linjc16/ctgov huggingface dataset:
CYPRESS Efficacy and Safety Study Extension

Study Overview
=================
Brief Summary
-----------------
This is an open-label, controlled, multisite, two-arm parallel group clinical trial of 36-month duration to evaluate the continued safety and efficacy of SightGlass Vision Diffusion Optics Technology (DOT) Spectacles in reducing the progression of juvenile myopia.

Official Title
-----------------
Control of Myopia Using Peripheral Diffusion Lenses: Efficacy and Safety Study Extension

Conditions
-----------------
Juvenile Myopia, Myopia

Intervention / Treatment
-----------------
* Device: Novel spectacle lens design
* Device: Spectacle lenses


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Previously a successfully completed participant in the CYPRESS study (NCT03623074) and having not exited this study for more than 30 days; Agree to wear the assigned spectacles constantly except for sleeping, swimming, or other activities in which spectacle wear would be dangerous or otherwise not possible (minimum of 10 hours per day); Willingness to participate in the trial for up to 3 years without contact lens wear; The subject's parent(s) or legal guardian(s) must read, understand and sign the Statement of Informed Consent and receive a fully executed copy of the form. Exclusion Criteria: Known allergy to proparacaine, tetracaine, or tropicamide.

Ages Eligible for Study
-----------------
Minimum Age: 6 Years
Maximum Age: 17 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: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: CYPRESS Extension Test Arm<br>Single vision, impact resistant spectacle lenses; CYPRESS Test Arm 1 and CYPRESS Test Arm 2 will move into CYPRESS Extension Test Arm | Device: Novel spectacle lens design<br>* Use of single vision, impact resistant spectacle lenses may reduce the rate of progression of juvenile myopia<br>|
| Placebo Comparator: CYPRESS Extension Control Arm<br>Single vision, impact resistant spectacle lenses; CYPRESS Control Arm remains in control lenses as the CYPRESS Extension Control Arm | Device: Spectacle lenses<br>* Single vision, impact resistant spectacle lenses<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Axial length | Test vs. control axial length change from baseline | 72 months | 
| Spherical equivalent refraction (SER) | Test vs. control spherical equivalent refraction (SER) change from baseline | 72 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Axial length | Change from baseline | 42 months | 
| SER | Change from baseline | 60 months |
Endoscopical Dilation of Benign Esophageal Strictures

Study Overview
=================
Brief Summary
-----------------
Although balloon dilatation is the primary treatment for benign dysphagia, information about the optimal inflation time is lacking. The aim of the current pilot study was to compare 10 seconds inflation time, with 2 minutes inflation time, regarding the efficacy

Official Title
-----------------
Endoscopical Dilation of Benign Esophageal Strictures - a Randomized, Clinical Trial, Comparing Two Different Inflation Times.

Conditions
-----------------
Dysphagia

Intervention / Treatment
-----------------
* Device: Dilation 10 sec
* Device: Dilation 2 min


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Symptomatic dysphagia with an endoscopic picture suggestive of a benign disease Exclusion Criteria: Suspicion of achalasia or malignancy. If the patients needed more than 3 dilations the first month this was also a considered an exclusion criterion

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 80 Years

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

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

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

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Group A<br>Dilation 10 sec | Device: Dilation 10 sec<br> <br> * Other names: CRE, Controlled Radial Expansion, Boston Scientific Cork Ltd;|
| Active Comparator: Group B<br>Dilation 2 min | Device: Dilation 2 min<br> <br> * Other names: CRE, Controlled Radial Expansion, Boston Scientific Cork Ltd;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Relief from dysphagia |  | 1 year from dilation | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Benign, Esophageal strictures, Esophagus, Balloon Dilation
Perminova Respiratory Effort Accuracy Validation 09-12-2013-Rev 2

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to validate the accuracy of the Perminova N4 Monitoring system Respiration Rate technology.

