linjc16/ctgov huggingface dataset:
Prevalence of COVID-19 Infection in a Cohort of Patients Infected by the HIV and Patients Taking PrEP

Study Overview
=================
Brief Summary
-----------------
The purpose of the study is to assess seroprevalence of COVID-19 infection in a cohort of HIV + patients and in a cohort of patients taking PrEP by emtricitabine / tenofovir.

Official Title
-----------------
Prevalence of COVID-19 Infection in a Cohort of Patient Infected by the HIV and Patients Taking PrEP Pre-exposure Prophylaxis

Conditions
-----------------
Covid19, Virus-HIV

Intervention / Treatment
-----------------
* Diagnostic Test: Serology test for COVID-19


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Aged ≥ 18 years patients infected by the HIV on treatment patients taking PreP (Pre-exposure prophylaxis (PrEP)) Being affiliated with or benefiting from a social security scheme Exclusion Criteria: Subject to a measure for the protection of justice

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

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

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| HIV positive patients<br> | Diagnostic Test: Serology test for COVID-19<br>* ELISA test<br>|
| Patients taking PrEP<br> | Diagnostic Test: Serology test for COVID-19<br>* ELISA test<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| % of patients with positive serological tests for covid-19 |  | 3 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Presence and quantification of CD4 / CD8 reactivity to COVID-19 epitopes in patient with positive and negative serological tests for covid-19 | % of anti-covid positive cells | 3 months |
Moderating Impact of Various Emotion Personality Factors on Salivary Cortisol Response to a TSST

Study Overview
=================
Brief Summary
-----------------
With the aim of evaluating the putative impacts of emotion related personality factors on physical and mental disease and the mechanisms of these impacts, 58 students were submitted to a social stress test (Trier Social Stress Test) and salivary cortisol samples were taken. The subjects were also submitted to several personality trait inventory, that evaluated respectively Alexithymia, Emotional Intelligence, Resilience and the Five Factor Model of Personality. The moderating impact of these factors on the cortisol response were analysed

Official Title
-----------------
Moderating Impact of Various Emotion Personality Factors on Salivary Cortisol

Conditions
-----------------
Psychological Stress

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Students Exclusion Criteria: Female, Smokers, Medication or alcohol abuse

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 30 Years

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

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 |
| --- | --- | --- |

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
emotion, personality, social stress, appraisal
HBA1c and Diagnosis of Type 2 Diabetes

Study Overview
=================
Brief Summary
-----------------
Following the 6th Tromso study subjects with HbA1c > 5.7 plus a subsample of subjects with lower hba1c values will be invited to an oral glucose tolerance test to see the predictive value of HBA1c in the diagnosis of type 2 diabetes.

Official Title
-----------------
HBA1c and Diagnosis of Type 2 Diabetes

Conditions
-----------------
Type 2 Diabetes

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: participated in the 6 Tromso study Exclusion Criteria: type 2 diabetes

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 |
| --- | --- |
| participants in the 6th tromsø study<br> | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of subjects with new diagnosis of type 2 diabetes |  | Up to 2 years after participation in the 6th Tromso study | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of subjects with new diagnosis of impaired glucose tolerance |  | Up to 2 years after participation in the 6th Tromso study | 
| Number of subjects with new diagnosis of impaired fasting glucose |  | Up to 2 years after participation in the 6th Tromso study | 
| Effect of vitamin D status on glucose tolerance |  | Up to 2 years after participation in the 6th Tromso study | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
type 2 diabetes, HbA1c, vitamin D, diagnosis
Graft Thrombosis After Endovascular Aortic Repair - a Single Center Experience With the Cook Zenith Alpha Spiral-Z®

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to assess the extent of thrombosis in the Zenith Alpha Spiral-Z® stent graft.

