linjc16/ctgov huggingface dataset:
Biomarker Analysis in Post-COVID Patients

Study Overview
=================
Brief Summary
-----------------
Headache is one of the most common neurological manifestations of COVID-19. However, it is unclear whether chronic headache after the initial diagnosis, is associated with ongoing damage of the central nervous system. We investigate cpost-COVID-19 patients with persistent headache lasting longer than 3 weeks, to hospitalized acute COVID-19 patients with neurological symptoms and to other non-COVID-19 disease-controls. Readout are neurologial and glial biomarkers in CSF.

Detailed Description
-----------------
Measurements of neuronal and glial markers in CSF were performed on a SIMOA analyzer (Quanterix) using the Neurology 4-Plex A (Nf-L, Tau, GFAP, UCH-L1) kit.

Official Title
-----------------
Biomarker Analysis in COVID and Post-COVID Patients

Conditions
-----------------
Post-COVID-19 Syndrome

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


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Diagnosis of COVID, Parkinson's disease, primary headache, Multiples Sclerosis, facial paralysis Persistent post-COVID-19 headache after 3 months of infection Post COVID-patients without persistent headache must be able to perform lumbar puncture Exclusion criteria unknown history of COVID infection lumbar puncture not possible

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 80 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 |
| --- | --- |
| Persistent post-COVID-19 headache<br>post-COVID-19 patients with persistent headache | Other: no intervention<br>* no intervention<br>|
| controls<br>Mild Neuro-COVID-19 patients without persistent headache and other neurological diseases | Other: no intervention<br>* no intervention<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Biomarker analysis in CSF | Levels of Nf-L, Tau, GFAP, UCH-L1 in CSF | after 3 months of initial infection | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
persistent headache
Multiparametric Approach to Identify a CMR-based Tricuspid Regurgitation Classification

Study Overview
=================
Brief Summary
-----------------
The aims of this study are: to explore a novel 2D-Cardiovascular magnetic resonance (CMR) indirect method for tricuspid regurgitation (TR) quantification (ATRIAL method) relying on right atrium variables, and assess its agreement with the traditional indirect method (involving right ventricle variables) and the direct method (based on through-plane phase contrast (PC) sequences on the tricuspid valve); to assess the agreement of TR volume (RVol) and regurgitant fraction quantification from 2D-CMR methods with transthoracic echocardiography and 4DF-CMR methods; to assess the diagnostic performance of 2D-CMR in classifying TR, in terms of RVol and regurgitant fraction, with respect to echocardiographic transthoracic echocardiography grades.

Official Title
-----------------
Multiparametric Approach to Identify a CMR-based Tricuspid Regurgitation Classification

Conditions
-----------------
Tricuspid Regurgitation Congenital

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: patients aged ≥ 18 years with the diagnosis of al least mild-degree tricuspid regurgitation, who: patients that are scheduled for a Cardiovascular Magnetic Resonance examination in our Institution Exclusion Criteria: Patients with previous surgical or transcatheter interventions on the tricuspid valve Patients with Ebstein's disease Subjects with pace-maker or intracardiac defibrillator Subjects with intrabody ferromagnetic material precluding patient's safety Patients with claustrophobia or breath-holding precluding an adequate CMR images quality Pregnant women

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

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

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 2D-CMR (different methods) |  | 3 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| RVol and RF |  | 3 years |
A Prospective Study of Fortiva in Hernia Repair

Study Overview
=================
Brief Summary
-----------------
The goal of this study is to evaluate safety and performance of the Fortiva Tissue Matrix. Participants will complete questionnaires to measure outcomes after hernia surgery for two years.

Detailed Description
-----------------
This is a post market, prospective, multi-center study of up to 120 participants at approximately 10 clinical study sites. Safety and performance will be measured after hernia repair for two years.

