TrialPanorama/Dataset huggingface dataset:
Please select the outcome measures that correspond to the clinical trial below.
Title: Cortical Pain Processing in Full Term Infants, After Giving Different Non-pharmacological Analgesia
Brief Summary: Minor painful procedures are frequently performed on newborn infants and non-pharmacological analgesia is commonly used. As more than one analgesic method may be applied simultaneously in clinical practice, the relative contribution and efficacy of analgesic components still needs to be further elucidated. In the present study neonatal cortical brain response during four types of non-pharmacological analgesia (oral glucose, expressed breastmilk, maternal holding plus oral glucose, maternal holding plus breastfeeding) will be studied. The aim is to assess the differential effect of oral solutions (glucose, breastmilk), when given alone or in combination with maternal relationship (holding, breastfeeding). The study will test the hypothesis that the mother-infant relationship would improve the analgesic effect of oral solutions.


Options:
A: Heart Rate (up to 2 weeks); Respiratory Rate (up to 2 weeks); O2 sats (up to 2 weeks); Activity level (up to 2 weeks); Sleep category (up to 2 weeks); Feeding (sucking and absorption) category (up to 2 weeks); Neonatal Abstinence Scoring (NAS) (up to 2 weeks)
B: Number of Participants Administered Morphine Treatment (Participants will be monitored for the duration of their newborn nursery stay, which is an expected mean of 7 days); Cumulative Pharmacological Treatment- Morphine Dose (Participants will be monitored for the duration of their hospitalization, which is an expected mean of 21 days); Hospitalization Length of Stay (Day of life infants discharged home, which is an expected mean of 21 days.); Hospitalization Length of Stay for Untreated Infants (Day of life untreated infants discharged home, which is an expected mean of 21 days.); Hospitalization Length of Stay for Treated Infants (Day of life treated infants discharged home, which is an expected mean of 21 days.); Length of Pharmacological Treatment-Duration (Participants will be monitored for the duration of their hospitalization, which is an expected mean of 21 days); Trajectory of Symptom Severity Among Treated Infants (Day of life infant started morphine treatment); Velocity of Weight Gain (Participants will be monitored for the duration of their hospitalization, which is an expected mean of 21 days); Neurobehavioral Outcomes Assessment (6 month and 12 months of life)
C: combined rate of mortality and neurodevelopmental disability in survivors at a corrected age of 18 months. (corrected age of 18 months)
D: Cortical oxy-haemoglobin increase (During the procedure)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: Cortical Pain Processing in Full Term Infants, After Giving Different Non-pharmacological Analgesia
Brief Summary: Minor painful procedures are frequently performed on newborn infants and non-pharmacological analgesia is commonly used. As more than one analgesic method may be applied simultaneously in clinical practice, the relative contribution and efficacy of analgesic components still needs to be further elucidated. In the present study neonatal cortical brain response during four types of non-pharmacological analgesia (oral glucose, expressed breastmilk, maternal holding plus oral glucose, maternal holding plus breastfeeding) will be studied. The aim is to assess the differential effect of oral solutions (glucose, breastmilk), when given alone or in combination with maternal relationship (holding, breastfeeding). The study will test the hypothesis that the mother-infant relationship would improve the analgesic effect of oral solutions.


Options:
A: The primary outcome: Feasibility and acceptability of study procedure (after the study completion (4 months after the baseline survey))
B: Hypersensitivity to pain (At 15 month vaccination (Visit 5))
C: G Power software was used to calculate the sample size of the study. (5 days)
D: Cortical oxy-haemoglobin increase (During the procedure)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: Home Care for the Patient With Heart Failure: Can Caregiver Education Prevent Hospital Admissions? A Clinical Randomized Trial.
Brief Summary: The study is aimed to evaluate if the education of the caregiver is able to reduce hospital admissions of patients with heart failure assisted at home.


