TrialPanorama/Dataset huggingface dataset:
Please select the outcome measures that correspond to the clinical trial below.
Title: Psychological/Immunity Studies With Women With Cancer Previously
Brief Summary: An investigative study of the effectiveness of the BioBehavioral Intervention on Stage II/III breast cancer patients. A total of 231 patients were split between an assessment-only control group and an experimental group receiving the Intervention and assessment. The goal of the Intervention is to use psychological, behavioral, and biologic methods with the primary goal of reducing cancer recurrence.


Options:
A: Physical Well-being a Subcale of the Functional Assessment of Cancer Therapy-Breast Quality of Life Instrument (FACT-B) (Baseline and 6 month assessment); Social/Family Well-being a Subcale of the Functional Assessment of Cancer Therapy-Breast Quality of Life Instrument (FACT-B) (Baseline and 6 month assessment); Emotional Well-being a Subscale of the Functional Assessment of Cancer Therapy-Breast Quality of Life Instrument (FACT-B) (Baseline and 6 month assessment); Breast Cancer Concerns a Subscale of the Functional Assessment of Cancer Therapy-Breast Quality of Life Instrument (FACT-B) (Baseline and 6 month assessment); Enjoyment of Life a Subscale of the Functional Assessment of Cancer Therapy-Breast Quality of Life Instrument (FACT-B) (Baseline and 6 month assessment); Total Score of the Functional Assessment of Cancer Therapy-Breast Quality of Life Instrument (FACT-B) (Baseline and 6 month assessment)
B: The efficacy of Mindfulness Based Stress Reduction on mood disorders (up to 5 years follow up)
C: SCL-90r Depression and anxiety subscales (baseline - 12 months)
D: Recurrence event (Ten years); Recurrence time (Ten years)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: Effectiveness of a School-based Tobacco Prevention Program for Middle School Students in Saudi Arabia: A Controlled Trial.
Brief Summary: This study evaluated a school-based tobacco program, "Dentists Fighting Nicotine Dependence (DFND)", to prevent the initiation of tobacco use among middle school students in Saudi Arabia using a social competences/social influence approaches.


Options:
A: Biochemically/pharmacologically-confirmed 12-month continuous abstinence as evidenced by self-reports of nonsmoking status in all interviews (i.e., at 3, 6, and 12 months) (12 months)
B: 7 Day Point Prevalence of Cigarette Abstinence (6-month follow up); 7 Day Point Prevalence of Cigarette Abstinence (Week 8)
C: Change from baseline prevalence of tobacco use at one week and at 2 years [Questionnaire] (One week and Two years after the completion of the intervention)
D: Safety (Baseline (week 0), Weeks 1-9, End of trial (Week 10)); Smoking cessation (End of trial (Week 10))

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: Donor-Derived Very-Rapid Manufactured CD19-Specific T Cells for Lymphoid Malignancies After Allogeneic Hematopoietic Stem-Cell Transplantation
Brief Summary: This phase I trial investigates the side effects and best dose of CD19 positive (+) specific CAR-T cells in treating patients with CD19+ lymphoid malignancies, such as acute lymphoblastic leukemia, non-Hodgkin lymphoma, small lymphocytic lymphoma, or chronic lymphocytic lymphoma. Sometimes researchers change the genetic material in the cells of a patient's T cells using a process called gene transfer. Researchers then inject the changed T-cells into the patient's body. Receiving the T-cell infusion may help to control the disease.