Official Title
-----------------
A Prospective Study of Fortiva in Hernia Repair

Conditions
-----------------
Ventral Hernia, Incisional Hernia, Abdominal Wall Reconstruction

Intervention / Treatment
-----------------
* Device: Fortiva Tissue Matrix


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: 18 years of age at time of consent Undergoing hernia surgery in which Fortiva Tissue Matrix will be used Have no contraindications to the test material (s) Able to provide informed consent Able to read, understand and complete study questionnaires Able and willing to return for scheduled study visits Exclusion Criteria: <18 years of age American Society of Anesthesiologists (ASA) physical class of 4,5 or 6 Currently enrolled or plans to enroll in another clinical study that would affect the validity of the study Hernia repairs involving active infection

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 |
| --- | --- |
| Fortiva Tissue Matrix<br> | Device: Fortiva Tissue Matrix<br>* Acellular Dermal Matrix used in hernia surgery<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Type of adverse events |  | 6 weeks, 6 months, 12 months and 24 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Patient satisfaction | SF-36 questionnaire has 8 multi-item scales with a higher score representing better health status. Each domain has a score range of 0-100 | 6 weeks, 6 months, 12 months and 24 months | 
| Pain measured using the visual analog scale for pain | Visual Analog Scale using a scale of 0-10 with 0 being no pain and 10 being unbearable pain | 6 weeks, 6 months, 12 months and 24 months | 
| Implant failure | Partial or total removal of Fortiva Tissue Matrix | 6 weeks, 6 months, 12 months and 24 months | 
| Hernia recurrence | Hernia recurrence requiring surgical reintervention | 12 months |
Feasibility of Dynamic Muscle Stimulation + Radiofrequency for Improving Blink Quality in Subjects With Dry Eye Disease

Study Overview
=================
Brief Summary
-----------------
To demonstrate that DMSt + RF improves eye blink quality in subjects with dry eye disease

Detailed Description
-----------------
The purpose of the study is to demonstrate that a combination of DMSt and RF applied on the periocular skin below the lower eyelids improves eye blink quality in subjects with moderate to severe signs and symptoms of dry eye disease.

Official Title
-----------------
Feasibility of Dynamic Muscle Stimulation (DMSt) Combined With Radiofrequency (RF) for Improving Blink Quality in Subjects With Dry Eye Disease (DED)

Conditions
-----------------
Eyelid Diseases, Eyelid Movement Disorders, Dry Eye, Dry Eye Syndromes, Skin Laxity

Intervention / Treatment
-----------------
* Device: TriLift device


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Subject is able to read, understand and sign an Informed Consent Form (ICF) 22 or older Lower lid laxity, as clinically judged with lower lid DT and the snapback test Moderate to severe OSDI (larger or equal to 23) TBUT smaller or equal to 5 sec in both eyes Exclusion Criteria: Abnormally high blink rate, as estimated by the study investigator Any ocular surgery or eyelid surgery, within 3 months prior to screening Blepharoptosis Moderate or Severe Floppy Lid Syndrome Corneal Dystrophy Exophthalmos Thyroid Eye Disease Ocular Chemical Injury or burn Limbal Stem Cell Deficiency Facial Nerve Palsy Blepharospasm Hemifacial Spasm Corneal neuropathy Pregnant or nursing women Participation in a different study Any condition revealed whereby the study investigator deems the subject inappropriate for this study

Ages Eligible for Study
-----------------
Minimum Age: 22 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
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: TriLift<br>Combination of Dynamic Muscle Stimulation and Radiofrequency | Device: TriLift device<br>* Dynamic Muscle Stimulation combined with tripolar Radiofrequency, administered on the skin of the inferior orbital rim and below the lower eyelids<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Impaired blink quality | binary (yes/no) variable, based on clinical estimation of the study investigator who will use a combination of two complementary tests (the lower lid distraction test and the snap-back test) to reach a yes/no decision. | 7 weeks after baseline (4 weeks after the 4th treatment) |
The Presence of a Therapy Dog Reduces Pain and Anxiety During Pediatric Elbow Pin Removal

Study Overview
=================
Brief Summary
-----------------
The purpose of this research study is to assess whether the presence of therapy dogs can reduce pain and anxiety in children ages 3 to 10 having pins removed from their elbow.

Detailed Description
-----------------
This procedure is done in an outpatient clinic 3-4 weeks after the pins are placed and can be uncomfortable and cause anxiety in some patients. Therapy dogs are trained to sit calmly with a patient on or near the exam table as a distraction from procedures.

