linjc16/ctgov huggingface dataset:
Efficacy and Safety of Posterior Scleral Reinforcement on Controlling Myopia in Adults With High Myopia

Study Overview
=================
Brief Summary
-----------------
This study will evaluate the efficacy and safety of posterior scleral reinforcement on controlling myopia progression, including change in refraction, axial elongation as well as sight-threatening complications, in adults with high myopia. Half the adults will receive posterior scleral reinforcement, while the other half will receive no surgerical treatment.

Official Title
-----------------
Posterior Scleral Reinforcement for Adults With High Myopia

Conditions
-----------------
High Myopia, Posterior Scleral Reinforcement, Adults, Axial Elongation, Myopia Progression

Intervention / Treatment
-----------------
* Procedure: Posterior scleral reinforcement


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Cycloplegic spherical equivalent less than -6.0 D Myopia progression greater than 1.0 D per year Normal IOP, no strabismus or any other ocular pathological changes no any other ocular or systematic diseases that may affect refractive development Exclusion Criteria: Currently or history using other interventions to control myopia progression (acupuncture, drugs, contact lens, ear needles and so on) Unable to cooperate with the ocular examination,questionnaire survey,or orthokeratology wearing

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 40 Years

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

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

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

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Surgical group<br>In this arm, the adults with high myopia will be given posterior scleral reinforcement. | Procedure: Posterior scleral reinforcement<br>* Posterior scleral reinforcement (pPSR) is a procedure applied with autologous or biological material or synthetic materials reinforcing pole of the sclera after eyeball, in order to prevent or alleviate myopic development.<br>|
| No Intervention: Control group<br>In this arm, the adults with high myopia will not be given any surgical treatment. | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Cycloplegic autorefraction | Level of myopia and myopia progression as assessed by autorefraction | 2 years | 
| Axial length | Longth of the eyeball as assessed by IOL Master or Lenstar | 2 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of participants with treatment-related adverse events | Bleeding, inflammation or retinal detachment as assessed by B scan, slitlamp, etc. | 2 years | 
| Visual acuity | An index for visual function measured by visual acuity chart | 2 years |
Valsartan and Amlodipine Compared to Losartan and Amlodipine in Hypertensive Patients

Study Overview
=================
Brief Summary
-----------------
Hypertensive patients with moderate hypertension have a risk to develop cardiovascular events of 15-20% over a period of 10 years. It is important to reach quickly the advised target, but often this result can be obtained with a combination therapy. Some evidences demonstrate sartans and calcium channels blockers can be very useful and safe, but it is also important to verify which association can give side effects or give some pharmacokinetic interactions that can negatively influence the clinical combination efficacy.

Official Title
-----------------
Evaluation of Antihypertensive Activity of Valsartan and Amlodipine Compared to Losartan and Amlodipine Through Ambulatory Blood Pressure Monitoring in Moderate Hypertensive Patients in a Randomized, Controlled, Double-Blind Study

Conditions
-----------------
Essential Hypertension

Intervention / Treatment
-----------------
* Drug: valsartan/amlodpine
* Drug: losartan/amlodpine


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: diastolic blood pressure in sitting position 100 to 109 mmHg and systolic blood pressure > 140 mmHg at the end of the selection period Exclusion Criteria: type 2 diabetes mellitus heart failure AMI in the previous 6 months angina pectoris secondary hypertension malignant hypertension women child-bearing potential women who are pregnant and lactating suspected history of allergy to the sartans or calcium channels blockers

Ages Eligible for Study
-----------------
Minimum Age: 35 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: Crossover Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 1<br>valsartan/amlodipine | Drug: valsartan/amlodpine<br>* tablets; 160mg/5mg; od; 4 weeks<br>|
| Active Comparator: 2<br>losartan/amlodpine | Drug: losartan/amlodpine<br>* tablets; 100mg/5mg; od; 4 weeks<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 24 hours mean, determinated through ABPM; diastolic mean after 4 weeks of losartan 100mg/amlodipine 5mg and valsartan 160mg/amlodipine 5mg treatment |  | after 4 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 24 hours systolic mean, determinated through ABPM; day systolic and diastolic mean determinated through ABPM; night systolic and diastolic mean determinated through ABPM |  | after 4 weeks |
Survival Analysis of Frail Patients With Localised Colorectal Cancer

