linjc16/ctgov huggingface dataset:
Stromal Gene Expression During Pulmonary Sarcoidosis

Study Overview
=================
Brief Summary
-----------------
to determine the genetic pathways operating at the tissue level to cause granulomatous inflammation in the lungs and lymph nodes of patients with sarcoidosis. By so doing, we hope to identify unique genetic mechanisms which will aid in the diagnosis of sarcoidosis and will help us understand the pathogenesis of this poorly understood disease.

Detailed Description
-----------------
to collect small sample of lung tissue recovered from a clinical procedure such as bronchoscopy, or a mediastinoscopy (a procedure in which a lighted instrument (mediastinoscope) is inserted through a neck incision to visually examine the structures in the top of the chest cavity and to take a sample (biopsy) of tissue.

Official Title
-----------------
Stromal Gene Expression During Pulmonary Sarcoidosis

Conditions
-----------------
Sarcoidosis

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: diagnosis of sarcoidosis Exclusion Criteria: inability to provide 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

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| sarcoidosis<br>sarcoidosis patients undergoing clinical bronchoscopy | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To Identify Gene Expression Patterns That Specifically Correlate With Active Pulmonary Sarcoidosis. |  | end of study | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To Determine if Gene Expression Patterns Correlate With The Severity of Illness Of Sarcoidosis Patients |  | end of study | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
sarcoidosis, stromal gene expression, pulmonary sarcoidosis, bronchoscopy
Prognostic Value of New Cardiac Biomarkers in Elderly Patients Undergoing Cardiac Surgery

Study Overview
=================
Brief Summary
-----------------
To evaluate the use of new cardiac biomarker for the prediction of in-hospital cardiovascular complications in elderly patients undergoing elective cardiac surgery.

Detailed Description
-----------------
Plasma N-terminal pro-brain natriuretic peptide (NT-proBNP, cardiac troponin T (cTnT), pregnancy-associated plasma protein A (PAPP-A), ischemia-modified albumin (IMA), myeloperoxidase (MPO), metalloproteinase (MMP) soluble CD 40 ligand (sCD40L), and inflammatory cytokine levels will be measured in 100 elderly patients undergoing elective cardiac surgery with cardiopulmonary bypass before induction of anesthesia and 12 h, 24 h, and 48 h after surgery. Optimum discriminators for prediction of postoperative cardiovascular complications wil be determined by the use of receiver operating characteristics (ROC) curves analyses.

Official Title
-----------------
Observational Cohort Study on the Prognostic Value of New Cardiac Biomarkers in Elderly Patients Undergoing Cardiac Surgery

Conditions
-----------------
Cardiac Surgery

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: patients aged 75 years or older undergoing elective cardiac surgery with CPB Exclusion Criteria: positive cardiac troponin T test within the week before surgery patients undergoing emergent procedures patients with preoperative mechanical cardiac support patients undergoing hemodialysis

Ages Eligible for Study
-----------------
Minimum Age: 75 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 |
| --- | --- | --- |

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Cardiac biomarker, cardiac surgery, elderly, postoperative complications, Patients aged 75 years or older undergoing cardiac surgery
Salvage Therapy With Idarubicin in Relapsing CNS Lymphoma

Study Overview
=================
Brief Summary
-----------------
The main objective of the trial is to assess the therapeutic activity of idarubicin as salvage treatment in patients with recurrent or progressive lymphoma in the central nervous system.

Official Title
-----------------
Salvage Therapy With Idarubicin in Immunocompetent Patients With Relapsed or Refractory Primary Central Nervous System Lymphomas

