linjc16/ctgov huggingface dataset:
Endoscopic Treatment for Zenker's Diverticulum

Study Overview
=================
Brief Summary
-----------------
Zenker's diverticulum (ZD) is a rare benign condition, due to an acquired sac-like outpouching of the mucosa and submucosa layers originating from the pharyngoesophageal junction. Endoscopic techniques like flexible endoscopic septum division (FESD) or per-oral endoscopic septotomy (POES), represent a minimally invasive alternative to surgery or to rigid endoscopic procedure to treat ZD. The goal of the research will be to evaluate the safety of the procedures and to measure Zenker-symptom severity in all patients treated by endoscopic procedures.

Official Title
-----------------
Clinical Outcome of Endoscopic Treatment for Zenker's Diverticulum

Conditions
-----------------
Zenker Diverticulum

Intervention / Treatment
-----------------
* Procedure: Endoscopic septotomy


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: patients with symptomatic ZD treated by endoscopic procedures Exclusion Criteria: pregnancy and breastfeeding

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: Endoscopic septotomy|Patients will be placed in left lateral decubitus position, either in conscious sedation or under deep sedation with propofol or endotracheal intubation.The procedure will be performed with a flexible standard endoscope and started with initial endoscopic examination with suction of possible retained material insidethe diverticulum. An incision of the bridge between the ZD and the esophagus will be done (using one endoscopic procedure as POES or FESD or other)|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Incidence of Adverse Events | Any complications as bleeding, perforation, others | 24 hours after the procedure | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| symptoms after the procedure | The frequency of symptoms such as dysphagia, regurgitation, weight loss | up to 5 years |
EASY EFFECTIVE SMOKELESS With NICORETTE®

Study Overview
=================
Brief Summary
-----------------
The actually most accepted method of effective smoking cessation is based on structured consultation and medical care in combination with supportive medical treatment. A group of experts developed the concept EINFACH ERFOLGREICH RAUCHFREI (EASY EFFECTIVE SMOKELESS) for general practitioners providing a structured compendium for negotiation. Physicians who have implemented this concept will conduct this non-interventional study. The implementation of the scheme will be investigated under general practice conditions and the applicability of the concept has to be assessed by the physicians. In addition further knowledge of smoking cessation in would-be non-smokers which decided to quit, supported by medical treatment with NICORETTE®-products, will be documented for a large patient collective under real practice conditions. To answer all above mentioned questions for a sufficient number of patients a multicenter, prospective non-interventional study design was used for this trial as only this instrument detects characteristics of the physicians' treatment without any further input or other influences.

Official Title
-----------------
Nicht-interventionelle Studie (NIS) Zur Strukturierten Raucherentwöhnung Nach Dem Konzept EINFACH ERFOLGREICH RAUCHFREI unterstützt Durch NICROETTE®-Produkte

Conditions
-----------------
Stereotyped Behavior, Tobacco Smoking Behavior

Intervention / Treatment
-----------------
* Drug: Nicotine replacement therapy


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Routine smokers Nicotine replacement therapy with Nicorette® according to physicians treatment decision Exclusion Criteria: Pregnancy Contraindication according to Summary of Product Characteristics (SPC) Other nicotine replacement therapy during the last month

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 |
| --- | --- |
| routine smokers<br>would-be non-smokers, no actual nicotine replacement therapy | Drug: Nicotine replacement therapy<br>* Nicorette® TX tape 10mg, 15mg, 25mg Nicorette® microtab 2mg Nicorette® inhaler 10mg Nicorette® chewing gum 2 mg, 4mg freshfruit, freshmint, mint, whitemint<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Further knowledge of smoking cessation in would-be non-smokers |  | Baseline (about 2 weeks before date of smoking cessation), Follow-up (about 3, 14 and 28 days after date of smoking cessation), Final examination (about 3 months after date of smoking cessation) | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
smoking cessation, nicotine replacement therapy, routine smokers
Pulse Pressure Variations as Index of Preload Dependency During Thoracic Surgery

