TrialPanorama/Dataset huggingface dataset:
Please select the outcome measures that correspond to the clinical trial below.
Title: A Phase III Randomized Trial of Three Antibiotic Regimens to Eradicate Helicobacter Pylori
Brief Summary: The purpose of this study is to compare the effectiveness of three different antibiotic regimens against Helicobacter pylori (H. pylori).


Options:
A: Eradication rate according to Intention to treat (ITT) and per-protocol (PP) analysis (6 weeks after eradication therapy)
B: To compare 2 experimental antibiotic regimens with a standard 14 day regimen with regard to H. pylori eradication rates at 6 weeks post-randomization. (week 6 post-randomization)
C: 13C urea breath test, upper endoscopy, histology, rapid urease test assessment
D: Number of Participants With Complete Eradication of Helicobacter Pylori (at the 6th week after the end of anti- H. pylori therapy)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: Effects of High(Deadlift) Versus Low Intensity Motor Control Exercises on Patients With Peripherally Mediated Low Back Pain
Brief Summary: The aim of the study is to evaluate and compare the effects of high-intensity (deadlift) versus low-intensity motor control exercises on selfrated pain, function and symptoms on patients with peripherally mediated pain


Options:
A: Lumbar spine flexion changes (baseline (day 1) to post-test (day 5)); Expectation of pain changes (baseline (day 1) to post-test (day 5)); Expectation of harm changes (baseline (day 1) to post-test (day 5))
B: Sickness absence days (Low back (LB) specific, other than LB, total) (6, 12, 24, 36, 48 months); Low back pain (VAS) (0, 3, 6, 12, 24 months); Disability (Roland Morris 18) (0, 3, 6, 12, 24 months); Quality of Life (15-D) (0, 3, 6, 12, 24 months)
C: Pain Intensity (5 weeks after randomization); Disability (Five weeks after randomization)
D: Selfrated function, symptoms and pain-rating (8 weeks, 6 month, 12 month)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: Effects of High(Deadlift) Versus Low Intensity Motor Control Exercises on Patients With Peripherally Mediated Low Back Pain
Brief Summary: The aim of the study is to evaluate and compare the effects of high-intensity (deadlift) versus low-intensity motor control exercises on selfrated pain, function and symptoms on patients with peripherally mediated pain


Options:
A: Selfrated function, symptoms and pain-rating (8 weeks, 6 month, 12 month)
B: Episodes of low back pain (2 years); Duration of low back pain (2 years); Severity of low back pain (2 years)
C: Pain (visual analogical scale and McGill pain questionnaire) (Six weeks); Functional disability (Oswestry disability questionnaire) (Six weeks); TrA muscle activation capacity (Pressure Biofeedback Unit = PBU) (Six weeks)
D: Muscle activity onset in transversus abdominal muscle (1 year)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: Effects of High(Deadlift) Versus Low Intensity Motor Control Exercises on Patients With Peripherally Mediated Low Back Pain
Brief Summary: The aim of the study is to evaluate and compare the effects of high-intensity (deadlift) versus low-intensity motor control exercises on selfrated pain, function and symptoms on patients with peripherally mediated pain


Options:
A: Pain (visual analogical scale and McGill pain questionnaire) (Six weeks); Functional disability (Oswestry disability questionnaire) (Six weeks); TrA muscle activation capacity (Pressure Biofeedback Unit = PBU) (Six weeks)
B: Pain (Visual Analog Scale) at baseline, weeks 4,12,26,52
C: Pain Intensity (2 months after randomisation); Disability (2 months after randomisation)
D: Selfrated function, symptoms and pain-rating (8 weeks, 6 month, 12 month)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: Prospective Randomized Placebo-Controlled Trial of SimvaSTATin in the Prevention of COPD Exacerbations (STATCOPE)
Brief Summary: To determine the effect of daily administration of 40 mgms simvastatin taken for at least 12 months (range 12-36 months) on the frequency of exacerbations of chronic obstructive lung disease (COPD) in patients with moderate to severe COPD who are prone to exacerbations and do not have other indications for statin treatment.


