TrialPanorama/Dataset huggingface dataset:
Please select the outcome measures that correspond to the clinical trial below.
Title: Clinical Decision Support for Women With a History of Gestational Diabetes
Brief Summary: The investigators hypothesize that computer-assisted decision support will increase the percentage of women with a history of gestational diabetes who receive appropriate follow-up screening.

Specific Aim 1: Develop an algorithm to identify cases of gestational diabetes among patients in the Partners Health Care system using administrative and laboratory data.

Specific Aim 2: Assess primary care provider knowledge, attitudes, beliefs, and barriers to compliance regarding screening guidelines for women with a history of gestational diabetes.

Specific Aim 3: Test whether a computer-assisted decision support tool to identify patients with a GDM history and prompt screening will increase compliance with guidelines. The investigators hypothesize that decision support will significantly increase in the percentage of women screened.


Options:
A: Proportion of visits to primary care clinic associated with antibiotic prescriptions (30 days)
B: a designated health care proxy (12 months after intervention made available); initial bone density scan (12 months after intervention made available); administration of annual influenza vaccine (12 months after intervention started); administration of pneumococcal vaccine (12 months after the start of the intervention)
C: Error rate per patient treated demonstrated by deviation from the algorithms
D: Rate of screening (1 year following implementation at all sites (Nov. 2011))

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: Is a Knee Arthroscopy of Any Benefit for the Middleaged Patient With Meniscal Symptoms?
Brief Summary: The purpose of this study is to determine whether a knee arthroscopy is effective in the treatment of middleaged patients with meniscal symptoms also receiving a standardised exercise program.


Options:
A: To compare between the two treatment groups the patients' disease-specific quality of life at 2 years using the Western Ontario McMaster (WOMAC) osteoarthritis index and (2 years)
B: Knee Injury and Osteoarthritis Outcome Score (KOOS) (PRE surgery (assessed 1-14 days prior to surgery) and at 12 weeks and 52 weeks follow-up)
C: the Knee Injury and Osteoarthritis Outcome Score (KOOS4) (Primary endpoint: Change from baseline to 12 months.)
D: KOOS (Knee injury and Osteoarthritis Outcome Score); Pain subscale (12 month)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: Is a Knee Arthroscopy of Any Benefit for the Middleaged Patient With Meniscal Symptoms?
Brief Summary: The purpose of this study is to determine whether a knee arthroscopy is effective in the treatment of middleaged patients with meniscal symptoms also receiving a standardised exercise program.


Options:
A: Knee Injury and Osteoarthritis Outcome Score (KOOS) Quality of Life (24 months follow up)
B: To compare between the two treatment groups the patients' disease-specific quality of life at 2 years using the Western Ontario McMaster (WOMAC) osteoarthritis index and (2 years)
C: KOOS (Knee injury and Osteoarthritis Outcome Score); Pain subscale (12 month)
D: WOMAC Functional Status - Difference From Baseline (Baseline and 6 months)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: Intracranial Pressure in Experimental Models of Headache
Brief Summary: The purpose of this study is to determine whether increased pressure in the head is elevated in people who suffer from High Altitude Headache. We hypothesise that head pressure will be elevated in people with High Altitude Headache.


Options:
A: Magnitude of Decrement in Exercise Time Trial Performance in Hypoxia (Low Oxygen) Compared With Normoxia (Normal Oxygen). (The exercise trial will begin within 5 hours of exposure to either normoxia or hypoxia)
B: Effect of study treatment on 24 h ambulatory systolic blood pressure at high altitude (After 6 weeks of study treatment, during high altitude visit)
C: acute mountain sickness (during ascent)
D: Change in Optic Nerve Sheath Diameter by Ultrasonography (Optic Nerve Sheath Diameter: baseline, 24 hours.)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: Intracranial Pressure in Experimental Models of Headache
Brief Summary: The purpose of this study is to determine whether increased pressure in the head is elevated in people who suffer from High Altitude Headache. We hypothesise that head pressure will be elevated in people with High Altitude Headache.


