TrialPanorama/Dataset huggingface dataset:
Please select the outcome measures that correspond to the clinical trial below.
Title: Prospective Cohort Study of 4,837 Post-myocardial Infarction Patients (Alpha Omega Cohort)
Brief Summary: The Alpha Omega Cohort is a prospective study of 4,837 state-of-the-art drug-treated Dutch patients aged 60-80 years who had a clinically diagnosed myocardial infarction up to 10 years before enrolment. During the first 40 months of follow-up, patients took part in an experimental study of low doses n-3 fatty acids (Alpha Omega Trial, ClinicalTrials.gov NCT00127452). At baseline (2002-2006), data on medical history, medication use, diet, lifestyle and other factors were collected by means of questionnaires. Patients were physically examined by trained research nurses and blood samples were obtained. Follow-up for vital status and cause-specific mortality is ongoing. The trial was approved by a central medical ethics committee (Haga Hospital, The Hague, The Netherlands) and all patients provided written informed consent.


Options:
A: Weighted Modified Rankin Scale (mRS) Score, Lead Co-Primary Efficacy Outcome (90 days); Functional Independence (mRS 0-2), Nested Co-Primary Efficacy Outcome (90 days); Stroke-related Mortality, Primary Safety Outcome (90 days)
B: Cardiovascular mortality (From entry into the study (baseline: 2002-2006) through study completion); All-cause mortality (From entry into the study (baseline: 2002-2006) through study completion); Major cardiovascular events (From entry into the study (baseline: 2002-2006) until November 2009)
C: The Composite of Major Adverse Cardiovascular Events (MACE) (From the date of randomization and up to completion of the end-of-treatment visit (Month 60) or at study closure)
D: Survival free of atrial fibrillation (12 months)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: Improving PTSD Treatments for Adults With Childhood Trauma
Brief Summary: The aim of this project is to investigate the effectiveness of phase-based trauma-focused therapy (PBT) and intensive trauma-focused therapy (I-TFT) for adult patients with PTSD related to childhood abuse.

We will carry out a RCT, randomizing 150 patients to receive either standard TFT, PBT or i-TFT. The effects will be assessed at two endpoints of treatment (4, 8 and 16 weeks) and after a 6 and 12 months follow-up in an intention-to-treat analysis.


Options:
A: Change in family economic hardship (Quarterly change for up to 15 months)
B: Change in PTSI symptoms (Baseline, Immediately Post- intervention, 2 months post-intervention, 6 months post-intervention)
C: Feasibility via recruitment rate (Screening to enrollment (Week 1)); Feasibility via retention rate (sessions completed/dropout rate) (Week 1 (NET Session 1) to Week 6 (NET Session 6)); Feasibility via retention rate (completion of follow-up questionnaires) (1 Week Post-treatment (Post-treatment Evaluation), 1 Month Post-treatment (Post-treatment Evaluation), 1 Month Post-partum (Follow-up Evaluation)); Acceptability of the NET intervention via participant satisfaction (1 Week Post-treatment (Post-treatment evaluation)); Acceptability of the NET intervention via participant expectancy (Week 1 (NET Session 1) , Week 2, Week 3, Week 4, Week 5, Week 6 (NET Sessions 6)); Acceptability of the NET intervention via perceived benefit (1 Week Post-treatment (Post-treatment evaluation), 1 Month Post-treatment (post-treatment evaluation), 1 Month Postpartum (follow-up evaluation)); Acceptability of the NET intervention via qualitative feedback (Upon study completion (up to 10 months) or upon early withdrawal from intervention); Change in Symptoms of PTSD (Week 1 (NET Session 1), 1 Week Post-treatment (Post-treatment evaluation), 1 Month Post-treatment (post-treatment evaluation), 1 Month Postpartum (follow-up evaluation))
D: PTSD symptom severity (16 weeks)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: Effectiveness of Apneic Oxygenation Using High-flow Nasal Cannula in Morbidly Obese Patients Undergoing General Anesthesia
Brief Summary: Before going off to sleep patients are given oxygen to saturate blood with oxygen to extend time before a decrease in the level of oxygen in the blood occurs. During this period, obese patients have a faster decrease in the level of oxygen in their blood. This study uses a device called "high-flow nasal cannula" (HFNC), which delivers humidified high-flow oxygen through 2 small plastic tubes placed just inside nostrils. In the intensive care unit settings this device has been used extensively and has become a standard practice. Purpose of this study is to determine whether these high-flow nasal cannula increase the time safely when going to sleep during elective surgery.


