TrialPanorama/Dataset huggingface dataset:
Please select the outcome measures that correspond to the clinical trial below.
Title: A Study of Novel Smoking Cessation Interventions in Current and Former Injection Drug Users
Brief Summary: Cigarette smoking is very common in current and former injection drug users and is known to cause chronic lung diseases. Quitting smoking is proven to improve the health of people addicted to cigarettes. . Little information exists regarding the perceptions and characteristics of drug users regarding quitting smoking. Additionally, most programs designed to help people quit smoking are not very successful. One reason these programs may not work well is because it is difficult to motivate people to quit smoking. New methods of motivating changes in behavior include small monetary payments for healthy behavior and reporting breathing tests with the concept of "lung age," which is the age of an average healthy person with similar breathing test results. For example, a health care provider can report results as "Although you are 50 years old, you have the lungs for a 70 year old". In this proposal, the investigators plan to first explore the beliefs and characteristics of current and former injection drug users and how they are related to quitting smoking. The investigators then plan to study whether the use of two new methods of motivation increases the chances that this group will stop smoking.


Options:
A: Biochemically verified smoking cessation rates at 6 months post-quit date
B: Salivary cotinine or anabasine testing (metabolites of nicotine) (at 6 months following the patient selected target quit date.)
C: Biologically confirmed tobacco cessation (6 months)
D: Urinary Cotinine (Change from baseline: weekly in treatment phase 1; between 0 to 16 times during treatment phase 2 (non-responders meet 16 times; responders meet 0 or 6 times depending on group); Follow-up interviews (Post-phase 1, Post-phase 2, 6-months and 12-months)); Longest Duration of Continuous Abstinence (Change from baseline: Weekly through treatment phase 1; between 0 to 16 times during treatment phase 2 (non-responders meet 16 times; responders meet 0 or 6 times depending on group)); Seven-Day Point-Prevalence (Follow-up interviews: Post-phase 1, Post-phase 2, 6-months and 12-months after treatment initiation.); Carbon Monoxide Results (Change from baseline: weekly in treatment phase 1; between 0 to 16 times during treatment phase 2 (non-responders meet 16 times; responders meet 0 or 6 times depending on group); Follow-up interviews (Post-phase 1, Post-phase 2, 6-months and 12-months))

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: A Study of Novel Smoking Cessation Interventions in Current and Former Injection Drug Users
Brief Summary: Cigarette smoking is very common in current and former injection drug users and is known to cause chronic lung diseases. Quitting smoking is proven to improve the health of people addicted to cigarettes. . Little information exists regarding the perceptions and characteristics of drug users regarding quitting smoking. Additionally, most programs designed to help people quit smoking are not very successful. One reason these programs may not work well is because it is difficult to motivate people to quit smoking. New methods of motivating changes in behavior include small monetary payments for healthy behavior and reporting breathing tests with the concept of "lung age," which is the age of an average healthy person with similar breathing test results. For example, a health care provider can report results as "Although you are 50 years old, you have the lungs for a 70 year old". In this proposal, the investigators plan to first explore the beliefs and characteristics of current and former injection drug users and how they are related to quitting smoking. The investigators then plan to study whether the use of two new methods of motivation increases the chances that this group will stop smoking.


Options:
A: Urinary Cotinine (3 weeks)
B: Continuous smoking abstinence since target quit date until last visit before delivery. (Last 6 months of pregnancy)
C: Biologically confirmed tobacco cessation (6 months)
D: Stimulant-free Weeks Assessed by Self-report and Twice-weekly Urine Drug Screens (Week 16)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: A Study of Novel Smoking Cessation Interventions in Current and Former Injection Drug Users
Brief Summary: Cigarette smoking is very common in current and former injection drug users and is known to cause chronic lung diseases. Quitting smoking is proven to improve the health of people addicted to cigarettes. . Little information exists regarding the perceptions and characteristics of drug users regarding quitting smoking. Additionally, most programs designed to help people quit smoking are not very successful. One reason these programs may not work well is because it is difficult to motivate people to quit smoking. New methods of motivating changes in behavior include small monetary payments for healthy behavior and reporting breathing tests with the concept of "lung age," which is the age of an average healthy person with similar breathing test results. For example, a health care provider can report results as "Although you are 50 years old, you have the lungs for a 70 year old". In this proposal, the investigators plan to first explore the beliefs and characteristics of current and former injection drug users and how they are related to quitting smoking. The investigators then plan to study whether the use of two new methods of motivation increases the chances that this group will stop smoking.


