linjc16/ctgov huggingface dataset:
A Study to Investigate the Effect of Food on the PK, PD of CKD-381 in Healthy Volunteers

Study Overview
=================
Brief Summary
-----------------
A study to investigate the effect of food on the Pharmacokinetics and pharmacodynamics of CKD-381 in healthy volunteers

Detailed Description
-----------------
A randomized, open-label, single-dose, crossover study to investigate the effect of food on the pharmacokinetics and pharmacodynamics of CKD-381 in healthy volunteers

Official Title
-----------------
A Randomized, Open-label, Single-dose, Crossover Study to Investigate the Effect of Food on the Pharmacokinetics and Pharmacodynamics of CKD-381 in Healthy Volunteers

Conditions
-----------------
GERD

Intervention / Treatment
-----------------
* Drug: CKD-381


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Between 19 aged and 50 aged in healthy adult Body weight more than 55.0kg and body mass index over 18.0kg/m2 and under 30.0kg/m2 Have negative result on Helicobacter Pylori antibody test Exclusion Criteria: Have clinically significant disease that hepatobiliary system, kidney, nervous system, immune system, respiratory system, endocrine system, hemato-oncology disease, cardiovascular system or mental illness, or a history of mental disease. Have a gastrointestinal disease history(including surgery) that can effect evaluation of safety, pharmacokinetics and pharmacodynamics of investigational product. Hypersensitivity reaction or clinically significant hypersensitivity reaction in the history of investigational product, additives or benzimidazole family.

Ages Eligible for Study
-----------------
Minimum Age: 19 Years
Maximum Age: 50 Years

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: Crossover Assignment
Interventional Model Description: Crossover Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Sequence 1<br>Period 1: fasted condition/ Period 2: fed condition | Drug: CKD-381<br>* single-dose, oral administration of CKD-381 1 tablet<br>|
| Experimental: Sequence 2<br>Period 1: fed condition/ Period 2: fasted condition | Drug: CKD-381<br>* single-dose, oral administration of CKD-381 1 tablet<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Cmax | maximum observed concentration after dose | 0-24 hours | 
| AUClast | Area under the plasma concentration versus time curve over the dosing interval after dose | 0-24 hours | 
| Percent decrease from baseline in integrated gastric acidity for 24-hour interval after dose |  | 0-24 hours | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
CKD-381
E-Cigarettes and SNA

Study Overview
=================
Brief Summary
-----------------
Randomized controlled trial of electronic cigarettes with nicotine, without nicotine, and sham control, on sympathetic nerve activity and markers of oxidative stress.

Detailed Description
-----------------
Participants will use an electronic cigarette on 3 occasions: 1) with nicotine, 2) without nicotine, 3) sham control, and measures of autonomic tone, including heart rate variability (HRV) and sympathetic nerve activity (MSNA: microneurography), and oxidative stress will be measured pre and post exposure.

Official Title
-----------------
The Effects of Electronic Cigarettes on Sympathetic Nerve Activity and Oxidative Stress

Conditions
-----------------
Nicotine Dependence

Intervention / Treatment
-----------------
* Other: one time exposure to e-cig with nicotine
* Other: One time exposure to e-cigarette without nicotine
* Other: one time exposure to empty e-cigarette


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Healthy Exclusion Criteria: Cardiac disease Respiratory disease Diabetes mellitus

Ages Eligible for Study
-----------------
Minimum Age: 21 Years
Maximum Age: 45 Years

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

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

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

Design Details

Primary Purpose: Basic Science
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: nicotine<br>use of an e-cigarette filled with liquid with nicotine | Other: one time exposure to e-cig with nicotine<br>* one time exposure to e-cigarette vapor with nicotine<br>|
| Experimental: no nicotine<br>Use of an e-cigarette filled with liquid without nicotine | Other: One time exposure to e-cigarette without nicotine<br>* One time exposure to e-cig without nicotine<br>|
| Sham Comparator: sham comparator<br>Use of empty e-cigarette (sham control) | Other: one time exposure to empty e-cigarette<br>* one time exposure to empty e-cigarette (sham control)<br>* Other names: sham control;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Heart Rate variability | Heart rate variability is a measure of autonomic tone | 10 minutes after exposure | 
| Paraoxonase | plasma oxidative stress | less than 1 hour after exposure | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| muscle sympathetic nerve activity | Muscle sympathetic nerve activity (MSNA) | 10 minutes after exposure | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
nicotine, autonomic tone, oxidative stress
Optimum Misoprostol Dose Prior to Office Hysteroscopy

