linjc16/ctgov huggingface dataset:
Surgical APGAR Score and Modified Surgical APGAR Score

Study Overview
=================
Brief Summary
-----------------
In this study we aimed to define a new modified SAS is to predict the incidence of postoperative complication and mortality in major abdominal and orthopedic surgery. We also identify the effectivity of this modified scoring system composed of the duration of operation in addition to the three intraoperative parameters of SAS.

Official Title
-----------------
Comparison of Surgical APGAR Score and Modified Surgical APGAR Score in Predicting Possible Postoperative Complications in Major Surgery

Conditions
-----------------
Perioperative/Postoperative Complications

Intervention / Treatment
-----------------
* Procedure: Modified Surgical APGAR Score


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Subject has major surgery More than 18 years Exclusion Criteria: Pregnant Younger than 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?
-----------------

Arms and Interventions

| Intervention/Treatment |
| --- |
|Procedure: Modified Surgical APGAR Score|Four intraoperative factors Lowest heart rate (HR), Lowest mean arterial pressure (MAP) Estimated blood loss Operation time|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Comparison of Surgical APGAR Score and Modified Surgical APGAR Score in Predicting Possible Postoperative Complications in Major Surgery | Operation time should be included as a simple, objective and practical indication of the SAS risk score in the major operations in our study including a single-center, prospective 308 case study, as it can be seen as an independent predictor of postoperative mortality and complications. | 01.06.2017 - 30.09.2017 | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Complication, Mortality, Modified, Surgical Apgar Score
Influence of Music on 6 Minutes Walking Distance in Healthy Children

Study Overview
=================
Brief Summary
-----------------
To evaluate the effect of different distractive auditory stimuli (fast, slow and preferred) on 6 Minute Walking Test (6MWT) and the measured parameters (dyspnea, heart rate, oxygen saturation) in healthy children.

Official Title
-----------------
Influence of a Distractive Auditory Stimulus on 6 Minute Walking Test in Healthy Children

Conditions
-----------------
Healthy Children

Intervention / Treatment
-----------------
* Behavioral: Listening to fast music
* Behavioral: Listening to preferred music
* Behavioral: Listening to slow music


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: the participation to the physical education program after the annual medical investigation Exclusion Criteria: a lung disease an overweight a motor disability based on parent's answers to a questionnaire

Ages Eligible for Study
-----------------
Minimum Age: 5 Years
Maximum Age: 18 Years

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

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

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

Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| No Intervention: Without music<br>6MWT without music | |
| Experimental: With fast music<br>6MWT with a fast music | Behavioral: Listening to fast music<br> <br> * Other names: Listening to fast music during the test;|
| Experimental: With slow music<br>6MWT with a slow music | Behavioral: Listening to slow music<br> <br> * Other names: Listening to preferred music during the 6MWT;|
| Experimental: With preferred music<br>6MWT with the preferred music of the child | Behavioral: Listening to preferred music<br> <br> * Other names: Listening to preferred music during the 6MWT;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Walked distance | The distance walked by subjects during a 6 minutes walking test | After 6 minutes | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Dyspnea | Dyspnea is measured by a visual analogue scale | At the end of the 6MWT | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
exercise tolerance, 6MWT
Effects of Oxygen on Lung Tissue During Anesthesia

Study Overview
=================
Brief Summary
-----------------
Collect exhaled breath condensates from patients scheduled for a routine surgical procedure before, during, and after surgery for measurements of IsoFs Draw blood from patients scheduled for a routine surgical procedure before, during, and after surgery for measurements of serum thrombomodulin.

