linjc16/ctgov huggingface dataset:
Descriptive Epidemiology of Clostridium Difficile Infection in Hospitalized Adult Patients in the Asia Pacific Region

Study Overview
=================
Brief Summary
-----------------
Clostridium difficile is an important pathogen, causing disease that ranges from mild self-limited diarrhea to life-threatening pseudomembranous colitis. It is estimated that C. difficile is responsible for 10% to 25% of all cases of antibiotic-associated diarrhea and for almost all cases of pseudomembranous colitis. C. difficile disease is mediated by two large toxins, A and B. The toxins damage intestinal epithelial cells and cause the clinical illness. Primary risk factors for C. difficile clinically apparent infection include antimicrobial therapy, hospitalization, residence in a long-term care facility, older age (≥ 65 years), and increased length of hospital stay. The incidence of CDI both in the hospital and the community is important in the understanding and characterization of the disease and its prevention. This observational, epidemiological study will advance the investigators understanding of CDI risk factors in several hospitals and possibly the community in the Asia Pacific region.

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

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Adult patients, aged ≥ 20 years at the time of hospitalization in specified wards PCR-diagnosed CDI while at the hospital Informed consent has been obtained from patients as required by local requirements Exclusion Criteria: Age < 20 years

Ages Eligible for Study
-----------------
Minimum Age: 20 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 |
| --- | --- |
| Laboratory (PCR)-confirmed C.difficile infection<br>patient who has experienced the passage of 3 or more unformed or loose stools [diarrhea] conforming to the shape of a container within a 24-hour period and has a positive laboratory test result confirmed by PCR. | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To estimate the incidence of laboratory-confirmed hospital-onset CDI cases for hospitalized adult patients | A laboratory-confirmed CDI case is defined as a patient who has experienced the passage of 3 or more unformed or loose stools [diarrhea] conforming to the shape of a container within a 24-hour period and has a positive laboratory test result confirmed by PCR. A hospital onset case is defined as a patient with diarrhea more than 48 hours after admission to a hospital. The study period is the study duration, which is defined as the first date of surveillance at each hospital until the sample collection date of the last CDI positive patient (N=100). | every 5 days after consented to enroll the exam |
Deployment of Functional Optical Brain Monitor [fNIR] in Clinical Anesthesia

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to determine whether or not a new brain function monitor can distinguish between anesthetized and awake patients. The device implemented utilizes functional near-infrared (fNIR) technology to detect anesthesia depth as well as reaction to stimuli during surgical procedure. After obtaining consent the device is placed across the forehead of the patient. A baseline signal is obtained prior to induction. The fNIR signal is continuously recorded throughout the procedure. Key events as well as administration of drug are recorded in order to observe changes in the signal trend. Neither the device nor the light emitted is hazardous to the patient - no risks or discomforts are involved.

Official Title
-----------------
Deployment of Functional Optical Brain Monitor [fNIR] in Clinical Anesthesia

Conditions
-----------------
Surgical Procedures, Operative

Intervention / Treatment
-----------------
* Device: fNIR light emitting and sensing device


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: All patients who will have surgery 18-80 years old No restrictions on gender, race, or religion Exclusion Criteria: Head and face surgery Induced hypotension Profound anemia Scar/tattoo on forehead Prior history of frontal lobe surgery Hemoglobinopathies Patients not undergoing general anesthesia Surgeries in the prone position Allergy to adhesive tape

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 80 Years

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

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

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

Design Details

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


Arms and Interventions

| Intervention/Treatment |
| --- |
|Device: fNIR light emitting and sensing device|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| This is a proof of concept study, primary outcome measure includes observation and calculation of causal relationships of oxygenated and de-oxygenated hemoglobin during administration of anesthetic. |  |  | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
No specific disease is being studied, few procedures are excluded., The focus of the study is to rule out the efficacy of the device, so the aim is to include as wide a variety of procedures as possible.
Long Term Effect of Somatropin in Subjects With Intrauterine Growth Retardation

Study Overview
=================
Brief Summary
-----------------
This trial is conducted in Europe. The aim of this trial is to assess the safety of long-term growth hormone treatment in growth-retarded children with intrauterine growth retardation (IUGR) enrolled in trial GHRETARD/F/1/F.

