linjc16/ctgov huggingface dataset:
First Report, Five Years Experience of the Acute Leukemia Work Group

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to describe the incidence, clinic characteristics, biological and suvirval in Lymphoblastic Leukemia patients in Mexico City reference hospitals.

Detailed Description
-----------------
Multicenter and retrospective revision of clinical files with Acute Lymphoblastic Leukemia diagnostic between 2009 and 2013 in Mexico City reference hospitals, in five hospitals with 50 and 100 new cases Acute Lymphoblastic Leukemia per year. With a expected sample between 500 and 1000 patients it will descriptive statistics of variables. The data collection with necessary variables for survival analysis study and risk factors with Kaplan-Meier curve and risk proportional method Cox.

Official Title
-----------------
Diagnostic and Treatment in Acute Lymphoblastic Leukemia Adults: A Multicenter Study of Five Years Experience, Retrospective in Acute Lymphoblastic Leukemia Adults Patients, Mexico City: First Report of the Acute Leukemia Work Group (GTLA)

Conditions
-----------------
Acute Leukemia (Category)

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Clinical diagnosis of Acute Lymphoblastic Leukemia Exclusion Criteria none

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 |
| --- | --- | --- |
| Get the incidence of Acute Lymphoblastic Leukemia in Mexico City reference hospitals | Date collection from clinical files with Acute Lymphoblastic Leukemia diagnostic between 2009 and 2013 in Mexico City in 5 reference hospitals | 5 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Clinic characteristics, biological and survival in Acute Lymphoblastic Leukemia patients in Mexico City reference hospitals | Date collection from clinical files with Acute Lymphoblastic Leukemia diagnostic between 2009 and 2013 in Mexico City in 5 reference hospitals | 5 years |
Turkish Validity and Reliability Study of The Bipolar Recovery Questionnaire

Study Overview
=================
Brief Summary
-----------------
In addition to objective criteria (no episode period for 6 months) for defining and monitoring recovery, evaluation of subjective criteria is also very important. Various Turkish scales related to recovery in progressive diseases have been developed or validity-reliability studies have been conducted. However, as far as we know, there is no scale that evaluates subjective improvement for a disorder such as bipolar disorder that progresses in episodes and has a heterogeneous appearance of loss of functionality. In this study, we aimed to conduct a validity and reliability study of the recovery questionnaire for BDD.

Official Title
-----------------
Turkish Validity and Reliability Study of The Bipolar Recovery Questionnaire

Conditions
-----------------
Bipolar Disorder, Recovery

Intervention / Treatment
-----------------
* Other: validity and realibility of scale


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Being between 18-65 ages Be diagnosed with bipolar affective disorder Be at least primary school graduate Exclusion Criteria: having a physical disability (blindness, etc.) that might prevent filling in the scales, having an additional neurological disease that prevented filling out the scale items.

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

Arms and Interventions

| Intervention/Treatment |
| --- |
|Other: validity and realibility of scale|Turkish validity and realibility of Bipolar Recovery Questionnare|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| validity and reability of scale | turkish validity and reability of Bipolar Recovery Questionnare | 5 months |
Recombinant Human Granulocyte Monocyte - Colony Stimulating Factor (GM CSF) for Prevention of Pneumonia in Patients With Cirrhosis

Study Overview
=================
Brief Summary
-----------------
Informed consent obtained from the patient or the patient's legal surrogate. The window for randomization and initiation of study drug infusion is 2 days from day of Admission. All further time points are relative to the day of randomization. Patients will be randomized (1:1) to receive either recombinant human GM-CSF or placebo. Using randomized block design of 10 each generated by computer and provided in sequential, sealed, opaque envelopes. Subjects will be stratified based on Child status. Patients who fulfil the inclusion criteria will receive either slow IV infusion of GM CSF (Sargamostatim-250mcg/M2) over 4 hour and inhalation of same dose by micronebulizer for 7 days OR Placebo(saline infusion and saline nebulization). Standard medical care will be given in both limbs.

