linjc16/ctgov huggingface dataset:
Safety and Effectiveness of the UV-X System for Corneal Collagen Cross-Linking for Compassionate Treatment in Pediatric Patients With Progressive Keratoconus

Study Overview
=================
Brief Summary
-----------------
This is a compassionate treatment protocol for the use of the UV-X system for corneal collagen cross-linking (CXL) in eyes with progressive keratoconus in patients who have conditions that limit their capacity to comply with the cross-linking treatment procedures required by ongoing clinical trials.

Detailed Description
-----------------
This is a non-randomized study. All eyes that qualify for the study will receive the cross-linking (CXL) procedure. Corneal collagen cross-linking is performed as a single treatment. Depending on the patient's condition, the CXL procedure may be performed under sedation or anesthesia. Subjects are followed for 12 months after the procedure to evaluate the long term effects of corneal collagen cross-linking.

Conditions
-----------------
Progressive Keratoconus

Intervention / Treatment
-----------------
* Other: Corneal collagen cross-linking with riboflavin/UVA light


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Age 6 to 18 years Having a diagnosis of progressive keratoconus Signed written informed consent Having a condition that limits the patient's capacity to comply with the cross-linking treatment procedures and/or the diagnostic tests and measurements required by the ongoing clinical studies Willingness and ability to comply with schedule for follow-up visits Exclusion Criteria: Corneal pachymetry at the screening exam that is <400 microns at the thinnest point Previous ocular condition in the eye(s) to be treated that may predispose the eye for future complications, for example (herpes simplex, herpes zoster keratitis, recurrent erosion syndrome, corneal melt, or corneal dystrophy, etc.) A history of delayed epithelial healing in the eye(s) to be treated Pregnancy or lactation during the course of the study A known sensitivity to study medications

Ages Eligible for Study
-----------------
Minimum Age: 6 Years
Maximum Age: 18 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: Corneal collagen cross-linking with riboflavin and UVA light<br> | Other: Corneal collagen cross-linking with riboflavin/UVA light<br>* Corneal collagen cross-linking with riboflavin/UVA light<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in keratometry |  | 3 Months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in manifest refraction spherical equivalent |  | 3 Month |
Bone Age of Chinese Child (BACC)

Study Overview
=================
Brief Summary
-----------------
The bone age of the hand and wrist will be assessed with X-rays in more than 20,000 healthy children age 3-18 years old recruited in 28 sites from 14 province.The bone mineral density (BMD) will be measured as well.

Detailed Description
-----------------
As part of the National Nutrition and Health Systematic Survey for 0-18 years old Children and Utilization of Survey Findings (ChiCTR1900022825), more than 20,000 children age 3-18 years old was recruited from 28 sites of 14 provinces within the framework of the ChiCTR190002282 study protocol. The population of this study was proportional to the ChiCTR190002282 study. The X-ray of no-dominant hand and wrist was taken with a mobile X-ray unit with shielding. A step wedge was imaged along the side of the hand at the same time for bone mineral density measurement. The bone age of the hand and wrist was assessed by trained MSK radiologists according to Chinese standard. The bone mineral density of the wrist was measured with radioabsorptiometry (RA). The demographic parameters were collected by the study of ChiCTR190002282 protocol.

Official Title
-----------------
The National Survey on Bone Age of Child in China

Conditions
-----------------
Bone Development

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: participants of ChiCTR1900022825 study healthy children age 3 to 18 years old. willing to participate this study Consent by parents Exclusion Criteria: no consent by parents under 3 years old

Ages Eligible for Study
-----------------
Minimum Age: 3 Years
Maximum Age: 18 Years

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

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

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| the bone age of the wrist and hand | The bone age assessed by radiologist with the hand and wrist X-ray | 3 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| bone mineral density (BMD) | The bone mineral density (BMD) measured with the wrist and hand X-ray The bone mineral density (BMD) measured with the wrist and hand X-ray calibrated with a step wedge | 3 years | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
bone age, bone mineral density, X-ray, Chinese child
Effect of Ischemic Preconditioning on Atrial Fibrillation After Electrocardioversion

Study Overview
=================
Brief Summary
-----------------
Remote ischemic preconditioning is one way to influence the success of therapy in cardiovascular patients. By means of remote ischemic preconditioning the incidence of atrial fibrillation after cardiac surgery was reduced by 54%. The investigators aim to investigate the effect of ischemic preconditioning in an easy-to-perform protocol with regard to the recurrence of atrial fibrillation after electrical cardioversion.

