TrialPanorama/Dataset huggingface dataset:
Please select the outcome measures that correspond to the clinical trial below.
Title: Effectiveness of Hydroxyurea and Magnesium Pidolate Alone and in Combination in Hemoglobin SC Disease: A Phase II Trial
Brief Summary: Sickle cell disease (SCD), also known as sickle cell anemia, is an inherited blood disease that can cause intense pain episodes. Hemoglobin SCD (HbSC) is a form of SCD that is characterized by dense red blood cells. The purpose of this study is to evaluate the safety and effectiveness of hydroxyurea and magnesium pidolate, alone and combined, at reducing red blood cell density and the frequency of pain episodes in people with HbSC.


Options:
A: Hospital Length of Stay (Hours) (From the time of the start of first study med infusion until hospital discharge or 12 hours after the last IV opioid, whichever occurs first, up to 10 days post enrollment)
B: Dose Limiting Toxicities as a Measure of Whether Infusional Lexiscan is Safe in Individuals With SCD. (30 to 54 hours plus 30-day follow-up)
C: N/A
D: Distribution of the Density of Hemoglobin SC Red Cells (measured 2 months after initiation of treatment)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: Effectiveness of Hydroxyurea and Magnesium Pidolate Alone and in Combination in Hemoglobin SC Disease: A Phase II Trial
Brief Summary: Sickle cell disease (SCD), also known as sickle cell anemia, is an inherited blood disease that can cause intense pain episodes. Hemoglobin SCD (HbSC) is a form of SCD that is characterized by dense red blood cells. The purpose of this study is to evaluate the safety and effectiveness of hydroxyurea and magnesium pidolate, alone and combined, at reducing red blood cell density and the frequency of pain episodes in people with HbSC.


Options:
A: Proportion of children with average hemoglobin ≥9.0 g/dL or average HbF ≥20% (Over 24 month period on study drug)
B: Occurrence of an Adjudicated Secondary Stroke During the 30-month Treatment Period (Because the study was terminated early, time frame is from beginning of treatment until end of treatment (up to 30 Months)); Liver Iron Content (LIC) Change-from-baseline (Because the study was terminated early, time frame is from beginning of treatment until end of treatment (up to 30 Months))
C: Number of Malaria Episodes (12 months)
D: Distribution of the Density of Hemoglobin SC Red Cells (measured 2 months after initiation of treatment)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: Critical Limb Ischemia Treatment by Local Intra-Muscular Injection of Autologous Mononuclear Cells
Brief Summary: The primary focus of the trial is safety and efficacy of the intra-muscular implantation of either bone-marrow, or peripheral blood mononuclear cells, in critical limb ischemia, as judged by the proportion of patients which are alive without major amputation 6 months after inclusion.


Options:
A: Survival without major amputation (6 months after implantation)
B: Change in Six-Minute Walk Performance at 12-week Follow-up (change from baseline to week 12)
C: Safety assessment (adverse events, physical examination,vital signs,ECG, laboratory tests...) (12 weeks)
D: Detection of FGF-1 mRNA (by real-time RT-PCR) in injected tissues at injection site (3 to 8 days after amputation)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: Critical Limb Ischemia Treatment by Local Intra-Muscular Injection of Autologous Mononuclear Cells
Brief Summary: The primary focus of the trial is safety and efficacy of the intra-muscular implantation of either bone-marrow, or peripheral blood mononuclear cells, in critical limb ischemia, as judged by the proportion of patients which are alive without major amputation 6 months after inclusion.


Options:
A: Peak Walking Time (PWT) (Assessed at baseline and 6 months); Leg Collateral Count (Via Contrast Enhanced-MR) (Assessed at baseline and 6 months); Peak Hyperemic Popliteal Flow (Phase Contrast MRA) (Assessed at baseline and 6 months); Capillary Perfusion (Assessed at baseline and 6 months)
B: Angiographic evaluation of angiogenesis and vasculogenesis at target limb (3 months)
C: AE and symptomatic relief (6 months)
D: Survival without major amputation (6 months after implantation)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: Critical Limb Ischemia Treatment by Local Intra-Muscular Injection of Autologous Mononuclear Cells
Brief Summary: The primary focus of the trial is safety and efficacy of the intra-muscular implantation of either bone-marrow, or peripheral blood mononuclear cells, in critical limb ischemia, as judged by the proportion of patients which are alive without major amputation 6 months after inclusion.


