TrialPanorama/Dataset huggingface dataset:
Please select the outcome measures that correspond to the clinical trial below.
Title: A 24-Week Multicenter, Randomized, Open-Label, Parallel-Group Study Comparing the Efficacy and Safety of Ixekizumab to Fumaric Acid Esters and Methotrexate in Patients With Moderate-to-Severe Plaque Psoriasis Who Are Naive to Systemic Treatment With an Extension Period
Brief Summary: The main purpose of this study is to evaluate the efficacy of ixekizumab compared to fumaric acid esters (FAE) and methotrexate (MTX) in participants with moderate-to-severe plaque psoriasis who are naive to systemic treatment.


Options:
A: Percentage of Participants With a ≥75% Improvement in Psoriasis Area and Severity Index (PASI 75) at Week 24 (Week 24)
B: 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)
C: Number of Participants Who Achieved Psoriasis Area and Severity Index (PASI) 75% Improvement at Week 12 (Week 12)
D: Percentage of Participants With a ≥90% Improvement in Psoriasis Area and Severity Index (PASI 90) (Week 16)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: A 24-Week Multicenter, Randomized, Open-Label, Parallel-Group Study Comparing the Efficacy and Safety of Ixekizumab to Fumaric Acid Esters and Methotrexate in Patients With Moderate-to-Severe Plaque Psoriasis Who Are Naive to Systemic Treatment With an Extension Period
Brief Summary: The main purpose of this study is to evaluate the efficacy of ixekizumab compared to fumaric acid esters (FAE) and methotrexate (MTX) in participants with moderate-to-severe plaque psoriasis who are naive to systemic treatment.


Options:
A: • The Proportion (Number) of Patients in Each Study Arm Who Achieved a PASI 75 at Week 12 of Treatment (week 12)
B: Percentage of Participants Achieving a 90% or Higher Improvement From Baseline in Psoriasis Area and Severity Index (PASI) Score at Week 12 (Week 12)
C: Percentage of Participants With a ≥75% Improvement in Psoriasis Area and Severity Index (PASI 75) at Week 24 (Week 24)
D: 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)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: Clinical Decision Support for Stroke Prevention in Atrial Fibrillation - a Cluster Randomized Trial in the Primary Care Setting
Brief Summary: A cluster randomised study in the primary care setting to evaluate a electronic clinical decision tool for stroke prophylaxis in patients with atrial fibrillation.


Options:
A: Rate of HPV vaccination among girls actively cared for at participating sites (Monthly, up to 1 year)
B: HbA1c (6 months)
C: Adherence to guidelines defined as the percentage of patients with atrial fibrillation and CHA2DS2VASc ≥ 1, (not only female gender) that are prescribed anticoagulant therapy (ATC-code B01A). (12 months after study commencement)
D: Rate of initiation of adequate measures to prevent stroke (oral anticoagulant prescription) by physician in charge (End of hospital stay (expected average duration of 1 week))

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: A Double-blind, Randomized, Placebo-controlled Phase III Trial to Investigate the Efficacy and Safety of NPC-12G Gel (Topical Formulation of Sirolimus) to Angiofibroma and Other Skin Lesions in Patients With Tuberous Sclerosis Complex
Brief Summary: The purpose of this trial is to evaluate the efficacy and safety of NPC-12G gel (topical formulation of sirolimus) versus placebo gel to facial angiofibroma and other skin lesions in patients with tuberous sclerosis complex (TSC)


Options:
A: Objective Response Rate (On treatment, patients were evaluated radiologically for response to therapy up to 52 weeks.)
B: Improvements in angiofibroma (12 weeks)
C: List Learning test (from the BIRT Memory and Information Processing Battery) (6 months); Complex Figure test (from the BIRT Memory and Information Processing Battery) (6 months); CANTAB - Stockings of Cambridge (SOC) (6 months); CANTAB - Spatial Working Memory (SWM) (6 months); Telephone search dual task (from the Test of Everyday Attention) (6 months)
D: Rapamycin level (6 months); Complete blood count (6 months); Total cholesterol (6 months); Dermatologic sensitivity at site of application (pain, erythema, edema, pruritis) (6 months)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: Flourishing App: Evaluation of the Effectiveness of a Well-being Application for Mobile Devices
Brief Summary: This protocol proposes a well-being program, delivered through an application for mobile devices, based on meditation and positive psychology principles such as human development, the improvement of virtues, quality of life and well-being. The investigators hypothesize that this program offered in mobile application may promote well-being and reduce stress related problems in the participants.

