linjc16/ctgov huggingface dataset:
Ocular Development and Refractive Error Changes Among Children and Adolescent - A Longitudinal Study

Study Overview
=================
Brief Summary
-----------------
The study aims to observe the ocular development and refractive error changes among school children and adolescents

Detailed Description
-----------------
This study aims to observe the refractive error changes of school children and adolescents for 3 years, and to collect data of ocular structural parameters, family history and environmental factors so as to understand the natural course and internal laws of myopia progression.

Official Title
-----------------
A Longitudinal Study on Ocular Development and Refractive Error Changes Among children-and Adolescent

Conditions
-----------------
Myopia

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: School children and adolescent at the age of 3(Junior Kindergarten), 6(Grade 1), 9(grade 4), 12(grade 7). No allergy to tropicamide or topical anesthetics written informed consent is obtained from guardian Be willing to cooperate with the relevant ophthalmological examination and complete the questionnaire. Exclusion Criteria: No history of eye diseases Receiving or has been received treatment of myopia control such as atropine eye drops, corneal contact lens or myopic glasses A history of allergy to topic amide or topical anesthetics Have severe systemic disease Missing ability to give informed consent

Ages Eligible for Study
-----------------
Minimum Age: 3 Years
Maximum Age: 12 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 |
| --- | --- | --- |
| spherical equivalent change | SE was measured by autorefractometer with cycloplegic once a year at scheduled time Every 12 months, follow up for 3 years | examine every 12 months, follow up for 3 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Axial length | Axial length is measured by IOMaster once a year at scheduled time | examine every 12 months, follow up for 3 years | 
| Anterior chamber depth | Anterior chamber depth is measured by IOMaster once a year at scheduled time | examine every 12 months, follow up for 3 years | 
| lens thickness | lens thickness is measured by IOMaster once a year at scheduled time | examine every 12 months, follow up for 3 years | 
| Vitreous length | Vitreous length was measured by IOMaster once a year at scheduled time | examine every 12 months, follow up for 3 years | 
| Environmental factor | Time of outdoor activities & short range reading,measured by questionnaire | examine every 12 months, follow up for 3 years | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
refractive error, ocular structural parameters
Relationship Between CT- Value With Prognosis in COVID-19 Patients

Study Overview
=================
Brief Summary
-----------------
evaluate the relationship between cycle threshold number with final prognosis in COVID-19 patients

Detailed Description
-----------------
evaluate the relationship between cycle threshold number with final prognosis in COVID-19 patients

Official Title
-----------------
Relationship Between CT- Value With Prognosis in COVID-19 Patients

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

Intervention / Treatment
-----------------
* Diagnostic Test: Cycle threshold


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: COVID-19 PCR positive Exclusion Criteria: -
Sexes Eligible for Study
-----------------
All

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

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

Arms and Interventions

| Intervention/Treatment |
| --- |
|Diagnostic Test: Cycle threshold|cycle threshold number|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| prognosis | death or alive | 6 months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
COVID-19
Evaluation Perioperative Nutrition on Donor Site Healing in Patients Undergoing Reconstructive Burn Surg

Study Overview
=================
Brief Summary
-----------------
The investigators hope to learn if taking a nutrition drink for a short time after surgery for an elective reconstructive burn injury improves donor site healing, muscle mass and scar maturation time (the point at which the redness, height and firmness of the wound has faded, flattened and softened, and no longer changes in appearance).

Conditions
-----------------
Burn, Reconstructive Surgical Procedure

Intervention / Treatment
-----------------
* Dietary Supplement: Juven (Ross Products) protein supplement


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: At least one year post-acute burn injury Admitted for surgery whereby split thickness donor site created Received initial acute treatment at Shriner's Hospital in Cincinnati Exclusion Criteria: Less than 6years of age Less than one year from acute burn injury Split thickness donor site/autograft not anticipated Initial treatment not at Shriners Hospital in Cincinnati

Ages Eligible for Study
-----------------
Minimum Age: 6 Years
Maximum Age: 24 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: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: A, treated<br>treated with Juven po supplement x 3 weeks postop | Dietary Supplement: Juven (Ross Products) protein supplement<br>* Juven supplement oral x 3 weeks postop<br>|
| No Intervention: B, control<br>Usual nutrition therapy received postop | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| donor site healing time |  | 3weeks | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
pediatrics
Safety Study of Shenmai(a Chinese Medicine Injection) Used in Hospitals in China

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to make a cohort event monitoring to see whether and how Shenmai injection in hospital results in adverse events or adverse drug reactions.

Detailed Description
-----------------
Safety surveillance on Chinese Medicine injection is an important problem that needs to be sorted out ,because in mainland China hospitals ,Chinese Medicine Injection are used widely. Population for taking medicine characteristics,the incidence rate of ADR and other uncertain factors influence can not be found now. A registry study for shenmai injection safety surveillance with 30000 patients will be conducted from Jan.2012 to Dec.2015. Eligibility criteria Patients who will use shenmai injection in selected hospitals.

