linjc16/ctgov huggingface dataset:
Near INfrared Spectroscopy in Aortic valvE ReplacemenT

Study Overview
=================
Brief Summary
-----------------
Transcatheter aortic valve implantation (TAVI) is an alternative for patients, that are considered to be too sick for conventional aortic valve replacement. There is no conclusive opinion about the best anesthesiologic management of these patients. Sedation and general anaesthesia are both adequate and the current literature shows no benefit towards one of these methods. This study wants to investigate the influence of these two anesthesiologic managements on the cerebral oxygen saturation during the rapid pacing-period during valvuloplasty. The patients are randomised allocated to one of these two anaesthesiological managements. The investigators use the Near-Infrared Spectroscopy (NIRS) to measure the cerebral oxygen saturation. Parallel there will be a measurement of cerebral biomarkers to monitor cerebral hypoxia.

Official Title
-----------------
Near Infrared Spectroscopy in Aortic Valve Replacement

Conditions
-----------------
Aortic Valve Stenosis, Transcatheter Aortic Valve Implantation, Eligibility for Both Anaesthetic Methods

Intervention / Treatment
-----------------
* Procedure: General anaesthesia
* Procedure: Sedation


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: informed consent transcatheter aortic valve implantation Exclusion Criteria: denial by patient denial by screening anaesthesist active neurodegenerative disease

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 |
| --- | --- |
| Active Comparator: General anaesthesia<br>General anaesthesia is performed under standardized conditions | Procedure: General anaesthesia<br>* general anaesthesia is performed according to the hospitals standard<br>|
| Active Comparator: Sedation<br>Sedation is performed under standardized conditions | Procedure: Sedation<br>* Sedation is performed according to the hospitals standard<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Cerebral oxygen desaturation during the rapid pacing period and periprocedural | Biomarkers for cerebral ischemia will be measured up to 48 hours | up to 48 hours |
Metabolic and Vascular Effects of Statins in Untreated Dyslipidemic Diabetic Patients

Study Overview
=================
Brief Summary
-----------------
Type 2 diabetes (T2D), because of impaired glucose regulation and consequent hyperglycemia, promotes the development of coronary heart disease. Secondary dyslipidemia is often associated with T2D and enhances the risk of cardiovascular complications. HMG-CoA reductase inhibitors (statins) are selectively administrated for the treatment of dyslipidemia, leading to a significant reduction of cardiovascular risk. More recently, revisions to guidelines have established a lower therapeutic LDL cholesterol goal for diabetic patients, requiring the administration of higher dose of statin. However, it is unclear whether high dose statin therapy could affect glycemic control in diabetic patients. Moreover, data regarding the effects of statins on insulin-resistance and endothelial function are controversial.

Conditions
-----------------
Type 2 Diabetes, Diabetic Dyslipidemia

Intervention / Treatment
-----------------
* Drug: Simvastatin
* Drug: Rosuvastatin


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Type 2 diabetes in good glycemic control, treated with metformin alone. Untreated dyslipidemia. BMI <30. Exclusion Criteria: History of cancer. History of cardiovascular diseases. Any other acute or cronic illness which requires administration of steroids or other drugs able to interfere with glucose metabolism.

Ages Eligible for Study
-----------------
Minimum Age: 50 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: Crossover Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Simvastatin<br>Simvastatin 20 mg/day | Drug: Simvastatin<br>* 20 mg/day in one oral administration<br>|
| Active Comparator: Rosuvastatin<br>Rosuvastatin 20 mg/day | Drug: Rosuvastatin<br>* 20 mg/day in one oral administration.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Glucose tolerance assessed by HbA1c and fasting glucose |  | 1, 6, 12 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| insulin-resistance assessed by clamp. Endothelial function assessed by FMD %. Inflammatory status assessed by biochemical markers. |  | 1, 6, 12 months. | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Statins administration in diabetic dyslipidemia
D Mannose for Prevention and Treatment of RUTIs

Study Overview
=================
Brief Summary
-----------------
The aim of this review is to address clinical reliability, efficacy and safety of long-term treatment with oral D Mannose for the prevention of recurrent urinary tract infections (RUTIs) in females.

Detailed Description
-----------------
A comprehensive systematic MEDLINE, Embase, Cochrane search was performed for English language reports published before December 2018 using the term recurrent urinary tract infections and d mannose. We searched Medline, Embase, and the Cochrane Register of Controlled Trials since January 2010 to December 2018. Eligible studies did not include non-oral therapy, local (vaginal) treatment in women with RUTIs. Study eligibility criteria- We identified eligible original articles. The heterogeneity of the available studies, their different rationale and aim, the assumption of d mannose for prophylaxis or treatment of recurrent UTIs need to be taken into account.

