TrialPanorama/Dataset huggingface dataset:
Please select the outcome measures that correspond to the clinical trial below.
Title: N/A
Brief Summary: During the last decade numerous new procedures have been presented regarding surgical treatment of urinary stress incontinence (1,2). Development of the midurethral tape procedure (TVT) changed the surgical procedure dramatically both regarding the extent of the surgical procedure and also decreased the morbidity remarkably. The success rate of the TVT procedure has been proven to be high (1,2 ). However, the development of the TOT/TVT-O procedures disclosed a new fixation point and further decreased the risk of bladder injury (1,2). Since the introduction of trans-obturator slings several mini-slings have been introduced in order to reduce the need of perforation of the skin and muscles (3,4,5). Although some systems seem promising (5) others have disclosed a long learning curve, pain problems following the procedure and lower success rates, compared to the traditional sling procedures. None of these mini-slings have been adjustable.

Recently the Ajust system for treatment of stress urinary incontinence was introduced. The system is a single incision sling procedure and consists of an adjustable Polypropylene mesh sling with self fixation anchors (6). In a feasibility study (6), the 6 months objective cure rate was 82%, but there is a lack of information regarding adverse events and durability of treatment success. Our preliminary experiences suggest, that the procedure has a rapid learning curve, low pain scores postoperatively and a 94% cure rate at 3 months follow-up (personal observation). Recently, several abstracts have indicated that the cure rate obtained by Ajust is comparable to TVT or TVT-O (10-12).

The purpose of the present study is (primary outcome):

To test the hypothesis that the Ajust and TVT, TVT-O and TOT, respectively are equal regarding subjective cure rate (cure is defined as subjectively not incontinent at all), i.e. the study is designed as a non-inferiority study. The study is performed as a randomised controlled trial without blinding. The study is powered to detect a 9% difference between the two groups. The subjective cure rate is based on ICIQ measurement

Secondary outcome:

* To test the hypothesis that Ajust is associated with a significantly lower postoperative pain perception.
* To test the hypothesis that antibiotic treatment is not necessary


Options:
A: Urine culture based on type of symptoms (2 weeks)
B: Incidence of Post-operative UTI Following the Placement of Sub-urethral Sling for the Treatment of Stress Urinary Incontinence (6 weeks); Incidence of Post-operative UTI in Placebo Group (6 weeks); Incidence of Post-operative UTI in Treatment Group (6 weeks)
C: To assess the effects of maternal obesity on the concentrations and adequacy of antimicrobial activity of prophylactically administered antibiotics within tissues (subcutaneous adipose and myometrial) at the time of cesarean delivery. (6 weeks)
D: A change in number of cured patients (Up to 1 year)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: Phase II Study of Bendamustine and Rituximab Induction Chemoimmunotherapy Followed by Maintenance Rituximab and Lenalidomide in Previously Untreated Chronic Lymphocytic Leukemia (CLL) and Small Lymphocytic Lymphoma (SLL)
Brief Summary: The investigators propose a treatment strategy where patients are treated with induction chemoimmunotherapy consisting of rituximab + bendamustine for 6 cycles, followed by initiation of maintenance rituximab and lenalidomide among patients achieving an objective response (i.e., at least stable disease with some tumor shrinkage) to induction therapy. The goal of maintenance therapy will be to capitalize on the cytoreduction following induction chemotherapy with a maintenance regimen that has also shown promising activity in CLL, in order to allow for improved PFS in this population.


Options:
A: Time to Progression (At least 24 months following completion of therapy, an average of 5 years)
B: Number of Participants (Par.) Classified as Responders (Rs) and Non-responders (NRs) for Objective Response in Accordance With the National Cancer Institute Working Group (NCIWG) 1996 Guidelines (Start of treatment (Week 0/Visit 2) until Week 52)
C: Progression-free Survival (PFS) (Up to 5 years)
D: Overall response rate (ORR) (84 days after first dose of last induction cycle)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: Long Term Evaluation of Sevelamer HCl vs. Calcium-based Phosphate Binder in the Treatment of Hyperphosphatemia in Hemodialysis Patients
Brief Summary: The study is designed to compare sevelamer vs. calcium-based phosphate binder in hemodialysis patients to achieve full-scale of medical care, including reduction of atherosclerotic risk factors, reduction of vascular access reconstruction rate, and pharmacoeconomic analysis.


