette Smoking at 24 Weeks (24 weeks)
C: Determine the efficacy of combined therapy (VRN+nicotine patches) versus monotherapy (VRN+placebo patches) in smoking cessation assessed as continuous abstinence rate (CAR) from week 2 to week 12. (Participants will be followed for the duration of treatment, 12 weeks.)
D: Biochemically Verified Abstinence Verified With Expired Carbon Monoxide (CO) < 8 p.p.m. (Week 12)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: Varenicline Treatment for Smoking Cessation in Patients With Bipolar Disorder
Brief Summary: The investigators' hypothesis is that add-on varenicline will be effective (versus placebo) in initiating abstinence from smoking in subjects with stable, euthymic bipolar disorder who are motivated to quit smoking within four weeks. This primary outcome will be assessed from randomization to 12 weeks or end of the treatment phase of the study. Secondarily, the investigators also hypothesize that varenicline will prevent relapse in the subsequent 12-weeks follow-up non-treatment phase. Furthermore, the investigators plan to test the effectiveness of varenicline in reducing nicotine withdrawal symptoms or urges to smoke, as well as its safety for use in stable bipolar patients when used as an add-on treatment for smoking cessation.

The investigators plan to test these hypotheses by conducting a randomized, placebo-controlled add-on treatment trial of Chantix with 60 recruited subjects diagnosed with DSM-IV bipolar disorder for a period of three months. The investigators will follow-up with them three months later to evaluate extended abstinence.


Options:
A: Time to Occurrence of Major Adverse Cardiovascular Event (MACE) During Treatment Period (up to Date of Last Dose of Study Drug) in Study NCT01456936. (Baseline to last dose of study drug in parent study NCT01456936 (up to 12 weeks).)
B: 7-day Prevalence of Abstinence From Cigarette Smoking at 12 Weeks (12 weeks); 7 Day Prevalence of Abstinence From Cigarette Smoking at 24 Weeks (24 weeks)
C: Pharmacokinetic parameters: Population mean estimate for apparent plasma clearance (CL/F), central volume of distribution (V2/F) and steady-state volume of distribution (Vss/F).
D: Smoking Status (at week 48)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: An Internet-based Self-management Program With Telephone Support for Adolescents With Arthritis: A Pilot Randomized Controlled Trial
Brief Summary: This study will evaluate the feasibility of "Teens Taking Charge: Managing Arthritis On-line" intervention that will help adolescents with arthritis to better manage their disease and improve their health-related quality of life (HRQL).


Options:
A: Overall peak external frontal knee moment and impulse (Baseline and 12 weeks)
B: Juvenile Arthritis Quality of Life Questionnaire (JAQQ) (Baseline (prior to randomization) and 3 months after intervention)
C: Accrual rates; Compliance with therapy; Acceptability of exercise program; Degree of conditioning of subjects at baseline; Proportion of completed exercise tests and questionnaires; Dropout rates; Estimates of the effect sizes for exercise tests and questionnaire data
D: PATIENT-RATED LOW BACK PAIN (3 and 12 months)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: An Internet-based Self-management Program With Telephone Support for Adolescents With Arthritis: A Pilot Randomized Controlled Trial
Brief Summary: This study will evaluate the feasibility of "Teens Taking Charge: Managing Arthritis On-line" intervention that will help adolescents with arthritis to better manage their disease and improve their health-related quality of life (HRQL).


Options:
A: Adherence (beginning at baseline - week 20)
B: Juvenile Arthritis Quality of Life Questionnaire (JAQQ) (Baseline (prior to randomization) and 3 months after intervention)
C: Abdominal Pain Index (Baseline, 1 week post treatment session 3, 3 months post treatment session 3, 6 months post treatment session 3, 12 months post treatment session 3)
D: N/A

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: An Internet-based Self-management Program With Telephone Support for Adolescents With Arthritis: A Pilot Randomized Controlled Trial
Brief Summary: This study will evaluate the feasibility of "Teens Taking Charge: Managing Arthritis On-line" intervention that will help adolescents with arthritis to better manage their disease and improve their health-related quality of life (HRQL).


