linjc16/ctgov huggingface dataset:
A Study to Explore the Role of Gut Flora in COVID-19 Infection

Study Overview
=================
Brief Summary
-----------------
This study seeks to determine whether the virus which causes COVID-19, SARS-CoV-2, is shed in the stools of patients who are infected.

Detailed Description
-----------------
In this study the stool of patients who are being treated for COVID-19 will be tested during treatment and then again following treatment to determine if the virus is shed in the stool during infection, afterwards, or both.

Official Title
-----------------
A Non-Interventional Pilot Study to Explore the Role of Gut Flora in COVID-19 Infection

Conditions
-----------------
Gut Microbiome, Gastrointestinal Microbiome, COVID, COVID-19, Corona Virus Infection, Coronavirus, Coronaviridae Infections, Coronavirus 19, Coronavirus-19, COVID 19

Intervention / Treatment
-----------------
* Other: There is no intervention in this study


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Signed informed consent, demonstrating that the patient understands the procedures required for the study and the purpose of the study Male or female of 18 years of age or older Diagnosis of COVID-19 infection by RT- PCR within 1 week of Screening Exclusion Criteria: Refusal to sign informed consent form History of bariatric surgery, total colectomy with ileorectal anastomosis or proctocolectomy. Postoperative stoma, ostomy, or ileoanal pouch Treatment with total parenteral nutrition

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 |
| --- | --- |
| General Population<br>The general population will have their microbiome sequenced from stool samples provided. | Other: There is no intervention in this study<br>* There is no intervention in this study<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Correlation of Microbiome to Disease via Relative Abundance Found in Microbiome Sequencing | Relative abundance of bacterial classes within taxonomic phyla and, more broadly, within their domain will be analyzed by sequencing the gut microbiome. These data will then be categorized among specific gastrointestinal disease types. | One year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Validation of Sequencing Methods | To validate the methods used to sequence samples | One year | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Microbiome, Coronavirus, Corona Virus, 19, COVID, COVID-19
Diagnosis Of Early Cardiac Dysfunction in Patients With Idiopathic Frequent Monomorphic PVCs

Study Overview
=================
Brief Summary
-----------------
Diagnosis Of Early Cardiac Dysfunction in Patients With Idiopathic Frequent Monomorphic PVCs and effect of ablation and comparison between different sites of ablation

Detailed Description
-----------------
Apply the speckle myocardial tracking technology to early diagnose dysfunction in patients with idiopathic frequent monomorphic PVCs Assessment of cardiac function before and after ablation and comparison before and after ablation and between sites of origin of the PVCs as diagnosed by the electrophysiologic and 3d mapping techniques that may be more confirmed by successful ablation whenever achieved

Official Title
-----------------
Diagnosis Of Early Cardiac Dysfunction in Patients With Idiopathic Frequent Monomorphic PVCs and Effect Effect of Ablation and Comparison Between Different Sites of Ablation

Conditions
-----------------
Cardiomyopathies

Intervention / Treatment
-----------------
* Procedure: Ablation


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: All patients of sample size admitted to the cardiology department of Assiut university hospital for ablation of idiopathic frequent monomorphic PVCs Exclusion Criteria: Patients with well-known factors of cardiac dysfunctions, including high blood pressure (over 140/90 mmHg), hypertrophic cardiomyopathy, left ventricular hypertrophy, bundle branch block, severe valvular disease, complete heart block, and previous CABG.

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 70 Years

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

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

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

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: Ablation<br>Comparison between different sites of ablation | Procedure: Ablation<br>* Ablation of ectopic foci causing PVCs<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| • Detection of early cardiac dysfunction in patients with idiopathic frequent monomorphic PVCs . | • Assessment of cardiac function in patients with idiopathic frequent monomorphic PVCs post - ablation and patients on medical treatment | Baseline |
Long Term Treatment of End Stage Renal Disease Patients With Lanthanum Carbonate (Fosrenol)

Study Overview
=================
Brief Summary
-----------------
Patients who have been treated with Fosrenol for a minimum of 12 consecutive weeks and are receiving dialysis will be followed for 5 years to compare mortality, bone fractures and incidence of selected morbidities to patients with no lanthanum exposure and to patients being treated for hyperphosphatemia with any marketed product.

