linjc16/ctgov huggingface dataset:
Integrated Clinical Evaluation of Traditional Chinese Medicine (TCM) and Conventional Medicine on Diabetic Patients

Study Overview
=================
Brief Summary
-----------------
In traditional Chinese medicine (TCM), examination of the tongue plays an important role in diagnosis. The characteristics of the tongue(e.g., color of the tongue body, tongue fur, teeth-marked tongue) provides some clues and prognosis, which are considered a reflection of the body's internal condition. Diabetes mellitus is a metabolic disorder of hyperglycemia, which lead to damage the kidneys, eyes, nerves, blood vessels, and heart. Long standing hyperglycemia can also be associated with buccal alteration. The purpose of this study was to survey on tongue diagnosis and other examinations associated with diabetic mellitus.

Conditions
-----------------
Diabetes Mellitus

Intervention / Treatment
-----------------
* Other: clinical evaluation


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: diabetic patients(ac sugar>126mg/dl or HbA1c>6.5, twice) pre-diabetic patients(100mg/dl <ac sugar<126mg/dl, or 5.9<HbA1c<6.5) non-diabetic patients(ac sugar<100mg/dl ) Exclusion Criteria: acute infectious disease, cancer, End Stage Renal Disease

Ages Eligible for Study
-----------------
Minimum Age: 20 Years
Maximum Age: 80 Years

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 |
| --- | --- |
| control group<br> | Other: clinical evaluation<br> <br> |
| pre-DM group<br> | Other: clinical evaluation<br> <br> |
| DM group<br> | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| tongue diagnosis |  | 1 year | 
| heart rate variability |  | 1 year | 
| nailfold videocapillaroscopy |  | 1 year | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
tongue diagnosis, heart rate variability, nailfold videocapillaroscopy
DAW1033D in Obstructive Sleep Apnea

Study Overview
=================
Brief Summary
-----------------
Obstructive sleep apnea (OSA) is common and has major health implications but treatment options are limited. OSA patients show a marked reduction in upper airway (UA) dilator muscle activity at sleep onset and this phenomenon leads to increased collapsibility of UA compared to normal subjects. In this protocol the investigators will test the effect of DAW1033D administered before sleep on OSA phenotype traits and OSA severity during sleep.

Official Title
-----------------
Effect of DAW1033D on Obstructive Sleep Apnea and Its Phenotypic Traits

Conditions
-----------------
Obstructive Sleep Apnea (OSA)

Intervention / Treatment
-----------------
* Drug: Placebo oral capsule
* Drug: DAW1033D oral capsule


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: - AHI > 15 Exclusion Criteria: Any medical condition other than well controlled hypertension, diabetes, hyperlipidemia Any medication known to influence breathing, sleep/arousal or muscle physiology. Claustrophobia. Inability to sleep supine. Allergy to lidocaine, Oxymetazoline HCl, DAW1033D. Individuals with underlying cardiac disease, such as arrhythmias. Individuals taking psychiatric medications, or any of the studied medications for medical care. History of seizures For women: Pregnancy. History of panic disorder / hyperventilation syndrome / Attention deficit-hyperactivity disorder (ADHD) / autism

Ages Eligible for Study
-----------------
Minimum Age: 21 Years
Maximum Age: 65 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: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Placebo Comparator: Placebo<br>Placebo capsule 30 minutes before sleep | Drug: Placebo oral capsule<br>* Placebo before sleep<br>|
| Active Comparator: DAW1033D<br>DAW1033D capsule 30 minutes before sleep | Drug: DAW1033D oral capsule<br>* DAW1033D before sleep<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Apnea Hypopnea Index (AHI, Events/Hour of Sleep) | Based on previous studies the investigators anticipate that DAW1033D will reduce AHI more effectively in subjects with moderate sleep apnea, and mild to moderate pharyngeal collapsibility. AHI describes the frequency of obstruction of the upper airway during sleep and is commonly used to describe the presence and severity of obstructive sleep apnea. | 1 night | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Collapsibility of the Upper Airway: VPassive | Ventilation when ventilatory drive is relatively low during sleep | 1 night |
Evaluation Research of the Nutrition Interventions in the INHP II Areas of CARE India

Study Overview
=================
Brief Summary
-----------------
This study is designed to evaluate the effectiveness of CARE India's Integrated Nutrition and Health Program (INHP II) to reduce malnutrition among children 0-23 months of age.

