TrialPanorama/Dataset huggingface dataset:
Please select the outcome measures that correspond to the clinical trial below.
Title: Hormonal Regulation of Body Weight Maintenance
Brief Summary: The investigators here propose to perform a collaborative clinical research effort including a randomized controlled trial investigating the mechanisms of weight maintenance and their relation to a lifestyle intervention in children, adolescents and adults. The detailed investigation and analysis of the variability and dynamics of the endocrine circuits responding to a negative energy balance and weight loss will be accompanied and enhanced by specific clinical projects targeting peripheral and central-nervous aspects of hormonal counter-regulation after weight loss. Mechanisms of endocrine counter-regulation and potential therapeutic approaches will be studied.


Options:
A: Body mass index (One school year)
B: N/A
C: Academic performance (October 2014 - June 2015 (8 months))
D: BMI will be assessed during lifestyle intervention in (1) children and adolescents and (2) adults vs. placebo (21 months)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: Hormonal Regulation of Body Weight Maintenance
Brief Summary: The investigators here propose to perform a collaborative clinical research effort including a randomized controlled trial investigating the mechanisms of weight maintenance and their relation to a lifestyle intervention in children, adolescents and adults. The detailed investigation and analysis of the variability and dynamics of the endocrine circuits responding to a negative energy balance and weight loss will be accompanied and enhanced by specific clinical projects targeting peripheral and central-nervous aspects of hormonal counter-regulation after weight loss. Mechanisms of endocrine counter-regulation and potential therapeutic approaches will be studied.


Options:
A: N/A
B: Academic performance (October 2014 - June 2015 (8 months))
C: BMI will be assessed during lifestyle intervention in (1) children and adolescents and (2) adults vs. placebo (21 months)
D: BMI and aerobic fitness (1 schoolyear)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: Diabetes Care in American Samoa
Brief Summary: As type 2 diabetes prevalence increases in the United States, the burden of diabetes falls more on groups with greater barriers to care, such as language and cultural differences, and lower economic resources. Healthy People 2010 targeted diabetes as one of six diseases for the elimination of racial and ethnic health disparities. These disparities extend to the US Territory of American Samoa, where the proportion of adults \>18 years with diabetes was 19.6% in 2002, compared to 6.4% of US adults. There have been no reported diabetes interventions in Samoans in the US. The overall purpose of this application is to translate recent advances in diabetes care into clinical practice for the American Samoan community by improving methods of health care delivery and methods of diabetes self management. We will conduct a randomized clinical trial to test the effectiveness of a community health worker (CHW) and primary-care coordinated intervention to provide outreach, education and support to 352 type 2 diabetes patients and their families in American Samoa. The CHW intervention will utilize evidence-based algorithms and protocols to prompt risk behavior interventions, communication with health care team, and visit schedule. The individual treatment action plans are also guided by the Precede-Proceed Model. The outcomes at a one-year follow-up will include glycosolated hemoglobin (HbA1c), cardiovascular disease risk factors, diet and exercise behaviors, and adherence to diabetes care guidelines. The study hypothesis is that diabetes patients in the CHW trial arm will have lower HbA1c levels, lower cardiovascular disease risk factor levels, increased exercise behaviors and healthy dietary intakes and greater adherence to diabetes care such as adherence to prescribed medications, keeping medical appointments for diabetes care and specialty referrals. The intervention builds upon best clinical practices for CHWs in diabetes care by translating effective strategies to American Samoans, while also extending prior CHW research, by using a model that is potentially replicable in other ethnic minority populations suffering the burden of diabetes.


Options:
A: glycosolated hemoglobin (HbA1c) levels (one year)
B: Hemoglobin A1c (6 months)
C: HbA1c (42 months)
D: HbA1c (12month); Blood pressure (12 month); Lipid profile (12 months); quality of life (12month)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: Safety of Acidform Lubricant (Amphora) in Women at Low Risk for HIV-1 Infection
Brief Summary: Topical microbicides, substances that kill microbes, are being studied to prevent sexual transmission of HIV and other disease pathogens. In the future, topical microbicides may be applied vaginally to prevent both acquisition and transmission of HIV and other sexually transmitted infections (STIs). The purpose of this study is to compare the safety of daily applications of Acidform lubricant and HEC gel in healthy women at low risk for HIV infection and assess the effect of a microbicide candidate on the natural immunity women have to STI pathogens.


