linjc16/ctgov huggingface dataset:
Endoscopic Ultrasound-Guided Fiducial Placement for Stereotactic Body Radiotherapy

Study Overview
=================
Brief Summary
-----------------
The purpose of this research study is to evaluate placing the radiation therapy markers (Fiducial) by using an endoscopic procedure. The endoscopic procedure is called an Endoscopic Ultrasound (EUS). This is a procedure using a special endoscope that has an ultrasound on the end. The ultrasound will allow the doctor's to see where the radiation therapy markers (Fiducial) is to be placed as outlined by the Radiation Oncologist.

Official Title
-----------------
EUS-Guided Fiducial Placement for Stereotactic Body Radiotherapy

Conditions
-----------------
Cancer

Intervention / Treatment
-----------------
* Procedure: Endoscopic Ultrasound (EUS) for fiducial placement


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Age 18 years or older, Scheduled to undergo fiducial placement, Subject must be able to give informed consent Exclusion Criteria: Any contraindication to performing endoscopy, Participation in another research protocol that could interfere or influence the outcomes measures of the present study, The subject is unable/unwilling to give informed consent

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 |
| --- | --- |
| Subjects requiring fiducial placement<br>Endoscopic Ultrasound (EUS) for fiducial placement | Procedure: Endoscopic Ultrasound (EUS) for fiducial placement<br>* Endoscopic Ultrasound (EUS) used for the placement of fiducial markers in tissue as outlined by the radiation oncologist<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Evaluation of the success and accuracy of endoscopic delivery of the Fiducials into pre-selected targets using dedicated EUS fiducial delivery system. | The outcome measure for this study is to determine: The successful delivery, to the targeted tissue,of the fiducials through the fiducial delivery system, The accuracy of the fiducial delivery into the targeted tissue and to see if the fiducials can be visualized via Endoscopic Ultrasound (EUS), Fluoroscopy and/or CT scan. The success and accuracy of the delivery will be evaluated by Endoscopic Ultrasound, fluoroscopy and/or CT scan to determine if the fiducials are in the targeted tissue. The subject's Oncologist will inform the endoscopist of the targeted tissue that is to receive the fiducials. | approximately one week | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Cancer, Radiation therapy, Fiducial markers
Study of Prednisone, Vinblastine, Doxorubicin, and Gemcitabine in Elderly Patients With Advanced Stages Hodgkin's Lymphoma

Study Overview
=================
Brief Summary
-----------------
The objectives of this study are to assess the feasibility and efficacy of a combination chemotherapy (PVAG) in elderly patients with advanced stages Hodgkin's lymphoma.

Detailed Description
-----------------
Gemcitabine shows promising activity in patients with relapsed lymphoma either administered as single agent or in combination with other cytotoxic agents. No trial to date evaluated its role in patients with primary Hodgkin's lymphoma. We therefore developed a three-weekly regimen based on the standard ABVD regimen.

Official Title
-----------------
PVAG - Phase I/II Dose Finding Trial in Elderly Patients (> 60 Years) With Advanced Stages Hodgkin's Lymphoma

Conditions
-----------------
Hodgkin's Disease

Intervention / Treatment
-----------------
* Drug: Prednisone
* Drug: Vinblastine
* Drug: Doxorubicin (Adriamycin)
* Drug: Gemcitabine


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Hodgkin's lymphoma (histologically proven) Clinical stage IIB (with risk factors bulky mediastinal mass and/or extranodal involvement), III, or IV No prior antitumor therapy Age 60 to 75 years WHO performance status 0-2 Normal pulmonary function Written informed consent Exclusion Criteria: The following histologies are excluded: lymphocyte predominant HD Leukocytes < 2,500/microL Platelets < 100,000/microL

Ages Eligible for Study
-----------------
Minimum Age: 60 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: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: Prednisone|nan|
|Drug: Vinblastine|nan|
|Drug: Doxorubicin (Adriamycin)|nan|
|Drug: Gemcitabine|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Phase I: Dose-limiting toxicities and dose reductions |  |  | 
| Phase II: Treatment administration and complete response rate |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Toxicities |  |  | 
| Supportive care (RBCT need, antibiotic need) |  |  | 
| Early progression rate |  |  | 
| Overall survival |  |  | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Lymphoma, Gemcitabine, Advanced stages Hodgkin's lymphoma, Elderly
Effects of Leptin Replacement in Children

Study Overview
=================
Brief Summary
-----------------
To assess the endocrine and immune effects of leptin replacement in leptin-deficient children, from a consanguineous family. The hypothesis is that leptin replacement will have significant effects on endocrine function.

