TrialPanorama/Dataset huggingface dataset:
Please select the outcome measures that correspond to the clinical trial below.
Title: Stroke With Transfusions Changing to Hydroxyurea
Brief Summary: The purpose of this study is to compare standard therapy (transfusions and chelation) with alternative therapy (hydroxyurea and phlebotomy) for the prevention of secondary stroke and management of iron overload in children with sickle cell anemia (SCA).


Options:
A: Treatment Differences of the Change in Qualitative Splenic Function From Baseline (Before initiation of treatment and at 2 years)
B: Occurrence of an Adjudicated Secondary Stroke During the 30-month Treatment Period (Because the study was terminated early, time frame is from beginning of treatment until end of treatment (up to 30 Months)); Liver Iron Content (LIC) Change-from-baseline (Because the study was terminated early, time frame is from beginning of treatment until end of treatment (up to 30 Months))
C: Conversion to Abnormal Maximum TAMV (30 months)
D: Distribution of the Density of Hemoglobin SC Red Cells (measured 2 months after initiation of treatment)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: Stroke With Transfusions Changing to Hydroxyurea
Brief Summary: The purpose of this study is to compare standard therapy (transfusions and chelation) with alternative therapy (hydroxyurea and phlebotomy) for the prevention of secondary stroke and management of iron overload in children with sickle cell anemia (SCA).


Options:
A: N/A
B: Recurrence of an Infarct, Defined as a Stroke or a New or Enlarged Silent Cerebral Infarct (From study entry to study exit)
C: Difference in TCD Time-averaged Mean Velocity (TAMV) on the Index Side (Since the study was terminated early, time frame is from beginning of treatment until end of treatment (up to 24 Months).)
D: Occurrence of an Adjudicated Secondary Stroke During the 30-month Treatment Period (Because the study was terminated early, time frame is from beginning of treatment until end of treatment (up to 30 Months)); Liver Iron Content (LIC) Change-from-baseline (Because the study was terminated early, time frame is from beginning of treatment until end of treatment (up to 30 Months))

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: Stroke With Transfusions Changing to Hydroxyurea
Brief Summary: The purpose of this study is to compare standard therapy (transfusions and chelation) with alternative therapy (hydroxyurea and phlebotomy) for the prevention of secondary stroke and management of iron overload in children with sickle cell anemia (SCA).


Options:
A: Occurrence of an Adjudicated Secondary Stroke During the 30-month Treatment Period (Because the study was terminated early, time frame is from beginning of treatment until end of treatment (up to 30 Months)); Liver Iron Content (LIC) Change-from-baseline (Because the study was terminated early, time frame is from beginning of treatment until end of treatment (up to 30 Months))
B: Difference in TCD Time-averaged Mean Velocity (TAMV) on the Index Side (Since the study was terminated early, time frame is from beginning of treatment until end of treatment (up to 24 Months).)
C: Distribution of the Density of Hemoglobin SC Red Cells (measured 2 months after initiation of treatment)
D: Number of Malaria Episodes (12 months)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: Patient-Physician Partnership to Improve High Blood Pressure Adherence
Brief Summary: To test the efficacy of a patient-centered, culturally tailored education and activation intervention designed to improve adherence to medication and life style recommendations among adults with uncontrolled hypertension.


Options:
A: Rate of LDL cholesterol control (< 100 mg/dL) (12 months); Rate of blood pressure control (< 130/80 mmHg) (12 months); Rate of HbA1c control (<7%) (12 months)
B: Health of Nations Outcome Scale (HONOS) (Baseline, 6 months, 12 months, 18 months,)
C: completion of colorectal cancer screening (1 year)
D: Patient adherence (12 months)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: Take Control of Your Blood Pressure (TCYB)
Brief Summary: The purpose of this study is to improve adherence to blood pressure (BP) monitoring and medication compliance in individuals with high BP.