Official Title
-----------------
Randomized Controlled Trial of Recombinant Human Granulocye Monocyte - Colony Stimulating Factor (GM CSF) for Prevention of Pneumonia in Patients With Cirrhosis

Conditions
-----------------
Cirrhosis

Intervention / Treatment
-----------------
* Drug: GMCSF
* Other: Placebo


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patient with cirrhosis admitted to ICU-HDU without pneumonia at admission 18-70 years of Age Child B/ C Exclusion Criteria: Patient having pneumonia If there is evidence of preexisting chronic respiratory failure If the patients is neutropenic (absolute neutrophil count <1000 cells/mm3 If there was a history of hematological malignancy or bone marrow transplantation Person having HCC Acute liver Failure Pregnancy HIV

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 70 Years

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

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

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

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Granulocyte/macrophage colony-stimulating factor (GM-CSF)<br>GM CSF (Sargamostatim-250mcg/M2) over 4 hour and inhalation of same dose by micronebulizer OR Placebo for 7 days. Both the groups will receive standard medical care | Drug: GMCSF<br>* GM CSF (Sargamostatim-250mcg/M2) over 4 hour and inhalation of same dose by micronebulizer<br>|
| Placebo Comparator: Placebo<br>Placebo will be given identical to the interventional | Other: Placebo<br>* Placebo identical to GMCSF will be given<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Survival in both groups |  | 1 year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Development of extra pulmonary organ failure during the course of study. |  | 1 year |
The Effect of Atorvastatin on Renal Function in Healthy Subjects During Normal and High Sodium Intake

Study Overview
=================
Brief Summary
-----------------
We wanted to test the hypothesis that acute treatment with atorvastatin changes renal sodium handling, renal hemodynamics, tubular function and vasoactive hormones in healthy humans during normal and high sodium intake.

Detailed Description
-----------------
We wanted to test the hypothesis that acute treatment with atorvastatin changes renal sodium handling, renal hemodynamics, tubular function and vasoactive hormones in healthy humans during normal and high sodium intake. We wanted to analyze if changes in renal hemodynamics, tubular function, hormones, blood pressure and HR under acute treatment with atorvastatin depends on sodium intake.

Official Title
-----------------
The Effect of Acute HMG-CoA-Reductase Inhibition (Atorvastatin) on Renal Sodium Excretion, Renal Hemodynamics, Tubular Function and Vasoactive Hormones in Healthy Subjects During Normal and High Sodium Intake

Conditions
-----------------
Healthy Subjects

Intervention / Treatment
-----------------
* Drug: Atorvastatin


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Age 20-50 yr BMI<30 Females had to use oral contraceptive treatment or IUD. Exclusion Criteria: Clinical signs or history of disease of the heart, lungs, kidneys, liver, brain or endocrine organs Abnormal laboratory blood tests (hemoglobin, sodium, potassium, albumin, creatinine, blood glucose, bilirubin, alanin amino transferase, alkalic phosphatase) Albuminuria or glucosuria cancer arterial hypertension alcohol abuse medical treatment, except contraceptives pregnancy or breast feeding blood donation one month before the study.

Ages Eligible for Study
-----------------
Minimum Age: 20 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: Double


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: Atorvastatin|80 mg atorvastatin on two following days each|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Glomerular filtration rate, clearance of sodium and lithium, fractional excretion of sodium and lithium, U-AQP-2, total sodium excretion, free water clearance |  | 6 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| AVP, Ang-II, Aldosterone, ANP, BNP, PRC, BP and HR. |  | 6 months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Atorvastatin, healthy, sodium excretion, hemodynamics, tubular function
A Study to Evaluate the Safety and Effectiveness of the 217z Laser With Zyoptix for Lasik

Study Overview
=================
Brief Summary
-----------------
A Study to demonstrate the safety and efficacy of wavefront laser refractive surgery treatments for myopia and astigmatism.

Conditions
-----------------
Myopia, Astigmatism

Intervention / Treatment
-----------------
* Device: 217z Laser


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Myopia with or without astigmatism. Exclusion Criteria: Contraindications to LASIK.

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: LASIK<br>LASIK correction of myopia and myopic astigmatism | Device: 217z Laser<br>* LASIK correction of myopia and myopic astigmatism<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Visual acuity |  | 24 months |
Coordinated Reset Deep Brain Stimulation

Study Overview
=================
Brief Summary
-----------------
The study will explore the viability of an alternative programming strategy in Deep Brain Stimulation (DBS) for patients with Parkinson's Disease (PD).