Options:
A: Efficacy as Determined by the Proportion of Women in Each Arm With HIV-1 Seroconversion After 120 Endpoints Are Observed in the Trial. (minimum of 12 months and a maximum of 14 months per participant); The Number of Participants That Experienced Grade 2, 3, 4 and Serious Adverse Events Over the Investigational Product Used Period (25 mg Dapivirine Administered in a Silicone Elastomer Vaginal Matrix Ring (DVR), Inserted Once Every 4 Weeks). (minimum of 12 months and a maximum of 14 months per participant)
B: Incidence of HIV-1 and HIV-2 infection as determined by detection of HIV antibodies from oral mucosal transudate (OMT) specimens.
C: Effectiveness (30 months); Safety (30 months)
D: Measured endogenous antimicrobial activity (Throughout study); Measured levels of mediators of host defense, including defensins, cytokines, and chemokines in CVL (Throughout study)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: Use of Combined Measurements of Serum Infliximab and Anti-infliximab Antibodies in the Treatment of Patients With Crohns Disease Failing Infliximab Therapy
Brief Summary: To compare treatment outcome in patients with Crohn's disease with secondary loss of response to infliximab (i.e. initial good response follow by loss of response) treated according to current standards based only on clinical features versus treatment based on serum levels of infliximab and anti-infliximab antibody (Ab) status.


Options:
A: Clinical remission without need for additional CD related therapy or surgery (52 weeks)
B: Percentage of Participants With Clinical Recurrence (CR) of Crohn's Disease (CD) Prior to or at Week 76 (Baseline up to Week 76)
C: Proportion of patients with response at week 12, i.e. CDAI decrease of 70 or more for patients with luminal disease, or reduction of 50 percent or more from base line in the number of draining fistulas for patients with fistulising disease. (12 weeks); Total expenses related to Crohn's disease during the study (inclusion to week 12). (12 weeks)
D: Endoscopic Recurrence: the Proportion of Patients in Endoscopic Recurrence at One Year (one year)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: Effect of Fenugreek on Milk Production
Brief Summary: Each year, approximately 3 million mothers in the USA alone leave the hospital breastfeeding an infant. However, a large number discontinue breastfeeding, because milk synthesis is poor or simply stops. Termed "Insufficient Milk Syndrome," this condition probably accounts for approximately 5-10% of the total population of breastfeeding mothers and includes many mothers with premature infants, mothers with polycystic ovary syndrome, and a myriad of other unknown causes. The mother's inability to breastfeed causes enormous feelings of inadequacy, grief, depression, and other problems, not to mention increased health risks to the infant.

The most popular herbal remedy used around the world for increasing milk synthesis is fenugreek. Fenugreek (Trigonella foenum graecum) is a seed product from the legume family that is commonly sold, since the dried, ripe seed and extracts are used as an artificial flavor for maple syrup. When used orally in amounts commonly found in foods, it has been granted Generally Recognized as Safe (GRAS) status in the USA by the FDA. Although it is used by millions of women around the world to increase their milk supply, we have only one small case report which suggested it might actually increase the milk supply.

In this one study, the authors found an approximate 40% increase in milk production, although the study was not blinded, nor did they use a control population. For these reasons, we still do not know with certainty if fenugreek works as a galactagogue.

This study is designed to accurately determine if seven days of fenugreek will stimulate milk production in a selected group of subjects with poor milk supply. We hypothesize that the women enrolled in the test group will have increased milk production at the end of the 8-day study.


