linjc16/ctgov huggingface dataset:
Effect of Electrostimulation on Denervated Muscles in Individuals With Spinal Cord Injury

Study Overview
=================
Brief Summary
-----------------
The aim of the study is to investigate whether there is an effect of electrical stimulation on the denervated gluteus muscle (buttocks) in individuals with chronic spinal cord injury. The expected outcome is an increase in muscle volume and a better pressure distribution during sitting. The stimulation of the gluteus muscle is performed daily for 35 minutes over a period of six months. The muscle volume and the pressure distribution are measured before stimulation, three months after having started stimulation and after six months.

Conditions
-----------------
Spinal Cord Injury

Intervention / Treatment
-----------------
* Device: Stimulette


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: chronic spinal cord injury (min. 2 years after injury) lesion height from T10-L5 ASIA (American Spinal Cord Injury Association) Impairment Scale A Exclusion Criteria: acute pressure sore in stimulated area (M. gluteus) arteriosclerosis skin irritation or infection in stimulated area (M. gluteus) < 3 months after plastic surgery in stimulated area (M. gluteus)

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: electrical stimulation<br>electrical Stimulation using the Stimulette device | Device: Stimulette<br>* electrical stimulation device by Dr. Schuhfried Medizintechnik GmbH, Vienna, Austria<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| change in muscle volume | determination of muscle volume using magnetic resonance images | day 0 to 3 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| change in muscle volume | determination of muscle volume using magnetic resonance images | 3 months to 6 months | 
| change in sitting pressure | pressure mapping system | day 0 to 3 months | 
| change in sitting pressure | pressure mapping system | 3 months to 6 months | 
| change in quality of life | questionnaire | day 0 to 3months | 
| change in quality of life | questionnaire | 3 months to 6 months |
Fu Zheng Jie Du Hua Yu Principle For Treatment Of Severe HBV Related Hepatocellular Carcinoma (FZJDHYPFTOSHBVHCC)

Study Overview
=================
Brief Summary
-----------------
The treatment of HBV related hepatocellular carcinoma has always been a worldwide problem. The aim of this study is to alleviate the progression of hepatitis B related hepatocellular carcinoma by the Chinese medicine Fu Zheng Jie Du Hua Yu Principle.

Official Title
-----------------
Forming a Comprehensive Treatment Plan for the Treatment of Hepatitis B Virus Related Hepatocellular Carcinoma With the Core Principles of Fuzheng Jiedu Huayu

Conditions
-----------------
Hepatocellular Carcinoma

Intervention / Treatment
-----------------
* Drug: Fu Zheng Jie Du Hua Yu therapy


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Meet the criteria of hepatocellular carcinoma Ages Eligible for Study: ≤75 years old; Informed consent from the patient. Exclusion Criteria: Serious problem of heart, lung, or kidney with severe dysfunction; Pregnant or child breast feeding women; Mental or cognitive disorders; Participating in other drug trials; Who are allergic to the study drug

Ages Eligible for Study
-----------------
Minimum Age: 18 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: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Fu Zheng Jie Du Hua Yu therapy<br> | Drug: Fu Zheng Jie Du Hua Yu therapy<br>* Fu Zheng Jie Du Hua Yu is a Chinese herbal compound<br>|
| Experimental: Routine medical care<br> | Drug: Fu Zheng Jie Du Hua Yu therapy<br>* Fu Zheng Jie Du Hua Yu is a Chinese herbal compound<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Time to Progression |  | 1 year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| overall survival |  | 1 year | 
| progression-free survival |  | 1 year | 
| complete response |  | 1 year |
Study of Denufosol Tetrasodium in Patients With Cystic Fibrosis Lung Disease

Study Overview
=================
Brief Summary
-----------------
The objectives of this study are to evaluate the safety, tolerability and preliminary efficacy of two dose levels of INS37217 (denufosol tetrasodium) Inhalation Solution in patients with cystic fibrosis (CF) lung disease.

