linjc16/ctgov huggingface dataset:
Effects of Parenteral and Enteral Nutrition on Skeletal Muscle Genomics

Study Overview
=================
Brief Summary
-----------------
The study investigates effects related to muscle protein metabolism at provision of Parenteral or enteral nutrition

Detailed Description
-----------------
Randomized study investigation alterations in muscle protein metabolism at provision of parenteral or enteral (oral drink) nutrition. The study uses a genomic/transcriptomic/proteomic approach to evaluate factors related to activation of skeletal muscle protein synthesis and protein degradation. Patients scheduled for major gastrointestinal surgery are included. Muscle specimens are collected during surgery.

Official Title
-----------------
Effects of Parenteral and Enteral Nutrition on Skeletal Muscle Genomics

Conditions
-----------------
Muscle Loss

Intervention / Treatment
-----------------
* Dietary Supplement: Parenteral nutrition (PN)
* Dietary Supplement: Enteral nutrition
* Other: Control


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Major gastrointestinal surgery. Assumed need of post-operative nutrition support. Exclusion Criteria: Insulin dependent diabetes. Steroid medication.

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: Basic Science
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Parenteral nutrition<br>Overnight infusion of parenteral nutrition. Supplied as all-in-one-bag format. Infusion rate of 0.2 g N/kg/day. | Dietary Supplement: Parenteral nutrition (PN)<br>* Overnight infusion of parenteral nutrition. Supplied as all-in-one-bag format. Infusion rate of 0.2 g N/kg/day.<br>* Other names: Total parenteral nutrition (TPN);|
| Active Comparator: Enteral nutrition<br>Oral nutrition drink. 2 * 200 ml on the night before operation. 1* 200 ml on the morning of operation day. | Dietary Supplement: Enteral nutrition<br>* Oral nutrition drink. 2 * 200 ml on the night before operation. 1* 200 ml on the morning of operation day.<br>* Other names: nutrition drink;|
| Placebo Comparator: control<br>Overnight infusion of crystalloid fluid (Ringer acetate) infused at the same rate (ml/kg) as intervention PN | Other: Control<br>* Overnight infusion of crystalloid fluid (Ringer acetate) infused at the same rate (ml/kg) as intervention PN<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Muscle protein metabolism | Alterations in skeletal muscle gene expression quantified by microarray |  12-14 hours. | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Skeletal muscle
Pain Relief of Metoprolol Versus Metoprolol Plus Morphine in Acute Chest Pain

Study Overview
=================
Brief Summary
-----------------
The primary aim was to evaluate the relief of chest pain during the first 30 minutes among patients who received metoprolol alone as compared with metoprolol plus morphine

Conditions
-----------------
Acute Coronary Syndromes

Intervention / Treatment
-----------------
* Drug: Metoprolol
* Drug: metoprolol plus morphine


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Acute chest pain ECG-signs indicating myocardial ischemia Exclusion Criteria: Heart rate < 60 beats/min Systolic blood pressure < 110 mmHg High degree AV-block Signs of obstructive pulmonary disease Signs of pulmonary oedema Unwillingness Participation in other studies Long delay between arrival of ambulance and randomisation
Sexes Eligible for Study
-----------------
All

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: A<br>A=metoprolol | Drug: Metoprolol<br> <br> |
| Active Comparator: B<br>B=metoprolol plus morphine | Drug: metoprolol plus morphine<br> <br> |

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

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

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Acute coronary syndrome, Chest pain, Betablockers, Morphine, Prehospital phase
SOLARIS Endoprosthesis in Iliac Occlusive Disease

Study Overview
=================
Brief Summary
-----------------
Fifty patients will be treated with Solaris Endoprosthesis and followed up to 2 years with Walking Impairment Questionnaire and Doppler Ultrasound evaluation in 30 days, 6 months and 12 months.

Official Title
-----------------
Solaris Endoprosthesis Performance in Treatment of Patients With Peripheral Occlusive Arterial Disease in the Iliac Territory - Post-Marketing Solaris I Study.

