TrialPanorama/Dataset huggingface dataset:
Please select the outcome measures that correspond to the clinical trial below.
Title: Comparison of Safety, Tolerability and Efficacy of Three Drug Combinations for Intermittent Preventive Treatment in Children Aged 1-5 Years in an Area of Seasonal Malaria Transmission in Upper River Division, The Gambia
Brief Summary: Intermittent preventive treatment (IPT) offers a way of preventing malaria infection without compromising the development of malaria immunity or encouraging drug resistance. The effect of IPT in children in the prevention of malaria has been evaluated in a number of trials in areas of seasonal malaria transmission. Results from these trials have shown that IPTc provided between 40% - 86% protection against clinical malaria. In 2006, a trial that compared two methods of IPTc delivery was carried out in Upper River Division, The Gambia. Preliminary results of the trial have shown that the treatment was very effective as only 4% (45/1133) of the children seen at the end of year cross-sectional survey were parasitaemic. Tolerability was assessed in a subset of 1100 children and the results showed that about 13.5% of children developed mild to moderate vomiting. Malaise was present in about 10% of the study subjects. Severe adverse events were rare. Thus it is important to investigate if other drug regimens might be equally effective in preventing malaria but less likely to cause adverse events. During the 2007 malaria transmission season, 1009 children aged 1-5 years will be individually randomized to receive amodiaquine plus SP, piperaquine plus SP or Artekin TM (dihdroartemisinin plus piperaquine) at monthly intervals on three occasions during the months of September, October, and November. To determine the prevalence of side effects following drug administration participants in each treatment group will be visited at home three and seven days after each round of drug administration and a side effects questionnaire completed. To help establish whether these adverse events are drug related, the same questionnaire will be administered after each treatment round, to 286 age-matched children who are not part of the trial. The primary ends points will be the incidence of adverse events.


Options:
A: Incidence of clinical malaria (2008-2009)
B: Prevalence of drug resistance
C: Clinical episodes of malaria
D: The safety and tolerability of AQ plus SP, PQP plus SP, and PQP plus DHA when used for seasonal IPT in children (Onset of IPT to end of malaria season)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: Comparison of Safety, Tolerability and Efficacy of Three Drug Combinations for Intermittent Preventive Treatment in Children Aged 1-5 Years in an Area of Seasonal Malaria Transmission in Upper River Division, The Gambia
Brief Summary: Intermittent preventive treatment (IPT) offers a way of preventing malaria infection without compromising the development of malaria immunity or encouraging drug resistance. The effect of IPT in children in the prevention of malaria has been evaluated in a number of trials in areas of seasonal malaria transmission. Results from these trials have shown that IPTc provided between 40% - 86% protection against clinical malaria. In 2006, a trial that compared two methods of IPTc delivery was carried out in Upper River Division, The Gambia. Preliminary results of the trial have shown that the treatment was very effective as only 4% (45/1133) of the children seen at the end of year cross-sectional survey were parasitaemic. Tolerability was assessed in a subset of 1100 children and the results showed that about 13.5% of children developed mild to moderate vomiting. Malaise was present in about 10% of the study subjects. Severe adverse events were rare. Thus it is important to investigate if other drug regimens might be equally effective in preventing malaria but less likely to cause adverse events. During the 2007 malaria transmission season, 1009 children aged 1-5 years will be individually randomized to receive amodiaquine plus SP, piperaquine plus SP or Artekin TM (dihdroartemisinin plus piperaquine) at monthly intervals on three occasions during the months of September, October, and November. To determine the prevalence of side effects following drug administration participants in each treatment group will be visited at home three and seven days after each round of drug administration and a side effects questionnaire completed. To help establish whether these adverse events are drug related, the same questionnaire will be administered after each treatment round, to 286 age-matched children who are not part of the trial. The primary ends points will be the incidence of adverse events.


