linjc16/ctgov huggingface dataset:
Impact of CYP3A4*1G Polymorphism on Non-analgesic Effects of Fentanyl in Chinese Han Patients

Study Overview
=================
Brief Summary
-----------------
Purpose: This study aimed to investigate the impact of CYP3A4*1G genetic polymorphism on non-analgesic effects of fentanyl in Chinese Han patients. Methods: 200 patients receiving elective surgery under general anesthesia were recruited into this study. Venous blood was withdrawn for genotyping of CYP3A4*1G before operation. Fentanyl 2 µg/kg was administered preoperatively. Bispectral Index (BIS), Respiratory rate(RR), etc at Tb (entering room), T0 (drug administration), T1 (2min), T2 (4min), T3(6min), T4(8min), T5(10min), T6(20min) were recorded.

Official Title
-----------------
Impact of CYP3A4*1G Polymorphism on Non-analgesic Effects of Fentanyl in Chinese Han Patients

Conditions
-----------------
Fentanyl

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: American Society of Anesthesiologists GradeⅠ-II,Patients undergo elective surgery for benign Reproductive diseases (including laparoscopic ovarian cyst removal, laparoscopic tubal ligation, laparoscopic tubal drainage, laparoscopic salpingoplasty, etc.) or breast disease. Aged 18-45 years Body Mass Index 18-25kg/m2,body weight 40-65 kilograms Agreed to participate the research Exclusion Criteria: Difficult airway upper respiratory tract infection within 2 weeks history of allergy or long-term use of propofol and opioids self-rating anxiety scale before operation indicates anxiety pregnancy or lactation.

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 45 Years

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

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| GG<br>wild-type homozygote (CYP3A4*1/*1, GG) | |
| GA<br>mutant heterozygote (CYP3A4*1/*1G, GA), | |
| AA<br>mutant homozygote (CYP3A4*1G/*1G, AA) | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| bispectral index | bispectral index(BIS): assessing the sedation, placed on the patient's forehead, BIS values 0-100, and the higher score means patients are more conscious | 20 min after administration | 
| respiratory rate | Number of breaths per minute | 20 min after administration | 
| CYP3A4*1G Polymorphism | The patients were classified by genotype including wild-type homozygote (CYP3A4*1/*1, GG), mutant heterozygote (CYP3A4*1/*1G, GA), and mutant homozygote (CYP3A4*1G/*1G, AA). | 1 week after operation |
New Tablet Containing Two FDA Approved Anti-HIV Drugs For Antiretroviral Therapy Experienced HIV-1 Infected Subjects

Study Overview
=================
Brief Summary
-----------------
A 48-week study to investigate the safety and effectiveness of a new compact formulation of two already FDA-approved anti-HIV drugs in subjects who have already been receiving treatment for their HIV infection.

Detailed Description
-----------------
A phase III, randomized, open-label, parallel, multicenter study to evaluate treatment with fixed-dose combination of abacavir/lamivudine (600mg/300mg) once-daily versus abacavir (300mg) twice-daily and lamivudine (300mg) once-daily in combination with tenofovir once-daily and a new PI or NNRTI for 48 weeks in ART-experienced HIV-1 infected patients.

Official Title
-----------------
See Detailed Description

Conditions
-----------------
Infection, Human Immunodeficiency Virus I, HIV Infection

Intervention / Treatment
-----------------
* Drug: abacavir/lamivudine
* Drug: abacavir
* Drug: lamivudine
* Drug: tenofovir


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Antiretroviral therapy (ART) experienced and currently receiving a stable regimen containing 3 nucleoside reverse transcriptase inhibitors (NRTIs), or 2 NRTIs plus a protease inhibitor (PI) or non-nucleoside reverse transcriptase inhibitors (NNRTI) for at least 3 months (there should be no significant ART modifications for at least 3 months and no ART change anticipated between Screening and initiation of the study therapy). Patients must be naive to tenofovir. HIV-1 RNA level > 1000 copies/ml on at least one occasion within 21 days of study entry. A CD4 cell count > 50 cells/mm3. Specified viral genotypes. Exclusion Criteria: Pregnant or breast-feeding women. Has an active diagnosis of AIDS. Additional qualifying criteria to be determined by the physician.

