linjc16/ctgov huggingface dataset:
Home Hemodialysis Assisted by a Nurse for Arterio-venous Fistula Cannulation

Study Overview
=================
Brief Summary
-----------------
Home HD (HHD) is associated with better outcome in end-stage renal disease patients compared to in-center HD, in particular in terms of quality of life. However fear of AVF cannulation is a known barrier for patient's choice and adoption of a HHD program. Providing nurse assistance for the cannulation can help developing HHD programs. The aim of this study is to evaluate the feasibility of assisted home hemodialysis, with the intervention of a nurse at home for arterio-venous fistula cannulation.

Detailed Description
-----------------
Monocentric prospective interventional study. Intervention is assisted HHD, defined as: rope-ladder cannulation at the patient's home provided by a trained private nurse at each dialysis session, and connection to the Nxstage System One pilot study, with main objective defined as feasibility of the investigator's assisted HHD program. Pilot study usually concerns a small population, allowing us to develop thereafter a bigger study if the results are encouraging. primary end-point criteria defined as definitive cessation of HHD with transfer to an other dialysis modality.

Official Title
-----------------
Feasibility of a Home HD Program Assisted by a Nurse Coming at Home for Arterio-venous Fistula (AVF) Cannulation

Conditions
-----------------
Nurse's Role, Hemolysis, Cannulation, Arteriovenous Fistula

Intervention / Treatment
-----------------
* Procedure: assisted home hemodialysis patients


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: The patient must be aged more than 18, able to read and write, and have a person with him at home during HD session, according to the french law. Exclusion criteria: medical contra-indication for HHD

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
Intervention Model: Single Group Assignment
Interventional Model Description: All incident and prevalent dialysis patients of our unit will get information on that assisted HHD program and will be able to choose this technique
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: assisted home hemodialysis patients<br>all patients starting assisted home hemodialysis during the study period | Procedure: assisted home hemodialysis patients<br>* Arteriovenous fistula cannulation at the patient's home provided by a trained private nurse at each dialysis session with the rope-ladder technique, and connection to the Nxstage System One<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| failure of assisted- HDD | definitive cessation of HHD with transfer to an other dialysis modality. | 12months |
Electrophysiological Study of Spatiotemporal Gait Parameters in Patients in Early Stage of Multiple Sclerosis

Study Overview
=================
Brief Summary
-----------------
35 patients with multiple sclerosis have been enrolled in a previous study to record and analyze gait parameters. This study aims to enroll gender and and matched healthy subjects for a control group, to compare patients' gait parameters with healthy subjects'.

Conditions
-----------------
Multiple Sclerosis

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: subjects without any gait trouble age ≥ 18 and < 55 years old gender and age (+/- 5 years) matched Exclusion Criteria: pathology with potential gait impairment pregnant or breast feeding patient patient under legal protection no health insurance coverage absence of written informed consent

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 54 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 |
| --- | --- |
| patients with multiple sclerosis<br>recruited in a former study | |
| healthy control subjects<br> | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Variation coefficient of gait cadence |  | baseline |
Gene Polymorphism Study of Normal Individual Inflammasome Genes

Study Overview
=================
Brief Summary
-----------------
This study is intended to collect blood from healthy individuals to investigate whether variations in immune-related (inflammasome) genes affect how the immune cells found in the blood can help fight infections and prevent diseases.

Official Title
-----------------
Immunological Characterization of Blood and Inflammasome Gene Segment Polymorphism Analysis of Normal Healthy Individuals

Conditions
-----------------
Healthy Individuals

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


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Healthy with no chronic or acute illnesses, or taking medication which in the opinion of the PI would impact the analyses being conducted. At least 18 years or older. Are capable of reading, understanding and providing written informed consent. Exclusion Criteria: Non-English speaking. Individuals under 18 years old. Woman who believe they are or may be pregnant. (Based on self reporting. Pregnancy testing will not be conducted for the purposes of this study) Individuals experiencing acute or chronic illnesses which in the opinion of the PI would impact the analyses being conducted. Currently taking prescription or over the counter medication which in the opinion of the PI would impact the analyses being conducted. Individual has donated blood more than twice in the last week or the amount to be drawn will exceed the maximum allowance in the last 8 weeks.

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>Normal healthy individuals will be consented and their blood drawn at the time of their visit. | Other: Blood Draw<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| analyze their ability to respond to exogenous challenges by changing the production of proteins, the expression of genes and their ability to migrate and ingest materials | Our intent is to collect these cells, divide them into subtypes such as monocytes, lymphocytes and neutrophils and then to analyze their ability to respond to exogenous challenges by changing the production of proteins, the expression of genes and their ability to migrate and ingest materials. We additionally will be interested in examining the cell components that may be released from these cells during various in vitro challenges. | one visit |
Clinical Pharmacology of MDA [3,4-methylenedioxyamphetamine]

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to investigate the pharmacological and cognitive effects of MDA in healthy humans.

