linjc16/ctgov huggingface dataset:
Highly Sensitive Serum Cardiac Troponin T and Cardiovascular Events in Patients With Systemic Lupus Erythematosus

Study Overview
=================
Brief Summary
-----------------
Identification of biological markers able to better stratify cardiovascular risks in systemic lupus erythematosus patients is needed. We aimed to determine whether serum cardiac troponin T levels measured with a highly sensitive assay (HS-cTnT) may predict cardiovascular events in systemic lupus erythematosus.

Detailed Description
-----------------
Cardiac Troponin (cTnT) is a marker of myocyte necrosis and injury in the early phase of acute myocardial infarction. Measured with high-sensitivity (HS) assays, HS-cTnT has proven predictive value for coronary heart disease, heart failure, and mortality in the general population at apparent low-risk for cardiovascular events. In a previous study, our group showed that HS-cTnT concentration was associated with subclinical atherosclerosis in systemic lupus erythematosus patients. The aim of this study was to determine whether HS-cTnT was associated with incident cardiovascular events in systemic lupus erythematosus

Official Title
-----------------
Highly Sensitive Serum Cardiac Troponin T and Cardiovascular Events in Patients With Systemic Lupus Erythematosus

Conditions
-----------------
Systemic Lupus Erythematosus

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patient with a systemic lupus erythematosus Exclusion Criteria: Inadequate follow-up period (< 20 months) -past history of CVE at baseline for inclusion in the TROPOPLUS study
Sexes Eligible for Study
-----------------
All

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Patients with systemic lupus erythematosus<br>Patients with systemic lupus erythematosus enrolled in the PLUS cohort between 2007 and 2010 | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The primary outcome was the occurrence of cardiovascular events over follow-up. | Incidents cardiovascular events (CVE) were ascertained by physician interview using a standardized questionnaire and through examination of medical records. cardiovascular events included coronary heart disease, stroke, revascularization procedure for other atherosclerotic cardiovascular diseases and sudden cardiac death. Coronary heart disease was defined as a history of angina, coronary revascularization, or myocardial infarction. All CVE that occurred through March 2019 were considered for analysis | Up to 10 years | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Systemic lupus erythematosus, Cardiovascular risk, Biomarkers, Troponin T
Hypertension Monitoring in Glioma Patients Treated With Bevacizumab

Study Overview
=================
Brief Summary
-----------------
Prospective casecontrol study in glioma patients undergoing treatment with bevacizumab (Avastin). At present there are no data on the correlation between occurrence of arterial hypertension and clinical outcome in patients with glioma or anaplastic astrocytoma. We will investigate whether glioma patients developing hypertension under bevacizumab treatment have a better outcome in terms of progression free survival, response rate and overall survival than equally treated patients remaining normotensive. Moreover, we will describe the dynamics of change in blood pressure after administration of bevacizumab in those patients developing hypertension. Trial with medicinal product

Official Title
-----------------
Hypertension Monitoring in Glioma Patients Treated With Bevacizumab

Conditions
-----------------
Glioma Patients

Intervention / Treatment
-----------------
* Drug: Bevacizumab


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion criteria: Patients aged 18 or older with histological diagnosis of anaplastic astrocytoma (WHO grade III) or glioma (WHO grade IV) Assigned to bevacizumab treatment (monotherapy or adjunctive to chemotherapy) for therapeutic reasons by an oncologist Patients should be on a stable or decreasing dose of steroids Willingness and ability to comply with the protocol Patient should present with a KPS of >=70 Signed informed consent Exclusion criteria: Previous anti-angiogenic drugs other than bevacizumab Allergy or hypersensitivity against bevacizumab Contraindications to bevacizumab according to the Summary of Product of Characteristics Unwillingness to comply with regular assessments of response and performance of study-related procedures Any condition considered relevant for proper performance of the study or risk to the patients, at the discretion of the investigator

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 |
| --- | --- |
| Glioma Patient receiving Bevacizumab<br>Patients with histological diagnosis of anaplastic astrocytoma (WHO Grad III) or Glioma (WHO Grad IV)assigned to bevacizumab treatment (monotherapy or adjunctive to chemotherapy) for therapeutic reasons | Drug: Bevacizumab<br>* Patients with histological diagnosis of anaplastic astrocytoma (WHO Grad III) or Glioma (WHO Grad IV) assigned to bevacizumab treatment (monotherapy or adjunctive to chemotherapy) for therapeutic reasons<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Incidence of Hypertension |  | Hypertension under treatment |
Detection of Dengue Virus in Plasma of Patients in Nepal

Study Overview
=================
Brief Summary
-----------------
To test whether Karius Infectious Disease Diagnostic Sequencing assay can detect Dengue Virus in plasma from suspected cases of Dengue or Dengue Fever like-illnesses from samples collected as part of a hospital-based multi-site study conducted in Nepal.

Detailed Description
-----------------
Blood samples will be obtained from consented subjects as part of a hospital-based multi-site study conducted in Nepal and will be shipped to Karius, Redwood City, CA. The investigators will test whether the Karius test can detect Dengue Virus in plasma from those suspected cases and measure the performance of the Karius test against standard tests (PCR, ELISA test and neutralization assays) used to determine a final diagnosis of Dengue Fever.

