TrialPanorama/Dataset huggingface dataset:
Please select the outcome measures that correspond to the clinical trial below.
Title: A Randomized, Double-blind, Parallel Group Study of Safety and the Effect on Clinical Outcome of Tocilizumab Subcutaneous (sc) Versus Placebo sc in Combination With Traditional Disease Modifying Anti-rheumatic Drugs (DMARDs) in Patients With Moderate to Severe Active Rheumatoid Arthritis
Brief Summary: This randomized, parallel-group, placebo-controlled, multicenter study will evaluate the reduction in disease activity and the safety of tocilizumab (RoActemra/Actemra) in combination with traditional disease-modifying anti-rheumatic drugs (DMARDs) in patients with active, moderate to severe rheumatoid arthritis. In the double-blind part of the study, patients will be randomized to receive either 162 mg tocilizumab or placebo subcutaneously every 2 weeks for 24 weeks using a pre-filled syringe. In the open-label part of the study, patients will be randomized to receive 162 mg tocilizumab subcutaneously every 2 weeks from Week 24 to Week 96 using a pre-filled syringe or an auto-injector.


Options:
A: Pharmacokinetics (PK) (Cmax, AUClast, AUCinf, t1/2, systemic clearance, and volume of distribution) following IV administration (169 days); Pharmacokinetics (PK) [Cmax, tmax, AUC (0-4wk), t1/2 for last dose only, R[AUC(0-4wk)] following SC administration (211 days); Plasma concentrations of golimumab following IV administration (169 days); Plasma concentrations of golimumab following SC administration (211 days)
B: MRI synovitis, bone edema and erosions score (baseline, week 18 and 52)
C: Change from Baseline in the Disease Activity Score (C-reactive protein) [DAS28(CRP)] for CDP6038 and placebo (Baseline, Week 12)
D: Percentage of Patients With an American College of Rheumatology 20 (ACR20) Response at Week 24 (Baseline to Week 24)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: A Randomized, Double-blind, Parallel Group Study of Safety and the Effect on Clinical Outcome of Tocilizumab Subcutaneous (sc) Versus Placebo sc in Combination With Traditional Disease Modifying Anti-rheumatic Drugs (DMARDs) in Patients With Moderate to Severe Active Rheumatoid Arthritis
Brief Summary: This randomized, parallel-group, placebo-controlled, multicenter study will evaluate the reduction in disease activity and the safety of tocilizumab (RoActemra/Actemra) in combination with traditional disease-modifying anti-rheumatic drugs (DMARDs) in patients with active, moderate to severe rheumatoid arthritis. In the double-blind part of the study, patients will be randomized to receive either 162 mg tocilizumab or placebo subcutaneously every 2 weeks for 24 weeks using a pre-filled syringe. In the open-label part of the study, patients will be randomized to receive 162 mg tocilizumab subcutaneously every 2 weeks from Week 24 to Week 96 using a pre-filled syringe or an auto-injector.


