TrialPanorama/Dataset huggingface dataset:
Please select the outcome measures that correspond to the clinical trial below.
Title: A Two-Arm, Single-Center, Open-Label Pilot Study of IL-2 Programmed or IL-7/IL-15 Programmed Anti-CD19:TCRz:CD28 T-cells in Patient With CD19-Positive Lymphoma That is Resistant or Refractory to Chemotherapy
Brief Summary: The goal of this clinical trial is to study how approaches for manufacturing chimeric antigen receptor (CAR)-modified T (CAR-T) cells affect their in vivo persistence and therapeutic efficacy against B lymphoma. Recently, cancer immunotherapy, treatments aiming to arm patients with immunity specifically against cancer cells, has emerged as a promising therapeutic strategy. Among the many emerging immunotherapeutic approaches, clinical trials utilizing CARs against B cell malignancies have demonstrated remarkable potential. CARs combine the variable region of an antibody with T-cell signaling moieties to confer T-cell activation with the targeting specificity of an antibody. Thus, CARs are not MHC-restricted so they are not vulnerable to MHC down regulation by tumors. However, defined by the activation and contraction program of their mother cells, the persistency and function of CAR-T cells are also restricted by the protocol of manufacturing. Previous clinical studies largely utilized interleukin-2 (IL-2) for the ex vivo expansion of CAR-T cells, which preferentially generate CAR-T cells with characteristics of terminally differentiated effector cells. Our preliminary data indicated that two common gamma chain cytokines, IL-7 and IL-15, can help to selectively expand CAR-T cells with various memory phenotypes. CAR-T Cells prepared under this condition resulted in improved therapeutic efficacy in preclinical animal models. This clinical investigation is to test a hypothesis whether IL-7/IL-15-programmed anti-CD19 CAR-T cells persist longer in lymphoma patients after infusion and whether the persistency of CAR-T cells can lead to improved anti-lymphoma efficacy.


Options:
A: Phase I: Determination of the maximum tolerated dose (MTD); Phase II: Evaluation of preliminary efficacy of FBTA05 in combination with DLI
B: Adverse events attributed to the administration of the anti-CD19 CAR-NK cells (2 years)
C: 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)
D: maximum tolerated dose (MTD) (2 years); safety (2 years)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: The Michigan Stroke Transitions Trial (MISTT): Improving Care Transitions for Acute Stroke Patients Through a Patient-centered Home Based Case Management Program
Brief Summary: The Michigan Stroke Transitions Trial (MISTT) is a patient-centered randomized control trial that aims to improve the experience of stroke patients after they return home. The MISTT study will test the effect of two complementary interventions against usual care. The two interventions include: a) Stroke Case Managers (SCMs) who are trained social workers, and b) an online informational website or portal. The 12 week intervention period begins when the stroke patient returns home from the hospital or rehab facility. The SCMs will conduct at least 2 home visits with the patient (one within 3-4 days and one around 30 days) along with weekly follow-up telephone calls. Supplemental home visits will be used as necessary over the 12 week period. At the first home visit the social workers will conduct a comprehensive in-home assessment and link patients and caregivers to local resources as necessary. Patients also assigned to the website will have access to a patient-centered online information and support resource called the Virtual Stroke Support Portal (VSSP). The investigators hypothesize that this personalized case management program will reduce patient and caregiver needs, improve quality of life, and decrease caregiver stress. The MISTT study will enroll 315 acute stroke patients discharged from 3 Michigan hospitals and will be completed by the end of 2017.


