linjc16/ctgov huggingface dataset:
Impact of IPT With Sulfadoxin Pyrimetamin on Pregnant Women and Their Babies Outcomes in Peri-urban Areas of Bobo-Dioulasso(Burkina Faso)

Study Overview
=================
Brief Summary
-----------------
The purpose of this is to determine the impact of intermittent preventive treatment (IPT) with sulfadoxine-pyrimethamine (SP) on the morbidities associated with malaria in pregnant women and newborns in rural peri-urban areas of Bobo-Dioulasso, 5 years after its implemented.

Detailed Description
-----------------
Malaria in pregnant women is a crucial issue in Burkina Faso. Faced with this problem, a strategy based on the use of treated nets and intermittent preventive treatment (IPT) based on sulfadoxine-pyrimethamine (SP) was adopted in 2005. Five years after its implementation, the investigators will check whether this strategy is still effective in the preventing maternal and congenital malaria on the one hand and maternal anemia, low birth weight and prematurity on the other hand.

Official Title
-----------------
Impact of Intermittent Preventive Treatment (IPT) With Sulfadoxine-pyrimethamine (SP) on the Morbidities Associated With Malaria in Pregnant Women and Newborns in Peri-urban Areas of Bobo-Dioulasso, 5 Years After Its Adoption by the National Program for Fight Against Malaria in Burkina Faso.

Conditions
-----------------
Malaria, Pregnancy

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Residing in the health area of Lafiabougou or secteur 24 Having agreed to give free and informed consent Exclusion Criteria: Bleeding from during the pregnancy eclampsia
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 |
| --- | --- | --- |
| Peripheral and placental malaria | The investigators will check if pregnant women have any malaria parasites by making a finger prick thick respectively at antenatal clinics and at delivery. A placental thin smear will be made at delivery. | Peripheral malaria : at antenatal clinics and at delivery. Placental malaria: at delivery | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Maternal anemia, congenital malaria,low birth weight, prematurity. | The investigators will check pregnant women haemoglobin level.A level< 11g/dl will be considered as anemia. Congenital malaria will be assessed through cord blood smear. Birth weight <2500g will be considered as low birth weight. Prematurity designs any birth before 37 gestation weeks. | Maternal anemia: at antenatal clinics and at delivery. Congenital malaria: at delivery. Low birth weight: at delivery. Prematurity: at delivery. | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Intermittent preventive treatment with sulfadoxin-pyrimethamine, in Bobo-Dioulasso peri-urban areas, 5 years after its implementation, Burkina Faso.
Genetic Polymorphisms of Mannan-binding Lectin (MBL)and Serum Levels of MBL in Patients With Endometriosis

Study Overview
=================
Brief Summary
-----------------
The purpose of the study is to investigate the possible association between low levels of MBL and the development of endometriosis

Detailed Description
-----------------
Endometriosis is a chronic, inflammatory disease, affecting approximately 10% of the female population. The pathogenesis of endometriosis is still unclear, but several studies have indicated that the immune system is involved. It has been suggested that endometriosis should be considered an autoimmune disease, considering the findings of elevated levels of cytokines, decreased cell apoptosis, increased incidence of autoantibodies and a higher frequency of other autoimmune diseases in endometriosis patients. MBL participates in the innate immune defence by activating complement on the surfaces of microorganisms, but several studies have suggested that MBL is also involved in autoimmune diseases. The individual MBL level is highly variable due to a number of polymorphic sites in the structural gene and in the promoter region, and approximately 12 % of the normal population have very low serum MBL levels (<100 ng/ml). The possible association between MBL and endometriosis has been investigated in two small studies, in which no association was found. The aim of the present study is to investigate the prevalence of individuals with low serum levels of MBL and with genotypes associated with low MBL production in a larger group of endometriosis patients.