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to analyse the survival of frail patients with localized colorectal cancer who undergo surgical treatment in comparison with those with palliative treatment

Detailed Description
-----------------
Patients with localized colorectal cancer will be visited by a colorectal surgeon who will explain the disease and the surgical treatment. In this visit the patient will be screened for frailty and asked for informed consent. Patients who meet the eligibility criteria will be sent to the internal medicine consultant to frailty evaluation, risk assessment and counselling in order to help patient decision process.

Official Title
-----------------
Survival Analysis of Frail Patients With Localised Colorectal Cancer: Multicentre Observational Study, Comparing Surgical vs Palliative Treatment

Conditions
-----------------
Colorectal Cancer, Surgery, Frailty

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Localised colorectal cancer Positive frailty screening Exclusion Criteria: None

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 |
| --- | --- |
| Surgical treatment<br> | |
| Palliative treatment<br> | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Survival |  | 1 year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Surgical complications |  | 30 days |
The Core Body Temperature Rhythms: Distinguishing MCS From UWS

Study Overview
=================
Brief Summary
-----------------
In this study, the core body temperature of 7 disorders of consciousness ( DOC ) patients were measured every 2 hour for 168 h .

Detailed Description
-----------------
Living beings have multicomponent biological rhythms. There was a research recorded 24-h virations in electroencephalographic patterns. In normal subjects, the circadian rhythms of core body temperature is close to 24 h. When the interference of environmental and mental elements were eliminated, circadian rhythm shows the endogenous circadian rhythm of body acquiescently (>24h ), which is also called free-running period. Measuring the continuous external auditory canal temperature of 4 unresponsive wakefulness syndrome (UWS) and 3 minimally conscious state(MCS) on the fluorescent lamp surrounding every 2 hours for 168 hours starting at 00:00 on the first day to address circadian capabilities. Researchers expected to see the difference between MCS and UWS.

Official Title
-----------------
The Core Body Temperature Rhythms:A Promising Indicator of Distinguishing MCS From UWS

Conditions
-----------------
Disorders of Consciousness

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: patients in minimally conscious state patients with stable condition patients free of sedative drugs and Na+ or Ca++ blockers (e.g., carbamazepine) or NMDA receptor antagonist (e.g., dextromethorphan) Exclusion Criteria: premorbid neurology antecedent patients in coma or vegetative state patients < 1 months after the acute brain injury

Ages Eligible for Study
-----------------
Minimum Age: 39 Years
Maximum Age: 69 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 |
| --- | --- | --- |
| Measuring the continuous external auditory canal temperature | VS patients have core body temperature periods which are longer than 24 hours; whereas MCS patients are shorter than 24 hours. | Continuous temperature measurements for 168 hours (8days) | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
unresponsive wakefulness syndrome, minimally conscious state, circadian rhythms, free-running period
Prevalence of Cesarean Section on Demand in Assiut University Hospital & Abnob Central Hospital

Study Overview
=================
Brief Summary
-----------------
Cesarean section on demand: defined as a primary cesarean section performed at the mother's request to avoid a vaginal birth, without any recognized medical or obstetric indication. The medical field now acknowledges a patient's right to actively participate in her choice of medical treatments, including method of delivery. There are many reasons for a cesarean section on demand: fear of delivery, fear of pain, family pressure, a previous bad experience, more control over events, improved care, and maintaining the integrity of the pelvic floor. of the pelvic floor.