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


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: abacavir/lamivudine|nan|
|Drug: abacavir|nan|
|Drug: lamivudine|nan|
|Drug: tenofovir|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| HIV viral load response as measured by change from baseline in HIV-1 RNA over 24 and 48 weeks. Safety |  | 48 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Viral load response T-cell count Health Outcomes Resistance |  |  | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
HIV-1 Abacavir Lamivudine Tenofovir
Associations of Vitamin D Receptor ApaI and Tru9I Polymorphisms With the Risk of Primary Open-angle Glaucoma

Study Overview
=================
Brief Summary
-----------------
This study investigated whether vitamin D receptor gene polymorphism is altered in primary open-angle glaucoma subjects carrying the risk allele.Primary open-angle glaucoma patients and age-matched people in the Han population were enrolled. Vitamin D receptor polymorphic analysis was studied by polymerase chain reaction-restriction fragment length polymorphism technique.

Official Title
-----------------
Associations of Vitamin D Receptor Polymorphisms With the Risk of Primary Open-angle Glaucoma

Conditions
-----------------
Primary Open- Angle Glaucoma

Intervention / Treatment
-----------------
* Other: Vitamin D receptor polymorphic analysis


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: intraocular pressure greater than 22 mmHg with two or more medications wide anterior chamber angle glaucomatous optic neuropathy (Glaucomatous optic nerve damage was defined as cup-to-disc ratio higher than 0.7 or focal loss of the nerve fiber layer (notch) associated with a consistent glaucomatous visual field defect) visual field loss consistent with optic nerve damage and visual fields were performed by using standard automated perimetry Exclusion Criteria: the presence of any secondary glaucoma including exfoliation syndrome or a history of ocular trauma high myopia macular degeneration other ocular diseases a known history of systemic diseases and administration of vitamin D3 or other analog

Ages Eligible for Study
-----------------
Minimum Age: 55 Years
Maximum Age: 65 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 |
| --- | --- |
| primary open-angle glaucoma patients<br>vitamin D receptor polymorphic analysis was studied by real-time polymerase-chain reaction high resolution melting analysis in primary open-angle glaucoma patients. | Other: Vitamin D receptor polymorphic analysis<br> <br> |
| randomly age-matched people<br>vitamin D receptor polymorphic analysis was studied by real-time polymerase-chain reaction high resolution melting analysis in randomly age-matched people. | Other: Vitamin D receptor polymorphic analysis<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| gene polymorphisms of vitamin D receptor |  | 1 day visit |
Endoarterial Treatment in Combination With Percutaneous Thermoablation for Medium-sized and Oligonodular Hepatocellular Carcinomas

Study Overview
=================
Brief Summary
-----------------
Background: The association of transcatheter arterial chemotherapy infusion (TAC) with percutaneous ablation (PT) has been introduced as a method to increase the ablative zone. The aim of this study was to evaluate the efficacy of PT and TAC performed in a single session for HCCs between 30 and 50 mm or oligonodular up to 30 mm. Methods: Thirty patients with a histologically proven HCC, uninodular between 30 and 50 mm or oligonodular (n≤3) up to 30 mm, treatment-naïve and non-metastatic, received combination treatment (PT+TAC group). A control group consisted of 34 patients with uninodular HCC up to 30 mm without any poor prognostic criteria treated with PT alone (PT group).

Official Title
-----------------
Endoarterial Treatment in Combination With Percutaneous Thermoablation for Medium-sized and Oligonodular Hepatocellular Carcinomas

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

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: - hepatocellular carcinoma pouved by pathology, Exclusion Criteria: - metastases

Ages Eligible for Study
-----------------
Minimum Age: 19 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 |
| --- | --- |
| PT Group<br>patients with hepatocellular carcinoma treated by percutaneous thermoablation alone | |
| PT+TAC group<br>patients with hepatocellular carcinoma treated by pecutaneous thermoablation comined in a single session with trans-arterial chemoembolization | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| overall survival | death | 30 minutes | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| relapse free survival | relapse | 30 minutes | 
| tolerance | apparition of complication define by CTCAE v5.0 | 30 minutes |
Comparison of Scalp Microbiome of Healthy Women Wearing Hijab and Those Who do Not Wear Hijab

Study Overview
=================
Brief Summary
-----------------
An observational study was performed on 48 women wearing hijab and 48 women not wearing hijab to compare the scalp microbiome.

