TrialPanorama/Dataset huggingface dataset:
Please select the outcome measures that correspond to the clinical trial below.
Title: A Single Arm, Open Label, Interventional Multicenter Study to Assess the Efficacy, Safety, and Tolerability of Once-Monthly Administration of Intravenous C.E.R.A. for the Maintenance of Hemoglobin Levels in Hemodialysis Patients With Chronic Renal Anemia
Brief Summary: This single-arm study will assess the long-term maintenance of hemoglobin levels, safety, and tolerability of once-monthly intravenous administration of Mircera in hemodialysis participants with chronic renal anemia. Those currently receiving darbepoetin alfa, epoetin alfa, or epoetin beta maintenance treatment will receive intravenous Mircera at a starting dose of 120, 200, or 360 micrograms (mcg) per month (based on the erythropoiesis stimulating agent \[ESA\] dose administered on Week -1). Subsequent doses will be adjusted to maintain hemoglobin levels within the country-specific target range (11 to 13 grams per deciliter \[g/dL\] for Switzerland and 10 to 12 g/dL for Austria).


Options:
A: Percentage of Participants With Lesser Than or Equal to One Gram Per Deciliter Decrease in Average Hemoglobin From Baseline and Maintaining Average Hemoglobin Level Greater Than or Equal to 10.5 g/dL Over Evaluation Period (Baseline (Week -4 to Week -1) and Evaluation period (Weeks 50 to 53))
B: Percentage of Participants Who Maintained Their Mean Hemoglobin Concentration Within +/- 1.0 Gram/Deciliter of Their Reference Hemoglobin Concentration and Between 10.0 and 12.0 Gram/Deciliter During the Efficacy Evaluation Period (EEP (Week 16 to Week 24))
C: Percentage of Participants Who Maintained Average Hb Within Plus/Minus (±) 1 g/dL of Reference Hb and Within Target Range During the Efficacy Evaluation Period (EEP) (Weeks -4, -3, -2, -1,and 0; pre-dose (0 hours) during Weeks 18, 20, 22, and 24)
D: Percentage of Participants Who Maintained Average Hb Within Plus/Minus (±) 1 g/dL of Reference Hb or Within Target Range During the Efficacy Evaluation Period (EEP) (At Weeks -4, -3, -2, -1, 0; pre-dose (0 hours) and immediately before dialysis (minimum 3 sessions per week) during Weeks 18, 20, 22, 24)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: A Phase III, Randomised, Double-Blind, Dose-Response, Stratified, Placebo-Controlled Study Evaluating the Safety and Efficacy of SPD476 Versus Placebo Over 104 Weeks in the Prevention of Recurrence of Diverticulitis.
Brief Summary: The purpose of this study is to determine whether SPD476 is effective in reducing recurrence of diverticulitis.


Options:
A: Percent of Subjects Without Recurrence of Diverticulitis (Up to 104 weeks)
B: discharge without complications +/- antibiotic therapy (Within 30 days after discharge)
C: diverticulitis relapse (24 months)
D: Percent of Subjects Without Recurrence of Diverticulitis (up to 104 Weeks)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: An 8 Week Study to Evaluate the Effectiveness of Adding Montelukast to Inhaled Corticosteroid (ICS) to the ICS/Long-Acting Beta 2-Agonist Therapy in Adult Subjects With Asthma and Allergic Rhinitis
Brief Summary: Effectiveness of adding montelukast to inhaled corticosteroids in adult subjects with both uncontrolled asthma and allergic rhinitis.


Options:
A: Trough (AM pre-dose and pre-rescue bronchodilator) FEV1 (at the end of the 6 week treatment period.)
B: Treatment Failure (16 weeks)
C: To evaluate distal airway function using high-resolution CT and lung function test (6 months)
D: Asthma Control (8 weeks (from Week 0 to Week 8))

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: An 8 Week Study to Evaluate the Effectiveness of Adding Montelukast to Inhaled Corticosteroid (ICS) to the ICS/Long-Acting Beta 2-Agonist Therapy in Adult Subjects With Asthma and Allergic Rhinitis
Brief Summary: Effectiveness of adding montelukast to inhaled corticosteroids in adult subjects with both uncontrolled asthma and allergic rhinitis.


