linjc16/ctgov huggingface dataset:
The Clinical Efficacy of Recently Developed Supraglottic Airway Device, I-gel™, in Neonates and Infants: Comparison With Classic-laryngeal Mask Airway (c-LMA)

Study Overview
=================
Brief Summary
-----------------
Although the safety and efficacy of the Classic-laryngeal mask airway (c-LMA) in children has been shown in several large observational studies, findings suggest that the smaller-sized c-LMAs, in particular sizes 1 and 1½, are less suitable for airway maintenance under general anesthesia in small infants and that they may even be associated with more frequent complications than with the facemask and endotracheal tube. The pediatric i-gel is a new supraglottic airway device for children. It is made of a soft, gel-like elastomer with a noninflatable cuff. Studies about I-gel in adults have been promising, showing an easy insertion, high airway leak pressures, and low complication rates with few postoperative complaints. The aim of this study is to compare clinical performance of the pediatric i-gel and c-LMA in infants.

Conditions
-----------------
Airway Complication of Anaesthesia

Intervention / Treatment
-----------------
* Device: classic-laryngeal mask airway (c-LMA)
* Device: i-gel™


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: infants (0-1 year of age) who scheduled for elective surgery of short duration (less than 2 hr) undergoing general anesthesia using supraglottic airway Exclusion Criteria: patients with an abnormal airway with reactive airway disease with gastroesophageal reflux disease with chronic respiratory disease has a history of an upper respiratory tract infection in the preceding 6-week period

Ages Eligible for Study
-----------------
Maximum Age: 1 Year

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

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

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

Design Details

Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: LMA group<br> | Device: classic-laryngeal mask airway (c-LMA)<br>* Insertion of c-LMA<br>|
| Experimental: I-gel group<br> | Device: i-gel™<br>* Insertion of I-gel<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| airway leak pressure | Airway leak pressure was determined by adjusting the expiratory valve of the breathing circle to 40 cmH2O (fixed fresh gas flow 3 L/min) and recording the pressure when equilibrium was reached. | within 5 min of insertion of each device | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
elective surgery of short duration (less than 2 hr) undergoing general anesthesia using supraglottic airway
Repeated Dose Phase I Study of FYU-981

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to assess the safety, tolerability, pharmacokinetics and pharmacodynamics of 7-day-repeated doses of FYU-981 administered orally to healthy male adults once daily. Participants are randomized to placebo (n=3) or FYU-981 (n=6) in each step. After follow-up examination in the step of lower dose, the next dose is administered.

Official Title
-----------------
Seven-day Repeated Dose Clinical Pharmacological Study of FYU-981 Administered to Healthy Male Adults (Phase I Study).

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

Intervention / Treatment
-----------------
* Drug: FYU-981, (Oral daily dosing for 7 days)
* Drug: Placebo, (Oral daily dosing for 7 days)


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Japanese healthy adult subjects Body mass index: >=18.5 and <25.0 Exclusion Criteria: Subjects with any disease or any history of diseases that might be unsuitable for participation in the clinical study

Ages Eligible for Study
-----------------
Minimum Age: 20 Years
Maximum Age: 35 Years

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

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

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

Design Details

Primary Purpose: Basic Science
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: FYU-981<br> | Drug: FYU-981, (Oral daily dosing for 7 days)<br>* Subjects randomized to the FYU-981 arm receive active drug, FYU-981.<br>|
| Placebo Comparator: Placebo<br> | Drug: Placebo, (Oral daily dosing for 7 days)<br>* Subjects randomized to the placebo arm receive placebo.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pharmacokinetics (Cmax: Maximum plasma concentration) |  | 1-, 4-, and 7-day | 
| Pharmacokinetics (Cmin: Minimum plasma concentration) |  | 1-, 2-, 3-, 4-, 5-, 6- and 7-day | 
| Pharmacokinetics (Tmax: Time to reach the peak plasma concentration) |  | 1-, 4-, and 7-day | 
| Pharmacokinetics (T1/2: Elimination half-life of plasma concentration) |  | 1-, 4-, and 7-day | 
| Pharmacokinetics (AUC: Area under the plasma concentration-time curve) |  | 1-, 4-, and 7-day | 
| Pharmacokinetics (Rauc: Accumulation ratio of AUC0-24) |  | 4-, and 7-day | 
| Pharmacokinetics (kel: Elimination rate constant) |  | 1-, 4-, and 7-day | 
| Pharmacokinetics (CLtot/F: Total clearance / Fraction of dose absorbed) |  | 1-, 4-, and 7-day | 
| Pharmacokinetics (Ae: Amount of drug excreted in urine) |  | 9 days | 
| Pharmacokinetics (fe: Fraction of dose excreted in urine) |  | 9 days |
A Prospective, Observational Study of Individuals Who Seroconvert While Taking Truvada® for Pre-Exposure Prophylaxis (PrEP)

