TrialPanorama/Dataset huggingface dataset:
Please select the outcome measures that correspond to the clinical trial below.
Title: CTN-0051: Extended-Release Naltrexone vs. Buprenorphine for Opioid Treatment
Brief Summary: CTN-0051 assesses the comparative effectiveness of extended release injectable naltrexone (XR-NTX, Vivitrol®), an opioid antagonist recently approved and indicated for the prevention of relapse to opioid dependence, versus buprenorphine-naloxone (BUP-NX, Suboxone®), a high affinity partial agonist indicated for maintenance treatment of opioid dependence, as pharmacotherapeutic aids to recovery.

The study is conducted in 8 NIDA Clinical Trials Network affiliated community based treatment programs. Up to 600 eligible participants will be randomized to treatment with XR-NTX or BUP-NX for 24 weeks (sufficient to include 350 participants who are randomized more than 72 hours after their last opioid).

The primary goal of the study is to estimate the difference, if one exists, between XR-NTX and BUP-NX in the distribution of the time to relapse (i.e.., loss of persistent abstinence) during the 6-month trial. Secondary objectives are to: (1) compare outcome on XR-NTX versus BUP-NX across a range of clinical safety and secondary efficacy domains, and (2) explore demographic and, clinical, and genetic predictors of successful treatment and moderators of differential effectiveness (i.e., what variables may help clinicians choose which of these treatments is best for a given patient).), and (3) collect a limited dataset to permit analyses of economic costs and benefits of the two treatments.


Options:
A: CDF of the percent of urine samples negative for opioids in Probuphine and Placebo groups from weeks 1-24 (1-24 weeks); CDF of the percent of urine samples negative for opioids from weeks 1-24 with imputation based on illicit drug use self-report data for Probuphine and placebo groups (1-24 weeks)
B: percentage of subjects abstinent from all opioids through the final day of detoxification (up to 12-week trial)
C: Illicit opioid abstinence (12 weeks)
D: Time to Relapse (Intent to Treat Population) (Weeks 3-24); Time to Relapse (Per Protocol Population) (Weeks 3-24)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: N/A
Brief Summary: Uraemic pruritus (UP) remains a frequent and distressing problem in patients with advanced chronic kidney disease (CKD) and end-stage renal disease (ESRD).

Calmmax is a new topical cream that was introduced recently by Calmmax Pharma, an Israeli pharmaceutical company developed a topical cream based on active plant extracts for treatment of skin inflammation. We intend to conduct a prospective, double blind, placebo controlled, randomized trial that will assess the therapeutic effect of Calmmax cream on UP in a cohort of CKD and ESRD patients.


Options:
A: Severity of Pruritis, as measured by a visual analogue scale (3 months)
B: Change From Baseline in Worst-itching 11-point Numerical Rating Scale (NRS) (2 weeks, 4 weeks and 8 week); Change From Baseline in Worst-itching Visual Analog Scale (VAS) (2 weeks, 4 weeks and 8 weeks); Change From Baseline in Itch Severity Score (2 weeks, 4 weeks and 8 weeks); Change From Baseline in Sleep Quality Assessment (2 weeks, 4 weeks and 8 weeks); Change From Baseline in QoL Assessment (Skindex-10) (2 weeks, 4 weeks and 8 weeks); The Mean Value in Treatment Satisfaction (Patient's Global Impression of Change ) (2 weeks, 4 weeks and 8 weeks); Change From Baseline in QoL Assessment (5-D-Itch Scale) (2 weeks, 4 weeks and 8 weeks); The Number of Patients in Excoriation (2 weeks, 4 weeks and 8 weeks)
C: the longitudinal changes of itching (every week, up to 12 weeks.)
D: Improvement of UP measured by reduction of VAS by more than 50 percent from baseline score (1 year)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: Exploring the Effects of a Memory Intervention on Memory and Everyday Life Activities With Persons With MS
Brief Summary: Past research has shown that items self-generated by an individual, such as words or concepts, are remembered better than items that are simply read or heard. The current study seeks to demonstrate the effectiveness of using the principles of the generation effect in a treatment intervention to improve memory and functional performance in individuals with Multiple Sclerosis who have learning and memory difficulties.The main purpose of the study is to conduct an experimental investigation on the effects of a self-generation strategy treatment, embedded within practice of various activities ranging from laboratory tasks (e.g. words and concepts) to functional tasks (e.g. activities of daily living). The treatment to be tested is geared toward helping patients selfdiscover their own strengths and abilities while using self-generation to be able to utilize it independently in everyday life situations.