Objectives: To evaluate the effectiveness of a well-being program delivered through an application for mobile devices in a sample of employees who work in a company (Natura Inovação/Cosméticos) and in a hospital (Hospital Israelita Albert Einstein).

Methods: Two hundred and fifty employees from Natura Inovação/Cosméticos and 250 employees from Hospital Israelita Albert Einstein will be recruited. The participants will be randomized in two groups of 125 participants each one, half of them in the control group (GC) and the other half to the intervention group (GI), by institution.


Options:
A: NICU health professional resilience (10 days, 1 month, 6 months, 12 months)
B: Burnout (12 month outcomes)
C: Changes in subjective symptoms of well-being at work (baseline, 4 weeks, 8 weeks); Changes in subjective symptoms of stress (baseline, 4 weeks, 8 weeks)
D: Pre-/post-intervention changes in mRNA transcript abundance across the entire transcriptome of circulating immune cells in the intervention group relative to the control group. (6 weeks); Pre-/post-intervention changes in IL-6 (6 weeks); Pre-/post-intervention changes in IL-8 (6 weeks); Pre-/post-intervention changes in IL-10 (6 weeks); Pre-/post-intervention changes in TNF-α (6 weeks); Pre-/post-intervention changes in IFN-γ (6 weeks); Pre-/post-intervention changes in peripheral blood mononuclear cell (PBMC) telomerase activity (6 weeks)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: Focal Cartilage Defects in the Knee - A Randomized Controlled Trial Comparing Arthroscopic Microfracture With Arthroscopic Debridement
Brief Summary: 114 patients between 18 and 50 years with an isolated focal cartilage defect in the knee will be randomized to either receive arthroscopic microfracture or arthroscopic debridement. Both groups will then undergo a systematic physiotherapy training regime for 6-9 months. The groups will then be compared for results, after 3, 6, 12 and 24 months, by using validated patient reported outcome scores (Lysholm, KOOS, Tegner) and EQ5D as well as clinical examination and radiological findings at 2 years (MRI).


Options:
A: pain ( VAS ) (6 months)
B: The Lysholm Knee Score (One year); Pain After Exercise (VAS) (One year); WOMET (Western Ontario Meniscal Tear -Disease Specific Quality of Life -Assessment Tool) (One year)
C: Knee Injury and Osteoarthritis Outcome Score (KOOS) Quality of Life (24 months follow up)
D: To compare between the two treatment groups the patients' disease-specific quality of life at 2 years using the Western Ontario McMaster (WOMAC) osteoarthritis index and (2 years)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: Continuous Versus Bolus Intermittent Loop Diuretic Infusion in Acutely Decompensated Heart Failure: Evaluation of Renal Function, Congestion Signs, BNP and Outcome
Brief Summary: DiurHF is a prospective, multicenter, observational, study that compares continuous with intermittent infusion of furosemide in patients admitted with a diagnosis of ADHF. Previous pilot study design was planned to anticipate a larger multicenter trial able to definitively evaluate the optimal loop diuretic use strategy in patients with ADHF.


Options:
A: Cardiac death and rehospitalization for HF (180 days)
B: number of hospitalizations for heart failure (End of study)
C: Changes in a composite clinical-lab score (Baseline and 96 h after randomization,precisely:48 h after end of the last UF session in the intervention arm;24 h after end of 72 h infusional drug treatment in the control arm)
D: Change in Serum Creatinine (Change from Baseline to Day 4); Change in Weight (Change from Baseline to Day 4)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: Prospective, Double-blind, Randomized, Multicenter Phase III Study Evaluating Efficacy and Safety of Three Different Dosages of NewGam in Patients With Chronic Inflammatory Demyelinating Poly(Radiculo)Neuropathy
Brief Summary: Study to evaluate the Efficacy and Safety of Three Different Dosages of NewGam in Patients With Chronic Inflammatory Demyelinating Poly(radiculo)neuropathy


