TrialPanorama/Dataset huggingface dataset:
Please select the outcome measures that correspond to the clinical trial below.
Title: The Role of Home-monitoring in the Adherence of Patients With Chronic Obstructive Pulmonary Disease to Long-term Rehabilitation
Brief Summary: The aim of this randomized controlled trial is to investigate the effects of adding PA monitoring and regular feedback of a pedometer (step counter) to an outpatient pulmonary rehabilitation (PR) program on daily PA levels and health status of patients with COPD.

Patients will be randomized to either receive a PR program with PA monitoring and regular feedback of a pedometer (experimental group \[EG\]) or a PR program alone (control group \[CG\]). During the PR program, patients in the EG will receive a pedometer to self-monitor their PA and individualized step-count goals. They will continue to use the pedometers and receive individualized goals for 3 months after the program.

It is expected that, by receiving individualized goals and a simple pedometer to self-monitor their PA during and after a PR program, patients with COPD will become more active and adhere to long-term rehabilitation, thus reducing the overall impact of COPD.


Options:
A: Exercise behavior (3 & 6 Months)
B: Change in physical activity levels (1 week before, 1 week after, 3 and 6 months after the PR program)
C: Feasibility of tai chi intervention (24 weeks)
D: Number of exacerbations (12 months)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: Phase I Gene Transfer Clinical Trial for Spinal Muscular Atrophy Type 1 Delivering AVXS-101
Brief Summary: The purpose of this trial is to evaluate safety and efficacy of intravenous delivery of AVXS-101 as a treatment of spinal muscular atrophy Type 1 (SMN1).


Options:
A: Time to death or respiratory intervention (Up to Day 2891)
B: To assess safety and tolerability of VPA in SMA patients greater than 2 years of age
C: Number of Participants That Experienced One Grade III or Higher Unanticipated, Treatment-related Toxicity That Presents With Clinical Symptoms and Requires Medical Treatment (2 years)
D: Percent of Participants Who Achieved Improvement in Motor Milestones as Assessed by Section 2 of the HINE at the Last Visit (Day 1352 or Early Termination)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: Phase I Gene Transfer Clinical Trial for Spinal Muscular Atrophy Type 1 Delivering AVXS-101
Brief Summary: The purpose of this trial is to evaluate safety and efficacy of intravenous delivery of AVXS-101 as a treatment of spinal muscular atrophy Type 1 (SMN1).


Options:
A: Number of Participants That Experienced One Grade III or Higher Unanticipated, Treatment-related Toxicity That Presents With Clinical Symptoms and Requires Medical Treatment (2 years)
B: Percentage of Motor Milestones Responders (assessed at the later of the Day 183, Day 302, or Day 394 study visits); Time to Death or Permanent Ventilation (Day 91, Day 182, Day 273, Day 364, Day 394)
C: Change From Baseline in Hammersmith Functional Motor Scale - Expanded (HFMSE) Score at Month 15 (Baseline and Month 15)
D: Manual Muscle Test (Medical Research Council scale-MRC), the Hammersmith Motor Ability Score (one year)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: Assessing the Effectiveness of a Pharmacist-delivered Smoking Cessation Program in the State of Qatar
Brief Summary: Thirty seven percent of adult male population smoke cigarettes in Qatar. The Global Youth Tobacco Survey also stated that 13.4% of male school students aged 13 to 15 years in Qatar smoke cigarettes. Smoking cessation is a key to reducing smoking related diseases and deaths. Health care providers are in an ideal position to encourage smoking cessation. Pharmacists are the most accessible health care providers and are uniquely situated to initiate behavior change among patients. Many western studies have shown that pharmacists can be successful in helping patients quit smoking. Studies demonstrating the effectiveness of pharmacist delivered smoking cessation programs are lacking in Qatar. This proposal aims to test the effect of a structured smoking cessation program delivered by trained ambulatory pharmacists in Qatar. A prospective, randomized, controlled trial will be conducted at 8 ambulatory pharmacies in Qatar. Participants will be randomly assigned to receive a 4-session face-to-face structured patient-specific smoking cessation program conducted by the pharmacist or 5 to 10 minutes of unstructured brief smoking cessation advice given by the pharmacist. Both groups will be offered nicotine therapy if feasible. The primary outcome of smoking cessation will be confirmed by exhaled carbon monoxide test at 12 months. If proven to be effective, this smoking cessation program will be considered as a model that Qatar and the region can apply to decrease smoking burden.


