TrialPanorama/Dataset huggingface dataset:
Please select the outcome measures that correspond to the clinical trial below.
Title: Home-based Pain Management Protocol for Children With Sickle Cell Disease
Brief Summary: Sickle cell disease (SCD) is a devastating chronic health condition that primarily affects African-Americans. Painful episodes are the most frequent form of morbidity in SCD and the most frequent reason for hospitalization. Cognitive-behavioral interventions for pain management have shown efficacy for improving coping abilities, reducing the amount of medication needed to manage pain, and improving daily functioning during painful episodes. However, difficulties with disseminating and implementing cognitive-behavioral treatments have resulted in almost no use of these techniques in pediatric settings. In South Carolina these difficulties are compounded by social and geographical factors that pose particular challenges. A major issue with implementing quality pain management protocols is the difficulty with providing adequate practice and monitoring of the use of the techniques, particularly given the rural population in South Carolina and transportation difficulties for economically disadvantaged families. Due to a history of under-treating pain in SCD it is also critical that psychological and medical treatments are presented in an integrated manner so that these approaches are viewed as complimentary, not mutually exclusive, approaches to pain management. Finally, we believe the same implementation issues for improving the use of behavioral coping skills are also important for improving adherence to medication protocols for appropriate home-based pain management.

The purpose of this proposal is to develop, implement, and evaluate a pain management protocol that uses portable electronic devices and other technologies to increase the practice of psychosocial pain management techniques, improve adherence to the overall biopsychosocial pain management protocol, and improve the clinician's ability to track progress with fewer office visits. In addition to addressing important dissemination issues, by embedding methods to assess for adherence into the technology it will be possible to continuously evaluate and modify protocol efficacy, resulting in a product that is effective, empirically sound, and flexible. Participants will be randomly assigned to the intervention or waitlist control condition. Those on the waitlist condition will receive the same study procedures after a 2 month wait periods. We anticipate that the intervention will result in better pain management and less impairment in the participants.


Options:
A: Adherence (beginning at baseline - week 20)
B: Abdominal Pain Index (Baseline, 1 week post treatment session 3, 3 months post treatment session 3, 6 months post treatment session 3, 12 months post treatment session 3)
C: N/A
D: Juvenile Arthritis Quality of Life Questionnaire (JAQQ) (Baseline (prior to randomization) and 3 months after intervention)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: A Randomized, Double-Blind, Placebo-Controlled, Parallel-Group, Fixed-Dose, Multicenter Study of Weight-Reducing Effect and Safety of SR141716 in Obese Patients With or Without Comorbidities (RIO-Europe)
Brief Summary: The primary objective was to assess the effect of SR141716 on weight loss and weight maintenance over a period of one year when prescribed with a hypocaloric diet in obese patients with or without comorbidities.

The main secondary objectives were to assess the effect of SR141716 on lipid parameters (HDL-C, TG), glucose tolerance status, the rate of patients with metabolic syndrome, waist circumference, glycemic parameters.


Options:
A: Change in Weight (kg) (52 weeks post-randomization); Proportion Maintaining >= 5% Loss of Initial Weight (52 weeks post-randomization)
B: change in body weight from baseline to 1 year.
C: Co-primary Endpoint- Percentage of Participants Achieving Greater Than or Equal to 5% Weight Loss From Baseline to Week 52 (Baseline and Week 52)
D: Change From Baseline in Apnoea-hypopnoea Index (AHI) (Week 0, Week 32)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: The Efficacy of Iron Fortified Whole Maize Flour on the Iron Status of School Children in Kenya
Brief Summary: The purpose of this study is to assess whether NaFeEDTA and electrolytic iron improve iron status of young school children, when added as iron fortificants in whole maize flour.


Options:
A: Haemoglobin; Plasma Ferritin; Plasma Transferrin receptor
B: Hemoglobin (Start of study (T=0), End of study (T=4months))
C: Mean birth weight (9 months)
D: Linear growth velocity (6 to 18 months of age)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: A Randomized, Parallel Group, Double-blind, Multi-center Study Comparing the Efficacy and Safety of AVANDAMET and Metformin After 80 Weeks of Treatment.
Brief Summary: This study will evaluate the longer-term glycemic effect of two medicines approved for initial treatment of type 2 diabetes. The study consists of a 2 week screening period (2 study visits), followed by an 80 week double-blind treatment period (11 study visits). Also, a sub-study was included to look at changes in bone mineral density (BMD) at the lumbar spine.


