linjc16/ctgov huggingface dataset:
Morphofunctional Imaging and Developmental Dyslexia

Study Overview
=================
Brief Summary
-----------------
Developmental dyslexia is a frequent learning disability. The aim of this study is to analyze cortical thickness and phonological treatment in right handed adults with developmental dyslexia. They are compared to control adults paired with age and laterality. To study phonological treatment, the researchers used functional magnetic resonance imaging (fMRI) with a rime judgement task and silent word generation.

Official Title
-----------------
Morphofunctional Imaging and Developmental Dyslexia

Conditions
-----------------
Developmental Dyslexia

Intervention / Treatment
-----------------
* Procedure: Morphological and functional MRI


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Developmental dyslexia according to Critchley. Normal performance intelligence quotient (PIQ) Age: 18-35 years Sex: Male Right handed No hearing deficit. Exclusion Criteria: No head injury No attention deficit hyperactivity disorder (ADHD)

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 35 Years

Sexes Eligible for Study
-----------------
Male

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Dyslexia<br>adults from 18-35 ans. | Procedure: Morphological and functional MRI<br>* one time<br>|
| Control<br>adults from 18-35 ans. | Procedure: Morphological and functional MRI<br>* one time<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Cortical thickness | The average cortical thickness maps of healthy subjects and dyslexic will be compared hemisphere by hemisphere. This will identify whether there are cortical areas including cortical thickness differed significantly between normal and dyslexic.ts of different ages | 2 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Average cortical thickness | For each group, cortical thickness maps of average left and right hemispheres are compared. This will identify whether there is an asymmetry left / right in terms of cortical thickness in normal subjects and dyslexic. | 2 years | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
phonological treatment, language, fMRI
Compassionate Use of IV Fish Oil for Parenteral Nutrition (PN) Liver Injury

Study Overview
=================
Brief Summary
-----------------
To establish a process by which critically ill infants with parenteral nutrition-associated liver disease can receive a fish oil-based intravenous lipid emulsion (Omegaven®) for compassionate use when no satisfactory alternative treatments are available.

Detailed Description
-----------------
Patients who meet the inclusion criteria (having a direct bilirubin ≥4.0 mg/dL) and are consented will be discontinued from standard soybean-based lipid emulsion and started on Omegaven®. Omegaven® will be infused continuously via either a peripheral or central catheter at a dose of 1 gm/kg/day along with parenteral nutrition (PN).

Official Title
-----------------
Compassionate Use of an Intravenous Lipid Emulsion Comprised of Fish Oil in the Treatment of Parenteral Nutrition Induced Liver Injury in Children

Conditions
-----------------
Liver Disease

Intervention / Treatment
-----------------
* Drug: Intravenous Lipid Emulsion Comprised of Fish Oil


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria : - >14 days <24 months* Anatomic short gut (< 50 % bowel removed) with total bilirubin > or = 4 mg/dL Or severe dysmotility of gut reflecting non functional gut with total bilirubin > or = 4 mg/dL Receiving at least 60 % calories by intravenous infusion Requires IV nutrition an additional 28 days * Patients with direct bilirubin > or = 6 mg/dL who do not meet criteria above but meet criteria with * If infants qualify for high risk ARM (gastroschisis, ileal atresia, <750 grams and stage III NEC) d bilirubin >1 mg/dL but less than 4 mg/dL. Exclusion Criteria: Congenital lethal condition (e.g. Trisomy 13) Clinically severe bleeding Evidence of viral hepatitis or primary liver disease as etiology of their cholestasis Other health problems such as survival extremely unlikely even if cholestasis improves Known allergies to eggs or shellfish

Ages Eligible for Study
-----------------
Minimum Age: 14 Days
Maximum Age: 24 Months

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

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

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

Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: Intravenous Lipid Emulsion Comprised of Fish Oil|IV lipid provided for parenteral nutrition when enteral feeds are not tolerated due to intestinal disease|

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
-----------------
cholestasis, parenteral nutrition
Effect of Growth Hormone on Bone Mineral Density in Young Adults With Child-hood Onset Growth Hormone Deficiency

Study Overview
=================
Brief Summary
-----------------
This trial is conducted in Europe. Growth Hormone in young adults with growth hormone deficiency in childhood. This trial compares a treated group of patients with an untreated group of patients.

