linjc16/ctgov huggingface dataset:
Physiopathological and Therapeutic Value of microRNA in the Progression of Carotid Artery Plaques: Carotid Protocol and microRNA

Study Overview
=================
Brief Summary
-----------------
Molecular analysis of the atheroma plaque. Screening for a novel biomarker of carotid status.

Official Title
-----------------
Physiopathological and Therapeutic Value of microRNA in the Progression of Carotid Artery Plaques: Carotid Protocol and microRNA

Conditions
-----------------
Carotid Arteries

Intervention / Treatment
-----------------
* Other: microRNA


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Adults having to undergo carotid thromboendarteriectomy social security coverage provision of study information consent to participation. Exclusion Criteria: Previous carotid artery surgery refusal to participate in the study or inability to give consent.

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

| Intervention/Treatment |
| --- |
|Other: microRNA|Extraction of the microRNA using the mirVana miRNA isolation kit and quantification using real-time PCRs|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| expression level of the seven miRNAs of interest | expression level of the seven miRNAs of interest in the serum and in carotid artery plaques : miR-100, miR-125a, miR-127, miR-133a, miR-145, miR-221 | Day of surgery | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
micro-RNA
The Development of De-novo Stress Urinary Incontinence After Stage II-III Pelvic Organ Prolapse Surgery

Study Overview
=================
Brief Summary
-----------------
Surgery for Stage II-III Pelvic organ prolapse

Official Title
-----------------
The Effect of Sacrospinous Ligament Fixation After Vaginal Hysterectomy to Development of De-novo Stress Urinary Incontinence and Postoperative Vaginal Length in Treating Stage II-III Pelvic Organ Prolapse Patients

Conditions
-----------------
Pelvic Organ Prolapse

Intervention / Treatment
-----------------
* Procedure: sacrospinous ligament fixation


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Pelvic organ prolapse stage II-III has no incontinence before surgery Exclusion Criteria: had surgery before Pelvic organ prolapse stage I or IV
Sexes Eligible for Study
-----------------
Female

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: sacrospinosus fixation group<br>The group which sacrospinous fixation was performed | Procedure: sacrospinous ligament fixation<br>* sacrospinous ligament fixation will be applied to prevent vaginal vault prolapse<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| development of stress urinary incontinence |  | in one year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| postoperative vaginal length |  | in one year | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
sacrospinous ligament fixation, stress urinary incontinence
Study of Safety and Efficacy of Doxercalciferol in Patients With Chronic Kidney Disease, Stage 3 or 4, and Secondary Hyperparathyroidism

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to demonstrate the safety and effectiveness of Hectorol® (doxercalciferol) capsules in treating patients with Stage 3 or Stage 4 chronic kidney disease (CKD) with secondary hyperparathyroidism who have vitamin D levels in the normal range. Previous studies with doxercalciferol were conducted in patients who had low levels of vitamin D.

Official Title
-----------------
A Phase 4, Multi-center, Randomized, Double-blind, Placebo-controlled, Parallel Study to Assess the Efficacy and Safety of Doxercalciferol Capsules in Vitamin D-replete Subjects With Chronic Kidney Disease (CKD) Stages 3 or 4 With Secondary Hyperparathyroidism (SHPT).

Conditions
-----------------
Secondary Hyperparathyroidism, Renal Failure, Chronic Renal Insufficiency

Intervention / Treatment
-----------------
* Drug: Hectorol (doxercalciferol capsules), 0.5mcg


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Plasma iPTH value above 110 pg/mL for CKD Stage 3 subjects or above 150 pg/mL for CKD Stage 4 Serum 25-hydroxyvitamin D level greater than or equal to 30 ng/mL CKD Stage 3 evidenced by a glomerular filtration rate (GFR) from the abbreviated MDRD equation between 30-59 mL/min or CKD Stage 4 evidenced by a glomerular filtration rate (GFR) from the abbreviated MDRD equation between 15-29 mL/min Exclusion Criteria: Serum cCa > 9.5 mg/dL Serum P > 4.6 mg/dL Abnormal liver functions Anticipated requirement for maintenance hemodialysis Use of active vitamin D sterol therapy