Detailed Description
-----------------
Cook Medical has reported thrombus formation with or without occlusion of the Zenith Alpha Spiral-Z®. The purpose of this study is to measure the extent of thrombus formation and occlusion of these stent graft limbs in patients with aortic aneurysms treated at St. Olavs Hospital in 2017, 2018 and 2019. Information is collected from the Norwegian registry for vascular surgery (NORKAR), electronic patient journal and the picture archiving and communication system (PACS). The total number of included patients is estimated to be approximately 100.

Official Title
-----------------
Graft Thrombosis After Endovascular Aortic Repair - a Single Center Experience With the Cook Zenith Alpha Spiral-Z®

Conditions
-----------------
Aorta Aneurysm

Intervention / Treatment
-----------------
* Procedure: Endovascular aortic repair with Zenith Alpha Spiral-Z®


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients that have received endovascular treatment with the Zenith Alpha Spiral-Z® for an aortic aneurysm The endovascular procedure was performed at St Olavs Hospital from January 2017 until December 2019 Exclusion Criteria: None
Sexes Eligible for Study
-----------------
All

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Patients treated with Zenith Alpha Spiral-Z®<br>Patients that from January 2017 until December 2019 received endovascular aortic repair with the Zenith Alpha Spiral-Z® at St. Olavs Hospital | Procedure: Endovascular aortic repair with Zenith Alpha Spiral-Z®<br>* The Zenith Alpha Spiral-Z® stent graft may have an increased risk of thrombosis. The intervention in this study is to assess the extent and degree of thrombosis in patients treated with the Zenith Alpha Spiral-Z® during endovascular repair of aortic aneurysm<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percentage of patients who have got treated post-surgery due to thrombosis or occlusion of stent graft leg | Any endovascular or surgical procedure to treat thrombosis or occlusion | 12-36 months | 
| Percentage of patients who got an amputation post-surgery due to thrombosis or occlusion of stent graft leg | Any amputation in the affected limb / same side as thrombosed stent graft leg | 12-36 months | 
| Percentage of patients who died post-surgery | Death of any cause during the observation time | 12-36 months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Stents, Thrombosis
Comparing HEPES-buffered With Bicarbonate-buffered as Handling Media During the ICSI Procedure on Live Birth Rate

Study Overview
=================
Brief Summary
-----------------
The pH stability during human gamete handling for intracytoplasmic sperm injection (ICSI) is physiologically sound. As the pH change for bicarbonate-buffered medium, scientists assumed whether the use of HEPES or MOPS buffered medium would provide more stable pH, thereby better outcomes. However, the oil use and time frame outside the incubators have not been accounted for. This study is to evaluate the use of HEPES buffered medium compared with the bicarbonate-buffered medium on ICSI outcomes.

Official Title
-----------------
Whether the Use of HEPES-buffered Medium Would Affect Live Birth Rate After ICSI

Conditions
-----------------
Infertility

Intervention / Treatment
-----------------
* Other: Bicarbonate-buffered handling medium


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: ICSI indicated cycles Exclusion Criteria: severe medical illness

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 40 Years

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

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

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

Design Details

Primary Purpose: Other
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Bicarbonate-buffered Medium<br> | Other: Bicarbonate-buffered handling medium<br>* The investigators will evaluate whether the usual bicarbonate culture medium can replace the HEPES buffered medium effectively.<br>|
| No Intervention: HEPES-MOPS-buffered Medium<br> | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| live birth rate | viable neonate after 30 weeks of Gestation | 40 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Clinical pregnancy rate | a positive heartbeat on ultrasound at ≥ 7 weeks of gestation | 12 weeks | 
| biochemical pregnancy rate | positive b-hCG at ≥ 14 days following embryo transfer | two weeks | 
| embryo developmental rates | fertilized oocyte per injected ones and developed embryos per fertilized oocytes | 6 days of culture | 
| Ongoing pregnancy rate | Continued pregnancy after week 12 of gestation | 16 weeks |
Effect of Thoracic Epidural Analgesia on Intravenous Closed-Loop Anesthesia

Study Overview
=================
Brief Summary
-----------------
The association of general anesthesia and of thoracic epidural anesthesia is used in thoracic surgery with a demonstrated benefit on the risk of postoperative respiratory complications. The objective of the study is to analyze the influence of thoracic epidural administration of chirocaine (5 mg/ml) on the administration of anesthetic agents (propofol and remifentanil), these drugs being administrated using a closed-loop system with the Bispectral Index as the controller. Two groups of patients are compared: one group will receive general anesthesia and thoracic epidural administration of saline. Chirocaine will be administered before patient's awakening, one group will receive general anesthesia and thoracic epidural administration of chirocaine (5 mg/ml). In both groups, the closed-loop system ensures that le depth of anesthesia is similar in both groups.

