linjc16/ctgov huggingface dataset:
Functional Assessment of a Vibration Feedback on the Gripping Pressure in the Territory of the Median Nerve

Study Overview
=================
Brief Summary
-----------------
The objective of this study is to investigate the effect of vibration feedback on the gripping pressure in the territory of the median nerve.

Official Title
-----------------
Preliminary Study of the Substitution of Sensory Deficits of the Hand by a Medical Device Embedded : a Functional Assessment of Vibration Feedback on the Gripping Pressure in the Territory of the Median Nerve.

Conditions
-----------------
Sensory Deficit

Intervention / Treatment
-----------------
* Procedure: pressure sensor and wrist shaker, not marked CE, developped by Texisense


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: person between 18 and 45 years old affiliation to the french social security system or equivalent person signed a consent to participate for the patient group: person with post-traumatic sensory deficit in the territory of the right median nerve above the wrist (<S3 according Zachary modified Dellon). Exclusion Criteria: person with a cognitive pathology incompatible with the use of the device, understanding and implementation of the protocol person with a concomitant nerve injury of any other nerve territory, person with pain or stiffness inconsistent with the achievement tests person with an allergy to any component of the device: polyamide, cotton, nickel, textile glue, rubber, plastic or latex, person with an infectious disease or dermatology of the right hand person deprived of freedom by judicial or administrative decision person hospitalized without their consent person under legal protection person hospitalized for psychiatric care pregnant and parturient women

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: Health Services Research
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Use of the glove<br>The subject wear the glove for the time of the trial | Procedure: pressure sensor and wrist shaker, not marked CE, developped by Texisense<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| intra-and inter-individual variance in pressure. | pressures are recorded during a test clamping with and without vibration feedback for the entire population | one year |
Fluor Varnish With Silver Nanoparticles for Dental Remineralization in Patients With Trisomy 21

Study Overview
=================
Brief Summary
-----------------
Patients with trisomy 21 are in greater danger of developing caries. It has been hypothesized that adding silver nanoparticles to fluor varnishes could promote remineralization of the teeth. A split-plot randomized controlled trial will be performed to address this question.

Official Title
-----------------
Efficacy of the Addition of Silver Nanoparticles to a Fluor Varnish in the Remineralization of Temporary Teeth in Patients With Trisomy 21. Randomized Clinical Trial.

Conditions
-----------------
Down Syndrome

Intervention / Treatment
-----------------
* Drug: Fluor varnish
* Drug: Fluor varnish with nanoparticles


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients with trisomy 21 diagnosed through caryotype Age 1 to 6 years old Any sex White spot present in both upper anterior teeth Parental agreement to participate in the study Exclusion Criteria: Hypersensibility to any of the substances used Non cooperating patients Caries in enamel or dentine in the upper anterior teeth Leukemia or diabetes Dental fluorosis present

Ages Eligible for Study
-----------------
Minimum Age: 1 Year
Maximum Age: 6 Years

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

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

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

Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Fluor varnish<br>Fluor dental varnish (Fluor Protector, Ivoclar Vivadent, Principality of Liechtenstein) | Drug: Fluor varnish<br>* Dental varnish will be applied to one anterior superior teeth in a random side.<br>* Other names: Fluor dental varnish;|
| Experimental: Fluor varnish with nanoparticles<br>Fluor dental varnish (Fluor Protector, Ivoclar Vivadent, Principality of Liechtenstein) plus 25% 50 nm silver nanoparticles. | Drug: Fluor varnish with nanoparticles<br>* Dental varnish with silver nanoparticles will be applied to one anterior superior teeth in a random side.<br>* Other names: Fluor dental varnish with silver nanoparticles.;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Remineralization | Remineralization status will be assessed through laser fluorescence of the tooth with a Diagnodent probe (Diagnodent, Kavo, Madrid, Spain) | 3 months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Down syndrome, Caries, Dental varnish
Directly Observed Therapy in HIV Infected Adolescent Focus Groups

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to help researchers use information from HIV infected adolescents to design a directly observed therapy (DOT) program that will help adolescents take their anti-HIV medications correctly.

