TrialPanorama/Dataset huggingface dataset:
Please select the outcome measures that correspond to the clinical trial below.
Title: Effects of a Combination of Varenicline and Transdermal Nicotine Patch on Post-quitting Urges to Smoke
Brief Summary: Varenicline and nicotine replacement therapy (NRT) are both effective smoking cessation treatments. Anecdotally smokers who are finding their quit attempt difficult have reported benefiting from adding NRT to varenicline. This proof-of-principle placebo-controlled double-blind study will examine whether combining NRT and varenicline provides better withdrawal and craving relief than varenicline alone. A total of 120 smokers would be randomised to receive varenicline +15mg/16hr patch or varenicline + placebo patch. All participants will receive standard NHS Stop Smoking Service support. The primary outcome would be ratings of craving and withdrawal discomfort 24 hours and one week after the target quit date.


Options:
A: Rating of urges to smoke one week after the target quit date assessed by Mood and Physical Symptoms Scale (1 week)
B: Days of abstinence following the programmed lapse (7 days)
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: Number of Responders With Carbon Monoxide (CO) Confirmed 4-week Continuous Quit Rate (CQR) for Last 4 Weeks of Treatment (Trtmt) (weeks 9 through 12)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: Effects of a Combination of Varenicline and Transdermal Nicotine Patch on Post-quitting Urges to Smoke
Brief Summary: Varenicline and nicotine replacement therapy (NRT) are both effective smoking cessation treatments. Anecdotally smokers who are finding their quit attempt difficult have reported benefiting from adding NRT to varenicline. This proof-of-principle placebo-controlled double-blind study will examine whether combining NRT and varenicline provides better withdrawal and craving relief than varenicline alone. A total of 120 smokers would be randomised to receive varenicline +15mg/16hr patch or varenicline + placebo patch. All participants will receive standard NHS Stop Smoking Service support. The primary outcome would be ratings of craving and withdrawal discomfort 24 hours and one week after the target quit date.


Options:
A: biologically verified smoking cessation or reduction (8 weeks and delivery)
B: 4 week continuous quit rate (CQR) at Weeks 9-12 and Weeks 4-7
C: Self- Reported 7-day Abstinence (6 Months); Carbon Monoxide (CO)-Confirmed 7-day Abstinence (6-Months); Rates of Smoking Cessation Continuous From First Quit Day to 6 Months (6-Months); Self-reported 7-day Abstinence (12 Months); CO-confirmed 7-day Abstinence (12 Months)
D: Rating of urges to smoke one week after the target quit date assessed by Mood and Physical Symptoms Scale (1 week)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: Effects of a Combination of Varenicline and Transdermal Nicotine Patch on Post-quitting Urges to Smoke
Brief Summary: Varenicline and nicotine replacement therapy (NRT) are both effective smoking cessation treatments. Anecdotally smokers who are finding their quit attempt difficult have reported benefiting from adding NRT to varenicline. This proof-of-principle placebo-controlled double-blind study will examine whether combining NRT and varenicline provides better withdrawal and craving relief than varenicline alone. A total of 120 smokers would be randomised to receive varenicline +15mg/16hr patch or varenicline + placebo patch. All participants will receive standard NHS Stop Smoking Service support. The primary outcome would be ratings of craving and withdrawal discomfort 24 hours and one week after the target quit date.


Options:
A: Number of participants reported adverse events of e-cigarettes or nicotine pouches (60 Weeks); Change in the number of combustible cigarettes per day (60 Weeks); Point-prevalence abstinence (60 Weeks)
B: Change in Biomarker Concentrations: Nicotine Equivalents (Baseline, Week 6); Change in Biomarker Concentrations: NNAL (Baseline, Week 6)
C: Continuous abstinence for the last 4 weeks of varenicline and NRT (Nicotine Replacement Therapy) treatment period
D: Rating of urges to smoke one week after the target quit date assessed by Mood and Physical Symptoms Scale (1 week)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: Effects of a Combination of Varenicline and Transdermal Nicotine Patch on Post-quitting Urges to Smoke
Brief Summary: Varenicline and nicotine replacement therapy (NRT) are both effective smoking cessation treatments. Anecdotally smokers who are finding their quit attempt difficult have reported benefiting from adding NRT to varenicline. This proof-of-principle placebo-controlled double-blind study will examine whether combining NRT and varenicline provides better withdrawal and craving relief than varenicline alone. A total of 120 smokers would be randomised to receive varenicline +15mg/16hr patch or varenicline + placebo patch. All participants will receive standard NHS Stop Smoking Service support. The primary outcome would be ratings of craving and withdrawal discomfort 24 hours and one week after the target quit date.


