linjc16/ctgov huggingface dataset:
Values of the Immune Activation Markers CD38 and HLA-DR and the Ratio CD4/CD8 According to the Delay of Combined AntiRetroviral Therapy (c-ART) Initiation in Primary HIV-infected Patients (PRIMIMMUNO)

Study Overview
=================
Brief Summary
-----------------
The objective was to identify factors associated with the normalization of the CD4/CD8 ratio (>=1) in patients with a history of primary HIV infection (PHI) and long-term combined antiretroviral therapy (cART).

Official Title
-----------------
Values of the Immune Activation Markers CD38 and HLA-DR and the Ratio CD4/CD8 According to the Delay of Combined AntiRetroviral Therapy (c-ART) Initiation in Primary HIV-infected Patients (PRIMIMMUNO)

Conditions
-----------------
HIV-infected Patients

Intervention / Treatment
-----------------
* Biological: lymphocytes immunophenotyping


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: all HIV patients with a known history of PHI and a minimum of 2 years of effective cART (< 200 copies/mL) without interruption or virological failure Exclusion Criteria: Patients with hepatitis C or B virus co-infection or with a history of neoplasia or immunosuppressive therapy after the date of PIH

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 |
| --- | --- |
| Primary HIV- Infected patients<br>Primary HIV- Infected patients with a minimum of 2 years of effective cART. | Biological: lymphocytes immunophenotyping<br>* The lymphocytes immunophenotyping were performed from fresh EDTA-anticoagulated blood harvested during a routine follow-up of patients in HIV Lyon centers. HIV patients with a known history of PHI and a minimum of 2 years of effective cART (< 200 copies/mL) without interruption or virological failure were included in 2 centers in Lyon (Croix-Rousse and Edouard Herriot hospital). Baseline factors at the time of PHI, delay, type and duration of first and duration of total cART, CMV status, nadir CD4 cells count and level of activation markers on CD4 and CD8 cells (CD38 and HLA-DR) at the time of the study were assessed. Patients with hepatitis C or B virus co-infection or with a history of neoplasia or immunosuppressive therapy after the date of PIH were excluded.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| percentage of CD4+ and CD8+ T lymphocytes with activation markers (CD38 + and HLA-DR) | percentage of CD4+ and CD8+ T lymphocytes with activation markers (CD38 + and HLA-DR) according to the delay of cART initiation (early 3 months or delayed > 3 months). | Day 0 | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
HIV-infected patients, cART, immune restoration, markers
Study on the Difference of Axilo-rectal Temperature in Appendicitis

Study Overview
=================
Brief Summary
-----------------
The investigators are studying prospectively the difference in axilo-rectal temperature in patients with acute appendicitis and using as a control group patients consulting with acute gastroenteritis at our emergency unit.

Official Title
-----------------
Prospective Study on the Difference of Axilar-rectal Temperature in Acute Appendicitis

Conditions
-----------------
Appendicitis, Gastroenteritis

Intervention / Treatment
-----------------
* Other: Observation and measurement of axilo-rectal temperature


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients with acute appendicitis Patients with acute gastroenteritis Patients older than 15 years of age Exclusion Criteria: Other acute abdominal diseases

Ages Eligible for Study
-----------------
Minimum Age: 15 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 |
| --- | --- |
| Group I<br>Patients with acute appendicitis | Other: Observation and measurement of axilo-rectal temperature<br>* Measurement of axilo-rectal temperature<br>|
| Group II<br>Patients with acute gastroenteritis | Other: Observation and measurement of axilo-rectal temperature<br>* Measurement of axilo-rectal temperature<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The real difference in axilo-rectal temperature in patients with acute appendicitis |  | 6 hours | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The differences in axilo-rectal temperature between patients with acute appendicitis and acute gastroenteritis |  | 6 hours | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
appendicitis, gastroenteritis, temperature, fever, acute abdomen, Axilo-rectal temperature in appendicitis, Axilo-rectal temperature in gastroenteritis
Effectiveness of Intravenous Tranexamic Acid in Reducing Blood Loss During and After Cesarean Section

Study Overview
=================
Brief Summary
-----------------
In this study, the efficacy and safety of tranexamic acid in the reducing the blood loss during and after elective LSCS will be investigated.

Detailed Description
-----------------
To state the effectiveness clinically and laboratory and safety of tranexamic acid in reducing blood loss during and after the elective lower segment cesarean section.

Official Title
-----------------
Effectiveness of Intravenous Tranexamic Acid in Reducing Blood Loss During and After Cesarean Section ,A Randomized Clinical Trial .