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: Hectorol (doxercalciferol capsules), 0.5mcg|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Laboratory measurement of intact parathyroid hormone (iPTH) |  | 6 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Laboratory measurement of serum bone markers |  | 6 months |
A Study of Nivolumab in Combination With Ipilimumab in Participants With Advanced Hepatocellular Carcinoma

Study Overview
=================
Brief Summary
-----------------
The main purpose of this study is to compare the overall survival (OS) of nivolumab plus ipilimumab versus standard of care (SOC) (sorafenib or lenvatinib) in all randomized participants with advanced hepatocellular carcinoma (HCC) who have not received prior systemic therapy.

Official Title
-----------------
A Randomized, Multi-center, Phase 3 Study of Nivolumab in Combination With Ipilimumab Compared to Sorafenib or Lenvatinib as First-Line Treatment in Participants With Advanced Hepatocellular Carcinoma

Conditions
-----------------
Hepatocellular Carcinoma

Intervention / Treatment
-----------------
* Drug: Nivolumab
* Drug: Ipilimumab
* Drug: Sorafenib
* Drug: lenvatinib


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Participants must have a diagnosis of HCC based on histological confirmation Participants must have an advanced HCC Participants must have at least one Response Evaluation Criteria in Solid Tumors (RECIST) 1.1 measurable previously untreated lesion Child-Pugh score 5 or 6 Eastern Cooperative Oncology Group (ECOG) performance status(PS) 0 or 1 Exclusion Criteria: Known fibrolamellar HCC, sarcomatoid HCC, or mixed cholangiocarcinoma and HCC Prior liver transplant Episodes of hepatic encephalopathy (greater than or equal to [>=] Grade 2) within 12 months prior to randomization Active brain metastases or leptomeningeal metastases Other protocol-defined inclusion/exclusion criteria apply.

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: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Nivolumab + Ipilimumab<br> | Drug: Nivolumab<br>* Participants will receive nivolumab as intravenous (IV) infusion.<br>Drug: Ipilimumab<br>* Participants will receive ipilimumab as IV infusion.<br>|
| Active Comparator: Sorafenib/lenvatinib<br> | Drug: Sorafenib<br>* Participants will receive sorafenib as oral tablets.<br>Drug: lenvatinib<br>* Participants will receive lenvatinib as oral capsules.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Overall Survival (OS) |  | Up to 4 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Objective Response Rate (ORR) |  | Up to 4 years | 
| Duration of Response (DOR) |  | Up to 4 years | 
| Time to Symptom Deterioration (TTSD) |  | Up to 4 years |
Predictive algoRithm for EValuation and Intervention in SEpsis

Study Overview
=================
Brief Summary
-----------------
In this prospective study, the ability of a machine learning algorithm to predict sepsis and influence clinical outcomes, will be investigated at Cabell Huntington Hospital (CHH).

Official Title
-----------------
Prediction of Severe Sepsis Using a Machine Learning Algorithm

Conditions
-----------------
Sepsis, Septic Shock, Severe Sepsis

Intervention / Treatment
-----------------
* Other: Severe Sepsis Prediction
* Other: Severe Sepsis Detection


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: All adult patients visiting the emergency department, or admitted to the participating intensive care unit (ICU) wards of Cabell Huntington Hospital will be eligible. Exclusion Criteria: All patients younger than 18 years of age will 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: Diagnostic
Allocation: Non-Randomized
Intervention Model: Factorial Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: With InSight<br>Healthcare provider receives an alert from InSight for patients trending towards severe sepsis. Healthcare provider also receives information from the severe sepsis detector in the CHH electronic health record. | Other: Severe Sepsis Prediction<br>* Upon receiving an InSight alert, healthcare provider follows standard practices in assessing possible (severe) sepsis and intervening accordingly.<br>Other: Severe Sepsis Detection<br>* Upon receiving information from the severe sepsis detector in the CHH electronic health record, healthcare provider follows standard practices in assessing possible (severe) sepsis and intervening accordingly.<br>|
| Active Comparator: Without Insight<br>Healthcare provider does not receive any alerts from InSight. Healthcare provider receives information from the severe sepsis detector in the CHH electronic health record. | Other: Severe Sepsis Detection<br>* Upon receiving information from the severe sepsis detector in the CHH electronic health record, healthcare provider follows standard practices in assessing possible (severe) sepsis and intervening accordingly.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| In-hospital mortality |  | Through study completion, an average of 30 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Hospital length of stay |  | Through study completion, an average of 30 days |
The Effect of Rosuvastatin on Adenosine Metabolism