Detailed Description
-----------------
High concentrations of oxygen are routinely administered to patients undergoing routine surgical procedures even though it is highly likely, at least in patients with normal lung function, that this is unnecessary and in fact may be doing unnecessary harm. Therefore, we plan to assess whether there is any evidence of lung injury during surgery resulted from administration of high concentrations of oxygen by measuring Isofurans (IsoFs) in exhaled breath condensate. In our studies in mice that were exposed to high concentrations of oxygen we also found that circulating levels of thrombomodulin were increased. Thrombomodulin is present in endothelial cells and upon injury they release thrombomodulin into the circulation. Endothelial cell injury is known to occur in hyperoxic-induced lung injury. Therefore, in addition to measuring IsoFs in exhaled breath condensate we will also measure plasma concentrations of thrombomodulin as an indicator of endothelial injury.

Official Title
-----------------
Effects of Oxygen on Lung Tissue During Anesthesia

Conditions
-----------------
Lung Injury, Acute

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: American Society of Anesthesiologists (ASA) Class I-III. Patient is undergoing elective surgery requiring mechanical ventilation Patient is an adult, 18 - 80 years old. Subject has voluntarily signed and dated the informed consent document approved by the Institutional Review Board (IRB). Exclusion Criteria: Surgical procedures boarded for less than 2 hours Current Smoker All Cardiac, Thoracic and/or Vascular surgeries involving the chest Patient unable to cooperate. Chronic airway diseases Asthma Medical contraindication to anesthetic technique (allergy, cardiac condition, neurologic condition, localized infection, bleeding disorder). Subjects who are pregnant.

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

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Exhaled Breath Condensate, elective surgery, mechanical ventilation, Isofurans, thrombomodulin, requiring, mechanical, ventilation
Analysis of Risk Factors for Death After Blunt Traumatic Rupture of the Thoracic Aorta

Study Overview
=================
Brief Summary
-----------------
Aortic injuries after blunt thoracic trauma are compared to the great incidence of accidents relatively rare, but potentially serious leading to death at scene in most of the cases. The study was undertaken to delineate mortality and its risk factors on three different levels (pre-hospital, in-hospital and overall). Between 1990 and 2003, all consecutive patients and victims with traumatic aortic rupture were retrospectively analyzed by reviewing hospital and autopsy records.

Detailed Description
-----------------
During the study period of 14 years (January 1990 to December 2003), all consecutive cases with traumatic rupture of the thoracic aorta being reported in the greater area of Zurich with about one million inhabitants were included in the present study. Related to the final outcome, patient data were drawn either from medical reports from the University Hospital of Zurich, which is a tertiary care teaching hospital and level I trauma center for the eastern part of Switzerland, or from autopsy reports from the Institute of Forensic Medicine of the University of Zurich, respectively. The latter group includes all patients, who died on the scene, in a assigning primary care hospital or on the way to the University Hospital of Zurich. In Switzerland, the criteria used for performing a full autopsy after a blunt traumatic death include all cases in which the events leading to the death are unclear or in which the cause of death is the result of suicide or extrinsic harm. Both, deaths at the scene and in-hospital deaths were included in the study.

Official Title
-----------------
Analysis of Risk Factors for Death After Blunt Traumatic Rupture of the Thoracic Aorta

Conditions
-----------------
Aortic Rupture

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion criteria: During the study period of 14 years (January 1990 to December 2003), all consecutive cases with traumatic rupture of the thoracic aorta being reported in the greater area of Zurich with about one million inhabitants were included in the present study Exclusion criteria: Non-traumatic aortic rupture Non-traumatic aortic dissection

Ages Eligible for Study
-----------------
Minimum Age: 16 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 |
| --- | --- | --- |
Quality of Life in Patients With Multiple Myeloma

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to determine Clinically important difference and Response shift in quality of life in patients with Multiple Myeloma.

Detailed Description
-----------------
Multiple myeloma is a plasma cell tumor with an annual incidence of 6 pr. 100 000. In the absence of curative treatment, the aim of the therapy is not only to induce an objective response and a prolongation of survival but also to improve the patients quality of life. This project will raise two problems which make QoL-data hard to interpret In a clinical trial where many patients are included, statistically significant differences are obtained. However, there is widespread agreement that p-values do not indicate whether a particular finding has clinical significance because statistical significance does not necessarily equate to a meaningful difference or change in QoL. A crucial task for clinicians in interpreting trial-based QoL results is to determine if the observed change is clinically important to the patient. When measuring changes in QoL in a pretest-posttest design,response shift can affect results. Patients with advanced disease can report surprisingly good QoL.Including response shift into quality of life research would allow a better understanding of changes in the QoL that patients report.

