linjc16/ctgov huggingface dataset:
Immuno-virological Characterization of Severe H1N1v Influenza Infection in Bronchoalveolar Lavage

Study Overview
=================
Brief Summary
-----------------
The influenza A/H1N1v pandemic virus causes severe pneumonia that can lead to acute respiratory distress syndrome and death even in healthy young individuals. The respective roles of viral replication, bacterial infection and immune alterations of the host during such severe influenza H1N1v infection need to be clarified in order to optimize patients care. In this context, we aim to study immune and virological parameters in bronchoalveolar lavage fluid during severe influenza A/H1N1v infection with pulmonary involvement in intensive care unit. Results will be correlated to bacterial or viral pulmonary co-infections and to peripheral blood immune and virological parameters.

Official Title
-----------------
Immuno-virological Characterization of Severe H1N1v Influenza Infection in Bronchoalveolar Lavage in Patients Requiring Mechanical Ventilation in Intensive Care Unit

Conditions
-----------------
Influenza, Acute Lung Injury, Acute Respiratory Distress Syndrome

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Suspected influenza A/H1N1 infection Diffuse bilateral pneumonia <96h with acute lung injury or respiratory distress syndrome Invasive or non-invasive ventilation in intensive care unit Age > 13 Exclusion Criteria: Other cause identified of acute lung injury or acute respiratory distress syndrome Contraindicated bronchoalveolar lavage

Ages Eligible for Study
-----------------
Minimum Age: 13 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 |
| --- | --- |
| Influenza A/H1N1 patients<br> | |
| Non influenza A/H1N1 patients<br> | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| immunological parameters in blood and bronchoalveolar lavage fluid |  | day 0 and day 5-7 of ventilation for both blood and BAL, day 30 and month 5 for blood | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| virological parameters in nose, broncho-alveolar lavage and peripheral blood |  | day 0 and day 5-7 of ventilation | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
influenza, H1N1, lymphocytes, T cell, CD4, CD8, cytokine, serology, broncho-alveolar lavage, acute respiratory distress syndrome, ventilation, intensive care unit
Characterization of Immunological Profile of Renal Transplant Patients Undergoing Induction Treatment With Thymoglobulin vs. IL-2 Receptor Antagonist Basiliximab

Study Overview
=================
Brief Summary
-----------------
The goal of the study is to find out the effects of two different drugs used at the beginning of organ transplantation on different populations of immune cells in the body of patients.

Official Title
-----------------
Characterization of Immunological Profile of Renal Transplant Patients Undergoing Induction Treatment With Thymoglobulin vs. IL-2 Receptor Antagonist Basiliximab

Conditions
-----------------
Renal Transplantation

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: all patients considered for transplantation 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 |
| --- | --- |
| 1<br>patients receiving IL-2 receptor antagonist (Simulect) as induction treatment | |
| 2<br>patients receiving Thymoglobulin as induction treatment | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The primary outcome is to look for expansion of regulatory T cells at one year. |  | 12 months |
Progesterone and Second Trimester Bleeding

Study Overview
=================
Brief Summary
-----------------
Working hypothesis and aims: To investigate whether progesterone treatment affects the incidence of preterm labor compared to placebo, among women with 2nd trimester bleeding. The participants will be allocated through randomization to a study or control group. Women in the study group will receive micronized progesterone 200 mg (Utrogestan, company) with an intra-vaginal tablet once daily while the control group will receive placebo. Both women and medical staff will be blinded to group allocation. Treatment will commence on the day of inclusion to the study, but not before 16 weeks and will continue until 36 weeks gestation. Data will be collected after the conclusion of pregnancy regarding the maternal and neonatal outcome.