Official Title
-----------------
Effect of Ischemic Preconditioning on Relapse of Nonvalvular Atrial Fibrillation After Electrocardioversion

Conditions
-----------------
Atrial Fibrillation

Intervention / Treatment
-----------------
* Procedure: Remote ischemic preconditioning
* Procedure: Sham preconditioning


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients with paroxysmal or persistent atrial fibrillation who give written informed consent to participate in the study Age > 18 years Consent capacity Exclusion Criteria: Age under 18 years Pregnancy Lack of consent capacity

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 99 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 |
| --- | --- |
| Active Comparator: Remote Ischemic Preconditioning<br>Remote ischemic preconditioining | Procedure: Remote ischemic preconditioning<br>* Remote ischemic preconditioning through inflation of a blood pressure cuff to systolic blood pressure values > 200mmHg for 5 minutes (3 times) each before electrocardioversion Electrical cardioversion for atrial fibrillation (100, 150, 200 Joule)<br>|
| Sham Comparator: Control<br>Sham preconditioning | Procedure: Sham preconditioning<br>* Inflation of a blood pressure cuff to systolic blood pressure values   20mmHg for 5 minutes (3 times) each before electrocardioversion<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of subjects with recurrence of atrial fibrillation 30 days after electrical cardioversion |  | 30 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Minimum energy required for successful electrocardioversion (in Joule) |  | 30 days | 
| Cumulative energy applied for successfull electrocardioversion (in Joule) |  | 30 days | 
| Cumulative number of shocks delivered for successfull electrocardioversion |  | 30 days | 
| Number of patients with short-term cardioversion success | Sinus rhythm after electrocardioversion | 30 minutes |
Optima Coronary Artery Disease (CAD) (Optimal Mechanical Evaluation)

Study Overview
=================
Brief Summary
-----------------
To evaluate the impact of left ventricular (LV) lead location on LV mechanical function.

Official Title
-----------------
Optima CAD (Optimal Mechanical Evaluation)

Conditions
-----------------
Heart Failure, Ischemic Cardiomyopathy

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria Ischemic Cardiomyopathy Left ventricular ejection fraction less than 40% Clinical indication for invasive electrophysiology testing Patient is at least 18 years of age Exclusion Criteria Unstable angina, acute myocardial infarction and/or revascularization procedure within 3 months CVA or TIA within the past 6 months Prosthetic heart valve Patient is status post heart transplant Women who are pregnant or with child -bearing potential and who are not on a reliable form of birth control. Women of child-bearing potential are routinely tested for pregnancy as part of the standard of care prior to EPS procedures being performed.

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

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

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

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

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

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
ischemic cardiomyopathy, cardiac resynchronization therapy, LV structure and function
Serum Brain Natriuretic Peptide Levels and Pulmonary Hypertension in Pediatric Sickle Cell Patients

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is To determine if Brain natriuretic peptide levels correlates with elevated tricuspid regurgitation flow velocity levels in pediatric patients with sickle cell disease To determine the role of age, gender, steady state hemoglobin and disease type on Brain natriuretic peptide levels and pulmonary hypertension

Detailed Description
-----------------
Pulmonary hypertension is recognized as a significant cause of morbidity and mortality in patients with sickle cell disease. Doppler echocardiography is a recommended noninvasive screening tool for sickle cell disease patients with pulmonary hypertension. Brain natriuretic peptide levels have been found to be a possible serum screening marker. This research will offer the opportunity to determine if there is any possible relationship between magnitude of BNP concentration and degree of TRV, if it can be used as a screening test in SCD pediatric patients with PHT and form the basis for a future multicenter study

Official Title
-----------------
Serum Brain Natriuretic Peptide Levels and Its Correlation With Echocardiographic Measurements Suggestive of Pulmonary Hypertension in Pediatric Patients With Sickle Cell Disease

