TrialPanorama/Dataset huggingface dataset:
Please select the outcome measures that correspond to the clinical trial below.
Title: Aneurysmal Subarachnoid Hemorrhage - Red Blood Cell Transfusion and Outcome (SAHaRA): A Randomized Controlled Trial
Brief Summary: The SAHaRA trial will clarify the role of treating anemia with Red Blood Cell (RBC) transfusion in a unique and vulnerable patient population, and determine whether that impacts on functional outcomes and mortality. It will guide best practice standards and clarify the optimal RBC transfusion strategy in patients with aSAH.


Options:
A: Recruitment: screening (One year); Recruitment: consent (One year); Recruitment: enrolment (One year)
B: Modified Rankin Scale (mRS) (12 months post)
C: A composite endpoint of all-cause post-randomization mortality, myocardial infarction (MI), coronary revascularization, acute renal failure, or post-randomization ischemic stroke up to 90 days after randomization. (90 days after randomization)
D: Incidence of Blood Stream Infection (1 week after randomization and weekly thereafter through discarge from hospital)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: Aneurysmal Subarachnoid Hemorrhage - Red Blood Cell Transfusion and Outcome (SAHaRA): A Randomized Controlled Trial
Brief Summary: The SAHaRA trial will clarify the role of treating anemia with Red Blood Cell (RBC) transfusion in a unique and vulnerable patient population, and determine whether that impacts on functional outcomes and mortality. It will guide best practice standards and clarify the optimal RBC transfusion strategy in patients with aSAH.


Options:
A: Physical Fatigue (on day 3 postpartum)
B: Modified Rankin Scale (mRS) (12 months post)
C: In-hospital death (In-hospital); Recurrent myocardial infarction (MI) (In-hospital); New or worsening heart failure (In-hospital)
D: Total Number of Units Transfused (From randomization until discharge from admission for delivery, an average of 2-3 days)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: Aneurysmal Subarachnoid Hemorrhage - Red Blood Cell Transfusion and Outcome (SAHaRA): A Randomized Controlled Trial
Brief Summary: The SAHaRA trial will clarify the role of treating anemia with Red Blood Cell (RBC) transfusion in a unique and vulnerable patient population, and determine whether that impacts on functional outcomes and mortality. It will guide best practice standards and clarify the optimal RBC transfusion strategy in patients with aSAH.


Options:
A: Functional ability (Measured 10 days after surgery + repeated measurement during 90 days after surgery)
B: Modified Rankin Scale (mRS) (12 months post)
C: Recruitment: screening (One year); Recruitment: consent (One year); Recruitment: enrolment (One year)
D: A composite endpoint of all-cause post-randomization mortality, myocardial infarction (MI), coronary revascularization, acute renal failure, or post-randomization ischemic stroke up to 90 days after randomization. (90 days after randomization)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: An Exploratory Phase 1/2 Trial To Evaluate The Safety And Efficacy Of JCAR017 Combinations In Subjects With Relapsed/Refractory B-Cell Malignancies (PLATFORM)
Brief Summary: This is a global, open-label, multi-arm, parallel multi-cohort, multi-center, Phase 1/2 study to determine the safety, tolerability, PK, efficacy and patient-reported quality of life of JCAR017 in combination with various agents. This protocol is intended to evaluate various drug combinations with JCAR017, as separate arms, over the life of the protocol, using the same objectives. Each combination will be evaluated separately (ie, the intention is not to compare between combinations) for the purposes of the objectives, trial design, and statistical analysis. The following combinations will be tested:

Arm A: JCAR017 in combination with durvalumab Arm B: JCAR017 in combination with CC-122 (avadomide) Arm C: JCAR017 in combination with CC-220 (iberdomide) Arm D: JCAR017 in combination with ibrutinib Arm E: JCAR017 in combination with relatlimab and/or nivolumab Arm F: JCAR017 in combination with CC-99282 Additional arms will be added by way of amendment once combination agents have been selected.

The study will consist of 2 parts: dose finding (Phase 1) and dose expansion (Phase 2). Dose expansion may occur in one or more arms.


