linjc16/ctgov huggingface dataset:
Thrombin Generation Test in Patient With Liver Cirrhosis

Study Overview
=================
Brief Summary
-----------------
Cirrhotic patients are patients with high morbidity and mortality, it is very important for determining the prognosis of these patients. The importance increases when these patients waiting for a liver transplant. The Model for End-Stage Liver Disease (MELD) is a reliable measure of mortality risk in patients with end-stage liver disease. It is used as a disease severity index to help prioritize allocation of organs for transplant. MELD uses the patient values for serum bilirubin, serum creatinine, and the international normalized ratio for prothrombin time (INR) to predict survival. Blood tests that we use today in daily practice to evaluate the coagulation system (PT, PTT) do not check actually the functioning of the system, but examine the level of clotting factors and therefore only verify that the side of Anticoagulant of the equation and not the side of the procoagulant . To examine the coagulation system function tests have been developed, One of them is the thrombin generation. The purpose of the trial is to determine whether thrombin generation test can be a prognostic indicator in patients cirrhosis.

Official Title
-----------------
Thrombin Generation Test in Patient With Liver Cirrhosis

Conditions
-----------------
Cirrhosis

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Cirrhosis patient MELD ( Model For End-Stage Liver Disease) above 12 Exclusion Criteria: Pregnant women

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 |
| --- | --- | --- |
| Complications of cirrhosis. | Complications of cirrhosis, such as ascites, bleeding Varicose veins, encephalopathy or thrombosis of the portal vein. | 3 month. | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Coagulation Factor, cirrhosis
Sulphadoxine-Pyrimethamine for Intermittent Preventive Treatment of Malaria in Pregnancy in Uganda

Study Overview
=================
Brief Summary
-----------------
The effectiveness of sulfadoxine-pyrimethamine (SP) as intermittent preventive treatment in pregnancy in malaria-endemic areas the effectiveness and efficacy of SP may be compromised by increased SP resistance. This study will evaluate the efficacy of SP by giving SP to asymptomatic parasitemic pregnant women and following them to determine the rates of parasite clearance.

Official Title
-----------------
Assessment of the Efficacy of Sulphadoxine-Pyrimethamine for Intermittent Preventive Treatment of Malaria in Pregnancy in Uganda

Conditions
-----------------
Intermittent Preventive Treatment, Placental Malaria

Intervention / Treatment
-----------------
* Drug: Sulfadoxine-pyrimethamine


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: 16-26 weeks gestation based on LMP or ultrasound or fundal height Axillary temperature <37.5 degrees C Informed consent HIV status known and negative Blood smear positive for falciparum malaria Exclusion Criteria: History of hypersensitivity reaction to SP or components of SP Axillary temperature ≥37.5 degrees C History of receipt of antimalarials or antibiotics with antimalarial activity* in the past month Residence > 30 km from the ANC clinic or unwillingness to return for follow-up visits Hemoglobin level < 5 gm/dL These medications include all antimalarials, rifampin, doxycycline, clindamycin, tetracycline, erythromycin, azithromycin, chloramphenicol.
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 |
| --- | --- |
| Experimental: SP<br>Asymptomatic parasitemic pregnant women who receive the standard dose of sulfadoxine-pyrimethamine for prevention of placental malaria | Drug: Sulfadoxine-pyrimethamine<br>* Sulfadoxine-pyrimethamine tablets, once<br>* Other names: Kamsidar, Fansidar;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Parasite clearance | Clearance of parasites in pregnant women with asymptomatic parasitemia after administration of SP | 42 days | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Malaria, Pregnancy
Pharmacogentic Screening of Coumarine Based Oral Anticoagulant Using Next Generation Seguencer

Study Overview
=================
Brief Summary
-----------------
As drug response is a complex trait in the majority of cases using an optimal starting dose for an individual may reduce the time taken to reach a stable INR, and reduce the risk of having either a high INR (with a risk of bleeding) or a low INR (with a risk of thrombosis)

Detailed Description
-----------------
The results of this project will benefit in (1) Identification of novel features or mutation types in warfarin resistance genomes. (2) To determine whether other polymorphisms in noncoding regions or their unique haplotype combinations contribute to the variability in the maintenance dose of warfarin, and (3)personalization of the drug and deciding the correct dose from the start.