Official Title
-----------------
Evaluation Research of the Nutrition Interventions in the INHP II Areas of CARE India

Conditions
-----------------
Stunting, Underweight, Wasting, Anemia

Intervention / Treatment
-----------------
* Behavioral: Maternal nutrition and infant feeding advice


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Mothers with a child 0-23 months of age Children 0-23 months of age Currently pregnant women Resides in the program or control area Exclusion Criteria: -
Sexes Eligible for Study
-----------------
All

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

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

Design Details

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


Arms and Interventions

| Intervention/Treatment |
| --- |
|Behavioral: Maternal nutrition and infant feeding advice|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Prevalence of underweight among children 0-23 months |  |  | 
| Prevalence of stunting among children 0-23 months |  |  | 
| Prevalence of wasting among children 0-23 months |  |  | 
| Prevalence of anemia among children 12-23 months |  |  | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
malnutrition, anemia, infants, children, India
The Evolution and Management of Migraine Recurrence Beyond 24 Hours

Study Overview
=================
Brief Summary
-----------------
What is the course of migraine headache recurrence, how is it managed, what characteristics are associated with it, and how does it influence patient satisfaction with treatment?

Official Title
-----------------
The Evolution and Management of Migraine Recurrence Beyond 24 Hours: A Prospective Study of Tertiary Care Center Patients

Conditions
-----------------
Migraine

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Female and male patients at University Headache Center with > 6 month diagnosis of migraine with and/or without aura (ICHD-II) Greater than or equal to 18 years old Exclusion Criteria: Greater than 15 days/month total headache days Analgesic use greater than 15 days/month (other than aspirin less than or equal to 325mg/d)

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 |
| --- | --- | --- |
| Primary efficacy outcomes will be sustained pain free response between 4 and 72 hours after initial abortive medication dosing (lack of recurrence over 72 hours) |  | 4 to 72 hours | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pain response and pain free data |  | 30 minutes, 1,2,4,24,48,and 72 hours | 
| Rate of recurrence, time of recurrence, time to re-dosing |  | 72 hours | 
| Rate of recurrence among multiple attacks per subject |  | 72 hours |
Study Concerning Relationship Between Mixed Venous Saturation (SvO2) and Balance

Study Overview
=================
Brief Summary
-----------------
It is the purpose of the investigators to investigate the possible relationship between fall in the amount of Oxygen in the blood and disturbances of balance-function before and after surgery.

Detailed Description
-----------------
It has been shown that the mixed venous saturation (SvO2) is usable as a parameter of fluid status. It has also been suggested that there is a connection between SvO2 and blood flow in tissue , and that a SvO2 of less than 40% is a sign of tissue hypoxia. Recently it has been shown that patients going through heart surgery experience a drop in SvO2 during early mobilization.This drop lasts throughout the mobilisation process. We want to investigate whether the same mechanism applies to patients going through other types of surgery, and whether there is a connection between a drop in SvO2 and orthostatic function. This will be done by making 3 tests. One pre-operatively,one six hours post-operatively and one 18-24 hours after surgery. The tests will consist of: 10 min of rest. 3 min of sitting upright on the side of the bed. C. 3 min of standing on the floor. D. 10 min of rest. Between each position a venous blood sample will be taken. Also 1 blood sample will be taken at the end of surgery. Continuous measurements by the Finapres system wil be made throughout the test-sequence to investigate changes in BP, SV, TPR and HR. At the same time the patient will be pain-scored when taking a new position.