Options:
A: Change From Baseline in HbA1c at Week 80 (Baseline and Week 80)
B: Change From Baseline in Hemoglobin A1c (A1C) at Week 24, Saxagliptin Plus Metformin Versus Saxagliptin Monotherapy (Baseline, Week 24); Change From Baseline in A1C at Week 24, Saxagliptin Plus Metformin Versus Metformin Monotherapy (Baseline, Week 24)
C: Changes in Insulin secretion rate (Baseline and 96 weeks)
D: Change from baseline in HbA1c at 24 weeks

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: Randomized Trial to Assess the Effects of Iron Supplementation in Heart Failure Patients With Anemia: The IRON-HF Study
Brief Summary: Anemia has been demonstrated to be a common finding in patients with heart failure (HF). Previous studies in hospitalized patients with HF have found a prevalence of anemia ranging from 15% to 63%. More importantly, anemic patients with HF have increased morbidity and mortality. The mechanisms underlying anemia in HF are multifactorial, involving mild to moderate forms of anemia of chronic disease and ferropenic anemia. The clinical impact of iron supplementation in HF patients who have a relatively preserved renal function and either chronic disease anemia, ferropenic anemia or both remains largely unknown. The route of iron administration that could be most clinically effective is also unclear. Thus, the primary aim of the IRON-HF study is to assess the effects of iron supplementation alone (IV or PO) on parameters of functional capacity in HF patients with anemia with decreased availability of iron.


Options:
A: Change in peak VO2 from baseline to week 18
B: The primary endpoint of the IRON-HF study is to assess the impact of iron supplementation alone (IV or PO) on changes in oxygen maximal consumption (peak VO2) assessed by ergospirometry over a 3-month follow-up period.
C: Change in six minute walk test from baseline to week 24 (24 weeks)
D: Incidence of severe adverse drug reactions (ADRs) (Immediate - during infusion)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: Randomized Trial to Assess the Effects of Iron Supplementation in Heart Failure Patients With Anemia: The IRON-HF Study
Brief Summary: Anemia has been demonstrated to be a common finding in patients with heart failure (HF). Previous studies in hospitalized patients with HF have found a prevalence of anemia ranging from 15% to 63%. More importantly, anemic patients with HF have increased morbidity and mortality. The mechanisms underlying anemia in HF are multifactorial, involving mild to moderate forms of anemia of chronic disease and ferropenic anemia. The clinical impact of iron supplementation in HF patients who have a relatively preserved renal function and either chronic disease anemia, ferropenic anemia or both remains largely unknown. The route of iron administration that could be most clinically effective is also unclear. Thus, the primary aim of the IRON-HF study is to assess the effects of iron supplementation alone (IV or PO) on parameters of functional capacity in HF patients with anemia with decreased availability of iron.


Options:
A: Reduce red-cell transfusion packs (60 days after hospital discharge)
B: The primary endpoint of the IRON-HF study is to assess the impact of iron supplementation alone (IV or PO) on changes in oxygen maximal consumption (peak VO2) assessed by ergospirometry over a 3-month follow-up period.
C: Number of Subjects Achieving 'Clinical Success'. Clinical Success is Defined as an Increase in Hemoglobin of ≥ 2.0 g/dL (Any time between baseline and the end of study or time to intervention)
D: Haemoglobin and Hematocrit values (2 years)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: A Randomized, Double-Blind, Placebo Controlled, Parallel Group, Multicenter Study To Evaluate Efficacy and Safety of XP12B for the Treatment of Menorrhagia
Brief Summary: The purpose of this study is to determine whether XP12B is effective and safe in the treatment of women with heavy menstrual bleeding associated with menorrhagia.


Options:
A: The Change in Absolute Value From Baseline Menstrual Blood Loss (MBL) to the End-of-study MBL (Cycle 6) (Baseline and up to 6 months); Percentage of Patients With Successful Treatment (At 6 months)
B: Mean Reduction From Baseline in Menstrual Blood Loss (MBL) (Baseline MBL over 6 menstrual cycles)
C: Amenorrhoea (6 months after the intervention.)
D: Randomized trial: Impact of surgery on bleeding, pain,; fatigue, and major problem (symptom) leading the woman to seek treatment for her condition.; Observational study: changes over time in treatment selected, DUB-related symptoms, and quality of life.

