TrialPanorama/Dataset huggingface dataset:
Please select the outcome measures that correspond to the clinical trial below.
Title: A 2 Week Single Blind Study to Evaluate Phosphate Binding of Chitosan Chewing Gum in Patients With Chronic Kidney Disease
Brief Summary: To determine the amount of phosphate recovered into 2 strengths of K2CG chewing gum in a modified formulation (with or without an extender) added to the gum core, in comparison to matching placebo gums.


Options:
A: The change in plasma phosphorus after 8 weeks of niacinamide versus placebo (8 weeks)
B: Total phosphorus bound and entrapped per piece of chewing gum (60 minutes)
C: Effect on p-creol levels (3 months)
D: Correlation between fasting salivary phosphorus and estimated glomerular filtration rate (single value between 7-11 am); Correlation between post meal salivary phosphorus and estimated glomerular filtration rate (single value after meal between 1-4 pm)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: A 2 Week Single Blind Study to Evaluate Phosphate Binding of Chitosan Chewing Gum in Patients With Chronic Kidney Disease
Brief Summary: To determine the amount of phosphate recovered into 2 strengths of K2CG chewing gum in a modified formulation (with or without an extender) added to the gum core, in comparison to matching placebo gums.


Options:
A: Total phosphorus bound and entrapped per piece of chewing gum (60 minutes)
B: Change in Serum Inorganic Phosphorus at the End of Treatment From Baseline (baseline and end of the chewing treatment during three week treatment period)
C: Calcium Balance (2 weeks)
D: To determine the effect of a phosphorus additives educational intervention on serum phosphorus levels. (3 months)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: Treatment With Ranolazine in Microvascular Coronary Dysfunction (MCD): Impact on Angina Myocardial Ischemia
Brief Summary: This research study is designed to test the use of ranolazine in patients with angina (chest discomfort due to reduced blood supply to the heart) due to microvascular coronary dysfunction (MCD; abnormalities in the small blood vessels of the heart). This drug is approved by the U.S. Food and Drug Administration (FDA) for treatment of chronic angina. The FDA has approved this drug based on studies primarily on patients with chronic angina with major blockages of the arteries.


Options:
A: Seattle Angina Questionnaire (SAQ) (2 weeks (first intervention) and 6 weeks (second intervention))
B: Time to first occurrence of any element of the composite of cardiovascular death, myocardial infarction or recurrent ischemia through the end of the follow-up in non-ST elevation ACS. (First occurrence)
C: Average Weekly Angina Frequency Over the Last 6 Weeks of Treatment (6 weeks)
D: Cardiac Magnetic Resonance (CMRs) (4 weeks and 10 weeks)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: Follow up After Self-poisoning by General Practitioner- a Randomised Clinical Trial
Brief Summary: The study hypothesis is that follow up from general practitioner after hospitalization for self poisoning will decrease suicidal behaviour.


Options:
A: Change in scores on Beck Scale for Suicidal Ideation (Baseline, post-therapy, 6 months and 12 months after therapy)
B: Suicidal behaviour (3 and 6 months); Suicidal behaviour (3 and 6 months)
C: The Zanarini Rating Scale for Borderline Personality Disorder (Weeks 0, 2, 4, 6, 8, 10, 12); Borderline Evaluation of Severity over Time (BEST) (Weeks 0,2,4,6,8,10,12)
D: Suicide Events (Measured after 6 months of treatment)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: Follow up After Self-poisoning by General Practitioner- a Randomised Clinical Trial
Brief Summary: The study hypothesis is that follow up from general practitioner after hospitalization for self poisoning will decrease suicidal behaviour.


Options:
A: Suicidal behaviour (3 and 6 months); Suicidal behaviour (3 and 6 months)
B: MHS heavy use (2 years)
C: episodes of parasuicide, alcohol intoxication, institutional care (12 months)
D: Number of days with hospital admission (Change between the period from 12 month retrospectively to Baseline and the period from baseline to 12 months prospectively)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: Follow up After Self-poisoning by General Practitioner- a Randomised Clinical Trial
Brief Summary: The study hypothesis is that follow up from general practitioner after hospitalization for self poisoning will decrease suicidal behaviour.


