TrialPanorama/Dataset huggingface dataset:
Please select the outcome measures that correspond to the clinical trial below.
Title: Botulinum Toxin A for Emotional Stabilization in Borderline Personality Disorder (BPD)
Brief Summary: The main objective of the trial is to test whether a single application of botulinum toxin A into the glabellar region will lead to emotional stabilization in borderline personality disorder through paralysis of facial muscles/attenuation of negative emotions.


Options:
A: Zanarini Scale for Borderline personality disorder (ZAN-BPD) (8 weeks)
B: CAPS-5 (Clinician Administered PTSD Scale) (12 months)
C: Affective symptoms measured with the Hamilton Depression Scale (Ham-D) and the Young Mania Rating Scale (YMRS). (weeks: 0, 2, 4, 6, 8, 10, 12); Impulsivity and aggressivity measured with the Time Paradigsm and the the Point Subtraction Aggression Paradigm. (0, 6, 12)
D: N/A

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: N/A
Brief Summary: ArmAssist is low cost simply robotic devise for arm training and assessment. It is suitable for extended home rehabilitation and prolonged hospital rehabilitation without therapist supervision. The device contains several games which are structured as exercise for disabled patients. The primary aim of this study is to correlate efficacy of the arm training with ArmAssist robot system to conventional care modified by duration and structure of exercise. The secondary aim of this study is to measure the correlation between standard clinical assessment scales and ArmAssist-based assessment metrics.


Options:
A: Fugl Mayer motor score for upper extremity (4 weeks)
B: Wolf Motor Function Test (8 Weeks)
C: Fugl-Meyer (FM-SEC and FM-WH) (7 months); Motor-Functional Independence Measure (m-FIM) (7 months); Frenchay Arm Test (FA-T) (7 months)
D: Action Research Arm Test (ARAT) (End of treatment at 8 weeks post enrolment)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: N/A
Brief Summary: ArmAssist is low cost simply robotic devise for arm training and assessment. It is suitable for extended home rehabilitation and prolonged hospital rehabilitation without therapist supervision. The device contains several games which are structured as exercise for disabled patients. The primary aim of this study is to correlate efficacy of the arm training with ArmAssist robot system to conventional care modified by duration and structure of exercise. The secondary aim of this study is to measure the correlation between standard clinical assessment scales and ArmAssist-based assessment metrics.


Options:
A: Evolution of the motor control deficiency assessed by the Fugl Meyer (FM) scale modified by LINDMARK (between day 0 and month 3)
B: Fugl Mayer motor score for upper extremity (4 weeks)
C: Fugl-Meyer Assessment (before and after intervention)
D: Change response time during a novel motor task. (Baseline, After Intervention (2 weeks), 30-day follow-up); Wolf Motor Function Task Rate (Baseline, After Intervention (2 weeks), 30-day follow-up)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: The Effectiveness of a Value-based Emotion-focused Educational Programme to Reduce Diabetes-related Distress in Malay Adults With Type 2 Diabetes (VEMOFIT): a Cluster Randomised Controlled Trial
Brief Summary: The purpose of the clinical trial is to evaluate the effectiveness of a relatively simple and short value-based emotion-focused educational programme in adults with type 2 diabetes (VEMOFIT) on diabetes-related distress, depressive symptoms, illness perception, medication adherence, quality of life, diabetes self-efficacy, self-care and clinical outcomes.


Options:
A: self-reported ART medication adherence (month 6 after enrolment); CD4 count (month 6 after enrolment)
B: Patient Health Questionnaire (PHQ-9) (8 weeks); WHO Disability Assessment Schedule 2.0 (WHODAS 2.0) (8 weeks)
C: Teachers' knowledge (At the end of 3 days workshop)
D: Diabetes-related distress (6-week (immediate post-intervention) [T1]); Diabetes-related distress (6-month [T2]); Diabetes-related distress (12-month [T3])

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: Does Early Initiation of Renal Replacement Therapy Have an Impact on 7-day Fluid Balance in Critically Ill Patients With Acute Kidney Injury With Positive Furosemide Stress Test?: a Multicenter Randomized Controlled Trial
Brief Summary: Does Early Initiation of Renal Replacement Therapy Have an Impact on 7-day Fluid Balance in Critically Ill Patients with Acute Kidney Injury with Positive Furosemide Stress Test?: a Multicenter Randomized Controlled Trial