Conditions
-----------------
Lymphoma, B-Cell

Intervention / Treatment
-----------------
* Drug: Idarubicin


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Histological or cytological diagnosis of non-Hodgkin's lymphoma Disease exclusively localised into the CNS at first diagnosis and failure Progressive or recurrent disease Previous treatment with HDMTX containing CHT and/or RT Presence of at least one target lesion, bidimensionally measurable Age 18 - 75 years ECOG performance status < 3 (Appendix 1). No known HIV disease or immunodeficiency HBsAg-negative and Ab anti-HCV-negative patients. Adequate bone marrow function (plt > 100000 mm3, Hb > 9 g/dl, ANC > 2.000 mm3) Adequate renal function (serum creatinine < 2 times UNL) Adequate hepatic function (SGOT/SGPT < 3 times UNL, bilirubin and alkaline phosphatase < 2 times UNL) Adequate cardiac function (VEF ≥ 50%) Absence of any psycological, familial, sociological or geographical condition potentially hampering compliance with the study protocol and follow-up schedule Non-pregnant and non-lactating status for female patients. Adequate contraceptive measures during study participation for sexually active patients of childbearing potential. No previous or concurrent malignancies at other sites with the exception of surgically cured carcinoma in-site of the cervix and basal or squamous cell carcinoma of the skin and of other neoplasms without evidence of disease since at least 5 years. No concurrent treatment with other experimental drugs. Informed consent signed by the patient before registration

Ages Eligible for Study
-----------------
Minimum Age: 18 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: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: Idarubicin|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| objective response to treatment |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| duration of response |  |  | 
| overall survival |  |  | 
| acute side effects of idarubicin |  |  |
Study Evaluating Drug Interaction Between Multiple Doses of Ketoconazole and a Single Dose of SKI-606

Study Overview
=================
Brief Summary
-----------------
To investigate a potential pharmacokinetic interaction between SKI-606 and ketoconazole when co-administered.

Official Title
-----------------
An Open-Label, Randomized, 2-Period Crossover Study to Evaluate the Potential Pharmacokinetic Interaction Between Multiple Doses of Ketoconazole and a Single Dose of SKI-606 Administered Orally to Healthy Subjects

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

Intervention / Treatment
-----------------
* Drug: SKI-606


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Healthy as determined by the investigator on the basis of medical history, physical examination, clinical laboratory test results, vital signs, and 12-lead ECG.

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: Treatment
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: SKI-606|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pharmacokinetics; safety and tolerability |  |  |
The Influence of Methotrexate on the Metabolism and Vascular Effects of Adenosine in Humans

Study Overview
=================
Brief Summary
-----------------
In this study we aim to determine whether methotrexate influences the metabolism and vascular effects of adenosine in humans in vivo. Adenosine is an endogenous purine-nucleoside with potent anti-inflammatory effects. Also, adenosine receptor stimulation induces vasodilation, ischaemic preconditioning and many other cardiovacular effects. Previous animal studies have provided limited evidence that the anti-inflammatory effects of methotrexate are mediated by adenosine receptor stimulation. In this study, we aim to determine whether also in humans in vivo, methotretate influences endogenous adenosine. Therefore, 10 patients with inflammatory arthritis are treated with methotretxae (15 mg/week orally) for 12 weeks. Before and after treatment, vasodilation to the infusion of adenosine and dipyridamole into the brachial artery is assessed as biomarker for the endogenous adenosine concentration. Also, blood is drawn for the determination of CRP, ESR, Adenosine deaminase activity adn homocysteine.

Official Title
-----------------
The Influence of Methotrexate on the Metabolism and Vascular Effects of Adenosine in Humans

Conditions
-----------------
Methotrexate, Vasodilation

Intervention / Treatment
-----------------
* Drug: Methotrexate 15 mg/week for 12 weeks


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: 18-75 year polyarthritis DAS score > 2.5 Exclusion Criteria: previous use of MTX concomitant use of dipyridamole/sulfazalasine Alcohol > 21 U/week elevated liver enzymes pregnancy, breast-feeding, asthma, renal insufficiency, thrombocytopenia, leucocytopenia

Ages Eligible for Study
-----------------
Minimum Age: 18 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: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: Methotrexate 15 mg/week for 12 weeks|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Vasodilator response to infusion of adenosine and dipyridamole into the brachial artery |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Adenosine deaminase activity |  |  | 
| CRP, BSE, DAS |  |  |
Transesophageal Echocardiography (TEE) and Simulation : a Preferred Learning Path