Options:
A: Rating of urges to smoke one week after the target quit date assessed by Mood and Physical Symptoms Scale (1 week)
B: Long term abstinence (one year)
C: Number of Participants With 4-week Continuous Abstinence (Weeks 9 through 12)
D: 7 Day Point Prevalence Abstinence From All Forms of Tobacco (4 weeks after beginning study)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: Effects of a Combination of Varenicline and Transdermal Nicotine Patch on Post-quitting Urges to Smoke
Brief Summary: Varenicline and nicotine replacement therapy (NRT) are both effective smoking cessation treatments. Anecdotally smokers who are finding their quit attempt difficult have reported benefiting from adding NRT to varenicline. This proof-of-principle placebo-controlled double-blind study will examine whether combining NRT and varenicline provides better withdrawal and craving relief than varenicline alone. A total of 120 smokers would be randomised to receive varenicline +15mg/16hr patch or varenicline + placebo patch. All participants will receive standard NHS Stop Smoking Service support. The primary outcome would be ratings of craving and withdrawal discomfort 24 hours and one week after the target quit date.


Options:
A: Rating of urges to smoke one week after the target quit date assessed by Mood and Physical Symptoms Scale (1 week)
B: Primary efficacy and Safety endpoint: (within 12 month from enrollment)
C: continuous abstinence (CAR) from weeks 9 to 12 of treatment (3 months)
D: Cigarette use (8 weeks)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: Effects of a Combination of Varenicline and Transdermal Nicotine Patch on Post-quitting Urges to Smoke
Brief Summary: Varenicline and nicotine replacement therapy (NRT) are both effective smoking cessation treatments. Anecdotally smokers who are finding their quit attempt difficult have reported benefiting from adding NRT to varenicline. This proof-of-principle placebo-controlled double-blind study will examine whether combining NRT and varenicline provides better withdrawal and craving relief than varenicline alone. A total of 120 smokers would be randomised to receive varenicline +15mg/16hr patch or varenicline + placebo patch. All participants will receive standard NHS Stop Smoking Service support. The primary outcome would be ratings of craving and withdrawal discomfort 24 hours and one week after the target quit date.


Options:
A: Success rates and safety at week 24 in the varenicline vs placebo. Success rates will be defined as the Continuous Quit Rate since last visit. Maintain abstinence during this period of time with end-expiratory exhaled CO measurements ≤ 10 ppm. (week 24)
B: 4 week continuous quit rate ( 4 week CQR ) for weeks 9 -12
C: To compare 12 weeks of treatment with varenicline 1 mg BID to placebo for smoking cessation, and to evaluate continuous abstinence from smoking for 12 weeks after the treatment period.
D: Rating of urges to smoke one week after the target quit date assessed by Mood and Physical Symptoms Scale (1 week)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: Effects of a Combination of Varenicline and Transdermal Nicotine Patch on Post-quitting Urges to Smoke
Brief Summary: Varenicline and nicotine replacement therapy (NRT) are both effective smoking cessation treatments. Anecdotally smokers who are finding their quit attempt difficult have reported benefiting from adding NRT to varenicline. This proof-of-principle placebo-controlled double-blind study will examine whether combining NRT and varenicline provides better withdrawal and craving relief than varenicline alone. A total of 120 smokers would be randomised to receive varenicline +15mg/16hr patch or varenicline + placebo patch. All participants will receive standard NHS Stop Smoking Service support. The primary outcome would be ratings of craving and withdrawal discomfort 24 hours and one week after the target quit date.


