TrialPanorama/Dataset huggingface dataset:
Please select the outcome measures that correspond to the clinical trial below.
Title: TeamCare PCN: Collaborative Care for Patients With Diabetes and Depression in Primary Care Networks
Brief Summary: Background \& Objective: Type 2 diabetes is a complex disease characterized by multiple comorbidities. Depression is one of the most common comorbidities in individuals with diabetes with prevalence rates reaching 30%. Depression complicates diabetes treatment, portends worse outcomes and increases health care costs. One novel approach to managing diabetes with co-morbid depression is a collaborative primary care model involving a multidisciplinary health care team guiding patient-centered care. This model has been tested in the US and showed a significant reduction of depressive symptoms, improved diabetes care and patient-reported outcomes, and saved money. Our aim is to evaluate the implementation of this collaborative care model for type 2 diabetes and comorbid depression within the non-metro Primary Care Network (PCN) setting in Canada.

Intervention: The intervention involves three phases: (1) improving depressive symptoms, (2) improving blood sugar, blood pressure and cholesterol, and (3) improving lifestyle behaviours. The intervention is administered by a CM in collaboration with family physicians, psychiatrists, and internists.

Hypotheses: The TeamCare-PCN intervention will reduce depressive symptoms, achieve targets for cardio-metabolic measures and improve lifestyle behaviours. Furthermore, the investigators anticipate this intervention will be acceptable and implemented in a cost-effective manner in the PCN environment.

Methods: The investigators will employ a mixed-methods approach to our evaluation, using a controlled "on-off" trial design. Our primary analysis will be based on a multivariable scaled marginal model for the combined outcome of depressive symptoms and medical care. Secondary analyses will assess changes in lifestyle behaviours and patient-reported outcomes.

Significance: Our work will serve as a platform upon which an emerging model of primary care can incorporate an effective and cost-effective depression intervention into the management of individuals with type 2 diabetes, and as a framework for implementing and evaluating similar interventions in individuals with other chronic conditions.


Options:
A: Hospital readmission (30 days)
B: Prevalence of latent heart failure and COPD. (6 months)
C: Work limitations (One year); Work engagement (One year)
D: Change in Patient Health Questionnaire-9 items (PHQ-9) score (Baseline, 3-month, 6-month, 9-month, 12-month)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: TeamCare PCN: Collaborative Care for Patients With Diabetes and Depression in Primary Care Networks
Brief Summary: Background \& Objective: Type 2 diabetes is a complex disease characterized by multiple comorbidities. Depression is one of the most common comorbidities in individuals with diabetes with prevalence rates reaching 30%. Depression complicates diabetes treatment, portends worse outcomes and increases health care costs. One novel approach to managing diabetes with co-morbid depression is a collaborative primary care model involving a multidisciplinary health care team guiding patient-centered care. This model has been tested in the US and showed a significant reduction of depressive symptoms, improved diabetes care and patient-reported outcomes, and saved money. Our aim is to evaluate the implementation of this collaborative care model for type 2 diabetes and comorbid depression within the non-metro Primary Care Network (PCN) setting in Canada.

Intervention: The intervention involves three phases: (1) improving depressive symptoms, (2) improving blood sugar, blood pressure and cholesterol, and (3) improving lifestyle behaviours. The intervention is administered by a CM in collaboration with family physicians, psychiatrists, and internists.

Hypotheses: The TeamCare-PCN intervention will reduce depressive symptoms, achieve targets for cardio-metabolic measures and improve lifestyle behaviours. Furthermore, the investigators anticipate this intervention will be acceptable and implemented in a cost-effective manner in the PCN environment.

Methods: The investigators will employ a mixed-methods approach to our evaluation, using a controlled "on-off" trial design. Our primary analysis will be based on a multivariable scaled marginal model for the combined outcome of depressive symptoms and medical care. Secondary analyses will assess changes in lifestyle behaviours and patient-reported outcomes.

Significance: Our work will serve as a platform upon which an emerging model of primary care can incorporate an effective and cost-effective depression intervention into the management of individuals with type 2 diabetes, and as a framework for implementing and evaluating similar interventions in individuals with other chronic conditions.