Options:
A: Suicide repetition (or death by suicide) (12 months)
B: Suicide attempts (measured by the Columbia Suicide Severity Rating Scale) (6-months); Suicidal ideation (measured by the Beck Suicide Scale (BSS)) (6-months)
C: Suicidal behavior and ideation (Weeks 4, 12, and 24)
D: Suicidal behaviour (3 and 6 months); Suicidal behaviour (3 and 6 months)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: Follow up After Self-poisoning by General Practitioner- a Randomised Clinical Trial
Brief Summary: The study hypothesis is that follow up from general practitioner after hospitalization for self poisoning will decrease suicidal behaviour.


Options:
A: suicidal act frequency (12 months)
B: suicidal ideation - Suicidal Ideation Questionnaire-JR (3 month)
C: Suicide Attempt Self-Injury Interview (SASII) (4 months, 8 months and 12 months)
D: Suicidal behaviour (3 and 6 months); Suicidal behaviour (3 and 6 months)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: Follow up After Self-poisoning by General Practitioner- a Randomised Clinical Trial
Brief Summary: The study hypothesis is that follow up from general practitioner after hospitalization for self poisoning will decrease suicidal behaviour.


Options:
A: Change in severity of borderline personality disorder assessed with the Zanarini Rating Scale for Borderline Personality Disorder (ZAN-BPD) interview (Assessed at baseline, and at 8, 16 and 24 months post-randomization)
B: Suicidal behaviour (3 and 6 months); Suicidal behaviour (3 and 6 months)
C: Days/skill (Daily measurements up to 1 year. (minimum 8 months.))
D: First recurrent suicide behavior (suicide attempted and completed suicide) (Minimum 1.5 year)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: Follow up After Self-poisoning by General Practitioner- a Randomised Clinical Trial
Brief Summary: The study hypothesis is that follow up from general practitioner after hospitalization for self poisoning will decrease suicidal behaviour.


Options:
A: Change in the self-rating of affective reactivity (ARI-S) (Assessed at Baseline, at week 5, week 10 and week 11.); Clinical Global Impression - Improvement (CGI-I) total score of 1 or 2 (much improved, very much improved). (assessed at weeks 5, 10, and 11.)
B: Psychosocial functioning (The outcomes will be assessed after 8, 18, 36, and 72 months:); symptom distress (after 8, 18, 36 and 72 months); self esteem (after 8, 18, 36 and 72 months); interpersonal problems, (after 8, 18, 36 and 72 months); self destructive behavior, (after 8, 18, 36 and 72 months); personality pathology, (after 36 and 72 months); quality of life, (after 8, 18, 36 and 72 months); health care utilization after (after 8, 18, 36 and 72 months)
C: Change from first investigation in Posttraumatic Symptom Severity at 18 months (Clinician-Administered PTSD Scale; CAPS) (first investigation (t1), after waiting list (3 months, t2), directly after therapy (3 months, t1), 1 year after therapy (15 months, t3))
D: Suicidal behaviour (3 and 6 months); Suicidal behaviour (3 and 6 months)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: A 12-week Study to Evaluate the 24 Hour Pulmonary Function of Fluticasone Furoate (FF)/Vilanterol Inhalation Powder (FF/VI Inhalation Powder) Once Daily Compared With Salmeterol/Fluticasone Propionate (FP) Inhalation Powder Twice Daily in Subjects With Chronic Obstructive Pulmonary Disease (COPD)
Brief Summary: The purpose of this study is to evaluate the 24-hour spirometry effect (FEV1) of Fluticasone Furoate/Vilanterol 100/25mcg once daily compared with Salmeterol/Fluticasone Propionate 50/500mcg twice daily over a 12-week treatmen period in subjects with COPD.


