linjc16/ctgov huggingface dataset:
Efficacy and Safety of Insulin Aspart Versus Glibenclamide in Type 2 Diabetes

Study Overview
=================
Brief Summary
-----------------
This trial is conducted in Japan. This is a clinical trial to study the efficacy and safety of thrice daily Insulin Aspart compared to Glibenclamide in type 2 diabetic patients.

Official Title
-----------------
A Clinical Trial to Study the Efficacy and Safety of Insulin Aspart Three Times Per Day Compared to Glibenclamide Once or Twice Daily in Type 2 Diabetes by Comparison of Ability to Control Blood Glucose

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

Intervention / Treatment
-----------------
* Drug: insulin aspart
* Drug: glibenclamide


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Type 2 diabetes Diet therapy for at least 12 weeks, or diet therapy and oral hypoglycaemic agent(s) other than SU agents for at least 12 weeks No previous treatment with insulin and/or SU agents HbA1c between 7.5% and 10.0% Body Mass Index (BMI) below 30.0 kg/m2 Exclusion Criteria: Proliferative retinopathy or maculopathy requiring acute treatment Impaired hepatic function Impaired renal function Cardiac diseases Uncontrolled hypertension Known hypoglycaemia unawareness or recurrent major hypoglycaemia Current treatment with systemic corticosteroids

Ages Eligible for Study
-----------------
Minimum Age: 20 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: None (Open Label)


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: insulin aspart|nan|
|Drug: glibenclamide|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| HbA1c |  | after 24 weeks of treatment | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Plasma glucose levels |  |  | 
| Percentage of subjects achieving the treatment target of HbA1c value < 6.5% |  |  |
Davallia Divaricata BL: The Use of Traditional Chinese Native Medicine for Osteoporosis

Study Overview
=================
Brief Summary
-----------------
We, the investigators at National Taiwan University Hospital, have determined the therapeutic and toxic effects of the traditional herb on the ovariectomized Wistar rat. The final years will determine its effects on the therapy of women who are over 45 years old and postmenopausal with osteoporosis.

Detailed Description
-----------------
Research of this traditional chinese clinical medicine, Gusuibu, curative effect is planned for three years time. The entire study aims to evaluate the effect of the traditional chinese medicine on postmenopausal osteoporosis as well as the possible side effects on the experimental animal and the human body. All subjects were postmenopausal women with established osteoporosis.

Official Title
-----------------
The Use Tradition Chinese Native Medicine Treats the Osteoporosis Research

Conditions
-----------------
Osteoporosis

Intervention / Treatment
-----------------
* Drug: Gu-Sui-Bu (Davallia Divaricata)


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Postmenopausal osteoporosis Exclusion Criteria: Insulin dependent diabetes

Ages Eligible for Study
-----------------
Minimum Age: 45 Years
Maximum Age: 70 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: Double


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: Gu-Sui-Bu (Davallia Divaricata)|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The project is aimed to investigate the clinical effects of the water extract of Gu-Sui-Bu from the aspects of animal and clinic studies. |  |  |
Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of Multiple Ascending Oral Doses of MYK-461 in Healthy Volunteers

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to establish safety, tolerability, pharmacokinetics and pharmacodynamics of multiple doses of MYK-461 in human subjects. This is a randomized, double-blind, placebo-controlled, sequential group, multiple ascending (oral tablet) dose study in healthy volunteers aged 18-55 years.

Official Title
-----------------
A Phase 1, Double-blind, Randomized, Placebo-controlled, Ascending Multiple Oral Dose Study to Evaluate Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of MYK-461 in Healthy Volunteers

Conditions
-----------------
Healthy

Intervention / Treatment
-----------------
* Drug: MYK-461
* Drug: Placebo


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Normal body mass index (BMI) Normal LVEF Normal electrocardiogram (ECG) Females must be non pregnant, non lactating and, if sexually active, be using an acceptable birth control method from the time of first dose through 3 months after the last dose of study drug Exclusion Criteria: Any structural abnormalities on echocardiography Positive results of HIV test and/or seropositive for HCV or HBV

