linjc16/ctgov huggingface dataset:
Impact of Age and Geriatric Co-morbidities on Lymphocyte Phenotype in Patients 70 Years of Age and Older

Study Overview
=================
Brief Summary
-----------------
An individual's immune profile changes with age, and can sometimes be involved in the development of certain diseases such as infections or cancers, in a process called immunosenescence. Some data tend to show that there is a link between this immune profile and geriatric fragility (autonomy, difficulties with walking, memory, undernutrition, co-morbidities, depression). The aim of this study is to describe this profile, or immune phenotype, and to see if there is a link with the different aspects of geriatric assessment in patients without cancer or infection. In addition, these data will serve as a basis for comparison with the same analyses performed on breast cancer patients at the Centre Georges François Leclerc.

Official Title
-----------------
Impact of Age and Geriatric Co-morbidities on Lymphocyte Phenotype in Patients 70 Years of Age and Older

Conditions
-----------------
Geriatrics Immunosenescence

Intervention / Treatment
-----------------
* Biological: Blood samples
* Other: Data collection


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Person who has not opposed to inclusion in the study Male or female aged 70 and over admitted to the Champmaillot Geriatric Center on an inpatient or outpatient basis. Exclusion Criteria: Person not affiliated to national health insurance system Person subject to a measure of legal safeguard (curatorship, etc) Person with an acute infection Person with suspected cancer or active cancer Long-term immunosuppressive or corticosteroid therapy HIV and/or HBV and/or HCV positive serology

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

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Seniors<br>70 years of age and over, inpatients or outpatients | Biological: Blood samples<br>* during the routine blood test, collection of additional blood samples: 1 x 5 mL heparinized tube for plasma collection and storage 1 heparinized 5 mL tube for immunophenotyping 4 x 10 mL EDTA tubes for white blood cell (WBC) collection and cryopreservation<br>Other: Data collection<br>* clinical examination data test results to measure the degree of geriatric fatigability Frailty screening questionnaire for neoplasia patients (G8 score)<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| percentage of immune cells in peripheral blood | technique used: flow cytometry | At inclusion |
Verapamil vs Steroid to Prevent Keloid Recurrence

Study Overview
=================
Brief Summary
-----------------
Keloid scarring is a severe cosmetic and painful disease of the skin. The gold standard treatment is yet to be clarified. This randomized clinical pilot study will compare the effects of two local treatments for preventing keloid recurrence after surgical removal; steroid and verapamil. Study hypothesis: Intralesional therapy with the calcium antagonist verapamil has equal treatment efficacy as steroid injection.

Official Title
-----------------
Assessment of Verapamil as an Adjunct for Prevention of Keloid Recurrence After Surgical Removal

Conditions
-----------------
Keloid Scars

Intervention / Treatment
-----------------
* Drug: Verapamil
* Drug: Kenalog 10


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patient undergoing surgical removal of keloid Patient 18 years old or greater Length of excisional scar after surgical removal of keloid between 2 and 10 cm Exclusion Criteria: Keloid in face or hands Pregnancy or lactation Dementia Any heart or pulmonary condition Systemic treatment with beta-blockers, ACE-inhibitors or calcium antagonists Systemic corticosteroidal therapy Intralesional steroid treatment within 2 months of surgery to remove keloid Flap surgery Lesions to face, hands and other cosmetically sensitive areas

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Verapamil<br>Verapamil 2.5 mg/mL injection sc intralesionally | Drug: Verapamil<br> <br> |
| Active Comparator: Kenalog 10<br>Kenalog 10 mg/mL injection sc intralesionally | Drug: Kenalog 10<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Keloid recurrence |  | 1 year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Vancouver Scar Scale Score |  | 1 year |
The Clinical Impact and Outcomes of Interventional Endoscopy Procedures

Study Overview
=================
Brief Summary
-----------------
The main purpose of the protocol is to collect and evaluate performance data after patients undergoing various interventional endoscopy procedures performed at H. H. Chao Comprehensive Digestive Disease Center (CDDC).