Official Title
-----------------
Clinical Pharmacology of MDA [3,4-methylenedioxyamphetamine]

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

Intervention / Treatment
-----------------
* Drug: MDA
* Drug: Placebo


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Healthy males and females age 18-50 Fluent English speaker Willing and able to give written consent Exclusion Criteria: Body mass index > 30 or < 18 Pregnancy or lactation FOR MORE DETAILS CONTACT THE RESEARCH CLINIC.

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 50 Years

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

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

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

Design Details

Primary Purpose: Basic Science
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: MDA<br> | Drug: MDA<br>* subjects will receive a single oral dose of MDA 98mg/70kg body weight<br>Drug: Placebo<br>* Subjects will receive a single oral dose of placebo<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| MDA will be metabolized to hydroxyamphetamine (HMA) and dihydroxyamphetamine (DHA) and will produce dose-dependent increases in neuroendocrine measures. |  | 0-48 hours post dose | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| MDA will produce dose-dependent increases in self-report entactogen-like and stimulant like measures. |  | 0-48 hours post dose | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
MDA, MDMA, Ecstasy, entactogen, pharmacokinetics, pharmacodynamics, Pharmacokinetics and pharmacodynamics of MDA studies in healthy volunteers
DYG Versus Cetrorelix in Oocyte Donation

Study Overview
=================
Brief Summary
-----------------
Prospective controlled study to assess the reproductive outcomes of OD recipients in which the donors were subjected to the DYG protocol (20mg/day) compared with those subjected to the short protocol with cetrorelix (0.25 mg/day) from Day 7 or since a leading follicle reached 14 mm. The OD cycles were triggered with triptoreline acetate and the trigger criterion was ≥3 follicles of diameter >18mm.

Official Title
-----------------
Comparison of Reproductive Outcomes After Progestin-primed Ovarian Stimulation With Dydrogesterone Versus Cetrorelix to Inhibit Spontaneous Ovulation in Oocyte Donation

Conditions
-----------------
Infertility, Female, Fertility Disorders

Intervention / Treatment
-----------------
* Drug: Dydrogesterone


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Oocyte donors between 21 and 30 years old, with regular menstrual cycles (24-35 d) and a body mass index (BMI) between 18 and 28 kg/m2 without any relevant personal or family history Exclusion Criteria: AMH less than 3 ng/dL A positive screening for sexually transmitted diseases

Ages Eligible for Study
-----------------
Minimum Age: 21 Years
Maximum Age: 30 Years

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| DYG<br>oocyte donors undergoing controlled ovarian stimulation in a progestin-primed ovarian stimulation protocol with DYG protocol (20mg/day) | Drug: Dydrogesterone<br>* progestin primed ovarian stimulation<br>|
| Cetrorelix<br>oocyte donors undergoing controlled ovarian stimulation in a GnRH antagonist protocol with cetrorelix (0.25 mg/day) from Day 7 or since a leading follicle reached 14 mm | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Live Birth Rate per transfer |  | 40 weeks after ET | 
| Clinical pregnancy per transfer |  | 12 weeks after ET | 
| Miscarriage rate |  | 12 weeks after ET | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of oocytes retrieved |  | at time of oocyte retrieval | 
| Number of mature oocytes |  | 1 day after IVF | 
| Number of fertilized oocytes |  | 1 day after IVF | 
| Number of blastocists |  | 5-6 days after OPU | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Oocyte donation, Gonadotrophin-releasing hormone (GnRH) analogues, Ovarian stimulation, Progestin-primed ovarian stimulation, Dydrogesterone
Education Against Tobacco Randomized Trial in Brazil

Study Overview
=================
Brief Summary
-----------------
A two armed randomized trial is evaluating the effect of the medical-student-delivered school-based intervention Education Against Tobacco on the smoking behavior of adolescents in 7-11th grade of secondary school. The primary endpoint is the change in smoking prevalence between the two groups.

Official Title
-----------------
Education Against Tobacco: Medical-student-delivered Smoking Prevention Programme for Secondary Schools in Brazil - Randomized Trial

Conditions
-----------------
Tobacco Prevention

Intervention / Treatment
-----------------
* Behavioral: Education Against Tobacco school-based intervention by medical students


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Visiting grades 7-11 of a regular public secondary school in Brazil. Exclusion Criteria: Not fulfilling inclusion criteria.

