TrialPanorama/Dataset huggingface dataset:
Please select the outcome measures that correspond to the clinical trial below.
Title: Randomized Controlled Trial for Health Promotion/ Obesity Prevention Targeting Low-income, Urban, African-American Adolescents
Brief Summary: The purpose of Challenge! is to determine if adolescents enrolled in a health promotion/ obesity prevention program will have a healthier BMI-for-age z-score and body composition (body fat %), will consume a healthier diet, and engage in higher levels of physical activity compared to those that did not receive the intervention over time.


Options:
A: Change in Stress (3 months); Change in Stress (1 month)
B: standardized body mass index (zbmi)
C: BMI-for-age z-score and percentiles (measured weight and height, self-reported gender and date of birth)and Body composition (Dual Energy X-ray Absorptiometry, and Bioelectrical Impedance Analysis) (2 years)
D: Total daily physical activity (Change between baseline and post-intervention (12 weeks) and 4-months post-intervention)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: Phase 3, Placebo Controlled, Randomized, Double-blinded, Nonsteroidal Antiinflammatory Drug add-on Clinical Trial of Mono-phase Low Dose Oral Contraceptive Pill for Treatment of Primary Dysmenorrhea.
Brief Summary: The purpose of this study is to determine whether combination oral contraceptive pill of norethindrone and ethinyl estradiol is effective in the treatment of primary dysmenorrhea.


Options:
A: Change in Visual Analog Scale (VAS) Score (Baseline and 6 months)
B: Doppler indices of uterine artery blood flows. (up to 10 minutes)
C: Number of In-treatment Pregnancies (With +2 Day Window) Per 100 Woman Years of Exposure (Pearl Index) (1 year (13 cycles)); Number of In-treatment Pregnancies (With +14 Day Window) Per 100 Woman Years of Exposure (Pearl Index) (1 year (13 cycles))
D: Patient Response to Treatment for Primary Dysmenorrhea, as Evaluated by Difference of Total Dysmenorrhea Score (Baseline/Pretreatment-End of Treatment) (16weeks)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: A Phase I, Open-Label, Randomized, Four Period Crossover Drug Interaction Study to Evaluate the Pharmacokinetic Profiles of VYVANSE™ and ADDERALL XR When Each is Administered Alone and in Combination With the Proton Pump Inhibitor Prilosec OTC™ in Healthy Adult Volunteers
Brief Summary: The purpose of this study is to determine if taking Vyvanse with Prilosec OTC or Adderall XR with Prilosec OTC changes how quickly the drug is absorbed into the body and/or changes how much of the drug is absorbed into the body.


Options:
A: Change from baseline in the sum of the inattention and hyperactivity/impulsivity subscale scores of the investigator-rated Conners' Adult ADHD Rating Scale at the end of the double-blind phase (5 weeks) compared with placebo.
B: Maximum Plasma Concentration (Cmax) of d-Amphetamine for Vyvanse and Adderall XR Alone and in Combination With Prilosec OTC (0 through 96 hours after dosing); Time of Maximum Plasma Concentration (Tmax) of d-Amphetamine for Vyvanse and Adderall XR Alone and in Combination With Prilosec OTC (0 through 96 hours after dosing); Area Under the Steady-state Plasma Concentration-time Curve (AUC) of d-Amphetamine for Vyvanse and Adderall XR Alone and in Combination With Prilosec OTC (0 through 96 hours after dosing); Terminal Half-life (T 1/2) of d-Amphetamine for Vyvanse and Adderall XR Alone and in Combination With Prilosec OTC (0 through 96 hours after dosing); Cmax of l-Amphetamine for Adderall XR Alone and in Combination With Prilosec OTC (0 through 96 hours after dosing); Tmax of l-Amphetamine for Adderall XR Alone and in Combination With Prilosec OTC (0 through 96 hours after dosing); AUC of l-Amphetamine for Adderall XR Alone and in Combination With Prilosec OTC (0 through 96 hours after dosing); T 1/2 of l-Amphetamine for Adderall XR Alone and in Combination With Prilosec OTC (0 through 96 hours after dosing); Cmax of Total Amphetamine for Adderall XR Alone and in Combination With Prilosec OTC (0 through 96 hours after dosing); Tmax of Total Amphetamine for Adderall XR Alone and in Combination With Prilosec OTC (0 through 96 hours after dosing); AUC of Total Amphetamine for Adderall XR Alone and in Combination With Prilosec OTC (0 through 96 hours after dosing); T 1/2 of Total Amphetamine for Adderall XR Alone and in Combination With Prilosec OTC (0 through 96 hours after dosing)
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: Dyadic Parent-Child Interaction Coding System (DPICS) - Behavior Counts (study endpoint- end of period II (between subjects trial)); Dyadic Parent-Child Interaction Coding System (DPICS) - Behavior Percentages (study endpoint- end of period II (between subjects trial))