Detailed Description
-----------------
The study will explore the feasibility of utilizing an alternative programming technique in Deep Brain Stimulation (DBS) for patients with Parkinson's Disease (PD).

Official Title
-----------------
Coordinated Reset Deep Brain Stimulation (RESET-DBS)

Conditions
-----------------
Parkinson's Disease (PD)

Intervention / Treatment
-----------------
* Device: New Programming Paradigm


Participation Criteria
=================
Eligibility Criteria
-----------------
Key Inclusion Criteria: Subject with PD implanted bilaterally in the STN and receiving DBS therapy for at least 3 months. Tolerates > 12 hours OFF medication and, per clinical judgment, be able to perform all study related procedures. Able to understand the study requirements and the treatment procedures and must provide written informed consent before any study-specific tests or procedures are performed. Key Exclusion Criteria: Exhibits significant psychiatric problems, including unrelated clinically significant depression as determined by the investigator. A female who is pregnant, is breastfeeding, or is of childbearing potential and planning to get pregnant
Sexes Eligible for Study
-----------------
All

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

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

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: New Programming Paradigm<br>This arm will include patients receiving stimulation with a new programming paradigm | Device: New Programming Paradigm<br>* A new programming paradigm will be evaluated.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Improvement in Quality of Life using new programming paradigm: PDQ-39 | Change in Parkinson's Disease Questionnaire (PDQ-39) summary index and sub-scores | up to 12 weeks |
Piezoelectric Vibrations and Tissue, Cellular and Molecular Mechanisms of Oral Wound Healing After Third Molar Surgery

Study Overview
=================
Brief Summary
-----------------
The aim of this clinical trial is to investigate and compare the effect of piezoelectric surgery on tissue, cellular and molecular level of oral surgical wound healing and postoperative outcomes (pain, swelling, trismus) after lower third molar surgery in healthy patients

Conditions
-----------------
Tooth, Impacted

Intervention / Treatment
-----------------
* Procedure: piezo surgery
* Procedure: conventional surgery


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: bilaterally symmetrically impacted lower third molars Exclusion Criteria: presence of intraoral infection chronic orofacial pain pregnancy/ lactation heavy tobacco smokers alcohol/ drug abuse allergic reaction to medicaments used

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 35 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: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: healthy, conventional surgery<br>Surgical bone removal by conventional rotary burs in healthy patients during third molar surgery | Procedure: conventional surgery<br> <br> |
| Experimental: healthy, piezo surgery<br>Surgical bone removal by piezoelectric vibrations in healthy patients during third molar surgery | Procedure: piezo surgery<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| SOD activity in alveolar bone specimen | Activity of enzyme superoxide dismutase in bone specimens obtained during lower third molar surgery | immediately after surgery | 
| VEGF levels in alveolar bone specimen |  | immediately after surgery | 
| MMP-9 level in alveolar bone specimen |  | immediately after surgery | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
piezolectric surgery, conventional surgery, lower third molars
Crossover Bioequivalence Study of Tinidazole 500 mg Tablets Under Fed Conditions

Study Overview
=================
Brief Summary
-----------------
The objective of this study was to prove the bioequivalence of Roxane Laboratories' Tinidazole 500 mg Tablet under fed conditions.

Official Title
-----------------
A Single Dose, Two-Period, Two-Treatment, Two-Way Crossover Bioequivalence Study of Tinidazole 500 mg Tablets Under Fed Conditions

Conditions
-----------------
Trichomoniasis

Intervention / Treatment
-----------------
* Drug: Tinidazole
* Drug: Tinidazole


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: No clinically significant abnormal findings on the physical examination, medical history, or clinical laboratory results during screening Exclusion Criteria: Positive test for HIV, Hepatitis B, or Hepatitis C. Treatment with known enzyme altering drugs. History of allergic or adverse response to tinidazole or any comparable or similar product.

