TrialPanorama/Dataset huggingface dataset:
Please select the outcome measures that correspond to the clinical trial below.
Title: HZC102970: A 52-week Efficacy and Safety Study to Compare the Effect of Three Dosage Strengths of Fluticasone Furoate/GW642444 Inhalation Powder With GW642444 on the Annual Rate of Exacerbations in Subjects With Chronic Obstructive Pulmonary Disease (COPD)
Brief Summary: The Purpose of this study is to assess the efficacy and safety of three strengths of the FF/GW642444 Inhalation Powder in subject with Chronic Obstructive Pulmonary Disease (COPD)


Options:
A: Annual Rate of Moderate and Severe COPD Exacerbations Expressed as Least Square Mean (From the start of the double blind study medication until Visit 11 (Week 52)/Early Withdrawal)
B: Total Number of Chronic Obstructive Pulmonary Disease (COPD) Exacerbations Per Patient-treatment Year (12 months); Rate of Exacerbations Per Subject-year (12 months)
C: Rate of moderate/severe exacerbations over a 52 week treatment period
D: Rate of moderate/severe exacerbations over a 52 week treatment period.

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: URGE-PD: A Multi-site, Double-blind, Randomized, Placebo Controlled Trial of Solifenacin Succinate (VESIcare) for the Treatment of Overactive Bladder in Parkinson's Disease
Brief Summary: This study will assess the effectiveness of solifenacin succinate (VESIcare) in reducing symptoms of overactive bladder in Parkinson's disease (PD) patients.


Options:
A: Number of Micturations Per 24 Hour Period (12 weeks)
B: Change From Baseline to End of Treatment in Overactive Bladder Questionnairre (OAB-q) Symptom Bother Score (Baseline and 12 Weeks)
C: N/A
D: Number of micturitions in a 24 hour bladder diary and number of urge urinary incontinence episodes by subjects' reports per week. (Phase I, II, and III)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: Safety and Efficacy of a Novel Antioxidant-rich Multivitamin Supplement for Persons With Cystic Fibrosis
Brief Summary: The purpose of this study is to test the safety and efficacy of the final commercial formulation of an antioxidant enriched multivitamin supplement in softgel capsule form (AquADEKs) in increasing the plasma levels of certain nutrients and antioxidants in individuals with cystic fibrosis.

Hypothesis: An oral antioxidant-rich multivitamin supplement (AquADEKs), which uses a Generally Regarded As Safe (GRAS) molecule to form micelle-like vehicles, will safely increase systemic levels of beta-carotene, coenzyme Q10, and gamma-tocopherol, decrease PIVKA-II levels, while maintaining levels of vitamins A and D in the normal range in persons with CF \> 10 years of age.


Options:
A: The Safety and Tolerability of a Single-dose of KB001. (Day 28)
B: Time to First Pulmonary Exacerbation (36 weeks)
C: Change in FEV1 (in liters) from baseline (At the end of the 14 day treatment period); Adverse events such as gastrointestinal complaints, wheezing, hepatitis or shortness of breath (70 weeks)
D: Plasma levels of beta-carotene (12 weeks)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: A Randomized, Double-blind, Parallel Group, Placebo Controlled, Multi-center Study of Fixed Dose Combinations of Solifenacin Succinate (6 mg and 9 mg) With Tamsulosin Hydrochloride OCAS 0.4 mg and Tamsulosin Hydrochloride OCAS 0.4 mg Monotherapy, in Male Subjects With Lower Urinary Tract Symptoms (LUTS) Associated With Benign Prostatic Hyperplasia (BPH) With a Substantial Storage Component
Brief Summary: Clinical study to examine the efficacy, safety and tolerability of combination therapy of tamsulosin hydrochloride and solifenacin succinate compared to monotherapy of tamsulosin hydrochloride in the treatment of males with LUTS associated with BPH with a substantial storage component.