Detailed Description
-----------------
After IRB Approval, eighteen volunteer test subjects will be entered into an accuracy study that is designed to validate accuracy of the respiratory rate technology of the Perminova N4 Monitoring system (Device Under Test). The subjects will be selected to represent a range of body types including small, average, muscular, and large with a range of BMI's. A range of stable respiratory rates will be elicited from each volunteer test subject. The rates will be approximately 5, 10, 15, 20, 25, 30, 35 and 40 breaths per minute; with some natural variation from these exact numbers. Each subject will be instrumented with an open system mask that allows for measurement of the end tidal carbon dioxide (EtCO2) respiratory rate and tidal volume. The EtCO2 monitor will be used as the Accuracy Reference Device (Reference) in this study. Performance of the currently released ECG Impedance Respiratory Rate monitor (Acceptance Standard) will be used to establish the acceptance criteria in this study by comparing to Reference.

Official Title
-----------------
Perminova Respiratory Effort Accuracy Validation 09-12-2013-Rev 2

Conditions
-----------------
Respiratory Rate Accuracy Test

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: male female 18-45 range of physiques healthy Exclusion Criteria: injury to sensor area skin inflammation implanted devices such as pacemakers pregnant

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| male female 18-45 years range of body types<br>18 male female subject mix that are 18-45 years of age and selected to represent a range of body types of varying physiques and body mass indexes | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Respiratory Rate of test subject as compared to end tidal CO2 |  | 1 week | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Respiratory Rate
Audit of Lung Cancer Screening Practice in Chest Physicians: An Update

Study Overview
=================
Brief Summary
-----------------
The investigators will conduct nationally representative survey in chest physicians in Egypt in 2016-2017. Self-administered questionnaire will be used to assess the physicians' knowledge of lung cancer screening guidelines, beliefs about the effectiveness of screening tests, and ordering of screening chest radiography, low-dose spiral computed tomography, or sputum cytology in the past 12 months.

Detailed Description
-----------------
Although current practice guidelines do not recommend screening asymptomatic patients for lung cancer, physicians may still order lung cancer screening tests. No recent national survey of health care professionals has focused on lung cancer screening

Official Title
-----------------
Lung Cancer Screening Practice in Chest Physicians

Conditions
-----------------
Lung Cancer Screening

Intervention / Treatment
-----------------
* Other: Audit


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Physicians practising in Egypt (Chest physicians, general practitioners, and general internists) Exclusion Criteria: Other nationalities Other specialities
Sexes Eligible for Study
-----------------
All

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

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

Arms and Interventions

| Intervention/Treatment |
| --- |
|Other: Audit|Questionnair|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Assessment of the use of guidelines of lung cancer screening |  | one year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Self- administrated questionnaire |  | 6 months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
audit, Lung cancer, screening practice, Egypt
Water Immersion in Right-Sided Heart Failure: A Pilot Study

Study Overview
=================
Brief Summary
-----------------
This is an unblinded pilot study comparing (against a randomized control day without water immersion) the diuretic and natriuretic effects of water immersion in patients with right heart failure.

Detailed Description
-----------------
Patients will be immersed in a tub for 3 hours (on one day) and neurohormones will be obtained before and after immersion. Urine will be collected for quantification and evaluation of sodium concentration.

Official Title
-----------------
Water Immersion in Right-Sided Heart Failure: A Pilot Study

Conditions
-----------------
Right Sided Cardiac Failure

Intervention / Treatment
-----------------
* Procedure: Water immersion


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients must have right sided failure secondary to right ventricular dysfunction, pulmonary hypertension, or tricuspid regurgitation Age greater than 18 years of age Right heart catheterization within the last year to rule out left-sided failure. Evidence of fluid overload as indicated by 2 or more of the following: 1.) 2+ or more pitting edema of the lower extremities, 2.) scrotal or penile edema, 3.) JVP greater than or equal to 10 cm, 4.) abdominal ascites Exclusion Criteria: Pulmonary capillary wedge pressure above 16 mmHg or history of elevated left ventricular filling pressures. Serum creatinine > 2.0 Current use of an angiotensin I converting enzyme inhibitor or angiotensin receptor blocker will preclude participation in the RAS neurohormone portion of the study.