Options:
A: Combined endpoint of deaths, hospitalisations (excepting day only hospitalisations), and serious out-of-hospital events (48 months + 36 month extension)
B: Composite clinical outcome measure- improvement in either HgA1C, SBP, or LDL (12 months)
C: Comorbidities treatment (6 months later); Auto-DAS: Patient education to calculate his Disease Activity Score (6 months after)
D: Change in Patient Health Questionnaire-9 items (PHQ-9) score (Baseline, 3-month, 6-month, 9-month, 12-month)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: Feasibility Study of the PneumRx, Inc. Lung Volume Reduction Coil for the Treatment of Emphysema
Brief Summary: This is a multicenter single arm open label study. The primary objective is to evaluate the safety and effectiveness of the Lung Volume Reduction Coil (LVRC) for the treatment of patients with emphysema in multiple centers.


Options:
A: Improvement in pulmonary function (FEV1) 6-minute walking test (3 months)
B: St. George's Respiratory Questionnaire (6 months)
C: The difference between the response rates of the treatment and control groups. (3-months post randomization)
D: Difference between responder rates of the treatment & control groups, responders defined as subjects with clinically meaningful improvements in disease-related health status (SGRQ) & regional lung volume changes as measured by quantitative CT scan. (6 months)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: Effect of Roflumilast on Exacerbation Rate in Patients With COPD Treated With Fixed Combinations of LABA and ICS. A 52-week, Randomised Double-blind Trial With Roflumilast 500 µg Versus Placebo. The REACT Trial
Brief Summary: The objective of the REACT trial is to investigate the effect of roflumilast 500 μg tablets once daily versus placebo on exacerbation rate and pulmonary function in COPD patients who are concomitantly treated with a fixed combination of long-acting β2-agonists (LABA) and inhaled glucocorticosteroids (ICS). In addition, data on safety and tolerability of roflumilast will be obtained. An additional objective is to further characterize the population pharmacokinetic profile of roflumilast and roflumilast N oxide and to further characterize their pharmacokinetics/pharmacodynamics (PK/PD) relationship in terms of efficacy and relevant safety aspects.

Patients to be included are required to have severe COPD associated with chronic bronchitis and a history of frequent exacerbations and must be concomitantly treated with a fixed combination of LABA and ICS. Two parallel treatment arms (roflumilast 500 μg once daily and placebo) are included.


Options:
A: Rate of Moderate or Severe COPD Exacerbations Per Patient Per Year. (Baseline to Week 52)
B: The frequency of patients experiencing at least one moderate or severe exacerbation during the treatment period.; Change in FEV1 from baseline during the treatment period.
C: All cause mortality at 3 years
D: Rate of Moderate or Severe COPD Exacerbations Per Patient Per Year (52 weeks)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: Effect of Roflumilast on Exacerbation Rate in Patients With COPD Treated With Fixed Combinations of LABA and ICS. A 52-week, Randomised Double-blind Trial With Roflumilast 500 µg Versus Placebo. The REACT Trial
Brief Summary: The objective of the REACT trial is to investigate the effect of roflumilast 500 μg tablets once daily versus placebo on exacerbation rate and pulmonary function in COPD patients who are concomitantly treated with a fixed combination of long-acting β2-agonists (LABA) and inhaled glucocorticosteroids (ICS). In addition, data on safety and tolerability of roflumilast will be obtained. An additional objective is to further characterize the population pharmacokinetic profile of roflumilast and roflumilast N oxide and to further characterize their pharmacokinetics/pharmacodynamics (PK/PD) relationship in terms of efficacy and relevant safety aspects.

Patients to be included are required to have severe COPD associated with chronic bronchitis and a history of frequent exacerbations and must be concomitantly treated with a fixed combination of LABA and ICS. Two parallel treatment arms (roflumilast 500 μg once daily and placebo) are included.