Options:
A: Number of Participants With an American College of Rheumatology (ACR) 50 Response at Week 14 (Week 0 to Week 14)
B: Percentage of Patients With an American College of Rheumatology 20 (ACR20) Response at Week 24 (Baseline to Week 24)
C: Percentage of Participants Achieving American College of Rheumatology 20% (ACR20) Response at Month 6 (Month 6); Change From Baseline in the Health Assessment Questionnaire-Disability Index (HAQ-DI) at Month 3 (Baseline, Month 3); Percentage of Participants With Disease Activity Score Using 28-Joint Count and Erythrocyte Sedimentation Rate (4 Variables) (DAS28-4 [ESR]) Less Than 2.6 at Month 6 (Month 6)
D: Initial Period: Primary Endpoints Were Standard Laboratory Safety Data (Chemistry, Hematology, Etc.) and Adverse Event (AE) Reports (Includes laboratory test abnormality data for all visits and adverse event data up to 999 days after last dose of study drug); Extension Period: Number of Participants With Treatment Emergent Adverse Events (AEs), Serious Adverse Events (SAEs) (Baseline (Day 1 at Entry of Extension Period) up to 28 days after last study drug dose in Extension Period (13 Months)); Extension Period: Number of Participants With Laboratory Test Abnormalities (Baseline (Day 1 at Entry of Extension Period) up to 28 days after last study drug dose in Extension Period (13 Months)); Initial Period: The Long Term Safety and Tolerability of CP-690,550 5 Milligrams (mg) Twice Daily (BID) and 10 mg BID for the Treatment of Rheumatoid Arthritis (Includes AEs for every visit and up to 999 days after last dose of study drug); Extension Period: Percentage of Participants With Adverse Events and Who Discontinued Treatment Due to Adverse Events to Assess Long-term Safety and Tolerability of Tofacitinib (Baseline (Day 1 at Entry of Extension Period) up to Month 6 of Extension Period; Month 6 of Extension Period to Month 12 of Extension Period)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: A Randomized, Double-blind, Parallel Group Study of Safety and the Effect on Clinical Outcome of Tocilizumab Subcutaneous (sc) Versus Placebo sc in Combination With Traditional Disease Modifying Anti-rheumatic Drugs (DMARDs) in Patients With Moderate to Severe Active Rheumatoid Arthritis
Brief Summary: This randomized, parallel-group, placebo-controlled, multicenter study will evaluate the reduction in disease activity and the safety of tocilizumab (RoActemra/Actemra) in combination with traditional disease-modifying anti-rheumatic drugs (DMARDs) in patients with active, moderate to severe rheumatoid arthritis. In the double-blind part of the study, patients will be randomized to receive either 162 mg tocilizumab or placebo subcutaneously every 2 weeks for 24 weeks using a pre-filled syringe. In the open-label part of the study, patients will be randomized to receive 162 mg tocilizumab subcutaneously every 2 weeks from Week 24 to Week 96 using a pre-filled syringe or an auto-injector.


Options:
A: Percentage of Patients With an American College of Rheumatology 20 (ACR20) Response at Week 24 (Baseline to Week 24)
B: American College of Rheumatology (ACR)-20 responder rate at Week 24 (24 weeks)
C: Number of Participants With an American College of Rheumatology (ACR) 50 Response at Week 14 (Week 0 to Week 14)
D: Percentage of Participants Achieving American College of Rheumatology 20% (ACR20) Response at Week 6 (Week 6)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: Multi-center, Randomized, Evaluator-blind, Active-controlled,Parallel-group Design to Determine Safety, Tolerability, and Efficacy of Multiple Daily Administration of LFF571 for 10 Days in Patients With Moderate Clostridium Difficile Infections
Brief Summary: This study will assess the safety and efficacy of multiple daily dosing of oral LFF571 in patients who have moderate Clostridium difficile infections.


Options:
A: Clinical cure rate at test-of-cure (Day 13 or 24-72 hours after end of treatment)
B: Resolution of diarrhea
C: POC: Difference in clinical response rate of LFF571 compared to vancomycin in patients with moderate C. difficile infections at day 12/13. (Day 12/13); POC: Safety and tolerability of LFF571 (Day 12/13); POC:Clinical response rates (clinical cure) of patients with moderate C. difficile infections to different LFF571 dose regimens and total daily doses (cohort 2). (Day 12/13); Cohort 2: Clinical response rate (clinical cure) of LFF571 in patients with mild and moderate C. difficile infections to different LFF571 dose regimens and total daily doses administered orally for 10 days (Day 12/13); Cohort 2: Dose-response relationship of different dose regimens and total daily dose s of LFF571 (Day 12/13); Cohort 2: Safety and tolerability of LFF571 dose regimens and total daily doses administered orally for 10 days to C. difficile infected patients. (Day 12/13)
D: The evaluation of the safety of HBT (13 Weeks post HBT); To determine the cure rate without recurrence of CDI at 13 weeks from the last HBT. (13 Weeks post HBT)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: Exercise Training in Patients With Coronary Heart Disease and Type 2 Diabetes
Brief Summary: Diabetes mellitus (DM) is an important risk factor in the development of cardiovascular disease, and people with type 2 diabetes have a two- to four-fold increased risk for cardiovascular morbidity and mortality. Physical activity is a well established therapeutic modality for type 2 diabetes. In patients with coronary artery disease (CAD), several clinical trials have shown reduced mortality and reduced progression of atherosclerosis with lifestyle intervention including physical activity. But few studies have investigated the effect of physical training in patients suffering from both diseases.