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: Crossover Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: 1<br>Patients will have water immersion on first day and sitting in a tub without water on the second day. | Procedure: Water immersion<br>* Subjects will sit in tub for four hours.<br>|
| Other: 2<br>Patients will sit in a tub without water on the first day and have water immersion on the second day. | Procedure: Water immersion<br>* Subjects will sit in tub for four hours.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Diuresis |  | 4 hours | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Neurohormonal activation |  | 4 hours | 
| Natriuresis |  | 4 hours |
ARON-2 Study-Multicentric International Retrospective Study

Study Overview
=================
Brief Summary
-----------------
The ARON-2 study retrospectively analyze patients treated with pembrolizumab as first-line therapy in patients platinum-unfit or as second-line therapy in patients progressed after previous platinum-based chemotherapy. The amendment has been designed to also analyze patients treated with enfortumab vedotin progressed to previous platinum-based chemotherapy and anti-PD-1/PD-L1 inhibitor.

Official Title
-----------------
ARON-2 Study-Multicentric International Retrospective Study

Conditions
-----------------
Urothelial Carcinoma

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients aged >18y Histologically confirmed diagnosis of UC of upper and/or lower urinary tract Histologically or radiologically confirmed metastatic disease Patients treated with at least one of the following: Treatment with pembrolizumab in patients progressed after previous platinum-based chemotherapy or as first-line therapy in patients platinum-unfit, and at least 1 cycle of pembrolizumab within the period from 1 January 2018 to 30 November 2021 Treatment with enfortumab vedotin in patients progressed to previous platinum-based chemotherapy and anti-PD-1/PD-L1 inhibitor and at least 1 cycle of enfortumab vedotin within the period from June 1st 2022 to July 31st 2023 Exclusion Criteria: Patients without histologically confirmed diagnosis of UC Patients without histologically or radiologically confirmed metastatic disease

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

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

Study Plan
=================
How is the study designed?
-----------------
What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Overall Survival (OS) of patients with metastatic Urothelial Cancer (UC) treated with pembrolizumab or enfortumab vedotin |  | November 15th, 2023 | 
| Progression-Free Survival (PFS) of patients with metastatic Urothelial Cancer (UC) treated with pembrolizumab or enfortumab vedotin |  | November 15th, 2023 | 
| Overall Response Rate (ORR) of patients with metastatic Urothelial Cancer (UC) treated with pembrolizumab or enfortumab vedotin |  | November 15th, 2023 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| prognostic role of smoking attitude, obesity and concomitant medications in patients treated with pembrolizumab or enfortumab vedotin | Statistical analysis of data obtained by medical charts related to smoking attitude, obesity and concomitant medications in patients with metastatic UC treated with pembrolizumab or enfortumab vedotin | November 15th, 2023 | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
efficacy of pembrolizumab, artificial intelligence technology, Artificial Neural Network, immunotherapy, real world experience
Routine Screening for Eosinophilic Esophagitis in Patients Presenting With Dysphagia

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to identify the prevalence of pathologic eosinophilic esophagitis (EoE) in the cohort of adult patients who present for specialty care in the gastroenterology clinics with complaint of difficulty swallowing (dysphagia). From this, the investigators will make recommendations regarding routine screening for the diagnosis in this cohort. The prevalence of EoE in patients presenting for specialty care in the gastroenterology clinics with the complaint of dysphagia is great enough that the diagnosis should be routinely screened against in this cohort.

Official Title
-----------------
Routine Screening for Eosinophilic Esophagitis in Patients Presenting With Dysphagia

Conditions
-----------------
Dysphagia

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: age > 18 complaint of dysphagia Exclusion Criteria: pregnancy age <18 on inhaled steroids within the last 30 days on systemic steroids in the last 30 days known diagnosis of Eosinophilic Esophagitis obvious obstructive etiology found at endoscopy increased risk of bleeding (on blood thinners or anti-platelet agents other than aspirin)

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 |
| --- | --- |
| Obstructive Dysphagia<br>Patients who complained of dysphagia, which had an obstructive etiology for their symptoms at the time of endoscopy (ring, mass, stricture, etc) | |
| Non-obstructive Dysphagia<br>Patients whose endoscopy was normal and without any obvious etiology for their symptoms noted. | |

