linjc16/ctgov huggingface dataset:
Fast Food Feeding in Youth

Study Overview
=================
Brief Summary
-----------------
The primary aim of the proposed pilot study is to assess the effects of fast food meals, varying in serving size and rate of delivery, on energy (calorie) intake in adolescents.

Detailed Description
-----------------
Using a three-period crossover design, the investigators will evaluate three acute feeding conditions. Under Condition A, the total amount of food in a large fast food meal will be delivered on a single tray at Time 0 (start of meal). Under Condition B, the same fast food meal will be equally divided among 4 separate portions, with all portions delivered at Time 0. Under Condition C, the meal again will be equally divided among 4 separate portions, but the portions will be delivered at 15-minute time intervals (Time 0, 15 minutes, 30 minutes, 45 minutes).

Official Title
-----------------
Fast Food Feeding in Youth

Conditions
-----------------
Obesity

Intervention / Treatment
-----------------
* Behavioral: Condition A (see detailed summary)
* Behavioral: Condition B (see detailed summary)
* Behavioral: Condition C (see detailed summary)


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Body mass index (BMI) between the 85th and 98th percentiles for sex and age Consumption of fast food at least one time per week Willingness to eat the foods specified in the research methods Parent/guardian willing and able to cooperate Access to a working telephone Exclusion Criteria: Major medical illness (eg, diabetes; heart, renal, or liver disease; cancer; endocrinopathy) Taking any prescription medication that may affect food intake Current smoking (i.e., any tobacco in the last month) Previous diagnosis of an eating disorder

Ages Eligible for Study
-----------------
Minimum Age: 13 Years
Maximum Age: 17 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
Accepts Healthy Volunteers

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Single


Arms and Interventions

| Intervention/Treatment |
| --- |
|Behavioral: Condition A (see detailed summary)|nan|
|Behavioral: Condition B (see detailed summary)|nan|
|Behavioral: Condition C (see detailed summary)|nan|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Energy (calorie) intake during fast food feedings, assessed by direct observation |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Energy (calorie) intake during the day of the visit and the day after the visit, assessed by multiple-pass dietary recall interview methodology |  |  |
The Efficacy of Adjunctive Use of Ondansetron in Patients With Sepsis and Septic Shock

Study Overview
=================
Brief Summary
-----------------
Sepsis is a systemic inflammatory response that has deleterious effects and considered the leading cause of death in critically ill patients 1 . One of the hallmarks of severe sepsis is the progressive, injurious inflammatory response to infection, mediated by the excessive release of inflammatory mediators and consequently, associated with multiple organs damage 2 . Various studies have demonstrated that adverse outcomes in sepsis patients are closely related to the development of myocardial dysfunction 3 . The mortality of sepsis combined with cardiac functional insufficiency has increased significantly to 70%-90% 4 . Therefore, targeting cardiac insufficiency and heart injury may represent a novel treatment strategy. Several reports documented critical involvement of serotonin 5-hydroxytryptamine in the pathogenesis of sepsis. The aim of the current study is to evaluate the efficacy of ondansetron adjuvant use in patients with sepsis and septic shock.

Official Title
-----------------
The Efficacy of Adjunctive Use of Ondansetron in Patients With Sepsis and Septic Shock

Conditions
-----------------
Sepsis, Septic Shock

Intervention / Treatment
-----------------
* Drug: Ondansetron
* Drug: Placebo


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: male or female adult patients, aged 18 years or older with sepsis or septic shock after surgery according to the 2016 third international consensus definitions for sepsis and septic shock Exclusion Criteria: diagnosis of septic shock longer than 24 hours ago known or suspected disease with a strong indication or contraindication for the study drugs Pregnant and lactating women.

