TrialPanorama/Dataset huggingface dataset:
Please select the outcome measures that correspond to the clinical trial below.
Title: ICON7 - A Randomised, Two-Arm, Multi-Centre Gynaecologic Cancer InterGroup Trial of Adding Bevacizumab to Standard Chemotherapy (Carboplatin and Paclitaxel) in Patients With Epithelial Ovarian Cancer
Brief Summary: RATIONALE: Drugs used in chemotherapy, such as carboplatin and paclitaxel, work in different ways to stop the growth of tumor cells, either by killing the cells or stopping them from dividing. Monoclonal antibodies, such as bevacizumab, can block tumor growth in different ways. Some block the ability of tumor cells to grow and spread. Others find tumor cells and help kill them or carry tumor-killing substances to them. Bevacizumab may also stop the growth of tumor cells by blocking blood flow to the tumor. It is not yet known whether giving carboplatin and paclitaxel together with bevacizumab is more effective than carboplatin and paclitaxel alone in treating patients with ovarian epithelial cancer, fallopian tube cancer, or primary peritoneal cavity cancer.

PURPOSE: This randomized phase III trial is studying carboplatin, paclitaxel, and bevacizumab to see how well they work compared with carboplatin and paclitaxel alone in treating patients with newly diagnosed ovarian epithelial cancer, fallopian tube cancer, or primary peritoneal cavity cancer.


Options:
A: Progression-free survival
B: Overall Objective Response (1 year after end inclusion)
C: To determine if AMG 386 plus PLD is superior to placebo plus PLD as measured by progression-free survival, defined as the time from randomization to the earliest of the dates of first radiologic disease progression per RECIST 1.1 with modifications (Radiological imaging will be performed 8 weeks ± 1 week, starting from date of randomization for the first 64 weeks, then every 16 weeks ± 1 week for the next 32 weeks, and then every 24 weeks ± 4 weeks thereafter.)
D: progression free survival (6 months from randomization)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: ICON7 - A Randomised, Two-Arm, Multi-Centre Gynaecologic Cancer InterGroup Trial of Adding Bevacizumab to Standard Chemotherapy (Carboplatin and Paclitaxel) in Patients With Epithelial Ovarian Cancer
Brief Summary: RATIONALE: Drugs used in chemotherapy, such as carboplatin and paclitaxel, work in different ways to stop the growth of tumor cells, either by killing the cells or stopping them from dividing. Monoclonal antibodies, such as bevacizumab, can block tumor growth in different ways. Some block the ability of tumor cells to grow and spread. Others find tumor cells and help kill them or carry tumor-killing substances to them. Bevacizumab may also stop the growth of tumor cells by blocking blood flow to the tumor. It is not yet known whether giving carboplatin and paclitaxel together with bevacizumab is more effective than carboplatin and paclitaxel alone in treating patients with ovarian epithelial cancer, fallopian tube cancer, or primary peritoneal cavity cancer.

PURPOSE: This randomized phase III trial is studying carboplatin, paclitaxel, and bevacizumab to see how well they work compared with carboplatin and paclitaxel alone in treating patients with newly diagnosed ovarian epithelial cancer, fallopian tube cancer, or primary peritoneal cavity cancer.


Options:
A: Percentage of Participants With Disease Progression or Death (Data Cutoff 14 November 2011) (Screening Visit, Every 8 weeks (or 9 weeks if receiving topotecan) until progression reported between day of first participant randomized (29 October 2009) until cutoff date of 14 November 2011); Progression Free Survival (PFS; Data Cutoff 14 November 2011) (Screening Visit, Every 8 weeks (or 9 weeks if receiving topotecan) until progression reported between day of first participant randomized (29 October 2009) until cutoff date of 14 November 2011)
B: Progression-free Survival (3 years)
C: Progression-free survival
D: Overall survival (OS) (This outcome measure will be assess approximately 4.5-5 years after the last patient enrolled)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: Renal Denervation in Patients With Refractory Hypertension
Brief Summary: To investigate the clinical utility of renal denervation in the treatment of refractory hypertension.


Options:
A: To provide confirmation that renal denervation is safe and feasible. (3 years)
B: Change in atrial fibrillation burden (from Baseline and 12 months)
C: Change in systolic blood pressure (ABPM mean value) (6 months)
D: Anti-arrhythmic Drug (AAD)-Free Single-procedure Freedom From Atrial Fibrillation Recurrence (up to 12 months)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: Renal Denervation in Patients With Refractory Hypertension
Brief Summary: To investigate the clinical utility of renal denervation in the treatment of refractory hypertension.