Official Title
-----------------
Genetic Polymorphisms of Mannan-binding Lectin (MBL) and Serum Levels of MBL in Patients With Endometriosis

Conditions
-----------------
Endometriosis

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: histologically verified endometriosis ASRM stage 2-4 Exclusion Criteria: pregnancy actual treatment with GnRh analog autoimmune diseases

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

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

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Patients<br>women with histologically verified endometriosis | |
| Controls<br>Healthy Danish blood donors | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Frequency of individuals with s-MBL < 100 ng/ml |  | baseline | 
| Frequency of individuals with MBL genotypes LXPA/O or O/O |  | baseline | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
endometriosis, mannan-binding lectin, immunology
Ultrasensitive Electroanatomic Mapping to Adjudicate Endpoints for Ablation In Paroxysmal AF Patients Using Cryoballoon

Study Overview
=================
Brief Summary
-----------------
Ultrasensitive Electroanatomic Mapping to Adjudicate Endpoints for Ablation In Paroxysmal AF Patients Using Cryoballoon

Detailed Description
-----------------
Collected data include procedural parameters relevant to pulmonary vein isolation as outlined in the protocol section, DE identified patient demographics, follow up information including rhythm status, antiarrhythmic medication usage, and symptoms or signs to suggest procedural complications relevant to the pulmonary vein isolation procedure.

Official Title
-----------------
Ultrasensitive Electroanatomic Mapping to Adjudicate Endpoints for Ablation In Paroxysmal AF Patients Using Cryoballoon

Conditions
-----------------
Paroxysmal Atrial Fibrillation

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients undergoing pulmonary vein isolation using cryoballoon at St. Joseph's Hospital in FL that sign informed consent Exclusion Criteria: -
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 |
| --- | --- | --- |
| Frequency of acute pulmonary vein isolation as adjudicated by pacing catheter based entrance/exit block, and Orion derived activation and voltage map. |  | 12 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| AT/AF free survival |  | 12 months | 
| Procedural endpoints including total procedure time, LA dwell time, total flouro time, total ablation time, and total mapping time. |  | 12 months |
Study to Investigate Effects of CAL-263 in Subjects With Allergic Rhinitis Exposed to Allergen in an Environmental Chamber

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to determine the safety and effect of CAL-263 in subjects with allergic rhinitis.

Detailed Description
-----------------
A Phase I, randomized, double-blind crossover study of CAL-263, an oral inhibitor of PI3K delta, in patients with allergic rhinitis.

Official Title
-----------------
A Phase 1, Randomized, Double-Blind, Placebo-Controlled, Two-Period Crossover Study to Investigate the Safety of CAL-263 in Allergic Rhinitis Subjects and Effects on the Response to Environmental Chamber Allergen Challenge

Conditions
-----------------
Allergic Rhinitis

Intervention / Treatment
-----------------
* Drug: CAL-263
* Drug: Placebo


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Age >18 and <55 years Has a history of seasonal allergic rhinitis for at least 2 years Has sensitivity to grass pollen demonstrated by a positive response to skin prick testing Has a positive Radio Allergen Sorbent Test (class 2 or greater) for grass pollen during the previous 12 months or at screening Is otherwise healthy Is able to provide written informed consent Exclusion Criteria: Is a female of childbearing History of chronic nasal or upper respiratory tract symptoms or disorders other than allergic rhinitis History of nonallergic rhinitis, chronic sinusitis or severe asthma Has a nasal condition likely to affect the outcome of the study Is currently taking regular medication, whether prescribed or not, including corticosteroids, vitamins, macrolides, anti-fungal agents and herbal remedies Has taken a prohibited medication within the specified interval prior to Visit 1

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum 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: Crossover Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: 1<br>CAL-263 | Drug: CAL-263<br>* CAL-263 10 mg or placebo once daily for 7 days<br>|
| Placebo Comparator: 2<br>Placebo | Drug: Placebo<br>* CAL-263 10 mg or placebo once daily for 7 days<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Evaluate the safety of CAL-263 in allergic rhinitis subjects |  | 46 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Determine the efficacy of CAL-263 on total nasal symptom scores following an allergen challenge in allergic rhinitis subjects |  | 7 days | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Allergic Rhinitis, Allergy, Phosphatidylinositol 3-kinase
Prevention of Hepatitis B Virus Vertical Transmission by Serovaccination and Tenofovir During Pregnancy

Study Overview
=================
Brief Summary
-----------------
The risk of vertical HBV transmission is related to HBV DNA level in pregnant women, around 30% in women with HBV DNA above 1, 000 000 I.U/mL despite serovaccination of newborns. Using tenofovir DF during the last trimester of pregnancy allows to reduce the risk, but data from Western countries are needed.