Detailed Description
-----------------
In general, the outcome data includes clinical management, hospitalization, and complications; to determine costs associated with endoscopy procedures; to determine performance data including technical success, procedure time, rate of repeat interventions; to compare endoscopy performance and outcome data collected at University of California, Irvine (UCI) and results from other institutions previously published in the literature. Additional parameters might be collected for specific interventional endoscopy procedures.

Official Title
-----------------
The Clinical Impact and Outcomes of Interventional Endoscopy Procedures

Conditions
-----------------
Gastrointestinal Diseases

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Subjects who are 18 years of age or older Subjects who are scheduled for a procedure at the H. H. Chao Comprehensive Digestive Disease Center (CDDC). Exclusion Criteria: Subjects who are not 18 years of age or older Subjects who are scheduled for a procedure at the H. H. Chao Comprehensive Digestive Disease Center (CDDC).

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

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Chart Review<br>Chart review of patients who had a procedure done at H. H. Chao Comprehensive Digestive Disease Center | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Collect and clinical management data | Outcome data includes clinical management (such as hospitalization information, and complications, costs associated with endoscopy procedures, etc.). | Day of procedure up to 5 years for follow-up (if needed). | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Collect Performance Data | Outcome performance data (such as, technical success, procedure time, rate of repeat interventions, lab/pathology results, etc.) | Day of procedure up to 5 years for follow-up (if needed). | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
gastroenterology, Endoscopy, Digestive System, Endosonography, Endoscopic Retrograde Cholangiopancreatography, gastrointestinal endoscopy
Postoperative Canadian Oral Anticoagulation Self-management (Post-COAGS) Trial

Study Overview
=================
Brief Summary
-----------------
This study will measure the efficacy and safety of an early postoperative anticoagulation self-management program, using the CoaguChek S device, in patients undergoing mechanical valve replacements. Patients will be randomized into a study group (self-management) or a control group (physician management).

Official Title
-----------------
Postoperative Canadian Oral Anticoagulation Self-Management (Post-COAGS) Trial

Conditions
-----------------
Cardiovascular Abnormalities

Intervention / Treatment
-----------------
* Device: CoaguChek S


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: adult patients, 18-70 years of age; recipient of a mechanical heart valve (aortic and/or mitral), +/- CABG, +/- postoperative atrial fibrillation. Exclusion Criteria: recipient of a bioprosthetic valve; post-operative thrombotic events; pre-operative utilization of oral anticoagulation.

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: Diagnostic
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Intervention/Treatment |
| --- |
|Device: CoaguChek S|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
Evaluation of Anatomic and Visual Outcomes of Initially Closed Macular Holes

Study Overview
=================
Brief Summary
-----------------
To evaluate the anatomic and visual outcomes in patients with initially closed macular holes after vitreoretinal surgery and with one to seven years of follow-up.

Detailed Description
-----------------
In recent years, peeling of the internal limiting membrane (ILM) has been used as a supplementary treatment to reducing the tangential tractional forces and inducing hole closure in macular hole surgery, and thus the anatomic success rate has increased to over 90%. However, despite these high rates of surgical success, the reopening of initially closed macular holes has also been observed from the first month to several years following surgery. Because about 45% to 95% of phakic patients frequently develop a progressive nuclear sclerosis cataract after macular hole surgery and require combined or subsequent cataract extraction to improve visual acuity, cataract extraction has become a potential factor in causing macular hole reopening, although this is still under debate. The purpose of this study is to describe the long-term anatomic and visual outcomes in patients who had initial anatomic success with macular hole surgery and who had postoperative follow-up of one or more years. All patient's charts were reviewed for age, macular hole stage (using the Gass classification), macular hole duration, epiretinal membrane of macula presence, ILM peeling, preoperative and postoperative visual acuity, rate of macular hole reopening, cataract extraction, and length of follow-up after vitrectomy.