Options:
A: Total Total Transient Dyspnea Index (TDI) Score After 6 Weeks of Treatment QVA149 Compared to Placebo (Baseline and 6 weeks)
B: Rate of COPD Exacerbations (52 weeks)
C: Change From Baseline in Trough FEV1 on Day 85 (Baseline (BL) and Day 85)
D: Change From Baseline Trough in 24-hour Weighted-mean FEV1 on Treatment Day 84 (Baseline and Day 84)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: A Multicenter, Open-label, Randomized Phase III Study to Evaluate the Efficacy and Safety of Erlotinib (Tarceva®) Versus Gemcitabine/Cisplatin as the First-line Treatment for Stage IIIB/IV Non-small Cell Lung Cancer (NSCLC) Patients With Mutations in the Tyrosine Kinase Domain of Epidermal Growth Factor Receptor (EGFR) in Their Tumors
Brief Summary: This open-label, randomized, parallel arm study assessed the efficacy and safety of Tarceva (erlotinib) versus gemcitabine/cisplatin combination chemotherapy as first-line treatment in patients with stage IIIB/IV non-small cell lung cancer with epidermal growth factor receptor (EGFR) mutations in their tumours. Patients were randomized to receive either Tarceva 150 mg orally daily or 3-week cycles of gemcitabine 1250 mg/m\^2 intravenously (iv) on Days 1 and 8 plus cisplatin 75 mg/m\^2 iv on Day 1.


Options:
A: Investigator-assessed Duration of Progression-free Survival (Baseline to the data cut-off date of 20 Jul 2012 (1 year, 4 months))
B: Median Progression Free Survival (PFS) in Months (Tumour assessments as per RECIST were performed at baseline and then every 42 days ± 7 days from randomization until data cut off (14th April 2008).)
C: Progression free survival (12 months)
D: Median Progression Free Survival (PFS) Time (Randomization until PD or death (assessed at baseline and every 8 weeks thereafter until PD, death or end of study [up to approximately 1.5 years]))

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: A Randomized, Double-blind, Placebo-Controlled, Comparative Multicenter Phase 3 Study to Evaluate the Safety and Efficacy of BA058 (Abaloparatide) for Injection for Prevention of Fracture in Ambulatory Postmenopausal Women With Severe Osteoporosis and at Risk of Fracture
Brief Summary: The purpose of this study is to determine whether BA058 (abaloparatide), a parathyroid hormone-related peptide, is effective in preventing fractures in postmenopausal women with severe osteoporosis who are at risk of fractures.


Options:
A: Change in Quantitative Computed Tomography (QCT) Bone Mineral Density of the Hip (One Year (at baseline and one year))
B: Relative variation of femoral bone mineral density after 24 months of follow-up (T-score evaluated by osteodensitometry) (24 months after inclusion)
C: Percentage of Participants With New Vertebral Fracture Through Month 12 (12 Months); Percentage of Participants With New Vertebral Fracture Through Month 24 (24 months)
D: Number of Participants With New Vertebral Fractures at 18 Months (18 months)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: Short- and Longterm Effects of Physical Activity and Dietary Restriction Postpartum on Women's Weight and Body Composition: a Randomized Study
Brief Summary: The study will investigate whether physical exercise, or dietary restrictions, or a combination of both, among overweight and obese postpartum women lead to a significantly larger reduction in weight in a longer perspective, compared to similar women not receiving the intervention. The study also will investigate the effects on body composition, cardiovascular fitness, blood lipids, insulin levels and inflammation markers. In total, 68 women with pre-pregnancy BMI 25 - 34.9 will be randomized at 10 wk postpartum into: (1) physical exercise, (2) dietary restrictions, (3) physical exercise + dietary restrictions and (4) control group. The intervention lasts for 12 wk and longterm effects are measured 1 yr after trial initiation. To date only studies showing short term (12 wk) effects exist. Our study is the first to include four intervention groups, so that separate effects of physical activity and dietary restriction and their interaction, can be assessed. Further, the investigators will estimate effects on body composition taking body water into account and estimate total energy expenditure with higher precision than previously. Overweight and obesity is an escalating problem in Sweden. Sustainable weight reduction programs are urgently needed. During the postpartum period, women may be motivated to lose weight. Information aimed at promoting life style changes among overweight and obese women could in a longer perspective be integrated in the regular maternal health care in Sweden.


Options:
A: Changes in the knowledge and belief about postpartum practice among the women (December 2009)
B: Postpartum weight retention (no more than 1.5 years)
C: Affect Balance Scale (4 weeks)
D: Body weight (12 weeks)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: A Randomized Controlled Study of YONDELIS (Trabectedin) or Dacarbazine for the Treatment of Advanced Liposarcoma or Leiomyosarcoma
Brief Summary: The purpose of this study is to evaluate whether overall survival for the trabectedin group is superior to the dacarbazine group for patients with advanced L-sarcoma (liposarcoma or leiomyosarcoma).