Conditions
-----------------
Pulmonary Hypertension

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Male and Female any age Diagnosis of SCD with PHT on echocardiogram Controls must have a diagnosis of sickle cell disease without Pulmonary hypertension, age, gender and disease type match to subjects with pulmonary hypertension Parent or Legal guardian willing to sign informed consent form Exclusion Criteria: Abnormal echocardiograms not related to PHT Parent or Legal guardian unwilling or unable to give written informed consent

Ages Eligible for Study
-----------------
Minimum Age: 7 Years
Maximum Age: 21 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 |
| --- | --- | --- |
| Correlation of Brain Natriuretic Peptide (BNP) levels to elevated Tricuspid Regurgitation Flow Velocity (TRV) | Subjects will be asked to participate in the study by allowing a review of their echocardiographic findings. In addition, they will be asked for a 1 ml blood sample during routine annual follow ups for BNP levels to be drawn. | one day | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Pulmonary hypertension, Sickle cell disease, Pediatric patients, Brain Natriuretic Peptide levels
The Association Between the Use of Complementary and Alternative Medicine and Medication Adherence in Hypertensive African-Americans

Study Overview
=================
Brief Summary
-----------------
The objective of this study is to better understand strategies used by African Americans with hypertension in order to control their blood pressure.

Detailed Description
-----------------
The objective of this study is to better understand strategies used by African Americans with hypertension in order to control their blood pressure. Through the use of qualitative interviews, the beliefs and attitudes toward complementary medicine of African Americans with hypertension will be elucidated.

Official Title
-----------------
The Association Between the Use of Complementary and Alternative Medicine and Medication Adherence in Hypertensive African-Americans

Conditions
-----------------
Hypertension

Intervention / Treatment
-----------------
* Behavioral: Self-affirmation intervention


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients will be African-American adults 18 years or older who were diagnosed with poorly controlled hypertension as defined by the 6th Joint National Committee guidelines (systolic >140 and diastolic >90). Patients will also be eligible if they are taking any prescribed anti-hypertensive medications. Patients must be able to provide informed consent in English. Participants will be recruited from Cornell Internal Medicine Associates, the primary care and general medicine practice at Cornell Medical Center, the same site as the parent grant. Exclusion Criteria: Patients who refused to participate. Patients who are unable to provide 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

| Intervention/Treatment |
| --- |
|Behavioral: Self-affirmation intervention|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The impact of positive affect induction and self-affirmation on medication adherence and blood pressure control. |  |  | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
African-American, Hypertension, Complementary medicine, Medication adherence
A Modified Approach for the Closure of Oral Sinus Communications

Study Overview
=================
Brief Summary
-----------------
The aim of this study is to describe a modified surgical approach for the closure of oral sinus communications, using a buccal trapezoidal flap combined with a connective pedicle flap rotated from the palate

Official Title
-----------------
A Modified Approach for the Closure of Oral Sinus Communications

Conditions
-----------------
Surgery Site Fistula

Intervention / Treatment
-----------------
* Procedure: modified buccal flap and subepithelial connective palatal flap


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patient with diagnosis of Oro-antral communication Patients with adequate radiographic status Patients who read and signed the informed consent Patients without periodontal disease Patients≥18 Exclusion Criteria: Pregnancy or breastfeeding patients Patients compliance and patients with mental disorders Patients with diabetes Patients with osteonecrosis Patients with head and neck cancer

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

Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Interventional Model Description: case series of a new surgical design
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: modified buccal flap and subepithelial connective palatal flap<br> | Procedure: modified buccal flap and subepithelial connective palatal flap<br>* The connective flap was harvested from the deeper area of the palatal mucosa. Pedicle flap dimensions were reported using the periodontal probe. The flap was then rotated to cover the oro antral communication (OAC) area. The rotation could be in mesial or distal direction, related to OAC position and for the convenience of the donor site. The connective palatal flap was sutured to the buccal periostium using mattress sutures.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Closure of the communication | Clinical observation | Day 30 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pain and discomfort | These parameters are described using VAS technique | Day 30 | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Extraction, Oro-antral communication, Oro-antral fistula
Frequency and Characteristics of Pruritus in Patients With Monoclonal Gammopathy