Options:
A: physical scale of the Stroke Impact Scale 3.0 (before discharge from acute care, four weeks after discharge from the hospital or rehabilitation (in case of referral to a medical rehabilitation) immediately before randomization (baseline assessment), and 12 months after randomization)
B: Change in Arm Motor Fugl-Meyer Score From Baseline to 30 Days Post-therapy (from the Baseline Visit to the 30 Day Follow Up Visit)
C: Change From Baseline (7-days Post Discharge) to 90-days in the PROMIS-10 Global Quality of Life, Physical Health T-scores (Patient) (7 days and 90 days post discharge); Change From Baseline (7-days Post Discharge) to 90-days in the PROMIS-10 Global Quality of Life, Mental Health T-scores (Patient) (7 days and 90 days post discharge); Change From Baseline (7-days Post Discharge) to 90-days in the Bakas Caregiving Outcomes Scale Scores (Caregiver) (7 days and 90 days post discharge)
D: Naming ability assessed by NGA (four month post randomization)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: Impact of Promoting Community Initiated Kangaroo Mother Care (KMC) for Low Birth Weight Infants
Brief Summary: This study is being conducted to assess the impact of promoting community initiated Kangaroo Mother Care (ciKMC) for low birth weight babies on post enrolment neonatal mortality and mortality post enrolment upto 6 months of age. This large individually randomized controlled trial will enroll 10500 low birth weight babies. The secondary objectives are examining the impact of the intervention on exclusive breast feeding and growth at 1 and 3 months, infections and hospitalizations in the neonatal period and from 1 to 5 months of age, recognition of illnesses and early care seeking from appropriate sources, motor and mental development in a subsample.

Newborns weighing \>=1500 to \<=2250gm are being enrolled into the study within 3 days of birth. Eligible babies are randomized to intervention or control arms. Mothers in the intervention arm are supported for KMC and breastfeeding by study ANM (Auxiliary Nurse Midwife) and study ASHA (Accredited Social Health Activist) like workers . Routine home visits are conducted in both intervention and control arms by government workers according to the existing government program.

Survival will be ascertained in all enrolled infants through contacts at 1, 3 and 6 months.

The data safety and monitoring committee (DSMC) conducted two interim analyses, first in September 2017 when about half of the infants had been enrolled, and second in June 2018, when almost three quarters of the enrolled babies had been followed till 28 days of age. Following the second interim analysis, the DSMC concluded that a sufficient number of infants would be enrolled by the end to September 2018 to clearly answer the study question concerning the impact of ciKMC on both neonatal and early infant mortality. The DSMC recommended that data collection be completed by the end of October 2018.


Options:
A: Health workers will visit households at three month intervals for 18 months and survey the status of the babies.
B: Newborn survival (to 28 days) (July 2010 to June 2013)
C: Neonatal mortality from post enrolment to 28 days (From post enrolment to 28 days); Early infant mortality from post enrolment to 6 months of age (From post enrolment to 6 months)
D: Post day 1 Neonatal mortality (birth to 28 days of age) in the communities receiving the intervention(cohort of infants born to women identified through pregnancy surveillance) (Over 30 Months); Neonatal mortality (from birth to 28 days of age) in the cohort identified through pregnancy surveillance (Over 30 Months); Post day 1 neonatal mortality (1 to 28 days of age) in the population of newborns who are more likely to have greater impact from the intervention i.e. those born at home and available in the study area within 7 days of birth (30 months); Neonatal mortality (from birth to 28 days of age) in the population more likely to benefit from the intervention (30 months); Infant mortality (birth to 365 days) in the communities receiving the intervention. (30 months)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: pRotective vEntilation With Veno-venouS Lung assisT in Respiratory Failure
Brief Summary: This is a trial of a new way of treating patients with respiratory failure. The investigators propose to deliver a multi-centre clinical trial to determine whether veno-venous extracorporeal carbon dioxide removal (VV-ECCO2R) and lower tidal volume mechanical ventilation improves outcomes and is cost-effective, in comparison with standard care in patients who are mechanically ventilated for acute hypoxaemic respiratory failure


Options:
A: All cause mortality on day 60 following randomization (60 days)
B: Achievement of VT reduction to 4 mL/kg while maintaining pH and PaCO2 to ± 20% of baseline values obtained at VT of 6 mL/kg. (maximum 28 days)
C: All cause mortality (90 days after randomisation)
D: Survival (Approximately 25 days)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: MabThera Drug Utilisation Study and Patient Alert Card Evaluation in Non-Oncology Patients in Europe: An Infusion Centre-Based Approach
Brief Summary: This study is to characterize the indications for which rituximab is being used and to evaluate the use of the Patient Alert Card (PAC) in participants receiving the medication for non-oncology conditions at infusion centers. The study involves the retrospective chart review of rituximab users' medical records in non-oncology indications as well as a survey to collect information on participant characteristics, and will include questions about participant knowledge on the risk of infections, participant receipt and review of the PAC, and any actions the participant has taken as a result of receiving the PAC.