Options:
A: Rates of COPD Exacerbations (up to 37 months)
B: Identifying new patient subtypes and endpoints for COPD (3 years)
C: Sputum cytokines (Up to 4 weeks)
D: Annual Rate of On-treatment Moderate/Severe Exacerbations Comparing FF/UMEC/VI With UMEC/VI and FF/VI (Up to Week 52)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: A Randomized, Double-blind, Placebo-controlled, Multicenter, Two-part, Dose Ranging and Confirmatory Study With an Operationally Seamless Design, Evaluating Efficacy and Safety of SAR153191 on Top of Methotrexate (MTX) in Patients With Active Rheumatoid Arthritis Who Are Inadequate Responders to MTX Therapy
Brief Summary: Primary Objectives:

Part A (dose ranging study):

To demonstrate that sarilumab (SAR153191/REGN88) on top of MTX was effective on reduction of signs and symptoms of rheumatoid arthritis at 12 weeks.

Part B (pivotal study):

To demonstrate that sarilumab added to MTX was effective in:

* reduction of signs and symptoms of rheumatoid arthritis at 24 weeks
* inhibition of progression of structural damage at 52 weeks
* improvement in physical function at 16 weeks

Secondary Objectives:

Part B:

To demonstrate that sarilumab added to MTX was effective in induction of a major clinical response at 52 weeks

To assess the safety of sarilumab added to MTX

To document the pharmacokinetic profile of sarilumab added to MTX in participants with active rheumatoid arthritis who were inadequate responders to MTX therapy.


Options:
A: American College of Rheumatology (ACR) 20 Response at Week 14. (Week 14)
B: American College of Rheumatology 20% (ACR20) Response at Week 12 (Baseline, Week 12)
C: Part A: Percentage of Participants Achieving American College of Rheumatology 20% (ACR20) Response at Week 12 (Baseline to Week 12); Part B: Percentage of Participants Achieving ACR20 Response at Week 24 (Baseline to Week 24); Part B: Change From Baseline in Health Assessment Question Disability Index (HAQ-DI) at Week 16 (Baseline, Week 16); Part B: Change From Baseline in Van Der Heijde Modified Total Sharp Score (mTSS) at Week 52 (Baseline, Week 52)
D: The Number of Participants Achieving Remission As Measured by a Disease Activity Score for 28 Joints (DAS 28) < 2.6. (12 months); Year 1 Participants Having an Annualized Modified Total Sharp Score (mTSS) < 0.5. (12 months)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: Effect of Erythritol and Xylitol on Dental Caries Prevention in Children
Brief Summary: This study aims at demonstrating the effect of erythritol and xylitol lozenges on preventing the new caries lesions and the possible remineralization effect of both polyols on incipient caries lesions.


Options:
A: caries reduction (3 years)
B: combined root and coronal D2FS (dental caries) increment (3 year)
C: MS colonization (2 years)
D: new decayed surfaces (1 year)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: The Contribution of Intra-arterial Thrombectomy in Acute Ischemic Stroke in Patients Treated With Intravenous Thrombolysis
Brief Summary: THRACE is a controled, multicenter and randomized trial.

The primary objective of this study is to determine whether a combined approach intravenous thrombolysis (IV) + Mechanical thrombectomy is superior to the reference treatment with IV thrombolysis alone, in the 3 hours of onset of symptoms in patients with occlusion of proximal cerebral arteries and with a neurological impairment accident (National Institutes of Health Stroke Scale \[NIHSS\] ≥ 10).

The second objective is to determine the cost-effectiveness of this procedure compared to the standard (IV thrombolysis). The assumption is that the combined approach, by improving the clinical outcome and speed recovery, allows for lower overall costs to the IV thrombolysis in 3 months and less than or at worst neutral to 1 year.


Options:
A: Modified Rankin Score (mRs ) (3 months after treatment)
B: Shift in the mRS score, defined by a proportional odds model. (90 days)
C: The Distribution of Scores on the Modified Rankin Scale (mRS) at Day 90 (Day 90)
D: modified Rankin Scale (mRS) (at 90 days from randomization)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: Effect of Two Amino Acid Solutions on Blood Amino Acid Levels and Frequency of Cholestasis in Neonates
Brief Summary: The purpose of this study is to analyze if the infants who received Primene solution, have lower serum levels of methionine and cysteine and higher serum levels of taurine, we also analyze if the infants who received Primene solution develop TPN-associated cholestasis in a smaller proportion than those who received Trophamine solution.