The aim of this study is to investigate the effect of one year of organized physical exercise in patients with both coronary heart disease and type 2 diabetes on glucometabolic state and progression of atherosclerosis.

The project is a randomized, controlled, open study on physical exercise. 136 patients will be randomized at inclusion to a physical exercise group or a control group, the latter with "normal" follow-up and not discouraged form physical activity. The intervention period will be 12 months, and the physical training program will be developed and conducted in collaboration with Norwegian School of Sport Sciences. The inclusion of patients started summer 2010, the exercise program begins in September 2010 and the practical issues of the study is planned to end during spring 2012.

The main hypothesis is that physical exercise improves the glucometabolic state and reduces progression of atherosclerosis in patients with coronary heart disease and type 2 diabetes, and secondary that physical exercise induces favourable changes in cardiovascular risk factors, use of medication, and co-morbidity associated with diabetes.


Options:
A: Proportion of Patients With Hospital Length of Stay Greater Than 7 Days. (Post-surgery (approximately 9 weeks after baseline))
B: Change in Mean Daily Steps (Baseline and end of Maintenance Period at Week 16)
C: Glucometabolic state (12 months); Atherosclerosis (12 months)
D: Peak oxygen uptake (baseline and 12 months)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: Pressure Ulcer Multi-disciplinary Teams Via Telemedicine (PUMTT): A Cluster Pragmatic Randomised Controlled Trial in Long Term Care
Brief Summary: The purpose of this study is to evaluate the effectiveness of 'enhanced' multi-disciplinary wound care teams (MDTs) vs. 'usual' care teams in Long Term Care (LTC) facilities in Ontario for the treatment of pressure ulcers. LTC facilities with more than 100 beds that are within a 100 km distance from St. Mikes and have a problem with pressure ulcers will be asked to participate. A total of 10 LTC facilities will be randomly selected (i.e. selected by chance) from those that agree to participate.

The 'enhanced' MDT will be an Advance Practice Nurse(APN) with expertise in wound care who has direct access to the wound care team at St. Mikes. This APN will develop treatment plans in consultation with facility staff, providing targeted pressure ulcer treatment education on an ongoing, case by case basis. Care is supported by telemedicine with the use of digital photography and online communication between members of the care team.

This study is a stepped wedge randomized trial, meaning LTC facilities are assigned to a start date for this study totally by chance. Changes in healing rates, wound related pain, cost, number of new pressure ulcers, and number of wounds healed will be measured before, and after the APN is introduced to facilities. In order to gain more insight into how people felt about this model of care, interviews will be held with individuals and groups of staff at 5 randomly selected facilities before, during, and after the study has been completed.


Options:
A: cumulative number of hospitalisation (within 12 months)
B: Days spent at hospital (24 months); Number of Intervention-related adverse events (6 to 15 months depending on the cluster affiliation)
C: Rate of reduction in wound surface area (cm2/days) (6 mths)
D: Change of hospital admissions (21 months)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: First-line Antimetabolites as Steroid-sparing Treatment Uveitis Pilot Trial
Brief Summary: The proposed study is a masked trial, with stratified block randomization by site, designed to determine which treatment, methotrexate or mycophenolate mofetil, is more effective as first-line steroid-sparing treatment for patients with non-infectious uveitis requiring corticosteroid-sparing therapy.

One hundred non-infectious uveitis patients in need of corticosteroid-sparing therapy will be randomized to receive either oral methotrexate or oral mycophenolate mofetil at Aravind Eye Hospitals (Madurai and Coimbatore, South India). They will be followed monthly for 6 months after enrollment or until treatment failure. The investigators hypothesize that the proportion achieving corticosteroid-sparing success at 6 months for patients taking mycophenolate mofetil will be improved in comparison with patients taking methotrexate.


Options:
A: Number of Participants Achieving Treatment Success at 6 Months (Phase I, 0-6 Months) (6 Months)
B: Rate of Recurrent Ocular Exacerbations in the Study Eye During 24 Weeks by Treatment (Baseline to week 24); Rate of Recurrent Ocular Exacerbations in the Study Eye During 24 Weeks by Treatment (24 weeks)
C: Time to First Recurrence in Any Eye of Active Intermediate, Posterior, or Panuveitis From Baseline (Baseline to 24 weeks)
D: Number of Participants Achieving Treatment Success (6 months)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: Metformin Addition to Gonadotropins Ovarian Stimulation in High Responder Patients With PCOS Undergoing In-vitro Fertilization
Brief Summary: The use of metformin pre-treatment and co-administration was recently proposed in infertile women affected by polycystic ovary syndrome (PCOS) treated with gonadotropins.