Official Title
-----------------
The Impact of Progesterone on the Risk of Preterm Birth Among Women With Second Trimester Bleeding. A Double Blind Placebo Controlled Trial

Conditions
-----------------
Antepartum Bleeding, Preterm Birth

Intervention / Treatment
-----------------
* Drug: micronized progesterone 200 mg (Utrogestan)
* Drug: placebo


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Viable pregnancy Gestational age between 13 to 26 weeks Vaginal bleeding from uterine origin Singleton pregnancy Normal clotting tests Hemodynamically stable woman Exclusion Criteria: Water leak Signs of preterm labor Fetal malformations incompatible with life Uterine malformations and other maternal conditions, i.e. liver disease, breast cancer, active thromboembolic state Past preterm birth

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

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

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

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

Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Utrogestan<br> | Drug: micronized progesterone 200 mg (Utrogestan)<br>* micronized progesterone 200 mg (Utrogestan, company) as an intra-vaginal tablet once daily<br>|
| Placebo Comparator: placebo<br> | Drug: placebo<br>* placebo 200mg vaginal tablets<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Incidence of spontaneous preterm birth - before 37 weeks. |  | 3 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Maternal and fetal outcomes |  | 3 years | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
second trimester vaginal bleeding, late abortion, preterm birth, progesterone
The Safety and Effectiveness of Transcatheter Aortic Valve Raplacemet in Intermediate Risk Patients With Bicuspid Aortic Stenosis

Study Overview
=================
Brief Summary
-----------------
Previous trials have shown that TAVR was a noninferior alternative to surgery in patients with severe aortic stenosis at intermediate surgical risk. However, patients with congenital bicuspid valve have been excluded in those trials. The purpose of this trial is to determine the safety and effectiveness of TAVR in intermediate-risk patients with bicuspid aortic valve stenosis.

Official Title
-----------------
A Prospective, Randomized, Controlled, Multi-Center Study to Establish the Safety and Effectiveness of Transcatheter Aortic Valve Raplacemet in Intermediate Risk Patients Who Have Severe, Calcific, Bicuspid, Aortic Stenosis Requiring Aortic Valve Replacement

Conditions
-----------------
Aortic Valve Disease

Intervention / Treatment
-----------------
* Procedure: TAVR
* Procedure: SAVR


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Severe, calcific bicuspid aortic stenosis. Heart team agrees the patient has a risk of operative mortality and has an STS <8 and >3. The study patient has been informed of the nature of the study, agrees to its provisions and has provided written informed consent as approved by the Institutional Review Board (IRB) of the respective clinical site. Exclusion Criteria: Ilio-femoral vessel characteristics that would preclude safe placement of the introducer sheath. Evidence of an acute myocardial infarction ≤ 1 month (30 days) before randomization. Severe aortic regurgitation (>3+). Severe mitral regurgitation (>3+).

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: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: TAVR group<br> | Procedure: TAVR<br>* Transcatheter Aortic Valve Replacement<br>|
| Active Comparator: SAVR group<br> | Procedure: SAVR<br>* Surgical Aortic Valve Replacement<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| All-cause mortality, all stroke, and re-hospitalization | This composite endpoint will be evaluated as a non-inferiority analysis based on a relative non-inferiority margin of 35% | 1 year post procedure |
Prevalence of Bacterial Contamination on Smart Cell Phone vs. Non-smart Phone

Study Overview
=================
Brief Summary
-----------------
Using smartphone is increasing in hospital with various purpose and it has more extended surface than non-smart phone. Therefore investigators can consider the bacterial contamination rate of smartphone will be higher than that of non-smartphone.

Detailed Description
-----------------
Hospital-acquired infections(HAI) are causing grave concern in almost all the hospitals of the world and causing increased morbidity and mortalities. The transmission of HAI occurs through hospital staff and inanimate hospital environment, equipment, and devices that the hospital staff use.Recently, cellphones (CP) were blamed to cause nosocomial infections. The mobile phones are used routinely all day long but not cleaned properly, as health care workers' may do not wash their hands as often as they should. The aim of the present study was to evaluate the prevalence of bacterial contamination of mobile phones in ICU health care providers. and especially compare the contamination rate between smartphone and non-smartphone. Using smartphone is increasing in hospital with various purpose and it has more extended surface than non-smart phone. therefore we can consider the bacterial contamination rate of smartphone will be higher than that of non-smartphone.