Options:
A: office BP (baseline, 6 months); 24-ABPM (baseline, 6 months); Magnetic resonance imaging (MRI) (baseline, 3 and 6 months); Albuminuria (baseline, 6 months); Systemic RAS activity (baseline, 6 months); Vascular structure and function of large and small arteries (baseline, 6 months); Local RAS activity (baseline, 6 months)
B: Change in systolic blood pressure (ABPM mean value) (6 months)
C: Anti-arrhythmic Drug (AAD)-Free Single-procedure Freedom From Atrial Fibrillation Recurrence (up to 12 months)
D: To provide confirmation that renal denervation is safe and feasible. (3 years)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: A Double-blind, Placebo-controlled Trial to Evaluate the Efficacy and Safety of Prucalopride (R108512) Tablets in Subjects With Chronic Constipation.
Brief Summary: The purpose of this study is to determine whether prucalopride is safe and effective in the treatment of chronic constipation.

Hypothesis:

Prucalopride 2 mg and 4 mg given once daily for 12 weeks is superior to placebo for the treatment of patients with chronic constipation and is well tolerated in those patients.


Options:
A: Patient's Global Assessment of severity of constipation and efficacy of treatment evaluated (for exploratory reasons only). (4 weeks)
B: Change From Pretreatment in Weekly Normalized Spontaneous Bowel Movement (SBM) Frequency (Change from Baseline to Week 4)
C: Colonic Transit at 24 Hours (24 hours post-radiolabeled meal)
D: Proportion of subjects with an average of 3 or more SCBM per week (12 weeks)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: A Double-blind, Placebo-controlled Trial to Evaluate the Efficacy and Safety of Prucalopride (R108512) Tablets in Subjects With Chronic Constipation.
Brief Summary: The purpose of this study is to determine whether prucalopride is safe and effective in the treatment of chronic constipation.

Hypothesis:

Prucalopride 2 mg and 4 mg given once daily for 12 weeks is superior to placebo for the treatment of patients with chronic constipation and is well tolerated in those patients.


Options:
A: Percentage of Participants Who Are Responder50. (6 months after last blinded treatment); Percentage of Participants Who Are Responder25. (12 months after last treatment)
B: FI - number of FI episodes per week and/or number of days with FI per week. Constipation - number of bowel movements per week; &/or decrease defecations requiring straining; &/or decrease defecations where there was incomplete emptying (Annually)
C: Proportion of subjects with an average of 3 or more SCBM per week (12 weeks)
D: Number of incontinence episodes Assess number of incontinence episodes. (Will be assessed every four weeks during a twelve-week period)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: The Individualized Management With Pegasys and Ribavirin Offering Viral Eradication (IMPROVE) Trial
Brief Summary: This study will compare the efficacy and safety of treatment with pegylated-interferon alfa-2a plus ribavirin in participants with non-genotype 2/3 CHC who, after 12 weeks of study treatment, have undetectable hepatitis C virus (HCV)-ribonucleic acid (RNA) or a greater than or equal to (\>=) 2 log10 drop in HCV-RNA. Participants will be randomized to receive pegylated-interferon alfa-2a 180 micrograms subcutaneously weekly plus ribavirin (1000-1400 milligram \[mg\]) orally daily for the specified duration, followed by 24 weeks of treatment-free follow-up. Participants with detectable HCV-RNA and less than (\<) 2 log10 drop in HCV-RNA at week 12 will discontinue therapy.


