linjc16/ctgov huggingface dataset:
Preference of Genetic Polymorphism and Pharmacokinetics

Study Overview
=================
Brief Summary
-----------------
Genetic polymorphism affects plasma concentration of antiretroviral therapy in HIV patients. The investigators investigate the prevalence of genetic polymorphism affecting efavirenz metabolism and the corresponding pharmacokinetics of different genotypes.

Detailed Description
-----------------
Eligible patients are invited to donate blood samples for pharmacokinetic study and genotype analysis

Official Title
-----------------
Preference of CYP450 2B6 516 G>T Polymorphism and Pharmacokinetics of Plasma Efavirenz in A Group of HIV Infected Southern Chinese

Conditions
-----------------
HIV

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Southern Chinese HIV patients on efavirenz Exclusion Criteria: Refuse to sign consent, HIV patients not on efavirenz
Sexes Eligible for Study
-----------------
All

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| efavirenz<br>HIV patients on efavirenz | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| pharmacokinetics | This includes plasma concentration of drugs in relation to time, in different genotypes | 24 hour | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| genotypes frequency |  | 1 year | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
HIV
Ease of Use Study for the Gambro Polyflux HD-C4 Small Dialyzer

Study Overview
=================
Brief Summary
-----------------
The purpose of the study is to study the ease of use of the Polyflux HD-C4 Small dialyzer under conditions of routine clinical use for hemodialysis

Detailed Description
-----------------
Market evaluation protocol. This ease of use study involves the use of FDA 510(k) cleared hemodialyzers and will have no impact on the patient's routine dialysis therapy. This study is strictly aimed at obtaining feedback from the nursing and technical staff regarding the use of the Polyflux HD-C4 Small dialyzer. The dialysis nursing staff will complete ease of use assessments following routine dialysis therapy.

Official Title
-----------------
The Gambro Polyflux HD-C4 Small Ease of Use Study

Conditions
-----------------
Hemodialysis

Intervention / Treatment
-----------------
* Device: Gambro HD-C4 Small Dialyzer


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: n/a routine dialysis patients Exclusion Criteria: n/a routine dialysis patients

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

| Intervention/Treatment |
| --- |
|Device: Gambro HD-C4 Small Dialyzer|Involves the use of FDA 510(k) cleared hemodialyzers and will have no impact on the patient's routine dialysis therapy.|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| For each dialyzer, the perceived ease of priming. |  | During priming of each dialyzer | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Visual assessment of residual blood in the dialyzer after rinse-back and if dialyzer clotted during treatment. |  | At the completion of each treatment | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Dialyzer
Assessing PTSD After Earthquake in Turkey

Study Overview
=================
Brief Summary
-----------------
Assessing the prevalence and natural course of PTSD after the 1999 Turkish earthquake

Conditions
-----------------
Post-Traumatic Stress Disorder

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: People were in the earthquake area while it occured Exclusion Criteria: People were not in the earthquake area while it occured

Ages Eligible for Study
-----------------
Minimum Age: 0 Years

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

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
A Portion-controlled Diet Will Prevent Weight Gain in Diabetics Treated With ACTOS

Study Overview
=================
Brief Summary
-----------------
We hypothesized that a portion controlled diet would prevent the weight gain associated with the use of a peroxisome profliferator-activated receptor-gamma (PPAR-g). This is a 4 months randomized clinical trial in type 2 diabetics who are treated with pioglitazone and a standard diet, pioglitazone and a portion-controlled diet and metformin with a standard diet.