Options:
A: 60-day All-cause Mortality (60 days)
B: Renal replacement therapy proportion (28 days)
C: Death (90 days)
D: number of RRT-free days (Day 28 after randomization)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: Worksite Phone Counseling for Smoking Cessation
Brief Summary: Social support is poorly understood but likely to influence outcomes of behavior change efforts. Social support may take a directive or nondirective approach. In directive support, the person attempting a behavior change is told what to do and even what to think. In nondirective support, the person attempting the behavior change decides what to discuss. In some contexts, interactions of race or income with social support have been reported. This is a randomized controlled trial of directive and nondirective coaching in the context of a smoking quitline offered to employees of two large corporations.


Options:
A: Smoking Abstinence for 7 Days at Last Contact (6-12 months)
B: Biochemically confirmed 7-day point prevalent smoking abstinence (52 weeks)
C: Self-reported, Prolonged Abstinence From Smoking Between a Quit Date and 6 Months Afterwards. (6 months from participant's quit date)
D: Smoking Cue Reactivity on Quit Day (4-weeks)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: Worksite Phone Counseling for Smoking Cessation
Brief Summary: Social support is poorly understood but likely to influence outcomes of behavior change efforts. Social support may take a directive or nondirective approach. In directive support, the person attempting a behavior change is told what to do and even what to think. In nondirective support, the person attempting the behavior change decides what to discuss. In some contexts, interactions of race or income with social support have been reported. This is a randomized controlled trial of directive and nondirective coaching in the context of a smoking quitline offered to employees of two large corporations.


Options:
A: Change in employer practices in health benefits, policies and programs (15 month follow-up survey)
B: Smoking Abstinence for 7 Days at Last Contact (6-12 months)
C: weight loss (3 months); Weight loss (1 year)
D: Physical Activity (Measured 5 times over 13 months, for seven days each time. Time points = baseline, 1-2weeks, 3 months, 6 months and 12 months)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: High-intensity Training in Patients With Lacunar Stroke (HITPALS)
Brief Summary: In a randomized-controlled study the effect of high-intensity training, 5 days a week at home for 12 weeks is tested in patients with lacunar stroke.


Options:
A: Glucose area under the curve (0 weeks and 2 weeks)
B: modified Rankin Score (3 months)
C: Feasibility (6 weeks)
D: Difference in the 'Graded Cycling Test with Talk Test' (at baseline, 3 (primary analysis), 6 and 12 months after baseline testing)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: High-intensity Training in Patients With Lacunar Stroke (HITPALS)
Brief Summary: In a randomized-controlled study the effect of high-intensity training, 5 days a week at home for 12 weeks is tested in patients with lacunar stroke.


Options:
A: Difference in the 'Graded Cycling Test with Talk Test' (at baseline, 3 (primary analysis), 6 and 12 months after baseline testing)
B: modified Rankin Score (3 months)
C: Ambulatory Activity Profile (6 months)
D: The number of steps taken per day by participants in each group (at baseline & at 6 weeks post randomisation)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: iPhone Helping Evaluate Atrial Fibrillation Rhythm Through Technology
Brief Summary: Atrial fibrillation (AF), a condition where the top chambers of the heart beat irregularly, is a major health problem. The long-term goal of this project is to use a personal, mobile heart monitor to help patients better recognize recurrent AF and improve patients' ability to better manage their condition. A total of 300 patients with a history of AF will be included in the study, with 150 patients receiving an iPhone with the mobile monitoring device and educational text messaging and the remaining 150 patients continuing with their regular medical care. Each patient will be included in the intervention period for 6 months. The rate of recurrent AF and treatments meant to manage AF and other heart conditions will be determined for both groups. Patients in both groups will complete a series of questionnaires at the start and end of the 6 month study period to look at differences in quality of life and knowledge of AF.