Options:
A: successful initiation of lactation as determined by lactogenesis II markers (7 days postpartum)
B: Percentage of mothers who exclusively breastfeed their child (At 6 weeks postpartum)
C: The Main Outcome Variable of This Study is the Quantity of Milk Produced. ("Day 0" , "Day 8")
D: Incident Type 2 Diabetes (baseline to 12 years postpartum)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: IPT in Schoolchildren: Comparison of the Efficacy, Safety, and Tolerability of Antimalarial Regimens in Uganda
Brief Summary: This will be a randomized, single-blinded, placebo-controlled trial to evaluate the efficacy, safety and tolerability of antimalarial regimens in healthy schoolchildren. The primary objective of the study is to compare the efficacy of different combination antimalarial regimens, including amodiaquine + sulfadoxine-pyrimethamine (AQ+SP), dihydroartemisinin-piperaquine (DP), and placebo, to SP for intermittent preventive treatment (IPT) in schoolchildren, as measured by risk of parasitaemia (unadjusted by genotyping) after 42 days of follow-up. This will assess both the efficacy for treatment of asymptomatic infections and the efficacy for prevention of new infections.


Options:
A: incidence rate of clinical malaria; in vivo adequate clinical and parasitological response of P. falciparum to SP
B: 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)
C: Risk of Parasitaemia (Unadjusted by Genotyping) (after 42 days of follow-up)
D: Prevalence of drug resistance

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: Safe and Efficacious Artemisinin-based Combination Treatments for African Pregnant Women With Malaria
Brief Summary: Malaria is the most important human parasitic disease and is responsible of high morbidity and mortality in resource-poor countries. Pregnant women, who are a high-risk group, are almost always excluded from clinical trials; thus, the investigators lack sufficient information on the safety and efficacy of most antimalarials in pregnancy. The recommendation of the World Health Organization to use artemisinin combination therapy (ACT) in the 2nd and 3rd trimester is already implemented in several African countries, however documentation of their efficacy and safety in pregnancy is still limited. Thus, the investigators propose to evaluate the efficacy and safety of 4 ACT(artemether-lumefantrine, amodiaquine-artesunate, mefloquine-artesunate and dihydroartemisinin-piperaquine), when used to treat pregnant women with P. falciparum malaria; the results will help to recommend the optimal therapy for this high-risk group in Africa.


Options:
A: Treatment Failure (PCR adjusted) (Day 63); Safety profiles including significant changes in relevant laboratory values (Until delivery)
B: Trial 1 (IPTp MQ vs IPTp SP): Low birth weight. (day 0, birth); Trial 2 (CTX+IPTp MQ vs. CTX+IPTp placebo): Peripheral parasitaemia. (day 0, delivery)
C: proportion of infants with low birthweight (<2,500 grams)
D: Evaluate whether two doses of intermittent treatment with SP delivered through antenatal clinics provides additional benefit to the protection afforded by ITNs on low birth weight

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: Safe and Efficacious Artemisinin-based Combination Treatments for African Pregnant Women With Malaria
Brief Summary: Malaria is the most important human parasitic disease and is responsible of high morbidity and mortality in resource-poor countries. Pregnant women, who are a high-risk group, are almost always excluded from clinical trials; thus, the investigators lack sufficient information on the safety and efficacy of most antimalarials in pregnancy. The recommendation of the World Health Organization to use artemisinin combination therapy (ACT) in the 2nd and 3rd trimester is already implemented in several African countries, however documentation of their efficacy and safety in pregnancy is still limited. Thus, the investigators propose to evaluate the efficacy and safety of 4 ACT(artemether-lumefantrine, amodiaquine-artesunate, mefloquine-artesunate and dihydroartemisinin-piperaquine), when used to treat pregnant women with P. falciparum malaria; the results will help to recommend the optimal therapy for this high-risk group in Africa.