Official Title
-----------------
Bacterial Contamination of Smart Phones of Health Care Workers

Conditions
-----------------
Health Care Workers, Including Physicians, Nurses, and Nursing Aids

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: healthcare providers of MICU who have cellular phones Exclusion Criteria: healthcare providers of MICU who have not cellular phones

Ages Eligible for Study
-----------------
Minimum Age: 19 Years
Maximum Age: 70 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 |
| --- | --- |
| HCPs with smartphone<br>healthcare providers in MICU who have smart cellular phones | |
| HCP with non-smart phones<br>healthcare providers in MICU who have non-smart cellular phones | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
Early Nutrition and Neurological Development of Very Preterm Infants

Study Overview
=================
Brief Summary
-----------------
The main goal of this study is to determine the association between: the quantity of mother's milk and duration of breastfeeding the intake of polyunsaturated fatty acids and iron during hospitalization and the development of preterm infants born with a GA < 32 weeks.

Official Title
-----------------
Early Nutrition and Neurological Development of Very Preterm Infants

Conditions
-----------------
Infant, Premature, Diseases, Infant Nutrition Disorders, Development; Delayed, Mental

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion criteria: infants with a gestational age < 32 weeks already included in the EPIPAGE2 study agreement of parents Exclusion criteria: death during hospitalisation
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 |
| --- | --- |
| Premature infants with a GA < 32 Weeks<br> | |
| New born with a GA > 37Weeks<br> | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Neurological development at 2 years of age | Age and Stages Questionnaire at 2 years of age Brunet Lezine test | 3 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Nutritional status at time of discharge | Polyunsaturated fatty acids status Iron status | 1 year | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
PUFA, Iron, Neurological development, Premature infant
A Study of the Safety and Efficacy of Nebivolol in Hypertensive Patients

Study Overview
=================
Brief Summary
-----------------
A study to determine the safety, efficacy and superiority of nebivolol to placebo for the treatment of elevated blood pressure in patients with mild to moderate hypertension.

Detailed Description
-----------------
This study was a multi-center, multi-national, randomized, double-blind, parallel group, placebo-controlled study of nebivolol over a range of doses in patients with mild to moderate hypertension. The study consisted of 2 phases: screening/washout/single-blind placebo run-in and 2) randomization/double-blind treatment. Patients had 7 scheduled clinic visits during the study.

Official Title
-----------------
A Double-Blind, Multi-Center, Randomized, Placebo-Controlled, Parallel Group Study of the Effects of Nebivolol on Safety and Efficacy in Patients With Mild to Moderate Hypertension

Conditions
-----------------
Hypertension

Intervention / Treatment
-----------------
* Drug: Nebivolol


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: An average sitting diastolic blood pressure of greater then or equal to 95 mmHg and less then or equal to 109 mmHg at baseline Exclusion Criteria: Recent myocardial infarction or stroke Secondary hypertension Contraindications to beta-blocker therapy or discontinuation of prior antihypertensive agents Pregnancy, nursing or women of childbearing age not using appropriate contraception

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: Double


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: Nebivolol|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The change of the average sitting diastolic blood pressure (24 plus/or minus 2 hours post-previous morning's dose) taken at trough at the end of the treatment compared to baseline |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| - The change of the average sitting, supine and standing systolic and diastolic blood pressure at trough and peak at end of treatment compared to baseline |  |  | 
| - Response rate |  |  | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Nebivolol, Hypertension, Beta-Blockers
A Study of Single and Multiple Doses of KHK6640 in Subjects With Prodromal or Mild to Moderate Alzheimer's Disease

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to evaluate the safety, tolerability and pharmacokinetics of KHK6640, given as a single dose and as multiple doses in patients with Prodromal Alzheimer's Disease (AD) or Mild to Moderate AD.