Detailed Description
-----------------
The rate of HIV infection among adolescents is increasing at an alarming rate. Adherence to antiretroviral therapy has been a major challenge in achieving and maintaining adequate control of the disease in this population. DOT has been shown effective in individuals with tuberculosis (TB), but DOT in HIV infected populations has not been thoroughly examined. This study will collect information from HIV infected adolescents in order to establish a DOT program that will increase successful adherence to HIV treatment and will benefit the public by preventing development of viral resistance and reducing the risk of transmission. Adolescent participants in this study will be assigned to one of three 2-hour focus group sessions, each at a different site. The participants will complete a questionnaire and will give input about designing a DOT intervention model that will be accepted by adolescents. The model will then be used in a pilot study to determine the feasibility of implementing DOT programs in the community to help HIV infected adolescents.

Official Title
-----------------
Directly Observed Therapy (DOT) in HIV-Infected Adolescents: Part A-Focus Groups

Conditions
-----------------
HIV Infections

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: HIV infected due to high-risk behavior Regular attendee of local adolescent HIV support group Current use of antiretrovirals or history of antiretroviral therapy Permission of parent or legal guardian if participant is less than the legal age of consent. Assent of the minor participant should be obtained where required. Exclusion Criteria: Perinatal HIV infection Visibly distraught or emotionally unstable Pregnancy or breast-feeding

Ages Eligible for Study
-----------------
Minimum Age: 16 Years
Maximum Age: 21 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 |
| --- | --- | --- |

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Treatment Experienced
SPARK a Healthy and Fit Lifestyle

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to determine the best format for delivering a brief behavioral weight loss intervention to young adults 18-25 years of age.

Official Title
-----------------
SPARK a Healthy and Fit Lifestyle

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

Intervention / Treatment
-----------------
* Behavioral: Face-to-Face
* Behavioral: Web-based
* Behavioral: Single session


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: 18-25 years old body mass index 25-45 willing to be randomly assigned to any of the 3 arms available during the time frame of the study willing to complete assessment visits at 0, 2, 4 and 6 months Exclusion Criteria: Age or BMI outside of eligible range Medical condition that would interfere with weight loss or make unsupervised physical activity unsafe Pregnant or nursing within 6 months recent weight loss >10% of body weight History of eating disorder Substance abuse or dependence

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 25 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: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Face-to-Face<br>8 sessions of weekly group behavioral weight loss treatment | Behavioral: Face-to-Face<br>* Face-to-Face behavioral weight loss<br>|
| Experimental: Web-based<br>Participants receive one group face-to-face session followed by 7 web-based lessons, reporting of key behaviors, and feedback on progress. | Behavioral: Web-based<br>* Web-based behavioral weight loss<br>|
| Active Comparator: Single Session<br>Single session behavioral weight loss | Behavioral: Single session<br>* The core of behavioral weight loss, including calorie and activity prescriptions, are delivered in a single group treatment session.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Weight |  | 2 months (post-treatment) |
Pharmacokinetics of Lu AF35700 in Subjects With Renal Impairment

Study Overview
=================
Brief Summary
-----------------
This study will evaluate the pharmacokinetics of Lu AF35700 after a single dose tablet to subjects with renal impairment (kidney insufficiency) and compare that with healthy subjects

Detailed Description
-----------------
If the initial data shows a substantial effect in subjects with severe renal impairment, the study will be expanded to include subjects with intermediate level (mild and moderate) of renal impairment.

