TrialPanorama/Dataset huggingface dataset:
Please select the outcome measures that correspond to the clinical trial below.
Title: REHAB-HF: A Trial of Rehabilitation Therapy in Older Acute Heart Failure Patients
Brief Summary: REHAB-HF: A Trial of Rehabilitation Therapy in Older Acute Heart Failure Patients, is a multicenter, randomized, attention-controlled, single-blind trial designed to examine the hypothesis that, in addition to standard care, a novel, tailored, progressive, multi-domain rehabilitation intervention administered to older patients with acute decompensated heart failure (ADHF) beginning early during hospitalization and continuing for 12 weeks will improve physical function and key clinical outcomes, including the rate of rehospitalization.


Options:
A: Exercise Capacity (20 weeks)
B: Short Physical Performance Battery (SPPB) at Month 3 (Month 3)
C: Change in VO2max every 6 months over the 24 months (every 6 months over the 24 months of outpatient follow-up); Change in Left ventricular ejection fraction every 6 months over the 24 months of outpatient follow-up (every 6 months over the 24 months of outpatient follow-up); Change on 6-min walk test every 6 months over the 24 months (every 6 months over the 24 months of outpatient follow-up); Change on Minnesota index of quality of life every 6 months over the 24 months (every 6 months over the 24 months of outpatient follow-up); Change on heart rate every 6 months over the 24 months (every 6 months over the 24 months of outpatient follow-up); Change on systolic blood pressure every 6 months over the 24 months (every 6 months over the 24 months of outpatient follow-up); Change on diastolic blood pressure every 6 months over the 24 months (every 6 months over the 24 months of outpatient follow-up); Change on body mass index every 6 months over the 24 months (every 6 months over the 24 months of outpatient follow-up); Change on creatine clearance every 6 months over the 24 months (every 6 months over the 24 months of outpatient follow-up)
D: Peak exercise capacity (16 weeks)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: A Phase 3, Multicenter, Randomized, Double-blind, Placebo-controlled Trial of the Safety and Efficacy of Fixed-dose Brexpiprazole (OPC-34712) as Adjunctive Therapy in the Treatment of Adults With Major Depressive Disorder With and Without Anxious Distress
Brief Summary: The purpose of this study is to assess the tolerability, safety, and efficacy of brexpiprazole (2.0 mg/day) as adjunctive therapy in adult subjects with a diagnosis of MDD with and without anxious distress


Options:
A: Mean Change From the End of Phase A (Week 8 Visit) to Phase B (Week 14 Visit) in the Montgomery-Asberg Depression Rating Scale for the Efficacy Sample Set (Baseline and Week 14); Mean Change in MADRS Total Score From Baseline End of Week 8 to Week 14 for the Efficacy Sample Per Final Protocol (Baseline and Week 14)
B: HAM-D17 (Before and after 3 months intervention)
C: Improvement in Work Related Disability Post Intervention (4 months post randomization)
D: Change in the Montgomery-Asberg Depression (From baseline (end of Phase A [Week 8]) to week 14)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: A Phase 3, Multicenter, Randomized, Double-blind, Placebo-controlled Trial of the Safety and Efficacy of Fixed-dose Brexpiprazole (OPC-34712) as Adjunctive Therapy in the Treatment of Adults With Major Depressive Disorder With and Without Anxious Distress
Brief Summary: The purpose of this study is to assess the tolerability, safety, and efficacy of brexpiprazole (2.0 mg/day) as adjunctive therapy in adult subjects with a diagnosis of MDD with and without anxious distress


Options:
A: Mean Change in the Montgomery Åsberg Depression Rating Scale (MADRS) (Baseline (Week 8) and Week 14)
B: Suicide completion and acts of deliberate self harm (DSH) will constitute the composite primary outcome (One year)
C: Change in the Montgomery-Asberg Depression (From baseline (end of Phase A [Week 8]) to week 14)
D: Change From Baseline in the Montgomery-Åsberg Depression Rating Scale (MADRS) Total Score at Week 10 (Baseline to Week 10)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: Enhancing Inpatient Psychotherapeutic Treatment With Online Self Help in a Randomised Controlled Trial: Acceptance and Efficacy
Brief Summary: The purpose of this study is to determine the acceptance and efficacy of the online self-help program deprexis® for depressed patients in reducing the clinical symptoms of their depression. The patients of the experimental group use deprexis® for 90 days, the patients of the placebo group receive weekly online information about depression for 90 days as well. Both groups receive their treatment in addition to their regular inpatient psychosomatic treatment and as an aftercare intervention.The investigators hypothesize that the online self-help group achieves a greater reduction of depression compared to the control group.