Study Overview
=================
Brief Summary
-----------------
This study will evaluate HIV-1 RNA and the presence or absence of resistance at baseline and following seroconversion, assess the frequency of HIV-1 screening and screening method(s) used for evaluation of seroconverters, and collect information regarding whether the seroconverter experienced signs and symptoms of acute HIV-1 infection prior to or at the time of seroconversion.

Official Title
-----------------
A Prospective, Observational Study of Individuals Who Seroconvert While Taking Truvada® for Pre-Exposure Prophylaxis (PrEP)

Conditions
-----------------
HIV

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Participant in a FTC/TDF PrEP demonstration project or FTC/TDF for PrEP clinical study HIV-1 negative adults (any sex/gender, including transgender) ≥ 18 years of age at time of enrollment in the demonstration project or clinical study. Evidence of seroconversion while receiving FTC/TDF for PrEP Exclusion Criteria: This is an observational nested study and will monitor all reported seroconversions without intervention/exclusion.

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 |
| --- | --- |
| FTC/TDF for PrEP<br>HIV-1 negative adults (any sex/gender, including transgender) who seroconvert while taking FTC/TDF for PrEP | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Seroconversion rate among all subjects exposed to emtricitabine (FTC)/ tenofovir disoproxil fumarate (TDF) (Truvada®) for a PrEP indication |  | Baseline to Year 3 | 
| Proportion of seroconverters with resistance mutations |  | Baseline to Year 3 | 
| Proportion of seroconverters with signs/symptoms at or before seroconversion |  | Baseline to Year 3 | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
HIV-1, Truvada, FTC/TDF, Pre-exposure prophylaxis, PrEP, Resistance
Long-term Follow-up in Patients Affected With Acrofacial Vitiligo

Study Overview
=================
Brief Summary
-----------------
Acrofacial vitiligo is a clinical form of vitiligo characterized by macules in distal digits, periorificial-facial and ano-genital areas. Vitiligo European Task Force classifies vitiligo as generalized or localized; generalized vitiligo may be further sub-divided into acrofacial, vulgaris and universalis, and localized vitiligo, into segmental and focal. Some authors do not believe that acrofacial is a real vitiligo clinical form, considering it as an initial form of vulgaris vitiligo. The aim of this study is to follow early- diagnosed acrofacial patients during ten years in order to define if these patients will maintain this clinical form or will evolute to a more severe clinical form.

Official Title
-----------------
Long-term Ten Years Follow-up in Patients Affected With Acrofacial Vitiligo

Conditions
-----------------
Vitiligo

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients of both genders, aged older than years, able to understand and provide written informed consent and able to allow compliance at the treatment and the requirements of the protocol; Presence of acrofacial vitiligo; Able to comprehend and willing to provide written informed consent in accordance with institutional and regulatory guidelines. Exclusion Criteria: 1- Subjects assessed as not suitable for the study in the opinion of the investigator 2 -Inability to complete survey

Ages Eligible for Study
-----------------
Minimum Age: 18 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 |
| --- | --- | --- |
Interstitial Lung Disease Research Unit Biobank

Study Overview
=================
Brief Summary
-----------------
Establish a interstitial lung disease (ILD) registry and biorepository to lead towards a further understanding of the disease.

Detailed Description
-----------------
The University of Kansas ILD and Rare Lung Disease clinic sees hundreds of new patients per year. The investigators would like to leverage this resource to develop an Interstitial Lung Disease Research Unit (ILDRU) repository and database to help develop new methods for early diagnosis, uncover underlying genetic and environmental risk factors, as well as potential treatment targets in the broad range of interstitial lung diseases and rare lung diseases (RLD).