Options:
A: Change in FDI (Functional Disability Inventory) Scores at End of Study (Baseline and 6 months (end of study))
B: Headache diaries assess headache frequency. (Completed one month prior to first visit, then weekly up to Week 20, then one month prior to Month 3, 6, 9, and 12 Follow-Up Visits.)
C: Juvenile Arthritis Quality of Life Questionnaire (JAQQ) (Baseline (prior to randomization) and 3 months after intervention)
D: Abdominal Pain Index (Baseline, 1 week post treatment session 3, 3 months post treatment session 3, 6 months post treatment session 3, 12 months post treatment session 3)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: An Internet-based Self-management Program With Telephone Support for Adolescents With Arthritis: A Pilot Randomized Controlled Trial
Brief Summary: This study will evaluate the feasibility of "Teens Taking Charge: Managing Arthritis On-line" intervention that will help adolescents with arthritis to better manage their disease and improve their health-related quality of life (HRQL).


Options:
A: School presence (one year); Severity of fatigue (one year); Physical functioning as measured by the subscale physical functioning (one year)
B: N/A
C: depression (pre, post and 6 months post treatment)
D: Juvenile Arthritis Quality of Life Questionnaire (JAQQ) (Baseline (prior to randomization) and 3 months after intervention)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: An Internet-based Self-management Program With Telephone Support for Adolescents With Arthritis: A Pilot Randomized Controlled Trial
Brief Summary: This study will evaluate the feasibility of "Teens Taking Charge: Managing Arthritis On-line" intervention that will help adolescents with arthritis to better manage their disease and improve their health-related quality of life (HRQL).


Options:
A: Change in FDI (Functional Disability Inventory) Scores at End of Study (Baseline and 6 months (end of study))
B: Headache diaries assess headache frequency. (Completed one month prior to first visit, then weekly up to Week 20, then one month prior to Month 3, 6, 9, and 12 Follow-Up Visits.)
C: symptoms of recurrent abdominal pain (measured one week following treatment and again in 3, 6 and 12 months); disability (measured one week following treatment and again in 3, 6 and 12 months)
D: Juvenile Arthritis Quality of Life Questionnaire (JAQQ) (Baseline (prior to randomization) and 3 months after intervention)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: N/A
Brief Summary: The participation in this clinical study will last approximately 21 weeks with a 1 week screening period and a 12 weeks treatment duration. If the study doctor finds, that the patients disease has significantly improved he/she will enter a treatment free follow-up period of 8 weeks. In total the study consists of 5 to 6 clinical visits (V1 - V6) and 1 telephone follow-up call.


Options:
A: The Proportion of Patients Responders to Dex 21-P vs Placebo (From baseline to End of treatment = 6 weeks ± 10 days (in chronic and steroid dependent IBD patients) or 28 weeks ± 5 days (in mesalazine refractory UC patients))
B: Induction Period (IP); Number of Participants With Crohn's Disease Activity Index (CDAI)-Defined Clinical Response at Both Day IP-57 and Day IP-85 (At both Day IP-57 (Wk 8) and Day IP-85 (Wk 12).); Maintenance Period (MP); Number of Participants In CDAI-Defined Clinical Remission (CDAI <150) at Day MP-365 (12 Months) (Day MP-365 (12 months) of maintenance therapy); Open-Label Extension Period (OL); Number of Participants With Adverse Events (AEs), Related AEs, Deaths, Serious AEs (SAEs), Related SAEs, and Discontinuation Due to AEs (Between Day OL-1 and Day OL-617); OL; Number of Participants With Adverse Events (AEs) of Special Interest (Between Day OL-1 and Day OL-617)
C: Number of Participants With Clinical Response (Week 6)
D: To assess the efficacy of IMP in mesalazine-refractory ulcerative colitis (From day 1 of treatment until end of treatment)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: Phase 4 Study of Effects of ARB Compared With Diuretics in Hypertension Patients With High Cardiovascular Risks
Brief Summary: The aim of the study is to investigate the optimized treatment strategy of hypertension, so as to make more patients to reach the blood pressure goals and to reduce cardio-cerebrovascular events. Objective and Methods: Patients are eligible for inclusion in the study if they are essential hypertension, 50-79 years of age with at least one cardiovascular risk factor and sign the informed consent forms. This project is a multi-centre, prospective randomized,，openlabel blind-endpoint evaluation controlled (PROBE) trial. 12000 patients will be randomly assigned to either of low-dose Amlodipine+Telmisartan group or Amlodipine+ diuretics group. Among those patients with serum cholesterol between 4.0-6.1mmol/L, they will be also randomized into small dose of statin-based regimen or standard management regimen; Patients will also randomly assigned to intensive lifestyle intervention group or standard intervention group according to the community area where the patients in.