Options:
A: Percentage of Subjects With Undetectable Plasma Hepatitis C Virus (HCV) Ribonucleic Acid (RNA) at Week 24 After the Completion of Study Drug Dosing (24 weeks after the completion of study drug dosing (up to Week 72))
B: Progression of Liver Disease as Indicated by Death, Hepatic Decompensation, Hepatocellular Carcinoma, or for Patients With Noncirrhotic Fibrosis at Baseline, an Increase in the Ishak Hepatic Fibrosis Score of 2 or More Points (1400 days (3.85 years) post randomization); Increase in Ishak Fibrosis Score by 2 Points or More at 2 or 4 Year Biopsies (1400 days (3.85 years) post randomization); Death From Any Cause (1400 days (3.85 years) post randomization); Development of Hepatocellular Carcinoma (HCC) (1400 days (3.85 years) post randomization); Child-Turcotte-Pugh (CTP) Score of 7 or Higher at Two Consecutive Study Visits (1400 days (3.85 years) post randomization); Variceal Hemorrhage (1400 days (3.85 years) post randomization); Ascites (1400 days (3.85 years) post randomization); Spontaneous Bacterial Peritonitis (1400 days (3.85 years) post randomization); Hepatic Encephalopathy (1400 days (3.85 years) post randomization)
C: Percentage of Participants With Sustained Virological Response (SVR) (Groups A and B) (At 24-week untreated follow-up visit (up to 72 weeks for Group A, up to 96 weeks for Group B))
D: Percentage of Subjects With Undetectable Plasma Hepatitis C Virus (HCV) Ribonucleic Acid (RNA) at Week 24 After the Completion of Study Drug Dosing (24 weeks after the completion of study drug dosing (up to Week 72))

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: The Long Term Effect of Inhaled Hypertonic Saline (6%) in Patients With Non-cystic Fibrosis Bronchiectasis.
Brief Summary: The purpose of this study is to determine whether the daily inhalation of nebulised hypertonic saline (6%) will decrease the incidence of pulmonary exacerbations and increase the quality of life for people with non cystic fibrosis bronchiectasis.


Options:
A: 24 hour sputum clearance (24 hours / 12 weeks); Quality of Life SGRQ (12 weeks)
B: Number of pulmonary exacerbations (One year)
C: FEV1 after 12 weeks of each of the following treatment regimens: *mannitol only *rhDNase only *mannitol + rhDNase (12 weeks)
D: Lung function (FEV1, FVC, FEF25-75)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: Cannabis and Psychosis. Randomized Clinical Trial: Specialized Addiction Treatment Versus Treatment as Usual for Young Patients With Cannabis Abuse and Psychosis
Brief Summary: The purpose of the trial is to investigate the effect of specialized treatment of cannabis abuse among young people with psychosis. The specialized treatment consists of manualized individual treatment and group therapy. It will be compared with the standard treatment, which consists of non-specialized, non-manualized treatment. 140 patients will be randomised to one of the two treatments, and the investigator(s) will be blinded to the treatment received.


Options:
A: longest continuous period of cocaine abstinence (Week 8)
B: Cognitive/Affective Functional Outcomes (Baseline, 6-month, 12-month and 18 month)
C: Number of cannabis-abstinent days in past month (Baseline, 6 months, 10 months)
D: Cannabis use reduction in the follow-up (Baseline, 16 weeks (posttreatment), at 3 and 6 months and at one year of follow up.); Improvement in the development of psychotic disorder (Baseline, 16 weeks (posttreatment), at 3 and 6 months and at one year of follow up); Changes in the components of the endogenous cannabinoid system (Baseline, 16 weeks (posttreatment), at 3 and 6 months and at one year of follow up); Normalizing the possible alterations in the endogenous cannabinoid system (Baseline, 16 weeks (posttreatment), at 3 and 6 months and at one year of follow up)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: Cannabis and Psychosis. Randomized Clinical Trial: Specialized Addiction Treatment Versus Treatment as Usual for Young Patients With Cannabis Abuse and Psychosis
Brief Summary: The purpose of the trial is to investigate the effect of specialized treatment of cannabis abuse among young people with psychosis. The specialized treatment consists of manualized individual treatment and group therapy. It will be compared with the standard treatment, which consists of non-specialized, non-manualized treatment. 140 patients will be randomised to one of the two treatments, and the investigator(s) will be blinded to the treatment received.


Options:
A: Marijuna use (marijuana use at 6 months)
B: Number of cannabis-abstinent days in past month (Baseline, 6 months, 10 months)
C: Use of illicit drugs in the past 30 days (baseline, 3, 6, 9, and 12 months); Enrollment in formal substance abuse treatment (baseline up to 2 years post-intervention); Medical, legal, employment, social, and psychiatric outcomes (baseline, 3, 6, 9, and 12 months)
D: Health of Nations Outcome Scale (HONOS) (Baseline, 6 months, 12 months, 18 months,)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: Randomized Clinical Trial Comparing a Medication, i.e., Sustained-Release Bupropion (Zyban®) With an Ultrashort (1 1/2 d) Manual-Based Psychotherapeutic Intervention, Psychodynamic Model Training®
Brief Summary: Background

Smokers often reject drugs as smoking cessation aids. Nonpharmacological interventions are notoriously under-evaluated.

