linjc16/ctgov huggingface dataset:
A Multi-center Study of the Effect of Orthokeratology on Myopia Progression

Study Overview
=================
Brief Summary
-----------------
This is a prospective study to validate an algorithm for predicting the effect of orthokeratology on myopia progression in children from 8 hospitals in China.

Detailed Description
-----------------
Orthokeratology (ortho-K) is thought to be an effective way to control the progression of Myopia in children, but its effectiveness may vary among different individuals. The investigators therefore conducted a prospective, multi-center study to use an algorithm to predict the progression of myopia among Chinese children wearing Orthokeratology lenses.

Official Title
-----------------
A Prospective, Multi-center Study of the Effect of Orthokeratology on Myopia Progression in Chinese Children

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

Intervention / Treatment
-----------------
* Device: Orthokeratology lenses


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: -6.0D≤SER≤-0.5D Astigmatism≤2.0D Exclusion Criteria: Contraindications of wearing Ortho-K. Diagnosis of strabismus, amblyopia and other refractive development of the eye or systemic diseases. Currently involved in other clinical studies.

Ages Eligible for Study
-----------------
Minimum Age: 8 Years
Maximum Age: 15 Years

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Children with myopia<br>A total of 1,000 children from 8 hospitals in China is required to undergo ophthalmic examinations and complete questionnaires at baseline and 1yr after wearing ortho-k lenses. | Device: Orthokeratology lenses<br>* Orthokeratology lenses<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| AUROC of the prediction algorithm for identifying fast progressing myopes | Age-specific axial length (AL) changes previously described by Wang et al.(IOVS, 52 (11), 7949-53, 2011) are used as cut-off values to determine whether a child is a fast progressor or not. A child whose AL change falls on or above the cut-off value is considered to be a fast progressor. | 1 year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Sensitivity and specificity of the prediction algorithm for identifying fast progressing myopes | The investigators will estimate sensitivity and specificity of the predictive algorithm for identifying fast progressing myopes. | 1 year | 
| Performance of an algorithm for predicting AL | The investigators will use mean absolute error (MAE), R square to evaluate the performance. | 1 year | 
| Performance of an algorithm for predicting spherical equivalent refractive error | The investigators will use mean absolute error (MAE), R square to evaluate the performance. | 1 year |
Open Label Extension Study of Nalbuphine HCl ER in Hemodialysis Patients With Uremic Pruritus

Study Overview
=================
Brief Summary
-----------------
The primary objective of the study is to evaluate the overall safety of nalbuphine HCL ER tablets during a treatment period of up to 24 weeks.

Official Title
-----------------
An Open Label Extension Study of the Safety and Anti-Pruritic Efficacy of Nalbuphine HCl ER Tablets in Hemodialysis Patients With Uremic Pruritus

Conditions
-----------------
Uremic Pruritus, Pruritus

Intervention / Treatment
-----------------
* Drug: nalbuphine HCl ER


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Subject completed participation in the TR02 study Subject is currently receiving in-center hemodialysis at the time of consent Exclusion Criteria: Subject receiving or anticipated to be receiving nocturnal dialysis or home hemodialysis treatment during the study Subject received opiates on a daily basis during the 1 week prior to screening Other than the TR02 Study Drug, Subject received any investigational drug within 4 weeks prior to Screening Subject is a pregnant or lactating female

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: nalbuphine HCl ER<br>nalbuphine HCl ER titrated from a dose of 30 mg QD to 120 BID for up to 3 weeks based on tolerability and efficacy, then maintained for an additional 21 weeks. Total duration of 24 weeks. | Drug: nalbuphine HCl ER<br>* nalbuphine HCl ER<br>* Other names: nalbuphine;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number and Percetage of Participants With Treatment Emergent Adverse Events (TEAEs) | The number of participants reporting at least one TEAE of a particular body system and preferred term are reported (incidence) | 24 weeks | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Uremic, Pruritus, Itch, Chronic Itch, Nalbuphine
A Pilot Study to Promote Maternal and Infant Oral Health

Study Overview
=================
Brief Summary
-----------------
The long term goals of this project are to develop and implement a combined prenatal and postnatal intervention to decrease early childhood caries. The program is based on risk assessment, diet intervention and counseling. To accomplish these goals a pilot study is needed to determine: 1) The ability to recruit and retain pregnant mothers in an intervention program; 2) The levels of S. mutans in pregnant mothers; 3) The ability of a diet intervention to decrease S. mutans in pregnant mothers.