Design: The proposed pilot study is a randomized clinical trial. Participants: Participants will include forty (40) persons with MS, between the ages of 18 and 65, who demonstrate memory impairments. Half of the participants will receive the self-generation training while learning different types of tasks (experimental group) and half of the participants (control group) will be asked to learn the same information but will receive a conventional practice (e.g. repetitions).

Expected results: We expect that participants undergoing the self-generation-training intervention will show better memory performance, functional performance, quality of life, and satisfaction with treatment and life compared to participants in the control condition.


Options:
A: A composite derived from a standardized battery of neuropsychological tests (12weeks)
B: Neuropsychological Assessment (Baseline assessment, and Week 3)
C: Efficacy of cognitive rehabilitation on quality of life at short term. (10 weeks); Efficacy of cognitive rehabilitation on quality of life at long term. (34 weeks)
D: Neurotrophic Factor BDNF (3-weeks)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: A Randomised, Double-blind, Parallel Group, Placebo-controlled Multi-centre Phase III Study to Assess the Efficacy and Safety of Olaparib Versus Placebo as Adjuvant Treatment in Patients With gBRCA1/2 Mutations and High Risk HER2 Negative Primary Breast Cancer Who Have Completed Definitive Local Treatment and Neoadjuvant or Adjuvant Chemotherapy
Brief Summary: Olaparib treatment in patients with germline BRCA1/2 mutations and high risk HER2 negative primary breast cancer who have completed definitive local treatment and neoadjuvant or adjuvant chemotherapy


Options:
A: Invasive Disease Free Survival (IDFS) (From date of randomisation to data cut off: 27 March 2020 (approximately 5 years 11 months))
B: Comparison: pCR in nab-paclitaxel/carboplatin vs. nab-paclitaxel/gemcitabine (After 12 weeks of therapy); Comparison: pCR in responders vs. non-responders (After 12 weeks of therapy)
C: Disease Free Survival (DFS) of 3 years (3 years after mastectomy)
D: Pathologic Complete Response (pCR) in the Breast. Defined as the Absence of Residual Invasive Carcinoma in the Breast (ypT0/is). (At the time of definitive surgical removal, up to 28 weeks); Pathologic Complete Response (pCR) in the Breast. Defined as the Absence of Residual Invasive Carcinoma in the Breast (ypT0/is). (At the time of definitive surgical removal, up to 28 weeks)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: A Phase 3 Evaluation of Daclatasvir Plus Sofosbuvir in Treatment-naïve and Treatment-experienced Chronic Hepatitis C (Genotype 1, 2, 3, 4, 5, or 6) Subjects Coinfected With Human Immunodeficiency Virus (HIV)
Brief Summary: A study of the efficacy and safety of the combination of daclatasvir and sofosbuvir in the treatment of hepatitis C virus and HIV coinfection.


Options:
A: Percentage of Participants With Extended Rapid Virologic Response (eRVR) at Weeks 4 and 12 (A Weeks 4 and 12)
B: Number of Participants With a Sustained Virologic Response (SVR) 12 Weeks After the Planned End of Treatment (EOT) (Week 12 and 24 (for the arms treated for 12 weeks) or Week 24 and 36 (for the arms treated for 24 weeks))
C: Percentage of Genotype 1 Hepatitis C Virus (HCV)-Infected Treatment-naive Participants With Sustained Virologic Response at Follow-up Week 12 (SVR12) (At follow-up Week 12)
D: Percentage of Participants With Sustained Virologic Response 12 Weeks After Treatment; Primary Analyses (12 weeks after last dose of study drug)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: A Phase 3 Evaluation of Daclatasvir Plus Sofosbuvir in Treatment-naïve and Treatment-experienced Chronic Hepatitis C (Genotype 1, 2, 3, 4, 5, or 6) Subjects Coinfected With Human Immunodeficiency Virus (HIV)
Brief Summary: A study of the efficacy and safety of the combination of daclatasvir and sofosbuvir in the treatment of hepatitis C virus and HIV coinfection.