Official Title
-----------------
A Registry Study on Safety Surveillance of Shenmai (a Chinese Medicine Injection) Used in China

Conditions
-----------------
Shock, Coronary Heart Disease

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: all inpatients use Shenmai injection in 30 selected hospitals during their hospital stay Exclusion Criteria: none
Sexes Eligible for Study
-----------------
All

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| a cohort using Shenmai injection<br> | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
Study of Lonafarnib in Patients With Recurrent Squamous Cell Carcinoma of the Head and Neck (Study P02530)

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to determine the safety and efficacy of an oral Farnesyl Protein Transferase Inhibitor (Lonafarnib/SCH 6636) as a single agent in Adult Patients With Squamous Cell Carcinoma of the Head & Neck and will help determine if further development is justified.

Official Title
-----------------
An Open-Label Phase 2 Study of Lonafarnib in Patients With Recurrent Squamous Cell Carcinoma of the Head and Neck

Conditions
-----------------
Carcinoma, Squamous Cell, Head and Neck Neoplasms

Intervention / Treatment
-----------------
* Drug: Farnesyl Protein Transferase Inhibitor


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Histologically or cytologically proven squamous cell carcinoma of the head & neck. Age greater than or equal to 18. ECOG performance status of 0 to 1 Measurable malignant disease. Patients that have failed at least one platinum-containing regimen and have received no more than three prior regimens and do not have other curative treatment options. Patients must be at least 2 wks post surgery or radiation therapy Patients must be at least 4 weeks post chemotherapy Meets protocol requirements for specified laboratory values. Written informed consent and cooperation of patient. Appropriate use of effective contraception if of childbearing potential. No investigational drugs of any type within 30 days prior to administration. Exclusion Criteria: Prior exposure to farnesyl transferase inhibitors Medical conditions that would interfere with taking oral medications. Patients with significant QTc prolongation at baseline (>500 msec.) Pregnant or nursing women Known HIV positivity or AIDS-related illness. Concomitant chemotherapy, hormonal therapy, radiotherapy or immunotherapy Patients with any signs of involvement of the dura, meninges, or brain. Patients with squamous cell carcinoma of the nasopharynx Patients who currently have other cancers or have been treated in the last 5 years for any other malignancy.

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

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

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

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

Design Details

Primary Purpose: Treatment
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: Farnesyl Protein Transferase Inhibitor|nan|

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
-----------------
Squamous Cell Carcinoma of the Head & Neck
A Study to Test Different Doses of BI 456906 in Patients With Obesity

Study Overview
=================
Brief Summary
-----------------
Main objective is to investigate the tolerability of different titration schemes of BI 456906 in otherwise healthy patients with obesity/overweight, and to determine a titration scheme for future studies.

Official Title
-----------------
A Phase I, Blinded Within Dose Groups, Multiple Dose, Placebo-controlled Study to Assess the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of Different Titration Schemes of BI 456906 in Patients With Obesity and Overweight.

Conditions
-----------------
Obesity

Intervention / Treatment
-----------------
* Drug: BI 456906
* Drug: Placebo


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Male and female patients ≥ 18 years and < 70 years of age at screening Body Mass Index (BMI) ≥ 27 kg/m2 and <40 kg/m2 at screening A minimum absolute body weight of 70 kg at screening and a stable body weight (defined as no more than 5% change) 3 months prior to screening HbA1c <6.5% Further inclusion criteria apply Exclusion Criteria: Women who are pregnant, nursing, or who plan to become pregnant while in the trial Supine blood pressure (BP) ≥160/100 mmHg at screening Major surgery (major according to the investigator's assessment) performed within 12 weeks prior to randomization or planned within 12 months after screening Any laboratory value outside the reference range that the investigator considers to be of clinical relevance Further exclusion criteria apply

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 70 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: BI 456906<br> | Drug: BI 456906<br>* Solution for injection<br>|
| Experimental: Placebo<br> | Drug: Placebo<br>* solution for injection<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Cumulative number [N (%)] of patients withdrawn from up-titration by up-titration scheme |  | Up to 132 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| AUC0-168 (area under the concentration-time curve of the analyte in plasma over the time interval from 0 to 168h) |  | Up to 168 hours | 
| Cmax (maximum measured concentration of the analyte in plasma) after first dose |  | Up to 132 days |
Effect of Liraglutide on Blood Glucose Control in Subjects With Type 2 Diabetes

Study Overview
=================
Brief Summary
-----------------
This trial is conducted in the United States of America (USA) and Canada. This trial is designed to show the effect of treatment with liraglutide when added to existing rosiglitazone and metformin combination therapy and to compare it with the effects of therapy with rosiglitazone and metformin alone.