Options:
A: To investigate the efficacy of rituximab compared with placebo, as measured by MRI scans of the brain for the total number of lesions observed, and to evaluate the safety and tolerability of rituximab in subjects with RRMS.
B: Analysis of Changes in CSF CXCL13 Induced by Active Treatment (Rituximab) Measured 3 Months After 1st Drug Administration (3 months); Analysis of Changes in CSF BAFF Induced by Active Treatment (Rituximab) Measured 3 Months After 1st Drug Administration (3 months)
C: Percentage of Participants Aware of Known and Potential Risks of Infection Associated with Rituximab (Up to 10 months); Percentage of Participants Using Rituximab Off-Label (Up to 10 months)
D: Number of Disease-free Patients (Baseline through 24 months)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: TIME - Targeted Interdisciplinary Model for Evaluation and Treatment of Neuropscyhiatric Symptoms
Brief Summary: Almost all people who suffer from dementia experience neuropsychiatric symptoms (NPS) in the course of the disease. TIME (Targeted Interdisciplinary Model for Evaluation and treatment of neuropsychiatric symptoms) is a multicomponent intervention based on the theoretical framework of cognitive behavioral therapy (CBT). The TIME trial is designed to assess the effects of TIME on NPS in nursing homes patients with dementia and the implementation process at staff and organization level.


Options:
A: Days spent at hospital (24 months); Number of Intervention-related adverse events (6 to 15 months depending on the cluster affiliation)
B: Successful discontinuation (mean difference in number of medications) (Baseline, 6 months)
C: Acceptability of the TM among the LTCF staff (6 months)
D: NPI-NH agitation/aggression (8 weeks and 12 weeks)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: A Phase 3, Randomized, Double-Blind, Placebo-Controlled, Multicenter Study of Niraparib Maintenance Treatment in Patients With Advanced Ovarian Cancer Following Response on Front-Line Platinum-Based Chemotherapy
Brief Summary: This study aims to assess efficacy of Niraparib (GSK3985771) as maintenance treatment in participants with Stage III or IV ovarian cancer. Participants must have completed front-line platinum based regimen with complete response (CR) or partial response (PR). Data collection for Secondary Outcome measures is ongoing and the approximate duration of the study will be 7 years.


Options:
A: Stage 1: Feasibility assessed as the number of cycles and dose intensity of protocol treatment delivered per patient. (6 months after the 50th patient has been randomised to each arm and 6 months after the 50th patient with a plan to undergo delayed primary surgery has been randomised to each arm); Stage 1: Safety assessed as the rate of any ≥ grade 3 toxicity experienced per patient. (6 months after the 50th patient has been randomised to each arm and 6 months after the 50th patient with a plan to undergo delayed primary surgery has been randomised to each arm); Stage 2: Progression Free Survival rate at 9 months after randomisation (9 months after first 62 patients randomised per arm); Stage 3: Progression Free Survival (PFS expected 1 year after last patient is randomised. OS expected 3 years after last patient is randomised.); Stage 3: Overall Survival (PFS expected 1 year after last patient is randomised. OS expected 3 years after last patient is randomised.)
B: Progression Free Survival (Up to 34 months)
C: Progression-free Survival (From study entry until first disease progression, death or date of last contact, up to 6 years)
D: 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 156 weeks, then every 24 weeks thereafter until objective radiological disease progression. DCO: 17 May 2018)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: A Phase 3, Randomized, Double-Blind, Placebo-Controlled, Multicenter Study of Niraparib Maintenance Treatment in Patients With Advanced Ovarian Cancer Following Response on Front-Line Platinum-Based Chemotherapy
Brief Summary: This study aims to assess efficacy of Niraparib (GSK3985771) as maintenance treatment in participants with Stage III or IV ovarian cancer. Participants must have completed front-line platinum based regimen with complete response (CR) or partial response (PR). Data collection for Secondary Outcome measures is ongoing and the approximate duration of the study will be 7 years.