Ages Eligible for Study
-----------------
Minimum Age: 5 Years
Maximum Age: 25 Years

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

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

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

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Intervention group<br>The intervention group receives a school-based module taking about two hours delivered by medical students in the schools. | Behavioral: Education Against Tobacco school-based intervention by medical students<br> <br> |
| No Intervention: Control group<br> | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Smoking prevalence measured via questionnaire. |  | 12 months follow-up | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Smoking onset: Difference in the number of new smokers at 12 months of follow-up who were not present at baseline |  | Baseline and 12 months | 
| Difference in the number of new non-smokers at 12 months of follow-up who were smoking at baseline |  | Baseline and 12 months | 
| Relevant differences due to the theory of planned behaviour between the two groups measured via questionnaire. |  | Difference in attitude towards smoking between the two groups at 12 months follow-up measured via questionnaires. | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
tobacco prevention
Laparoendoscopic Single-site Radical Nephrectomy for Localized Renal Cell Carcinoma

Study Overview
=================
Brief Summary
-----------------
Surgical resection is the only potential curative treatment available for renal cell carcinoma. The purpose of this study is to clarify the surgical and oncologic outcomes of laparoendoscopic single-site radical nephrectomy for localized Renal Cell Carcinoma.

Official Title
-----------------
Comparison of Laparoendoscopic Single-site Radical Nephrectomy With Conventional Laparoscopic Radical Nephrectomy for Localized Renal Cell Carcinoma

Conditions
-----------------
Localized Renal Cell Carcinoma

Intervention / Treatment
-----------------
* Procedure: Radical nephrectomy


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients with localized renal cell carcinoma Exclusion Criteria: Patients with lymph node or distant metastasis

Ages Eligible for Study
-----------------
Minimum Age: 20 Years
Maximum Age: 80 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 |
| --- | --- |
| LESS<br>Patients who underwent LESS radical nephrectomy | Procedure: Radical nephrectomy<br>* Surgical options to treat localized renal cell carcinoma<br>|
| Conventional laparoscopy<br>Patients who underwent conventional laparoscopic radical nephrectomy | Procedure: Radical nephrectomy<br>* Surgical options to treat localized renal cell carcinoma<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Surgical outcomes such as operative time, estimated blood loss |  | 1 year | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Localized renal cell carcinoma
A Prospective Study Evaluating Seroprevalence and Seroconversion of Antibodies Against Adeno-associated Virus (AAV)

Study Overview
=================
Brief Summary
-----------------
A prospective cohort study utilizing biospecimen sample collection from adult Hemophilia A subjects to evaluate and characterize seroprevalence and the seroconversion of antibodies against AAV serotypes

Detailed Description
-----------------
This is a multinational, multi-center, prospective cohort study utilizing biospecimen sample collection from adult Hemophilia A subjects to evaluate and characterize seroprevalence and the seroconversion of antibodies against AAV serotypes

Official Title
-----------------
A Multinational, Multi-center, Prospective Cohort Study Evaluating Seroprevalence and Seroconversion of Antibodies Against Adeno-associated Virus (AAV) Serotypes in Subjects With Hemophilia A

Conditions
-----------------
Hemophilia A

Intervention / Treatment
-----------------
* Procedure: Biospecimen Collection


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Adult Subjects with Hemophilia A Exclusion Criteria: Subject previously treated with AAV vector gene therapy

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Patient Cohort<br>All Patients are within the same arm | Procedure: Biospecimen Collection<br>* Biospecimen Sample Collection<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To qunatify Seroprevalence of antibodies to selected AAV serotypes | Number of patients with detectable antibodies to selected AAV serotypes | 52 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To describe and characterize selected AAV serotypes antibody responses in adult subjects with Hemophilia A | Antibody titer levels measured in target population to selected AAV serotypes | 104 weeks |
Prognostic and Predictive Biomarkers in Ovarian Cancers

Study Overview
=================
Brief Summary
-----------------
The investigators therefore propose to conduct a biological study of prospectively collected patient tumour samples, ascites, blood and other residual samples (feces, urine, cervical smear) throughout the disease course where markers (at diagnosis and their change with treatment) will be correlated to outcome in order to investigate how genetic diversity in OC prior to treatment and adaptation following treatment contribute to chemotherapy resistance. In addition freshly collected ascitic samples (and tumour samples) will be subjected to ex vivo DNA repair functional assays and isolated in primary culture (and established as xenografts) for target validation experiments.

Official Title
-----------------
Prognostic and Predictive Biomarkers in Ovarian Cancers

Conditions
-----------------
Ovarian Cancer

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


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: New patient with a diagnosis of OC, or Previously treated patient with frozen or formalin fixed paraffin embedded primary tumour sample available that can be retrieved by the center presenting with progressive disease, and consenting to CT guided biopsy of relapsed disease, or Previously treated patient with frozen or formalin fixed paraffin embedded primary tumour sample available that can be retrieved by the center scheduled for surgery for relapsed disease. Signed informed consent Age ≥ 18 Patient affiliated to a social security regimen or beneficiary of the same Exclusion Criteria: Patients who do not fit the inclusion criteria and those who refuse an antitumoral treatment; Coagulation abnormalities that contra-indicates the biopsy

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

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

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

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

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: Patients with ovarian cancer<br> | Procedure: Blood sample<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Progression Free Survival | up to 12 months | Correlation of baseline biomarkers with PFS will occur at 12 months following last patient inclusion |