TrialPanorama/Dataset huggingface dataset:
Please select the outcome measures that correspond to the clinical trial below.
Title: Preventing Depression in Late Life: A Model for Low and Middle Income Countries
Brief Summary: This study is being conducted in GOA India. The study addresses specific issues of depression prevention in older adults living in low- and middle income countries (LMICs), by developing risk-reduction strategies through the use of lay health counselors. We will be training Lay Health Counselors (LHC's) to deliver simple behaviorally oriented interventions, designed to enhance the ability to relax, to improve active coping via better problem solving, and to increase protective factors such as good quality sleep. Lay Health Counselors are inhabitants of Goa.

The aim of phase 1 is to create a depression and anxiety prevention intervention for use by lay health counselors. We will test the feasibility and acceptability of Problem Solving Therapy for Primary Care (PST-PC) and Brief Behavioral Treatment for Insomnia (BBTI). The products of phase 1 will be a prevention and counseling manual to standardize the implementation of the interventions for further testing in a randomized prevention trial (Specific Aim 2) and the adaptation of PST-PC and BBTI for the Indian population.

In Phase 2, we will: gather data on the feasibility of identifying, enrolling, randomizing and retaining participants; implement the experimental intervention and enhanced usual care; identify "real world", barriers and develop strategies for addressing them; and assess the fidelity of the interventions.


Options:
A: Percent of Participants Who Develop Major Depression and Anxiety Disorders (One year); General Health Questionnaire (GHQ) Scores (One year)
B: HIV sero-incidence (24 months post-baseline)
C: Proportion With STIs From Baseline to Follow-up Assessments (Baseline); Proportion With STIs From Baseline to Follow-up Assessments (12 months)
D: Participant attendance (weekly for 16 weeks during each intervention wave (over 2 years)); Caregiver participation as measured by questionnaire (during 2 caregiver sessions); Caregiver participation as measured by attendance sheet (during 2 caregiver sessions); Fidelity as measured by weekly supervisor meeting (weekly for 16 weeks during the intervention wave (over 2 years)); Fidelity as measured by fidelity checklists (weekly for 16 weeks during the intervention wave (over 2 years))

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: The Effect of Cognitive Functional Therapy on Patients With Non-specific Chronic Low Back Pain: a Multi-centre Randomized Trial
Brief Summary: The purpose of this study is to evaluate whether individual cognitive functional therapy (CFT), when compared to group exercise classes is effective in reducing pain and disability in patients with non-specific chronic low back pain.


Options:
A: Pain VAS
B: The primary outcome measure is actual LBP, as measured with an "11 point box scale". (10 weeks and 12 months)
C: Intensity of pain, measured at baseline, 90, and 180 days later (6 months); Disability, measured at baseline, 90, and 180 days later (6 months); Sick leave, measured at baseline, 90, and 180 days later (6 months)
D: Change in Oswestry Disability Index (ODI) (Baseline, post intervention (at 8-14 weeks), 6, 12 and 36 months)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: Validation of a Simple Questionnaire to Assess Gastrointestinal Symptoms After Oral Ferrous Sulphate Supplementation.
Brief Summary: Oral iron supplementation is often associated with rapid onset of gastrointestinal side-effects. The aim of this study was to develop and trial a short, simple questionnaire to capture these early side-effects and to determine which symptoms are more discriminating.

The study was a double-blind placebo-controlled randomized parallel trial with one week treatment followed by one week wash-out. Subjects were randomized into two treatment groups (n=10/group) to receive either ferrous sulphate (200 mg capsules containing 65 mg of iron) or placebo, both to be taken at mealtimes twice daily during the treatment period. Subjects completed the questionnaires daily for 14 days. The questionnaire included gastrointestinal symptoms commonly reported to be associated with the oral intake of ferrous iron salts (i.e. nausea, vomiting, heartburn, abdominal pain, diarrhoea, and constipation).