Official Title
-----------------
Pharmacogentic Screening of Coumarine Based Oral Anticoagulant Using Next Generation Seguencer

Conditions
-----------------
Thrombosis

Intervention / Treatment
-----------------
* Diagnostic Test: Genetic Mutations


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients with thrombosis and warfarin resistance Exclusion Criteria: less than 18 years

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

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Warfarin resistant patients<br>Genetic Mutations | Diagnostic Test: Genetic Mutations<br>* By next generation sequencing<br>|
| Placebo Comparator: Control<br>Genetic Mutations | Diagnostic Test: Genetic Mutations<br>* By next generation sequencing<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| number of patients with genetic polymorphism | patients with abnormal polymorphisms | 6 months |
Study Of The Safety Of CE 224,545 And Methotrexate In Patients With Rheumatoid Arthritis

Study Overview
=================
Brief Summary
-----------------
CE 224,535 is being developed for the treatment of rheumatoid arthritis. The purpose of this study is to evaluate the safety and tolerability of CE 224,535 after 4 weeks of treatment in subjects with rheumatoid arthritis already receiving methotrexate

Official Title
-----------------
A Phase 1, Double Blind Study Of The Safety And Pharmacokinetics Of Multiple Doses Of CE 224,535 In Subjects With Rheumatoid Arthritis Receiving Methotrexate

Conditions
-----------------
Arthritis, Rheumatoid

Intervention / Treatment
-----------------
* Drug: CE-224,535
* Drug: Methotrexate


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Adults patients with rheumatoid arthritis Patients who have received stable weekly doses of oral methotrexate (5 to 25 mg/week administered as a single dose) for a minimum of 28 days (4 weeks/4 doses) Exclusion Criteria: History of chronic infectious disease such as genitourinary, pulmonary or sinus infections. Any current or known malignancy or history of malignancy within the previous 5 years Pregnant or lactating women; women of child-bearing potential who are unwilling to unable to use an acceptable method of birth control during 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?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: CE-224,535|nan|
|Drug: Methotrexate|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Incidence and severity of adverse events throughout the study |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pharmacokinetics of CE 224,535 on Days 7 and 8 |  |  | 
| Pharmacokinetics of Methotrexate on Days 1 and 8 |  |  |
Effectiveness Of A Program That Includes Counseling And Patient Support On Adherence To Treatment With Lipitor

Study Overview
=================
Brief Summary
-----------------
Despite extensive reports of the benefits of statins in reducing serious cardiovascular events such as stroke and heart disease in patients with elevated LDL-cholesterol, patients do not take their medicines regularly as prescribed. Reasons include forgetfulness, lack of understanding of the seriousness of the disease, and fear of side effects. An intervention strategy comprising 3-5 minutes of counseling, emotional support and cost-sharing may be motivational and improve adherence to treatment.

Official Title
-----------------
Impact Of An Integrated Intervention Program On Adherence To Atorvastatin

Conditions
-----------------
Medication Non-Adherence

Intervention / Treatment
-----------------
* Behavioral: No Patient Counseling
* Behavioral: Adherence Counseling


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Male and female aged >21 years Have received a new or re-fil prescription for atorvastatin at first study visit to Prairie Heart Institute Signed informed consent Exclusion Criteria: Unwilling to give written informed consent Failed statin treatment in the past Switched from another statin to atorvastatin because of co-pay program Participated in an earlier Market Research study on Impact of cholesterol management behaviors post in-clinic adherence intervention

Ages Eligible for Study
-----------------
Minimum Age: 21 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 |
| --- | --- |
| Control<br> | Behavioral: No Patient Counseling<br>* Patients do not receive any adherence counseling, or other patient support services<br>|
| Intervention Arm<br> | Behavioral: Adherence Counseling<br>* Patients receive 3-5 minutes of adherence counseling, and other patient support services<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Proportion of Days Covered (PDC) |  | 180 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Medication Possession Ratio (MPR) |  | 180 days | 
| Persistence-the number of continuous days a patient is supplied with medication using the allowable grace period or gap (30 or 60 days). |  | 180 days | 
| Percent of patients that are at least 80% adherent (PDC>0.8) |  | 180 days | 
| Percent of patients who fill at least one atorvastatin prescription during the period of study |  | 180 days | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Integrated program on adherence using counseling, support services including cost-sharing where appropriate and educational materials mailed monthly.
Stimulation Therapy for Apnea: Reporting Thoughts

