linjc16/ctgov huggingface dataset:
Persistence of the Immune Response to Hepatitis B in 7-9 Years Old Children Previously Vaccinated With DTPa-HBV-IPV/Hib

Study Overview
=================
Brief Summary
-----------------
Persistence of seroprotective antibody concentrations & immunological memory shown by the ability to mount a response to a challenge dose of HBV vaccine

Official Title
-----------------
Multicentre Study to Assess Persistence of Antibodies Against Hepatitis B and Immune Response to a Hepatitis B Challenge Dose in Healthy Children 7 to 9 Years Old Previously Vaccinated With 4 Doses of GSK Biologicals' DTPa-HBV-IPV/Hib Vaccine

Conditions
-----------------
Hepatitis B

Intervention / Treatment
-----------------
* Biological: hepatitis B vaccine


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: A male or female aged 7 to 9 years at the time of study entry . Subjects who have received a total of 4 doses of DTPa-HBV-IPV/Hib vaccine or a total of 4 doses of HBV vaccine in previous vaccination studies. Evidence of previous hepatitis B booster vaccination or disease since administration of the fourth dose of DTPa-HBV-IPV/Hib or HBV vaccine.

Ages Eligible for Study
-----------------
Minimum Age: 7 Years
Maximum Age: 9 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: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Intervention/Treatment |
| --- |
|Biological: hepatitis B vaccine|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Anti-HBs antibody concentration |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Persistence of antibodies to the other DTPa-HBV-IPV/Hib vaccine antigens. |  |  | 
| Sol & unsol symptoms after HBV vaccination, SAEs |  |  | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Prophylaxis for hepatitis B disease
Open-Label Safety Study of AXS-05 in Subjects With TRD (EVOLVE)

Study Overview
=================
Brief Summary
-----------------
This study is a multi-center, open-label trial to evaluate the long-term safety and efficacy of AXS-05 in subjects with treatment resistant depression (TRD) and major depressive disorder (MDD).

Detailed Description
-----------------
Eligible subjects must have either completed Study AXS-05-TRD-201 immediately prior to enrollment in this study or meet the DSM-5 criteria for major depressive disorder (MDD) without psychotic features.

Official Title
-----------------
An Open-Label Study to Assess the Long-term Safety and Efficacy of AXS-05 in Subjects With Treatment Resistant Depression

Conditions
-----------------
Treatment Resistant Depression, Major Depressive Disorder

Intervention / Treatment
-----------------
* Drug: AXS-05 (dextromethorphan-bupropion)


Participation Criteria
=================
Eligibility Criteria
-----------------
Completed Study AXS-05-TRD-201 OR currently meets the DSM-5 criteria for MDD without psychotic features Continued depression despite treatment with antidepressants in the current depressive episode Agree to use adequate method of contraception for the duration of the study Additional criteria may apply

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
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: AXS-05 (dextromethorphan-bupropion)<br> | Drug: AXS-05 (dextromethorphan-bupropion)<br>* - AXS-05 tablet, taken daily (up to 15 months)<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Incidence of treatment-emergent AEs (TEAEs) following dosing with AXS-05 |  | Up to 15 months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
AXS-05, Treatment Resistant Depression, TRD, NMDA receptor, Refractory depression, Resistant depression, Depression, Major depression, Dextromethorphan, Bupropion, MDD
Detection of Plasma DNA in Non Small Cell and Small Cell Lung Cancer Patients

Study Overview
=================
Brief Summary
-----------------
The majority of lung cancer patients have a tumor-derived genetic alteration in circulating plasma DNA that could be exploited as a diagnostic tool. The aim of this study is to evaluate if plasma DNA can be used as a valuable non invasive test to monitor disease progression without assessing the tumor.

Official Title
-----------------
Detection of Plasma DNA by Allelotyping in Non Small Cell and Small Cell Lung Cancer Patients. Evolution During Treatment and Follow-up.

Conditions
-----------------
Non-Small Cell Lung Carcinoma, Small Cell Lung Cancer

Intervention / Treatment
-----------------
* Procedure: Biopsy samples


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Presence of lung tumor to use fiberoscopy or surgical intervention for diagnosis. No lung instability. Individuals give all informed consent

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: Screening
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Intervention/Treatment |
| --- |
|Procedure: Biopsy samples|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
-----------------
Lung cancer, plasma DNA, allelotyping, follow-up, Prospective Study, Non-Small Cell Lung Cancer, Small Cell Lung Cancer
Impact of Systematic Infants Vaccination Against Rotavirus on Gastroenteritis Hospitalization: a Prospective Study in Brest District, France.