Options:
A: Trial 1 (IPTp MQ vs IPTp SP): Low birth weight. (day 0, birth); Trial 2 (CTX+IPTp MQ vs. CTX+IPTp placebo): Peripheral parasitaemia. (day 0, delivery)
B: Treatment Failure (PCR adjusted) (Day 63); Safety profiles including significant changes in relevant laboratory values (Until delivery)
C: proportion of infants with low birthweight (<2,500 grams)
D: Evaluate whether two doses of intermittent treatment with SP delivered through antenatal clinics provides additional benefit to the protection afforded by ITNs on low birth weight

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: Restrictive Versus Liberal Intraoperative Goal-directed Fluid Management During Major Abdominal Surgery:a Prospective Randomized Study
Brief Summary: Postoperative organ dysfunction severely affects the prognosis of surgical patients. Despite several trials evaluating restrictive or liberal fluid strategies, the ideal fluid replacement strategy remains controversial. Owing to the risk of altered tissue perfusion, a key trigger of organ dysfunction, the purpose of this study was to compare the influence of restrictive and liberal fluid regimens, using a goal-directed approach, on hypovolemia and postoperative organ dysfunction.


Options:
A: complications until 30 days after surgery according to the zurich classification (30 days postoperative)
B: Postoperative Complications (30 days post procedure)
C: The volume of crystalloid solutions administered intraoperatively. (Start of Anesthesia until the doppler is removed at the end of surgery, approximately 8 hours)
D: incidence of intraoperative hypovolemia (intraoperative)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: Effects of Macrolides on Asthma Control, Airway Inflammation and Bacterial Colonisation in Smokers With Asthma.
Brief Summary: Asthma is a common disease in Westernised societies, affecting up to 10% of the population. Corticosteroids are the most effective treatment for asthma but the therapeutic response varies considerably between individuals. A major cause of corticosteroid insensitivity in asthma is cigarette smoking. Active cigarette smoking occurs in over 25% of adults with asthma and a further 25% are ex-smokers. In a series of proof of concept clinical studies the investigators demonstrated for the first time that the efficacy of inhaled and oral corticosteroids is markedly impaired in smokers with asthma and to a lesser extent in ex-smokers with asthma. Active cigarette smoking has other detrimental effects on asthma morbidity including more severe symptoms, increased rates of hospitalisation, and accelerated decline in lung function. Smoking cessation advice is often ineffective because many adult smokers with asthma do not believe that they are personally at risk from their smoking, take many years until stopping smoking and frequently restart smoking after quitting. Alternative or additional drugs to corticosteroids are needed for smokers with asthma who are unable to obtain the clinical benefits associated with stopping smoking. In a proof of concept clinical trial the investigators will test the hypothesis that macrolides improve asthma control and reduce sputum neutrophil counts of smokers with chronic asthma.


Options:
A: Peak expiratory flow rate. (12 weeks)
B: Changes in proportions of macrolide-resistant streptococcal (MRS) carriage in the oropharynx
C: Diary card summary symptom score (10 days after randomisation)
D: Annualized Rate of Severe Exacerbation Events During The 52-Week Treatment Period: Intent-to-Treat (ITT) Population (Baseline to Week 52); Absolute Change From Baseline in Pre-Bronchodilator Forced Expiratory Volume in 1 Second (FEV1) at Week 12: ITT Population (Baseline, Week 12)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: Effects of Macrolides on Asthma Control, Airway Inflammation and Bacterial Colonisation in Smokers With Asthma.
Brief Summary: Asthma is a common disease in Westernised societies, affecting up to 10% of the population. Corticosteroids are the most effective treatment for asthma but the therapeutic response varies considerably between individuals. A major cause of corticosteroid insensitivity in asthma is cigarette smoking. Active cigarette smoking occurs in over 25% of adults with asthma and a further 25% are ex-smokers. In a series of proof of concept clinical studies the investigators demonstrated for the first time that the efficacy of inhaled and oral corticosteroids is markedly impaired in smokers with asthma and to a lesser extent in ex-smokers with asthma. Active cigarette smoking has other detrimental effects on asthma morbidity including more severe symptoms, increased rates of hospitalisation, and accelerated decline in lung function. Smoking cessation advice is often ineffective because many adult smokers with asthma do not believe that they are personally at risk from their smoking, take many years until stopping smoking and frequently restart smoking after quitting. Alternative or additional drugs to corticosteroids are needed for smokers with asthma who are unable to obtain the clinical benefits associated with stopping smoking. In a proof of concept clinical trial the investigators will test the hypothesis that macrolides improve asthma control and reduce sputum neutrophil counts of smokers with chronic asthma.


