TrialPanorama/Dataset huggingface dataset:
Please select the outcome measures that correspond to the clinical trial below.
Title: Improving Adherence With Oral Contraceptives Using Daily Text Messaging Reminders
Brief Summary: The purpose of this study is to determine whether there is increased oral contraceptive pill (OCP) adherence in women receiving daily text messaging reminders to take their OCP, compared to women who do not receive reminders. The investigators hypothesize that women who receive daily text messaging reminders to take their OCP will have increased pill adherence compared to women who do not receive reminders.

The investigators also hope to determine whether there is a difference in OCP adherence as measured by electronic monitoring device and wireless real-time data collection versus traditional patient pill diaries. The investigators hypothesize that electronic monitoring device and wireless real-time data collection will demonstrate lower adherence compared to traditional patient pill diaries.


Options:
A: Change in Glycemic Control (HbA1c) (6 months (baseline to 6 months))
B: Pill count (18 months)
C: Percentage of Participants With Depression Treatment Response (6 months)
D: Average number of missed pills per cycle (3 months)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: The Effects of Flaxseed Supplement on Cardio-metabolic Risk Factors in Patients With Metabolic Syndrome
Brief Summary: The purpose of this study is to determine whether daily supplement of 30 grams flaxseed is effective in the treatment of metabolic syndrome (MetS).


Options:
A: Change in Weight (2, 4, 6, 8, 10, and 12 weeks); Change in Blood Lipids (4, 8, and 12 weeks); Change in Blood Pressure (2, 4, 6, 8, 10, and 12 weeks); Change in Hedonics of peanut consumption (12 weeks); Change in Body Composition (2, 4, 6, 8, 10, and 12 weeks); Change in Fasting Blood Glucose (4, 8, and 12 weeks); Change in Cortisol (4, 8, and 12 weeks); Change in Insulin (4, 8, and 12 weeks); Change in Pulse (2, 4, 6, 8, 10, and 12 weeks)
B: Metabolic syndrome status (12 weeks)
C: To evaluate the effects of an almond-enriched (2 oz/day) hypocaloric, low-fat diet on body weight and body composition in overweight and obese persons (6 months)
D: N/A

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: Phase IV Study of the Use of Sequential DFP-DFO Versus DFP in Thalassemia Major Patients
Brief Summary: Changes in chelation treatment and transfusion practices, during the past two decades, have dramatically improved the prognosis of thalassemia major patients.Deferiprone (DFP) has been compared with deferoxamine (DFO), using different schedules of treatment, in the majority of the 13 clinical trials published between 1990 and 2008.No statistically significant difference was shown between these two interventions during, at most, 18 months of treatment.Three randomised trials that compared sequential DFP-DFO treatment versus DFO alone reported controversial results but this could be due to small sample sizes and short treatment duration. In fact, no trial with treatment duration longer than 18 months15, which reported on mortality, adverse events, serum ferritin concentrations, as well as costs has so far been published.

This long-term sequential DFP-DFO treatment versus DFP alone treatment trial was conducted to assess the impacts of these chelation treatments on serum ferritin concentrations, mortality, adverse events, and costs in thalassemia major patients.


Options:
A: Demonstrate non-inferiority to deferoxamine in its effects on liver iron content (LIC)
B: Percentage of Successfully Chelated Patients (at baseline and after 12 months)
C: difference between multiple observations of the serum ferritin concentrations (five-year treatment)
D: To evaluate if fixed starting doses of ICL670, based on transfusion history and subsequent dose titration can provide clinically acceptable chelation as measured by serum ferritin (at baseline and at 52 weeks)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: Phase IV Study of the Use of Sequential DFP-DFO Versus DFP in Thalassemia Major Patients
Brief Summary: Changes in chelation treatment and transfusion practices, during the past two decades, have dramatically improved the prognosis of thalassemia major patients.Deferiprone (DFP) has been compared with deferoxamine (DFO), using different schedules of treatment, in the majority of the 13 clinical trials published between 1990 and 2008.No statistically significant difference was shown between these two interventions during, at most, 18 months of treatment.Three randomised trials that compared sequential DFP-DFO treatment versus DFO alone reported controversial results but this could be due to small sample sizes and short treatment duration. In fact, no trial with treatment duration longer than 18 months15, which reported on mortality, adverse events, serum ferritin concentrations, as well as costs has so far been published.

