linjc16/ctgov huggingface dataset:
Vanderbilt Childhood Obesity Registry

Study Overview
=================
Brief Summary
-----------------
In order to better understand early onset obesity and to identify patients in interested in future research studies, including clinical trials, we aim to develop a registry for patients with early onset obesity.

Detailed Description
-----------------
Obesity is an epidemic effecting the pediatric population. Currently, 17% of children are classified as obese and 32% as overweight. Many of these children develop complications including type 2 diabetes, dyslipidemia, hypertension and hepatic steatosis. Obesity is a global epidemic that lacks effective treatment options. Obesity has many underlying causes including genetic predisposition and environmental factors. Understanding the genetic basis of obesity may allow for more precisely targeted interventions including specific dietary plans and pharmacologic treatments. The most common cause of genetic obesity is haploinsufficiency of the melanocortin-4 receptor (MC4R). In obese adult cohorts, the prevalence of pathogenic MC4R mutations is 1-2%. Commercial testing is available for many obesity syndromes, but the cost is high and charges are not always covered by insurance. Clinicians have little motivation to test patients for MC4R mutations as no treatments are available and it is not clear if genetic testing results change patient behavior. This particular lab and other groups are working to develop novel pharmacologic treatments for obesity syndromes, such as MC4R deficiency. In order to better understand early onset obesity and to identify patients in interested in future research studies, including clinical trials, the investigators aim to develop a registry for patients with early onset obesity.

Official Title
-----------------
Vanderbilt Childhood Obesity Registry

Conditions
-----------------
Childhood Onset Obesity, Pediatric Obesity, Childhood Obesity

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: BMI >97th percentile for age and gender before 6 years old Able to give written, informed consent/assent Exclusion Criteria: Diagnosis of Prader-Willi syndrome Use of exogenous steroids or other medications known to cause abnormal weight gain Cushing's syndrome, untreated growth hormone deficiency or untreated hypothyroidism as an etiology for the obesity Hypothalamic obesity (obesity due to a brain tumor, head trauma or other brain lesion) Currently pregnant

Ages Eligible for Study
-----------------
Minimum Age: 2 Years
Maximum Age: 100 Years

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

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

Study Plan
=================
How is the study designed?
-----------------
What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Prevalence of genetic mutations in DNA analysis |  | 5 years |
Phase III Comparative Study(Open-Label) of MRA for Rheumatoid Arthritis(RA)

Study Overview
=================
Brief Summary
-----------------
To evaluate clinical efficacy and tolerability of MRA, patients with RA are randomized to receive either MRA or conventional DMARDs.

Official Title
-----------------
An Open-Label, Phase III Study to Evaluate the Efficacy and Safety of MRA in Patients With RA

Conditions
-----------------
Rheumatoid Arthritis

Intervention / Treatment
-----------------
* Drug: MRA (Tocilizumab)
* Other: current treatment


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion criteria Diagnosed as having RA, on the basis of the criteria stipulated by the American Conference on Rheumatism (ACR) in 1987. With RA that has continued for at least 6 months but less than 5 years, with the date of first appearance being taken as the date of RA diagnosis. Active RA despite at least one DMARD or immunosuppressant. Active disease is defined as having at least 6 tender and 6 swollen joints among 49 and 46 joints stipulated by the Japanese Rheumatism Foundation's Drug Evaluation Committee and ESR at least 30 mm/hr and CRP not less than 2.0mg/dL. Exclusion criteria Shown to have class-IV Steinbrocker's functional activity in an evaluation carried out within 4 weeks before administration of the study drug. Treated with drugs that delay joint destruction (infliximab, etanercept, leflunomide, etc.) within 3 months before administration of the study drug. The oral corticosteroid dose (prednisolone equivalent of up to 10 mg/day)has not been fixed 2 weeks before administration of the study drug. Subjected to any of the following within 4 weeks before administration of the study drug: (i) Change in dosage of currently administered DMARDs and/or immunosuppressive agents. (ii) Plasma exchange method. (iii) Surgical treatment (operations, etc.).