Options:
A: Anemia (6 months following the start of the intervention)
B: gastrointestinal symptoms (14 days)
C: Time to recovery of hemoglobin after blood donation (Up to 24 weeks after blood donation)
D: Duration of diarrhea (within the first 72 hours during hospitalization)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: Evaluating the Real-world Effectiveness of Varenicline and Bupropion for Long-term Smoking Cessation
Brief Summary: Clinically proven medications such as nicotine replacement therapy, bupropion and varenicline are available to help smokers quit but there are not widely used. The primary objective of this study is to evaluate the real-world long-term effectiveness of of bupropion and varenicline treatment in a community sample of smokers interested in quitting. The investigators hypothesize that varenicline treatment will result in higher quit rates at end of treatment and at one year after treatment compared to bupropion. Smoking status will be biochemically confirmed at various time points using salivary cotinine measures. Furthermore, since 50% of the variation in quit success is genetically determined, and the effectiveness of different cessation medication may differ considerably in sub-groups of smokers carrying certain genetic variants, the investigators will collect saliva samples from consenting participants to evaluate the moderating effect of genetics on treatment response.


Options:
A: 7-day Point Prevalence Quit Rate at End-of-Treatment (EOT) (Week 11)
B: 4 week continuous quit rate ( 4 week CQR ) for weeks 9 -12
C: Percentage of Participants With Carbon Monoxide (CO) Confirmed 10-Week Continuous Abstinence (CA) From Smoking (Week 15 - 24)
D: Change in smoking status over time (At 12, 26, and 52 weeks following start of treatment)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: Evaluating the Real-world Effectiveness of Varenicline and Bupropion for Long-term Smoking Cessation
Brief Summary: Clinically proven medications such as nicotine replacement therapy, bupropion and varenicline are available to help smokers quit but there are not widely used. The primary objective of this study is to evaluate the real-world long-term effectiveness of of bupropion and varenicline treatment in a community sample of smokers interested in quitting. The investigators hypothesize that varenicline treatment will result in higher quit rates at end of treatment and at one year after treatment compared to bupropion. Smoking status will be biochemically confirmed at various time points using salivary cotinine measures. Furthermore, since 50% of the variation in quit success is genetically determined, and the effectiveness of different cessation medication may differ considerably in sub-groups of smokers carrying certain genetic variants, the investigators will collect saliva samples from consenting participants to evaluate the moderating effect of genetics on treatment response.


Options:
A: The Fagerstrom Test for Nicotine Dependence, expired CO level, and urine cotinine will be used to determine if bupropion SR, when used as an adjunct to antipsychotic medication, is superior to placebo for helping patients with schizophrenia improve their (Expired CO weekly, Fagerstrom baseline and end of study, Urine cotinine baseline, week 2 and week 8); Neuropsychological testing will be used to determine the effects of smoking cessation on patient's attention and memory function. (Beginning and end of study)
B: Biochemically-verified point-prevalence abstinence (7, 11, 16, and 30 weeks post-quit); Likelihood of progression to a relapse (e.g., return to baseline smoking) following a slip at any time in study. (At any point following the quit date.); Treatment completion. (Weeks 7 and 30.); Daily cigarette smoking rate. (Weekly); Frequency and severity of bupropion and naltrexone side effects. (Weekly during treatment)
C: Change in smoking status over time (At 12, 26, and 52 weeks following start of treatment)
D: Participants Abstinent From Cigarettes (Two years)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: Evaluating the Real-world Effectiveness of Varenicline and Bupropion for Long-term Smoking Cessation
Brief Summary: Clinically proven medications such as nicotine replacement therapy, bupropion and varenicline are available to help smokers quit but there are not widely used. The primary objective of this study is to evaluate the real-world long-term effectiveness of of bupropion and varenicline treatment in a community sample of smokers interested in quitting. The investigators hypothesize that varenicline treatment will result in higher quit rates at end of treatment and at one year after treatment compared to bupropion. Smoking status will be biochemically confirmed at various time points using salivary cotinine measures. Furthermore, since 50% of the variation in quit success is genetically determined, and the effectiveness of different cessation medication may differ considerably in sub-groups of smokers carrying certain genetic variants, the investigators will collect saliva samples from consenting participants to evaluate the moderating effect of genetics on treatment response.