Options:
A: Change in Optic Nerve Sheath Diameter by Ultrasonography (Optic Nerve Sheath Diameter: baseline, 24 hours.)
B: Incidence measured by Lake Louise acute mountain sickness score (LLS) ≥ 3 with headache and one other symptom. (within 18 hours after ascent to altitude 3100m)
C: Effect of study treatment on 24 h ambulatory systolic blood pressure at high altitude (After 6 weeks of study treatment, during high altitude visit)
D: Acute mountain sickness score (At 3230m and 4,130m(Annapurna base camp))

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: Intracranial Pressure in Experimental Models of Headache
Brief Summary: The purpose of this study is to determine whether increased pressure in the head is elevated in people who suffer from High Altitude Headache. We hypothesise that head pressure will be elevated in people with High Altitude Headache.


Options:
A: acute mountain sickness (during ascent)
B: prevention of high altitude pulmonary edema
C: Change in Optic Nerve Sheath Diameter by Ultrasonography (Optic Nerve Sheath Diameter: baseline, 24 hours.)
D: Magnitude of Decrement in Exercise Time Trial Performance in Hypoxia (Low Oxygen) Compared With Normoxia (Normal Oxygen). (The exercise trial will begin within 5 hours of exposure to either normoxia or hypoxia)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: The Use of Human Albumin for the Treatment of Ascites in Patients With Hepatic Cirrhosis: a Multicenter, Open-label Randomized Clinical Trial
Brief Summary: Ascites is the most frequent complication of liver cirrhosis and carries a significant worsening of the prognosis. Approximately 10% of patients per year develop refractory ascites because of either the lack of response to medical treatment or the onset of diuretic-induced complications that preclude the use of an effective dosage. Refractory ascites is associated with an increased incidence of severe complications of cirrhosis. Thus, the overall probability of survival of patients with refractory ascites is very poor, being approximately 30% at 2 years. Repeated large-volume paracentesis, transjugular intrahepatic portosystemic shunt (TIPS), and liver transplantation represent the therapeutic alternatives for refractory ascites. As renal sodium retention and ascites formation are the consequence of portal hypertension and effective hypovolemia, the preservation of the central blood volume represents a major purpose in the management of patients with advanced cirrhosis. Although albumin is responsible for about 70% of the plasma oncotic pressure, the absence of large multicenter randomized studies together with its high cost explains why albumin infusion is not usually included among the therapeutic options for difficult-to-treat ascites.

The objective of the present study is to define the effectiveness of the prolonged administration of human albumin in the treatment of liver cirrhosis with ascitic decompensation. This goal will be reached by performing a multicenter, prospective, randomized clinical trial comparing the efficacy of chronic albumin administration on top of standard medical treatment versus standard medical treatment alone in patients with cirrhosis and ascites.

The study will be conducted in 44 Italian clinical centers and will enrol 440 in- or out-patients affected by liver cirrhosis with uncomplicated ascites who will be randomized with a ratio of 1:1. The duration of the study for each patient is 18 months from randomization. The enrolment of patients will last 18 months and will be competitive between centers. Treatment will be interrupted if one of the following condition occur: orthotopic liver transplantation, TIPS, need of 3 paracentesis/month (indication to TIPS), patient refusal to continue, and medical judgement.

An ancillary optional study will be performed in a subset of patients to analyze the non-oncotic properties of albumin.