Official Title
-----------------
The Presence of a Therapy Dog Reduces Pain and Anxiety During Pediatric Elbow Pin Removal

Conditions
-----------------
Elbow Injury

Intervention / Treatment
-----------------
* Behavioral: No Dog Present
* Behavioral: Dog is Present


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: presenting to clinic for elbow pin removal post elbow fracture surgery Exclusion Criteria: dog allergy fear of dogs

Ages Eligible for Study
-----------------
Minimum Age: 3 Years
Maximum Age: 10 Years

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

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

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

Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: control group or therapy group
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Control Group<br>Dog will not be in room when child has elbow pins removed | Behavioral: No Dog Present<br>* Dog is not present during pin removal<br>|
| Experimental: Therapy Dog Group<br>The dog will come in a few minutes before to meet with you and your child and ensure ease. The therapy dog will be present throughout the procedure and is able to sit on the exam table if desired. | Behavioral: Dog is Present<br>* Dog is present during pin removal<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pain Response | Wong-Baker FACES scale, a validated scale for assessing pain in pediatric patients, will be used to compare pain response; The scale contains a series of six faces ranging from a happy face at 0 to indicate no hurt to a crying face at 10 to indicate hurts worst. | 1 year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Anxiety Response | anxiety response will be assessed with the Faces, Legs, Activity, Cry and Consolability (FLACC) Scale, This scale ranges from: 0 = Relaxed and comfortable ; 1-3 = Mild discomfort ; 4-6 = Moderate pain ; 7-10 = Severe discomfort/pain | 1 year | 
| Anxiety Response | anxiety response will be assessed with heart rate in beats per minute | 1 year |
Neonatal Infection Surveillance Database

Study Overview
=================
Brief Summary
-----------------
NeonIN is a is a neonatal infection surveillance database which will facilitate active surveillance for bacterial infections through a network of neonatal units, using standardised definitions, proformas and microbiological techniques. The centralised and secure web-based database will allow real-time entry of data and rapid and timely analysis of results.

Detailed Description
-----------------
The neonIN surveillance network captures data on episodes of invasive neonatal infection on a web-based database (www.neonin.org.uk). Over 25 UK neonatal units currently contribute to this database in real-time. An episode of neonatal infection is defined as a positive culture collected from a normally sterile site such as the blood, cerebrospinal fluid (CSF) or urine (via catheter or suprapubic aspirate) for which clinicians prescribed at least five days of appropriate antibiotics. Clinical, demographic and microbiological data (including antimicrobial susceptibilities) are collected using a standardised online questionnaire, and denominator data regarding the total number of live-births and neonatal-admissions are collected for each neonatal unit.

Official Title
-----------------
Neonatal Infection Surveillance Database

Conditions
-----------------
Neonatal Infection

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Infants on participating Neonatal Units who have an episode of infection with a positive culture Exclusion Criteria: -

Ages Eligible for Study
-----------------
Minimum Age: 1 Minute
Maximum Age: 12 Months

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

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Incidence of infection | Collection of neonIN data on episodes of significant neonatal bacterial infections in NNUs recruiting to neonIN | 6 months | 
| Antibiotic susceptibility | Collection of neonIN data on susceptibility profiles of significant neonatal bacterial infections | 6 months | 
| Features of bacterial infections | Collection of neonIN data on gestation, birth weight, age of onset, clinical presentation and prior antibiotic use of significant neonatal bacterial infections | 6 months |
Next-Generation-Sequencing Approach to Neutropenic Sepsis

Study Overview
=================
Brief Summary
-----------------
The aim of this prospective, observational, non-interventional, multi-centre study of the diagnostic use of DISQVER in neutropenic patients with FN is to provide further evidence of the efficacy of an NGS-based approach for detecting bloodstream infection in neutropenic patients.

Detailed Description
-----------------
The aim of this prospective, observational, non-interventional, multi-centre study of the diagnostic use of DISQVER (Platform for digital pathogen diagnostics from Noscendo GmbH) in neutropenic patients with FN (Febrile neutropenia) is to provide further evidence of the efficacy of an NGS (Next-generation seqzencing)-based approach for detecting bloodstream infection in neutropenic patients.

