linjc16/ctgov huggingface dataset:
COVID-19 Respiratory Distress and Antithrombotic Drugs in Subject's Habits

Study Overview
=================
Brief Summary
-----------------
Current management of VID-19 consists of oxygen support without specific treatment. Hospitalization may suddenly require delayed resuscitation. This evolution corresponds to an atypical acute respiratory distress syndrome (ARDS), the mechanism of which is poorly understood and difficult to predict. The general pathophysiology of ARDS, the vascular tropism of SARS-Cov2, the description of coagulopathy and numerous pulmonary artery thromboses in resuscitation and the encouraging investigation of antithrombotics in general ARDS

Official Title
-----------------
COVID-19 Respiratory Distress and Antithrombotic Drugs inSubject's Habits

Conditions
-----------------
Sars-CoV2

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Major Subject (≥18 years) Subject hospitalised in HUS or GHRMSA for COVID-19 The diagnosis COVID-19 confirmed by smear or evoked by CT scan or chest X-ray without a differential diagnosis retained in the medical record Subjects who, after being informed, do not wish to have their data reused for the purposes of this research Exclusion Criteria: Subject who expressed opposition to participating in the study Subject under guardianship or trusteeship Subject under safeguard of justice Patient hospitalized in a geriatric service or in a ward not labeled COVID (surgery, oncology,...) or in a short-term hospitalization unit without transfer to another service. Serious patient on admission to the emergency room and recused from resuscitation.

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

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

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Analysis of Respiratory Distress and Antithrombolytic Therapy in Patients with covid19 |  | 1 month | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Sars-CoV2, Covid-19, Antithrombotic treatments, ARDS, Hypoxemia, Thrombosis, Pulmonary arteries, Endothelial
Vaccination of Children Following Allogeneic Stem Cell Transplantation

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to determine the immunogenicity and tolerability of the DTaP-IPV-HBV/Hib combination vaccine Infanrix hexa and the heptavalent pneumococcal conjugate vaccine Prevenar in pediatric recipients of allogeneic haematopoietic stem cell transplantation.

Official Title
-----------------
Immunogenicity of the DTaP-IPV-HBV/Hib Combination Vaccine Infanrix Hexa and the Heptavalent Pneumococcal Conjugate Vaccine Prevenar in Pediatric Recipients of Allogeneic Haematopoietic Stem Cell Transplantation

Conditions
-----------------
Allogeneic Haematopoietic Stem Cell Transplantation

Intervention / Treatment
-----------------
* Biological: DTaP-IPV-HBV/Hib combination vaccine, Infanrix hexa
* Biological: heptavalent pneumococcal conjugate vaccine, Prevenar


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: pediatric recipient of allogeneic haematopoietic stem cell transplantation complete remission of underlying malignant disease (if applicable) stable haematopoietic engraftment Lansky-/Karnofsky-score >= 60% Exclusion Criteria: primary immunodeficiency hepatitis B or C, HIV infection application of radio-/ chemotherapy following stem cell transplantation extended chronic graft-versus-host disease (Karnofsky-scale < 60%) coagulopathy known allergy/hypersensitivity towards ingredients of study vaccines seizure disorder, progressive neurologic disease

Ages Eligible for Study
-----------------
Maximum Age: 17 Years

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

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

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

Design Details

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


Arms and Interventions

| Intervention/Treatment |
| --- |
|Biological: DTaP-IPV-HBV/Hib combination vaccine, Infanrix hexa|nan|
|Biological: heptavalent pneumococcal conjugate vaccine, Prevenar|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| serologic response at 1 months following primary three dose vaccination series |  | first month | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| serologic response at 1 months following booster immunization |  | first month | 
| tolerability of primary and booster vaccination |  | at least monthly | 
| identification of factors influencing immunogenicity and tolerability of study vaccines |  | at least monthly | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
children, allogeneic haematopoietic stem cell transplantation, bone marrow transplantation, vaccination, invasive pneumococcal disease, tetanus, diphtheria, poliomyelitis, pertussis, Hepatitis B, Haemophilus influenzae type B infection
Prospective Study of Pregnancy in Women With Cystic Fibrosis

Study Overview
=================
Brief Summary
-----------------
In this study, the investigators aim to evaluate changes in lung function in women with cystic fibrosis (CF) during pregnancy and for 2 years after pregnancy based on exposure to highly effective cystic fibrosis transmembrane conductance regulator (CFTR) modulators.