Options:
A: incidence rate of clinical malaria; in vivo adequate clinical and parasitological response of P. falciparum to SP
B: Proportion of children with moderate anaemia (hemoglobin [Hb] <7 g/dl (at end of the malaria transmission season); haemoglobin concentration (At the end of malaria transmission season); hemoglobin concentration (at the end of malaria transmission season)
C: Incidence of malaria (Four months)
D: The safety and tolerability of AQ plus SP, PQP plus SP, and PQP plus DHA when used for seasonal IPT in children (Onset of IPT to end of malaria season)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: PROTECT II: A Prospective, Multi-center, Randomized Controlled Trial of the IMPELLA RECOVER LP 2.5 System Versus Intra Aortic Balloon Pump (IABP)in Patients Undergoing Non Emergent High Risk PCI
Brief Summary: The IMPELLA® 2.5 System will be superior to Intra Aortic Balloon Pump in preventing the composite rate of major adverse events during and after the PCI procedure.


Options:
A: death, myocardial infarction or refractory (up to and including Day 9); major bleeding (Up to Day 9)
B: Composite rate of 10 major adverse events including death; MI;Stroke or TIA; and repeat revascularization. (30 days +/- 10 days)
C: 30-day mortality (30 day)
D: Cardiac index (within 1 hour after device implantation)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: Lantus vs Sulfonylurea as add-on Therapy in Type 2 Diabetic Patients Failing Metformin Monotherapy: Comparison of Effects on Beta Cell Function and Metabolic Profile.
Brief Summary: Primary objective:

To compare long-term glycemic control and preservation of beta cell function when basal insulin or sulfonylurea is added on metformin in the early Type 2 Diabetes Mellitus patients

Secondary objective:

To assess the change of insulin resistance, microvascular complication incidence, patient satisfaction with treatment


Options:
A: ß-cell Function parameter (From the signature of the Informed Consent Form (ICF) up to the end of study); Glucose Homeostasis and glycemic control status (From the signature of the Informed Consent Form (ICF) up to the end of study)
B: Adjusted Mean Change From Baseline in A1C Levels (Last Observation Carried Forward [LOCF]) (Baseline to Week 24)
C: Change From Baseline in HbA1c at Week 52 (Baseline and Week 52)
D: Percentage of patients experiencing at least one Hypoglycaemic Event (HE) during the Ramadan fasting period to test superiority (1 month)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: Immediate Versus Delayed IUD Insertion Following Suction Aspiration Between 5 and 12 Weeks Gestation: a Randomized Trial
Brief Summary: The purpose of this multi-center clinical trial is to evaluate the safety and effectiveness of inserting an intrauterine device (IUD) immediately after a suction aspiration procedure compared to inserting the IUD 2-6 weeks after the procedure. This study will also evaluate how satisfied women are with the timing of their IUD placement. Subjects will be able to choose between the Paraguard IUD or the Mirena IUD.

The researchers hypothesize that:

1. the expulsion rates measured at 1, 3 and 6 months will be clinically equivalent with immediate insertion compared with delayed insertion,
2. satisfaction and tolerance of side effects will be higher with immediate IUD insertion compared with delayed insertion, and
3. overall IUD use/continuation rates measured at 1, 3 and 6 months will be higher with immediate IUD insertion compared with delayed insertion.


Options:
A: Evaluate the efficacy and tolerability of nitroprusside gel applied intracervically as an intervention to improve the IUD insertion experience for both patient and provider. (over one year)
B: Provider Perceived Ease of Insertion on a 100 Point Visual Analogue Scale (assessed immediately post IUD insertion)
C: Mean Maximum Procedural Pain Scores (2 minutes after the procedure.)
D: IUD expulsion (1, 3 and 6 months after insertion)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: Ranibizumab for Branch Retinal Vein Occlusion Associated Macular Edema Study (RABAMES)
Brief Summary: The primary objective of this pilot study is to compare the functional and anatomic outcomes of chronic macular edema secondary to branch retinal vein occlusion (BRVO) treated with argon laser photocoagulation versus intravitreal ranibizumab (Lucentis®) injection versus a combination of both.


Options:
A: Best corrected visual acuity (At 12 week); Macular thickness by OCT (At 12 week)
B: Mean Change in Visual Acuity: BCVA Change at Month 6 Compared to Baseline in Patients With Visual Impairment Due to Branch Retinal Vein Occlusion (BRVO) (Baseline, 6 Months)
C: N/A
D: Changes in best spectacle-corrected visual acuity (BSCVA) (from baseline to month 6)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: A Phase IV, Randomized, Observer-Blind, Placebo-Controlled, Multi-Centre Study to Evaluate the Efficacy, Safety and Tolerability of CSL Limited's Influenza Virus Vaccine in Adults Aged ≥ 18 to < 65 Years.
Brief Summary: This study will assess the Efficacy, Safety and Tolerability profile of CSL's Influenza Vaccine administered intramuscularly against laboratory-confirmed influenza illness in a population defined as being not at risk of severe complications following influenza infection.