Official Title
-----------------
Discontinued Administration (6 Months a Year) of Growth Hormone to Children With Very Short Stature and Having Suffered From Intrauterine Growth Retardation: Safety and Effect on Growth of Long-term Therapy

Conditions
-----------------
Foetal Growth Problem, Small for Gestational Age

Intervention / Treatment
-----------------
* Drug: somatropin
* Drug: somatropin
* Drug: somatropin


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients born with IUGR enrolled in trial GHRETARD/F/1/F Bone age below 14 years in boys and 12 years in girls Exclusion Criteria: Bone age above 14 years in boys and 12 years in girls
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

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 1.2, continuous treatment<br> | Drug: somatropin<br>* 1.2 IU/kg/week, one injection per day, in six days out of seven days, for 12 months<br>|
| Experimental: 1.2, non-continuous treatment<br> | Drug: somatropin<br>* 1.2 IU/kg/week, one injection per day, in six days out of seven days, for 6 months out of 12 months (i.e. alternating periods of 6 months of treatment and non-treatment, respectively)<br>|
| Experimental: 2.4, non-continuous treatment<br> | Drug: somatropin<br>* 2.4 IU/kg/week, one injection per day, in six days out of seven days, for 6 months out of 12 months (i.e. alternating periods of 6 months of treatment and non-treatment, respectively)<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Glucose tolerance as assessed by hyperglycaemia induced by oral ingestion |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Bone Age determined according to Greulich and Pyle method and measured on the left hand X-ray |  |  | 
| Pubertal development, assessed according to Tanner method |  |  | 
| Height velocity |  |  | 
| Final height |  |  | 
| Number of Adverse Events |  |  |
Biometry of Occult Lens Subluxation Misdiagnosed as Primary Acute Angle Closed Glaucoma

Study Overview
=================
Brief Summary
-----------------
In this work, we evaluated the biometry data of lens subluxation inducing acute angle closure which were misdiagnosed as primary angle closure at the first visit, and compared with the data of chronic angle closure glaucoma, cataract, primary acute angle closure.

Official Title
-----------------
Biometric Indicators of Eyes With Occult Lens Subluxation

Conditions
-----------------
Subluxation of Lens

Participation Criteria
=================
Eligibility Criteria
-----------------
ASAC-LS was diagnosed according to the following criteria, including sudden pain in the eye, decreased vision with or without nausea and vomiting. Slit lamp microscopy reveals phacodonesis, lens inclination or vitreous herniation into the anterior chamber, central and peripheral shallow anterior chamber, and asymmetric iris bulge. All patients were confirmed during the surgery to have LS. APACG was diagnosed with the following criteria6, 7 8, including substantially elevated IOP and closed angle, acute eye pain, blurred vision, or nausea and vomiting. More importantly, ischemic injury caused by acute ocular hypertension, ciliary or mixed congestion, corneal edema, and glaucoma flecks should be detected. The diagnostic criteria of CPACG included narrow angle with anterior synechiae of varying widths, IOP > 22 mmHg, and glaucomatous optic disc damage and visual field shrinkage9-11 The angle closure should be more than two quadrants, yet there was no ischemic injury in the anterior segment caused by acute ocular hypertension. Exclusion criteria were history of laser peripheral iridotomy or peripheral iridectomy, glaucoma filtration surgery, angle closure caused by ocular trauma, uveitis, neovascularization or lens swelling or hyper mature lens. The patients with acute angle closure in both eyes were excluded. The subjects in which Lenstar LS900 examination could not be performed because of severe lens opacity or corneal edema were also not included in the study.
Sexes Eligible for Study
-----------------
All

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Acute primary angle closure<br> | |
| Acute secondary angle closure induced by LS<br> | |
| Cataract<br> | |
| Primary chronic angle closed glaucoma<br> | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Eye anterior segment biometry | Anterior segment biometry measure by Lenstar LS900 | 1 day | 
| Intraocular pressure | Intraocular pressure was measured by Goldmann tonometer | 1 year | 
| visual acuity | visual acuity before and after surgery | 1 year |
Czech Anesthesia Day 2019

Study Overview
=================
Brief Summary
-----------------
Czech Anesthesia Day 2019 was designed as a prospective observational trial with the aim to evaluate the current anesthesiology practice in Czech Republic.