Options:
A: Progression free survival (up to 18 months)
B: Overall Survival (OS) (From randomization until the date of first documented progression or date of deaths from any cause, whichever came first, assessed up to 30 months (based on cutoff date: 19 September 2018).); Progression Free Survival (PFS) Based on Blinded Independent Central Review (BICR) According to Response Evaluation Criteria in Solid Tumors (RECIST) Version 1.1 (From randomization to date of first documentation of PD or death due to any cause whichever was first (up to 30 months); based on cutoff date: 19 September 2018.)
C: Overall Response Rate Per RECIST Version 1.1 (Part 2) (Time from first dose to date of progression, up to approximately 8 months); Number of Participants With a Dose Limiting Toxicity (DLT) (Cycle 1 Day 1 to Cycle 1 Day 21); PK Profile of Rucaparib - Cmax (Part 1) (Cycle 1 Day 1 to Cycle 1 Day 15, or approximately 15 days); PK Profile of Rucaparib - Tmax (Part 1) (Cycle 1 Day 1 to Cycle 1 Day 15, or approximately 15 days); PK Profile of Rucaparib - AUC Last (Part 1) (Cycle 1 Day 1 to Cycle 1 Day 15, or approximately 15 days)
D: Progression Free Survival (Up to 34 months)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: Assessment and Treatment of Patients With Long-term Dizziness in Primary Care
Brief Summary: Brief Summary:

The purpose of the present study is to examine the effects of a Group based intervention consisting of vestibular rehabilitation (VR) combined with cognitive behavioral therapy (CBT) in patients with long--lasting vestibular dizziness. The study also aims to describe sociodemographic, physical and psychological characteristics in the patients, and to examine prognostic factors related to functional status and disability following participation in the intervention.

Prior to the RCT, a feasibility study will be conducted to examine the feasibility of the study protocol.


Options:
A: Dizziness Handicap Inventory (DHI) (3 min); 6 m walking test preferred velocity (5 min)
B: Static balance will be measured by the "One leg Stand test" (16 weeks of rehabilitation)
C: Vertigo-related quality of life (Improvement at follow-up (12 months after treatment))
D: Dizziness Handicap Inventory (DHI), change between baseline and endpoint (56 days)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: Effect of Neuromuscular Electrical Stimulation Versus Cycle Ergometer Training in a Pulmonary Rehabilitation Program
Brief Summary: The aim of this study is to evaluate the effectiveness of quadriceps strengthening with neuromuscular electrical stimulation versus cycle ergometer as part of pulmonary rehabilitation program , in patients with severe or very severe COPD , according to GOLD with BODE index ≥ 5 .


Options:
A: Daily number of steps (changes from baseline to 3 months)
B: functional capacity of the lower limb muscles (21 - 4 days / +7 days)
C: Peak Inspiratory Capacity (IC) After 21 Days of Treatment (21 days)
D: Dyspnea (Change from baseline to 12 months)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: Ultrasound-guided Fascia Iliaca Compartment Block Versus Periarticular Infiltration for Pain Management After Total Hip Arthroplasty: A Randomized Controlled Trial
Brief Summary: This randomized, controlled, observer-blinded study clinical trial was designed to evaluate ultrasound-guided fascia iliaca compartment block with ropivacaine and periarticular infiltration with ropivacaine for postoperative pain management after total hip arthroplasty.


Options:
A: Respiratory complications (During hospital stay, up to 1 month)
B: Acute complications during insertion of regional anesthesia (at the day of insertion, day zero)
C: Postoperative Pain Score at Resting (Postoperative 48 hours); Postoperative Pain Score With Movement (Postoperative 48 hours)
D: The incidence of post-operative delirium after hip fracture surgery (immeidately to 5 days post operatively)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: Effect of Resistance Training in Adults With Complex Congenital Heart Disease
Brief Summary: Adults with complex congenital heart disease have impaired muscle function compared both to health controls and patients with lesions classified as simple. There is only one study assessing the effects of resistance training in patients palliated with Fontan procedure. The hypotheses of the present study is that home based resistance training will improve muscle function in adults with different complex congenital hear diseases.