Official Title
-----------------
University of Kansas Medical Center Interstitial Lung Disease Research Unit (ILDRU) Biobank

Conditions
-----------------
Interstitial Lung Disease, Sarcoidosis, Idiopathic Pulmonary Fibrosis, Pulmonary Fibrosis, Hypersensitivity Pneumonitis

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: The participant is a patient at TUKHS or has agreed to participate in a study approved by the KUMC Human Research Protection Program (HRPP) The participant is being followed for the presence of autoimmune disease, ILD or other rare lung diseases at TUKHS. The participant is ≥ 18 years of age. The participant has signed an approved consent for this study (living patients only)

Ages Eligible for Study
-----------------
Minimum Age: 18 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 |
| --- | --- | --- |
| Collect clinically obtained data for patients with ILD, RLD and risk for ILD/RLD to support research. |  | Enrollment to Year 10 | 
| Establish a collection of biological samples from patients with ILD, RLD and subjects at risk for ILD. |  | Enrollment to Year 10 | 
| Correlate biological samples with individual longitudinal clinical data. |  | Enrollment to Year 10 | 
| Provide biological samples to researchers performing studies in ILD and RLD. |  | Enrollment to Year 10 | 
| Collect historical data and imaging from deceased patients with ILD. |  | Enrollment to Year 10 | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Interstitial Lung Disease, Sarcoidosis, Idiopathic Pulmonary Fibrosis, Pulmonary Fibrosis, Hypersensitivity Pneumonitis
Prevention of Pressure Ulcer by Lateral Tilt Bed in Neurocritical Care

Study Overview
=================
Brief Summary
-----------------
Patient positioning is an essential part of a preventive strategy for neurocritical care patients. The aim of the study will be to determine whether the positioning of the bed is the same or better compared to the positioning of the patient's bed in the presence of pressure ulcer.

Detailed Description
-----------------
In the monocentric, intervention, prospective, randomized study, we will investigate incidence of pressure ulcer in 300 adult consecutive patients admitted to our Neurointensive Care Unit (NICU). All patients will suffer from acute primary brain disease and will be unconscious with artificial pulmonary ventilation.

Official Title
-----------------
Prevention of Pressure Ulcer by Lateral Tilt Bed in Neurocritical Care

Conditions
-----------------
Pressure Ulcer

Intervention / Treatment
-----------------
* Other: Body positioning


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Primary brain disease Hospitalization in JIP neurocenter Age> 18 years Unconsciousness Artificial pulmonary ventilation Exclusion Criteria: Intracranial hypertension Decubitus on the skin upon admission

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: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Intervention: parallel assignment. Blind for statisticians: statisticians from a different institution will only know type A or B randomization.
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Lateral tilt bed<br>Special lateral tilt bed. | Other: Body positioning<br>* Comparison lateral tilt bed to standard patient´s body positioning in the bed.<br>|
| No Intervention: Body positioning<br>Standard NICU preventive strategy | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Incidence of pressure ulcer | Pressure ulcer will be evaluated in accordance with EPUAP (European Pressure Ulcer Advisory Panel) | Through study completion, on average every 24 weeks. | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Prolonging the stay in the NICU | The incidence of the pressure ulcer shall prolong the patient´s NICU stay | Through study completion, on average every 24 weeks. | 
| Cost effectiveness of patient´s NICU stay | Therapeutic Intervention Scoring System (TISS) | Through study completion, on average every 24 weeks. | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Pressure Ulcer, Neurocritical Care, Acute Brain Disease, Unconsciousness, Preventive Strategy
Evaluation of a Rapid Diagnostic Device, CL Detect, for the Diagnosis of Cutaneous Leishmaniasis in Tunisia

Study Overview
=================
Brief Summary
-----------------
The purpose of the study is to evaluate the sensitivity and specificity of CL Detect, in subjects with suspected CL in Tunisia.

Detailed Description
-----------------
Subjects were selected based on clinical appearance of the skin lesion characteristics of cutaneous leishmaniasis (CL). Study compared the CL Detect Rapid Test vs microscopic identification of Leishmania amastigotes in a stained lesion sample. Two diagnostic samples were collected from the subjects lesion in the following order: 1) obtained with a dental broach for use with the CL Detect Rapid Test and 2) a second sample was obtained by scraping for use in the microscopic identification of amastigotes. Samples were analyzed by microscopy and CL Detect Repaid Test by different operators who evaluated each sample independently blinded to the other assay result.