Options:
A: lowest pulse oxymetry (SpO2) during intubation (From the beginning of the endotracheal intubation procedure (beginning of laryngoscopy, immediately after induction) to completed orotracheal intubation (airway catheterization). Usual duration is inferior to 10 minutes)
B: Reintubation (within 72 hours after extubation or at ICU discharge)
C: Change in arterial carbon dioxide (pCO2) (From start of anaesthesia to end of apnoea oxygenation or max 30 minutes); Change in arterial pH (From start of anaesthesia to end of apnoea oxygenation or max 30 minutes); Change in arterial oxygen tension (pO2) (From start of anaesthesia to end of apnoea oxygenation or max 30 minutes)
D: Measurement of safe apnea time (Maximum up to 6 minutes)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: A Multi-Centre, Randomised, Open-Label, Controlled Trial Evaluating the Efficacy and Safety of Prophylactic Administration of Concizumab in Haemophilia A and B Patients With Inhibitors
Brief Summary: This trial is conducted in Africa, Asia, Europe and North America. The aim of the trial is to assess the efficacy of concizumab administered s.c. (subcutaneously, under the skin) once daily in preventing bleeding episodes in haemophilia A and B patients with inhibitors.


Options:
A: Occurrence of FVIII Inhibitor Development (Up to Week 26 +/- 7 days, or up to 50 exposure days (EDs) if reached prior to Week 26)
B: The Number of Bleeding Episodes (During at least 24 weeks from treatment onset (week 0))
C: AUC from time 0 to the last data point (Pre-Dose and up to 120 hours post dose)
D: N/A

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: A Multi-Centre Trial Evaluating Efficacy and Safety of Prophylactic Administration of Concizumab in Patients With Severe Haemophilia A Without Inhibitors
Brief Summary: This trial is conducted in Asia, Europe and the United States of America (USA). The aim of the trial is to assess the efficacy of concizumab administered s.c. (subcutaneously, under the skin) once daily in preventing bleeding episodes in patients with severe haemophilia A without inhibitors.


Options:
A: Annualized Number of All Bleeds (Up to 12 months (6 months per mode of potency assignment according to the randomized cross-over design))
B: Number of Participants With Any Positive Inhibitor Development (Approximately 5 years)
C: Occurrence of FVIII Inhibitor Development (Up to Week 26 +/- 7 days, or up to 50 exposure days (EDs) if reached prior to Week 26)
D: The Number of Bleeding Episodes During at Least 24 Weeks From Treatment Onset (During at least 24 weeks from treatment onset)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: Effectiveness of an Eye-Cervical Re-education Program (ECRP) to Decrease Pain and Increase Mobility in the Cervical Area Compared to a Combined Physiotherapy Protocol (CPP) in Patients With Chronic Neck Pain Symptoms.
Brief Summary: The aim of the present study is to value the effectiveness of an Eye-Cervical Re-education Program (ECRP) to decrease pain and increase mobility in the cervical area compared to a Combined Physiotherapy Protocol (CPP) in patients with chronic neck pain symptoms.


Options:
A: Global Perceived Effect (GPE), Neck disability index (NDI-DV ) (0-3-7-13-26-52 weeks)
B: Change in functionality assessment NDI (Neck Disability Index) & SPADI (Shoulder Pain and Disability Index) (at baseline, one week after the end of the treatment sessions, at 3 months); Pain assessment 0-10 (at baseline); Change in Pain assessment (at baseline, one week after the end of the treatment sessions, at 3 months)
C: Global Rating of Change (GROC) scale (following 6 weeks of treatment, 3 months and 6 months)
D: Change of pain (Baseline and end of treatment(4 weeks)); Change of range of motion (Baseline and end of treatment (4 weeks))

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: Guided Meditation as an Adjunct to Enhance Postoperative Recovery: A Feasibility Study
Brief Summary: The primary purpose of this trial is to test the feasibility of implementing a meditation program in the perioperative period.