Options:
A: Percentage of Participants With Sustained Virologic Response 12 Weeks After Discontinuation of Therapy (SVR12) (Posttreatment Week 12); Adverse Events Leading to Permanent Discontinuation of Study Drug(s) (Up to 24 weeks)
B: Percentage of Genotype 1 Hepatitis C Virus (HCV)-Infected Treatment-naive Participants With Sustained Virologic Response at Follow-up Week 12 (SVR12) (At follow-up Week 12)
C: Sustained Virologic Response (SVR) Rate (At Follow-up Week (FW) 24)
D: Phase 2a and Phase 2b: Safety, as measured by the frequency of SAEs and discontinuations due to AEs (12 weeks after first dose); Antiviral activity as determined by proportion of HCV genotype 1 subjects with extended rapid virologic response (eRVR), defined as undetectable HCV RNA (Week 4); Antiviral activity as determined by proportion of HCV genotype 1 subjects with extended rapid virologic response (eRVR), defined as undetectable HCV RNA (Week 12); Phase 2b only: Antiviral activity, as determined by the proportion of HCV genotype 1 subjects with 24-week sustained virologic response (SVR24), defined as undetectable HCV RNA (at follow-up Week 24)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: Randomized Controlled Trial Comparing the Effects on Psychosocial Functioning of Cognitive Rehabilitation Versus Psychoeducation in Borderline Personality Disorder
Brief Summary: Study design was a multicenter, randomized, rater-blind clinical trial. There were two-parallel arms (1:1) to evaluate functional, clinical and cognitive efficacy of a specific cognitive rehabilitation group intervention (CR) compared with a psychoeducational group intervention (PE) in subjects with Borderline Personality Disorder (BPD).


Options:
A: Social Processing (Cyberball) fMRI Task: fMRI Responses (Pre-treatment (baseline) and post-treatment (up to 2 weeks)); Ecological Momentary Assessment (EMA): Duration, Intensity, and Severity of NSSI Urges and Behavior (One week before tDCS (baseline), two weeks during tDCS (during tDCS), one week post-tDCS (post-tDCS)); Self Injurious Thoughts and Behaviors Inventory Part 1 (Pre-treatment (baseline) and post-tDCS (up to 2 weeks after baseline)); Ecological Momentary Assessment (EMA): NSSI Urges and Behavior (One week before tDCS (baseline), two weeks during tDCS (during tDCS), one week post-tDCS (post-tDCS)); Self Injurious Thoughts and Behaviors Inventory Part 2 (pre-treatment (baseline) and post-treatment (up to 2 weeks)); Self Injurious Thoughts and Behaviors Inventory Part 3 (Pre-treatment (baseline) and post-tDCS (up to 2 weeks after baseline)); Self Injurious Thoughts and Behaviors Inventory Part 4 (Pre-treatment (baseline) and post-tDCS (up to 2 weeks after baseline))
B: Functioning Assessment Scale Test (FAST) (up to three years)
C: Change From Baseline in the Zanarini Rating Scale for Borderline Personality Disorder (ZAN-BPD) Total Score (Baseline (Day 0) to Week 10)
D: Difficulties in Emotion Regulation Scale (DERS) (1-past week); Barrat Impulsiveness Scale (BIS-11) (1-past week)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: Randomized Controlled Trial Comparing the Effects on Psychosocial Functioning of Cognitive Rehabilitation Versus Psychoeducation in Borderline Personality Disorder
Brief Summary: Study design was a multicenter, randomized, rater-blind clinical trial. There were two-parallel arms (1:1) to evaluate functional, clinical and cognitive efficacy of a specific cognitive rehabilitation group intervention (CR) compared with a psychoeducational group intervention (PE) in subjects with Borderline Personality Disorder (BPD).


Options:
A: Functioning Assessment Scale Test (FAST) (up to three years)
B: First recurrent suicide behavior (suicide attempted and completed suicide) (Minimum 1.5 year)
C: Number of days with hospital admission (Change between the period from 12 month retrospectively to Baseline and the period from baseline to 12 months prospectively)
D: Change in severity of borderline personality disorder assessed with the Zanarini Rating Scale for Borderline Personality Disorder (ZAN-BPD) interview (Assessed at baseline, and at 8, 16 and 24 months post-randomization)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: Randomized Controlled Trial Comparing the Effects on Psychosocial Functioning of Cognitive Rehabilitation Versus Psychoeducation in Borderline Personality Disorder
Brief Summary: Study design was a multicenter, randomized, rater-blind clinical trial. There were two-parallel arms (1:1) to evaluate functional, clinical and cognitive efficacy of a specific cognitive rehabilitation group intervention (CR) compared with a psychoeducational group intervention (PE) in subjects with Borderline Personality Disorder (BPD).


Options:
A: Change in Recovery Assessment Scale (Change from baseline in Recovery Assessment Scale at 12th meeting (6 up to 12 weeks))
B: Outcome Questionnaire -45.2 (Lambert et al., 2004) (3 months)
C: Functioning Assessment Scale Test (FAST) (up to three years)
D: Days/skill (Daily measurements up to 1 year. (minimum 8 months.))