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: A Long-Term Safety and Efficacy Study of Eszopiclone in Elderly Subjects With Primary Chronic Insomnia
Brief Summary: To evaluate the long-term safety and efficacy of eszopiclone administered for 12 weeks in elderly subjects with primary chronic insomnia.Administration of eszopiclone 2 mg daily at bedtime for 12 weeks in elderly subjects with a diagnosis of primary chronic insomnia will be safe and well tolerated, improve subjective sleep measures, improve measures of Quality of Life and next day insomnia symptoms, and have no significant withdrawal central nervous system adverse events or rebound insomnia.


Options:
A: Overall Incidence of Adverse Events (12 Months (from the 1st dose to the end of study))
B: Mean Change From Baseline in Subject-Reported Total Sleep Time (TST) Averaged Over the 12 Week Double Blind Study Period. (Baseline (week 0), Day 1 (post first dose)-12 weeks)
C: Short PTSD Rating Interview (SPRINT) (8 weeks); Pittsburgh Sleep Quality Index (PSQI) (8 weeks)
D: Pittsburgh Sleep Quality Index (PSQI) (8 weeks and 5 months); Insomnia Severity Index (8 weeks and 5 months); Actigraphy (8 weeks)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: A Phase 2 Study to Evaluate Dose and Duration of Treatment of Drotrecogin Alfa (Activated) Using Serial Measurements of Protein C in Patients With Severe Sepsis and Multiple Organ Dysfunction
Brief Summary: In this trial, patients with severe sepsis and low protein C levels will receive drotrecogin alfa (activated) at the normal, approved dose and time of administration \[24 microgram/kilogram/hour (mcg/kg/hour) for 96 hours\] or will receive the normal, approved dose or higher doses than the approved dose for a longer administration time. After the drug administration is complete, the protein C levels from the patients receiving the normal, approved dose will be compared to protein C levels from patients receiving the normal, approved dose or higher dose for a longer duration to determine if the protein C levels improve faster if given higher dose and/or longer administration time.

Note: The protocol was amended to remove the option of shorter infusion durations.


Options:
A: 28-Day All-Cause Mortality (Day 28)
B: 90-day mortality (90 day)
C: Mean Change in Protein C Levels From Day 1 to Day 7 (Day 1, Day 7)
D: That drotrecogin alfa (activated) compared with placebo reduces severe-sepsis-induced organ dysfunction (3 Years)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: Vaginal Cleansing at Cesarean Delivery to Reduce Infection: A Randomized, Controlled Trial
Brief Summary: The objective of the project is to find out whether cleansing the vagina before a cesarean delivery decreases the risk of complications and infections after having the baby. If this is the case, cleansing the vagina before cesarean delivery can help improve outcomes for many women and make their early postpartum recovery much more pleasant, giving a healthier start for the family.


Options:
A: Number of cases of endometritis after cesarean section (15 days)
B: Cesarean Surgical Site Infection (42 days after delivery)
C: Number of Participants Who Experienced Composite Endometritis Plus Wound Complications. (1 month)
D: Number of Subjects with post cesarean endometritis (48 hours)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: Calcium Supplementation for a Healthy Weight- LITE
Brief Summary: The purpose of the study is to find out if taking calcium and vitamin D supplements, while following a low-calorie diet, can help people lose weight.


Options:
A: The primary outcome measure is change in 25OHD with various D2 and D3 dosing regimens. (12 months)
B: C peptide
C: Chang in Disposition Index, a Measure of Beta Cell Function (baseline and 4 months)
D: Change in body weight (Baseline and at 16 weeks)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: A Randomized, Investigator-Blinded, Multicenter, Parallel-Group Study to Compare Efficacy, Safety and Tolerability of Arthemeter/ Lumefantrine Dispersible Tablet Formulation vs. Artemether/ Lumefantrine 6-Dose Crushed Tablet in the Treatment of Acute Uncomplicated Plasmodium Falciparum Malaria in Infants and Children.
Brief Summary: This study will evaluate the safety and efficacy of artemether-lumefantrine against uncomplicated malaria caused P. falciparum in children of 5-35 kg bodyweight.