Official Title
-----------------
Oral D Mannose in the Prevention and Treatment of Recurrent Urinary Tract Infections: a Systematic Review

Conditions
-----------------
Recurrent Urinary Tract Infections, Antibiotic Prophylaxis, Antibiotic Resistance

Intervention / Treatment
-----------------
* Other: systematic review


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: recurrent urinary tract infections (RUTIs) Exclusion Criteria: Upper urinary tract infections, severe clinical symptoms, fever > 37,5 with lumbar pain

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

Arms and Interventions

| Intervention/Treatment |
| --- |
|Other: systematic review|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| research literature data on d mannose for prevention and treatment of recurrent urinary tract infections. | literature search of the Medline, Embase, and Cochrane Library databases | January 2010-December 2018 | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
recurrent urinary tract infections, d mannose prophylaxis, antibiotic prophylaxis
Hospital Based Registry of Childhood Cancer in Pediatric Oncology Units in French Speaking Africa

Study Overview
=================
Brief Summary
-----------------
The ultimate aim of this registry is to collect precise information concerning the children coming to oncology units working with the French African Oncology Group. This data will help to plan and provide correct pediatric oncology treatment and care for this population. Collecting the data will give much needed information on numbers, stage, treatment and outcome. The register will give data for local and national health authorities in planning pediatric cancer programs.

Detailed Description
-----------------
This register is a registration of all children entering hospital based pediatric oncology units, working in selected hospitals in French speaking Africa. The data collected includes: demographic and socioeconomic status as well as clinical status and outcome. The register also collects information on vital status, treatment abandonment and loss to follow-up. Data, collected locally is entered on line using the Research Electronic Data Capture (REDCap) program. Data are stored under the responsibility of the IT department at Gustave ROUSSY in Paris- Villejuif.

Official Title
-----------------
French African Pediatric Oncology Registry

Conditions
-----------------
Pediatric Cancer

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Any child presenting at any one of the participating units for treatment Any child with any type of cancer Any child or adolescent less than 18 years of age. Exclusion Criteria: No cancer found Age greater than 18 years -

Ages Eligible for Study
-----------------
Minimum Age: 1 Day
Maximum Age: 18 Years

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

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of children with a suspicion of any type of cancer in a given unit | Number of children with details of : the type of cancer the stage of the identified cancer coming into a given unit | in any 12 month period | 
| VITAL STATUS: | Dead or alive The number of children living the number of children dead | in any 12 month period | 
| Illness status | The number of children relapsed, The number of children whos illness has progressed. | in any 12 month period | 
| Treatment Status | The number of children who had treatment administered, The number of children who abandoned treatment | in any 12 month period |
Blood Testing at Entia

Study Overview
=================
Brief Summary
-----------------
The investigators are recruiting healthy volunteers to donate a finger prick blood sample or a small venous sample to Entia for the further development and testing of our blood analyser. The venous samples are taken by a registered nurse hired via a third party company. The results of the blood tests are not informed to the participants unless they explicitly ask for it.

Official Title
-----------------
Blood Donation of Healthy Blood for Prototype Testing at Entia

Conditions
-----------------
Healthy

Intervention / Treatment
-----------------
* Diagnostic Test: Affinity


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: aged 18 years and above healthy with no known conditions Exclusion Criteria: Has a known health condition, including blood-borne diseases Inadequate understanding of the English language (written and verbal) that would require a translator

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 |
| --- | --- |
| Capillary Sample<br>This group donates finger prick blood samples to Entia for the purpose of development. | Diagnostic Test: Affinity<br>* Blood Analyser<br>|
| Venous Sample<br>This group donates venous blood samples to Enta, taken by a registered nurse. | Diagnostic Test: Affinity<br>* Blood Analyser<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The difference in counts of the device tested blood vs the gold standard tested blood. | Venous blood drawn will be tested on a laboratory analyser, in which the results will be compared against the results when tested on Entia's analyser. | 3 years |
Long Term Prognosis of MRI Diagnosed Partial Thickness Tears of the Rotator Cuff

Study Overview
=================
Brief Summary
-----------------
Patients diagnosed with partial thickness tears of the rotator cuff are sometimes surgically repaired, while other cases are not. It is unknown how patients fare over time without electing surgical repair and how outcomes differ by type of injury.

Detailed Description
-----------------
We plan to conduct a retrospective cohort study to assemble a research database of all patients with shoulder pain from 1/1/02-12/31/06 presenting at the Hershey Medical Center. Participants will be identified using billing codes in the medical records office, with inclusion/exclusion criteria as described above. Data extraction will include medical record number, demographic data (age, race/ethnicity, sex, insurance type), pre-fracture functional status, pre-admission residence, medical co-morbidities, prior hospitalization within 30 days, abnormal clinical findings on admission, shoulder score, pain score, range of motion score, type of diagnosis (partial tear, full thickness tear, tendonitis, shoulder pain), occupation, past medical history, physical therapy and duration of physical therapy, cigarette/cigar use, drug use, alcohol use, treatment protocols (anti-inflammatory medication, injections, etc.), and complaints by patient of pain status.