Methods

We conducted a randomized clinical trial in which we compared a medication, i.e., sustained-release bupropion (Zyban®; 413 subjects), at the time of the trial the most efficacious pharmacological smoking cessation aid, with an ultrashort psychotherapeutic intervention, Psychodynamic Model Training® (366 subjects), a manual-based psychodynamically oriented 1 ½ day autosuggestion training. Outcome criterion was 12-month self-reported continuous abstinence confirmed by urine cotinine levels below the level of detection (13 ng/ml) or, in an independent analysis, by exhaled carbon monoxide of 10 ppm or less at all interviews conducted at 3, 6, and 12 months.


Options:
A: Prolonged Smoking Abstinence at End of 12 Weeks of Varenicline Treatment (12 weeks)
B: Biochemically/pharmacologically-confirmed 12-month continuous abstinence as evidenced by self-reports of nonsmoking status in all interviews (i.e., at 3, 6, and 12 months) (12 months)
C: Smoking Behavior (2)
D: Point prevalence of smoking cessation (those who have quitted smoking and have not smoked in the past week prior to the assessment date). (52 weeks after starting the treatment)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: Randomized Clinical Trial Comparing a Medication, i.e., Sustained-Release Bupropion (Zyban®) With an Ultrashort (1 1/2 d) Manual-Based Psychotherapeutic Intervention, Psychodynamic Model Training®
Brief Summary: Background

Smokers often reject drugs as smoking cessation aids. Nonpharmacological interventions are notoriously under-evaluated.

Methods

We conducted a randomized clinical trial in which we compared a medication, i.e., sustained-release bupropion (Zyban®; 413 subjects), at the time of the trial the most efficacious pharmacological smoking cessation aid, with an ultrashort psychotherapeutic intervention, Psychodynamic Model Training® (366 subjects), a manual-based psychodynamically oriented 1 ½ day autosuggestion training. Outcome criterion was 12-month self-reported continuous abstinence confirmed by urine cotinine levels below the level of detection (13 ng/ml) or, in an independent analysis, by exhaled carbon monoxide of 10 ppm or less at all interviews conducted at 3, 6, and 12 months.


Options:
A: Point prevalence of smoking cessation (those who have quitted smoking and have not smoked in the past week prior to the assessment date). (52 weeks after starting the treatment)
B: Biochemically/pharmacologically-confirmed 12-month continuous abstinence as evidenced by self-reports of nonsmoking status in all interviews (i.e., at 3, 6, and 12 months) (12 months)
C: Cotinine-validated 7-day point prevalence tobacco abstinence at 1 year follow-up; Cotinine-validated 7-day point prevalence tobacco abstinence at 3 month follow-up (end of treatment)
D: Number of Participants Not Smoking in the Previous 7 Days, Confirmed by Expired Carbon Monoxide Reading < 10 Parts Per Million at Week 52 (7-day point prevalence)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: Randomized Clinical Trial Comparing a Medication, i.e., Sustained-Release Bupropion (Zyban®) With an Ultrashort (1 1/2 d) Manual-Based Psychotherapeutic Intervention, Psychodynamic Model Training®
Brief Summary: Background

Smokers often reject drugs as smoking cessation aids. Nonpharmacological interventions are notoriously under-evaluated.

Methods

We conducted a randomized clinical trial in which we compared a medication, i.e., sustained-release bupropion (Zyban®; 413 subjects), at the time of the trial the most efficacious pharmacological smoking cessation aid, with an ultrashort psychotherapeutic intervention, Psychodynamic Model Training® (366 subjects), a manual-based psychodynamically oriented 1 ½ day autosuggestion training. Outcome criterion was 12-month self-reported continuous abstinence confirmed by urine cotinine levels below the level of detection (13 ng/ml) or, in an independent analysis, by exhaled carbon monoxide of 10 ppm or less at all interviews conducted at 3, 6, and 12 months.


Options:
A: 7-day point prevalence abstinence measured at 6 months (6 months)
B: Biochemically/pharmacologically-confirmed 12-month continuous abstinence as evidenced by self-reports of nonsmoking status in all interviews (i.e., at 3, 6, and 12 months) (12 months)
C: Number of Participants With Smoking Abstinence at Month 6 (Month 6)
D: 7-day Point Prevalence All Tobacco Abstinence (12 weeks - end of treatment)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: Randomized Clinical Trial Comparing a Medication, i.e., Sustained-Release Bupropion (Zyban®) With an Ultrashort (1 1/2 d) Manual-Based Psychotherapeutic Intervention, Psychodynamic Model Training®
Brief Summary: Background

Smokers often reject drugs as smoking cessation aids. Nonpharmacological interventions are notoriously under-evaluated.