Options:
A: adverse events (6 months); ankle-brachial systolic pressure index (3 mo); transcutaneous oxygen value (mm Torr) (3 mo); quality of life (questionnaires) (3 mo)
B: Limb salvage/wound healing at t=6 months; Pain free walking distance (6 months)
C: Number of participants with treatment-related adverse events occurring during the enrollment period as assessed by the Investigator using the MeDRA scale. (Primary follow up in a 6 month period)
D: Survival without major amputation (6 months after implantation)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: Critical Limb Ischemia Treatment by Local Intra-Muscular Injection of Autologous Mononuclear Cells
Brief Summary: The primary focus of the trial is safety and efficacy of the intra-muscular implantation of either bone-marrow, or peripheral blood mononuclear cells, in critical limb ischemia, as judged by the proportion of patients which are alive without major amputation 6 months after inclusion.


Options:
A: Ankle brachial index (6 months)
B: Ankle brachial index (6 months); Healing (1 year); Amputation rate (1 year)
C: The patient is alive, the patient has not undergone any major amputation, complete primary wound healing has been achieved, no ipsilateral relapse has occurred (12 months)
D: Survival without major amputation (6 months after implantation)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: Treating Suicidal Behavior and Self-Mutilation in Borderline Personality Disorder
Brief Summary: This study will determine whether dialectical behavior therapy and fluoxetine are more effective combined or alone in treating people with borderline personality disorder.


Options:
A: Reduction of dissociative symptoms (End of 3rd week treatment of naltrexon)
B: Suicide Attempts (Assessed bimonthly)
C: Suicidal thoughts or attempts (Measured at Year 2)
D: Psychosocial functioning (The outcomes will be assessed after 8, 18, 36, and 72 months:); symptom distress (after 8, 18, 36 and 72 months); self esteem (after 8, 18, 36 and 72 months); interpersonal problems, (after 8, 18, 36 and 72 months); self destructive behavior, (after 8, 18, 36 and 72 months); personality pathology, (after 36 and 72 months); quality of life, (after 8, 18, 36 and 72 months); health care utilization after (after 8, 18, 36 and 72 months)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: Treating Suicidal Behavior and Self-Mutilation in Borderline Personality Disorder
Brief Summary: This study will determine whether dialectical behavior therapy and fluoxetine are more effective combined or alone in treating people with borderline personality disorder.


Options:
A: Rate of suicide attempts (Annual)
B: Suicide Attempts (Assessed bimonthly)
C: change from baseline in borderline symptoms after a 10 week intervention (10 weeks)
D: Number of days with hospital admission (Change between the period from 12 month retrospectively to Baseline and the period from baseline to 12 months prospectively)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: Treating Suicidal Behavior and Self-Mutilation in Borderline Personality Disorder
Brief Summary: This study will determine whether dialectical behavior therapy and fluoxetine are more effective combined or alone in treating people with borderline personality disorder.


Options:
A: Suicide ideation (12 month)
B: Change from baseline Adult Suicidal Ideation at 1-month, 2-month and 3-month (Baseline, 1 month, 2 months, 3 months); Change from baseline Measurement of Hopelessness at 1-month, 2-month and 3-month (Baseline, 1 month, 2 months, 3 months); Change from baseline Interpersonal Needs at 1-month, 2-month and 3-month (Baseline, 1 month, 2 months, 3 months); Change from baseline Service Utilization at 1-month, 2-month and 3-month (Baseline, 1 month, 2 months, 3 months); Change from baseline Suicidality at 1-month, 2-month and 3-month (Baseline, 1 month, 2 months, 3 months)
C: Suicide Attempts (Assessed bimonthly)
D: Social Processing (Cyberball) fMRI Task: fMRI Responses (Pre-treatment (baseline) and post-treatment (up to 2 weeks)); Ecological Momentary Assessment (EMA): Duration, Intensity, and Severity of NSSI Urges and Behavior (One week before tDCS (baseline), two weeks during tDCS (during tDCS), one week post-tDCS (post-tDCS)); Self Injurious Thoughts and Behaviors Inventory Part 1 (Pre-treatment (baseline) and post-tDCS (up to 2 weeks after baseline)); Ecological Momentary Assessment (EMA): NSSI Urges and Behavior (One week before tDCS (baseline), two weeks during tDCS (during tDCS), one week post-tDCS (post-tDCS)); Self Injurious Thoughts and Behaviors Inventory Part 2 (pre-treatment (baseline) and post-treatment (up to 2 weeks)); Self Injurious Thoughts and Behaviors Inventory Part 3 (Pre-treatment (baseline) and post-tDCS (up to 2 weeks after baseline)); Self Injurious Thoughts and Behaviors Inventory Part 4 (Pre-treatment (baseline) and post-tDCS (up to 2 weeks after baseline))