Study Overview
=================
Brief Summary
-----------------
Background: calculation of the pulse pressure variation (PPV) has repeatedly been shown to be a reliable predictor of fluid responsiveness in mechanically ventilated patients. But PPV measurement has not been yet validated in thoracic surgery during one-lung ventilation. The modifications of intrathoracic pressure induced by one-lung ventilation may altered the capabilities of PPV to predict fluid responsiveness.This study was designed to assess the ability of PPV predict fluid responsiveness during one-lung ventilation in thoracic surgery. Methods: a prospective observational study. Thirty five patients undergoing a pulmonary resection (lobectomy or pneumonectomy) will be included to achieve around one hundred fluid challenges with a 250 milliliters colloid solution in response to hemodynamic instability.Hemodynamic instability is defined as a decrease by 20 % of artery pressure from baseline and/or an increase by 20% heart rate from baseline. Fluid responsiveness is defined as an increase in stroke volume index (SVI)>10% (measured with oesophageal doppler). PPV will be calculated from recorded artery pressure curve (PPVref) before and after each fluid challenge. An automated measurement of PPV proposed by the monitor Intelview (Philips) will be recorded simultaneously before and after each fluid challenge. Statistical analysis: receiver operating characteristic curve will be used to assess the PPV capability to predict fluid responsiveness. Correlation analysis will be achieved using a Pearson test or Spearman's rho test when necessary. Continuous data will compared using a Student t test or a Mann-Whitney test when necessary.

Detailed Description
-----------------
pulse pressure variation preload dependency one-lung ventilation thoracic surgery

Official Title
-----------------
Pulse Pressure Variations as Index of Preload Dependency During Thoracic Surgery

Conditions
-----------------
Fluid Response

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: All patients undergoing a thoracic surgery (lobectomy, bilobectomy or pneumonectomy). All patients requiring a hemodynamic monitoring (artery catheter, oesophageal doppler). Exclusion Criteria: Arrythmia. Pregnant patient. Patients less than 18 years old. oesophageal or gastric pathologies precluding the use of oesophageal doppler. pathologies precluding the use of artery catheter.

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
-----------------
pulse pressure variation, preload dependency, one-lung ventilation, thoracic surgery
ALS Study Determining Various Biomarkers and Strength Comparison After Exercise

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to determine the muscle strength of a muscle in the thigh after 12 weeks of home exercise.

Detailed Description
-----------------
Study participation lasts a total of three months and includes two study visits. Subjects are asked to undergo strength testing, physical exams, lab draws, and muscle biopsies at each study visit. Muscle biopsies are done in the quadriceps muscle. In between study visits, subjects are asked to maintain a weekly exercise regimen given to them by the study physical therapist.

Official Title
-----------------
ALS Study Determining Various Biomarkers and Strength Comparison After Exercise

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

Intervention / Treatment
-----------------
* Other: Resistance Exercise Program


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Diagnosis of possible, probable or definite amyotrophic lateral sclerosis (ALS) based on the revised El-Escorial criteria Presence in ipsilateral leg of either weakness in any muscle group or of active denervation by needle electromyography (EMG) which is a surrogate marker of early denervation Ipsilateral quadriceps femoris strength: >=4 Ambulatory with or without assistance Revised ALS Functional Rating Scale (ALSFRS-R) Score > 30 Forced expiratory vital capacity (FVC) >50% of predicted Exclusion Criteria: ALSFRS-R ≤ 30 Quadriceps femoris strength <4 Unable to walk or uses wheelchair as primary means of mobility More than mild atrophy of quadriceps Bleeding disorder or uptake of anticoagulants Unwilling to comply with exercise and needle muscle biopsy Not a good research candidate according to the medical opinion of investigator

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: Exercise Program<br>Participants will be asked to take part in an exercise program that is focused on quadriceps strengthening. | Other: Resistance Exercise Program<br>* The resistance exercise program will involve three sets of 10 repetitions of each exercise in levels 1 and 2 every day. Participants will be given instructions to follow.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in functional muscle strength | determine the functional muscle strength of quadriceps femoris muscles before and after 12 weeks of home exercise | Week 12 | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
ALS
SIRT1 Gene Polymorphism With Premature Myocardial Infarction in Young Egyptian Patients

