TrialPanorama/Dataset huggingface dataset:
Please select the outcome measures that correspond to the clinical trial below.
Title: A Phase 3, Multi-Center, Randomized, Double-Blind, Placebo-Controlled Study to Assess Efficacy, Immunogenicity and Safety of 3'-Aminomethylnicotine-P. Aeruginosa r-Exoprotein A Conjugate Vaccine (NicVAX) as an Aid to Smoking Cessation
Brief Summary: The purpose of this study is to evaluate NicVAX as an aid to smoking cessation for long term abstinence.


Options:
A: Evaluate NicVAX as an aid to smoking cessation for long term abstinence. (one year)
B: Abstinence from smoking defined as self-reported abstinence and confirmed by measurement of carbon monoxide in exhaled air less than 10ppm (Monthly up to month 6, and during follow-up at months 9 and 12); Immunogenicity of the vaccine, by measuring specific anti-nicotine IgG antibodies by ELISA (Baseline, monthly up to month 6, and months 9 and 12); Safety and tolerability by recording adverse events, injection site examinations, vital signs, standard clinical laboratory (serum chemistry, hematology) (Baseline, and at various times up to month 12)
C: Continuous smoking abstinence (8 week interval (Weeks 19 to 26, inclusive, following the first vaccination))
D: Anti-nicotine antibody concentration (12 time points between screening and week 20)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: A Randomised Controlled Trial and Cost-effectiveness Evaluation of "Booster" Interventions to Sustain Increases in Physical Activity in Middle-aged Adults in Deprived Urban Neighbourhoods.
Brief Summary: Adults that increase their physical activity can improve their health, and reduce future risks to health, but long-term changes are difficult to sustain. This study assesses whether it is worth providing further support, 3 months after giving initial advice, to those who have managed to do more physical activity. All participants will initially be given an interactive DVD. A researcher from Sheffield Hallam University will provide two telephone follow ups at one month intervals to assess physical activity levels. Only those that have increased their physical activity at this point will remain in the study. These participants will receive a "mini booster", a "full booster" or no booster. The "mini booster" consists of a two telephone calls one month apart to discuss physical activity and usage of the DVD. A "full booster" consists of a face-to-face meeting with the facilitator at the same intervals. The purpose of these booster sessions is to help the individual to maintain their increase in physical activity. The investigators will measure the differences in physical activity, quality of life and costs, associated with the booster interventions, 3 months and 9 months from randomisation. The research will be carried out in 20 of the most deprived neighbourhoods in Sheffield. These locations have large, ethnically diverse populations, high levels of economic deprivation, low levels of physical activity, poorer health and shorter life expectancy. Participants will be recruited through general practices and community groups, as well as by postal invitation to ensure the participation of minority ethnic groups and those with lower levels of literacy. Sheffield City Council and Primary Care Trust fund a range of facilities and activities to promote physical activity and variations in access to these between neighbourhoods will make it possible to examine whether the effectiveness of the intervention is modified by access to community facilities.