Options:
A: Number of Subjects Developing Influenza Infection, as Confirmed by Viral Culture and Typing of Naso-pharyngeal Specimens (21 days to 180 days after the date of vaccination); The Consistency of Immune Response Produced by 3 Different Lots of VCIV Based on HIA Titer Values (21 Days after vaccination)
B: CSL's IVV Overall Vaccine Efficacy (VE) Versus Placebo Through Assessment of Incidence of Laboratory Confirmed Influenza A/B Infection (2008 and 2009 Southern Hemisphere influenza seasons, until 30 November 2009)
C: Medically-attended adverse events (Within one month after any dose)
D: Seroconversion Rate 21 Days After the First Vaccination (21 days after the first vaccination); Seroconversion Rate 21 Days After the Second Vaccination (21 days after the second vaccination); Percentage of Participants Achieving an Hemagglutination Inhibition (HI) Antibody Titer of 1:40 or More 21 Days After the First Vaccination (21 days after the first vaccination); Percentage of Participants Achieving an HI Antibody Titer of 1:40 or More 21 Days After the Second Vaccination (21 days after the second vaccination)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: EARLY: Prospective, Randomised, National, Multi-centre, Open-label, Blinded Endpoint Study to Compare Aggrenox b.i.d. (200 mg Dipyridamole MR + 25 mg Acetylsalicylic Acid) When Started Within 24 Hours of Stroke Onset on an Acute Stroke Unit, and Aggrenox b.i.d. When Started After a 7-day Therapy With ASA 100 mg Once Daily Outside Off an Acute Stroke Unit, in Symptomatic Ischaemic Stroke Patients Over a Three Months Treatment Period an Exploratory Study
Brief Summary: German stroke units are hesitating to use Aggrenox for secondary ischaemic stroke / transient ischaemic attack (TIA) prevention in a sub-acute treatment setting. They argue that clinical experience with sub-acute Aggrenox treatment is limited and poorly documented when compared with sub-acute acetylsalicylic acid (ASA) treatment. However, long term treatment (started after 3-6 months after stroke/TIA) with Aggrenox was safe and superior to ASA treatment in preventing recurrent strokes. There is no evidence for ASA to prevent from neurological progression after stroke during the first 3 months. Results from a cohort study suggest that starting Aggrenox within 72 hours after stroke predicts clinical improvement in the National Institute of Health Stroke Scale (NIHSS) at discharge from the hospital. Dipyridamole suppresses acute inflammatory responses to stroke.

This study is designed to investigate the tolerability and efficacy of a secondary stroke prevention treatment with Aggrenox when initiated within 24 hours of stroke onset on a stroke unit compared to later initiation after a 7 day ASA treatment and outside off a stroke unit setting.