Official Title
-----------------
Effect on Glycemic Control of Liraglutide in Combination With Rosiglitazone Plus Metformin Versus Rosiglitazone Plus Metformin in Subjects With Type 2 Diabetes

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

Intervention / Treatment
-----------------
* Drug: liraglutide
* Drug: rosiglitazone
* Drug: metformin


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Type 2 diabetes Treated with oral anti-diabetic (OAD) drugs for at least 3 months Treated with one or more OAD and in moderate to poor glycemic control Body Mass Index (BMI) less than or equal to 45.0 kg/m2 Exclusion Criteria: Treatment with insulin within the last three months prior to the trial except due to intercurrent illness, at the discretion of the Investigator Any serious medical condition Treatment with any drug that could interfere with glucose level

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: Double


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: liraglutide|nan|
|Drug: rosiglitazone|nan|
|Drug: metformin|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| HbA1c |  | after 26 weeks of treatment | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| body weight |  |  | 
| Safety and tolerability |  |  | 
| Glycaemic control |  |  |
Apical Support During Hysterectomy for Pelvic Organ Prolapse

Study Overview
=================
Brief Summary
-----------------
This is a retrospective chart review using TriHealth Electronic Privacy Identification Center (EPIC) to determine whether gynecologic surgeons at a large community hospital are already meeting the recently recommended best practice of supporting the vaginal apex.

Detailed Description
-----------------
The prevalence of pelvic organ prolapse (POP) in the United States is estimated to be between 40-50% with an anticipated increase over the next several decades. Approximately 300,000 women undergo surgeries to repair POP in the United States every year. Following pelvic reconstructive surgery, recurrence rates of symptomatic prolapse range between 6-30%. Our understanding of pelvic anatomy and its support has been significantly improved over recent decades, with many researchers reporting on details and mechanics previously not understood. In November 2017, the American College of Obstetricians and Gynecologists released a new practice bulletin outlining the current standard of care for the treatment of women with pelvic organ prolapse. In this bulletin, they state that a hysterectomy alone is not adequate treatment for pelvic organ prolapse, and further that any woman having a hysterectomy for pelvic organ prolapse should undergo a concurrent apical suspension procedure as a standard of care. The purpose of this study is to determine the proportion of patients already meeting the recently recommended best practice of supporting the vaginal apex at the time of hysterectomy for pelvic organ prolapse among the population who underwent the surgery performed at a TriHealth facility between October 2012 and October 2017.

Official Title
-----------------
Are we Supporting the Apex During Hysterectomy for Pelvic Organ Prolapse?

Conditions
-----------------
Pelvic Organ Prolapse

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Adults 18 years of age or older Underwent hysterectomy for pelvic organ prolapse, performed at a TriHealth facility between October 2012 and October 2017 Exclusion Criteria: Age < 18 years old Pelvic Organ Prolapse was not an indication for their surgery Surgery performed by a physician of Cincinnati Urogynecology Associates.

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

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

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 |
| --- | --- | --- |
| Proportion of Patients Having Concurrent Apical Suspension Performed | proportion of patients who had concurrent apical support procedures performed | at time of hysterectomy for pelvic organ prolapse |
TLK286 (Telcyta) in Combination With Carboplatin (Paraplatin) Versus Doxil in Platinum Refractory or Resistant Ovarian Cancer

Study Overview
=================
Brief Summary
-----------------
The purpose of this research study is to determine if TLK286 given in combination with carboplatin is more effective than liposomal doxorubicin in treating women who have recurrent ovarian epithelial cancer, fallopian tube cancer, or primary peritoneal cancer, that is refractory or resistant to platinum chemotherapy.

Official Title
-----------------
Phase III Randomized Study of TLK286 (Telcyta) in Combination With Carboplatin (Paraplatin) Versus Liposomal Doxorubicin (Doxil) as Second-Line Therapy in Platinum Refractory or Resistant Ovarian Cancer [ASSIST-3]

Conditions
-----------------
Ovarian Neoplasms

Intervention / Treatment
-----------------
* Drug: TLK286 in Combination with Carboplatin
* Drug: Doxorubicin HCl Liposome Injection


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Are a woman 18 years of age or older Have histologically or cytologically confirmed epithelial cancer of the ovary or fallopian tube, or primary peritoneal cancer Have platinum refractory or resistant cancer Measurable disease according to radiographic RECIST criteria with documented tumor progression Exclusion Criteria: Had treatment with first-line chemotherapy other than platinum-based regimens (carboplatin or cisplatin) Have clinically significant cardiac disease Have any sign of intestinal obstruction interfering with nutrition at the time of study entry Are pregnant or lactating Had prior treatment with liposomal doxorubicin for ovarian cancer Had prior treatment with TLK286

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

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 |
| --- | --- |
| Experimental: TLK286 in Combination with Carboplatin<br> | Drug: TLK286 in Combination with Carboplatin<br>* Experimental Arm<br>|
| Active Comparator: Doxorubisin HCl Liposome Injection<br> | Drug: Doxorubicin HCl Liposome Injection<br>* Active Comparator<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Study Objectives | To demonstrate superiority in the objective response rate (ORR) of TLK286 in combination with carboplatin as compared to active control therapy with liposomal doxorubicin | Every 8 Weeks | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Ovary