Official Title
-----------------
Long Term Prognosis of MRI Diagnosed Partial Thickness Tears of the Rotator Cuff

Conditions
-----------------
Rotator Cuff Tear

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients examined at the Hershey Medical Center from 1/1/02-12/31/06 with a documented MRI report of a partial thickness tear of the rotator cuff that was treated non-operatively. Exclusion Criteria: Full thickness tear of the rotator cuff, surgically repaired rotator cuff, and patients who do not fit criteria listed in inclusion criteria.

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 |
| --- | --- |
| Partial Rotator Cuff Tear<br>Patients who presented from 1/1/02 to 12/31/06 to Hershey Medical Center with complaint of shoulder pain and were treated by the Orthopaedic Department | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Creation of a database of patients with partial rotator cuff tears documented by MRI. |  | Retrospective review from 1/1/02 to 12/31/06, four years. | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Partial Thickness, Rotator Cuff
Community-Associated Uropathogen Antimicrobial Resistance Among Emergency Department Patients With Acute Pyelonephritis

Study Overview
=================
Brief Summary
-----------------
Pyelonephritis is a serious infection that manifests with fever, back pain, nausea, and vomiting. In the U.S., it is estimated that there are 20 cases of pyelonephritis per 10,000 annually, with the highest incidence in young women. Escherichia coli (E. coli) causes over 80% of these infections. Over the last two decades, E. coli resistance has emerged to commonly prescribed antimicrobials, such as ampicillin and trimethoprim-sulfamethoxazole (TMP/SMX). Most recently, resistance to fluoroquinolones and strains producing extended-spectrum beta-lactamases (ESBL) have been observed. In order to better understand the evolution and current state of antibiotic resistance among E. coli urinary tract isolates so as to better inform treatment decisions, the investigators propose to conduct an investigation to: a) determine the prevalence of antimicrobial resistance among E. coli causing acute pyelonephritis in various patient groups, and specifically healthy community-dwellers with uncomplicated infections, b) determine the specific prevalence of fluoroquinolone-resistance and ESBL-producing E. coli, and c) determine potential risk factors for fluoroquinolone and ESBL-producing E. coli infections.

Official Title
-----------------
Surveillance and Risk Factor Analysis of Community-Associated Uropathogen Antimicrobial Resistance Among Emergency Department Patients With Acute Pyelonephritis in the United States

Conditions
-----------------
Pyelonephritis

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


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: patients > 18 years of age with flank pain and/or costovertebral angle tenderness documented temperature in the emergency department of ≥38°C/100.4°F by any method of measurement, documented temperature in the emergency department of ≥38°C/100.4°F by any method of measurement, Exclusion Criteria: complicated pyelonephritis

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 |
| --- | --- |
| pyelonephritis<br>Patients > 18 years of age with flank pain and/or costovertebral angle tenderness, documented temperature in the emergency department of ≥38°C/100.4°F by any method of measurement, and clinically suspected acute pyelonephritis. Patients will be identified by their emergency department treating physicians. | Other: No intervention<br>* There is no intervention<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Prevalence of antimicrobial resistant E. coli in the U.S. |  | July 2013-July 2014 |
Benign Acute Pericarditis: Brief Versus Longer Treatment Using Aspirin

Study Overview
=================
Brief Summary
-----------------
Treatment of pericarditis largely remains empirical due to the relative lack of randomized controlled trials. Nevertheless, some recommendations have been formulated to guide management and follow-up of acute pericarditis. Aspirin or an NSAID at medium to high dosages is the mainstay of treatment. Optimal length of treatment is not established. PERICARDITE is a French multicentric placebo controlled double blind randomized trial assessing efficacy of a brief treatment based on Aspirin (4 days) versus a longer treatment (21days) in treating a first episode of probably idiopathic acute pericarditis. It is a non inferiority trial. Exclusion criteria are: diseases known to cause pericarditis: (recent myocardial infarction, autoimmune disease, postpericardiotomy syndromes, connective tissue disease, tuberculosis, neoplastic disease). Primary endpoint is: 30 days recovery defined as the normalization of all clinical and paraclinical initial abnormalities. Secondary endpoint is: 6-month recurrence.

Official Title
-----------------
Benign Acute Pericarditis: Brief Versus Longer Treatment. Randomized, Multicentric, Double Blind, Non Inferiority Trial

Conditions
-----------------
Pericarditis

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


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: age over 18 first episode of acute pericarditis chest pain lasting less than 24 hours Exclusion Criteria: contraindication to aspirin previous history of atypical chest pain previous history of connective tissue disease, tuberculosis, recent MI, auto immune disease, neoplastic disease, thoracic trauma, previous thoracic surgery, antiplatelet routine treatment, anticoagulation

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: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: aspirin<br> | Drug: Aspirin<br>* 3000mg/day of aspirin during the 4th first days and 2000mg/day of aspirin during the 17th following days<br>|
| Placebo Comparator: placebo<br> | Drug: placebo<br>* 3000mg/day of aspirin during the 4th first days and 2000mg/day of placebo during the 17th following days<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| recovery |  | 30 days | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
acute pericarditis, treatment, recurrence