Study Overview
=================
Brief Summary
-----------------
The aim of this study is to show whether rosuvastatin influences adenosine metabolism. Therefore we will determine whether rosuvasatin increases dipyridamole-induced vasodilation by increased adenosine receptor stimulation.

Official Title
-----------------
Rosuvastatin Augments Dipyridamole Induced Vasodilation by Increased Adenosine Receptor Stimulation.

Conditions
-----------------
Adenosine Metabolism

Intervention / Treatment
-----------------
* Drug: placebo
* Drug: rosuvastatin


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: age 18 - 50 years Signed informed consent Exclusion Criteria: hypertension hypercholesterolemia diabetes Mellitus alanine aminotransferase > 90 U/L creatinine Kinase > 440 U/L cardiovascular disease GFR < 80 ml/min

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

Design Details

Primary Purpose: Basic Science
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Placebo Comparator: 1<br> | Drug: placebo<br>* 1 dd for 7-10 days<br>|
| Experimental: 2<br> | Drug: rosuvastatin<br>* 1 dd 20 mg for 7-10 days<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| forearm vasodilatory response to dipyridamole |  | 7 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| lipid profile |  | 7-10 days | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
rosuvastatin, dipyridamole, caffeine
Responses to Chemotherapy of Patients With Non-small Cell Lung Cancer Harboring a Known Somatic Activating HER2 Mutation

Study Overview
=================
Brief Summary
-----------------
This chart review describe the response to systemic chemotherapy of patients with non-small cell lung cancer (NSCLC) harbouring a known somatic activating human epidermal growth factor receptor 2 (HER2) mutation. The analysis of this data will provide an initial description of the response to systemic chemotherapy in patients with NSCLC harboring an activating HER2 mutation in order to inform the design and powering of future randomized controlled clinical trials of HER2-directed therapy.

Official Title
-----------------
Review of Responses to Systemic Chemotherapy of Patients With Non-small Cell Lung Cancer Harboring a Known Somatic Activating HER2 Mutation

Conditions
-----------------
Lung Cancer

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


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: patients with advanced nonsmall-cell lung cancer known HER2 exon-20 insertion treated with chemotherapy and/or HER2-targeted drugs Exclusion Criteria: none

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

| Intervention/Treatment |
| --- |
|Other: No specific intervention|Clinical, drug and data collection : characteristics of patients (age, sex and histology), non HER 2-directed treatments including response and duration of response|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Overall response rate |  | 24 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Median progression-free survival (PFS) with conventional chemotherapy |  | 24 months |
Improved Estimation of GFR by Cystatin C in Preventing Contrast Induced Nephropathy by NAC or Zn

Study Overview
=================
Brief Summary
-----------------
Background Prevention of contrast media (CM) induced nephropathy (CIN) by pharmacological prophylaxis (e.g. N-acetylcysteine; NAC) is controversially discussed. So far, in all interventional studies assessment of kidney function was based on measurements of serum creatinine although this surrogate biomarker has several limitations. We investigated the antioxidants NAC and zinc (Zn) for the prevention of CIN by monitoring concomitantly serum levels of creatinine and cystatin C.