Detailed Description
-----------------
The scalp sample of all subjects was taken to be analyzed for its microbial diversity. The samples were processed with Next-Generation Sequencer and analyzed with bioinformatics analysis. The primary outcome was the characteristics of scalp microbiome

Official Title
-----------------
Comparison of Scalp Microbiome of Healthy Women Wearing Hijab and Those Who do Not Wear Hijab

Conditions
-----------------
Microbial Colonization, Scalp--Diseases

Intervention / Treatment
-----------------
* Procedure: Swab


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Healthy women Aged 18 years old or older who had not undergone menopause Consenting to the study Exclusion Criteria: Scalp and hair diseases (e.g. alopecia, trichotillomania, scalp infection, malignancy) Systemic diseases (diabetes mellitus, liver diseases, renal diseases, autoimmune diseases) Use of topical and oral antifungal agents Use of cytostatic agents Use of topical and oral antibiotics Use of topical and oral vitamin D Use of chemical products on hair (e.g. bleaching, permanent blow, hair coloring, hair straightener) Pregnancy Lactating Hypersensitivity towards basic ingredients of shampoo (e.g. synthetic detergent, conditioner, thickening agent).

Ages Eligible for Study
-----------------
Minimum Age: 18 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 |
| --- | --- |
| Hijab<br>Women wearing hijab whose scalp sample was taken for microbiome analysis | Procedure: Swab<br>* The scalp was swabbed with five strokes which were performed each in a vertical, horizontal, left diagonal, and right diagonal direction. The swab was moved back and forth for 10 times<br>|
| No hijab<br>Women not wearing hijab whose scalp sample was taken for microbiome analysis | Procedure: Swab<br>* The scalp was swabbed with five strokes which were performed each in a vertical, horizontal, left diagonal, and right diagonal direction. The swab was moved back and forth for 10 times<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Alpha diversity and beta diversity of scalp microbiome | The alpha and beta diversity of scalp microbiome which is generated by bioinformatics analysis from the sample processed with Next-Generation Sequencing | Up to 2 years | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
scalp, microbiome, hijab
Drug Use Investigation for Cell-culture Derived Influenza A (H1N1) Emulsion HA Vaccine

Study Overview
=================
Brief Summary
-----------------
This is to evaluate safety of cell-derived A/H1N1 influenza HA vaccine in healthy Japanese subjects.

Official Title
-----------------
Observational Study to Evaluate Safety of Cell-derived A/H1N1 Influenza HA Vaccine in Healthy Japanese Subjects

Conditions
-----------------
Swine-Origin Influenza A H1N1 Virus

Intervention / Treatment
-----------------
* Biological: Cell-derived A/H1N1 influenza HA vaccine


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: 1. Healthy Japanese Exclusion Criteria: The person has received any other company's new influenza vaccine (swine-derived A/H1N1) before vaccination with this product. The person has participated in any clinical study of this product or any other company's new influenza vaccine (swine-derived A/H1N1) and received the investigational vaccine. The person is regarded as a subject in one of the following items 3) to 6) who is not appropriate to receive preventive vaccination as described in the current package insert. The person shows obvious fever. The person obviously suffers from serious acute disease. The person has obviously shown anaphylaxis due to an ingredient of this vaccine. The person is otherwise in an inappropriate state to receive preventive vaccination.
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 |
| --- | --- |
| Healthy<br> | Biological: Cell-derived A/H1N1 influenza HA vaccine<br>* Single group vaccinated<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Evaluate clinical symptoms according to the subject background after vaccination |  | 28 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The kinds, degrees, durations and onset ratios of adverse events |  | 28 days | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Influenza A, H1N1 subtype, Vaccine, Adjuvant, Cell culture
Vitreo-papillary Traction as an Entity Identified by Optical Coherence Tomography (OCT).

Study Overview
=================
Brief Summary
-----------------
Optical Coherence Tomography (OCT) is a relatively new imaging technique in ophthalmology. This clear and documented imaging identified new diseases/ observations that were not previously known.

Detailed Description
-----------------
In ophthalmology vitreo-macular adhesion, vitreo-macular traction and posterior vitreous detachment were recognized entities for a long time. On the other hand vitreo-papillary adhesion/ traction is a fairly new concept in ophthalmology that became known after the use of OCT in ophthalmology imaging. Reasons, effects and ways of treatment of vitreo-papillary traction will take some time to evolve. The case study in which this traction was documented was initiated by an observation of a persistent, tiny single retinal hemorrhage above the optic disc of an eye. The patient was completely asymptomatic because of the vitreo-papillary traction but the OCT documentation of the case was so clear and striking.

