linjc16/ctgov huggingface dataset:
The Significance of Blood-tryptase and c-Kit Mutation in Insect Venom Immunotherapy

Study Overview
=================
Brief Summary
-----------------
The investigators wish to evaluate the association between tryptase values as well as c-Kit mutation and adverse effects in the course of immunotherapy. The investigators also intend to assess the effect of immunotherapy on tryptase levels.

Detailed Description
-----------------
According to the presently available reports there is an association between systemic allergic responses to hymenoptera venom and elevated tryptase levels or c-Kit mutation. The presence of these findings may imply the existence of mast cell activation syndrome or mastocytosis. Therefore, baseline tryptase evaluation has become standard evaluation in patients with systemic responses. Meir Medical Center is the only hospital in Israel in which tryptase can be measured. Consequently, the Meir Clinic has accumulated considerable data with regards to tryptase levels in subjects with allergy to hymenoptera venom. The investigators wish to evaluate the association between tryptase values as well as c-Kit mutation and adverse effects in the course of immunotherapy. The investigators also intend to assess the effect of immunotherapy on tryptase levels.

Official Title
-----------------
The Significance of Blood-tryptase Levels and c-Kit Mutation in the Evaluation of Prognosis and Adverse Reactions in Subjects Undergoing Venom Immunotherapy for Insect Allergy

Conditions
-----------------
Hypersensitivity, Immediate, Insect Bites and Stings, Mastocytosis

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: history of systemic response to hymenoptera sting. subject under current or planned venom immunotherapy. Exclusion Criteria: previously diagnosed mast cell disorder

Ages Eligible for Study
-----------------
Minimum Age: 4 Years
Maximum Age: 75 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 |
| --- | --- |
| subjects undergoing venom immunotherapy<br>The study group will include all the subjects receiving routine venom immunotherapy at the Meir Medical Center Allergy Clinic. | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The association between tryptase values/c-Kit mutation and immunotherapy adverse events will be evaluated using blood sample analysis and patient medical records. |  | up to 12 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The association between tryptase values/c-Kit mutation and severity of index sting event will be evaluated using blood sample analysis and patient medical records. |  | up to 12 months |
German Off Pump Coronary Artery Bypass in Elderly Study

Study Overview
=================
Brief Summary
-----------------
Comparison of two operative techniques (on-pump vs off-pump)of coronary revascularisation of the best treatment concept for patients older or 75 years old. Hypothesis: The coronary bypass operation without use of the heart-lung machine (off-pump=OPCAB) reduces the combined endpoint in comparison with the conventional coronary bypass operation (on-pump).

Official Title
-----------------
German Off Pump Coronary Artery Bypass in Elderly Study

Conditions
-----------------
Heart Disease

Intervention / Treatment
-----------------
* Other: coronary artery bypass grafting


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: older or 75 years indication for elective bypass operation patient has signed written consent before randomization Exclusion Criteria: previous heart surgery patient unable to give informed 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?
-----------------

Design Details

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


Arms and Interventions

| Intervention/Treatment |
| --- |
|Other: coronary artery bypass grafting|on pump off pump|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| All cause mortality |  | 1 month and 12 month | 
| Myocardial infarction |  | 1 month and 12 month | 
| Stroke |  | 1 month and 12 month | 
| Any revascularisation |  | 1 month and30 month | 
| renal failure |  | 1 month and 12 month | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| ventilation time |  | post op | 
| blood transfusion |  | post op | 
| length of stay in intensive-care unit |  | post op | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
OPCAB, coronary, bypass, grafting, off pump
Effect of Different Body Position on Intraabdominal Pressure in Mechanically Ventilated Patients

Study Overview
=================
Brief Summary
-----------------
Measuring intraabdominal pressure in the semi-recumbent position and supine position.

Detailed Description
-----------------
Each set of measurements of intraabdominal pressure included intra bladder and intragastric pressure in the supine position followed by the semi-recumbent position at head of bed 30. All four measurements were taken over a period of 5 to 10 min or less to reduce the possibility of changes in intraabdominal pressure over time. Three sets of readings were taken at least 4 h apart over a 24-h period.