This long-term sequential DFP-DFO treatment versus DFP alone treatment trial was conducted to assess the impacts of these chelation treatments on serum ferritin concentrations, mortality, adverse events, and costs in thalassemia major patients.


Options:
A: difference between multiple observations of the serum ferritin concentrations (five-year treatment)
B: Demonstrate non-inferiority to deferoxamine in its effects on liver iron content (LIC)
C: Myocardial T2*
D: Clinical efficacy (Iron balance and liver iron concentration) (At baseline and at 12 months)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: Phase IV Study of the Use of Sequential DFP-DFO Versus DFP in Thalassemia Major Patients
Brief Summary: Changes in chelation treatment and transfusion practices, during the past two decades, have dramatically improved the prognosis of thalassemia major patients.Deferiprone (DFP) has been compared with deferoxamine (DFO), using different schedules of treatment, in the majority of the 13 clinical trials published between 1990 and 2008.No statistically significant difference was shown between these two interventions during, at most, 18 months of treatment.Three randomised trials that compared sequential DFP-DFO treatment versus DFO alone reported controversial results but this could be due to small sample sizes and short treatment duration. In fact, no trial with treatment duration longer than 18 months15, which reported on mortality, adverse events, serum ferritin concentrations, as well as costs has so far been published.

This long-term sequential DFP-DFO treatment versus DFP alone treatment trial was conducted to assess the impacts of these chelation treatments on serum ferritin concentrations, mortality, adverse events, and costs in thalassemia major patients.


Options:
A: The prevalence and incidence of complications specific to thalassemia and its treatment among participants (Measured throughout the duration of the study)
B: to assess efficacy of combining DFP and deferasirox compared to combined DFP and DFO in decreasing the serum ferritin level in conditions with severe chronic iron overload. (12 months)
C: Core Study: Change From Baseline in Myocardial T2* (Magnetic Resonance T2-star (T2*) Technique for the Measurement of Tissue Iron) After 12 Months Treatment (12 Month)
D: difference between multiple observations of the serum ferritin concentrations (five-year treatment)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: Hypotonic Versus Isotonic Parenteral Fluids in Children - a Randomized Controlled Trial
Brief Summary: Children who are undergoing surgery need intravenous fluids to prevent dehydration and maintain their electrolyte balance. The current standard of care in these children is to use a fluid which is low in sodium (hypotonic fluid). The safety of this practice has never been tested. There is ongoing concern from the medical community that this type of fluid increases the child's risk of developing low sodium levels, and hence may not be safe for all children. Low sodium can lead to significant complications such as seizures, coma and even death, risks of which are often underestimated and not anticipated by their caregivers. Experts in the field suggest that giving a solution with a similar sodium content to that of blood (isotonic fluid) reduces the risk of these problems in these children. This study will compare these two types of intravenous fluids (hypotonic versus isotonic), in a blinded fashion (i.e. neither the patient nor caregivers or investigators will be aware which type of fluid the patient is receiving), in children following surgery. The investigators goal is to see which type of fluid is safer, and leads to more stable sodium levels. This would in turn lead to a lower risk of complications as described above.

This is the first time such a study is preformed in pediatrics. There are unnecessary number of complications and potential deaths from this disorder, and hence the safety of everyday fluid practice in children needs to be scientifically tested. The results of this study will enable the investigators to propose scientifically based guidelines on how to minimize risks associated with intravenous infusions in children.


Options:
A: Incidence of Hyponatremia (Defined as Serum Sodium Less Than 130 mmol/L) (72 hrs)
B: Serum Sodium Levels in Both Groups (first 48 hours)
C: rate of change in serum sodium (8 to 20 hours)
D: Hospital Acquired Acute Plasma Sodium Derangements (Hypo- or Hypernatremia) (During the treatment and follow-up period.); Hyponatremia (during the study intervention)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: TIPS Versus Portacaval Shunt for Acute Bleeding Varices in Cirrhosis
Brief Summary: In unselected cirrhotic patients with acute portal hypertension-related bleeding to compare the effectiveness in control of bleeding, mortality rate, duration of life, quality of life, and economic costs of two widely used treatment measures: (1) emergency transjugular intrahepatic portal-systemic shunt (TIPS), and (2) emergency portacaval shunt.