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: Structured Contraceptive Counseling--A Randomized Controlled Trial
Brief Summary: In the United States, highly effective methods of birth control are often not used. Healthcare providers use birth control counseling and patient education as ways to increase the usage of birth control. However, little evidence exists to show that patient education and birth control counseling changes birth control use.

We want to evaluate the effectiveness of using a uniform set of birth control information to provide birth control education to women having an early pregnancy termination. The counselors will allow the clients to both read as well as hear the information. We propose to evaluate whether this counseling will lead to 1) more women choosing highly effective nonpermanent birth control methods and 2) more women continuing to use these methods for a longer time.

Women in the study will complete a questionaire about their health. Half of them will have the structured counseling and half will have the routine counseling currently offered to women as a part of their routine care. We will contact all study participants with a telephone call three months and six months later to have a 10 minute conversation about what birth control they are using.


Options:
A: Measurement of contraceptive adherence (12 months); Measurement of dual method use (12 months); Measurement of pregnancy rates and sexually transmitted diseases (STDs) (12 months)
B: Drinks per drinking day (6 months); Rate of effective contraception (6 months)
C: Choice of contraceptive method on day of enrollment. (Day of enrollment)
D: Contraceptive use at time of last sexual intercourse (18 months)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: A Prospective Single Blind Controlled Study to Assess the Efficacy of a Lung Protective Ventilation Strategy in the Prevention of Reperfusion Lung Injury Following PTE
Brief Summary: Chronic thromboembolic pulmonary hypertension (CTEPH) is caused by unresolved thromboemboli in the pulmonary arteries, which lead to pulmonary hypertension and, left untreated, right heart failure. This disease can be potentially cured by performing a pulmonary thromboendarterectomy (PTE) to remove the blood clots. The surgery is not without risk and the most worrisome complication is the development of a form of acute lung injury called reperfusion lung injury, which occurs in about 40 percent of patients.

The landmark publication of the ARDSNET study demonstrated that a low tidal volume strategy of mechanical ventilation, decreased morbidity and mortality in patients who had acute respiratory distress syndrome (ARDS). Since then there have been some studies examining the role of a low tidal volume strategy in all patients who are mechanically ventilated. Some studies have demonstrated a decreased incidence of acute lung injury while others have failed to do the same. In patients at high risk for developing acute lung injury, such as patients undergoing PTE, there may be a benefit to using low tidal volumes to reduce the incidence of reperfusion lung injury.

To assess the efficacy of a low tidal volume ventilation strategy in patients undergoing PTE, 134 patients will be randomized at the time of surgery to either low tidal volumes (6ml/kg of ideal body weight), or standard tidal volumes (10ml/kg of ideal body weight). Patients will be followed clinically to assess for the development of reperfusion lung injury. This will be defined as the development of hypoxemia (PaO2/FiO2 ratio less than 300) and chest infiltrates in the area of reperfused lung with no other identifiable etiology within the first 72 hours of surgery. Patients will also be assessed for other factors known to contribute to acute lung injury including: plateau pressures, peak inspiratory pressures, fluid balance, and number of transfusions received. Secondary endpoints of the study will be: time to successful spontaneous breathing trial, ventilator free days, ICU free days, hospital free days, and mortality.


