TrialPanorama/Dataset huggingface dataset:
Please select the outcome measures that correspond to the clinical trial below.
Title: Strengthening Mental Health Care in Chronic Care Patients With Hypertension. A Cluster Randomised Control Trial
Brief Summary: A pragmatic cluster randomized controlled trial (RCT) in 20 public sector primary care clinics in the Dr Kenneth Kaunda district of the North West Province of South Africa to assess mental health and health outcomes for depressed adults receiving hypertensive treatment by measuring the real-world effectiveness of a facility-based stepped care intervention combining stress and depression case detection and management by non-physician clinicians and referral pathways for anti-depressant medication and/or group/individual counselling delivered by lay-health workers for patients with depression. The control condition is enhanced usual primary health care where non-physician clinicians have been equipped with the basic skills to identify stress and depression/anxiety but with limited access to doctors authorized to prescribe antidepressant medication, and with no specific psychosocial interventions.


Options:
A: Depression (6 Months)
B: Psychiatric diagnosis at 6-month follow-up (6-month follow-up)
C: Sustained change weight (for less) of 5% of previous body weight. This is a level known to improve physical health (metabolic) outcomes. (Baseline, 25-weeks (end) treatment, 6 and12 months follow-up.)
D: Rate of Maternal HIV Viral Suppression (Two months post pregnancy); Mean Maternal Antiretroviral (ART) Adherence (Past 6 months, assessed at 2 months after the completion of pregnancy); Rate of Prevention of Mother-to-child-transmission (PMTCT) Care Retention (through study completion, an average of 48 weeks); Rate of Delivery in Health Facility (two months post pregnancy); Rate of Infant Use of ART (First 6 weeks of life)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: Effectiveness of a Home Telerehabilitation Program for People With Proximal Humerus Fracture Treated Conservatively: a Randomized Clinical Trial.
Brief Summary: The main objective of the study is to compare the clinical effects of the innovative telerehabilitation approach (TELE group) compared to face-to-face visits to a clinic (CLINIC group) for patients treated for a proximal humerus fracture.


Options:
A: DASH (6 months); DASH (1 year); DASH (2 year)
B: Functional shoulder score according to Constant (Original described Differences between the injured and uninjured shoulder as well as Adjusted according to age and gender). (12 and 24 months)
C: Constant Disability Scale (3 years)
D: Shoulder function (score /100) (Pre-intervention: 1 to 3 weeks post fracture (T1) and Post-intervention: after the 8-week intervention (T2))

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: Multicenter, Randomized, Double-blind, Parallel-group, Active-controlled, Superiority Study to Compare the Efficacy and Safety of Ponesimod to Teriflunomide in Subjects With Relapsing Multiple Sclerosis
Brief Summary: International clinical trial to compare ponesimod and teriflunomide in relapsing multiple sclerosis


Options:
A: Annualized Relapse Rate (ARR) (Baseline up to 2.5 years)
B: Number of Combined Unique (CU) Active Magnetic Resonance Imaging (MRI) Lesions at Week 16 (16 Weeks); Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs) (Baseline up to Week 40)
C: Annualized Confirmed Relapse Rate (From randomization to end of study (Week 108))
D: Hazard ratio for relapses (During the first and during the second 52 weeks)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: A Phase 4, Multicenter, Randomized, Placebo-controlled, Double-blind, Study of the Efficacy and Safety of Apremilast (CC-10004) in Subjects With Moderate Plaque Psoriasis
Brief Summary: This study will evaluate the clinical efficacy, the patients quality of life, and safety of oral apremilast 30 mg twice daily (BID) compared to placebo, in adult patients with moderate plaque psoriasis during the 16 week Placebo controlled Phase and then upto 1 year in the Extension Phase of the trial.