Detailed Description
-----------------
Advances in medical treatment, including the use of highly effective CFTR modulators have greatly increased life expectancy in women with CF, but the effects of pregnancy on women with CF are yet unknown. It is anticipated that over 90% of the CF population will be on CFTR modulators in the next few years. More knowledge about the effects of CFTR modulators in pregnancy is needed. This is a prospective, multi-center, observational study to follow pregnant women with CF, conducted at 40 US sites. Women are enrolled in the first trimester of pregnancy and assessed every 3 months during pregnancy and during the first year after delivery, then every 6 months for an additional year. Changes in lung function over the course of pregnancy will be evaluated based on cumulative CFTR modulator use while pregnant while accounting for other factors that may influence changes in pulmonary function: baseline lung function, genotype, history of exacerbations, and pre-existing co-morbid conditions.

Official Title
-----------------
A Prospective Study Evaluating Maternal and Fetal Outcomes in the Era of Modulators

Conditions
-----------------
Pregnancy Related, Cystic Fibrosis

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Pregnant, intending to continue pregnancy, enrolled in the Cystic Fibrosis Foundation Patient Registry (CFFPR) Exclusion Criteria: None

Ages Eligible for Study
-----------------
Minimum Age: 16 Years

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

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 |
| --- | --- | --- |
| Forced expiratory volume at one second (FEV1) percent predicted after delivery and restart of modulators | Change in FEV1 percent predicted after delivery and restart of modulators relative to measures assessed prior to pregnancy | 42 weeks | 
| Forced expiratory volume at one second (FEV1) percent predicted after delivery | Change in FEV1 percent predicted after delivery relative to measures assessed prior to pregnancy | 42 weeks | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Pregnancy/obstetric health in women with cystic fibrosis, Pregnancy, CFTR modulators, Cystic Fibrosis
The Effect of Flexible Thoracolumbar Brace on Spinal Alignment, Pain and Quality of Life in Subjects With Neuromuscular Scoliosis

Study Overview
=================
Brief Summary
-----------------
In the initial evaluation, the degree of spine is measured quantitatively using Cobb's angle and Muscular Dystrophy Spine Questionnaire (MDSQ). The patients who had Cobbs angle of 20-45 'by spinal plain radiography were evaluated for the effects of flexpine brace wearing and rehabilitation for 6 months. After 12 months, whole spine X-ray was taken for the followed up the patient's status.

Official Title
-----------------
The Effect of Flexible Thoracolumbar Brace on Spinal Alignment, Pain and Quality of Life in Subjects With Neuromuscular Scoliosis : A Longitudinal Study

Conditions
-----------------
Neuromuscular Scoliosis

Intervention / Treatment
-----------------
* Device: thoracolumbar brace (Flexpine brace)


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: 20-45' degrees of cobb's angle in the neuromuscular disease Exclusion Criteria: patient's who had spinal surgery less than 20 degree or more than 45 degree of cobb's angle acute lumbar pain

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?
-----------------

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: single-arm trials<br>longitudial study of the thoracolumbar brace in the neuromuscular scoliosis for 6 months | Device: thoracolumbar brace (Flexpine brace)<br>* Patient's would wear the FLEXpine brace over 18 hours a day for the 6 month<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| change of the scoliosis | Cobb's angle in the whole spine anteroposterior view of X-ray before, immediately after, and 6-month after wearing FLEXpine brace | 6months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| change of pain | pain scale checked through the visual analog scale | 6months | 
| change of pulmonary function | assessed by spirometer of forced vical capacity | 6 months | 
| change of quality of life | Parents assessed the quality of life through the muscular dystrophy spine qusetionnaire | 6 months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
brace, neuromuscular disease, scoliosis
Clinical Pattern of Stroke and Transient Ischemic Attack Mimics

Study Overview
=================
Brief Summary
-----------------
wide range of diagnoses may present like stroke, called stroke mimics as well as transient ischemic attacks .