Study Overview
=================
Brief Summary
-----------------
This is an observertional study aimed at Study the association of SIRT1(rs7069102 ) Gene polymorphism with premature myocardial infarction in young Egyptian patients

Official Title
-----------------
Association of SIRT1(rs7069102 ) Gene Polymorphism With Premature Myocardial Infarction in Young Egyptian Patients

Conditions
-----------------
Premature Myocardial Infarction in Young Egyptian Patients

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: All patient with recent MI admitted to Sohag University Hospital , CCU under 40 years Exclusion Criteria: patients above 40 year old. Patients with malignancies, major trauma or surgery in the previous six months, and acute or chronic infectious disease

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 40 Years

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

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Diseased<br>young Egyptian patients with premature myocardial infarction | |
| Control<br>healthy young Egyptians | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Endothelial nitric oxide synthase level | detect the serum level of Endothelial nitric oxide synthase by ELIZA in nanogram per millilitre (ng/ml) | 6 months | 
| SIRT1 Genotyping | whether homgenetic or heterogenetic | 6 months |
Sleep-disordered Breathing and Perioperative Atrial Fibrillation in Cardiac Surgery

Study Overview
=================
Brief Summary
-----------------
In patients undergoing elective coronary artery bypass grafting (CABG) surgery, coronary artery disease, sleep-disordered breathing (SDB), atrial fibrillation (AF) perioperative atrial fibrillation and complications will be assessed. The primary objective is to determine, whether SDB patients have a higher rate of Major Adverse Cardiac and Cerebrovascular Events (MACCE) within 30 days after surgery compared to those without SDB.

Official Title
-----------------
ImpaCt of Sleep-disOrdered breathiNg on Atrial Fibrillation and Perioperative complicationS In Patients unDERgoing Coronary Artery Bypass graFting Surgery

Conditions
-----------------
Elective Coronary Artery Bypass Grafting (CABG) Surgery, Coronary Artery Disease, Sleep-disordered Breathing (SDB), Atrial Fibrillation

Intervention / Treatment
-----------------
* Other: Stratification, no intervention


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients undergoing elective CABG surgery at the Department of Cardiac and Thoracic Surgery, University Hospital Regensburg. Written informed consent Exclusion Criteria: Preoperative use of inotropes or intra aortic balloon pump Severe obstructive pulmonary disease Patients on oxygen therapy, nocturnal positive airway pressure support or mechanical ventilation

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 85 Years

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

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| no SDB<br>apnea-hyponea index <15/hour | Other: Stratification, no intervention<br> <br> |
| SDB<br>apnea-hyponea index >=15/hour | Other: Stratification, no intervention<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Major Adverse Cardiac and Cerebrovascular Events (MACCE) | periprocedural and late myocardial infarction (MI), non-fatal stroke and transitory ischemic attack (TIA) as well as all-cause mortality | 30 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| postoperative atrial fibrillation (POAF) | assessed by ECG | 30 days after CABG surgery | 
| Stroke | assessed by questionnaire | within 1 year after CABG surgery | 
| MACCE | assessed by questionnaire | within 1 and 2 years after CABG surgery | 
| Major pulmonary complications | assessed by questionnaire | within 30 days as well as 1 and 2 years |
Chiropractic Adjustment on Physiological Measurements

Study Overview
=================
Brief Summary
-----------------
This research is designed to study the effects of chiropractic adjustment on the physiological responses (EEG, EMG, HRV, skin temperature, and respiration) of college student and faculty population.