Options:
A: Percentage of Participants With a Psoriasis Area and Severity Index 100 (PASI100) Response at Week 16 (Week 16)
B: Percentage of Participants Achieving 90% Improvement in Psoriasis Area and Severity Index (PASI) Score (PASI90) at Week 16 in Participants Who Received Risankizumab Compared With Placebo (Part A) (Week 16); Percentage of Participants Achieving a Static Physician Global Assessment (sPGA) Score of Clear or Almost Clear at Week 16 in Participants Who Received Risankizumab Compared With Placebo (Part A) (Week 16)
C: Mean Percentage Change From Baseline in the Product of BSA (%) and the sPGA Which is Considered as the Total Psoriasis Severity Index at Week 16 (Baseline to Week 16 (end of phase))
D: Percentage of Participants With Psoriasis Area Severity Index (PASI) 75 at Week 12 (12 weeks); Percentage of Participants With Static Physician Global Assessment (sPGA) Success Score (Score of 0 or 1) at Week 12 - Comparison to Placebo (12 weeks)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: A Phase 4, Multicenter, Randomized, Placebo-controlled, Double-blind, Study of the Efficacy and Safety of Apremilast (CC-10004) in Subjects With Moderate Plaque Psoriasis
Brief Summary: This study will evaluate the clinical efficacy, the patients quality of life, and safety of oral apremilast 30 mg twice daily (BID) compared to placebo, in adult patients with moderate plaque psoriasis during the 16 week Placebo controlled Phase and then upto 1 year in the Extension Phase of the trial.


Options:
A: Percentage of Participants Achieving a 75 Percent (%) Improvement in Psoriasis Area and Severity Index (PASI 75) Score at Week 24 (Week 24)
B: The Efficacy of Three Induction Regimens of AIN457 Administered Subcutaneously in Patients With Moderate to Severe Chronic Plaque-type Psoriasis With Respect to PASI 75 Achievement After 12 Weeks of Treatment, Compared to Placebo. (13 weeks)
C: Mean Percentage Change From Baseline in the Product of BSA (%) and the sPGA Which is Considered as the Total Psoriasis Severity Index at Week 16 (Baseline to Week 16 (end of phase))
D: Percent Improvement From Baseline in Psoriasis Area and Severity Index (PASI) at Week 16 (Baseline and Week 16)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: A Phase 4, Multicenter, Randomized, Placebo-controlled, Double-blind, Study of the Efficacy and Safety of Apremilast (CC-10004) in Subjects With Moderate Plaque Psoriasis
Brief Summary: This study will evaluate the clinical efficacy, the patients quality of life, and safety of oral apremilast 30 mg twice daily (BID) compared to placebo, in adult patients with moderate plaque psoriasis during the 16 week Placebo controlled Phase and then upto 1 year in the Extension Phase of the trial.


Options:
A: Proportion of patients in remission defined by disease specific composite scores Study part A (30 weeks); Sustained disease control throughout the study period without disease worsening defined by disease specific composite scores Study part B (52 weeks)
B: Mean Percentage Change From Baseline in the Product of BSA (%) and the sPGA Which is Considered as the Total Psoriasis Severity Index at Week 16 (Baseline to Week 16 (end of phase))
C: N/A
D: Percentage of Participants Achieving 90% Improvement in Psoriasis Area and Severity Index (PASI) Score (PASI90) at Week 16 (Part A) (Week 16)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: A Phase 4, Multicenter, Randomized, Placebo-controlled, Double-blind, Study of the Efficacy and Safety of Apremilast (CC-10004) in Subjects With Moderate Plaque Psoriasis
Brief Summary: This study will evaluate the clinical efficacy, the patients quality of life, and safety of oral apremilast 30 mg twice daily (BID) compared to placebo, in adult patients with moderate plaque psoriasis during the 16 week Placebo controlled Phase and then upto 1 year in the Extension Phase of the trial.