Options:
A: Rate of Moderate or Severe COPD Exacerbations Per Patient Per Year (52 weeks)
B: change in FEV1 from baseline during the treatment period; number of COPD exacerbations.
C: Pre-bronchodilator Forced Expiratory Volume in First Second (FEV1) (Change from baseline over 24 weeks of treatment)
D: Induced Sputum Proline-glycine-proline (PGP) Levels at Baseline (baseline); Mean Induced Sputum Proline-glycine-proline (PGP) Levels at 1 Month After Randomization. (1 month after baseline); Mean Induced Sputum Proline-glycine-proline (PGP) Levels at 3 Months After Randomization (3 months after baseline)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: Effect of Roflumilast on Exacerbation Rate in Patients With COPD Treated With Fixed Combinations of LABA and ICS. A 52-week, Randomised Double-blind Trial With Roflumilast 500 µg Versus Placebo. The REACT Trial
Brief Summary: The objective of the REACT trial is to investigate the effect of roflumilast 500 μg tablets once daily versus placebo on exacerbation rate and pulmonary function in COPD patients who are concomitantly treated with a fixed combination of long-acting β2-agonists (LABA) and inhaled glucocorticosteroids (ICS). In addition, data on safety and tolerability of roflumilast will be obtained. An additional objective is to further characterize the population pharmacokinetic profile of roflumilast and roflumilast N oxide and to further characterize their pharmacokinetics/pharmacodynamics (PK/PD) relationship in terms of efficacy and relevant safety aspects.

Patients to be included are required to have severe COPD associated with chronic bronchitis and a history of frequent exacerbations and must be concomitantly treated with a fixed combination of LABA and ICS. Two parallel treatment arms (roflumilast 500 μg once daily and placebo) are included.


Options:
A: Trough Forced Expiratory Volume in 1 Second (FEV1). (12 weeks)
B: Rate of Moderate or Severe COPD Exacerbations Per Patient Per Year (52 weeks)
C: Mean Change From Baseline (BL) in Aortic Pulse Wave Velocity (aPWV) at the End of the 12-week Treatment Period (Day 84) (Baseline to Day 84 (Early Withdrawal))
D: Rate of COPD Exacerbations (52 weeks)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: Tailored Youth Drug Intervention In Primary Care
Brief Summary: This study examines the impact of tailored computer-delivered and therapist-delivered brief motivations prevention/interventions both for adolescents who have not initiated marijuana use (prevention), and those who use marijuana (intervention). Key moderators of prevention/intervention effectiveness will be examined, including behavioral intentions, self-efficacy, stage of change, school involvement, susceptibility to peer pressure, and potential health consequences such as STD/HIV risk behaviors. This project will provide the critical first step toward the development and implementation of marijuana use prevention/intervention programs that have the potential to be delivered to a large segment of youth who seek care in our nation's primary care settings.


Options:
A: Alcohol use (3 months); Alcohol use (6 months); Alcohol use (12 months)
B: Condom use (one year)
C: marijuana use (12 months)
D: Primary outcome variables include alcohol misuse and violent behaviors. (12-months)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: Periodical Presumptive Treatment of Gonorrhoea in Female Sex Workers: Impact on Prevalence of the Disease in Sex Workers and Their Clients
Brief Summary: In the early years of the HIV epidemic in Africa, female sex workers (FSWs) were identified as a high-prevalence, high-incidence, core group among whom the extraordinary prevalence of other sexually transmitted infections (STIs) facilitated transmission of the virus to their clients, who then infected low-risk women not involved in the sex trade. In resource-poor settings, control of Neisseria gonorrhoeae (NG) and Chlamydia trachomatis (CT) among FSWs is difficult. The purpose of this study is to determine whether periodical antibiotic treatment (PAT) is effective in controlling these infections among West African FSWs.

The study is designed as a cluster-randomized double-blind placebo-controlled trial conducted in West Africa. The study population consists of "seaters" FSWs who work from their homes in well-defined areas. Clusters will be paired according to their size and demographic characteristics of FSWs and clients. Within each pair, one cluster will be randomly allocated to the intervention and the other to the placebo group.

At enrollment, participants will be interviewed, a pelvic examination performed, cervical swabs obtained for NG and CT polymerase chain reaction (PCR), and current cervicitis or vaginitis managed syndromically. Blood specimens will be obtained for HIV testing. All participants will be given free condoms and counseled on risk reduction.

Monthly follow-up will be conducted within FSW communities, alternating with clinic visits where cervical samples will be collected. Study drugs (azithromycin 1 g and ciprofloxacin 500 mg, and their identical placebos) will be distributed every month according to a predefined schedule: directly-observed intake of azithromycin at months 1, 4 and 7, and ciprofloxacin at months 2, 3, 5, 6, 8 and 9.

Data will be analyzed with SAS. The investigators will assess the time trends in NG and CT prevalence separately in both study groups using χ2-for-trend.