Official Title
-----------------
Prevalence of Cesarean Section on Demand in Assiut University Hospital & Abnob Central Hospital

Conditions
-----------------
Cesarean Section

Intervention / Treatment
-----------------
* Other: questionnaire


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Accepting to participate in the study. pregnant Women undergoing Cesarean section Exclusion Criteria: pregnant Women undergoing Cesarean section due to medical or obstetric indication Caesarean hysterectomy .
Sexes Eligible for Study
-----------------
Female

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

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

Arms and Interventions

| Intervention/Treatment |
| --- |
|Other: questionnaire|asking about details of indication of cesarean section|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| the percentage of cesarean section on request in patients | through a questionnaire | 1 year |
Real World Data Study Assessing The Persistency Of Xalacom And The Other Fixed Dose Combination Products, Duotrav And Ganfort, In The United Kingdom

Study Overview
=================
Brief Summary
-----------------
The hypothesis is that there is no difference in persistency between Xalacom and the alternative fixed dose combination products (Duotrav and Ganfort) over a 12 month period.

Official Title
-----------------
Persistence Of Use Of Topical Prostaglandin Fixed Dose Combination In The United Kingdom Primary Care: An Observational Study In Thin

Conditions
-----------------
Glaucoma, Ocular Hypertension

Intervention / Treatment
-----------------
* Drug: XALACOM
* Drug: Duotrav
* Drug: Ganfort


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients who had received a prescription for either Xalacom, Ganfort and DuoTrav Greater than 18 years old Diagnosed with glaucoma or ocular hypertension Registered at the primary care practice for > 12 months Exclusion Criteria: None

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 100 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 |
| --- | --- |
| fixed dose prostaglandin combination<br> | Drug: XALACOM<br>* Xalacom eye drops<br>Drug: Duotrav<br>* Duotrav eye drops<br>Drug: Ganfort<br>* Ganfort eye drops<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Frequency distribution of persistent and non-persistent patients across study cohorts |  | 12 months | 
| Frequency distribution of switchers, re-starters and discontinuing patients as well as patients commencing add-on therapy across the study cohorts |  | 12 months | 
| Time to discontinuation of each cohort |  | 12 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Age and sex: Townsend Score of social deprivation, time since first THIN diagnosis of glaucoma or ocular hypertension |  | 12 months | 
| Procedures: Laser, Trabeculectomy, viscocanalostomy, deep sclerectomy |  | 12 months | 
| Ocular Pharmacological Treatments: Beta-blockers and Alpha-agonists |  | 12 months | 
| Prostaglandin mono-therapies |  | 12 months | 
| The cohort of patients which were evaluated in this study were investigated for the presence of history of disease for asthma, cardiovascular disease, diabetes, renal failure and systemic hypertension. The number of patients in each cohort were |  | 12 months | 
| presented who had had (i) a 12 month history of any of the diseases or (ii) had had a history of any of the diseases. |  | 12 months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Real world, observational, retrospective, database analysis
Biomarkers of Renal Dysfunction in Neuroblastoma Survivors

Study Overview
=================
Brief Summary
-----------------
The main purpose of this study is to learn more about biomarkers of kidney function in the blood and urine of neuroblastoma survivors. A biomarker is a biological molecule found in blood, urine, other body fluids, or tissues that is a sign of a normal or abnormal process, or of a condition or disease. A biomarker may be used to see how well the body responds to a treatment for a disease or condition.

Official Title
-----------------
Biomarkers of Renal Dysfunction in Neuroblastoma Survivors

Conditions
-----------------
Neuroblastoma Survivors

Intervention / Treatment
-----------------
* Other: Urine sample


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Diagnosis of neuroblastoma between 0-18 years of age < 21 years of age at time of study enrollment Two or more years from completion of systemic chemotherapy and/or radiation therapy Exclusion Criteria: Patients treated with observation only Patients with multiple primary cancers

Ages Eligible for Study
-----------------
Maximum Age: 20 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 |
| --- | --- |
| survivors of neuroblastoma treated with nephrotoxic therapy<br>Upon enrollment, all subjects will receive a urine collection kit by mail. Participants will bring in a first-morning urine specimen on the day of their routinely scheduled long-term follow-up visit, and will then have an additional blood and urine sample drawn with their other clinical care labs upon arrival to MSK. | Other: Urine sample<br>* The urine collected from the first morning void will be used to assess urine creatinine and microalbumin. The fresh urine specimen will be analyzed for novel urinary biomarkers of (urinary NGAL, TGF-β1, IL-18 and KIM-1). Serum BUN, creatinine, and cystatin-C will be assessed using serum samples drawn for routine clinical care.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| indicators of renal injury | urine collected from the first morning void will be used to assess urine creatinine | 2 years | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Kidney Function, Biomarkers, 19-160
A Study of Multiple Doses of HM15211 in Obese Subjects With NAFLD