Options:
A: Number and severity of adverse events assessed by CTCAE v5.0, except for Cytokine Release Syndrome and Immune Effector Cell-Associated Neurotoxicity Syndrome, which will be assessed by ASTCT consensus grading criteria (3 months after administration)
B: Number of Participants With Dose-Limiting Toxicity (DLT) (From first dose of the combination agent until 1 month (28 days) after JCAR017 infusion (pre- JCAR017 cohort) or from JCAR017 infusion until 1 month (28 days) after the first dose of combination agent (post-JCAR017 cohort)); Complete Response Rate (CRR) (At 3 and 6 months post-JCAR017 infusion.)
C: Safety as assessed by dose limiting toxicities (DLTs) (28 days); Safety as assessed by determination of the maximum tolerated dose (MTD) (24 months); Safety as assessed by determination of the recommended phase 2 dose (RP2D) (24 months); Safety as assessed by and adverse events, laboratory assessments and physical examinations (24 months); Safety as assessed by mini-mental state examination (MMSE) (24 months)
D: Proportion of participants with treatment-emergent adverse events (AEs) (From initiation of study treatment to 12 months following CAR-T infusion, approximately 15 months); Proportion of participants who experience a dose-limiting toxicity (DLT) (From initiation of study treatment to 30 days following CAR-T infusion)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: Homestead Agriculture and Nutrition Project in Rufiji District, Tanzania
Brief Summary: HANU is an evaluation of the effects of an integrated, gender-focused nutrition-sensitive intervention on the nutrition and health of young children and women of reproductive age in rural Tanzania.


Options:
A: Exclusive Breastfeeding Rates in Burkina Faso (at 3 months of age); Infant Morbidity, 2 Week Diarrhoea Prevalence (at 3 months of age); Exclusive Breastfeeding Rates in Uganda (at 3 months of age); Exclusive Breastfeeding Rates in South Africa (at 3 months of age)
B: Dietary diversity defined as number of food groups consumed out of 10 (12 and 36 months)
C: Linear growth: Mean change from baseline in length-for-age Z-scores at at 9-, 12- and 15-months-old (Length-for-age Z-scores: Baseline (6 months-old), Month 9, Month 12 and Month 15)
D: Absolute change pre/post intervention (VHV ICCM training) in proportion of U5s receiving (a) antimalarial for fever (b) ORS/Zn for diarrhea (c) Abx for pneumonia (pre- (Dec 2010) post- (Dec 2012) intervention (2 years))

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: A European, Prospective, Multi-Center, Double-Blind, Randomized, Controlled, Clinical Trial Investigating the Effects of High Frequency Wireless Spinal Cord Stimulation (SCS) Over Exiting Nerve Roots in the Treatment of Chronic Back Pain
Brief Summary: Prospective, double blinded, randomized, clinical study investigating the effects of high frequency SCS over exiting nerve roots at T9 for the treatment of chronic back or back and leg pain.


Options:
A: Visual Analog Scale (VAS) on Back Pain (12 weeks)
B: Change from baseline in disease-specific functional outcome between active burst stimulation and placebo stimulation periods (12 months)
C: Percent pain relief obtained during the one-month follow-up compared to baseline; The magnitude of change in other indexes of function, such as MPI, during the one-month follow-up period
D: Responder rate (1 month post-implant)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: A European, Prospective, Multi-Center, Double-Blind, Randomized, Controlled, Clinical Trial Investigating the Effects of High Frequency Wireless Spinal Cord Stimulation (SCS) Over Exiting Nerve Roots in the Treatment of Chronic Back Pain
Brief Summary: Prospective, double blinded, randomized, clinical study investigating the effects of high frequency SCS over exiting nerve roots at T9 for the treatment of chronic back or back and leg pain.


Options:
A: Change in Visual Analog Scale (VAS) score (Pre-implant visit, up to approximately 2 weeks)
B: Evaluation of pain (28 days)
C: Responder rate (1 month post-implant)
D: Usual pain intensity in lower extremity(ies) (Will be measured at day 7 to day 13 in each period (to avoid carry-over effects from previous treatment period))

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: A European, Prospective, Multi-Center, Double-Blind, Randomized, Controlled, Clinical Trial Investigating the Effects of High Frequency Wireless Spinal Cord Stimulation (SCS) Over Exiting Nerve Roots in the Treatment of Chronic Back Pain
Brief Summary: Prospective, double blinded, randomized, clinical study investigating the effects of high frequency SCS over exiting nerve roots at T9 for the treatment of chronic back or back and leg pain.


