linjc16/ctgov huggingface dataset:
Identification of Gene Biomarkers in Aging Skin

Study Overview
=================
Brief Summary
-----------------
This study is a blinded, prospective, single-center, clinical study conducted in Japanese female subjects between the ages of 20-75 years. This design uses skin biopsy samples from environmentally exposed areas and unexposed (control) areas within the same subjects to assess the gene expression profile from three different age groups.

Detailed Description
-----------------
The primary objective of the skin aging study is to investigate changes in gene expression patterns that occur during the aging process.

Official Title
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Identification of Gene Biomarkers in Aging Skin; a Blinded, Prospective, Single-center, Clinical Study

Conditions
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Hyperpigmentation, Skin Aging

Participation Criteria
=================
Eligibility Criteria
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Inclusion Criteria: Individuals who are willing to read and sign an informed consent form prior to participating in the study. Individuals who have a temperature of less than or equal to 100 degrees F at the time of biopsy collection. Individuals who had not applied any sunless tanning product on the arms within the past year. Individuals with no prior history of alcoholism (or who consume fewer than 2 to 3 alcoholic beverages per day). Individuals who have not consumed any anti-aging nutritional supplements (multivitamins and multiminerals are acceptable) or aspirin, NSAIDS, or other pain medication in the last 48 hours before biopsy. Exclusion Criteria: Male gender Individuals who did not fit the 'inclusion criteria' above.

Ages Eligible for Study
-----------------
Minimum Age: 20 Years
Maximum Age: 75 Years

Sexes Eligible for Study
-----------------
Female

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Group 1<br>Young age: 20 to 30 years old | |
| Group 2<br>Middle Age: 38 to 48 years old (pre-menopausal only) | |
| Group 3<br>Elderly Age: 60 to 75 years old (Post-menopausal only) | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The primary objective of the study is to investigate changes in gene expression patterns that occur during the aging process. A significant fold change in differential gene expression will be >1.5 and an adjusted p-value of <0.05. |  | 1 year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Secondary outcome measures are the evaluation of genetic expression changes in sun-protected and sun-exposed skin and an investigation of their biological pathways. |  | 1 year | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
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Skin, Aging, Dermogenomics, Genetic, Biomarker, Dermatology
Comparison Between Pure Laparoscopic Donor Right Hepatectomy and Convensional Donor Right Hepatectomy

Study Overview
=================
Brief Summary
-----------------
Perioperative clincal outcome between PLDRH and conventional open donor right hepatectomy (ODRH) will be compared retrospectively.

Detailed Description
-----------------
the superiority of laparoscopic liver resection was well known in terms of reduced blood loss and minimized hospital stay compared with open liver resection. However, pure laparoscopic donor hepatectomy is a challenging procedure for beginner liver surgeons because of the major vessel preservation required during liver parenchymal transection. this study was designed to identify the superiority of laparoscopic donor hepatectomy.

Official Title
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Clinical Outcome of Living Donor Hepatectomy for Liver Transplantation: a Retrospective Study

Conditions
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Healthy Donors for Liver Transplantation

Intervention / Treatment
-----------------
* Procedure: pure laparoscopic donor hepatectomy
* Procedure: conventional open donor hepatectomy


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: patients received right or right extended hepatectomy for liver donation at gangnam severance hospital Exclusion Criteria: none

Ages Eligible for Study
-----------------
Minimum Age: 17 Years
Maximum Age: 65 Years

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| PLDRH<br>patients who underwent pure laparoscopic donor right hepatectomy | Procedure: pure laparoscopic donor hepatectomy<br>* pure laparoscopic donor hepatectomy: patients who underwent pure laparoscopic right or right extended hepatectomy for liver donation at gangnam severance hospital<br>|
| ODRH<br>patients who underwent conventaional open donor right hepatectomy | Procedure: conventional open donor hepatectomy<br>* conventional open donor hepatectomy: patients who underwent conventional right or right extended hepatectomy for liver donation at gangnam severance hospital<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| blood loss during hepatectomy | bleeding amount during hepatectomy will be calculated in mL. based on the blood in the sucker machine and the surgical towels. | intraoperative |
Cognitive Training in Parkinson's Disease

Study Overview
=================
Brief Summary
-----------------
The study evaluates a computerized cognitive therapy in patients with Parkinson's disease who have a mild cognitive impairment or mild dementia. The control group is trained using Nintendo Wii. The main outcome parameter is a neuropsychological evaluation.