Options:
A: occurrence of allergic reactions (14 days)
B: Blood Amino Acid levels and Frequency of Cholestasis in Neonates (At baseline, day 7, 14, 21 and 28 of the administration of total parenteral nutrition (TPN)
C: Hypoallergenicity as Assessed by Reaction to Amino-acid Based Infant Formula (14 days)
D: Weight (14 days of age to 112 days of age)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: South Danish Hypertension and Diabetes Study
Brief Summary: The purpose of this study is to estimate the effect of spironolactone on blood pressure resistant to therapy in type-2 diabetics.


Options:
A: Change of of Systolic Blood Pressure (4 months); Change of Diastolic Blood Pressure (4 months)
B: Albuminuria (Screening, (Low-risk: year 1, 2 and 3), (high-risk: week 13, 26, 39, 52, 65, 78, 91, 104, 117, 130, 143, 156))
C: Change of serum potassium (4 weeks)
D: Change in 24 hour urine albumin to creatinine ratio after 12 months of treatment

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: Prevention of Parenteral Nutrition-Associated Cholestasis With Cyclic Parenteral Nutrition in Infants
Brief Summary: Hypothesis to be Tested:

Since the first description of intravenous alimentation over half a century ago, parenteral nutrition (PN) has become a common nutritional intervention for conditions characterized by inability to tolerate enteral feeds such as Short Bowel Syndrome, Chronic Intestinal Pseudoobstruction, Microvillus Inclusion Disease, Crohn's disease, multi-organ failure and prematurity. Parenteral Nutrition-Associated Liver Disease (PNALD) encompasses a spectrum of disease including cholestasis, hepatitis, steatosis and gallbladder sludge/stones which may progress to liver cirrhosis and even failure.

There is a direct correlation between duration of parenteral nutrition and development of cholestasis in infants. There is evidence in animals and humans that cycling of parental nutrition, defined as infusing nutrients over a time period shorter than 24 hours, reduces cholestasis. There is also data that premature infants with gestational age (GA) \< 32 weeks and birth weight \<1500g, as well as infants with congenital anomalies of the gastrointestinal tract, are among those at highest risk of developing Parenteral Nutrition-Associated Cholestasis (PNAC).

We therefore hypothesize that infants with gestational age (GA) \<32 weeks and birth weight (BW) between \<1500g, or with congenital anomaly of the gastrointestinal tract regardless of GA or BW, receiving PN over a period of 20 hours will have a decrease severity of PNAC, demonstrated by a lower peak direct bilirubin, compared to a similar control population receiving standard 24 hour infusion.


Options:
A: Hypoallergenicity as Assessed by Reaction to Amino-acid Based Infant Formula (14 days)
B: Time to the Primary Outcome (Earlier of Ammonia <50 µmol/L or Hospital Discharge) (Average of all measurements of hyperammonemia, for up to 7 days)
C: Study to assess the allergic symptoms, using a questionnaire. (5 months)
D: The primary outcome is a decreased peak direct bilirubin in infants with GA <32 weeks and BW between <1500g, or with congenital anomaly of the gastrointestinal tract regardless of GA or BW, requiring prolonged PN (receiving >75% PN on dol 7). (Peak direct bilirubin during time period: Initiation to Discontinuation of PN (Defined as successfully off PN for 7days))

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: A Comparison of the Efficacy of Continuous Venovenous Hemofiltration Versus Continuous Venovenous Hemodialysis for Renal Replacement Therapy in Acute Kidney Injury
Brief Summary: Acute kidney injury is often treated with the use of continuous renal replacement therapy. Two commonly used treatments are continuous venvenous hemofiltration (CVVH)and continuous venovenous hemodialysis (CVVHD). CVVH uses convective clearance to remove toxins and solutes from the patients circulation, while CVVHD relies on diffusive clearance to remove these same toxins/solutes. This study will evaluate which of these two methods is more effective at clearing the body of waste/solutes.

We hypothesize that renal replacement therapy by either modality (hemodialysis or hemofiltration; CVVHD or CVVH, respectively) using a modern membrane and higher blood flow rates will be associated with similar clearances of both small and middle molecular weight solutes. We further believe that continuous renal replacement therapy using CVVHD will be associated with decreased clotting events and longer hemofilter survival, as well as improved resource utilization (i.e. nursing time, alarms, etc.).