Official Title
-----------------
Descriptive Study Concerning the Connection Between SvO2 and Orthostatic Function Post Operatively

Conditions
-----------------
Surgery

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients going through Radical Prostatectomy, where CVC is standard. Exclusion Criteria: Non informed consent ASA > II Age less than 18, or more than 80 years Diabetes Mellitus Epidural analgetics Alcohol abuse (investigators assessment) Unable to understand written or spoken information Using beta-blockers

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

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

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
-----------------
Fluid, SvO2, Mobilisation, Orthostatic function
High-dose Etoposide Could Discriminate Patients With Refractory/Relapsed Lymphoma Benefit From APBSCT

Study Overview
=================
Brief Summary
-----------------
patients with refractory /relapsed lymphoma received high-dose etoposide for hematopoietic stem cell (HSC) mobilization.All patients received high-dose etoposide 20-25 mg/kg/d intravenously for two consecutive days followed by rhG-CSF10ug/kg/day subcutaneously at 48 hours after chemotherapy; rhG-CSF was continued until the end of harvesting for HSCs/HPCs. Peripheral blood counts were performed daily for all patients following the initiating of rhG-CSF. Leukapheresis was performed when peripheral blood white blood count exceeded 4×109/L with blood cell The harvested cells reached at least 2*108/kg for mononuclear cells and/or 2*106/kg for CD34+ cells with once to twice leukapheresis. The final product was kept frozen in liquid nitrogen.Auto-PBSCT

Official Title
-----------------
2008 WHO Myeloid and Lymphocytic Tumor Diagnostic Criteria

Conditions
-----------------
Lymphoma

Intervention / Treatment
-----------------
* Drug: high-dose etoposide


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: relapsed/refractory lymphoma ,siut APBSCT Exclusion Criteria: bone marrow without involvement by lymphoma cells

Ages Eligible for Study
-----------------
Minimum Age: 16 Years
Maximum Age: 60 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 |
| --- | --- |
| Disease status at mobilization PR<br> | Drug: high-dose etoposide<br>* an epipodophyllotoxin, is one of the most common chemotherapy agents for lymphoma without reciprocal resistance with other kinds of agents.<br>|
| Disease status at mobilization PD<br> | Drug: high-dose etoposide<br>* an epipodophyllotoxin, is one of the most common chemotherapy agents for lymphoma without reciprocal resistance with other kinds of agents.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| death | death | 10 years | 
| CR | Complete response | 10 years | 
| relapse | relapse | 10 years | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
high-dose etoposide,autologous peripheral blood stem cell transplantation
CLinical EValuation of WEB 0.017 Device in Intracranial AneuRysms

Study Overview
=================
Brief Summary
-----------------
The study is an observational, European, multi-center, prospective assessment of the clinical utility of the 0.017 WEB Aneurysm Embolization System in subjects with intracranial aneurysms deemed appropriate for endovascular treatment.

Detailed Description
-----------------
All eligible subjects presenting to the participating Centers will be considered for entry into the study. Up to 160 evaluable subjects meeting the study entry criteria will be enrolled. Subjects will be followed per Institution's standard of care.

Official Title
-----------------
CLEVER: CLinical EValuation of WEB 0.017 Device in Intracranial AneuRysms

Conditions
-----------------
Brain Aneurysm

Intervention / Treatment
-----------------
* Device: WEB Aneurysm Embolization System


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Subject must be ≥ 18 years of age and ≤80 years of age Subject must have an intracranial aneurysm (IA), Subject must sign and date Ethics Committee approved written informed consent prior to initiation of any clinical interventional procedures or when applicable, register the patient non opposition to the study data collection For ruptured aneurysm, Subject with Hunt & Hess Score ≤ III Exclusion Criteria: Subject has an IA with characteristics unsuitable for endovascular treatment Subject's index IA was previously treated Subject has stroke-in-evolution within the prior 30 days An additional aneurysm must be treated during the procedure