Official Title
-----------------
A Computerized, Multidimensional and Disease Specific Training of Cognition in Patients With M. Parkinson

Conditions
-----------------
Mental Competence

Intervention / Treatment
-----------------
* Other: Cognitive Training
* Other: computer game


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Parkinson's disease and mild cognitive impairment (MCI) or mild dementia Exclusion Criteria: Moderate or severe dementia, other pathologies of the brain, physical conditions that prevent the participation, unsufficient knowledge of german, pregnancy
Sexes Eligible for Study
-----------------
All

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

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

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Sham Comparator: Computer game<br>Nintendo Wii | Other: computer game<br> <br> |
| Experimental: Cognitive Training with Cogniplus<br>CogniPlus | Other: Cognitive Training<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Neuropsychological parameters: Tests of episodic memory, working memory, executive functions, visio-construction | Neuropsychological tests: mini mental status (MMS), Clock drawing test, Boston Naming Test, Calculating, Semantic Fluency, Phonematic Fluency, California Verbal Learning Test, Corsi Block Tapping Test, Trail Making Test, Digit Span, Testbatterie zur Aufmerksamkeitsprüfung (alteredness, Working Memory, Divided Attention, Flexibility), Wisconsin Card Sorting Test, Apraxias, 5 Points Test, Mosaik Test | Neuropsychological assessment immediatly before and after the training and 6 month later |
Assessing the Variability Over Time of Tobacco Carcinogen Biomarkers in Smokers - 2

Study Overview
=================
Brief Summary
-----------------
Lung cancer is the leading cause of cancer death in the United States. Currently it remains impossible to predict which smokers will get cancer. Each puff of a cigarette delivers a mixture of over 60 known carcinogens. Biomarkers that quantify carcinogen levels and metabolism are a useful tool and available to use. The purpose of this study is to assess the variability of tobacco smoke carcinogen biomarker levels over one year in a group of smokers.

Detailed Description
-----------------
Lung cancer is the leading cause of cancer death in the United States. Approximately 90% of lung cancer is caused by cigarette smoking. While most lung cancer cases occur in smokers or ex-smokers, only 15-25% of smokers will get lung cancer. Currently it remains impossible to predict which smokers will get cancer. Each puff of a cigarette delivers, along with nicotine, a mixture of over 60 known carcinogens. Most of these carcinogens require metabolic activation before they can negatively affect cell DNA and cause cancer. Biomarkers that quantify carcinogen levels and metabolic activity of carcinogens are a useful tool and available to use. The purpose of this study is to assess the variability of tobacco smoke carcinogen biomarker levels over one year in a group of smokers. This longitudinal observational study will involve a repeated measure analysis of 6 different tobacco carcinogen biomarkers. Fifty current smokers who intend to continue smoking for the duration of the study will be recruited through advertisements. Participants will be compensated for their time. Blood samples will be collected every two months for one year. All samples will be analyzed for the 6 different carcinogen biomarkers and individual variability in biomarker levels will be assessed.

Official Title
-----------------
Longitudinal Study of Prostate, Lung, Colon, and Ovarian Cancer (PLCO) Screen Trial

Conditions
-----------------
Tobacco Use Disorder

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Currently smokes Intends to continue smoking for the 12 months following enrollment Exclusion Criteria: Unstable physical or mental condition

Ages Eligible for Study
-----------------
Minimum Age: 55 Years
Maximum Age: 74 Years

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

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

Study Plan
=================
How is the study designed?
-----------------
What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
Observational,Prospective Study to Develop and Validate a Prognostic Tool to Optimize Therapy in Patients With HCV G1/4

Study Overview
=================
Brief Summary
-----------------
Primary objective: • Develop and validate a tool towards patients with chronic hepatitis C genotype 1 and 4 to allow optimize treatment.