Options:
A: Patient's Global Impression of Change (PGIC)
B: Responder rate (1 month post-implant)
C: Visual Analog Scale (VAS) on Back Pain (12 weeks)
D: Global Pain VAS Visual Analogic Scale (VAS) (Month 3)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: Phase II Multicentric Study: Efficacy Evaluation of Neoadjuvant Treatment Associated With Maintenance Therapy by Anti-PD1 Immunotherapy on Disease-free-survival (DFS) in Patients With Resectable Head and Neck Mucosal Melanoma
Brief Summary: The main objective will be to estimate the disease free survival (DFS) of patients with resectable head and neck mucosal melanomas treated by neo-adjuvant anti-PD1 (in combination or not with lenvatinib) followed by surgery, radiotherapy and maintenance immunotherapy in order to compare it to historical DFS results of this kind of patients treated by surgery and radiotherapy. Our primary end-point will be disease-free survival at 2 years


Options:
A: Disease Free Survival (Up to 2 years)
B: Major Pathologic Response (MPR) (54 weeks)
C: Event-free survival (EFS) (Up to 4 years)
D: Relapse-free survival (RFS) (Up to 1 year)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: Phase II Multicentric Study: Efficacy Evaluation of Neoadjuvant Treatment Associated With Maintenance Therapy by Anti-PD1 Immunotherapy on Disease-free-survival (DFS) in Patients With Resectable Head and Neck Mucosal Melanoma
Brief Summary: The main objective will be to estimate the disease free survival (DFS) of patients with resectable head and neck mucosal melanomas treated by neo-adjuvant anti-PD1 (in combination or not with lenvatinib) followed by surgery, radiotherapy and maintenance immunotherapy in order to compare it to historical DFS results of this kind of patients treated by surgery and radiotherapy. Our primary end-point will be disease-free survival at 2 years


Options:
A: Overall Survival (From randomization (initiated January 2010) to December 30 2010. Median follow-up time in the vemurafenib group was 3.75 months (range 0.3 to 10.8) and in the dacarbazine group was 2.33 months (range <0.1 to 10.3).); Progression-free Survival (From randomization (initiated January 2010) to December 30 2010.)
B: Safety as measured by the frequency of grade 3/4 immune-related adverse events, using CTCAE 4.03 (During the first 12 weeks.); Response rate according to RECIST 1.1 (At 6 weeks); Pathological response according to central pathological revision, according to pathological response criteria (At 6 weeks); Pathologic response rate according to central revision of the marked index lymph node (At 6 weeks, prior surgery); RFS at 24 months in patients achieving pCR or pnCR in their marked index lymph node and did not undergo CLND. RFS will be calculated from date of resection of the marked lymph node. (24 months); RFS at 24 months in patients with pNR and being subsequently treated with adjuvant nivolumab+optional radiotherapy (or dabrafenib/trametinib if BRAFV600E pos. and treatment is approved). RFS will be calculated from day of resection of marked lymph node. (24 months)
C: Two-Year Event-Free Survival Rate (2 years)
D: Disease Free Survival (Up to 2 years)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: Early Physical Therapy Intervention in Preterm Infants During the Stay in the Neonatal Intensive Care Unit and at Home to Promote Motor Development
Brief Summary: The hypothesis of this study is that early physical therapy intervention, initiated during the NICU stay and up to 2 months corrected age, based on the family-centered model, could promote preterm infants motor development in short-term (2 months corrected age) and long-term (8 months corrected age).

There is a high evidence level of different systematic reviews, which support the effectivity of early intervention with preterm infants.

The principal aim of this randomized controlled trial is to evaluate the effectiveness of early physiotherapy intervention to promote motor development in preterm infants at 2 and 8 months corrected age.

The secondary purpose is to study the motor development of those preterm infants who received early physical therapy intervention.


Options:
A: Fidgety Movements at 12 weeks (post-term age) (12 weeks post-term age)
B: Parent-child interaction (12 months corrected age.)
C: Motor development. (2 months corrected age and 8 months corrected age)
D: Bayley Scaled of Infant and Toddler Development Cognitive and Gross Motor Scaled Scores (6 months)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: Effect of Spironolactone on the Progression of Coronary Calcification in Peritoneal Dialysis Patients
Brief Summary: Vascular calcification is a frequent complication in dialysis patients and is strongly associated with mortality. Its pathogenesis is complex and involves a series of markers that act on the vascular microenvironment. There is evidence that aldosterone is one of the biomarkers and may have a role in osteoinductive pathways.The aim of this study was to evaluate the effect of spironolactone, an inhibitor of mineralocorticoid receptor, in the progression of coronary calcification in patients undergoing peritoneal dialysis.