Options:
A: Haemostasis (24 hours)
B: Survival (10 years)
C: Treatment failure (5 days)
D: Survival (10 years)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: TIPS Versus Portacaval Shunt for Acute Bleeding Varices in Cirrhosis
Brief Summary: In unselected cirrhotic patients with acute portal hypertension-related bleeding to compare the effectiveness in control of bleeding, mortality rate, duration of life, quality of life, and economic costs of two widely used treatment measures: (1) emergency transjugular intrahepatic portal-systemic shunt (TIPS), and (2) emergency portacaval shunt.


Options:
A: recurrence rate of variceal hemorrhage (Participants will be followed for up to 6 months starting from the date of randomization.)
B: Survival (10 years)
C: Survival (10 years)
D: Number of participants with variceal rebleeding (4 years)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: TIPS Versus Portacaval Shunt for Acute Bleeding Varices in Cirrhosis
Brief Summary: In unselected cirrhotic patients with acute portal hypertension-related bleeding to compare the effectiveness in control of bleeding, mortality rate, duration of life, quality of life, and economic costs of two widely used treatment measures: (1) emergency transjugular intrahepatic portal-systemic shunt (TIPS), and (2) emergency portacaval shunt.


Options:
A: Number of participants with variceal rebleeding (4 years)
B: Survival (10 years)
C: Number of survival without liver transplantation (2 years)
D: Survival (One Year)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: TIPS Versus Portacaval Shunt for Acute Bleeding Varices in Cirrhosis
Brief Summary: In unselected cirrhotic patients with acute portal hypertension-related bleeding to compare the effectiveness in control of bleeding, mortality rate, duration of life, quality of life, and economic costs of two widely used treatment measures: (1) emergency transjugular intrahepatic portal-systemic shunt (TIPS), and (2) emergency portacaval shunt.


Options:
A: The primary endpoint of the study is the the proportions of patients who develop large varices (Gd 3 or Gd 4) during the period of 2 year in each group. (2 Years)
B: Survival (10 years)
C: Rebleed, death (At least 3 months after last enrollment)
D: Survival (10 years)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: A Double Blind, Double Dummy, Randomised, Multicentre, Four Arm Parallel Group Study to Assess the Efficacy and Safety of FlutiForm® pMDI 250/10µg (2 Puffs Bid) vs Fluticasone pMDI 250µg (2 Puffs Bid) Plus Formoterol pMDI 12µg (2 Puffs Bid) Administered Concurrently in Adult Subjects With Severe Persistent, Reversible Asthma.
Brief Summary: The study compares the efficacy and safety of FlutiForm® vs Flixotide® plus Foradil® in the treatment of severe persisent asthma in adult subjects.


Options:
A: Comparison of FEV1 (Forced expiratory volume in the first second) values. (8 weeks)
B: 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)
C: Change from start of treatment in evening pre-dose FEV1 (2, 6 and 12 weeks after starting treatment)
D: 'Well-controlled Asthma Week' - a Derived Binary Variable (Yes/No) (Weekly, up to 52 weeks)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: A Double Blind, Double Dummy, Randomised, Multicentre, Four Arm Parallel Group Study to Assess the Efficacy and Safety of FlutiForm® pMDI 250/10µg (2 Puffs Bid) vs Fluticasone pMDI 250µg (2 Puffs Bid) Plus Formoterol pMDI 12µg (2 Puffs Bid) Administered Concurrently in Adult Subjects With Severe Persistent, Reversible Asthma.
Brief Summary: The study compares the efficacy and safety of FlutiForm® vs Flixotide® plus Foradil® in the treatment of severe persisent asthma in adult subjects.


Options:
A: Time to first severe asthma exacerbation
B: Mean percentage of symptom-free days over a 52-week treatment period
C: Comparison of FEV1 (Forced expiratory volume in the first second) values. (8 weeks)
D: Asthma control assessed by asthma exacerbations (Continuosly throughout the treatment period)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: A Phase 2/3, Placebo-Controlled, Efficacy and Safety Study of Once-Weekly, Subcutaneous LY2189265 Compared to Sitagliptin in Patients With Type 2 Diabetes Mellitus on Metformin
Brief Summary: This is an adaptive dose finding study and a Phase 3 efficacy study to evaluate the effects of once weekly injection of LY2189265 compared to Sitagliptin on glucose by measuring glycosylated hemoglobin (HbA1c) change from baseline after 52 weeks in participants with type 2 diabetes mellitus on Metformin.