Study Overview
=================
Brief Summary
-----------------
Misoprostol is an effective agent for cervical priming before office hysteroscopy, vaginal route is the best, optimum dose not yet known.

Detailed Description
-----------------
The investigators will compare between 2 different doses of vaginal misoprostol, group (1) 200 ug, group (2) 400 ug, 3hours prior to office hysteroscopy , Infertile patient, patients with abnormal bleeding and patient with recurrent abortion Outcome measure: pain score, easiness of the procedure, procedure time, complications

Official Title
-----------------
The Optimum Dose of Vaginal Misoprostol Prior to Office Hysteroscopy: Double Blind Randomized Controlled Trial

Conditions
-----------------
Infertility, Abnormal Uterine and Vaginal Bleeding, Unspecified, Recurrent Abortion

Intervention / Treatment
-----------------
* Drug: Misoprostol
* Drug: Misoprostol


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Female patient pre- or postmenopausal undergo office hysteroscopy. Age: from 20 to 60. BMI between 18 and 30. Exclusion Criteria: PID or Heavy uterine bleeding Cervical malignancy. Symptoms suggestive of endometriosis . Any cervical abnormality such as pinhole cervix that would obviate passage of a catheter through the cervix.

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 55 Years

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

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: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Misoprostol vaginally, 200 ug<br>200 ug misoprostol in the posterior vaginal fornix | Drug: Misoprostol<br>* 200 ug<br>|
| Active Comparator: Misoprostol vaginally, 400ug<br>Misoprostol in the posterior vaginal fornix | Drug: Misoprostol<br>* Misoprostol vaginally, 400 ug<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pain score | Pain score by VAS | 1year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Easiness | ease of entry of the office hysteroscopy into the cervix recorded on a 5-point Likert scale: very difficult= 1, difficult = 2, fair = 3, easy = 4, and very easy = 5; | 1year | 
| Duration of the procedure | Duration of hysteroscopy in seconds | 1year | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Office hysteroscopy, Cervical priming, Misoprostol
Methylation Effects of COV-19 Infection and Vaccinations

Study Overview
=================
Brief Summary
-----------------
This is a retrospective non-randomized clinical study of 60 patients total to assess the effects of SARS-CoV-2 infection and the SARS-CoV-2 vaccination. This study will have 2 arms evaluating the epigenomes of patients pre and post-exposure to one of the interventions. The first arm of the study will analyze 40 patients' epigenomes whose DNA methylation was examined pre and post SARS-CoV-2 infection. The second arm of this study is analyzing 20 patients' epigenomes whose DNA methylation was examined pre and post-injection of the SARS-CoV-2 vaccine.

Official Title
-----------------
Measuring the DNA Methylation Effects From COVID-19 Infection and COVID-vaccinations

Conditions
-----------------
Covid19

Intervention / Treatment
-----------------
* Biological: SARS-CoV-2 mRNA vaccine


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Subjects that are healthy individuals and of any sex, ethnicity, and anyone above the age of 18 years old.