Official Title
-----------------
Lecturer in Critical Care Nursing Department

Conditions
-----------------
Intraabdominal Hypertension

Intervention / Treatment
-----------------
* Procedure: head of bed elevation 30 degree
* Procedure: urinary catheter


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: older than 18 years of age. to be sedated mechanically ventilated and to have both a nasogastric tube and indwelling urine catheter in place Exclusion Criteria: recent oesophageal, gastric or bladder surgery; patients who were moribund and unlikely to survive 24 h; patients who were pregnant and patients who were unable to lay flat for any reason.

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 60 Years

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

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

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

Arms and Interventions

| Intervention/Treatment |
| --- |
|Procedure: head of bed elevation 30 degree|the intraabdominal pressure will be measured by nasogastric tube when the head of bed elevated to 30 degree|
|Procedure: urinary catheter|the intraabdominal pressure will be measured by urinary catheter when the patient in supine position|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| determine the effect of different body position on the intraabdominal pressure | the intraabdominal pressure will be measured by urinary catheter and nasogastric tube when the patient in semi-recumbent position at 30 head of bed elevation) | up to 24 hour |
Evaluation of Side Effects of Mitotane

Study Overview
=================
Brief Summary
-----------------
Mitotane is standard therapy in the treatment of adrenocortical carcinoma. However, many adverse effects are not well documented. Therefore, we are aiming at collecting data about adverse effects in patients treated with mitotane

Official Title
-----------------
Evaluierung Von Nebenwirkungen Einer Therapie Mit Mitotane Beim Nebennierenkarzinom- Evaluation of Side Effects of Mitotane in Adrenocortical Carcinoma

Conditions
-----------------
Adrenocortical Carcinoma

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Adrenocortical carcinoma Treatment with mitotane monotherapy as first-line therapy (in adjuvant setting or advanced disease)
Sexes Eligible for Study
-----------------
All

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Mitotane<br>Patients with adrenocortical carcinoma treated with mitotane monotherapy | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Documentation of adverse effects | Adverse effects will be documented using the NCI CTC AE v5.5 | from starting mitotane until discontinuation of mitotane (since this is very variable from patient to patient no specific number of days or weeks can be entered (standard therapy would be about 2 years) or start of additional other medical therapies | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
adrenal cancer, mitotane (Lysodren), adverse events
Effects of Exercise-intensity on Physiological Adaptations in Overweight and Obese

Study Overview
=================
Brief Summary
-----------------
The main purpose of our study is to examine the physiological adaptations in oxygen transport chain for high-intensity exercise and moderate exercise in overweight and obese humans. The main goals are: To investigate the most effective short-and long-interval training in terms of VO2max, pulmonary diffusion, cardiac output, endothelial function and mitochondrial function. How these physiological adaptations affect the aerobic endurance and performance, and how this training can reduce the risk of cardiovascular diseases related to overweight and obesity.

Official Title
-----------------
Effects of Exercise-intensity on Physiological Adaptations in Overweight and Obese

Conditions
-----------------
Overweight, Obesity

Intervention / Treatment
-----------------
* Behavioral: Long distanse moderate training
* Behavioral: Long interval training
* Behavioral: Short interval training


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: BMI > 25 Exclusion Criteria: Exclusion criteria will be cardiovascular disease or another disease that is not consistent with high physical activity. Subjects should not have exercised regularly before the study.