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

Intervention / Treatment
-----------------
* Device: ProAdjuster


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Asymptomatic subjects (without somatosensory peripheral pain) will be recruited in the study. Exclusion Criteria: Subjects with heart failure and any nervous system diseases will be excluded from the study. Additional exclusions include osteoporosis, pregnancy, diabetes, vascular insufficiency, and history of joint replacement therapy. Subjects under medical treatment, surgery and trauma within six months will be excluded

Ages Eligible for Study
-----------------
Minimum Age: 20 Years
Maximum Age: 60 Years

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

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

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

Design Details

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


Arms and Interventions

| Intervention/Treatment |
| --- |
|Device: ProAdjuster|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| to understand the physiological response of a chiropractic adjustment |  |  |
Hernia Surgery Urinary Retention

Study Overview
=================
Brief Summary
-----------------
Investigating whether pre-operative treatment with a selective alpha1-adrenoceptor antagonist affects the likelihood of male patients developing post-operative urinary retention following hernia repair.

Detailed Description
-----------------
The purpose of this study will be to investigate whether pre-operative treatment with a selective alpha1-adrenoceptor antagonist affects the likelihood of male patients developing post-operative urinary retention following hernia repair surgery. It is also of interest to determine whether or not a well-known urological screening tool, the IPSS, can identify patients at risk for urinary retention following elective laparoscopic or open hernia repair surgery. We will investigate if it is possible to pre-treat patients with a selective alpha1-adrenoceptor antagonist which we think can reduce the incidence of post-operative urinary retention and the associated adverse consequences, especially in those patients at higher risk.

Official Title
-----------------
Post-operative Urinary Retention: A Prospective Randomized Study Identifying Patients at Risk and Reducing the Incidence Using Tamsulosin Pretreatment

Conditions
-----------------
Hernia, Urinary Retention

Intervention / Treatment
-----------------
* Drug: Tamsulosin


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Male 18 years of age Presenting with hernia requiring surgical intervention Exclusion Criteria: Intolerability of tamsulosin or related drugs Investigator discretion Unwillingness or inability to comply with protocol procedures and assessments

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

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

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

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

Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Randomization to 1 of 2 possible arms, control and treatment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Treatment<br>treatment with a selective alpha1-adrenoceptor antagonist | Drug: Tamsulosin<br>* Tamsulosin treatment for 7 days pre-operatively<br>* Other names: Flomax;|
| No Intervention: Control<br>no treatment | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Post-operative urinary retention | Incidence of post-operative urinary retention in patients undergoing hernia repair | 2 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Effect of IPSS | the variance in the relationship between treatment arm and incidence of post-operative urinary retention in patients undergoing hernia repair that is attributable to International Prostate Symptom Score (IPSS) | 2 weeks |
Genetic and Epidemiologic Studies of Premature Coronary Artery Disease - SCOR in Arteriosclerosis

Study Overview
=================
Brief Summary
-----------------
To identify genetic mechanisms controlling apolipoprotein levels and other 'non-traditional' risk factors in families ascertained through probands with premature coronary artery disease (CAD).

Detailed Description
-----------------
BACKGROUND: Preliminary work for this project was carried out as part of the Johns Hopkins Coronary Artery Disease study (R01-HL-34791) which provided extensive data on families ascertained through equal numbers of white male and female probands undergoing elective angiography. DESIGN NARRATIVE: The study, a subproject within an Arteriosclerosis SCOR, had three components. In Component 1, the group of 203 probands under study R01HL34791 was expanded with an additional 50 black patients undergoing angiography, meeting identical criteria. In Component 2, segregation analysis was carried out on lipoproteins, apolipoproteins, and selected non-traditional risk factors on families of all probands and the etiologic heterogeneity among different groups of families was tested. In Component 3, linkage was tested between putative Mendelian loci defined in Component 2 and markers in and around candidate loci involved in lipid metabolism. Preliminary results provided evidence of Mendelian control for apolipoprotein A1 and B, and the candidate loci examined included apo B, lipoprotein lipase, and the A1-CIII-A4 gene cluster. The major hypothesis was that these apolipoprotein levels and other non-traditional risk factors might be under genetic control. Genetic analysis of these risk factors was used to direct molecular studies to identify specific mutations. The study completion date listed in this record was obtained from the Completed Date entered in the Query View Report System (QVR).

Conditions
-----------------
Cardiovascular Diseases, Heart Diseases, Coronary Disease

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

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