Official Title
-----------------
Quality of Life in Patients With Multiple Myeloma

Conditions
-----------------
Multiple Myeloma, Quality of Life

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Multiple Myeloma Age > 18 years Informed consent Exclusion Criteria: Terminal illness with life expectancy less than 3 months Unable to fill in a questionnaire in norwegian

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 |
| --- | --- | --- |

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Multiple Myeloma, Quality of Life, Response Shift, Clinically Important Difference
Molecular & Clinical Evaluation of Low HDL Syndromes

Study Overview
=================
Brief Summary
-----------------
To study the genetic cause of low HDL-C, a risk factor for premature atherosclerotic vascular disease in patients with normal total cholesterol. The focus is primarily on the identification of a single mutation, as has been demonstrated in one family.

Detailed Description
-----------------
BACKGROUND: Low levels of high density lipoprotein cholesterol (HDL-C) have been found to be associated with an increased risk for coronary artery disease (CAD). However, the genetic basis for this association is not well understood and the clinical implications of this association have not been extensively addressed. The study, in seeking to elucidate the genetic basis for low HDL-C and examine the clinical implications of low HDL-C, focuses upon an important research topic. DESIGN NARRATIVE: Specific aims of the study include: 1) Collection and characterization of plasma and DNA from probands with very low HDL-C. Linkage analysis will be performed using highly polymorphic markers within or near HDL-C candidate genes. The hypothesis to be tested is that polymorphic microsatellites segregate with the low HDL-C phenotype. 2) Further genetic characterization of families evidence of linkage to specific HDL-C candidate genes identified in Specific Aim 1. The hypothesis to be tested is that structural variants in HDL-C candidates are responsible for low HDL-C. 3) Evaluate the physiologic significance of novel genomic variants identified in Specific Aim 2. The hypothesis to be tested is that structural variants will affect expression of the gene product. 4) Examine early atherosclerosis in low HDL-C syndromes. The hypothesis to be tested is that increased carotid intima-medial thickness is prevalent with isolated low HDL-C.

Conditions
-----------------
Cardiovascular Diseases, Heart Diseases, Atherosclerosis

Participation Criteria
=================
Eligibility Criteria
-----------------
No eligibility criteria

Ages Eligible for Study
-----------------
Maximum Age: 100 Years

Sexes Eligible for Study
-----------------
Male

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Pedigree 1<br> | |
| Pedigree 2<br> | |
| Pedigree 3<br> | |
| Pedigree 4<br> | |
| Pedigree 5<br> | |
| Pedigree 6<br> | |
| Pedigree 7<br> | |
| Pedigree 8<br> | |
| Pedigree 9<br> | |
| Pedigree 10<br> | |
| Pedigree 11<br> | |
| Pedigree 12<br> | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Gene discovery |  | 20 years |
Study of ONTAK in Patients With B-Cell Chronic Lymphocytic Leukemia (CLL)

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to evaluate the safety and effectiveness of ONTAK in previously treated patients with chronic lymphocytic leukemia (CLL)

Official Title
-----------------
A Multicenter, Phase II Study of ONTAK (Denileukin Diftitox) in Patients With Previously-Treated Chronic Lymphocytic Leukemia

Conditions
-----------------
Leukemia, Lymphocytic, Chronic

Intervention / Treatment
-----------------
* Drug: ONTAK


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients with B-cell Chronic Lymphocytic Leukemia, Rai Stage 0-II with indication for treatment by NCI Working Group Criteria or Rai Stage III or IV. Patients must have received at least one prior purine analogue-based chemotherapy regimen. ECOG Performance Status of 0, 1, or 2. Female patients cannot be pregnant and must use birth control during the course of the study and for three weeks after the study ends. Exclusion Criteria: Prior treatment with ONTAK (DAB389IL-2) or DAB486IL-2. Received any therapy for CLL within 35 days prior to study entry.