Official Title
-----------------
A Phase-IV, Long-term, Observational Safety Study in End Stage Renal Disease Subjects Treated With Lanthanum Carbonate (Fosrenol)

Conditions
-----------------
Hyperphosphatemia

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Test Group Signed informed consent Patient must have ESRD and be receiving dialysis Prior treatment with Fosrenol for a minimum of 12 consecutive weeks Primary payer of healthcare must be Medicare (patient must supply Medicare Claim Number) Patient must be 18 years of age or older Exclusion Criteria: Test Group Patients that do not meet inclusion criteria

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 |
| --- | --- |
| 1<br>Test group: Patients who have received a minimum of 12 consecutive weeks of treatment with Fosrenol | |
| 2<br>Historical control group: Patients with no lanthanum exposure | |
| 3<br>Concomitant therapy group: Patients being treated for hyperphosphatemia with any marketed product | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Compare all-cause mortality and bone fractures among three groups of subjects with end stage renal disease (ESRD) |  | 5 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Compare the incidence of selected morbidities among three groups of patients with ESRD |  | 5 years |
Gender Dysphoria: Epidemiological Data

Study Overview
=================
Brief Summary
-----------------
Retrospective study in a single academic regional transgender referral center. data from the cohort follow-up in CHRU de Nancy

Official Title
-----------------
Epidemiological Characteristics of the Population of Persons With Gender Dysphoria : Data From the Cohort Follow-up in CHRU de Nancy

Conditions
-----------------
Gender Dysphoria

Intervention / Treatment
-----------------
* Other: descriptive study


Participation Criteria
=================
Eligibility Criteria
-----------------
Retrospective analysis of available data as a part of the regular care of subjects with gender dysphoria. All measurements were made at the time of the routine follow-up visits
Sexes Eligible for Study
-----------------
All

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

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

Arms and Interventions

| Intervention/Treatment |
| --- |
|Other: descriptive study|Retrospective analysis of existing data collected as a part of the regular follow-up|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Incdience rate of cardiovascular diseases | Number of new cases of arterial hypertension, stroke, myocardial infarction during the specified period (2004-2020) /Time each person was observed, totaled for all persons | 2004-2020 | 
| Incidence rate of dyslipidemia | Number of new cases of dyslipidemia during the specified period (2004-2020) /Time each person was observed, totaled for all persons | 2004-2020 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Incidence rate of oncological diseases | Number of new cases of malignancies during the specified period (2004-2020) /Time each person was observed, totaled for all persons | 2004-2020 | 
| Incidence rate of psychiatric diseases | Number of new cases of psychiatric diseases malignancies during the specified period (2004-2020) /Time each person was observed, totaled for all persons | 2004-2020 | 
| Overall mortality rate | Mortality during the specified period (2004-2020) /Time each person was observed, totaled for all persons | 2004-2020 |
Salt Intake and Lactobacillus Abundance

Study Overview
=================
Brief Summary
-----------------
To investigate the influence of an increased salt intake (6 g/d for 14 days) on the relative abundance of gut lactobillus species in healthy men

Official Title
-----------------
Influence of Increased Salt Intake on Lactobacillus Abundance in Healthy Men

Conditions
-----------------
Healthy Volunteers, Probiotics, Sodium

Intervention / Treatment
-----------------
* Dietary Supplement: Probiotics
* Dietary Supplement: Salt


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Healthy men 18 - 50 years Body mass index 18,5 - 29,9 kg/m2 Exclusion Criteria: Clinically relevant heart, lung, liver, and kidney disease Current or chronic infections Habitual intake of probiotics or dietary supplements

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

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

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

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 |
| --- | --- |
| Experimental: Probiotics and salt<br>Lactobacillus enrichment and salt increase | Dietary Supplement: Probiotics<br>* Day 1-21: 2 capsules per day<br>* Other names: Vivomixx;Dietary Supplement: Salt<br>* Day 8-21: 10 tablets à 600 mg per day<br>* Other names: Slow Sodium Tablets;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Decrease of relative abundance of four lactobacillus species |  | 14 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Increase of systolic blood pressure |  | 14 days | 
| Increase of pulse wave velocity |  | 14 days | 
| Increase of lymphocytic pro-inflammatory mediators |  | 14 days |
Eye Health in Children and Adolescents: Repeated Cross-sectional Survey