Options:
A: 4-week continuous quit rate (CQR) at Weeks 4-7 and 9-12 .
B: Biochemically verified 7 day point prevalence abstinence from smoking.
C: Patient report (Within 3 days of the dental encounter)
D: Rating of urges to smoke one week after the target quit date assessed by Mood and Physical Symptoms Scale (1 week)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: Effects of a Combination of Varenicline and Transdermal Nicotine Patch on Post-quitting Urges to Smoke
Brief Summary: Varenicline and nicotine replacement therapy (NRT) are both effective smoking cessation treatments. Anecdotally smokers who are finding their quit attempt difficult have reported benefiting from adding NRT to varenicline. This proof-of-principle placebo-controlled double-blind study will examine whether combining NRT and varenicline provides better withdrawal and craving relief than varenicline alone. A total of 120 smokers would be randomised to receive varenicline +15mg/16hr patch or varenicline + placebo patch. All participants will receive standard NHS Stop Smoking Service support. The primary outcome would be ratings of craving and withdrawal discomfort 24 hours and one week after the target quit date.


Options:
A: Continuous abstinence Weeks 13 -24.
B: Rating of urges to smoke one week after the target quit date assessed by Mood and Physical Symptoms Scale (1 week)
C: Prolonged Smoking Abstinence Rates at 12 Weeks in Cigarettes Smokers. (3 months); Point Prevalence Abstinence at 3 Months. (3 months)
D: 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).

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: A Single-arm Study to Demonstrate the Efficacy and Safety of Privigen in the Treatment of Subjects With Chronic Inflammatory Demyelinating Polyneuropathy (CIDP)
Brief Summary: The objective of this study is to demonstrate the efficacy and safety of Privigen in subjects with CIDP.


Options:
A: Comparison of the Responder Rates Between Two Treatment Groups in the Efficacy Period (6 months)
B: proportion of patients with more than 1point improvement in the INCAT score relative to baseline at 28weeks. (28weeks); proportion of patients with more than 1point exacerbation in the INCAT score relative to 28weeks at 52weeks. (52weeks)
C: Percentage (%) of Subjects With CIDP Relapse or Are Withdrawn for Any Other Reason During the Subcutaneous (SC) Treatment Period (Up to 25 weeks)
D: Responder Rate (25 weeks)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: Effect of Patient Education on Kidney Recipients Knowledge, Coping and Quality of Life. A Randomized Controlled Trial.
Brief Summary: For patients with end-stage kidney disease, transplantation is the treatment of choice, offering improved quality of life by restored metabolism and freedom from dialysis. However, demands regarding the acquirement of knowledge in life post transplantation are high. In order to reduce rejection episodes, graft loss and the negative consequences of life-long immunosuppressive medication, it is essential for kidney recipients to possess knowledge about important aspects regarding immunosuppressive medication, graft surveillance and the benefit of specific lifestyle behavior. Consequently, patient education is required for this patient group. This randomized controlled trial is investigating the effect of a structured patient education program on kidney recipients' knowledge, coping and quality of life


Options:
A: Incidence of clinical or subclinical allograft injury at any timepoint as assessed by the appearance of de novo donor specific anti-HLA antibody (dnDSA) OR biopsy proven allograft rejection. (9 months); Change in Patient Reported Transplant Symptoms (Baseline, 2.5 months, 4.5 months, 7 months, 9 months); Change in Patient Reported Medication Adherence and Barriers (Baseline, 2.5 months, 4.5 months, 7 months, 9 months); Incidence of Adverse Events (AE) and Serious Adverse Events (SAE) as a measure of safety (2 weeks, 2.5 months, 4.5 months, 5 months, 7 months, 9 months); Change in Patient Reported Distress (Baseline, 2.5 months, 4.5 months, 7 months, 9 months)
B: Kidney recipients'knowledge level (7-8 weeks post kidney transplantation); Kidney recipients'knowledge level (6 months post kidney transplantation)
C: Occurrence of adverse events (composite endpoint) (at month 60)
D: Calcineurin trough levels (6 month)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: Myfortic® Combined With Low-dose Steroid in Minimal Change Nephrotic Syndrome
Brief Summary: Study objective: To investigate the potential therapeutic efficacy of enteric-coated mycophenolate sodium combined with low-dose corticosteroid as first-line treatment for minimal change nephrotic syndrome (MCNS).


Options:
A: Remission (4 to 16 weeks)
B: Time to first relapse (5 months); Assessment of steroid induced morbidity (5 months)
C: Complete remission (24 hour urine protein < 0.3 g) (at 6 months)
D: Nephrotic Syndrome Remission (3 days)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: A Single Center, Open Label, Randomized Study to Compare the Effect of Vytorin (Simvastatin/Ezetimibe) 10/20mg Versus Atorvastatin 20mg on ApoB/ApoA1 Ratio in Subjects With Diabetes
Brief Summary: A single center, open label, randomized, clinical trial comparing ApoB/ApoA ratio of Vytorin 10/20mg vs atorvastatin 20mg treatment.

