linjc16/ctgov huggingface dataset:
The Effect of Testosteron Replacement Treatment on the Fibroblast Growth Factor-23, Asymmetric Dimethylarginine and Vitamin D Levels in the Congenital Hypogonadotropic Hypogonadism

Study Overview
=================
Brief Summary
-----------------
The study is designed to answer the following questions: 1) What is the effect of testosteron replacement treatment on the endothelial dysfunction. 2/ What is the effect of testosteron replacement on the bone mineral metabolism.

Detailed Description
-----------------
this is an interventional study which is examine the effect of testosteron replacement treatment on the endothelial dysfunction and bone mineral metabolism in hypogonadotropic hypogonadal patients.

Official Title
-----------------
Phase 4 Study of Effect of Testosteron Replacement Treatment on the Fibroblast Growth Factor-23, Asymmetric Dimethylarginine and Vitamin D Levels in the Congenital Hypogonadotropic Hypogonadism

Conditions
-----------------
Hypogonadism

Intervention / Treatment
-----------------
* Drug: Testosterone


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Men Congenital hypogonadism Treatment Naive Exclusion Criteria: Previous history of androgen replacement Hypertension Diabetes mellitus

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 28 Years

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

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 |
| --- | --- |
| Other: testosterone<br>testosterone 250 mg injection per 3-4 weeks for 6 months | Drug: Testosterone<br>* Testosterone 250 mg injection per 3-4 weeks for 6 months<br>* Other names: sustanon 250 mg;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| the effect of testosteron replacement treatment on the Fibroblast Growth Factor-23. | Plasma FGF-23 levels were determined by ELISA, (Human Intact FGF-23 ELISA Kit, Inc., San Clement, CA, USA). | 6 months | 
| the effect of testosteron replacement treatment on the asymmetric dimethylarginine. | Plasma ADMA levels were determined by ELISA (Immunodiagnostic, Bernheim, Germany) | 6 months | 
| the effect of testosteron replacement treatment on the vitamin D levels. | Plasma 25-OH vitamin D3 levels were measured by Immuchrom kits (Hessen, Germany) using isocratic HPLC method with UV detector in Prominence HPLC system. | 6 months. | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
endothelial dysfunction, bone mineral metabolism, testosteron replacement treatment
Overview of Telemedicine in Children With Type 1 Diabetes

Study Overview
=================
Brief Summary
-----------------
Assessment of the proportion of pediatric patients with type 1 diabetes with access to remote monitoring

Detailed Description
-----------------
In the follow-up of type 1 diabetes in children, contact with families besides the appointements with medical et paramedic staff (paediatrician, diabetologist, nurses) is very common but not well coded, start from telehealth hubs (like myDiabby), to less unofficial contact by phone or email. This is even more so widespread since generalization of continuous glucometer (freestyle, dexcom,...), which allowed a quick data transfer to the medical staff. Some studies had shown that telemedicine in diabetes allowed a better glycemic control and a higher implication in the desease. Indeed, in 1999 already, HbA1c significant improvement was shown when patients was regularly called by a nurse (Thompson et al.). Same finding was demonstrated in Schiaffini and al. clinical trial in 2016. This trial also shown a better adhesion to the follow up into the telemedicine group. Despite all of this studies, in France, remote monitoring isn't standardised and financed, except the national experimentation ETAPES which promotes and financially supports the deployment of remote monitoring projects around the territory.

Official Title
-----------------
State of Play of Telemedicine in the Follow-up of Children With Type 1 Diabetes

Conditions
-----------------
Telemedicine, Diabetes Mellitus, Type 1, Children, Only

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Children with type 1 diabetes Exclusion Criteria: No consent

Ages Eligible for Study
-----------------
Maximum Age: 17 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 |
| --- | --- | --- |
| Assessment of the proportion of pediatric patients with access to remote monitoring | Proportion of pediatric patients with access to remote monitoring | 1 day | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Description of the different means and modalities of remote monitoring for patients | Proportion of patients in the different modalities of remote monitoring | 1 day | 
| Description of the different means and modalities of remote monitoring for patients | Proportion of patients in the different objectives of remote monitoring | 1 day | 
| Evaluation of patients' (and parents') perception of telemonitoring using a scale | Perceived importance of this remote monitoring score using a scale from 1 (mean no importance, I could do without) to 10 (mean it's very important, I think it's essential) | 1 day | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Diabetes mellitus type 1, Children, Telemedicine
Immunogenicity of Hepatitis A Vaccine in Inflammatory Bowel Disease (IBD) Patients

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to measure the immune response in 18-40 year old IBD patients after receiving the hepatitis A vaccine.