Options:
A: Self-reported 7-day Point Prevalence Abstinence (3 months); Self-reported 30 Day Smoking Abstinence (3 months); Self-reported Continuous Abstinence at 3 Months (3 months); Self-reported 7-day Point Prevalence Abstinence (6 months); Self-reported 30-day Point Prevalence Abstinence (6 months); Self-reported Continuous Abstinence (6 months); Self-reported 7-day Point Prevalence Abstinence (12 months); Self-reported 30-day Point Prevalence Abstinence (12 months); Self-reported Continuous Abstinence (12 months); Objective Smoking Abstinence (12 months)
B: To better determine COPD with a multidimensional assessment and the phenotypic progression of COPD (5 years)
C: Rate of 7-day Point Prevalence Abstinence at the End of the Relapse Prevention Phase (Study Week 53) in the Extended Duration Pharmacotherapy Group vs. the Placebo Group (76 weeks)
D: Emotional Reactivity By Pharmacotherapy (Baseline to 1 month); Emotional Reactivity By Pharmacotherapy Moderated by DRD2 A1 Allele (Baseline to 1 month)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: Promoting Exercise Among Older Malaysians Using SMS Reminders. The Malaysian Physical Activity for Health Study (myPAtHS): A Randomized Controlled Trial
Brief Summary: The purpose of the study is:

1) To evaluate the efficacy and feasibility of an SMS reminder intervention for promoting an health-related exercise programme (myPAtHS) among older Malaysian adults, in a randomized controlled trial (RCT).

Hypothesis: Frequency and duration of the exercise programme execution will be higher for the SMS reminder condition compared to the programme only condition. The effect may be reduced from post- to follow-up measurement (24 weeks after baseline and 12 weeks after post-measurement) but all outcomes will remain significantly higher at 24 weeks.


Options:
A: Number of myPAtHS exercise sessions. (12 weeks & 24 weeks); Time spent doing the myPAtHS exercise programme. (12 weeks & 24 weeks)
B: REACH Session Feedback (6 weeks)
C: Time spent being physically active (2 months); Time spent sitting (2 months); Changes in food consumption (2 months)
D: Change in objective total, light and moderate-to-vigorous physical activity (PA) (Pretest, posttest (6 weeks) and follow-up (6 months)); Change in objective sedentary behaviour (Pretest, posttest (6 weeks) and follow-up (6 months)); Change in self-reported total, moderate and moderate-to-vigorous physical activity (PA) as well as total work-related, transport-related, household-related and leisure time PA. (Pretest, posttest (6 weeks) and follow-up (6 months)); Change in self-reported sedentary behaviour (Pretest, posttest (6 weeks) and follow-up (6 months))

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: Efficacy of the Mckenzie Method in Patients With Chronic Non-Specific Low Back Pain: A Randomized Placebo-Controlled Trial
Brief Summary: The purpose of this study is to assess the efficacy of the McKenzie method in patients with chronic non-specific low back.


Options:
A: Change in Oswestry Disability Index (ODI) (Baseline, post intervention (at 8-14 weeks), 6, 12 and 36 months)
B: Pain Intensity (5 weeks after randomization); Disability (Five weeks after randomization)
C: N/A
D: The primary outcome measure is actual LBP, as measured with an "11 point box scale". (10 weeks and 12 months)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: THE EFFECT OF WALKING MEDITATION TRAINING ON GLYCEMIC CONTROL AND VASCULAR FUNCTION IN PATIENTS WITH TYPE 2 DIABETES
Brief Summary: Walking Meditation training would yield more favorable adaptations than walking alone in improving glycemic control and vascular function in patients with type 2 diabetes.