Options:
A: Calcium Balance (2 weeks)
B: Serum phosphorus levels at 8 weeks. (8 weeks)
C: Composite end-point of Ca, P, Ca*P within K/DOQI recommendation (12 months)
D: Change in left ventricular mass (36 weeks)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: A Multicenter, Randomized, Double-Blind Study to Evaluate the Safety, Tolerability, and Efficacy of the Addition of MK-3102 to Subjects With Type 2 Diabetes Mellitus Who Have Inadequate Glycemic Control on Metformin Therapy
Brief Summary: The purpose of this study is to assess the safety and efficacy of omarigliptin compared to placebo in participants with inadequate glycemic control on metformin monotherapy. The primary hypothesis is that after 24 weeks, the addition of treatment with omarigliptin provides greater reduction in hemoglobin A1c (A1C) than placebo.


Options:
A: Change From Baseline in HbA1c at Week 30 (Week 0 to Week 30)
B: Change in HbA1c From Baseline to Week 26 (Day 1 (Baseline) and Week 26)
C: HbA1c Change From Baseline at Week 24 (Baseline and week 24)
D: Change From Baseline in Glycosylated Hemoglobin (A1C) at Week 24 (Phase A) (Baseline and Week 24); Percentage of Participants Who Experienced at Least One Adverse Event (Phase A+B) (Up to 107 weeks); Percentage of Participants Who Discontinued Study Drug Due to an Adverse Event (Phase A+B) (Up to 104 weeks); Percentage of Participants Who Experienced an Adverse Event Which Were Included Under the System Order Class of Investigations (Phase A+B) (Up to 104 weeks)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: Effect of Steroids on Cerebrospinal Fluid Markers of Inflammation and Neuronal Damage After Surgical Aortic Valve Replacement
Brief Summary: The purpose of this study is to investigate if methylprednisolone is effective in reducing the cerebral inflammatory response after open heart surgery with cardiopulmonary bypass.


Options:
A: Comparison of postoperative PaO2/FiO2 (at 10 minutes after anesthetic induction)
B: SOFA Score (24 hours before until day 9 post-surgery)
C: Changes in cerebrospinal fluid (CSF) levels of IL-6, IL-8, S100B, alb (24h after surgery)
D: Evaluation of the safety and feasibility of xenon application for general anesthesia before and after CABG implantation (an average of 4 to 6 hours)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: Effectiveness of an Interactive Web-based Platform and a Disease Specific Information Website in Patients With Heart Failure: a 3-arm Randomised Trial.
Brief Summary: The number of people with heart failure is increasing in the western world. Mainly due to better treatment of myocardial infarctions and ageing of the population. The amount of health care workers is unfortunately not increasing. We want to investigate how two electronic devices (a website and an interactive web-based platform) influence the self-care, quality of life, hospitalizations and mortality by delivering care from a distance. We also want to investigate if a higher quality of care is delivered despite of less frequent visits to a nurse and/or doctor. The study takes place in the Netherlands and is a randomized trial. Patients with heart failure, registered by an outpatient heart failure clinic or general practitioner can take part. They will be randomized to 3 groups: group 1 receives standard care, group 2 receives standard care with the website, group 3 receives an adjusted care pathway, with both the website and the interactive web-based platform connected to a telemonitoring system. In this group all routine consultations with heart failure nurses and general practitioner will be substituted by this device.