Study Overview
=================
Brief Summary
-----------------
Upper airway stimulation (UAS) via unilateral implantation of a phasic hypoglossal nerve stimulation device is a safe and effective alternative treatment for patients with moderate to severe obstructive sleep apnea (OSA) who are unwilling or unable to adhere to positive airway pressure (PAP) therapy. Although adherence to UAS is higher than to PAP, there remain patients who are not using UAS consistently. The aim of this project is to explore critical factors in the use of UAS by OSA patients using qualitative research methods (personal interviews). The proposed study will provide crucial information about patients' concerns regarding UAS use and suggestions for how to support new UAS recipients.

Official Title
-----------------
Stimulation Therapy for Apnea: Reporting Thoughts

Conditions
-----------------
Obstructive Sleep Apnea

Intervention / Treatment
-----------------
* Device: Upper airway stimulation (Inspire Medical Systems, Inc.)


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: 18 years of age and older ADHERE registry patient Received UAS implant from June 2017 to present Exclusion Criteria: Patients without up to date contact information

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

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

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Exposure<br>Patients with moderate to severe OSA treated with UAS (Inspire Medical Systems, Inc) | Device: Upper airway stimulation (Inspire Medical Systems, Inc.)<br>* phasic hypoglossal nerve stimulation device<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Experiences with UAS therapy | individual qualitative interview via telephone | up to 4 years | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
obstructive sleep apnea, upper airway stimulation therapy
Long-term Benefits of CPAP or MAD Treatment on the Sleep of OSAS Patients

Study Overview
=================
Brief Summary
-----------------
The REMAP study aims to follow a cohort of 400 patients in around ten sleep centers in France and to collect clinical routine data. The objectives of this study are to investigate the effects of one-year management of OSA by CPAP or MAD on sleep architecture defined by objective macro and micro sleep architecture parameters using a sleep test device. sleep connected at home, to assess the quality of sleep and the quality of life reported by patients. The study will also allow us to define predictive factors for improving sleep quality during OSA treatment.

Official Title
-----------------
Long-term Benefits of Continuous Positive Pressure Therapy or Mandibular Advancement Devise on the Sleep of Patients With Obstructive Sleep Apnea

Conditions
-----------------
OSA

Intervention / Treatment
-----------------
* Device: CPAP
* Device: MAD


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patient already included in the SunSAS study (No. ID/RCB: 2021-A01827-34) Patient with a sleep test performed with the Sunrise device Men or Women from 18 to 80 years old Patient with OSAS eligible for CPAP or MAD therapy Affiliated patient or beneficiary of a social security scheme Signed informed consent Exclusion Criteria: Patient previously treated for OSAS by CPAP or MAD Patient with COPD or other respiratory diseases. Patient with contraindications to PPC or MAD therapy Patient with unstable heart disease or New York Heart Association class III or IV heart failure Patient unable to complete the study

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Patient treated with CPAP<br> | Device: CPAP<br>* Fixed-pressure CPAP device for the treatment of sleep apnea with optional humidification and heated circuit. This device is a Class II device. It has a remote monitoring function allowing service providers to track the use of the device.<br>|
| Patient treated with MAD<br> | Device: MAD<br>* mandibular device orthosis made to measure from the dental impressions of patients, made by the specialist in the masticatory apparatus for the treatment of sleep apnea.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To determine the evolution of deep slow-wave sleep at one year in OSA patients according to the treatment initiated by continuous positive pressure or mandibular advancement device (MAD). | Objective evolution of deep slow-wave sleep time. Changes collected with a home-connected sleep testing device by comparing data from the initial visit (diagnosis) with data collected at 12 months (± 2 weeks) in a patient treated with CPAP or MAD. | 12 months |
Evaluation of the Efficacy of Hippotherapy for Children With Developmental Disorders

Study Overview
=================
Brief Summary
-----------------
Hippotherapy is every program of horseback riding meant to treat people with physiological, mental, social, cognitive or behavioral problems. The purpose of the current research is to evaluate the efficacy of hippotherapy for children with developmental disabilities. The hypothesis is that children with developmental disabilities who are treated with hippotherapy will show better outcomes than children with the same problems who are not treated with hippotherapy.

