TrialPanorama/Dataset huggingface dataset:
Please select the outcome measures that correspond to the clinical trial below.
Title: Comparing the Efficacy of Two Frequently Used Doses of Enoxaparin for VTE Prophylaxis After Bariatric Surgery
Brief Summary: Approximately two thirds of the adult population in developed countries is categorized as over-weight or obese (BMI\>30). In spite of worldwide increasing awareness, obesity is a major health concern. In the presence of numerous diets, medical therapies, and robust research, bariatric surgery remains the most effective means of weight reduction in morbidly obese patients (BMI\>40, or BMI\>35 with co-morbidities). However, bariatric surgery harbors a relatively high risk for postoperative complications; of them, venous thromboembolic events (VTE) are not common, but potentially lethal. Taken together with the propensity of morbidly obese patients to develop VTE, perioperative thromboprophylaxis is mandatory.

To date, low molecular weight heparins (LMWH) are most commonly used for VTE prophylaxis in the aforementioned population. Due to the pharmacologic properties of LMWH and the characteristics of surgically treated obese patients, the optimal dose that is to be utilized for VTE prophylaxis in this population remains unclear. Assessment of anti-FXa levels in the patients' plasma can be used in order to monitor LMWH activity. Levels of 0.2-0.5 U/ml have been proposed by some authors for VTE prophylaxis.

Few studies have compared different dosing regimens of enoxaparin (between 30mg-60mg q/12h) for VTE prophylaxis in the population undergoing bariatric surgery; nevertheless, these were small non- randomized trials, containing numerous methodological weaknesses. Hence, the optimal regimen of enoxaparin to be used for the prevention of VTE in the discussed population remains unclear.

The aim of the present study is to evaluate plasma levels of anti-FXa activity, comparing two most commonly used enoxaparin prophylactic regimens (40mg vs 60mg q/24h) in a large and homogenous cohort of sleeve gastrectomy patients. Although universally used by bariatric surgeons, the pharmacologic efficacy of these regimens has not been evaluated in patients undergoing bariatric surgery.


Options:
A: P/F ratio (three days of intervention)
B: Changes from baseline in USPIO-enhanced MRI signal in carotid plaques at 6 weeks and 12-weeks in low and high dose atorvastatin groups (within groups' comparison).
C: Anti-factor Xa plasma levels (within 3 days after surgery)
D: D-dimer level (7 days post randomization); Seven-category ordinal scale recommended by the WHO (7 days post randomization)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: AA Linkage for Alcohol Abusing Women Leaving Jail
Brief Summary: The primary aims of this study are to test the hypotheses that among alcohol abusing and dependent jailed women returning to the community, adding an Alcoholic Anonymous (AA) linkage intervention will result in less alcohol use at follow-up, increased AA attendance once released, and decreased HIV/STI sexual risk behavior. Additionally, this study seeks to test the hypotheses that increased AA attendance will mediate the effect of the AA linkage intervention on alcohol use and that percent days abstinent will mediate the effect of the intervention on HIV/STI sexual risk-taking outcomes.


Options:
A: Drug abstinence
B: Change in number of alcohol use days from baseline to 6 months (Baseline, 1, 3, and 6 months)
C: Linkage to Alcohol Behavioral Therapy Counseling (i.e., "Aftercare") (1 month)
D: Mean Number of Alcohol and Drug Use Days Out of Past 30 (30 days previous, assessed at 12-month follow-up)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: A Pilot Treatment Study of Insulin-Like Growth Factor-1 (IGF-1) in Autism Spectrum Disorder
Brief Summary: The proposed project will pilot the use of IGF-1 as a novel treatment for core symptoms of autism. We will use a double-blind, placebo-controlled crossover trial design in five children with autism to evaluate the impact of IGF-1 treatment on autism-specific impairments in socialization, language, and repetitive behaviors. We expect to provide evidence for the safety and feasibility of IGF-1 in ameliorating social withdrawal in children with Autistic Disorder. Further, we expect to demonstrate that IGF-1 is associated with improvement on secondary outcomes of social impairment, language delay, and repetitive behavior, as well as on functional outcomes of global severity.