DM2 patients will be screened for inclusion criteria. Patients (n=66 in each arm) will be randomized to either Ezetimibe/simvastatin 10/20mg or atorvastatin 20mg after 4 week washout or TLC period. Primary and secondary endpoints will be assessed at week 12.

Primary endpoint:

1) change of ApoB/ApoA ratio at week 12.

Secondary endpoint:

1. Change of lipid parameters (TC, LDL-C, HDL-C, TG, apoB 48) at week 12.
2. Change of HbA1C at week 12.
3. Change of HOMA index at week 12

   - HOMA =\[Fasting insulin (mIU/L) × Fasting glucose (mmol/L)\] / 22.5
4. Change of hsCRP at week 12
5. Safety assessment

Hypotheses:

* Three months treatment of Vytorin 10/20mg will be superior to atorvastatin 20mg in ApoB/ApoA ratio.
* In DM patients, Ezetimibe/Simvastatin Combination will be well-tolerated.


Options:
A: Percent Change in Non-High Density Lipoprotein Cholesterol (Non-HDL-C) From Baseline to Week 8 During 10 mg Atorvastatin Treatment Period (Baseline and Week 8)
B: change of ApoB/ApoA1 (after 12 weeks' treatment)
C: Evaluate the efficacy of atorvastatin treatment during 3 months (80mg/day) on cerebral vasoreactivity (CVR) in lacunar patients. CVR, humeral and carotid vasoreactivity will be measured in all patients at M0 and M3.
D: Percent Changes From Baseline to End-of-treatment in Non-HDL Cholesterol, HDL Cholesterol, and Triglycerides by LCP-AtorFen Versus Atorvastatin Monotherapy (baseline(randomization) to 12 weeks)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: A Dose Blinded Extension Study to the CBAF312A2201 Study to Evaluate Long-term Safety, Tolerability and Efficacy of BAF312 Given Orally Once Daily in Patients With Relapsing-remitting Multiple Sclerosis
Brief Summary: This study consisted of a two year dose blinded phase during which patients received one of five doses of siponimod (10, 2, 1.25, 0.5 or 0.25mg) following which patients were switched to open label treatment with siponimod 2mg for approximately a further 3 years. It will provide data on long term safety, tolerability and efficacy of siponimod in the RRMS patient population


Options:
A: Total Number of Adverse Events During Evaluation of Long Term Safety and Tolerability of BAF312A in Extension Study. (Baseline up to approximately 5 years); Number of Participants With Cardiac Conduction Abnormalities During the Titration Phase of the Study (Without Washout) (Baseline Extension up to day 10); Number of Participants With Cardiac Conduction-IVCD Abnormality During the Titration Phase of the Study (With Washout) (Baseline Extension up to day 10); Number of Participants With Changes in Blood Pressure for Overall Extension Study. (Extension Analysis Set) (Baseline Extension up to approximately 5 years); Number of Participants With Viral Infections of Interest Greater or Equal to 5% in Any Dose Group (Extension Set) (Baseline Extension up to approximately 5 years); Number of Participants With Dermatologic Alterations - Basal Cell Carcinoma (Extension Set) (Baseline Extension up to approximately 5 years)
B: Time to Onset of Clinical Disability Progression (CDP) Sustained for at Least 12 Weeks During the Double-Blind Treatment Period (Maximal follow up: 216 weeks for Placebo arm and 217 weeks for Ocrelizumab arm)
C: The Number of T1-Gadolinium Enhancing Lesions During Months 7-9 (9 months)
D: To investigate the efficacy of rituximab compared with placebo, as measured by MRI scans of the brain for the total number of lesions observed, and to evaluate the safety and tolerability of rituximab in subjects with RRMS.