Options:
A: Comparison of the Responder Rates Between Two Treatment Groups in the Efficacy Period (6 months)
B: Decrease in the Inflammatory Neuropathy Cause and Treatment (INCAT) Disability Score (at Week 24)
C: proportion of patients with more than 1point improvement in the INCAT score relative to baseline at 28weeks. (28weeks); proportion of patients with more than 1point exacerbation in the INCAT score relative to 28weeks at 52weeks. (52weeks)
D: Percentage (%) of Subjects With CIDP Relapse or Are Withdrawn for Any Other Reason During the Subcutaneous (SC) Treatment Period (Up to 25 weeks)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: A Phase 3, Randomized, Double-blind, Placebo-controlled Multicenter Study to Evaluate the Efficacy and Safety of Ospemifene in Patients With Moderate to Severe Vaginal Dryness, a Symptom of Vulvo-vaginal Atrophy (VVA) Due to Menopause
Brief Summary: The objective of this study is to evaluate the efficacy and safety of ospemifene 60 mg once daily (QD) compared with placebo in treatment of vulvo-vaginal atrophy (VVA) due to menopause in women with moderate to severe vaginal dryness as the most bothersome symptom (MBS) of VVA.


Options:
A: Comparison of Progression-Free Survival (PFS) in Patients Treated With Fulvestrant With Those Treated With Anastrozole (Baseline RECIST 1.1 assessments (Day 0) and then every 12 weeks until the earliest of disease progression evident, patient dies or has surgery/radiotherapy for their disease (up to approximately 38 months))
B: Change From Baseline in the Percentage of Parabasal Cells in the Maturation Index of the Vaginal Smear at Week 12 (Baseline and Week 12); Change From Baseline in the Percentage of Superficial Cells in the Maturation Index of the Vaginal Smear at Week 12 (Baseline and Week 12); Change From Baseline in the Vaginal pH at Week 12 (Baseline and Week 12); Change From Baseline in the Severity of Self-reported Most Bothersome Symptom (MBS) of Vaginal Dryness at Week 12 (Baseline and Week 12); Number of Participants With Adverse Events (From the first dose of study drug up to 14 days after the last dose; 14 weeks)
C: Vaginal Dryness (6 months)
D: Relief of vaginal symptoms (over 12 months of treatment); Safety: Long-term effect on the endometrium assessed through evaluation of endometrial biopsies. AEs, clinical laboratory data and serum hormone levels

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: Effects of Blastocyst Stage Embryo Transfer Compared With Cleavage Stage Embryo Transfer in Women ≤ 38 Years
Brief Summary: Single center randomized study including 388 women aged less than 39 years, performing in vitro fertilization, to determine if blastocyst stage (Day 5 to 6) embryo transfer (ETs) improves implantation and pregnancy rate compared with cleavage stage (Day 2 to 3) ETs.


Options:
A: Implantation rate (8 weeks after replacement)
B: Pregnancy rate (8 weeks after inclusion)
C: Clinical pregnancy (fetal heartbeat observed on ultrasound at 7 weeks gestation) (7 weeks gestation)
D: Ongoing pregnancy (12 weeks of gestation)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: The Efficacy of Transcervical Foley Balloon Plus Vaginal Misoprostol Versus Vaginal Misoprostol Alone For Cervical Ripening In Nulliparous Obese Women: A Randomized, Comparative Effectiveness Trial
Brief Summary: Obese pregnant women (BMI ≥ 30 kg/m2) are more likely than their normal-weight counterparts to require induction of labor because of increased rates of obstetric complications including pregnancy related hypertensive disorders, diabetes, and prolonged gestations. Several studies have shown that obese women experience increased labor duration and oxytocin needs when compared to normal-weight women. This in turn results in increased rates for unplanned cesarean delivery (CD) as a result of failed induction of labor (IOL), arrest disorders and non-reassuring fetal heart rate tracing, that is dose-dependent with increasing class of obesity. The investigators hypothesize that obese pregnant women and unfavorable cervix (Bishop score ≤ 6), IOL ≥ 24 weeks gestation using the Foley balloon plus vaginal misoprostol will result in reduced cesarean delivery rates when compared to vaginal misoprostol alone.