Study Overview
=================
Brief Summary
-----------------
Universal rotavirus vaccination program for infants born in Brest after February 2007, applied by the Centers for Maternal and Infant Health Protection, pediatricians and general practitioners. Prospective surveillance of hospitalizations for gastroenteritis within the Pediatric Units of Brest University Hospital with systematic testing for Rotavirus. Evaluation of the impact of the vaccination program on rotaviral gastroenteritis hospitalizations from 2007-2008 and 2008-2009, by comparison with epidemiological data from 2002-2007 in the absence of vaccination. The principal judgement criterion is the number of pediatric hospitalizations for rotaviral GEA during the 2008-2009 epidemic in children A) under the age of 2 and B) residing in the suburbs of Brest.

Official Title
-----------------
Impact of Systematic Infants Vaccination Against Rotavirus on Gastroenteritis Hospitalization: a Prospective Study in Brest District, France.

Conditions
-----------------
Rotavirus Gastroenteritis

Intervention / Treatment
-----------------
* Biological: Rotateq vaccine


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: infants aged 6 to 12 weeks born in Brest District, France born between Feb 01, 2007 and Nov 19, 2009 Exclusion Criteria: contraindication to rotavirus vaccine

Ages Eligible for Study
-----------------
Minimum Age: 6 Weeks
Maximum Age: 12 Weeks

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

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

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

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: 1<br>Cohort of vaccinated infants against rotavirus | Biological: Rotateq vaccine<br>* Vaccination against rotavirus Three oral doses (2 mL) between 6 to 26 weeks of life with at least 4 weeks between each dose.<br>* Other names: Rotateq;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Hospitalization for gastroenteritis |  | 2 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Emergency department consultation for gastroenteritis |  | 2 years | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
prevention, rotavirus vaccine, gastroenteritis, systematic vaccination, infants, aged 6 to 12 weeks
The PEACE (Posthumous Evaluation of Advanced Cancer Environment) Study

Study Overview
=================
Brief Summary
-----------------
Historically, cancer research has been limited by sample acquisition in late stage disease, often restricted to single sites of disease with limited parallel clinical data collection in terms of prior therapy exposure. The PEACE study is intended to facilitate tissue donation from multiple tumour sites in the post-mortem setting and enable future research using samples collected at post-mortem within different disciplines related to cancer research.

Official Title
-----------------
The PEACE (Posthumous Evaluation of Advanced Cancer Environment) Study

Conditions
-----------------
Solid Tumor, Adult, Cancer

Intervention / Treatment
-----------------
* Other: Tissue Harvest


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Age 18 years or older Confirmed diagnosis of any form of solid malignancy with metastatic disease (where the site of origin is known or unknown), with the exception of primary brain tumour in which there may not be evidence of metastatic disease Oral and written informed consent from patient to enter the study and to undergo tumour harvesting after death or informed consent from a person in a qualifying relationship after the patient has died. Exclusion Criteria: Medical or psychiatric condition that would preclude informed consent History of intravenous drug abuse within the last 5 years History of known high-risk infections (e.g. HIV/AIDS-positive, hepatitis B/C, tuberculosis and Creutzfeldt-Jacob disease).

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 |
| --- |
|Other: Tissue Harvest|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Perform 500 post mortems |  | 5 years |
Tele-assessment in Individuals With COVID-19

Study Overview
=================
Brief Summary
-----------------
In most countries, after the measures taken to reduce the effects of the epidemic and quarantine practices, a remote screening tool has emerged in order to screen the needs developing after COVID-19 and to make the necessary rehabilitation applications in time. Sivan et al. A comprehensive multi-system phone scan of the COVID-19 Yorkshire Rehabilitation Screening Tool (C19-YRS) has been developed by a multidisciplinary rehabilitation team. This study, which will be carried out using the C19-YRS tool and the 30-second sit-and-go test that evaluates functional capacity and mobility conditions, is expected to contribute to the clinical and literature since most of the studies on COVID-19 focused only on the acute and subacute periods. In addition, considering the pandemic conditions all over the world, it will be possible to benefit from the advantages of the tele-assessment application and by reaching more people, possible clinical problems/needs and whether there is a change functional capacities in individuals after COVID-19 will be identified.

