linjc16/ctgov huggingface dataset:
Type 2 Diabetes in Fayoum

Study Overview
=================
Brief Summary
-----------------
study the prevalence of type II diabetes mellitus, prevalence of newly diagnosed type II diabetic patients

Detailed Description
-----------------
study the prevalence of type II diabetes mellitus, prevalence of newly diagnosed type II diabetic patients, status of glycemic control and associated risk factors and complications of diabetes among population of Fayoum governorate

Official Title
-----------------
Prevalence of Type 2 Diabetes in Fayoum Governorate

Conditions
-----------------
Diabetes Mellitus

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: community sample as obese persons,family history of diabetes,diabetics,hypertensives,dyslipidemics Exclusion Criteria: subjects known to have:chronic liver disease,CKD,Cushing

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Males<br>Male diabetics or male subjects proved to be diabetics | |
| Female<br>Female diabetics or male subjects proved to be diabetics | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Prevalence of diabetes in Fayoum | Prevalence of diabetes in Fayoum governorate | 11 months |
Efficacy and Safety of Rebamipide in Subjects With Dry Eye Syndrome

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to evaluate the efficacy and safety of rebamipide ophthalmic suspension in subjects with dry eye syndrome.

Official Title
-----------------
A Phase 3 Study to Determine the Efficacy and Safety of Rebamipide in Subjects With Dry Eye Syndrome

Conditions
-----------------
Dry Eye Syndrome

Intervention / Treatment
-----------------
* Drug: Rebamipide 2% ophthalmic suspension
* Drug: Placebo (vehicle)


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: History of dry eye-related ocular symptoms for at least 20 months. Meet protocol-defined criteria for corneal and conjunctival staining. Meet protocol-defined criteria for ocular discomfort. Exclusion Criteria: Active anterior segment ocular disease other than dry eye syndrome. Inability to suspend the use of topical ophthalmic medications throughout the duration of the study. Inability to suspend the use of contact lenses for the duration of the study. Judged by the investigator to be ineligible for the study because of a past or concurrent systemic disease, or safety concerns. Received any other investigational product within 4 months before the screening visit.

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

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

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

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

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Placebo Comparator: Placebo (vehicle)<br> | Drug: Placebo (vehicle)<br>* Instill one drop into each eye 4 times a day for 4 weeks.<br>|
| Experimental: Rebamipide 2% ophthalmic suspension<br> | Drug: Rebamipide 2% ophthalmic suspension<br>* Instill one drop into each eye 4 times a day for 4 weeks.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Primary ocular sign: Fluorescein corneal staining total score |  | 4 weeks | 
| Primary ocular symptom: Worst ocular symptom severity score |  | 4 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Fluorescein corneal staining total score |  | 2 weeks | 
| Worst ocular symptom severity score |  | 2 weeks |
Learning Curves of Intubation for Simulated Difficult Airway Scenarios by Manikin: Comparison of Combined Pentax Airwayscope-fiberoptic Bronchoscope and Fiberoptic Bronchoscope Alone

Study Overview
=================
Brief Summary
-----------------
Acquisition of knowledge and skills pertinent to the use of fibreoptic endoscopy is an important part of training in various medical and surgical specialties such as anesthesiology, emergency medicine, otolaryngology, and pulmonary medicine. It has been shown that there is a wide variation in the learning curves of residents and the number of attempts to achieve proficiency in performing upper airway endoscopy. recently, combined use of fiberoptic bronchoscope and videolaryngoscope has been suggested to be a good alternative. So, the aim of this study is to compare the number of attempt to achieve proficiency using fiberoptic bronchoscope alone or fiberoptic bronchoscope with Pentax-AWS.