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 55 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: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: MYK-461<br>Oral Tablet x 28 days | Drug: MYK-461<br> <br> |
| Placebo Comparator: Placebo<br>Oral Tablet x 28 days | Drug: Placebo<br>* Placebo comparator<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Safety as measured by the incidence of adverse events | Incidence of adverse events | 63 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Determination of pharmacokinetic parameters | maximum concentration (Cmax) | 63 days | 
| Determination of pharmacokinetic parameters | time of the maximum measured concentration (Tmax) | 63 days | 
| Determination of pharmacokinetic parameters | area under the concentration time curve (AUC) | 63 days | 
| Determination of pharmacokinetic parameters | half-life (t1/2) | 63 days | 
| Characterize pharmacodynamic parameters | echocardiogram assessment | 63 days | 
| Characterize pharmacodynamic parameters | peak oxygen consumption | 63 days |
Diagnosing Tuberculosis in HIV Infected Children in Peru

Study Overview
=================
Brief Summary
-----------------
Tuberculosis is a major cause of mortality among AIDS patients in the developing world. The diagnosis of tuberculosis in HIV infected children is complicated by inefficient and expensive tuberculosis tests and vague diagnostic criteria. This study will evaluate the accuracy and efficiency of several different tuberculosis tests that could be used in developing countries.

Detailed Description
-----------------
HIV infection has been shown to increase mortality from tuberculosis (TB) fivefold in parts of Subsaharan Africa. Increasingly, HIV infected children in developing countries are becoming infected with Mycobacterium tuberculosis (Mtb) and dying at an early age. This project will evaluate novel approaches to the diagnosis of AIDS-related pediatric TB in a hyperendemic setting using rapid, cost-effective Mtb culture and susceptibility methods based on direct microscopic observation techniques. This study will utilize alternative noninvasive Mtb tests that are performed on nasopharyngeal aspirates (NPA) and stool. An optional component will assess improved rapid detection of Mtb by a semi-nested polymerase chain reaction assay (N2 PCR), a technique appropriate for regional reference laboratories in developing countries. Two hundred-sixty children with clinically diagnosed pulmonary TB (including at least 100 HIV infected children) from the Hospital del Nino, Lima, Peru, and 260 age-matched controls will be enrolled in this study. Mtb will be detected in NPAs and stool by new and traditional culture methods and by N2 PCR. Gastric aspirates from children with a clinical diagnosis of TB will also be tested. Children with a positive N2 PCR but without clinical evidence of TB requiring antituberculous therapy will be followed longitudinally.

Official Title
-----------------
Diagnostics For AIDS-Related Pediatric TB, Peru

Conditions
-----------------
Tuberculosis, Tuberculosis, Pulmonary, HIV Infections

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria Inability to produce sputum sample Clinical picture suggestive of pulmonary TB, score > 7 according to the Stegen and Toledo criteria as adapted by WHO Exclusion Criteria Antituberculous therapy

Ages Eligible for Study
-----------------
Maximum Age: 12 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 |
| --- | --- | --- |

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Pediatrics, Polymerase Chain Reaction
The Effect of Dexmedetomidine on Neuroendocrine Stress Hormone Release and Heart Rate Variability in Patients Undergoing Major Spinal Surgery

Study Overview
=================
Brief Summary
-----------------
Surgical stress induces stress hormone release and sympathetic hyperactivation. Dexmedetomidine has sympatholytic effect and attenuates stress responses. This study investigate the effect of dexmedetomidine on stress responses and autonomic nervous system balance in patients undergoing major spine surgery.