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: A Dose Blinded Extension Study to the CBAF312A2201 Study to Evaluate Long-term Safety, Tolerability and Efficacy of BAF312 Given Orally Once Daily in Patients With Relapsing-remitting Multiple Sclerosis
Brief Summary: This study consisted of a two year dose blinded phase during which patients received one of five doses of siponimod (10, 2, 1.25, 0.5 or 0.25mg) following which patients were switched to open label treatment with siponimod 2mg for approximately a further 3 years. It will provide data on long term safety, tolerability and efficacy of siponimod in the RRMS patient population


Options:
A: Percentage of Participants With 3-month Confirmed Disability Progression (CDP) Events as Measured by the Expanded Disability Status Scale (EDSS) (Baseline, every 3 month up to the maximum of approximately 3 years)
B: Dose Responsiveness of BAF312 Based on the Number of Combined Unique Active MRI Lesions (CUAL) (3 months of treatment)
C: Total Number of Adverse Events During Evaluation of Long Term Safety and Tolerability of BAF312A in Extension Study. (Baseline up to approximately 5 years); Number of Participants With Cardiac Conduction Abnormalities During the Titration Phase of the Study (Without Washout) (Baseline Extension up to day 10); Number of Participants With Cardiac Conduction-IVCD Abnormality During the Titration Phase of the Study (With Washout) (Baseline Extension up to day 10); Number of Participants With Changes in Blood Pressure for Overall Extension Study. (Extension Analysis Set) (Baseline Extension up to approximately 5 years); Number of Participants With Viral Infections of Interest Greater or Equal to 5% in Any Dose Group (Extension Set) (Baseline Extension up to approximately 5 years); Number of Participants With Dermatologic Alterations - Basal Cell Carcinoma (Extension Set) (Baseline Extension up to approximately 5 years)
D: Change in frequency of MBP-reactive Th17 cells (From baseline to the follow-up time points (Open label phase + 6 months and OLP +12 months).)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: A Multiple-Dose Study To Evaluate Safety, Tolerability, Pharmacokinetics and Antiviral Activity of Ritonavir-Boosted RO5190591 in Combination With Peginterferon Alfa-2a Plus Ribavirin in Patients With Chronic Hepatitis C Genotype 1
Brief Summary: This study will evaluate the efficacy, safety and tolerability of danoprevir (RO5190591) plus ritonavir as compared to danoprevir alone or placebo plus ritonavir in patients with chronic hepatitis C genotype 1 receiving Pegasys (peginterferon alfa-2a) and ribavirin. Patients in cohorts will be randomized to receive either oral doses of danoprevir, or danoprevir plus ritonavir, or placebo plus ritonavir. All patients will receive Pegasys (180mcg sc once weekly) plus ribavirin (1000-1200mg/day po), with the option to continue this treatment after completion of study drug treatment. Anticipated time on study treatment is up to 12 weeks.


Options:
A: Safety and tolerability: Adverse events, ECG, laboratory parameters (approximately 3 years); Pharmacokinetics: Cmax, AUC, Cmin, Tmax, Cl, T1/2 (Days 3-9); Antiviral activity: HCV RNA (COBAS Taqman HCV Test) (from baseline to Day 28)
B: Mean Reduction From Baseline in Log10 Plasma Hepatitis C Virus (HCV) Ribonucleic Acid (RNA) at Day 5 - HCV GT1 (Baseline (Predose on Day 1) and 24-hour post-dose on Day 5); Mean Reduction From Baseline in Log10 Plasma HCV RNA at Day 5 - HCV GT3 (Baseline (Predose on Day 1) and 24-hour post-dose on Day 5); Mean Reduction From Baseline in Log10 Plasma HCV RNA at Day 5 - HCV GT1a (Baseline (Predose on Day 1) and 24-hour post-dose on Day 5); Mean Maximum Reduction in Log10 HCV Viral Load - HCV GT1 (Up to 5 days); Mean Maximum Reduction in Log10 HCV Viral Load - HCV GT3 (Up to 5 days); Mean Maximum Reduction in Log10 HCV Viral Load - HCV GT1a (Up to 5 days); Number of Participants Experiencing an Adverse Event (AE) - Day 1 to Day 5 (Up to 5 days); Number of Participants Who Had Study Drug Discontinued Due to an Adverse Event (Up to 5 days)
C: Percentage of Participants With Sustained Virologic Response (SVR) 12 Weeks After the Last Planned Dose of Study Drugs (SVR12 Planned) (End of trial, 12 weeks after last planned dose)
D: Sustained Virological Response (SVR12) (60 weeks)

Answer: A