TrialPanorama/Dataset huggingface dataset:
Please select the outcome measures that correspond to the clinical trial below.
Title: Effects of Intravenous Albumin Administration on Renal Function and Survival in Patients With Cirrhosis and Infections Unrelated to Spontaneous Bacterial Peritonitis. A Prospective, Stratified, Randomized and Controlled Study.
Brief Summary: Spontaneous bacterial peritonitis (SBP) present in cirrhotic patients induces severe circulatory dysfunction, which results in renal failure in up to 30% of the patients. Renal failure is an important prognostic marker, representing the major predictive factor of in-hospital mortality.

Recent studies have shown that plasma volume expansion with albumin associated with cefotaxime in patients with SBP is more efficient to prevent renal failure than cefotaxime treatment alone. The in-hospital and three-month mortality rates, furthermore, were significantly lower in the group treated with albumin.

It is not known if other bacterial infections unrelated to SBP represent a risk factor for the development of renal failure among cirrhotic patients. The researcher's group has recently performed a study to evaluate the incidence, characteristics and outcome, of renal failure in patients with cirrhosis and bacterial infections unrelated to SBP associated with the systemic inflammatory response syndrome (Terra, unpublished results). Among a total of 106 patients, 29 (27%) presented renal failure during the course of infection. Renal failure was characterized by intense renal vasoconstriction (intrarenal resistive index of 0.83 +/- 0.09, measured by Doppler ultrasound), reduction of mean arterial pressure and an important activation of endogenous vasoconstriction systems. The three-month survival probability of patients with infection and renal failure was 34 %, much lower than that of patients with infection but not presenting renal failure (87%, p\<0.0001). These results suggest that the development of renal failure in patients with cirrhosis and bacterial infections different from SBP, associated with signs of a systemic inflammatory response, is very frequent and results in a very poor prognosis. Taken as a whole, these data strongly indicate the need to consider these patients as candidates for liver transplantation and to plan strategies for its prevention.

The objective of this project, therefore, is to evaluate if the plasma volume expansion with albumin, associated with conventional antibiotic therapy, can prevent the development of renal failure and increase survival rates in cirrhotic patients with bacterial infections unrelated to spontaneous bacterial peritonitis.


Options:
A: Mortality or dialysis-dependency (90 days)
B: Renal failure rate (at 3 months)
C: To evaluate complications (renal failure, hepatic encephalopathy, hyponatremia, infection and gastrointestinal bleeding) in patients with cirrhosis awaiting for liver transplant. (When 97 patients are included (% of the whole population))
D: Renal failure rate (During hospitalization); Renal failure rate (at 3 month)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: Efficacy of Intrarectal Versus Intravenous Quinine for the Treatment of Childhood Cerebral Malaria: a Randomized Clinical Trial
Brief Summary: Cerebral malaria is the most lethal complication of P.falciparum infection with a mortality rate between 5 and 40%. Intravenous quinine remains the recommended treatment for cerebral malaria. However its administration is often not feasible due to lack of simple equipment or trained staff. When referral is not possible, a viable alternative is needed. The intrarectal route is of interest in children since it is painless and simple. Studies of the efficacy of intrarectal quinine in the treatment of cerebral malaria are limited. The study aims to establish the efficacy of intrarectal quinine in the treatment of childhood cerebral malaria.


Options:
A: Changes in Haemoglobin Concentration From Day 3 Post Treatment of Malaria Episode to Day 90 in the Weekly Chloroquine and Placebo Arms (90 days)
B: Efficacy:; The proportion of children with at least one episode of anemia from 3 to 18 months of life; The proportion of children with at least one episode of malaria from 3 to 18 months of life; Safety:; The proportion of children with at least one episode of an adverse event; The proportion of children with at least one episode of a serious adverse event; Rebound:; The proportion of children with at least one episode of anemia from 18-30 months of life, the proportion of children with at least one episode of malaria from 18-30 months of life
C: 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)
D: Parasite clearance time