Options:
A: BP measurement (Measured at 6 months)
B: Compare efficacy of 3-component model telemedicine intervention to standard care in terms of depression and pain at baseline and 1, 3, 6, and 12 months
C: Changes in Diabetes Self-management Behaviors as Measured by Summary of Diabetes Self-Care Activities (SDSCA) Scale (Baseline and 1 year); Changes in Minutes of Moderate Physical Activity (Baseline and 1 year); Changes in Minutes of Vigorous Exercise (Baseline and 1 year)
D: To assess the numbers of patients who receive thrombolytics and the time to treatment in patients evaluated by telemedicine (90 days)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: Oral Health and Ventilator-associated Pneumonia
Brief Summary: Recent studies have found that poor oral hygiene may foster the colonization of the oropharynx by potential respiratory pathogens in mechanically-ventilated (MV), intensive care unit (ICU) patients. Thus, improvements in oral hygiene in MV-ICU patients may prevent ventilator-associated pneumonia (VAP).

The specific aims of this investigation are: 1) to organize the necessary infrastructure to develop and perform a pilot clinical trial to evaluate alternative oral hygiene procedures to prevent VAP; 2) to use this organization to perform a pilot clinical trial to determine if the use of oral topical chlorhexidine gluconate (CHX) will prevent dental plaque, oropharyngeal colonization by respiratory pathogens, and VAP in MV-ICU patients.


Options:
A: Nosocomial Infection
B: Colonization of the Oral Cavity by Respiratory Pathogens (on Teeth/Denture/Buccal Mucosa) as Determined by Quantitative Cultures Expressed as Colony Forming Units (Cfu) Per ml (CFU/mL) of the Aerobic Cultivable Flora After 48 Hours (Every 48 hours until discharge)
C: Intensive Care Unit (ICU) Mortality (14 months)
D: Ventilator associated pneumonia (48 hours after tracheal intubation)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: Oral Health and Ventilator-associated Pneumonia
Brief Summary: Recent studies have found that poor oral hygiene may foster the colonization of the oropharynx by potential respiratory pathogens in mechanically-ventilated (MV), intensive care unit (ICU) patients. Thus, improvements in oral hygiene in MV-ICU patients may prevent ventilator-associated pneumonia (VAP).

The specific aims of this investigation are: 1) to organize the necessary infrastructure to develop and perform a pilot clinical trial to evaluate alternative oral hygiene procedures to prevent VAP; 2) to use this organization to perform a pilot clinical trial to determine if the use of oral topical chlorhexidine gluconate (CHX) will prevent dental plaque, oropharyngeal colonization by respiratory pathogens, and VAP in MV-ICU patients.


Options:
A: Prevention of ventilator-associated pneumonia (60 days)
B: Colonization of the Oral Cavity by Respiratory Pathogens (on Teeth/Denture/Buccal Mucosa) as Determined by Quantitative Cultures Expressed as Colony Forming Units (Cfu) Per ml (CFU/mL) of the Aerobic Cultivable Flora After 48 Hours (Every 48 hours until discharge)
C: N/A
D: Development of Ventilator Acquired Pneumonia (During the period of intubation)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: Randomised Placebo-Controlled Trial of Modafinil for Methamphetamine Dependence
Brief Summary: The study aims to evaluate the safety and efficacy of modafinil (200 mg/day) over 10 weeks plus a tailored cognitive behavioural therapy program in the treatment of methamphetamine dependence.


Options:
A: Urinalysis results negative for methamphetamine over 10 weeks (10 weeks); Adverse events (10 weeks); Compliance (10 weeks); Retention (10 weeks)
B: Proportion of Cocaine Positive Urine Tests Per Week (Weekly Measures over 12 weeks)
C: Last Three Weeks of Cocaine Abstinence Based on Urine Toxicology Results and Self Reported Use (weekly for 14 weeks of trial or for length of participation); ADHD Symptoms Based on ADHD Rating Scale (measured once per week for 14 weeks or length of study participation)
D: Stimulant-free Weeks Assessed by Self-report and Twice-weekly Urine Drug Screens (Week 16)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: Randomised Placebo-Controlled Trial of Modafinil for Cocaine Dependence
Brief Summary: The study aims to evaluate the safety and efficacy of modafinil (200 mg/day) over 10 weeks plus a tailored cognitive behavioural therapy program in the treatment of cocaine dependence.