Options:
A: Treatment-related adverse events (AEs) (2 years); Dose-limiting toxicities of JWCAR029 (28 days after JWCAR029 infusion); Objective response rate (ORR) (2 years)
B: Phase I Escalation - Safety (incidence of Grade 3-5 toxicities) and identification of recommended Phase II dose and schedule. (Within 75 days of AUTO3 infusion); Phase I Expansion - Safety (incidence of Grade 3-5 toxicities) in the outpatient / ambulatory care setting (Within 75 days of AUTO3 infusion); Phase II - Overall response rate as per Lugano criteria (Up to 2 years)
C: Incidence of adverse events (Up to 15 years); Maximum tolerated dose (MTD) as determined by dose limiting toxicity (DLT) (Up to 30 days post-infusion)
D: Phase 1: Safety measured by occurrence of study related adverse effects defined by NCI CTCAE 4.0 (4 weeks); Phase 2: Overall complete remission rate defined by the standard response criteria for malignant lymphoma for each arm (8 weeks); Phase 2: Comparison of overall complete remission rate for the two arms (One year)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: Immunotherapy With Ex Vivo-Expanded Cord Blood-Derived CAR-NK Cells Combined With High-Dose Chemotherapy and Autologous Stem Cell Transplantation for B-Cell Lymphoma
Brief Summary: This phase I/II trial studies the side effects and best dose of chimeric antigen receptor (CAR).CD19-CD28-zeta-2A-iCasp9-IL15-transduced cord blood NK cells when given together with high-dose chemotherapy and stem cell transplant and to see how well they work in treating participants with B-cell lymphoma. Cord blood-derived CAR-NK cells may react against the B-cell lymphoma cells in the body, which may help to control the disease. Giving chemotherapy before a stem cell transplant may help kill any cancer cells that are in the body and helps make room in the patient's bone marrow for new blood-forming cells (stem cells) to grow. The stem cells are then returned to the patient to replace the blood-forming cells that were destroyed by the chemotherapy.


Options:
A: Phase 1 Study: Number of Participants Experiencing Adverse Events (AEs) Defined as Dose Limiting Toxicities (DLTs) (First infusion date of axicabtagene ciloleucel up to 30 days); Phase 2 Pivotal Study (Cohorts 1 and 2): Overall Response Rate (ORR) as Assessed by Investigator Per Revised International Working Group (IWG) Response Criteria for Malignant Lymphoma (First infusion date of axicabtagene ciloleucel up to last follow-up visit (maximum duration: 7.7 years)); Phase 2 Safety Management Study (Cohort 3): Percentage of Participants With Treatment-Emergent Cytokine Release Syndrome (CRS) and Neurologic Toxicities by Severity Grades (First infusion date of axicabtagene ciloleucel up to last follow-up visit (maximum duration: 6.8 years)); Phase 2 Safety Management Study (Cohort 4): Percentage of Participants With Treatment-Emergent CRS and Neurologic Toxicities by Severity Grades (First infusion date of axicabtagene ciloleucel up to last follow-up visit (maximum duration: 5.4 years)); Phase 2 Safety Management Study (Cohort 5): Percentage of Participants With Treatment-Emergent CRS and Neurologic Toxicities by Severity Grades (First infusion date of axicabtagene ciloleucel up to last follow-up visit (maximum duration: 4.4 years)); Phase 2 Safety Management Study (Cohort 6): Percentage of Participants With Treatment-Emergent CRS and Neurologic Toxicities by Severity Grades (First infusion date of axicabtagene ciloleucel up to last follow-up visit (maximum duration: 4.1 years))
B: Overall complete remission rate (Half a year)
C: Incidence of adverse events defined as graft failure, grade 3, 4 graft versus host disease, grade 3,4 cytokine release syndrome, grade 3, 4, neuro-toxicity, or death from any cause (Up to 30 days within natural killer (NK) cell infusion); Complete response (CR) or partial response (PR) (At day 30 post NK cell infusion)
D: Safety as assessed by dose limiting toxicities (DLTs) (28 days); Determination of maximum tolerated dose and proposed recommended Phase 2 dose (24 weeks)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: Could Low-Cost Mobile Health Interventions Make a Difference?:Enhancing Outcomes of Noncommunicable Diseases Care in Rural Settings and Refugee Camps
Brief Summary: Rural areas and refugee camps are characterized by poor access of patients to needed noncommunicable disease (NCD)-related health services, including diabetes and hypertension. This community trial study aims to assess the effect of employing low-cost mHealth tools on the accessibility to health services and improvement of health indicators of individuals with NCDs in rural areas and refugee camps in Lebanon.


Options:
A: difference in change in systolic BP between the intervention and usual care groups (6 months)
B: Change in the proportion of patients achieving glycaemic and BP control (1 year)
C: Processes of clinical care for diabetes; Cardiovascular risk as determined by UKPDS Risk; Metabolic outcomes (HgbA1c); Metabolic outcomes (LDL Cholesterol); Metabolic Outcomes (Systolic Blood Pressure)
D: Blood Pressure Control (blood pressure (SBP/DBP) <140/90 mmHg)) (At 1 year from the time of initiation of the intervention); Mean HbA1c (At 1 year from the time of initiation of the intervention)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: Could Low-Cost Mobile Health Interventions Make a Difference?:Enhancing Outcomes of Noncommunicable Diseases Care in Rural Settings and Refugee Camps
Brief Summary: Rural areas and refugee camps are characterized by poor access of patients to needed noncommunicable disease (NCD)-related health services, including diabetes and hypertension. This community trial study aims to assess the effect of employing low-cost mHealth tools on the accessibility to health services and improvement of health indicators of individuals with NCDs in rural areas and refugee camps in Lebanon.