Official Title
-----------------
Determination of Long Term Rehabilitation Needs and Assessment of Functional Capacity in Individuals With COVID-19 With Tele-assessment Methods

Conditions
-----------------
Covid19

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria being 18 years of age or older, Patients who have had COVID-19 and whose treatment was completed and the PCR test was negative for 2 times or who passed the positive PCR test for 28 days, Individuals who can take and execute verbal orders, giving consent on a voluntary basis Exclusion Criteria: individuals who have not had covid 19 or Acute-stage patients with COVID-19 individuals who refuse to participate in the tele-assessment individuals with dementia, cognitive problems or communication problems

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 75 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 |
| --- | --- | --- |
| Covid-19 Yorkshire Rehab Screen (C19YRS) | The C19YRS was developed as a screening tool to monitor long-term symptoms due to Covid-19. The screening tool covers 19 items which combines yes/no answers and an 11 point ordinal scale (0-10) where a higher score denotes increased symptom severity. | Baseline | 
| 30-sec sit and go test | It will be used for functional evaluation. | Baseline | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
COVID-19, tele-assessment, C19-YRS, rehabilitation needs, functional capacity
Cytomegalovirus (CMV) Transmission by Frozen Breast Milk in Preterms

Study Overview
=================
Brief Summary
-----------------
Cytomegalovirus infection threatens preterm infant. We investigated, whether thawed breast milk is a mode of transmission

Detailed Description
-----------------
Preterm infants are at risk of symptomatic human cytomegalovirus infections transmitted by breast milk. This study evaluates incidence, timing, and clinical rlevance of acquired human CMV infections in preterm infants younger than 32 weeks of gestational age receiving maternal thawed frozen breast milk until 33 completed weeks of gestational age.

Official Title
-----------------
Incidence and Clinical Outcome of Human Cytomegalovirus Transmission Via Thawed Frozen Breast Milk in Preterm Infants <31 Weeks. A Prospective Trial.

Conditions
-----------------
Cytomegalovirus

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: preterm infants of less than 32 weeks of gestation Exclusion Criteria: preterm infant of 32 weeks of gestational age or older, feeding with solely formula milk ourborn infants retroviral infection CMV status of mother unclear informed consent missing

Ages Eligible for Study
-----------------
Minimum Age: 24 Weeks
Maximum Age: 31 Weeks

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

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| A<br>mother CMV positive | |
| B<br>mother CMV negative | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| CMV status of preterm infants |  | 2005-2008 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| clinical manifestations of CMV infection |  | 2005-2008 | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
cytomegalovirus breast milk preterm infants transmission, transmission of CMV via thawed frozen breast milk
Effects of Vitamin D on Beta Cell Function and Insulin Sensitivity in Pre-diabetes and Diabetes Mellitus Type 2

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to evaluate if treatment with vitamin D increase beta cell function and insulin sensitivity in subjects with pre-diabetes or newly diagnosed diabetes mellitus type 2.

Official Title
-----------------
Effects of Vitamin D on Beta Cell Function and Insulin Sensitivity in Pre-diabetes and Diabetes Mellitus Type 2 - EVIDENS

Conditions
-----------------
Diabetes Mellitus, Type 2, Glucose Intolerance, Vitamin D Deficiency

Intervention / Treatment
-----------------
* Drug: Vitamin D3
* Drug: Placebo


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Meeting criteria for IFG, IGT, IFG+IGT or diabetes mellitus at OGTT. BMI ≤ 32 kg/m2. HbA1c ≤ 7.0 % (MonoS) or ≤ 63 mmol/mol (IFCC). Fasting plasma glucose < 9 mmol/l S-25-OH-vitamin D3 < 75 nmol/l. Exclusion Criteria: Treatment with any vitamin D preparation. Regular sun-bathing in solarium. Hypercalcemia at screening, defined as free s-calcium > 1.35 mmol/l. Hyperphosphatemia at screening, defined as s-phosphate > 1.5 mmol/l. Sarcoidosis or other granulomatous disease. Treatment with phenytoin, barbiturates, rifampicin, isoniazid, cardiac glycosides, orlistat or colestyramin. Impaired hepatic function. Impaired renal function Cardiac disease defined as: Unstable angina pectoris Myocardial infarction within the last 6 months Congestive heart failure NYHA class III and IV Cerebral stroke within the last 6 months. Anti-diabetic medication of any kind. Females of childbearing potential who are pregnant, breast-feeding or intend to become pregnant or are not using adequate contraceptive methods.