Options:
A: N/A
B: Mean Percentage of Days With Worsening Asthma (as Measured on Daily Diaries) in Pediatric Asthmatic Participants (8 Week treatment period initiated at the beginning of a school year)
C: Asthma Control (8 weeks (from Week 0 to Week 8))
D: Symptom-free days; Quality of Life Questionnaire (AQLQ, PAQLQ); Rate of asthma-related hospitalizations over 18 months of enrollment; Rate of asthma-related emergency room (ER) visits over 18 months of enrollment

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: A Prospective, Randomized, Multi-Center, Double-Blind, 26 Week, Placebo-Controlled Trial of Memantine (10mg BID) for the Frontal and Temporal Subtypes of Frontotemporal Dementia
Brief Summary: The primary objective of the study is to determine whether memantine is effective in slowing the rate of behavioral decline in frontotemporal dementia.

The secondary objective of the study is to assess the safety and tolerability of long-term treatment with memantine in patients with frontotemporal dementia (FTD) or semantic dementia (SD). To determine whether memantine is effective in slowing the rate of cognitive decline in frontotemporal dementia. To evaluate whether memantine delays or decreases the emergence of parkinsonism in frontotemporal dementia.

The tertiary objective of the study is to determine whether treatment with memantine affects changes in weight


Options:
A: No primary or secondary outcome measures are defined. This study is exploratory (see above under detailed description).
B: Change in Neuropsychiatric Inventory (NPI) (Baseline, 26 weeks); Clinical Global Impression of Change (CGIC) (26 Weeks)
C: to assess the efficacy of Memantine in improving memory deficit in MS patients using the SRT scale (6 months)
D: Alzheimer's Disease Cooperative Study/Activities of Daily Living (ADCS/ADL) Inventory Change From Baseline (6, 12, 18, 24, 30, 36, 42 and 48 months minus baseline); Mini-Mental State Examination Change From Baseline (6, 12, 18, 24, 30, 36, 42 and 48 months minus baseline); Alzheimer's Disease Assessment Scale - Cognitive (ADAS-cog) Change From Baseline (6, 12, 18, 24, 30, 36, 42 and 48 months minus baseline); Neuropsychiatric Inventory Change From Baseline (6, 12, 18, 24, 30, 36, 42 and 48 months minus baseline); Caregiver Activity Survey Change From Baseline (6, 12, 18, 24, 30, 36, 42 and 48 months minus baseline)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: Prospective Randomized Trial of Laparoscopy-assisted Distal Gastrectomy (LADG) Versus Open Distal Gastrectomy (ODG) in Patients With Early Gastric Cancer (EGC)
Brief Summary: Rationale: For the treatment of early gastric cancer (EGC) in the distal portion of the stomach, subtotal gastrectomy and lymph node dissection has been a standard operation. With the increasing tendency toward minimally invasive surgery, there has been an effort to apply minimally invasive techniques to the treatment of EGC. Laparoendoluminal mucosectomy and lesion-lifting gastric wedge resection have been developed for this purpose. However, these methods have the disadvantage of limited indications according to the size, shape and depth of invasion. Kitano et al. performed the first laparoscopy-assisted subtotal gastrectomy with lymph node dissection and manual anastomosis with anterior wall lifting method for a patient with EGC. In 1995, Uyama et al. and Nagai et al. performed laparoscopy-assisted subtotal gastrectomy with lymph node dissections using an automatic stapler instead of manual anastomosis for the gastroduodenal anastomosis. It has been possible to maintain an adequate distance from the lesion to the proximal and distal margins of resection, to perform radical lymph node dissection, and to achieve excellent postoperative recovery. However, there is a very limited evidence of superiority of laparoscopic gastrectomy over open surgery. There is only one interim report of randomized clinical trial of comparing laparoscopic gastrectomy and open gastrectomy. A well-designed clinical study to prove the benefit and safety is definitely needed Objective: to compare Laparoscopy - assisted Distal Gastrectomy (LADG) with Open Distal Gastrectomy (ODG) in terms of survival, recovery, pain, complications, and quality of life (QOL) Hypothesis: LADG is beneficial in QOL, pain, recovery, complications while maintaining equivalent survival with ODG


Options:
A: Extent of lymph node dissection (two weeks)
B: 5 year disease free survival (1week, 1 month, 3 months, 6 months,1 year, 2 years, 3 years,4 years, & 5 years)
C: Post-operative hospital stay (During admission, an expected average of 2 weeks)
D: overall survival

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: An Open-label, Randomized, Multi-center, Parallel Group Study to Demonstrate Correction of Anemia Using Intravenous Injections of RO0503821 in Patients With Chronic Kidney Disease Who Are on Dialysis
Brief Summary: This 2 arm study will evaluate the efficacy of intravenous Mircera treatment for the correction of anemia in patients with chronic kidney disease who are on dialysis. Patients will be randomized to receive either Mircera 0.6 micrograms/kg i.v. every 2 weeks, or epoetin 3 times per week i.v. according to approved treatment recommendations. The anticipated time on study treatment is 3-12 months, and the target sample size is 100-500 individuals.


