linjc16/ctgov huggingface dataset:
Hospital Mortality in Patients Submitted to Pharmacoinvasive Strategy With Tenecteplase (TNK)

Study Overview
=================
Brief Summary
-----------------
This study has the following objective: To identify related factors to hospital mortality in patients with ST-segment elevation acute myocardial infarction submitted to pharmacoinvasive strategy within a structured healthcare network.

Detailed Description
-----------------
Primary percutaneous coronary intervention is the main therapy for patients with ST-segment elevation acute myocardial infarction. However, a significant portion of these patients won't receive optimal treatment due to the small number of tertiary centers with interventional laboratories available for 24 hours a day, 7 days a week. Specially in large urban centers and rural areas, where tertiary care hospitals are restricted to a specific region, alternative approaches must be developed. The pharmacoinvasive strategy has emerged as an alternative for patients admitted to primary care centers. It is based in up-front intravenous thrombolytic therapy and transfer to a tertiary center where early, systematic, coronary intervention will be performed between 3 to 24 hours after the administration of thrombolytic drugs, even in cases in which successful reperfusion was obtained.

Official Title
-----------------
Hospital Mortality After ST Segment Elevation Acute Myocardial Infarction Submitted to Pharmacoinvasive Strategy With Tenecteplase (TNK): Analysis of 398 Patients.

Conditions
-----------------
Acute Coronary Syndrome

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Clinical diagnosis of ST-segment elevation acute myocardial infarction submitted to pharmacoinvasive strategy with tenecteplase. Exclusion Criteria: Absence of obstructive coronary disease Surgical reference Did not undergo catheterization

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 |
| --- | --- | --- |
| Hospital Mortality |  | During hospital stay,an expected average of 15 days |
Fatty Liver and Obstructive Sleep Apnea

Study Overview
=================
Brief Summary
-----------------
Non-alcoholic fatty liver disease is associated with obstructive sleep apnea. Abnormalities in liver enzymes can improve following continuous positive airway pressure in patients with obstructive sleep apnea. Computerized tomography can be used to quantify fatty liver changes. We hypothesize that continuous positive airway pressure can reduce morphologic fatty liver changes in patients with obstructive sleep apnea and non-alcoholic fatty liver, an that this reduction can be evident using computerized tomography

Official Title
-----------------
Fatty Liver and Obstructive Sleep Apnea

Conditions
-----------------
Non-Alcoholic Fatty Liver Disease, Obstructive Sleep Apnea

Intervention / Treatment
-----------------
* Device: Continuous positive airway pressure


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Obstructive sleep apnea, defined as AHI>5/h Exclusion Criteria: Consumption of more than 20 grams of alcohol per 24 h Known autoimmune disease Usage of known hepatotoxic drugs Medical history positive for viral hepatitis or other chronic liver disease

Ages Eligible for Study
-----------------
Minimum Age: 30 Years
Maximum Age: 60 Years

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

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

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

Design Details

Primary Purpose: Treatment


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: A<br>continuous positive airway pressure | Device: Continuous positive airway pressure<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Reduction in fatty liver changes on computerized tomography |  | Within 1-2 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Improved liver enzymes abnormalities |  | Within 1-2 years |
Treatment of Early Stage Renal Failure With Active Vitamin D or a Phosphate Binder.

Study Overview
=================
Brief Summary
-----------------
Patients with reduced renal function normally develop hyperparathyroidism, which in turn is associated with increased cardiovascular risk and de-calcification. Hyperparathyroidism may be enhanced by an increased level of FGF23 which is often seen in the early stage of renal failure. This pilot study will investigate the FGF23-lowering effect of early initiation of treatment with a phosphate binder versus active vitamin D in an open crossover design.

Official Title
-----------------
An Open, Randomized, Crossover Phase 2 Pilot Study of Treatment of Stage 3B Renal Failure With Active Vitamin D or a Phosphate Binder to Evaluate the Effect on the FGF23 and PTH Levels.