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

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Patients infected with SARS-CoV-2<br>The first part of this study looks at the methylation patterns in individuals who have a baseline test taken of their DNA methylation patterns in their epigenome and then a follow-up test after they contracted SARS-CoV-2 | |
| Patients who have received an mRNA vaccination<br>The second part of the study looks at the methylation patterns in individuals who have a baseline test taken of their DNA methylation patterns in their epigenome and then a follow-up test after SARS CoV-2 mRNA vaccine injection. | Biological: SARS-CoV-2 mRNA vaccine<br>* mRNA vaccine for COVID<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Methylation age clock testing | The DNA clocks that will be used to precisely measure aging is TruAge Biological Age test, which estimates biological age vs. chronological age | Change from baseline after COVID-19 infection | 
| Methylation age clock testing | The DNA clocks that will be used to precisely measure aging is TruAge Biological Age test, which estimates biological age vs. chronological age | Change from baseline after COVID-19 mRNA vaccination | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Overall state of health | Questionnaire assessing overall health | Change from baseline after COVID-19 infection | 
| Overall state of health | Questionnaire assessing overall health | Change from baseline after COVID-19 mRNA vaccination |
Expanded Access to Risankizumab

Study Overview
=================
Brief Summary
-----------------
This is an expanded access program (EAP) for eligible participants with Crohn's Disease (CD). This program is designed to provide access to risankizumab, prior to approval by the local regulatory agency, to patients with the highest unmet need and an urgent need for treatment, where risankizumab may prolong survival, prevent occurrence of clinical events associated with significant morbidity and/or mortality, or stabilize a progressive debilitating disease. Availability will depend on a review of the eligibility of the patient and local approval status of risankizumab for CD. A medical doctor must decide whether the potential benefit outweighs the risk of receiving an investigational therapy based on the individual patient's medical history and program eligibility criteria.

Official Title
-----------------
Expanded Access to Risankizumab

Conditions
-----------------
Crohn's Disease, Ulcerative Colitis (UC)

Intervention / Treatment
-----------------
* Drug: Risankizumab


Participation Criteria
=================

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


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

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

Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: Risankizumab|Tablet|

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
-----------------
Expanded Access, Pre-approval Access, Compassionate Use, Special Access Program, Named Patient Basis, Special Access Scheme
Laryngeal Mask Airway With Video-stylet

Study Overview
=================
Brief Summary
-----------------
In this randomized controlled trial, we aimed to compare the efficacy of video-stylet guided laryngeal mask airway real time insertion technique with the standard recommended index finger-guided insertion technique in pediatric patients.

Detailed Description
-----------------
Compare the efficacy and safety of using video-stylet guided laryngeal mask airway insertion with blind technique

Official Title
-----------------
Video Stylet Guided Laryngeal Mask Airway Insertion in Pediatrics: a Randomized Controlled Trial

Conditions
-----------------
Anesthesia; Functional

Intervention / Treatment
-----------------
* Device: Laryngeal mask insertion with videostylet guided technique
* Device: Laryngeal mask insertion with standard blind technique


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: pediatric patients undergoing general anesthesia using laryngeal mask airways Exclusion Criteria: recent (within 2 weeks) upper respiratory infection

Ages Eligible for Study
-----------------
Minimum Age: 2 Years
Maximum Age: 6 Years

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

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

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

Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Videostylet<br>Laryngeal mask airway insertion using video stylet guided technique | Device: Laryngeal mask insertion with videostylet guided technique<br> <br> |
| Active Comparator: Blind<br>Laryngeal mask insertion using standard index finger-guided technique | Device: Laryngeal mask insertion with standard blind technique<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| the time required for inserting the laryngeal mask airways |  | time interval between the caregiver picked up and put down the laryngeal mask airway an expected average of 30 seconds | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| the numbers of insertion attempt |  | interval between the caregiver picked up and put down the laryngeal mask airway an expected average of 30 seconds |
Uterus Transplantation LD - Feasibility Study - Sahlgrenska - BMC

Study Overview
=================
Brief Summary
-----------------
Medical know-how concerning uterus transplantation will be transferred to new site by structured process involving theory, animal workshops and a clinical feasibility study on human subjects.