Study Overview
=================
Brief Summary
-----------------
The investigator will take a mixed-methods approach to gather relevant information from both children or adolescents, and their parents on profiles of eye health, as well as routinely available indicators. This includes a series of baselining and follow-up analyses of cohort data collected on epidemiological, clinical, therapeutic, and service aspects of eye health and individual-level outcomes

Detailed Description
-----------------
The investigator will take a mixed-methods approach to gather relevant information from both children or adolescents, and their parents on profiles of eye health, as well as routinely available indicators. This includes a series of baselining and follow-up analyses of cohort data collected on epidemiological, clinical, therapeutic, and service aspects of eye health (e.g., social environment, preventive behaviours, risk factors, knowledge and attitudes, health and social care, etc.) and individual-level outcomes (e.g., clinical parameters and symptoms, biomarkers, self-reported measures, risk profiles, etc.).

Official Title
-----------------
Eye Health in Children and Adolescents: Repeated Cross-sectional Survey

Conditions
-----------------
Visual Acuity

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion: Subjects with valid information on eye health-related profiles Completion of eye health examination delivered by trained ophthalmic professionals Exclusion: Inability to give informed consent Unable to retrieve individual records on eye health examination

Ages Eligible for Study
-----------------
Minimum Age: 3 Years
Maximum 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 |
| --- | --- | --- |
| visual acuity | The primary aims of the research project are to explore the profiles of eye health and how lifestyle behaviours, social environment, and individual risk factors are associated with health outcomes. | Baseline and changes up to 4 years |
Pharmacokinetic (PK) Study of Twice Daily vs Once Daily Lamivudine (3TC) and Abacavir (ABC) as Part of Combination Antiretroviral Therapy (ART) in HIV Infected Children

Study Overview
=================
Brief Summary
-----------------
Cross-over 28 week study of the plasma pharmacokinetic profiles of twice daily 3TC (4mg/kg/dose BD) with once daily 3TC (8mg/kg/dose OD) and twice daily ABC (8mg/kg/dose BD) with daily ABC (16mg/kg/dose OD) where one or both drugs are being taken as part of combination antiretroviral therapy.

Official Title
-----------------
Pharmacokinetic Study of Twice Daily vs Once Daily Lamivudine and Abacavir as Part of Combination Antiretroviral Therapy in Children With HIV Infection

Conditions
-----------------
HIV Infection

Intervention / Treatment
-----------------
* Drug: ABC Twice Daily
* Drug: ABC Once Daily
* Drug: 3TC Once Daily
* Drug: 3TC Twice Daily


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Children with definitive HIV infection Age > 2 and < 13 years Currently on combination ART including 3TC and / or ABC, for at least 6 months, with stable CD4 cell count and HIV RNA viral load and expected to stay on this regimen for at least a further 3 months. Exclusion Criteria: • Intercurrent illness Receiving concomitant therapy except prophylaxis against Pneumocystis carinii pneumonia (PCP) Abnormal renal or liver function (grade 3 or above)

Ages Eligible for Study
-----------------
Minimum Age: 2 Years
Maximum Age: 13 Years

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

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

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

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Twice daily<br> | Drug: ABC Twice Daily<br> <br> Drug: 3TC Twice Daily<br> <br> |
| Experimental: Once daily<br> | Drug: ABC Once Daily<br> <br> Drug: 3TC Once Daily<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Area Under Curve (AUC) of lamivudine after qd and bid dosing |  | week 0 and Week 4 | 
| Cmin of lamivudine after qd and bid dosing |  | week 0 and week 4 | 
| Cmax of lamivudine after qd and bid dosing |  | week 0 and week 4 | 
| AUC of abacavir after qd and bid dosing |  | week 0 and week 4 | 
| Cmin of abacavir after qd and bid dosing |  | week 0 and week 4 | 
| Cmax of abacavir after qd and bid dosing |  | week 0 and week 4 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To describe trough intracellular levels of 3TC on twice daily and once daily dosage regimens |  | Week 0 and week 4 | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
HIV, paediatric, Abacavir, lamivudine
Body Composition Reference Data for Preterm Infants