Data from meta-analyses showed that metformin administration significantly reduced the stimulation length and the total dose of gonadotropins used in PCOS women undergoing gonadotropins stimulation for non in-vitro fertilization (IVF) cycles. On the other hand, in IVF cycles metformin was demonstrated to significantly reduce the ovarian hyperstimulation syndrome (OHSS) rate in infertile patients with PCOS treated with gonadotropins.

The metformin regulating effect on the ovarian response was also observed in a randomized controlled trial (RCT) on young non-obese insulin-resistant women with PCOS receiving gonadotropins for mono-ovulation induction. In particular, metformin increased the mono-ovulatory cycles, the duration of stimulation and the amount of gonadotropins used, while it reduced the number of dominant follicles and the estradiol (E2) levels.

The aim of the present study was to evaluate the effect of metformin administration in high responder PCOS patients undergoing gonadotropins ovarian stimulation for IVF cycles.


Options:
A: Rate of OHSS (one month)
B: Total number of retrieved oocytes (Two weeks Metformin treatment)
C: To investigate whether four months of Metformin treatment before IVF (in-vitro-fertilisation) or ICSI (intra-cytoplasmic sperm injection) will increase clinical pregnancy rate in normal weight PCOS-women (Vaginal ultrasound in pregnancy week 7)
D: Rate of cancellation due to low ovarian response (one month)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: Metformin Addition to Gonadotropins Ovarian Stimulation in High Responder Patients With PCOS Undergoing In-vitro Fertilization
Brief Summary: The use of metformin pre-treatment and co-administration was recently proposed in infertile women affected by polycystic ovary syndrome (PCOS) treated with gonadotropins.

Data from meta-analyses showed that metformin administration significantly reduced the stimulation length and the total dose of gonadotropins used in PCOS women undergoing gonadotropins stimulation for non in-vitro fertilization (IVF) cycles. On the other hand, in IVF cycles metformin was demonstrated to significantly reduce the ovarian hyperstimulation syndrome (OHSS) rate in infertile patients with PCOS treated with gonadotropins.

The metformin regulating effect on the ovarian response was also observed in a randomized controlled trial (RCT) on young non-obese insulin-resistant women with PCOS receiving gonadotropins for mono-ovulation induction. In particular, metformin increased the mono-ovulatory cycles, the duration of stimulation and the amount of gonadotropins used, while it reduced the number of dominant follicles and the estradiol (E2) levels.

The aim of the present study was to evaluate the effect of metformin administration in high responder PCOS patients undergoing gonadotropins ovarian stimulation for IVF cycles.


Options:
A: Number of mature(MII) oocyte (Day1(from the day of oocyte retrieval to fertilization confirmation))
B: Rate of OHSS (one month)
C: Pregnancy rates (1 year)
D: Clinical pregnancy rate (4 weeks after embryo transfer)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: A Phase II/III, Randomized, Cross-over, Open-label Trial to Demonstrate Superiority of Prophylaxis Over On-demand Therapy in Previously Treated Subjects With Severe Hemophilia A Treated With Plasma Protein-free Recombinant FVIII Formulated With Sucrose (BAY 81-8973)
Brief Summary: The objective of the trial is to demonstrate that 2-3 times per week prophylaxis therapy with BAY81-8973 is superior to on-demand therapy with BAY81-8973 in patients with severe Hemophilia A. The hypothesis is that prophylaxis will result in fewer bleeds than on-demand treatment.


