linjc16/ctgov huggingface dataset:
The Microbiome Variability and Antibiotic Resistance of Chronic Suppurative Otitis

Study Overview
=================
Brief Summary
-----------------
ear swabs will be collected from 120 patients with established CSOM at the ear-nose-throat (ENT) outpatient clinic at the Ziv medical center, and 120 swabs will be taken from children with Otitis Media with Effusion (OME) undergoing elective tympanostomy tube insertion, serving as a control group. Ear swabs will be frozen at -80C until analysis.DNA will be purified from ear swabs, and amplified by PCR so that a barcoded 16S rRNA library from each subject will be generated. Using correlation analysis, we will compare between microbial compositions in chronic otorrhea patients vs. control groups.An additional ear swab will be collected from patients and cultured to test antibiotic resistance.

Official Title
-----------------
The Microbiome Variability and Antibiotic Resistance of Chronic Suppurative Otitis Media in Pediatric Patients in Northern Israel

Conditions
-----------------
Suppurative Otitis Media

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion otitis media with effusion,parental informed consent, age between 1 - 9 years, no known immune deficient disorder - Exclusion Criteria:no parental consent, known immune disorder, current acute otitis media. -

Ages Eligible for Study
-----------------
Minimum Age: 1 Year
Maximum Age: 9 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 |
| --- | --- |
| suppurative otitis media with effusion<br> | |
| non suppurative otitis media with effusion<br> | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| microbiome variability | detection of microbiome differces between suppurative and non-suppurative otitis media in pediatric patients | 2 years |
Ability of Cardio Q for Prediction of Hypotension

Study Overview
=================
Brief Summary
-----------------
Evaluation the ability of each indicator of Cardio Q in predicting hypotension after position changes in robot-assisted laparoscopic radical prostatectomy

Detailed Description
-----------------
Hypotension is common in patients who undergo general anesthesia. Hypotension may cause hypoperfusion in the organs of the body, resulting in ischemia and increased mortality within one year. Hypotension may occur at any time during general anesthesia but may also occur with changes in posture. In robot-assisted laparoscopic radical prostatectomy, hypotension often occurs when posture is changed from a Trendelenburg position to a supine position. However there is no data regarding which hemodynamic parameters can predict hypotension induced by position change. Excessive administration of the fluid in steep Trendelenburg position may lead to fluid overload and lead to complications such as pulmonary edema. Thus, the predictors are should be identified to manage patients without fluid overload. Therefore, the aim of this study is to investigate the parameters of Cardio Q which are useful for predicting hypotension after position change.

Official Title
-----------------
Ability of Cardio Q for Prediction of Hypotension After Postural Change in Robot-Assisted Laparoscopic Radical Prostatectomy

Conditions
-----------------
Prostate Cancer

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients undergoing robot-assisted laparoscopic radical prostatectomy ASA 1-3 Exclusion Criteria: Patients that Unstable angina, left ventricular ejection fraction <40% Severe vascular disease Insertion type : pacemaker / defibrillator Autonomic nervous system diseases When esophageal varices are present If the subject includes a person who can not read the written consent (eg, illiterate, foreigner, etc.)

Ages Eligible for Study
-----------------
Minimum Age: 20 Years
Maximum Age: 85 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 |
| --- | --- | --- |
| Mean arterial pressure | The changes mean arterial pressure | Before position change, After position change (1, 3, 5, 7, and 10 minutes) | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Robotic surgery, Position, Cardio Q, hypotension
Study Evaluating the Efficacy and Safety of Simvastatin Alone Compared With Simvastatin Plus Ezetimibe in Type 2 Diabetic Patients (0653-021)(COMPLETED)

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to determine if the addition of ezetimibe 10 mg daily to ongoing 20 mg simvastatin daily will reduce LDL Cholesterol to a greater extent than increasing the dose of simvastatin to 40 mg daily in Type 2 diabetics treated with Thiazolidinediones (TZD).