Options:
A: Preoperative Carbon Monoxide Levels (the morning of surgery); Exhaled CO Level Measured Immediately Prior to Surgery (The median time from study assessment at POE to surgery was 1 day with an interquartile range of 1 to 3 days.)
B: Biologically confirmed tobacco cessation (6 months)
C: Smoking abstinence: self reported abstinence (12 or more months smoking free. (24 months after last recruitment)
D: Motivation to quit smoking, utilization of available resources, smoking cessation rate (1 year)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: Letrozole and CC Alone in an IUI Program in Women With Surgically Treated Minimal to Mild Endometriosis
Brief Summary: To evaluate pregnancy rates with letrozole and CC alone in an IUI program for women with recently surgically treated minimal to mild endometriosis.


Options:
A: Multiple Gestation Rate Following Recruitment of Multiple Follicular Development With an AI, as Compared to CC and FSH. (Participants were followed for the duration of their treatment and, if pregnant through 6 weeks post-delivery, up to 66 weeks)
B: Number of mature follicles in the study and control group.
C: Clinical pregnancy rate (5 weeks after intrauterine insemination)
D: Clinical pregnancy rate per cycle (6-7 weeks gestation)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: A Program to Protect Young Children From Tobacco Smoke Exposure
Brief Summary: The goal of this research project is to develop and evaluate an intervention to reduce young child tobacco smoke exposure


Options:
A: N/A
B: Number of Symptom Free Days (Average Symptom Free Days, over 2 weeks, during peak asthma season (November-February))
C: Presence of a total home smoking ban (Change from baseline in reported total home smoking bans at 3-month and 6-month follow-up)
D: Child exposure to tobacco smoke - hair nicotine (Baseline, 6 months post-intervention)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: Brief Motivational Interviewing to Reduce Child Body Mass Index
Brief Summary: BMi 2 is a study that tests a behavioral counseling approach to reduce obesity in children. Practitioners (Pediatricians, Nurse Practitioners) were randomly assigned to one of three groups. The first group continued with standard care; in group 2, each practitioner delivered four study Motivational Interviewing visits with the parent/caregiver, and in group 3 in addition to the practitioner, a registered dietitian delivered 6 Motivational Interviewing visits. The primary outcome will be the child's percentile BMI change between the baseline and 2-year follow-up. Secondary outcomes will include behavior change around fruits and vegetables, sweetened beverages and exercise. Our hypothesis is that there will be a larger decrease in BMI percentile for children in group 3 than in group 2, and that children in group 2 will have a decrease in BMI percentile when compared to group one.


Options:
A: Child BMI Percentile (2 years after recruitment)
B: Percent BMI overweight for child and parent (baseline-6,12,18, 24 months)
C: Primary - Body Mass index (2 years)
D: Primary Outcome Measure: BMI (6 months, 1 year, 2 year, 5 year)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: Brief Motivational Interviewing to Reduce Child Body Mass Index
Brief Summary: BMi 2 is a study that tests a behavioral counseling approach to reduce obesity in children. Practitioners (Pediatricians, Nurse Practitioners) were randomly assigned to one of three groups. The first group continued with standard care; in group 2, each practitioner delivered four study Motivational Interviewing visits with the parent/caregiver, and in group 3 in addition to the practitioner, a registered dietitian delivered 6 Motivational Interviewing visits. The primary outcome will be the child's percentile BMI change between the baseline and 2-year follow-up. Secondary outcomes will include behavior change around fruits and vegetables, sweetened beverages and exercise. Our hypothesis is that there will be a larger decrease in BMI percentile for children in group 3 than in group 2, and that children in group 2 will have a decrease in BMI percentile when compared to group one.