Options:
A: Aberrant Behavior Checklist - Social Withdrawal Subscale (Phase 1 - Week 4 and 12, Phase 2 - Week 4 and 8)
B: ADHD Rating Scale (ADHDRS)-Home Version Total Score (Randomized Phase) (8 weeks)
C: Change From Baseline in Vineland™-II Adaptive Behavior Scale Two Domain Composite (2DC) Score at Week 24 for Balovaptan (R05285119) 10 mg Equivalent Compared to Placebo (Baseline, Week 24)
D: Efficacy of Intranasal Oxytocin vs. Placebo on Measures of Social Function (12 and 24 weeks)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: A Pilot Treatment Study of Insulin-Like Growth Factor-1 (IGF-1) in Autism Spectrum Disorder
Brief Summary: The proposed project will pilot the use of IGF-1 as a novel treatment for core symptoms of autism. We will use a double-blind, placebo-controlled crossover trial design in five children with autism to evaluate the impact of IGF-1 treatment on autism-specific impairments in socialization, language, and repetitive behaviors. We expect to provide evidence for the safety and feasibility of IGF-1 in ameliorating social withdrawal in children with Autistic Disorder. Further, we expect to demonstrate that IGF-1 is associated with improvement on secondary outcomes of social impairment, language delay, and repetitive behavior, as well as on functional outcomes of global severity.


Options:
A: ADHD Rating Scale-IV-Parent Version: Investigator Scored - Total Score (Baseline and 8 weeks)
B: Aberrant Behavior Checklist - Social Withdrawal Subscale (Phase 1 - Week 4 and 12, Phase 2 - Week 4 and 8)
C: The primary measure will be a global composite derived by calculating the z scores on each measure other than CGI from published norms (or from the baseline descriptives, then averaging the z scores of the various outcome measures for each individual. (Baseline, weeks 2, 4, 6, 8, 10,12, and 14.)
D: Changes in the Autism Diagnostic Observation Schedule (ADOS) (At baseline and after 12 weeks of treatment); Clinical Global Impression Scale (CGI) (At baseline and every 4 week up to 12 weeks)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: A Pilot Treatment Study of Insulin-Like Growth Factor-1 (IGF-1) in Autism Spectrum Disorder
Brief Summary: The proposed project will pilot the use of IGF-1 as a novel treatment for core symptoms of autism. We will use a double-blind, placebo-controlled crossover trial design in five children with autism to evaluate the impact of IGF-1 treatment on autism-specific impairments in socialization, language, and repetitive behaviors. We expect to provide evidence for the safety and feasibility of IGF-1 in ameliorating social withdrawal in children with Autistic Disorder. Further, we expect to demonstrate that IGF-1 is associated with improvement on secondary outcomes of social impairment, language delay, and repetitive behavior, as well as on functional outcomes of global severity.


Options:
A: Clinical Global Impression Improvement (CGI-AD) (Administered weekly, initial and week 8 reported)
B: Aberrant Behavior Checklist - Social Withdrawal Subscale (Phase 1 - Week 4 and 12, Phase 2 - Week 4 and 8)
C: Change in Aberrant Behavior Checklist Irritability (ABC-I) Subscale (Baseline and 6 weeks)
D: Core autistic symptoms (ATEC) (Once every 4 weeks during the first three mounth); Side effects and adverse events questionnaire (Once every 4 weeks during the first phase(12 weeks))

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: A Phase 3, Multicenter, Randomized, Double-blind Study Evaluating the Efficacy and Safety of ABP 501 Compared With Adalimumab in Subjects With Moderate to Severe Plaque Psoriasis
Brief Summary: The purpose of this research study is to compare the efficacy and safety of ABP 501 and adalimumab (HUMIRA®) in adults with plaque psoriasis.


Options:
A: Percent Improvement From Baseline in Psoriasis Area and Severity Index (PASI) at Week 16 (Baseline and Week 16)
B: Percent Change From Baseline in Target Plaque Severity Score (TPSS) at Week 4 (Baseline, Week 4)
C: Percentage of Participants Achieving a 75% Reduction in the Psoriasis Area and Severity Index (PASI75) at Week 12 (Week 12); Percentage of Participants Achieving a Physician's Global Assessment (PGA) Response of "Clear" or "Almost Clear" at Week 12 (Week 12)
D: • The Proportion (Number) of Patients in Each Study Arm Who Achieved a PASI 75 at Week 12 of Treatment (week 12)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: A Phase 3, Multicenter, Randomized, Double-blind Study Evaluating the Efficacy and Safety of ABP 501 Compared With Adalimumab in Subjects With Moderate to Severe Plaque Psoriasis
Brief Summary: The purpose of this research study is to compare the efficacy and safety of ABP 501 and adalimumab (HUMIRA®) in adults with plaque psoriasis.