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: Efficacy of Intrarectal Versus Intravenous Quinine for the Treatment of Childhood Cerebral Malaria: a Randomized Clinical Trial
Brief Summary: Cerebral malaria is the most lethal complication of P.falciparum infection with a mortality rate between 5 and 40%. Intravenous quinine remains the recommended treatment for cerebral malaria. However its administration is often not feasible due to lack of simple equipment or trained staff. When referral is not possible, a viable alternative is needed. The intrarectal route is of interest in children since it is painless and simple. Studies of the efficacy of intrarectal quinine in the treatment of cerebral malaria are limited. The study aims to establish the efficacy of intrarectal quinine in the treatment of childhood cerebral malaria.


Options:
A: Malaria incidence (the number of OPD attendances with clinical malaria that meet the case definitions as indicated below during the surveillance period ) and the number of hospital admissions with malaria during the surveillance period. (during malaria transmission period); Cost-effectiveness of the delivery system. (during the study period)
B: Malaria incidence (the number of study subjects seen at the OPD clinic with clinical malaria during the surveillance period). (During the surveillance period (September to December 2008))
C: Parasite clearance time
D: malaria morbidity by active and passive case detection. (during the entire study period); asexual parasite prevalence and density by microscopy, rapid diagnostic test and molecular QT-NASBA (monthly during the entire study period); gametocyte prevalence and density by QT-NASBA and microscopy (monthly during the entire study period); transmission intensity quantified by entomologic inoculation rate (continuously during the study period); human infectious reservoir (prior to the intervention and several months after the intervention)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: Efficacy of Intrarectal Versus Intravenous Quinine for the Treatment of Childhood Cerebral Malaria: a Randomized Clinical Trial
Brief Summary: Cerebral malaria is the most lethal complication of P.falciparum infection with a mortality rate between 5 and 40%. Intravenous quinine remains the recommended treatment for cerebral malaria. However its administration is often not feasible due to lack of simple equipment or trained staff. When referral is not possible, a viable alternative is needed. The intrarectal route is of interest in children since it is painless and simple. Studies of the efficacy of intrarectal quinine in the treatment of cerebral malaria are limited. The study aims to establish the efficacy of intrarectal quinine in the treatment of childhood cerebral malaria.


Options:
A: 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)
B: Parasite clearance time
C: Prevalence of anaemia (Hb <112g/L) (March 2006)
D: incidence rate of clinical malaria; in vivo adequate clinical and parasitological response of P. falciparum to SP

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: A Randomized Multicenter Clinical Trial to Evaluate the Efficacy of Amitriptyline for the Treatment of Painful Bladder Syndrome (PBS) in Newly Diagnosed Patients
Brief Summary: This is a randomized clinical trial study to test the efficacy and safety of amitriptyline in the treatment of patients newly diagnosed with painful bladder syndrome (PBS). PBS is defined by symptoms--frequent urination day and night and increasing pain as the bladder fills--according to the International Continence Society. The syndrome includes interstitial cystitis (IC), which has been estimated to affect as many as 700,000 people, mostly women. Estimates for PBS vary widely, but as many as 10 million people may suffer from this condition. Although amitriptyline is a Food and Drug Administration (FDA)-approved medication used for depression, the way it works makes it useful for treating the pain of fibromyalgia, multiple sclerosis, and other chronic pain syndromes. Prior small studies in interstitial cystitis (IC) suggested the drug may be a wise choice for this syndrome as well, because it blocks nerve signals that trigger pain and may also decrease muscle spasms in the bladder, helping to relieve the symptoms of pain and frequent urination.