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: Treating Suicidal Behavior and Self-Mutilation in Borderline Personality Disorder
Brief Summary: This study will determine whether dialectical behavior therapy and fluoxetine are more effective combined or alone in treating people with borderline personality disorder.


Options:
A: Number of suicide reattempts in every group (6 months)
B: Change in BHS Scores (Baseline, 6 weeks, and 12 weeks)
C: Repetition of self-harm (Three months); Change scores on the Suicide Behaviors Questionnaire from baseline (Baseline and three months)
D: Suicide Attempts (Assessed bimonthly)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: Treating Suicidal Behavior and Self-Mutilation in Borderline Personality Disorder
Brief Summary: This study will determine whether dialectical behavior therapy and fluoxetine are more effective combined or alone in treating people with borderline personality disorder.


Options:
A: Job satisfaction (baseline to 3 month)
B: Difficulties in Emotional Regulation Scale (DERS). (Hervás 2008) (one year); Automatic Anger and Hostility Thoughts Scale (IPRI) (Magán 2010) (one year); Coping Styles and Strategies Scale (COPE) (Crespo 1997) (one year)
C: Suicide Attempts (Assessed bimonthly)
D: Connor-Davidson's Resilience Scale (CDRISC; Connor and Davidson, 2003) (Up to 3 months)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: Treating Suicidal Behavior and Self-Mutilation in Borderline Personality Disorder
Brief Summary: This study will determine whether dialectical behavior therapy and fluoxetine are more effective combined or alone in treating people with borderline personality disorder.


Options:
A: Suicidal thoughts or attempts (Measured at Year 2)
B: Suicide Attempts (Assessed bimonthly)
C: Affective symptoms measured with the Hamilton Depression Scale (Ham-D) and the Young Mania Rating Scale (YMRS). (weeks: 0, 2, 4, 6, 8, 10, 12); Impulsivity and aggressivity measured with the Time Paradigsm and the the Point Subtraction Aggression Paradigm. (0, 6, 12)
D: Zanarini Rating Scale for Borderline Personality Disorder (Baseline (Visit 1), Week 1 (Visit 2), Week 2 (Visit 3), Week 4 (Visit 4), Week 6 (Visit 5), Week 8 (Visit 6), Week 10 (Visit 7), Week 12 (Visit 8))

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: Head to Head Comparison of Myfortic vs. Cellcept in the Treatment of Kidney Transplant Recipients Using Our Current Center Standardized Concomitant Immunosuppressive Protocol
Brief Summary: The comparison the incidence of G.I. toxicity between Myfortic® vs. Cellcept® in 150 sequential patients, in which 75 will be randomized to Cellcept® and 75 to Myfortic® in first and second living or deceased donor renal transplant recipients.


Options:
A: GFR calculated from the serum creatinine with the Cockcroft-Gault formula at 12 months posttransplantation
B: Observation of G.I. toxicity (nausea, vomiting, or diarrhea). One year patient and graft survival after initiation of study agent.Incidence of biopsy-proven acute rejection (vide infra). 4. Incidence of chronic allograft nephropathy (vide infra). (1 year)
C: Number of Participants With Incidence of Composite Efficacy Failure (12 Months)
D: Evaluation of functional graft (The study is planned to analyze all patients at the end of the fifth year after transplantation. However, an interim analysis will be done at the end of each year.)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: Head to Head Comparison of Myfortic vs. Cellcept in the Treatment of Kidney Transplant Recipients Using Our Current Center Standardized Concomitant Immunosuppressive Protocol
Brief Summary: The comparison the incidence of G.I. toxicity between Myfortic® vs. Cellcept® in 150 sequential patients, in which 75 will be randomized to Cellcept® and 75 to Myfortic® in first and second living or deceased donor renal transplant recipients.