Ages Eligible for Study
-----------------
Minimum Age: 18 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Intervention<br> | Drug: Ondansetron<br>* patients will receive, in addition to standard therapy, ondansetron IV bolus 8 mg BID for 3 days<br>|
| Placebo Comparator: Control<br> | Drug: Placebo<br>* patients will receive, in addition to standard therapy, normal saline IV bolus BID for 3 days<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Sequential organ failure assessment (SOFA score) | Difference between study groups in mean change from baseline in SOFA score | 3 days post randomization |
Responsiveness to Dalfampridine-ER Treatment Among Multiple Sclerosis Patients

Study Overview
=================
Brief Summary
-----------------
Ampyra (dalfampridine-ER) was approved by the FDA (2010) for improving walking speed in persons with multiple sclerosis. This project seeks to determine if there are other benefits to taking dalfampridine besides an increase in walking speed. This is strictly an observational study and research staff will not be involved in any decisions to stop or start taking the medication.

Detailed Description
-----------------
Subjects will be evaluated before starting medication, throughout a 14week period after starting D-ER as well as at 12 and 18months following the start date of medication regardless of if they stayed on medication or not.

Official Title
-----------------
Responsiveness to Dalfampridine Treatment Among Multiple Sclerosis Patients Followed at the Mandell MS Center: Characterizing Clinical Predictors of Response and Identifying Additional Outcomes

Conditions
-----------------
Multiple Sclerosis

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Confirmed clinical diagnosis of MS by McDonald criteria Prescribed ampyra (dalfampridine) as part of usual care, but have not yet started taking the medication before baseline visit Receive MS care at the Mandell MS center Cognitively able to understand directions and complete protocol (score of 22 or greater on the MMSE) 18 years of age or older Exclusion Criteria: Already began to take drug prior to baseline research visit Not planning to continue care at Mandell Center for at least 14 weeks after initiation of therapy Unwilling or unable to complete assessments

Ages Eligible for Study
-----------------
Minimum Age: 18 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| pwMS prescribed dalfampridine-ER<br>Anyone prescribed D-ER per usual clinical care was recruited into this observational study. All those willing to participate were consented and observed pre-drug and for a 14week period with two follow-up visits scheduled at 12 and 18months. | |

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in 25ft walk time |  | Baseline (pre drug) and followup at 3.5 weeks, 7 weeks, 10.5 weeks and 14weeks | 
| Change in 6 minute walk distance | Measure of endurance | Baseline (pre drug) and followup at 3.5 weeks, 7 weeks, 10.5 weeks and 14weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change of Upper extremity dexterity with 9hole peg test |  | Baseline (pre drug) and followup at 3.5 weeks, 7 weeks, 10.5 weeks and 14weeks | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Multiple Sclerosis, Dalfampridine-ER, Walking speed
Assessment of Anaemia Attributable to Schistosomiasis in School Children in Kenya: Mechanisms and Effect of Treatment

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to determine the extend and the nature of anemia in school children and the correlation between anemia and schistosomiasis infections, malaria infections and/or malnutrition (iron deficiency).

Detailed Description
-----------------
The study will be carried out in an area around Lake Victoria in Kenya where the prevalence of schistosomiasis and malaria are highest in the areas nearest to the Lake. Depending on the prevalence of schistosomiasis a sample of between 876 to 2.524 children will be enrolled in the study. The children who will be in the age between 9 to 12 year, will have their stool and urine examined for schistosomiasis and intestinal worms and a blood sample will be examined for malaria parasites and the hemoglobin level. Children will also be weight, measured and examined by a doctor and register their food intake over one week, to determine their nutritional status. Children who are found to be infected with schistosomiasis, intestinal worms or malaria will be offered treatment. Children who are found to have anemia will be offered a course of iron supplementation, children with severe anemia will be referred to the nearest health facility for treatment. 12 months after the initial examinations and treatment all children will have a re-examination of their stool, urine and blood.