Options:
A: Number of Participants With a Need for Cesarean Delivery (Induction to delivery)
B: Time From Start of Labor Induction to Vaginal Delivery (72 hours)
C: The Time Interval From Induction to Delivery: All Participants (Day 1); Time (Hours) From Induction to Delivery: Nulliparous (Day 1); Time (Hours) From Induction to Delivery: Multiparous (Day 1); Time From Induction to Delivery: VD (Day 1); Time From Induction to Delivery: CD (Day 1); Per Treatment Protocol: Time (Hours) From Induction to Delivery (day 1)
D: To evaluate and compare the efficacy of the Atad Ripening Device (ARD), of the double balloon instillation device (AID) with concomitant continuous extra-amniotic NS instillation - 50 Ml/hour and of the folly catheter combined with continuous extra-a (2 years)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: The Use of Random Telephone Calls to Measure Immunosuppressive Therapy Adherence in Patients With Renal Transplants
Brief Summary: Nonadherence to medication is a major obstacle to successful treatment of renal transplant patients. This study has two primary aims. The first is to test whether a culturally sensitive cognitive-behavioral adherence promotion program could significantly improve medication adherence to tacrolimus prescription. Participants will be randomly assigned to either group CBT or to standard care. The second aim is to pilot a novel strategy of adherence measurement - unannounced telephone pill counts, which has been shown to be a valid and reliable means to measure medication adherence in other patient populations. Participants will be recruited from waiting area of the kidney transplant clinic at SUNY Downstate Medical Center in Brooklyn, NY. Three unannounced telephone pill counts will be conducted prior to start of the intervention in order to establish baseline adherence and three pill counts will be conducted post-intervention. Tacrolimus trough concentration levels will also be collected as an additional biological measure of adherence.


Options:
A: 12-week immunosuppression medication adherence (12 weeks)
B: Adherence as measured by unannounced telephone pill count (3 months)
C: Drug adherence (at 6 months after enrollment)
D: Incidence of Rejection (2 Years)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: Trauma-sensitive Yoga for Female Veterans With PTSD Who Experienced Military Sexual Trauma
Brief Summary: In this study, we are evaluating the effectiveness of a yoga intervention to treat posttraumatic stress disorder (PTSD), its associated symptoms of chronic pain and insomnia, and biological and physiological responses to trauma and PTSD in women Veterans who experienced military sexual trauma (MST). If effective, this yoga intervention could reduce PTSD symptoms and chronic pain, improve sleep quality, and decrease the body's automatic "fight or flight" stress response and the damage this stress response causes in the body, including heart disease and diabetes. This intervention could improve these women Veterans' quality of life and social functioning, for example, going to work and having satisfying relationships with family and friends. This study may support an innovative, complementary and alternative PTSD treatment for women Veterans who experienced MST. This new, evidence-based PTSD treatment could supplement current PTSD treatments. Clinical guidelines for this yoga intervention could be implemented nationally in the VA health care system.


Options:
A: Posttraumatic Stress Disorder Symptom Scale- Interview Version (PSS-I) (12 weeks); Timeline Followback Heavy Episodic Drinking Episodes (12 weeks)
B: Self-efficacy (Change from Baseline in Self efficacy at 6 months)
C: condom use (4.5 months)
D: Clinician Assessed PTSD Checklist-5 (CAPS-5): Change in Mean Total Severity Scores From Baseline to 3-months Post-intervention (Baseline to 3-Months Post-Treatment (3-m PT): 3-m PT data were collected 11-13 weeks after the final session of TCTSY and CPT cohorts, which began in the same week. TCTSY (10 weeks) 3-m PT data collection occurred 2 weeks prior to CPT (12 weeks).); PTSD Symptom Checklist-5 (PCL-5): Change in Mean Total Score From Baseline to 3-month Post-intervention (Baseline to 3-Months Post-Treatment (3-m PT): 3-m PT data were collected 11-13 weeks after the final session of TCTSY and CPT cohorts, which began in the same week. TCTSY (10 weeks) 3-m PT data collection occurred 2 weeks prior to CPT (12 weeks).)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: Prevention of Post-Endoscopic Retrograde Cholangiopancreatography (ERCP) - Induced Pancreatitis Using Aggressive Lactated Ringer's Infusion and/or Rectal Indomethacin
Brief Summary: Post-ERCP pancreatitis is a well-known and sometimes life-threatening complication of ERCP. Both LR and rectal indomethacin have shown benefit in preventing post-ERCP pancreatitis. Despite this, no study to date has evaluated both of these measures for preventing post-ERCP pancreatitis. It is our hope to evaluate the combination of these two modalities for preventing post-ERCP pancreatitis compared with either modality alone.