Official Title
-----------------
A Randomized, Double-Blind, Parallel, Multicenter Study to Evaluate the Efficacy and Safety of Simvastatin Monotherapy Compared With Simvastatin Plus Ezetimibe (SCH 58235) in Type 2 Diabetic Patients Treated With Thiazolidinediones

Conditions
-----------------
Diabetes Mellitus, Type 2

Intervention / Treatment
-----------------
* Drug: MK0653, ezetimibe / Duration of Treatment: 30 Weeks
* Drug: Comparator : ezetimibe (+) simvastatin / Duration of Treatment: 30 Weeks


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Men or women age between 30 and 75 with Type 2 diabetes mellitus who are treated with pioglitazone or rosiglitazone Additionally, patients must have an LDL-C >100 mg/dL at Visit 1 or prior to initiation of statin therapy Exclusion Criteria: Patients taking sliding scale insulin, selected lipid lowering medications, oral anticoagulants and cyclical sex hormones Patients with heart disease, kidney disease, liver disease, uncontrolled high blood pressure, and insulin dependent diabetes

Ages Eligible for Study
-----------------
Minimum Age: 30 Years
Maximum Age: 75 Years

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

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

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

Design Details

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


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: MK0653, ezetimibe / Duration of Treatment: 30 Weeks|nan|
|Drug: Comparator : ezetimibe (+) simvastatin / Duration of Treatment: 30 Weeks|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percent change in fasting LDL-C from baseline to the average of the Week 6/Week 12 measurements |  | 6 & 12 Weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Well tolerated in patients in Diabetic patients |  | 30 Weeks |
Skeletal Metastasis Registry

Study Overview
=================
Brief Summary
-----------------
This is a prospective, observational study designed to contribute data from patients with symptomatic metastatic bone disease treated at Sibley Memorial Hospital and Johns Hopkins Medicine to an international registry hosted by the Swedish Regional Cancer Centrum in Stockholm, Sweden. This protocol supports a worldwide effort to collect and store information from patients treated for symptomatic bone metastases within the International Skeletal Metastasis Registry (ISMR)

Detailed Description
-----------------
The registry is designed to update a suite of clinical decision-support tools designed for use when treating patients with metastatic bone disease. The models estimate the likelihood of survival at 1, 3, 6, 12, 18, and 24 months post surgery, which in turn, may be used for surgical decision-making.

Official Title
-----------------
The International Skeletal Metastasis Registry

Conditions
-----------------
Metastatic Bone Tumor

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Adult patients, age 22 or older Biopsy-proven or clinically-obvious metastatic bone disease Symptomatic bone lesion requiring intervention o Including, not limited to, radiotherapy, cryotherapy, radiofrequency ablation, operative fixation, prosthetic replacement, amputation, or any combination of the above.

Ages Eligible for Study
-----------------
Minimum Age: 22 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 |
| --- | --- | --- |
| Overall survival (OS) | OS (in months) calculated from the date of intervention. | Up to 24 Months post surgery | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Reoperation or retreatment for any reason | Number of participants with reoperation or retreatment for any reason. | Up to 24 24 months post surgery | 
| Time to reoperation or retreatment for any reason | Timing of reoperation calculated from the date of intervention. | Up to 24 months post surgery | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Biopsy-proven or clinically-obvious metastatic bone disease
Deflazacort Expanded Access Program for Children, Adolescents and Adults With Duchenne Muscular Dystrophy

Study Overview
=================
Brief Summary
-----------------
The expanded access program will provide access to treatment with deflazacort in children, adolescent, and adult patients with DMD in the U.S. who are ineligible, unable, or otherwise unwilling to enroll in a clinical study examining the efficacy of deflazacort while a new drug application is under preparation and review. Enrollment is open to all eligible patients.

Detailed Description
-----------------
Deflazacort will be supplied free of charge and shipped directly to patients or caregivers, as appropriate. Treating physicians will continue to follow their standard of care activities and procedures for management of DMD. Treating physicians participating in the expanded access program are required to collect/document any patient or caregiver reported safety events and report to the sponsor..