Options:
A: Change From Baseline to End of Treatment in Detrusor Pressure at Maximum Flow Rate (PdetQmax) (Baseline and Week 12); Change From Baseline to End of Treatment in Maximum Flow Rate (Qmax) (Baseline and Week 12)
B: Patient Perception of Treatment Benefit at Week 12:; Treatment benefit, treatment satisfaction, and willingness to continue treatment questions at week 12
C: Change From Baseline to End of Treatment in Total International Prostate Symptom Score (Baseline and Week 12); Change From Baseline to End of Treatment in Total Urgency Frequency Score (TUFS, Previously Known as Total Urgency Score [TUS]) (Baseline and Week 12)
D: Assess whether the combination of solifenacin succinate and tamsulosin hydrochloride provides improved efficacy compared to tamsulosin hydrochloride alone in males with LUTS associated with BPH (12 weeks)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: Results of Open Mesh Versus Suture Repair in Treatment of Abdominal Wall (Multicentric, Prospective, Randomised, Internet-based, Clinical Trial)
Brief Summary: The purpose of this study is to:

1. compare the long term results of mesh versus suture repair in treatment of abdominal wall defects;
2. find the optimal location of implanted prosthesis, comparing the two most useful position of mesh in abdominal wall hernia surgery.


Options:
A: recurrence rate after hernia surgery (5 years)
B: Pain (1 measurement, 2nd postoperative day)
C: Overall complication rates at eight weeks and the odds of complications, adjusted for study site, body mass index, and hernia type (Eight (8) weeks post-operatively)
D: Postoperative pain recorded in SF-36 (3 weeks after surgery)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: A Randomized, Placebo-Controlled Trial of Duloxetine Added to Nonsteroidal Anti-inflammatory Drugs in Patients With Knee Pain Due to Osteoarthritis Who Have Had Suboptimal Response to Nonsteroidal Anti-inflammatory Drug Treatment.
Brief Summary: The study will test the hypothesis that, in patients with knee pain due to osteoarthritis (OA) who are taking nonsteroidal anti-inflammatory drugs (NSAIDs) but still have significant knee pain, duloxetine 60 to 120 milligrams (mg) daily for 10 weeks will provide additional reduction in pain.


Options:
A: Decrease From the Baseline GCSI of at Least 50% on Any Two Consecutive Follow-up Visits (at end of treatment, 15 weeks from baseline assessment)
B: Change From Baseline in the Weekly Mean of the 24-Hour Average Pain Score at 8 Weeks (Baseline, 8 weeks (blinded endpoint))
C: Assess efficacy of duloxetine versus placebo on the treatment of pain in patients with fibromyalgia syndrome
D: Mechanical and Heat Hyperalgesia (2 week intervals)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: A Randomized, Placebo-Controlled Trial of Duloxetine Added to Nonsteroidal Anti-inflammatory Drugs in Patients With Knee Pain Due to Osteoarthritis Who Have Had Suboptimal Response to Nonsteroidal Anti-inflammatory Drug Treatment.
Brief Summary: The study will test the hypothesis that, in patients with knee pain due to osteoarthritis (OA) who are taking nonsteroidal anti-inflammatory drugs (NSAIDs) but still have significant knee pain, duloxetine 60 to 120 milligrams (mg) daily for 10 weeks will provide additional reduction in pain.


Options:
A: Change From Baseline to Week 13 in Brief Pain Inventory (BPI), 24-hour Average Pain Scores (Baseline, Week 13)
B: Change From Baseline in the Weekly Mean of the 24-Hour Average Pain Score at 8 Weeks (Baseline, 8 weeks (blinded endpoint))
C: Change From Baseline to Week 1 in Weekly Mean of the 24-hour Average Pain Scores (Baseline, Week 1); Change From Baseline to Week 2 in Weekly Mean of the 24-Hour Average Pain Scores (Baseline, Week 2); Change From Baseline to Week 3 in Weekly Mean of the 24-Hour Average Pain Scores (Baseline, Week 3); Change From Baseline to Week 4 in Weekly Mean of the 24-Hour Average Pain Scores (Baseline, Week 4); Change From Baseline to Week 5 in Weekly Mean of the 24-Hour Average Pain Scores (Baseline, Week 5); Change From Baseline to Week 6 in Weekly Mean of the 24-Hour Average Pain Scores (Baseline, Week 6); Change From Baseline to Week 7 in Weekly Mean of the 24-Hour Average Pain Scores (Baseline, Week 7); Change From Baseline to Week 8 in Weekly Mean of the 24-Hour Average Pain Scores (Baseline, Week 8); Change From Baseline to Week 9 in Weekly Mean of the 24-Hour Average Pain Scores (Baseline, Week 9); Change From Baseline to Week 10 in Weekly Mean of the 24-Hour Average Pain Scores (Baseline, Week 10); Change From Baseline to Week 11 in Weekly Mean of the 24-Hour Average Pain Scores (Baseline, Week 11); Change From Baseline to Week 12 in Weekly Mean of the 24-Hour Average Pain Scores (Baseline, Week 12); Change From Baseline to Week 13 Endpoint in Weekly Mean of the 24-Hour Average Pain Scores (Baseline, Week 13)
D: Change in Brief Pain Inventory (BPI) 24-hour Average Rating (Baseline, Week 4, Week 7, Week 13)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: Evaluation of the Efficacy of the CRF1 Antagonist GSK561679 in Women With Post-traumatic Stress Disorder
Brief Summary: This study will test the hypothesis of whether an antagonist at the corticotropin releasing factor type 1 (CRF1) receptor (i.e. GSK561679) is superior to placebo in reducing symptoms of post-traumatic stress disorder (PTSD).