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: Randomized Controlled Trial Comparing the Effects on Psychosocial Functioning of Cognitive Rehabilitation Versus Psychoeducation in Borderline Personality Disorder
Brief Summary: Study design was a multicenter, randomized, rater-blind clinical trial. There were two-parallel arms (1:1) to evaluate functional, clinical and cognitive efficacy of a specific cognitive rehabilitation group intervention (CR) compared with a psychoeducational group intervention (PE) in subjects with Borderline Personality Disorder (BPD).


Options:
A: Borderline Symptoms (6 weeks)
B: Functioning Assessment Scale Test (FAST) (up to three years)
C: Repetition of self-harm (Three months); Change scores on the Suicide Behaviors Questionnaire from baseline (Baseline and three months)
D: To assess the efficacy of olanzapine therapy (5.0-10.0 mg/day) compared with placebo in patients with BPD,as defined by DSM-IV-TR criteria,; in improving overall symptomatology as measured by the last observation carried forward (LOCF) mean change from baseline to endpoint in the ZAN-BPD total score for up to 12 weeks of double-blind treatment.

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: Effect of Aerobic Training on Bronchial Hyperresponsiveness and Systemic Inflammation in Patients With Moderate or Severe Asthma: a Randomized Controlled Trial
Brief Summary: Exercise training has been proposed as adjunctive therapy in asthma to improve many clinical outcomes; however its effects on bronchial hyperresponsiveness (BHR) and inflammation, characteristic features in asthma, remains poorly understood. We aim to investigate the effects of aerobic training on BHR (primary aim) and systemic inflammation (secondary aim). In addition, clinical control and health related quality of life (HRQoL) will be also assessed.


Options:
A: psychosocial morbidity and airway inflammation (3 months)
B: Asthma control Questionnaire (Juniper) (Within 1 week of completion of the intervention (i.e., after 12 weeks))
C: Asthma Control Questionnaire (Baseline, 6- and 12-months)
D: Bronchial hyperresponsiveness (Before and after 3 months of intervetion)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: Phase 4 Study of the Impact of Daily Bathing With Chlorhexidine-gluconate Impregnated Bathing Cloths on Nosocomial Infections in Critically Ill Patients
Brief Summary: Healthcare-associated infections are a major cause of morbidity among critically ill patients. Bathing critically ill patients with cloths impregnated with the broad-spectrum antimicrobial agent chlorhexidine-gluconate may decrease healthcare-associated infections. The purpose of this study is to evaluate the effect of daily bathing with disposable chlorhexidine-impregnated bathing cloths, as compared to daily bathing with disposable standard non-chlorhexidine-impregnated bathing cloths, on the rates of healthcare-associated infections in critically-ill patients.

Hypothesis: Daily bathing of the skin with chlorhexidine-impregnated bathing cloths will result in reduced rates of healthcare-associated infections in patients admitted to intensive care units (ICU).


Options:
A: A composite of healthcare-associated infections (Daily)
B: Colonization with MRSA, VRE and ESBL (On admission); Colonization with MRSA, VRE and ESBL (During ICU stay)
C: The overall rate of Multidrug resistant bacteria acquisition at 7 days after received 2% chlorhexidine wipe bathing versus with soap bathing (7 days after recieved 2% chlorhexidine wipes)
D: hospital acquired infections incidence (infections occured 48 hours after admission to ICU/PC-ICU)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: Manipulating the Microbiome in IBD by Antibiotics and Fecal Microbiota Transplantation (FMT): a Randomized Controlled Trial
Brief Summary: the etiology of Inflammatory Bowel Diseases (IBD) is closely associated with the gut microbiome. The results of previous studies on the effectiveness of antibiotics and fecal macrobiota transplantation (FMT) are contradicting.

Aims: to evaluate the effectiveness of wide-spectrum antibiotic regimens in acute severe colitis in an addition to standard corticosteroid therapy (UC and isolated "UC-like" Crohn's colitis). The secondary aim is to assess the outcome of FMT in those not responding to five days of therapy (in either arm). As an exploratory aim, any IBD patient with a resistant disease to at least two immunosuppressive medications, may be treated with either interventions.


