linjc16/ctgov huggingface dataset:
Triage Assessment and NEWS-score as Risk Predictor in Older Frailty Adults in the ED

Study Overview
=================
Brief Summary
-----------------
Emergency Department Triage Systems have not been shown to sufficiently recognize frail elderly patients in need of urgent assessment and care. In this prospective, observational study the performance of the 3-level triage system and the National Early Warning Score (NEWS) 2 are assessed (separately and combined) for predicting adverse outcomes in older frailty patients visiting in the ED. Observational data for this study is gathered as part of GAOPS - main study (ClinicalTrials.gov Identifier: NCT03751319).

Official Title
-----------------
3-level Triage Assessment and National Early Warning Score as Predictor for Mortality, Hospital Admission and ED Readmission for Older Frailty Patients in the ED

Conditions
-----------------
Frailty, Aged, Triage

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Clinical Frailty Scale minimum 4 estimated at the arrival to the ED by nurse Exclusion Criteria: • Non-resident of the counties (City of Espoo, Kirkkonummi, Kauniainen) of the hospital district.

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

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Older Adult Patients<br>ED patients age of ≥ 75 who have nurse assessed Clinical Frailty Scale ≥ 4. | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Mortality | Mortality during the 30 day follow-up | 30 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Hospital admission | Admission to hospital from the Emergency Department | Day 0 | 
| ICU/HDU admission | Admission to the Intensive Care Unit or High Dependency Unit from the Emergency Department | Day 0 | 
| Readmission in the ED | Re-visits to the ED after the index-visit | Hour 72, Day 30 | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Emergency triage
Evaluation 2% Chlorhexidine Gluconate

Study Overview
=================
Brief Summary
-----------------
Medline 2% CHG cloth (Active) - A single cloth from the pack was used per treatment area. The investigational test article was applied topically by vigorously scrubbing the skin in a back and forth motion for three minutes (and halfway through the 3-minute application time, the cloth was turned over) over the treatment area (7 x 10 of the subject's back), and the skin was allowed to air dry.

Official Title
-----------------
Evaluation of the Area Covered by Medline 2% Chlorhexidine Gluconate Cloth Preoperative Skin Preparation

Conditions
-----------------
Skin Coverage

Intervention / Treatment
-----------------
* Drug: 2% CHG


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Healthy males of at least 18 years of age having skin within 6 inches of the test regions that were free of tattoos, dermatoses, abrasions, cuts, lesions or other skin disorders, with no history of sensitivity to CHG and were able to lie prone for up to 30 minutes.

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

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

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

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

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Chlorhexidine Gluconate<br>2% CHG | Drug: 2% CHG<br>* Chlorhexidine Gluconate<br>* Other names: Medline 2% CHG cloth;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Medline 2% CHG Cloth Dosage of Coverage Area | To measure the dosage of the coverage area of a single investigational test article, Medline 2% CHG cloth calculated in grams per square centimeter | 3 minutes | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Post-application Drying Time | To assess post-application drying time after a single dose topical application of Medline 2% CHG cloth. Drying time is defined as when the entire treatment area appears visibly dry. | Approximately 1 minute |
Outpatient Treatment of Patients With Morbid Obesity - a Two-year Follow up

Study Overview
=================
Brief Summary
-----------------
This study is a pilot project to investigate any effect on these markers in conjunction with lifestyle changes / conservative treatment. Useful and significant information in this pilot project is intended to be used as background for further research on this issue in connection with a doctorate. What is the effect of two years of outpatient treatment for lifestyle change for weight markers, waist, BMI, HbA1c, HDL and LDL cholesterol, triglycerides and uric acid in adults with morbid obesity?

Official Title
-----------------
Qualitative Retrospective Study Where the Intervention Consisted of Group Therapy and Individual Interviews Over a Two-year Period

Conditions
-----------------
Morbid Obesity

Intervention / Treatment
-----------------
* Device: lifestyle advice


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Adults from 18 - 60 years, both sex

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

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

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

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

Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: lifestyle advice<br> | Device: lifestyle advice<br> <br> |

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
-----------------
obesity, adults, lifestyle intervention, effect after two years treatment for lifestyle change - morbid obesity adults
Surveillance Study of Candiduria in Hospitalized Patients

Study Overview
=================
Brief Summary
-----------------
The purpose of the study is to explore the epidemiology, underlying diseases, indwelling catheter duration, laboratory data, diagnosis, treatment and prognosis of patients with Candiduria.