Study Overview
=================
Brief Summary
-----------------
This study is a phase 1 study to evaluate the safety, tolerability, pharmacokinetics and pharmacodynamics of multiple doses of HM15211 in obese subjects with NAFLD

Official Title
-----------------
A Phase 1 Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of Multiple Doses of HM15211 in Obese Subjects With NAFLD

Conditions
-----------------
NAFLD

Intervention / Treatment
-----------------
* Drug: HM15211
* Drug: Placebo of HM15211


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Body mass index ≥ 30 kg/m2 Waist circumference ≤ 57 inches Fasting Plasma Glucose < 7 mmol/L (126 mg/dL) HbA1c < 6.5% Controlled Attenuation Parameter ≥ 300 dB/m by FibroScan Liver fat by MRI-PDFF ≥ 10%. Exclusion Criteria: A history of or active chronic liver disease due to alcohol, auto-immune, HIV, HBV or active HCV-infection or NASH disease Any history of clinically significant chronic liver disease including esophageal varices, ascites, encephalopathy or any hospitalization for treatment of chronic liver disease; or Model for End Stage Liver Disease (MELD) ≥ 10 Previous surgical treatment for obesity Uncontrolled hypertension Any weight control treatment History or current diagnosis of acute or chronic pancreatitis or factors for pancreatitis History of major depression, anxiety, suicidal behavior or attempts, or other psychiatric disorder requiring medical treatment History or current diagnosis of heart disease Presence of clinically significant ECG findings History of renal disease or abnormal kidney function tests History of alcohol or illicit drug abuse Daily heavy use of cigarettes or any tobacco product

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 65 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: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: HM15211<br> | Drug: HM15211<br>* A sterile solution of HM15211 contained in pre-filled syringes<br>|
| Placebo Comparator: Placebo<br> | Drug: Placebo of HM15211<br>* A sterile, matching solution in pre-filled syringes<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Adverse Events | Incidence of adverse events | 12 weeks | 
| Clinical lab abnormalities | Incidence of clinical lab abnormalities | 12 weeks | 
| Physical examination | Incidence and severity of clinical findings on physical examination | 12 weeks | 
| Vital signs | Change from baseline in vital signs | 12 weeks | 
| 12-lead ECG | Change from baseline in 12-lead ECG | 12 weeks |
Clinical Outcomes for Deep Brain Stimulation

Study Overview
=================
Brief Summary
-----------------
The object of this study is to longitudinally collect clinical outcomes of patients receiving deep brain stimulation for movement disorders with the objective of making retrospective comparisons and tracking of risks, benefits, and complications.

Official Title
-----------------
Clinical Outcomes for Deep Brain Stimulation for Parkinson Disease, Tremor, and Dystonia

Conditions
-----------------
Parkinson Disease, Essential Tremor, Dystonia

Intervention / Treatment
-----------------
* Device: Deep Brain Stimulation


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Levodopa responsive Parkinson disease OR Medically refractory Essential Tremor OR Medically refractory Dystonia Exclusion Criteria: Dementia (Mattis Dementia Rating Scale <130) Structural abnormalities precluding intracranial surgery
Sexes Eligible for Study
-----------------
All

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

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

Arms and Interventions

| Intervention/Treatment |
| --- |
|Device: Deep Brain Stimulation|High frequency electrical stimulation of deep brain nuclei for the treatment of movement disorders|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| UPDRS | United Parkinson's Disease Rating Scale (global assessment of motor, non-motor, and quality of life associated with symptoms of Parkinson disease). Total scores range from 0-199. Particular emphasis is paid to subsection 3 (motor), where scores range from 0-56. | Change in UPDRS at 1 year after DBS (from preoperative baseline). | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Deep brain stimulation