Official Title
-----------------
A Multi-Center, Double-Blind, Randomized, Placebo-Controlled, 28-Day Study of Denufosol Tetrasodium (INS37217) Inhalation Solution in Patients With Cystic Fibrosis Lung Disease

Conditions
-----------------
Cystic Fibrosis

Intervention / Treatment
-----------------
* Drug: denufosol tetrasodium (INS37217)


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Have confirmed diagnosis of CF Have an FEV1 greater than or equal to 60% or less than or equal to 90% of predicted normal Have oxygen saturation greater than or equal to 90% on room air Be clinically stable with no evidence of acute upper or lower respiratory tract infection or current pulmonary exacerbation Be able to reproducibly perform spirometry maneuvers Exclusion Criteria: Have changed their physiotherapy technique or schedule within 7 days prior to screening Have clinically significant comorbidities Using prior and concurrent medications according to the protocol

Ages Eligible for Study
-----------------
Minimum Age: 8 Years
Maximum Age: 50 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: denufosol tetrasodium (INS37217)|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| respiratory function |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| adverse events |  |  | 
| change in standard safety parameters |  |  | 
| respiratory symptoms via questionnaire |  |  | 
| pulmonary exacerbation |  |  | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
lung disease
CT/MRI Co-registration Prostate Cancer

Study Overview
=================
Brief Summary
-----------------
The target volume in prostate cancer radiotherapy typically consists of the entire prostate gland which is localized by contours drawn on axial computed tomography (CT) radiation planning images. Compared with CT, magnetic resonance (MR) can provide better definition of the prostate gland with respect to the surrounding tissues and the use of multi-plannar reconstruction avoids the problem of partial volume averaging inherent in CT. CT has been shown to significantly overestimate the volume of the gland using the MR-defined prostate volume as the gold standard. Co-registration of MR and CT datasets, matched on fixed bony landmarks, has enabled radiation planning using a MR-defined clinical target volumes, combined with CT-based electron density information necessary for radiation treatment planning. Rationale and Hypothesis: Co-registration may allow better delineation of tumour volumes in prostate cancer. This investigation is a fesibility study designed to evaluate and optimize imaging parameters and co-registration techniques for CT planning and MRI Simulator.

Official Title
-----------------
Evaluation of Planning Computed Tomography Scan and Magnetic Resonance Imaging Simulator Scan Co-Registration for Delineation of Gross Tumour Volume in Radiotherapy Treatment of Localized Prostate Cancer

Conditions
-----------------
Prostatic Neoplasm

Intervention / Treatment
-----------------
* Device: Computed Tomography Scan and Magnetic Resonance Imaging


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Histological confirmation of Prostate Adenocarcinoma Undergoing RT with fiducial markers, IMRT or Escalated Dose Conformal RT Exclusion Criteria: Contraindication for MRI

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

Sexes Eligible for Study
-----------------
Male

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

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

Arms and Interventions

| Intervention/Treatment |
| --- |
|Device: Computed Tomography Scan and Magnetic Resonance Imaging|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
Comparison Between Low Carbohydrate Diet and Traditionally Recommended Diabetic Diet in the Treatment of Diabetes Mellitus Type 2.

Study Overview
=================
Brief Summary
-----------------
The purpose of the clinical trial is to investigate whether low carbohydrate diet is better than the traditional diabetic diet in the treatment of patients with diabetes mellitus type 2, for blood sugar and body weight.

Official Title
-----------------
Comparison Between Low Carbohydrate Diet and Traditionally Recommended Diabetic Diet in the Treatment of Diabetes Mellitus Type 2.

Conditions
-----------------
Diabetes

Intervention / Treatment
-----------------
* Dietary Supplement: Low carbohydrate - high fat diet
* Dietary Supplement: High carbohydrate - low fat diet


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Diabetes mellitus type 2 Exclusion Criteria: Severe psychiatric disease or difficulties in understanding Swedish language.
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