Options:
A: Peritoneal fibrosis (6 months)
B: cardio- and cerebrovascular events
C: Relative progression of the coronary calcium score (12 months)
D: permanent discontinuation of the study medication for hyperkalemia or permanent discontinuation of the study medication for hyperkalemia or hypotension (13 weeks)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: Instrumental or Physical-exercise Rehabilitation of Balance Improve Both Balance and Gait in Parkinson's Disease.
Brief Summary: We hypothesized that rehabilitation specifically addressing balance in Parkinson ́s disease patients might improve not only balance, but locomotion as well. Two balance training protocols (standing on a moving platform, and traditional balance exercises) were compared by assigning patients to two groups: moving platform (n=15) and balance exercises (n=17). Platform moved periodically in antero-posterior, latero-lateral and oblique direction, with and without vision in different trials. Balance exercises were based on Otago Exercise Program. Both platform and exercises sessions were administered from easy to difficult. Outcome measures were: a) balancing behaviour, assessed both by index of stability (IS) on platform and by Mini-BESTest, b) gait, assessed both by baropodometry and by Timed Up and Go (TUG) test. Falls Efficacy Scale-International (FES-I) and Parkinson's Disease Questionnaire (PDQ-8) were administered. Both groups exhibited better balance control, as assessed both by IS and by Mini-BESTest. Gait speed at both baropodometry and TUG also improved in both groups. Scores of FES-I and PDQ-8 showed a marginal improvement. A four-week treatment featuring no gait training, but focussed on challenging balance tasks produces considerable gait enhancement in mildly to moderately affected patients. Walking problems in PD depend on postural instability and are successfully relieved by appropriate balance rehabilitation.


Options:
A: frequency and severity of adverse events, active vs placebo (Every two weeks during dosing (week 0 to week 12) and weekly thereafter for 2 weeks following cessation of dosing); measure of impulse control (rMIDI), active vs placebo (at screening and 4 weeks, 10 weeks, 12 weeks and 14 weeks)
B: Ten meters walking test (about 4 weeks)
C: Assessment of balancing behaviour by sinusoidal translation of the supporting platform. (4 weeks); The Mini-Balance Evaluation Systems Test (4 weeks); Assessment of gait performance by baropodometry (4 weeks); Timed Up and Go Test (TUG) (4 weeks)
D: Falls Diary (6-7 Months)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: Italian Multicenter Randomized Phase II Study of Weekly Paclitaxel vs. Cediranib-Olaparib (Continuous vs. Intermittent) in Patients With Platinum Resistant High Grade Epithelial Ovarian, Fallopian Tube, or Primary Peritoneal Cancer
Brief Summary: This is a Phase II, randomized, multi-centre study aiming at comparing the efficacy of Olaparib and Cediranib vs. weekly Paclitaxel in terms of progression free survival (PFS) in platinum refractory or resistant recurrent ovarian cancer.

Patients will be randomised in a 1:1:1 ratio to three treatment arms:

* Arm A: Paclitaxel 80 mg/mq every week
* Arm B: Cediranib 20 mg/day + Olaparib 600 mg / day (i.e. 300 mg BD) given every day
* Arm C: Cediranib 20 mg/day given 5 days per weeks + Olaparib 600 mg / day (i.e. 300 mg BD) given 7 days per weeks


Options:
A: Progression Free Survival (PFS) (Tumour assessment was to be assessed at screening, every 8 weeks during the study and at the withdrawal visit, up to 56 weeks. (Data cut-off for primary analysis of PFS: 15 September 2009))
B: Progression Free Survival (PFS) Using Investigator Assessment According to Modified Response Evaluation Criteria In Solid Tumours (RECIST 1.1) (Radiologic scans performed at baseline then every ~12 weeks up to 72 weeks, then every ~ 24 weeks thereafter until objective radiological disease progression. Assessed until 19 Sep 2016 DCO (16 Jan 2017 DCO for China Cohort); up to a maximum of 36 months.)
C: Percentage of Participants With an Overall Response Rate (an average of 126 days for ovarian; 71 days for TNBC; for crossover intervention, pts stayed on study for an avg of 134 days for ovarian; 50 days for TNBC.); Progression Free Survival (Ovarian cancer patients stayed on study for an average of 126 days and triple-negative breast cancer patients for an average of 71 days.)
D: Efficacy: Progression Free Survival (PFS) (An average of 30 months for each participant); Safety: Number of Evacuations Per Day (Evacuation were collected daily for the first four weeks of treatment of experimental drugs)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: Italian Multicenter Randomized Phase II Study of Weekly Paclitaxel vs. Cediranib-Olaparib (Continuous vs. Intermittent) in Patients With Platinum Resistant High Grade Epithelial Ovarian, Fallopian Tube, or Primary Peritoneal Cancer
Brief Summary: This is a Phase II, randomized, multi-centre study aiming at comparing the efficacy of Olaparib and Cediranib vs. weekly Paclitaxel in terms of progression free survival (PFS) in platinum refractory or resistant recurrent ovarian cancer.