Official Title
-----------------
A Phase 1 Double-blind, Placebo-controlled, Single- and Multiple-ascending-dose Study of KHK6640 in Alzheimer's Disease

Conditions
-----------------
Alzheimer's Disease

Intervention / Treatment
-----------------
* Drug: KHK6640
* Drug: Matching Placebo


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients with prodromal AD or mild to moderate AD Clinical Dementia Rating (CDR) score of 0.5, 1.0, or 2.0 Have a cognitive impairment Low Aβ and high Tau in Cerebrospinal fluid (CSF) Mini Mental State Examination (MMSE) score > 16 at Screening Exclusion Criteria: Previous active treatment with an AD immunotherapy in an investigational study Use of another investigational drug within 30 days of screening History or presence of clinically significant seizures, brain trauma, transient ischemic attack, and/or cerebrovascular disease Presence of a neurological condition that could be contributing to cognitive impairment above and beyond that caused by the subject's AD Evidence of infection, tumor, or other clinically significant lesions that could indicate a dementia diagnosis other than AD

Ages Eligible for Study
-----------------
Minimum Age: 55 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: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: KHK6640<br>KHK6640 | Drug: KHK6640<br>* Single ascending dose and multiple ascending doses administration<br>|
| Placebo Comparator: Placebo<br>Placebo | Drug: Matching Placebo<br>* Single ascending dose and multiple ascending doses administration<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of Participants with Adverse Events as a Measure of Safety and Tolerability | Safety assessment variables will include all adverse events (AEs) including serious and non-serious AEs, laboratory parameters (hematology, chemistry, and urinalysis), vital signs, 12-lead electrocardiograms, physical and neurological examinations, and brain MRI | Up to 7 months |
Long-Term Follow-Up Study of Human Stem Cells Transplanted in Subjects With Connatal Pelizaeus-Merzbacher Disease (PMD)

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to determine the long term safety and preliminary effect of HuCNS-SC cells transplanted in subjects with Connatal Pelizaeus-Merzbacher Disease (PMD).

Detailed Description
-----------------
Only subjects who underwent HuCNS-SC transplantation under Protocol CL-N01-PMD will be enrolled in this long term follow-up study. Subjects will return to the site six months and one year after completion of the Phase I study and then annually for a total study duration of four years. Phone calls will also be made by the Investigator to the subject's parent/legal guardian bi-annually to conduct a phone visit through the four-year duration of the study.

Official Title
-----------------
Long-Term Follow-Up Safety and Preliminary Efficacy Study of Human Central Nervous System Stem Cell (HuCNS-SC®) Transplantation in Subjects With Connatal Pelizaeus-Merzbacher Disease (PMD)

Conditions
-----------------
Pelizaeus-Merzbacher Disease, PMD

Intervention / Treatment
-----------------
* Biological: HuCNS-SC transplant in the lead-in phase


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Subjects who received HuCNS-SC cells under Protocol CL-N01-PMD Exclusion Criteria: Subjects who received off-protocol immunosuppressive medications. Subjects who are concurrently enrolled in another investigational study.
Sexes Eligible for Study
-----------------
Male

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| HuCNS-SC transplanted subjects in the lead-in phase<br>Subjects who had HuCNS-SC transplant in the lead-in phase study CL-N01-PMD | Biological: HuCNS-SC transplant in the lead-in phase<br>* Long-term safety follow-up study<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Incidence of serious adverse events (SAEs), results of physical and neurological examination, laboratory tests and vital signs. |  | 4 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Preliminary efficacy using Bayley-III and Callier-Azusa Scale. | Changes compared to baseline | 4 years | 
| Changes in brain magnetic resonance imaging (MRI), electroencephalogram (EEG), seizure frequency and somato-sensory evoked potentials (SSEP). | Changes compared to baseline | 4 years | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Long term follow-up, HuCNS-SC cells, human central nervous system stem cells