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Low carbohydrate diet (F)<br>The group attended to low carbohydrate diet | Dietary Supplement: Low carbohydrate - high fat diet<br>* The diet has an energy content of 1600 kcal or 1800, with 50% from fat, 20% from carbohydrates and 30% from proteins.<br>|
| Active Comparator: Traditional diet (K)<br>The group attended to traditional diet | Dietary Supplement: High carbohydrate - low fat diet<br>* The diet has an energy content of 1600 or 1800 kcal, with 30% from fat, 55-60% from carbohydrates and 10-15% from proteins.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Laboratory findings and body composition |  | 2 years | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Low carbohydrate diet. Dietary treatment of diabetes mellitus., Diabetes mellitus type 2 and dietary treatment.
IOP Monitoring After Trabeculectomy Using iCare Home

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to investigate how much trabeculectomy influences intraocular pressure (IOP) fluctuations measured with iCare Home rebound tonometry (RTHome) in patients with primary open-angle glaucoma (POAG) or pseudo-exfoliation glaucoma (PEX).

Detailed Description
-----------------
Fifty glaucoma patients (POAG and PEX) planned for trabeculectomy will be recruited. At baseline, patients will be trained to use the iCare Home tonometer (RTHome), a handheld device based on rebound tonometry and designed for patients to use at home. After the training session and when patients feel confident, a measurement will be recorded. At the same visit, a new measurement will be obtained by the study staff, an optometrist or a nurse, using the same device. No IOP values will be visible for the examiner at that point. A single IOP measurement will be obtained by the same study staff using Goldmann applanation tonometry (GAT). Patients will come for a second visit where new measurements will be made in the same way as at baseline. In between visits, patients will borrow the iCare Home tonometer to measure their IOP at 06 and 10 am, and at 2, 6 and 10 pm during three consecutive days to obtain an IOP curve. Two-three months after trabeculectomy, a new IOP curve will be obtained following the same procedure as pre-operatively. There will be no restrictions in patients' daily activities regarding diet, physical activity or slee. If patients use any eyedrops, they will continue to use them as prescribed.

Official Title
-----------------
IOP Monitoring After Trabeculectomy Using iCare Home

Conditions
-----------------
Glaucoma, Open-Angle, Pseudo Exfoliation Syndrome

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: POAG PXG Exclusion Criteria: previous trabeculectomy reduced hand and arm mobility (e. due to rheumatism)

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 |
| --- | --- | --- |
| Lowering of IOP levels after trabeculectomy | Mean (SD) IOP pre- and post trabeculectomy | 2-3 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Lowering of IOP fluctuations after trabeculectomy | Mean (SD) IOP range pre- and post trabeculectomy | 2-3 months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
IOP fluctuations, iCare Home, Trabeculectomy, self-tonometry
Investigation of Pupillometry as Guide for Extubation Readiness in Anesthetized Children

Study Overview
=================
Brief Summary
-----------------
Investigation of pupillometry as guide for extubation readiness in anesthetized children.

Detailed Description
-----------------
Can a pupil metric be used to make extubation more safe in anesthetized children?

Official Title
-----------------
Investigation of Pupillometry as Guide for Extubation Readiness in Anesthetized Children

Conditions
-----------------
Anesthesia, Laryngospasm on Emergence

Intervention / Treatment
-----------------
* Diagnostic Test: Pupillometry


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Children undergoing general anesthesia and endotracheal intubation for surgery. American Society of Anesthesiologists Physical Status Class I and II patients. Exclusion Criteria: Central nervous system abnormality. Ophthalmologic abnormality.

Ages Eligible for Study
-----------------
Minimum Age: 2 Years
Maximum Age: 10 Years

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

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 |
| --- | --- |
| No Intervention: Group 1<br>Traditional deep extubation at 1.5 minimum alveolar concentration (MAC) | |
| Experimental: Group 2<br>Deep extubation guided by pupillometry -- at < 0.5 MAC of vapor + propofol and fentanyl | Diagnostic Test: Pupillometry<br>* Pupillometry prior to extubation<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Extubation success | Extubation without pathologic airway response such as laryngospasm | Immediately after extubation | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Anesthetic vapor concentration at extubation |  | At the time of extubation | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Pediatric, Anesthesia, Extubation, Pupillometry
Saeboflex Dynamic Hand Orthosis for Inpatient Rehabilitation Stroke Patients

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to determine what the potential utility of the Functional Tone Management (F.T.M) Arm Training Program using the SaeboFlex in an inpatient stroke rehabiliation hospital