Options:
A: Health related quality of life (12 months); HbA1c change over time (participants with T2DM only) (12 months)
B: Medication Adherence (3 Months)
C: Heart Failure-specific Quality of Life (twelve-month followup)
D: Rate of Recurrence of Atrial Arrhythmias (Six months); Time to Treatment for Recurrence of Atrial Arrhythmia (Six months); Number of Intervention and Control Group Patients Treated for Recurrent Atrial Arrhythmia (6 months)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: Combination With Intravenous Iron Supplementation or Doubling Erythropoietin Dose for Patients With Chemotherapy-induced Anaemia Inadequately Responsive to Initial Erythropoietin Treatment Alone
Brief Summary: A multicentre, randomized, open-label, parallel-group, active controlled non-inferiority study


Options:
A: Progression-free Survival (PFS) Rate at 3 Years (Assessed every 3 months until progression up to 4 years and 8 months)
B: Change in Hb Concentration (Baseline week 4)
C: Proportion of Patients With Major Erythroid Response (MER) (Assessed after completion of 16 weeks of treatment)
D: Hb response rate (up to week 15)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: Short-and Long-term Effects of a Home-based Rehabilitation Program on Functional Capacity, Peripheral Muscle Strength and Quality of Life in Patients With Bronchiectasis: Randomized Controlled Trial
Brief Summary: This study will investigate the short-and long-term effects of the home-based pulmonary rehabilitation on peripheral muscle strength, functional capacity and quality of life in patients with bronchiectasis. The participants will be randomized into two groups: control group (usual care and recommendations for practice exercise) and training group, that will perform aerobic (stepping training) and resistance training (lower and upper limbs) for eight weeks, three times a week. At baseline, immediately after finishing and after six months the patients will undergo assessments.


Options:
A: Distance, in meters, performed in the Incremental Shuttle Walk Test (up to 9 months)
B: 6 minute walk distance (8 weeks post exacerbation)
C: The primary endpoint of this study is improvement in exercise tolerance from an incremental walk test. (8 weeks)
D: To evaluate the efficacy of ELTGOL in stable state patients with bronchiectasis compared to placebo (1 year)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: Implementation Research for Vulnerable Women in South Africa
Brief Summary: This study sought to implement the Women's Health CoOp (Cooperative) (WHC) intervention into healthcare, antenatal, and substance treatment clinics in South Africa and translated this evidence-based intervention into real-world settings. Implementation, service, and patient outcomes will be evaluated through an iterative stepped wedge design.


Options:
A: Effectiveness of brief intervention for decreasing problem drinking and partner violence (Weekly for 3 months; then 6 and 12 months)
B: Implementation and Service Outcomes: Readiness for appropriate change (appropriateness) (Baseline); Implementation and Service Outcomes: Readiness for appropriate change (appropriateness) (6-months post-enrollment); Implementation and Service Outcomes: Readiness for appropriate change (appropriateness) (Baseline); Implementation and Service Outcomes: Acceptability of the Women's Health CoOp (WHC) intervention (Baseline); Implementation and Service Outcomes: Acceptability of the Women's Health CoOp (WHC) intervention (6-months post-enrollment); Implementation and Service Outcomes: Acceptability of the Women's Health CoOp (WHC) intervention (Baseline); Implementation and Service Outcomes: Acceptability of the Women's Health CoOp (WHC) intervention (6-months post-enrollment); Implementation and Service Outcomes: Acceptability of the Women's Health CoOp (WHC) intervention (Baseline); Implementation and Service Outcome: Adoption of the Women's Health CoOp (WHC) intervention (Baseline); Implementation and Service Outcome: Adoption of the WHC intervention (6-months post-enrollment); Implementation and Service Outcome: Cost (Baseline); Implementation and Service Outcome: Cost (6-months post-enrollment); Implementation and Service Outcome: Feasibility (Throughout the period of the study, up to a maximum of one year); Implementation and Service Outcome: Fidelity (Throughout the study at bimonthly intervals for up to one year); Implementation and Service Outcomes: Sustainability (Throughout the period of the study, up to a maximum of one year); Implementation and Service Outcomes: Sustainability (6 months post-intervention)
C: depression (On completion of intervention and six months post-intervention)
D: Intimate partner violence (One year)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: A Phase II Trial of Pembrolizumab in Patients With Non-small Cell Lung Cancer and a Performance Status of 2
Brief Summary: This study is to determine that pembrolizumab is safe and tolerable at the selected dose for the treatment of Non-Small Cell Lung Cancer (NSCLC) in patients with a performance status of 2. All patients will receive pembrolizumab.