Ages Eligible for Study
-----------------
Minimum Age: 18 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: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Long distanse moderate training<br>40 minutes moderate treadmill running | Behavioral: Long distanse moderate training<br>* Moderate exercise<br>|
| Experimental: Long interval training<br>4x4min interval treadmill running | Behavioral: Long interval training<br>* High-intensity exercise, long duration<br>|
| Experimental: Short interval training<br>10x1min interval treadmill running | Behavioral: Short interval training<br>* High intensity exercise, short duration<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Maximal oxygen uptake | Change in maximal oxygen uptake will be measured after six weeks of various exercise training and related to changes in blood volume, cardiac function, endothelial function and mitochondrial function. | 6 weeks | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Exercise, High-intensity, Interval training
Genetic Factors and Pheochromocytomas in Neoplasia Type 2

Study Overview
=================
Brief Summary
-----------------
Multiple endocrine neoplasia type 2A (MEN2A) is a rare syndrome associated with activating mutations in the RET proto-oncogene, combining medullary thyroid cancer in approximately 100% of cases and pheochromocytoma in 10-80% of cases. While it is accepted that the RET mutation causes variable penetrance of pheochromocytoma in the MEN2A patient population, there is no pathophysiological explanation for the phenotypic variability among patients with the same mutation, including within the same family. The aim of this study is to better characterise the genetic factors that may explain the variable penetrance of pheochromocytoma in MEN2. To this end, the investigatoes plan to perform a whole exome analysis in 2 families carrying the p. Cys634Arg mutation causing NEM2A, followed in Marseille by the principal investigator: the 1st family has 11 members all aged over 35 years, for which 8 are carriers of pheochromocytoma while 3 have not developed it (while their age is higher than the latest age of diagnosis of pheochromocytoma in this family); the 2nd family has 3 members (father and daughter with pheochromocytoma developed before 25 years; son without pheochromocytoma at an age of 42 years). The investigators believe that the analysis of these patients should allow the isolation of variants on genes potentially involved in the genesis of a pheochromocytoma in MEN2.

Official Title
-----------------
Genetic Modifying Factors and Pheochromocytomas in Multiple Endocrine Neoplasia Type 2

Conditions
-----------------
Neoplasia, Pheochromocytoma

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patient aged 18 years or older Male or female patient Patient followed in the investigating department for familial NEM2A C634R (multiple endocrine neoplasia type 2) with or without pheochromocytoma Patient affiliated to or benefiting from a social security scheme Patient having given his non-opposition to participate in this study Patient who has given his consent for the genetic analysis carried out in the framework of the study Patient able to understand the purpose of the study Exclusion Criteria: Protected persons (articles L1121-5, L1121-6 and L121-8 of the Public Health Code): pregnant or breastfeeding women, persons deprived of their liberty, under guardianship or curator Patients unable to understand the purpose of the study and the information note

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 |
| --- | --- | --- |
| Genetic profile | whole-exome analysis between patients with and without pheochromocytoma | Month 0 | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
neoplasia, pheochromocytoma
Local Anesthesia With Sedation for Cochlear Implant Surgery

Study Overview
=================
Brief Summary
-----------------
ABSTRACT Objectives: The aim of this article is to illustrate the possibility of performing a cochlear implant with local anesthesia and sedation, the anesthesic technique and the advantages of that in comparison to a general anesthesia. Materials and method: The investigators describe two successful surgeries done with local anesthesia, including the neural telemetry and the conditions the patient presented after the surgery, with a very good recovery and no complications during and after the procedure. Key words: local anesthesia, cochlear implant

Official Title
-----------------
Local Anesthesia With Sedation for Cochlear Implant Surgery: 3 Case Report

Conditions
-----------------
Cochlear Implant Surgery

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: adult patients with total deafness Exclusion Criteria: children under 18 years old

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 |
| --- | --- | --- |
| Good liability and pos operative period of the patients submitted to cochlear implant surgery with local anestesia and sedation |  | one year | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
local anesthesia, cochlear implant, sedation, 3 patients submitted to cochlear implant surgery with local anesthesia with sedation
Subcuticular Suture Versus Synthetic Glue in Thyroidectomy Incision

Study Overview
=================
Brief Summary
-----------------
The aim of this study is to compare aesthetic results of two different type of sutures (subcuticular versus synthetic glue) in post-thyroidectomy incisions. It is a randomized clinical trial (single blinded) designed as a superiority study, since in the authors' hypotheses glue can give better results compared with subcuticular suture in this particular district. Secondary objective is to investigate if other factors (like the use of cold/warm blade, the sex, the presence of diabetes, the lenght of incision) can influence aesthetic results.

