linjc16/ctgov huggingface dataset:
Measurement of Neonatal Microvascular Hemodynamics Using Non-invasive Optical Technologies

Study Overview
=================
Brief Summary
-----------------
Alterations to microvascular blood flow in premature infants, are known to contribute to several major disease entities. The optically-measured tissue blood flow, to determine tissue perfusion that can be use to detect blood loss.

Detailed Description
-----------------
The researchers want to use optical technologies to non-invasively detect blood flow that can tell the onset of blood loss. The research can measure blood flow in stable premature infants in the Neonatal Intensive Care Unit over the duration of several weeks. The technologies are Laser Speckle Imaging and Diffuse Optical Spectroscopy. Laser Speckle Imaging non-contact imaging technology, is sensitive to blood flow in superficial tissues. Diffuse Optical Spectroscopy, a probe-based contact technology like pulse oximetry, measures hemoglobin concentrations and states deeper below the skin surface.

Official Title
-----------------
Measurement of Neonatal Microvascular Hemodynamics Using Non-invasive Optical Technologies

Conditions
-----------------
Infant, Premature, Diseases

Intervention / Treatment
-----------------
* Device: Laser Speckle Imaging and Diffuse Optical Spectroscopy


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: premature infants born or transferred to neonatal intensive care unit with a gestational age of 28-35 weeks Exclusion Criteria: NONE premature infants born or transferred to neonatal intensive care unit

Ages Eligible for Study
-----------------
Minimum Age: 1 Minute
Maximum Age: 1 Month

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

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| premature infant<br>Laser Speckle Imaging and Diffuse Optical Spectroscopy | Device: Laser Speckle Imaging and Diffuse Optical Spectroscopy<br>* Laser Speckle Imaging and Diffuse Optical Spectroscopy<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Normal Blood flow in premature infant |  | up to 4 weeks |
The Influence of Suture Method in Conjunctival Autograft Transplantation on Postoperative Ocular Discomfort for Primary Pterygium

Study Overview
=================
Brief Summary
-----------------
To evaluate the efficacy and effect on patient comfort of a hidden-knot continuous suture for pterygium excision with conjunctival autograft，compared with two-knot continuous sutures and multi-knot interrupted sutures.

Official Title
-----------------
The Influence of Suture Method in Conjunctival Autograft Transplantation on Postoperative Ocular Discomfort for Primary Pterygium

Conditions
-----------------
the Efficacy and Effect on Patient Comfort of a Hidden-knot Continuous Suture for Pterygium Excision With Conjunctival Autograft

Intervention / Treatment
-----------------
* Procedure: suture


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: patients with primary pterygium Exclusion Criteria: eye surgery history acute ocular surface imflamation patients with coagulation or diabetes mellitus

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 80 Years

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

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

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

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: hidden-knot group<br> | Procedure: suture<br>* suture methods of autograft conjunctival transplantation<br>|
| Active Comparator: two-knot group<br> | Procedure: suture<br>* suture methods of autograft conjunctival transplantation<br>|
| Active Comparator: multi-knot group<br> | Procedure: suture<br>* suture methods of autograft conjunctival transplantation<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Patient comfort | discomfort grading on a visual analog scale | 6 months |
ADME Study in Healthy Male Subjects With TA-8995

Study Overview
=================
Brief Summary
-----------------
A study to measure the absorption, metabolism and excretion of a single dose of radiolabelled TA-8995 (10mg) in healthy male subjects.

Official Title
-----------------
A Phase I Study to Assess the Mass Balance Recovery, Pharmacokinetics, Metabolism and Excretion of 14C-TA-8995 in Healthy Male Subjects

Conditions
-----------------
Dyslipidemia

Intervention / Treatment
-----------------
* Drug: TA-8995


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Healthy male subjects Exclusion Criteria: Clinically significant abnormalities

Ages Eligible for Study
-----------------
Minimum Age: 30 Years
Maximum Age: 65 Years

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

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

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: Radiolabelled TA-8995<br> | Drug: TA-8995<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| AUC of TA-8995 |  | 35 days | 
| Mass balance recovery of total radioactivity from excreta for radiolabelled TA-8995 |  | 35 days | 
| Measure the amount of radiolabelled TA-8995 recovered from urine and faeces. |  | 35 days | 
| Measure the levels of major metabolites of TA-8995 in plasma, urine and faeces after oral administration of radiolabelled TA-8995 |  | 35 days | 
| Elimination of half-life of radiolabelled TA-8995 |  | 35 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of adverse events |  | 35 days |
Safety and Initial Performance of the DiaGone Device on Type 2 Diabetes Patients

Study Overview
=================
Brief Summary
-----------------
This is a multi-center, prospective, open label study of the Duodenal Glycemic Control™ procedure on type 2 diabetes patients sub-optimally controlled, to examine the safety and initial performance of the DiaGone™ system.

