linjc16/ctgov huggingface dataset:
Age Related Changes in Calciotropic Hormones and Their Impact on Male Osteoporosis

Study Overview
=================
Brief Summary
-----------------
The purpose of this pilot study is to generate preliminary data regarding the skeletal effects of age-related changes in calcium and vitamin D metabolism in older men.

Official Title
-----------------
Pilot Study to Assess the Skeletal Effects of Age-related Changes in Calcium and Vitamin D Metabolism in Men

Conditions
-----------------
Low Bone Density

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: healthy men age 50 yrs and older Exclusion Criteria: smokers known history of metabolic bone disease, known history of hypogonadism or renal insufficiency.

Ages Eligible for Study
-----------------
Minimum Age: 50 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 |
| --- | --- |
| 1<br>men 50 yrs of age or older | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Bone density of hip and spine |  | measured after screening evaluation | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| calciotropic hormones, including calcium, PTH and vitamin D metabolites |  | measured after screening evaluation | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
male osteoporosis, male osteopenia, calciotropic hormones
Pathophysiological Explorations of Red Blood Cells

Study Overview
=================
Brief Summary
-----------------
GR-Ex is a program labelled by Labex (Laboratory of Excellence) by the French Ministry of Higher Education and Research. This program aims to develop the means to improve knowledge in the physiology and pathologies of erythropoiesis, red blood cells and iron metabolism, and to develop new therapeutic protocols capable of providing added value in terms of innovation.

Official Title
-----------------
Pathophysiological Explorations of Red Blood Cells

Conditions
-----------------
Red Blood Cell Disorder

Intervention / Treatment
-----------------
* Other: Biological sampling


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: To be affected or have a family history of disease bound to the red blood cell, For adult subjects, have signed an informed consent form, For minor or major under legal safeguard subjects, the form must be signed by both parents (for minors) or by the legal representative, Be affiliated to health insurance. Exclusion Criteria: Being deprived of freedom
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 |
| --- | --- |
| Affected patients<br>Biological samples of blood for all patients. Biological samples of saliva, surgical remainder (skin, tumor, kidney,....), saliva, urine, hair. | Other: Biological sampling<br>* Biological samples including blood, surgical remainder, urine,...<br>|
| Non affected relatives<br>Biological samples of blood for all relatives. | Other: Biological sampling<br>* Biological samples including blood, surgical remainder, urine,...<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Innovative markers of spleen fonctionality | Retention rate (%) of red blood cells using Microsphiltration compared with non affected subjects | 20 years | 
| Quantification of inflammation in sickle cell disease | Activation rate of circulating mastocytes (%) | 20 years | 
| Markers of post-artesunate hemolysis | Concentration of pitted red blood cells at day 3 | 20 years | 
| Correlation between transfusion yield and the storage of red blood cell bags | Increasing in haemoglobin concentration at 6 hours post transfusion | 20 years | 
| Efficiency of Phosphodiesterase inhibitor on neutrophil adhesion in Sickle cell disease | Proportional change in adhesion rate (%) of neutrophils measured in the peripheral blood before and after treatment with phosphodiesterase inhibitors | 20 years | 
| Quantification of mitochondria removal during erythropoiesis in SDC patients, consequences on the mature RBC | Mitochondria rate and level of ROS in RBC measured by Flow Cytometry | 20 years | 
| Study of iron metabolism in Diamond-Blackfan Anemia patients | Dosage of iron metabolism parameters | 20 years |
Evaluation of the Effects of Duloxetine on Norepinephrine

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to evaluate how taking duloxetine 60mg every day affects the transfer of two normal body chemicals, 3,4-dihydroxyphenylglycol (DHPG) and norepinephrine (NE), across cells in blood and cerebrospinal fluid.

Official Title
-----------------
Evaluation of the Effects of Duloxetine on Norepinephrine Transporter Inhibition in Healthy Subjects

Conditions
-----------------
Major Depressive Disorder

Intervention / Treatment
-----------------
* Drug: Duloxetine
* Drug: Escitalopram
* Drug: Placebo


Participation Criteria
=================
Eligibility Criteria
-----------------
Healthy subjects between the ages of 18-65 years are nonsmokers or are willing to refrain from smoking and are not taking concomitant medications which may inhibit or induce CYP1A2 or CYPD6 or is an MAOI.

