linjc16/ctgov huggingface dataset:
Better Weight-Better Sleep (BWBS) Trial

Study Overview
=================
Brief Summary
-----------------
The hypothesis of this study is that overweight and obese patients exposed to sleep focused counseling and standard dietary and exercise counseling will have better outcomes than similar patients exposed to standard dietary and exercise counseling only.

Detailed Description
-----------------
Objective: To explore the feasibility of integrating sleep management interventions with dietary and exercise interventions for obesity in a 12-week randomized trial. Methods: We randomized 49 overweight or obese adult patients either to a better weight (BW) cognitive behavioral intervention, or to a combination of the BW intervention and a better sleep intervention, better weight-better sleep (BWBS). Results: The BWBS group lost weight faster (P=.04), and coping self-efficacy accelerated (P=.01). Conclusions: These preliminary results merit replication in a larger primary care-based trial with a longer continuous intervention and followup period. Key words: obesity, sleep, weight loss, primary care, health behavior E Logue et al. Am J Health Behav. 2012;36(3):319-334 DOI: http://dx.doi.org/10.5993/AJHB.36.3.4

Official Title
-----------------
The Better Weight-Better Sleep Study: A Pilot Intervention in Primary Care

Conditions
-----------------
Overweight, Obesity

Intervention / Treatment
-----------------
* Behavioral: Better Weight
* Behavioral: Better Weight & Better Sleep


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: BMI 25 to 39.9 ages 18 to 84 PCP permission patient in Family Medicine Center with an encounter in the last six months Exclusion Criteria: various obesity and sleep related disorders

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 84 Years

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

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

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

Design Details

Primary Purpose: Health Services Research
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: 1<br> | Behavioral: Better Weight<br>* Standard cognitive behavioral treatment focused on dietary & exercise behavior<br>|
| Experimental: 2<br> | Behavioral: Better Weight & Better Sleep<br>* Standard CBT to support dietary and exercise change plus sleep hygiene and sleep focused CBT<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| percent baseline weight lost |  | 16 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| feasibility, variance-covariance estimates |  | 16 weeks | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
obesity, primary care
Controlling And Lowering Blood Pressure With the MobiusHDTM Device

Study Overview
=================
Brief Summary
-----------------
To evaluate the safety and performance of the MobiusHD system in subjects with resistant hypertension.

Detailed Description
-----------------
This is a prospective, randomized, double-blind, sham-controlled, multi-center post market study investigating the efficacy and safety of MobiusHD System, and the efficacy of the MobiusHD device in lowering mean systolic 24-hour ABP in subjects with resistant hypertension.

Official Title
-----------------
CALM-START - Controlling And Lowering Blood Pressure With the MobiusHDTM Device: STudying Effects in A Randomized Trial

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

Intervention / Treatment
-----------------
* Device: MobiusHD
* Other: Sham Implantation


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Aged 18-70 years; Diagnosed with resistant hypertension; A mean systolic 24-hour ABP of 135-170 mmHg following at least 30 days on a stable antihypertensive medication regimen (no changes in medications or dose). A mean systolic 24-hour ABP of 135-170 mmHg after washout of all antihypertensive medications. Exclusion Criteria: Known or clinically suspected baroreflex failure or autonomic neuropathy Treatable cause of resistant hypertension Hypertension secondary to an identifiable and treatable cause other than sleep apnea

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

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: MobiusHD Implantation<br> | Device: MobiusHD<br>* The MobiusHD device is a self-expanding nitinol implant that is delivered intravascularly to the internal carotid sinus via the delivery catheter.<br>|
| Sham Comparator: Sham Implantation<br>Sham | Other: Sham Implantation<br>* Sham Implantation<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The change in mean systolic 24-hour ABP from baseline to 90 days post-randomization, between the treatment arm and the sham arm. | Reduction in mean systolic 24-hour ABP | From Baseline to 90 days post-randomization | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Major adverse clinical events, including death, stroke, carotid interventions, and myocardial infarction, from baseline to 30 days post-randomization, between the treatment arm and the sham arm. | Adverse Events | From Baseline to 30 days post-randomization |
Role of T Follicular Helper Cells in Autoimmune Hemolytic Anemia (TFH in AIHA)