Options:
A: Change from baseline in HbA1c at 52 weeks
B: Safety during 104 weeks of treatment; Change from baseline in HbA1c at 104 weeks
C: Glycosylated Hemoglobin (HbA1c) Change From Baseline (Baseline, 52 weeks)
D: Change from baseline in HbA1c at 24 weeks

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: Concurrent Nicotine Patch / Denicotinized Cigarette Therapy for Smoking Cessation II
Brief Summary: The main goals of the study are to assess benefits of higher doses of the nicotine patch prior to smoking cessation for high- and low-dependent smokers, and to investigate the potential relationship between genetic factors and smoking cessation success. There will be a two-week double-blind pre-cessation exposure to nicotine patch treatment in a sample of 240 high-dependent \& 240 low-dependent smokers; half of each group will wear two 21mg nicotine patches (42mg) daily, and half will wear one 21mg nicotine patch and one comparable placebo patch daily, resulting in the following four conditions (120 subjects each) during the 2-week pre-quit period: 1) Less Dependent/21mg nic., 2) Less Dependent/42mg nic., 3) More Dependent/21mg nic., and 4) More Dependent/42mg nic. After the quit date, subjects will continue with the same nicotine dosage for the 1st 4 weeks; after that the treatment will no longer be double-blind as only nicotine patches will be used: all subjects will wear one 21-mg patch daily for 2 weeks, one 14-mg patch daily for the following 2 weeks, and one 7-mg patch for the remaining 2 weeks. The four treatment groups will be distributed over 4 sites: Durham, Raleigh, Charlotte, and Winston-Salem. After the screening visit, subjects will have 7 lab visits: at 2 weeks, 1 week, and 1 day prior to the quit-smoking date, and at 1 week, 3 weeks, 6 weeks and 10 weeks after the quit-smoking date.


Options:
A: 7-Day Point Prevalence Abstinence From Smoking by Intervention (26 weeks after the target quit smoking date); 7-Day Point Prevalence Abstinence From Smoking by Nicotine Replacement Therapy (NRT) Group (26 weeks after the target quit smoking date)
B: sustained smoking abstinence (during the study)
C: Biochemically-confirmed 7-Day Point-Prevalence Abstinence at 26 Weeks (Assessed 26 weeks after the target quit day.)
D: Continuous Abstinence From Smoking at Ten Weeks Post-quit (May 2009)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: Concurrent Nicotine Patch / Denicotinized Cigarette Therapy for Smoking Cessation II
Brief Summary: The main goals of the study are to assess benefits of higher doses of the nicotine patch prior to smoking cessation for high- and low-dependent smokers, and to investigate the potential relationship between genetic factors and smoking cessation success. There will be a two-week double-blind pre-cessation exposure to nicotine patch treatment in a sample of 240 high-dependent \& 240 low-dependent smokers; half of each group will wear two 21mg nicotine patches (42mg) daily, and half will wear one 21mg nicotine patch and one comparable placebo patch daily, resulting in the following four conditions (120 subjects each) during the 2-week pre-quit period: 1) Less Dependent/21mg nic., 2) Less Dependent/42mg nic., 3) More Dependent/21mg nic., and 4) More Dependent/42mg nic. After the quit date, subjects will continue with the same nicotine dosage for the 1st 4 weeks; after that the treatment will no longer be double-blind as only nicotine patches will be used: all subjects will wear one 21-mg patch daily for 2 weeks, one 14-mg patch daily for the following 2 weeks, and one 7-mg patch for the remaining 2 weeks. The four treatment groups will be distributed over 4 sites: Durham, Raleigh, Charlotte, and Winston-Salem. After the screening visit, subjects will have 7 lab visits: at 2 weeks, 1 week, and 1 day prior to the quit-smoking date, and at 1 week, 3 weeks, 6 weeks and 10 weeks after the quit-smoking date.