Official Title
-----------------
Evaluation of a Diagnostic Device, CL Detect Rapid Test, for the Diagnosis of Cutaneous Leishmaniasis in Tunisia

Conditions
-----------------
Skin Diseases, Parasitic

Intervention / Treatment
-----------------
* Other: No Intervention


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: At least 18 years of age and generally healthy Subject able to give written informed consent Subject has a lesion suspicious for leishmaniasis that satisfies the following criteria for an index lesion: less than 4 months in age primarily ulcerative, ie not purely verrucous or nodular, and does not have clear clinical evidence of cellulitis in a location suitable for collecting samples by dental broach, scraping, and aspiration In the opinion of the investigator, the subject is capable of understanding and complying with the protocol Exclusion Criteria: • Received treatment for leishmaniasis within the last 2 months prior to signing consent, with the exception of mercurochrome

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 |
| --- | --- |
| CL Detect Rapid Test and Microsopy Samples<br>Samples taken to be evaluated in the CL Detect and Microscopy assays | Other: No Intervention<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Positive Result Comparison: CL Detect Rapid Test With Microscopy and Culture Results | Comparison of CL Detect Rapid Test positive results with Microscopy and Culture results. Note: only data where results for all three methods were available were included in the analysis. | within 1 hour after taking samples | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Leishmaniasis, Leishmania
The Correlation Between Luteal Serum Progesterone and Live Birth Rate

Study Overview
=================
Brief Summary
-----------------
The study design is an observational cohort study. Level of serum P4 will be collected on day OR+4 as well as on the day of embryo transfer (ET) either day OR+3 or OR+5.

Official Title
-----------------
The Correlation Between Luteal Serum Progesterone and Live Birth Rate in IVF - a Prospective Cohort Study (LUT-2)

Conditions
-----------------
Infertility

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Signed informed consent BMI <35kg/m2 Exclusion Criteria: No fresh embryo transfer Prior participation in the study

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 41 Years

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

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 |
| --- | --- | --- |
| Live birth rate in relation to luteal serum progesterone levels on day four and three or five | The birth of a live born child after gestational week 22+0 | 9-24 months after inclusion | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pregnancy rate in relation to luteal serum progesterone levels | Serum Human chorionic gonadotropin<10 IU/l | 14-16 days after oocyte retrieval | 
| Clinical pregnancy rate in relation to luteal serum progesterone levels | Ultrasound scan detection of intrauterine fetal heartbeat in gestational week 7-9 | 7-9 weeks after inclusion |
Self-Scored Cardiovascular Disease Risk Appraisal

Study Overview
=================
Brief Summary
-----------------
To develop and test a self-scored cardiovascular disease health risk appraisal.

Detailed Description
-----------------
BACKGROUND: Health risk appraisals (HRA) are being used increasingly by health centers and worksites to inform people of their personal mortality and morbidity risks. However, recent research suggests that many HRAs have limited reliability and validity with respect to coronary heart disease, the leading cause of death in this country. Self-scored HRAs appear to be considerably less accurate in predicting CHD risk than computerized instruments, chiefly because people do not always know the physiologic values required by these instruments and because they frequently make errors computing their scores. DESIGN NARRATIVE: During Phase I, a new appraisal named CardioRisk was developed. The Phase I prototype version contained eight major self-reported risk factors. CardioRisk predicted the risk of developing cardiovascular disease (CVD) in a 12-year period using an equation based on recent accelerated failure time models from the Framingham Heart Study. The purpose of Phase II was to thoroughly test and refine the prototype instrument. The Phase II analyses were designed to assess the psychometric properties of CardioRisk, to evaluate its utility as judged by patients, and to determine whether the instrument changed perceptions of personal CVD risk. These results were compared to data for other appraisals to determine whether CardioRisk outperformed comparable products. In the proposed commercial application, CardioRisk would be distributed by health promotion organizations to increase awareness of the risk factors for cardiovascular disease. Estimates from the American Heart Association put the demand for these products at 180,000 HRAs per year. The potential market for this product includes worksites, community health centers, managed health care organizations, public health departments, and clinics. The study completion date listed in this record was obtained from the End Date entered in the Protocol Registration and Results System (PRS) record.

Conditions
-----------------
Cardiovascular Diseases, Heart Diseases, Coronary Heart Disease Risk Reduction

Participation Criteria
=================
Eligibility Criteria
-----------------
No eligibility criteria

Ages Eligible for Study
-----------------
Maximum Age: 100 Years

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

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 |
| --- | --- | --- |