Detailed Description
-----------------
The prevalence of HBs Ag carriage in pregnant women varies in France, according to the native country, with higher rates in those originating from sub-Saharan Africa and Asia (5 to 8% in Parisian area). The level of HBV DNA varies according to HBe status and geographical origin, and is strongly predictive of the risk of HBV mother-to-child transmission (MTCT). The rate of vertical transmission (Yuan J et al. J Viral Hepatitis 2006) was 0% in newborns to mothers with HBV DNA less than 100,000 copies/mL and up to more than 40% in newborns to mothers with HBV DNA above 8 Log10 copies/mL, despite serovaccination at birth, thus justifying the use of tenofovir DF during the last trimester of pregnancy in highly viraemic pregnant women, as mentionned in EASL 2012 Guidelines. Data are needed concerning the results of this strategy in western countries, justifying this prospective study.

Official Title
-----------------
Prevention of Hepatitis B Virus (HBV) Mother-to-Child (MTC) Transmission by Serovaccination of Newborns and Use of Tenofovir DF During the Last Trimester of Pregnancy in Mothers With HBV DNA Above 100, 000 I.U/mL

Conditions
-----------------
Pregnancy, HBV

Intervention / Treatment
-----------------
* Drug: Tenofovir DF


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: pregnant women positive for HBs Ag HBV DNA above 100,000 I.U/mL Exclusion Criteria: HIV co-infection HDV co-infection requiring, according to the physician's decision, a treatment for herself and not only to prevent HBV MTC transmission

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: tenofovir<br>tenofovir DF one pill (245 mg) per day from week 28 of pregnancy to week 12 after birth | Drug: Tenofovir DF<br>* Tenofovir DF will be started at week 28 of pregnancy and stopped or not, according to the physician's decision, at week 12 after birth<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Rate of chronically infected (positive HBs Ag) children born from mothers with HBV DNA above 100, 000 I.U/mL being given tenofovir during the last trimester of pregnancy. |  | At 9 months after birth |
Study of a Pandemic Influenza Vaccine in Elderly Participants

Study Overview
=================
Brief Summary
-----------------
The World Health Organisation has warned that an influenza pandemic is inevitable. The avian influenza H5N1 virus strain is one of the leading candidates to cause the next influenza pandemic. The elderly are likely to be a special target group for vaccination; therefore, this study will test the safety and immunogenicity of a H5N1 pandemic influenza vaccine in a healthy elderly population.

Official Title
-----------------
Phase II Study of a Pandemic Influenza Vaccine in Elderly Participants

Conditions
-----------------
Influenza

Intervention / Treatment
-----------------
* Biological: H5N1 Pandemic Influenza Vaccine


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Healthy male and female participants Exclusion Criteria: History of clinically significant medical conditions History of Guillain-Barre syndrome or active neurological disease Resident of nursing home or long-term care facility

Ages Eligible for Study
-----------------
Minimum Age: 65 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: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Intervention/Treatment |
| --- |
|Biological: H5N1 Pandemic Influenza Vaccine|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Safety and immunogenicity |  |  | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Pandemic, Influenza, Prevention, Vaccine, Prevention of Pandemic Influenza
Bariatric Surgery and the Kidney

Study Overview
=================
Brief Summary
-----------------
The purpose of the project is to study the relationship between post-bariatric surgery changes in weight and renal parameters.

Official Title
-----------------
Study of Renal Parameters After Bariatric Surgical Weight Loss

Conditions
-----------------
Proteinuria

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: bariatric patients Exclusion Criteria: age <18 dialysis dependency

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| GFR |  | April 2014 | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
glomerular filtration rate
Breath Analysis in Lung Fibrosis

Study Overview
=================
Brief Summary
-----------------
The aim of the study is to answer the question whether a disease specific profile of breath in patients with idiopathic lung fibrosis can be detected by an untargeted metabolomic study using exhaled breath analysis by mass spectrometry.