Options:
A: Incidence and severity of biopsy-proven acute rejection at 1 year. (1 year)
B: graft survival (1 year)
C: Percentage of Participants With Sustained Accumulation of Disability (SAD) (Up to 2 years); Annualized Relapse Rate (Up to 2 years)
D: Observation of G.I. toxicity (nausea, vomiting, or diarrhea). One year patient and graft survival after initiation of study agent.Incidence of biopsy-proven acute rejection (vide infra). 4. Incidence of chronic allograft nephropathy (vide infra). (1 year)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: Phase II Randomized, Open-Label Study of IMC-1121B With or Without Dacarbazine in Patients With Metastatic Malignant Melanoma
Brief Summary: The primary objective of this study is to determine the progression-free survival (PFS) of participants with previously untreated metastatic malignant melanoma when treated with IMC-1121B (ramucirumab) alone or in combination with dacarbazine.


Options:
A: Progression free survival (June 2009)
B: Progression-free Survival (PFS) as Assessed by the Investigator (Time interval between the date of randomization and the earlier of the date of disease progression or the date of death due to any cause (up to 9.9 months)); Progression-free Survival (PFS) as Assessed by an Independent Radiologist: Randomized Phase (Time interval between the date of randomization and the earlier of the date of disease progression or the date of death due to any cause (up to 9.9 months))
C: Overall Survival (Survival was assessed every 3 months if patient is < 2 years from study entry. Every 6 months is patient is 2-5 years from study entry.)
D: Progression Free Survival (PFS) (Baseline up to 36 months)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: A Phase II Non Randomized Community Intervention Trial in 4 Public Sectors Schools in Karachi. Exercise Intervention in Female School Children: Effect on Blood Pressure, BMI, and Maths Scores
Brief Summary: Healthy physical activity decreases blood pressure in young female school children. It also has effects on BMI and maths scores.


Options:
A: MET-weighted MVPA: Daily Minutes of Moderate-to-vigorous Physical Activity (MVPA) Weighted by Metabolic Equivalent of Task (MET) (Post-2 year intervention); MET-weighted MVPA: Daily Minutes of Moderate-to-vigorous Physical Activity (MVPA) Weighted by Metabolic Equivalent of Task (MET) (Post-3 year intervention)
B: Blood pressure (6 months)
C: change from baseline in meeting physical activity recommendation at 1 month (baseline and 1 month); change from baseline in physical activity recommendation at 7 months (baseline and 7 months); change from baseline in meeting screen time recommendation at 1 month (baseline and 1 month); change from baseline in meeting screen time recommendation at 7 month (baseline and 7 month)
D: Changes in the composite ICH score of adolescents from baseline to year 2 and 4 (2 and 4 years)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: A Phase II Non Randomized Community Intervention Trial in 4 Public Sectors Schools in Karachi. Exercise Intervention in Female School Children: Effect on Blood Pressure, BMI, and Maths Scores
Brief Summary: Healthy physical activity decreases blood pressure in young female school children. It also has effects on BMI and maths scores.


Options:
A: Percent of infants sleeping 5 consecutive hours at night at 2 months of age (2.5 years)
B: BMI and aerobic fitness (1 schoolyear)
C: Anthropometric Variables (every two years)
D: Blood pressure (6 months)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: A Phase IIIb, Multi-Center, Randomized, Withdrawal Study to Evaluate the Immunogenicity and Safety of Subcutaneous Administered Abatacept in Adults With Active Rheumatoid Arthritis
Brief Summary: The purpose of the study is to determine whether subcutaneous abatacept administered to patients with rheumatoid arthritis is associated with increased immunogenicity or increased safety events upon withdrawal and reintroduction.


Options:
A: MRI synovitis, bone edema and erosions score (baseline, week 18 and 52)
B: EULAR Good Response (at 24 weeks); ACR50 Response Rate (at 24 weeks); Radiographic Progression Defined by Change in Van Der Heijde-modified Total Sharp Score (at 52 weeks)
C: Double-blind Withdrawal (DBW) Period; Percentage of Participants With Positive Anti-Abatacept or Anti-Cytotoxic T-Lymphocyte Antigen 4 (CTLA4) Antibody Responses by Enzyme-Linked Immunosorbent Assay (ELISA) at Day 169 (Day 169); Re-introduction (RI) Period; Percentage of Participants With Positive Anti-Abatacept or Anti-CTLA4 Antibody Responses by ELISA at Day 253, by DBW Period Groups (Day 253 (short term))
D: Proportion of Participants With an American College of Rheumatology (ACR) 20 Response at Week 14 (Week 14)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: A Phase IIIb, Multi-Center, Randomized, Withdrawal Study to Evaluate the Immunogenicity and Safety of Subcutaneous Administered Abatacept in Adults With Active Rheumatoid Arthritis
Brief Summary: The purpose of the study is to determine whether subcutaneous abatacept administered to patients with rheumatoid arthritis is associated with increased immunogenicity or increased safety events upon withdrawal and reintroduction.