Options:
A: 7-day Point Prevalence Quit Rate at End-of-Treatment (EOT) (Week 11)
B: Continuous Abstinence From Smoking at Ten Weeks Post-quit (May 2009)
C: Participants Abstinent From Cigarettes (Two years)
D: 4 week Continuous Quit Rate ( 4 week CQR ) for weeks 9 -12

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: Concurrent Nicotine Patch / Denicotinized Cigarette Therapy for Smoking Cessation II
Brief Summary: The main goals of the study are to assess benefits of higher doses of the nicotine patch prior to smoking cessation for high- and low-dependent smokers, and to investigate the potential relationship between genetic factors and smoking cessation success. There will be a two-week double-blind pre-cessation exposure to nicotine patch treatment in a sample of 240 high-dependent \& 240 low-dependent smokers; half of each group will wear two 21mg nicotine patches (42mg) daily, and half will wear one 21mg nicotine patch and one comparable placebo patch daily, resulting in the following four conditions (120 subjects each) during the 2-week pre-quit period: 1) Less Dependent/21mg nic., 2) Less Dependent/42mg nic., 3) More Dependent/21mg nic., and 4) More Dependent/42mg nic. After the quit date, subjects will continue with the same nicotine dosage for the 1st 4 weeks; after that the treatment will no longer be double-blind as only nicotine patches will be used: all subjects will wear one 21-mg patch daily for 2 weeks, one 14-mg patch daily for the following 2 weeks, and one 7-mg patch for the remaining 2 weeks. The four treatment groups will be distributed over 4 sites: Durham, Raleigh, Charlotte, and Winston-Salem. After the screening visit, subjects will have 7 lab visits: at 2 weeks, 1 week, and 1 day prior to the quit-smoking date, and at 1 week, 3 weeks, 6 weeks and 10 weeks after the quit-smoking date.


Options:
A: Number of Participants With Prolonged Abstinence Through 6 Months Verified by Carbon Monoxide Measurement (6 months)
B: Continuous Abstinence From Smoking at Ten Weeks Post-quit (May 2009)
C: Sustained 50% reduction in the number of cigarettes smoked per day at week-12 from baseline (week-12); Sustained smoking abstinence at week-12 (week 12)
D: Percentage of Participants With Carbon Monoxide (CO) Confirmed 10-Week Continuous Abstinence (CA) From Smoking (Week 15 - 24)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: Concurrent Nicotine Patch / Denicotinized Cigarette Therapy for Smoking Cessation II
Brief Summary: The main goals of the study are to assess benefits of higher doses of the nicotine patch prior to smoking cessation for high- and low-dependent smokers, and to investigate the potential relationship between genetic factors and smoking cessation success. There will be a two-week double-blind pre-cessation exposure to nicotine patch treatment in a sample of 240 high-dependent \& 240 low-dependent smokers; half of each group will wear two 21mg nicotine patches (42mg) daily, and half will wear one 21mg nicotine patch and one comparable placebo patch daily, resulting in the following four conditions (120 subjects each) during the 2-week pre-quit period: 1) Less Dependent/21mg nic., 2) Less Dependent/42mg nic., 3) More Dependent/21mg nic., and 4) More Dependent/42mg nic. After the quit date, subjects will continue with the same nicotine dosage for the 1st 4 weeks; after that the treatment will no longer be double-blind as only nicotine patches will be used: all subjects will wear one 21-mg patch daily for 2 weeks, one 14-mg patch daily for the following 2 weeks, and one 7-mg patch for the remaining 2 weeks. The four treatment groups will be distributed over 4 sites: Durham, Raleigh, Charlotte, and Winston-Salem. After the screening visit, subjects will have 7 lab visits: at 2 weeks, 1 week, and 1 day prior to the quit-smoking date, and at 1 week, 3 weeks, 6 weeks and 10 weeks after the quit-smoking date.


Options:
A: Four-week Continuous Abstinence From Cigarette Smoking (Study week 8 thru week 11)
B: Pharmacokinetic parameters: Population mean estimate for apparent plasma clearance (CL/F), central volume of distribution (V2/F) and steady-state volume of distribution (Vss/F).
C: Continuous Abstinence From Smoking at Ten Weeks Post-quit (May 2009)
D: To Determine the Safety of Varenicline in PLWH Who Smoke (3 months)

Answer: C