linjc16/ctgov huggingface dataset:
Implantable Cardiac Defibrillators for the Prevention of Sudden Death in Patients With Cardiac Sarcoidosis

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to identify patients with cardiac sarcoidosis who may be at risk for sudden death.

Detailed Description
-----------------
Sarcoidosis is an inflammatory disease that can effect many organ systems. Patients with sarcoidosis involving the heart are at risk of sudden death related to ventricular arrythmias. However, we currently do not have a clinical test which can predict sudden cardiac death in these patients. While implantable cardioverter defibrillators(ICDs) can prevent sudden cardiac death in high risk patients, we do not know which patients will benefit from implantation of these devices. This clinical problem is important because we would like to identify patients at risk for sudden death who will benefit from ICD implantation. Additionally, we would like to avoid the risks to patients and financial expenses of inserting ICDs in patients who will not benefit from them.

Official Title
-----------------
Efficacy if Implantable Cardioverter Defibrillators for the Prevention of Sudden Death in Patients With Cardiac Sarcoidosis

Conditions
-----------------
Sarcoidosis of the Heart, Cardiomyopathy

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Diagnosis of Cardiac Sarcoidosis Previous Implantable Cardioverter Defibrillator (ICD)

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 |
| --- | --- |
| Cardiac Sarcoidosis<br>Patients with Cardiac Sarcoidosis who had an ICD implanted | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| retrospective collection of demographic and clinical data on patients with cardiac sarcoidosis who had an ICD implanted to correlate clinical variables with ICD therapies for ventricular arrhythmias |  | one year | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Implantable Cardioverter-Defibrillator (ICD)- pre-existing
Prediction of Secondary Neurological Deterioration in Patients With Moderate Traumatic Brain Injury

Study Overview
=================
Brief Summary
-----------------
Patients with moderate traumatic brain injury (mTBI) are 1,5 times more frequent than those with severe TBI and some of them will develop secondary neurologic deterioration (SND) within the first 7 days. However, identifying at risk patients of SND is still challenging. This study aimed to determine risk factors associated with SND after mTBI.

Official Title
-----------------
Prediction of Secondary Neurological Deterioration in Patients With Moderate Traumatic Brain Injury : an Observational Study

Conditions
-----------------
Traumatic Brain Injury

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Adults Admitted in Brest hospital between 2015 and 2018 for moderate TBI, defined by Glasgow coma scale (GCS) score 9-13 Exclusion Criteria: Non consenting patients

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 |
| --- | --- | --- |
| Secondary neurologic deterioration | SND was defined either by a decrease in GCS or by a deterioration in neurologic status sufficient to warrant intervention like mechanical ventilation, transfer to the ICU or neurosurgical intervention | Within 7 days after hospital admission |
TAXUS ARRIVE: TAXUS Peri-Approval Registry: A Multi-Center Safety Surveillance Program

Study Overview
=================
Brief Summary
-----------------
The TAXUS ARRIVE study is a multi-center safety and surveillance study designed to to compile safety surveillance and clinical outcomes data for the TAXUS™ Express2™ Paclitaxel-Eluting Coronary Stent System in routine clinical practice and to identify low frequency TAXUS related clinical events.

Official Title
-----------------
TAXUS ARRIVE: TAXUS Peri-Approval Registry: A Multi-Center Safety Surveillance Program

Conditions
-----------------
Coronary Artery Disease

Intervention / Treatment
-----------------
* Device: TAXUS Express 2™


Participation Criteria
=================
Eligibility Criteria
-----------------
Appropriate Patient Criteria: Patient is eligible to receive a Boston Scientific TAXUS Stent. Inappropriate Patients Criteria: Known sensitivity to paclitaxel. Known allergy to stainless steel. Patients in whom antiplatelet and / or anticoagulant therapy is contraindicated. Patients judged to have a lesion that prevents complete inflation of an angioplasty balloon or proper placement of the stent or delivery device. Patients with unresolved vessel thrombus at the lesion site. Patients with coronary artery reference vessel diameters < 2.5 mm or > 3.75 mm. Patients with lesions located in the left main coronary artery, ostial lesions, or lesions located at a bifurcation. Patients with diffuse disease or poor overflow distal to the identified lesions. Patients with tortuous vessels in the region of the obstruction or proximal to the lesion. Patients with a recent acute myocardial infarction where there is evidence of thrombus or poor flow.