Options:
A: Number of patients who achieve a DAS28 < 3.2 (0, 1, 3, 6, 9, 12 and 24 months (DAS28))
B: Percentage of patients with ACR 20 response (Week 24)
C: American college of Rheumatolofy (ACR)-20 responder rate at Week 24
D: Double-blind Withdrawal (DBW) Period; Percentage of Participants With Positive Anti-Abatacept or Anti-Cytotoxic T-Lymphocyte Antigen 4 (CTLA4) Antibody Responses by Enzyme-Linked Immunosorbent Assay (ELISA) at Day 169 (Day 169); Re-introduction (RI) Period; Percentage of Participants With Positive Anti-Abatacept or Anti-CTLA4 Antibody Responses by ELISA at Day 253, by DBW Period Groups (Day 253 (short term))

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: A Phase IIIb, Multi-Center, Randomized, Withdrawal Study to Evaluate the Immunogenicity and Safety of Subcutaneous Administered Abatacept in Adults With Active Rheumatoid Arthritis
Brief Summary: The purpose of the study is to determine whether subcutaneous abatacept administered to patients with rheumatoid arthritis is associated with increased immunogenicity or increased safety events upon withdrawal and reintroduction.


Options:
A: Double-blind Withdrawal (DBW) Period; Percentage of Participants With Positive Anti-Abatacept or Anti-Cytotoxic T-Lymphocyte Antigen 4 (CTLA4) Antibody Responses by Enzyme-Linked Immunosorbent Assay (ELISA) at Day 169 (Day 169); Re-introduction (RI) Period; Percentage of Participants With Positive Anti-Abatacept or Anti-CTLA4 Antibody Responses by ELISA at Day 253, by DBW Period Groups (Day 253 (short term))
B: Percentage of ACR20 (American College of Rheumatology 20% Improvement) Responders at Week 34 in Patients Randomized at Week 18 (Baseline, Week 34)
C: Change From Baseline in Adjusted Mean of American College of Rheumatology Response (ACR-N) Area Under Curve (AUC) Over 16 Weeks (16 weeks)
D: Proportion of Participants With an American College of Rheumatology (ACR) 20 Response at Week 14 (Week 14)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: A Phase IIIb, Multi-Center, Randomized, Withdrawal Study to Evaluate the Immunogenicity and Safety of Subcutaneous Administered Abatacept in Adults With Active Rheumatoid Arthritis
Brief Summary: The purpose of the study is to determine whether subcutaneous abatacept administered to patients with rheumatoid arthritis is associated with increased immunogenicity or increased safety events upon withdrawal and reintroduction.


Options:
A: Double-blind Withdrawal (DBW) Period; Percentage of Participants With Positive Anti-Abatacept or Anti-Cytotoxic T-Lymphocyte Antigen 4 (CTLA4) Antibody Responses by Enzyme-Linked Immunosorbent Assay (ELISA) at Day 169 (Day 169); Re-introduction (RI) Period; Percentage of Participants With Positive Anti-Abatacept or Anti-CTLA4 Antibody Responses by ELISA at Day 253, by DBW Period Groups (Day 253 (short term))
B: Baseline change in disease activity, assessed as the Disease Activity Score (DAS28) and erythrocyte sedimentation rate, or DAS28-(4)-ESR (Day 85); Incidence and severity of adverse events and clinical laboratory abnormalities as a measure of safety and tolerability of MLTA3698A (Length of study (through Day 85))
C: Number of Participants Meeting American College of Rheumatology 50% (ACR50) Response Criteria at Week 52 (Baseline and 52 Weeks); Change From Baseline in Modified Total Sharp Score (mTSS) at Week 52 (Baseline and Week 52)
D: The objective of this study is to evaluate the therapeutic response including radiographic changes and safety of etanercept alone, methotrexate (MTX) alone, and the combination of etanercept and MTX in patients with rheumatoid arthritis (RA)

Answer: A