TrialPanorama/Dataset huggingface dataset:
Please select the outcome measures that correspond to the clinical trial below.
Title: Evaluation of the Educational Program of Diabetes Mellitus: Focus on Empowerment
Brief Summary: With health education, patients will have knowledge of the disease and may modify their attitudes to diabetes. Have a different behavior, will perform self-management of their health. Will adhere to physical activity, the better control of the disease and have quality of life. Empower the patient through the educational practices.


Options:
A: Glycated hemoglobin level before and after intervention (1 year after start of the intervention)
B: Rate of Change in Hemoglobin A1c (12 month period)
C: HbA1c (12 months)
D: The change in mean daytime systolic BP from baseline to the last (12-month) visit on 24-hour ambulatory. (1 year)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: Controlled Education Of Patients After Stroke
Brief Summary: The main objective of the study is to compare the benefit of optimised follow-up by nursing personnel from the vascular neurology department, including therapeutic follow-up and an educational program directed to the patient and a caregiving member of his social circle, with that of a typical follow-up.


Options:
A: Change in Systolic Blood Pressure (baseline and 6 months); Change in HDL Level (baseline and 6 months); Change in LDL Level (baseline and 6 months); Change in Triglyceride Level (baseline and 6 months); Change in HbA1c Level (baseline and 6 months); Change in Glycaemia Level (baseline and 6 months); Change in BMI Value (baseline and 6 months)
B: Barthel Index (Change from Baseline to 2, 4, 12 and 22 weeks)
C: Increase in Adherence and Control of Stroke Risk Factors (1, 3, 6, 9 and 12 months)
D: blood pressure (12 months)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: Nifedipine for Acute Tocolysis of Preterm Labor
Brief Summary: The purpose of this study is to determine if nifedipine treatment of women in preterm labor receiving corticosteroids results in postponement of delivery when compared to placebo.


Options:
A: Prolongation of pregnancy (From allocation to the delivery)
B: delivery within 48 hours (48 hours after enrollment)
C: N/A
D: Number of Participants With Preterm Birth (Less than 37 weeks of gestation)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: CD19-targeting 3rd Generation CAR T Cells for Refractory B Cell Malignancy - a Phase I/IIa Trial.
Brief Summary: Chimeric antigen receptor (CAR) T cells targeting CD19 will be evaluated for safety and efficacy in patients with B cell lymphoma or leukemia. The CAR consists of a CD19 targeting antibody scFv with three intracellular signaling domains derived from CD3 zeta, CD28 and 4-1BB. Autologous T cells will be gene engineered with the CAR gene using a retrovirus vector. Prior to T cell infusion, the patients will be subjected to preconditioning treatment. After T cell infusion, the patients will be evaluated for 24 months for adverse reactions, persistence of CAR T cells and efficacy.


Options:
A: Incidence and severity of dose limiting toxicities (DLTs) following chemotherapy preparative regimen and infusion of CD19/CD22 chimeric antigen receptor (CAR) T cells (Up to 28 days); Maximum tolerated dose of CD19/CD22 chimeric antigen receptor (CAR) T cells defined as the dose level immediately below the level at which the enrollment is stopped due to a dose limiting toxicity (Up to 28 days); Rate of successful manufacture and expansion of the CD19/CD22 chimeric antigen receptor (CAR) T cells to satisfy the targeted dose level and meet the required release specifications outlined in the Certificate of Analysis (Up to 15 years)
B: CAR T cell persistence (At week 1 and 5, there after every 3 months post treatment up to 24 months)
C: Adverse Events That Are Related to Treatment (2 years)
D: Frequency, relatedness, severity and duration of treatment emergent and treatment related adverse events (35 days); Number of first cycle dose limiting toxicities (DLT) as assessed by Common Terminology Criteria for Adverse Events (CTCAE) (up to 1 year)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: Rate Control Versus Rhythm Control For Postoperative Atrial Fibrillation
Brief Summary: The purpose of this study is to compare the therapeutic strategies of rate control versus rhythm control in cardiac surgery patients who develop in-hospital postoperative atrial fibrillation or atrial flutter (AF). In patients who develop AF during hospitalization after cardiac surgery, the hypothesis is that a strategy of rhythm control will reduce days in hospital within 60 days of the occurrence of AF compared to a strategy of rate control.