Options:
A: Percentage of Participants With Physician Global Assessment (PGA) Score of Cleared (0) or Minimal (1) at Week 16 (Week 16)
B: Long-term Safety and Tolerability of Secukinumab (Week 268)
C: Percentage of Participants Who Achieved >75 or Higher (Psoriasis Area and Severity Index) PASI Score at 12 Weeks (12 weeks); Percentage of Participants Who Achieved (Investigator's Global Assessment) IGA Score of 0 or 1 (12 weeks)
D: Percent Improvement From Baseline in Psoriasis Area and Severity Index (PASI) at Week 16 (Baseline and Week 16)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: A Phase 3, Multicenter, Randomized, Double-blind Study Evaluating the Efficacy and Safety of ABP 501 Compared With Adalimumab in Subjects With Moderate to Severe Plaque Psoriasis
Brief Summary: The purpose of this research study is to compare the efficacy and safety of ABP 501 and adalimumab (HUMIRA®) in adults with plaque psoriasis.


Options:
A: Percent Improvement From Baseline in Psoriasis Area and Severity Index (PASI) at Week 16 (Baseline and Week 16)
B: Long-term Safety and Tolerability of Secukinumab (Week 268)
C: Dose-response Efficacy Profile of AMG 827 Compared With Placebo as Measured by the Percent Improvement From Baseline in Psoriasis Area and Severity Index (PASI) Score at Week 12 (Baseline and 12 weeks)
D: Percentage of Participants With Psoriasis Area Sensitivity Index 75 (PASI-75) Response at Week 12 (Base Study) (Week 12 (or end of trial if prior to Week 12)); Percentage of Participants With a Physician's Global Assessment (PGA) Score of Clear or Minimal With at Least a 2 Grade Reduction From Baseline at Week 12 (Base Study) (Baseline and Week 12 (or end of trial if prior to Week 12)); Number of Participants Experiencing an Adverse Event Up to Week 12 (Base Study) (Up to 12 weeks); Number of Participants Discontinuing Study Drug Due to an Adverse Event Up to Week 12 (Base Study) (Up to 12 weeks); Number of Participants Discontinuing Study Drug Due to a Drug-Related Adverse Event (Base Study) (Up to 12 weeks)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: A Phase 3, Multicenter, Randomized, Double-blind Study Evaluating the Efficacy and Safety of ABP 501 Compared With Adalimumab in Subjects With Moderate to Severe Plaque Psoriasis
Brief Summary: The purpose of this research study is to compare the efficacy and safety of ABP 501 and adalimumab (HUMIRA®) in adults with plaque psoriasis.


Options:
A: Percent Improvement From Baseline in Psoriasis Area and Severity Index (PASI) at Week 16 (Baseline and Week 16)
B: Number of Participants Who Achieved Psoriasis Area and Severity Index (PASI) 75% Improvement at Week 12 (Week 12)
C: 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)
D: Change in PASI score from baseline in the two groups (12 weeks)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: Addressing Hospital Patient Information Needs Using a Personal Health Record Portal
Brief Summary: The aim of this study is to evaluate the impact of an inpatient personal health record (PHR) portal intervention within the hospital environment. The intervention hopes to improve patient engagement with their care and to measure patient activation and satisfaction. Additional clinical measure (e.g. number of adverse events that occur during the stay, changes to medication orders, etc.) will also be studied. Characterization of hospital patient and clinician attitudes towards patient engagement will also be formalized.


Options:
A: Hemoglobin A1C (Baseline, 6 months and 12 months)
B: Change in Patient Activation Measure (Admission to Unit and 3-5 days after)
C: Improvement in Self-Administered Psoriasis Area and Severity Index (SA-PASI) (12 months)
D: Severity and duration of symptom distress (At baseline and at 2, 4, 6, 8 and 12 months); Anxiety and depression (At baseline an at 2, 4, 6, 8 and 12 months)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: A 28-Week, Multi-Center, Randomized, Double Blind, Parallel-Group, Active-Controlled Safety Extension Study to Evaluate the Safety and Efficacy of PT003, PT001, and PT005 in Subjects With Moderate to Very Severe COPD, With Spiriva® Handihaler® as an Active Control
Brief Summary: This is a multi-center, randomized, double-blind, parallel group, chronic dosing, active-controlled, 28-week safety extension study of the two pivotal 24-week safety and efficacy studies (Studies PT003006 and PT003007). This study is designed to assess the long-term safety and tolerability of Glycopyrrolate (GP) and Formoterol Fumarate (FF) combination (GFF) metered dose inhaler (MDI), GP MDI, and FF MDI in subjects with moderate to very severe COPD over a total observation period of 52 weeks. Open-label Spiriva is included as an active control. To be eligible for this study, a subject must complete participation in Study PT003006 (NCT01854645) or Study PT003007 (NCT01854658).