Options:
A: Overall survival (1-year)
B: Toxicity Rate (Date of patient registration until 6 months after the administration of the last treatment (a maximum of 2 years treatment and 6 months followup after end of treatment)); Durable Clinical Benefit (≥18 weeks, up to maximum of 2 years)
C: To determine and compare the median survival produced by combined Gemcitabine plus Paraplatin versus Gemcitabine as a single-agent in patients with NSCLC and a PS equal to 2.
D: Progression-free Survival (PFS) as Assessed by Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1) (Up to approximately 19 months); Overall Survival (OS) (Up to approximately 19 months)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: Impact of a Medication Review on Hospital Readmission: Study Protocol of a Randomized Controlled Trial
Brief Summary: The study is a randomized controlled clinical trial. A total 1400 hospitalized patients will be randomized in two groups:

1. group receiving a pharmacist-led standardized medication review (experimental group); and
2. group not receiving the medication review (control group).

The patients will be followed up at 30 days after initial hospitalization. Outcome measures include the number of readmissions; patient satisfaction, quality of medical admission prescription and number of consultation after initial hospitalization.

Discussion: A randomized controlled trial will provide the highest level of evidence on the impact of pharmacist-led standardized medication review on early hospital readmission for extreme age population.


Options:
A: Rate of readmission (30 days)
B: Rate (%) of 30-day Post-discharge Hospitalization and ED Visits (Including Hospitals at Least Statewide) (Hospitalization to a hospital or ED visit within 30 days of discharge (checking at least all same state facilities))
C: Improvement in proportion of quality indicators achieved, for target diseases as a most responsible or primary diagnosis, between groups. (in hospital)
D: Number of patients with probable and definite adverse drug events in hospital (Up to Day 14 of hospital admission)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: Physiological and Psychological Effects of Testosterone During Severe Energy Deficit and Recovery: a Randomized, Placebo Controlled Trial
Brief Summary: The objective of this study is to determine whether maintaining a eugonadal state, during severe, sustained energy deficit, attenuates physiological decrements, particularly the loss of lean body mass.


Options:
A: Insulin Resistance (40 weeks)
B: Small effect of an intervention (immediate after completion of study); Moderate effect of an intervention (immediate after completion of study); Large effect of an intervention (immediate after completion of study)
C: Body Composition at the End of Each Study Phase (end of each study phase: Day 11 for Phase 1, Day 39 for Phase 2, up to Day 85 for Phase 3)
D: Lean body mass (approximately three years)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: Randomized Controlled Clinical Trial to Evaluate the Efficacy of Supplementation With L. Reuteri + Vit. D3 in Asthmatic Children
Brief Summary: The purpose of this project is to evaluate in a randomized clinical trial, double-blind, controlled, the effects of a dietary supplement containing Lactobacillus reuteri DSM 17938 and vitamin D3 in reducing bronchial inflammation and improve asthma control in patients in children with mild / moderate persistent asthma .


Options:
A: Reduction of allergic bronchial inflammation (Up to 3 months); Reduction of allergic bronchial inflammation (Up to 3 months)
B: Treatment Failure (Twenty-eight week intervention period from randomization until end of trial.)
C: Days to a Severe Asthma Exacerbation (48 weeks)
D: serum Vitamin D (3 months)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: Impact of Different Dosages and Time of Administration of Metronidazole and Amoxicillin in the Treatment of Generalized Chronic Periodontitis: A Randomized Clinical Trial
Brief Summary: The aim of this study was to compare the clinical and microbiological outcomes of different dosages of metronidazole (MTZ) and of the duration of the systemic administration of MTZ and amoxicillin as adjunct to scaling and root planing (SRP) in the treatment of generalized chronic periodontitis (GChP).


Options:
A: Percentage of sites showing attachment loss ≥ 1.3 mm over a 27.5-months period (27.5-months period (six measurements))
B: Percentage of subjects reaching ≤ 4 periodontal sites with probing depth (PD) ≥ 5 mm at 12 months (12 months)
C: Percentage of subjects reaching ≤ 4 periodontal sites with probing depth (PD) ≥ 5 mm at 12 months (12 months)
D: Change in Mean Clinical Attachment Level. (Baseline, 3, 6 and 12 months)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: Impact of Different Dosages and Time of Administration of Metronidazole and Amoxicillin in the Treatment of Generalized Chronic Periodontitis: A Randomized Clinical Trial
Brief Summary: The aim of this study was to compare the clinical and microbiological outcomes of different dosages of metronidazole (MTZ) and of the duration of the systemic administration of MTZ and amoxicillin as adjunct to scaling and root planing (SRP) in the treatment of generalized chronic periodontitis (GChP).