Options:
A: Time to All-cause Mortality or Cardiovascular (CV) Events Including Hospitalization Due to Acute Myocardial Ischemia, Congestive Heart Failure (CHF), Myocardial Infarction (MI), and Cerebrovascular Accident (CVA) (Until a primary cardiovascular event (death, myocardial ischemia, congestive heart failure, myocardial infarction or cerebrovascular accident) occurred or 28 March 2009, whichever occurred first); Time to All-cause Mortality or End Stage Renal Disease (ESRD) (Until a primary cardiovascular event (death, myocardial ischemia, congestive heart failure, myocardial infarction or cerebrovascular accident) occurred or 28 March 2009, whichever occurred first)
B: TSAT (transferrin saturation), serum albumin, serum ferritin, serum transferrin, serum C reactive protein (after randomization at month 1, 2, 3, 6, 12)
C: The primary outcome will be a composite consisting of mortality (all cause), myocardial infarction, stroke, and CHF hospitalization (not including those hospitalizations during which RRT occurs)
D: Percentage of Participants Who Achieved Hemoglobin Response up to Week 24 (Up to Week 24)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: An Open-label, Randomized, Multi-center, Parallel Group Study to Demonstrate Correction of Anemia Using Intravenous Injections of RO0503821 in Patients With Chronic Kidney Disease Who Are on Dialysis
Brief Summary: This 2 arm study will evaluate the efficacy of intravenous Mircera treatment for the correction of anemia in patients with chronic kidney disease who are on dialysis. Patients will be randomized to receive either Mircera 0.6 micrograms/kg i.v. every 2 weeks, or epoetin 3 times per week i.v. according to approved treatment recommendations. The anticipated time on study treatment is 3-12 months, and the target sample size is 100-500 individuals.


Options:
A: Mean Change in Hemoglobin Concentration (g/dL) From Baseline to Evaluation Period (Baseline (Week -4 to Week -1) and Evaluation Period (Week 29 to Week 36))
B: Percentage of Participants Who Maintained Average Hb Within Plus/Minus (±) 1 g/dL of Reference Hb or Within Target Range During the Efficacy Evaluation Period (EEP) (At Weeks -4, -3, -2, -1, 0; pre-dose (0 hours) and immediately before dialysis (minimum 3 sessions per week) during Weeks 18, 20, 22, 24)
C: The primary outcome will be a composite consisting of mortality (all cause), myocardial infarction, stroke, and CHF hospitalization (not including those hospitalizations during which RRT occurs)
D: Percentage of Participants Who Achieved Hemoglobin Response up to Week 24 (Up to Week 24)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: Effect of Early Prescription of Immunosuppressants on First Three-year Course of Crohn's Disease
Brief Summary: Pluricentric randomized study comparing two therapeutic strategies at beginning of Crohn's disease: early immunosuppressants (prescription within the six first months following diagnosis) vs. conventional strategy (immunosuppressants given only in case of steroid failure, in a selected group of patients being at high risk of disabling course. The hypothesis is that immunosuppressants given early may improve the disease course during the 3 following years in this subset of patients.


Options:
A: Clinical Remission (Baseline to Week 12); Frequency and Severity of Adverse Events Through Week 12 (Baseline through Week 12 Visit)
B: Percentage of Participants With Corticosteriod-free Clinical Remission (Week 26)
C: number of 3-months periods with remission (3 yrs)
D: Reduction of 50% or more from baseline to week 12 in the number of draining perianal fistulas. (12 week)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: Effect of Early Prescription of Immunosuppressants on First Three-year Course of Crohn's Disease
Brief Summary: Pluricentric randomized study comparing two therapeutic strategies at beginning of Crohn's disease: early immunosuppressants (prescription within the six first months following diagnosis) vs. conventional strategy (immunosuppressants given only in case of steroid failure, in a selected group of patients being at high risk of disabling course. The hypothesis is that immunosuppressants given early may improve the disease course during the 3 following years in this subset of patients.