Options:
A: Percentage of Participants With PCR-Corrected ACPR on Day 28 (Day 28)
B: Proportion of patients free of parasites at day 28.
C: PCR-corrected adequate clinical and parasitological response (ACPR) (day 28 after initial dose)
D: Adherence (Day 4)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: N/A
Brief Summary: This open-label, randomized study will compare the efficacy, safety, and acceptability of mifepristone 200 mg followed in 24-36 hours either by buccal (i.e., in the cheeks) or oral misoprostol 800 mcg for termination of pregnancy in women up to 63 days L.M.P.


Options:
A: Efficacy defined as complete abortion without recourse to surgical abortion. (2 weeks)
B: Complete evacuation (six weeks after initial treatment)
C: efficacy
D: Efficacy (At 10-14 days follow up)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: A Multicenter, Double-Blind Placebo-Controlled Crossover Study to Investigate the Effects of an Inhaled Corticosteroid on Cardiopulmonary Exercise Parameters in Patients With Chronic Obstructive Pulmonary Disease
Brief Summary: To test the effect of the research study drug, inhaled fluticasone on lung function in exercising patients with Chronic Obstructive Pulmonary Disease (COPD).


Options:
A: Forced Expiratory Volume in 1 Second (FEV1; L) 60 Minutes Post-dose (from baseline up to 12 weeks)
B: Standardized Dyspnea Score at Isotime During Exercise (2 Weeks)
C: The primary efficacy endpoint is defined as area under the curve of change in FEV1 from baseline for the time period from pre-dose to 2 hours post dose (AUC0 2hFEV1) after 12 weeks of randomised treatment. (week 12)
D: Pre-dose Forced Expiratory Volume in One Second (FEV1) (Before randomization, 0, 4, 8 and 12 weeks after randomization)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: A Multicenter, Double-Blind Placebo-Controlled Crossover Study to Investigate the Effects of an Inhaled Corticosteroid on Cardiopulmonary Exercise Parameters in Patients With Chronic Obstructive Pulmonary Disease
Brief Summary: To test the effect of the research study drug, inhaled fluticasone on lung function in exercising patients with Chronic Obstructive Pulmonary Disease (COPD).


Options:
A: Pre-dose and 1-hour post-dose FEV1 over the 6 months treatment period
B: Mean Area Under the Time Curve From 0 to 12 Hours (AUC(0-12 Hours)) of Change From Baseline to Week 13 in Forced Expiratory Volume (Liters) in 1 Second (FEV1) (Baseline to Endpoint (13 weeks)); Mean Change From Baseline to Week 13 Endpoint in AM Predose FEV1 (Baseline to Endpoint (13 weeks))
C: Standardized Dyspnea Score at Isotime During Exercise (2 Weeks)
D: Mean Area Under the Time Curve From 0 to 12 Hours (AUC(0-12 Hours)) of Change From Baseline to Week 13 in Forced Expiratory Volume (Liters) in 1 Second (FEV1) (Baseline to Endpoint (13 weeks)); Mean Change From Baseline to Week 13 Endpoint in AM Predose FEV1 (Baseline to Endpoint (13 weeks))

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: A Multicenter, Double-Blind Placebo-Controlled Crossover Study to Investigate the Effects of an Inhaled Corticosteroid on Cardiopulmonary Exercise Parameters in Patients With Chronic Obstructive Pulmonary Disease
Brief Summary: To test the effect of the research study drug, inhaled fluticasone on lung function in exercising patients with Chronic Obstructive Pulmonary Disease (COPD).


Options:
A: Change in serum C-reactive protein levels over 3 months between treatment groups.
B: Rate of healthcare utilisation based exacerbations of COPD
C: Inflammation: localisation, numbers and profile of neutrophils, eosinophils, macrophages, and CD8+T cells in bronchial biopsy specimens after 6 months and 2.5 years treatment.
D: Standardized Dyspnea Score at Isotime During Exercise (2 Weeks)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: Efficacy {FEV1, COPD Exacerbations & HRQoL} & Safety of 5mcg Tiotropium Respimat in COPD
Brief Summary: The objective of the study is to evaluate the long-term (one year) efficacy and safety of tiotropium delivered by the Respimat inhaler in patients with COPD. Specifically, the study will examine the effect of treatment on COPD exacerbations.