Study Overview
=================
Brief Summary
-----------------
The American Academy of Pediatrics has recommended that growth in size (weight, length, and head circumference) and in body composition (fat and lean mass) in preterm infants should adhere as close as possible to the growth and body composition of a healthy infant in utero at the same gestational age. However, there are no body composition reference curves available at this time for the preterm infant population. The purpose of this study is to collect cross-sectional body composition data using air displacement plethysmography (PEA POD Infant Body Composition System, Life Measurement, Inc) on approximately 240 preterm infants within 3 days of birth, for the purpose of generating means, standard deviations, and percentile values for total body fat mass, total fat free mass, and percent body fat for infants born at 30-36 weeks gestation. Relatively healthy infants without evidence of growth retardation will be selected for form the reference sample. The goal is to generate a set of common reference curves to be used in clinical centers against which to compare body composition status for individual infants.

Official Title
-----------------
Body Composition Reference Data for Preterm Infants

Conditions
-----------------
Preterm Birth

Intervention / Treatment
-----------------
* Other: Body Composition


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Appropriate for gestational age (AGA), singleton, 30+0 and 36+6 weeks gestational age Exclusion Criteria: Congenital defects that affect growth Inability to tolerate room air for 5 minutes without desaturation or bradycardia <1 kg birth weight Parents did not provide consent

Ages Eligible for Study
-----------------
Minimum Age: 24 Hours
Maximum Age: 72 Hours

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

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

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

Arms and Interventions

| Intervention/Treatment |
| --- |
|Other: Body Composition|No intervention. This is an observational, normative study of body composition variation in preterm infants|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Fat mass | Total body fat mass measured by air displacement plethysmography, in kg | Within 72 hours of birth | 
| Fat-free mass | Total body fat-free mass measured by air displacement plethysmography, in kg | Within 72 hours of birth | 
| Percent body fat | Percent body fat measured by air displacement plethysmography, in % | Within 72 hours of birth |
Effects of Sofosbuvir/Ledipasvir Treatment on the Pharmacokinetics and Renal Safety of Tenofovir

Study Overview
=================
Brief Summary
-----------------
This study evaluates the effect of sofosbuvir/ledipasvir (SOF/LDV) treatment on the pharmacokinetics (PK) and renal safety of tenofovir. Subjects receiving tenofovir-based antiretroviral therapy with human immunodeficiency virus (HIV) protease inhibitors (HIV PI/r) and initiating SOF/LDV treatment for Hepatitis C virus (HCV) will be invited to participate. The study consists of three visits: a screening visit and two abbreviated 4-hour pharmacokinetic visits (one before initiating SOF/LDV and a second approximately 4 weeks after initiating SOF/LDV).

Official Title
-----------------
Effects of Sofosbuvir/Ledipasvir Treatment on the Pharmacokinetics and Renal Safety of Tenofovir

Conditions
-----------------
Hepatitis C and HIV Coinfection

Intervention / Treatment
-----------------
* Other: Blood draws for tenofovir PK, renal function


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: On tenofovir and a ritonavir-boosted PI for at least 30 days initiating HCV treatment with SOF/LDV HCV RNA <48 copies/mL at most recent clinic visit Exclusion Criteria: eGFR < 60 ml/min history of renal disease Pregnant or planning pregnancy Any medical, social, or mental-health issue(s) that, in the opinion of the investigators, could interfere with study participation or the study outcomes

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 70 Years

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

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

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

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Tenofovir PK before and after SOF/LDV<br> | Other: Blood draws for tenofovir PK, renal function<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in area under the plasma concentration (AUC) of tenofovir | Compare tenofovir AUC0-24 before and after administration of SOF/LDV | 4 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in Estimated Glomerular Filtration Rate (eGFR) | Compare eGFR calculated using Modification of Diet in Renal Disease (MDRD) equation before and after the addition of SOF/LDV. | 14 weeks | 
| Change in concentrations of tenofovir-diphosphate | Compare concentrations of tenofovir-diphosphate in peripheral blood mononuclear cells and red blood cells before and after the addition of SOF/LDV | 4 weeks |