Official Title
-----------------
Assessment of Anaemia Attributable to Schistosomiasis in School Children in Kenya: Mechanisms and Effect of Treatment

Conditions
-----------------
Anaemia, Schistosomiasis Infection, Malaria, Iron Deficiency

Intervention / Treatment
-----------------
* Drug: praziquantl, iron, ACT


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: school children between 9 to 12 year

Ages Eligible for Study
-----------------
Minimum Age: 9 Years
Maximum Age: 12 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| children 9-12 years of age<br>Children with schistosomiasis, malaria and anaemia | Drug: praziquantl, iron, ACT<br> <br> |

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| hemoglobin level |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Schistosomiasis infection |  |  | 
| malaria infection |  |  | 
| iron deficiency |  |  | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
schistosomiasis, anaemia, malaria, iron deficiency
A Study Using Botulinum Toxin Type A in Adolescents With Axillary Hyperhidrosis

Study Overview
=================
Brief Summary
-----------------
A study using Botulinum Toxin Type A in adolescents with axillary hyperhidrosis.

Conditions
-----------------
Hyperhidrosis

Intervention / Treatment
-----------------
* Biological: Botulinum Toxin Type A


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Marked axillary hyperhidrosis Exclusion Criteria: Previous use of botulinum toxin for hyperhidrosis

Ages Eligible for Study
-----------------
Minimum Age: 12 Years
Maximum Age: 17 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 1<br>Botulinum Toxin Type A | Biological: Botulinum Toxin Type A<br>* 100 U up to 6 times during the study depending on the response to treatment<br>* Other names: BOTOX®;|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Subject's assessment of the severity of hyperhidrosis using the HDS Scale |  | Monthly | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Measurement of axillary sweat production |  | Week 4, Week 8 and any re-injection visit |
Contribution of Narrow Band Imaging (NBI) for the Characterization of Scalloped Polyps (NBI POLYPES COLIQUES)

Study Overview
=================
Brief Summary
-----------------
This prospective bicentric trial aims to evaluate the diagnostic performance of the characterization of scalloped polyps less than 20 millimeter in NBI (Narrow Band Imaging) in patients with screening colonoscopy. The NBI is a so-called virtual electronic staining technique available on conventional OLYMPUS endoscopes without additional intervention. The colonoscopy procedure for each patient will not be different from a conventional colonoscopy examination with excision of all polyps visualized and anatomopathological analysis, except for a short time of analysis in NBI for each polyp detected before excision to classify the polyp in existing endoscopic classifications (ie NICE classification for adenomatous polyps and WASP classification for festooned polyps).

Official Title
-----------------
Contribution of Narrow Band Imaging (NBI) for the Characterization of Scalloped Polyps

Conditions
-----------------
Polyps of Colon

Intervention / Treatment
-----------------
* Other: Colonoscopy with NBI


Participation Criteria
=================
Eligibility Criteria
-----------------
Pre-inclusion criteria: Major patient with a colonoscopy scheduled in one of the participating hospitals (CHD Vendée and CHU Nantes). Patient who agreed to participate in the study and gave his express consent Patient affiliated with a social security system or beneficiary of a scheme Inclusion Criteria: Patient with 1 or more polyps less than 20 mm observed during colonoscopy Exclusion Criteria: Patient with an emergency colonoscopy for ongoing digestive bleeding or occlusion symptoms Patient with chronic inflammatory bowel disease (IBD): Crohn's disease or unclassified colitis Patient with familial adenomatous polyposis Pregnant or lactating woman Minor patient Major patient under tutorship, curatorship, or deprived of liberty Patient unable to understand protocol and / or give express consent Patient not affiliated with a social security system or beneficiary of such a scheme Patient hospitalized or treated without their consent

Ages Eligible for Study
-----------------
Minimum Age: 18 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Prevention
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Colonoscopy with NBI<br> | Other: Colonoscopy with NBI<br>* Colonoscopy with NBI<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Sensitivity of the NBI compared to the anatomopathological analysis (= reference method) | Number of polyps characterized as scalloped (NICE II-) by NBI relative to the number of polyps characterized as scalloped in standard histology | An average of 1 month |
Merci Registry - Real World Use of the Merci Retrieval System in Acute Ischemic Stroke

Study Overview
=================
Brief Summary
-----------------
Post-Market Registry on Use of Merci Retrieval System. Primary data to be collected will include: Post-procedure revascularization success 90-day mRS 0-2 90-day mortality

Detailed Description
-----------------
The Merci Registry is a prospective multicenter registry with up to 3000 patients enrolled at a maximum of 100 sites. The registry requires use (at least one pass in the intracranial vasculature) of any Merci Retriever device (X Series, L Series, V Series) in the setting of acute ischemic stroke due to large vessel intracranial occlusion.