Options:
A: HIV incidence
B: Presence of gonococcal infection (3 months); Presence of gonococcal infection (6 months); Presence of gonococcal infection (9 months)
C: Cohort I: 12 month experience of intimate partner violence; Cohort II: Condom use with last non-spousal partner; Cohort III: Condom use with last non-spousal partner; Cohort III: HIV incidence
D: Linked Partner HIV Infection Rates in Early-ART and Delayed-ART Arms (Throughout study); All Partner HIV Infection Rates in Early-ART and Delayed-ART Arms (Throughout study)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: The ATOMIC Study: A Multicenter, Open-label, Randomized, Duration Finding Study to Investigate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics Following Oral Administration of PSI-7977 in Combination With Pegylated Interferon and Ribavirin in Treatment-Naive Patients With Chronic HCV Infection Genotype 1,4, 5, or 6
Brief Summary: The purpose of this study is to assess the safety, tolerability, and efficacy of sofosbuvir (GS-7977; PSI-7977) administered in combination with pegylated interferon and ribavirin (PEG/RBV) in treatment-naive patients with HCV genotypes 1,4,5,6, or indeterminate genotype.


Options:
A: Percentage of Participants Achieving SVR24 Following Treatment With Vaniprevir 600 mg b.i.d. (Up to 72 weeks); Number of Participants Experiencing an Adverse Event (AE) (Up to 73 weeks); Number of Participants Discontinuing From Study Treatment Due to AEs (Up to 48 weeks)
B: Percentage of Participants With Sustained Virologic Response 24 Weeks Following Completion of Treatment (SVR24) (Post-treatment Week 24); Percentage of Participants Who Experienced Adverse Events (Baseline (Day 1) to post-treatment Day 30)
C: The Percentage of Participants Achieving a Sustained Virologic Response 12 Weeks After the Planned End of Treatment (SVR12) (Week 36 or Week 60)
D: Change From Baseline in Plasma Hepatitis C Virus (HCV) Ribonucleic Acid (RNA) Levels (log10 IU/mL) at Week 4 in Treatment-Naïve HCV-Infected Participants (Cohort 1 and 2, Panel A) (Week 4); Change From Baseline in Plasma Hepatitis C Virus (HCV) Ribonucleic Acid (RNA) Levels (log10 IU/mL) at Week 4 in Treatment-Naïve HCV-Infected Participants (Cohort 1 and 2, Panel B) (Week 4); Change From Baseline in Plasma Hepatitis C Virus (HCV) Ribonucleic Acid (RNA) Levels (log10 IU/mL) at Week 4 in Treatment-Experienced HCV-Infected Participants (Cohort 4, Panel C and Cohort 5, Panel D) (Week 4)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: The ATOMIC Study: A Multicenter, Open-label, Randomized, Duration Finding Study to Investigate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics Following Oral Administration of PSI-7977 in Combination With Pegylated Interferon and Ribavirin in Treatment-Naive Patients With Chronic HCV Infection Genotype 1,4, 5, or 6
Brief Summary: The purpose of this study is to assess the safety, tolerability, and efficacy of sofosbuvir (GS-7977; PSI-7977) administered in combination with pegylated interferon and ribavirin (PEG/RBV) in treatment-naive patients with HCV genotypes 1,4,5,6, or indeterminate genotype.


Options:
A: Sustained virologic response (SVR) at 12 weeks post-treatment (SVR12) (12 weeks post-treatment)
B: Percentage of Participants With Sustained Virologic Response 24 Weeks Following Completion of Treatment (SVR24) (Post-treatment Week 24); Percentage of Participants Who Experienced Adverse Events (Baseline (Day 1) to post-treatment Day 30)
C: Proportion of Randomized Subjects Achieving Sustained Viral Response (SVR), Demonstrated by Achieving Undetectable HCV RNA 24 Weeks After Last Dose of Study Treatment (SVR24) (24 weeks after the last planned dose of study treatment)
D: Percentage of Participants With Sustained Virologic Response 12 Weeks After Stopping All Study Drugs (SVR12) (Post-treatment Week 12)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: The ATOMIC Study: A Multicenter, Open-label, Randomized, Duration Finding Study to Investigate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics Following Oral Administration of PSI-7977 in Combination With Pegylated Interferon and Ribavirin in Treatment-Naive Patients With Chronic HCV Infection Genotype 1,4, 5, or 6
Brief Summary: The purpose of this study is to assess the safety, tolerability, and efficacy of sofosbuvir (GS-7977; PSI-7977) administered in combination with pegylated interferon and ribavirin (PEG/RBV) in treatment-naive patients with HCV genotypes 1,4,5,6, or indeterminate genotype.