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

Intervention / Treatment
-----------------
* Drug: Renvela
* Drug: Etalpha


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Renal failure stage 3B 25(OH)vitamin D level above 50 nmol/l Age over 18 years Written consent Exclusion Criteria: Major surgery during the previous 6 months Myocardial infarct during the previous 6 months Unstable heart failure Ongoing treatment for any malignancy History of frequent infections Pregnancy Ongoing treatment with steroids, lithium or biphosphonates

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: Crossover Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Renvela<br>Treatment for 2 weeks | Drug: Renvela<br>* 800mg t.i.d. over 2 weeks<br>* Other names: Sevelamercarbonate;|
| Experimental: Etalpha<br>Vit D Treatment for 2 weeks | Drug: Etalpha<br>* 0.25ug o.d. for 2 weeks<br>* Other names: Alfakalsidol;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| FGF23 serum level |  | Change over 2 weeks of treatment | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Calcium serum level |  | Change over 2 weeks of therapy | 
| Phosphate serum level |  | Change over 2 weeks of therapy | 
| CTX-1 serum level |  | Change over 2 weeks of therapy | 
| PINP serum level |  | Change over 2 weeks of therapy | 
| PTH serum level |  | Change over 2 weeks of therapy | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Renal failure stage 3B
The Changes in Carotid Plaque Neovascularization After Elovocumab Therapy

Study Overview
=================
Brief Summary
-----------------
150 selected patients will be recruited, who have at least one atherosclerotic plaque in the carotid artery that is thicker than 2.0 mm and which is determined to be uniformly or predominantly echolucent by standard ultrasonography. For each of the plaques, standard ultrasonography will be used to evaluate lesion echogenicity, while contrast-enhanced ultrasonography (CEUS) will be used to perform the visual and quantitative analysis of neovascularization. Each technique will be applied at baseline (at the time of study enrollment) and following 0.5、1 year of Elococumab Injection treatment. During the study, these patients will be treated with Elococumab Injection (1ml:140mg),ih, every two weeks.

Official Title
-----------------
The Changes in Carotid Plaque Neovascularization After Long-term Elovocumab Injection Therapy: A Follow-Up Study by Contrast Enhanced Ultrasonography

Conditions
-----------------
Carotid Artery Diseases

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: 1. have at least one atherosclerotic plaque in the carotid artery that is thicker than 2.0 mm and which is determined to be uniformly or predominantly echolucent by standard ultrasonography; 2.patients were referred for optimal medical treatment; 3.patients agreed to undergo follow-up CEUS at half-year and 1-year interval. Exclusion Criteria: 1.patients had previous history of cerebral thrombosis or cerebral embolism; 2.patients were contraindicated to the usage of contrast media; 3.image quality of baseline or follow-up CEUS was severely impaired (in presence of severe artifact, non-diagnostic); 4.patients withdrew the informed consents during follow-up; 5.patients experienced major adverse cerebrovascular events during follow-up; 6.patients refused to undergo follow-up CEUS; 7.lost follow-up

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 85 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 |
| --- | --- | --- |
| The Changes in Carotid Plaque Neovascularization | We will use the time-signal intensity curve to calculate the changes in carotid plaque neovascularization.The time-intensity curve parameters includes: Baseline intensity(BI) and peak intensity (PI).Due to the ultrasound contrast agent, the intra-plaque signal intensity increased. Thus, enhanced intensity (EI) was calculated as follows: EI = PI - BI. EI is a parameter that measures the intensity differences between pre- and post-injections of the intravascular tracer. Relative plaque enhancement (EI-R), measured at the separate peak enhancement point in the blood and plaque, will be calculated as the ratio of enhanced intensity in the carotid artery lumen (EI-L) to the enhanced intensity in the plaque (EI-P) using the following formula: EI-R=EI-L/EI-P. | June 2020 to December 2021 |
The FLASH Study: A Study of Roflumilast Versus Placebo in Patients With Asthma (BY217/M2-023)

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to confirm the dose of roflumilast to be used for asthma management by comparing the effects of 250 mcg and 500 mcg oral roflumilast with placebo on pulmonary function and asthma symptoms.