Study Overview
=================
Brief Summary
-----------------
T follicular helper (TFH) cells represent a T cell subset dedicated to the activation of B cells. They have been involved in the pathogenesis of autoimmune diseases in humans such as lupus and Sjögren disease. We recently showed that TFH are implicated in the activation of autoreactive B lymphocytes during ITP. Autoimmune hemolytic anemia (AIHA) is an autoimmune disease due to antibodies targeting red blood cells. To date, the role of TFH in the pathogenesis of AIHA is not known. We hypothesize that AIHA is associated with an increase in the number and/or function of TFH, that could participate in the activation of autoreactive B lymphocytes.

Official Title
-----------------
Role of T Follicular Helper Cells in Autoimmune Hemolytic Anemia (TFH in AIHA)

Conditions
-----------------
Autoimmune Hemolytic Anemia

Intervention / Treatment
-----------------
* Biological: blood sample
* Procedure: spleen sample


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients with a diagnosis of warm AIHA defined by Hemoglobin <11 g/dl Low haptoglobin level Positive direct antiglobulin test (IgG or IgG + complement) Reticulocyte count >120 G/L Patients naive to treatment for hemolytic anemia or a in relapse Older than 18 years Able to understand written and spoken French Persons who have provided written consent Control population Patients who have given consent Patients over 18 years Patients with cold agglutinin disease (progressive AIHA and different treatments of warm autoantibody AIHA) can be included as a sub-group of controls Patients with non-auto-immune hemolytic anemia (constitutional of enzymatic origin, membrane-related,…) can be included as a sub-group of controls Exclusion Criteria: Patients without national health insurance Pregnancy or breast-feeding women Adults under guardianship Patients with cancer or malignant hemopathy Patients with an on-going infection Patients treated with corticoids or immunosuppressants

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| patient<br> | Biological: blood sample<br> <br> Procedure: spleen sample<br> <br> |
| control<br> | Biological: blood sample<br> <br> Procedure: spleen sample<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| the proportion of circulating T follicular helper lymphocytes (TFH) in patients with Autoimmune Hemolytic Anemia (AIHA) and in control subjects. |  | baseline | 
| the proportion of circulating TFH in patients with Autoimmune Hemolytic Anemia (AIHA), at diagnosis and after 3 months of treatment with steroids |  | through study completion, an average of 1 year |
Safety and Efficacy Study of DuoTrav APS Versus DuoTrav

Study Overview
=================
Brief Summary
-----------------
The purpose of the study is to demonstrate that the IOP-lowering efficacy of DuoTrav APS, dosed once-daily in the morning, is non-inferior to that of DuoTrav, dosed once-daily in the morning.

Conditions
-----------------
Open-angle Glaucoma, Ocular Hypertension

Intervention / Treatment
-----------------
* Drug: DuoTrav APS
* Drug: DuoTrav


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients with open-angle glaucoma or ocular hypertension who would benefit from a fixed combination medication, in the opinion of the investigator and who are currently on a stable treatment of IOP-lowering medication Exclusion Criteria: VA not worse than 0.60 additional clinically relevant ocular or systemic conditions may be excluded

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

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: DuoTrav APS<br>DuoTrav APS QD AM | Drug: DuoTrav APS<br>* DuoTrav APS QD AM<br>|
| Active Comparator: DuoTrav<br>DuoTrav QD AM | Drug: DuoTrav<br>* DuoTrav QD AM<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Mean Intraocular Pressure (IOP) |  | 3 Months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
open-angle glaucoma, ocular hypertension, open-angle glaucoma (with or without pseudoexfoliation or pigment dispersion component)
The Effect of COVID-19 Pandemia on Follow up of Patients With Chronic Kidney Disease

Study Overview
=================
Brief Summary
-----------------
COVID-19 pandemic affected the admission of patients to the hospital especially the older patients (> 65 years old) because of curfews and the reluctance of patients to apply to the hospitals. Chronic kidney disease is characterized with the progressive loss of kidney function over the time and regular follow-up of patients for their kidney function and treatment of complications is recommended in these patients.