Options:
A: Mortality or readmission (one year)
B: Recruitment (Baseline); Dropout (24 weeks); Satisfaction with intervention (12 weeks); Number of contacts (24 weeks); Content of contacts (24 weeks); CR attendance (12 weeks); CR attendance (24 weeks); Change in Health-related Quality of Life (Baseline to 24 weeks); Change in Self-efficacy (Baseline to 24 weeks); Change in symptoms of anxiety and depression (Baseline to 24 weeks); Change in dietary quality (Baseline to 24 weeks); Change in physical activity (Baseline to 24 weeks)
C: Motivation (12 weeks); Needs Satisfaction (12 weeks)
D: Hospital admissions for any cause (Twelve months)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: Efficacy of Penile Traction Therapy Using a Novel Device: A Controlled, Single-blinded, Randomized Trial
Brief Summary: This clinical trial is designed to assess the safety, dosing, and preliminary efficacy of a novel penile traction device on correcting deformities relating to Peyronie's disease, a condition which results in penile curvature and length loss. The trial is designed as a randomized, placebo-controlled study with men randomized to receiving no therapy or penile traction therapy 30 minutes once, twice, or three times daily. The study will occur over a 3 month period, after which an open label phase for 3 months will be conducted. Final assessments for adverse effects will also be assessed at 9 months.


Options:
A: Percentage Change From Baseline in Penile Curvature (Baseline and Week 52); Change From Baseline in the Peyronie's Disease Bother Domain of the Peyronie's Disease Questionnaire (PDQ) (Baseline and Week 52)
B: Percentage Change From Baseline in Penile Curvature (Baseline and Week 52); Change From Baseline in the Peyronie's Disease Bother Domain of the Peyronie's Disease Questionnaire (PDQ) (Baseline and Week 52)
C: Percentage Change From Baseline in Penile Curvature (Baseline and Week 36); Change From Baseline in the Peyronie's Disease Bother Domain of the Peyronie's Disease Questionnaire (PDQ) (Baseline and Week 36)
D: Adverse Events at Baseline (Baseline); Adverse Events at 3 Months (3 months); Adverse Events at 6 Months (6 months); Adverse Events at 9 Months (9 months)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: Working Within an Integrated Learning Healthcare System to Improve Living Kidney Donation Knowledge Across the CKD Continuum for All Racial Groups
Brief Summary: Today, there are 25 million Americans with chronic kidney disease (CKD) and 660,000 patients in full kidney failure, the final CKD stage, known as end stage renal disease (ESRD). Over half of ESRD patients are Black, Hispanic, or Asian. ESRD patients must either receive regular dialysis treatments, by which waste is filtered from the blood by a machine, or a kidney transplant from a deceased or living donor. Five-year survival on dialysis is only 40%, compared to 74% with a deceased donor kidney transplant (DDKT) and 87% with a living donor kidney transplant (LDKT). Despite the known health benefits of DDKT and LDKT, 70% of ESRD patients remain on dialysis, especially ethnic/racial minorities.

An American Society of Transplantation (AST) Consensus Conference recently recommended that patients in all CKD stages should have the opportunity to learn about and decide which treatment option is right for them, particularly about LDKT. However, early education about LDKT and DDKT is inconsistent and often poor, with early stage CKD patients and ethnic/racial minorities even less likely to receive it.

Through previous HRSA grants, Dr. Waterman designed the Explore Transplant@Home (ET@Home) video-guided education program, and found that it significantly increased LDKT knowledge and informed decision-making for Black and White dialysis patients in Missouri when delivered by mail and supported through bimonthly postcards and texting. Now based at the University of California, Los Angeles (UCLA), she has partnered with Kaiser Permanente Southern California (KPSC), an integrated learning healthcare system providing insurance coverage and comprehensive care to 65,000 patients in CKD Stages 3, 4 and 5 (ESRD) (24% Hispanic, 52% White, 15% Black, and 9% Asian; 10% Spanish-speaking).


Options:
A: Self-Reported physical activity (Baseline, 3 months, and 6 months)
B: Deceased Donor Kidney Transplant (DDKT) and Living Donor Kidney Transplant (DDKT) Knowledge (6 months)
C: Weight in Kilograms (Baseline, 6, 12, and 18 months); Waist Circumference in Centimeters (Baseline, 6, 12, and 18 months)
D: Up to Date Well Child Care (24 months); Emergency/Urgent Care Utilization (24 months); Parent experience of care (12 months)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: An International Multicenter, Randomized, Double-blind, Placebo-Controlled Clinical Study of Efficacy and Safety of Two Dosing Regimens of BCD-085 (JSC BIOCAD, Russia) in Patients With Moderate to Severe Plaque Psoriasis
Brief Summary: BCD-085 is an innovative drug, a monoclonal antibody against interleukin-17. The toxicity, safety, and pharmacokinetics of BCD-085 were investigated in animals, in phase I clinical study in healthy volunteers, and in phase III clinical study in patients with moderate to severe plaque psoriasis. This clinical study aims at investigating the efficacy and safety of BCD-085 every other week regimen (after induction for the first 3 weeks) versus BCD-085 one per month regimen (after induction for first 3 weeks) versus placebo in patients with moderate to severe plaque psoriasis.

