linjc16/ctgov huggingface dataset:
Sleep-disordered Breathing After Solid Organ Transplantation

Study Overview
=================
Brief Summary
-----------------
Sleep-disordered breathing (SDB) describes a group of disorders in which partial or complete cessation of breathing occurs many times throughout the night, resulting in daytime sleepiness or fatigue that interferes with a person's ability to function and reduces quality of life. Transplantation has become an important treatment modality for end-stage organ failure. Transplant recipients are now living longer and, hence, develop chronic adverse medical conditions. Furthermore, transplantation is associated with weight gain. Despite the high prevalence of poor sleep and cardiovascular conditions among transplant patients, SDB is not well studied in these patients.

Detailed Description
-----------------
The primary research objective is to evaluate the prevalence, incidence and type (central or obstructive) of SDB in patients after lung transplantation. Secondary research objectives are the evaluation of correlations between severity of SDB and clinical findings (weight, medical therapy, heart function, lung function, renal function, graft failure, …). Furthermore, the investigators will evaluate the relationship between SDB and cardiovascular morbidity.

Conditions
-----------------
Lung Transplantation, Sleep-disordered Breathing

Intervention / Treatment
-----------------
* Other: No intervention - Diagnostic polysomnography at 1 year after lung transplantation


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients 1 year after lung transplantation Exclusion Criteria: Refusal of PSG Medical contra-indication to perform PSG

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 |
| --- | --- |
| SDB and lung transplantation<br>Polysomnography at 1 year after lung transplantation. | Other: No intervention - Diagnostic polysomnography at 1 year after lung transplantation<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of participants with SDB and type (central or obstructive) of SDB | Prevalence of different types of SDB after lung transplantation | 1 year after lung transplantation | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Echocardiography | Correlations between SDB and heart function | 1 year after lung transplantation | 
| Lung function measurement | Correlations between SDB and lung function | 1 year after lung transplantation | 
| Blood analysis | Correlations between SDB and renal function | 1 year after lung transplantation | 
| 24h blood pressure | Evaluation of relationship between hypertension and SDB | 1 year after lung transplantation |
Sun Protection Factor Assay

Study Overview
=================
Brief Summary
-----------------
To evaluate the Sun Protection Factor efficacy on human skin.

Official Title
-----------------
Sun Protection Factor (SPF) Assay, UVA Protection Factor Assay (UVAPF), Minimal Persistent Pigment- Darkening Dose (MPPD)

Conditions
-----------------
Sunscreening Agent

Intervention / Treatment
-----------------
* Drug: Coppertone (BAY987517)


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Fitzpatrick Skin Type l, ll and/or lll for UVB testing. Fitzpatrick Skin Type ll, lll and/or lV for UVA testing. Male and female Aged between 18-70 years old. Good health as determined from the HRL SHF(Self History Form) Signed and dated Informed Consent Form Signed and dated HIPAA (Health Insurance Portability and Accountability Act) Form An unbAmbiguous MED (Minimal Erythema Dose) or MPPD (Minimal Persistent Pigment Darkening Dose) Exclusion Criteria: Subjects on test at any other research laboratory or clinic. Known allergy or sensitivity to sunscreens, cosmetics and toiletries, topical drugs and/or ultraviolet light. Pre-existing dermatologic conditions which have been diagnosed by a medical professional (e.g. psoriasis, eczema, etc.) which would interfere with this study. Pre-existing other medical conditions (e.g. adult asthma. diabetes). Treatment with antihistamines or corticosteroids within one week prior to initiation of the test. Treatment with antibiotics within two weeks prior to initiation of the test. Chronic medication which could affect the results of the study. Known pregnant or nursing women.

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 70 Years

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

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: BAY987517<br>Each test site area is divided into test subsite areas that are approximately at least 0.5 cm*2. The application of test material is 2 mg/cm*2. Thus, each 50 cm*2 test site area of a subject requires 100 mg of a test material to obtain a standard 2 mg/cm*2 test application. | Drug: Coppertone (BAY987517)<br>* Each 50 cm*2 test site area of a subject requires 100 mg of a test material to obtain a standard 2 mg/cm*2 test application.(Formulation Number - SR15-47-Z13-076)<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Minimal Erythema Dose (MED) |  | Up to 15 minutes | 
| Minimal Persistent Pigment Darkening Dose (MPPD) |  | Up to 15 minutes |
Digital Image Correlation in Right Ventricular Evaluation

Study Overview
=================
Brief Summary
-----------------
Observational study of patients undergoing open heart surgery. During the procedure video clips of right heart are stored and compared to trans-oesophageal ultrasound recordings and ECG recordings.

Detailed Description
-----------------
Observational study of patients undergoing open heart surgery. During the procedure video clips of right heart are stored and compared to trans-oesophageal ultrasound recordings and ECG recordings. Right heart volume status and function is controlled and induced with theophylline and ventilator regulated positive end-expiratory pressure recordings.