Options:
A: Lifestyle (3 months); Quality of Life (QoL) (3 months); Behavioral flexibility (3 months)
B: Readmission and death rate at 6 months' follow up.
C: Change in self-care behaviour measured with the validated European Heart Failure Self Care Behaviour Scale(EHFScB scale) (at 3, 6 and 12 months); Change in health related quality of life measured with the generic short-form health survey with 36 questions (SF36), EuroQol five Dimensions (EQ-5D) and the disease-specific Minnesota Living with Heart Failure Questionnaire (MLHFQ) (at 3, 6 and 12 months)
D: exercise tolerance (1 year); exercise tolerance (12 weeks)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: A Phase 2, Randomized, Double-Blind, Multicenter, Dose-Ranging, Crossover Study to Evaluate the Safety and Efficacy of Subcutaneous Administration of CINRYZE® (C1 Esterase Inhibitor [Human]) With Recombinant Human Hyaluronidase (rHuPH20) for the Prevention of Angioedema Attacks in Adolescents and Adults With Hereditary Angioedema
Brief Summary: The primary objectives of the study are to evaluate the safety, tolerability, and efficacy of two doses of CINRYZE with recombinant human hyaluronidase (rHuPH20) administered by subcutaneous (SC) injection to prevent angioedema attacks.


Options:
A: Frequency of All HAE Attacks (Duration of the study)
B: Time to Beginning of Substantial Relief of the Defining Symptom (Within 4 hours after initial treatment)
C: Normalized Number of Angioedema Attacks During the Treatment Period (From Visit 1 (Week 1) up to Visit 16 (Week 8) during each treatment period)
D: Number of Confirmed HAE Attacks (Investigators collected data from patient diaries from the first day of dosing through to Day 29 or last day of dosing +24 hrs (the effective dosing period).); Proportion of Subjects Who Were HAE Attack-free During the Entire Dosing Period (Investigators collected data from patient diaries from the first day of dosing through to Day 29 or last day of dosing +24 hrs (the effective dosing period).)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: Alcohol Harm Reduction Intervention Among Female Sex Workers in Mombasa, Kenya
Brief Summary: The main study objective is to investigate whether female sex workers (FSWs) at drop-in centers in Mombasa, Kenya, who report harmful or hazardous alcohol intake and participate in a brief alcohol intervention (vs. those who participate in a nutrition intervention in the control group), will reduce their alcohol use and incidence of STIs, HIV, and sexual violence, as well as increase their condom use.


Options:
A: Alcohol: change in mean number of heavy drinking days in last month of study period compared with baseline (6 months); TB: successful treatment vs. non-successful treatment as defined by the WHO (6 months)
B: Alcohol use and STI/HIV infection (up to 12 months)
C: Baby's health status (6 days after birth; 6 months after birth; 12 months after birth)
D: Number of Participants With and Without Non-hazardous Drinking, as Determined by Self-report and the Biomarker Phosphatidylethanol, at 3- and 6-months. (Both 3 months and 6 months (composite measure)); Number of Participants With >90% Isoniazid (INH) Adherence During Prescribed Course of INH (6 months)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: The Safety and Feasibility of Administering Xenon to Patients Undergoing Off-pump Coronary Artery Bypass Graft Surgery: a Pilot Study
Brief Summary: Purpose of this study is to test whether xenon application during off-pump-coronary artery bypass (OPCAB)-surgery is safe and feasible.


Options:
A: Composite of all-cause mortality, non-fatal myocardial infarction, any new stroke, and/or acute renal failure (In-hospital)
B: The incidence of explicit recall of events during the surgical and anesthetic periods. (Three years)
C: Postoperative delirium rate within 7 days after surgery (7 days after surgery)
D: Feasibility/Safety of xenon anesthesia (Intraoperatively)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: A Multi-center, Randomised, Double-blind, Parallel-group Phase III Study to Assess High Dose Esomeprazole Na i.v. Treatment (Bolus Infusion of 80 mg Followed by a Continuous Infusion of 8 mg Per Hour Administered for 72 Hours) for Prevention of Rebleeding
Brief Summary: To describe the rate of clinically significant rebleeding during 72 hours continuous i.v. infusion of high dose esomeprazole Na in patients in China with primary successful endoscopic haemostatic therapy of a bleeding peptic ulcer, with cimetidine i.v. in


Options:
A: recurrent bleeding (within 28 days after the first bleeding event)
B: early intranvenous infusion of a high-dose poton-pump inhibitor before endoscopy would have a therapeutic effect on bleeding ulcers, reduce the need for endoscopic therapy, and result in improved clinical outcomes.
C: Re-bleeding rate after endoscopic treatment of bleeding peptic ulcers (30 days after endoscopic therapy)
D: Rate of Clinically Significant Rebleeding Within 72 Hours (72 hours)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: N/A
Brief Summary: Protocol is intended to characterize the overall safety and tolerability of eculizumab in this population.