Options:
A: Composite Neurological Outcome of Clinical Stroke or New Ischemic Brain Lesion on Diffusion Weighted MRI or Neurocognitive Dysfunction 4 to 6 Weeks After Surgery. (Up to 6 weeks post-operative)
B: Incidence of Delirium (Participants will be followed for the duration of the hospital stay, an average of 5 days)
C: Total Number of Days in Hospital (Within 60 days of randomization)
D: composite of post-operative all-cause mortality and major complications (participants will be followed for the duration of hospital stay after the index cardiac operation, an expected average of 2 weeks)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: Restorative Exercise for Strength Training and Operational Resilience
Brief Summary: The purpose of the study is to learn about the effect of integrative therapies on chronic or recurrent low back pain.

The intervention called RESTORE (Restorative Exercises for Strength Training and Operational Resilience) is based on a series of gentle stretching and strengthening exercises incorporating breath-work and mindfulness. The study is designed to discover the impact of RESTORE on pain levels, physical function, and behavioral health.


Options:
A: Change in Oswestry Disability Index (ODI) (Baseline, post intervention (at 8-14 weeks), 6, 12 and 36 months)
B: Sickness absence days (Low back (LB) specific, other than LB, total) (6, 12, 24, 36, 48 months); Low back pain (VAS) (0, 3, 6, 12, 24 months); Disability (Roland Morris 18) (0, 3, 6, 12, 24 months); Quality of Life (15-D) (0, 3, 6, 12, 24 months)
C: The Roland Morris Disability Questionnaire (RDQ) Score (12 months)
D: Pain Scores (Baseline, Midtreatment, Posttreatment, 3 month follow-up, 6 month follow-up)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: Restorative Exercise for Strength Training and Operational Resilience
Brief Summary: The purpose of the study is to learn about the effect of integrative therapies on chronic or recurrent low back pain.

The intervention called RESTORE (Restorative Exercises for Strength Training and Operational Resilience) is based on a series of gentle stretching and strengthening exercises incorporating breath-work and mindfulness. The study is designed to discover the impact of RESTORE on pain levels, physical function, and behavioral health.


Options:
A: Pain Scores (Baseline, Midtreatment, Posttreatment, 3 month follow-up, 6 month follow-up)
B: Number of Days on Sick Leave (12 MONTHS)
C: Average pain intensity (up to 12 weeks); Modified Roland Morris Disability Questionnaire for back pain-specific disability (up to 12 weeks)
D: Client Satisfaction Questionnaire (3 months); Credibility Expectancy Questionnaire (CEQ) (1 month); Participant adherence (3 months); Participant homework adherence (3 months); Instructor manual fidelity checklist (3 months); Systematic Assessment of Treatment-Emergent Events - General Inquiry (3 months)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: A Double-blind, Randomized, Placebo Controlled Study to Evaluate the Efficacy and Safety of Intranasal Esketamine for the Rapid Reduction of the Symptoms of Major Depressive Disorder, Including Suicidal Ideation, in Subjects Who Are Assessed to be at Imminent Risk for Suicide
Brief Summary: The purpose of this study is to evaluate the efficacy of intranasal esketamine 84 milligram (mg) compared with intranasal placebo along with standard care treatment, in reducing the symptoms of major depressive disorder (MDD) (an affective disorder manifested by either a dysphoric mood or loss of interest or pleasure in usual activities, the mood disturbance is prominent and relatively persistent), including the risk for suicide as assessed by the Investigator, in participants who will be assessed to be at imminent risk for suicide.