Detailed Description
-----------------
A total of 60 male and female type 2 diabetic subjects will be recruited and randomized into 1 of 3 treatment groups for the 4 months long trial ACTOS plus a standard diet ACTOS plus a portion-controlled diet Metformin plus a standard diet. The end-point of the trial is the change in body fat content from baseline to the end of the trial

Official Title
-----------------
A Portion-controlled Diet Will Prevent Weight Gain in Diabetics Treated With ACTOS

Conditions
-----------------
Diabetes Mellitus

Intervention / Treatment
-----------------
* Other: Actos plus standard diet
* Other: Actos plus structured diet
* Other: Metformin plus standard diet


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Men and women age 35 to 75 who have type 2 diabetes mellitus Exclusion Criteria: Individuals with co-existing other diseases

Ages Eligible for Study
-----------------
Minimum Age: 35 Years
Maximum Age: 75 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

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: A<br>ACTOS plus standard diet | Other: Actos plus standard diet<br>* Actos plus standard diet<br>|
| Experimental: B<br>Actos plus structured diet | Other: Actos plus structured diet<br>* Actos plus structured diet<br>|
| Experimental: C<br>Metformin plus standard diet | Other: Metformin plus standard diet<br>* Metformin plus standard diet<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| glucose |  | 4 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in lipids |  | 4 months | 
| blood pressure |  | 4 months |
Cerebral Oximeter Comparison Study

Study Overview
=================
Brief Summary
-----------------
In this prospective study to try to standardize the care for patients, the investigators are planning to compare two cerebral oximeters currently in use at NCH in terms of their accuracy in determining the cerebral oxygen saturation as determined by jugular bulb oxygen saturation. Also, the investigators will compare these devices in terms of their response to changes in hemodynamics that occur during cardiac surgery.

Official Title
-----------------
Comparison of the FORE-SITE and INVOS Cerebral Oximeters During Cardiac Surgery

Conditions
-----------------
Cardiac Bypass Patients

Intervention / Treatment
-----------------
* Device: Somanetics cerebral oximeter
* Device: CASMED cerebral oximeter


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients undergoing cardiac surgery Exclusion Criteria: None
Sexes Eligible for Study
-----------------
All

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Cardiac bypass patients<br> | Device: Somanetics cerebral oximeter<br>* Somanetics cerebral oximeter<br>Device: CASMED cerebral oximeter<br>* CASMED cerebral oximeter<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Oxygen saturation | cannulation, decannulation, hemodynamic instability | during surgery - Day 1 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Mean arterial pressure | cannulation, decannulation, hemodynamic instability | during surgery - Day 1 |
Mifepristone and Misoprostol for 2nd Trimester Termination of Pregnancy in Burkina Faso

Study Overview
=================
Brief Summary
-----------------
The goal of this study is to examine the effectiveness and feasibility of a mifepristone-misoprostol medical abortion regimen in terminating pregnancies 13-22 weeks in Burkina Faso.

Official Title
-----------------
Mifepristone and Misoprostol for 2nd Trimester Termination of Pregnancy (13-22 Weeks LMP) in Burkina Faso

Conditions
-----------------
Medical; Abortion, Fetus

Intervention / Treatment
-----------------
* Drug: Mifepristone
* Drug: Misoprostol


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Having an ongoing pregnancy of 13-22 weeks gestation Be willing to undergo surgical completion if necessary Have no contraindications to study procedures, according to provider Be willing and able to consent to participate in the study Be willing to follow study procedures Respect legal indications for obtaining an abortion Exclusion Criteria: Known allergy to mifepristone or misoprostol/prostaglandin Any contraindications to vaginal delivery, including placenta previa Previous transmural uterine incsion
Sexes Eligible for Study
-----------------
Female

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

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: Medical abortion arm<br>200mg of Mifepristone and repeat doses of 400mcg of misoprostol every 3 hours administered for medical abortion in 2nd trimester | Drug: Mifepristone<br>* Medication used in conjunction with misoprostol for abortion<br>* Other names: Medabon;Drug: Misoprostol<br>* Medication used in conjunction with mifepristone for abortion<br>* Other names: Misoclear;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Rate of successful abortion | Rate of successful abortion, complete evacuation of foetus and placenta with study drugs, within 24 hours of taking misoprostol | 24 hours |
Health Care Access for Asylum Seekers in Brittany : Description, Associated Factors and Levers of Improvement