Detailed Description
-----------------
The study is a retrospective study. Investigators will review medical records of patients with Candiduria from January 2015 to December 2017 to collect data about personal data, underlying diseases, indwelling catheter duration, laboratory data of urine routines and urine cultures, the symptom of fever, diagnosis, treatment and prognosis. After the data collection, investigators will run a descriptive statistics to find out the profile of the medical care of Candiduria in Taiwan.

Official Title
-----------------
Retrospective Surveillance Study of Candiduria in Hospitalized Patients

Conditions
-----------------
Candiduria

Intervention / Treatment
-----------------
* Other: no intervention


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: patients with Candiduria Exclusion Criteria: patients without Candiduria
Sexes Eligible for Study
-----------------
All

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

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

Arms and Interventions

| Intervention/Treatment |
| --- |
|Other: no intervention|Investigators review patients' medical records and collect personal data, underlying diseases, indwelling catheter duration, laboratory data, diagnosis, treatment and prognosis.|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| prevalence rate of Candiduria | the number of patients with Candiduria/ the number of all hospitalized patients | January 2015 to December 2017 | 
| morbidity rate of underlying diseases | the proportion of patients with every specific underlying disease | January 2015 to December 2017 | 
| indwelling catheter rate | the proportion of patients with indwelling catheter | January 2015 to December 2017 | 
| pyuria rate | the proportion of patients with pyuria | January 2015 to December 2017 | 
| Candiduria rate | the proportion of patients with Candiduria | January 2015 to December 2017 | 
| treatment rate | the proportion of patients with Candiduria treated with antifungal agents | January 2015 to December 2017 | 
| mortality rate | the number of patients who die / the number of all hospitalized patients the number of patients who die from Candiduria/ the number of all hospitalized patients | January 2015 to December 2017 | 
| average indwelling catheter duration | The sum of indwelling catheter durations / the number of all hospitalized patients with Candiduria | January 2015 to December 2017 |
VIsual Cerebral ConnecTivity On Functional Magnetic Resonance Imaging in Patients With Hereditary REtinal Dystrophies

Study Overview
=================
Brief Summary
-----------------
The Rothschild Foundation A Hospital follows a cohort of approximately 300 patients with hereditary retinal dystrophy. These patients are followed in ophthalmology consultation every year. In order to plan the MRI on the day of the annual consultation and to avoid additional travel for patients, patients will be informed of the study before the consultation (transmission of an information letter and the information note from study). If patients agree to participate in the study, rMRI will be scheduled. During the follow-up ophthalmologic consultation, after checking the inclusion and non-inclusion criteria, the study information will be repeated, and patients who still agree to participate will sign the study consent.

Official Title
-----------------
VIsual Cerebral ConnecTivity On Functional Magnetic Resonance Imaging in Patients With Hereditary REtinal Dystrophies

Conditions
-----------------
Vision Functional Brain Networks in Patients With Hereditary Retinal Dystrophies

Intervention / Treatment
-----------------
* Device: IRMf-r (séquence resting state)


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patient over 18 years old Diagnostic clinique de dystrophie rétinienne héréditaire ou maculopathie héréditaire, syndromique ou non syndromique Artificial vision treatment such as a retinal implant, or optogenetics scheduled in the next 6 months Express consent to participate in the study Affiliate or beneficiary of a social security scheme Exclusion Criteria: Patient benefiting from a legal protection measure Pregnant or breastfeeding woman Contraindication to MRI (claustrophobia, implanted equipment such as pacemaker). Other additional ocular pathology that can significantly affect vision Recent eye surgery less than 3 months old