Options:
A: Proportion of Cocaine Positive Urine Tests Per Week (Weekly Measures over 12 weeks)
B: Urinalysis results negative for methamphetamine over 10 weeks (10 weeks); Adverse events (10 weeks); Compliance (10 weeks); Retention (10 weeks)
C: Stimulant-free Weeks Assessed by Self-report and Twice-weekly Urine Drug Screens (Week 16)
D: Urinalysis negative for cocaine over 10 weeks (10 weeks); Adverse events (10 weeks); Compliance (10 weeks); Retention (10 weeks)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: A Pilot Study of the Treatment of Eosinophilic Esophagitis With Omalizumab
Brief Summary: Eosinophilic esophagitis (EE) is an increasingly recognized condition characterized by dysphagia, food impaction or other obstructive esophageal symptoms in children and young adults.

The pathophysiology of EE appears to be an allergy/atopy mediated disease. A personal and family history of allergic diseases (food allergies, atopic dermatitis, asthma, allergic rhinitis or conjunctivitis) has been noted in 62-85% of patients with EE. The rising incidence of EE may be related to the worldwide allergy and asthma epidemic.

Current treatment of EE is directed at decreasing esophageal allergic inflammation. Oral and topical corticosteroids, cromolyn sodium, montelukast and elemental/elimination diets have all been shown to be effective. However, none of these treatments are directed at the specific pathophysiologic mechanism of EE and some have significant side effects.

The shared pathogenetic mechanisms of EE and asthma suggest that therapeutic strategies directed at asthma may also be effective for EE. Specifically those targeted at the allergic immune mechanisms involved with asthma may be effective. Omalizumab is a recently developed anti-IgE antibody that has been shown to decrease the use of inhaled and oral corticosteroids, reduce the frequency of asthma exacerbations, and improve asthma related symptoms in patients with allergic asthma. The objective of the study is to determine the efficacy of omalizumab in the treatment of eosinophilic esophagitis


Options:
A: Mean Eosinophil Count (Week 16)
B: Number of Participants With Improvement of Espohageal Eosinophilia (3 Months)
C: Change in Eosinophil Numbers Per High Power Field Proximally and Distally Between Baseline and Post-treatment and Between Both Groups (16 weeks)
D: Peak Esophageal Eosinophil Count (2 months)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: Comparison of Esomeprazole to Aerosolized, Swallowed Fluticasone for Eosinophilic Esophagitis
Brief Summary: Eosinophilic esophagitis (EE) is a recently recognized entity. It has been thought to be related to both allergies and acid reflux. There have been reports that both swallowed, aerosolized steroids and proton pump inhibitors have been effective treatments. The researchers propose to directly compare the efficacy of aerosolized fluticasone to esomeprazole in the treatment of eosinophilic esophagitis. The hypothesis is that aerosolized fluticasone (Flovent) will be more effective in relieving symptoms of EE than esomeprazole (Nexium) treatment. Patients will undergo endoscopy, pH monitoring and manometry for diagnosis. Following diagnosis of EE by pathology (biopsy of esophagus), patients will be randomized to esomeprazole or swallowed fluticasone for 8 weeks. At the end of 8 weeks, subjects will be asked to repeat upper endoscopy with biopsies. Three questionnaires (dysphagia, gastroesophageal reflux disease \[GERD\], and allergy) will be completed by the patient at the first endoscopy and at the end endoscopy. The primary objective is to measure change in eosinophil infiltration of the esophagus in response to treatment of allergy (swallowed fluticasone) versus treatment for reflux (esomeprazole) in EE patients.