Conditions
-----------------
Bleeding

Intervention / Treatment
-----------------
* Drug: Tranexamic Acid


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: - Women undergoing caesarean delivery for various elective indications. Full term primiparas / multiparas. Singleton pregnancy being delivered by LSCS. Exclusion Criteria: - Medical problems involving the heart, liver, kidney and brain . Blood disorders. Allergy to tranexamic acid. History of thromboembolic disorders, abnormal placentation, severe pre-eclampsia, uterine anomalies and pathology. Multiple pregnancy, macrosomia. Polyhydromnios . Patients requiring blood transfusion due to anemia

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 40 Years

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

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

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

Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: group A<br>receiving tranexamic acid | Drug: Tranexamic Acid<br>* Intravenous Injection<br>* Other names: in 200 ml saline;|
| No Intervention: group B<br>does not receive tranexamic acid | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Amount of blood loss during cesarean section after placental delivery till end of the operation. |  | during and 2hours post cesarean section | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 1.Vital signs eg:blood pressure ,heart rate ,respiratory rate during first two post operative hours . | composite | up to 24hours postoperative | 
| Adverse affect of tranexamic acid on mother and neonate . | eg:drug allergy ,drug interaction ,thrombotic manifestation and the number of participant . | first 24 hours | 
| 24 hours post operative haemoglobin and haematocrit . | composite | after 24 hours. |
Trial to Examine Text-message Based mHealth in Emergency Department Patients With Diabetes

Study Overview
=================
Brief Summary
-----------------
The investigators propose an innovative, ED-based mHealth intervention: TExT-MED (Trial to Examine Text-Based mHealth for Emergency department patients with Diabetes). TExT-MED is a technologically simple solution using unidirectional daily text messages to consisting of educational materials, trivia questions and challenges promoting healthy lifestyle choices and reminders to check blood sugar, take medications and go to clinic appointments. The investigators believe TExT-MED will improve health outcomes including blood glucose control and encourage weight loss, healthy eating and exercise. TExT-MED is low cost, easy to use and can be quickly adapted to other practice environments.

Official Title
-----------------
Trial to Examine Text-message Based mHealth in Emergency Department Patients With Diabetes

Conditions
-----------------
Diabetes

Intervention / Treatment
-----------------
* Other: Daily text messages


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: 1) ≥18 years old 2) have Type 2 diabetes 3) have a text message capable mobile phone 4) know how to receive text messages 5) speak and read English or Spanish and 6) have a HbA1C ≥8%. Exclusion Criteria: 1) overt psychosis 2) unable to provide informed consent and 3) pregnancy.

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: Health Services Research
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Text messages<br>Patients randomized to this arm will receive daily text messages to their mobile phones consisting of educational materials, motivational materials, trivia questions, and challenges to engage in healthy lifestyle choices | Other: Daily text messages<br>* 2-3 times daily text messages regarding diabetes care and healthy lifestyle choices<br>|
| No Intervention: Control<br> | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Hemoglobin A1C at 6 months |  | 6 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| DIet/ Weight Loss |  | 6 months | 
| Diabetes self-efficacy/empowerment |  | 6 months | 
| Diabetes knowledge |  | 6 months |
Characteristic of Drug Users Chronic Wound

Study Overview
=================
Brief Summary
-----------------
The aim of this study is to describe demographic, clinical, etiological characteristic and evolution of drug addict's chronic wounds .

Official Title
-----------------
Characteristic of Drug Users Chronic Wound

Conditions
-----------------
Wound, Drug Use

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: all drug addict with chronic wound ( evolving at least since 1 month) Exclusion Criteria: use following medication inductor of cutaneous ulcer: hydroxycarbamide, gefitinib, cetuximab, sunitinib, sorafenib, pazopanib, gemcitabine, sirolimus, methotrexate, nicorandil .
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 |
| --- | --- | --- |
| clinical venous insufficiency - presence of oedema | presence of oedema | at inclusion | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| clinical venous insufficiency - presence of varicose | presence of varicose | at inclusion | 
| clinical venous insufficiency - presence of white atrophy | presence of white atrophy | at inclusion | 
| clinical venous insufficiency - presence of varicose eczema | presence of varicose eczema | at inclusion |
Evaluation of the BodyGuardian End-to-end Remote Monitoring Platform in an Outpatient Heart Failure Population

Study Overview
=================
Brief Summary
-----------------
We will evaluate the end to end remote monitoring system in a less controlled environment and concurrently develop the infrastructure to support the back end of the system

Detailed Description
-----------------
The overall objective of our research is to test, adapt, refine and validate the BodyGuardian technology and related end-to-end remote monitoring system to be used outside usual medical care environments to reduce hospital readmissions and facilitate independent living for heart failure patients. An important component of our overall strategy for continued development and refinement of the remote monitoring system is the incorporation of iterative behavioral evaluations to facilitate assessment and refinement in order to optimize adherence, utilization, and usability for patients as well as efficiency and functionality for providers.