Detailed Description
-----------------
The spread of hepatitis A has prompted the need for vaccination against this virus. It is uncertain that IBD patients can achieve a truly protective response after vaccination. The efficacy and safety of hepatitis A vaccination have not been evaluated in this population of patients. We would like to estimate the efficacy and safety of vaccination against hepatitis A in patients with IBD.

Official Title
-----------------
Immunogenicity of Hepatitis A Vaccine in Patients With Inflammatory Bowel Disease

Conditions
-----------------
Inflammatory Bowel Disease, Crohn's Disease, Ulcerative Colitis, Hepatitis A

Intervention / Treatment
-----------------
* Biological: Epaxal Berna (virosomal hepatitis A vaccine)


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients suffering from inflammatory bowel disease: Crohn's disease/Ulcerative colitis Age 18-40 Willing to provide informed consent Exclusion Criteria: Have history of vaccination to hepatitis A Have other autoimmune disease Have any malignancy Have acute infectious disease Unwilling to provide consent

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 40 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: IBD patients<br>Patients diagnosed with IBD -> receive Epaxal Berna (virosomal hepatitis A vaccine) | Biological: Epaxal Berna (virosomal hepatitis A vaccine)<br>* standard 0.5 mL dose of Epaxal Berna (virosomal hepatitis A vaccine) given at Day 0, Month 6.<br>* Other names: Epaxal Berna;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| antibody titer to hepatitis A vaccine |  | Month 7 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| vaccine-associated adverse events and side effects |  | within the first 30 days after first vaccination | 
| vaccine-associated adverse events and side effects |  | within the first 30 days after second vaccination | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Crohn's disease, Ulcerative colitis, Hepatitis A, vaccine
Analysis of the Microbiota in Goldmann Applanation Tonometers at a Reference Service in Goiânia

Study Overview
=================
Brief Summary
-----------------
This study aims to evaluate the microbiota of goldmann tonometers and its possible change over the visits

Official Title
-----------------
Analysis of the Microbiota in Goldmann Applanation Tonometers at a Reference Service in Goiânia

Conditions
-----------------
Intraocular Pressure

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: collection of material in the period Exclusion Criteria: collection of material out of the period
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 |
| --- | --- | --- |
| Analysis of the microbiota in tonometers performed by means of swab collections | collect swabs of the tonometers before and after the visits to evaluate the change of the microbiota and, therefore, to evaluate the effectiveness of the asepsis. | 1 month |
Genetics of Alpha Thalassemia in Israeli Ethnic Groups

Study Overview
=================
Brief Summary
-----------------
Alpha thalassemia causes mild anemia and is found in many ethnic groups. Usually it is found in regions where malaria is endemic. We have found that alpha thalassemia is common in Ashkenazim, whose countries of origin are in temperate climates. We are analyzing the alpha globin genes of individuals of many ethnic groups and will compare to try to define the origin of thalassemia in these individuals of European extraction.

Detailed Description
-----------------
Alpha thalassemia causes mild anemia and is found in many ethnic groups. Usually it is found in regions where malaria is endemic. We have found that alpha thalassemia is common in Ashkenazim, whose countries of origin are in temperate climates. We are analyzing the alpha globin polymorphisms to determine the haplotypes of individuals of many ethnic groups and will compare to try to define the origin of thalassemia in these individuals of European extraction.

Official Title
-----------------
Haplotype Analysis of Alpha Globin Genes in Israeli Ethnic Groups

Conditions
-----------------
Alpha Thalassemia

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: diagnosis of deletional alpha thalassemia Exclusion Criteria: under age 18

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 |
| --- | --- | --- |
Assessement of Hepcidin in Saliva in Human Volunteers

Study Overview
=================
Brief Summary
-----------------
Iron deficiency with or without anemia is considered the most widespread nutritional deficiency in the world. To diagnose iron deficiency anemia (hemoglobin and ferritin measurement), a venous blood sample is necessary. Whole saliva is a potentially attractive fluid for disease biomarker discovery and diagnostic efforts, because it is readily available from most individuals, can be easily collected and the collection procedure is non-invasive. The iron storage protein ferritin is too big, to be secreted into saliva. However, the main iron regulatory protein hepcidin is a very small protein and there is some evidence for hepcidin detection in saliva. The production of serum hepcidin positively correlates with serum ferritin, thereby reflecting patient's iron status. Whether hepcidin is detectable in saliva and whether saliva hepcidin correlates with serum hepcidin with current assays, needs to be tested.