Options:
A: Mortality (18 months)
B: 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))
C: Number of patients with control of ascites (3 months)
D: Paracentesis free survival (6 months)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: The Use of Human Albumin for the Treatment of Ascites in Patients With Hepatic Cirrhosis: a Multicenter, Open-label Randomized Clinical Trial
Brief Summary: Ascites is the most frequent complication of liver cirrhosis and carries a significant worsening of the prognosis. Approximately 10% of patients per year develop refractory ascites because of either the lack of response to medical treatment or the onset of diuretic-induced complications that preclude the use of an effective dosage. Refractory ascites is associated with an increased incidence of severe complications of cirrhosis. Thus, the overall probability of survival of patients with refractory ascites is very poor, being approximately 30% at 2 years. Repeated large-volume paracentesis, transjugular intrahepatic portosystemic shunt (TIPS), and liver transplantation represent the therapeutic alternatives for refractory ascites. As renal sodium retention and ascites formation are the consequence of portal hypertension and effective hypovolemia, the preservation of the central blood volume represents a major purpose in the management of patients with advanced cirrhosis. Although albumin is responsible for about 70% of the plasma oncotic pressure, the absence of large multicenter randomized studies together with its high cost explains why albumin infusion is not usually included among the therapeutic options for difficult-to-treat ascites.

The objective of the present study is to define the effectiveness of the prolonged administration of human albumin in the treatment of liver cirrhosis with ascitic decompensation. This goal will be reached by performing a multicenter, prospective, randomized clinical trial comparing the efficacy of chronic albumin administration on top of standard medical treatment versus standard medical treatment alone in patients with cirrhosis and ascites.

The study will be conducted in 44 Italian clinical centers and will enrol 440 in- or out-patients affected by liver cirrhosis with uncomplicated ascites who will be randomized with a ratio of 1:1. The duration of the study for each patient is 18 months from randomization. The enrolment of patients will last 18 months and will be competitive between centers. Treatment will be interrupted if one of the following condition occur: orthotopic liver transplantation, TIPS, need of 3 paracentesis/month (indication to TIPS), patient refusal to continue, and medical judgement.

An ancillary optional study will be performed in a subset of patients to analyze the non-oncotic properties of albumin.


Options:
A: Mortality or dialysis-dependency (90 days)
B: Renal failure rate (During hospitalization); Renal failure rate (at 3 month)
C: Mortality (18 months)
D: 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))

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: Comparison of the Efficacy and Safety of Two ACTs Plus Primaquine for Uncomplicated Plasmodium Vivax Malaria in North Sumatera, Indonesia: 1 Year Followup
Brief Summary: This randomized clinical trial will be conducted in subjects with uncomplicated Plasmodium vivax malaria during November 2010 to March 2012. The aim of the study is to compare the efficacy and safety of artesunate-amodiaquine plus primaquine (AS-AQ + PQ) and dihydroartemisinin-piperaquine plus primaquine (DHP + PQ) in uncomplicated vivax malaria. The significance of the study is to find alternative drug for treating patients with vivax malaria in case the standard treatment is not available or become resistance. This study will give thorough information about the efficacy and safety of 2 artemisinin-based combination therapies (ACTs) in combination with primaquine. It will also inform the Indonesian Ministry of Health on their suggested policies for radical cure of vivax malaria, and provides evidence based treatment options for chloroquine resistant vivax malaria. This study will also provide information about prevalence of glucose-6-phosphate dehydrogenase (G6PD) deficiency and G6PD variants in North Sumatera population.


Options:
A: Assessment of cure rate of both arms AS-AQ + PQ and DHP+PQ (42 days)
B: Cure rate (63 days)
C: 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)
D: Primary Efficacy Variable: Proportion with relapse(s) of P. vivax in 12 months of follow-up. (2004-March 2007)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: Comparison of the Efficacy and Safety of Two ACTs Plus Primaquine for Uncomplicated Plasmodium Vivax Malaria in North Sumatera, Indonesia: 1 Year Followup
Brief Summary: This randomized clinical trial will be conducted in subjects with uncomplicated Plasmodium vivax malaria during November 2010 to March 2012. The aim of the study is to compare the efficacy and safety of artesunate-amodiaquine plus primaquine (AS-AQ + PQ) and dihydroartemisinin-piperaquine plus primaquine (DHP + PQ) in uncomplicated vivax malaria. The significance of the study is to find alternative drug for treating patients with vivax malaria in case the standard treatment is not available or become resistance. This study will give thorough information about the efficacy and safety of 2 artemisinin-based combination therapies (ACTs) in combination with primaquine. It will also inform the Indonesian Ministry of Health on their suggested policies for radical cure of vivax malaria, and provides evidence based treatment options for chloroquine resistant vivax malaria. This study will also provide information about prevalence of glucose-6-phosphate dehydrogenase (G6PD) deficiency and G6PD variants in North Sumatera population.