Official Title
-----------------
Effect of Two Years of Treatment With Norditropin® SimpleXx® on Bone Mineral Density in Young Adults With Childhood-Onset Growth Hormone Deficiency

Conditions
-----------------
Growth Hormone Disorder, Adult Growth Hormone Deficiency

Intervention / Treatment
-----------------
* Drug: somatropin


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Child-hood onset growth hormone deficiency Subjects received growth hormone replacement therapy during pre-puberty and puberty Exclusion Criteria: GH treatment during the month preceding randomisation Treatment within the previous 6 months with medication that may affect bone mineral density Diseases which may affect bone metabolism

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: None (Open Label)


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: somatropin|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Changes in bone mineralisation |  | After 2 years treatment | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Other markers of bone mineral content. |  |  |
Preschool CGM Use and Glucose Variability in Type 1 Diabetes

Study Overview
=================
Brief Summary
-----------------
The objectives of this clinical study is to evaluate the efficacy continuous glucose monitoring (CGM) use on glucose variability (GV) in preschool children with T1D treated with CSII. Downloads from CGM and CSII saved in pdf from will be retrospectively reviewed and analysed for all preschool children with type 1 diabetes in Slovenia. Glucose variability and other glycemic parameters will be analyzed separately for periods when CGM was used (CGM and SMBG data) and compared to periods when CGM was not used (SMBG only data).

Official Title
-----------------
The Effect of Continuous Glucose Monitoring Use on Glucose Variability in Preschool Children With Type 1 Diabetes

Conditions
-----------------
Type 1 Diabetes Mellitus

Intervention / Treatment
-----------------
* Device: CGM ON
* Device: CGM OFF


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Subject with Type 1 diabetes (&gt; 6 months since diagnosis) Insulin infusion pump CSII therapy for at least 3 months Age ≤ 7 years HbA1c at inclusion ≥ 6.5 and < 10 BMI SDS - below the 95th percentile for age Exclusion Criteria: Concomitant diseases that influence metabolic control Participation in any other interventional study Known or suspected allergy to trial products

Ages Eligible for Study
-----------------
Maximum Age: 7 Years

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

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

Arms and Interventions

| Intervention/Treatment |
| --- |
|Device: CGM ON|The period of time when continuous glucose monitoring was used, in edition to SMBG|
|Device: CGM OFF|The period of time when continuous glucose monitoring was not used, only SMBG|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Glucose variability | Glucose variability as SD and CV of glucose levels measured with CGM and blood glucose | Three years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Mean intersticial glucose | Mean glucose as measured with CGM | Three years | 
| Mean blood glucose | Mean glucose as measured with SMBG | Three years | 
| HbA1c | glycosilated hemoglobin | Three years |
Dulaglutide Versus Liraglutide in Obese Type 2 Diabetic Adolescents Using Metformin

Study Overview
=================
Brief Summary
-----------------
To compare the efficacy and effect on glycemic control of Dulaglutide versus Liraglutide in obese Type 2 diabetic adolescents using metformin

Detailed Description
-----------------
To observe the efficacy, effect on glycemic control, impact on BMI and incidence of adverse effects of Dulaglutide and to compare it to Liraglutide in individuals aged thirteen to eighteen who have Type 2 diabetes mellitus and are obese.

Official Title
-----------------
Dulaglutide Versus Liraglutide in Obese Type 2 Diabetic Adolescents Using Metformin: Results From a Randomized Double Blinded Clinical Trial

Conditions
-----------------
Type 2 Diabetes Treated With Insulin, Obesity, Adolescent Obesity

Intervention / Treatment
-----------------
* Drug: Dulaglutide
* Drug: Liraglutide


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Type 2 Diabetes Mellitus Obese Taking metformin Male or female Exclusion Criteria: Non obese Not taking metformin Taking other injectable diabetic medications

Ages Eligible for Study
-----------------
Minimum Age: 12 Years
Maximum Age: 19 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: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Group DUL<br>Group taking Dulaglutide injections | Drug: Dulaglutide<br>* Dulaglutide injections<br>* Other names: Group DUL;|
| Placebo Comparator: Group LIR<br>Group taking Liraglutide injections | Drug: Liraglutide<br>* Liraglutide injections<br>* Other names: Group LIR;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Glycemic level | HbA1c | 24 weeks for the duration of the study | 
| BMI | BMI measurements using weight and height measurements (anthropometric) | 24 weeks for the duration of the study | 
| Adverse effects | Recording of adverse effects | 24 weeks for the duration of the study |
Is There Intravascular Hemolysis in Patients With Pulmonary Hypertension?