Ages Eligible for Study
-----------------
Minimum Age: 20 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: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 1<br> | Drug: MRA (Tocilizumab)<br>* 8mg /kg /4week for 52 weeks<br>|
| Other: 2<br>continue current treatment | Other: current treatment<br>* continue current treatment<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in the erosion score, as determined by the modified Sharp method. |  | week 52 | 
| Frequency and severity of adverse events and adverse drug reactions |  | throughout study | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in the erosion score |  | week 28 | 
| Changes in the joint space narrowing score and total Sharp score |  | week 28, 52 |
Conception of an ICF Core Set for Systemic Sclerosis

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to create and validate an ICF core Set for Systemic sclerosis

Detailed Description
-----------------
In 2002 was published WHO's International Classification of Functioning, Disability and Health (ICF). ICF defines disability as the negative aspects of the interaction between an individual (with a health condition) and that individual's contextual factors (personal and environmental factors). Interactions are specified in five domains, classified from body, individual and societal perspectives by means of two lists: a list of body functions and structure, and a list of domains of activity and participation. Since an individual's functioning and disability occurs in a context, the ICF also includes a list of environmental factors. ICF core sets, which are short lists of ICF categories relevant for specific conditions, serve as practical tools for clinical practice and allow standardisation of data for health information and research. Core sets have already been developed and validated for several musculoskeletal diseases, such as low back pain, osteoarthritis, or osteoporosis, but not yet for systemic sclerosis.

Official Title
-----------------
Conception of an ICF Core Set for Systemic Sclerosis

Conditions
-----------------
Systemic Sclerosis

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Male or female aged 18 and older Diagnosis of ScS made according to ACR and/or Leroy et Medsger criteria Patient giving his informed consent to participate in the study Exclusion Criteria: Severe chronic disease associated with ScS : stroke, multiple sclerosis, Parkinson's disease,… Cognitive or behavioral disorders making assessment impossible Inability to speak and write French

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

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

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

Study Plan
=================
How is the study designed?
-----------------
What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Validation of an ICF core Set for Systemic sclerosis | Submit the list of items to a cohort of 100 patients and experts. | Between the 13th and 24th month | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Translation of concepts identified such as items ICF (linking). | Translation of extracted data and set up the core set | Between the 10th and 12th month | 
| Creation of a database from a qualitative survey | This database will be elaborated considering information from a qualitative survey of 100 patients, a consultation with experts and a review of the literature | During the first 9 months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
ICF, Core sets, Systemic sclerosis, Function, Evaluation
Pilot Safety Study of Injectable SIS for Critical Limb Ischemia

Study Overview
=================
Brief Summary
-----------------
This study is intended to collect safety and effectiveness data on the Cook Injectable Small Intestinal Submucosa (SIS)

Official Title
-----------------
Pilot Safety Study of Injectable Small Intestine Submucosa (SIS) for Critical Limb Ischemia

Conditions
-----------------
Critical Limb Ischemia, Peripheral Arterial Disease, Peripheral Vascular Disease

Intervention / Treatment
-----------------
* Device: Injectable SIS


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Diagnosis of critical limb ischemia Rutherford 4-5 or Leriche-Fontaine IIIB Patient unable to be treated by endovascular or surgical means Exclusion Criteria: Patient's age is <21 Patient is pregnant or breast-feeding (or is planning to become pregnant within the next year) Patient has had a previous surgery, within 30 days of the study procedure Patient has any planned surgical or interventional procedure within 30 days after the study procedure Patient has a life expectancy less than 1 year Patient has a known allergy to pigs or pig products, or has a religious or cultural objection to the use of pig tissue Additional restrictions as specified in the Clinical Investigation Plan

Ages Eligible for Study
-----------------
Minimum Age: 21 Years

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

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

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

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Treatment<br>Injectable SIS | Device: Injectable SIS<br>* Injectable SIS<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Frequency and types of adverse events after treatment with the Cook Injectable SIS |  | 180 days | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
critical limb ischemia, wound healing, amputation
Evaluation of Novel Antimicrobial Hand Towels

Study Overview
=================
Brief Summary
-----------------
In March 2012, the investigators initiated a prospective, cluster-randomized, controlled field trial in Kisumu County, located in an area in western Kenya which has the highest under-five mortality rate in Kenya with 149 childhood deaths per 1,000 live births 9. The study was designed to evaluate the effectiveness of an antimicrobial hand towel (hereafter referred to as towel) in preventing diarrheal diseases, acute respiratory infections, self-reported fever, and skin infections in children <2 years old.