Patients will be randomised in a 1:1:1 ratio to three treatment arms:

* Arm A: Paclitaxel 80 mg/mq every week
* Arm B: Cediranib 20 mg/day + Olaparib 600 mg / day (i.e. 300 mg BD) given every day
* Arm C: Cediranib 20 mg/day given 5 days per weeks + Olaparib 600 mg / day (i.e. 300 mg BD) given 7 days per weeks


Options:
A: Progression Free Survival (PFS) (from date of randomisation to date of progression or death, which ever occurs earlier. Assessed up to 5 years 3 months)
B: PFS Based on Investigator Assessment According to Modified Response Evaluation Criteria in Solid Tumors, Version 1.1 (mRECIST), and Additional Clinical Criteria. (First drug administration to date of disease progression or death whichever occurs first , upto 29 months); PFS Based on Investigator Assessment According to Modified Response Evaluation Criteria in Solid Tumors, Version 1.1 (mRECIST), and Additional Clinical Criteria (Follow up Analysis). (First drug administration to date of disease progression or death whichever occurs first until final Data Base Lock (DBL) 26September16, upto 62 months)
C: overall survival (18 months)
D: Efficacy: Progression Free Survival (PFS) (An average of 30 months for each participant); Safety: Number of Evacuations Per Day (Evacuation were collected daily for the first four weeks of treatment of experimental drugs)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: Italian Multicenter Randomized Phase II Study of Weekly Paclitaxel vs. Cediranib-Olaparib (Continuous vs. Intermittent) in Patients With Platinum Resistant High Grade Epithelial Ovarian, Fallopian Tube, or Primary Peritoneal Cancer
Brief Summary: This is a Phase II, randomized, multi-centre study aiming at comparing the efficacy of Olaparib and Cediranib vs. weekly Paclitaxel in terms of progression free survival (PFS) in platinum refractory or resistant recurrent ovarian cancer.

Patients will be randomised in a 1:1:1 ratio to three treatment arms:

* Arm A: Paclitaxel 80 mg/mq every week
* Arm B: Cediranib 20 mg/day + Olaparib 600 mg / day (i.e. 300 mg BD) given every day
* Arm C: Cediranib 20 mg/day given 5 days per weeks + Olaparib 600 mg / day (i.e. 300 mg BD) given 7 days per weeks


Options:
A: Overall Objective Response (1 year after end inclusion)
B: Progression Free Survival (For those patients whose disease can be evaluated by physical examination, progression was assessed prior to each 21-day cycle. CT scan or MRI if used to follow lesion for measurable disease every other cycle, Up to 5 years)
C: progression free survival (6 months from randomization)
D: Efficacy: Progression Free Survival (PFS) (An average of 30 months for each participant); Safety: Number of Evacuations Per Day (Evacuation were collected daily for the first four weeks of treatment of experimental drugs)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: Italian Multicenter Randomized Phase II Study of Weekly Paclitaxel vs. Cediranib-Olaparib (Continuous vs. Intermittent) in Patients With Platinum Resistant High Grade Epithelial Ovarian, Fallopian Tube, or Primary Peritoneal Cancer
Brief Summary: This is a Phase II, randomized, multi-centre study aiming at comparing the efficacy of Olaparib and Cediranib vs. weekly Paclitaxel in terms of progression free survival (PFS) in platinum refractory or resistant recurrent ovarian cancer.

Patients will be randomised in a 1:1:1 ratio to three treatment arms:

* Arm A: Paclitaxel 80 mg/mq every week
* Arm B: Cediranib 20 mg/day + Olaparib 600 mg / day (i.e. 300 mg BD) given every day
* Arm C: Cediranib 20 mg/day given 5 days per weeks + Olaparib 600 mg / day (i.e. 300 mg BD) given 7 days per weeks


Options:
A: Time to Repeat Paracentesis (TRP) (From Day 1 up to 6 months from randomization)
B: Efficacy: Progression Free Survival (PFS) (An average of 30 months for each participant); Safety: Number of Evacuations Per Day (Evacuation were collected daily for the first four weeks of treatment of experimental drugs)
C: Radiographic imaging and clinical evaluation will be used for tumor assessment (every 6 weeks)
D: Progression-free survival

Answer: B