Options:
A: Body mass index (BMI) at 1 year.
B: Child BMI Percentile (2 years after recruitment)
C: Changes in BMI z-score (Measured at Month 12)
D: Change from baseline physical activity at 12 weeks (12 weeks)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: Brief Motivational Interviewing to Reduce Child Body Mass Index
Brief Summary: BMi 2 is a study that tests a behavioral counseling approach to reduce obesity in children. Practitioners (Pediatricians, Nurse Practitioners) were randomly assigned to one of three groups. The first group continued with standard care; in group 2, each practitioner delivered four study Motivational Interviewing visits with the parent/caregiver, and in group 3 in addition to the practitioner, a registered dietitian delivered 6 Motivational Interviewing visits. The primary outcome will be the child's percentile BMI change between the baseline and 2-year follow-up. Secondary outcomes will include behavior change around fruits and vegetables, sweetened beverages and exercise. Our hypothesis is that there will be a larger decrease in BMI percentile for children in group 3 than in group 2, and that children in group 2 will have a decrease in BMI percentile when compared to group one.


Options:
A: To evaluate and compare in overweight children the effectiveness of the following interventions: a parent-centered dietary modification program; a physical activity skill development program; and a parent-centered dietary modification + physical activity skill development program.
B: Child BMI Z-score (Pre-intervention); Child BMI Z-score (post-intervention); Child BMI Z-score (6-months post-intervention); Child BMI Z-score (12-months post-intervention)
C: Primary Outcome Measure: BMI (6 months, 1 year, 2 year, 5 year)
D: Child BMI Percentile (2 years after recruitment)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: A 52 Weeks, Double Blind, Randomized, Placebo-controlled Trial Evaluating the Effect of Oral BIBF 1120, 150 mg Twice Daily, on Annual Forced Vital Capacity Decline, in Patients With Idiopathic Pulmonary Fibrosis (IPF)
Brief Summary: Idiopathic Pulmonary Fibrosis (IPF) is a chronic disease of unknown cause that results in scarring of the lung and there is a high unmet medical need for effective treatment to halt lung function decline, delay or avoid exacerbation (flare-ups), and ultimately to reduce the death rate.

In a large Phase 2 trial (1199.30) (NCT00514683), investigating the effects of 52 weeks of treatment with BIBF 1120 in patients with IPF, a positive effect was seen on lung function of patients treated with high dose of BIBF 1120 compared to placebo.

Hence it is the purpose of this trial to investigate and confirm the efficacy and safety of BIBF 1120 at a high dose in treating patients with IPF, compared with placebo. The trial will be conducted as a prospective, randomised design with the aim to collect safety and efficacy data.

Respiratory function is globally accepted for assessment of treatment effects in IPF patients. The chosen endpoint (Forced Vital Capacity (FVC) decline) is easy to obtain and is part of the usual examinations done in IPF patients.


Options:
A: Annual Rate of Decline in Forced Vital Capacity (FVC) Over 52 Weeks (52 weeks)
B: changes in six minute walking distance after 6 months (6 months)
C: Peak VO2 (Before and after 12 weeks of Pulmonary Rehabilitation); 6 min walk test (Before and after 12 weeks of Pulmonary Rehabilitation)
D: Absolute Change in Percent Predicted Forced Vital Capacity(FVC) (Baseline to week 72)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: A 52 Weeks, Double Blind, Randomized, Placebo-controlled Trial Evaluating the Effect of Oral BIBF 1120, 150 mg Twice Daily, on Annual Forced Vital Capacity Decline, in Patients With Idiopathic Pulmonary Fibrosis (IPF)
Brief Summary: Idiopathic Pulmonary Fibrosis (IPF) is a chronic disease of unknown cause that results in scarring of the lung and there is a high unmet medical need for effective treatment to halt lung function decline, delay or avoid exacerbation (flare-ups), and ultimately to reduce the death rate.