Study Overview
=================
Brief Summary
-----------------
Pruritus is most often secondary to dermatitis but can also occur without skin lesions, it is called pruritus sine materia. The causes of pruritus sine materia are various: haematological (myeloproliferative neoplasia ...), hepatic (cholestasis ...), renal (chronic renal failure, dialysis), endocrine (iron deficiency ...), secondary to drug intake ... or idiopathic when no cause is found. Gammapathies are among the causes of pruritus sine materia, and as such electrophoresis of serum proteins is usually part of the pruritus assessment to look for monoclonal gammopathy (MGUS, multiple myeloma, Waldenström disease). However, there is very little data on the frequency of pruritus in patients with monoclonal gammopathy and the characteristics of this pruritus. So the aim of this study is to compare the frequency of pruritus between patients with monoclonal gammapathy and controls

Official Title
-----------------
Frequency and Characteristics of Pruritus in Patients With Monoclonal Gammopathy

Conditions
-----------------
Pruritus, Monoclonal Gammopathy

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria for case : Major patient Realized Serum protein electrophoresis between 2014 and 2017 Hematology follow-up at Brest CHR Positive monoclonal gammopathy Non-opposition formulated Inclusion Criteria for Control : Major patient Realized Serum protein electrophoresis between 2014 and 2017 Hematology follow-up at Brest CHR Negative gammopathy Non-opposition formulated Exclusion Criteria: Minor patient Major protected Patient with another haemopathy secreting a monoclonal immunoglobulin (lymphoma, LLC ...) Physical or mental incapacity Refusal to participe

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 |
| --- | --- |
| Patients with monoclonal gammopathy<br> | |
| patients with a normal plasma protein electrophoresis<br> | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Frequency of pruritus |  | through study completion, an average of 1 year |
A Study Comparing LBEC0101 to Enbrel® in Subjects With Active Rheumatoid Arthritis Despite Methotrexate Therapy

Study Overview
=================
Brief Summary
-----------------
This is a randomized, double-blind, parallel group, multicenter clinical study to evaluate the efficacy, safety, pharmacokinetics and immunogenicity of LBEC0101 compared to Enbrel in subjects with active Rheumatoid Arthritis despite Methotrexate therapy.

Official Title
-----------------
Multi-center (in Korea and Japan), Double-blind, Randomized, Parallel-group Study to Evaluate Similarity of Efficacy and Safety of LBEC0101 50mg Subcutaneous Weekly Injection to Enbrel® 50mg Subcutaneous Weekly Injection, as Adjunctive Therapy to Methotrexate (MTX), in Patients With Active Rheumatoid Arthritis Who Had an Inadequate Response to MTX

Conditions
-----------------
Arthritis, Rheumatoid

Intervention / Treatment
-----------------
* Drug: Enbrel
* Drug: LBEC0101


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Male or Female patients from 20 years to 75 years of age when signing Informed Consent. Diagnosed as having RA according to the revised 1987 ACR criteria for at least 6 months prior to screening Patients who have inadequate response to MTX administered for at least 12 weeks before the beginning of screening period and on a stable dose. Exclusion Criteria: patients with active tuberculosis or latent tuberculosis based on current clinical symptoms, chest X-ray test and IFN-γ release assay at screening patients with any of the following concomitant diseases and/or history within 24 weeks before the first administration of investigational products in this study; Serious infectious disease, Opportunistic infection, Chronic or recurrent infectious disease patients with any seropositive result for hepatitis B or hepatitis C or HIV patients who have any of the following diseases; Sepsis, Demyelinating disorders, Lymphoproliferative disease, Infection with prosthetic joint, Autoimmune diseases other than rheumatoid arthritis

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
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: LBEC0101<br>Etanercept | Drug: LBEC0101<br>* Etanercept<br>|
| Active Comparator: Enbrel<br>Etanercept | Drug: Enbrel<br>* Etanercept<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Disease activity score based on a 28 joint count (DAS28) |  | Week 24 |