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


Arms and Interventions

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

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Objective Clinical Response |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Time-to-Progression |  |  | 
| Duration of response |  |  |
Magnesium and Dexmedetomidine in Pheochromocytoma

Study Overview
=================
Brief Summary
-----------------
Anesthesia management of pheochromocytoma excision surgery is associated with severe hemodynamic fluctuations.The objective of this study was to compare the hypertensive episodes requiring sodium nitroprusside administration between the group treated with magnesium-dexmedetomidine and conventional group in pheochromocytoma.

Official Title
-----------------
Magnesium and Dexmedetomidine Combination Reduces Sodium Nitroprusside Requirement in Laparoscopic Pheochromocytoma

Conditions
-----------------
Phaeochromocytoma Crisis, Hemodynamic Instability

Intervention / Treatment
-----------------
* Drug: Magnesium-Dexmedetomidine


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: American Society of Anesthesiologists classification (ASA) 1-3 high urinary catecholamine or metabolites tumor sizes < 5 cm body mass index (BMI) <35 kg/m2 Exclusion Criteria: open surgery bilateral masses tumor larger than 5 cm incomplete data

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Conventional group (GC)<br>Not receive perioperative additional medication. | |
| Magnesium-dexmedetomidine therapy group (GMD)<br>Received oral 300 mg magnesium one week before surgery and magnesium-dexmedetomidine combination perioperatively. | Drug: Magnesium-Dexmedetomidine<br>* Received oral 300 mg magnesium one week before surgery and magnesium-dexmedetomidine combination perioperatively<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Sodium nitroprusside (SNP) requirement | intraoperative hypertensive episodes requiring SNP therapy | intraoperative period | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| vasoactive therapy | hemodynamic fluctuations (hypotension, tachycardia, severe hypertensive crisis) which needed vasoactive therapy. | intraoperative period | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Magnesium, Dexmedetomidine, Nitroprusside, Pheochromocytoma
To Evaluate the Efficacy and Safety of Levocetirizine Versus Loratadine for Treatment of Seasonal Allergic Rhinitis

Study Overview
=================
Brief Summary
-----------------
To Evaluate the Efficacy and Safety of Levocetirizine Versus Loratadine for Treatment of Seasonal Allergic Rhinitis

Official Title
-----------------
Study Evaluating the Efficacy and Safety of 5 mg Levocetirizine Oral Tablets, Once Daily Versus 10 mg Loratadine Oral Tablets, Once Daily for the Treatment of Seasonal Allergic Rhinitis (SAR)

Conditions
-----------------
Rhinitis, Allergic, Seasonal

Intervention / Treatment
-----------------
* Drug: Levocetirizine dihydrochloride


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Male or female, 18 to 60 years old, inclusive two-year history of allergic rhinitis due to tree, grass or weed pollen sufficient histamine-dependent symptoms of rhinitis during the selection week (T5SS ≥ 5) Exclusion Criteria: An ear, nose or throat (ENT) infection asthma requiring daily drug therapy other than ß2 inhaled agonists taken prn atopic dermatitis or urticaria requiring an antihistamine or corticosteroid treatment an associated ENT disease use of decongestants nasal or ocular topical treatment

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

Design Details

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


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: Levocetirizine dihydrochloride|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Investigator rated T5SS (Total 5 symptom Score) over 2 weeks |  | 2 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Investigator's global efficacy evaluation at 2 weeks; the patient's mean T5SS and 5 individual symptoms (over the last 24 hours) over the first week and over the 2 weeks of treatment; the Symptoms Score Reducing Index (SSRI). |  | 2 weeks | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Levocetirizine dihydrochloride, Xyzal tablets