Official Title
-----------------
Pathogen Detection and Host Response in Plasma of Patients With Dengue and Dengue Fever Like Illnesses in Nepal.

Conditions
-----------------
Dengue Fever

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: 18 years and older, suspected of having Dengue or Dengue Fever-like illnesses. Exclusion Criteria: Inability to understand instructions and comply with study-related procedures, inability to understand and/or sign informed consent, any condition that will prevent the subject from completing the study.

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

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

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

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Sensitivity and Specificity of the Karius Test in detecting the Dengue Virus in plasma. | Test the sensitivity and specificity of the Karius Infectious Disease Diagnostic Sequencing Assay in detecting the Dengue Virus in plasma (measured in molecules per mL) from suspected cases of Dengue Virus from a hospital-based multicentered study conducted in Nepal. | 3 years | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
NGS, Sequencing
Treatment of Chronic Critical Limb Ischemia With G-CSF-mobilized Autologous Peripheral Blood Mononuclear Cells

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to determine the safety and efficacy of G-CSF-mobilized autologous peripheral blood mononuclear cell injection to ischemic limbs of patients with critical limb ischemia.

Official Title
-----------------
Pilot Study of Treatment of Chronic Critical Limb Ischemia With G-CSF-mobilized Autologous Peripheral Blood Mononuclear Cells

Conditions
-----------------
Critical Limb Ischemia, Atherosclerosis, Ischemic Ulcer, Gangrene

Intervention / Treatment
-----------------
* Biological: Peripheral blood mononuclear cell


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients with critical limb ischemia confirmed by toe pressure, ABI, TCOM Levels of arterial occlusion are femoropopliteal or tibioperoneal occlusion Poor distal artery runoff Age 18-70 year Exclusion Criteria: Planned for major amputation within 4 weeks Receive blood component within 4 weeks Acute myocardial infarction severe valvular heart disease renal failure liver failure Cancer Hypercoagulable state Severe infection Pregnancy

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: peripheral blood mononuclear cells<br>peripheral blood mononuclear cells will be injected to calf muscle of critical limb ischemia | Biological: Peripheral blood mononuclear cell<br>* Peripheral blood mononuclear cell solution 59 cc will be injected to the gastrocnemius muscle of ischemic limb of patients with critical limb ischemia<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of patients without major amputation after mononuclear cell injection |  | 3 month | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
critical limb ischemia, atherosclerosis, ischemic ulcer, rest pain, gangrene
Osteoarthritis Relationships and Tobacco  Ancillary Study Khoala 

Study Overview
=================
Brief Summary
-----------------
The role of tobacco in osteoarthritis remains controversial. The Khoala cohort is the first multicenter French cohort of subjects with knee and / or hip osteoarthritis prevalent . It guarantees its methodology great representativeness and therefore an interesting material for the study of risk factors in the population. In addition, it should have little here Radiographs of hands for all its patients. It therefore has the opportunity to study a possible relationship between tobacco and hip osteoarthritis , knee and hand but also to study the relationship between tobacco and structural evolution of hip osteoarthritis and / or symptomatic knee.

Official Title
-----------------
Osteoarthritis Relationships and Tobacco  Ancillary Study Khoala 

Conditions
-----------------
Osteoarthrosis

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Men or women aged between 40 and 75 years hip osteoarthritis and / or knee ( stifle ) , unilateral or bilateral , symptomatic with a confirmed diagnosis and meeting the ACR criteria , representative of prevalent cases in France during the constitution of the cohort Affiliation to social security Exclusion Criteria: Presence of a hip or knee prosthesis of the painful joint at baseline ; Antecedent osteotomy ; severe comorbidity likely to affect significantly the quality of life or induce a major healthcare consumption regardless of osteoarthritis ; Knee pain with patellofemoral osteoarthritis isolated , that is to say without tibiofemoral osteoarthritis associated ; Other pathologies of these joints adults subject to a legal protection measure or unable to express their opposition not to participate in the study

Ages Eligible for Study
-----------------
Minimum Age: 40 Years
Maximum Age: 75 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 |
| --- | --- | --- |
| relationship between smoking and severity of functional impairment in patients with osteoarthritis of hip and knee osteoarthritis using datas from cohort KOHALA |  | 5 years |
Tolerance of Infants Fed a Hydrolysate Formula

Study Overview
=================
Brief Summary
-----------------
This is a prospective, randomized, multicenter study to assess the tolerance of infant formulas.