Options:
A: Medication Adherence (12 months)
B: Proportion of people who respond to text messages and are persistently hypertensive (3 weeks)
C: Blood Pressure Control (blood pressure (SBP/DBP) <140/90 mmHg)) (At 1 year from the time of initiation of the intervention); Mean HbA1c (At 1 year from the time of initiation of the intervention)
D: MEMS Adherence (12 months follow up)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: The CAPTURE Study: Validating a Unique Chronic Obstructive Pulmonary Disease (COPD) Case Finding Tool in Primary Care
Brief Summary: A prospective, multicenter study including a cross-section validation to define sensitivity and specificity of CAPTURE to identify previously undiagnosed patients with clinically significant Chronic Obstructive Pulmonary Disease (COPD), and its impact on clinical care across a broad range of primary care settings in a cluster randomized controlled clinical trial.


Options:
A: Collated quality indicator score (The care period for each patient (approx. 3 weeks up to 1 year))
B: "Quality of care process" (one year)
C: Change in exercise tolerance (Up to 6 months); Change in lung microbiota (Up to 6 months)
D: Proportion of CAPTURE+ Participants Who Meet a Composite Endpoint for Diagnosis and Management of COPD (Baseline to 12 months)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: An International Phase 3, Randomized, Double-Blind, Active (Tolterodine)-Controlled Multicenter Extension Study to Evaluate the Long-Term Safety and Efficacy of Vibegron in Patients With Symptoms of Overactive Bladder
Brief Summary: This study is designed to evaluate the safety, tolerability, and efficacy of vibegron administered once daily in participants with OAB for up to 52 weeks.


Options:
A: Change from baseline in mean number of urgency episodes/24 hours at EOS -from the Patient Perception of Intensity of Urgency Scale at void (PPIUS) grades 3 and 4 (Week 16)
B: Baseline Average Number of Daily Incontinence Episodes (Baseline); Change From Baseline in Average Daily Number of Incontinence Episodes (Baseline to Week 12)
C: Number of Participants With the Indicated Type of Treatment-emergent Adverse Event (up to 56 weeks)
D: Change in Mean Number of Micturition Episodes Per 24 Hours at Week 12 Relative to Baseline. (Baseline and Week 12)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: Second-Line Uterotonics in Postpartum Hemorrhage: A Randomized Clinical Trial
Brief Summary: The aim of this study is to evaluate in a randomized fashion the comparative efficacy of two second-line medications, methylergonovine and carboprost for treating atonic postpartum hemorrhage (PPH). The investigators hypothesize that administration of methylergonovine will produce superior uterine tone to carboprost in atonic PPH.


Options:
A: Difference in differences: change in use of oxytocin for prevention of postpartum hemorrhage (Baseline, Midline (6 months), Endline (12 months))
B: Uterine Tone (at 10 minutes following administration of the first study drug)
C: Haemoglobin concentration (Hb) of greater than or equal to 2 g/dl from pre- to post-delivery (3-5 days after delivery)
D: Hb of greater than or equal to 2 g/dl from pre- to post-delivery (3-5 days after delivery)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: Intensive Blood Pressure Intervention in Stroke (IBIS) Trial
Brief Summary: The investigators propose to conduct a multicenter randomized controlled trial to test the effect of a systolic blood pressure target of less than 120 mmHg (intensive treatment) compared to a target of less than 140 mmHg (standard treatment) on the risk of total recurrent stroke (ischemic and hemorrhagic) among patients with a recent ischemic stroke. The study findings will help in the development of clinical guidelines for blood pressure management among patients with ischemic stroke and will have an important global impact on reducing stroke-related morbidity and mortality.