Options:
A: Percentage of Participants With a Psoriasis Area and Severity Index (PASI)75 Response at Week 16 (Week 16); Number of Participants Experiencing Adverse Events (Up to 72 weeks); Number of Particpants Discontinuing Study Treatment Due to Adverse Events (Up to 52 weeks)
B: Mean Percentage Change From Baseline in the Product of BSA (%) and the sPGA Which is Considered as the Total Psoriasis Severity Index at Week 16 (Baseline to Week 16 (end of phase))
C: The Percentage of Participants With Moderate to Severe Psoriasis Experiencing a 75% Improvement (Reduction From Baseline) in PASI Score (PASI-75 Response Rate) on Day 85 (Week 12) (Day 1 to Day 85); Number of Participants With Adverse Events (Day 1 to day 115)
D: Percentage of Participants With a ≥75% Improvement in Psoriasis Area and Severity Index (PASI 75) at Week 24 (Week 24)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: A Phase III, Multicenter, Randomized, Placebo-Controlled Study of Atezolizumab (Anti-PD-L1 Antibody) in Combination With Nab-Paclitaxel Compared With Placebo With Nab-Paclitaxel for Patients With Previously Untreated Metastatic Triple-Negative Breast Cancer
Brief Summary: This multicenter, randomized, double-blind study evaluated the efficacy, safety, and pharmacokinetics of atezolizumab (MPDL3280A) administered with nab-paclitaxel compared with placebo in combination with nab-paclitaxel in participants with locally advanced or metastatic triple-negative breast cancer (TNBC) who have not received prior systemic therapy for metastatic breast cancer (mBC). The safety of single-agent nab-paclitaxel has been determined in previous studies of participants with mBC and the safety data to date suggest that atezolizumab can be safely combined with standard chemotherapy agents.


Options:
A: Progression Free Survival (PFS) According to Response Evaluation Criteria in Solid Tumors (RECIST) Version 1.1 (v1.1) in All Randomized Participants (Baseline up to approximately 34 months); PFS According to RECIST v1.1 in Participants With Detectable Programmed Death-Ligand 1 (PD-L1) (Baseline up to approximately 34 months); Overall Survival (OS) in All Randomized Participants (Baseline until death due to any cause (up to approximately 58 months)); OS in Participants With Detectable PD-L1 (Baseline until death due to any cause (up to approximately 58 months))
B: Progression-Free Survival (PFS) (Radiographic evaluation every 9 weeks, clinical evaluation every cycle (data cutoff date: 04 March 2016); maximum duration of follow up for PFS was 34 months.)
C: progression free survival (until cut-off date established from deaths rate); Overall survival (until cut-off date established from deaths rate)
D: Progression-free Survival (PFS) Using Blinded Independent Central Review (BICR) According to Modified Response Evaluation Criteria In Solid Tumours (RECIST v1.1) (Radiological scans performed at baseline then every ~6 weeks up to 24 weeks, then every ~ 12 weeks thereafter until objective radiological disease progression. Assessed up to a maximum of 30 months.)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: Bronchopulmonary Function in Response to Azithromycin Treatment for Chronic Lung Disease in HIV-infected Children
Brief Summary: Chronic pulmonary disease (CLD) is the most common manifestation of HIV/AIDS among children, accounting for more than 50% of HIV-associated mortality. Recently, a novel form of CLD, affecting more than 30% of African HIV-infected older children was described by Ferrand et al in Zimbabwe, high-resolution CT scanning findings showed predominantly small airways disease consistent with constrictive obliterative bronchiolitis (OB). . Azithromycin has anti-inflammatory activity and treatment of CLD with this agent may lead to suppression of generalized immune activation.

This specific aims of this project are to:

1. Primary objective: To investigate whether adjuvant treatment with azithromycin results in improvement in lung function in HIV-infected children with chronic lung disease, who are stable on antiretroviral therapy.
2. Secondary objectives:

   1. To investigate the intervention effect on mortality, exacerbations of lung disease, quality of life, morbidity.
   2. To investigate adverse events related to azithromycin treatment

In total, 400 children aged 6-16 years, living with HIV and diagnosed with CLD will be enrolled at Harare Children´s Hospital in Harare (Zimbabwe) and Queen Elizabeth Central Hospital in Blantyre (Malawi). These will receive weekly treatment with azithromycin or placebo during 12 months. Another 100 children (50 per site) living with HIV but with no CLD will be enrolled as a comparison group for laboratory sub-studies.

Lung function will be assess using spirometry and the Forced expiratory volume in the first minute (FEV1) will be the primary outcome. The mean change in FEV1 z-score levels will be compared between trial arms after 12 months of initiation of azithromycin treatment.