Options:
A: CRRT-filter life span in hours (during continuous renal replacement therapy up to 1 year); Overall survival in a 90day follow-up period (90 days)
B: Functions of inflammatory cells (24 hours); Regulation of inflammatory reactions and and opsonization in microorganisms (24 hours); Activity of acute phase protein during acute inflammation (24 hours)
C: To compare the clearance of urea and creatinine by renal replacement therapy (RRT) using continuous venovenous hemofiltration versus continuous venovenous hemodialysis. (48 hours)
D: mortality (2 years)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: A PHASE III, MULTI-CENTER, RANDOMIZED OPEN LABEL STUDY OF VELCADE, MELPHALAN, PREDNISONE AND THALIDOMIDE (V-MPT) Versus VELCADE, MELPHALAN, PREDNISONE (V-MP) IN ELDERLY UNTREATED MULTIPLE MYELOMA PATIENTS
Brief Summary: The proposed study will evaluate whether the combination of VELCADE, Thalidomide , Melphalan and Prednisone (V-MPT), as induction treatment for newly diagnosed elderly MM patients, improves outcomes compared to the combination VELCADE-MP.


Options:
A: Progression-free Survival (From date of registration to date of first documentation of progression or symptomatic deterioration, or death due to any cause, assessed up to 6 years)
B: Progression Free Survival (PFS) (From randomization until disease progression. Median follow-up time was 43 months.)
C: Determine whether the V-MPT combination improves progression free survival (PFS) (Approximately 24 months)
D: response rate (12 months)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: A PHASE III, MULTI-CENTER, RANDOMIZED OPEN LABEL STUDY OF VELCADE, MELPHALAN, PREDNISONE AND THALIDOMIDE (V-MPT) Versus VELCADE, MELPHALAN, PREDNISONE (V-MP) IN ELDERLY UNTREATED MULTIPLE MYELOMA PATIENTS
Brief Summary: The proposed study will evaluate whether the combination of VELCADE, Thalidomide , Melphalan and Prednisone (V-MPT), as induction treatment for newly diagnosed elderly MM patients, improves outcomes compared to the combination VELCADE-MP.


Options:
A: Number of Patients With Overall Response (Complete Response + Partial Response) (Over 4 cycles (prior to the addition of dexamethasone))
B: Rate of CR+nCR to induction treatment (63 days after the start day of either TD or VTD as induction therapy)
C: Best Overall Response Rate (ORR) (A0: Subjects evaluated for disease response on Day 24 of Cycles 2, 4, 6, 9, and 12. Onset of response measured on Day 15 of Cycle 1. A1: Subjects evaluated for disease response on Day 15 of Cycle 1, Day 1 of Cycles 2 through 12 and at End of Study.)
D: Determine whether the V-MPT combination improves progression free survival (PFS) (Approximately 24 months)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: Low Glycemic Index Diets to Improve Glycemic Control and Cardiovascular Disease in Type 2 Diabetics
Brief Summary: A low glycemic index diet may improve glycemic control and reduce plaque buildup in arteries of those with type 2 diabetes. Subjects will be randomly assigned to receive dietary advice on either a low glycemic index diet, or a high cereal fibre diet, for three years.


Options:
A: plaque volume (1, 3 years)
B: weight loss at 12 weeks; Fat loss at 12 weeks; Lean mass change at 12 weeks
C: For adults: body weight loss maintenance (6 Month)
D: Body Weight (4 months); Body Weight (7 Months)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: A Randomised, Double Blinded, Multicentre Phase II Study to Assess the Efficacy of Olaparib (AZD2281, KU-0059436) in Combination With Paclitaxel Versus Paclitaxel in Patients With Recurrent or Metastatic Gastric Cancer Who Progress Following First-line Therapy
Brief Summary: To assess the efficacy of olaparib when given in combination with paclitaxel compared with paclitaxel alone as defined by progression-free survival (PFS), in all patients with recurrent and metastatic gastric cancer who progress following first-line therapy.