Detailed Description
-----------------
Anesthesiology centers in Czech Republic was screened for cooperation during the year 2018. Data from centers with previously confirmed cooperation will be screened and filled into the electronic database. The basic information about the centre, patient´s demography, American Society of Anesthesiologist classification (ASA), type of surgery/anesthesia, airway management, type of anesthesia induction, drugs for anesthesia induction a and anesthesia maintenance, used monitors of vital signs and functions, type and amount of infusions, temperature management, intravenous lines management, patient blood management, mechanical ventilation settings and postoperative admission will be recorded.

Official Title
-----------------
Czech Anesthesia Day 2019: Observational Trial

Conditions
-----------------
Anesthesia Practice

Intervention / Treatment
-----------------
* Other: Anesthesia


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients from confirmed Anesthesiology Centers - previously confirmed the cooperation (center is registered in the online database with the unique identification) Exclusion Criteria: Data from centers with not confirmed cooperation
Sexes Eligible for Study
-----------------
All

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Patients undergoing anesthesia in Czech Republic<br>Patients undergoing anesthesia in Czech Republic in the selected period from the confirmed Anesthesia Center | Other: Anesthesia<br>* Patients undergoing anesthesia from the cooperating Anesthesia center<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Anesthesia description | Data from confirmed center will be recorded with the aim to describe the daily anesthesia practice in Czech Republic | From anesthesia induction until the admission to postanesthesia care | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Anesthesia, Practice, Czech Republic
Allogeneic Hematopoietic Stem Cell Transplantation Evaluation in High Risk Myelodysplasia: an Observational Non-interventional Study

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to compare outcome of high risk myelodysplasia patients aged from 50 to 70 years with or without HLA compatible (9 or 10 identities / 10) donor. High risk myelodysplasia includes IPSS intermediate 2 and high myelodysplasia and patients with sever thrombocytopenia. Patients are registered when they acquire risk factors.

Official Title
-----------------
Allogeneic Hematopoietic Stem Cell Transplantation Evaluation in High Risk Myelodysplasia: an Observational Non-interventional Study Comparing Outcome of Patients Aged From 50 to 70 Years With or Without Donor

Conditions
-----------------
Myelodysplasia

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: 50 to 70 years For myelodysplasia other than CMML: patients can be included if they have at least one of these criteria: IPSSintermediate 1 and poor cytogenetics (complex, 3 or 7 abnormality); thrombopenia < 20x10ex9/L: IPSS intermediate 2 or high For CMML: patients can be included if they have at least one of these criteria: 2 of these criteria: hyperleucocytosis > 10x10exp9/L, splenomegaly>18cm, hemoglobin < 10gr/dl, platelet < 100x10ex9/L IPSS intermediate 2 or high Exclusion Criteria: Patient not eligible for transplantation (including patients without donor)because of severe co-morbidity including: Renal failure with creatinine clearance < 30ml/min Cirrhosis or hepatic failure Respiratory disease with vital capacity < 30% Uncontrolled cardiac failure Uncontrolled neurological disease Poor performance status with karnofsky < or = 60%

Ages Eligible for Study
-----------------
Minimum Age: 50 Years
Maximum Age: 70 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 |
| --- | --- | --- |
| overall survival in patient with or without donor |  | 36 months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
myelodysplasia, allogeneic hematopoietic stem cell transplantation, Survival, Transplantation
Investigation of Ritonavir Effects on Afatinib Exposure in Healthy Subjects