Official Title
-----------------
OCT Documents Vitreo-papillary Traction

Conditions
-----------------
Tomography, Optical Coherence

Intervention / Treatment
-----------------
* Other: Optical Coherence Tomography (OCT)


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: any human subject that is found to have VPT by OCT. Exclusion Criteria: -

Ages Eligible for Study
-----------------
Minimum Age: 40 Years
Maximum Age: 90 Years

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

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

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

Arms and Interventions

| Intervention/Treatment |
| --- |
|Other: Optical Coherence Tomography (OCT)|Optical Coherence Tomography is a fairly new imaging technique in ophthalmology|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Tomography, Optical Coherence (OCT) | Vitreo-papillary traction (VPT) is a relatively new finding in ophthalmology that became very well known and documented by Optical Coherence Tomography (OCT) | through study completion, usually one day. |
Masimo O3 Regional Oximetry Device in Pediatric Patients Undergoing Cardiac Surgery

Study Overview
=================
Brief Summary
-----------------
We evaluate the relationship between the regional tissue oxygenation value (ScO2 - cerebral, StO2 - lower limb) and mixed venous saturation (SvO2) and arterial oxygen saturation (SaO2) measured before and after correction surgery in pediatric patients undergoing cardiac surgery. In addition, we compared the sCO2 and sTO2 with reference value which is calculated using SvO2 and SaO2.

Official Title
-----------------
Validation of Masimo O3 Regional Oximetry Device in Pediatric Patients Undergoing Cardiac Surgery

Conditions
-----------------
Pediatric Cardiac Surgery

Intervention / Treatment
-----------------
* Device: Masimo O3


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: children under 7 years old Exclusion Criteria: Hyperbilirubinemia Skin disease at sensor attachment site Single ventricle physiology

Ages Eligible for Study
-----------------
Maximum Age: 6 Years

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

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

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

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Children with congenital cardiac disease<br>Pediatric patients aged < 7 years undergoing cardiac surgery | Device: Masimo O3<br>* After anesthesia induction, a masimo O3 sensors are attached to the forehead (ScO2) and the sole of the foot (StO2). About 0.4 ml blood samples are obtained from arterial line and central venous line at three epochs before and after cardiopulmonary bypass (total 6 times) T1: before cardiopulmonary bypass (CPB), fraction of inspired oxygen (FiO2) 0.2 T2: before CPB, FiO2 0.5 T3: before CPB, FiO2 0.8 T4: after CPB, FiO2 0.8 T5: after CPB, FiO2 0.5 T6: after CPB, FiO2 0.2 Hemoglobin oxygen saturation values are confirmed in each sample (arterial sample: SaO2, venous sample: SvO2). Each O3 values (ScO2 and StO2) are compared to the values of SvO2, 0.7 × SvO2 + 0.3 × SaO2.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Validation of Masimo O3 value | Comparison of ScO2 and StO2 to reference level (SvO2, 0.7×SvO2 + 0.3×SaO2) | During surgery |
High Dose BAYA1040 CR: a Long Term Extension Study

Study Overview
=================
Brief Summary
-----------------
This is a clinical study evaluating the safety and efficacy of long term administration of oral BAYA1040 CR 80 mg/day (40 mg twice daily) in patients with essential hypertension for whom the test drug is tolerable during the 8 week double blind treatment phase of Study 13176.

Official Title
-----------------
A Multicenter, Open Label, Long Term Extension Study of Oral BAYA1040 CR 80 mg (40 mg Bid) for 44 Weeks in Patients With Essential Hypertension (Extension From Study 13176)

Conditions
-----------------
Hypertension

Intervention / Treatment
-----------------
* Drug: Nifedipine (Adalat, BAYA1040)


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients who complete the 8 week double blind treatment phase of Study 13176 and for whom the test drug is tolerable Exclusion Criteria: Patients with expected difficulties for the continuous 1 year follow up

Ages Eligible for Study
-----------------
Minimum Age: 20 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: Arm 1<br> | Drug: Nifedipine (Adalat, BAYA1040)<br>* BAYA1040 CR 40mg BID<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Safety variables will be summarized using descriptive statistics based on adverse events collection |  | Week 52 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Changes from baseline in diastolic blood pressure (DBP) while sitting |  | Baseline, week 10, 12, 16, 24, 28, 32, 36, 40, 44, 48 and 52 | 
| Changes from baseline in systolic blood pressure (SBP) while sitting |  | Baseline, week 10, 12, 16, 24, 28, 32, 36, 40, 44, 48 and 52 | 
| Proportion of subjects achieving a target BP based on the Japanese Society of Hypertension (JSH) 2009 guidelines |  | Baseline, week 10, 12, 16, 24, 28, 32, 36, 40, 44, 48 and 52 | 
| Proportion of subjects achieving a target DBP and SBP based on JSH 2009 guidelines or a >10 mmHg reduction of DBP |  | Baseline, week 10, 12, 16, 24, 28, 32, 36, 40, 44, 48 and 52 | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
BAYA1040 CR, Nifedipine, Essential hypertension, Japanese Patients, Phase III, Extension study