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

Arms and Interventions

| Intervention/Treatment |
| --- |
|Device: WEB Aneurysm Embolization System|Subjects aged ≥ 18 years, but ≤ 80 years requiring treatment for single ruptured or unruptured intracranial aneurysms.|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Aneurysm occlusion | Angiographic (conventional Angio) occlusion based on Raymond-Roy occlusion scale The Raymond-Roy occlusion classification (RROC) is an angiographic classification scheme for grading the occlusion of endovascularly treated intracranial aneurysms. class I: complete obliteration class II: residual neck class III: residual aneurysm | 12 months | 
| Incidence of major stroke or neurological deaths | The proportion of subjects with death of any nonaccidental cause or any major stroke within the first 30 days after treatment or major ipsilateral stroke or death due to neurologic cause from day 31 to the 1 year after treatment | 12months |
Clinical Evaluation of Cohera Sylys Surgical Sealant as an Adjunct to Standard Bowel Anastomosis Closure

Study Overview
=================
Brief Summary
-----------------
A first in human study evaluating the safety of Sylys Surgical Sealant in protecting the anastomotic junction created during a stoma reversal procedure.

Conditions
-----------------
Stoma Reversal Procedure

Intervention / Treatment
-----------------
* Device: Sylys Surgical Sealant


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Be at least 18 years of age Be in good general health in the opinion of the investigator with no conditions that would significantly impact wound healing as determined by medical history and review of recent concomitant medications Be scheduled for an ileostomy reversal procedure Be willing to follow instructions for incision care Agree to return for all follow-up evaluations specified in this protocol Sign informed consent Exclusion Criteria: Anesthesia risk judged to be higher than ASA2 Have severe co-morbid conditions that pose a high risk for surgery and adequate recovery (e.g., heart disease) Any condition involving compromised immune system Any condition known to effect wound healing, such as collagen vascular disease Known blood clotting disorder Be receiving antibiotic therapy for pre-existing condition or infection Concurrent use of fibrin sealants or other anastomosis care devices Be currently taking systemic steroids or immunosuppressive agents Have known or suspected allergy or sensitivity to any test materials or reagents Be participating in any current clinical trial or have participated in any clinical trial within 30 days of enrollment in this study

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: Test<br>All test arm subjects received Sylys Surgical sealant around anastomotic junction after closure. | Device: Sylys Surgical Sealant<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of Adverse Events |  | 30 days |
Effect of the Pigment-free Optical Zone Diameter of Decorative Tinted Soft Contact Lenses on Visual Function

Study Overview
=================
Brief Summary
-----------------
Investigators planned to investigate changes in visual function after wearing decorative tinted soft contact lenses with different pigment-free optical zone diameters.

Conditions
-----------------
Tinted Contact Lense

Intervention / Treatment
-----------------
* Device: EyeLIKe Callamatch II, Koryo Eyetech Co, Seoul, Korea
* Device: EyeLIKe Shine, Koryo Eyetech Co


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: normal subject aged above 20 years old Exclusion Criteria: subject who had a history of ocular diseases, such as ocular infection, ocular allergy, and autoimmune disease, patients with continuous use of topical ocular medications before surgery, or histories of ocular surgery or ocular injury.

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

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

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

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

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: wearing contact lense group<br>normal subjects after wearing tinted/normal contact lenses | Device: EyeLIKe Callamatch II, Koryo Eyetech Co, Seoul, Korea<br>* tinted contact lens, daily-wear tinted lens<br>Device: EyeLIKe Shine, Koryo Eyetech Co<br>* clear lens<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| score of best-corrected visual acuity (BCVA) |  | 1 day | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Total score of ocular higher-order aberrations | ocular higher-order aberrations measured by iTrace (Tracey Technologies, Houston, Texas, USA; software V.4.1.0) | 1 day | 
| contrast sensitivity with tinted lense | contrast sensitivity measured by Optec 6500 test system (Stereo Optical Co, Chicago, Illinois, USA) at five spatial frequencies (1.5, 3, 6, 12 and 18 cycles/degree (cpd)) under photopic (luminance value of 85 candelas/square metre (cd/m2)) and mesopic conditions (target luminance value of 3 cd/m2) with or without glare after wearing clear lens and tinted lenses with different pigment-free optical zone diameters (4, 5 and 6 mm). | 1 day |