Options:
A: Change From Baseline in Morning Pre-dose Forced Expiratory Volume in 1 Second (FEV1) (Change from Baseline to 12 weeks)
B: Trough Forced Expiratory Volume in 1 Second (FEV1) After 12 Weeks of Treatment (Non-inferiority Analysis) (Week 12)
C: Change From Baseline in Morning -Pre-dose Trough FEV1 Over 52 Weeks (Baseline and Weeks 2 to 52)
D: Annual Rate of Moderate and Severe COPD Exacerbations Expressed as Least Square Mean (From the start of the double blinded study medication until Visit 11 (Week 52)/Early Withdrawal)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: A 28-Week, Multi-Center, Randomized, Double Blind, Parallel-Group, Active-Controlled Safety Extension Study to Evaluate the Safety and Efficacy of PT003, PT001, and PT005 in Subjects With Moderate to Very Severe COPD, With Spiriva® Handihaler® as an Active Control
Brief Summary: This is a multi-center, randomized, double-blind, parallel group, chronic dosing, active-controlled, 28-week safety extension study of the two pivotal 24-week safety and efficacy studies (Studies PT003006 and PT003007). This study is designed to assess the long-term safety and tolerability of Glycopyrrolate (GP) and Formoterol Fumarate (FF) combination (GFF) metered dose inhaler (MDI), GP MDI, and FF MDI in subjects with moderate to very severe COPD over a total observation period of 52 weeks. Open-label Spiriva is included as an active control. To be eligible for this study, a subject must complete participation in Study PT003006 (NCT01854645) or Study PT003007 (NCT01854658).


Options:
A: Change From Baseline in Morning -Pre-dose Trough FEV1 Over 52 Weeks (Baseline and Weeks 2 to 52)
B: Trough Forced Expiratory Volume in 1 Second (FEV1) at End of Treatment (Week 12) (End of treatment (Week 12))
C: Change From Baseline (BL) in Trough Forced Expiratory Volume in One Second (FEV1) on Day 169 (Week 24) (Baseline and Day 169)
D: Forced Expiratory Volume in 1 Second Area Under the Curve (FEV1 AUC) 0-12 (Week 26)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: Vascular Access in Cancer Patients - PICC vs PORT in a Randomized Controlled Trial.
Brief Summary: As of today there is very limited scientific knowledge in whicj of the two vascular access devices (PICC-line or venous ports) that offers the lowest complicationrates in cancerpatients. The study group wants to clearify this unsolved matter by comparing the two systems. Our primary endpoint is the presens of catheter related venous thrombosis. We are also looking at all catheter related complications and patient satisfaction.


Options:
A: Reducing the use of CVC and PVC (through study completion, an average of 7 month)
B: The occurence of catheter related venous thrombosis (Upon clinical suspiscion during the one the patient i enrolled in the study)
C: Device Failures Within 72 Hours (72 hours after device placement)
D: length of use of the catheter measured in number of days (seven days)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: Randomized, Single-blind, Placebo-controlled, Multiple Ascending Dose Study to Evaluate Safety, Tolerability, Pharmacokinetics & Pharmacodynamics of JTZ-951 Administered Once Daily for 15 Days in Anemic Subjects With End-stage Renal Disease
Brief Summary: The purpose of this study is to determine the safety, tolerability, pharmacokinetics (PK), and pharmacodynamics (PD) of sequential ascending doses of JTZ-951 administered for 15 days in anemic subjects with end-stage renal disease (ESRD) receiving hemodialysis.


Options:
A: Number of subjects with adverse events (15 days); Vital signs and 12 lead ECGs (15 days); Cmax (maximum concentration) (15 days); tmax (time to reach maximum concentration) (15 days); t1/2 (elimination half-life) (15 days); AUC (area under the concentration-time curve) (15 days); AR (accumulation ratio) (15 days); RBC (red blood cell) count (15 days); Hgb (hemoglobin) (15 days); TSAT (transferrin saturation) (15 days); serum ferritin (15 days)
B: Change in hemoglobin (Hb) between Baseline (average pretreatment Hb) and the primary evaluation period (average Hb from Weeks 20 to 26, inclusive) (Baseline; Weeks 20 to 26)
C: Mean Change From Baseline in Hb Averaged Over Week 28 to Week 52 (Baseline (Day 1, Week 0) and Week 28 to Week 52.)
D: Responder rate: proportion of responders among the subjects (Week 30 to 36)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: Mother-infant Signalling During Breastfeeding: A Randomised Trial Investigating the Effects of a Relaxation Intervention in Breastfeeding Mothers on Breast Milk Production, Breast Milk Cortisol and Infant Behaviour and Growth.
Brief Summary: Primary hypotheses