Options:
A: Diary card summary symptom score (10 days after randomisation)
B: Symptom scoring (1 to 3 years of age); Duration in days of each asthmatic episode from randomisation start (1 to 3 years of age)
C: Peak expiratory flow rate. (12 weeks)
D: Patient's daily diary summary symptom scores/Morning diary PEFR (During the Study Conduct)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: Effects of Macrolides on Asthma Control, Airway Inflammation and Bacterial Colonisation in Smokers With Asthma.
Brief Summary: Asthma is a common disease in Westernised societies, affecting up to 10% of the population. Corticosteroids are the most effective treatment for asthma but the therapeutic response varies considerably between individuals. A major cause of corticosteroid insensitivity in asthma is cigarette smoking. Active cigarette smoking occurs in over 25% of adults with asthma and a further 25% are ex-smokers. In a series of proof of concept clinical studies the investigators demonstrated for the first time that the efficacy of inhaled and oral corticosteroids is markedly impaired in smokers with asthma and to a lesser extent in ex-smokers with asthma. Active cigarette smoking has other detrimental effects on asthma morbidity including more severe symptoms, increased rates of hospitalisation, and accelerated decline in lung function. Smoking cessation advice is often ineffective because many adult smokers with asthma do not believe that they are personally at risk from their smoking, take many years until stopping smoking and frequently restart smoking after quitting. Alternative or additional drugs to corticosteroids are needed for smokers with asthma who are unable to obtain the clinical benefits associated with stopping smoking. In a proof of concept clinical trial the investigators will test the hypothesis that macrolides improve asthma control and reduce sputum neutrophil counts of smokers with chronic asthma.


Options:
A: Peak expiratory flow rate. (12 weeks)
B: 24 Hour Sputum Volume (Visit 3 (Baseline); Visit 6 (Week 12); Visit 8 (Week 24))
C: Prevalence of Bronchiolitis Obliterans Syndrome (BOS) (2 years post-transplant); Overall Survival (2 years post-transplant)
D: Time to clinical failure (Will be assessed between day 1 (from 1 hour after first drug intake) till day 90 (24 hours after last study drug intake))

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: Computerized Assessment for Patients With Cancer-ESRA-C II
Brief Summary: This research study will test a new online computer program for patients, the Electronic Self-Report Assessment-Cancer (ESRA-C 2). The program allows patients to report symptoms and quality of life issues and learn information about how to deal with these experiences. The computer program is being tested to see if it can improve communications between patients and their care team and if it can improve patients' experiences during and after treatment.


Options:
A: Symptom burden and quality of life 2-4 weeks post treatment (3 years)
B: Number of Days the Subjects Are Adherent to Using Sunscreen (6 weeks)
C: Alcohol Use Disorders Identification Test - Consumption scale (AUDIT-C scale) (6 weeks)
D: Depressive symptoms (Pre-, post-monitoring, 6-week follow up & 6 month follow-up); Emotional Self Awareness (Pre-, post-, 6-weeks post- and 6-months post-test)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: A Phase II Randomized, Double Blind, Placebo Controlled Dose Finding Study Investigating the Efficacy of HP802-247 in Venous Leg Ulcers
Brief Summary: This is a 16-week study for subjects with a venous leg ulcer between the knee and ankle. This research is being done to determine the effectiveness of two dosing frequencies and two different concentrations of HP802-247, together with standard care, compared to placebo, plus standard care.


Options:
A: The Average Percent (%) Change From Baseline in the Target Wound Area in Each Treatment Group Over the Twelve-week Double-blind Treatment Period. (Weekly, over the 12 week treatment period, or until wound closure, which ever occurred first)
B: Proportion of patients with complete healing of reference ulcer (24 weeks)
C: Wound Closure (16 Weeks)
D: Compare the Treatment Groups for the Number of Subjects With Complete Wound Closure Over the 12-Week Treatment Period From Baseline (Weekly, over 12 Weeks or until wound closure, which ever occurred first)

Answer: A