Study Overview
=================
Brief Summary
-----------------
Transesophageal echocardiography (TEE) has gradually become the technique of choice for continuous functional examination of the heart despite the significant training required for its interpretation. It has proven to be the safest, fastest, and most reliable technique for diagnosing most intra- and postoperative hemodynamic problems. Indeed, the transesophageal route is particularly well adapted to the situation of intubated patients, whether in the operating room, in the outpatient department or in intensive care. It offers images that are easier to obtain and of better quality than the transthoracic route; it can be performed without interfering with surgical activity or resuscitation. However, TEE training is often poor during the DES training in anesthesia and resuscitation, reserved for the few interns who will learn in a specific department where TEE is used on a daily basis. Thus, simulation is a logical and recognized means by which technical aspects, mechanisms involved in the understanding of a situation, reasoning and decision making can be analyzed and improved. The RFE SFAR 2019 recommendations suggest the use of simulation for the learning of technical gestures in initial training in order to improve their acquisition. This study is therefore part of a technical and diagnostic improvement of a practice, which appears to be essential in several fields in anesthesia and intensive care, for a technique still not sufficiently acquired by many future practitioners.

Official Title
-----------------
Transesophageal Echocardiography (TEE) and Simulation : a Preferred Learning Path

Conditions
-----------------
Cardiac Disease

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion criteria: 1st or 2nd year DESAR interns who participated in the continuing education program Interns who agreed to participate in the professional practice evaluation study Exclusion criteria : Interns who did not participate in the training Residents who do not agree to take the final test

Ages Eligible for Study
-----------------
Minimum 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 |
| --- | --- | --- |
| Ability of a population of medical students to perform a TEE thanks to the contribution of simulation to their learning compared to a population of interns not trained on a high definition simulator Time in seconds required to make the 11 cuts |  | 1 hour after operation | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Cardiac disease, Transesophageal echocardiography, TEE, High definition simulator
Effect of Salmeterol on Brain-Derived Neurotrophic Factor (BDNF) Concentrations in Asthma

Study Overview
=================
Brief Summary
-----------------
BDNF has been linked to the pathogenesis of airway hyperresponsiveness in asthma. In this trial, the impact of a treatment with salmeterol and salmeterol / fluticasone on BDNF concentrations will be assessed in patients with asthma. The investigators hypothesize that salmeterol impacts on BDNF concentrations in patients with asthma.

Official Title
-----------------
Effect of Salmeterol on Brain-Derived Neurotrophic Factor (BDNF) Concentrations in Asthma

Conditions
-----------------
Allergic Asthma

Intervention / Treatment
-----------------
* Drug: Salmeterol and Salmeterol / Fluticasone


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Age > 18 years, a physician's diagnosis of allergic asthma A documented sensitization to aero-allergens (pollen, animal hair, or house dust mite) A pre-bronchodilator forced expiratory volume in the first second (FEV1) > 80 % of the predicted value (% predicted), a provocative concentration of histamine causing a 20 % fall in FEV1 (PC20) of < 8 mg histamine / ml Exclusion Criteria: No regular treatment (only short-acting inhalers on demand were allowed) No history of or evidence for any other chronic disease than asthma No history of smoking, absence of any signs or symptoms of an infection

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: A<br>Treatment with Salmeterol for 2 weeks, followed by a treatment with Salmeterol and Fluticasone for 2 weeks. | Drug: Salmeterol and Salmeterol / Fluticasone<br>* Patients inhale salmeterol for 2 weeks, followed by an inhalation of both salmeterol and fluticasone for 2 weeks.<br>* Other names: Viani;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| BDNF concentrations in serum, platelets and plasma |  | 2006 - 2007 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Airway hyperresponsiveness |  | 2006 - 2007 | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Airway hyperresponsiveness
Influence of Audiovisual Aids in the Preanesthetic Interview

Study Overview
=================
Brief Summary
-----------------
1000 patients will be asked to fill out a questionnaire about preanesthetic visit right after the interview. On a daily randomization the Groups will be assigned to: Group A = face-to-face interview; Group B = interview plus brochure, Group C= interview plus movie. Evaluation of patient satisfaction und knowledge transfer will be evaluated with a questionnaire filled out right after the interview with the anesthesist.