Options:
A: post ERCP pancreatitis rate (up to 4 weeks)
B: Post-ERCP pancreatitis (30 days after ERCP)
C: Percentage of successful selective biliary cannulation
D: The Number of Participants With Acute Pancreatitis After ERCP as Assessed by Worsening Abdominal Pain Plus Either Elevated Amylase or Lipase 3 x Upper Limit of Normal (30 days after ERCP); The Number of Participants With Acute Pancreatitis After ERCP as Assessed by Worsening Abdominal Pain Plus Imaging Suggestive of Acute Pancreatitis (30 days after ERCP)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: Does Follicular Flushing Improve the Outcome in Monofollicular IVF Therapy?
Brief Summary: Follicular aspiration as well as follicular flushing are standardized techniques and have been practiced in polyfollicular IVF (in vitro fertilization) therapy for years. Monofollicular IVF therapy is a standard technique as well. IVF can be done in natural cycles or with a minimal stimulation with clomifen citrate to achieve a monofollicular response. Our study aims to compare follicular aspiration and follicular flushing in monofollicular stimulation. First the investigators want to answer the question whether flushing is beneficial for the oocyte yield. In case of a positive result the investigators want to establish a recommendation about the optimal number of flushings taking into account the duration of the procedure and the pain during manipulation.


Options:
A: Frequency of Ovarian Hyperstimulation Syndrome (OHSS) (3 years)
B: Number of retrieved oocytes per procedure (through study completion, 9 months)
C: Proportion of mature oocytes retrieved (day of intervention)
D: FOLLICULAR FLUSHING ON CYCLE OUTCOMES IN POOR RESPONDERS (2 weeks)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: Prevention of Cardiovascular Disease With the Vegetarian Diet: the CARDIVEG Study
Brief Summary: The study is a randomized, open, cross-over trial designed to test whether a vegetarian diet would benefit the cardiovascular risk profile of the participants, compared with a Mediterranean diet.


Options:
A: Systolic Blood Pressure (12 weeks); Total Cholesterol (12 weeks)
B: Change in body weight (kg) (26 weeks)
C: Primary endpoint: Change from baseline in cardiovascular (CVD) risk as assessed by the PROCAM and Framingham risk engines. (three months)
D: Changes in Body Weight From Baseline (baseline and 6 months)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: To Assess the Efficacy of Granulocyte Colony Stimulating Factor Versus Standard Medical Therapy in Patients of Decompensated Cirrhosis
Brief Summary: Background and Aims: Liver transplantation is the only curative treatment modality for decompensated cirrhosis and is limited by donor organ availability and financial resources; thus many patients die while awaiting liver transplant. Granulocyte colony stimulating factor (GCSF) therapy can mobilize bone marrow stem cells for tissue regeneration, and has been shown to benefit patients with liver disease. The investigators evaluated the efficacy of GCSF therapy in decompensated cirrhosis in an open labelled randomized control trial.

Patients and Methods: Consecutive patients with decompensated cirrhosis of mixed etiologies were randomized to receive either a 5-day course of GCSF (5 μg/kg/d) plus standard medical therapy for 6 months (Group-A); or standard medical therapy alone for 6 months (Group-B). At the end of 6 months their survival were compared.


Options:
A: Survival rates (12 weeks)
B: Proportion of Survival of subjects in both group (4 weeks and 12 weeks)
C: Transplant free survival (1 year)
D: Number of participants alive at 6 months (6 months)

Answer: D