Options:
A: Change from baseline in self-rated sense of coherence (13-item); The sense of coherens scale, SOC 13-item at week 52. (baseline and after 12 months); Changes from baseline in self-rated Health related quality of Life (36 item); The SF 36 - item short-form health status survey at week 52 (baseline and after 12 mounth); Changes from baseline in self-rated mastering (7 item); The 7-item Mastery scale at week 52 (baseline and after 12 months)
B: Low-density lipoprotein (LDL)cholesterol (Baseline and 12 months); Blood pressure (baseline and 12 months); Body Mass Index (baseline and 12 months); Psychological Well-Being (Baseline and 12 months)
C: Success meeting recruitment goals (20 patients within 3-4 months) (4-month recruitment window); Willingness to participate in study (>10% of eligible) (4-month recuitment window); Adherence rate (≥70% attendance, 7 of 10 classes) (12-weeks); Retention (≤25% drop-out) (6-months)
D: Change from baseline in glycemic control (Baseline, Week 12); Change from baseline in vascular reactivity (baseline, week 12)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: Safety of Lactobacillus Reuteri in Healthy Children Ages 2 to 5 Years in Peru
Brief Summary: This is a Phase 1 study to assess the safety and tolerability of Lactobacillus reuteri (Lr) strain DSM 17938 in healthy children in Peru. It is a preliminary study in support of a clinical trial to assess safety and efficacy of L. reuteri for treatment of pediatric diarrhea in Peru.


Options:
A: The Number (Rate) of Patients With Acute Respiratory Infections (first 28 days of life)
B: Number of Participants With Positive Blood Culture for L Reuteri (Participants are followed an average of 36 days); Mean Daily Temperature (Study days 1-5, 8,12, 15, 18, 28, and 36)
C: Natural killer cell activity (At baseline); Natural killer cell activity (At 12-week follow-up); Change from baseline natural killer cell activity at 12-week (At baseline and 12-week follow-up)
D: Common infections in children

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: High Cessation Rates in Smokers Using Personal Vaporizers: A Prospective 6-month Pilot Study
Brief Summary: E-cigarettes are proving to be an attractive long-term alternative to conventional cigarettes. Although they may also help smokers to remain abstinent during their quit attempt, recent clinical trials with first generation e-cigarettes have shown only modest quit rates. Second generation devices may result in much higher quit rates. Their efficacy and safety in long-term smoking cessation and/or smoking reduction studies have never been investigated.

In this prospective proof-of-concept study we monitored modifications in smoking habits of 50 regular smokers (unwilling to quit) who were asked to switch to a second generation device focusing on smoking reduction and smoking abstinence. Study participants were invited to attend a total of five study visits: at baseline, week-4, week-8, week-12 and week-24. Product usage, number of cigarettes smoked, and exhaled carbon monoxide (eCO) levels were measured at each visit. Smoking reduction and abstinence rates were calculated. Adverse events and participants' opinions of these products were also reviewed.


Options:
A: Prolonged Smoking Abstinence Rates at 12 Weeks in Cigarettes Smokers. (3 months); Point Prevalence Abstinence at 3 Months. (3 months)
B: reducers (week-24 from baseline)
C: A significant percentage of surgical patients will be receptive to smoking cessation interventions in the preadmission clinic and will refrain from smoking at 24 and 52 weeks after starting the treatment. (2 years)
D: 7 Day Point Prevalence Abstinence From All Forms of Tobacco (4 weeks after beginning study)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: High Cessation Rates in Smokers Using Personal Vaporizers: A Prospective 6-month Pilot Study
Brief Summary: E-cigarettes are proving to be an attractive long-term alternative to conventional cigarettes. Although they may also help smokers to remain abstinent during their quit attempt, recent clinical trials with first generation e-cigarettes have shown only modest quit rates. Second generation devices may result in much higher quit rates. Their efficacy and safety in long-term smoking cessation and/or smoking reduction studies have never been investigated.

In this prospective proof-of-concept study we monitored modifications in smoking habits of 50 regular smokers (unwilling to quit) who were asked to switch to a second generation device focusing on smoking reduction and smoking abstinence. Study participants were invited to attend a total of five study visits: at baseline, week-4, week-8, week-12 and week-24. Product usage, number of cigarettes smoked, and exhaled carbon monoxide (eCO) levels were measured at each visit. Smoking reduction and abstinence rates were calculated. Adverse events and participants' opinions of these products were also reviewed.