In a large Phase 2 trial (1199.30) (NCT00514683), investigating the effects of 52 weeks of treatment with BIBF 1120 in patients with IPF, a positive effect was seen on lung function of patients treated with high dose of BIBF 1120 compared to placebo.

Hence it is the purpose of this trial to investigate and confirm the efficacy and safety of BIBF 1120 at a high dose in treating patients with IPF, compared with placebo. The trial will be conducted as a prospective, randomised design with the aim to collect safety and efficacy data.

Respiratory function is globally accepted for assessment of treatment effects in IPF patients. The chosen endpoint (Forced Vital Capacity (FVC) decline) is easy to obtain and is part of the usual examinations done in IPF patients.


Options:
A: Annual Rate of Decline in Forced Vital Capacity (FVC) Over 52 Weeks. (52 weeks)
B: Functional exercise capacity
C: Absolute Change in Percent Predicted Forced Vital Capacity (FVC) (From baseline up to 72 weeks)
D: Annual Rate of Decline in Forced Vital Capacity (FVC) Over 52 Weeks (52 weeks)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: The Effect of Neoadjuvant Chemotherapy on Lactate Threshold in Patients With Surgically Resectable Upper Gastrointestinal Cancer.
Brief Summary: It is important to assess patients' fitness for major cancer surgery which carries a high risk of mortality. Patients with poor heart and lung function have a higher risk of death after major cancer surgery. Cardiopulmonary exercise testing, CPET, is an objective measure of patients' fitness. Most patients, before surgery to resect their cancer, undergo a period of chemotherapy. Chemotherapy often regresses the cancer but also has adverse effects on cell function. Our hypothesis is that chemotherapy alters patient fitness, as assessed by CPET, prior to major cancer surgery. Participating patients will undergo fitness testing by CPET before and after their chemotherapy, prior to their surgery.


Options:
A: Change From Baseline in Cortical Silent Period (CSP) Will be Determined Using Transcranial Magnetic Stimulation (TMS) of the Motor Cortex. (10-15 minutes prior to the control/exercise condition ('pre-test') and 10-15 minutes after the control/exercise condition ('post-test').)
B: What is the effect of chemotherapy on the fitness of patients prior to cancer surgery? (2 years)
C: Change in Cardiorespiratory fitness (pre-NACRT (baseline), post-NACRT (an average of 6 weeks))
D: Maintain or improve physical fitness (anaerobic threshold measured by CPET)after treatment with neoadjuvant chemoradiotherapy in colorectal cancer patients. (3 years)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: Pharmacist Intervention for Glycemic Control in The Community (The RxING Study)
Brief Summary: Background: Approximately 1.9 million Canadians are living with diabetes and this is estimated to increase by 75% over the next few decades. Pharmacists are front line primary healthcare professionals who see patients with diabetes frequently and in Alberta, they have been allowed to prescribe medications and order laboratory tests. As such, pharmacists could systematically identify poorly controlled diabetes patients and provide greater access to diabetes interventions to improve blood sugar control.

Objective: The aim of this study is to determine the effect of a community pharmacist intervention on blood sugar control in individuals with poorly controlled diabetes.

Project description:

100 adults with type 2 diabetes and uncontrolled blood sugar will be defined by the participating pharmacists. Blood sugar control is going to assessed using hemoglobin A1c test (a blood test to measure individual's blood sugar control over the last 3 months). This test requires obtaining a blood spot from the patient which will be obtained by pricking his/her fingertip. Based on the hemoglobin A1c test result the pharmacist will assess the patient's need for insulin glargine, if the patient needs insulin glargine the pharmacist is going to prescribe it for him/her and educate him/her on its use. Patients are going to be followed up closely by the pharmacists for 6 months with regular updates to the patients' family physicians. This multi-centre study should demonstrate pharmacists' ability to improve glycemic control and improve access to care.