Official Title
-----------------
Evaluation of the BodyGuardian End-to-end Remote Monitoring Platform in an Outpatient Heart Failure Population

Conditions
-----------------
Congestive Heart Failure

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Outpatients Stable New York Heart Association Class I-III HF (defined as no admissions for > 1 year) Recruited from the Mayo Heart Failure Clinic, including 15 men and 15 women Age > 50 years Reside in Olmsted County Exclusion Criteria: Hospital admission for HF within past year Dementia Overall life expectancy < 2 months Blindness Pregnancy or women able to become pregnant Skin allergy to adhesives Inadequate cell phone coverage (international patients or international travel during study period) Documented Ejection Fraction of >40%

Ages Eligible for Study
-----------------
Minimum Age: 50 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 |
| --- | --- | --- |
| adherence and utilization of end-to-end system in 30 subjects with stable New York Heart Association class I-III Heart Failure for 2 weeks | To evaluate subject adherence, data transfer, clinical utilization and work-flow as well as perceptions and experiences of HF outpatients (n=30) and providers of the end-to-end remote monitoring system. | 12 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| effect of end-to-end system on life quality | Evaluation of end-to-end remote monitoring system in a less controlled environment by evaluating ease of use and clinical management. | 12 months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Congestive Heart Failure
An Observational Study of Avastin (Bevacizumab) in Patients With Glioblastoma Multiforme in First or Second Relapse

Study Overview
=================
Brief Summary
-----------------
This single-arm, open-label, multicenter, observational study will evaluate the efficacy and safety of Avastin (bevacizumab) in patients with glioblastoma multiforme in first or second relapse. Data will be collected from eligible patients initiated on Avastin treatment according to local label for up to 3 years.

Official Title
-----------------
A Single-arm, Open-label, Multicenter, Non-interventional Study to Assess Bevacizumab (Avastin) in Relapsed Glioblastoma

Conditions
-----------------
Glioblastoma Multiforme

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Adults patients, >/= 18 years of age Histologically confirmed glioblastoma multiforme in first or second relapse Exclusion Criteria: Patients not qualifying for Avastin treatment as per local label

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 |
| --- | --- |
| Cohort<br> | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Progression-free survival at 6 months |  | approximately 3 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Progression-free survival |  | approximately 3 years | 
| Time to disease progression |  | approximately 3 years | 
| Duration of objective response |  | approximately 3 years | 
| Overall survival |  | approximately 3 years | 
| Safety: Incidence of adverse events |  | approximately 3 years |
Effect of BGG492 on EEG in Patients With Photosensitive Epilepsy

Study Overview
=================
Brief Summary
-----------------
This study will evaluate the efficacy of BGG492 in reducing the sensitivity to flashing lights of patients with photosensitive epilepsy, using EEG as a readout.

Official Title
-----------------
A Multicenter, Single-blind, Within-subject, Placebo-controlled Proof of Concept Study to Assess the Effect of Single Oral Doses of BGG492 on the Photoparoxysmal EEG Response in Patients With Photosensitive Epilepsy

Conditions
-----------------
Photosensitive Epilepsy

Intervention / Treatment
-----------------
* Drug: BGG492
* Drug: BGG492
* Drug: Placebo


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: diagnosis of photosensitive epilepsy Exclusion Criteria: - inconsistent photoparoxysmal response when stimulated by photic stimulation Other protocol-defined inclusion/exclusion criteria may apply.

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 65 Years

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

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

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

Design Details

Primary Purpose: Treatment
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Cohort 1<br> | Drug: BGG492<br> <br> |
| Experimental: Cohort II<br> | Drug: BGG492<br> <br> |
| Experimental: Cohort III<br> | Drug: Placebo<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Outcome Measure: Photoparoxysmal response (PPR) and standardized photoparoxysmal response (SPR) determined by EEG on all treatment days. |  | Days 1, 2 and 3 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Outcome Measure: Safety and tolerability of BGG492 in patients with photosensitive epilepsy |  | From Day 1 until Day 33 after treatment start. | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Photosensitive Epilepsy, photic stimulation, electroencephalogram
A Study to Investigate the Safety and Efficacy of Replenine®-VF in Haemophilia B Patients Undergoing Major Surgery.

Study Overview
=================
Brief Summary
-----------------
The main objective of the study is to investigate the safety and efficacy of Replenine®-VF administered by continuous infusion in appropriate dosage to prevent bleeding and achieve haemostasis in patients with haemophilia B undergoing major surgery.

Official Title
-----------------
An Open Study to Investigate the Safety and Efficacy of Replenine®-VF by Continuous Infusion in Haemophilia B Patients Undergoing Major Surgery.

Conditions
-----------------
Haemophilia B

Intervention / Treatment
-----------------
* Biological: Replenine®-VF (High Purity Factor IX)


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients with moderate to severe Haemophilia B (≤5% baseline Factor IX level) due to undergo major surgery, previously treated patients, at least 16 years of age without inhibitors, currently receiving Factor IX concentrate. Exclusion Criteria: -

Ages Eligible for Study
-----------------
Minimum Age: 16 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 |
| --- | --- |
| Experimental: Replenine®-VF<br> | Biological: Replenine®-VF (High Purity Factor IX)<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Assessment of control of prevention of bleeding | Investigator's assessment as excellent, good, moderate or none. | End of study (Day 5 to Day 10) |