Options:
A: Change From Baseline in the Weekly Mean of the 24-Hour Average Pain Score at 8 Weeks (Baseline, 8 weeks (blinded endpoint))
B: Mean Change From Baseline at 12-Week Endpoint in the Weekly Mean of Pain Severity Score (Baseline, 12 weeks)
C: Global Response Assessment (GRA) (12 Weeks)
D: Change From Baseline in Mean Systolic Blood Pressure Following 12-hour Period Post-AM Dose at Visit 4 (4 weeks (1 week of dose-escalation, 3 weeks of 100 mg/d)); Change From Baseline in Mean Systolic Blood Pressure Following 12-hour Period Post-AM Dose at Visit 6 (7 weeks (1 week of dose-escalation, 3 weeks of 100 mg/d, followed by 1 week at 150 mg/d and 2 weeks of 200 mg/d))

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: A Randomized Multicenter Clinical Trial to Evaluate the Efficacy of Amitriptyline for the Treatment of Painful Bladder Syndrome (PBS) in Newly Diagnosed Patients
Brief Summary: This is a randomized clinical trial study to test the efficacy and safety of amitriptyline in the treatment of patients newly diagnosed with painful bladder syndrome (PBS). PBS is defined by symptoms--frequent urination day and night and increasing pain as the bladder fills--according to the International Continence Society. The syndrome includes interstitial cystitis (IC), which has been estimated to affect as many as 700,000 people, mostly women. Estimates for PBS vary widely, but as many as 10 million people may suffer from this condition. Although amitriptyline is a Food and Drug Administration (FDA)-approved medication used for depression, the way it works makes it useful for treating the pain of fibromyalgia, multiple sclerosis, and other chronic pain syndromes. Prior small studies in interstitial cystitis (IC) suggested the drug may be a wise choice for this syndrome as well, because it blocks nerve signals that trigger pain and may also decrease muscle spasms in the bladder, helping to relieve the symptoms of pain and frequent urination.


Options:
A: Net change of Patient Perception of Visual Analogue Scale (VAS) (Baseline and 8 weeks)
B: Global Response Assessment (GRA) (12 Weeks)
C: IC/BPS Symptoms Change With Overall Global Response Assessment (GRA) (Week 2)
D: Change From Baseline in Treatment Response as Measured by the Total Score on the O'Leary-Sant Questionnaire (Assessed at baseline, 3 and 6 weeks; change from baseline to week 6 reported)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: Randomized, Multicenter, Double-Blind, Placebo-Controlled, Two-Arm Parallel Group Trial of Rimonabant 20-mg od, for Inhibition of Atherosclerosis Progression Assessed by IVUS (IntraVascular UltraSounds), in Overweight Patients With Clustering Risk Factors
Brief Summary: The purpose of this study is to determine if rimonabant 20 mg once daily (od) administered during 18-20 months will reduce progression of coronary atherosclerosis as assessed by intravascular ultrasound (IVUS) when administered on top of standard behavioral and pharmacological therapy given as needed, in patients with abdominal obesity associated with current smoking and/or metabolic syndrome.


Options:
A: Change From Baseline in Apnoea-hypopnoea Index (AHI) (Week 0, Week 32)
B: change from baseline in percent atheroma volume (PAV) (Month 18 visit)
C: Co-primary: Body Weight- Mean Percent Change (Baseline, 56 weeks); Co-primary: Body Weight- Proportion of Subjects With ≥5% Decrease (Baseline, 56 weeks)
D: Percentage of Participants With a Confirmed Occurrence of Major Adverse Cardiovascular Event (MACE) (Confirmed occurrence of event between Day 1 (randomization) and up to a maximum of 4 years of follow-up)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: Misoprostol for Preventing Postpartum Hemorrhage
Brief Summary: This hospital-based, multicenter, randomized, placebo-controlled trial will assess the effects of misoprostol as part of active management of the third stage of labor on postpartum blood loss, complications, and side effects. Twelve hundred eligible women will receive routine oxytocics (oxytocin 5-10 IU) plus either 400 mcg sublingual misoprostol or placebo during or immediately after delivery. The primary outcome will be measured blood loss of =\>500 mls within one hour after enrollment.