Detailed Description
-----------------
Therapeutic interventions for the recovery of hand function after a neurological injury have historically been very limited. A significant body of research now supports the use of an upper extremity retraining approach for functional recovery after neurological injury. Few therapeutic approaches offer any intervention specifically focused on grasp and release retraining. In an effort to address this deficit, the SaeboFlex dynamic hand orthosis was developed by occupational therapists. The F.T.M. Arm Training Program has been safely used by hundreds of occupational and physical therapists on over one thousand patients in outpatient neurological rehabilitation over the last 2 years. It is currently an accepted modality of treatment for the management of hand paresis in the acquired brain injury outpatient population. Two factors, other than the severity of the initial injury, have been clinically identified as having a significant affect on the outcomes achieved in F.T.M. Arm Training treatment. They are learned non-use and soft tissue shortening of the finger flexors. All treatment delivered to the subjects that partake in this study will be clinical care and the only research component of this study will be the assessment of outcomes. The purpose of this study is to explore the potential patient population that may qualify to use the SaeboFlex Dynamic Hand Orthosis as a therapeutic option in the inpatient population.

Official Title
-----------------
Screening of Inpatient Rehabilitation Stroke Patients for Their Potential to Qualify to Use the Saeboflex Dynamic Hand Orthosis

Conditions
-----------------
Stroke

Intervention / Treatment
-----------------
* Device: SaeboFlex Dynamic Hand Orthosis
* Procedure: Saebo F.T.M. Arm Training Program


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criterion: All patients admitted to the Stroke Rehabilitation Program at the Kessler Institute for Rehabilitation locations (East Orange, Saddlebrook, and Chester). Approval from treating physician.
Sexes Eligible for Study
-----------------
All

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

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

Arms and Interventions

| Intervention/Treatment |
| --- |
|Device: SaeboFlex Dynamic Hand Orthosis|nan|
|Procedure: Saebo F.T.M. Arm Training Program|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
-----------------
Stroke, SaeboFlex, Hand function
Comparison of Pharmacodynamics and Pharmacokinetics of Biphasic Insulin Aspart 50 to Biphasic Insulin Aspart 70 in Type 2 Diabetes

Study Overview
=================
Brief Summary
-----------------
This trial is conducted in Europe. The aim of this trial is to compare the pharmacodynamics and pharmacokinetics of biphasic insulin aspart 50 three times a day to biphasic insulin aspart 70 three times a day in non-obese and obese with type 2 diabetes.

Official Title
-----------------
Comparison of the Pharmacodynamics and Pharmacokinetics of Biphasic Insulin Aspart 50 to Biphasic Insulin Aspart 70 in Non-obese and Obese With Type 2 Diabetes Mellitus

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

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


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Type 2 diabetes for at least 12 months Stable glycaemic control, having been on the existing treatment for at least 1 month BMI between 23-28 kg/m2 (non-obese) or between 30-35 kg/m2 (obese) HbA1c below 9.0% Willing to eat three main meals per day during the trial period and perform Self-Monitoring of Blood Glucose (SBGM) regularly Exclusion Criteria: A history of drug abuse or alcohol dependence Blood donation within the last 3 months Currently being treated with systemic corticosteroids, Mono Amine Oxidase (MAO) inhibitors, beta-adrenergic blocking agents, anabolic steroids or any other drug affecting blood glucose Severe, uncontrolled hypertension Proliferative retinopathy or maculopathy requiring acute treatment Pregnancy, breast-feeding, intention of becoming pregnant or judged not to be using adequate contraceptive measures (for women of childbearing potential only contraceptive pills and intra uterine devices are considered as adequate contraceptive methods)

Ages Eligible for Study
-----------------
Minimum Age: 30 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: Crossover Assignment
Masking: Double


Arms and Interventions

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

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Area under the serum glucose concentration profile during 24 hours |  | after 4 weeks of treatment | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pharmacodynamics properties |  |  | 
| Pharmacokinetic properties |  |  | 
| 8-point self-monitored blood glucose profiles |  |  | 
| Adverse events |  |  | 
| Hypoglycaemic episodes |  |  |