Official Title
-----------------
A Pilot Study to Promote Maternal and Infant Oral Health

Conditions
-----------------
Dental Caries

Intervention / Treatment
-----------------
* Behavioral: Nutrition plus education
* Behavioral: Education only


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Age 18 or over; Pregnant High S. mutans levels Exclusion Criteria: Younger than 18; Other health conditions

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

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

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

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

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 1<br> | Behavioral: Nutrition plus education<br>* Nutritional instruction in small groups plus education<br>|
| Active Comparator: 2<br> | Behavioral: Education only<br>* Educational video and pamphlets<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Sugar intake |  | 3 months post partum | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| mutans streptococci levels |  | 3 months post partum |
Study Evaluating the Safety of HCV-796 in Subjects With Liver Disease and in Healthy Adults

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to assess the pharmacokinetics (PK) of HCV-796 in subjects with chronic hepatic impairment and in matched healthy adults.

Official Title
-----------------
An Open-Label, Single-Dose, Parallel-Group Study of the Pharmacokinetics and Safety of HCV-796 in Subjects With Chronic Hepatic Impairment and in Matched Healthy Adults

Conditions
-----------------
Hepatitis C, Hepatic Insufficiency

Intervention / Treatment
-----------------
* Drug: HCV-796


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Men and women of non-childbearing potential. Hepatic impairment subjects: Child-Pugh class A, B, or C according to the C-P classification based on history, physical examination, and laboratory test results. Healthy volunteers: healthy as determined by the investigator. Exclusion Criteria: History of alcoholism within 1 year. Hepatic impairment subjects: evidence of unstable clinically significant disease other than impaired hepatic function. Healthy volunteers: positive serologic findings for hepatitis B surface antigen (HBsAg) and/or hepatitis C virus (HCV) antibodies.

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 70 Years

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

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

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

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 1<br>HCV-796 1000mg single dose | Drug: HCV-796<br>* HCV-796 1000mg single dose<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To assess PK in subjects with chronic hepatic impairment and in matched healthy adults |  | 7 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To assess the safety and tolerability in subjects with chronic hepatic impairment and in matched healthy adults |  | 15 days | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Hepatitis C, Hepatic Impairment, Healthy Volunteer, Phase 1, Hepacivirus
Comparison of Two Doses of Intranasal Dexmedetomidine as Premedication in Children

Study Overview
=================
Brief Summary
-----------------
Intranasal dexmedetomidine has shown to be an effective sedative when used prior to anaesthetic induction as premedication. 1mcg/kg intranasal dexmedetomidine was used in previous study and it produced satisfactory sedation in more than 50% of the children at the time of anaesthetic induction with no adverse effect. In this study we aim to compare 1mcg/kg with 2mcg/kg intranasal dexmedetomidine in children. We expect more children would attain satisfactory sedation prior to anaesthetic induction when higher dose is used.

Official Title
-----------------
Comparison of Two Doses of Intranasal Dexmedetomidine as Premedication in Children - a Double-blinded Randomized Controlled Trial

Conditions
-----------------
Patient Between 1-8 Years Old Undergoing Elective Surgery at Queen Mary Hospital

Intervention / Treatment
-----------------
* Drug: Dexmedetomidine


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Age 1-12 years old American Society of Anesthesiologists (ASA) 1-2 Elective surgery Children with autism or pervasive personality disorder Exclusion Criteria: American Society of Anaesthesiologists (ASA) 3-5 Allergy or hypersensitive reaction to dexmedetomidine Known cardiac arrhythmia or congenital heart disease Mentally disabled