Options:
A: Surgical wound infection (30 days)
B: Incidence of Reperfusion Lung Injury (72 Hours)
C: Reduction of lung and systemic postoperative complications (Up to 7 postoperative days)
D: Lung cytokines in mechanically ventilated patients (30 months)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: Can Simple and Inexpensive Techniques Enhance Patient Comfort in Sedation Risk-free Screening and Surveillance Colonoscopy?
Brief Summary: This research study compares two methods of performing colonoscopy without sedation. The standard method is to insert the colonoscope without adding any water to the colon, and when colonic spasms occur during the examination, waiting for the spasms to subside before continuing with the insertion of the colonoscope. The study method involves putting 200 ml (7 oz) of warm water through the colonoscope into the colon at the beginning of the examination, and when colonic spasms occur during the examination, putting 30 ml (1 oz) of warm water into the spastic area(s) to relax the colonic spasms.


Options:
A: Increments of medications used for sedation (duration of procedure)
B: To compare Study Treatment of warm water loading and irrigation when spasms occur with Control Treatment of no water loading and waiting for spasms to subside. The proportion of patients complaining of abdominal discomfort and their discomfort score are (Immediately after the procedure.)
C: Primary outcome - success of cecal intubation without sedation (1 year)
D: Proportion of Patients Without Pain (up to 12 months)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: Double-blind, Double-dummy, Randomised, Multi-centre, Comparative Phase III Clinical Study on the Efficacy and Tolerability of an 8 Week Oral Treatment With 9 mg Budesonide or 3 g Mesalazine in Patients With Active Ulcerative Colitis
Brief Summary: The purpose of this study is to prove the therapeutic equivalence and safety of once-daily 9 mg budesonide versus 3 g mesalazine in a 8-week treatment in patients with active ulcerative colitis.


Options:
A: Rate of clinical remission
B: Period 1: Clinical and Endoscopic Remission (Week 8); Period 2: Clinical Response, Open-Label Extended Induction (Week 16); Period 3: Clinical Remission (Week 38)
C: Rate of clinical remission (defined by CAI <= 4, with stool frequency and rectal bleeding subscores of ´0´) at week 8 (LOCF) (week 8 (LOCF))
D: Primary efficacy criterion: remission after 8 weeks of treatment, defined on the basis of the UC-DAI score less than or equal to 1 (12 weeks)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: Double-blind, Double-dummy, Randomised, Multi-centre, Comparative Phase III Clinical Study on the Efficacy and Tolerability of an 8 Week Oral Treatment With 9 mg Budesonide or 3 g Mesalazine in Patients With Active Ulcerative Colitis
Brief Summary: The purpose of this study is to prove the therapeutic equivalence and safety of once-daily 9 mg budesonide versus 3 g mesalazine in a 8-week treatment in patients with active ulcerative colitis.


Options:
A: Rate of clinical remission (defined by CAI <= 4, with stool frequency and rectal bleeding subscores of ´0´) at week 8 (LOCF) (week 8 (LOCF))
B: Proportion of patients with AEs of severe intensity or AEs leading to treatment withdrawal (7, 14, 21, 28, 56 days)
C: Clinical and Endoscopic Remission. (8 weeks)
D: To Achieve Clinical Remission in Subjects With Active Ulcerative Colitis (UC). (6 weeks)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: Double-blind, Double-dummy, Randomised, Multi-centre, Comparative Phase III Clinical Study on the Efficacy and Tolerability of an 8 Week Oral Treatment With 9 mg Budesonide or 3 g Mesalazine in Patients With Active Ulcerative Colitis
Brief Summary: The purpose of this study is to prove the therapeutic equivalence and safety of once-daily 9 mg budesonide versus 3 g mesalazine in a 8-week treatment in patients with active ulcerative colitis.


Options:
A: Rate of clinical remission (defined by CAI <= 4, with stool frequency and rectal bleeding subscores of ´0´) at week 8 (LOCF) (week 8 (LOCF))
B: Clinical and Endoscopic Remission. (8 weeks)
C: The proportion of patients with clinical response, defined as a decrease from baseline in the Mayo score by = 30% and = 3 points, with a decrease in the rectal bleeding subscore of = 1 or a rectal bleeding subscore of 0 or 1, at week 8 .
D: The proportion of patients with clinical response, defined as a decrease from baseline in the Mayo score by = 30% and = 3 points, with a decrease in the rectal bleeding subscore of = 1 or a rectal bleeding subscore of 0 or 1, at week 8.