Conditions
-----------------
Difficult Airway

Intervention / Treatment
-----------------
* Device: manikin
* Device: fiberoptic bronchoscope
* Device: pentax-airwayscope


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: resident in Department of anesthesiology Exclusion Criteria: resident who has an experience of successful fiberoptic bronchoscopic intubation in difficult case
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: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: fiberoptic bronchoscope<br>Tracheal intubation in manikin using fiberoptic bronchoscope | Device: manikin<br> <br> Device: fiberoptic bronchoscope<br> <br> |
| Experimental: fiberoptic bronchoscope with pentax-airwayscope<br>Tracheal intubation in manikin using fiberoptic bronchoscope with pentax-airwayscope | Device: manikin<br> <br> Device: fiberoptic bronchoscope<br> <br> Device: pentax-airwayscope<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| trial number to achieve 'proficient' in terms of cumulative sum analysis |  | up to 2 weeks |
CT Assessment of Minimally Invasive Surgery and Computer Assisted Navigation in Total Knee Arthroplasty

Study Overview
=================
Brief Summary
-----------------
The functional flexion axis of the knee can be established by computer-assisted intra-operative data, through range of motion techniques, not specific landmarks such as epicondyles.

Official Title
-----------------
CT Assessment of Minimally Invasive Surgery and Computer Assisted Navigation in Total Knee Arthropla

Conditions
-----------------
Total Knee Arthroplasty

Intervention / Treatment
-----------------
* Device: Computer assisted navigation


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Males and Females over the age of 18 and equal to or less than the age of 60 Patients scheduled for elective Total knee arthroplasty surgery Patients who have signed informed consent and HIPAA Authorization Able to speak and understand English Exclusion Criteria: Patients presenting with evidence of recent trauma, active infection, chronic pain syndrome of the spine, dementia or have been diagnosed with Alzheimer's disease Pregnant women Patients that will not sign the informed consent

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

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: Functional flexion axis of the knee<br>The functional flexion axis of the knee can be established by computer-assisted intra-operative data, through range of motion techniques, not specific landmarks such as epicondyles. | Device: Computer assisted navigation<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
Noncoding RNAs in COVID-19 and COVID-19 Related Kidney Dysfunction

Study Overview
=================
Brief Summary
-----------------
In this study, critically ill patients with highly suspected or confirmed COVID-19 will be included. Main goal is the identification of noncoding RNAs in COVID-19 associated organ dysfunction with an emphasis on acute kidney injury.

Official Title
-----------------
The Role of Noncoding RNAs in COVID-19 and COVID-19 Associated Acute Kidney Injury (MiRCOVID)

Conditions
-----------------
COVID-19

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: COVID-19 Exclusion Criteria: kidney transplantation eGFR < 30 ml/Min dialysis within last 90 days chronic dialysis pregnancy

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 90 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 |
| --- | --- | --- |
| predicitive value of noncoding RNAs in COVID-19 associated organ dysfunction |  | 12 months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
acute kidney injury (AKI), organ dysfunction
Exercise and Glycemic Control in Type 2 Diabetes

Study Overview
=================
Brief Summary
-----------------
Hyperglycemia is an independent risk factor for the development of diabetic complications in type 2 diabetes. Exercise improves glycemic control, however, the role of exercise characteristics (e.g. intensity, type of exercise, timing, frequency) remains to be elucidated. This study aims to assess the effect of several exercise characteristics on hyperglycemia in various subgroups of type 2 diabetes patiënts.

Official Title
-----------------
Defining the Optimal Exercise Program to Improve Glycemic Control in Various Stages of Type 2 Diabetes.

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

Intervention / Treatment
-----------------
* Behavioral: Exercise intervention
* Behavioral: No exercise


Participation Criteria
=================
Eligibility Criteria
-----------------
Impaired glucose tolerant subjects Inclusion Criteria: BMI 25 - 35 kg/m2 Impaired Glucose Tolerant (according to ADA guidelines) Exclusion Criteria: Cardiac disease (cardiac event in the last 5 years) Type 2 diabetes Use of orale blood glucose lowering medication or exogenous insulin HbA1c >10% Insulin treated type 2 diabetes patients Inclusion Criteria: BMI 25 - 35 kg/m2 Insulin therapy diagnosed with type 2 diabetes >2 yr Exclusion Criteria: Cardiac disease (cardiac event in the last 5 years) HbA1c >10% Type 2 diabetes patients on oral blood glucose lowering medication Inclusion Criteria: BMI 25 - 35 kg/m2 diagnosed with type 2 diabetes >2 yr Exclusion Criteria: Cardiac disease (cardiac event in the last 5 years) HbA1c >10% use of exogenous insulin