Official Title
-----------------
Exhaled Breath Analysis by Secondary Electrospray Ionization - Mass Spectrometry (SESI-MS) in Patients With Pulmonary Fibrosis

Conditions
-----------------
Idiopathic Lung Fibrosis, Idiopathic Pulmonary Fibrosis

Intervention / Treatment
-----------------
* Other: No intervention


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Clinical symptoms consistent with IPF Age 40 through 80 years Diagnosis of UIP or IPF by HRCT and surgical lung biopsy as outlined in table 1. Only patients fulfilling the category YES will be included in the study. Extent of fibrotic changes (honeycombing, reticular changes) greater than extent of emphysema on HRCT scan No features supporting an alternative diagnosis Exclusion Criteria: Acute exacerbation within the last 6 weeks. Any relevant lung disease other than pulmonary fibrosis. Acute inflammatory disease (e.g. common cold) within the last 6 weeks. Acute or chronic hepatic disease. Renal failure or renal replacement therapy.

Ages Eligible for Study
-----------------
Minimum Age: 40 Years
Maximum Age: 80 Years

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

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Idiopathic lung fibrosis<br>20 IPF patients | Other: No intervention<br> <br> |
| Controls<br>20 subjects with no apparent lung disease and normal lung function testing. Matched for gender, age and smoking history. | Other: No intervention<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| IPF-specific mass spectrometric profile of volatile organic compounds of exhaled breath analysis (markers of IPF in exhaled breath) |  | 1 day | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Mass spectrometry, Exhaled breath analysis
Study of the Orsiro Drug Eluting Stent System

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to compare the BIOTRONIK Orsiro Drug Eluting Stent System with the Abbott Xience Prime™ Drug Eluting Stent System with respect to in-stent Late Lumen Loss in a non-inferiority study in de novo coronary lesions at 9 months.

Official Title
-----------------
BIOTRONIK-Safety and Clinical PerFormance of the Drug ELuting Orsiro Stent in the Treatment of Subjects With Single de Novo Coronary Artery Lesions - II

Conditions
-----------------
Coronary Artery Disease

Intervention / Treatment
-----------------
* Device: Percutaneous Coronary Intervention (Abbott Laboratories - Xience Prime DES)
* Device: Percutaneous Coronary Intervention (Orsiro DES)


Participation Criteria
=================
Eligibility Criteria
-----------------
Main Inclusion Criteria: Subject has provided a written informed consent Single de novo lesion with ≥ 50% and <100% stenosis in up to 2 coronary arteries The target lesion length is ≤ 26 mm The target reference vessel diameter is ≥ 2.25 mm and ≤ 4.0 mm Main Exclusion Criteria: Evidence of myocardial infarction within 72 hours prior to index procedure Unprotected left main coronary artery disease (stenosis >50%) Three-vessel coronary artery disease at time of procedure Thrombus in target vessel Target lesion involves a side branch > 2.0 mm in diameter Heavily calcified lesion Target lesion is located in or supplied by an arterial or venous bypass graft

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 80 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: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Abbott Laboratories - Xience Prime DES<br> | Device: Percutaneous Coronary Intervention (Abbott Laboratories - Xience Prime DES)<br>* Stenting<br>|
| Experimental: Biotronik - Orsiro DES<br> | Device: Percutaneous Coronary Intervention (Orsiro DES)<br>* stenting<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Late Lumen Loss |  | 9 months post index procedure |
The Circadian Rhythm of Copeptin

Study Overview
=================
Brief Summary
-----------------
The circadian rhythm of copeptin will be examined in healthy subjects.

Detailed Description
-----------------
In 18 healthy volunteers the circadian rhythm of copeptin will be examined by withdrawing blood samples for copeptin levels every 30 minutes for 24 hours.

Official Title
-----------------
The Circadian Rhythm of Copeptin

Conditions
-----------------
Circadian Rhythm, Copeptin Blood Levels

Intervention / Treatment
-----------------
* Other: observation


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: healthy subjects Exclusion Criteria: acute illness chronic illness pregnancy Anemia defined as Hb < 30g/l

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 50 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 |
| --- | --- |
| observational<br>Blood samples will be taken for measuring copeptin levels in healthy subjects. | Other: observation<br>* blood sampling during 24 hours<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| measurement of copeptin values in mmol/l within 24 hours to assess the amount of release in a day curve. | The primary outcome measure is to compare the copeptin concentration in the early afternoon and the early morning by blood sampling at different time points. Evaluation of the question if there is a circadian rhythm in the copeptin release. | 24 hours |