Options:
A: Cognitive impairment assessed with a Neuropsychological Test Battery, and Stroop and Trail Making tests. (2 years)
B: First Occurrence of a Major Cardiovascular Event (MCE); Specifically Nonfatal Heart Attack, Nonfatal Stroke, or Cardiovascular Death (Measured Throughout the Study) in the Glycemia Trial. (4.9 years); First Occurrence of Major Cardiovascular Event (MCE) in the Blood Pressure Trial. (4.7 years); First Occurrence of Major Cardiovascular Event (MCE) in the Lipid Trial. (4.7 years)
C: The primary study outcomes are composite of non-fatal stroke, non-fatal myocardial infarction and cardiovascular death. (3-4 years)
D: The composite of; Cardiovascular death, non-fatal myocardial infarction, non-fatal stroke. (Biannually); The composite of; cardiovascular death, resuscitated cardiac arrest, non-fatal myocardial infarction, non-fatal stroke, heart failure, arterial revascularizations (Biannually)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: Characterizing Alpha5 Nicotinic Receptors in Alcohol and Nicotine Dependence
Brief Summary: Purpose: This is an outpatient, randomized, double-blinded, placebo-controlled study in which either varenicline (twice daily) or placebo will be administered over a 12 week study period to examine genetic influences on treatment response to varenicline for reduction of hazardous drinking.


Options:
A: Continuous abstinence (from week 7 until week 24)
B: Average Number of Cigarettes Smoked Between the Varenicline and Placebo Groups for Completers Through Week 12. (Weeks 1-12)
C: Continuous 4-week Abstinence From Smoking Between Weeks 8-11 After the Quit Date (Through the End of Treatment) (weeks 8-11 after quit date)
D: Point Prevalence Tobacco Abstinence (Week 12); Point Prevalence Tobacco Abstinence (Week 24)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: Safety and Efficacy of Aprepitant, Ramosetron, and Dexamethasone for Chemotherapy-Induced Nausea and Vomiting in Patients With Ovarian Cancer Treated With Taxane/Carboplatin
Brief Summary: The current recommended guideline for patients receiving moderately emetogenic chemotherapy (MEC) is the combination of a 5-HT3 receptor antagonist and corticosteroid. Incidence of chemotherapy induced nausea and vomiting (CINV) is approximately 50% in patients receiving MEC. An incidence rate of 25-38% for delayed emesis and 55-60% for delayed nausea has been observed. Hence, there is clearly a need for more effective prevention of CINV in patients receiving MEC, especially in women with ovarian carcinoma who are particularly susceptible to these symptoms. Therefore the investigators designed a study with the objective to evaluate if new combination (Aprepitant/Ramosetron/Dexamethasone) may improve actual CINV control in ovarian carcinoma patients treated with taxane/carboplatin.


Options:
A: A Complete Response (no Vomiting and no Use of Rescue Therapy) Overall (in the 120 Hours Following Initiation of Cisplatin). (Overall (in the 120 hours following initiation of cisplatin chemotherapy).)
B: Efficacy of the Aprepitant/Ramosetron/Dexamethasone Regimen in Terms of the Proportion of Patients With a Complete Response (CR) During the 120 Hour Following Initiation of Chemotherapy. (120 hours); Safety and Tolerability of the Aprepitant/Ramosetron/Dexamethasone Regimen (120 hours)
C: Patient vomiting
D: Proportion of Patients With Complete Response (CR) During Acute Phase (0-24 Hours) After Administration of Chemotherapy Course 1 (0-24 Hours); Proportion of Patients With CR During Delayed-onset Phase (24-120 Hours) After Administration of Chemotherapy Course 1 (24-120 Hours)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: N/A
Brief Summary: RCT colloids versus cristalloids only in severe burn victims.