Options:
A: Moderate to Vigorous Physical Activity (MVPA) (From baseline to follow-up (approximately 22 weeks).)
B: Change in muscle strength (Newton, N) (Change from baseline muscle strength at 12 weeks follow-up)
C: Consent rate (1 year); Enrolment rate (1 year); Adherence rate (1 year); Completion rate (1 year); Attrition rate (1 year); Acceptability questionnaire (Investigator-generated satisfaction questionnaire) (1 year)
D: Improvement exercise tolerance and physical capacity (Baseline and 4 months)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: Effect of Resistance Training in Adults With Complex Congenital Heart Disease
Brief Summary: Adults with complex congenital heart disease have impaired muscle function compared both to health controls and patients with lesions classified as simple. There is only one study assessing the effects of resistance training in patients palliated with Fontan procedure. The hypotheses of the present study is that home based resistance training will improve muscle function in adults with different complex congenital hear diseases.


Options:
A: Improvement exercise tolerance and physical capacity (Baseline and 4 months)
B: Moderate to Vigorous Physical Activity (MVPA) (From baseline to follow-up (approximately 22 weeks).)
C: Change in muscle strength (Newton, N) (Change from baseline muscle strength at 12 weeks follow-up)
D: Cardiac Rehabilitation Enrollment (12 weeks after patient is discharged from hospital)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: A Phase 1, Multi-center, Single-masked, Randomized, Placebo-controlled, Parallel-group Study to Investigate the Ophthalmologic Safety and Pharmacodynamics of 300mg Single Doses of Tafenoquine (SB 252263) in Adult Healthy Volunteers
Brief Summary: The study aims to provide evidence of retinal safety to support the use of tafenoquine as a potential single dose radical cure treatment for patients with Plasmodium vivax (P. vivax) malaria (i.e., co-administration of a schizonticidal drug with TQ). The study will be conducted as a single masked, randomized, placebo-controlled, parallel group design. It will assess retinal changes from baseline using spectral domain optical coherence tomography (OCT) and fundus auto fluorescence (FAF) at Month 3 (90 days) post-dose in adult healthy volunteers (participants). A placebo control group will be used to compare the results in the TQ group. Interim analysis will be conducted after completing 100 out of 300 participants in TQ group and 50 out of 150 participants in matched placebo.


Options:
A: Number of Participants With Recurrence-free Efficacy at 6 Months Post Dose (6 months post dose)
B: Percentage of Participants With Clinically Relevant Hemolysis. (Up to Day 180); Percentage of Female Participants With Moderate Glucose-6 Phosphate Dehydrogenase (G6PD) Deficiency Experiencing Clinically Relevant Hemolysis. (Up to Day 180)
C: Proportion of participants in the TQ group having retinal changes from Baseline in Central subfield thickness and Central retinal lesion thickness (Baseline and Day 90(follow-up)); Proportion of participants in the TQ group having retinal changes from Baseline in Total macular volume (Baseline and Day 90(follow-up)); Proportion of participants in the TQ group having retinal changes from Baseline in Ellipsoid zone disruption (Baseline and Day 90(follow-up)); Proportion of participants in the TQ group having retinal changes from Baseline in abnormal auto-fluorescence patterns (Baseline and Day 90(follow-up))
D: Adequate Clinical Response (ACR) of Tafenoquine: 28 Day Cure Rate (28 Days)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: N/A
Brief Summary: This study evaluates the early infant feeding in the infant intestinal microecology and the long term health. 300 healthy term newborns were involved into the study on its first stage. Depending on the type of feeding the infants were divided into 3 groups with random allocation to one of the formula feeding groups: the group A included 100 infants consuming the formula supplement with superior quality whey protein, the group B -100 infants fed with a standard formula, and the group C -100 infants who were breastfed.


Options:
A: Infant weight gain (Between ages 14 weeks (+/- 1 week) and 12 months (+/- 2 weeks))
B: Mean weight gain (3 years); Mean weight gain (5 years)
C: Comparison of the compositions of the intestinal microbiota of infants fed formula and breast milk by high-throughput sequencing (up to 8 months)
D: Body mass index BMI: derived from measured body height (m) and body weight (kg) as body weight / height² (At age 11 years and 18 years)

Answer: C