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: Randomised Control Trial to Compare the Effects of G-CSF and Autologous Bone Marrow Progenitor Cells Infusion on the Quality of Life and Left Ventricular Function in Patients With Heart Failure Secondary to Ischaemic Heart Disease
Brief Summary: The purpose of this study is to determine whether adult bone marrow derived stem/progenitor cells improve cardiac function and symptoms in patients with heart failure and to establish the optimal method of delivery of these cells.

Study hypotheses:

* Administration of G-CSF to patients with heart failure secondary to ischaemic heart disease will lead to an increase in circulating progenitor cells as measured by peripheral CD34+ positive cell counts
* Cardiac function and symptoms will improve in patients in whom the peripheral CD34+ counts increase in response to G-CSF administration
* Direct coronary injection of autologous bone marrow derived stem cells will confer an additional improvement in cardiac function and symptoms above that derived from G-CSF infusion alone
* Direct intramyocardial injection of autologous bone marrow derived stem cells will lead to an improvement in cardiac function and symptoms above that derived from G-CSF infusion alone


Options:
A: N/A
B: Change in global left ventricular ejection fraction (12 months)
C: Troponin samples (1 day after cell injection); Number of patients with adverse events at short term (within 1 week after cell injection); Number of patients with adverse events at mid/long term (up to 12 months after cell injection)
D: Changes in left ventricular ejection fraction and dimensions (1 year)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: Intervention Program for Physically Inactive and Overweight Immigrant Women From the Middle East and Latin America Living in Sweden
Brief Summary: The purpose of this study is to improve and analyze the level of physical activity in immigrant women from the Middle East and Latin America living in Sweden. The investigators will also investigate if glucose, insulin, and lipid metabolism; stress-related hormone production; and subclinical inflammatory activity are affected by the intervention. The follow-up period is 2 years.


Options:
A: Behavior change (6 month -12 months post-partum)
B: self-reported status of the series of HBV vaccinations by follow-up calls in seven months after mailing the results verified by the medical records (Seven months after mailing the results)
C: The relative effectiveness of two physical activity programs in affecting glucose metabolism, lipid metabolism and stress-related hormone production (2 years)
D: HbA1c (12month); Blood pressure (12 month); Lipid profile (12 months); quality of life (12month)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: A Phase III, Open Label, Randomized, Multicenter Trial of Ofatumumab Added to Chlorambucil Versus Chlorambucil Monotherapy in Previously Untreated Patients With Chronic Lymphocytic Leukemia
Brief Summary: The purpose of this study was to evaluate the safety and efficacy of ofatumumab added to chlorambucil in patients with untreated Chronic Lymphocytic Leukemia.


Options:
A: Progression-Free Survival (PFS), as Assessed by the Independent Review Committee (IRC) (From randomization to the date of first documented disease progression or death due to any cause, whichever occured first, reported between day of first patient randomized up to about 49 months)
B: Progression-free Survival (PFS) (Median observation time at time of analysis was approximately 21 months); Final Analysis: Time to Progression-free Survival Event (Median observation time was approximately 66.4 months)
C: N/A
D: Number of Participants (Par.) With Complete Remission (CR), Measured From Start of Treatment Until 3 Months After Last Infusion (Start of treatment (Day 1 of Week 0) until 3 months after start of last infusion (up to Week 32)); Number of Participants (Par.) Who Were Classified as Responders and Non-responders (From start of treatment (Day 1 of Week 0) until 3 months after start of last infusion (up to Week 32))

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: The ParkFit Study; Effectiveness of an Active Lifestyle Promotion Program for Patients With Parkinson's Disease
Brief Summary: Patients with Parkinson's disease (PD) are heavily inclined towards a sedentary lifestyle. This is caused by a combination of physical impairments and cognitive dysfunction. However, regular physical activity in PD is highly desirable, for two reasons. First, physical activity has positive generic effects in preventing complications such as cardiovascular diseases, type II diabetes mellitus, osteoporosis and certain cases of cancer. Secondly, physical activity has additional disease-specific merits in PD such as depression, sleep disturbances and constipation. These effects lead to raised quality of life. Furthermore, animal studies suggest that physical activity could slow down disease progression.