Options:
A: Objective response rate (ORR) (about 10 month (until progression))
B: Response Rate (Complete and Partial) in Patients With Measurable Esophageal or GE Junction Adenocarcinoma (Up to 2 years post-treatment)
C: Progression-free Survival (PFS) According to Response Criteria in Solid Tumors Version 1.1 (RECIST 1.1) Based on Blinded Independent Central Review (BICR) in Programmed Death-Ligand 1 (PD-L1) Positive Participants (Up to 30 months (through database cut-off date of 26 Oct 2017)); Overall Survival (OS) in PD-L1 Positive Participants (Up to 30 months (through database cut-off date of 26 Oct 2017))
D: Progression Free Survival (PFS) in the Overall Study Population (Tumour assessments were carried out at baseline and then follow up assessments taken every 8 weeks up to Week 40 and then every 16 weeks until objective disease progression as defined by RECIST 1.1, assessed maximum up to 27 months); Progression Free Survival (PFS) in Patients With Tumours Defined as Homologous Recombination Deficient by Loss of Ataxia-Telangiectasia Mutation (ATM) Protein [ATM Negative Patients] (Tumour assessments are carried out at baseline and then follow up assessments taken every 8 weeks up to Week 40 and then every 16 weeks until objective disease progression as defined by RECIST 1.1, assessed maximum up to 27 months)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: Rehabilitating Muscle After Intensive Care
Brief Summary: The study will examine the effect of amino acid supplements and enhanced physiotherapy on physical recovery following critical illness in intensive care.


Options:
A: The change in the distance walked by patients in 6 minutes (6 minute walk test) between recruitment to the study and 3 months post intensive care discharge (3 months)
B: Physical Functioning subscale of the SF-36 (6 weeks)
C: Mortality (Measured at Months 3, 6, 12, 24, 36, 48 and 60)
D: Individual Physical Function and Mental Health domains from SF-36 (for participants who complete the phone surveys); 6-minute walk distance and memory evaluation (for participants who attend the study visits) (Measured at Months 6 and 12)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: A Prospective, Randomized, Double-Blind, Placebo-Controlled, Parallel-Group, Multicenter Study of the Efficacy and Safety of Dapoxetine in Men With Premature Ejaculation and Concomitant Erectile Dysfunction Treated With a Phosphodiesterase-5 Inhibitor
Brief Summary: The purpose of this study is to evaluate the efficacy and safety of dapoxetine compared to placebo in men with premature ejaculation and erectile dysfunction who are currently being treated with a phosphodiesterase-5 inhibitor (ie, sildenafil, vardenafil, or tadalafil) for erectile dysfunction.


Options:
A: The Average Intravaginal Ejaculatory Latency Time (IELT) at Week 12 (Baseline, Week 12)
B: Average Intravaginal ejaculatory latency time (IELT), as measured by stopwatch, during sexual intercourse, at the end of the treatment period (week 24)
C: Average Intravaginal ejaculatory latency time (IELT), as measured by stopwatch, during sexual intercourse at the end of the treatment period (Week 12)
D: Average intravaginal ejaculatory latency time (IELT), as measured by stopwatch during sexual intercourse, between last 2 visits during the treatment period

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: Influence of Local Biopsy of the Endometrium Prior to Controlled Ovarian Stimulation for IVF or ICSI Procedure on the Rates of Embryo Implantation, Clinical Pregnancy and Live Birth in ART
Brief Summary: In vitro fertilization (IVF) is the only available solution for many couples with various forms of infertility. The embryo implantation step in the IVF procedure is a complex multistage process and represents the majority of the causes of the IVF failure. Several approaches have been evaluated to improve implantation rates but none has demonstrated its superiority. However, endometrial receptivity is important for pregnancy and several studies suggest that local injury to the endometrium of IVF patients improves the rates of embryo implantation, clinical pregnancy and live birth.


Options:
A: Pregnancy Rate (12 weeks)
B: Rate of clinical pregnancy (Individual outcome will be evaluated within 8 weekes after embryo transfer. Overall outcome will be evaluated after 3 years.)
C: Rate of clinical pregnancy (5 weeks after the embryo implantation in an IVF procedure)
D: Positive Pregnancy Test (12 to 14 days after embryo transfer); Clinical Pregnancy (5 weeks of pregnancy)

Answer: C