Options:
A: The change in HbA1c from baseline to week 26 (6 months)
B: Change in systolic blood pressure (6 months)
C: The difference in change in estimated cardiovascular risk between advanced care and usual care groups (3 months)
D: Percentage of Participans With A1c<7%, LDL Cholesterol <100mg/dL, Systolic Blood Pressure <130mm Hg and Diastolic Blood Pressure <80 mm Hg (4 months)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: Effectiveness of Occupational Therapy in Parkinson's Disease: a Randomized Controlled Trial
Brief Summary: The purpose of this study is to determine the effectiveness of occupational therapy in Parkinson's disease.


Options:
A: Canadian Occupational Performance Measure (COPM) (3 months)
B: Change From Baseline in the Blinded Rater Unified Parkinson's Disease Rating Scale (UPDRS) Total Score at Month 15 (Baseline and Month 15)
C: Change in Total Unified Parkinson's Disease Rating Scale (UPDRS) Score From Baseline (12w, 24w, 36w, 42w, 48w, 54w, 60w, 66w, 72w)
D: UPDRS part 3 (motor score)and change from baseline to 24 weeks maintenance treatment (6 months)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: Phase II Randomized Double-Blind Placebo-Controlled Study to Evaluate the Efficacy and Safety of rhuMAb Beta7 in Patients With Moderate to Severe Ulcerative Colitis
Brief Summary: This Phase II study is a randomized, double-blind, placebo-controlled multicenter study to evaluate the efficacy and safety of rhuMAb Beta7 in patients with moderate to severe ulcerative colitis.


Options:
A: The Proportion of Patients Responders to Dex 21-P vs Placebo (From baseline to End of treatment = 6 weeks ± 10 days (in chronic and steroid dependent IBD patients) or 28 weeks ± 5 days (in mesalazine refractory UC patients))
B: N/A
C: Proportion of subject who were relapse free after 6 months of treatment (6 months)
D: Clinical remission defined as a Mayo Clinic Score (MCS) </= 2 with no individual subscore exceeding 1 point (Week 10)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: Phase II Randomized Double-Blind Placebo-Controlled Study to Evaluate the Efficacy and Safety of rhuMAb Beta7 in Patients With Moderate to Severe Ulcerative Colitis
Brief Summary: This Phase II study is a randomized, double-blind, placebo-controlled multicenter study to evaluate the efficacy and safety of rhuMAb Beta7 in patients with moderate to severe ulcerative colitis.


Options:
A: Number of Participants With Clinical Response at Week 6 (Baseline, Week 6)
B: Induction Phase: Percentage of Participants With a Clinical Response at Week 6 (Baseline and Week 6); Maintenance Phase: Percentage of Participants in Clinical Remission at Week 52 (Week 52)
C: Clinical remission defined as a Mayo Clinic Score (MCS) </= 2 with no individual subscore exceeding 1 point (Week 10)
D: Proportion of Participants With Clinical Remission Per Mayo Score at Week 8 (Week 8)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: Multi-Center Medication Reconciliation Quality Improvement Study
Brief Summary: Patients often have problems after they leave the hospital, in part because errors are made in the medications they are prescribed. The goal of this project is to develop a more accurate and safe medication prescription process when patients enter and leave the hospital and implement this process at six U.S. hospitals. The investigators will measure the success of the project and develop lessons learned so this process can be applied to other hospitals.


Options:
A: Effects on hospital visits (1 year)
B: The primary outcome will be unintentional medication discrepancies in admission orders and discharge orders with potential for patient harm (6 months prior to implementation of intervention to 21 months during intervention)
C: Improvement in proportion of quality indicators achieved, for target diseases as a most responsible or primary diagnosis, between groups. (in hospital)
D: Wrong-patient Order Sessions, Defined as Order Sessions That Include at Least One Wrong-Patient Retract-and-Reorder (RAR) Event, As-randomized Analysis (19-month study period. All order sessions placed by randomized clinicians during the study period were included in the analysis. The time frame for each participant varied.)

Answer: B