Official Title
-----------------
Digital Image Correlation in Right Ventricular Evaluation in Cardiac Surgery

Conditions
-----------------
Heart Ventricles

Intervention / Treatment
-----------------
* Drug: Theophylline
* Procedure: Ventilator positive end expiratory pressure adjustment
* Device: Videorecording


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: open heart surgery, patient acceptance and informed consent, age 75 or more Exclusion Criteria: patient refusal, psychiatric disorder or intoxication, irrepairable coronary artery disease, epilepsy or active neurological condition, active tbc or other contagious infection.

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

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

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

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

Design Details

Primary Purpose: Device Feasibility
Intervention Model: Single Group Assignment
Interventional Model Description: Patients undergo medication intervention (w/intravenous theophylline) and ventilator volume adjustements, and serial ventricular function parameters are compared (pre-and post-intervention measurements).
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Study group<br>Patients undergo procedure with stepwise measurements and ventilator + volume adjustment + iv theophylline Myocardial movement recording using videoscanning | Drug: Theophylline<br>* iv injection<br>Procedure: Ventilator positive end expiratory pressure adjustment<br>* Positive end-expiratory pressure variation<br>Device: Videorecording<br>* Myocardial movement videorecording<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Heart ventricle function | Changes in heart ventricle contraction status | Within the operation |
Assessment of Ultrasound-guided Inserted Peripheral Intravenous Catheter

Study Overview
=================
Brief Summary
-----------------
Evaluate the safety and efficacy of an an ultrasound-guided inserted peripheral intravenous catheter during a period of seven days.

Official Title
-----------------
A Clinical Assessment of an Ultrasound-guided Inserted Peripheral Intravenous Catheter

Conditions
-----------------
Venous Puncture

Intervention / Treatment
-----------------
* Procedure: peripheral venous puncture


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Hospitalized patients with need of an intravenous therapy on peripheral line Unsuccessful attempts at establishing a peripheral intravenous line by nurse Age over 18 YO Written informed consent obtained Exclusion Criteria: pregnant woman local contra-indication for venous puncture unconscious patient need of intravenous therapy requiring central line

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

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: one intervention arm<br> | Procedure: peripheral venous puncture<br>* Ultrasound imaging of the arm is performed. If a suitable vein is identified, a percutaneous puncture is performed under ultrasound guidance. Then, an intravenous catheter is inserted according Seldinger method.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| length of use of the catheter measured in number of days |  | seven days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| adverse event during the period of use of the catheter | extravasation and/or catheter removal before the end of the treatment and/or local complications (bleeding, neurologic trouble, venous thrombosis..) | seven days | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
venous puncture, seldinger technique, ultrasound guidance
Assessment of the Impact of Acquisition Time, Respiratory Gating and New Qclear Reconstruction Modalities on the Quantification of Dosimetry in Selective Internal Radiotherapy

Study Overview
=================
Brief Summary
-----------------
Post-processing of Positron Emission Tomography (PET) acquired images, performed following radioembolization treatment with microspheres at 90Y in hepatocellular carcinoma patients, is subject to changes commercialized by General Electric : respiratory motion correction, specific reconstruction algorithms. We propose to test the possible combinations of these reconstruction parameters to determine which ones to apply for an optimal quality exam with the shortest scan time possible

Official Title
-----------------
Assessment of the Impact of Acquisition Time, Respiratory Gating and New Qclear Reconstruction Modalities on the Quantification of Dosimetry in Selective Internal Radiotherapy

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

Intervention / Treatment
-----------------
* Procedure: PET/CT Exam


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: patient with hepatocellular carcinoma with radioembolization treatment decided over the age of 18 Exclusion Criteria: radiembolization not possible acquisition of PET/CT imaging at 90Y not possible

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 |
| --- |
|Procedure: PET/CT Exam|PET/CT image processing application of reconstruction parameters: scan time, respiratory gating, Q-clear|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Average dose value (Gy) of tumor liver and healthy liver obtained according to reconstruction configuration. |  | Day 0 (PET/CT Exam) |
Clostridioides Difficile Infection - a Prospective Nationwide Epidemiologic Study in Korea

Study Overview
=================
Brief Summary
-----------------
Our objective of this study is to derive a real incidence of CDI in tertiary hospitals located through Korean peninsula. In order to get a close value to the truth, the study is planned to co-perform with a national study which was proposed in evaluation process to include more hospitals. Along with the incidence of CDI, clinical characteristics and outcome of CDI will be examined and microbiologic characteristics of C. difficile isolates from CDI patients are studied.