Options:
A: Composite of Ischemic Stroke, Myocardial Infarction, or Death From Ischemic Vascular Causes (Up to 90 days); Major Hemorrhage (Up to 90 days)
B: Telephone Modified Rankin Scale (Centralised, Blinded Assessment) (90 days)
C: Number of Participants With Composite of Stroke/MI/Death (From randomization up to 97 days)
D: Number of Participants With Any Abnormal Laboratory Test Results (Part 1* and 2) (Day 1 (Baseline) up to Day 90); Number of Participants With Vital Signs Data Met Criteria of Potential Clinical Concern (Part 1* and 2) (Day 1 (Baseline) up to follow-up (28 days after Day 90)); Number of Participants With Electrocardiograms (ECGs) Data Met Criteria of Potential Clinical Concern (Part 1* and 2) (Day 1 (Baseline) to Day 90); Number of Participants With Significant Change in Physical Examination Findings (Part 1* and 2) (Day 1 (Baseline) up to Day 90); Number of Participants With Significant Change in Neurological Examination Findings (Part 1* and 2) (Day 1 (Baseline) up to Day 90); Number of Participants With Suicidal Behavior and/or Ideation as Assessed by Columbia-Suicide Severity Rating Scale (C-SSRS) (Part 1* and 2) (Day 7 (Baseline) up to follow up (28 days after Day 90)); Percentage of Participants With Modified Rankin Scale (mRS) Less Than or Equal to (<=2) at Day 90 (Part 2) (Day 90)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: EARLY: Prospective, Randomised, National, Multi-centre, Open-label, Blinded Endpoint Study to Compare Aggrenox b.i.d. (200 mg Dipyridamole MR + 25 mg Acetylsalicylic Acid) When Started Within 24 Hours of Stroke Onset on an Acute Stroke Unit, and Aggrenox b.i.d. When Started After a 7-day Therapy With ASA 100 mg Once Daily Outside Off an Acute Stroke Unit, in Symptomatic Ischaemic Stroke Patients Over a Three Months Treatment Period an Exploratory Study
Brief Summary: German stroke units are hesitating to use Aggrenox for secondary ischaemic stroke / transient ischaemic attack (TIA) prevention in a sub-acute treatment setting. They argue that clinical experience with sub-acute Aggrenox treatment is limited and poorly documented when compared with sub-acute acetylsalicylic acid (ASA) treatment. However, long term treatment (started after 3-6 months after stroke/TIA) with Aggrenox was safe and superior to ASA treatment in preventing recurrent strokes. There is no evidence for ASA to prevent from neurological progression after stroke during the first 3 months. Results from a cohort study suggest that starting Aggrenox within 72 hours after stroke predicts clinical improvement in the National Institute of Health Stroke Scale (NIHSS) at discharge from the hospital. Dipyridamole suppresses acute inflammatory responses to stroke.

This study is designed to investigate the tolerability and efficacy of a secondary stroke prevention treatment with Aggrenox when initiated within 24 hours of stroke onset on a stroke unit compared to later initiation after a 7 day ASA treatment and outside off a stroke unit setting.


Options:
A: Telephone Modified Rankin Scale (Centralised, Blinded Assessment) (90 days)
B: Comparison of the frequency of mRS 0, 1, 2 at 90 days (at 90 days)
C: Number of Patients With First Recurrent Cerebral Infarction (Fatal or Non-fatal) (Up to 124 weeks)
D: Composite of Ischemic Stroke, Myocardial Infarction, or Death From Ischemic Vascular Causes (Up to 90 days); Major Hemorrhage (Up to 90 days)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: EARLY: Prospective, Randomised, National, Multi-centre, Open-label, Blinded Endpoint Study to Compare Aggrenox b.i.d. (200 mg Dipyridamole MR + 25 mg Acetylsalicylic Acid) When Started Within 24 Hours of Stroke Onset on an Acute Stroke Unit, and Aggrenox b.i.d. When Started After a 7-day Therapy With ASA 100 mg Once Daily Outside Off an Acute Stroke Unit, in Symptomatic Ischaemic Stroke Patients Over a Three Months Treatment Period an Exploratory Study
Brief Summary: German stroke units are hesitating to use Aggrenox for secondary ischaemic stroke / transient ischaemic attack (TIA) prevention in a sub-acute treatment setting. They argue that clinical experience with sub-acute Aggrenox treatment is limited and poorly documented when compared with sub-acute acetylsalicylic acid (ASA) treatment. However, long term treatment (started after 3-6 months after stroke/TIA) with Aggrenox was safe and superior to ASA treatment in preventing recurrent strokes. There is no evidence for ASA to prevent from neurological progression after stroke during the first 3 months. Results from a cohort study suggest that starting Aggrenox within 72 hours after stroke predicts clinical improvement in the National Institute of Health Stroke Scale (NIHSS) at discharge from the hospital. Dipyridamole suppresses acute inflammatory responses to stroke.

This study is designed to investigate the tolerability and efficacy of a secondary stroke prevention treatment with Aggrenox when initiated within 24 hours of stroke onset on a stroke unit compared to later initiation after a 7 day ASA treatment and outside off a stroke unit setting.