Detailed Description
-----------------
This study is a multi-center, prospective, open label trial of type 2 diabetes patients sub-optimally controlled on at least one oral anti-diabetic medication. Subjects who meet all inclusion and exclusion criteria after screening are hospitalized and go through the Duodenal Glycemic Control™ treatment. Duodenal Glycemic Control™ treatment is conducted by a gastroenterologist, in an endoscopic suite, with an off-the-shelf endoscope, using the DiaGone™ system. Patients are followed for 6 months for AE and SAE. Patients are followed for 12 months for glycemic control parameters.

Official Title
-----------------
DiaGone™ First in Human (FIH) Study - Safety and Performance of the DiaGone™ Device for the Treatment of Type 2 Diabetes

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

Intervention / Treatment
-----------------
* Device: DiaGone™


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Subjects who are ≥ 18 years and ≤ 75 years of age. HbA1c at 7.5%-12% On oral glucose lowering drugs in a stable medication regimen Fasting plasma glucose level at ≥125mg/dL BMI 25-40 Kg/m2 Exclusion Criteria: Diagnosed Type I diabetes Serum C peptide <1ng/ml

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Duodenal Glycemic Control™<br> | Device: DiaGone™<br>* Duodenal Glycemic Control™ using the DiaGone™ system<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Incidence of procedure related SAEs. |  | 7 days | 
| Incidence of procedure related SAEs. |  | 6 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change to Fasting Glucose levels |  | 12 months | 
| Change to Post Prandial Glucose levels |  | 12 months | 
| Change to HbA1c levels |  | 12 months |
Microvascular Function Assessment in Healthy Subjects

Study Overview
=================
Brief Summary
-----------------
Current stimulation induces microvascular dilation in human skin. The investigators aimed to study (1) whether the current vasodilation is amplified after two segmental current stimulation as compared to one stimulation; (2) whether this amplification relies on prostaglandin-sensitive mechanisms. A double-blind randomized placebo-controlled crossover trial is conducted in Angers, France.

Official Title
-----------------
Amélioration Des Techniques d'étude de la Micro-cirulation cutanée Chez Des Sujets Sains

Conditions
-----------------
Physiology of Microvascular Skin

Intervention / Treatment
-----------------
* Drug: acetylsalicilic acids (Aspirin)
* Drug: Placebo


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Age > or equal to 18 years old Healthy subjects Exclusion Criteria: Aspirin allergy

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 80 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: Crossover Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Aspirin<br>Aspirin | Drug: acetylsalicilic acids (Aspirin)<br>* single oral dose of 1g.<br>* Other names: Aspegic 1000mg, sanofi aventis.;|
| Placebo Comparator: Placebo<br>Placebo | Drug: Placebo<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The increase of Laser Doppler Blood Flow after the second current stimulation |  | 1 hour | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The increase of Laser Doppler Blood Flow after the second current stimulation after aspirin administration |  | 1 hour | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Laser Doppler flowmetry, skin, microcirculation
Effect of Insoles in Patients With Systemic Lupus Erythematosus

Study Overview
=================
Brief Summary
-----------------
Demonstrate that custom-made insoles improve painful symptomatology, health and foot function in subjects with SLE and podiatric involvement.

Official Title
-----------------
Effectiveness of Custom-made Foot Orthoses in Patients With Systemic Lupus Erythematous

Conditions
-----------------
Lupus Erythematosus, Systemic, Foot Orthoses, Musculoskeletal Pain

Intervention / Treatment
-----------------
* Device: Custom-Made Foot Orthoses
* Device: Placebo


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: 18 years or more. Medical diagnosis of LES. Foot involvement. Exclusion Criteria: Treatment with foot orthoses. LES with acute symptomatic flare. Ulcers. Skin involvement. Neurological problems. Cognitive deterioration. Need for walking assistance. Refused to change footwear to use the foot orthoses.

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: Other
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Custom-made foot orthoses<br> | Device: Custom-Made Foot Orthoses<br>* The foot orthoses were custom made using phenolic foam molds of the feet. They consisted of a polypropylene layer of 2 mm from heel to just proximal to the metatarsal heads, an upper sheet of 30 Shore A polyethylene foam.<br>|
| Placebo Comparator: Control Group<br> | Device: Placebo<br>* The insole made using phenolic foam molds of the feet. They consisted of an upper sheet of 30 Shore A polyethylene foam.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 11-point Numeric Pain Rating Scale | With a range of 0 = no pain to 10 = pain as bad as it can be. | 1 minute | 
| SF- 12 Quality of Life | To describe the relationships among functional health status measures. This has values between 0 and 100, with higher values corresponding to lower quality of life. | 10 minutes | 
| Foot Function | Foot Function Index | 5 minutes | 
| Foot Disability | Manchester Foot Pain and Disability Index | 5 minutes | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Lupus Erythematosus, Systemic, Foot Orthoses, Foot, Pain
An Evaluation of the Psychological Impact of Early Phase Clinical Trials in Cancer Patients.

Study Overview
=================
Brief Summary
-----------------
This is an exploratory prospective observational cohort study to establish the levels of psychological distress in early phase clinical trial patients and evaluate the psychological impact of early phase clinical trials on cancer patients. Participants will be requested to complete self-reported questionnaires, measuring levels of anxiety, depression and hope, at different time points along the clinical trials pathway.