Official Title
-----------------
Intravenous Opioid-sparing Effect of Thoracic Epidural Administration of Chirocaine (5 mg/ml) During Thoracotomy

Conditions
-----------------
General Anesthesia

Intervention / Treatment
-----------------
* Drug: remifentanil


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: patients undergoing a thoracotomy under general anesthesia and epidural anesthesia Exclusion Criteria: age lower than 18 years, pregnant woman, psychotropic treatment, central neurological disorder or lesion cerebral, allergy to propofol or to a muscle relaxant, refusal or contra-indication of epidural anesthesia, severe emphysema, coronary disease, treatment with a beta-blocker or a vasoactive drug.

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: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Placebo Comparator: 1<br>general anesthesia and thoracic epidural administration of saline | Drug: remifentanil<br>* dosage<br>* Other names: Remifentanil: Ultiva;|
| Active Comparator: 2<br>general anesthesia and thoracic epidural administration of chirocaine | Drug: remifentanil<br>* dosage<br>* Other names: Remifentanil: Ultiva;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| amount of remifentanil delivered by the closed-loop system |  | end of anesthesia | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| amount of propofol delivered by the closed-loop system |  | end of anesthesia |
Study by Metagenomics and Culturomicsapproaches of Bacterial and Viral Flora of Diabetic Foot Infection

Study Overview
=================
Brief Summary
-----------------
This work also highlights the presence of an unknown virus double-stranded DNA. In this project we propose 1) incorporating a bank of 150 samples from patients with diabetic foot infection in grades 2-4; 2) to study the microbial flora of a selection of 50 diabetic feet previously untreated with antibiotics for bacterial metagenomics, viral metagenomics and a minimum of 10 per culturomique; 3) to evaluate the use of targeted quantitative PCR on the most frequent new species frequency in the disease and incidentally get a sense of their role in the evolution and prognosis of the disease, including failures of and targeted antibiotic therapy on all 150 samples.

Detailed Description
-----------------
Patients will be included by the infectious and tropical diseases and diabetes services the Nîmes Teaching Hospital which have a large active file and proven expertise internationally in this pathology. The usual agents of infection will be searched by standard bacteriological techniques as part of the microbiological documentation of such cases and will be performed by the microbiology laboratory of CHU Nîmes which will freeze the rest of the sample to -80 ° C the will send it to the Marseille Microbiology Federation for realization of metagenomics-culturomics

Conditions
-----------------
Diabetic Foot Infection

Intervention / Treatment
-----------------
* Other: biopsy


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients were taken care by the services(departments) of Diabetology or Infectious diseases of the CHU(TEACHING HOSPITAL) of Nîmes, were hospitalized or were seen in consultation and presenting a wound chronicle of the foot and/or the ankle of Rank 2 - 4 (Classification of the IWGDF) [IWGDF, Lipsky Clin Infect Dis on 2004], inaugural or récidivante. Exclusion Criteria: The patient participates in another study The patient is in period of exclusion determined by a previous study The patient is under protection(saving) of justice, under guardianship or under guardianship The patient refuses to sign the consent It turns out impossible to give about the lit(enlightened) information The patient is pregnant, parturiente, or she breast-feeds The patients having no wound The patients diabetics having a wound chronicles of Rank 1 (Classification of the IWGDF) [IWGDF, Lipsky Clin Infect Dis on 2004]

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

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

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| diabetic patient with foot infection<br> | Other: biopsy<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| dermal sample |  | 36 months |
AIM2: Adequate Selection of Patients for Thyroid Biopsy: Evaluation of a Shared Decision Making Conversation Aid

Study Overview
=================
Brief Summary
-----------------
There is an epidemic of thyroid cancer that is harmful to patients and the medical system. The study hypothesizes that the use of an electronic conversation aid during clinical visits can help patients and clinicians collaborate. The study aims to update a conversation aid prototype that was developed to support shared decision making in the diagnosis of thyroid cancer and conduct a pilot clinical trial to evaluate the feasibility of conducting a larger efficacy study.