Study Overview
=================
Brief Summary
-----------------
The main objective of this research is to study the logics and the associated factors with asylum seekers use of dedicated health structures. This objective aims to address major concerns related to the entry and continued participation in the health care system of asylum seekers, including the medical and social dimensions. It aims to produce, then analyze and disseminate data on the factors associated with seeking asylum seekers to optimize the care of migrants in the French health system

Official Title
-----------------
Health Care Access for Asylum Seekers in Brittany : Description, Associated Factors and Levers of Improvement

Conditions
-----------------
Adult Asylum Seekers Who Have Applied for Asylum at the Regional Prefecture in Rennes

Intervention / Treatment
-----------------
* Other: access to healthcare


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: - Adult asylum seekers who have applied for asylum in the prefecture of Brittany from May 22, 2018 to May 21, 2019 (or one year after obtaining authorization from the CCTIRS and the CNIL). Exclusion Criteria: Migrants not asylum seekers (with tourist visa, migrants of the European Union (foreign nationality and not membership in the Schengen area), migrants arriving in a family reunification, migrant in irregular situation). Minor : unaccompanied foreign minor or with their family Incapacity of a person to consent

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

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

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

Arms and Interventions

| Intervention/Treatment |
| --- |
|Other: access to healthcare|use or non-use of dedicated health facilities|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Use of health care structure | Factors associated with the use or non-use of dedicated health facilities will be the individual (sociodemographic, migration), organizational (access to rights, characteristics of the organization of dedicated structures) and the environment characteristics reported by asylum seekers having or not having recourse to the dedicated health structures. | 6 months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Primary health, migrants, health care utilization, access to healthcare
Kidney Transplant Volumetry

Study Overview
=================
Brief Summary
-----------------
This study assesses the reproducibility of 3 different formulas in calculating the volume of a transplanted kidney by ultrasound in-vivo measurements. 3 series of measurements will be performed by 2 different operators during the usual ultrasound follow-up of the renal transplant.

Detailed Description
-----------------
The 3 series of measurements Longitudinal section: maximum longitudinal length, width at the hilum, maximum width, width at the upper third, longitudinal cross-sectional area Transverse section at the hilum : thickness, width, hilar cross-sectional area Largest transverse section : thickness, width, maximum transverse cross-sectional area Clinical and biological patient data collection: age, gender, date of transplantation, serum creatinine and glomerular filtration rate (GFR), kidney transplant placement (right or left iliac fossa), acute illness or usual follow-up

Official Title
-----------------
Assessment of the Reproducibility of Kidney Transplant Sonographic Volume Measurement

Conditions
-----------------
Kidney Transplant; Complications

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Kidney transplant recepients with ultrasound follow-up at the University Hospital of Tours Age more than 18 years old Exclusion Criteria: Renal deformity of extrinsic origin Early post-transplant period (first 3 days post-transplant) Transplanted organ out of the field of view Dual kidney transplant Opposition to the data collection

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 |
| --- | --- | --- |
| Intraclass coefficient of correlation of the ultrasound volume measurement | The inter-observer and intra-observer variability of the ultrasound volume measurement of the kidney graft will be assessed using the intraclass coefficient of correlation (ICC) | 6 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Intraclass coefficient of correlation of the volume formula parameters. | The reproducibility of each formula parameter will also be assessed. | 6 months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Kidney transplant, volumetry, ultrasound
Survey of Current Management of Orthopaedic Complications in CMT Patients

Study Overview
=================
Brief Summary
-----------------
Charcot-Marie-Tooth (CMT) disease is the most common inherited peripheral neuropathy. Foot deformities are frequent complications in CMT patients and orthopaedic surgery is often required. As yet there are no systematic studies on the management of orthopaedic complications in CMT patients and the current approach varies between centres. This study is a survey with the aim of understanding the current surgical approach to orthopaedic complications in CMT. The target population includes orthopaedic surgeons who perform surgical procedures for foot deformities in CMT patients attending centres participating in the Inherited Neuropathies Consortium (INC).