Options:
A: The Primary Outcome Variable Was Probing Depth. (6-months)
B: Percentage of subjects reaching ≤ 4 periodontal sites with probing depth (PD) ≥ 5 mm at 12 months (12 months)
C: Clinical Attachment Level (6 months)
D: probing depth (six months)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: Effect of Adapalene 0.3% - Benzoyl Peroxide 2.5% Gel Versus Vehicle Gel on the Risk of Formation of Atrophic Acne Scars in Moderate to Severe Acne Subjects
Brief Summary: This was a multi-centre, randomized, investigator blinded, vehicle controlled trial using intra-individual comparison (right half-face versus left half-face).

Participants with each half-face randomized to one of the two following treatments:

* Adapalene 0.3 percent (%) - benzoyl peroxide (BPO) 2.5% gel (TactuPump® Forte).
* Vehicle gel

The main objective of this trial was to evaluate the effect of Adapalene 0.3% - BPO 2.5% (ABPO Forte) gel versus vehicle gel on the risk of formation of atrophic acne scars in moderate to severe acne participants.


Options:
A: Mean Change From Baseline in Erythema at Weeks 1, 2, 4, 8, and 12 (Baseline and Weeks 1, 2, 4, 8, and 12); Mean Change From Baseline in Dryness at Weeks 1, 2, 4, 8, and 12 (Baseline and Weeks 1, 2, 4, 8, and 12); Mean Change From Baseline in Peeling at Weeks 1, 2, 4, 8, and 12 (Baseline and Weeks 1, 2, 4, 8, and 12); Mean Change From Baseline in Burning/Stinging at Weeks 1, 2, 4, 8, and 12 (Baseline and Weeks 1, 2, 4, 8, and 12); Mean Change From Baseline in Itching at Weeks 1, 2, 4, 8, and 12 (Baseline and Weeks 1, 2, 4, 8, and 12); Mean Change From Baseline in Oiliness at Weeks 1, 2, 4, 8, and 12 (Baseline and Weeks 1, 2, 4, 8, and 12); Mean Change From Baseline in Skin Overall Comfort at Weeks 1, 2, 4, 8, and 12 (Baseline and Weeks 1, 2, 4, 8, and 12)
B: Absolute Change in Total Lesion Count From Baseline to Week 12 (Baseline (Week 0) and Week 12); Number of Participants With an Improvement of 2 Grades in the Investigator Static Global Assessment (ISGA) Score From Baseline to Week 12 (Baseline (Week 0) and Week 12); Number of Participants With an Improvement of 2 Grades in the Investigator Static Global Assessment (ISGA) Score From Baseline to Week 12 (Baseline (Week 0) and Week 12)
C: Success Rate (Week 12); Changes From Baseline in Inflammatory Lesion Counts (Baseline - Week12); Changes From Baseline in Non-Inflammatory Lesion Counts (Baseline - Week 12)
D: Part 1: Total Atrophic Acne Scar Count Per Half-face (Week 24)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: Randomized, Embedded, Multifactorial Adaptive Platform Trial for Community- Acquired Pneumonia
Brief Summary: REMAP-CAP is a randomised, embedded, multifactorial, adaptive platform trial for community-acquired pneumonia.

The purpose of this study is to evaluate the effect of a range of interventions to improve outcome of patients admitted to intensive care with community-acquired pneumonia.

In addition, REMAP-CAP provides and adaptive research platform for evaluation of multiple treatment modalities in the event of a respiratory pandemic such as COVID-19.

REMAP-COVID is a sub-platform of REMAP-CAP that evaluates treatments specific to COVID-19 in the United States of America.


Options:
A: Survival without needs of ventilator utilization at day 14. (14 days); WHO progression scale <=5 at day 4 (4 days); Cumulative incidence of successful tracheal extubation (defined as duration extubation > 48h) at day 14 (14 days); WHO progression scale at day 4 (4 days)
B: Mechanical Ventilation or Death (28 days)
C: All-cause mortality (Day 90); Days alive and not receiving organ support in ICU (Day 21)
D: Time to Clinical Improvement (at day 15)

Answer: C