Options:
A: Recurrence of P. vivax (52 weeks)
B: Primary Efficacy Variable: Proportion with relapse(s) of P. vivax in 12 months of follow-up. (2004-March 2007)
C: Pharmacokinetic Parameters of Primaquine and Carboxyprimaquine in breast milk. Area Under Curve (AUC) (13 Days. Time Frame: predose, 0,1,2,3,4,6,8,12,24,72 hours; Day 7, Day 13 post-dose)
D: Assessment of cure rate of both arms AS-AQ + PQ and DHP+PQ (42 days)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: Vitamin D Supplementation Enhances Immune Response to BCG Vaccination in Infants
Brief Summary: The purpose of this study is to determine whether a single oral dose of vitamin D given to infants prior to Bacille-Calmette-Guerin (BCG) vaccination will enhance the immune response to BCG vaccination.


Options:
A: Bacille-Calmette-Guerin (BCG) vaccine efficacy (2 months); Bacille-Calmette-Guerin (BCG) vaccine efficacy (6 months); Bacille-Calmette-Guerin (BCG) vaccine efficacy (1 year)
B: To evaluate the effects of supplemental vitamin D in enhancing calcium absorption in healthy children 4 to 8 yrs of age. (End of the study)
C: Blood 25 Hydroxyvitamin D (25OHD) Concentrations (1 day (On admission to the pediatric intensive care unit (PICU) following CHD surgery))
D: Maternal and Neonatal complications (six months post enrolement)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: Smoking Cessation in Hospitalized Smokers
Brief Summary: When smokers are hospitalized they quit smoking, either voluntarily or involuntarily. Most of them, however, go back to smoking soon after discharge. This study will test an innovative approach which includes dispensing nicotine patches at discharge, providing proactive telephone counseling post discharge, or giving a combination of the two. The interventions are aimed at increasing the long term quit rate of these patients.

The specific aims of the study are to demonstrate the effects of two interventions, dispensing nicotine patches at discharge and providing proactive telephone counseling soon after discharge, on 12-month quit rates of hospitalized smokers in a 2 x 2 factorial design.


Options:
A: N/A
B: Smoking abstinence rate (At 12 months); Cost-effectiveness (At 12 months)
C: Treatment Satisfaction (End of treatment (seven weeks after baseline))
D: Percentage of Participants With 30-day Abstinence (6-months post enrollment)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: Smoking Cessation in Hospitalized Smokers
Brief Summary: When smokers are hospitalized they quit smoking, either voluntarily or involuntarily. Most of them, however, go back to smoking soon after discharge. This study will test an innovative approach which includes dispensing nicotine patches at discharge, providing proactive telephone counseling post discharge, or giving a combination of the two. The interventions are aimed at increasing the long term quit rate of these patients.

The specific aims of the study are to demonstrate the effects of two interventions, dispensing nicotine patches at discharge and providing proactive telephone counseling soon after discharge, on 12-month quit rates of hospitalized smokers in a 2 x 2 factorial design.