Options:
A: Changes in Body Mass Index (BMI) measured by Bio-electrical Impedance Analysis (TANITA) (Pretreatment-Posttreatment (5 months)-7 months follow-up); Changes in eating habits estimated by 24h recall and PREDIMED questionnaire (Pretreatment-Posttreatment (5 months)-7 months follow-up); Changes in the level of physical exercise estimated by the International Physical Activity Questionnaire (IPAQ) (Pretreatment-Posttreatment (5 months)-7 months follow-up); Changes in emotional eating estimated by the Dutch Eating Behaviour Questionnaire (DEBQ) (Pretreatment-Posttreatment (5 months)-7 months follow-up); Changes in the quality of life estimated by the Impact of Weight in the Quality of Life-Lite Questionnaire (IWQOL-Lite) (Pretreatment-Posttreatment (5 months)-7 months follow-up); Changes in weight self-stigma estimated by the Weight Self-Stigma Questionnaire (WSSQ) (Pretreatment-Posttreatment (5 months)-7 months follow-up)
B: Adherence to implementing a meditation program in the perioperative period (Baseline through 1 month post surgery)
C: Functional connectivity on fMRI (8 weeks)
D: Problem Areas in Diabetes Scale (PAID) -(Measures Diabetes Distress) (baseline, 12 weeks and 24 weeks)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: Prostaglandin Insert (Propess) Versus Trans-cervical Balloon Catheter for Out-patient Labour Induction: A Randomised Controlled Trial of Feasibility
Brief Summary: This study will randomise low-risk women to compare the effectiveness of trans-cervical balloon catheter for pre-induction cervical ripening for out-patient induction of labour with current practice (Propess). Women will be randomised to two treatment groups. The investigators wish to explore if such a trial is feasible, acceptable to women and what data collection is required for a future trial. Since no data exist, the investigators propose a study with approximately 60 women in each arm across two recruiting sites.


Options:
A: Time From Induction of Labor Until Delivery (Time from induction to delivery (average 14.2 hours))
B: To evaluate and compare the efficacy of the Atad Ripening Device (ARD), of the double balloon instillation device (AID) with concomitant continuous extra-amniotic NS instillation - 50 Ml/hour and of the folly catheter combined with continuous extra-a (2 years)
C: induction time to delivery (Time from induction to delivery, average 12-28 hours)
D: feasibility of randomised Induction of Labour Trial in Out-patient setting (12 months)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: Prostaglandin Insert (Propess) Versus Trans-cervical Balloon Catheter for Out-patient Labour Induction: A Randomised Controlled Trial of Feasibility
Brief Summary: This study will randomise low-risk women to compare the effectiveness of trans-cervical balloon catheter for pre-induction cervical ripening for out-patient induction of labour with current practice (Propess). Women will be randomised to two treatment groups. The investigators wish to explore if such a trial is feasible, acceptable to women and what data collection is required for a future trial. Since no data exist, the investigators propose a study with approximately 60 women in each arm across two recruiting sites.


Options:
A: The Time Interval From Induction to Delivery: All Participants (Day 1); Time (Hours) From Induction to Delivery: Nulliparous (Day 1); Time (Hours) From Induction to Delivery: Multiparous (Day 1); Time From Induction to Delivery: VD (Day 1); Time From Induction to Delivery: CD (Day 1); Per Treatment Protocol: Time (Hours) From Induction to Delivery (day 1)
B: feasibility of randomised Induction of Labour Trial in Out-patient setting (12 months)
C: Rate of vaginal delivery within 24 hours (within 24 hours)
D: Delivery rate (proportion) (Within 24 hours)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: A Study of the Management of the Patient's Disease Based on the Life Log Data of Patients With Lifestyle-related Diseases Through a Wearable Device
Brief Summary: In order to study the effectiveness of personalized healthcare intervention for lifestyle-related diseases, investigators designed this study using mobile application and clinical feedback from clinicians