Ages Eligible for Study
-----------------
Minimum Age: 1 Year
Maximum Age: 8 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: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: 1mcg/kg<br>1mcg/kg intranasal dexmedetomidine administered 45 minutes befoe anesthesia induction | Drug: Dexmedetomidine<br>* Intranasal dexmedetomidine is given as premedication prior to induction of anesthesia<br>|
| Active Comparator: 2mcg/kg<br>2mcg/kg intranasal dexmedetomidine given 45 minutes prior to anesthetic induction | Drug: Dexmedetomidine<br>* Intranasal dexmedetomidine is given as premedication prior to induction of anesthesia<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| proportion of children attained satisfactory sedation |  | one hour | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| time to onset of sedation |  | one hour |
The Effect of Mannitol on the Serum Potassium During Craniotomy

Study Overview
=================
Brief Summary
-----------------
This is an observational study designed to research the effect of mannitol on the concentration of intraoperative serum potassium in patients undergoing craniotomy, and to guide the safe use of mannitol during craniotomy.

Detailed Description
-----------------
Patients were assigned to receive 20% mannitol (1g/kg) solution administered intravenously 15-20 minutes at the time of drilling skull.The serum potassium was measured by arterial blood gas analysis before infusion (T0), infusion finished (T1), 15min (T2), 30min (T3), 60min (T4) and 120min (T5) after infusion.

Official Title
-----------------
The Effect of Mannitol on Intraoperative Serum Potassium in Patients Undergoing Craniotomy：an Observational Study

Conditions
-----------------
Mannitol Adverse Reaction, Hyperkalemia

Intervention / Treatment
-----------------
* Other: Mannitol


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: age 18 to 70 American Society of Anesthesiologists physical status I to II liver and kidney function is normal preoperative concentration of serum potassium was from 3.5 to 5.5 mmol/L Exclusion Criteria: history or presence of congestive heart failure (New York Heart Association class III to IV) history or presence of renal failure(diabetes insipidus, or syndrome of inappropriate antidiuretic hormone secretion) intraoperative blood transfusion

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Mannitol<br>Mannitol was intravenous infused within 15-20 mins when drilling skull | Other: Mannitol<br>* Mannitol was intravenous infused within 15-20 mins when drilling skull<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| the concentration of serum potassium | measured by arterial blood gas analysis | two hours within infusioning mannitol |
Propranolol Versus Propranolol and Clonidine in Sympathetic Hyperactivity After Moderate Traumatic Brain Injury

Study Overview
=================
Brief Summary
-----------------
evaluation of the effect of Propranolol versus propranolol and clonidine on decreasing sympathetic hyperactivity after moderate traumatic brain injury

Detailed Description
-----------------
measuring catecholamine levels after moderate traumatic brain injury after giving propranolol and clonidine

Official Title
-----------------
Propranolol Versus Propranolol and Clonidine in Sympathetic Hyperactivity After Moderate Traumatic Brain Injury

Conditions
-----------------
Traumatic Brain Injury

Intervention / Treatment
-----------------
* Drug: Propranolol


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: GCS on admission between 9 and 12 age 18 up to 60 years both sexes Exclusion Criteria: history of heart disease, cardiac arrhythmia and myocardial infarction diagnosis ofpreexisting brain dysfunction. impending brain herniation and craniotomy diagnosis of spinal cord injuries. diagnisis of severe liver and renal disease current use of beta blocker and or alpha agonist current using of intravenous vasopressor contraindication to enteral feeding and can not swallow pregnancy

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 60 Years

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

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

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

Design Details

Primary Purpose: Diagnostic
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: propranolol group<br>we will give propranolol 40 milligram tablet twice daily in orogastric or nasogastric tube | Drug: Propranolol<br>* Test of catecholamines level in moderate traumatic brain injury<br>* Other names: Clonidine;|
| Active Comparator: propranolol clonidine<br>we will give propranolol 20 milligram tablet twice daily and clonidine 150 microgram tablet twice daily in orogatric or nasogastric tube | Drug: Propranolol<br>* Test of catecholamines level in moderate traumatic brain injury<br>* Other names: Clonidine;|
| No Intervention: control group<br>we will give conventional treatment, no propranolol nor clonidine | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| catecholamine level on day 7 | measuring catecholamine level on day 7 after giving study drugs | seven days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| mean arterial blood pressure every 4 hours herat rate every 4 hours temperature every 4 hours respiratory rate every 4 hours | measuring hemodynamics every 4 hours | 7 days | 
| Glascow coma scale | measuring glascow coma scale twice daily between 9 and 12 and higher score means better outcome. | 7 days |
Dietary Interventions in Prediabetes