Options:
A: 6 Month Self-reported Abstinence From Smoking (6 months)
B: 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)
C: Hamilton Depression Rating Scale (Ham-D) (Week 8); Memory Saccadic Positional Error, Degrees (Week 8); Predictive Pursuit Gain (Week 8); Maintenance Pursuit Gain (Week 8); Digit Symbol Test (Week 0, Week 2 and Week 8); Conner's Continuous Performance Test (CPT) Detectability Score (Week 0, Week 2 and Week 8); Antisaccade Error Rates (Week 0, Week 2 and Week 8); P50 (Week 0, Week 2 and Week 8)
D: Change in smoking status over time (At 12, 26, and 52 weeks following start of treatment)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: A Pilot Randomized, Placebo-Controlled, Crossover Study of the Effect of the Nicotine Nasal Spray and Varenicline on Cigarette Smoking Following Methadone Dosing in Methadone-Maintained Patients
Brief Summary: The objective is to provide a preliminary test of the ability of two pharmacological treatments, the nicotine nasal spray and varenicline, relative to placebos, to reduce smoking during the 4 hours following methadone dosing.


Options:
A: Number of cigarettes smoked per day (End of 6 week intervention)
B: 4 week continuous quit rate ( 4 week CQR ) for weeks 9 -12
C: 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)
D: Proportion of Daily Cigarettes Smoked in the 4 Hours After Receiving Methadone Dose (7 weeks)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: A Pilot Randomized, Placebo-Controlled, Crossover Study of the Effect of the Nicotine Nasal Spray and Varenicline on Cigarette Smoking Following Methadone Dosing in Methadone-Maintained Patients
Brief Summary: The objective is to provide a preliminary test of the ability of two pharmacological treatments, the nicotine nasal spray and varenicline, relative to placebos, to reduce smoking during the 4 hours following methadone dosing.


Options:
A: Proportion of Daily Cigarettes Smoked in the 4 Hours After Receiving Methadone Dose (7 weeks)
B: 7 day point prevalence of cigarette abstinence (End of trial (week 10))
C: Expired-air Carbon Monoxide Confirmed Smoking Abstinence (52 weeks)
D: 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.

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: A Pilot Randomized, Placebo-Controlled, Crossover Study of the Effect of the Nicotine Nasal Spray and Varenicline on Cigarette Smoking Following Methadone Dosing in Methadone-Maintained Patients
Brief Summary: The objective is to provide a preliminary test of the ability of two pharmacological treatments, the nicotine nasal spray and varenicline, relative to placebos, to reduce smoking during the 4 hours following methadone dosing.


Options:
A: Number of participants with 7-day point prevalence smoking abstinence (52 weeks)
B: Change in Biomarker Concentrations: Nicotine Equivalents (Baseline, Week 6); Change in Biomarker Concentrations: NNAL (Baseline, Week 6)
C: Proportion of Daily Cigarettes Smoked in the 4 Hours After Receiving Methadone Dose (7 weeks)
D: Number of Participants With Smoking Abstinence at Month 6 (Month 6)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: A Pilot Randomized, Placebo-Controlled, Crossover Study of the Effect of the Nicotine Nasal Spray and Varenicline on Cigarette Smoking Following Methadone Dosing in Methadone-Maintained Patients
Brief Summary: The objective is to provide a preliminary test of the ability of two pharmacological treatments, the nicotine nasal spray and varenicline, relative to placebos, to reduce smoking during the 4 hours following methadone dosing.