Conditions
-----------------
Spinal Stenosis

Intervention / Treatment
-----------------
* Drug: dexmedetomidine group
* Drug: control group


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: patient between 20 and 70 of age with ASA physical status Ⅰ-Ⅲ patient scheduled for major spine surgery Exclusion Criteria: ASA physical status Ⅳ congestive heart failure severe hepatorenal disease insulin dependent DM(diabetes mellitus) cancer or metastasis pregnancy problem with communication

Ages Eligible for Study
-----------------
Minimum Age: 20 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: Other
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Dexmedetomidine Group<br>dexmedetomidine infusion (0.4 mcg/kg/h) from immediately after anesthetic induction to end of surgery | Drug: dexmedetomidine group<br>* dexmedetomidine infusion (0.4 mcg/kg/h) from immediately after anesthetic induction to end of surgery<br>|
| Placebo Comparator: Control Group<br>0.9% saline infusion | Drug: control group<br>* 0.9% saline infusion<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Stress hormone level | The levels of stress hormone including epinephrine, norepinephrine, cortisol, and glucose will be measured during spinal surgery. | immediately after anesthetic induction | 
| Stress hormone level | The levels of stress hormone including epinephrine, norepinephrine, cortisol, and glucose will be measured during spinal surgery. | 1 hour after start of surgery | 
| Stress hormone level | The levels of stress hormone including epinephrine, norepinephrine, cortisol, and glucose will be measured during spinal surgery. | 2-hour after start of surgery | 
| Stress hormone level | The levels of stress hormone including epinephrine, norepinephrine, cortisol, and glucose will be measured during spinal surgery. | 1 second after the end of surgery | 
| Stress hormone level | The levels of stress hormone including epinephrine, norepinephrine, cortisol, and glucose will be measured during spinal surgery. | 1 hour after the end of surgery |
Neurobiology of Opioid Dependence: 2 - 2

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to evaluate the effects of gamma hydroxybutyric on naloxone-precipitated opiate withdrawal.

Official Title
-----------------
Neurobiology of Opioid Dependence: 2

Conditions
-----------------
Opioid-Related Disorders

Intervention / Treatment
-----------------
* Drug: Gamma hydroxybutyric


Participation Criteria
=================
Eligibility Criteria
-----------------
Please contact site for information.
Sexes Eligible for Study
-----------------
Male

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

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

Design Details

Primary Purpose: Treatment
Masking: Double


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: Gamma hydroxybutyric|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Behavioral, subjective, measures of naloxone-preci |  |  | 
| Phsyiological, neuroendocrine measures of naloxone |  |  | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Opioid disorders
Endo-Vac-Therapy for Post-Sleeve Gastrectomy Leaks

Study Overview
=================
Brief Summary
-----------------
Endoscopic negative pressure therapy (ENPT) is a safe technique, showing promising results in the treatment of leakages of the upper and lower gastrointestinal tract. The purpose of this study is to determine the safety and efficacy of ENPT in the management of proximal staple line leak after sleeve gastrectomy.

Detailed Description
-----------------
Clinical data of 40 cases of post-SG proximal staple line leak treated with ENPT are analysed. Success is defined as resolution of the fistula with no further need for intervention (surgical or endoscopic).

Official Title
-----------------
Endoscopic Negative Pressure Therapy for Post-sleeve Gastrectomy Proximal Staple Line Leaks

Conditions
-----------------
Anastomotic Leak

Intervention / Treatment
-----------------
* Procedure: Endoscopic negative pressure therapy


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Staple line leak detected by endoscopy and/or CT within 30 days after surgery. Age 18 years or older. Written informed consent. Exclusion Criteria: Declined informed consent. Leaks detected later than 30 days after surgery.

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

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

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

Arms and Interventions

| Intervention/Treatment |
| --- |
|Procedure: Endoscopic negative pressure therapy|Endoscopic placement of a sponge in/at staple line leaks under negative pressure.|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of patients with closure of staple line leak | Resolution of the fistula with no further need for intervention (surgical or endoscopic). | up to 16 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of endoscopic interventions | Number of endoscopic interventions in each patient | up to 16 weeks | 
| Hospital stay | Time of hospital stay for each patient | up to 24 weeks | 
| Mortality | Mortality rate during hospital stay | up to 24 weeks | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
staple line leak, endoscopic vacuum therapy, endoscopic negative pressure therapy, laparoscopic sleeve gastrectomy
Far-infrared Ray Effect on CV12 Acupoint

Study Overview
=================
Brief Summary
-----------------
The purpose of the present study was to investigate the effect of far-infrared ray at CV12 acupoints area on the skin temperature and skin blood flow of palm central area of right hand, and the correlation between them.