Methods

We conducted a randomized clinical trial in which we compared a medication, i.e., sustained-release bupropion (Zyban®; 413 subjects), at the time of the trial the most efficacious pharmacological smoking cessation aid, with an ultrashort psychotherapeutic intervention, Psychodynamic Model Training® (366 subjects), a manual-based psychodynamically oriented 1 ½ day autosuggestion training. Outcome criterion was 12-month self-reported continuous abstinence confirmed by urine cotinine levels below the level of detection (13 ng/ml) or, in an independent analysis, by exhaled carbon monoxide of 10 ppm or less at all interviews conducted at 3, 6, and 12 months.


Options:
A: 7-day point prevalence abstinence measured at 6 months (6 months)
B: 7-day Point Prevalence Smokeless Tobacco Abstinence Biochemically Confirmed With Urine Cotinine at the End of 12 Weeks of Treatment. (At the end of treatment (12 weeks))
C: Number of Participants With Salivary Cotinine-verified Smoking Abstinence at 6 Months (6 months)
D: Biochemically/pharmacologically-confirmed 12-month continuous abstinence as evidenced by self-reports of nonsmoking status in all interviews (i.e., at 3, 6, and 12 months) (12 months)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: Randomized Clinical Trial Comparing a Medication, i.e., Sustained-Release Bupropion (Zyban®) With an Ultrashort (1 1/2 d) Manual-Based Psychotherapeutic Intervention, Psychodynamic Model Training®
Brief Summary: Background

Smokers often reject drugs as smoking cessation aids. Nonpharmacological interventions are notoriously under-evaluated.

Methods

We conducted a randomized clinical trial in which we compared a medication, i.e., sustained-release bupropion (Zyban®; 413 subjects), at the time of the trial the most efficacious pharmacological smoking cessation aid, with an ultrashort psychotherapeutic intervention, Psychodynamic Model Training® (366 subjects), a manual-based psychodynamically oriented 1 ½ day autosuggestion training. Outcome criterion was 12-month self-reported continuous abstinence confirmed by urine cotinine levels below the level of detection (13 ng/ml) or, in an independent analysis, by exhaled carbon monoxide of 10 ppm or less at all interviews conducted at 3, 6, and 12 months.


Options:
A: Biochemically/pharmacologically-confirmed 12-month continuous abstinence as evidenced by self-reports of nonsmoking status in all interviews (i.e., at 3, 6, and 12 months) (12 months)
B: Four-week Continuous Abstinence From Cigarette Smoking (Study week 8 thru week 11)
C: Prolonged Smoking Abstinence Rates at 12 Weeks in Cigarettes Smokers. (3 months); Point Prevalence Abstinence at 3 Months. (3 months)
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: A
Please select the outcome measures that correspond to the clinical trial below.
Title: Polycystic Ovary Syndrome (PCOS) - The Female Metabolic Syndrome Genes And Processes In The Aetiology And Pathogenesis Of PCOS And Identification Of New Treatment Strategies
Brief Summary: Hypothesis:

The overall hypothesis is that women with PCOS, both obese and non-obese, have larger adipocytes, altered metabolism and signs of inflammation in adipose tissue and that these changes are associated with high sympathetic nerve activity, hyperandrogenism hyperinsulinaemia, insulin resistance with progression to type II diabetes and cardiovascular disease (CVD) as well as psychological distress and reduced quality of life. Physical exercise and electro-acupuncture decrease high concentrations of androgens, induce regulare menstrual pattern, inhibits high sympathetic activity and restore the PCOS induced disturbances.


Options:
A: serum testosterone
B: To measure if physical exercise and electro-acupuncture restores endocrine, neuroendocrine, metabolic and immunological disturbances related to sympathetic nerve activity as well as psychological distress and improve quality of life in women with PCOS. (One year)
C: Metformin versus Metformin plus low-dose Spironolactone on metabolic parameters of Patients with Polycystic Ovary Syndrome: a randomized study (six months)
D: Change in Testosterone After 6 Months of Treatment (baseline and 6 months)

Answer: B