Official Title
-----------------
Interventional, Open Label, Reduced/Staged, Single Dose Study Investigating the Pharmacokinetic Properties of Lu AF35700 in Subjects With Renal Impairment and in Healthy Subjects

Conditions
-----------------
Renal Failure

Intervention / Treatment
-----------------
* Drug: Lu AF35700


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: -Healthy subjects: The subject has a Glomerular Filtration Rate as based on creatinine clearance (CLCr) ≥90 mL/min (estimated by the Cockcroft-Gault method) -Subjects with renal impairment: The subject has any form of renal dysfunction which includes polycystic kidney disease The subject is classified as having renal impairment at Screening according to Cockroft-Gault method for estimating creatinine clearance: Severe: CLCr ≤ 29 mL/min Moderate: 30 mL/min ≤ CLCr ≤ 59 mL/min Mild: 60 mL/min ≤ CLCr ≤ 89 mL/min Exclusion Criteria: -The subject has previously been dosed with Lu AF35700

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 70 Years

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

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

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

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Subjects with severe renal impairment (Group A)<br> | Drug: Lu AF35700<br>* Single dose, 10 mg film coated tablet<br>|
| Experimental: Healthy subjects (Group B)<br> | Drug: Lu AF35700<br>* Single dose, 10 mg film coated tablet<br>|
| Experimental: Subjects with moderate renal impairment (Group C)<br> | Drug: Lu AF35700<br>* Single dose, 10 mg film coated tablet<br>|
| Experimental: Subjects with mild renal impairment (Group D)<br> | Drug: Lu AF35700<br>* Single dose, 10 mg film coated tablet<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| AUC0-inf | Area under the Lu AF35700 plasma concentration-time curve from zero to infinity | Predose to day 57 postdose | 
| Cmax | Maximum observed plasma concentration of Lu AF35700 | Predose to day 57 postdose |
Neuropsychological Functioning Among Children With Tourret's Disorder and ADHD

Study Overview
=================
Brief Summary
-----------------
Tourette's disorder (TD) is a childhood-onset neuropsychiatric disorder, manifesting motor and vocal tics with increased likelihood of comorbid with attention-deficit/hyperactivity disorder (ADHD) and other psychiatric disorders. Literature documents the comorbid condition with ADHD predicts an increased functional deficit among individuals with ADHD. The information about neuropsychological functioning among individuals with TD adn/or ADHD is little in Asian population. This study aims to validate the diagnoses of TD, ADHD, and TD comorbid ADHD by symptomatology, neuropsychological measures, and social adjustment. This is a case-control study with a sample of 30 subjects with TD, 60 with ADHD, 30 with TD+ADHD, and 60 controls aged from 6 to 18. All subjects will receive comprehensive assessment including standard psychiatric diagnostic interviews using (K-SADS-E), behavioral assessments (SNAP-IV, CPRS:R-S, CTRS:R-S, CBCL, YBOCS, YGTSS), social adjustment (SAICA, GCAS), parenting (PBI, APGAR) and neuropsychological assessment (CPT, CANTAB, WISC-III). We anticipate that this study will provide the primitive data to validate the TD and ADHD using neuropsychological and clinical measures.

Official Title
-----------------
Neuropsychological Functioning, Symptomatology, and Social Adjustment Among Children With Tourret's Disorder, Attention-Deficit/Hyperactivity Disorder, and Comorbid Conditions.

Conditions
-----------------
Tourette Disorder, Attention-Deficit/Hyperactivity Disorder

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: patients aged 8-16 without the diagnosis of ADHD, and/or Tourette's disorder IQ > 80 both children/adolescents and their parents consent to participate and have the ability to complete self-administered measures in this study Exclusion Criteria: diagnosis of psychotic disorders, bipolar affective disorders, pervasive developmental disorder, seizure, or major physical disorders. in addition, control subjects will be excluded from the control group if have a history of the following condition as defined by DSM-IV: ADHD, ODD, or CD in addition to the above exclusion criteria.

Ages Eligible for Study
-----------------
Minimum Age: 8 Years
Maximum Age: 16 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 |
| --- | --- | --- |

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Tourette disorder, ADHD, comorbidity, neuropsychological
Association of Cytokines With the Development of Complications in Burn and Toxic Epidermal Necrolysis (TENS) Patients

Study Overview
=================
Brief Summary
-----------------
This study will involve blood draws to test for specific cytokines. The study goal is to gain a better understanding of the role of inflammatory response in the development of specific complications in burn and TENS patients.