Options:
A: Receipt of colorectal cancer screening exam (fecal occult blood test, flexible sigmoidoscopy, or colonoscopy) within 4 months following delivery of an electronic message within the personal health record
B: Change in Patient Activation Measure (Admission to Unit and 3-5 days after)
C: Hemoglobin A1C (Baseline, 6 months and 12 months)
D: Body weight change (baseline and after 4weeks of lifestyle intervention)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: Phase IIIb/IV Cohort Event Monitoring Study To Evaluate, In Real Life Setting, The Safety And Tolerability In Malaria Patients Of The Fixed-Dose Artemisinin-Based Combination Therapy Pyramax®
Brief Summary: The study is to be performed in public health facilities in Central and West Africa where Pyramax will be used as treatment of uncomplicated malaria episodes, including repeat episodes. The study is to assess the safety of Pyramax, particularly in patients with underlying liver function abnormalities, in patients who have co-morbid conditions, such as HIV, and also in very small children (\<1 year of age).


Options:
A: PCR-corrected adequate clinical and parasitological response (ACPR) (day 28 after initial dose)
B: PCR-Corrected ACPR at Day 28 (Day 28)
C: parasite clearance times in relation to artesunate/DHA plasma concentrations (PK-PD) (June 2008)
D: Evaluation and identification of hepatic safety events, including raised liver function tests (Assessment up to Day 28.)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: iCanCope With Sickle Cell Disease: A Mobile Pain Management Intervention for Adolescents
Brief Summary: The project will test a tailored web and smartphone-based application (iCanCope with SCD) to improve pain self-management and functioning in youth (aged 12-18) with sickle cell disease. The program will include goal setting, peer-based social support, and pain self-management training. The investigators will determine initial program effectiveness through a pilot three-site randomized controlled trial in 160 youth randomized to treatment compared to attention control.


Options:
A: Pain Diary - Average Daily Pain (Baseline,12 weeks, and 26 weeks); Pain Diary - Average Daily Activity Limitations (Baseline,12 weeks, and 26 weeks); Adaptive Coping - Coping Attempts (Baseline,12 weeks, and 26 weeks)
B: Accrual rates; Compliance with therapy; Acceptability of exercise program; Degree of conditioning of subjects at baseline; Proportion of completed exercise tests and questionnaires; Dropout rates; Estimates of the effect sizes for exercise tests and questionnaire data
C: Juvenile Arthritis Quality of Life Questionnaire (JAQQ) (Baseline (prior to randomization) and 3 months after intervention)
D: Number of recurrences during the follow-up period. (2 1/2 year)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: Efficacy and Safety of Low Doses of Trazodone in Patients Affected by Painful Diabetic Neuropathy: Randomized, Controlled, Pilot Study.
Brief Summary: The aim of the study is to collect preliminary information on the effect of low doses of trazodone on pain intensity in patients with painful diabetic neuropathy and to evaluate the neuropathic pain symptoms, anxiety, sleep, quality of life, safety and tolerability.


Options:
A: Mechanical and Heat Hyperalgesia (2 week intervals)
B: Pain reduction (16 weeks)
C: Change of item 5 score in Brief Pain Inventory Short Form (BPI-SF) scale (Baseline - Day 56)
D: Change From Baseline to Week 13 in Brief Pain Inventory (BPI), 24-hour Average Pain Scores (Baseline, Week 13)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: Hospital-Level Care at Home for Acutely Ill Adults: A Randomized Controlled Trial
Brief Summary: The investigators propose a home hospital model of care that substitutes for treatment in an acute care hospital. Limited studies of the home hospital model have demonstrated that a sizeable proportion of acute care can be delivered in the home with equal quality and safety, reduced cost, and improved patient experience.


Options:
A: Total direct cost of hospitalization, $ (From date of admission to date of discharge, an expected average of 4 days)
B: Change in daytime PaCO2 (Baseline, 6 months)
C: Total cost of hospitalization, $ (Day of admission to day of discharge)
D: NIHSS Stroke Scale, relapse rate (360 days)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: Hospital-Level Care at Home for Acutely Ill Adults: A Randomized Controlled Trial
Brief Summary: The investigators propose a home hospital model of care that substitutes for treatment in an acute care hospital. Limited studies of the home hospital model have demonstrated that a sizeable proportion of acute care can be delivered in the home with equal quality and safety, reduced cost, and improved patient experience.