Official Title
-----------------
The FLASH Study: A Randomized, Controlled Study of Roflumilast 250 mcg and 500 mcg Versus Placebo in Patients With Asthma

Conditions
-----------------
Asthma

Intervention / Treatment
-----------------
* Drug: Roflumilast


Participation Criteria
=================
Eligibility Criteria
-----------------
Main Inclusion Criteria: Diagnosis of persistent chronic bronchial asthma Baseline lung function within specified parameters No change in asthma treatment during the last 4 weeks prior to start of baseline period Stable clinical state Except for asthma, in good health Non-smokers or ex-smokers Main Exclusion Criteria: Poorly controlled asthma Diagnosis of chronic pulmonary disease and/or other relevant lung diseases Patients using continuously (more than 3 days per week) > 8 puffs/day rescue medication

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: Roflumilast|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| change in lung function. |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| change in morning PEF |  |  | 
| asthma symptom score |  |  | 
| rescue medication |  |  | 
| time to withdrawal due to worsening asthma. |  |  | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Roflumilast, Asthma
Frameless Stereotactic Radiosurgery for Brain Metastases

Study Overview
=================
Brief Summary
-----------------
The investigators plan to study high dose, single treatment radiation, using a plastic mask instead of a head frame that pins into a patient's skull. The investigators need to (1) quantify set-up accuracy and patient motion during radiation treatment and (2) ensure that without the head frame the tumour control rate and risk of complications are similar to our previous experience using the head frame.

Official Title
-----------------
Frameless Stereotactic Radiosurgery for Brain Metastases

Conditions
-----------------
Brain Metastases

Intervention / Treatment
-----------------
* Device: Frameless Stereotactic Radiosurgery with radiation mask


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients with brain metastases from a biopsy-proven primary extra-cranial tumor site, excluding lymphoma, germ cell, and small cell lung carcinoma histologies. One to four metastases, and all lesions < 3.5 cm in maximal diameter. Extracranial metastases is of minimal volume or stable with treatment. - Karnofsky performance status ≥ 70 Exclusion Criteria: None of the lesions is abutting or within critical neurological structures: *brainstem optic chiasm eye, and optic nerve. The clearance between metastatic lesions and all critical structures must be at least 2 mm. Patients must not have leptomeningeal disease. Contraindications to imaging or radiation (e.g. pregnancy, elevated serum creatinine, allergy to contrast agents, severe claustrophobia, metal particles in the eye).

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Open Arm<br>Each study patient will receive high dose, single treatment radiation using a plastic mask instead of a head frame that pins into a patient's skull. | Device: Frameless Stereotactic Radiosurgery with radiation mask<br>* Linac-based radiosurgery using a thermoplastic mask (single treatment)<br>* Other names: Frameless Stereotactic Radiosurgery using radiation mask;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Quantification of patient movement occurring during treatment. |  | overall | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Local tumour control |  | overall | 
| risk of complication (radionecrosis) |  | overall | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Radiosurgery, Frameless radiosurgery, Accuracy
A Comparison Study Of Two Different Techniques For Identifying The Epidural Space In Parturients In Labour

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to determine whether the use of the Epidrum device to identify the epidural space in labouring parturients reduces morbidity, when compared to standard loss of resistance techniques.

Official Title
-----------------
A COMPARISON STUDY OF TWO DIFFERENT TECHNIQUES FOR IDENTIFYING THE EPIDURAL SPACE IN PARTURIENTS IN LABOUR: A PILOT PROSPECTIVE RANDOMIZED STUDY.

Conditions
-----------------
Labouring Parturients Requiring/Requesting Epidural Analgesia as Part of Their Peri-partum Care

Intervention / Treatment
-----------------
* Device: Epidrum


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Parturients receiving epidural analgesia for labour Exclusion Criteria: parturients that withold consent parturients less than 18 years old