Detailed Description
-----------------
The proposed study of the treatment of a child with congenital leptin deficiency will permit to elucidate key aspects of human endocrine function, and will give new insights on the role of leptin in human endocrine regulation.

Official Title
-----------------
Effects of Leptin Replacement in Children

Conditions
-----------------
Obesity, Metabolic Syndrome, Diabetes

Intervention / Treatment
-----------------
* Drug: Recombinant methionyl human leptin


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Children with a functional leptin gene mutation from a consanguineous Turkish family. Only one leptin-naïve child from this family is alive and eligible. Exclusion Criteria: N/A

Ages Eligible for Study
-----------------
Minimum Age: 5 Years
Maximum Age: 18 Years

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

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

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

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Recombinant Methionyl Human Leptin<br>Recombinant methionyl human leptin: Recombinant methionyl human leptin, subcutaneous, once a day, 0.02 to 0.04 mg/kg (adjusted according to weight loss). | Drug: Recombinant methionyl human leptin<br>* Recombinant methionyl human leptin, subcutaneous, once a day, 0.02 to 0.04 mg/kg (adjusted according to weight loss), indeterminate duration.<br>* Other names: r-metHuLeptin;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Weight |  | Baseline, 58 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Glucose Levels |  | Baseline, 58 months | 
| Bone Mineral Density |  | Baseline, 58 months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Congenital leptin deficiency, Obesity, Metabolic Syndrome, Diabetes
Ultrasound in Evaluation of Difficult Airway Management Predictive Indexes

Study Overview
=================
Brief Summary
-----------------
evaluate the efficacy of the ultrasound approach in predicting difficult mask ventilation in a heterogeneous population of patients undergoing general anesthesia.

Detailed Description
-----------------
Preoperative ultrasound of the upper airway and detection of 5 ultrasound measurements: Trachea-skin distance at the level of the thyroid isthmus; Trachea-skin distance at the jugular level Front commissure-skin distance; Distance from skin to the thyroid membrane Distance between hyoid bone and skin. Comparison of this measurement with HAN-scale for prediction of difficult mask ventilation during general anesthesia

Official Title
-----------------
Ultrasound in Evaluation of Difficult Airway Management Predictive Indexes

Conditions
-----------------
Airway Complication of Anesthesia

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: - all patient > 18years old undergoing general anesthesia for elective surgery Exclusion Criteria: Patients with fractures of the bones of the facial mass; Patients with laryngeal tumors Patients previously undergoing demolition of the larynx or neck; Tracheostomized patients; Pregnancy; Inter-incisive distance <3 cm; severely limited cervical mobility; Patients who are not given muscle relaxants Patient rejection.

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 |
| --- | --- |
| ultrasound assessment<br>all patient are evaluated by an ultrasound assessment before general anaesthesia | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| ultrasound assessment | the association between the ultrasound measurement and the difficulty of mask ventilation measured with the Han scale. Han scale classify mask-ventilation in five grade of progressive difficulty: 0) mask ventilation did not attempt, 1) easy 2) difficult and requiring oral airway 3) very difficult requiring two practitioners 4) unable to mask ventilate. Han scale is the only grading scale available used routinely in anesthesiologic assessment of bag-mask ventilation. | Ultrasound assessment will be performed 30 minutes before induction of general anaesthesia and the mask ventilation evaluation will be performed 3 minutes after induction with ''Han scale. |
Natural History and Patient Journey in Dementia: a Nationwide Linked Electronic Health Records Study of 5.6 Million Individuals.