Official Title
-----------------
Clinical Pattern of Stroke and Transient Ischemic Attack Mimics in Patients Attending Neuropsychiatry Department in Assuit University Hospital

Conditions
-----------------
Stroke, Transient Ischemic Attack

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Male or female aged above 18 years Accept all requirements of the study Exclusion Criteria: .Refuse participation in the study

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 |
| --- | --- | --- |
| True estimation of frequency of stroke and TIA mimics in patients attending Neuropsychiatry department in Assuit University Hospital. | frequency of stroke and TIA mimics in patients attending Neuropsychiatry department in Assuit University Hospital. | 1 year |
Evaluation of cccDNA and Total HBV DNA Kinetics in Lymphocytes, Total Blood and Serum in Chronic Hepatitis B Patients Treated With Adefovir Dipivoxil and Peg Interferon Alpha 2a

Study Overview
=================
Brief Summary
-----------------
Serum HBV DNA is a referent but insufficient marker of therapeutic follow-up in chronic hepatitis B treatment. Intra hepatic cccDNA disappearance reflects HBV eradication in the liver. Intra lymphocyte cccDNA could be a new marker of HBV eradication after treatment. The major interest of this marker is that it can be measured by a simple blood test instead of a liver biopsy.

Detailed Description
-----------------
- Studying intra lymphocyte and blood cccDNA: before inclusions, D0 then each month during the first three months each three months during treatment and follow-up. - Viral kinetics:Before inclusions, at D0, then monthly till the end of treatment and follow-up: Evolution of quantitative viraemia in serum Evolution of quantitative viraemia in circulating lymphocytes Evolution of quantitative viraemia in total blood - Studying viral genotypes

Official Title
-----------------
Evaluation of cccDNA and Total HBV DNA Kinetics in Lymphocytes, Total Blood and Serum in Chronic Hepatitis B Patients Treated With Adefovir Dipivoxil and Peg Interferon Alpha 2a

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

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Male and female patients >18 years of age and <70 years of age Patients AgHbs+ and AgHbe+ or AgHbe-, and B viral DNA >104 copies/ml PCR COBAS MONITOR Patients treated with adefovir dipivoxil and peg interferon alpha 2a Chronic liver disease consistent with chronic hepatitis B infection on a biopsy obtained within the past 24 months Naïve patients or patients having a relapse or a therapeutic failure after monotherapy lamivudine or interferon, or bitherapy interferon alpha-lamivudine Exclusion Criteria: Co-infection HIV, HCV

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Kinetic cccDNA | Studying the kinetics of cccDNA in cells and whole blood | 6 months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Chronic hepatitis B, CCC DNA kinetics, Total HBV DNA kinetics, Adefovir-Dipovixil, Peg interferon alpha 2a
A Pilot Study of Pulmonary Function in Dysphagic Infants

Study Overview
=================
Brief Summary
-----------------
Infants less than 2 years old who have been newly diagnosed with problems swallowing will have pulmonary function tests performed to try to detect the presence of chronic lung disease. Six months later after the infants have received appropriate therapy for their swallowing problems, pulmonary function tests will be performed again to see if there has been any change in their chronic lung disease.

Detailed Description
-----------------
Twenty-five infants between the ages of 1 month and 24 months who have just been diagnosed with dysphagia via a modified barium feeding study will be recruited into the study. The infants will be sedated with chloral hydrate and have pulmonary functions measured (pre- and post-bronchodilator spirometry and lung volume) using the infant pulmonary laboratory. Treatment for the infants' dysphagia/chronic aspiration will be treated as determined by the primary care physicians. Six months later the infants will again be sedated and have pulmonary functions measured. Results of the two sets of tests will be compared statistically.

Official Title
-----------------
A Pilot Study of Pulmonary Function in Dysphagic Infants

Conditions
-----------------
Chronic Lung Disease

Intervention / Treatment
-----------------
* Procedure: Infant Pulmonary Function Tests


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: infants between ages 1-24 months who have been newly diagnosed with dysphagia Exclusion Criteria: cystic fibrosis obstructive sleep apnea seizures allergy or adverse reaction to chloral hydrate heart disease liver disease kidney disease pneumonia pleural effusion neuromuscular disease major congenital anomalies tracheoesophageal fistula vascular ring bronchopulmonary dysplasia pharyngeal anomalies Arnold-Chiari malformation

Ages Eligible for Study
-----------------
Minimum Age: 1 Month
Maximum Age: 24 Months

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

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

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

Design Details

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


Arms and Interventions

| Intervention/Treatment |
| --- |
|Procedure: Infant Pulmonary Function Tests|Tests will be performed on study patients within 1 week of study enrollment and again 6 months later.|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| infant pulmonary function test results |  | On admission to study and 6 months later | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
pulmonary function tests, infants, chronic lung disease, dysphagia, chronic aspiration
Immunogenicity and Safety of a Monovalent Glycoprotein-Conjugated (Diptheria Toxin -CRM197) Hib Vaccine in 13-59 Months Old Healthy Children

Study Overview
=================
Brief Summary
-----------------
This study will evaluate the safety and immunogenicity of single dose of two commercially available vaccines used to prevent Haemophilus influenzae type b infections in children 13-59 months of age.