Options:
A: Stroke event (Up to four years of follow-up)
B: Number of Participants With First Occurrence of a Myocardial Infarction (MI), Acute Coronary Syndrome (ACS), Stroke, Heart Failure (HF), or CVD Death (6 years)
C: Recurrent stroke (five years)
D: change of percent atheroma volume (1.5-year)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: Intensive Blood Pressure Intervention in Stroke (IBIS) Trial
Brief Summary: The investigators propose to conduct a multicenter randomized controlled trial to test the effect of a systolic blood pressure target of less than 120 mmHg (intensive treatment) compared to a target of less than 140 mmHg (standard treatment) on the risk of total recurrent stroke (ischemic and hemorrhagic) among patients with a recent ischemic stroke. The study findings will help in the development of clinical guidelines for blood pressure management among patients with ischemic stroke and will have an important global impact on reducing stroke-related morbidity and mortality.


Options:
A: Mobility - Measured by Change in Gait Speed (Change from baseline to 36 months)
B: Evidence of clinically defined ischemic stroke (focal neurological deficits persisting for more than 24 hours) confirmed by non-investigational CT or MRI (Mean follow up of 4 years); Evidence of hemorrhagic stroke; a neurologic deficit associated with intraparenchymal or subarachnoid space lesion on CT/MRI or cerebral hemorrhage demonstrated by surgery or autopsy. (within mean follow-up of 4 years)
C: First Occurrence of a Major Cardiovascular Event (MCE); Specifically Nonfatal Heart Attack, Nonfatal Stroke, or Cardiovascular Death (Measured Throughout the Study) in the Glycemia Trial. (4.9 years); First Occurrence of Major Cardiovascular Event (MCE) in the Blood Pressure Trial. (4.7 years); First Occurrence of Major Cardiovascular Event (MCE) in the Lipid Trial. (4.7 years)
D: Stroke event (Up to four years of follow-up)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: Effects of Transcutaneous Perineal Stimulation Versus Anal Stimulation on Urinary Incontinence After Radical Prostatectomy
Brief Summary: This study evaluates whether surface perineal stimulation is as effective as anal stimulation in reducing urinary incontinence secondary to radical prostatectomy.

Half of participants will receive a treatment with surface perineal stimulation, while the other half will receive a treatment with anal stimulation.


Options:
A: Recovery of urinary continence (postoperative 1 month)
B: Effects of transcutaneous perineal stimulation compared to anal stimulation (Baseline, 6 and 10 weeks)
C: Amount of Urinary Leakage (Measured at baseline, 3 months after baseline, and then 6 months after the baseline assessment); Frequency of Daily Urinary Leakage (Measured at baseline, 3 months after baseline, and then 6 months after the baseline assessment)
D: Incontinence Visual Analogue Scale (I-VAS) (7 months)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: Refugee Emergency: DEFining and Implementing Novel Evidence-based Psychosocial Interventions - The Turkey Site
Brief Summary: This study evaluates the effectiveness and cost-effectiveness of the SH+ in Arabic speaking people including Syrians under the temporary protection of Republic of Turkey and other Arabic speaking immigrants and asylum seekers with psychological distress in Turkey. Half of participants will receive Self Help Plus (SH+), while the other half will receive enhanced treatment as usual.


Options:
A: Psychiatric diagnosis at 6-month follow-up (6-month follow-up)
B: Difference in Diabetes Empowerment Scale (DES) scores between OHP+TAU (experimental group) and TAU alone (control group), and within OHP plus TAU across time (Week 1, Week 5, Week 18, Week 30); Difference in Diabetes Management Self-Efficacy Scale (DMSES) scores between OHP+TAU (experimental group) and TAU alone (control group), and within OHP plus TAU across time (Week 1, Week 5, Week 18, Week 30)
C: School Climate (Up to 7 months)
D: Systolic blood Pressure (Baseline and 12 months); Glycated haemoglobin (HbA1c) (Baseline and 12 months)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: Refugee Emergency: DEFining and Implementing Novel Evidence-based Psychosocial Interventions - The Turkey Site
Brief Summary: This study evaluates the effectiveness and cost-effectiveness of the SH+ in Arabic speaking people including Syrians under the temporary protection of Republic of Turkey and other Arabic speaking immigrants and asylum seekers with psychological distress in Turkey. Half of participants will receive Self Help Plus (SH+), while the other half will receive enhanced treatment as usual.