Options:
A: Child Urine Cotinine (up to 12 months); Parent-reported Second-hand Smoke Exposure in Cigarettes Per Day From All Sources (up to 12 months)
B: Change in Weight (Baseline, 3 months, 6 months, 9 months, 12 months and 1 year post program follow up); Change in the 6 minute walk test (Baseline, 3 months, 6 monhts, 9 months, 12 months, and 1 year post program completion follow up); Change in Days of Abstinence-Timeline follow back interview for tobacco smokers (Baseline, 3 months, 6 months, 9 months, 12 months, and 1 year post program completion follow up); Change in Carbon Monoxide Level (Baseline, 3 months, 6 months, 9 months, 12 months, and 1 year post program completion follow up)
C: Percentage of Participants With 30-day Abstinence (6-months post enrollment)
D: Smoking abstinence (6 months)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: Smoking Cessation in Hospitalized Smokers
Brief Summary: When smokers are hospitalized they quit smoking, either voluntarily or involuntarily. Most of them, however, go back to smoking soon after discharge. This study will test an innovative approach which includes dispensing nicotine patches at discharge, providing proactive telephone counseling post discharge, or giving a combination of the two. The interventions are aimed at increasing the long term quit rate of these patients.

The specific aims of the study are to demonstrate the effects of two interventions, dispensing nicotine patches at discharge and providing proactive telephone counseling soon after discharge, on 12-month quit rates of hospitalized smokers in a 2 x 2 factorial design.


Options:
A: Percentage of Participants With 30-day Abstinence (6-months post enrollment)
B: Abstinence at 12 months postpartum (through 12 months)
C: Self Reported Relapse Rate at 2 Months (2 months after joining the groups for the social networking services.); Self Reported Relapse Rate at 6 Months (6-months)
D: smoking, self-report (6 months follow-up)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: Smoking Cessation in Hospitalized Smokers
Brief Summary: When smokers are hospitalized they quit smoking, either voluntarily or involuntarily. Most of them, however, go back to smoking soon after discharge. This study will test an innovative approach which includes dispensing nicotine patches at discharge, providing proactive telephone counseling post discharge, or giving a combination of the two. The interventions are aimed at increasing the long term quit rate of these patients.

The specific aims of the study are to demonstrate the effects of two interventions, dispensing nicotine patches at discharge and providing proactive telephone counseling soon after discharge, on 12-month quit rates of hospitalized smokers in a 2 x 2 factorial design.


Options:
A: Percentage of Participants With 30-day Abstinence (6-months post enrollment)
B: Prolonged Abstinence (7 weeks, 6 months and 12 months)
C: Smoking cessation (6 month follow-up)
D: 7-day Point Prevalence Quit Rate at End-of-Treatment (EOT) (Week 11)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: Smoking Cessation in Hospitalized Smokers
Brief Summary: When smokers are hospitalized they quit smoking, either voluntarily or involuntarily. Most of them, however, go back to smoking soon after discharge. This study will test an innovative approach which includes dispensing nicotine patches at discharge, providing proactive telephone counseling post discharge, or giving a combination of the two. The interventions are aimed at increasing the long term quit rate of these patients.

The specific aims of the study are to demonstrate the effects of two interventions, dispensing nicotine patches at discharge and providing proactive telephone counseling soon after discharge, on 12-month quit rates of hospitalized smokers in a 2 x 2 factorial design.


Options:
A: Percentage of Participants With 30-day Abstinence (6-months post enrollment)
B: evaluate the abstinence of tobacco consumption (12 months)
C: Abstinence at 12 months postpartum (through 12 months)
D: The primary endpoint will be 6M of abstinence measured 18M after enrollment. (18M)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: Smoking Cessation in Hospitalized Smokers
Brief Summary: When smokers are hospitalized they quit smoking, either voluntarily or involuntarily. Most of them, however, go back to smoking soon after discharge. This study will test an innovative approach which includes dispensing nicotine patches at discharge, providing proactive telephone counseling post discharge, or giving a combination of the two. The interventions are aimed at increasing the long term quit rate of these patients.

The specific aims of the study are to demonstrate the effects of two interventions, dispensing nicotine patches at discharge and providing proactive telephone counseling soon after discharge, on 12-month quit rates of hospitalized smokers in a 2 x 2 factorial design.


Options:
A: smoking cessation (date of surgery)
B: Percentage of Participants With 30-day Abstinence (6-months post enrollment)
C: Participants Abstinent From Cigarettes (Two years)
D: N/A

Answer: B