Options:
A: Level of Depression as assessed by the HAM-D (Day 1-7)
B: Change From Baseline to Day 1: 4-Hour Post-dose in Montgomery Asberg Depression Rating Scale (MADRS) Total Score (Double-blind Phase) (Baseline (Day 1-Predose) to Day 1: 4-hours post-dose)
C: Change in Scale for Suicidal Ideation (Day 1 (24 hours) post-treatment)
D: Montgomery-Asberg Depression Rating Scale (MADRS) Total Score. (60 minutes (min) prior to dosing (baseline); and 60 min, 80 min, 110 min, 230 min, 1 day, 2 days, 3 days and 7 days following dosing.)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: A Phase II Randomized Controlled Trial to Evaluate a Brief Psychosocial Intervention Together With Early Palliative Care in Reducing Depressive Symptoms of Patients With Advanced Cancer Starting First Line Palliative Chemotherapy
Brief Summary: The purpose of this study is to determine whether a brief psychosocial intervention together with early palliative care are feasible, acceptable and effective in the reduction of depressive symptoms of patients with advanced cancers starting first line palliative chemotherapy.


Options:
A: length of stay hospital, intensive care unit and emergency admissions (1 year)
B: Patient Heath Related Quality of Life (HRQL) as measured by the FACT-G, QUAL-E and FACIT-Sp. (Three months after enrollment.)
C: Quality of life as measured by Functional Assessment of Cancer Therapy-Palliative care version (FACT-Pal) at baseline, one month, and every three months thereafter (Baseline, one month, every three months); Symptom management as measured by Edmunton Symptom Assessment Scale at baseline, one month, and every three months thereafter (Baseline, one month, every three months); Health care utilization by a chart review of days in hospital, ICU, ER visits at baseline, one month, and every three months thereafter (Baseline, one month, every three months); Correlate preferences for care and care received as measured by After Death Bereaved Family Member Interview with a family member of the deceased (Baseline, one month, every three months)
D: Change from baseline in depression symptoms on the HADS-D and PHQ-9 at day 90. (Baseline, Day 90.); Change from baseline in satisfaction with care on the FAMCARE-patient scale at days Days 45, 90, 120 and 180. (Baseline, Days 45, 90, 120 and 180.); Descriptive results about feasibility of the study. (Average duration in minutes of each intervention session (both regarding Palliative Care consultation and Psychological session); number of non-attendance to the interventions (absences); reasons reported by patients for missing.)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: Phase III, Multicenter, Randomized, Double-blind, Placebo-controlled Study to Evaluate the Efficacy and Safety of Live Attenuated Bovine-Human Rotavirus Reassortant Pentavalent Vaccine (BRV-PV) Against Severe Rotavirus Gastroenteritis in Healthy Indian Infants
Brief Summary: This is a Phase 3 multicentre, randomized, double blind, placebo-controlled study to determine the effectiveness of the rotavirus vaccine.


Options:
A: Efficacy against severe rotavirus gastroenteritis (>=11 on the 20 point Vesikari scoring scale) caused by non vaccine rotavirus (Up to 2 years of age)
B: Number of Participants Developing a Serum Anti-rotavirus Immunoglobulin (Ig) A Titer of 20 or Greater in the WC3 IgA Assay (3-6 weeks after the last vaccination); Number of Participants Developing a Serum Anti-rotavirus Immunoglobulin (Ig) A Titer of 20 or Greater in the 89-12 IgA Assay (3-6 weeks after the last vaccination); Geometric Mean Serum Anti-rotavirus IgA Titer (3-6 weeks after the last dose of vaccine)
C: occurrence of Severe Rotavirus Gastroenteritis (Up to 2 years of age of participants)
D: Primary study endpoint: acute rotavirus diarrhoea occurring from 6 weeks of age to the end of the follow-up period in subjects who resided in randomized villages during the period when they were age-eligible to have received Rotarix. (24 months)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: Phase III, Multicenter, Randomized, Double-blind, Placebo-controlled Study to Evaluate the Efficacy and Safety of Live Attenuated Bovine-Human Rotavirus Reassortant Pentavalent Vaccine (BRV-PV) Against Severe Rotavirus Gastroenteritis in Healthy Indian Infants
Brief Summary: This is a Phase 3 multicentre, randomized, double blind, placebo-controlled study to determine the effectiveness of the rotavirus vaccine.