Options:
A: Need for additional treatment after initial PPH study treatment (all additional interventions recorded following initial uterotonic treatment)
B: Blood loss =>500 mls within one hour after enrollment
C: Incidence of acute postpartum hemorrhage: blood loss ≥ 500 ml within two hours of delivery
D: Blood loss greater than or equal to 500 mls after enrolment (Blood loss measured for minimum of 1 hour or until active bleeding ceased)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: Misoprostol for Preventing Postpartum Hemorrhage
Brief Summary: This hospital-based, multicenter, randomized, placebo-controlled trial will assess the effects of misoprostol as part of active management of the third stage of labor on postpartum blood loss, complications, and side effects. Twelve hundred eligible women will receive routine oxytocics (oxytocin 5-10 IU) plus either 400 mcg sublingual misoprostol or placebo during or immediately after delivery. The primary outcome will be measured blood loss of =\>500 mls within one hour after enrollment.


Options:
A: Blood loss =>500 mls within one hour after enrollment
B: Immediate hemodynamic effects of carbetocin and oxytocin (1 day)
C: To evaluate the efficacy of buccal misoprostol in the prevention of uterine atony and postpartum hemorrhage (PPH) after caesarean section (an expected average 1 week)
D: Uterine tone. (2 minutes)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: Misoprostol for Preventing Postpartum Hemorrhage
Brief Summary: This hospital-based, multicenter, randomized, placebo-controlled trial will assess the effects of misoprostol as part of active management of the third stage of labor on postpartum blood loss, complications, and side effects. Twelve hundred eligible women will receive routine oxytocics (oxytocin 5-10 IU) plus either 400 mcg sublingual misoprostol or placebo during or immediately after delivery. The primary outcome will be measured blood loss of =\>500 mls within one hour after enrollment.


Options:
A: To evaluate the efficacy of buccal misoprostol in the prevention of uterine atony and postpartum hemorrhage (PPH) after caesarean section (an expected average 1 week)
B: Maximal uterine tone (within the first 5 minutes after cord clamping)
C: Mean change in hemoglobin (during 3rd trimester and 1-3 days postpartum)
D: Blood loss =>500 mls within one hour after enrollment

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: The Potential for Diet Modification to Improve Glycaemic Control and Cardiovascular Risk Factors Over and Above Drug Therapy in Type 2 Diabetes at High Risk of Cardiovascular Disease
Brief Summary: In the past, nutritional management formed the cornerstone of treatment of type 2 diabetes (T2DM). More recently, this aspect of treatment has received less attention as drug therapy aimed not only to lower glucose, but also to treat raised blood pressure and blood fats (including cholesterol) has been more widespread. While there is evidence to suggest that blood pressure and blood fat levels have improved, overall diabetes control has not and people with diabetes appear to be becoming progressively more overweight, following trends in the general population. The proposed study involves a randomised controlled trial in which people with T2DM continuing with their regular drug treatment and surveillance, will be randomly allocated to additionally receive intensive advice regarding diet or remain on their usual treatment in this regard. The results will be judged principally in terms of body weight, waist circumference, blood pressure, blood glucose control and blood fats.


Options:
A: body weight (prior to and after 4, 8, and 12 months of dieting)
B: Change in body weight (measured at Year 2)
C: Body mass index (BMI); Glycated Haemoglobin (HbA1c); Triglycerides; Dietary intake as measured by 3-day weighed diet records; All measures to be compared at end of study (6 months)
D: Changes in body weight; Weight loss maintenance efficacy (>5% and >10%); Body composition (whole body DEXA-scanning); Drop-out rate; Glucose metabolism (Oral Glucose Tolerance Test); Endothelium function (flow-mediated vasodilatation, FMD)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: The Potential for Diet Modification to Improve Glycaemic Control and Cardiovascular Risk Factors Over and Above Drug Therapy in Type 2 Diabetes at High Risk of Cardiovascular Disease
Brief Summary: In the past, nutritional management formed the cornerstone of treatment of type 2 diabetes (T2DM). More recently, this aspect of treatment has received less attention as drug therapy aimed not only to lower glucose, but also to treat raised blood pressure and blood fats (including cholesterol) has been more widespread. While there is evidence to suggest that blood pressure and blood fat levels have improved, overall diabetes control has not and people with diabetes appear to be becoming progressively more overweight, following trends in the general population. The proposed study involves a randomised controlled trial in which people with T2DM continuing with their regular drug treatment and surveillance, will be randomly allocated to additionally receive intensive advice regarding diet or remain on their usual treatment in this regard. The results will be judged principally in terms of body weight, waist circumference, blood pressure, blood glucose control and blood fats.