Options:
A: Minutes of physical activity per week based on 7-Day Physical Activity Recall Interview.
B: This randomized controlled trial was designed to assess the effectiveness of a primary care physical activity intervention, in increasing adherence to physical activity in general population, as well as their self-reported physical activity. (baseline-3-6-12-18)
C: Physical activity measured by accelerometry. (3 months post-randomisation)
D: Accelerometer (Omron Active Style Pro HJA-350IT) Measured Daily Steps (Baseline, 3, and 9 months); Accelerometer (Omron Active Style Pro HJA-350IT) Measured Moderate to Vigorous Physical Activity (Minutes Per Day) (Baseline, 3 and 9 months)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: A Randomised Controlled Trial and Cost-effectiveness Evaluation of "Booster" Interventions to Sustain Increases in Physical Activity in Middle-aged Adults in Deprived Urban Neighbourhoods.
Brief Summary: Adults that increase their physical activity can improve their health, and reduce future risks to health, but long-term changes are difficult to sustain. This study assesses whether it is worth providing further support, 3 months after giving initial advice, to those who have managed to do more physical activity. All participants will initially be given an interactive DVD. A researcher from Sheffield Hallam University will provide two telephone follow ups at one month intervals to assess physical activity levels. Only those that have increased their physical activity at this point will remain in the study. These participants will receive a "mini booster", a "full booster" or no booster. The "mini booster" consists of a two telephone calls one month apart to discuss physical activity and usage of the DVD. A "full booster" consists of a face-to-face meeting with the facilitator at the same intervals. The purpose of these booster sessions is to help the individual to maintain their increase in physical activity. The investigators will measure the differences in physical activity, quality of life and costs, associated with the booster interventions, 3 months and 9 months from randomisation. The research will be carried out in 20 of the most deprived neighbourhoods in Sheffield. These locations have large, ethnically diverse populations, high levels of economic deprivation, low levels of physical activity, poorer health and shorter life expectancy. Participants will be recruited through general practices and community groups, as well as by postal invitation to ensure the participation of minority ethnic groups and those with lower levels of literacy. Sheffield City Council and Primary Care Trust fund a range of facilities and activities to promote physical activity and variations in access to these between neighbourhoods will make it possible to examine whether the effectiveness of the intervention is modified by access to community facilities.


Options:
A: Feasibility of Using Facebook and Text Messaging to Deliver a Physical Activity Program to African American Women (Post Intervention (up to 8 weeks))
B: Reduction in incidence of diabetes at 3 years (3 years from entry into the study)
C: Physical activity measured by accelerometry. (3 months post-randomisation)
D: Accelerometer (Omron Active Style Pro HJA-350IT) Measured Daily Steps (Baseline, 3, and 9 months); Accelerometer (Omron Active Style Pro HJA-350IT) Measured Moderate to Vigorous Physical Activity (Minutes Per Day) (Baseline, 3 and 9 months)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: A Randomised Controlled Trial and Cost-effectiveness Evaluation of "Booster" Interventions to Sustain Increases in Physical Activity in Middle-aged Adults in Deprived Urban Neighbourhoods.
Brief Summary: Adults that increase their physical activity can improve their health, and reduce future risks to health, but long-term changes are difficult to sustain. This study assesses whether it is worth providing further support, 3 months after giving initial advice, to those who have managed to do more physical activity. All participants will initially be given an interactive DVD. A researcher from Sheffield Hallam University will provide two telephone follow ups at one month intervals to assess physical activity levels. Only those that have increased their physical activity at this point will remain in the study. These participants will receive a "mini booster", a "full booster" or no booster. The "mini booster" consists of a two telephone calls one month apart to discuss physical activity and usage of the DVD. A "full booster" consists of a face-to-face meeting with the facilitator at the same intervals. The purpose of these booster sessions is to help the individual to maintain their increase in physical activity. The investigators will measure the differences in physical activity, quality of life and costs, associated with the booster interventions, 3 months and 9 months from randomisation. The research will be carried out in 20 of the most deprived neighbourhoods in Sheffield. These locations have large, ethnically diverse populations, high levels of economic deprivation, low levels of physical activity, poorer health and shorter life expectancy. Participants will be recruited through general practices and community groups, as well as by postal invitation to ensure the participation of minority ethnic groups and those with lower levels of literacy. Sheffield City Council and Primary Care Trust fund a range of facilities and activities to promote physical activity and variations in access to these between neighbourhoods will make it possible to examine whether the effectiveness of the intervention is modified by access to community facilities.