Options:
A: Percentage of Participants With Corticosteriod-free Clinical Remission (Week 26)
B: remission without corticosteroids and without surgical resection (month 6 and 12 after inclusion)
C: number of 3-months periods with remission (3 yrs)
D: The primary endpoint was therapeutic failure at one year, defined as CDAI score ≥200 and an increase of ≥60 points from baseline, or study drug discontinuation due to lack of efficacy or intolerable adverse drug reaction. (12 months)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: A Randomized, Double-Blinded, Placebo-Controlled, Phase I/II, Dose-Ranging Study of the Safety, Reactogenicity, and Immunogenicity of Intramuscular Inactivated Influenza A/H7N7 Vaccine in Healthy Adults
Brief Summary: The purpose of this study is to evaluate the safety, any adverse events or side effects, and the body's immune response to an experimental flu vaccine \[Inactivated Influenza A/H7N7 Vaccine\] being given in increasing doses. Researchers will try to find the smallest dose of flu vaccine needed to cause antibody responses against the flu virus in both single and repeat doses. The study will enroll 125 healthy adults ranging in age from 18 to 40 years old. Subjects will be given 2 doses of the vaccine 28 days apart. Study procedures will include obtaining a medical history, physical exam, blood sample collections, and use of patient memory aids. The volunteers will be in the study for about 7 months.


Options:
A: Laboratory-confirmed (Culture and/or PCR) Symptomatic Influenza (one influenza season - 2007-2008)
B: Number of Subjects Developing Influenza Infection, as Confirmed by Viral Culture and Typing of Naso-pharyngeal Specimens (21 days to 180 days after the date of vaccination); The Consistency of Immune Response Produced by 3 Different Lots of VCIV Based on HIA Titer Values (21 Days after vaccination)
C: the proportion of subjects with antibody titers of 1:40 or more on hemagglutination-inhibition assay (21 days after each vaccination)
D: Adverse event (AE) or serious adverse event (SAE) information (solicited in-clinic and via memory aids, concomitant medications, and periodic targeted physical assessment). (Duration of study.); Proportion of subjects in each dose group achieving a serum neutralizing antibody titer of greater than or equal to 40 against the influenza A/H7N7 virus. (28 days after receipt of the second dose of vaccine (approximately Day 56).); Geometric mean titer (GMT) and frequency of 4-fold or greater increases in neutralizing antibody titers in each group and serum hemagglutination inhibition (HAI) antibody titers in each group. (1 month after receipt of each dose, and 7 months after receipt of the first dose of vaccine.)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: The Chronic and Acute Postprandial Vascular Effects of Exenatide vs. Metformin in Abdominally Obese Patients With Impaired Glucose Tolerance
Brief Summary: The purpose of this study is to compare the effects of exenatide versus metformin on vascular health with chronic (3-month) therapy and during a 2-hour period following a meal in patients with pre-diabetes. It is predicted that exenatide will improve vascular health to a greater degree compared to metformin.


Options:
A: Change in Reactive Hyperemic Index Over the 3-month Treatment Period (Change from baseline to 3 months)
B: Inflammatory Biomarker 1: Plasma hsCRP Concentration (2 months); Inflammatory Biomarker 2: Plasma IL-6 Concentration (2 months); Inflammatory Biomarker 3: Serum D-dimer Concentration (2 months)
C: ß-cell Response Measured by Hyperglycemic Clamp (3-months after medication washout (Month 15)); M/I (3-months after a medication washout)
D: Mean Percentage Change in Fasting Body Weight From Baseline (Week 0, week 56); Percentage of Subjects Who Maintained Their run-in Fasting Weight Loss From Week 0 (Week 0, week 56); Percentage of Subjects Who Lost More Than or Equal to 5% of Fasting Body Weight From Week 0 (Week 0, week 56)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: A Phase 2 Randomized Trial of Radiotherapy Plus Panitumumab Compared to Chemoradiotherapy With Unresected, Locally Advanced Squamous Cell Carcinoma of the Head and Neck
Brief Summary: The purpose of this study is to estimate, with pre-specified precision, the difference in local-regional control (LRC) rate at 2 years in subjects receiving chemoradiotherapy (CRT) or panitumumab plus radiotherapy (PRT) as first line treatment for locally advanced squamous cell carcinoma for the head and neck (SCCHN). A formal hypothesis will not be tested in this trial; however, the treatment arm difference in LRC rates at 2 years will be estimated.