Options:
A: Change From Baseline in Clinician-Administered Posttrautamtic Stress Disorder (PTSD) Scale (CAPS) to Week 6 (Baseline (Week 0) and at Week 2, Week 4 and Week 6)
B: Efficacy, Measured by Change in the Clinician-Administered PTSD Scale (CAPS) Score (Baseline, Week 6)
C: Symptoms of post-traumatic stress disorder (Measured at Month 3); Symptoms of depression (Measured at Month 3)
D: Clinician-Administered PTSD Scale for DSM-5 (CAPS-5) (2 weeks after the first infusion)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: Absorption of Heme and Non-Heme Iron in Pregnant and Non-pregnant Women and Mechanisms of Fetal Iron Transfer
Brief Summary: The three specific aims of this study are 1) to assess the impact of iron status on relative differences in absorption of heme and non-heme iron among pregnant women and non-pregnant women, 2) to assess the magnitude and the determinants of heme and non-heme iron transfer to the fetus over the last trimester of pregnancy, and 3) to characterize relationships between placental iron binding proteins with the enrichment of stable iron isotopes in the neonate at birth. The investigators hypothesize that there will be up regulation of heme and non-heme iron absorption and up regulation of placental iron transport proteins in response to low maternal iron stores.


Options:
A: Heme and Non-Heme Iron Absorption (two-weeks post dosing (3rd trimester for pregnant subjects)); Heme and Non-Heme Transfer to Fetus (Delivery)
B: Birth weight; 3-month infant mortality
C: Hematologic status at 6 months of age; Iron status at 6 months of age
D: The primary outcome is a comparison of area under the curve (AUC) for change in serum iron for each intervention adjusted for diurnal variation. The use of AUC will provide a single outcome for each participant. (3 weeks)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: A Randomized Controlled Trial of Women's Adherence to Women-only, Home-based and Traditional Cardiac Rehabilitation (Cardiac Rehabilitation for Her Heart Event Recovery [CR4HER])
Brief Summary: The purpose of this study is to compare women's cardiac rehabilitation program adherence across three program models.


Options:
A: Maximal oxygen consumption (At baseline and after 6 months)
B: Duration and Intensity of Physical Activity (1 month, 3 months and 12 months after discharge)
C: Change in Chronic Heart Failure Health Status Between Baseline and 12 Months. (12 months)
D: CR Program Adherence (6 months)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: A Randomized Controlled Trial of Women's Adherence to Women-only, Home-based and Traditional Cardiac Rehabilitation (Cardiac Rehabilitation for Her Heart Event Recovery [CR4HER])
Brief Summary: The purpose of this study is to compare women's cardiac rehabilitation program adherence across three program models.


Options:
A: Physical Fitness (Measured after 12 weeks and after one year); Physical Activity Level (PAL) (measured after 12 weeks and after one year)
B: Maximal oxygen consumption (At baseline and after 6 months)
C: CR Program Adherence (6 months)
D: VO2peak (baseline, after 12 weeks and after 1 year)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: A Randomized Controlled Trial of Women's Adherence to Women-only, Home-based and Traditional Cardiac Rehabilitation (Cardiac Rehabilitation for Her Heart Event Recovery [CR4HER])
Brief Summary: The purpose of this study is to compare women's cardiac rehabilitation program adherence across three program models.