Options:
A: Labor Market Participation in Ordinary Paid Employment, or Education. (1 year (2016))
B: Change From Baseline in HAM-D17 Total Score at Week 8 or Final On-therapy (FOT) Evaluation (Baseline and Week 8 or FOT)
C: Reduction of depression measured with the "Beck's Depression Inventory" (BDI-II) (Three months after randomization)
D: N/A

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: Gut Microbiome Study in Preterm Infants - a Norwegian Multi Centre Study
Brief Summary: Necrotizing enterocolitis (NEC) is a leading cause of morbidity and mortality among infants in the neonatal intensive care unit (NICU). It has been postulated that abnormal colonization of the preterm gut, or an unfavorable balance between gut bacteria may contribute to the development of NEC.

Recent clinical randomized studies and meta-analysis have shown that proactive colonization of probiotic bacteria reduce the frequency of NEC. Based on this evidence, in April 2014 all Norwegian NICUs started routinely administration of probiotics to all extremely premature neonates susceptible to NEC (gestational age \<28 weeks/birth weight \<1000g).

The current project is investigating the gut microbiome in patients receiving probiotics and compare the the gut microbiome with moderate premature infants not receiving probiotics. In addition, we are including a control of healthy full-term infants.

Samples containing feces from participants will be analyzed by state of the art whole-genome sequencing techniques. Bacterial diversity will be analysed with bioinformatic tools.

Study hypotheses:

* Probiotics given to extremely preterm infants will change the biodiversity of the gut microflora.
* Antibiotics given to these patients may influence the gut microflora also in infants receiving probiotics. In particular use of vancomycin may change the gut flora.
* After cessation of probiotic prophylaxis the gut flora of infants receiving probiotics will gradually resemble the gut flora of infants not receiving probiotics.
* A cross-contamination of probiotic bacteria between patients treated with probiotics and patients not treated with antibiotics may occur.


Options:
A: To assess gut microbiome composition (meta genome sequencing) of preterm infants receiving probiotics versus preterm infants not receiving probiotics (4 time points: 7 days of age, 4 weeks of age, 4 months corrected age and 12 months corrected age)
B: Sepsis (8 weeks)
C: the incidence of combined death and necrotizing enterocolitis (at 36 weeks correct gestational age)
D: Effect of Saccharomyces boulardii on necrotizing enterocolitis in VLBW infants (up to 6 months)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: BiClamp Forceps Liver Transection Versus Clamp Crushing Technique in Liver Resections: A Randomized Clinical Trial
Brief Summary: The purpose of this study is to compare short-term and long-term efficacy of BiClamp forceps hepatectomy and clamp-crushing technique for parenchymal transection during elective hepatic resection.


Options:
A: Intraoperative blood loss (2.5 hours)
B: Proportion of patients with hemostasis 3 minutes after application of the haemostat product (3 minutes)
C: Time to hemostasis, as measured by the incidence of hemostasis within 10 minutes (10 minutes)
D: The Total Blood Loss (an expected average of 80 minutes)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: Vitamin D In the Prevention of Viral-induced Asthma of Preschoolers: a Randomised Controlled Trial (RCT)- (DIVA)
Brief Summary: In this 7-month randomized controlled trial, children aged 1-6 years with asthma attacks triggered mostly by colds, will receive a high dose of vitamin D or a placebo every 3.5 months during their usual clinic visit. This study will test whether children receiving a high dose of vitamin D have less frequent and less severe asthma exacerbations compared with those receiving placebo.The study will also document the safety profile of this strategy.


Options:
A: Change From Baseline in Serum 25OHD (During the 7-month follow-up period)
B: Time to first upper respiratory tract infection (One year); Time to first severe asthma exacerbation (One year)
C: Treatment Failure (Twenty-eight week intervention period from randomization until end of trial.)
D: Time to first upper respiratory tract infection (One year); Time to first moderate / severe COPD exacerbation (One year)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: Vitamin D In the Prevention of Viral-induced Asthma of Preschoolers: a Randomised Controlled Trial (RCT)- (DIVA)
Brief Summary: In this 7-month randomized controlled trial, children aged 1-6 years with asthma attacks triggered mostly by colds, will receive a high dose of vitamin D or a placebo every 3.5 months during their usual clinic visit. This study will test whether children receiving a high dose of vitamin D have less frequent and less severe asthma exacerbations compared with those receiving placebo.The study will also document the safety profile of this strategy.