Detailed Description
-----------------
In March 2012, the investigators initiated a prospective, cluster-randomized, controlled field trial in Kisumu County, located in an area in western Kenya which has the highest under-five mortality rate in Kenya with 149 childhood deaths per 1,000 live births 9. The study was designed to evaluate the effectiveness of an antimicrobial hand towel (hereafter referred to as towel) in preventing diarrheal diseases, acute respiratory infections (ARIs), self-reported fever, and skin infections in children <2 years old.

Official Title
-----------------
Evaluation of Novel Antimicrobial Hand Towels

Conditions
-----------------
Fever, Diarrheal Diseases, Acute Respiratory Infections, Skin Infection

Intervention / Treatment
-----------------
* Other: Antimicrobial Hand Towel


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Mother of a child <2 years old Exclusion Criteria: Inaccessible enumeration area in the rainy season Multiple eligible children in a single compound Moved between census and round 1
Sexes Eligible for Study
-----------------
Female

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

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

Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| No Intervention: Comparison<br>Hand hygiene education. | |
| Experimental: Intervention<br>Hand hygiene education and 4 antimicrobial hand towels | Other: Antimicrobial Hand Towel<br>* Novel antimicrobial hand towel.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of participants with diarrheal disease | The number of participants that experience 3 or more loose or watery stools | Within 48 hours of enrollment | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of participants with respiratory infections |  | Within 48 hours of enrollment | 
| Number of participants with a subjective fever |  | Within 48 hours of enrollment | 
| Number of participants with a skin infection |  | Within 48 hours of enrollment |
Evaluation of Impaired Microcirculation During Septic Shock With Contrast Enhanced Ultrasound

Study Overview
=================
Brief Summary
-----------------
Microcirculatory disorders play a central role in the pathogenesis of sepsis and septic shock. Without adequate therapy that may lead to multi-organ failure and death. Therefore useful therapeutic measures aim to improve the microcirculation, to avoid tissue hypoxia and thus multiple organ failure or death. Clinically, the microcirculation can currently be indirectly evaluated using the diuresis and metabolic parameters (eg, lactate). The aim of the present study is to measure the microcirculation in septic shock by means of contrast-enhanced sonography of the calf muscles. For this purpose, the method is applied to 24 subjects during and after septic shock. It will be investigated in this study whether the microcirculation measurement with ultrasound contrast reflects the severity of the disease. As well as to evaluate whether the use of this diagnostic method could lead to better treatment of the septic shock.

Official Title
-----------------
Messung Von Mikrozirkulationsstörungen im Septischen Schock Mit Kontrastmittel- verstärkter Sonographie Evaluation of Impaired Microcirculation During Septic Shock With Contrast Enhanced Ultrasound

Conditions
-----------------
Sepsis

Intervention / Treatment
-----------------
* Other: Contrast enhanced ultrasound


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: septic shock Exclusion Criteria: myocardial infarction
Sexes Eligible for Study
-----------------
All

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

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

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Contrast enhanced ultrasound<br>Contrast enhanced ultrasound during septic shock | Other: Contrast enhanced ultrasound<br>* Contrat enhanced ultrasound during septic shock<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Contrast transit time during and after septic shock |  | 24 months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
sepsis, septic shock, contrast-enhanced ultrasound, microcirculation
Role of Color Doppler Ultrasonography in Assessment of Vascular Access Surveillance in Hemodialysis Patients.

Study Overview
=================
Brief Summary
-----------------
The aim of this study is to provide an overview of the possible applications of DUS during the maturation and postoperative follow-up of vascular access, with particular emphasis to establish a relationship between doppler Ultrasound parameters including: Flow volume. Outflow vein diameter. Outflow vein depth. Resistive index.