Ages Eligible for Study
-----------------
Minimum Age: 40 Years
Maximum Age: 65 Years

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

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

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 |
| --- | --- |
| Experimental: Exercise<br> | Behavioral: Exercise intervention<br>* various exercise characteristics<br>|
| Experimental: No exercise<br> | Behavioral: No exercise<br>* No exercise control period<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Hyperglycemia |  | 24h | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Mean Blood Glucose |  | 24h | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Continuous Glucose Monitoring System, Exercise
Environmental Factor and Onset of Spontaneous Pneumothorax

Study Overview
=================
Brief Summary
-----------------
The study aims to evaluate the association between spontaneous pneumothorax onset and weather parameters.

Detailed Description
-----------------
The aim of this study is to analyse the relation between onset of the PSP and exposure to environmental factors such as atmospheric pressure. A case-crossover epidemiological study will be conducted in 14 French hospitals. SP recorded from 2009 to 2013 will be exhaustively included. Demographic and clinical characteristics will be collected. For each incident case of SP, the period of occurrence of the event (case period) will be compared to several other periods temporally distant from the case period (control periods prior to and after the event). Exposure will be assessed using meteorological stations localized in the vicinity of each patient's home. A potential threshold effect and/or time lag effect between exposure and admission for SP will be explored. The results of this study will help to identify the meteorological factors associated with the occurrence of SP, and to deepen our knowledge of the pathophysiological mechanisms of SP especially the influence of meteorological factors on bleb rupture.

Official Title
-----------------
Impact of Meteorological Conditions on the Onset of First Episod of Spontaneous Pneumothorax : a French Multicenter Case-crosserover Study About 945 Subjects in 14 Centers

Conditions
-----------------
Spontaneous Pneumothorax

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: age over 18 years first episode of primary spontaneous pneumothorax Exclusion Criteria: Patients with traumatic Patients with secondary pneumothorax Patients with recurrent pneumothorax and patients with short-term readmissions (recurrence was defined as a new ED admission for the same diagnosis more than 14 days after the first admission).

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 |
| --- | --- | --- |
| Estimate odds ratio for the association between meteorological data and onset of PSP. |  | 28 days | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
environment, pressure, temperature, case-crossover
Ventrointermediate Nucleus (VIM DBS) and Working Memory

Study Overview
=================
Brief Summary
-----------------
This is part of a larger study for which participants have already completed memory and thinking tests. In this study, investigators are trying to learn how deep-brain stimulation affects memory skills in essential tremor (ET) patients. We are especially trying to figure out how stimulation on each side of the brain may affect working memory.

Official Title
-----------------
VIM DBS and Working Memory

Conditions
-----------------
Essential Tremor

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: ET PATIENTS: Clinical diagnosis of essential tremor affecting the upper extremities. Previous unilateral or bilateral DBS of the VIM Ages 40 -70 A useable pre-surgical MR scan CONTROLS: Spouse or acquaintance of enrolled patient participant Ages 40 - 70 Exclusion Criteria: ET PATIENTS: Clinical evidence of other neurological conditions Significant psychiatric condition CONTROLS: Clinical evidence of other neurological conditions Significant psychiatric condition

Ages Eligible for Study
-----------------
Minimum Age: 40 Years
Maximum Age: 70 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 |
| --- | --- |
| ET Group<br>Total of 25 participants with ET | |
| Controls<br>25 controls without ET | |

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
-----------------
Essential Tremor
Use of a Heating Cable to Obtain Hyperthermia During Intraperitoneal Chemotherapy