Options:
A: Total number of days alive and off respiratory support in the first 28 days (28 days); Serum vitamin D concentration (Day after birth 28)
B: Change From Baseline in Serum 25OHD (During the 7-month follow-up period)
C: Weight gain in children (2 Months)
D: incidence of pneumonia (18 months)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: A Randomized Controlled Trial on the Effect of Endometrial Injury on Improving Ongoing Pregnancy Rate in Subfertile Women Undergoing Frozen-thawed Embryo Transfer Treatment Cycles
Brief Summary: This is a randomised controlled trial on the effect of endometrial injury in the cycle preceding the frozen-thawed embryo transfer (FET) cycles. The study hypothesis is that endometrial injury will increase the ongoing pregnancy rate in FET cycles.


Options:
A: Ongoing pregnancy rate (pregnancy at 10-12 weeks)
B: Rate of clinical pregnancy (5 weeks after the embryo implantation in an IVF procedure)
C: Pregnancy Rate (12 weeks)
D: Clinical Pregnancy Rate (Five weeks gestation, as dated from the egg retrieval)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: Domiciliary Physiotherapy During Breast Cancer Radiation
Brief Summary: Background: Breast cancer is the most common type of cancer among women. Its treatment, including radiotherapy (RT), can cause potential complications to be treated by the physiotherapy. Objective: To evaluate the effect of domiciliary physiotherapy on the upper limb applied during the period of radiotherapy in women submitted to surgical and radiotherapy for breast cancer. Study design: This is a prospective randomized controlled clinical trial. Methods: Thirty six volunteers were recruited from November 2009 to March 2012 and they were appraised at three different times: pre-RT, post-RT and 2 months after the end of RT. The parameters evaluated were: shoulder range of movement (ROM) and arm circumference. They were divided into two groups: CG) control group, submitted only to the assessments and SG) study group, submitted to domiciliary physiotherapy.


Options:
A: Gain in range of movement measured in degrees (Three months)
B: Change From Baseline in Cortical Silent Period (CSP) Will be Determined Using Transcranial Magnetic Stimulation (TMS) of the Motor Cortex. (10-15 minutes prior to the control/exercise condition ('pre-test') and 10-15 minutes after the control/exercise condition ('post-test').)
C: Changes in body composition, waist circumference, blood pressure, and serum levels of insulin, glucose, lipids, C-reactive protein, and HbA1c (At week 16); Improvement of physical fitness, cardiorespiratory fitness, and muscle strength (At week 16); Feasibility of a supervised exercise program for cancer survivors (At week 16); Maintain positive benefits of an exercise intervention (12 weeks post-intervention)
D: change in physical activity (6 months)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: Effects of Mobility-Enhancing Nursing Intervention in Patients With MS and Stroke: Randomised Controlled Trial
Brief Summary: Objectives: This parallel RCT investigated the effect of a new nursing intervention (Mobility Enhancing Nursing Intervention - MFP) designed to improve the rehabilitation programs' outcomes and patients' quality of life.

Intervention: The IG combined standard care with the 30-day mobility-enhancing-nursing intervention (MFP). MFP placed patients on a mattress on the floor and used constant tactile-kinaesthetic stimulation in everyday tasks to increase spatial orientation, to teach patients to get up safely and to move independently.

Primary and secondary outcome measures: Outcomes were defined as functionality (Extended Barthel Index, EBI), quality of life (WHOQoL), and fall-related self-efficacy (FES-I).