Detailed Description
-----------------
The study protocol consists of a survey addressed to orthopaedic surgeons. The survey will be completed once and it includes two different scenarios of typical CMT patients (one adult and one child). The orthopaedic surgeons will be asked which surgical procedures they would apply to each scenario: forefoot cavus, clawtoes and hindfoot varus No medications or therapeutic agents are a component of this project.

Official Title
-----------------
Survey of Current Management of Orthopaedic Complications in Charcot Marie Tooth Disease Patients

Conditions
-----------------
Charcot-Marie-Tooth Disease

Intervention / Treatment
-----------------
* Other: Survey


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Orthopaedic surgeons who perform surgical procedures for foot deformities in CMT patients attending centres participating in the Inherited Neuropatheis Consortium (INC) Willing to complete survey Exclusion Criteria: Does not read or speak English Inability to provide informed consent
Sexes Eligible for Study
-----------------
All

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Orthopaedic surgeons<br>Orthopaedic surgeons who perform surgical procedures for foot deformities in CMT patients at participants centres. | Other: Survey<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Procedural correlations among orthopaedic surgeons on management of foot deformities in CMT patients |  | 1 day |
Study of Allogeneic Bone Marrow Transplantation Following Cyclophosphamide and Radiotherapy in Patients With Myelodysplastic Syndrome and Acute Leukemia Related to Fanconi's Anemia

Study Overview
=================
Brief Summary
-----------------
OBJECTIVES: I. Determine the effectiveness of moderate dose cyclophosphamide and radiotherapy in terms of improving survival and reducing the morbidity following allogeneic bone marrow transplantation in patients with myelodysplastic syndrome and acute leukemia related to Fanconi's anemia.

Detailed Description
-----------------
PROTOCOL OUTLINE: Patients receive cyclophosphamide IV over 1-2 hours on day -6 through -3 and total body radiotherapy on day -1. Patients undergo allogeneic bone marrow transplantation on day 0.

Conditions
-----------------
Fanconi's Anemia, Myelodysplastic Syndromes, Leukemia, Nonlymphocytic, Acute, Leukemia, Lymphocytic, Acute

Intervention / Treatment
-----------------
* Drug: cyclophosphamide
* Procedure: Allogeneic Bone Marrow Transplantation


Participation Criteria
=================
Eligibility Criteria
-----------------
Diagnosis of Fanconi's anemia with the family history and typical phenotype including: Short stature Hypoplastic radii Skin pigmentation Renal anomalies Chromosomal fragility Evidence of Fanconi's myelodysplastic syndrome Bone marrow dysplasia of all 3 marrow cell lines AND Clonal cytogenetic abnormalities demonstrable in marrow cells First complete remission following therapy for Fanconi's acute leukemia allowed Must have related histocompatible donor No evidence of excessive in vitro chromosome fragility typical of Fanconi's anemia Normal CBC and bone marrow

Ages Eligible for Study
-----------------
Minimum Age: 0 Years
Maximum Age: 54 Years

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

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

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

Design Details

Primary Purpose: Treatment


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: cyclophosphamide|nan|
|Procedure: Allogeneic Bone Marrow Transplantation|nan|

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
-----------------
Fanconi's anemia, acute leukemia, acute lymphocytic leukemia, acute myeloid leukemia, acute undifferentiated leukemia, adult acute lymphoblastic leukemia, adult acute lymphoblastic leukemia in remission, adult acute myeloid leukemia, adult acute myeloid leukemia in remission, aplastic anemia, childhood acute lymphoblastic leukemia, childhood acute lymphoblastic leukemia in remission, childhood acute myeloid leukemia, childhood acute myeloid leukemia in remission, de novo myelodysplastic syndrome, hematologic disorders, hematopoietic/lymphoid cancer, leukemia, myelodysplastic syndrome, oncologic disorders, previously treated myelodysplastic syndrome, rare disease, secondary myelodysplastic syndrome