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


Arms and Interventions

| Intervention/Treatment |
| --- |
|Device: TAXUS Express 2™|TAXUS Express™ Paclitaxel-Eluting Coronary Stent System|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Rate of TAXUS stent related cardiac events at a 1-year post implant procedure as classified by the Clinical Events Committee |  | 1 year post-implant procedure | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Rate of TAXUS stent related cardiac events as classified by the Clinical Events Committee |  | 30 days, 6 months, 2 years post-implant procedure | 
| Rate of target vessel related cardiac events as classified by the Clinical Events Committee |  | 30 days, 6 months, 1 and 2 years post-implant procedure | 
| Rate of other TAXUS related events |  | 30 days, 6 months, 1 and 2 years post-implant procedure |
Regulation of Hepatic Insulin Extraction

Study Overview
=================
Brief Summary
-----------------
This study is in the area of Type 2 diabetes and genetics Healthy Volunteers and those with mild type 2 diabetes may be eligible to participate This study is searching for genes that may affect the body's processing/digestion of glucose/sugar

Detailed Description
-----------------
This study is looking at the genetic influences of type 2 diabetes. It also is investigating the various gastric hormones including but not limited to: insulin, C-peptide, GIP, GLP, & Xenin.

Official Title
-----------------
Regulation of Hepatic Insulin Extraction:Alterations of Insulin Secretion in Subjects With Genetic Variants That Determine Risk for Non-Insulin Dependant Diabetes Mellitus

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

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: ages 18-65 non-diabetic diabetes controlled with diet or with pills no family history of diabetes family history of type 2 diabetes personal history of gestational diabetes Exclusion Criteria: < 18 or > 65 years of age medications that affect glucose (sugar) levels kidney disease liver disease heart/cardiovascular disease

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 65 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 |
| --- | --- |
| Entry<br>This group is just entering the study and will need to be genotyped. | |
| Affected<br>This group has been genotyped and has the gene undergoing study at that time. | |
| Control<br>This group has been genotyped and does not have the gene currently under study. | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Genes affecting the development of Type 2 diabetes will be identified |  | 1 year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Any differences between genetic groups in the metabolism of glucose/sugar will be studied to the extent that the data allow |  | 1 year | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
diabetes, genetics, oral glucose tolerance testing, family history of diabetes, gestational diabetes
Lung Cancer and Idiopathic Pulmonary Fibrosis : Pathological and Molecular Characterization

Study Overview
=================
Brief Summary
-----------------
Retrospective inclusion of lung cancers developed in a context of idiopathic pulmonary fibrosis, diagnosed and / or treated in participating centers. The cases are recovered retrospectively from the records of the pulmonology and pathology departments of our various partners.

Detailed Description
-----------------
Primary objective: Characterize altered molecular pathways in lung cancer in patients with IPF versus lung cancer in non-IPF patients. Secondary objectives: Identify specific therapeutic targets Describe a cohort of lung cancers on IPF (clinical / radiological and pathological data) To study the relationship between neoplastic / preneoplastic lesions and pulmonary parenchyma reshaped by fibrosis.

Official Title
-----------------
Lung Cancer and Idiopathic Pulmonary Fibrosis : Pathological and Molecular Characterization

Conditions
-----------------
Lung Cancer and Idiopathic Pulmonary Fibrosis

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Lung carcinoma Idiopathic pulmonary fibrosis Exclusion Criteria: - No tumor sample available

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 |
| --- | --- |
| Lung carcinoma on IPF<br>Lung carcinoma on IPF | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Molecular profile of IPF-associated lung carcinomas | Next generation sequencing of carcinomas with Ion S5 XL sequencer and Oncomine™ Comprehensive Panel | 1 month / 8 samples | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pathological characterization of lung carcinomas | Histological classification of carcinomas and immunohistochemistry with lineage markers | 1 month / 8 samples | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Lung cancer; Idiopathic pulmonary fibrosis
Respiratory Decompensation and Model for the Triage of COVID-19 Patients

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to prospectively evaluate a machine learning algorithm for the prediction of outcomes in COVID-19 patients.

Detailed Description
-----------------
In a multi-center prospective clinical trial, a machine learning algorithm was deployed at five partner hospitals to analyze live patient data, including blood pressure and Creatinine levels, to determine the algorithm's ability to predict COVID-19 patient prognosis. The primary endpoint was mechanical ventilation of study subjects within 24 hours after hospital admission separate from a decompensation alert related to oxygen levels.

Official Title
-----------------
Prediction Of Respiratory Decompensation In Covid-19 Patients Using Machine Learning: The READY Trial

Conditions
-----------------
COVID-19, Coronavirus, Mortality, Mechanical Ventilation

Intervention / Treatment
-----------------
* Device: COViage


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients aged 18 years or older Confirmed COVID-19 infection through RT-PCR test Exclusion Criteria: Patients aged less than 18 years

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: COViage<br>Machine learning intervention | Device: COViage<br>* The COViage machine learning algorithm is designed to predict mechanical ventilation and mortality within 24 hours after hospital admission.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Mechanically ventilated patient outcome | Ventilated or not ventilated within 24 hours | Through study completion, an average of 2 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Mortality or mechanically ventilated patient outcome | Death or ventilated, or no death or not ventilated within 24 hours | Through study completion, an average of 2 months |
Fertility After Prostate Brachytherapy