Options:
A: Fugl-Meyer Assessment (FMA) (At baseline and immediately after the completion of intervention); Motor Status Scale (MSS) (At baseline and immediately after the completion of intervention); Modified Ashworth Scale (MAS) (At baseline and immediately after the completion of intervention); MyotonPRO (At baseline and immediately after the completion of intervention); Muscle metabolism (NIRS) (At baseline and immediately after the completion of intervention); Box and Block Test (BBT) (At baseline and immediately after the completion of intervention); Revised Nottingham Sensory Assessment (RNSA) (At baseline and immediately after the completion of intervention); Functional Independence Measure (FIM) (At baseline and immediately after the completion of intervention); Motor Activity Log (MAL) (At baseline, immediately after the completion of intervention, at a 6-month follow up); ABILHAND Questionnaire (At baseline, immediately after the completion of intervention, at a 6-month follow up); Adelaide Activities Profile (AAP) (At baseline, immediately after the completion of intervention, at a 6-month follow up); EQ-5D-5L (At baseline and immediately after the completion of intervention); Accelerometers (At baseline, immediately after the completion of intervention, at a 6-month follow-up.); Functional magnetic resonance imaging (fMRI) (At baseline and immediately after the completion of intervention); Kinematic analysis (At baseline and immediately after the completion of intervention); Inflammatory markers (At baseline and immediately after the completion of intervention); Oxidative stress markers (At baseline and immediately after the completion of intervention); Erythrocyte deformability (At baseline and immediately after the completion of intervention); Blood glucose indicators (At baseline and immediately after the completion of intervention)
B: Change in Extended Barthel Index (EBI) between admission and discharge (Data were collected before randomisation (T0), after 15 days (T1) and at discharge / 30 days (T2))
C: Change of motor function (0 week and 1 week)
D: Maximum torque around the knee joint; gait velocity

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: A Phase 4 Trial Assessing the ImPact of Residual Inflammation Detected Via Imaging TEchniques, Drug Levels and Patient Characteristics on the Outcome of Dose TaperIng of Adalimumab in Clinical Remission Rheumatoid ArThritis (RA) Subjects (PREDICTRA)
Brief Summary: The primary objective of the study was to investigate the association between residual disease activity at Baseline as detected by Magnetic Resonance Imaging (MRI) and the occurrence of flares in participants with rheumatoid arthritis (RA) randomized to an adalimumab dose tapering regimen controlled by adalimumab withdrawal.


Options:
A: Percentage of Participants Achieving 28 Joint Disease Activity Score (DAS28) Less Than or Equal to (≤) 3.2 at Week 88 (Week 88)
B: Number of Participants That Met Sustained Remission at Week 76 and Week 91 Based on DAS28 Score (76 and 91 weeks)
C: Percentage of Participant Who Were Non-Failures (Week 48)
D: Association Between Baseline Hand and Wrist Synovitis Rheumatoid Arthritis Magnetic Resonance Imaging Scoring System (RAMRIS) Score and Flare up to Week 40 in the Tapering Arm (From Week 4 to Week 40); Association Between Baseline Bone Marrow Edema RAMRIS Score and Flare up to Week 40 in the Tapering Arm (From Week 4 to Week 40); Association Between a Composite of Baseline Hand and Wrist Synovitis and Bone Marrow Edema RAMRIS Scores and Flare up to Week 40 in the Tapering Arm (From Week 4 to Week 40)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: N/A
Brief Summary: The accumulation of p-cresol, a product of the metabolism of aromatic aminoacid operated by resident intestinal bacteria increases the cardiovascular risk of chronic kidney disease (CKD) patients. Therefore, therapeutic strategies to reduce plasma p-cresol levels are highly demanded. It has been reported that the phosphate binder sevelamer sequesters p-cresol in vitro, while in vivo studies on dialysis patients showed controversial results. Aim of our study was to evaluate the effect of sevelamer on p-cresol levels in CKD patients.


Options:
A: electron-beam CT coronary artery calcification AGATSTON score (change at 12 mo from baseline)
B: Percentage Changes in Fibroblast Growth Factor-23 (FGF-23) Levels (Week 0 - 12); Percentage Changes in Parathyroid Hormone (PTH) Levels (Week 0 - 12)
C: Effect on p-creol levels (3 months)
D: Change in serum phosphorus from baseline to Day 29 (Day 1 and Day 29)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: Usual Care Randomized Study Measuring the Impact of an Online Personal Health Record (Sanoia) in Rheumatoid Arthritis Patients on Reported Outcomes
Brief Summary: Recommendations of Rheumatoid Arthritis management agree on the necessity of patient self-involvement in the care. In parallel, the observation of the adoption rate of websites directed toward patients may indicate that this involvement is shared by a large number ot the population.

However, most of these sites are only informative and few of them offer patients to be engaged to generate their own data that can impact on the patient-physician relationship by easing the dialog and then leading to better mutual understanding.