Official Title
-----------------
An Open Label, Expanded Access Protocol Intended to Provide Treatment With MP-104 (Deflazacort) to U.S. Children, Adolescents, and/or Adults With Duchenne Muscular Dystrophy

Conditions
-----------------
Duchenne Muscular Dystrophy

Intervention / Treatment
-----------------
* Drug: Deflazacort


Participation Criteria
=================
Eligibility Criteria
-----------------
Main Inclusion Criteria: Confirmed diagnosis of Duchenne muscular dystrophy The patient is ≥ 5 years old Current on all childhood vaccinations including the chicken pox vaccine Main Exclusion Criteria: History or current medication condition that could affect safety or poses an additional risk Hypersensitivity or allergic reaction to steroids or their formulations

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

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

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

Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: Deflazacort|Deflazacort, a glucocorticoid with anti-inflammatory and immunosuppressive effects, is used in treating a variety of diseases. Pharmacologically it is an inactive pro-drug which is metabolized immediately to the active metabolite, 21 desacetyl-DFZ. The elimination of this metabolite is primarily via the urine in humans. Its potency is approximately 70 to 90% of prednisone and 6 mg of deflazacort has approximately the same anti-inflammatory potency as 5 mg of prednisolone or prednisone.|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
Effectiveness of Glucose Control, β Cell Function in Response to Short-term Insulin Pump Therapy in Type 2 Diabetes

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to investigate and evaluate the significance of intravenous glucose tolerance test in assessment of β-cell function improvement after short course of intensive insulin therapy, trying to illustrate the relationship between fasting plasma glucose and acute insulin release under different stage of type 2 diabetes with poor glycemic control.

Official Title
-----------------
Effectiveness and Determinants of Glucose Control, β-cell Function in Response to Short-term Intensive Insulin Pump Therapy in Different Duration of Type 2 Diabetes Mellitus.

Conditions
-----------------
Diabetes Mellitus, Type 2

Intervention / Treatment
-----------------
* Drug: Insulin LISPRO


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: different course of type 2 diabetes with poor glycemic control - Exclusion Criteria: acute complication or severe comorbidities

Ages Eligible for Study
-----------------
Minimum Age: 20 Years
Maximum Age: 75 Years

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

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

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

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: duration of disease<br>different duration of disease receive insulin LISPRO | Drug: Insulin LISPRO<br>* receive short-term insulin pump therapy by using insulin LISPRO, continue treatment for 7 more days when euglycemia achieved<br>* Other names: humalog;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| fasting plasma glucose after insulin therapy |  | 10 hour |
Two or Five cm From Pylorus During Laparoscopic Sleeve Gastrectomy

Study Overview
=================
Brief Summary
-----------------
The investigators compare two techniques for laparoscopic sleeve gastrectomy. in the first one the distal margin of stapling is 2 cm from the pylorus and in the second it is 6 cm away from the pylorus.

Official Title
-----------------
Comparative Study Between Two and Five cm Resection During Laparoscopic Sleeve Gastrectomy

Conditions
-----------------
Morbid Obesity

Intervention / Treatment
-----------------
* Procedure: laparoscopic sleeve gastrectomy


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: morbid obese patients Exclusion Criteria: contraindication to laparoscopy

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

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 2 cm from pylorus<br>at laparoscopic sleeve gastrectomy the distal point of gastric division is 2 cm from the pylorus. | Procedure: laparoscopic sleeve gastrectomy<br> <br> |
| Active Comparator: 6 cm from pylorus<br>at laparoscopic sleeve gastrectomy the distal point of gastric division is 6 cm from the pylorus | Procedure: laparoscopic sleeve gastrectomy<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| percentage of excess weight loss |  | 2 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| complications |  | 2 years |
Molecular Studies and Clinical Correlations in Human Prostatic Disease