Study Overview
=================
Brief Summary
-----------------
Although brachytherapy toxicity data on erectile dysfunction, urethral dysfunction and bladder and bowel impact has been collected for a number of years, there is limited information on its effect on male fertility. This study aims to investigate the effect of brachytherapy on fertility

Detailed Description
-----------------
Brachytherapy is a commonly employed technique in the treatment of all prostate cancer risk groups. It delivers a high radiation localised to the prostate gland. The effects of this on fertility have not been systematically studied. An increasing number of younger men for whom fertility is an issue are being diagnosed with prostate cancer and may be offered brachytherapy amongst their treatment choices. This study therefore addresses this issue with a systematic evaluation of sperm count and quality before and after both high dose rate and low dose rate brachytherapy.

Official Title
-----------------
A Single Site Prospective Descriptive Study on the Effect of Brachytherapy Monotherapy for Prostate Cancer on Male Fertility

Conditions
-----------------
Prostate Cancer

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Male 18 years or older Receiving brachytherapy monotherapy; High or Low dose rate Ability to ejaculate Able to provide written informed consent Exclusion Criteria: History of infertility or vasectomy Previous chemotherapy or pelvic radiotherapy Prior use of androgen deprivation therapy 5 alpha-reductase inhibitors within the last 4 months Alpha blockers within 7 days of semen collection

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

Sexes Eligible for Study
-----------------
Male

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Low dose rate brachytherapy<br>20 patients receiving low dose rate brachytherapy | |
| High dose rate brachytherapy<br>20 patients receiving high dose rate brachytherapy. | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To define effect of prostate brachytherapy on male fertility. | measure by sequential sperm counts | 12 months |
Influence of Muscle Relaxation With Rocuronium Bromide During General Anaesthesia on Muscle Trauma and Postoperative Analgetic Consumption in Patients With Total Hip Prosthesis Implantation

Study Overview
=================
Brief Summary
-----------------
The researchers want to investigate the effects of muscle relaxation with rocuronium bromide during general anaesthesia on muscle trauma (serum CK, CRP) and postoperative analgesic consumption in patients with total hip prosthesis replacement (general vs. spinal anaesthesia).

Conditions
-----------------
Muscle Relaxation, Muscle Trauma, Analgetic Consumption, Total Hip Replacement

Intervention / Treatment
-----------------
* Procedure: effect of muscle relaxation on muscle trauma, control group without relaxation


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: patient agreement indication for total hip replacement age 55 - 80 years weight 65 - 95 kg first intervention ASA classification I - III general and spinal anaesthesia possible in this patient Exclusion Criteria: a) neuromuscular diseases b) surgery with muscle trauma (within the last 3 months) c) permanent immobility d) intramuscular injections (within the last 4 weeks) e) medication with opioids f) medication with co-analgetics g) contraindications for general or spinal anaesthesia h) dementia, cognitive dysfunction or sleep apnea -

Ages Eligible for Study
-----------------
Minimum Age: 55 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: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: general anaesthesia<br>patients receiving general anaesthesia and rocuronium bromide for muscle relaxation | Procedure: effect of muscle relaxation on muscle trauma, control group without relaxation<br>* effect of muscle relaxation on muscle trauma, control group without relaxation<br>|
| Active Comparator: spinal anaesthesia<br>patients receiving spinal anaesthesia without muscle relaxation | Procedure: effect of muscle relaxation on muscle trauma, control group without relaxation<br>* effect of muscle relaxation on muscle trauma, control group without relaxation<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| degree of muscle trauma | serum CK and CRP levels are measured | 24 hours | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| consumption of analgetics | consumption of piritramide is measured | 3 days |
Antioxidant Supplementation in Trauma Patients

Study Overview
=================
Brief Summary
-----------------
Administration of antioxidants to trauma patients will improve measures of oxidant stress in the blood

Official Title
-----------------
Antioxidant Supplementation in Trauma Patients

Conditions
-----------------
Multiple Trauma

Intervention / Treatment
-----------------
* Dietary Supplement: powdered antioxidant
* Dietary Supplement: powdered cornstarch placebo


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Adult non pregnant non lactating trauma patient Exclusion Criteria: GCS <6 Renal dysfunction (cre > 2.5 mg/dl) Hepatic dysfunction ( TBili > 3.0 mg/dl) Expected survival < 48 hours Burns over > 20% body surface area Immune-deficiency syndromes Steroid use

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

Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 1<br> | Dietary Supplement: powdered antioxidant<br>* one vial mixed with water every day orally or through enteral tube<br>|
| Placebo Comparator: 2<br> | Dietary Supplement: powdered cornstarch placebo<br>* one vial mix with water and administer orally or via enteral tube<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| measures of malondialdehyde level/total antioxidant status and F2 isoprostane |  | 7 days | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
antioxidant, oxidant stress, trauma, free radical