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 65 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: Randomized
Intervention Model: Crossover Assignment
Masking: Single


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: Duloxetine|nan|
|Drug: Escitalopram|nan|
|Drug: Placebo|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Concentrations of DHPG and NE in plasma (in sitting and standing positions), urine, and CSF after multiple daily doses (steady state). |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Effect of duloxetine versus escitalopram on ex vivo reuptake inhibition of NE and F-hydroxytryptamine (5-HT) in serum and relationship to exposure. |  |  | 
| Effect of duloxetine versus escitalopram on heart rate variability. |  |  | 
| Ratio of duloxetine exposure in plasma to CSF at steady state. |  |  | 
| Relationship between DHPG and NE concentrations and duloxetine exposure in CSF and plasma. |  |  |
Study of Metabolic Connectivity in Drug-resistant Temporal Epilepsy

Study Overview
=================
Brief Summary
-----------------
18F-Fluoro-deoxy-glucose (18F-FDG) positron emission tomography (PET) has a high sensitivity for temporal lobe epilepsy (TLE), the most common form of focal epilepsy, with a detection range of 86-90% . Therefore, 18F-FDG PET is a useful tool to identify the epileptogenic zone (ETZ) in the inter-ictal phase of drug-resistant temporal epilepsy during pre-surgical evaluation . Based on stereotactic electroencephalography (SEEG) findings, a correspondence between electrical data and metabolic changes on PET was found at the group level by identifying four different patterns of TLE . As expected, hypometabolism was not limited to the EZ defined by SEEG, but underlay broader epileptic networks . Because of the different electroclinical presentations of TLE, 18F-FDG PET appears to be a very useful tool in these temporal epilepsies. Indeed, it has been recently demonstrated that a gradient of PET hypometabolism from the uninvolved area to the spreading area, then to the epileptogenic area and to the lesion area is observed with consequently a good performance of 18F-FDG PET in defining the EZ . Therefore, it is interesting to study PET metabolism as a network and not as a combination of regional metabolic measures in epilepsy.

Official Title
-----------------
Study of Metabolic Connectivity in Drug-resistant Temporal Epilepsy

Conditions
-----------------
Epilepsy

Intervention / Treatment
-----------------
* Diagnostic Test: PET-CT at 18F-FDG


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients with drug-resistant temporal epilepsy with an accurate diagnosis on SEEG Patients with epilepsy who have had a PET/CT scan with 18F-FDG as part of a pre-operative assessment Person having received complete information on the organization of the research and not having objected to the use of these data; Patients affiliated to a social security system Exclusion Criteria: Person who has not received full information on the organization of the research and who has opposed the use of this data A person of full age who is the subject of a legal protection measure (guardianship, curatorship, safeguard of justice). A person of full age who is unable to give consent and who is not subject to a legal protection measure

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 56 Years

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

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

Arms and Interventions

| Intervention/Treatment |
| --- |
|Diagnostic Test: PET-CT at 18F-FDG|PET-CT at 18f6FDG in nuclear medicine departement of Nancy's hospital|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Metabolic connectivity | Metabolic connectivity of hypometabolic clusters in each temporal epilepsy subgroup defined by IRCA (interregional correlation analysis) and graph theory | 1 month |
The Cervical Length and Thickness of Cesarean Section Scar With Preterm Labor

Study Overview
=================
Brief Summary
-----------------
Although the Cesarean section is one of the most common obstetric operations around the world, the World Health Organization recognizes that where cesarean rates are higher than 10%, there is no increase in beneficial maternal and newborn outcomes. some researchers noted that in countries where cesarean rates are above 15%, populations experience higher maternal, infant, and neonatal mortality rates. infants born by cesarean delivery are more likely to require neonatal intensive care unit and have greater respiratory complications, and higher odds for childhood asthma, and obesity. Preterm is defined as babies born alive before completing 37 weeks of pregnancy. Preventing Preterm birth is a global priority due to increased risk for neonatal morbidity and mortality.