Options:
A: CR Program Adherence (6 months)
B: Change in total volume of weekly active energy expenditure (3 and 6 months)
C: Duration and Intensity of Physical Activity (1 month, 3 months and 12 months after discharge)
D: Maximal oxygen consumption (At baseline and after 6 months)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: N/A
Brief Summary: During IVF treatment women will be randomized into supplementation with a high or a low dose of Vitamin D Main outcome Laboratory pregnancy, live pregnancy at 12 weeks, Baby take home rate, OHSS Secondary outcome: 1. Pregnancy complications (pregnancy hypertension, SGA, Diabetes) 2.Thrombin generation


Options:
A: Thiol oxido-reductive index levels in spermatozoa and seminal plasma. The investigators evaluated the effects of zinc sulfate (220 mg/d) supplementation on Thiol oxido-reductive index levels. (up to three months.)
B: Laboratory pregnancy, live pregnancy at 12 weeks, take home baby rate (4 weeks to 9 month)
C: Live Birth (At delivery); Semen Volume (6 months); Sperm Concentration (6 months); Sperm Motility (6 months); Sperm Morphology (6 months); DNA Fragmentation Index (6 months); Total Motile Sperm Count (6 months)
D: Effect of resveratrol on oocyte quality (40 days)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: N/A
Brief Summary: During IVF treatment women will be randomized into supplementation with a high or a low dose of Vitamin D Main outcome Laboratory pregnancy, live pregnancy at 12 weeks, Baby take home rate, OHSS Secondary outcome: 1. Pregnancy complications (pregnancy hypertension, SGA, Diabetes) 2.Thrombin generation


Options:
A: Rates of live birth (Participants who will become pregnant: for the duration before they get pregnant and up to the end of pregnancy, an expected average of 18 months. Participants who will not become pregnant: 18 months)
B: Laboratory pregnancy, live pregnancy at 12 weeks, take home baby rate (4 weeks to 9 month)
C: Effect of resveratrol on oocyte quality (40 days)
D: Spontaneous clinical pregnancy rate (12 months)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: A Phase III, Randomized, Multicentre Trial Comparing Allogeneic Filgrastim Mobilised Peripheral Blood Progenitor Cell Transplantation (PBPCT) With Allogeneic Bone Marrow Transplantation (BMT) in Patients With Acute Leukemia, Chronic Myelogenous Leukemia or Myelodysplastic Syndrome
Brief Summary: 350 patients with early leukemias were assigned to receive peripheral blood or bone marrow transplantation; the occurrence of acute and chronic graft versus host disease, survival, transplantation-related mortality, and relapse rates were compared.


Options:
A: The primary end point of the study was the maximum grade of acute graft versus host (GVH) disease observed in the recipient.
B: Health related quality of life EORTC QLQ-30 EORTC QLQ-35 (Baseline); Health related quality of life EORTC QLQ-30 EORTC QLQ-35 (Four weeks); Health related quality of life EORTC QLQ-30 EORTC QLQ-35 (10 weeks); Health related quality of life EORTC QLQ-30 EORTC QLQ-35 (18 weeks); Health related quality of life EORTC QLQ-30 EORTC QLQ-35 (52 weeks)
C: Mental condition (from baseline until 6 months)
D: The M.D. Anderson Symptom Inventory (MDASI) (Week 5 and week 11); Patient Reported Outcomes Measurement Information System (PROMIS) V 1.0 (Week 5 and week 11); Quality of Life Index (QLI) (Week 5 and week 11); Use of Unscheduled Health Service (Week 11)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: Randomized Controlled Trial on the Cardiovascular Effects of Lung Volume Reduction Surgery in Patients With Chronic Obstructive Pulmonary Disease
Brief Summary: A randomised controlled trial will be performed to evaluate the effects of lung volume reduction surgery (LVRS) in patients with COPD on systemic inflammation, oxidative stress, endothelial function, arterial stiffness and blood pressure. We hypothesize that LVRS will lead to a reduction of systemic inflammation, oxidative stress, arterial stiffness and blood pressure and to improved endothelial function.

For this purpose 30 patients with severe/very severe COPD (GOLD III-IV) and pulmonary emphysema who are to undergo LVRS will be randomised to one of two groups: group 1 receiving immediate LVRS and group 2 receiving LVRS after a delay of 3 months.

Measures of systemic inflammation, oxidative stress, endothelial function, arterial stiffness and blood pressure will be measured at baseline and 3 months after surgery and no surgery, respectively (group 2 receiving surgery only after a delay of 3 months will serve as control group) to investigate the effects of LVRS on the described outcomes.