Options:
A: Overall survival
B: Event-free survival; Overall survival
C: Event-free survival (Time from study entry until disease progression, death without progression of disease, occurrence of a second malignant neoplasm or last follow-up, whichever comes first, assessed up to 5 years)
D: Overall Survival (OS) (approximately 3 years 8 months (From Study start date [27 May 2011] up to final analysis data cut-off [05 January 2015])

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: A Randomized Controlled Study of YONDELIS (Trabectedin) or Dacarbazine for the Treatment of Advanced Liposarcoma or Leiomyosarcoma
Brief Summary: The purpose of this study is to evaluate whether overall survival for the trabectedin group is superior to the dacarbazine group for patients with advanced L-sarcoma (liposarcoma or leiomyosarcoma).


Options:
A: To Determine if Surgical Secondary Cytoreduction in Addition to Adjuvant Chemotherapy Increases the Duration of Overall Survival in Patients With Recurrent Platinum Sensitive Epithelial Ovarian Cancer, Peritoneal Primary or Fallopian Tube Cancer (The time frame is 82.5 months (median duration of follow-up)); To Determine if the Addition of Bevacizumab Increases the Duration of Overall Survival Relative to Second-line Paclitaxel and Carboplatin Alone in Patients With Recurrent Platinum Sensitive Epithelial Ovarian, Peritoneal Primary or Fallopian Tube Cancer (The time frame is 82.5 months (median duration of follow-up).)
B: Progression free survival (3 years)
C: Complete response rate (average 24 months)
D: Overall Survival (OS) (approximately 3 years 8 months (From Study start date [27 May 2011] up to final analysis data cut-off [05 January 2015])

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: Staying on Track: Increasing Completion of the HPV Vaccine Series With the Use of an Innovative Patient and Provider Information and Tracking Tool
Brief Summary: Planned Parenthood Federation of America's (PPFA) Medical Affairs Division will conduct a prospective, cluster randomized trial to determine which factors influence the acquisition of the second and third human papillomavirus (HPV) vaccine doses among young women ages 19 to 26. This descriptive and interventional study will provide data to assess impact of a computerized tool upon HPV vaccine series completion. The interventional aspect of this study includes determination of patient assistance and provider support programs applicable to each woman's situation as well as the implementation of a computer software system for customized patient reminders.


Options:
A: receipt of vaccine of interest at 28 days (28 days)
B: Completion of 3 Doses of Pentavalent Vaccine (8 months of age)
C: On-time Completion of the Human Papillomavirus Vaccine Series (32 weeks after receipt of initial vaccine)
D: Evaluate effectiveness of population-based reminder/recall methods versus practice-based reminder/recall methods in 14 Colorado counties (rural and urban) (6 months post-intervention (December 2010))

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: Staying on Track: Increasing Completion of the HPV Vaccine Series With the Use of an Innovative Patient and Provider Information and Tracking Tool
Brief Summary: Planned Parenthood Federation of America's (PPFA) Medical Affairs Division will conduct a prospective, cluster randomized trial to determine which factors influence the acquisition of the second and third human papillomavirus (HPV) vaccine doses among young women ages 19 to 26. This descriptive and interventional study will provide data to assess impact of a computerized tool upon HPV vaccine series completion. The interventional aspect of this study includes determination of patient assistance and provider support programs applicable to each woman's situation as well as the implementation of a computer software system for customized patient reminders.


Options:
A: Intention to treat analysis (13 months)
B: On-time Completion of the Human Papillomavirus Vaccine Series (32 weeks after receipt of initial vaccine)
C: HPV completion rate (One Year)
D: Exclusive breastfeeding (6 months postpartum)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: Staying on Track: Increasing Completion of the HPV Vaccine Series With the Use of an Innovative Patient and Provider Information and Tracking Tool
Brief Summary: Planned Parenthood Federation of America's (PPFA) Medical Affairs Division will conduct a prospective, cluster randomized trial to determine which factors influence the acquisition of the second and third human papillomavirus (HPV) vaccine doses among young women ages 19 to 26. This descriptive and interventional study will provide data to assess impact of a computerized tool upon HPV vaccine series completion. The interventional aspect of this study includes determination of patient assistance and provider support programs applicable to each woman's situation as well as the implementation of a computer software system for customized patient reminders.