Options:
A: Physical activity measured by accelerometry. (3 months post-randomisation)
B: Functional performance, balance and reduced self-reported upper and lower body functional limitations in sedentary, older adults' physical activity. (Baseline, 6-month, 12-month follow-up)
C: 7-Day Physical Activity Recall (7-Day PAR) (6 months)
D: Minutes of Moderate or Vigorous Physical Activity Per Week After 12-months (12 months)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: A Randomised Controlled Trial and Cost-effectiveness Evaluation of "Booster" Interventions to Sustain Increases in Physical Activity in Middle-aged Adults in Deprived Urban Neighbourhoods.
Brief Summary: Adults that increase their physical activity can improve their health, and reduce future risks to health, but long-term changes are difficult to sustain. This study assesses whether it is worth providing further support, 3 months after giving initial advice, to those who have managed to do more physical activity. All participants will initially be given an interactive DVD. A researcher from Sheffield Hallam University will provide two telephone follow ups at one month intervals to assess physical activity levels. Only those that have increased their physical activity at this point will remain in the study. These participants will receive a "mini booster", a "full booster" or no booster. The "mini booster" consists of a two telephone calls one month apart to discuss physical activity and usage of the DVD. A "full booster" consists of a face-to-face meeting with the facilitator at the same intervals. The purpose of these booster sessions is to help the individual to maintain their increase in physical activity. The investigators will measure the differences in physical activity, quality of life and costs, associated with the booster interventions, 3 months and 9 months from randomisation. The research will be carried out in 20 of the most deprived neighbourhoods in Sheffield. These locations have large, ethnically diverse populations, high levels of economic deprivation, low levels of physical activity, poorer health and shorter life expectancy. Participants will be recruited through general practices and community groups, as well as by postal invitation to ensure the participation of minority ethnic groups and those with lower levels of literacy. Sheffield City Council and Primary Care Trust fund a range of facilities and activities to promote physical activity and variations in access to these between neighbourhoods will make it possible to examine whether the effectiveness of the intervention is modified by access to community facilities.


Options:
A: This randomized controlled trial was designed to assess the effectiveness of a primary care physical activity intervention, in increasing adherence to physical activity in general population, as well as their self-reported physical activity. (baseline-3-6-12-18)
B: Physical activity level (7-day Physical Activity Recall [PAR]) (six months from the start of the intervention)
C: 7-Day Physical Activity Recall (7-Day PAR) (6 months)
D: Physical activity measured by accelerometry. (3 months post-randomisation)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: Two-Arm, Randomized (2:1), Open-Label Phase II/III Study in EpCAM Positive Cancer Patients With Symptomatic Malignant Ascites Using the Trifuncitonal Bispecific Antibody Removab (Anti-EpCAM x Anti-CD3) Versus an Untreated Control Group
Brief Summary: The study will be performed to obtain further efficacy and safety data in order to obtain a marketing authorization (pivotal study). In addition, health economic data are to be collected.


Options:
A: Recurrence Free Survival Evaluated by Clinical Event Adjudication Committee (CEAC) (Every 12 weeks up to recurrence or up to 3 months after last administered dose)
B: Selection of better dose level based on the confirmed tumor response.
C: Progression-free Survival (Baseline to 48 weeks after the last visit or dose of Cvac (up to 104 weeks))
D: N/A

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: Two-Arm, Randomized (2:1), Open-Label Phase II/III Study in EpCAM Positive Cancer Patients With Symptomatic Malignant Ascites Using the Trifuncitonal Bispecific Antibody Removab (Anti-EpCAM x Anti-CD3) Versus an Untreated Control Group
Brief Summary: The study will be performed to obtain further efficacy and safety data in order to obtain a marketing authorization (pivotal study). In addition, health economic data are to be collected.