Options:
A: Forced Expiratory Volume in one second z score (FEV1) (12 months)
B: the prevalence of nasopharyngeal carriage of the newborn of any of the following bacteria: 1) Group B Streptococci (GBS) , 2) S.pneumoniae and 3) S.aureus (6 days)
C: Estimation of crude mortality by any reason of each study group; Estimation of attributable mortality by VAP of each study group; 7-day mortality rate of each group; 28-mortality rate of each group; Rate of progression to multiple organ failure and septic shock (and number of failing organs) of each study group; Time to progression to multiple organ failure and septic shock of each study group; Days of resolution of VAP; Days in ICU after diagnosis of VAP
D: Duration of diarrhea in days (up to 10 days)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: Interventional Left Atrial Appendage Closure vs. Novel Anticoagulation Agents in High-risk Patients With Atrial Fibrillation (PRAGUE-17 Study)
Brief Summary: Atrial fibrillation (AF) is the most common cardiac arrhythmia with a prevalence of 1-2%. Without antithrombotic treatment, the annual risk of a cardioembolic event is 5-6%. The source of a cardioembolic event is a thrombus, which usually forms in the left atrial appendage (LAA). The prevention of cardioembolic events involves treatment with anticoagulant drugs, which were limited to, until recently, vitamin K antagonists (e.g. warfarin). Anticoagulant treatment with warfarin can lead to adverse bleeding events, some of which can be life threatening. Recently, two new options for thrombus prevention have been developed. The first is the novel anticoagulants (NOAC), which were associated with slightly better safety profiles due to a lower frequency of intracranial bleeding in large randomized trials . The second option involves interventional occlusion of the LAA. The aim of this project is to compare the LAA occlusion intervention to NOAC pharmacological treatment in a randomized multicenter study of AF patients at high risk of a cardioembolic event.


Options:
A: Combined endpoint: stroke OR systemic cardioembolic event OR clinically significant bleeding OR cardiovascular death OR procedure or device-related complications (From the date of randomization until the date of 6 month follow-up visit of the last enrolled patient)
B: Stroke or Systemic Embolism (From randomization until the common study end date (average of 3 years)); Major hemorrhage (From randomization until the common study end date (median 2 years))
C: Recurrent Stroke (Average of 6 years)
D: Number of Participants With Symptomatic and Asymptomatic Venous Thromboembolism (10 days)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: Conducting Outreach to Improve Cervical Cancer Screening Rates Among Underscreened Patients at an Urban Community Health Center
Brief Summary: The purpose of this project is to determine whether outreach to HIV-negative patients who are overdue for a Pap smear at a New England urban community health center can increase cervical cancer screening rates. It additionally seeks to determine which form of outreach - via letter, email, phone, or a mixture of those modalities- is most effective among these patients.


Options:
A: Proportion of Patients Who Receive a Pap Test at End of Follow up (18 months)
B: Measles vaccination coverage (10 months)
C: Intention to treat analysis (13 months)
D: Proportion of women who received a Pap smear within 6 months from the date when the study randomization began. (6 months after randomization of study)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: Conducting Outreach to Improve Cervical Cancer Screening Rates Among Underscreened Patients at an Urban Community Health Center
Brief Summary: The purpose of this project is to determine whether outreach to HIV-negative patients who are overdue for a Pap smear at a New England urban community health center can increase cervical cancer screening rates. It additionally seeks to determine which form of outreach - via letter, email, phone, or a mixture of those modalities- is most effective among these patients.


Options:
A: Participant attends cervical cancer screening (Within 7 months of the intervention)
B: Number of Participants Completing a Self-sampling Test (2 to 6 months)
C: Proportion of Patients Who Receive a Pap Test at End of Follow up (18 months)
D: Proportion of participants self-reporting receipt of Pap test (One month post-intervention)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: Conducting Outreach to Improve Cervical Cancer Screening Rates Among Underscreened Patients at an Urban Community Health Center
Brief Summary: The purpose of this project is to determine whether outreach to HIV-negative patients who are overdue for a Pap smear at a New England urban community health center can increase cervical cancer screening rates. It additionally seeks to determine which form of outreach - via letter, email, phone, or a mixture of those modalities- is most effective among these patients.