Study Overview
=================
Brief Summary
-----------------
Assessment of glucose metabolism and liver fat after 12 week dietary intervention in pre diabetes subjects. Subjects will be randomized to either high fat (olive oil supplemented),high carb/high fiber (beans supplemented) and high carb/low fiber diets. Glucose metabolism will be assessed by labeled oral glucose tolerance test and liver fat by magnetic resonance spectroscopy pre randomization and at 8 and 12 week after starting dietary intervention.

Official Title
-----------------
The Effects of Dietary Supplementation on Hepatic Insulin Action and Glucose Tolerance in Pre-diabetes

Conditions
-----------------
Impaired Fasting Glucose, Pre Diabetes, Liver Fat

Intervention / Treatment
-----------------
* Dietary Supplement: Dietary intervention


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Impaired fasting glucose(100-125 mg/dl) HbA1c 5.7-6.4 % BMI 26-40 kg/sq.m Exclusion Criteria: MRS contraindication Pregnant women Liver disease

Ages Eligible for Study
-----------------
Minimum Age: 30 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: Basic Science
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: high fat ( MUFA) diet<br>intervention using high fat diet. | Dietary Supplement: Dietary intervention<br>* three different diets ( high fat-low carb-low fiber/high carb-low fat - high fiber/high carb-low fat-low fiber)<br>|
| Experimental: high carb/high fiber<br>diet using high carb-high fiber with dry beans | Dietary Supplement: Dietary intervention<br>* three different diets ( high fat-low carb-low fiber/high carb-low fat - high fiber/high carb-low fat-low fiber)<br>|
| Experimental: high carb/low fat<br>Habitual diet | Dietary Supplement: Dietary intervention<br>* three different diets ( high fat-low carb-low fiber/high carb-low fat - high fiber/high carb-low fat-low fiber)<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Changes in liver fat content after 12 weeks of intervention |  | 12 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in glucose metabolism after 12 weeks of intervention |  | 12 weeks |
Immunointervention With Calcitriol in New-Onset Type 1 Diabetes

Study Overview
=================
Brief Summary
-----------------
This is a randomized, two-arm, placebo-controlled phase-2 trial to determine whether the daily intake of 1,25-dihydroxy-vitamin D3 [1,25(OH)2D3], improves beta cell function in patients with recently diagnosed type 1 diabetes. The treatment consists of the daily oral administration of 0.25 µg 1,25(OH)2D3 or placebo for 9 months and an equal follow-up time without supplementation. Fasting, peak and AUC C-peptide concentrations during a 2-hour mixed meal tolerance test are measured at the beginning of the study, as well as at the end of the treatment and the follow-up period in month 9 and 18. The null hypothesis is that there is no difference between 1,25(OH)2D3 treated subjects and the placebo group in the AUC C-peptide at month 18.

Official Title
-----------------
Immunointervention With 1,25-dihydroxy-vitamin D3 in New-onset Type 1 Diabetes

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

Intervention / Treatment
-----------------
* Drug: 1,25-dihydroxy-vitamin D3 (calcitriol)
* Drug: placebo


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: New onset Typ 1 diabetes (< 6 weeks insulin therapy) Age 18-39 years GADA and/or IA-2A positive Exclusion Criteria: Kidney disease Pregnancy Lactating

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 39 Years

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

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

Design Details

Primary Purpose: Prevention


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: calcitriol<br> | Drug: 1,25-dihydroxy-vitamin D3 (calcitriol)<br> <br> |
| Placebo Comparator: pill without agent<br> | Drug: placebo<br>* pill without agent<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
-----------------
new-onset