Options:
A: Rate of moderate/severe exacerbations over a 52 week treatment period.
B: Change From Baseline in Trough Forced Expiratory Volume in 1 Second (FEV1) at Day 337 (Baseline and Day 337); Time to First Chronic Obstructive Pulmonary Disease (COPD) Exacerbation (During actual study treatment period (planned Day 1 to Day 337))
C: Change from baseline in trough FEV1 (Forced expiratory volume in one second) (after 12 weeks); Change from baseline in FEV1 2 hours post inhalation (after 12 weeks)
D: First Occurrence of (Moderate or Severe) COPD Exacerbation (52 weeks)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: Efficacy {FEV1, COPD Exacerbations & HRQoL} & Safety of 5mcg Tiotropium Respimat in COPD
Brief Summary: The objective of the study is to evaluate the long-term (one year) efficacy and safety of tiotropium delivered by the Respimat inhaler in patients with COPD. Specifically, the study will examine the effect of treatment on COPD exacerbations.


Options:
A: Trough FEV1 response (after 12 weeks)
B: Change From Baseline in Trough Forced Expiratory Volume in 1 Second (FEV1) at Day 337 (Baseline and Day 337); Time to First Chronic Obstructive Pulmonary Disease (COPD) Exacerbation (During actual study treatment period (planned Day 1 to Day 337))
C: The primary efficacy endpoint is defined as area under the curve of change in FEV1 from baseline for the time period from pre-dose to 2 hours post dose (AUC0 2hFEV1) after 12 weeks of randomised treatment. (week 12)
D: morning peak expiratory flow rate (PEFR) (50 weeks)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: A Randomized, Double-blind, Placebo Controlled, Multicentre, Phase II Study of Oral Lapatinib in Combination With Concurrent Radiotherapy and Cisplatin Versus Radiotherapy and Cisplatin Alone, in Subjects With Stage III, IVA, B Squamous Cell Carcinoma of the Head and Neck (SCCHN)
Brief Summary: This is a phase II study comparing the effects of lapatinib versus placebo when administered concurrently with cisplatin and radiotherapy followed by 1 year monotherapy with lapatinib or placebo. The study is designed to evaluate and compare the two treatment groups with respect to complete response rate at 6 months following chemoradiation completion.


Options:
A: Disease Free Survival (DFS) (Up to 5 years)
B: Local Regional Control Rate at 2 Years (2 years)
C: Overall Response Rate (ORR) (Up to 36 months); Response to Treatment (Up to 36 months)
D: Number of Participants (Par.) With Complete Response (CR), as Assessed by Independent Radiological Review (From the date of randomization until 6 months post chemoradiation treatment, assessed for a median time of 13 months)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: Swiss Interventional Study on Silent Ischemia (SWISSI 2)
Brief Summary: Silent ischemia has been shown to negatively affect prognosis in patients after myocardial infarction. However, long-term outcome data in totally asymptomatic patients is missing and it is unknown whether angioplasty in addition to secondary preventive measures is superior to antiischemic drug therapy in these patients. Therefore, the SWISSI 2 study was started 15 years ago with the aim of comparing the effects of angioplasty with medical therapy on long-term outcome in patients with recent myocardial infarction and silent ischemia.


Options:
A: Impact of personalized risk information (baseline); Impact of personalized risk information (3 month)
B: Combination of cardiac death, non-fatal myocardial infarction, and symptom-driven revascularization
C: proportion of participants who reported using any tobacco dependence treatment during the 3-month study period (3 months)
D: Medication adherence; Exacerbation of heart failure; Health-related quality of life

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: A Randomized Clinical Trial Comparing Laparoscopic and Open Surgery for Colon Cancer
Brief Summary: COLOR trial is a randomized, international, multi center study comparing the outcomes of laparoscopic and conventional resection of colon carcinoma with curative intent. Clinical and operative data will be collected centrally in the coordinating centre in Rotterdam, The Netherlands. Quality of life and costs will be assessed on a national basis.


Options:
A: Disease free survival (3 years)
B: Lymph nodes isolated, circumferential margin involved, rate of complications and length of stay (1 month)
C: Primary endpoint is cancer free survival at three years.
D: locoregional recurrence rate (3 years post operatively)

Answer: C