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 |
| --- | --- |
| Patients for whom there is no planned implant surgery<br> | Device: IRMf-r (séquence resting state)<br>* Functional MRI of functional brain networks<br>|
| Patients for whom implantation surgery is planned<br> | Device: IRMf-r (séquence resting state)<br>* Functional MRI of functional brain networks<br>|
| case<br> | Device: IRMf-r (séquence resting state)<br>* Functional MRI of functional brain networks<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Localization and characterization of neural networks | neuronal networks description using rest and morphological functionnal MRIs | baseline | 
| Evolution of neuronal networks after retinal implantation | neuronal networks description using rest and morphological functionnal MRIs | baseline |
Evaluation of Weight Bearing After Total Hip and Knee Replacement

Study Overview
=================
Brief Summary
-----------------
The regime in the aftercare after total hip and knee arthroplasty(THA/TKA) differs a lot between orthopedic surgeons concerning weight bearing. The type of implant and the way of implants' anchoring are considered. In the literature there is no data so far about the way patient take care of the recommended weight bearing during the first 6 weeks after THA and TKA. Over a one year period starting August 2010 all patients undergoing TKA or THA at the investigators institution will have a technical device in their shoes (sole) to measure the load in each step they do in these shoes during the first 6 weeks. Patients are asked to fill out a standardised pain protocol every day (VAS) and document need of pain medication. The investigators recommend 20kg of weight on the operated leg for 6 weeks and full weight bearing at the end of week six. The investigators believe that patients will adjust weight bearing to their level of pain and not to their surgeons recommendations.

Official Title
-----------------
Evaluation of Weight Bearing in Patients After Total Hip and Knee Replacement

Conditions
-----------------
Arthropathy of Hip, Arthropathy of Knee

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: received a THA or TKA in the mentioned period of time is able to walk on crutches is able to understand our recommendations signed informed consent Exclusion Criteria: not able to walk on crutches not able to understand our recommendations other deformities of lower limbs
Sexes Eligible for Study
-----------------
All

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| TKA/THA<br>All patients receiving TKA/THA meeting inclusion but not exclusion criteria | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| full weight bearing allowed and accomplished end of 6th week | full weight bearing allowed and accomplished, documented by special soles with an electronic device, which will record weight bearing continuously on an USB stick | 6 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| pain under partial weight bearing (recommended) | Patients will have a official standardised pain diary and should document their pain and need of analgetics according to instructions given (VAS, Schweizer Krebsliga) at least on a daily basis. | 6 weeks | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
weight bearing, pain, total hip arthroplasty, total knee arthroplasty, weight bearing after TKA or THA
Measuring Parkinson's Disease With Tear Fluid

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to assess whether tear secretion in patients with Parkinson's disease will be altered to exhibit a characteristic or diagnostic biomarker profile, that will be reflected in changes in the protein composition of tear fluid, which can be measured relatively easily, cost-effectively, and non-invasively. Tear fluid samples will be collected from Parkinson's patients, and through biochemical assays, the profile of proteins in tears will be characterized and compared to that from control subjects. The profiles will be analyzed with respect to any differences between Parkinson's patients and control subjects. If differences appear, the levels of these potential biomarkers in Parkinson's patients will be compared to the severity of their disease.

Official Title
-----------------
Identification of Tear Biomarkers for Parkinson's Disease Patients

Conditions
-----------------
Idiopathic Parkinson Disease

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: established Parkinson's Disease for at least 6 months Healthy controls without neurological illness Exclusion Criteria: currently taking anti-cholinergic medication dementia have an exposure to neuroleptic medications other than Quetiapine or Clozapine in the 6 months prior to screening have an active eye infection or have had eye surgery within 3 months prior to screening control subjects will be excluded if they have a history of neurological disease PD subjects will be excluded if they have an atypical Parkinsonian syndrome

Ages Eligible for Study
-----------------
Minimum Age: 35 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 |
| --- | --- |
| Parkinson's Disease<br> | |
| Control<br> | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Tear protein composition to discriminate between participants with Parkinson's disease and healthy controls | 4 potential biomarkers will be evaluated in collected tear fluid and will be followed longitudinally for 3-4 visits | up to 12 months |
Human Papillomavirus and Oropharynx Carcinoma

Study Overview
=================
Brief Summary
-----------------
High risk papillomavirus (HR-HPV) have an oncogenic role in Oropharyngeal squamous cell carcinomas (OP-SCC) in at least 25% of the cases and the prevalence is increasing. HPV+ might be more chemo and radio sensible with a better prognosis (disease-free survival (DFS) and overall survival (OS) as compared to HPV negative OP-SCC ; hypothesis : 2y DFS > 20% improvement). The principal objective is to determine the impact of the status of HR-HPV in the prognosis of the OP-SCC. The principal criteria is the 2-years DFS. Secondary objective : virologic characteristics of HPV+ tumors.