Detailed Description
-----------------
Medical know-how concerning uterus transplantation will be transferred to new site by structured process involving theory, animal workshops and surgery. Theory and common animal workshops have been ongoing for 3 years. The team from Bellevue Medical Centre is affiliated to St Joseph, University, Beirut

Official Title
-----------------
Uterus Transplantation LD - Feasibility Study - Sahlgrenska - Bellevue Medical Centre

Conditions
-----------------
Mrk Anomaly, Infertility, Female

Intervention / Treatment
-----------------
* Procedure: uterus transplantation surgery and IVF


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion criteria recipient age < 38 years psychologicaly stable BMI < 35 no systemic disease no standing medication in a stable relationship or married normal ovarian reserve absolute uterine factor infertility normal kidney function Inclusion criteria donor close relative to recipient age < 60 years normal pregnancies maximum two cesarean sections BMI < 35 no major systemic disease no previous major surgery

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 60 Years

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

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

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

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: uterus transplantation<br>uterus transplantation from living donor with the donor being close relative | Procedure: uterus transplantation surgery and IVF<br>* IVF before surgery living donor uterus transplantation ET<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| live birth | live birth | 3 years | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
uterus, infertility, transplantation
Efficacy of Ventavis Used in Real-life Setting.

Study Overview
=================
Brief Summary
-----------------
This is a registry of patients diagnosed with pulmonary arterial hypertension, scheduled for treatment with Ventavis. Typical clinical measures and quality of life will be prospectively followed in 12 months period.

Official Title
-----------------
The Efficacy of Inhaled Iloprost in Patients Treated Within the Pulmonary Arterial Hypertension Therapeutic Programme.

Conditions
-----------------
Pulmonary Arterial Hypertension

Intervention / Treatment
-----------------
* Drug: Inhaled iloprost (Ventavis, BAYQ6256)


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Pulmonary arterial hypertension in WHO functional class III or IV Age 18+ Patients newly treated with Ventavis or switched from sildenafil Exclusion Criteria: Retrospective documentation is not allowed

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 |
| --- | --- |
| Group 1<br>Drug (incl. Placebo) | Drug: Inhaled iloprost (Ventavis, BAYQ6256)<br>* Patients treated with inhaled iloprost (Ventavis) 2.5 or 5 micrograms 6-9 times daily<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Changes of the exercise capacity as measured by 6-minutes walking distance |  | 3, 6, 9 and 12 months vs. baseline | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Changes of depression score over time |  | 3, 6, 9 and 12 months vs. baseline | 
| Changes of functional capacity as measured by WHO classification system |  | 3, 6, 9 and 12 months vs. baseline | 
| Changes of pulmonary haemodynamics |  | 3, 6, 9 and 12 months vs. baseline | 
| Changes of serum level of natriuretic peptide B |  | 3, 6, 9 and 12 months vs. baseline | 
| Changes of Quality of Life score |  | 3, 6, 9 and 12 months vs. baseline | 
| Changes in cardiac echo parameters |  | 3, 6, 9 and 12 months vs. baseline | 
| Number of patients with treatment-emergent adverse events |  | Up to 12 months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Pulmonary arterial hypertension, Inhaled iloprost, Quality of life
Periodontal Infection and Prematurity Study

Study Overview
=================
Brief Summary
-----------------
This research project is a multi-center double-blind, parallel, randomized, controlled clinical trial design comparing the efficacy of dental scaling and root planing to control treatment (superficial cleaning) for the prevention of preterm birth in pregnant women with periodontal disease.

Official Title
-----------------
Periodontal Infection and Prematurity Study

Conditions
-----------------
Periodontal Diseases, Premature Birth

Intervention / Treatment
-----------------
* Procedure: Scaling and root planing


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Gestational age between 6 and 20 completed weeks Exclusion Criteria: Periodontal treatment during the pregnancy Antibiotic use within 2 weeks of enrollment Use of antimicrobial mouthwash within 2 weeks Multiple gestation Known mitral valve prolapse
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: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 1<br> | Procedure: Scaling and root planing<br>* Scaling and root planing<br>|
| Placebo Comparator: 2<br> | Procedure: Scaling and root planing<br>* Scaling and root planing<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Whether screening and treating periodontal disease using scaling and root planing early in pregnancy can reduce the incidence of spontaneous preterm birth <35 weeks |  | 9 months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Dental scaling