Study Overview
=================
Brief Summary
-----------------
The investigator will study the possibility of in situ heating of the liquid containing the chemotherapy, so as to avoid the need for an external pumping system with its complexity, and its associated risks and costs. The use of a heating cable (prototype hereinafter called Thermowire, made by the company EFS, which is in charge of its development) was patented and tested in pigs in two studies that included 15 animals altogether (in 7 of which the heating cable was used). The aim of the first study was the purely safety aspects, while the efficacy to obtain hyperthermia, the quality and the homogeneity of the hyperthermia and its effect on the tissue penetration of the chemotherapy were evaluated in a second study. The results obtained justify transfer to use in humans in the context of a clinical trial so as to obtain CE certification.

Official Title
-----------------
Use of a Heating Cable to Obtain Hyperthermia During Intraperitoneal Chemotherapy

Conditions
-----------------
Intraperitoneal Chemotherapy

Intervention / Treatment
-----------------
* Device: Thermowire


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients with national health insurance cover With scheduled hyperthermic intraperitoneal chemotherapy (HIPEC) because of known peritoneal disease (primary or secondary) Who have provided written consent Exclusion Criteria: Persons under guardianship Persons under 18 years old Pregnant or breast-feeding women Allergy to latex Abandon of HIPEC following surgical exploration

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Heating cable<br> | Device: Thermowire<br> <br> * Other names: Heating cable;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| SAE due to use of Thermowire | In particular visceral thermal lesions or electric accidents. | Through study completion up to 22 months |
Bee Venom Acupuncture for the Treatment of Chronic Low Back Pain

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to evaluate the efficacy of bee venom acupuncture on pain intensity, functional status and quality of life of patients with chronic low back pain.

Official Title
-----------------
Clinical Trial to Evaluate the Efficacy of Bee Venom Acupuncture on Chronic Low Back Pain

Conditions
-----------------
Chronic Low Back Pain

Intervention / Treatment
-----------------
* Procedure: Bee Venom Acupuncture Therapy
* Drug: Loxoprofen
* Procedure: Placebo


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: nonspecific, chronic low back pain over 3 months Must have LBP of more than VAS 4 Exclusion Criteria: cancer, vertebral fracture, spinal infection, inflammatory spondylitis spinal operation radicular pain other musculoskeletal pain physicological or mental disorders allergic history to BV therapy or insect bite

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: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Bee Venom Acupuncture & Loxoprofen<br> | Procedure: Bee Venom Acupuncture Therapy<br>* Bee Venom 1:20,000 under BVA Increment Protocol Increment Protocol as 1st week : SC 0.2cc/day, 2days/week 2nd week : SC 0.4cc/day, 2days/week 3rd week : SC 0.8cc/day, 2days/week<br>* Other names: pharmacopuncture;Drug: Loxoprofen<br>* 60 mg/Tab, pers os 1Tab tid, for 3 weeks<br>* Other names: Loxonin;|
| Placebo Comparator: Sham Bee Venom Acupuncture & Loxoprofen<br> | Drug: Loxoprofen<br>* 60 mg/Tab, pers os 1Tab tid, for 3 weeks<br>* Other names: Loxonin;Procedure: Placebo<br>* Normal Saline (0.9% NaCl) under NS Increment Protocol Increment Protocol as 1st week : SC 0.2cc/day, 2days/week 2nd week : SC 0.4cc/day, 2days/week 3rd week : SC 0.8cc/day, 2days/week<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Visual Analogue Scale for bothersomeness |  | Changes from baseline in VAS at 1 month | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Visual Analogue Scale for pain intensity |  | Changes from baseline in VAS at 1 month | 
| Disability scores on Oswestry Disability Index |  | Changes from baseline in ODI at 1 month | 
| Quality of Life scores on EQ-5D |  | Changes from baseline in EQ-5D at 1 month | 
| Depression scores on Beck Depression Inventory |  | Changes from baseline in BDI at 1 month | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
chronic low back pain, bee venom acupuncture