As new web or mobile services allowing patients to self-report their outcomes are flourishing only a very few of them have already addressed the their impact of the patient-physician relationship.

The main objective of this study is to quantify the effect of a website (Sanoia) on the quality of patient-doctor interactions, as perceived by the patient using the french translations of the Peppi Questionnaire during the 12 months observation period.

In France, the patient protection committee (CPP) has ranked this study in "Soins Courants" (Usual Care).


Options:
A: Change from baseline Estimated Glomerular Filtration Rate (eGFR) at 18 months (Measured at baseline, 6, 12 and 18 months after randomisation)
B: Improvement in Quality Indicators (adapted from the American Gastroenterological Association (AGA) outpatient IBD quality metrics and other consensus recommendations) (up to 2 years)
C: Change from Baseline to 12 months after inclusion of Perceived efficacy by the patient of patient-physician interactions (PEPPI) (Baseline and Month 12)
D: Decision quality (40 to 52 weeks after baseline)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: Study of Binocular Computer Activities for Treatment of Amblyopia
Brief Summary: The purpose of the study is to compare the effectiveness of 1 hour/day of binocular game play 7 days per week with 2 hours/day patching 7 days per week in children 5 to \<17


Options:
A: Visual acuity in the amblyopic eye (6 months)
B: Change in Distance Visual Acuity From Baseline in the Younger Cohort (5 to <13 Years) (Baseline and 16 weeks); Mean Amblyopic Eye Visual Acuity (Younger Cohort) (16 Weeks from baseline); Mean Change in Amblyopic-eye Visual Acuity in the Older Cohort (13 to <17 Years) (Baseline and 16 weeks); Mean Amblyopic-eye Visual Acuity in the Older Cohort (13 to <17 Years) (16 weeks); Distribution of Change in Amblyopic-eye Visual Acuity (Baseline and 16 weeks); Distribution of Amblyopic-eye Visual Acuity (At 16 weeks)
C: Visual Acuity of the Amblyopic Eye HOTV (for children <7 y) or ETDRS for children 7+y (2 weeks (for strabismic, anisometropic, and combined mechanism amblyopia); 4 weeks (for deprivation amblyopia))
D: The primary outcome measure was logMAR visual acuity, measured 6-weekly for 18 weeks in refractive adaptation phase. In occlusion phase measured 2-weekly until no further gains

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: Study of Binocular Computer Activities for Treatment of Amblyopia
Brief Summary: The purpose of the study is to compare the effectiveness of 1 hour/day of binocular game play 7 days per week with 2 hours/day patching 7 days per week in children 5 to \<17


Options:
A: Distribution of Visual Acuity in the Amblyopic Eye at 17 Weeks (17 weeks); Mean Visual Acuity in the Amblyopic Eye at 17 Weeks (17 weeks); Distribution of Change in Visual Acuity in the Amblyopic Eye From Baseline to 17 Weeks (Baseline to 17 weeks); Mean Change in Visual Acuity in the Amblyopic Eye From Baseline to 17 Weeks (Baseline to 17 weeks)
B: Visual Acuity Mean Score in the Amblyopic Eye (18 weeks); Visual Acuity Distribution in the Amblyopic Eye (18 weeks); Mean Change in Visual Acuity in the Amblyopic Eye (baseline to 18 weeks); Distribution of Change in Visual Acuity in the Amblyopic Eye (baseline to 18 weeks)
C: Visual Acuity of the Amblyopic Eye HOTV (for children <7 y) or ETDRS for children 7+y (2 weeks (for strabismic, anisometropic, and combined mechanism amblyopia); 4 weeks (for deprivation amblyopia))
D: Change in Distance Visual Acuity From Baseline in the Younger Cohort (5 to <13 Years) (Baseline and 16 weeks); Mean Amblyopic Eye Visual Acuity (Younger Cohort) (16 Weeks from baseline); Mean Change in Amblyopic-eye Visual Acuity in the Older Cohort (13 to <17 Years) (Baseline and 16 weeks); Mean Amblyopic-eye Visual Acuity in the Older Cohort (13 to <17 Years) (16 weeks); Distribution of Change in Amblyopic-eye Visual Acuity (Baseline and 16 weeks); Distribution of Amblyopic-eye Visual Acuity (At 16 weeks)

Answer: D