Official Title
-----------------
Role of Color Doppler Ultrasonography in Assessment of Vascular Access Surveillance in Hemodialysis Patients.

Conditions
-----------------
Arteriovenous Fistula

Intervention / Treatment
-----------------
* Device: doppler ultrasound


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: ESRD patients on dialysis with heamodialysis vascular access with adult age group (18 years and above). Exclusion Criteria: Patients with chronically occluded vascular access with failed surgical or interventional attempts.

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

| Intervention/Treatment |
| --- |
|Device: doppler ultrasound|a 7.5 MHz ultrasound (US) linear probe is needed, grey-scale ultrasound and Color Doppler and a minimum display facility of the Doppler velocity spectrum for blood flow calculation are mandatory tools.|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Maturation of arteriovenous fistulas | Assess the role of grey scale and color Doppler US in the early detection of failure in the hemodialysis vascular access. Maturation and monitoring\ surveillance of arteriovenous fistula. | 6 weeks duration follow up |
Dietary Quality During Adolescence is Associated With Mother's Dietary Quality During Pregnancy

Study Overview
=================
Brief Summary
-----------------
We will examine the association between diet quality in offspring at age 14 years and maternal diet quality during pregnancy in the Danish National Birth Cohort

Detailed Description
-----------------
Background: Dietary exposures in fetal life may have long lasting impact on the individual's susceptibility for several non-communicable diseases. Although offspring's own dietary habits become increasingly independent from parental influence other external factors are likely to exist. Further insights are needed to interpret and separate potential influence from exposures in pregnancy from later dietary habits on later disease risk. Objectives: We will examine the association between diet quality in offspring at age 14 years and maternal diet quality during pregnancy in the Danish National Birth Cohort (DNBC). Design: A total of 19620 DNBC offspring-mother pairs will be matched by offspring dietary intake assessed at age  14 years with a 150-item food frequency questionnaire (FFQ) and dietary intake assessed with a 300-item FFQ during mid-pregnancy (1996-2003). A Healthy Eating Index (HEI) will be developed as an indicator for diet quality based on current Danish Food-Based Dietary Guidelines including 8 components; fruit and vegetables, fish, dietary fibers, red meat, saturated fatty acids, sodium, sugar-sweetened beverages, and added sugar.

Official Title
-----------------
Dietary Quality During Adolescence is Associated With Mother's Dietary Quality During Pregnancy: 15 Years Follow up From a Large National Birth Cohort

Conditions
-----------------
Eating Behavior

Intervention / Treatment
-----------------
* Behavioral: Observational


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Participants in the Danish National Birth Cohort Exclusion Criteria: If mother did not complete a food frequency questionnaire during pregnancy

Ages Eligible for Study
-----------------
Minimum Age: 14 Years
Maximum Age: 14 Years

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

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Danish National Birth Cohort<br> | Behavioral: Observational<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Diet quality | Healthy Eating Index depicting diet quality | Reported intake during one year | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
diet quality, pregnancy, adolescence, longitudinal study, food frequency questionnaire
New Therapeutic Approach Against BK Virus Infection Based on Monoclonal Antibodies

Study Overview
=================
Brief Summary
-----------------
BK virus (BKV) infection has a major negative impact on transplant recipients. No BKV-specific antiviral therapy is available, so there is an urgent need to develop new anti-BKV preventive and therapeutic strategies.

Official Title
-----------------
New Therapeutic Approach Against BK Virus Infection Based on Monoclonal Antibodies

Conditions
-----------------
BK Virus Infection

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: BK positive adult ok to participed to research Exclusion Criteria: under guardianship under curatorship opposed to research deprived of liberty

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

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

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

Study Plan
=================
How is the study designed?
-----------------
What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Ability of the isolated monoclonal antibodies to neutralize all 3 BKV genotypes | The neutralization titer will be defined as the dilution of the sample that produced 50% inhibition of pseudovirion infectivity (IC50) | 5 years |