Study purpose:

To investigate the efficacy and safety of BCD-085 versus placebo in patients with moderate to severe plaque psoriasis (psoriasis vulgaris)

Study objectives:

1. To compare the efficacy of BCD-085 every 2 weeks versus BCD-085 every 4 weeks versus placebo, based on the proportion of patients who achieved a PASI75, target sPGA score, and on other secondary efficacy measures.
2. To evaluate the proportion of patients in each study arm who develop adverse events with multiple injections of BCD-085 and placebo. Compare the safety profiles of BCD-085 when used every 4 weeks and when used every 2 weeks.
3. 4. To assess the immunogenicity of BCD-085 defined as the proportion of patients who develop anti-drug antibodies (binding or neutralizing).


Options:
A: The Number of Visits at Which Participants Achieved a Static Physician Global Assessment (PGA) Score of Cleared (0) or Minimal (1) (Up to 24 weeks (Week 88 up to Week 112 [total 7 visits]))
B: Proportion of subjects who achieve a PGA of 0 or 1 response relative to baseline at Week 12 (12 Weeks); Proportion of subjects who achieve a PASI 75 response relative to baseline at Week 12 (12 Weeks)
C: • The Proportion (Number) of Patients in Each Study Arm Who Achieved a PASI 75 at Week 12 of Treatment (week 12)
D: Proportion of patients with at least 75% improvement in PASI from baseline (PASI75) at Week 16. (Baseline to week 16)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: An International Multicenter, Randomized, Double-blind, Placebo-Controlled Clinical Study of Efficacy and Safety of Two Dosing Regimens of BCD-085 (JSC BIOCAD, Russia) in Patients With Moderate to Severe Plaque Psoriasis
Brief Summary: BCD-085 is an innovative drug, a monoclonal antibody against interleukin-17. The toxicity, safety, and pharmacokinetics of BCD-085 were investigated in animals, in phase I clinical study in healthy volunteers, and in phase III clinical study in patients with moderate to severe plaque psoriasis. This clinical study aims at investigating the efficacy and safety of BCD-085 every other week regimen (after induction for the first 3 weeks) versus BCD-085 one per month regimen (after induction for first 3 weeks) versus placebo in patients with moderate to severe plaque psoriasis.

Study purpose:

To investigate the efficacy and safety of BCD-085 versus placebo in patients with moderate to severe plaque psoriasis (psoriasis vulgaris)

Study objectives:

1. To compare the efficacy of BCD-085 every 2 weeks versus BCD-085 every 4 weeks versus placebo, based on the proportion of patients who achieved a PASI75, target sPGA score, and on other secondary efficacy measures.
2. To evaluate the proportion of patients in each study arm who develop adverse events with multiple injections of BCD-085 and placebo. Compare the safety profiles of BCD-085 when used every 4 weeks and when used every 2 weeks.
3. 4. To assess the immunogenicity of BCD-085 defined as the proportion of patients who develop anti-drug antibodies (binding or neutralizing).


Options:
A: Percentage of Participants With Physician Global Assessment (PGA) of Psoriasis Score of 'Clear' or 'Almost Clear' at Week 16 (Week 16); Percentage of Participants With a Psoriasis Area and Severity Index 75 (PASI 75) Response at Week 16 (Week 16)
B: • The Proportion (Number) of Patients in Each Study Arm Who Achieved a PASI 75 at Week 12 of Treatment (week 12)
C: Change in PASI score from baseline in the two groups (12 weeks)
D: Percent Change From Baseline in Target Plaque Severity Score (TPSS) at Week 4 (Baseline, Week 4)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: Investigation for Individualized Noninvasive Neuromodulation in Neurorehabilitation of Brain Disease: Longitudinal Study
Brief Summary: Repetitive transcranial magnetic stimulation (rTMS) or transcranial direct current stimulation (tDCS) has been used for the modulation of stroke patients' motor function by altering the cortical excitability. Recently, more challenging approaches, such as stimulation of two or more sites or use of dual modality have been studied in stroke patients. In this study, simultaneous stimulation using both inhibitory rTMS (1Hz) and anodal tDCS (dual-mode stimulation) over bilateral primary motor cortices (M1s) was investigated to compare its modulatory effects with single inhibitory rTMS stimulation in subacute stroke patients.