Detailed Description
-----------------
This Tool: Predicting the overall impact of prognostic factors (including the new factor of genetic polymorphism of the IL28B) on Sustained Viral Response (SVR). Identify those patients most likely to respond. Therapy and therefore optimize resources The validation tool will check into clinical practice its predictive power (it will consider its ability to calibrate and discriminate) and make correct inferences and interpretations of the scores obtained when applying.

Official Title
-----------------
Observational,Post-authorization Prospective Study to Develop and Validate a Prognostic Tool for Optimizing Therapy in Patients With Hepatitis C Virus (HCV) Genotype 1 and 4.

Conditions
-----------------
Hepatitis C, Chronic

Intervention / Treatment
-----------------
* Drug: Peginterferon alfa-2a
* Drug: Ribavirin


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients with > 18 years old. Patients diagnosed with chronic hepatitis C in the presence of HCV RNA in plasma that meet criteria for initiating antiviral therapy in routine clinical practice conditions. Patients Genotype 1 and 4. Patients with the results of all the factors evaluable at the time of inclusion. Patients who have accepted their participation in the study through informed consent. Exclusion Criteria: Patients previously treated with interferon (IFN) and ribavirin (RBV). Patients with genotype 2, 3, 5 and 6. Patients with co-infection with hepatitis B. Patients with other liver diseases. Patients with any contraindications to the drugs used in the treatment of hepatitis C.

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 65 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 |
| --- | --- |
| Pegasys, injection subcutaneous<br>HCV patients monoinfected or coinfected genotype 1/4 treated with Peginterferon alfa-2a and Ribavirin | Drug: Peginterferon alfa-2a<br>* Treatment as usual clinical practice<br>* Other names: Pegasys;Drug: Ribavirin<br>* Treatment as usual clinical practice<br>* Other names: Copegus;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Sustained Viral Response (RVS) | Measurement of HCV RNA negativization 24 weeks after treatment | 1 ½ years (72 weeks) |
Comparison of Nasal Positive End Expiratory Pressure Valve to Dental Device as an Alternative Treatment for Obstructive Sleep Apnea

Study Overview
=================
Brief Summary
-----------------
Determine the clinical efficacy in terms of Apnea Hypopnea Index (AHI), excessive daytime sleepiness (EDS), nocturnal oxygenation of a nasal Positive end-expiratory pressure (PEEP) valve Provent in obstructive sleep apnea. The hypothesis is the efficacy will be better than dental device.

Official Title
-----------------
Comparison of Nasal Positive End Expiratory Pressure Valve to Dental Device as an Alternative Treatment for OSA

Conditions
-----------------
Obstructive Sleep Apnea, Adverse Effects

Intervention / Treatment
-----------------
* Device: nasal peep valve Provent


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Symptomatic patients confirmed of OSA by sleep study (PSG according to AASM criteria or validated level 3 portable monitoring devices with AHI > 10/hr) Not using CPAP for any reasons or patients on dental device but would like to try alternative treatments for OSA. Able to sign informed consent and use the PEEP nasal valve. Age between 18-65 years old. Willing to attend follow up. Exclusion Criteria: Known nasal problems like deformities or significant rhinitis affecting application of PEEP nasal valve. Unable to sign consent or use PEEP nasal valve. Significant or unstable co-morbidities requiring other forms of treatment for OSA as priority. Coexisting sleep disordered breathing condition other than OSA requiring more complex treatment. E.g. central sleep apnea, significant Cheyne Stokes respiration or hypoventilation syndrome.