Study Overview
=================
Brief Summary
-----------------
Patients with hemolytic disorders (e.g. sickle cell anemia or thalassemia) are known to develop pulmonary hypertension. Hemolysis is where red blood cells are destroyed and their contents released into the circulation. It is thought that these red-cell contents cause constriction and thrombosis of the blood vessels in the lungs. Conversely, it is possible that patients with pulmonary hypertension have hemolysis. In this study we will be drawing blood from a range of patients and normal controls for a panel of blood tests related to hemolysis.

Conditions
-----------------
Pulmonary Artery Hypertension

Intervention / Treatment
-----------------
* Procedure: Blood test


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: One of the following four conditions : Pulmonary artery hypertension Obstructive sleep apnea with pulmonary hypertension Lung transplant candidates without pulmonary hypertension Normal Controls Exclusion Criteria: Known hemolytic disorder Recent blood loss (<3 months) Recent blood transfusion (<3 months) Liver disease

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

| Intervention/Treatment |
| --- |
|Procedure: Blood test|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
Physiopathology Study of the Microbiota Biodiversity of HIV Seropositive Patients

Study Overview
=================
Brief Summary
-----------------
The bacterial diversity of HIV patients digestive microbiota seropositive is poorly understood, it remains to be defined.

Official Title
-----------------
Correlation Between Microbiota Biodiversity of HIV Seropositive Patients With Their Clinical and Immunological Status (ANRS EP 55 MICROGUT).

Conditions
-----------------
HIV-1 Infection

Intervention / Treatment
-----------------
* Other: Physiopathology study


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patient aged 18 or more. Patients with a confirmed diagnosis of HIV infection 1. Patient who signed an informed consent form. Patient affiliated or beneficiary of a social security system. Exclusion Criteria: Patient known to be suffering from inflammatory bowel disease (Crohn's disease or ulcerative colitis). Patient HIV-2 or HIV-1/HIV-2 co-infected Patient having received immunotherapy Patient participating in another research. Pregnant women, parturient or lactating person under guardianship, or deprived of liberty by a judicial or administrative decision.

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 |
| --- | --- |
| HIV-1 patients<br> | Other: Physiopathology study<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Proportion and type of OTU (Operational Taxonomic Unit) assigned to the rank of phylum genus and species of bacteria in the intestinal microbiota of HIV-1 seropositive patients. |  | Baseline | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Proportion and OTU types in the gastrointestinal microbiota of HIV-1 seropositive patients compared to the general population |  | Baseline | 
| Proportion and OTU types in the gastrointestinal microbiota of HIV-1 seropositive patients based on CD4, viral load, the Elite controller status, antiretroviral and antibiotic treatment and the existence of invasive bacterial infections. |  | Baseline | 
| Proportion and OTU types in the gastrointestinal microbiota of HIV-1 seropositive patients based on inflammation parameters (IL-6, TNF-a, IP-10), CRPus, CD14 and integrity of the epithelial barrier (I-FABP). |  | Baseline | 
| Transcriptomic analysis in the groups that present differences in the microbiota and analysis of lymphocyte populations Th17 and Treg. |  | Baseline |
Multiple Dose Safety Study of PF-04802540 in Healthy Volunteers

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to evaluate the safety, tolerability, and pharmacokinetics of multiple ascending doses of PF-04802540 administered orally to healthy adult subjects.