Options:
A: Validated smoking cessation (6 months)
B: 7-day point prevalence abstinence measured at 6 months (6 months)
C: Proportion of Daily Cigarettes Smoked in the 4 Hours After Receiving Methadone Dose (7 weeks)
D: Biochemically-confirmed 7-Day Point-Prevalence Abstinence at 26 Weeks (Assessed 26 weeks after the target quit day.)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: A Pilot Randomized, Placebo-Controlled, Crossover Study of the Effect of the Nicotine Nasal Spray and Varenicline on Cigarette Smoking Following Methadone Dosing in Methadone-Maintained Patients
Brief Summary: The objective is to provide a preliminary test of the ability of two pharmacological treatments, the nicotine nasal spray and varenicline, relative to placebos, to reduce smoking during the 4 hours following methadone dosing.


Options:
A: Proportion of Daily Cigarettes Smoked in the 4 Hours After Receiving Methadone Dose (7 weeks)
B: Smoking Status (at week 48)
C: Smoking Behavior (2)
D: Percent Compliance With Chantix (Months 1, 2, 3)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: A Pilot Randomized, Placebo-Controlled, Crossover Study of the Effect of the Nicotine Nasal Spray and Varenicline on Cigarette Smoking Following Methadone Dosing in Methadone-Maintained Patients
Brief Summary: The objective is to provide a preliminary test of the ability of two pharmacological treatments, the nicotine nasal spray and varenicline, relative to placebos, to reduce smoking during the 4 hours following methadone dosing.


Options:
A: Comparison of Prolonged Abstinence (up to12 weeks post-quit)
B: Proportion of Daily Cigarettes Smoked in the 4 Hours After Receiving Methadone Dose (7 weeks)
C: 6 Month Smoking Abstinence (6 months after smoking quit date); 12 Month Smoking Abstinence (12 months after smoking quit date)
D: Cotinine Level (Baseline, 4 weeks, 8 weeks); Change From Baseline in Cognitive Performance (basline and 8 weeks (or end of study iif patient ended participation before the 8-weeks))

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: A Pilot Randomized, Placebo-Controlled, Crossover Study of the Effect of the Nicotine Nasal Spray and Varenicline on Cigarette Smoking Following Methadone Dosing in Methadone-Maintained Patients
Brief Summary: The objective is to provide a preliminary test of the ability of two pharmacological treatments, the nicotine nasal spray and varenicline, relative to placebos, to reduce smoking during the 4 hours following methadone dosing.


Options:
A: Proportion of Daily Cigarettes Smoked in the 4 Hours After Receiving Methadone Dose (7 weeks)
B: Prevention in relapse (Up to 6 months)
C: Seven-day point prevalence and treatment or treatment strategy (At week 6); Main effects of varenicline and nicotine patch + lozenge on smokers who remain on these medications throughout the trial as documented in questionnaires (Up to 12 weeks); Probability of response at week 12 conditional on response at week 6 and continuation of treatment (At 12 weeks); Probability of response at week 12 conditional on non-response at week 6 and continuation of treatment (At 12 weeks); Probability of response at week 12 conditional on non-response at week 6 and augmentation of treatment (At 12 weeks); Probability of response at week 12 conditional on non-response at week 6 and treatment switching (At 12 weeks); Probability that treatment continuation, switching, or augmentation confers benefit conditional upon failing to quit after the initial treatment with nicotine patch + lozenge for six weeks (12 weeks); Probability that treatment continuation, switching, or augmentation confers benefit conditional upon failing to quit after initial treatment with varenicline for six weeks (12 weeks)
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: A Pilot Randomized, Placebo-Controlled, Crossover Study of the Effect of the Nicotine Nasal Spray and Varenicline on Cigarette Smoking Following Methadone Dosing in Methadone-Maintained Patients
Brief Summary: The objective is to provide a preliminary test of the ability of two pharmacological treatments, the nicotine nasal spray and varenicline, relative to placebos, to reduce smoking during the 4 hours following methadone dosing.