Official Title
-----------------
The Assessment of Cervical Length and Thickness of Cesarean Section Scar as Predictors for Preterm Labor in Patients With Previous Cesarean Section

Conditions
-----------------
Preterm Labor

Intervention / Treatment
-----------------
* Radiation: Ultrasound


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: singleton pregnant gestational age at 18 weeks previous vaginal or Cesarean section Exclusion Criteria: twins pregnancy in their second birth previous preterm labor diabetic during the second pregnancy hypertensive during the second pregnancy cigarette use during the second pregnancy congenital anomalies

Ages Eligible for Study
-----------------
Minimum Age: 20 Years
Maximum Age: 35 Years

Sexes Eligible for Study
-----------------
Female

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

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

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: Non-scared uterus of pregnant women<br> | Radiation: Ultrasound<br>* ultrasound assessment of pregnant women<br>|
| Other: Scared uterus of pregnant women<br> | Radiation: Ultrasound<br>* ultrasound assessment of pregnant women<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of preterm labor in both groups |  | 6 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| number of babies will enter the neonatal intensive care unit |  | 6 months | 
| Gestational age at time of delivery |  | 6 months |
CoViD-19 Patient in Reims University Hospital in March to April 2020

Study Overview
=================
Brief Summary
-----------------
Medical context: Follow-up of a retrospective cohort of 499 cases of CoViD-19, hospitalized at the University Hospital of Reims during the health crisis, prospectively up to two years of follow-up. Possible intervention for serological monitoring, leading to a change from category 3 to category 2 (French law on human person research) Aim of the study: To know the factors of gravity of CoViD-19, to know its prognostic factors, to see how the evolution of the treatments implemented have influenced the fate of the patients. Material and methods: Type of study: cohort study Population: Patients in the CoViD-19 cohort - Reims Calendar: September 2020 - July 2022 Expected results: Better knowledge of the cares of patients with CoViD-19

Official Title
-----------------
Follow-up CoViD-19 Patients Hospitalized in Reims University Hospital Between the 01/03/2020 and 30/04/2020

Conditions
-----------------
Coronavirus Infections

Intervention / Treatment
-----------------
* Biological: serology


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patient hospitalized for CoViD-19 infection during the health crisis, in a short-stay service of Reims University Hospital and included in Covid-19 Cohort Age > 18 years Patient who benefit from the national health insurance coverage patient agree for participation (consent form signed) Exclusion Criteria: Patient protected by law
Sexes Eligible for Study
-----------------
All

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| CoViD-19 patients cohort<br>Patients are followed for 2 years after diagnosis. The only one intervention is blood samples withdrawn for serologies | Biological: serology<br>* biological blood samples withdrawn at 6, 12 and 24 months<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Health status in the 2 years after CoViD-19 diagnosis | status : dead or alive persistante respiratory distress (yes / no) | 2 years follow up |
INITIATE Plus (INITiation of Insulin to Reach A1c TargEt) Study

Study Overview
=================
Brief Summary
-----------------
This trial is conducted in the United States of America (USA). The purpose of this study is to compare the effectiveness and safety of a biphasic insulin aspart standard titration regimen when coupled with dietary intervention to standard titration without dietary intervention.

Official Title
-----------------
Efficacy and Safety of a Standard Titration Algorithm Coupled With a Conventional Dietary Intervention or Intensive Dietary Intervention Versus a Standard Titration Algorithm, Alone, in Patients With Type 2 Diabetes Initiating NovoLog® Mix 70/30 Therapy

Conditions
-----------------
Diabetes, Diabetes Mellitus, Type 2

Intervention / Treatment
-----------------
* Drug: biphasic insulin aspart
* Behavioral: dietary regimen


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Type 2 Diabetes

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

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

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

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

Design Details

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


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: biphasic insulin aspart|nan|
|Behavioral: dietary regimen|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| HbA1c and Incidence of hypoglycemia |  | After 24 weeks of treatment | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Postprandial glucose from 8-point SMBG spontaneously reported adverse events; any changes from baseline |  |  |
Genetic Linkage Study of Idiopathic Talipes Equinovarus (ITEV) (Clubfoot)

Study Overview
=================
Brief Summary
-----------------
The goal of this study is to identify and characterize the genetic loci causing idiopathic talipes equinovarus (clubfoot). The hypothesis is that a few genes account for a substantial fraction of ITEV and that these genes can be identified in defined populations. Towards this goal, in preliminary studies, Dr. Hecht's group has identified two genes, NAT2 and CASP10, which demonstrate evidence for linkage and association to ITEV.