Conditions
-----------------
Peripheral Arterial Disease

Intervention / Treatment
-----------------
* Device: Endoprosthesis implantation


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Rutherford Class 2 to 5; Tasc II Class A, B, C or D; Unilateral or bilateral lesion, de novo or restenotic but not in-stent; Target lesion of 3 to 10 cm length; ≥ 50% stenosis or common iliac or external iliac artery; Reference vessel diameter ≥ 5 and ≤ 9 mm; Deep femoral artery patent and at least one infrapopliteal artery patent; Informed Consent provided. Exclusion Criteria: Thrombocytopenia induced by heparina or tPA intravenous, clopidogrel, ticlopidine or aspirin sensitivity; Target lesion near to aneurysm, highly calcified or excessively tortuous; Previous stent on target vessel; Presence of other lesions that need treatment within 30 days; Rutherford Class 6; Acute thrombotic occlusion; History on amputation on the target limb.

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 |
| --- | --- |
| Endoprosthesis implantation<br>Device implantation | Device: Endoprosthesis implantation<br>* Endoprosthesis implantation by Percutaneous Angioplasty<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Major Adverse Events | MAE is defined as death related to study device/ procedure, Myocardial Infarction, Target Vessel Revascularization or member amputation | 1 day | 
| Target Lesion Patency | Stenosis < 50% and systolic velocity up to 2.5 cm2/s and no TLR | 6 months |
Prevention of Cardiovascular Diseases Caused by Complex Treatment of Patients With Primary Operated Breast Cancer

Study Overview
=================
Brief Summary
-----------------
To develop a method of medical prevention of cardiovascular diseases caused by cardiotoxicity against the background of complex treatment of patients with primary resectable breast cancer to reduce the risk of cardiovascular complications

Detailed Description
-----------------
Purpose of the study: to develop a method of medical prevention of cardiovascular diseases caused by cardiotoxicity against the background of complex treatment of patients with primary resectable breast cancer to reduce the risk of cardiovascular complications

Official Title
-----------------
To Develop and Implement a Method for Medical Prevention of Cardiovascular Diseases Caused by Complex Treatment of Patients With Primary Operated Breast Cancer

Conditions
-----------------
Women With Breast Cancer

Intervention / Treatment
-----------------
* Drug: Bisoprolol; Perindopril;


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: women with breast cancer, with a morphologically confirmed diagnosis before the appointment of anticancer therapy. Exclusion Criteria: presence of other oncological diseases
Sexes Eligible for Study
-----------------
Female

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

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

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| No Intervention: Group 1<br>women with breast cancer, with a morphologically confirmed diagnosis before the appointment of anticancer therapy, untreated | |
| Active Comparator: Group 2<br>women with breast cancer, with a morphologically confirmed diagnosis before the appointment of anticancer therapy, receiving treatment with a combination of bisoprolol and perindopril | Drug: Bisoprolol; Perindopril;<br>* based on the results of the patient study, different drug therapy regimens for cardiovascular complications during chemotherapy will be proposed<br>* Other names: Bisoprolol; Perindopril;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| development of cardiovascular diseases and complications | hypertension, cardiomyopathy, arrhythmia's, myocardial infarction, heart failure | 4 years |
Effect of Metformin on Gut Microbiota Changes and Glycemic Control of Newly Diagnosed Type 2 Diabetes

Study Overview
=================
Brief Summary
-----------------
This study was aimed to investigate the effect of metformin on the gut microbiota and glycemic control in newly diagnosed type 2 diabetes patients.

Detailed Description
-----------------
This study was aimed to investigate the effect of metformin on the gut microbiota and glycemic control in newly diagnosed type 2 diabetes patients. All the recurited patients were treated with metformin 1500-2000mg daily for 3 months. Stool specimens and blood samples were collected at the beginning and 3 months later.

Official Title
-----------------
Effect of Metformin on Gut Microbiota Changes and Glycemic Control of Newly Diagnosed Type 2 Diabetes

Conditions
-----------------
Type 2 Diabetes

Intervention / Treatment
-----------------
* Drug: Metformin Hydrochloride


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: newly diagnosis type 2 diabetes ,HbA1c >7 % Exclusion Criteria: history of cardiovascular disease, hypertension, severe renal dysfunction defined as glomerular filtration rate < 45 mL/min/1.73 m2; severe illness or diabetic ketoacidosis within 30 days, inability to tolerate ≥500 mg metformin twice per day and pregnancy.