Options:
A: Determination of the optimal doses for pazopanib (phase I) (42 months); Overall response rate according to RECIST criteria / clinical benefit (stable disease or partial response or complete response) (phase II) (12 weeks after start of treatment)
B: N/A
C: clinical benefit of combining bevacizumab treatment to weekly paclitaxel (after 6 months of treatment)
D: overall survival (overall)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: Safety and Neuroprotective Effects of Polyphenon E in Multiple Sclerosis
Brief Summary: This study is an open label 6 month study. All subjects will be treated with Polyphenon E (400 mg EGCG twice a day) for six months. The main outcome of this pilot phase will be safety. Secondary outcomes are the change in NAA levels over 6 months as measured by MR-spectroscopy. NAA levels are a marker of neuronal function. We think that Polyphenon E will protect neurons and thus increase NAA levels.


Options:
A: Fasting and postprandial lipid oxidation in grams per hour, assessed by indirect calorimetry, after 3 months intake of green tea extract versus placebo (Three months)
B: Brain Atrophy by MRI (% change brain volume from baseline to year 2)
C: Number of Participants Experiencing Serious Adverse Events (six months)
D: Time to onset of a first UTI within one year of treatment. (one year)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: Evaluation Of The Efficacy Of The Modified Atkins Diet In Children With Refractory Epilepsy: A Randomized Controlled Trial.
Brief Summary: Seizures are a frequent cause of morbidity in the pediatric age group. Uncontrolled seizures pose a variety of risks to children, including higher rates of mortality, developmental delay and/or regression, and cognitive impairment. The ketogenic diet is a well known treatment option for refractory epilepsy. However it is very restrictive and requires strict weighing of foods. The modified Atkins diet is a dietary therapy for intractable childhood epilepsy that was designed to be a less restrictive alternative to the traditional ketogenic diet. Early studies have demonstrated efficacy and safety.There are no randomized trials evaluating the efficacy of the modified Atkins diet in children with refractory epilepsy. Hence this study has been planned to investigate whether there are clear benefits in terms of seizure control in children with refractory epilepsy who are treated with the modified Atkins diet, versus controls.


Options:
A: Number of seizures (6 - 8 weeks)
B: Change in seizure frequency (3 months)
C: seizure outcome 3months after dietary therapy. (3 months)
D: Reduction in seizure frequency at 3 months in the two groups: the modified Atkins diet group, and the control group. (3 months)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: An Evaluation of Treximet in the Treatment of Acute Migraine Headache: A Placebo-Controlled, Double-Blind, Crossover Study, Assessing Cognitive Function.
Brief Summary: Migraine headache occurs frequently in women more than men and is associated with symptoms not only of significant pain but also of symptoms typically including of photophobia, phonophobia, nausea and vomiting. Many migraine patients report difficulty in cognition from lack of concentration, difficulty in word finding or inability to remember. Many of these cognitive symptoms seem to be independent of the pain intensity and may occur completely separately from the headache pain but can be disabling. It is likely that the frequency and importance of cognitive symptoms associated with migraine are underreported.

The Mental Efficacy Workload Test (MEWT) is a computerized battery that is designed to be an efficient and accurate measure of cognition during migraine headache. Treximet is a new migraine treatment recently FDA approved for the treatment for the relief of acute migraine that may be effective for the cognitive symptoms for migraine patients who have a history of cognitive dysfunction during a migraine headache. The primary efficacy parameter is to evaluate the effectiveness of treatment with Treximet versus placebo in patients with acute migraine headache measuring neuropsychological function using the MEWT during the migraine and comparing that score with a prior MEWT score when the patient had no migraine symptoms. A double blind, placebo-controlled, crossover study was chosen so that each patient may be her or his own control.

It is the intent of this study to determine the type and intensity of cognitive dysfunction associated with migraine headache and to what extent that Treximet may relieve the cognitive dysfunction in a safe and effective manner.