Detailed Description
-----------------
Blood Collection: For this study, the investigators need to obtain blood samples from members of families in which clubfoot has occurred; more specifically, blood samples from the affected child and both parents. DNA will be extracted from blood samples. The DNA will then be tested to look for genetic factors that cause clubfoot. Study Questionnaires: As well as the blood samples, the investigators have a short questionnaire for the mother of the child with clubfoot to complete.

Official Title
-----------------
Genetic Linkage Study of Idiopathic Talipes Equinovarus (ITEV) (Clubfoot)

Conditions
-----------------
Clubfoot

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: One family member, usually child, must have clubfoot
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
-----------------
Genetics, Clubfoot, DNA, Idiopathic Talipes Equinovarus also known as Clubfoot
Determinants of Compliance With Glaucoma Therapy

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to determine which medical, demographic, and health belief factors are associated with glaucoma therapy compliance.

Official Title
-----------------
Determinants of Compliance With Glaucoma Therapy

Conditions
-----------------
Open Angle Glaucoma

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: open angle glaucoma be well controlled on current medical therapy be using a prostaglandin analogue

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 |
| --- | --- | --- |
| Compliance with glaucoma medication at 1 month | Compliance is measured using the Travatan Dosing Aid, a device that records when patients administer their topical glaucoma medication. | 1 month after enrollment | 
| Compliance with glaucoma medication at 3 months | Compliance is measured using the Travatan Dosing Aid, a device that records when patients administer their topical glaucoma medication. | 3 months after enrollment | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
open angle glaucoma, compliance, adherence
A Open-label Study to Assess the Safety of Oral Long-term Use of SA-001 in Pancreatic Exocrine Insufficiency

Study Overview
=================
Brief Summary
-----------------
This study is to evaluate the safety of 3.0 g/day of SA-001 (to be flexibly increased or decreased with the range from 1.5 g/day to 6.0 g/day), which will orally be administered for 52 weeks to patients with pancreatic exocrine insufficiency caused by chronic pancreatitis in the non-compensatory stage or by pancreatectomy.

Official Title
-----------------
A One-year Open-label Study to Assess the Safety of Oral Long-term Use of SA-001 in Patients With Pancreatic Exocrine Insufficiency Caused by Chronic Pancreatitis or by Pancreatectomy

Conditions
-----------------
Pancreatic Exocrine Insufficiency, Chronic Pancreatitis, Pancreatectomy

Intervention / Treatment
-----------------
* Drug: SA-001


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria Subjects who complete the S245.3.122 clinical study (excluding discontinued subjects). Exclusion Criteria Subjects who are assessed to be inappropriate for continuing long-term use of SA-001, at the discretion of the investigator or the sub-investigator, because they experienced adverse drug reactions in the S245.3.122 clinical study.

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 1<br> | Drug: SA-001<br>* 0.25 g of SA-001 pellets/capsule, 12 capsules/day for 52 weeks<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Safety of long-term use of 3.0 g/day SA 001 (12 capsules/day), flexibly increased or decreased within the range of 1.5 g/day SA 001 (6 capsules/day) to 6.0 g/day SA-001 (24 capsules/day) |  | 52 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Efficacy data (nutritional evaluation items) of 3.0 g/day SA-001 (12 capsules/day), flexibly increased or decreased within the range of 1.5 g/day SA 001 (6 capsules/day) to 6.0 g/day SA-001 (24 capsules/day) |  | 52 weeks | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
SA-001, Pancreatic Exocrine Insufficiency, Chronic Pancreatitis, Pancreatectomy