Official Title
-----------------
Tolerance of Infants Fed a Hydrolysate Formula Manufactured With a New Processing Method

Conditions
-----------------
Gastrointestinal Tolerance

Intervention / Treatment
-----------------
* Other: Hydrolysate Infant Formula 1
* Other: Hydrolysate Infant Formula 2


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Subject is judged to be in good health Singleton from a full-term birth Birth weight was > or = to 2490 g Between 0 and 14 days of age at enrollment Parent(s) confirm their intention to feed their infant the assigned study product as the sole source of nutrition for the duration of the study Parent(s) confirm their intention not to administer vitamin or mineral supplements, solid foods or juices to their infant from enrollment through the duration of the study Subject's parent(s) has voluntarily signed and dated an Informed Consent Form (ICF) Exclusion Criteria: An adverse maternal, fetal or subject medical history that is thought by the investigator to have potential for effects on tolerance, growth, and/or development. Subject is taking and plans to continue medications, home remedies, herbal preparations or rehydration fluids that might affect gastrointestinal (GI) tolerance Subject participates in another study that has not been approved as a concomitant study Subject has an allergy or intolerance to any ingredient in the study product Subject has been treated with antibiotics within 2 weeks prior to enrollment

Ages Eligible for Study
-----------------
Maximum Age: 14 Days

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

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

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

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Hydrolysate Infant Formula 1<br>Ready to feed infant formula in can | Other: Hydrolysate Infant Formula 1<br>* Feed ad lib<br>|
| Experimental: Hydrolysate Infant Formula 2<br>Ready to feed infant formula in bottle | Other: Hydrolysate Infant Formula 2<br>* Feed ad lib<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Stool Characteristics | Parent completed diary | Study Day 1 - Study Day 21 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Formula Intake | Parent completed diary | Study Day 1 - Study Day 21 | 
| Weight | Scale | Study Day 1 - Study Day 21 | 
| Length | Length board | Study Day 1 - Study Day 21 |
The Effects of Lower Body Resistance Training on Balance and Fall Prevention in the Elderly

Study Overview
=================
Brief Summary
-----------------
The aim of the study is to prevent falls related to poor lower body strength adn balance in the elderly.

Detailed Description
-----------------
The purpose of the study is to determine the effects of a structured lower body resistance training program on balance in an elderly population. Our hypothesis is that elderly adults will improve their balance following a structured lower body strength training program compared to those who do not engage in a lower body strength training program.

Official Title
-----------------
The Effects of Lower Body Resistance Training on Balance and Fall Prevention in the Elderly

Conditions
-----------------
Fall Prevention

Intervention / Treatment
-----------------
* Behavioral: Resistance training


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Healthy male and female adults 65 or older with physician consent to participate Exclusion Criteria: Unable to obtain physician consent to participate

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

Allocation: Randomized
Intervention Model: Single Group Assignment


Arms and Interventions

| Intervention/Treatment |
| --- |
|Behavioral: Resistance training|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Balance improvement | Measured by: Postural orthostatic hypotension test-blood pressure taken while sitting and standing. Balanced test with Biodex Balance System SD-a person's ability to maintain balance on an unstable surface. | 8 weeks |
Dexamethasone and Block Duration in Upper Extremity

Study Overview
=================
Brief Summary
-----------------
Effect of dexamethasone on prolonging upper extremity block is well known. But it not known if the effect comes from its local effect on the nerves or from its general analgesic effect. In this study we will compare the systemic effect to its local effect to find out if there is a difference or not.

Official Title
-----------------
A Study of the Effect of Dexamethasone on Duration of Upper Extremity Blocks With Bupivacaine

Conditions
-----------------
Duration of Pain Relief

Intervention / Treatment
-----------------
* Drug: Dexamthsone
* Drug: Bupivacaine


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: age 18-75, no contraindication to regional anesthesia, Exclusion Criteria: opioid user, chronic pain conditions, peripheral neuropathy

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 75 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: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Bupivacaine<br>Control | Drug: Bupivacaine<br> <br> |
| Experimental: Bupivacaine with Dexamethasone<br>Dexamethasone will be mixed with bupivacaine | Drug: Dexamthsone<br> <br> Drug: Bupivacaine<br> <br> |
| Active Comparator: Intravenous Dexamethasone<br>Dexamethasone will be given intravenously | Drug: Dexamthsone<br> <br> Drug: Bupivacaine<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Analgesia Duration |  | 72 hrs | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
block duration, analgesia
SILS Cholecystectomy: Cholangiography of the Biliary Tract

Study Overview
=================
Brief Summary
-----------------
Single Incision Laparoscopic Surgery (SILS) can be performed for different standard operations such as appendectomy and cholecystectomy. During laparoscopic cholecystectomy sometimes a cholangiography (marking the biliary tract with contrast agent) is necessary to identify and preserve relevant structures. The investigators want to evaluate feasibility of performing cholangiography during SILS cholecystectomy.

Official Title
-----------------
Performing Cholangiography During SILS Cholecystectomy: is it Feasible?

Conditions
-----------------
Cholecystolithiasis

Intervention / Treatment
-----------------
* Procedure: SILS cholangiography


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: cholecystolithiasis Exclusion Criteria: acute cholecystitis

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 90 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: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: SILS cholangiography<br>Performing cholangiography in all patients undergoing SILS cholecystectomy. | Procedure: SILS cholangiography<br>* intraoperative<br>* Other names: E-NOTES;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Feasibility of cholangiography during SILS cholecystectomy |  | at operation | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| biliary tract injury |  | 2 weeks | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
cholelithiasis