Options:
A: Number of Patients With First Recurrent Cerebral Infarction (Fatal or Non-fatal) (Up to 124 weeks)
B: Telephone Modified Rankin Scale (Centralised, Blinded Assessment) (90 days)
C: Two (2) year incidence of stroke or Hard TIA (2 years); All cause mortality for the first 30 days of follow up/discharge, whichever is longer (30 days); Neurological mortality from 31 days of follow up (F/U) or longer (31 days)
D: Number of Participants With Composite of Stroke/MI/Death (From randomization up to 97 days)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: Nt-proBNP Guided Prevention of Cardiovascular Events in a Population of Diabetic Patients Without a History of Cardiac Disease
Brief Summary: Increased levels of NT-proBNP are known to increase the risk of cardiac events in diabetic patients. The other way around, patients with normal values have an excellent prognosis on short-term. We intend in our study to proof the hypothesis, whether it is possible to decrease NT-proBNP levels by intensified cardiac prevention care We aim those patients, who already have elevated levels, although no history of a cardiac disease. This decrease in NT-proBNP should be translated consequently in a decrease in cardiac events


Options:
A: Difference in total number of days alive and outside the hospital between the NT-proBNP guided and the clinical guided group. (minimum of one year)
B: Prevalence and severity of LVD (5 year)
C: Effect of Standard of Care therapy versus Standard of Care plus NT-proBNP targeted therapy on total cardiovascular events (One year)
D: Reduction in cardiac events (2)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: Monitoring Asthma Treatment Using Exhaled Nitric Oxide
Brief Summary: Asthma is a chronic inflammatory condition in which the airways develop increased responsiveness to various stimuli such as exposure to an allergen, cold air or exercise. It is characterized by airway hyper-responsiveness, inflammation, increased mucus production, and airway obstruction. Since inflammation is an important feature of asthma, the use of non-invasive tests to measure lung inflammation to monitor asthma are of interest.The purpose of the study is to relate costs associated with healthcare utilization and loss of work and school time to the primary health outcome of cumulative number of symptom-free days. This will enable the researchers to determine whether the costs of monitoring exhaled NO to regular management strategy in recently diagnosed asthma will be offset by reductions in other costs of asthma-related care, and, if not, whether the additional costs are likely to be acceptable in terms of the improvement in health outcomes as measured by the additional number of symptom-free days.


Options:
A: Change in FENO (2 weeks)
B: Time to Treatment Failure (Measured in Days) (Measured during the 36-week treatment period)
C: Mean maximum symptom days per 2 weeks, as assessed by questionnaire (At Visits 3 and 8)
D: symptom-free days (1 year time frame with visits every 3 months)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: Monitoring Asthma Treatment Using Exhaled Nitric Oxide
Brief Summary: Asthma is a chronic inflammatory condition in which the airways develop increased responsiveness to various stimuli such as exposure to an allergen, cold air or exercise. It is characterized by airway hyper-responsiveness, inflammation, increased mucus production, and airway obstruction. Since inflammation is an important feature of asthma, the use of non-invasive tests to measure lung inflammation to monitor asthma are of interest.The purpose of the study is to relate costs associated with healthcare utilization and loss of work and school time to the primary health outcome of cumulative number of symptom-free days. This will enable the researchers to determine whether the costs of monitoring exhaled NO to regular management strategy in recently diagnosed asthma will be offset by reductions in other costs of asthma-related care, and, if not, whether the additional costs are likely to be acceptable in terms of the improvement in health outcomes as measured by the additional number of symptom-free days.


Options:
A: Change in FENO (2 weeks)
B: symptom-free days (1 year time frame with visits every 3 months)
C: Mean maximum symptom days per 2 weeks, as assessed by questionnaire (At Visits 3 and 8)
D: Time to Treatment Failure (Measured in Days) (Measured during the 36-week treatment period)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: Open, Randomised, Parallel Group Multicentre Study to Compare the Efficacy & Safety of Flutiform® pMDI vs Fluticasone pMDI Plus Formoterol DPI in Adolescent & Adult Subjects With Mild to Moderate-severe Persistent, Reversible Asthma
Brief Summary: Flutiform® compared with the individual components Flixotide® (Fluticasone) and Foradil® (Formoterol) in adolescent and adult patients.


Options:
A: The Percentage of Participants Who Had Experienced Asthma Exacerbation(s) at the End of the Study (week 52)
B: Comparison of mean Forced Expriatory Volume in the 1st second (FEV1) values. (12 weeks)
C: 'Well-controlled Asthma Week' - a Derived Binary Variable (Yes/No) (Weekly, up to 52 weeks)
D: Percent Change in Maximum Post-exercise Forced Expiratory Volume in One Second (FEV1) Fall After 6 Weeks (Baseline and Visit 6)

Answer: B