Options:
A: Change in active control zone of the elbow (2 weeks and 1 month)
B: Upper-limb reaching analysis evaluated by means of the 3-D motion analysis system (BTS SMART DX 400) (Change from Pre to Post 1 (after the 10th session) and Post 3 (3 months follow-up))
C: change in function before/after tDCS (Before intervention, immediately after intervention, 10-20-30-40-50-60 min after intervention; long-term after intervention : 1-2-3-4 weeks, 2-3-4-5-6-7-8-9-10-11-12 months)
D: Fugl-Meyer Assessment score (2 months post-stimulation)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: A Phase 3, Randomized, Open-Label Study Evaluating the Efficacy of Axicabtagene Ciloleucel Versus Standard of Care Therapy in Subjects With Relapsed/Refractory Diffuse Large B Cell Lymphoma (ZUMA-7)
Brief Summary: The goal of this clinical study is to assess whether axicabtagene ciloleucel therapy improves the clinical outcome compared with standard of care second-line therapy in patients with relapsed/refractory diffuse large B-cell lymphoma (DLBCL).


Options:
A: To evaluate the safety of adoptive transfer of gene-modified autologous CD19-specific T cells in adult patients with B-ALL. (2 years)
B: Number of Participants With Dose Limiting Toxicities (DLTs) (Within 28 days of T-cell infusion); Woodchuck Hepatitis Virus Post-transcriptional Regulatory Element (WPRE) Detection Above Background (28 days post T cell infusion); Number of Days of Quantifiable CD19 CAR Post T-cell Infusion (28 days post T cell infusion)
C: Overall Response Rate (ORR) (From first dosing (single administration, Day 1) up to End of Study Visit (EOS), an average of 60 Months)
D: Event Free Survival (EFS) Per Blinded Central Assessment (From randomization date up to a median follow-up: 24.9 months)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: Promoting Self-Management of Breast and Nipple Pain in Breastfeeding Women
Brief Summary: This pilot project will provide an understanding of the contextual variables responsible for breast and nipple pain during breastfeeding initiation. These variables include, genetic variation, pain sensitivity, reactivity, pain catastrophizing and perceived stress. The purpose is to understand the efficacy of self-management (SM) strategies on each of these contextual variables, in an effort to inform a personalized approach to managing breastfeeding pain and its effect on improved health outcomes.


Options:
A: Pain Sensitivity (Baseline); Genetic variations in COMT (Baseline)
B: Breastfeeding intensity at 1,3, and 6 months (1,3, and 6 months after birth of the baby)
C: Exclusive breastfeeding (EBF) among children 0-6 months of age (4 years after baseline); Child anthropometry (height, weight) among children 24-48 months of age (4 years after baseline); Complementary feeding among children 6-23.9 months of age (4 years after baseline); Anemia among children 6-23.9 months (4 years after baseline)
D: Effectiveness of a nutrition advice programme in exclusive breastfeeding. (1 year); Effectiveness of a nutrition advice programme in dietary intake (1 year); Effectiveness of a nutrition advice programme in dietary intake (4 years); Effectiveness of a nutrition advice programme in dietary intake (8 years); Effectiveness of a nutrition advice programme in dietary intake (12 years)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: Promoting Self-Management of Breast and Nipple Pain in Breastfeeding Women
Brief Summary: This pilot project will provide an understanding of the contextual variables responsible for breast and nipple pain during breastfeeding initiation. These variables include, genetic variation, pain sensitivity, reactivity, pain catastrophizing and perceived stress. The purpose is to understand the efficacy of self-management (SM) strategies on each of these contextual variables, in an effort to inform a personalized approach to managing breastfeeding pain and its effect on improved health outcomes.


Options:
A: infant pain response, as measured by facial grimacing and changes in heart rate and oxygen saturation during the procedure
B: Physiological and behavioral parameters were assessed by Brazelton's neonatal behavior assessment scale, and the pain was evaluated by NFCS scale. The mean of Brazelton's scale was reduced after the procedures from 5,88 ± 0.35 to 1,38 ± 0.74, p < 0.001. (At two years)
C: Pain Sensitivity (Baseline); Genetic variations in COMT (Baseline)
D: N/A

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: Randomised Controlled Trial of Mechanochemical Ablation Versus Cyanoacrylate Adhesive for the Treatment of Varicose Veins
Brief Summary: This study will be comparing the treatment of varicose veins using either mechanochemical ablation (MOCA) or cyanoacrylate adhesive (CAE). Patients will be randomised to receiving either MOCA or CAE.