Options:
A: Percentage of Participants With Sustained Virologic Response (SVR) at 12 Weeks After Discontinuation of Therapy (SVR12) (Posttreatment Week 12); Incidence of Adverse Events Leading to Permanent Discontinuation of Study Drug(s) (Baseline to Week 12)
B: Percentage of Participants With Sustained Virologic Response at Post Treatment Week 12 (SVR12) (Follow-up Week 12)
C: Percentage of Participants With Sustained Virologic Response 24 Weeks Following Completion of Treatment (SVR24) (Post-treatment Week 24); Percentage of Participants Who Experienced Adverse Events (Baseline (Day 1) to post-treatment Day 30)
D: Number of Participants With Sustained Virologic Response (SVR) 24 Weeks After the Last Planned Dose of Study Medication - SVR24 Planned (Week 72)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: The ATOMIC Study: A Multicenter, Open-label, Randomized, Duration Finding Study to Investigate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics Following Oral Administration of PSI-7977 in Combination With Pegylated Interferon and Ribavirin in Treatment-Naive Patients With Chronic HCV Infection Genotype 1,4, 5, or 6
Brief Summary: The purpose of this study is to assess the safety, tolerability, and efficacy of sofosbuvir (GS-7977; PSI-7977) administered in combination with pegylated interferon and ribavirin (PEG/RBV) in treatment-naive patients with HCV genotypes 1,4,5,6, or indeterminate genotype.


Options:
A: The Percentage of Participants Achieving a Sustained Virologic Response 12 Weeks After the Planned End of Treatment (SVR12) (Week 36 or Week 60)
B: The safety and tolerability of ascending multiple oral doses of ANA598 administered for 3 days to adult patients with chronic HCV infection and compensated liver disease; (10 days); The antiviral activity of ANA598, assessed by changes in serum HCV RNA levels (10 days)
C: Proportion of treated subjects with SVR12, defined as HCV RNA < LOQ at post treatment Week 12, for subjects who are prior null or partial responders to P/R or are treatment-naive (At 12 weeks post-treatment)
D: Percentage of Participants With Sustained Virologic Response 24 Weeks Following Completion of Treatment (SVR24) (Post-treatment Week 24); Percentage of Participants Who Experienced Adverse Events (Baseline (Day 1) to post-treatment Day 30)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: An Evaluation of Hydrocodone/Acetaminophen for Pain Control in First Trimester Surgical Abortion
Brief Summary: The purpose of this study is to determine whether preoperatively administered hydrocodone/acetaminophen (HC/APAP) reduces pain during a first trimester surgical abortion.


Options:
A: Visual Analog Pain Score for Mean Maximum Procedural Pain (Mean maximum pain experienced during the procedure and assessed 5 minutes after the procedure)
B: Patient Perception of Pain (At time of uterine aspiration (baseline))
C: Pain at Time of Uterine Evacuation (During the procedure on Study Day 1)
D: Pain Score on 100-mm VAS (Visual Analog Scale) at 5 Minutes Post-procedure (5 minutes)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: EXCImer Laser Randomized Controlled Study for Treatment of FemoropopliTEal In-Stent Restenosis
Brief Summary: The purpose of the study is to evaluate the safety and efficacy of laser atherectomy with balloon angioplasty compared to balloon angioplasty alone in the treatment of above the knee peripheral artery in-stent restenosis.


Options:
A: Freedom From Target Lesion Revascularization (TLR) (6 months); Freedom From Major Adverse Events (MAE) (30 days)
B: Target Lesion Percent Stenosis (1 year)
C: Percentage diameter stenosis (6 months)
D: The primary endpoint will be primary patency of the treated site at 6 months. Primary patency is defined as <50% loss of luminal diameter at the treated site on CT arteriography (CTA) without re-intervention in the interim. (6 months)

Answer: A