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Dental device<br>Provent nasal peep valve vs dental device | Device: nasal peep valve Provent<br>* application of nasal peep valve vs dental device and cpap<br>|
| Active Comparator: CPAP<br>continuous positive airway pressure CPAP vs nasap peep valve Provent | Device: nasal peep valve Provent<br>* application of nasal peep valve vs dental device and cpap<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Apnea Hypopnea Index (AHI) |  | 1 month | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| side effects as a measure of tolerability |  | 1 month | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
OSA
Evaluation of a Clinical Decision Support System for Fungal Infections

Study Overview
=================
Brief Summary
-----------------
Invasive fungal infections are serious and frequent diseases in our hospitals, especially in intensive care units. In accordance with the institutional recommendations, it is necessary to have a clinical decision support system to support the clinicians in a rapid and optimal prescription of antifungals for invasive fungal diseases. This clinical decision support system will benefit patients but also clinicians who will gain in medical efficiency. It will also have an ethical dimension since it will guarantee optimal antifungal treatments for all patients. The purpose of the research is to define the percentage of concordance between the medical prescription and the recommendation of the clinical decision support system.

Official Title
-----------------
Evaluation of a Clinical Decision Support System for the Treatment of Invasive Fungal Infections

Conditions
-----------------
Invasive Fungal Infections

Intervention / Treatment
-----------------
* Device: Medical device


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients receiving antifungal therapy for the treatment of invasive fungal disease Exclusion Criteria: Patients not receiving antifungal therapy for the treatment of invasive fungal disease
Sexes Eligible for Study
-----------------
All

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Antifungal treatment prescribed by the clinician for an invasive fungal disease<br> | |
| Antifungal treatment recommended by the clinical decision support system<br> | Device: Medical device<br>* Clinical decision support system<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percentage of concordance between the medical prescription and the recommendation of the clinical decision support system |  | January to september 2023 | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
invasive fungal infections, antifungal treatment, clinical decision support system
Post Market Study for an Adhesion Barrier Following Laparoscopic Myomectomy

Study Overview
=================
Brief Summary
-----------------
This study is planned as a prospective, randomised, parallel, controlled, multi-centre, open label, comparative evaluation of SprayShield™ Adhesion Barrier plus good surgical technique, versus good surgical technique alone, with a blinded, third party video evaluation of adhesion formation at second look laparoscopy (SLL) following laparoscopic myomectomy.

Official Title
-----------------
A Randomised, Prospective, Multi-Centre Clinical Study of SprayShield™ Adhesion Barrier System as a Barrier for the Prevention of Adhesion Formation After Laparoscopic Myomectomy

Conditions
-----------------
Fibroid, Myoma, Leiomyoma

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


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Females, 18 years of age or older, of child-bearing potential. Subject has at least one myoma >= 3 cm. Exclusion Criteria: Pregnant or lactating females. Females undergoing prior open or closed myomectomy for treatment of myomas. Evidence of current active endometriosis or infection History of or active inflammatory bowel disease or pelvic inflammatory disease. Presence of a frozen pelvis, or hydrosalpinges.

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

Sexes Eligible for Study
-----------------
Female

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

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

Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: SprayShield™<br>SprayShield™ | Device: SprayShield™<br>* Anti-adhesion barrier<br>|
| No Intervention: Control<br>No adhesion barrier administered. | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of Sites Adherent to the Uterus | The number of times an adhesion is attached to the uterus. | 8-12 weeks post myomectomy | 
| Mean Severity Score of Sites Adherent to the Uterus | The scoring for severity is as follows: 0=no adhesions, 1=filmy, avascular adhesions, 2=vascular and/or dense adhesions, and 3=cohesive adhesions. | 8-12 weeks post myomectomy | 
| Mean Extent Score of Sites Adherent to the Uterus | 0 =no adhesions, 1=covering <25% of locations' total area, 2=covering 26% to 50% of locations' total area, and 3=covering >51% of locations' total area. | 8-12 weeks post myomectomy | 
| Area of Sites Adherent to the Uterus (cm^2) |  | 8-12 weeks post myomectomy | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Adhesion, Fibroid, Myoma, Leiomyoma, Myomectomy