Options:
A: To evaluate the effectiveness of treatment with Treximet versus placebo in patients with acute migraine headache on the neuropsychological function before treatment and at one and two hours after treatment of a migraine. (2 hours post dose)
B: Score on a 4-pt migraine pain scale for a single menstrual migraine attack (2 to 48 hours)
C: Trexima will be evaluated for efficacy as an acute treatment for migraine based on its superiority over placebo at 2 hours for: a) pain relief (no or mild pain), b) incidence of photophobia, c) incidence of phonophobia and d) incidence of nausea.
D: Score on a 4-point migraine pain scale for a single menstrual migraine attack (2 to 48 hours)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: Influence of Physical Training on Cardiopulmonary Exercise Capacity and Right Ventricular Function in Patients With D-TGA and Atrial Switch Operation.
Brief Summary: In transposition patients after atrial switch operation, the morphological right ventricle serves as the systemic ventricle. These patients often develop signs of heart failure. It is not known, whether physical training can safely be recommended in these patients- like heart failure guidelines recommend training in patients with normal anatomy. Furthermore it is not known, whether these TGA-patients benefit from training with respect to cardiopulmonary exercise capacity.


Options:
A: Change of maximal oxygen uptake during exercise, measured in ml/kg/min (3 months)
B: Cardiac Rehabilitation Enrollment (12 weeks after patient is discharged from hospital)
C: Maximal inspiratory pressure in kilopascal (12 weeks)
D: Cardiac MRI Right Ventricular Ejection Fraction (6 and 12 months); Cardiopulmonary exercise capacity (6 and 12 months)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: Estrogen Dosing in Turner Syndrome:Pharmacology & Metabolism
Brief Summary: Estrogen is necessary for feminization during puberty and to decrease bone resorption, the latter critical for the achievement of peak bone mass and normal bone health in the female. The practicing pediatric endocrinologist often faces the dilemma of how to best feminize girls with hypogonadism (lack of estrogen), manifested as delayed or arrested puberty, due to disorders of the brain or the ovaries. We propose a series of studies to address which type, dose, and route of delivery of estrogen are suitable choices in feminizing and sustaining estrogen concentrations in adolescent girls with Turner syndrome. To accomplish this we will study girls/young woman between the ages of 13 to 20 with Turner Syndrome in 2 protocols. In Protocol # 1 we will study 24 girls with TS, they will receive 3 different estrogen preparations, either by mouth or via a patch for a total of 6 weeks. They will come to the clinical research center for blood draws after 2 wks of taking the estrogen. With this study, we hope to learn how the body responds to estrogen differently, depending on the form estrogen is given and how high, estrogen levels gets in the blood in these girls with Turner Syndrome. We will be comparing these patients estrogen levels to girls that menstruate normally and do not have Turner Syndrome. In Protocol #2, 40 patients with TS will be recruited; these patients will take estrogen for 1 year, either by mouth or via a patch. Patients will come to the lab for blood drawn in 7 occasions and we will measure estrogen levels as well as other hormones and lipid levels. We will also perform a Dual-energy X-ray absorptiometry (DXA) study (like an X ray) to assess body composition and bone mineralization. We will adjust doses based on the estrogen levels we find. With this study we hope to learn how estrogen affects body composition, i.e., the amount of fat vs. muscle, and how different forms of estrogen affect blood cholesterol and other hormones. This study will allow us to understand better how to best replace young woman with Turner Syndrome with estrogen.


Options:
A: Change in Weight From Baseline at 12 Months (12 months); Change in Body Mass Index From Baseline at 12 Months (12 months); Change in Percent Fat Mass From Baseline in 12 Months (12 months); Change in Fat Free Mass From Baseline at 12 Months (12 months)
B: The size of the uterus evaluated by magnetic resonance (MR)-scan (5 years); Bones evaluated by dual-energy X-ray absorptiometry (DEXA)-scan (5 years)
C: Change in 24 hour ambulatory blood pressure (Before each washout period, then at 0, 3, 6 and 12 months of each treatment); Bone mineral density measurements (DEXA) (Baseline, 14 and 24 months); Uterine ultrasound scan to assess uterine volume, endometrial thickness, and uterine artery blood flow (Before each washout period, then at 0, 3, 6 and 12 months of each treatment)
D: N/A

Answer: A