Official Title
-----------------
Study of the Anatomic and Visual Outcomes in Patients With Initially Closed Macular Holes After Vitreoretinal Surgery

Conditions
-----------------
Macular Holes

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: successful closure of a macular hole after initial vitreoretinal surgery a follow-up of at least one year Exclusion Criteria: post-traumatic holes, myopic macular holes, macular holes associated with a rhegmatogenous retinal detachment, eyes with silicone oil tamponade.
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
-----------------
Reopening of macular hole;, Visual acuity;, Phacoemulsification cataract surgery;, Vitrectomy
PS-Omega3 Supplementation to Attention Deficit Hyperactivity Disorder (ADHD) Children

Study Overview
=================
Brief Summary
-----------------
To assess the effect of phosphatidylserine-omega-3 consumption on the immune system parameters in children suffering from attention and concentration deficits.

Official Title
-----------------
Phase 2b Study of PS-Omega3 Conjugate Supplementation to ADHD Diagnosed Children

Conditions
-----------------
ADHD

Intervention / Treatment
-----------------
* Dietary Supplement: PS-Omega3 conjugate supplementation
* Dietary Supplement: placebo


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Parental written informed consent. Age: 13≥ years ≥8 (including). Gender: both male and female. TOVA computerized test score ≤-1.8 at baseline. Language: Subjects, parents, and teachers must be able to read, write and speak Hebrew. Normal weight and height according to Israeli standards. 21 days without any treatment for ADHD symptoms, whether medication or food supplement. Exclusion Criteria: History or current diagnosis of any serious systemic (e.g., diabetes, hyper/hypothyroidism, etc.) or neurological condition (e.g., epilepsy, brain tumors, etc.) Pervasive developmental disorder or Non-Verbal Learning Disability Any evidence of psychotic disorders, suicidal risk, any current psychiatric co-morbidity that required psychiatric pharmacotherapy. History of allergic reactions or sensitivity to marine products (seafood), soy or corn as well as any illness, which may jeopardize the participants health or limit their successful trial completion. Having a sibling already included in the study.

Ages Eligible for Study
-----------------
Minimum Age: 8 Years
Maximum Age: 13 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: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: 1<br>Patients receiving active product | Dietary Supplement: PS-Omega3 conjugate supplementation<br> <br> |
| Placebo Comparator: 2<br>Patients receiving placebo | Dietary Supplement: placebo<br> <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
-----------------
ADHD, ADHD diagnosed children
Study on Improvement of Blood Glucose Control in Patients With Diabetes Type 2 Using SMBG

Study Overview
=================
Brief Summary
-----------------
This clinical study is to determine if the use of structured testing, which is a blood glucose monitoring, via the Accu-Chek 360° View blood glucose analysis tool has a positive effect on the subjects overall glycemic control.

Official Title
-----------------
Study on Improvement of Blood Glucose Control in Patients With Diabetes Type 2 Using SMBG

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

Intervention / Treatment
-----------------
* Device: ;Accu-Chek Compact Plus LCM bulk Japan


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: 1. Age:= and >20 years. 2. Intend to paticipate in this study after education of structured testing. 3.HbA1c:= and >7.5% in the recect 2 months. Exclusion Criteria: 1.Pregancy. 2. Heavy complication 3. judged unsuitable by doctor

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

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

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

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Single arm<br> | Device: ;Accu-Chek Compact Plus LCM bulk Japan<br>* HbA1c would be changed by more careful control in blood glucose with SMBG.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Improvement in HbA1c in 6 months |  | 6 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 1. Comparison with historical control in HbA1c change. |  | Baseline to 6 months | 
| 2. Change in blood gulucose. |  | Baseline to 6 months | 
| 3. Change in BMI. |  | Baseline to 6 months | 
| 4. Occurance of sever hypoglycemia. |  | Baseline to 6 months | 
| 5. Doctor's opinion for Accu-Chek 360° View. |  | Baseline to 6 months |
Significance of Early Mobilization After VATS-L

Study Overview
=================
Brief Summary
-----------------
The main endpoint is physiological rehabilitation after VATS-L under early mobilization. The secondary endpoints are exploring the effect of early mobilization on postoperative physiology. Investigators hypothesis that early mobilization is clearly advantaged to advance the physiological recovery.