Study Overview
=================
Brief Summary
-----------------
The trajectory of dementia patients within the national health system and their recent temporal trends remains to be fully elucidated. To study the dementia incidence, mortality and case-fatality, we implemented a longitudinal cohort study with the linked electronic health records of 5.6 million population in the UK from 1998 to 2016 (CALIBER). A matched case-control study design was used to investigate the causes of hospitalization and death comparing individuals with and without incident dementia.

Official Title
-----------------
Natural History and Patient Journey in Dementia: a Nationwide Linked Electronic Health Records Study of 5.6 Million Individuals.

Conditions
-----------------
Dementia, Alzheimer, Electronic Health Records, Hospitalizations, Epidemiology, Comorbidity, United Kingdom, Incidence, Mortality, Cause of Death

Intervention / Treatment
-----------------
* Other: The study does not have an intervention, but observe the dementia incidence of the UK disease-free population.


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: We identify individuals aged 30 years or older and registered in the current primary care practice for at least one year. Exclusion Criteria: Individuals are excluded if they had a prior history of dementia before study entry.

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

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

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

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

Arms and Interventions

| Intervention/Treatment |
| --- |
|Other: The study does not have an intervention, but observe the dementia incidence of the UK disease-free population.|The study does not have an intervention, but observe the dementia incidence of the UK disease-free population.|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Incidence and mortality of dementia |  | Jan 1st 1998 - May 31st 2016 |
Treatment of Moderate FMR During AVR

Study Overview
=================
Brief Summary
-----------------
Debates exist on the treatment of moderate functional mitral regurgitation (FMR) in patients undergoing aortic valve replacement (AVR) for aortic valve disease. This study aims to evaluate the left ventricular function, which was evaluated through global longitudinal strain, after isolated AVR and AVR + mitral valve repair (MVr) in this group of patients.

Official Title
-----------------
Surgical Treatment of Aortic Valve Disease With Moderate Functional Mitral Regurgitation

Conditions
-----------------
Functional Mitral Regurgitation

Intervention / Treatment
-----------------
* Procedure: mitral valve repair


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients who received AVR (with or without concomitant MVr) from two center (Fuwai Yunnan Cardiovascular Hospital and Fuwai Hospital, Chinese Academy of Medical Sciences). Age more than 18 years. Exclusion Criteria: Those with a history of rheumatic valvular disease or infective endocarditis. Primary mitral valve lesions. Patients receiving mitral valve replacement. Patient who refuse to participate in this study, or cannot complete 6-month follow-up after surgery. Age < 18 years.

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 |
| --- | --- |
| isolated aortic valve replacement group<br>Isolated aortic valve replacement surgery. | Procedure: mitral valve repair<br>* Repair of mitral valve concomitant to aortic valve replacement.<br>|
| aortic valve replacement with mitral valve repair group<br>Aortic valve replacement with mitral valve repair | Procedure: mitral valve repair<br>* Repair of mitral valve concomitant to aortic valve replacement.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| left ventricular global longitudinal strain | The change of left ventricular global longitudinal strain compared to before surgery | 10/10/2022-10/10/2023 | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
functional mitral regurgitation, aortic valve replacement, mitral valve repair
A Safety and Tolerability Study of VC-02™ Combination Product in Subjects With Type 1 Diabetes Mellitus

Study Overview
=================
Brief Summary
-----------------
The purpose of this trial is to test if VC-02™ combination product can be implanted subcutaneously in subjects with Type 1 Diabetes and maintained safely for up to four (4) months.