Simply informing patients about the importance of physical activity is not enough to initiate and maintain an adequate level of physical activity. We propose to develop a physical activity promoting program for sedentary patients with PD in order to raise their level of daily physical activity.

Objective: The first aim of the study is to investigate whether a physical activity promotion program will result in an increase in physical activity in sedentary patients with PD.

The second aim is to demonstrate an increase in physical fitness and quality of life.


Options:
A: 306A Efficacy: Change in Orthostatic Hypotension Questionnaire Score (OHQ) (Baseline, Week 8); 306B Efficacy: Change in Dizziness/Lightheadedness/Feeling Faint/Feeling Like You Might Black Out (OHSA Item 1) (Baseline, Week1)
B: No primary or secondary outcome measures are defined. This study is exploratory (see above under detailed description).
C: Percentage of "Off" Time During Waking Hours at End of Study (22 weeks)
D: Level of Physical Activity based on the LAPAQ questionnaire (Average of 6, 12, 18 and 24 months)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: The ParkFit Study; Effectiveness of an Active Lifestyle Promotion Program for Patients With Parkinson's Disease
Brief Summary: Patients with Parkinson's disease (PD) are heavily inclined towards a sedentary lifestyle. This is caused by a combination of physical impairments and cognitive dysfunction. However, regular physical activity in PD is highly desirable, for two reasons. First, physical activity has positive generic effects in preventing complications such as cardiovascular diseases, type II diabetes mellitus, osteoporosis and certain cases of cancer. Secondly, physical activity has additional disease-specific merits in PD such as depression, sleep disturbances and constipation. These effects lead to raised quality of life. Furthermore, animal studies suggest that physical activity could slow down disease progression.

Simply informing patients about the importance of physical activity is not enough to initiate and maintain an adequate level of physical activity. We propose to develop a physical activity promoting program for sedentary patients with PD in order to raise their level of daily physical activity.

Objective: The first aim of the study is to investigate whether a physical activity promotion program will result in an increase in physical activity in sedentary patients with PD.

The second aim is to demonstrate an increase in physical fitness and quality of life.


Options:
A: Modified MACTAR scale (6 months)
B: The equilibrium score (ES) and sensory ratio were measured. The verbal reaction time (VRT) was recorded. (6 weeks)
C: Functional Reach (baseline, 4, 10, 16 months)
D: Level of Physical Activity based on the LAPAQ questionnaire (Average of 6, 12, 18 and 24 months)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: The ParkFit Study; Effectiveness of an Active Lifestyle Promotion Program for Patients With Parkinson's Disease
Brief Summary: Patients with Parkinson's disease (PD) are heavily inclined towards a sedentary lifestyle. This is caused by a combination of physical impairments and cognitive dysfunction. However, regular physical activity in PD is highly desirable, for two reasons. First, physical activity has positive generic effects in preventing complications such as cardiovascular diseases, type II diabetes mellitus, osteoporosis and certain cases of cancer. Secondly, physical activity has additional disease-specific merits in PD such as depression, sleep disturbances and constipation. These effects lead to raised quality of life. Furthermore, animal studies suggest that physical activity could slow down disease progression.

Simply informing patients about the importance of physical activity is not enough to initiate and maintain an adequate level of physical activity. We propose to develop a physical activity promoting program for sedentary patients with PD in order to raise their level of daily physical activity.

Objective: The first aim of the study is to investigate whether a physical activity promotion program will result in an increase in physical activity in sedentary patients with PD.

The second aim is to demonstrate an increase in physical fitness and quality of life.


Options:
A: Falls rate (6 months post intervention)
B: Level of Physical Activity based on the LAPAQ questionnaire (Average of 6, 12, 18 and 24 months)
C: Parkinson's Disease Quality of Life Questionnaire (PDQL) (8 months); AMC Linear Disability Score (ALDS) (8 months)
D: The equilibrium score (ES) and sensory ratio were measured. The verbal reaction time (VRT) was recorded. (6 weeks)

Answer: B