Official Title
-----------------
Association of Cytokines With the Development of Complications in Burn and Toxic Epidermal Necrolysis (TENS) Patients

Conditions
-----------------
Inflammatory Response, Multi Organ Failure, Nosocomial Infection, Deep Vein Thrombosis

Intervention / Treatment
-----------------
* Other: Blood Draw


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: is ≥18 years of age has been admitted to the Joseph M. Still Burn Center at Doctors Hospital Augusta with a burn diagnosis, or TENS OR SJS diagnosis (confirmed or non-confirmed), with an expected length of stay to be at least 7 days the subject or their legally authorized representative is able to provide informed consent has a negative urine or serum pregnancy test at screening (if female and has potential for pregnancy) Exclusion Criteria: is moribund, or in the opinion of the investigator is not expected to survive has sustained an electrical burn

Ages Eligible for Study
-----------------
Minimum Age: 18 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 |
| --- | --- |
| Blood Draw<br>This study will involve blood draws to test for specific cytokines | Other: Blood Draw<br>* This study will involve blood draws to test for specific cytokines<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Cytokine Response that develops into complications | The number of burn and TENS patients that develop subsequent medical complications | up to one year |
Risk Stratification in End Stage Renal Disease (ESRD) - ISAR Study

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to evaluate the use of non-invasive markers of the autonomic function and micro- and macrocirculation to predict mortality and cardiovascular end points in end-stage renal disease patients. Furthermore we aim at getting new insight into the insufficiently understood pathophysiology leading to excessively high cardiovascular and non-cardiovascular mortality in dialysis patients.

Official Title
-----------------
Risk Stratification in End Stage Renal Disease (ISAR)

Conditions
-----------------
End Stage Renal Disease, Chronic Kidney Disease, Cardiovascular Event, Sudden Cardiac Death

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Age 18 or older End-stage renal disease (ESRD) and receiving maintenance hemodialysis Exclusion Criteria: Any clinically significant infection. pregnancy history of malignant disease with a prognostic life expectancy less than 24 months missing of written and informed 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?
-----------------
What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Mortality of all causes | 24 month follow up | 24 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Incidence of cardiovascular events | 24 month follow up | 24 months | 
| Blood pressure drops within a dialysis session | 24 month follow up | 24 months | 
| Incidence of infections requiring antibiotic treatment | 24 month follow up | 24 months | 
| Incidence of shunt thrombosis | 24 month follow up | 24 months | 
| incidence of death and hospitalization due to infection | 24 month follow up | 24 months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
end stage renal disease, chronic kidney disease, cardiovascular event, sudden cardiac death, autonomic function
Immune Activation, Hypoxia and Vasoreaction in Sepsis of Pulmonary Versus Abdominal Origin

Study Overview
=================
Brief Summary
-----------------
Sepsis remains a common entity in critical care patients with remarkable mortality. Pulmonary and abdominal infections (with subsequent sepsis) are the most common in the ICU. Despite extended research activities, no differences in patient outcome or organ dysfunction were revealed. Sepsis is a complex immune reaction phenomenon based on unbalanced activation and suppression. In addition to changes of cytokine levels and immune cell activity, underlying genetic reactions are present. For instance, expression of miRNA (as a potential important step of immune cell activation) is likely changed during systemic and local immune reactions. The aim of this study is to perform a detailed assay of immune cell activation, to investigate the levels of pro- and antiinflammatory cytokines and the various expression of miRNA depending on the origin of infection in the two most common sides. This means in ICU patients with early pulmonary or abdominal sepsis as well as in healthy controls. Additionally, clinical parameters of organ function, current infection markers as CRP and procalcitonin, cardiovascular function and heart rate variability will be assessed. Parameters of local tissue perfusion in a dynamic testing during forearm ischemia and plasma adenosine concentration will be measured.

Official Title
-----------------
Immune Activation, Hypoxia and Vasoreaction in Sepsis of Pulmonary Versus Abdominal Origin

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

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: sepsis (according to the criteria of the International Sepsis Definition Conference) Exclusion Criteria: pregnancy malignancy corticoid therapy organ transplantation renal insufficiency with HD

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

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

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

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
sepsis, tissue oxygenation, tissue perfusion, immune reaction