Detailed Description
-----------------
In a prospective, placebo-controlled, double blind trial patients with moderate impaired kidney function receiving hypoosmolar, nonionic contrast medium were randomly assigned to an oral treatment for 2 days with 1.2g/day of NAC (n=19), for 1 day with 60mg/day of Zn (n=18) or placebo (n=17). All patients were periprocedural hydrated with 1ml/kg/h of 0.45% saline for 24h. At baseline (before hydration), prior to exposure of CM as well as 2 and 6 days after CM serum levels of creatinine and cystatin C have been measured.

Official Title
-----------------
Improved Estimation of Glomerular Filtration Rate by Serum Cystatin C in Preventing Contrast Induced Nephropathy by N-Acetylcysteine or Zinc

Conditions
-----------------
Chronic Kidney Failure

Intervention / Treatment
-----------------
* Drug: Acetylcysteine
* Drug: Zinc


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: older than 18 years of age, serum creatinine > 1.2 mg/dl or a creatinine clearance < 50 ml/min (measured by a 12 or 24 hour urine collection). Exclusion Criteria: acute inflammatory disease, medication with NSAID or metformin until 3 days before entering study, abnormal findings in physical examinations, e.g. signs of dehydration or decompensated heart failure.

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: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: Acetylcysteine|nan|
|Drug: Zinc|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Incidence of acute renal failure |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Rise in creatinine of > 0.5 mg/dl |  |  | 
| Rise in creatinine > 25% |  |  | 
| Significant rise in serum cystatin C) |  |  | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
contrast-induced nephropathy, Acetylcysteine, Zinc, Cystatin C, Creatinine
3D Craniofacial Cephalometric Analysis

Study Overview
=================
Brief Summary
-----------------
Development of three-dimensional craniofacial cephalometric analysis for virtual planning in orthognathic surgery.

Detailed Description
-----------------
Cone beam computed tomography is taken for diagnosis independently from this study. Investigators are using this medical imaging for performing the 3D cephalometric analysis. Investigators apply a set of well described landmarks of three-dimensional reconstruction of the skull from patients suffering from diverse craniofacial malformations. Then a set of specific measurements is taken from the patient and provide insights how to modify the anatomy of the patient to improve the skull's architecture and symmetry

Official Title
-----------------
Clinical Validation of the Three-dimensional Computer Tomography Based Craniofacial Cephalometric Analysis

Conditions
-----------------
Malocclusion

Intervention / Treatment
-----------------
* Radiation: cone beam computed tomography
* Radiation: computer tomography


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: maxillomandibular dysmorphoses, facial asymmetry, craniofacial syndromes Exclusion Criteria: patients with orthodontic treatment only growing patients

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

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

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

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

Arms and Interventions

| Intervention/Treatment |
| --- |
|Radiation: cone beam computed tomography|A preoperative CBCT is performed for all patients in this study for medical reason|
|Radiation: computer tomography|One cone beam computer tomography examination before surgery|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| topological description of maxillomandibular dysmorphosis (angles, distances) | Anterior cranial base angle on three-dimensional CT recostruction of the skull (in degrees) Posterior cranial base angle on three-dimensional CT recostruction of the skull (in degrees) Ratio between distance from nasion to anterior nasal spine/anterior nasal spine to chin landmark (without unit of maesurment) Measurements between various anatomic landmarks for orbits and maxillary sinus structures on the three-dimensional CT reconstruction of the patient's skull (in mm). | 2014 | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
cephalometry, three-dimensional, CT scan, lateral radiography, facial symmetry, maxillomandibular dysmorphoses
Association of the Intrarenal Resistance Index (RI) of Transplanted Kidneys With Generalized Atherosclerosis

Study Overview
=================
Brief Summary
-----------------
Cross sectional observational ultrasound study of transplanted kidneys and the carotid artery in consecutive recruited outpatients.

Conditions
-----------------
Renal Transplantation

Intervention / Treatment
-----------------
* Procedure: Vascular ultrasound


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion criteria: Patients after renal transplantation with stable renal function Exclusion criteria: Known impairment of renal function (e.g. acute rejection) Known renal artery or carotid artery stenosis

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

| Intervention/Treatment |
| --- |
|Procedure: Vascular ultrasound|RI ist predictive for arteriosclerosis|

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

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