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 45 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

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: tindamax<br>500 mg tablet | Drug: Tinidazole<br>* 500 mg tablet<br>* Other names: Tindamax®;|
| Active Comparator: tinidazole<br>500 mg tablet | Drug: Tinidazole<br>* 500 mg tablet<br>* Other names: Tindamax;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| bioequivalence determined by statistical comparison Cmax |  | 8 days |
The Length of the Right Main Stem Bronchus as a Guide to Right-sided Double-lumen Tube Use

Study Overview
=================
Brief Summary
-----------------
The Length of the Right Main Stem Bronchus Measured by Computerised Tomography as a Guide to Right-sided Double-lumen Tube Use

Detailed Description
-----------------
The double lumen tube (DLT) is the most popular way to isolate the lungs for thoracic surgery. The variable anatomy of the length of the right main stem bronchus seems to be the main reason clinicians are unwilling to use the right-sided DLT (R-DLT). The factors that could compromise the adequate ventilation of the right lung are mostly the variable length of the Right Main Stem Bronchus and the misalignment of the lateral orifice of the right-sided DLT in regard to the right upper lobe bronchus (RULB). The objectives of this study were to validate an alternative method to estimate the length of the Right Main Stem Bronchus by Computerised Tomography as a Guide to Right-sided Double-lumen Tube Use

Official Title
-----------------
The First Hospital of Qinhuangdao, Qinhuangdao, Hebei, China.

Conditions
-----------------
Therapeutic Procedural Complication

Intervention / Treatment
-----------------
* Other: the Length of Right Main Stem Bronchus


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Adult patients undergoing thoracic surgery Exclusion Criteria: Age>70 or <18 years ASA classifications >III BMI >35kg/m2 Modified Mallampati classification ≥III Thoracic surgery within the last one month Severe cardiopulmonary disease

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 70 Years

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

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

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

Design Details

Primary Purpose: Other
Allocation: Randomized
Intervention Model: Factorial Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: the Length of Right Main Stem Bronchus >=15mm<br> | Other: the Length of Right Main Stem Bronchus<br>* The distance between the carina and the proximal margin of the right upper lobe orifice on the coronal plane measured by computerised tomography<br>|
| Experimental: the Length of Right Main Stem Bronchus <15mm<br> | Other: the Length of Right Main Stem Bronchus<br>* The distance between the carina and the proximal margin of the right upper lobe orifice on the coronal plane measured by computerised tomography<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The incidence of Uniblocker displacement |  | 1 year | 
| The number of adjust the right-sided double-lumen tube to optimum location |  | 1 year |
The Efficacy of Transversalis Fascia Plane Block in Pediatric Inguinal Hernia Repair

Study Overview
=================
Brief Summary
-----------------
In patients undergoing lower abdominal surgery, postoperative pain management is frequently provided with systemic opioids use or neuraxial methods. Ultrasound-guided TFP block is the preferred method to reduce the use of opioids and systemic analgesics for postoperative pain management. TFP block provides anesthesia and analgesia in the inguinal region by blocking the ilioinguinal and iliohypogastric nerves. In this study, we aimed to evaluate the effects of ultrasound-guided TFP Block on postoperative pain scores in pediatric lower abdominal surgery.

Official Title
-----------------
The Efficacy of Transversalis Fascia Plane Block on Postoperative Pain in Pediatric Inguinal Hernia Repair

Conditions
-----------------
Inguinal Hernia

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


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: American Society of Anesthesiologist's physiologic state I-II patients undergoing ınguinal hernia repair Exclusion Criteria: American Society of Anesthesiologist's physiologic state III-IV

Ages Eligible for Study
-----------------
Minimum Age: 1 Year
Maximum Age: 8 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

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| No Intervention: Group C<br> | |
| Active Comparator: Group TFP<br>Transversalis fascia plane block, before the surgical procedure. | Drug: Bupivacaine Hydrochloride<br>* Ultrasound-guided Transversalis Fascia Plane Block with 0.5 ml/kg %0.25 bupivacaine<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pain Score | Pain will be evaluated with a FLACC (Face, Legs, Activity, Cry, Consolability) score of 0-10 (0= no pain and 10= worst pain) | Postoperative first 24 hours | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Additional Analgesic | Additional Analgesic consumption during postoperative 24 hours | Postoperative first 24 hours |