Options:
A: Percentage Of Participants With Complete Thrombotic Microangiopathy (TMA) Response at Week 26 (Week 26)
B: Percentage Of Complement Inhibitor Treatment-naïve Participants With Complete Thrombotic Microangiopathy (TMA) Response at Week 26 (Week 26)
C: Adverse events and serious adverse events and their severity and relationship to the drug (12 weeks)
D: Percentage of Patients With TMA Event-free Status (Through 26 weeks); Percentage of Patients With Hematologic Normalization (Through 26 weeks); Percentage of Patients With Complete TMA Response (Through 26 weeks)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: Effect of Topical Oil Application on Trans-Epidermal Water Loss in Preterm Infants - A Randomized Clinical Trail
Brief Summary: The skin of newborn infants is immature and ineffective as a barrier. Preterm skin exhibits even more vulnerability to the environment due to poor self regulatory heat mechanisms, paucity of fatty tissue and its thinness. Most preterm babies lose up to 13% of their weight as water loss from their skin during the first week of life. Many strategies have been utilized by neonatologists to decrease this water loss. Edible coconut oil application on the skin acts as a non permeable barrier and can help in achieving this. Hence the investigators decided to undertake this study to objectively assess the reduction in water loss from skin after oil application.


Options:
A: Trans Epidermal Water Loss(TEWL) (first 7 days of life)
B: Presence of eczema (12 months of age.); Confirmed diagnosis of food allergy at 12 months (52 weeks). (12 months of age)
C: Atopic dermatitis (AD) (AD 0-12 months, with follow-up investigations at 2 and 3 yrs and at intervals up to year 2044, provided funding); Food allergy to any intervention allergen (0-36 months, assessed first at 36 months, with follow-up investigations at intervals up to year 2044, provided funding)
D: Hospital Acquired Blood Stream Infection (28 days of life)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: Effect of Topical Oil Application on Trans-Epidermal Water Loss in Preterm Infants - A Randomized Clinical Trail
Brief Summary: The skin of newborn infants is immature and ineffective as a barrier. Preterm skin exhibits even more vulnerability to the environment due to poor self regulatory heat mechanisms, paucity of fatty tissue and its thinness. Most preterm babies lose up to 13% of their weight as water loss from their skin during the first week of life. Many strategies have been utilized by neonatologists to decrease this water loss. Edible coconut oil application on the skin acts as a non permeable barrier and can help in achieving this. Hence the investigators decided to undertake this study to objectively assess the reduction in water loss from skin after oil application.


Options:
A: Skin Barrier Function (The Skin Barrier Function will be carried out by measuring trans epidermal water loss 10 minutes before first bath and 10 minutes after first bath.)
B: Trans Epidermal Water Loss(TEWL) (first 7 days of life)
C: Presence of eczema (12 months of age.); Confirmed diagnosis of food allergy at 12 months (52 weeks). (12 months of age)
D: Cumulative incidence of provider-diagnosed AD (up to 24 months)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: A Double Blind, Double Dummy, Randomised, Multi-centre Study to Assess the Tolerability and Efficacy Profile of Vildagliptin Compared to Gliclazide as Dual Therapy With Metformin in Muslim Patients With Type 2 Diabetes Fasting During Ramadan
Brief Summary: To evaluate vildagliptin as compared to gliclazide, given in combination with metformin in Muslim patients with type 2 diabetes fasting during Ramadan.