Detailed Description
-----------------
The study has no impact on the treatment of the observed population. The clinical study include TNM status, previous story of HPV infection, smoking and alcoholic habits, treatment and outcome during 5 years. The virologic study include : HPV type, E6-E7 viral charge of HPV16, viral DNA integration in the tumoral genome, HPV16 variants, expression of HPV 16, 18, 31, 45 coding oncoproteins E6-E7 mRNA. Moreover a serologic study will be done.

Official Title
-----------------
Impact of the Human Papillomavirus (HPV) Status in Carcinologic Prognosis of Oropharynx Squamous Cell Carcinoma.

Conditions
-----------------
Oropharyngeal Neoplasms

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Squamous cell carcinoma of Oropharynx proven histologically All stages TNM informed consent No previous or simultaneous Head Neck cancer Age >18 Exclusion Criteria: Squamous cell carcinoma other than oropharynx 2nd synchronous SCC localization No consent age < 18

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 |
| --- | --- |
| 1<br>Patients with oropharyngeal squamous cell carcinomas | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| DFS at 2 years in HPV + and - tumors |  | at 2 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Overall survival |  | At 2 years | 
| HPV status |  | At the inclusion | 
| Overall survival |  | At 5 years | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Squamous cell carcinoma of Oropharynx, Human papillomavirus., Biological prognostic markers.
Single Dose Safety, Tolerability, Pharmacokinetics And Pharmacodynamics Study Of PF-06291874 In Healthy Adult Subjects

Study Overview
=================
Brief Summary
-----------------
The primary purpose of this trial is to evaluate the safety and tolerability, pharmacokinetics, and pharmacodynamics of single oral doses of PF-06291874 in healthy volunteers.

Official Title
-----------------
A Phase 1, Randomized, Double Blind, Sponsor Open, Placebo-Controlled, Single Dose Escalating Study To Assess The Safety, Tolerability, Pharmacokinetics, And Pharmacodynamics Of PF-06291874 After Administration Under Fasted And Fed Conditions In Healthy Adult Subjects

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

Intervention / Treatment
-----------------
* Drug: PF-06291874
* Other: placebo


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Healthy male and/or female subjects of non childbearing potential. Body Mass Index (BMI) of 17.5 to 30.5 kg/m2; and a total body weight >50 kg Exclusion Criteria: Evidence or history of clinically significant hematological, renal, endocrine, pulmonary, gastrointestinal, cardiovascular, hepatic, psychiatric, neurologic, or allergic disease (including clinically significant drug allergies, but excluding untreated, asymptomatic, seasonal allergies at the time of dosing).

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 55 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
Intervention Model: Crossover Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Experimental: Cohort A<br>Each subjects in Cohort A will receive 2 single doses of PF-06291874 and 1 placebo dose in random order in Periods 1-3; in addition, 1 dose of PF-06291874 will be administered in Period 4 in the fed state. | Drug: PF-06291874<br>* PF-06291874 will be administered as an extemporaneously prepared suspension for all doses within the initially planned range of 75 mg to 500 mg.<br>Other: placebo<br>* Correspondingly, placebo doses will be administered as suspension.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Area Under the Curve From Time Zero to Last Quantifiable Concentration (AUClast) |  | 0-72/dose | 
| Area Under the Curve From Time Zero to Extrapolated Infinite Time [AUC (0 - inf)] |  | 0-72/dose | 
| Maximum Observed Plasma Concentration (Cmax) |  | 0-72/dose | 
| Time to Reach Maximum Observed Plasma Concentration (Tmax) |  | 0-72/dose | 
| Plasma Decay Half-Life (t1/2) |  | 0-72/dose | 
| Apparent Oral Clearance (CL/F) |  | 0-72/dose | 
| Apparent Volume of Distribution (Vz/F) |  | 0-72/dose | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
T2DM, Diabetes Mellitus Type 2