Options:
A: Body mass index (BMI); Glycated Haemoglobin (HbA1c); Triglycerides; Dietary intake as measured by 3-day weighed diet records; All measures to be compared at end of study (6 months)
B: The primary outcome measure is HDL-C (12 weeks and 24 weeks)
C: Diet Quality assessed using the Alternative Healthy Eating Index (AHEI) (6 months)
D: 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)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: The Potential for Diet Modification to Improve Glycaemic Control and Cardiovascular Risk Factors Over and Above Drug Therapy in Type 2 Diabetes at High Risk of Cardiovascular Disease
Brief Summary: In the past, nutritional management formed the cornerstone of treatment of type 2 diabetes (T2DM). More recently, this aspect of treatment has received less attention as drug therapy aimed not only to lower glucose, but also to treat raised blood pressure and blood fats (including cholesterol) has been more widespread. While there is evidence to suggest that blood pressure and blood fat levels have improved, overall diabetes control has not and people with diabetes appear to be becoming progressively more overweight, following trends in the general population. The proposed study involves a randomised controlled trial in which people with T2DM continuing with their regular drug treatment and surveillance, will be randomly allocated to additionally receive intensive advice regarding diet or remain on their usual treatment in this regard. The results will be judged principally in terms of body weight, waist circumference, blood pressure, blood glucose control and blood fats.


Options:
A: Change in body weight (measured at Year 2)
B: The primary objective will be to compare the effects of the two different diet recommendations with respect to the one-year change in body weight.
C: Body mass index (BMI); Glycated Haemoglobin (HbA1c); Triglycerides; Dietary intake as measured by 3-day weighed diet records; All measures to be compared at end of study (6 months)
D: Number of participants with allergic disease (Up to 13 years); Weight gain (Up to 13 years); Number of patients with chronic inflammatory disease (Up to 13 years)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: The Potential for Diet Modification to Improve Glycaemic Control and Cardiovascular Risk Factors Over and Above Drug Therapy in Type 2 Diabetes at High Risk of Cardiovascular Disease
Brief Summary: In the past, nutritional management formed the cornerstone of treatment of type 2 diabetes (T2DM). More recently, this aspect of treatment has received less attention as drug therapy aimed not only to lower glucose, but also to treat raised blood pressure and blood fats (including cholesterol) has been more widespread. While there is evidence to suggest that blood pressure and blood fat levels have improved, overall diabetes control has not and people with diabetes appear to be becoming progressively more overweight, following trends in the general population. The proposed study involves a randomised controlled trial in which people with T2DM continuing with their regular drug treatment and surveillance, will be randomly allocated to additionally receive intensive advice regarding diet or remain on their usual treatment in this regard. The results will be judged principally in terms of body weight, waist circumference, blood pressure, blood glucose control and blood fats.


Options:
A: Serum estrone concentrations as measured by radioimmunoassay (At baseline and 12 months timepoint)
B: N/A
C: Body mass index (BMI); Glycated Haemoglobin (HbA1c); Triglycerides; Dietary intake as measured by 3-day weighed diet records; All measures to be compared at end of study (6 months)
D: The occurrence of myocardial infarction, coronary bypass surgery, percutaneous transluminal coronary angioplasty, stroke, carotid endarterectomy, percutaneous transluminal cerebral angioplasty, carotid artery stenting, or death (Every 12 months, at the end of the study.)

Answer: C