Options:
A: A composite endpoint including: all-causes mortality, non fatal myocardial infarction (MI) - including silent MI- , non fatal stroke, unplanned coronary revascularization (48 months)
B: Number of Patients With Drug Related Adverse Events (After the first drug intake until 7 days after the last treatment administration, up to 383 days)
C: Percentage of patients experiencing at least one Hypoglycaemic Event (HE) during the Ramadan fasting period to test superiority (1 month)
D: Change in HbA1c From Baseline to Week 26 (Day 1 (Baseline) and Week 26)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: A Double Blind, Double Dummy, Randomised, Multi-centre Study to Assess the Tolerability and Efficacy Profile of Vildagliptin Compared to Gliclazide as Dual Therapy With Metformin in Muslim Patients With Type 2 Diabetes Fasting During Ramadan
Brief Summary: To evaluate vildagliptin as compared to gliclazide, given in combination with metformin in Muslim patients with type 2 diabetes fasting during Ramadan.


Options:
A: Hypoglycemia (29 days of Ramadan); Hyperglycemia (29 days of Ramadan)
B: Postprandial glucose (mg/dl) (180 minutes)
C: Change in HbA1c (Baseline Pre-Ramadan (3 months prior to Ramadan), during Ramadan (+ 4 weeks) and post Ramadan (3 months after Ramadan))
D: Percentage of patients experiencing at least one Hypoglycaemic Event (HE) during the Ramadan fasting period to test superiority (1 month)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: N/A
Brief Summary: Acute kidney injury (AKI) frequently occurs after cardiac surgery using cardiopulmonary bypass (CPB). Recombinant human erythropoietin (rHuEPO) is known to provide organ protection against ischemia-reperfusion injury through its anti-inflammatory properties. The aim of the present study was to investigate the effect of a single preoperative bolus of EPO on the incidence of AKI following complex valvular heart surgery in a randomized, controlled and double-blind trial.


Options:
A: Time to All Cause Death or First Hospitalization for Worsening Heart Failure (From randomization to the end of study; maximum time on study was 73 months)
B: Infarct Size in the Territory of the Infarct Related Artery (performed 2 to 6 days after study medication administration (first CMR))
C: Left ventricular ejection fraction measured by magnetic resonance imaging (4-6 months)
D: incidence of acute kidney injury (change of renal function including SCr, cystatin C, creatinine clearance from 24 h before operation to postoperative day (POD) 5)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: A Multicenter, Double-Blind, Placebo-Controlled, Ascending-Dose, Repeat-Dose Safety and Pharmacokinetic Investigation of a Delayed-Release, Enteric-Coated Capsule Formulation of AVX 470 [Anti-TNF (Tumor Necrosis Factor) Globulin (Bovine)] in Patients With Active Ulcerative Colitis
Brief Summary: The purpose of this study is to evaluate the safety and tolerability as well as the pharmacodynamic effects of multiple doses of AVX-470 administered orally in patients with active ulcerative colitis.


Options:
A: Number of Participants With Clinical Response (Week 6)
B: Safety and tolerability of AVX-470 over 28 days of treatment (5 weeks)
C: Clinical remission defined as a Mayo Clinic Score (MCS) </= 2 with no individual subscore exceeding 1 point (Week 10)
D: Remission defined as a decrease in Mayo score to ≤ 2 points at week 4 (week 4)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: Effects of 3 Months of Controlled Whole Body Vibrations With Low Exposure Period on the Risk of Falls Among Nursing Home Residents
Brief Summary: Tiredness, lack of motivation and low compliance can be observed in nursing home residents during the practice of physical activity. Because exercises should not be too vigorous, whole body vibration could potentially be an effective alternative.

The objective of this randomized controlled trial is to assess the impact of 3-month training by whole body vibration on the risk of falls among nursing home residents.

Patients were randomized into two groups: the whole body vibration group which received 3 training sessions every week composed of 5 series of only 15 seconds of vibrations at 30 Hz intensity and a control group with normal daily life for the whole study period.

The impact of this training on the risk of falls was assessed blindly by three tests: the Tinetti Test, the Timed Up and Go test and a quantitative evaluation of a 10-second walk performed with a tri-axial accelerometer.


Options:
A: The outcome measure will be rate of patients falls per 1000 patient days (1/2009-6/2009)
B: Proportion of residents receiving at least one antipsychotic medication after 12 months (12 months)
C: Risk of fall (3 months)
D: Successful medication discontinuation (4 months)

Answer: C