Ages Eligible for Study
-----------------
Minimum Age: 45 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: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Vitamin D3<br> | Drug: Vitamin D3<br>* Oral drops 30000 IU weekly<br>* Other names: Vigantol oil;|
| Placebo Comparator: Placebo<br> | Drug: Placebo<br>* Matching placebo<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Beta cell function | Assessed by hyperglycemic clamp investigation | 8 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Insulin sensitivity | Assessed by hyperglycemic clamp investigation | 8 weeks | 
| Glucose tolerance | Assessed by OGTT | 8 weeks | 
| Hypercalcemia |  | 8 weeks |
Individualized Lung Recruitment Maneuver Guide by Pulse-oximetry in Anesthetized Patients

Study Overview
=================
Brief Summary
-----------------
General anesthesia and mechanical ventilation promotes atelectasis and airway closure. The open-lung approach (OLA) strategy restores the functional residual capacity. Pulse oximetry hemoglobin saturation (SpO2) using room air can diagnose shunt induced by lung collapse during general anesthesia and the SpO2 breathing air was useful to detect the lung´s opening and closing pressure during a recruitment maneuver (RM) in morbidly obese anesthetized patients. Investigators hypothesized that the SpO2 breathing air can personalize the open-lung approach.

Detailed Description
-----------------
Increase in airway pressure until the SpO2 reaches 97% (lung´s opening pressure) during the incremental positive end-expiratory (PEEP) limb. Decrease in the PEEP level until the SpO2 decreases bellow 97% (lung´s closing pressure)

Official Title
-----------------
Individualized Lung Recruitment Maneuver Guide by Pulse-oximetry in Anesthetized Patients

Conditions
-----------------
Abdominal Cancer

Intervention / Treatment
-----------------
* Other: Open-lung approach


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Non-obese patients with ASA physical status I-III undergoing elective abdominal laparoscopic surgery with an expected operating time of less than 2 hours were included. Exclusion Criteria: age of <18 years, preoperative SpO2 ≤97% while breathing room air, and patients with previous known cardiac or respiratory disease.

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 |
| --- |
|Other: Open-lung approach|Increase and decrease in airway pressure to open the lung and keep them opened.|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| open-lung condition | The role of the SpO2 to detect lung´s closing and opening pressures was evaluated by the discrete receiver operating characteristic (ROC) analysis. With PtpEE and PaO2/FIO2 as the reference methods, a binary classification of 1 to the open-lung condition defined as positive PtpEE or PaO2/FIO2 >400 mmHg and 0 presence of lung collapse defined as negative PtpEE or PaO2/FIO2 <400 mmHg. Also, a value of 1 was assigned when the SpO2 was ≥ 97% and a value of 0 when the value was < 97%. | During the experimental protocol (Intraoperative) |
Mechanical Alternans Study

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to determine whether mechanical alternans (alternating strong and weak heart beats with a constant beat-to-beat interval), can be used to predict malignant ventricular arrhythmias, requiring defibrillation or appropriate ICD therapies, and to predict progression of heart failure and death.

Official Title
-----------------
Study of Mechanical Alternans for Prediction of Ventricular Tachyarrhythmias

Conditions
-----------------
Ischemic Cardiomyopathy, Nonischemic Cardiomyopathy, Heart Failure

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: structural heart disease ischemic or non-ischemic cardiomyopathy Exclusion Criteria: pregnancy age < 18 years old

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 |
| --- | --- | --- |
| sudden arrhythmic death | appropriate ICD therapy due to fast ventricular tachycardia or ventricular fibrillation, or sudden cardiac death | 5 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| cardiovascular mortality |  | 5 years | 
| all-cause death |  | 5 years | 
| appropriate ICD therapies | either ICD shock or antitachycardia pacing due to ventricular arrhythmia | 5 years | 
| composite heart failure endpoint | pump-failure death, or heart transplantation, or heart failure hospitalization, whichever came first | 5 years |