Official Title
-----------------
An Evaluation of the Psychological Impact of Early Phase Clinical Trials in Cancer Patients.

Conditions
-----------------
Cancer, Depression, Anxiety, Hope, Psychological Distress

Intervention / Treatment
-----------------
* Other: None (observational study)


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Aged 18 years and older Able to provide informed consent Are being considered for an early phase clinical trial Exclusion Criteria: Patients unable to comprehend English language

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

| Intervention/Treatment |
| --- |
|Other: None (observational study)|None (observational study)|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Levels of anxiety and depression as per the Hospital Anxiety and Depression Scale questionnaire. |  | Approximately 14 weeks. | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Levels of hope as per the Adult Hope Scale. |  | Approximately 14 weeks. | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Clinical trials, Early phase clinical trials, Experimental cancer medicine
The Application of Fibrin Glue in Ocular Surface Diseases

Study Overview
=================
Brief Summary
-----------------
This clinical trial tries to use tissue fibrin glues (Tisseel) to treat various ocular surface diseases or surgeries, which includes pterygium surgery, corneal melting/perforation, Gunderson's flap, conjunctival laceration, and muscle/clinical/filtering surgery.

Detailed Description
-----------------
This clinical trial tries to use tissue fibrin glues (Tisseel) to treat various ocular surface diseases or surgeries. The inclusion criteria are: ocular surface disease which may need amniotic membrane transplantation (corneal pro epithelization, pterygium surgery, etc) infectious or noninfectious corneal ulcer with perforation less than 3 mm conjunctival transplantation/suture corneal surgeries which can be treated by conventional suture technique or application with cyanoacrylic acid tissue glues. Informed consents will be obtained from the patients before applications. After surgeries, topical steroids and antibiotics will be used, and therapeutic contact lens will be used. The patients will be followed up for at least three months.

Official Title
-----------------
Phase 1 Study of Applying Fibrin Glue in Patients With Corneal Ulcer or Patients Requiring Wound Closure by Suture

Conditions
-----------------
Pterygium, Corneal Ulcer

Intervention / Treatment
-----------------
* Drug: tissue fibrin glue application (Tisseel)


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Ocular surface diseases, which are expected to be treated by tissue fibrin glues Exclusion Criteria: Pregnancy Children younger than 3 years old

Ages Eligible for Study
-----------------
Minimum Age: 3 Years

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

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

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

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 1<br>Use of fibrin glue after corneal surgery or transplantation | Drug: tissue fibrin glue application (Tisseel)<br>* Apply several droplets within several seconds to several minutes<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| cure of the diseases |  | 1week, 2 weeks, 3 weeks, 4 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| integrity of the ocular surface |  | 1week, 2 weeks, 3 weeks, 4 weeks | 
| visual acuity |  | 1week, 2 weeks, 3 weeks, 4 weeks | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
fibrin glue, corneal perforation, pterygium, conjunctiva, corneal ulcer
The Effect of CoQ10 Administration on Hemodialysis Patients

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to examine whether CoQ10 administration is effective as an antioxidant in hemodialysis patients.

Detailed Description
-----------------
Oxidative stress has been recognized as a potential risk factor for such complications as atherosclerosis in hemodialysis patients. This study investigates whether CoQ10 administration is effective for protecting oxidative stress in hemodialysis patients. The subjects were recruited from day-time hemodialysis patients in Iwata City Hospital. 100 mg CoQ10 was administered every HD for 6 months. Several oxidative and antioxidative markers were measured in plasma at pre, 1, 3, 6 months and after washout.

Official Title
-----------------
The Effect of CoQ10 Administration on the Oxidative and Antioxidative Markers in Hemodialysis Patients

Conditions
-----------------
Chronic Renal Failure, Hemodialysis

Intervention / Treatment
-----------------
* Drug: Coenzyme Q10 (drug)


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: hemodialysis for at least 6 months Exclusion Criteria: none

Ages Eligible for Study
-----------------
Minimum Age: 0 Years
Maximum Age: 85 Years

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

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

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

Design Details

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


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: Coenzyme Q10 (drug)|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Oxidative protein concentration at 6 month |  |  | 
| Antioxidant capacity at 6 month |  |  | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
CoQ10, hemodialysis, oxidative marker, antioxidant
SYMBICORT® in the Treatment of COPD

Study Overview
=================
Brief Summary
-----------------
A Scientific Research Program to evaluate the efficacy of SYMBICORT® 320/9μg in the treatment of COPD in real life environment by General Practitioners

Official Title
-----------------
A Scientific Research Program to Evaluate the Efficacy of SYMBICORT® 320/9μg in the Treatment of COPD in Real Life Environment by General Practitioners

Conditions
-----------------
COPD

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: patients (m/f) with COPD (GOLD stadium III and IV) Exclusion Criteria: patients who recently quit smoking (<3months)

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 |
| --- | --- | --- |

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
COPD, Symbicort, General Practitioners