Options:
A: N/A
B: Disease Free Survival (DFS) (Up to 5 years)
C: Local Regional Control Rate at 2 Years (from study day 1 to 2 years)
D: Disease free survival (3 years)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: Anesthésie Totale Intraveineuse en " Boucle d'Asservissement " guidée Par l'Index Bispectral : Effet de l'Adjonction de Protoxyde d'Azote (Effect of Nitrous Oxide on Intravenous Closed-loop Anesthesia)
Brief Summary: The main objective of the study is to analyze the influence of nitrous oxide on propofol and remifentanil requirements.


Options:
A: The Percentage of Incidences With Explicit Recall in the BIS Versus MAC Alert Groups. (Outcome of awareness is assessed 30-days after the operation)
B: Measure: influence of nitrous oxide on the automated administration of propofol and remifentanil. (during anesthesia)
C: The primary endpoint is hospital length of stay (LOS), defined from the start of surgery until actual hospital discharge. Patients transferred to another hospital will be tracked until final discharge to home (or other final destination). LOS is likely
D: The Primary Endpoint is a Composite of Death and Cardiovascular Events (Clinical and Silent MI, Cardiac Failure, Cardiac Arrest, Pulmonary Embolism, and Stroke) Measured at 30 Days After Surgery. (30 days post op)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: Recurrent Throat Infections and Tonsillectomy
Brief Summary: The purpose of this study is to find out if tonsillectomy reduces the short-term risk of having an objectively confirmed (sequential changes in serum crp and procalcitonin levels) delayed pharyngitis episode among patients suffering from recurrent pharyngitis episodes. Other aims are to find out the effect of tonsillectomy to reduce the number of pharyngitis episodes or symptoms. Still, the possible disadvantages of tonsillectomy and changes in the quality of life after tonsillectomy among these patients are examined.


Options:
A: Changes in polysomnographic parameter AHI (Apnea Hypopnea Index) (One, three and ten years)
B: microbiologically confirmed streptococcal pharyngitis episodes
C: Difference between the three arms regarding serum IL1 beta, TNF alpha, IL2, IL6. (12 months)
D: Absolute percentage difference between groups of patients having pharyngitis with delayed recovery time defined by symptoms and blood sample values (crp, procalcitonin) (5 months follow up)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: HELPING HANDS: a Comparison of Short- and Long Term Effects of Alternative Strategies for Promoting Hand Hygiene in Hospital Nurses.
Brief Summary: Hand hygiene prescriptions are the most important measure in the prevention of hospital acquired infections. Yet compliance rates are generally below 50% of all opportunities for hand hygiene adherence. This study will test the short- and long term effects of two strategies for promoting hand hygiene in hospital nurses


Options:
A: Percentage of adherence of opportunities for hand hygiene (march 2008, october 2008, may 2009, november 2009)
B: Cumulative Number of Reported Days-off Episodes in the Arm Due to Own Infectious Disease Over the Total Number of Follow-up Weeks in the Arm (At the end of the entire study period (16 months)); Cumulative Number of Reported Episodes of Infectious Disease in the Arm Over the Total Number of Follow-up Weeks in the Arm (At the end of the study period (16 months))
C: The number of household contacts who will develop within 7 days of the inclusion of the index patient a respiratory syndrome defined by fever> = 37.8 ° C and a cough or a sore throat. (during the study)
D: Incidence of Skin and Soft Tissue Infection (SSTI) (At the end of the 20 month study); Incidence of Methicillin-resistant Staphylococcus Aureus (MRSA)-Associated SSTI (At the end of the 20 month study)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: HELPING HANDS: a Comparison of Short- and Long Term Effects of Alternative Strategies for Promoting Hand Hygiene in Hospital Nurses.
Brief Summary: Hand hygiene prescriptions are the most important measure in the prevention of hospital acquired infections. Yet compliance rates are generally below 50% of all opportunities for hand hygiene adherence. This study will test the short- and long term effects of two strategies for promoting hand hygiene in hospital nurses


Options:
A: N/A
B: Percentage of adherence of opportunities for hand hygiene (march 2008, october 2008, may 2009, november 2009)
C: The proportion of patients starting bisphosphonate treatment within 6 months of fracture (6 months)
D: Number of LTC residents on vitamin D (16 months)

Answer: B