Options:
A: Change in Weight (Baseline, 3 months, 6 months, 9 months, 12 months and 1 year post program follow up); Change in the 6 minute walk test (Baseline, 3 months, 6 monhts, 9 months, 12 months, and 1 year post program completion follow up); Change in Days of Abstinence-Timeline follow back interview for tobacco smokers (Baseline, 3 months, 6 months, 9 months, 12 months, and 1 year post program completion follow up); Change in Carbon Monoxide Level (Baseline, 3 months, 6 months, 9 months, 12 months, and 1 year post program completion follow up)
B: 7-day point prevalent CO validated smoking cessation. (Three months after lung screening)
C: Change in pulmonary health (dry cough, breath shortness, mouth irritation) index (baseline, 6 months, 12 months)
D: reducers (week-24 from baseline)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: High Cessation Rates in Smokers Using Personal Vaporizers: A Prospective 6-month Pilot Study
Brief Summary: E-cigarettes are proving to be an attractive long-term alternative to conventional cigarettes. Although they may also help smokers to remain abstinent during their quit attempt, recent clinical trials with first generation e-cigarettes have shown only modest quit rates. Second generation devices may result in much higher quit rates. Their efficacy and safety in long-term smoking cessation and/or smoking reduction studies have never been investigated.

In this prospective proof-of-concept study we monitored modifications in smoking habits of 50 regular smokers (unwilling to quit) who were asked to switch to a second generation device focusing on smoking reduction and smoking abstinence. Study participants were invited to attend a total of five study visits: at baseline, week-4, week-8, week-12 and week-24. Product usage, number of cigarettes smoked, and exhaled carbon monoxide (eCO) levels were measured at each visit. Smoking reduction and abstinence rates were calculated. Adverse events and participants' opinions of these products were also reviewed.


Options:
A: Rate of Smoking Abstinence (18 months & 24 months post study enrollment)
B: Electronic cigarette use (weekly measurements from baseline to 10 weeks and a final assessment at 24 weeks); electronic cigarette acceptability (Baseline, week 2, week6, week 10 and week 24); Respiratory symptoms (weekly measures from baseline to 10 weeks and at 24 weeks); Cotinine (Baseline, week 2, 6, 10 and 24); Nitrosamines (Baseline and at 6 week); Side effects of antipsychotics (weekly the first 10 weeks and at 24 weeks); Withdrawal symptoms (weekly the first 10 weeks and at 24 weeks); Respiratory symptoms (weekly the first 10 weeks and at 24 weeks)
C: Change in Metabolic Syndrome Prevalence (Changes in the prevalence of Metabolic Syndrome from baseline will be assessed at 3 months, 6 months, 1 year, and 2 years)
D: reducers (week-24 from baseline)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: High Cessation Rates in Smokers Using Personal Vaporizers: A Prospective 6-month Pilot Study
Brief Summary: E-cigarettes are proving to be an attractive long-term alternative to conventional cigarettes. Although they may also help smokers to remain abstinent during their quit attempt, recent clinical trials with first generation e-cigarettes have shown only modest quit rates. Second generation devices may result in much higher quit rates. Their efficacy and safety in long-term smoking cessation and/or smoking reduction studies have never been investigated.

In this prospective proof-of-concept study we monitored modifications in smoking habits of 50 regular smokers (unwilling to quit) who were asked to switch to a second generation device focusing on smoking reduction and smoking abstinence. Study participants were invited to attend a total of five study visits: at baseline, week-4, week-8, week-12 and week-24. Product usage, number of cigarettes smoked, and exhaled carbon monoxide (eCO) levels were measured at each visit. Smoking reduction and abstinence rates were calculated. Adverse events and participants' opinions of these products were also reviewed.


Options:
A: verified abstinence 6 months (6 months)
B: Number of Participants With Smoking Cessation (12 WEEK)
C: reducers (week-24 from baseline)
D: Rate of Smoking Abstinence (18 months & 24 months post study enrollment)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: High Cessation Rates in Smokers Using Personal Vaporizers: A Prospective 6-month Pilot Study
Brief Summary: E-cigarettes are proving to be an attractive long-term alternative to conventional cigarettes. Although they may also help smokers to remain abstinent during their quit attempt, recent clinical trials with first generation e-cigarettes have shown only modest quit rates. Second generation devices may result in much higher quit rates. Their efficacy and safety in long-term smoking cessation and/or smoking reduction studies have never been investigated.