Detailed Description
-----------------
Hippotherapy is every program of horseback riding meant to treat people with physiological, mental, social, cognitive or behavioral problems. Most studies that tested hippotherapy were uncontrolled and focused on motor problems, such as cerebral palsy. Today, hippotherapy is used for various developmental problems such as Attention deficit / Hyperactivity disorder (ADHD) and Autism spectrum disorder (ASD), without clear information about its efficacy for these populations. The purpose of the current research is to evaluate the efficacy of 6 months of hippotherapy for children with developmental disabilities. The hypothesis is that children with developmental disabilities who are treated with hippotherapy for 6 months will show better outcomes than children with the same problems who are not treated with hippotherapy. Assessment: BRIEF questionnaire Stony Brook Questionnaire All questionnaires will be applied at the beginning of the study and after 6 months.

Official Title
-----------------
Evaluation of the Efficacy of Hippotherapy for Children With Developmental Disorders

Conditions
-----------------
Attention Deficit Hyperactivity Disorder, Autism Spectrum Disorder

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Age: 5-17 years. A diagnosis of ADHD or ASD. Exclusion Criteria: None.

Ages Eligible for Study
-----------------
Minimum Age: 5 Years
Maximum Age: 17 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 |
| --- | --- |
| Hippotherapy_ADHD<br>10 children with ADHD who receive hippotherapy | |
| Hippotherapy_ASD<br>10 children with ASD who receive hippotherapy | |
| Control_ADHD<br>10 children with ADHD who DO NOT receive hippotherapy | |
| Control_ASD<br>10 children with ASD who DO NOT receive hippotherapy | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Improving the parameters of autism | Repetitive behaviors Eye contact Communication | Repetitive behaviors | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
ADHD, ASD
Advanced Surface Ablation (ASA) vs Laser-Assisted In Situ Keratomileusis (LASIK)

Study Overview
=================
Brief Summary
-----------------
The purpose of this combined retrospective and prospective chart review analysis is to investigate the safety, efficacy, and predictability obtained via Laser-Assisted In Situ Keratomileusis (LASIK) and Advanced Surface Ablation (ASA) over a wide range of refractive errors The working hypothesis is that there will be no difference in clinical outcomes between patients treated with LASIK or ASA.

Detailed Description
-----------------
Excimer laser vision correction (LVC) is a widely used procedure to correct nearsightedness, farsightedness, and astigmatism by reshaping the surface of the eye (cornea). Laser-Assisted In Situ Keratomileusis (LASIK) and Advanced Surface Ablation (ASA) and are techniques currently used to prepare the cornea for Excimer LVC. This review is intended to study whether LASIK is equal in visual outcome (null hypothesis), more effective (alternate hypothesis 1) or less effective (alternate hypothesis 2) than ASA in clinical outcome up to one year.

Official Title
-----------------
A Combined Retrospective and Prospective Chart Review Analysis of Visual Outcomes Following Excimer Laser Vision Correction

Conditions
-----------------
Nearsightedness, Farsightedness, Astigmatism

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Eyes that were treated for LASIK or ASA Excimer laser vision correction before December 1st 2006 and newly recruited eyes that qualify for LASIK or ASA Excimer laser vision correction may be enrolled in this study. Exclusion Criteria: There are no exclusion criteria; all patients that went forward with Excimer laser vision correction may be included.
Sexes Eligible for Study
-----------------
All

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| ASA<br>Participants treated for Excimer laser vision correction using Advanced Surface Ablation (ASA). | |
| LASIK<br>Participants treated for Excimer laser vision correction using Laser-Assisted In Situ Keratomileusis (LASIK) | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Visual Acuity |  | 1 day, 1W, 1M, 3M, 6M, 9M, 12M |