Official Title
-----------------
Adequate Selection of Patients for Thyroid Biopsy: Evaluation of a Shared Decision Making Conversation Aid

Conditions
-----------------
Thyroid Nodules, Thyroid Cancer

Intervention / Treatment
-----------------
* Behavioral: Counseling using the electronic conversation aid
* Behavioral: counseling by routine care


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Adults >18 years old presenting for evaluation of a thyroid nodule Exclusion Criteria: Patients with hyperthyroidism Patients with previous biopsy of the nodule of interest Pregnant patients Prisoners

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 99 Years

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

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

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

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Intervention group<br>Counseling using the electronic conversation aid | Behavioral: Counseling using the electronic conversation aid<br>* Patients receive counseling about thyroid biopsy with the use of the conversation aid.<br>|
| Active Comparator: Control Group<br>Routine counseling only | Behavioral: counseling by routine care<br>* Patients receive counseling by routine care without the use of the conversation aid<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Proportion of eligible patients for feasibility | Proportion of participants that are eligible relative to total trial referrals.To measure the proportion of eligible patients after review of upcoming clinical visits, enrollment and refusal reasons, ability to randomize patients and tolerability by patients and clinicians of the required assessments (time to complete assessments and obtain complete assessment at 6 months of follow up). | at 6 months of follow up | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
thyroid nodules, shared decision making
Effect of Low Protein Diet in Preventing the Progression of Diabetic Nephropathy

Study Overview
=================
Brief Summary
-----------------
Diabetic nephropathy is the leading cause of chronic kidney disease all the world in spite of progress in new treatment for diabetes and anti hypertensive drugs. Additional treatments are thus needed to arrest the progression of diabetic nephropathy. Although there is insufficient evidence to suggest that a low-protein diet improves renal dysfunction, it is recommended as a mainstay of nutritional management. We here assessed the role of low protein diet in renal function as well as albuminuria in type 2 diabetic patients with nephropathy for a median of 5 years.

Conditions
-----------------
Diabetic Nephropathies

Intervention / Treatment
-----------------
* Behavioral: low protein diet


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Type 2 diabetes mellitus Urinary protein excretion 1-10 g/day Serum Cr <2.0 mg/dl With diabetic retinopathy > SDR Normal protein intake instruction Patients whose consent is obtained at >20 or age =<65 Exclusion Criteria: Type 1 Diabetes Mellitus Non-diabetic nephropathy Urinary tract infection Congestive heart failure Unstable angina Myocardial infarction Stroke Severe hepatopathy Life threatening disease such as malignant tumor Patients on ACE-I and or ARB treatment Patients on instruction of low protein diet BW< 80% of IBW Pregnant, lactating, and probably pregnant patients Patients judged as being inappropriate fir the subjects

Ages Eligible for Study
-----------------
Minimum Age: 20 Years
Maximum Age: 65 Years

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

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

| Intervention/Treatment |
| --- |
|Behavioral: low protein diet|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| annual change of GFR |  |  | 
| annual change of Ccr |  |  | 
| annual change of 1/Cr |  |  | 
| incidence rate of the doubling of sCr |  |  | 
| time to the doubling of sCr |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| urinary albumin and protein excretion |  |  | 
| % change of urinary albumin and protein excretion from baseline |  |  | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Low protein diet, type 2 Diabetic nephropathy, Comparing the effect of Low protein Diet on diabetic nephropathy to that of normal protein diet