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

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

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

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

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: EPIDRUM<br>EPIDRUM DEVICE IS USED TO SITE THE EPIDURALS IN THE PATIENTS RANDOMISED TO THIS ARM | Device: Epidrum<br>* Epidrum is used<br>* Other names: Epidrum is the trade name of the device manufactured by Exmore Plastics Uk;|
| No Intervention: Control<br>This arm is the control where normal technique is used | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| RATE OF OCCURRENCE OF DURAL PUNCTURE |  | FIRST 48 HRS | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| RATE OF EPIDURAL BLOOD PATCH |  | I MONTH AFTER LAST PATIENT RECRUITED | 
| RATE OF EPIDURAL FAILURE REQUIRING RE-SITING OF CATHETER |  | 24 HOURS | 
| RATE OF FAILURE IN IDENTIFYING EPIDURAL SPACE REQUIRING CHANGE OF OPERATOR |  | 24 |
Effects of Whole Grain Rye on Metabolic Risk Markers and Mood

Study Overview
=================
Brief Summary
-----------------
The purpose of the study is to investigate, in healthy middle age subjects, effects of whole grain rye on cognitive functions, mood, and cardiovasculair risk markers

Official Title
-----------------
Effects of Whole Grain on Cognitive Performance and Mood, and the Relationships to Cardiometabolic Risk Markers

Conditions
-----------------
Metabolic Disorders and Cognitive Decline

Intervention / Treatment
-----------------
* Other: whole grain
* Other: reference


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: healthy BMI 19-28 plasma glucose < 6.1 mmol/L non smooker Exclusion Criteria: known metabolic diseases known gastrointestinal disorders known cognitive decline.

Ages Eligible for Study
-----------------
Minimum Age: 50 Years
Maximum Age: 70 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: Crossover Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: whole grain<br> | Other: whole grain<br>* whole grain rye<br>|
| Other: refrence<br>white wheat based product | Other: reference<br>* white wheat bread<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| cognitive performance | test of working memory capacity | postprandial 0-180 min after breakfast | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| glucose tolerance | postprandial glucose concentrations | 0-180 min after breakfast |
Sleeve Gastrectomy Versus One-anastomosis Gastric Bypass: Randomized Trial

Study Overview
=================
Brief Summary
-----------------
Hormonal changes after SG and OAGB involve alterations in the levels of many enteric hormones, among these hormones are ghrelin and glucagon-like peptide-1 (GLP-1). Ghrelin is an orexigenic hormone that stimulates food intake and has a documented role in the development of obesity. While ghrelin levels decrease significantly after SG as the fundus, which is the main source of that hormone, is completely removed, they tend to increase after OAGB GLP-1 plays an important role in glucose homeostasis via affecting food intake and satiety. It enhances insulin secretion, stimulates the proliferation and growth of pancreatic beta cells, inhibits food and water intake, and promotes satiety. Some studies reported that both OAGB and SG are followed by increased GLP-1 levels. We conducted this randomized study to compare SG and OAGB with regards to weight loss, comorbidity resolution, changes in ghrelin and GLP-1 hormones, and complications.

Official Title
-----------------
Weight Loss and Change in Ghrelin and GLP-1 Levels After Sleeve Gastrectomy and One-anastomosis Gastric Bypass: a Randomized Clinical Trial

Conditions
-----------------
Morbid Obesity

Intervention / Treatment
-----------------
* Procedure: sleeve gastrectomy
* Procedure: one anastomosis gastric bypass


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Adult patients of both genders with morbid obesity (defined as BMI > 40 kg/m2 or > 35 Kg/m2 with at least one associated comorbidity) were included. Patients who underwent previous surgery for morbid obesity were also included. Exclusion Criteria: patients ageing more than 60 years patients with endocrine disorders patients with psychiatric disorders that influence perception of the study protocol patients unfit for general anesthesia.

Ages Eligible for Study
-----------------
Minimum Age: 16 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
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Sleeve gastrectomy<br>5-port standard sleeve gastrectomy was conducted | Procedure: sleeve gastrectomy<br>* 5-port sleeve gastrectomy<br>|
| Active Comparator: one anastomosis gastric bypass<br>5-port standard one-anastomosis gastric bypass was performed | Procedure: one anastomosis gastric bypass<br>* 5-port one anastomosis gastric bypass<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| excess weight loss | the percentage of excess weight loss after surgery | 12 months after surgery |