Options:
A: Proportion of Daily Cigarettes Smoked in the 4 Hours After Receiving Methadone Dose (7 weeks)
B: Participants Abstinent From Cigarettes (Two years)
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: 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.)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: Prevention of Seroma Formation and Wound Complications Using NPWT Devices
Brief Summary: The specific aim of this study is to improve post-operative wound care in the morbidly-obese body-contouring patient population following massive weight loss undergoing either panniculectomy or formal abdominoplasty, those patients undergoing complex abdominal wall reconstruction (i.e. ventral hernia repair) and breast reconstruction with acellular dermal matrix, as well as patients undergoing regular lipo-abdominoplasty by comparing the effectiveness of standard closed-suction drains versus the immediate application of continuous negative pressure via a NPWT (negative pressure wound therapy) device attached to non-compressible drains. Additionally, we aim to demonstrate increases both in cost-effectiveness and quality of life in these patients with the use of the NPWT wound care apparatus.

Hypothesis 1 Continuous negative pressure devices decrease the incidence of wound complications in comparison with conventional closed suction drains when used in patients after massive weight loss undergoing body-contouring procedures (panniculectomies alone and formal abdominoplasties), and in patients undergoing VHR and breast reconstruction with acellular dermal matrix, as well as those undergoing regular lipo-abdominoplasty.

Hypothesis 2 Although initially more costly than traditional closed suction drains, the use of continuous negative pressure devices will in the long-term result in lower total health care costs in the above-stated patient population due to a decreased need for additional procedures and/or clinical management, including surgical interventions, hospital admissions, administration of antibiotics, multiple follow-up office visits, and chronic wound care.

Hypothesis 3 Better quality of life is associated with the use of continuous negative pressure devices compared to closed suction drains in these patient populations.


Options:
A: Incisional Dehiscence (last post operative visit, up to 2 years); Post operative infection (last post operative visit, up to 2 years)
B: Early Complications of Vascular Zone (2 weeks)
C: Post-operative Seroma Formation (Two weeks following drain removal)
D: Postoperative Surgical Site Infection (SSI) (30 days following operation)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: Prevention of Seroma Formation and Wound Complications Using NPWT Devices
Brief Summary: The specific aim of this study is to improve post-operative wound care in the morbidly-obese body-contouring patient population following massive weight loss undergoing either panniculectomy or formal abdominoplasty, those patients undergoing complex abdominal wall reconstruction (i.e. ventral hernia repair) and breast reconstruction with acellular dermal matrix, as well as patients undergoing regular lipo-abdominoplasty by comparing the effectiveness of standard closed-suction drains versus the immediate application of continuous negative pressure via a NPWT (negative pressure wound therapy) device attached to non-compressible drains. Additionally, we aim to demonstrate increases both in cost-effectiveness and quality of life in these patients with the use of the NPWT wound care apparatus.

Hypothesis 1 Continuous negative pressure devices decrease the incidence of wound complications in comparison with conventional closed suction drains when used in patients after massive weight loss undergoing body-contouring procedures (panniculectomies alone and formal abdominoplasties), and in patients undergoing VHR and breast reconstruction with acellular dermal matrix, as well as those undergoing regular lipo-abdominoplasty.

Hypothesis 2 Although initially more costly than traditional closed suction drains, the use of continuous negative pressure devices will in the long-term result in lower total health care costs in the above-stated patient population due to a decreased need for additional procedures and/or clinical management, including surgical interventions, hospital admissions, administration of antibiotics, multiple follow-up office visits, and chronic wound care.

Hypothesis 3 Better quality of life is associated with the use of continuous negative pressure devices compared to closed suction drains in these patient populations.


Options:
A: Number of participants with seroma (3 months)
B: Post-operative Seroma Formation (Two weeks following drain removal)
C: Surgical Site Infection (30 days)
D: Postoperative Surgical Site Infection (SSI) (30 days following operation)

Answer: B