Study Overview
=================
Brief Summary
-----------------
To study the effect of the P-glycoprotein inhibitor ritonavir on the pharmacokinetics (PK) of afatinib depending on the timepoint of ritonavir administration

Official Title
-----------------
Relative Bioavailability of a Single Oral Dose of 40 mg Afatinib Given Alone Compared to Concomitant and Timed Administration of Multiple Oral Doses of Ritonavir - an Open-label, Randomised, Three-way Crossover Trial in Healthy Male Volunteers

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

Intervention / Treatment
-----------------
* Drug: afatinib
* Drug: ritonavir + afatinib
* Drug: ritonavir + afatinib


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion criteria: 1. healthy male subjects Exclusion criteria: 1. any relevant deviation from healthy conditions

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

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

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

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

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: treatment A<br>1 tablet afatinib single dose | Drug: afatinib<br>* standard therapeutic dose<br>|
| Experimental: treatment B<br>2 x 2 tablets ritonavir for 3 days + 1 tablet afatinib on the second treatment day | Drug: ritonavir + afatinib<br>* simultaneous intake of ritonavir and afatinib on second treatment day<br>|
| Experimental: treatment C<br>2 x 2 tablets ritonavir for 3 days + 1 tablet afatinib on the second treatment day | Drug: ritonavir + afatinib<br>* on the second treatment day the first ritonavir tablet will be taken 6 hours after the afatinib tablet<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Area Under Curve From 0 to tz (AUC0-tz) | AUC0-tz represents the area under the concentration curve of the analyte in plasma from 0 to the time of the last quantifiable plasma contentration of the analyte. | 0, 0.5, 1, 2, 3, 4, 5, 6, 7, 8, 10, 12, 24, 36, 48, 72, 96, 120 hours post | 
| Maximum Concentration (Cmax) | Cmax represents the maximum concentration of the analyte in plasma. | 0, 0.5, 1, 2, 3, 4, 5, 6, 7, 8, 10, 12, 24, 36, 48, 72, 96, 120 hours post | 
| Area Under Curve From 0 to ∞ Hours (AUC0-∞) | AUC0-∞ represents the area under the concentration curve of the analyte in plasma from 0 extrapolated to infinity. | 0, 0.5, 1, 2, 3, 4, 5, 6, 7, 8, 10, 12, 24, 36, 48, 72, 96, 120 hours post |
Locobase® REPAIR Used as an Adjunctive to Standard Therapy in Children With Moderate to Severe Atopic Dermatitis

Study Overview
=================
Brief Summary
-----------------
To assess the efficacy of Locobase REPAIR® when used in children with moderate to severe AD

Official Title
-----------------
A Phase IV,Open Label Study of the Treatment of Children With Moderate to Severe Atopic Dermatitis (AD) Using Locobase® REPAIR as an Adjunctive to Standard Treatment

Conditions
-----------------
Dermatitis, Atopic

Intervention / Treatment
-----------------
* Drug: Locobase® REPAIR


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Has given written informed consent (parents or guardian, child if applicable) Moderate to severe AD Continuous use of topical corticosteroid or topical calcineurin inhibitor (TCI) as active treatment of AD for more than 4 weeks prior to screening (no change in topical corticosteroid or TCI is allowed between screening and day 1) In the opinion of the investigator, subject is unlikely to require a significant change to his/her current treatment regimen during the study period Exclusion Criteria: Has infected lesions The last assessment of any clinical study within 3 months prior to the expected date of entering into the study Current use of Locobase® REPAIR Known allergy to Locobase® REPAIR or any of its components Any clinical condition which, in the opinion of the investigator, would not allow safe completion of the study

Ages Eligible for Study
-----------------
Minimum Age: 18 Months
Maximum Age: 16 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: 1<br> | Drug: Locobase® REPAIR<br>* emollient<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in mEASI from baseline to week 3 |  | 3 Weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Physicians Global Evaluation of Clinical Response |  | 6 Weeks | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Atopic Dermatitis