Study Overview
=================
Brief Summary
-----------------
The Genitourinary Oncology/Urology Services at Memorial Sloan-Kettering Cancer Center (MSKCC) participates in research for the control, treatment, and cure of cancer. The purpose of this study is to collect normal and cancerous tissues, in addition to blood, and other body fluid samples from men with prostate cancer or prostatic disease. These samples may be stored for future use or used immediately by researchers who study prostate cancer and try to find better ways to diagnose, prevent, and treat it. We will look for genetic changes and protein markers on these cells. We hope to learn more about what makes some people get prostate cancer, why some cancers are more aggressive than others, and why some cancers respond to or resist different treatments. We may also try to grow the tumor cells in the lab. We may find a new treatment for prostate cancer based on this research.

Detailed Description
-----------------
The therapeutics program for advanced prostate cancer is based on the hypothesis that the factors contributing to and associated with progression change as the disease evolves. To categorize these changes we now consider the disease as a series of states. 1 The states represent points where an intervention might be considered to prevent cancer from developing, to eliminate established disease, or to delay progression. The states also represent clinically significant milestones that can be used to assess treatment effects.

Official Title
-----------------
Molecular Studies and Clinical Correlations in Human Prostatic Disease

Conditions
-----------------
Prostate Cancer

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Men with prostate conditions representing the following disease states: No Cancer Diagnosis Clinically Localized Disease Rising PSA Clinical Metastases: Noncastrate Clinical Metastases: Castrate (Testosterone ≤ 50 ng/ml) Signed informed consent Exclusion Criteria: -Patients without any prostate related problems.
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 |
| --- | --- | --- |

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
benign, Rising PSA, Clinical Metastases, 90-040
Pre-surgical Motivation for Bariatric Surgery

Study Overview
=================
Brief Summary
-----------------
A study investigating the motivations of patients who had undergone bariatric surgery using data collected from questionnaires given to patients prior to surgery.

Official Title
-----------------
A Retroactive Study on the Motivations of Patients Undergoing Bariatric Surgery

Conditions
-----------------
Bariatric Surgery

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Undergone bariatric surgery at Singapore General Hospital and completed the life center questionnaire. Exclusion Criteria: -
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 |
| --- | --- | --- |
| Weight Loss | Weight Loss in Kilograms | 5 years post surgery |
A Study of the Absorption of GT267-004 in Patients With Clostridium Difficile-Associated Diarrhea

Study Overview
=================
Brief Summary
-----------------
Approximately 24 patients will be entered into this study taking place in Canada. The aim of this study is to determine if an investigational drug is absorbed (taken up) in patients with C. difficile-associated diarrhea (CDAD). The investigational drug will be given in addition to current standard antibiotic treatment so that all patients will receive active medication. All study related care is provided including doctor visits, physical exams, laboratory tests, and study medication. The total length of participation is approximately 7 days.

Official Title
-----------------
A Study of the Pharmacokinetics of GT267-004 in Patients With Clostridium Difficile-Associated Diarrhea

Conditions
-----------------
Pseudomembranous Colitis, Clostridium Difficile Diarrhea, Antibiotic-Associated Diarrhea

Intervention / Treatment
-----------------
* Drug: tolevamer potassium-sodium (GT267-004)


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: 18 years of age or older The presence of CDAD at the time of enrollment with no other likely etiology for the diarrhea Exclusion Criteria: > 72 hours of treatment with metronidazole, vancomycin, or other antibacterial therapy specifically targeting the current acute episode of CDAD Patient not considered sufficiently stable clinically to complete the study period

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: tolevamer potassium-sodium (GT267-004)|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The extent of GT267-004 absorption as measured in the blood and urine by pharmacokinetic analysis |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Safety as measured by physical examinations (including vital signs), adverse events and changes in safety laboratory values |  |  | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
CDAD, Clostridium difficile-associated diarrhea, C. difficile, Clostridium difficile, Clostridium difficile Disease, Clostridium Enterocolitis, Antibiotic-Associated Colitis, Infectious diarrhea