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 65 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
Interventional Model Description: newly diagnosed type 2 diabetes was treated with metfomin for 3 months.
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: metformin group<br>all the patients were treated with metformin 1500-2000mg daily for 3 months. | Drug: Metformin Hydrochloride<br>* treated with metformin 1500-2000mg daily<br>* Other names: intervention group;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| gut micribiota | the changes of gut micribiota | 3 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| glycemic control | HbA1c | 3 months |
Zileuton and Exhaled Nitric Oxide in Asthmatics

Study Overview
=================
Brief Summary
-----------------
Evaluate the additive role of zileuton 600mg qid to clinically stable asthmatics on Advair 250/50 bid. Since asthma is an endogenous inflammatory disease there usually is increased total exhaled, bronchial and alveolar nitric oxide which are markers of eosinophilic driven pathways of inflammation. The addition of zileuton which is a leukotriene synthesis inhibitor by itself or together with inhaled corticosteroids should reduce nitric oxide gas exchange.

Official Title
-----------------
Evaluation of Additive Effects of Zileuton to Advair on Total Exhaled, Bronchial, and Alveolar Nitric Oxide in Asthmatics

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

Intervention / Treatment
-----------------
* Drug: zileuton


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Non-smoking Moderate to severe persistent asthmatics Clinically stable X 6 weeks on Advair 250/50 bid for at least 12 months Exclusion Criteria: No leukotriene synthesis inhibitors or receptor antagonists for 6 weeks

Ages Eligible for Study
-----------------
Minimum Age: 21 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: Non-Randomized
Intervention Model: Crossover Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: 1<br>Advair 250/50 (baseline) fluticasone/salmeterol 250/50 | Drug: zileuton<br>* zileuton (Zyflo) 600mg qid for 2hr and for 30 days<br>* Other names: zyflo;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| nitric oxide gas exchange including total exhaled nitric oxide, bronchial and alveolar nitric oxide |  | 2 hr to 1 month | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| expiratory spirometry and asthma symptom Juniper score |  | 2 hr to 1 month | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
asthma, nitric oxide gas exchange, lung function
Impact and Utility of PET Versus Clinical Score for the Assessment of Inflammatory Activity in Takayasu Arteritis

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to demonstrate that [18F]FDG PET is a a better method than clinical and laboratory values for the identification and assessment of inflammatory activity in patients with Takayasu Arteritis (TA), allowing long-term follow-up with a precise evaluation of response to therapy.

Detailed Description
-----------------
Inflammatory activity and fibrosis are the main causes of morbidity and mortality in patients with Takayasu arteritis. The investigators objective is to determine the utility of using 18F-FDG PET in the basal evaluation and follow-up of patients and compare the results with Dabague's clinical score.

Official Title
-----------------
Impact and Utility of Positron Emission Tomography (PET) for the Assessment of Inflammatory Activity Arteritis Versus Clinical Score and Laboratory Values in Takayasu Arteritis: a Cohort Study

Conditions
-----------------
Takayasu Arteritis

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: TA was diagnosed if the patient met 3 or more ACR criteria.
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 |
| --- | --- | --- |
Outcomes of Veno Arterial ECMO

Study Overview
=================
Brief Summary
-----------------
veno arterial (VA) extra corporeal membrane oxygenation (ECMO) is a rescue therapy with various indications including refractory cardiac arrest and refractory cardiogenic shock. Amiens hospital university has an ECMO program and is a regional center to address patients requiring VA ECMO. In spite of the application of international guidelines, the mortality of patients with VA remains high with an admitted survival rate at hospital discharge at 40%.

Official Title
-----------------
In-hospital Mortality of Patients With Veno Arterial ECMO: a Prospective Observational Study

Conditions
-----------------
Mortality, Extra Corporeal Membrane Oxygenation

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: age : ≥ 18 Patient with a VA ECMO Exclusion Criteria: age<18

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 |
| --- | --- | --- |
| In-hospital mortality | In-hospital mortality of patients with : veno arterial (VA) extra corporeal membrane oxygenation (ECMO) | Up to hospital discharge, an average of 1 month | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
veno arterial, mortality, extra corporeal membrane oxygenation
Evaluation of Colecalciferol Substitution in Dialysis Patients