Official Title
-----------------
Detection of Hepcidin in Saliva and Its Utility as a Diagnostic Marker for Iron Deficiency

Conditions
-----------------
Hepcidin, Saliva

Intervention / Treatment
-----------------
* Other: blood and saliva sampling


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Normal-weight (BMI 18-24.9kg/m2) fasting Participants Need to have brushed their teeth at least 1 hour before the visit Exclusion Criteria: acute, chronic illness use of long-term medication other than contraception medical Problems known to affect Fe homeostasis smoking

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

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

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

Arms and Interventions

| Intervention/Treatment |
| --- |
|Other: blood and saliva sampling|blood and saliva sampling|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Saliva hepcidin |  | Day 1am | 
| Serum hepcidin |  | Day 1am | 
| Serum ferritin | Iron Status parameter | Day 1am | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Hemoglobin |  | Day 1am | 
| Transferrin receptor | Iron Status parameter | Day 1am | 
| c-reactive protein | Inflammation parameter | Day 1am | 
| alpha-glycoprotein | Inflammation parameter | Day 1am | 
| Saliva hepcidin | to assess variability in saliva hepcidin during the day | Day 1pm | 
| Saliva hepcidin | to assess variability in saliva hepcidin in two samples measured at the same time of the day | Day 2am |
Volar Locked Plating Versus Bridging External Fixation

Study Overview
=================
Brief Summary
-----------------
A randomized, prospective comparison of volar locked plating versus Hoffman II bridging external fixation supplemented by K-wire fixation in patients with comminuted distal radius fractures, AO/OTA type C2 & C3. Hypothesis: There is no significant difference in using volar plates compared to Hoffman II bridging external fixation supplemented by K-wire fixation in patients with comminuted distal radius fractures, AO/OTA type C2 & C3 as evaluated by a Quick-DASH score at 24 months follow-up.

Detailed Description
-----------------
We have designed a randomized, prospective study for comparison of volar locked plating versus Hoffman II bridging external fixation supplemented by K-wire fixation in patients with comminuted distal radius fractures, AO/OTA type C2 & C3. On the basis of power analysis a total of 140 patients are to be included in this project. The follow-up period is 2 years and evaluation is based on x-ray analysis, grip strength, range of movement, pain and various tools to measure quality of life and satisfaction with the treatment (EQ-5d, SF-36, Quick-DASH).

Official Title
-----------------
Volar Locked Plating Versus Bridging External Fixation

Conditions
-----------------
Distal Radius Fracture

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: All patients admitted to Ahus and Lillestrom legevakt with a distal radius fracture are to be classified according to the system of the Orthopaedic Trauma Association (AO/OTA). All patients between the age of 18 and 70 diagnosed with a C2- or C3-type fracture, or a dislocated C1-fracture, are eligible for inclusion. Exclusion Criteria: Gustillo-Anderson type III open fractures Previous distal radius/ulna-fracture and/or disabling hand injury of the same extremity Dementia Congenital anomaly Bilateral radius fracture Pathological fracture other than osteoporotic fracture Congenital bone disease (for example osteogenesis imperfecta) Age below 18 and above 70 Disabling nury to other parts og the movement apparatus at the same time as the current injury

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 70 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 |
| --- | --- | --- |
| Quick-DASH |  | 2 year follow-up |
Etoricoxib in the Treatment of Osteoarthritis (MK-0663-007)

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to evaluate the safety and efficacy of etoricoxib in the treatment of osteoarthritis of the knee.

Official Title
-----------------
A Placebo-Controlled, Parallel-Group, Double-Blind Study to Assess Safety and to Define the Clinically Effective Dose Range of MK0663 in Patients With Osteoarthritis of the Knee, Followed by a Double-Blind, Active-Comparator-Controlled Extension.