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
-----------------
Eosinophilic Esophagitis
Administration of Increased Dose of GnRH Antagonist for Coasting for Decreasing the Risk for Ovarian Hyperstimulation Syndrome( OHSS)

Study Overview
=================
Brief Summary
-----------------
Coasting is one of the means to reduce the risk of OHSS for patients at risk for severe OHSS. During coasting gonadotrophin administration is withheld until serum E2 levels drop to a range considered safe. Prolonged coasting reduces the chance for implantation and pregnancy. The aim of the study is to explore whether an increased dose of GnRH Antagonist will shorten the coasting period without an adverse effect on cycle outcome.

Detailed Description
-----------------
30 patients undergoing IVF using a GnRH antagonist protocol that present with a high response to gonadotrophin stimulation, will be randomized into one of two groups: group A - withdrawal of gonadotrophin support and continue a daily dose of 0.25 mg of the GnRH antagonist. group B - withdrawal of gonadotrophin support and continue a double daily dose of 0.5 mg of the GnRH antagonist. The main outcome measures will be the duration of coasting (days)and the rate of serum E2 drop (%).

Official Title
-----------------
Administration of Increased Dose of GnRH Antagonist for Coasting for Decreasing the Risk for Ovarian During Controlled Ovarian Stimulation(COH) for In Vitro Fertilisation(IVF)

Conditions
-----------------
Administration of Increased Dose of GnRH Antagonist for Coasting for Decreasing the Risk for Ovarian Hyperstimulation Syndrome( OHSS)

Intervention / Treatment
-----------------
* Drug: Cetrotide


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria:30 women undergoing IVF cycle with GnRH Antagonist protocol under 35 years old. E2 higher than 3000 pg/ml. - Exclusion Criteria: 3 or more failed fresh IVF cycles. -

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

Sexes Eligible for Study
-----------------
Female

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Cetrotide<br> | Drug: Cetrotide<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
Exercise and Diet in Type 2 Diabetic Women

Study Overview
=================
Brief Summary
-----------------
The purpose of this study was to evaluate the effects of 12 weeks' increased daily physical activity versus diet restriction on regional fat distribution, insulin sensitivity and adipokines including retinol binding protein-4 (RBP-4), leptin, adiponectin, and a new marker, adiponectin to leptin ratio (AL ratio), in type 2 diabetic women.

Official Title
-----------------
Clinical Trial of Exercise and Diet in Type 2 Diabetic Women

Conditions
-----------------
Insulin Sensitivity, Type 2 Diabetes

Intervention / Treatment
-----------------
* Behavioral: Standard life style modification for type 2 diabetes
* Behavioral: Diet restriction
* Behavioral: Exercise
* Behavioral: Diet and exercise


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Type 2 diabetic patient BMI>23kg/m2 Female Exclusion Criteria: The patients with co-morbidity such as heart failure, chronic kidney disease or liver cirrhosis
Sexes Eligible for Study
-----------------
Female

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

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

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Placebo Comparator: Control<br>Conventional education of life style intervention for type 2 diabetes | Behavioral: Standard life style modification for type 2 diabetes<br>* Two session of education for exercise and diet. ----------- Exercise: 30min/day x 4/week Diet: ideal body weight x 30 35kcal/day<br>|
| Active Comparator: Diet<br>Dietary calorie restriction | Behavioral: Diet restriction<br>* Education for diet and exercise every 2 weeks ----------- Dietary calorie restriction: reduce their usual intake by -500kcal/day<br>|
| Active Comparator: Exercise<br>Encourage to increase exercise amount: more than 60min's of exercise with moderate activity level two times per day | Behavioral: Exercise<br>* Education for diet and exercise every 2 weeks ----------- Exercise: more than 60min/day of exercise with moderate activity level twice per day<br>|
| Active Comparator: Diet and exercise<br>Intervention for both of exercise and diet | Behavioral: Diet and exercise<br>* Education for diet and exercise every 2 weeks ----------- Exercise education like as exercise group and diet education like as diet group<br>|

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
-----------------
Intra-Abdominal Fat, Adipokines, Exercise, Diet therapy