Detailed Description
-----------------
The chronis kidney disease patients followed in Nephrology outpatient unit are going to be enrolled in the study and their kidney functions (calculated with the mdrd formula to asses the estimated glomerular filtration rate (eGFR)) will be evaluated 6 months before and after the COVID-19 pandemia. And the rate of initiation of renal replacement therapies and the change in proteinuria will be evaluated 6 months before and after the COVID-19 pandemic.

Official Title
-----------------
The Effect of COVID-19 Pandemia on Follow up of Patients With Chronic Kidney Disease

Conditions
-----------------
Covid19, Chronic Kidney Diseases, Proteinuria

Intervention / Treatment
-----------------
* Other: change in kidney function and proteinuria


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: patients with chronic kidney disease on regular follow-up for 6 months before the COVID19 pandemic. Exclusion Criteria: patients without chronic kidney disease patients not on routine follow-up for 6 months before the COVID19 pandemic

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 85 Years

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

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

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

Arms and Interventions

| Intervention/Treatment |
| --- |
|Other: change in kidney function and proteinuria|change in eGFR nad proteinuria in patients with chronic kidney disease|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| eGFR change | a rise or decrease in eGFR | 6 months | 
| change in proteinuria | increase or decrease in ptoteinuria levels | 6 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| initiation of renal replacement therapies | need for hemodialysis or peritoneal dialysis | 6 months |
Linkage to Care - Part I

Study Overview
=================
Brief Summary
-----------------
This first phase of a two-phase study involves three components: Review of existing linkage-to-care protocols and sources of referrals for care; Semi-structured telephone or face-to-face interviews with a minimum of two personnel per site who are associated with linkage to medical care. (Preference will be given to personnel with direct experience in linkage to care); and Structured observations of referral sessions.

Official Title
-----------------
HIV-Related Care Engagement: Linkage to Care and Care-Seeking for HIV-Infected Adolescents, Phase I

Conditions
-----------------
HIV

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Component 1: Documents identified by clinical site personnel as pertaining to post-test counseling, linkage to care, or standard operating procedures addressing post-test counseling and linkage to care. Component 2: Persons employed by one of the AMTUs or an identified linkage-to-care partner and work as clinical staff or a case-manager or is a person familiar to linkage to care; or persons involved in posttest counseling and linkage-to-care processes. Clinical staff and case managers are chosen based on direct experience in the assistance of HIV seropositive youth obtaining medical care. This definition includes, but is not limited to, physicians, nurses, psychologists, social workers, and case managers (who may have diverse professional backgrounds). Component 3: All AMTU sites will be included. Exclusion Criteria: Component 1: No a priori exclusions. Component 2: No a priori exclusions. Component 3: No a priori exclusions.
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 |
| --- | --- |
| Component 1<br>Existing linkage to care protocols will be obtained from the 15 sites. This component does not involve study subjects. | |
| Component 2<br>Person-to-person or telephone interviews with ATN clinical site staff and staff from their community partners will be audio-taped. | |
| Component 3<br>Notes from direct observation of the linkage to medical care process within sites will be taken. | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Describe and evaluate community screening standards and practices. |  | 1 year | 
| Describe and evaluate the relationships of screening venues with care-providing venues. |  | 1 year | 
| Describe and evaluate referral and intake protocols. |  | 1 year | 
| Describe and evaluate care adherence support (including support from both clinical and non-clinical sources). |  | 1 year | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Care engagement, Linkage to care, HIV Infections
A Prospective Study of Application of Platelet Mapping in HBV-related Acute-on-chronic-liver Failure in China