1. The use of a relaxation tape by breastfeeding mothers that will be given starting at week 2 postpartum, will result in : i) reduced maternal stress and anxiety ii) the production of a higher volume of breast milk iii) lower milk cortisol concentrations iv) favourable effects on infant behaviour (less crying, more sleeping) v) higher milk intake by the infant vi) more optimal growth, specifically higher lean mass and lower fat mass (body composition)

Secondary hypotheses (i) Infant temperament/behaviour and gender influence milk and energy intake and hence early growth and body composition (ii) Non-nutrient factors in breast milk (hormones including ghrelin and leptin) influence infant behaviour and feeding patterns and hence infant growth and body composition.


Options:
A: fat tissue (6 months)
B: Number of eligible participants who consent and complete study intervention (1-4 days postpartum)
C: Maternal stress and anxiety (Baselibne to 12 weeks); Breast milk volume at 12 weeks assessed non-invasively using stable isotope techniques (12 weeks); Breast milk cortisol concentrations at 12 weeks (12 weeks); Infant behaviour measured using a 3-day diary at 12 weeks (12 weeks); Infant weight and body composition measured using stable isotopes at 12 weeks (12 weeks); Physiological changes (maternal saliva cortisol, breast milk cortisol and milk volume) before and after physiological-mini test in intervention group at 2,6 and 12 weeks. (2,6,12 weeks)
D: Gastrointestinal tract infection (12 months of age)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: Mother-infant Signalling During Breastfeeding: A Randomised Trial Investigating the Effects of a Relaxation Intervention in Breastfeeding Mothers on Breast Milk Production, Breast Milk Cortisol and Infant Behaviour and Growth.
Brief Summary: Primary hypotheses

1. The use of a relaxation tape by breastfeeding mothers that will be given starting at week 2 postpartum, will result in : i) reduced maternal stress and anxiety ii) the production of a higher volume of breast milk iii) lower milk cortisol concentrations iv) favourable effects on infant behaviour (less crying, more sleeping) v) higher milk intake by the infant vi) more optimal growth, specifically higher lean mass and lower fat mass (body composition)

Secondary hypotheses (i) Infant temperament/behaviour and gender influence milk and energy intake and hence early growth and body composition (ii) Non-nutrient factors in breast milk (hormones including ghrelin and leptin) influence infant behaviour and feeding patterns and hence infant growth and body composition.


Options:
A: Number of Participants With Implant Use at Three Months (Three months)
B: skin to skin contact (within first 28 days after birth); careseeking for newborn (within first 28 days after birth)
C: Karitane parenting confidence scale, KPCS. Change is being assessed. (measured at 2 weeks, 3 and 9 months post partum); Infant Care Index (measured 4 months post partum); Ages & States questionnarie, ASQ-SE. Change is being assessed. (measured at 2 weeks, 3 and 9 months post partum)
D: Maternal stress and anxiety (Baselibne to 12 weeks); Breast milk volume at 12 weeks assessed non-invasively using stable isotope techniques (12 weeks); Breast milk cortisol concentrations at 12 weeks (12 weeks); Infant behaviour measured using a 3-day diary at 12 weeks (12 weeks); Infant weight and body composition measured using stable isotopes at 12 weeks (12 weeks); Physiological changes (maternal saliva cortisol, breast milk cortisol and milk volume) before and after physiological-mini test in intervention group at 2,6 and 12 weeks. (2,6,12 weeks)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: Effectiveness of Physical Activity Intervention to Prevent Obesity and Improve Academic Performance in Children With and Without Attention Deficit Hyperactivity Disorder (ADHD) Risk
Brief Summary: Coordinated project whose objectives are: a) to test the effectiveness of a promotion of physical activity intervention (MOVI-KIDS) on preventing obesity; and b) to improve the academic performance in both children with and without attention deficit hyperactivity disorder (ADHD)


Options:
A: Academic performance (October 2014 - June 2015 (8 months))
B: Event-related brain potentials (Change from baseline, 36-40 weeks); Task Performance (Change from baseline, 36-40 weeks); Academic Achievement (Change from baseline, 36-40 weeks)
C: Our outcome measure was reduction of screen time (4 waves of data)
D: Body fat percentage (One year (interim analysis))

Answer: D