Detailed Description
-----------------
Evaluation of safety and pharmacokinetics

Official Title
-----------------
A Phase I Study To Evaluate The Safety, Tolerability, And Pharmacokinetics Of PF-04802540 After Multiple Oral Dose Administration To Healthy Adult Volunteers

Conditions
-----------------
Healthy

Intervention / Treatment
-----------------
* Drug: PF-04802540
* Drug: Placebo


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Males or females of non-childbearing capacity aged 21 to 55 years inclusive at screening. Body mass index in the range of 18 to 30 kg/m2 and body weight>45 kg. Healthy as determined by the investigator on the basis of screening evaluation. Exclusion Criteria: Use of prescription or nonprescription drugs Any condition possibly affecting drug absorption

Ages Eligible for Study
-----------------
Minimum Age: 21 Years
Maximum Age: 54 Years

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

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

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

Design Details

Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: PF-04802540<br> | Drug: PF-04802540<br>* Multiple ascending doses for 10 days; planned doses include 5, 10 and 15 mg capsules q12 hours, doses may be adjusted based on accumulating data<br>|
| Placebo Comparator: Placebo<br> | Drug: Placebo<br>* Placebo capsules q12 hours for 10 days<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Adverse events |  | 12 days | 
| Safety assessments: vital signs, ECG, physical examination, laboratory tests |  | 12 days | 
| Pharmacokinetics |  | 12 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| No secondary outcomes measures. |  | Timeframe N/A | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
PF-04802540 multiple dose safety study
Register of Telaprevir and Boceprevir in Routine Clinical Practice

Study Overview
=================
Brief Summary
-----------------
Know through routine clinical practice the effectiveness and safety of current treatment of hepatitis C virus, genotype 1, for patients who have never been treated and for patients who have been previously treated

Conditions
-----------------
Hepatitis C

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients infected by hepatitis C virus, genotype 1 Indication of treatment with telaprevir or boceprevir in F3 and F4 fibrosis Exclusion Criteria: Being taking part in other Inability to follow a monitoring Contra-indications on triple therapy Coinfected with HIV and HBV (hepatitis B virus)
Sexes Eligible for Study
-----------------
All

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Patients with hepatitis C, genotype 1<br>Patients with hepatitis C, genotype 1, treated with telaprevir or boceprevir | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Effectiveness of current treatment of hepatitis C virus, genotype 1, for patients who have never been treated and for patients who have been previously treated | Know through routine clinical practice the percentage of patients who have negative VHC-ARN | 12 months | 
| Safety of current treatment of hepatitis C virus, genotype 1, for patients who have never been treated and for patients who have been previously treated | Number and frequencies of serious adverse event (SAE) during the treatment | 12 months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
HCV, Hepatitis C, telaprevir, boceprevir, clinical practice
Mucopolysaccharidosis (MPS) VI Clinical Surveillance Program (CSP)

Study Overview
=================
Brief Summary
-----------------
The objectives of this program are: to further characterize the natural progression of MPS VI disease; to generate and disseminate information on the care and management of MPS VI patients to clinical and medical professionals; to provide a resource to physicians and patients by providing information for optimizing patient care based on aggregate data; to characterize the clinical response to long-term Naglazyme® (galsulfase) treatment; to further characterize the long-term safety of Naglazyme® treatment.

Official Title
-----------------
MPS VI Clinical Surveillance Program (CSP)

Conditions
-----------------
Mucopolysaccharidosis VI (MPS VI, Maroteaux-Lamy Syndrome)

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria All patients must meet the following criteria to qualify for enrollment in the CSP: Patient or patient's parent or legal guardian, if child is under 18 year old or is unable to consent, has provided a signed Patient Information and Authorization Form. Patient has laboratory results confirming a diagnosis of MPS VI disease based on detection of deficient ARSB activity (on fibroblasts, leucocytes or dried blood spots)and/or abnormality on the ARSB gene. Patient is willing to undergo general assessments to establish baseline data or permits physician to enter assessment data recorded prior to CSP entry if available in the patient's medical records. General assessments include: urinary GAG level, urinary protein level, serum sample for antibody levels, height, weight, and patient history.
Sexes Eligible for Study
-----------------
All

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Observational<br>No intervention. This is an observational program. | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To further characterize the natural progression of MPS VI disease, irrespective of treatment modality and to evaluate efficacy and safety treatment with Galsulfase. |  | at least 15 years |