In this prospective proof-of-concept study we monitored modifications in smoking habits of 50 regular smokers (unwilling to quit) who were asked to switch to a second generation device focusing on smoking reduction and smoking abstinence. Study participants were invited to attend a total of five study visits: at baseline, week-4, week-8, week-12 and week-24. Product usage, number of cigarettes smoked, and exhaled carbon monoxide (eCO) levels were measured at each visit. Smoking reduction and abstinence rates were calculated. Adverse events and participants' opinions of these products were also reviewed.


Options:
A: Number of Participants With Smoking Cessation (12 WEEK)
B: reducers (week-24 from baseline)
C: Change in Metabolic Syndrome Prevalence (Changes in the prevalence of Metabolic Syndrome from baseline will be assessed at 3 months, 6 months, 1 year, and 2 years)
D: Change in pulmonary health (dry cough, breath shortness, mouth irritation) index (baseline, 6 months, 12 months)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: High Cessation Rates in Smokers Using Personal Vaporizers: A Prospective 6-month Pilot Study
Brief Summary: E-cigarettes are proving to be an attractive long-term alternative to conventional cigarettes. Although they may also help smokers to remain abstinent during their quit attempt, recent clinical trials with first generation e-cigarettes have shown only modest quit rates. Second generation devices may result in much higher quit rates. Their efficacy and safety in long-term smoking cessation and/or smoking reduction studies have never been investigated.

In this prospective proof-of-concept study we monitored modifications in smoking habits of 50 regular smokers (unwilling to quit) who were asked to switch to a second generation device focusing on smoking reduction and smoking abstinence. Study participants were invited to attend a total of five study visits: at baseline, week-4, week-8, week-12 and week-24. Product usage, number of cigarettes smoked, and exhaled carbon monoxide (eCO) levels were measured at each visit. Smoking reduction and abstinence rates were calculated. Adverse events and participants' opinions of these products were also reviewed.


Options:
A: reducers (week-24 from baseline)
B: Number of cigarettes smoked per day (End of 6 week intervention)
C: Intervention effect on Flow-mediated dilatation (FMD) assessed via ultrasound (%FMD). (6 months following quit day.)
D: Determine Levels of nicotine effectively delivered by various types and brands of ENDS to the bloodstream and compare them to levels delivered from conventional cigarettes (Up to 1 year); Levels of nicotine effectively delivered by various types and brands of ENDS to the bloodstream and compare them to levels delivered from conventional cigarettes (Up to 1 year); Levels of nicotine effectively delivered by various types and brands of ENDS to the bloodstream and compare them to levels delivered from conventional cigarettes (up to 1 year); Changes in withdrawal symptoms (up to 1 year); Subjective nicotine effect will be analyzed (up to 1 year); Changes in feelings and emotions (up to 1 year)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: High Cessation Rates in Smokers Using Personal Vaporizers: A Prospective 6-month Pilot Study
Brief Summary: E-cigarettes are proving to be an attractive long-term alternative to conventional cigarettes. Although they may also help smokers to remain abstinent during their quit attempt, recent clinical trials with first generation e-cigarettes have shown only modest quit rates. Second generation devices may result in much higher quit rates. Their efficacy and safety in long-term smoking cessation and/or smoking reduction studies have never been investigated.

In this prospective proof-of-concept study we monitored modifications in smoking habits of 50 regular smokers (unwilling to quit) who were asked to switch to a second generation device focusing on smoking reduction and smoking abstinence. Study participants were invited to attend a total of five study visits: at baseline, week-4, week-8, week-12 and week-24. Product usage, number of cigarettes smoked, and exhaled carbon monoxide (eCO) levels were measured at each visit. Smoking reduction and abstinence rates were calculated. Adverse events and participants' opinions of these products were also reviewed.


Options:
A: smoking status (baseline, 3, 6, 12, and 18 months follow-up); commitment to abstinence (baseline, 3, 6, 12, and 18 months); quit attempts (3, 6, 12, and 18 months follow-up)
B: reducers (week-24 from baseline)
C: Traditional smoking cessation rate (5 years); Change from baseline in the number of traditional cigarette smoked (6, 12, 24, 36 and 60 months.)
D: urine carcinogen biomarker of exposure, NNAL (week 24)

Answer: B