Options:
A: Immunogenicity (7 months)
B: occurrence of Severe Rotavirus Gastroenteritis (Up to 2 years of age of participants)
C: Safety of Rotavin-M1 vaccine in healthy adult volunteers (3 months)
D: Presence of Fecal Shedding of Polio Vaccine Virus Determined by Culture (Polio Trial) (25 days following week 52 visit); Number of Participants With One or More Episodes of Rotavirus-associated Diarrhea (Rotavirus Trial) (Birth to one year)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: Phase III, Multicenter, Randomized, Double-blind, Placebo-controlled Study to Evaluate the Efficacy and Safety of Live Attenuated Bovine-Human Rotavirus Reassortant Pentavalent Vaccine (BRV-PV) Against Severe Rotavirus Gastroenteritis in Healthy Indian Infants
Brief Summary: This is a Phase 3 multicentre, randomized, double blind, placebo-controlled study to determine the effectiveness of the rotavirus vaccine.


Options:
A: Seroprotection for each polio serotype 1 month after the 3rd dose.
B: Percentage of Participants Achieving Seroresponse for Meningiococcal Group C Serotype (28 days after the second dose of MCC vaccine (approximately 20 weeks))
C: occurrence of Severe Rotavirus Gastroenteritis (Up to 2 years of age of participants)
D: Occurrence of RV GE

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: A Single Centre Randomised Controlled Study Into the Segmentation of Preimplantation Genetic Diagnosis (PGD) Treatment by Comparing Cumulative Pregnancy Rates Following Cryopreservation of All Genetically Transferable Embryos After PGD, Compared to Fresh Embryo Transfer Cumulative With Frozen Embryo Transfer of Genetically Transferable Embryos.
Brief Summary: A single centre observational study into the segmentation of preimplantation genetic diagnosis (PGD) treatment by comparing cumulative pregnancy rates following cryopreservation of all genetically transferable embryos after PGD, compared to fresh embryo transfer cumulative with frozen embryo transfer of genetically transferable embryos.The primary aim of the study is to assess the feasibility and effectiveness of segmentation in terms of pregnancy rates. The secondary aim is to assess the logistic advantage of segmentation in PGD cycles.

Experimental questions

1. Is the cumulative live birth rate rate of a single PGD treatment when all genetically transferable embryos are cryopreserved by vitrification prior to consecutive in utero transfer in unstimulated cycles, superior to PGD treatment with fresh embryo transfer cumulative with transfer of supernumerary cryopreserved embryos?
2. Does the technique of segmentation allow better planning of DNA amplification and genetic analysis?

Design The proposed design is a pragmatic, prospective randomised controlled trial


Options:
A: cumulative live birth rate of a single PGD treatment (1 year)
B: Live birth rates (≥ 35 weeks of gestation after the first single blastocyst embryo transfer according to fresh or deferred-frozen transfer.)
C: Clinical pregnancy (fetal heartbeat observed on ultrasound at 7 weeks gestation) (7 weeks gestation)
D: Implantation rate (8 weeks after replacement)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: Impact of Transcranial Direct Current Stimulation (tDCS) on Locomotion and Bipedal Equilibrium in Hemiplegic Patients: a Crossover Randomized Controlled Trial
Brief Summary: The aim of this trial is to quantify the improvement of locomotion and equilibrium induced par tDCS in anode polarity position in post stroke hemiplegic patients.


Options:
A: Change from Baseline in the motor impairment as assessed by the Fugl-Meyer Motor Assessment Scale (upper extremity subsection) (6 weeks)
B: Quantify of variability of the center-of-mass movement (30 minutes)
C: change in function before/after tDCS (Before intervention, immediately after intervention, 10-20-30-40-50-60 min after intervention; long-term after intervention : 1-2-3-4 weeks, 2-3-4-5-6-7-8-9-10-11-12 months)
D: Upper Extremity Component of Fugl-Meyer Assessment (week 0, week 2, week 4)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: Changes in Methylation Status of BDNF Gene After Receiving Dialectical Behavior Therapy in Patients With Borderline Personality Disorder
Brief Summary: Borderline personality disorder (BPD) is a chronic and debilitating syndrome associated with considerable morbidity, mortality, and high rates of medical and psychiatric utilization services. Research focusing on finding a biological observable marker for the purpose of monitoring treatment effects has started to draw attention. Recent research has implicated that brain-derived neutrophilic factor (BDNF) might be a natural candidate for a biological correlate of early life stress. The alterations in levels of BDNF or BDNF methylation in BPD patients compared to general population, or pre- and post- psychotherapeutic treatment might indicate the consequence of epigenetic modification associated with stressful experience or suicide, and may later be able to explain the psychopathology or neuro-development of BPD.