Options:
A: Proportion of clinics which recorded at least one non-epilepsy CAMH diagnosis in the intervention compared to the control group. (3 months)
B: Psychiatric diagnosis at 6-month follow-up (6-month follow-up)
C: the DCM intervention results in improved outcomes compared with CAU at both the provider (e.g., greater adherence to quality indicators) and patient levels (e.g., greater reduction in depressive symptoms) (16 weeks)
D: Posttraumatic Stress Syndrome (PTSS) (Baseline, 3 months); Childhood Traumatic Grief (Baseline, 3 months)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: Cluster Randomized Controlled Trial to Test the Feasibility, Acceptability and Preliminary Effectiveness of a Psychosocial Intervention to Support Alzheimer's Family Caregivers in Vietnam
Brief Summary: This is a cluster randomized controlled trial to determine the feasibility and preliminary effectiveness of culturally adapted psychosocial intervention for Alzheimer's family caregivers in Vietnam. The psychosocial intervention is being compared with an enhance control condition.


Options:
A: Appetitive aggression (sumscore; 0-60 indicating higher levels) (Change from baseline to 3-5 and 6-9 months post treatment); Current violent behavior (sumscore; 0-96 indicating more acts) (Change from baseline to 3-5 and 6-9 months post treatment)
B: Stunting (One year starting with baseline (August-September 2014) and finishing with end line (September 2015); Amendment: also measured at year two (extension) endline); Cognitive function (End line (after one year); Amendment: BSID-III at year two (extension) endline)
C: Zarit Burden Inventory-4 (3 months)
D: Psychosocial Stress: Insecurity (Regional Measure) (11 weeks); Psychosocial stress: Distress (Regional Measure) (11 weeks); Psychosocial Stress (International Measure) (11 weeks)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: Continuous Fascia Iliaca Block for Acute Hip Fractures: a Randomized Controlled Pilot Study
Brief Summary: Hip fractures are a major cause of morbidity and mortality in the elderly with over 30,000 hip fractures occuring in Canada annually and over 1300 in Saskatchewan. The estimated cost associated with hip fractures is over $600 million nationally and 28 million dollars in Saskatchewan. Hip fractures cause a great deal of pain and immobility and are mainly treated with surgical fixation. In the perioperative period, hip fracture patients are treated mainly with opioids and other adjuncts such as NSAIDS and acetaminophen. Opioid consumption in the elderly population can predispose to delirium and respiratory complications such as atelectasis, respiratory depression, and pneumonia.

Fascia iliaca blocks have been shown to be an effective mode of analgesia for patients with hip fractures, but are underutilized for varying reasons including culture of practice, expertise with performing the block, and having a dedicated service to do so.

This study aims to compare the efficacy of fascia iliaca blocks to standard treatment (opioids) in the management of pain in hip fracture patients with a particular focus on outcomes such as the incidence of delirium, respiratory complications, and length of stay in hospital. Our idea is that if we can reduce the amount of opioids these patients receive then they will have improved pain control, fewer respiratory complications, earlier time to mobilizing, and shorter hospital stays. As far as we are aware this relation has not been well studied.


Options:
A: Postoperative Pain Score at Resting (Postoperative 48 hours); Postoperative Pain Score With Movement (Postoperative 48 hours)
B: Pain scores (For 24 hours after performance the blockade)
C: Overall rate of incident delirium (Time of injury to post-injury day 7); Time to onset of incident delirium (Time of injury to post-injury day 7)
D: Respiratory complications (During hospital stay, up to 1 month)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: Multicenter, rAndomized, Double-blind, Placebo-conTrolled, 52-week stUdy to demonstRatE the Efficacy, Safety and Tolerability of Secukinumab Injections With 2 mL Auto-injectors (300 mg) in Adult Subjects With Plaque Psoriasis
Brief Summary: The primary purpose of this study is to assess efficacy, safety and tolerability of a 2 mL pre-filled auto-injector (AI) of 300 mg secukinumab in patients with moderate to severe plaque psoriasis


Options:
A: PASI 75 Response After 12 Weeks of Treatment (12 weeks); IGA Mod 2011 0 or 1 Response After 12 Weeks of Treatment (12 weeks)
B: Percentage of Participants With a Physician's Global Assessment (PGA) Response of "Clear" or "Almost Clear" at Week 12 (Week 12); Percentage of Participants With a Psoriasis Area and Severity Index 75 (PASI75) Response at Week 12 (Week 12)
C: Number of Participants Who Achieved Psoriasis Area and Severity Index (PASI) 75% Improvement at Week 12 (Week 12)
D: Percentage of Participants Achieving a 75 Percent (%) Improvement in Psoriasis Area and Severity Index (PASI 75) Score at Week 24 (Week 24)

Answer: A