Options:
A: Effect of SMS intervention on attendance rate to follow-up screening appointment (up to 14 months)
B: Adherence to cervical cancer screening (step1) (Up to 20 months)
C: Proportion of fully immunized children (When the participants reach 2 years of age)
D: Proportion of Patients Who Receive a Pap Test at End of Follow up (18 months)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: Tailored Peer-Based Sleep Health Education and Social Support Among Blacks With Obstructive Sleep Apnea
Brief Summary: The primary purpose of this study is to ascertain the effectiveness of tailored, peer based sleep health education and social support in increasing adherence rates to recommended Obstructive Sleep Apnea (OSA) evaluation and treatment among blacks at risk of Obstructive Sleep Apnea.


Options:
A: Rate of adherence to recommended home OSA evaluation and treatment after intervention exposure (12 Months)
B: Ambulatory blood pressure monitoring (Change from Baseline in Blood Pressure at 6 months)
C: Structural and functional brain changes (at baseline and after 3 months of treatment)
D: 24 h blood pressure (mean blood pressure; mmHg) (Changes from Baseline in 24 h BP at 6 and 12 weeks, respectively)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: Evaluation of a Transition Intervention for Family Caregivers of Persons With Alzheimer Disease and Multiple Chronic Conditions
Brief Summary: With the number of Canadians with Alzheimer's disease and related dementias (ADRD) growing, supporting family care partners of persons with ADRD is critical. Family caregivers provide about 90 per cent of in-home care for persons with ADRD, and the care is often difficult due to co-morbidities in persons with ADRD. Family caregivers of older persons with ADRD and multiple chronic conditions (MCC) experience significant, complex, distressing transitions such as changes to their environment, roles and relationships, physical and mental health, isolation, and taking on new tasks. An online Transition Toolkit (My Tools 4 Care) was developed for family caregivers of persons with ADRD and MCC living at home, to support caregivers through transitions and increase their self-efficacy, hope, and quality of life (QOL).

Through this pragmatic mixed methods randomized controlled trial the investigators expect to find that family caregivers receiving the online My Tools 4 Care Toolkit will show greater improvement in hope, self-efficacy and QOL, at no additional cost from a societal perspective, compared with those in an educational control group. Following baseline data collection 180 participants will be randomly assigned to one of the groups with repeated measures at one, three and six months.


Options:
A: Effects of the WeCareAdvisor Tool on Caregiver Upset (4 weeks); Effect of the WeCareAdvisor Tool on Caregiver Confidence (4 weeks)
B: Change from Baseline in Health Related Quality of Life at One, Three and Six Months (One, three and six months)
C: Change from baseline in subjective burden using the Zarit Burden Interview (ZBI) (Baseline, Month 3, Month 6)
D: Center for Epidemiological Studies Depression scale (Pre- and post-training, 3 months and 6 months); Spielberger State-Trait Anger and Anxiety Scales (Pre-and post-training, 3 months and 6 months); Perceived Stress Scale (Pre- and post-training, 3 months and 6 months); Pittsburgh Sleep Quality Index (Pre-and post-training, 3 months and 6 months); Heart rate and blood pressure at rest and during recall of caregiver situation (Pre-and post-training, 3 months and 6 months); Salivary cortisol upon awakening, 30 minutes later, and prior to going to bed at night (Pre-and post-training, 3 months and 6 months)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: A Clinical Evaluation of the Eclipse™ System, a Vaginal Bowel Control (VBC) Therapy for Fecal Incontinence in Women
Brief Summary: Multi-center, prospective, within-subject control, open label clinical trial to evaluate the durability of the safety and effectiveness of the Eclipse™ System after 3 and 12 months of use.


Options:
A: Count of Treatment Responders in the Intent to Treat (ITT) Cohort (3 months)
B: Change from baseline in ovarian function as measured by Anti-Mullerian Hormone (AMH) (AMH blood samples collected prior to surgery at day 1 (the day of the surgery) and at 1 and 3 months after day 1.)
C: Participants With ≥ 50% Reduction in Stress Incontinence Episode Frequency From Baseline to 12 Months Post-treatment; as Assessed by 3 Day Diary (Baseline and 12 months)
D: Menopause-related quality of life (Up to 5 years after last surgery)

Answer: A