Official Title
-----------------
Comparison of Esthetic Results Between Subcuticular Suture and Synthetic Glue in Thyroidectomy Incision: a RCT

Conditions
-----------------
Goiter, Thyroid Neoplasms, Parathyroid Pathologies

Intervention / Treatment
-----------------
* Device: Octylcyanoacrylate (Dermabond)
* Device: Subcuticular reabsorbable suture (Caprosyn)


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients underwent thyroidectomy, emithyroidectomy, parathyroidectomy Exclusion Criteria: Former neck operations with external incisions Post-operative bleeding Cervical nodes involvement (with the necessity of widened incisions)
Sexes Eligible for Study
-----------------
All

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

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

Design Details

Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: A<br>Patients underwent thyroidectomy, emithyroidectomy, parathyroidectomy sutured with synthetic glue | Device: Octylcyanoacrylate (Dermabond)<br>* Synthetic glue for surgical use (skin closure)<br>* Other names: Dermabond;|
| Active Comparator: B<br>Patients underwent thyroidectomy, emithyroidectomy, parathyroidectomy sutured with subcuticular suture | Device: Subcuticular reabsorbable suture (Caprosyn)<br>* Every stitch is positioned in the subcuticular tissue by a continuous technique<br>* Other names: Caprosyn;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Scar evaluation scale for short term esthetic results (Hollander, J. E., Singer, A. J., Valentine, S., and Henry, M. C. Wound registry: Development and validation. Ann. Emerg. Med. 25: 675, 1995.) |  | 10 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Scar Evaluation Scale (by Adam J. Singer, M.D. et al. Development and Validation of a Novel Scar Evaluation Scale Plastic and Reconstructive Surgery ,December 2007 Volume 120, Number 7 ,1892-1897) |  | 3 months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
thyroidectomy, surgery, synthetic glue, subcuticular suture
Body Composition Changes During Stem Cell Transplantation: The Case Of Lymphoma Patients

Study Overview
=================
Brief Summary
-----------------
Skeletal Muscle Index (SMI) and Visceral Adipose Ratio (VAR) assess body composition changes and disclose malnutrition risk effectively. The aims of the study are to assess prevalence of malnutrition in patients planned for SCT, to characterize changes in body composition (SMI, total adipose tissue and VAR) that occur in the peri transplantation phase, and to identify Waist Circumference (WC) cut off points associated with the metabolic syndrome (MetSyn) in patients with B and T cell Lymphoma.

Detailed Description
-----------------
This study is a retrospective cohort study of patients having B and T cell lymphoma, who underwent SCT in the Bone Marrow Transplantation (BMT) unit at AUBMC. Consecutive patients having B and T lymphoma who underwent SCT at AUBMC will be identified by the research team and will be included as per the below inclusion and exclusion criteria. Starting from June 2016, patients who meet the inclusion criteria will be included in the study up until June 2006. The radiologist will access the AUBMC PACS system to review PET/CT scans of the identified patients. SMI, visceral, subcutaneous and intramuscular adipose tissues will be established by assessing at the level of L3.

Official Title
-----------------
Body Composition Changes During Stem Cell Transplantation: The Case Of Lymphoma Patients

Conditions
-----------------
Hematopoietic Stem Cell Transplantation, Malnutrition, Metabolic Syndrome

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Age>16 years Patients having B and T cell lymphoma who have undergone SCT at AUBMC Exclusion Criteria: Patients with a missing pre-SCT PET/ CT scan Patients with 2 missing post SCT PET / CT scan

Ages Eligible for Study
-----------------
Minimum Age: 16 Years
Maximum Age: 80 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 |
| --- | --- | --- |
| Sarcopenia Prevalence |  | 3 months post Stem Cell Transplantation | 
| Skeletal Muscle Index Changes |  | 3 months post Stem Cell Transplantation | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Skeletal Muscle Index, Visceral Adipose Tissue, Metabolic Syndrome