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to determine the effect of a colecalciferol substitution in dialysis patients on bone metabolism and immune system

Official Title
-----------------
Evaluation of Colecalciferol Substitution in Dialysis Patients

Conditions
-----------------
RENAL INSUFFICIENCY, CHRONIC, Hyperparathyroidism, Secondary

Intervention / Treatment
-----------------
* Drug: Colecalciferol


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Serum 25-OH-Vit.D-levels < 60 ng/ml Age > 18 years dialysis treatment > 3 Months signed written informed consent Serum-Calcium-levels < 2,6 mmol/l within the last 4 weeks Serum-Phosphate-levels < 7,0 mg/dl within the last 4 weeks Ca x P-Product < 75 mg2/dl2 within the last 4 weeks Exclusion Criteria: Serum 25-OH-Vit.-D-levels > 60 ng/ml concommitant participation in another interventional trial psychiatric disorders preventing from valid informed consent Hyperphosphatemia (> 7,0 mg/dl) within the last 4 weeks Hypercalcemia (> 2,6 mmol/l) within the last 4 weeks Ca x P-Product > 75 mg2/dl2 within the last 4 weeks pregnancy or lactation known malignancy liver disease, defined as 2-fold upper limit of ASAT-, or ALAT-levels PTH levels < 50 pg/ml current clinically relevant infections treated with antibiotic therapy and raised hsCRP levels Chronic viral Infectious diseases (e.g. HIV, Hepatitis B or C) Immunosuppressant Medication known hematologic disorders, other than renal anemia age below 18 years known anaphylactic reaction against the study medication or other ingredients of the study drug preparation renal calculus Pseudohypoparathyroidism Medication including cardiac glycosides Sarkoidosis

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: Colecalciferol|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| CD14/CD16-Monocyte-Subsets (Frequency) |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Production of Cytokines: IFN-γ, TNF-α |  |  | 
| Serum levels of Calcium, Phosphorus, iPTH, hsCRP, alkaline phosphatase |  |  | 
| Th1/Th2- and Tc1/Tc2-Lymphocyte-Frequency |  |  |
A Phase 1 PK Study of Tolperisone in Healthy Subjects

Study Overview
=================
Brief Summary
-----------------
This is a randomized, single-blind, single and multiple dose crossover subjects in healthy adult subjects

Detailed Description
-----------------
This is a single-center, in-patient, treatment sequence-randomized, single-blind SD and MD crossover study in 27 healthy adult male and female subjects. Subjects will be admitted to the clinic on Day-1 and discharged the morning of Day 5 of each treatment period. Subjects will be on a standard diet during each inpatient treatment period; study drug will be administered in the fasted state for PK assessments on Days 1 and 4 of each treatment period. Subjects will have a follow-up phone call 7 to 10 days after the last dose in Period 3. There will be a 6 to 8 day washout between the last dose in Period 1 and the first dose in Period 2, and between the last dose in Period 2 and the first dose in Period 3.

Official Title
-----------------
A Phase 1 Crossover Study of Single and Multiple Dose Pharmacokinetics, and Dose Linearity, of Tolperisone in Healthy Subjects

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

Intervention / Treatment
-----------------
* Drug: Tolperisone


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Generally Healthy Subjects BMI between 18.5 and 32.5 kg/m2 Exclusion Criteria: - pregnant or breastfeeding

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 64 Years

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: Crossover Assignment
Interventional Model Description: sequence randomized
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 50 mg Tolperisone<br>50 mg tablets (2 days SD, 2 days TID) | Drug: Tolperisone<br>* tablets<br>|
| Experimental: 100 mg of Tolperisone<br>100 mg tablets (2 days SD, 2 days TID) | Drug: Tolperisone<br>* tablets<br>|
| Experimental: 200 mg Tolperisone<br>200 mg tablets (2 days SD, 2 days TID) | Drug: Tolperisone<br>* tablets<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Cmax | Maximum plasma concentration of tolperisone | taken over 4 days per dose | 
| Tmax | Time of maximum plasma concentration of tolperisone | taken over 4 days per dose | 
| AUC | Area under the curve of tolperisone plasma concentrations | taken over 4 days per dose | 
| T1/2 | Half life of tolperisone | taken over 4 days per dose |