Detailed Description
-----------------
The purpose of the present study was to investigate the effect of far-infrared ray at CV12 acupoints area (the center is CV12 acupoints and the diameter is 10 cm) on the skin temperature and skin blood flow of palm central area of right hand, and the correlation between them.

Official Title
-----------------
Far-infrared Ray Illuminates Area of CV12 Acupoint to Investigate the Correlation of Skin Temperature and Skin Blood Flow Between CV12 Acupoint and Palm Central Part of Right Hand

Conditions
-----------------
Reaction of Far Infrared Ray, Reaction of Skin Temperature

Intervention / Treatment
-----------------
* Procedure: far-infrared ray


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Healthy adult volunteers, male or female, ages between 20 and 40 years Neurological and physical examination without abnormal functions Far-infrared ray illumination without allergic reaction and contra- indication The participants were explained the objective of the study, agreed to accept the test and signed a letter of consent Exclusion Criteria: People less than 20 years of age or more than 40 years Women in pregnant or lactating People with mental or behavioral anomalies could not follow the researchers People suffered from serious diseases such as myocardial infarction , heart failure, serious arrhythmia, hypertension, diabetes, autoimmune disease, chronic obstructive pulmonary diseases, and kidney failure, liver cirrhosis and cancer People suffered from limb edema and serious skin diseases People did not sign a letter of consent

Ages Eligible for Study
-----------------
Minimum Age: 20 Years
Maximum Age: 40 Years

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

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

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

Design Details

Primary Purpose: Basic Science
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Intervention/Treatment |
| --- |
|Procedure: far-infrared ray|The duration of far-infrared ray is 20 minutes.|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| far-infrared ray on CV12 acupoint area may increase the skin temperature |  | Each period was 20 min in duration |
Treatment of Depression in Parkinson's Disease Trial

Study Overview
=================
Brief Summary
-----------------
The goal of this study is to evaluate the effectiveness and safety of two antidepressants--nortriptyline and paroxetine, compared to placebo in patients with Parkinson's disease and depression.

Detailed Description
-----------------
Depression is the most common neuropsychiatric disorder found in patients with Parkinson's disease (PD). It causes immense personal suffering and is associated with increased disability and caregiver burden. Despite the adverse consequences of depression in patients with PD, there are virtually no empirical data to guide clinical treatment. This study will begin to answer some questions on the treatment of depression by testing a SSRI (selective serotonin reuptake inhibitor) antidepressant, paroxetine, a tricyclic antidepressant, nortriptyline, and placebo in a placebo-controlled trial. A total of 75 patients with PD will be randomized to each of the three arms in a balanced design.

Official Title
-----------------
Treatment of Depression in Patients With Parkinson's Disease

Conditions
-----------------
Parkinson Disease, Depression

Intervention / Treatment
-----------------
* Drug: paroxetine
* Drug: Nortriptyline
* Other: placebo


Participation Criteria
=================
Eligibility Criteria
-----------------
inclusion criteria: Parkinson's disease without dementia. Depression. Males or females. exclusion criteria: Psychosis Heart block

Ages Eligible for Study
-----------------
Minimum Age: 35 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: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: nortriptyline<br>drug | Drug: Nortriptyline<br>* nortriptyline 25 - 75 mg q hs<br>* Other names: Pamelor;|
| Experimental: paroxetine<br>drug | Drug: paroxetine<br>* Paroxetine CR 12.5 - 25 mg q hs<br>* Other names: Paxil CR;|
| Placebo Comparator: placebo<br>placebo | Other: placebo<br>* matching placebo<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Hamilton Depression Scale | total score on HDRS (0-54 higher score is worse) | 8 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percent Responders | Percent of patients who had a 50% decrease in total HDRS at 8 weeks | 8 weeks | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Parkinson's disease, Parkinson disease, depression, antidepressants, nortriptyline, paroxetine