Official Title
-----------------
Physiological Evidence for Early Mobilization in Thoracoscopic Lobectomy

Conditions
-----------------
Lung Neoplasm, Physiology, Exercise, Lung Function, Arterial Oxygen Saturation

Intervention / Treatment
-----------------
* Behavioral: Early mobilization


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: VATS lobectomy; Speak and understand Danish or English; Informed consent obtained. Exclusion Criteria: Co-VATS lobectomy (more than one lobe resection); Supplementary oxygen therapy later 6 h after surgery; No willing to wear electronic device; No willing to exam arterial oxygen saturation.

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 |
| --- |
|Behavioral: Early mobilization|Mobilization as soon as patients can, which is not limited on walking|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Postoperative forced expiratory volume in one second (FEV1) | FEV1 is the amount of air you can force from your lungs in one second. Participants will be examed via spirometer. | Through study completion, an average of 3 days | 
| Postoperative arterial oxygen saturation. | Oxygen saturation is the fraction of oxygen-saturated hemoglobin relative to total hemoglobin (unsaturated + saturated) in the blood. Participants will be tested via oximeter. | Through study completion, an average of 3 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The quantization of activity counts |  | Through study completion, an average of 3 days | 
| The quantization of pain | The numeric rating scale (NRS) ranging from 0 (no pain) to 10 (excruciating pain) is used to score postoperative pain. | Through study completion, an average of 3 days | 
| length of stay in hospital |  | Through study completion, an average of 3 days | 
| Duration of chest tube |  | Through study completion, an average of 2 days | 
| Postoperative complications | Pneumothorax, subcutaneous emphysema, pneumonia, empyema, bleeding, pulmonary embolism, prolong air leakage, re-intervention, re-surgery and re-admission will be recording specifically. | up to 30 days | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Postoperative mobilization, Physiology, Thoracoscopy, Lobectomy
Clinical Pharmacology of FYU-981 (Final Formulation)

Study Overview
=================
Brief Summary
-----------------
This is a randomized, open-label, 2-period crossover study. The purpose of this study is to assess the pharmacokinetics and safety after single oral administration of final formulation of FYU-981 to healthy male adults in fasted and fed conditions. Participants are randomized to fasted (n=6) or fed conditions (n=6) in each step. The effect of food to pharmacokinetics of FYU-981 is also investigated.

Official Title
-----------------
Clinical Pharmacology Study of Final Formulation of FYU-981 Administered to Healthy Male Adults

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

Intervention / Treatment
-----------------
* Drug: FYU-981


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Japanese healthy adult subjects Body mass index: >=18.5 and <25.0 Exclusion Criteria: Subjects with any disease or any history of diseases that might be unsuitable for participation in the clinical study

Ages Eligible for Study
-----------------
Minimum Age: 20 Years
Maximum Age: 35 Years

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

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: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Fasted dosing followed by fed dosing<br>Dosing of FYU-981 in the fasted state followed by fed dosing | Drug: FYU-981<br>* Single administration of FYU-981 under Fasted and fed conditions in the morning.<br>* Other names: Final formulation of FYU-981;|
| Experimental: Fed dosing followed by fasted dosing<br>Dosing of FYU-981 in the fed state followed by fasted dosing | Drug: FYU-981<br>* Single administration of FYU-981 under Fasted and fed conditions in the morning.<br>* Other names: Final formulation of FYU-981;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pharmacokinetics (Cmax: Maximum plasma concentration) |  | 48 hours | 
| Pharmacokinetics (Tmax: Time to reach the peak plasma concentration) |  | 48 hours | 
| Pharmacokinetics | T1/2: Elimination half-life of plasma concentration | 48 hours | 
| Pharmacokinetics (AUC: Area under the plasma concentration-time curve) |  | 48 hours | 
| Pharmacokinetics (CLtot/F: Total clearance/Fraction of dose absorbed) |  | 48 hours | 
| Pharmacokinetics (kel: Elimination rate constant) |  | 48 hours | 
| Pharmacokinetics (Vd/F: Distribution volume/Fraction of dose absorbed) |  | 48 hours | 
| Pharmacokinetics (MRT: Mean residence time) |  | 48 hours | 
| Safety (Incidence of treatment-emergent adverse events) |  | 13 days |