Official Title
-----------------
Clostridioides Difficile Infection - a Prospective Nationwide Epidemiologic Study in Korea

Conditions
-----------------
Clostridium Difficile Infection

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: aged older than 19 years more than 3 times of unformed stools passage per day positive results of toxin gene test: GDH (+) + PCR (+), GDH (+) + toxin (+), or PCR (+) + toxin (+) agree with informed consent Exclusion Criteria: less than 3 times of unformed stool passage per day use of oral metronidazole or vancomycin more than 24 hours before enrollment use of laxative before enrollment recurrent episode of CDI disagree with study protocol

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

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

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

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| incidence of CDI | Incidence of CDI among hospitalized adults per 100,000 patient*days/10,000 patient*admission in enrolled tertiary hospitals. | through Oct 2020 to Dec 2021 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| mortality rate | Proportion of CDI cases who died during the 60-day follow-up period | through Oct 2020 to May 2022 | 
| recurrence rate | Proportion of CDI cases with recurrence/reinfection between Day 14 and Day 60 | through Oct 2020 to May 2022 | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
clostridium difficile, incidence
The Circadian Rhythm of Urine Output in Healthy Infants

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to describe the 24-hour urine output including the urinary excretion of hormones, electrolytes and other osmotically active substances in healthy children age 0 to 3 years old.

Detailed Description
-----------------
The purpose of this study is to describe the 24-hour urine output including the urinary excretion of hormones, electrolytes and other osmotically active substances in healthy children age 0 to 3 years old.

Official Title
-----------------
The Circadian Rhythm of Urine Output in Healthy Infants

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

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Healthy children, free of medication Exclusion Criteria: History of urinary diseases

Ages Eligible for Study
-----------------
Minimum Age: 6 Days
Maximum Age: 3 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 |
| --- | --- | --- |

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
urine, circadian rhythm
Study the Effects of CYP2C Polymorphisms on the Pharmacokinetics and Pharmacodynamics of Glipizide

Study Overview
=================
Brief Summary
-----------------
The aims of this study were to investigate the effects of CYP2C9 and CYP2C19 polymorphisms on the pharmacokinetics and pharmacodynamics of glipizide in healthy Chinese subjects.

Detailed Description
-----------------
Compared with CYP2C19, CYP2C9 polymorphism appears to have a dominant role in glipizide pharmacokinetics and pharmacodynamics in vivo. This indicated that dose adjustment based on CYP2C9 genotype may improve antidiabetic treatment.

Official Title
-----------------
Study the Effects of CYP2C9 and CYP2C19 Polymorphisms on the Pharmacokinetics and Pharmacodynamics of Glipizide in Healthy Chinese Subject

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

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: nonsmokers and in good health Exclusion Criteria: family history of diabetes mellitus taking any drug, alcohol, foods containing caffeine, or grapefruits and juice before study

Ages Eligible for Study
-----------------
Minimum Age: 21 Years
Maximum Age: 27 Years

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

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| 1<br>CYP2C9*1/*1 and CYP2C19*1/*1 alleles carrier | |
| 2<br>CYP2C19 PMs (CYP2C19*2/*2, CYP2C19*2/*3 or CYP2C19*3/*3) | |
| 3<br>CYP2C9*1/*3 and CYP2C19*1/*1 alleles carrier | |

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
-----------------
genotype
Dexmedetomidine for Continuous Sedation

Study Overview
=================
Brief Summary
-----------------
The study aims to demonstrate that dexmedetomidine is non-inferior to current best practice sedation with propofol/midazolam and daily sedation stops, in maintaining a target depth of sedation in long-stay intensive care unit (ICU) patients, and that dexmedetomidine, compared with current best practice, reduces the length of ICU stay.

Official Title
-----------------
A Prospective, Multi-Centre, Randomised, Double-Blind Comparison of Intravenous Dexmedetomidine With Propofol/Midazolam for Continuous Sedation (24 Hours to 14 Days) of Ventilated Patients in Intensive Care Unit

Conditions
-----------------
Conscious Sedation

Intervention / Treatment
-----------------
* Drug: Dexmedetomidine


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Clinical need for sedation and mechanical ventilation Receiving full intensive care life support Expected stay in ICU of at least 48 hours (h) from time of admission Expected requirement for sedation of at least 24h from time of randomisation Written informed consent within 36h of ICU admission Exclusion Criteria: Acute severe neurological disorder Acute uncompensated circulatory failure at time of randomisation Severe bradycardia Atrioventricular (AV) conduction block (II-III) unless pacemaker fitted Severe hepatic impairment Need for muscle relaxation at time of randomisation Loss of hearing or vision or any condition interfering significantly with RASS assessment Positive pregnancy test or currently lactating

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: Double


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: Dexmedetomidine|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Proportion of time during sedative infusion with a Richmond Agitation Sedation Scale (RASS) score within the individually-prescribed target range |  |  | 
| Time from ICU admission to discharge |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Nurse's assessment of subject communication |  |  | 
| Duration of mechanical ventilation, weaning time and ventilator-free days in ICU |  |  | 
| Length of total hospital stay |  |  | 
| Functional recovery during hospitalisation |  |  | 
| Need for rescue medication to maintain sedation |  |  | 
| Frequency of delirium |  |  | 
| Frequency of organ failures and failure-free days |  |  | 
| Frequency of critical illness polyneuropathy |  |  | 
| ICU- and in-hospital survival |  |  | 
| Cost of care in the ICU |  |  | 
| Total cost of hospitalisation |  |  | 
| Blood levels of dexmedetomidine seen with long-term treatment |  |  |