Conditions
-----------------
Osteoarthritis

Intervention / Treatment
-----------------
* Drug: MK0663, etoricoxib / Duration of Treatment: Part I (6 weeks), Part II (8 weeks)
* Drug: Placebo;Diclofenac 50mg(tid)/Duration of Treatment: Part I (Placebo) 6 weeks;Part II (Diclofenac) 8 weeks


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: At least 40 years of age with a clinical diagnosis of Osteoarthritis (OA)of the knee for 6 months prior to study entry (ARA class I, II, or III). Positive therapeutic effect from prior NSAID therapy. Worsening of symptoms upon withdrawal of prior treatment. With the exception of OA, in otherwise good health Exclusion Criteria: Weight no more than 280 pounds (male or female). Recent, sustained use of gastroprotective agents. History of arthroscopy of the affected knee within 6 months prior to study entry. History of acute ligamentous or meniscal injury of the study joint within the previous 2 years.

Ages Eligible for Study
-----------------
Minimum Age: 40 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

| Intervention/Treatment |
| --- |
|Drug: MK0663, etoricoxib / Duration of Treatment: Part I (6 weeks), Part II (8 weeks)|nan|
|Drug: Placebo;Diclofenac 50mg(tid)/Duration of Treatment: Part I (Placebo) 6 weeks;Part II (Diclofenac) 8 weeks|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| WOMAC Pain Subscale, Investigator Global Assessment of Disease Status, and Patient Global Assessment of Response to Therapy (not a primary endpoint in extension periods) |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Physical Function Subscale (WOMAC), Stiffness Subscale (WOMAC), Patient Global Assessment of Disease Status, Investigator Global Assessment of Response to Therapy , Proportion of Patients Discontinued Due to Lack of Efficacy |  |  | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Arcoxia
Laparoscopy in Children: Does it Decrease the Metabolic, Endocrine and Inflammatory Stress Response to Surgery

Study Overview
=================
Brief Summary
-----------------
The aim of this trial was to characterise the intra and post operative metabolic, endocrine and inflammatory response to laparoscopic fundoplication in children. We are testing the hypothesis that laparoscopic fundoplication is associated with a lack of hypermetabolism and catabolism and blunting of the endocrine/inflammatory stress response

Conditions
-----------------
Gastro-Oesophageal Reflux

Intervention / Treatment
-----------------
* Procedure: Laparoscopic fundoplication
* Procedure: open Nissen fundoplication


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: infants and children with gastro-oesophageal reflux Exclusion Criteria: septic shock, multi-organ dysfunction syndrome, cardiac, renal or congenital metabolic abnormalities

Ages Eligible for Study
-----------------
Minimum Age: 1 Month
Maximum Age: 16 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

| Intervention/Treatment |
| --- |
|Procedure: Laparoscopic fundoplication|nan|
|Procedure: open Nissen fundoplication|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| resting energy expenditure |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| whole body protein turnover |  |  | 
| indices of inflammatory response |  |  | 
| pro and anti inflammatory cytokines |  |  | 
| free radical production |  |  | 
| post operative pain |  |  |
A Longitudinal Study in Parkinson's Disease (PD) Patients

Study Overview
=================
Brief Summary
-----------------
This is a longitudinal study in patients with Parkinson's Disease (PD) carriers of a genetic mutation - substitution of gly with ser in position 2019 (G2019S) in the leucine-rich repeat kinase 2 (LRRK2) gene. The purpose of this study is to explore the association between genetic mutations in the known genes and their influence on disease manifestation over few years of follow up

Official Title
-----------------
A Longitudinal 5 Years Follow up Study in Parkinson's Disease (PD) Patients Carriers of the LRRK2 Gene G2019S Mutation

Conditions
-----------------
Parkinson's Disease

Intervention / Treatment
-----------------
* Other: neurological exam


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: parkinson'd disease patients that already participated in a pasr cross sectional study Exclusion Criteria: subjects with cognitive decline by the parameters defined in Diagnostic and Statistical Manual of Mental Disorders (DSM)- IV subjects with psychiatric disorder subjects unable to sign a consent form

Ages Eligible for Study
-----------------
Minimum Age: 30 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 |
| --- | --- |
| PD patients<br>PD patients carriers of the G2019S mutation in the LRRK2 gene | Other: neurological exam<br>* motor and cognitive functions<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| change from baseline in updrs motor and total scores |  | the participants will be followed for 5 years. the measurements will be taken evry 18 month. |