Options:
A: Absolute Change From Baseline in Straumann Dysphagia Instrument (SDI) Patient Reported Outcome (PRO) Total Score at Week 10 (Baseline, Week 10)
B: Change in Eosinophil Numbers Per High Power Field Proximally and Distally Between Baseline and Post-treatment and Between Both Groups (16 weeks)
C: Percentage of Subjects With ≤6 Peak Eosinophils/High-power Field (HPF) (Week 12)
D: To measure change in eosinophil infiltration and degranulation at 8 weeks in response to treatment of allergy versus treatment for GER in EE patients (8 weeks)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: Telephone Care Coordination to Improve Smoking Cessation Counseling
Brief Summary: TeleQuit is a group randomized trial testing whether a telephone care coordination program increases the rate of smoking cessation treatment for VA patients at study sites. We are testing whether proactive care coordination (counselor initiates the call to the patient) is more effective than reactive coordination (coordinator waits for the patient to call); and whether multi-session counseling is more effective than brief primary care-based counseling plus self-help materials. We randomly assigned study sites to either quitline counseling or brief counseling only. All patients receive brief smoking cessation counseling from their primary care physician, smoking cessation medications (once they are in contact with the VA care coordinator), and a follow-up call at 6 months. Care coordination will be provided by VA clinical staff. Intensive counseling is provided by the California Smokers' Helpline.


Options:
A: Completion of one quitline counseling session (Three months postoepratively)
B: 7-day Point Prevalence Abstinence From Smoking (6 month)
C: 7-day point prevalence of smoking six months following completion of the intervention protocol (nine months post randomization). (2 years)
D: Blood Pressure, Health-Related Quality of Life(Medical outcome Study Short Form-36) (Baseling, 12month, 24month)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: Tai Chi or Hydrotherapy for People With Osteoarthritis of the Hip(s) or Knee(s)
Brief Summary: The aim of this study is to determine, in the framework of a randomized controlled clinical trial, whether Tai Chi can affect measurable improvements in self-reported outcomes such as pain, physical function and psychological well-being in people with osteoarthritis (OA) mainly affecting the hips or knees. The effectiveness of Tai Chi will be compared with both a non-intervention control group as well as with a formal exercise program, hydrotherapy. Hydrotherapy has long been considered an effective intervention for people with chronic OA although scientific evidence is weak at present. The main study hypotheses are that Tai Chi or hydrotherapy can significantly decrease pain and physical limitations; improve health-related quality of life; and promote psychological well being in patients with OA of the hip(s) or knee(s); and that Tai Chi and hydrotherapy are of equal efficacy.


Options:
A: Pain (week 0, 13, 39 and 65); Physical function (week 0, 13, 39 and 65); Patient global assessment (week 13, 39 and 65)
B: Self-reported pain and function (WOMAC)
C: Absolute Value of OA Symptoms at 8 Weeks (8 weeks); Absolute Value of OA Pain at 8 Weeks (8 weeks)
D: Change in the Western Ontario and McMaster University Index (WOMAC) Pain Subscale Between Baseline and 12 Weeks (between baseline and 12 weeks.)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: Treatment of Persistent Urinary Incontinence in Children
Brief Summary: The purpose of this study is to determine whether surgical section of the filum terminale in children, when added to standard medical therapy, will result in a reliable and clinically-significant improvement in two main markers of incontinence within/at 12 months after treatment.


Options:
A: Quality of life, as measured by a validated enuresis-specific quality of life scale
B: Clinical effects evaluated by home registrations of degree of incontinence, VAS score of degree of urgency and frequency volume charts at specified intervals. Acute effect evaluated by urodynamics.
C: voiding frequency (before therapy and at end of therapy)
D: Change From Baseline to End of Treatment (EoT) in Mean Volume Voided (MVV) Per Micturition (Baseline and Week 12)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: Asthma in a Decentralized Patient Population: Is Traditional Disease Management Enough? A Randomized, Controlled Trial Comparing Traditional Care to Two Systems of Disease Management for a Decentralized Population of Patients in South Texas
Brief Summary: This is a health services demonstration project that evaluates three methods of health care delivery for the management of individuals with symptoms of asthma. This study will evaluate the impact of a telephonic asthma disease management process, with and without a home intervention program, on preventing asthma-related morbidity through patient/family asthma education.