Options:
A: Number of Participants With Death (Both on and Off Treatment) Due to Any Cause, Time up to or on the Pre-determined Common End Date (From the date of randomization until date of death due to any cause (average of 2 study years))
B: Total direct cost of hospitalization, $ (From date of admission to date of discharge, an expected average of 4 days)
C: Re-hospitalizations (During the 30days after discharge)
D: N/A

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: Hospital-Level Care at Home for Acutely Ill Adults: A Randomized Controlled Trial
Brief Summary: The investigators propose a home hospital model of care that substitutes for treatment in an acute care hospital. Limited studies of the home hospital model have demonstrated that a sizeable proportion of acute care can be delivered in the home with equal quality and safety, reduced cost, and improved patient experience.


Options:
A: Number of unscheduled hospital days (up to 12 months)
B: Number of hospitalizations due to exacerbation of COPD avoided (1 year)
C: To evaluate impact and costs on health care resources of a telemedicine programme (TM) for severe patients discharged with oxygen and/or home mechanical ventilation (HMV) with high risk of hospital readmission. (3 years)
D: Total direct cost of hospitalization, $ (From date of admission to date of discharge, an expected average of 4 days)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: Hospital-Level Care at Home for Acutely Ill Adults: A Randomized Controlled Trial
Brief Summary: The investigators propose a home hospital model of care that substitutes for treatment in an acute care hospital. Limited studies of the home hospital model have demonstrated that a sizeable proportion of acute care can be delivered in the home with equal quality and safety, reduced cost, and improved patient experience.


Options:
A: Number of all unplanned hospitalizations /1000 resident care days (21 months)
B: Total direct cost of hospitalization, $ (From date of admission to date of discharge, an expected average of 4 days)
C: The primary outcome is a composite outcome of all-cause mortality (30 days post-discharge); 30-day readmission. (30 days post-discharge)
D: Anxiety and depression (HADS) (At 1 month, 3 months and 12 months, change from baseline)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: The Wise App Trial for Improving Health Outcomes in People Living With HIV
Brief Summary: The overall goal of this study is to design a user-centered design app linked to a smart pill box for people living with HIV (PLWH) and evaluate its effects in a randomized controlled trial. The proposed trial is scientifically significant in representing a principled and systematic effort to test the efficacy of a smartphone intervention linked to a smart pill box for antiretroviral (ART) adherence in PLWH in the United States (US). Guided by a strong theoretical framework building on earlier user-centered design work and integrating a real-time monitoring device, this work has the potential to improve ART adherence in PLWH and have a sustainable public health impact.


Options:
A: Percentage of Women With Triage Pap Smears at 120 Days After HPV Results (120 days)
B: Linkage to HIV Care (Indicated by a HIV-related Laboratory Blood Test Within 8 Months) (Recruitment +8 months)
C: Change in ART Adherence - Clever Cap (Up to 6 months)
D: LARC uptake (at time of intervention (baseline (0 weeks))

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: The Wise App Trial for Improving Health Outcomes in People Living With HIV
Brief Summary: The overall goal of this study is to design a user-centered design app linked to a smart pill box for people living with HIV (PLWH) and evaluate its effects in a randomized controlled trial. The proposed trial is scientifically significant in representing a principled and systematic effort to test the efficacy of a smartphone intervention linked to a smart pill box for antiretroviral (ART) adherence in PLWH in the United States (US). Guided by a strong theoretical framework building on earlier user-centered design work and integrating a real-time monitoring device, this work has the potential to improve ART adherence in PLWH and have a sustainable public health impact.


Options:
A: Linkage to HIV Care (Indicated by a HIV-related Laboratory Blood Test Within 8 Months) (Recruitment +8 months)
B: Change in ART Adherence - Clever Cap (Up to 6 months)
C: Highly-effective contraceptive use (6 months postpartum)
D: Unprotected sex, no contraceptive (6-week post-baseline (in the past 6 weeks)); Unprotected sex, no highly effective contraceptive (6-week post-baseline (in the past 6 weeks))

Answer: B