Official Title
-----------------
A Phase III Observer-blind, Randomized, Controlled, Single-coordinating Center Study to Investigate Immunogenicity and Safety of a Monovalent Glycoprotein-conjugated (Diptheria Toxin -CRM197) Hib Vaccine in 13-59 Months Old Healthy Children in China, According to the Recommended Regimen of 1 Dose

Conditions
-----------------
Haemophilus Influenzae Type b (Hib) Infection

Intervention / Treatment
-----------------
* Biological: Monovalent glyco-conjugated vaccine against Haemophilus influenzae type b (Hib)
* Biological: Tetanus toxoid polysaccharide-conjugated vaccine against Haemophilus influenzae type b (Hib)


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Infants 13-59 months of age. Exclusion Criteria: Prior Hib vaccine administration. History of serious reaction(s) following vaccination. Any vaccination within 7 days of study vaccination. Known or suspected immune impairment. Premature (before 37th week of gestation) or birth weight less than 2500g For additional entry criteria please refer to the protocol.

Ages Eligible for Study
-----------------
Minimum Age: 13 Months
Maximum Age: 59 Months

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

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

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

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Arm 1<br> | Biological: Monovalent glyco-conjugated vaccine against Haemophilus influenzae type b (Hib)<br>* a single dose was administered<br>|
| Active Comparator: Arm 2<br> | Biological: Tetanus toxoid polysaccharide-conjugated vaccine against Haemophilus influenzae type b (Hib)<br>* a single dose was administered<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Anti-PRP antibody levels at day 31 post last vaccination |  | 30 days after last vaccination | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Solicited local and systemic reactions, AEs, and SAEs |  | 30 days post last vaccination | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Haemophilus influenzae type b (Hib), Vaccine, Anti PRP antibody
Rehabilitation, Quality of Life, and Exercise Tolerance in Patients With an ICD

Study Overview
=================
Brief Summary
-----------------
RELAX-ICD Trial/Research Study; Quality of Life/Protocol No.P-KARE-01: A 3-month outpatient rehabilitation therapy and psychological counselling including informative talks with conventional therapy, by a cardiologist or general practitioner after implantation of an internal cardioverter defibrillator (ICD) in adult patients, whereby the effects of three different strategies are compared. Study hypothesis: the rehabilitation programme will be beneficial in the management of any psychological problems possibly as a result from the intervention, and will help to overcome anxiety, and contribute to improved quality of life.

Detailed Description
-----------------
University Hospital Inselspital Berne,Switzerland: Site Nr. 1 - Jean-Paul Schmid, MD, ... recruiting / Virga Jesseziekenhuis,Hasselt, Belgium: Site No. 2 - Paul Dendale,MD,.... recruiting / Medical University of Gdansk, Poland, Site No. 3 - Dominika Zielinska,PhD,.... recruiting / Cliniques Universitaires Saint Luc, Brussel, Belgium: Site No. 4 - Christian Brohet,MD Prof.... recruiting / State Hospital for Cardiology, Balantonfüred, Hungary: Site No. 5 - Gabor Veress, MD Prof, ...recruiting

Official Title
-----------------
Rehabilitation, Quality of Life, and Exercise Tolerance in Internal Cardioverter-Defibrillator-patients, RELAX-ICD Trial

Conditions
-----------------
Heart Patients After ICD Implantation

Intervention / Treatment
-----------------
* Procedure: psycho-educational


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: First ICD implant within past 12 weeks Agrees to sign patient/partner informed consent Exclusion Criteria: Angina pectoris CCS III & IV NYHA functional class IV Inability to follow rehabilitation programme Exercise limitations due to clinical condition Symptomatic exercise-induced tachyarrhythmias Any major non-cardiac condition that would adversely affect survival during study duration Unable to comply to study procedures Participates in a concurrent study

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

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

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

Design Details

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


Arms and Interventions

| Intervention/Treatment |
| --- |
|Procedure: psycho-educational|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Anxiety and Depression |  |  | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
ICD, distress, anxiety, quality-of-life