Options:
A: Forced Expiratory Volume in 1 second (FEV1) (12 Months)
B: Reduction in gas trapping (12 weeks post treatment); SAEs - Safety of treatment and the procedure (2 years post treatment)
C: 1. Systemic inflammation 2. Vascular function (Before and 3 months after surgery/no surgery)
D: Reduction in gas trapping (12 weeks post treatment); SAEs - Safety of treatment and the procedure (2 years)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: Association Between the Diet, the Composition of Microbiota of the Intestinal Tract, Human Health and Well-being
Brief Summary: Metabolic syndrome and thereby obesity is associated with low-grade systemic inflammation and it is likely that this is also the case in children (Ley et al., 2005). It has also been shown that the gut microbiota is different in obese individuals compared to normal weight individuals and that the microbiota seems to have a role in fat storage (Backhead et al, 2004).

Intervention study with overweight and normal weight school age children. The children will be randomised to receive selected probiotics or a placebo. Fecal and blood samples will be collected, and anthropometric measurements (weight, height, skin folds) will be recorded before and after the intervention. The dynamic of the microbiota of the GI will be monitored by molecular methods. Markers of intestinal inflammation (calprotectin) and permeability will be analysed. Blood samples will be analysed to evaluate how the intervention influence the systemic polarization of the immune response by means of cytokine analyses. Furthermore, blood pressure, blood lipid profile and early markers of metabolic syndrome will be evaluated. Hypotheses This study will examine if overweight in children is associated with a different intestinal microbiota and if a change in microbiota caused by probiotics can modify inflammation and risk factors for the metabolic syndrome.


Options:
A: Change in Hemoglobin A1c (6 months); Change in Fasting Glucose (6 months)
B: Changes in glucose metabolism, changes in transcriptomic and metabolomic profiles (By 2010)
C: Microbiota diversity (one year); Inflammation, CRP (2 months)
D: Weight Loss

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: A Randomized, Placebo-controlled Phase II Trial Investigating SUNITINIB Versus Placebo in Patients With Chemorefractory Advanced Adenocarcinoma of the Stomach or Lower Esophagus Treated With Chemotherapy FOLFIRI
Brief Summary: This trial will be conducted to evaluate the efficacy, safety and tolerability of SUNITINIB as add-on therapy with a widely used second-line palliative FOLFIRI chemotherapy in patients with chemo-refractory advanced or metastatic adenocarcinoma of stomach or lower esophagus (mGC).

There is a clear scientific rationale for the use of Sunitinib to treat patients with mGC. Despite recent therapeutic advances, the median overall survival (OS) in patients with mG is still ≤ 12 months. Therefore, newer agents with novel mechanisms of action are desperately needed for treatment of these patients.


Options:
A: Overall Survival (From randomization until death, up to 26 months)
B: The primary endpoint is the Progression-free survival (PFS) according to RECIST V1.1. (Average time period: up to one year (participants are followed until progression or death))
C: Overall Survival (OS) (2.5 years)
D: Overall Survival (OS)- Phase 3 (Date of randomization until death (up to 2 years 3 months)); Overall Survival (OS) - Phase 2 (Dose Selection Portion of the Study) (Date of randomization until death (up to 1 year))

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: A Randomized, Placebo-controlled Phase II Trial Investigating SUNITINIB Versus Placebo in Patients With Chemorefractory Advanced Adenocarcinoma of the Stomach or Lower Esophagus Treated With Chemotherapy FOLFIRI
Brief Summary: This trial will be conducted to evaluate the efficacy, safety and tolerability of SUNITINIB as add-on therapy with a widely used second-line palliative FOLFIRI chemotherapy in patients with chemo-refractory advanced or metastatic adenocarcinoma of stomach or lower esophagus (mGC).

There is a clear scientific rationale for the use of Sunitinib to treat patients with mGC. Despite recent therapeutic advances, the median overall survival (OS) in patients with mG is still ≤ 12 months. Therefore, newer agents with novel mechanisms of action are desperately needed for treatment of these patients.


Options:
A: Overall Survival (Survival contact from the date of randomization and then every 8 weeks following objective disease progression and in the 7 days following OS Data Cut off (DCO); Time point(s) at which outcome measure is assessed up to 4 years)
B: Overall Survival (OS) (From the date of randomization to the data cut-off date (maximum duration: up to approximately 46 months))
C: Overall Survival (OS) (From randomization up to 627 days)
D: The primary endpoint is the Progression-free survival (PFS) according to RECIST V1.1. (Average time period: up to one year (participants are followed until progression or death))

Answer: D