The pain scores, clinical scores, quality of life scores, occlusion and re-intervention rate at 2 weeks, 3, 6 and 12 months as well as the cost effectiveness of each intervention will be assessed.


Options:
A: Occlusion rate (up to 5 years)
B: Pain Score During Ablation (On day 0 immediately following vein ablation)
C: Complete Closure of the Target Vein at 5 years after index treatment in the VeClose study (NCT01807585). (5 years)
D: long-term QoL follow-up of patients after UGFS and surgical stripping (6-10 years follow-up)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: Evaluation of a Program for Routine Implementation of Shared Decision-Making in Cancer Care: A Stepped Wedge Cluster Randomized Trial
Brief Summary: This study aims to evaluate a theoretically and empirically grounded implementation program designed to foster shared decision-making in routine cancer care. The intervention program consists of several components (e.g. training for health care professionals, patient empowerment strategies) that will be rolled out in three clinics at a comprehensive cancer center in Germany.


Options:
A: Increased linkages between low income families and established services in their communities (Baseline, 12-month, 24-month, 36-month follow-up)
B: Youth functioning (One year)
C: Change in Emergency Department Visits + Hospital Days (Pre-Intervention (09/01/2012 to 03/09/2014); Post-Intervention (03/10/2014-09/30/2015)
D: Change in uptake of shared decision-making from the patients' perspective (All clinics: baseline, 8 months, 16 months, 24 months)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: Evaluation of a Program for Routine Implementation of Shared Decision-Making in Cancer Care: A Stepped Wedge Cluster Randomized Trial
Brief Summary: This study aims to evaluate a theoretically and empirically grounded implementation program designed to foster shared decision-making in routine cancer care. The intervention program consists of several components (e.g. training for health care professionals, patient empowerment strategies) that will be rolled out in three clinics at a comprehensive cancer center in Germany.


Options:
A: Change in uptake of shared decision-making from the patients' perspective (All clinics: baseline, 8 months, 16 months, 24 months)
B: Physicians' acquisition of communication skills addressing uncertainty and hope in encounters with a simulated advanced stage cancer patient through validated tools and questionnaires (4 months)
C: Mean Patient-centered Communication in Advanced Cancer Score (3 years)
D: Enhanced goal-consistent care (up to 2 years); PEACE (up to 2 years)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: Mentors Offering Maternal Support (M-O-M-S™): A Prenatal Program Building Maternal Self-Esteem, Coping, and Resilience and Decreasing Depression.
Brief Summary: The M-O-M-S project evaluates the effectiveness of the M-O-M-S program for improving birth outcomes and maternal-infant attachment and role satisfaction in a large military sample.


Options:
A: Level of childbirth related fear (FOBS) (36 weeks of gestation)
B: The use of epidural analgesia during birth (At birth)
C: Lederman Self-Evaluation Questionnaire (assessing change between gestational weeks 12, 16, 24, and 32 of pregnancy); Rosenberg Self-Esteem Scale (assessing change between gestational weeks 12, 16, 24, and 32 of pregnancy and 1, 3, & 6 months postpartum); Family Adaptability and Cohesion Evaluation Scales (assessing change between gestational weeks 12, 16, 24, and 32 of pregnancy and 1, 3, & 6 months postpartum); Edinburgh Postnatal Depression Scale (assessing change between gestational weeks 12, 16, 24, and 32 of pregnancy and 1, 3, & 6 months postpartum); Social Support Index (assessing change between gestational weeks 12, 16, 24, and 32 of pregnancy and 1, 3, & 6 months postpartum); Family Index Coherence (assessing change between gestational weeks 12, 16, 24, and 32 of pregnancy and 1, 3, & 6 months postpartum); Brief Resilience Scale (assessing change between gestational weeks 12, 16, 24, and 32 of pregnancy and 1, 3, & 6 months postpartum); Postpartum Self-Evaluation Questionnaire (assessing change between 1, 3, & 6 months postpartum)
D: Pregnancy-Related Anxiety Questionnaire (In the end of second session of intervention- up to 4 weeks from screening)

Answer: C