* Trial with medicinal product


Options:
A: Reduced amount of fluids given (3 days)
B: Mortality or dialysis-dependency (90 days)
C: Mortality; Quality of Life
D: All cause mortality (90 days)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: A Randomized, Double-blind, Placebo Controlled, Multicenter, 3-period Crossover Study to Compare the Effect of Indacaterol (150μg o.d.) on Inspiratory Capacity to Placebo in Patients With Moderate COPD, Using Open Label Tiotropium (18μg o.d.) as Active Control
Brief Summary: This study is being conducted to assess the effect of indacaterol (150 μg o.d.) on inspiratory capacity (IC), using placebo and open label tiotropium (18 μg o.d.) as comparators in patients with moderate chronic obstructive pulmonary disease (COPD). In particular, spirometric timepoints are included to elucidate the peak-IC in a period of approximately 4 hour post inhalation


Options:
A: Prevalence of risk factors to develop comorbidities (vascular dysfunction, osteoporosis, muscle wasting and metabolic syndrome) (baseline); Incidence and worsening of risk factors to develop comorbidities (vascular dysfunction, osteoporosis, muscle wasting and metabolic syndrome) (3 years)
B: The benefits of resistance training during exacerbation of COPD on peripheral muscle strength during hospitalization (Will be evaluated on the second day of hospitalization, the day of hospital discharge (this time interval must be longer than five days))
C: Peak Inspiratory Capacity (IC) After 21 Days of Treatment (21 days)
D: Change From Baseline in Peak Inspiratory Capacity (IC) Comparison Between QVA149 and Placebo (Baseline, day 22, baseline day 36, day 57); Change From Baseline in the Comparison of QVA149 Versus Placebo With Respect to Average Physical Activity Level (Baseline, day 22, baseline day 36, day 57)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: N/A
Brief Summary: The purpose of this study is to study the efficacy of dexamethasone added to ramosetron for preventing postoperative nausea and vomiting in highly susceptible patients following spine surgery.


Options:
A: Number of Participants Experiencing Postoperative Nausea and Vomiting in 24h Postoperatively (within 24h after operation)
B: Effect of Granisetron and Ondansetron on QTc interval Prolongation at various time intervals after administration (0 mins (before injection of study drug), 2 mins, 5 mins, 15mins, 1 hour and 2 hours)
C: Rates of vomiting and retching (after surgery)
D: the incidence of postoperative nausea and vomiting(PONV) (After spinal surgery)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: Effects of Atorvastatin on Endothelial Function, Vascular and Myocardial Redox State in High Cardiovascular Risk Patients
Brief Summary: The present study constitutes a study examining the effect of atorvastatin on vascular function in high cardiovascular risk patients. For this purpose the investigators will record atorvastatin effects on statin-naïve patients (patients that start statins treatment for first time). More specifically the investigators will study atorvastatin effects on:

1. Endothelial function
2. Arterial elastic properties
3. Systemic Inflammatory/thrombotic mechanisms
4. Vascular and myocardial redox state


Options:
A: To evaluate the effect of high dose atorvastatin in STEMI - 30 Days MACE(death, myocardial infarction, target vessel revascularization) (30 days)
B: Vascular Nitric oxide bioavailability (Arm A + B) (At the start and at the end of 2-week treatment period (arm A) and at the start and at the end of 3-day treatment period (arm B))
C: Number of Participants With Acute Kidney Injury (postoperative day 2); Number of Participants With Delirium (while in ICU (about 2 days))
D: The mean peak increase of serum creatinine concentration during day1 and day2.

Answer: B