Options:
A: Area under the factor IX activity-time curve from 0 to infinity dose-normalised to 50 IU/kg (From time 0 (dosing) up to 240 hours post-dose)
B: Annualized Number of All Bleeds (Up to 12 months (6 months per mode of potency assignment according to the randomized cross-over design))
C: Incidence Rate of FVIII Inhibitor Development (up to 52 weeks ± 2 weeks); Number of Participants With Treatment-emergent Adverse Events (TEAEs) and Treatment-emergent Serious Adverse Events (TESAEs) (up to 52 weeks + 30 days ± 1 week); Number of Participants With Potentially Clinically Significant Abnormal Laboratory Values From Baseline (up to 52 weeks ± 2 weeks); Number of Participants With Clinically Relevant Abnormalities in Vital Signs or Relevant Changes From Baseline in Vital Signs (up to 52 weeks ± 2 weeks); Annualized Bleeding Rate (up to 52 weeks ± 2 weeks (efficacy period as defined in description)); Comparison of Annualized Bleeding Rates: Arm 1 Versus Arm 3 (up to 52 weeks ± 2 weeks (efficacy period as defined in description)); Area Under the Curve (AUC) Per Dose (One-stage Clotting Assay) (See Measure Description for complete time frame.); Elimination Half Life (t1/2; One-stage Clotting Assay) (See Measure Description for complete time frame.); Clearance (CL; One-stage Clotting Assay) (See Measure Description for complete time frame.); Mean Residence Time (MRT; One-stage Clotting Assay) (See Measure Description for complete time frame.); Incremental Recovery (One-stage Clotting Assay) (See Measure Description for complete time frame.)
D: AUC from time 0 to the last data point (Pre-Dose and up to 120 hours post dose)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: A Phase II Randomised, Double-blind, Placebo Controlled, Cross-over Efficacy and Safety Comparison of Three Doses of Tiotropium Inhalation Solution Delivered Via Respimat Inhaler (1.25, 2.5 and 5.0 Mcg Once Daily) Versus Placebo in Patients With Moderate Persistent Asthma.
Brief Summary: Rationale for the current trial is to evaluate the efficacy and safety of three doses (1.25 µg, 2.5 µg and 5.0 µg ex mouthpiece) of tiotropium inhalation solution in patients with moderate persistent asthma who are still symptomatic despite regular maintenance therapy with inhaled corticosteroids (ICS).

The data collected in the present trial will provide useful information to health care providers and patients regarding the efficacy and safety of a once daily inhalation of three different doses of tiotropium solution delivered by the Respimat® inhaler in addition to inhaled corticosteroids in the treatment of not fully controlled moderate asthma in comparison to placebo. The Pharmacokinetics (PK) of tiotropium is well established in COPD patients. However, there is currently no PK data available for the 3 doses of tiotropium being tested in this trial in patients with moderate persistent asthma. Tiotropium is a once daily drug. Hence, the rationale for blood and urine sampling for PK analysis over 24 hours in a subset of patients is to confirm the PK of the 3 doses in moderate asthma patients. Rationale for the 24-hour pulmonary function test sub-investigation is to demonstrate that a once daily dosing of tiotropium inhalation solution is effective and safe in the treatment of moderate persistent asthma.


Options:
A: Model Predicted Change From Baseline Trough Force Expiratory Volume in 1 Second (FEV1) (Baseline (Day 1) and Day 15 of each treatment period); Percentage of Chance That FF 100 mcg Alone Corrected Change From Baseline FEV1 Response Would Exceed a Target Response by Dose of UMEC Combined With FF 100 mcg (Baseline (Day 1) and Day 15 of each treatment period); Mean Change From Baseline in Trough FEV1 on Day 15 of Each of the 3 Treatment Periods (Baseline (Day 1) and Day 15 of each treatment period)
B: Peak Forced Expiratory Volume in 1 Second (FEV1) Response Within 3 Hours Post Dosing (0-3h) After a Treatment Period of 24 Weeks. (Baseline and 24 weeks); Trough FEV1 Response Determined After a Treatment Period of 24 Weeks. (Baseline and 24 weeks); Time to First Severe Asthma Exacerbation During the 48-week Treatment of the Pooled Data From the Two Twin Trials 205.416 (NCT00772538) and the Present 205.417 (NCT00776984). (48 weeks)
C: Peak FEV1 Within 3 Hours Post-dose Response (24 weeks); Trough FEV1 Response (24 weeks); The Responder Rate as Assessed by the ACQ From the Two Twin Trials 205.419 (NCT01172821) and the Present 205.418 (NCT01172808) (24 weeks)
D: Forced Expiratory Volume in One Second (FEV1) Peak Within 0-3 Hours Post-dose Response (10 minutes (min) before drug administration and 30 min, 1h, 2h, 3h after drug administration)

Answer: D