Method: The investigators therefore propose this current randomized control trial to test whether epigenetic changes happen during and after DBT treatments, and not TAU. Proportions having suicide or non-suicidal self injurious behaviors will be followed and tested against changes in BDNF methylation levels. Other clinical symptoms will as be assessed, including suicidality, depression, hopelessness, quality of life, disability, service utilization, and function.

In the first to third years of this study, the investigators will aim to recruit 180 study and control subjects, to gather information, to collect biological samples, to give out one-year of psychotherapy per subject, to evaluate results before, during, and after treatment. In addition, the investigators also hope to explore the effects of known or unknown drugs associated with the change of DNA methylation at cell level.

Hypothesis:

Responders of participants who receive DBT will show greater decrease in BDNF methylation levels than patients receiving TAU.


Options:
A: Borderline Symptom Checklist (BSL-23) (Changes in scores of BSL-23 before treatment, and at 4, 8, 12 months after starting the treatment)
B: drinking - measured using the TLFB (12 weeks); craving - measured using the OCDS (12 weeks); aggression - measured using the STAE (12 weeks)
C: assessing change in number of suicide attempts/self-harming acts (baseline, 0, 12, 24 and 52 weeks after the start of the inpatient treatment)
D: Suicide Attempts (Assessed bimonthly)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: Changes in Methylation Status of BDNF Gene After Receiving Dialectical Behavior Therapy in Patients With Borderline Personality Disorder
Brief Summary: Borderline personality disorder (BPD) is a chronic and debilitating syndrome associated with considerable morbidity, mortality, and high rates of medical and psychiatric utilization services. Research focusing on finding a biological observable marker for the purpose of monitoring treatment effects has started to draw attention. Recent research has implicated that brain-derived neutrophilic factor (BDNF) might be a natural candidate for a biological correlate of early life stress. The alterations in levels of BDNF or BDNF methylation in BPD patients compared to general population, or pre- and post- psychotherapeutic treatment might indicate the consequence of epigenetic modification associated with stressful experience or suicide, and may later be able to explain the psychopathology or neuro-development of BPD.

Method: The investigators therefore propose this current randomized control trial to test whether epigenetic changes happen during and after DBT treatments, and not TAU. Proportions having suicide or non-suicidal self injurious behaviors will be followed and tested against changes in BDNF methylation levels. Other clinical symptoms will as be assessed, including suicidality, depression, hopelessness, quality of life, disability, service utilization, and function.

In the first to third years of this study, the investigators will aim to recruit 180 study and control subjects, to gather information, to collect biological samples, to give out one-year of psychotherapy per subject, to evaluate results before, during, and after treatment. In addition, the investigators also hope to explore the effects of known or unknown drugs associated with the change of DNA methylation at cell level.

Hypothesis:

Responders of participants who receive DBT will show greater decrease in BDNF methylation levels than patients receiving TAU.


Options:
A: assessing change in number of suicide attempts/self-harming acts (baseline, 0, 12, 24 and 52 weeks after the start of the inpatient treatment)
B: Borderline Symptom Checklist (BSL-23) (Changes in scores of BSL-23 before treatment, and at 4, 8, 12 months after starting the treatment)
C: Changes in scores on Beck's Scale for Suicide Ideation (BSSI) (From baseline to 6 and 12 months after patient is included in the study)
D: Change in mindfulness (Baseline and after 12-weeks); Change in borderline symptom severity (Baseline and after 12-weeks); Change in overall psychiatric symptom severity (Baseline and after 12-weeks); Change in severity in symptoms of depression (Baseline and after 12-weeks)

Answer: B