Official Title
-----------------
Influence of Audiovisual Aids in the Preanesthetic Interview: A Comparison of the Effect of Face-to-face-interview Versus a Brochure and Video Assisted Interview

Conditions
-----------------
Patient Satisfaction

Intervention / Treatment
-----------------
* Behavioral: questionnaire
* Behavioral: face-to-face interview
* Behavioral: brochure
* Behavioral: movie


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: voluntary Exclusion Criteria: language Problems not able to read or write patients does not want to fill out questionnaire
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: Sequential Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: interview<br>questionnaire after face-to-face interview | Behavioral: questionnaire<br>* questionnaire post preanesthetic interview<br>Behavioral: face-to-face interview<br>* Group A = face-to-face interview<br>Behavioral: brochure<br>* after reading a brochure a face to face interview will take place<br>Behavioral: movie<br>* after seeing a film about the procedure a face-to-face interview will take place<br>|
| Placebo Comparator: brochure<br>questionnaire interview plus brochure | Behavioral: questionnaire<br>* questionnaire post preanesthetic interview<br>Behavioral: brochure<br>* after reading a brochure a face to face interview will take place<br>|
| Placebo Comparator: movie<br>questionnaire interview plus movie | Behavioral: questionnaire<br>* questionnaire post preanesthetic interview<br>Behavioral: movie<br>* after seeing a film about the procedure a face-to-face interview will take place<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Patient satisfaction on a questionnaire | Patient satisfaction after the preanesthetic interview is measured | 15 Minutes | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| time | time needed for the preanesthetic interview in Minutes | 30 Minutes | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
preanesthesia, movie, patient satisfaction, brochure, face-to-face interview
Creatine for the Treatment of Amyotrophic Lateral Sclerosis

Study Overview
=================
Brief Summary
-----------------
Creatine is a naturally occurring chemical involved in the production of energy in muscle. Abnormalities in creatine have been linked to the progression of degenerative neuromuscular diseases such as amyotrophic lateral sclerosis (ALS, or Lou Gehrig's Disease). This study will test whether taking creatine can improve the symptoms of ALS.

Detailed Description
-----------------
Amyotrophic lateral sclerosis is a progressive neurodegenerative disorder selectively affecting motor neurons, resulting in progressive weakness. Currently there is no known cure and a specific cause has not been identified. Creatine is a nutritional supplement that improves mitochondrial function and has been shown to protect motor neurons in animal models of ALS. Preliminary research indicates that creatine may also improve strength in patients with ALS. This study will determine the effect of creatine treatment on short-term muscle strength and long-term muscle deterioration in patients with ALS. Participants in this study will be randomly assigned to receive either creatine or placebo. Participants will be enrolled in the study for 9 months. Quantitative muscle testing will be done weekly for the first 3 weeks; participants will then be followed monthly for the next 4 months and bimonthly for the remainder of the 9-month study. The study will also monitor purposeful exercise to determine if this enhances the benefit of creatine usage on muscle strength. Pulmonary function testing will accompany the muscle testing to determine if creatine strengthens respiratory muscles, thereby enhancing pulmonary function.

Official Title
-----------------
Clinical Trial of Creatine in Amyotrophic Lateral Sclerosis

Conditions
-----------------
Amyotrophic Lateral Sclerosis

Intervention / Treatment
-----------------
* Drug: creatine monohydrate


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria Diagnosis of probable or definite ALS At least 5 of 10 testable upper extremity muscle groups (shoulder and elbow extensors/flexors and grip) of Medical Research Council (MRC) grade 4 or better At least 5 years from onset of symptoms Exclusion Criteria Requires tracheostomy ventilation History of renal disease

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: Randomized
Intervention Model: Factorial Assignment
Masking: Double


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: creatine monohydrate|nan|

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
-----------------
ALS, Creatine