Options:
A: The Proportion who tested for HIV over 2 months follow-up (2 months following the first text message)
B: Effect of SMS intervention on attendance rate to follow-up screening appointment (up to 14 months)
C: On-time Completion of the Human Papillomavirus Vaccine Series (32 weeks after receipt of initial vaccine)
D: Adherence to PrEP (Baseline to Week 48)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: Enhancing Participation of Chronic Stroke Patients in Primary Care by Modified Constraint Induced Movement Therapy (HOMECIMT)
Brief Summary: The aim of this study is to evaluate the efficacy of a modified approach of constraint induced movement therapy ("CIMT at home") for chronic stroke patients, compared to conventional physiotherapy and occupational therapy ("therapy as usual) with regard to the ability to participate in everyday activities.


Options:
A: Jette Late Life Functional and Disability Instrument (LLFDI) (3 months)
B: The primary outcome, caregiver's perceived social support, will be assessed by Medical Outcomes Study Social Support Scale. (Baseline, 3, 6 and 12-months post-stroke)
C: Motor Activity Log - Quality Of Movement (MAL-QOM) and Wolf Motor Function Test - Performance Time (WMFT-PT) (4 weeks (post-treatment) relative to baseline performance)
D: Fugl Meyer (FM) Assessment (Baseline, post intervention and 3 month follow-up)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: A Phase III, Randomised, Double-blind and Placebo-controlled Study of Once Daily BI 201335 120 mg for 12 or 24 Weeks or BI 201335 240 mg for 12 Weeks in Combination With Pegylated Interferon-alpha and Ribavirin in Treatment-naïve Patients With Genotype 1 Chronic Hepatitis C Infection
Brief Summary: The objective of this trial is to evaluate the efficacy and safety of two different treatment regimens with BI 201335, both in combination with PegIFN/RBV) as compared to standard of care (SOC) with PegIFN/RBV alone.


Options:
A: Number of Participants With Sustained Virologic Response (SVR) 24 Weeks After the Last Planned Dose of Study Medication - SVR24 Planned (Week 72)
B: Number of Participants With Virologic Response Defined as >= 3 Log Drop in Viral Load From Baseline at Day 28 With no Evidence of Virologic Rebound During These 28 Days. Virologic Rebound is Defined as >= 1 Log Increase in Viral Load From Nadir. (Baseline and 4 weeks)
C: Change From Baseline at Day 7 in log10 Hepatitis C Virus (HCV) RNA of All Participants (Baseline, Day 7)
D: Sustained Virological Response 12 Weeks Post-treatment (SVR12) (12 weeks post treatment, up to 60 weeks)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: A Phase III, Randomised, Double-blind and Placebo-controlled Study of Once Daily BI 201335 120 mg for 12 or 24 Weeks or BI 201335 240 mg for 12 Weeks in Combination With Pegylated Interferon-alpha and Ribavirin in Treatment-naïve Patients With Genotype 1 Chronic Hepatitis C Infection
Brief Summary: The objective of this trial is to evaluate the efficacy and safety of two different treatment regimens with BI 201335, both in combination with PegIFN/RBV) as compared to standard of care (SOC) with PegIFN/RBV alone.


Options:
A: Sustained Virological Response 12 Weeks Post-treatment (SVR12) (12 weeks post treatment, up to 60 weeks)
B: Safety Outcome Measures (Safety and tolerability assessments will be performed for a period of 7 days after administration of a single dose)
C: Phase 2a and Phase 2b: Safety, as measured by the frequency of SAEs and discontinuations due to AEs (12 weeks after first dose); Antiviral activity as determined by proportion of HCV genotype 1 subjects with extended rapid virologic response (eRVR), defined as undetectable HCV RNA (Week 4); Antiviral activity as determined by proportion of HCV genotype 1 subjects with extended rapid virologic response (eRVR), defined as undetectable HCV RNA (Week 12); Phase 2b only: Antiviral activity, as determined by the proportion of HCV genotype 1 subjects with 24-week sustained virologic response (SVR24), defined as undetectable HCV RNA (at follow-up Week 24)
D: Percentage of Participants Achieving SVR12 (Posttreatment Week 12); Adverse Events Leading to Permanent Discontinuation of Study Drug (Baseline to Week 16)

Answer: A