Study Overview
=================
Brief Summary
-----------------
Ineffective hemostasis or a paradoxical prothrombotic state of Acute-on-chronic liver disease (ACLF) has been well established. Thrombelastography measures the dynamics of thrombin production and provides a global assessment of coagulation incorporating the cumulative effect of the interactions at various levels between plasma components and cellular component of coagulation. And through the platelet mapping, it can help provide a picture of patients' function of platelet. This study aims to explore the predictive role of platelet mapping in ACLF prognosis, organ failure developments and short term mortality.

Official Title
-----------------
A Prospective Study of Application of Platelet Mapping in HBV-related Acute-on-chronic-liver Failure in China

Conditions
-----------------
Thrombelastography,Acute on Chronic Liver Failure, Platelet

Intervention / Treatment
-----------------
* Other: standard treatment


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: patient with previously diagnosed or undiagnosed HBV related chronic liver disease/cirrhosis INR≥1.5 and total bilirubin≥85μmol/L Exclusion Criteria: INR≤1.5 or total bilirubin≤85μmol/L; underlying chronic liver disease was other than chronic HBV infection related; those who had hepatocellular carcinoma or other types of malignancies; obstructive biliary diseases or other disease lead to bilirubin evaluation; those who had acute hemorrhage one week before admission those who received platelet, cryo transfusion or plasmapheresis one week before admission using steroid or immunosuppressant or antiplatelet or anticoagulant drugs in 4 weeks any kind of decompensation which persisted over a month pregnancy and breastfeeding those who received liver transplantation or kidney transplantation; combine with other disease lead to organ failure including heart failure (NYHA IV),respiratory failure（PaO2<60mmHg),renal insufficiency(CKD 5) and conscious disturbance (GCS<8) readmission; death within 24 hours.

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

| Intervention/Treatment |
| --- |
|Other: standard treatment|standard medical treatment|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 28-day mortality | death within 28-day | 28-day | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 28-day progression | progressed to EASL defined ACLF | 28-day | 
| 90-day mortality | death within 90-day | 90-day | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Thrombelastography,acute on chronic liver failure, platelet
Epidural Sonoanatomy Between Parturient and Non-Pregnant

Study Overview
=================
Brief Summary
-----------------
The failure in indwelling epidural catheter for a parturient might cause an anesthetic difficulty. Furthermore, no one can predict the accuracy of needle placement prior to skin puncture with any of landmark-based technique. This may result in multiple trying attempts at needle puncture, pain and discomforts of patients and poor patient satisfaction. The aim of this study was to explore the difference of epidural space between parturient and non-pregnant women by assessing ultrasound image.

Detailed Description
-----------------
We will enroll 30 non-pregnant female volunteers and 30 parturients(ASA I-III) underwent epidural blocks. A low frequency ultrasound (2-5 MHz) with a curved array transducer is used to obtain spinal sonography for each subject. The paramedian axis was used to obtain optimal ultrasound image for spinal sonography. Outcome was evaluated by the diameter and depth of epidural space at three lumbar interspaces. Paired T-test was carried out to evaluate the statistical significance of epidual diameter and depth.

Official Title
-----------------
To Compare Epidural Sonoanatomy Between Parturient and Non-Pregnant Young Female in Chinese Population

Conditions
-----------------
Parturients

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: parturients scheduled to receive lumbar epidurals for elective cesaeran delivery labor analgesia Exclusion Criteria: Pregancy induced hypertension gestational Diabetes patients who refuse

Ages Eligible for Study
-----------------
Minimum Age: 25 Years
Maximum Age: 45 Years

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

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| 1: volunteers<br>non-pregnant female | |
| 2: parturients<br>parturients was scheduled to receive lumbar epidurals for elective cesaeran delivery labor analgesia | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
ultrasound image, epidural space