Options:
A: Response rate at 8 weeks defined as a drop in PCDAI (Pediatric Crohn's Disease Activity Index ) of at least 12.5 points (or remission without steroids, intention to treat principle) (8 weeks)
B: Safety and Tolerability of SER-287 (Day 246); Composition of the Intestinal Microbiome (Baseline and 8 weeks); Engraftment of SER-287 Bacteria in All Treatment Arms (Baseline and 8 weeks)
C: Total PUCAI (Pediatric Ulcerative Colitis Activity Index) score (at day 5 after treatment (compared between the two treatment groups).)
D: Clinical response as defined by the Oxford's criteria (48 hours)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: A High Protein Weight Loss Intervention for Sarcopenic Obesity in Women
Brief Summary: The purpose of the trial is to assess the effects of combining regular, generous intakes of high quality protein (primarily from lean pork and other animal source proteins) with calorie restriction on functional status and lean muscle mass in frail, obese, women who participate in a 6 month intervention and 9 month intervention.


Options:
A: Triglyceride level, glycated hemoglobin level, fasting plasma glucose (baseline and every 3 months during year 1, every 6 months therafter)
B: Physical function (Baseline, 4, 6, and 9 months); Lean Mass (Baseline, 4, 6, and 9 months)
C: Predicted Mean Difference in Body Weight From Baseline, by Assigned Dietary Group (12 months); Predicted Mean Differences in Lean Mass From Baseline, by Assigned Dietary Group (12 months); Predicted Mean Differences in Fat Mass From Baseline, by Assigned Dietary Group (12 months); Predicted Mean Differences of Waist Circumference From Baseline, by Assigned Dietary Group (12 months); Predicted Mean Differences in Total Cholesterol Level From Baseline by Assigned Dietary Group (12 months); Predicted Mean Differences in LDL Cholesterol Level From Baseline, by Assigned Dietary Group (12 months); Predicted Mean Differences in HDL Cholesterol From Baseline, by Assigned Dietary Group (12 months); Predicted Mean Differences in Total-HDL Cholesterol Ratio From Baseline, by Assigned Dietary Group (12 months); Predicted Mean Differences in Triglycerides From Baseline, by Assigned Dietary Group (12 months); Predicted Mean Differences in Systolic Blood Pressure From Baseline, by Assigned Dietary Group (12 months); Predicted Mean Difference in Diastolic Blood Pressure, by Assigned Dietary Group (12 Months); Predicted Mean Difference in Plasma Glucose Level, by Assigned Dietary Group (12 months); Predicted Mean Differences in Serum Insulin Level From Baseline, by Assigned Dietary Group (12 months); Predicted Mean Differences in C-reactive Protein Level From Baseline, by Assigned Dietary Group (12 Months); Predicted Mean Differences in Serum Creatinine Level From Baseline, by Assigned Dietary Group (12 Months); Predicted Mean Differences of 10-y Framingham Risk Score From Baseline, by Assigned Dietary Group (12 Months)
D: Hemoglobin A1c at month 3 (3 months into treatment); Hemoglobin A1c at month 6 (6 months into treatment); Hemoglobin A1c at month 12 (12 months into treatment); Change in Body Weight at month 3 (Baseline and 3 months into treatment); Change in Body Weight at month 6 (Baseline and 6 months into treatment); Change in Body Weight at month 12 (Baseline and 12 months into treatment)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: A Phase 3, Randomized, Double-Blind, Placebo-Controlled, 26-Week Multicenter Study With a 78-Week Extension To Evaluate The Efficacy And Safety Of Ertugliflozin In Subjects With Type 2 Diabetes Mellitus And Inadequate Glycemic Control On Metformin Monotherapy.
Brief Summary: This is an efficacy and safety study of ertugliflozin in participants with type 2 diabetes mellitus (T2DM) and inadequate glycemic control on metformin monotherapy. The primary study hypothesis is that at Week 26, the mean reduction from baseline in hemoglobin A1c (HbA1c) for ertugliflozin is greater than that for placebo.


Options:
A: Change From Baseline in A1C at Week 26 (Excluding Rescue Approach) (Baseline and Week 26); Percentage of Participants Experiencing An Adverse Event (AE) (Including Rescue Approach) (Up to Week 106); Percentage of Participants Discontinuing Study Treatment Due to an AE (Including Rescue Approach) (Up to Week 104)
B: HbA1c Change From Baseline at Week 18 (Interim Analysis) (Baseline and week 18); HbA1c Change From Baseline at Week 18 (Final Analysis) (Baseline and week 18)
C: Change From Baseline in HbA1c at Week 52 (Baseline and Week 52)
D: HbA1c Change From Baseline at Week 52 (Baseline and week 52); HbA1c Change From Baseline at Week 104 (Baseline and week 104)

Answer: A