Official Title
-----------------
Merci Registry - Real World Use of the Merci Retrieval System in Acute Ischemic Stroke

Conditions
-----------------
Ischemic Stroke

Intervention / Treatment
-----------------
* Procedure: Mechanical Thrombectomy


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patient with ischemic stroke is treated with a Merci Retriever that is indicated for thrombus removal in ischemic stroke. Treated is defined as being when a Merci Retriever is deployed in the neurovasculature of a patient with an ischemic stroke Patient/patient's surrogate provides informed consent and is willing to comply with the protocol requirements and complete required clinical evaluations, or in the absence of informed consent, an IRB/EC approved waiver of consent and executed data use agreement are in place Exclusion Criteria: -There are no exclusion criteria for this protocol
Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Acute Ischemic Stroke patients<br>Patients presenting with signs and symptoms consistent with a diagnosis of Acute Ischemic Stroke, who are treated with the Merci Retrieval System during a Mechanical Thrombectomy procedure. | Procedure: Mechanical Thrombectomy<br>* Thrombectomy performed with the Merci Retriever in the setting of acute ischemic stroke.<br>* Other names: Merci Retrieval System;|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Post-procedure revascularization success |  | post-procedure | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| NIHSS change from baseline to 24-hours |  | 24-hour | 
| 90-day mRS outcomes |  | 90-day | 
| 90-day mortality |  | 90-day | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Stroke, Ischemic, Thrombus, Embolectomy, Thrombectomy, Merci, Concentric, Embolus, Embolism, Mechanical
Positron Emission Tomagraphy (PET) Study Following a Single Oral Dose of OPC-34712

Study Overview
=================
Brief Summary
-----------------
Determine the degree of striatal D2 receptor occupancy induced by OPC-34712 at differenht dose levels in healthy volunteers.

Detailed Description
-----------------
Subjects will receive a dose of study medication and will undergo a PET scan at 4 hrs and 23.5 hours post dose. Subjects will remain in the clinic from Day-1 to Day 7 for PK sample collection and safety monitoring. Subjects will return to the clinic on Day 10 for a follow-up safety assessment.

Official Title
-----------------
A Phase I, Open-Label,Positron Emission Tomography (PET) Study Healthy Subjects Following a Single Oral Dose of OPC-34712

Conditions
-----------------
Schizophrenia

Intervention / Treatment
-----------------
* Drug: OPC-34712


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Males and non-child bearing potential females between 18 and 45 years of age, inclusive. BMI between 19 and 32 kg/m2, inclusive. Exclusion Criteria: Condition or history which may present a safety concern to the subject or interfere with outcome variables. History of or current drug or alcohol abuse, hepatitis, AIDS, or drug allergy. Use of prescription, over-the-counter, or herbal medication, or vitamin supplements within 14 days or antibiotics within 30 days. Use of tobacco products or daily exposue to second hand smoke. Blood pressure higher than 140/90 mmHg or lower than 100/50 mmHg: heart rate outside 40 to 90 beats/minute. History of serious mental disorder.

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 45 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
Accepts Healthy Volunteers

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Basic Science
Masking: None (Open Label)


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: OPC-34712|Single oral dose, 0.5 to 25 mg|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pharmacodynamic: Percent occupancy of D2 receptor, as judged by PET scan. |  | 10 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Measure safety: adverse events, vital signs, ECGs, and clinical laboratory tests |  | 30 days | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Healthy Volunteers, Phase I, Pet Scan