Official Title
-----------------
Next-Generation-Sequencing Approach to Neutropenic Sepsis

Conditions
-----------------
Febrile Neutropenia

Intervention / Treatment
-----------------
* Diagnostic Test: DISQVER


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Age ≥18 years Informed consent Neutropenia defined as <500 ANC (Absolute neutrophil Count)/µl or <1000 WBC (White bloddcell Count)/µl if ANC is not available Fever (with an onset < 24h) or Sepsis (with an onset <24h) Patients with a life-threatening - organ dysfunction caused by a dysregulated host response to a suspected or proven infection. Exclusion Criteria: Age < 18 years Refusal or inability to give consent Inability to give informed consent if no acceptable patient representative is available Patients who had previously been included, but develop a new episode of fever during the same hospitalization, will not be included a second time Death is deemed imminent and inevitable

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 |
| --- |
|Diagnostic Test: DISQVER|NGS based infection diagnosis|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Evaluation of the performance of a NGS-based | Number of Participants with detection of pathogen | Baseline | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Average process time for NGS-based measurements | Timeframe of sampling to result of NGS-based sampling | Baseline |
Pharmacokinetics of BPDO-1603 or BPDO-16031 and BPDO-16033 Administration in Healthy Adults

Study Overview
=================
Brief Summary
-----------------
Pharmacokinetics and safety of BPDO-1603 or BPDO-16031 and BPDO-16033 administration in healthy adults. Randomized, open-label, single-dose, cross-over, Phase 1 study

Official Title
-----------------
Pharmacokinetics and Safety of BPDO-1603 or BPDO-16031 and BPDO-16033 Administration in Healthy Adults. Randomized, Open-label, Single-dose, Cross-over, Phase 1 Study

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

Intervention / Treatment
-----------------
* Drug: BPDO-1603


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Healthy adults aged 19 or older and 55 or less at the time of screening tests Men weigh 55 kg or more and women weigh 50 kg or more Those with a body mass index of 18.5 kg/m2 or more and less than 27.0 kg/m2 Exclusion Criteria: Clinically significant active chronic diseases, hepatometer (severe liver disorder, etc.), kidney (severe kidney disorder, etc.), and nervous system (hepatorespiratory tract patients). Parkinson's disease, immune system, respiratory system (asthenia, obstructive pulmonary disease, etc.), urinary system, digestive system (digestive ulcer, etc.), endocrine system, blood/tumor, cardiovascular system (cardiac infarction, heart failure, uncontrolled hypertension, atrioventricular junction disorder, etc.), or have a history. A person who has a serious urinary tract infection due to renal tubular acidosis, etc. or has a history of history Those with genetic problems such as galactose intolerance, Lapp lactase deficiency, or glucose-galactose malabsorption

Ages Eligible for Study
-----------------
Minimum Age: 19 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: Treatment
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: BPDO-1603<br>1 tablet contains memantine 20mg/donepezil 10mg | Drug: BPDO-1603<br>* donepezil/mematine<br>|
| Active Comparator: BPDO-16031,BPDO-16033<br>1 tablet memantine 20mg and 1 tablet donepezil 10mg | Drug: BPDO-1603<br>* donepezil/mematine<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Cmax of memantine and donpezil | pharmacokinetic properties | from baseline to day 10 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| AUClast of memantine and donpezil | pharmacokinetic properties | from baseline to day 10 | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Alzheimer's disease, Dementia
Online Hemodiafiltration Versus Hemodialysis in Removal of Indoxyl Sulfate in Chronic Hemodialysis Patients

Study Overview
=================
Brief Summary
-----------------
this study aimed to compare the removal of indoxyl sulphate between hemodiafiltration, high flux hemodialysis and low flux hemodialysis

Official Title
-----------------
Hemodiafiltration Versus Hemodialysis in Removal of Indoxyl Sulfate in Chronic Hemodialysis Patients

Conditions
-----------------
Hemodialysis

Intervention / Treatment
-----------------
* Procedure: online hemodiafiltration
* Procedure: high flux hemodialysis
* Procedure: low flux hemodialysis


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: maintenance hemodialysis patients aged more than 18 years Exclusion Criteria: active illnesses, hospitalization, malignancy

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 75 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: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: online hemodiafiltration<br> | Procedure: online hemodiafiltration<br>* 20 patients on regular hemodialysis received online hemodiafiltration<br>|
| Active Comparator: high flux hemodialysis<br> | Procedure: high flux hemodialysis<br>* 20 patients on regular hemodialysis received high flux hemodialysis<br>|
| Active Comparator: low flux hemodialysis<br> | Procedure: low flux hemodialysis<br>* 20 patients on regular hemodialysis received low flux hemodialysis<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| dialytic removal of indoxyl sulpahte | assessed by the reduction ration of indoxyl sulphate | one month when all samples were collected |