Official Title
-----------------
An Open-Label Study Evaluating the Safety and Tolerability of VC-02™ Combination Product in Subjects With Type 1 Diabetes Mellitus

Conditions
-----------------
Type 1 Diabetes Mellitus

Intervention / Treatment
-----------------
* Combination Product: VC-02 Combination Product (aka PEC-Direct)


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Men and non-pregnant women of non-childbearing potential Diagnosis of T1DM for a minimum of five (5) years Stable diabetic treatment Willingness to use a continuous glucose meter Acceptable candidate for implantation Exclusion Criteria: History of islet cell, kidney, and/or pancreas transplant. Two (2) or more severe, unexplained hypoglycemic events within six (6) months of enrollment Uncontrolled or untreated thyroid disease or adrenal insufficiency Diabetic complications such as severe kidney disease or renal dysfunction, proliferative retinopathy, diabetic foot ulcers, amputations attributable to diabetes, and/or severe peripheral neuropathy Non-compliance with current anti-diabetic regimen

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Single-group<br>Up to six (6) VC-02-20 implants | Combination Product: VC-02 Combination Product (aka PEC-Direct)<br>* PEC-01 cells loaded into a Delivery Device<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Incidence of all adverse events reported for subjects |  | Thru the Month 4 Visit] |
Clinical and Biochemical Presentation of Polycystic Ovary Syndrome in Different Age Group

Study Overview
=================
Brief Summary
-----------------
To study the clinical and biochemical characteristics women with polycystic ovary syndrome (PCOS) in different aged groups.

Detailed Description
-----------------
Polycystic ovarian syndrome (PCOS) is the most frequent endocrine disorder of reproductive age women, affecting an estimated 9-18% of all women in this age group. To diagnose of PCOS in early life is especially important because it is now thought to increase metabolic and cardiovascular risks. Investigating PCOS is crucial as it is now considered to increase metabolic and cardiovascular risk, thereby impacting the health of women to a much greater extent than previously thought. We are plan using retrospective analysis to evaluate the clinical and biochemical presentation of PCOS in different aged groups.

Official Title
-----------------
Clinical and Biochemical Presentation of Polycystic Ovary Syndrome in Different Age Group

Conditions
-----------------
Polycystic Ovary Syndrome

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Reproductive age women with sufficient data Exclusion Criteria: Disorders of uterus (e.g. Asherman's Syndrome, Mullerian agenesis) and chromosomal anomalies (e.g. Turner syndrome) women who had had menarche at less than 3 years of age, Day 3 FSH > 15, or who were older than 46 women with inadequate clinical/biochemical records and women who had had ovarian cysts or ovarian tumors in ultrasonography examination pregnancy women

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 46 Years

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

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental Group<br> | |
| Control 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
-----------------
Polycystic ovarian syndrome (PCOS)
Vitamin D Deficiency in Obese Adolescent Girls and Influence of Vitamin D on Insulin Secretion and Sensitivity

Study Overview
=================
Brief Summary
-----------------
Sub-clinical vitamin D deficiency is a commonly unrecognized disorder in obese adolescents. The investigators hypothesize vitamin D deficiency will be highly prevalent in obese adolescents and those who are vitamin D deficient will be more insulin resistant.

Detailed Description
-----------------
This is a cross-sectional study of obese female adolescents matched for age, sex and pubertal staging. Serum 25-OH vitamin D, intact PTH , lipid profile, serum CRP measurements and oral glucose tolerance tests (with glucose and insulin level measurements) will be done to assess the prevalence of vitamin D deficiency and to assess the insulin sensitivity- resistance indices.

Official Title
-----------------
Assessment of Prevalence of Vitamin D Deficiency in Obese Adolescent Girls and Influence of Vitamin D on Insulin Secretion and Sensitivity

Conditions
-----------------
Vitamin D Deficiency, Obesity, Insulin Resistance

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Female adolescents Obese: BMI > 95th percentile Menarchal Tanner stage ≥ 4 Exclusion Criteria: Children with diabetes, other endocrine or acute or chronic medical illnesses, children on oral contraceptive pills, diuretics and anticonvulsant medications

Ages Eligible for Study
-----------------
Minimum Age: 10 Years
Maximum Age: 18 Years

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

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| 1<br>Obese female adolescents | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To determine the prevalence of subclinical vitamin D deficiency in obese female adolescents. |  | At study entry | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To assess the relationship of serum 25 (OH) D statuses to insulin and glucose concentrations during an OGTT and to serum transaminases and CRP. |  | At study entry | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Vitamin D deficiency, Obesity, Insulin resistance, Glucose tolerance