The investigators' central thesis is that comprehensive clinical disease management protocols for the management of asthma will improve clinical outcomes; reduce fiscal resource consumption; and improve both patient satisfaction and patient quality of life. Additionally, individualized, in-home patient education and environmental assessment, when added to the telephonic protocol, will further improve these measures. However, incremental improvement will vary according to the population's access to care.


Options:
A: N/A
B: Asthma Quality of Life Questionnaire (Baseline, 6 weeks, 3 months, 6 months)
C: N/A
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: D
Please select the outcome measures that correspond to the clinical trial below.
Title: Asthma in a Decentralized Patient Population: Is Traditional Disease Management Enough? A Randomized, Controlled Trial Comparing Traditional Care to Two Systems of Disease Management for a Decentralized Population of Patients in South Texas
Brief Summary: This is a health services demonstration project that evaluates three methods of health care delivery for the management of individuals with symptoms of asthma. This study will evaluate the impact of a telephonic asthma disease management process, with and without a home intervention program, on preventing asthma-related morbidity through patient/family asthma education.

The investigators' central thesis is that comprehensive clinical disease management protocols for the management of asthma will improve clinical outcomes; reduce fiscal resource consumption; and improve both patient satisfaction and patient quality of life. Additionally, individualized, in-home patient education and environmental assessment, when added to the telephonic protocol, will further improve these measures. However, incremental improvement will vary according to the population's access to care.


Options:
A: Follow-up with a Primary Care Physician (PCP) (4 weeks, 3 months and 6 months after Emergency Department visit)
B: Reduce the cost of asthma health care. (18 Months)
C: 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
D: N/A

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: Asthma in a Decentralized Patient Population: Is Traditional Disease Management Enough? A Randomized, Controlled Trial Comparing Traditional Care to Two Systems of Disease Management for a Decentralized Population of Patients in South Texas
Brief Summary: This is a health services demonstration project that evaluates three methods of health care delivery for the management of individuals with symptoms of asthma. This study will evaluate the impact of a telephonic asthma disease management process, with and without a home intervention program, on preventing asthma-related morbidity through patient/family asthma education.

The investigators' central thesis is that comprehensive clinical disease management protocols for the management of asthma will improve clinical outcomes; reduce fiscal resource consumption; and improve both patient satisfaction and patient quality of life. Additionally, individualized, in-home patient education and environmental assessment, when added to the telephonic protocol, will further improve these measures. However, incremental improvement will vary according to the population's access to care.


Options:
A: Asthma Control (8 weeks (from Week 0 to Week 8))
B: 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
C: The primary efficacy variable is the number of responders with a very good asthma symptom control defined as requiring no rapid acting beta agonist (RABA) between the 2. and 6th week of intervention (end of trial)
D: The Number of Participants With a Differential Response to the Three Step-up Therapies Based on Fixed Threshold Criteria for the Following Three Asthma Control Measures: Use of Oral Prednisone for Acute Asthma Exacerbations, Asthma Control Days and FEV1. (Measured during the last 12 weeks of each 16-week treatment period)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: Ultrafiltration Versus IV Diuretics for Patients Hospitalized for Acute Decompensated Heart Failure: A Prospective Randomized Clinical Trial
Brief Summary: The purpose of this study is to compare patients who are suffering from heart failure and who are fluid overloaded to determine if ultrafiltration (UF) can remove more of the extra fluid as measured by weight loss while in the hospital and improve the patient's breathing.


Options:
A: Evaluate the number and percentage of eligible patients who are discharged on optimal therapy. Evaluate all HF indicators recommended by JCAHO and CMS.
B: Percentage of Participants With Confirmed Cardiovascular (CV) Death Through Day 180 (180 days); Percentage of Participants With Worsening of Heart Failure (WHF) Through Day 5 (Day 5)
C: Heart Failure (HF) Event (in 90 days after discharge); Cardiovascular Death up to 90 Days After Randomization. (in 90 days after discharge)
D: Total weight loss during first 48 hours of randomization; Change in dyspnea score during first 48 hours of randomization

Answer: D