linjc16/ctgov huggingface dataset:
Entia Liberty: Capillary Validation

Study Overview
=================
Brief Summary
-----------------
This study is a clinical performance validation study to evaluate the performance of the Entia Liberty device. Patients undergoing routine venepuncture blood tests will be recruited to have an Entia Liberty test (by finger-prick) done on them by a trained healthcare professional. The results from that finger-prick test will be compared against the results from the routine venepuncture blood test (reference method) and subsequently, excess blood from the routine venepuncture test will be run on another Entia Liberty device in the laboratory. All three results (Entia Liberty capillary, Entia Liberty venous and gold standard venous) will be compared against each other to prove Entia Liberty's performance claims.

Official Title
-----------------
Entia Liberty: Clinical Performance Validation - Capillary Performance

Conditions
-----------------
Cancer

Intervention / Treatment
-----------------
* Device: Entia Liberty


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Age >18 years old at the time of study entry Currently receiving standard of care systemic anti- cancer therapy (chemotherapy, immunotherapy, endocrine and targeted therapy) for solid organ malignancy and has received at least one cycle. Scheduled to be undergoing routine venous laboratory blood tests as part of standard of care Can provide written informed consent Blood samples collected and stored in K2-EDTA vacutainers only Exclusion Criteria: Known inherited or acquired bleeding disorder History of haematological malignancy Known poorly controlled anti-coagulation Inadequate use and understanding of the English language, requiring a translator

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 |
| --- |
|Device: Entia Liberty|Home monitoring device|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To obtain/validate the value of the total error of the Entia Liberty device. | The dataset from this study will provide evidence to support the device's performance claims. | 3 months | 
| To obtain/validate the value of the linearity of the Entia Liberty device. | The dataset from this study will provide evidence to support the device's performance claims. | 3 months | 
| To obtain/validate the value of the bias of the Entia Liberty device. | The dataset from this study will provide evidence to support the device's performance claims. | 3 months |
BiPAP for Cardiomyopathy With Central Sleep Apnea

Study Overview
=================
Brief Summary
-----------------
We investigated whether treatment of central sleep apnea-hypopnea with bilevel positive airway pressure (BiPAP) in patients with idiopathic dilated cardiomyopathy (IDCM) would improve LV function.

Conditions
-----------------
Dilated Cardiomyopathy

Intervention / Treatment
-----------------
* Device: bilevel positive airway pressure
* Device: bilevel positive airway pressure (Device)


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Idiopathic dilated cardiomyopathy Exclusion Criteria: a history of alcohol abuse, diabetes mellitus, endocrine disorders, hypertension, obstructive sleep apnea syndrome, and chronic obstructive pulmonary disease

Ages Eligible for Study
-----------------
Minimum Age: 20 Years
Maximum Age: 70 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

| Intervention/Treatment |
| --- |
|Device: bilevel positive airway pressure|nan|
|Device: bilevel positive airway pressure (Device)|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
Open-label V565 Target Engagement Study

Study Overview
=================
Brief Summary
-----------------
The purpose of the study is to confirm that V565 enters inflamed tissue, binds to TNF and reduces inflammation after oral dosing to patients with IBD.

Detailed Description
-----------------
Single-site, open-label study in up to 6 patients treated for up to 7 days with sigmoidoscopy and biopsies before and after treatment period to determine biological activity.

Official Title
-----------------
An Open-label Exploratory Study in Patient Volunteers With Ulcerative Colitis (UC), to Investigate Lamina Propria Presence and Evidence of Biological Effect of the Oral Domain Antibody V565

Conditions
-----------------
Ulcerative Colitis

Intervention / Treatment
-----------------
* Biological: V565


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Established diagnosis of UC for 12 months or more Distal disease, accessible by flexible sigmoidoscopy Mild to moderate UC as defined as Mayo score between 3 - 10 with Mayo endoscopic sub score ≥1 Exclusion Criteria: A known hypersensitivity to any of the inactive ingredients of the study treatment A diagnosis of any IBD except UC Isolated proctitis Stool culture positive for C. difficile or other enteric infection Untreated tuberculosis (TB); positive QuantiFERON-TB Gold Test result (performed by Central Laboratory) Evidence of previous or present hepatitis B or C infection Known severe viral infection within six weeks prior to Visit 1 Current use of topical mesalazine or anti-infectives for serious infection (or within 1 week) Anti-TNFα therapy other than the study drug Parenteral or enteral nutrition therapy Current use of any biologic agent Primary failure or secondary loss of response (LOR) to use of a TNFα inhibitor Contraindication to TNFα inhibitor Clinically significant abnormal laboratory test result at screening Taken an investigational drug within 3 months or 5 half-lives (whichever is longer) prior to the first dose in this study.

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: V565<br>V565 orally three times daily for up to 7 days | Biological: V565<br>* Capsules for oral administration<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Reduction of phosphorylation in mucosal biopsies |  | After 7 days oral treatment | 
| Presence of drug in mucosal biopsies |  | After 7 days oral treatment |
Infective Keratitis in Minia Governate

Study Overview
=================
Brief Summary
-----------------
The purpose of the study is to determine the microbiological aetiology, epidemiological factors, and clinical profile and treatment outcomes of infective keratitis in Ophthalmology department, Minia University. Egypt

Detailed Description
-----------------
Prospective, non-randomized, observational clinical series of cases, including 150 patients clinically diagnosed as infective corneal ulcer, attending the Ophthalmology Department - Faculty of Medicine. Minia University, Minia, Egypt. From 2018 to 2020. Detailed history taking and all clinical findings were collected. Corneal scrapings were obtained from patients and subjected to staining and culture for bacterial and fungal pathogens; Bacterial and fungal growth were identified by standard laboratory procedures.

Official Title
-----------------
Epidemiology, Clinical Profile and Treatment Outcomes of Bacterial and Fungal Keratitis in Minia Governate, Egypt

Conditions
-----------------
Infective Keratitis

Intervention / Treatment
-----------------
* Other: antimicrobial treatment


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: clinically diagnosed as infective corneal ulcer, attending the Ophthalmology Department - Faculty of Medicine - Minia University, Minia, Egypt Exclusion Criteria: healed keratitis

Ages Eligible for Study
-----------------
Minimum Age: 12 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: Treatment
Intervention Model: Sequential Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: infective keratitis<br>150 patients with mean age 30 (range 12 to 85 years), 90 patients (60 %) were males and 60 (40%) were females, clinically diagnosed as infective corneal ulcer, attending the Ophthalmology Department - Faculty of Medicine. Minia University, Minia, Egypt. From 2018 to 2020. | Other: antimicrobial treatment<br>* Detailed history taking and all clinical findings were collected. Corneal scrapings were obtained from patients and subjected to staining and culture for bacterial and fungal pathogens; Bacterial and fungal growth were identified by standard laboratory procedures.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Positive smear and culture | positive smear culture for bacteria and fungi | 1 month | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
infective keratitis, Bacterial keratitis, Fungal keratitis
HILO-HF Registry: High Versus Low SpO2 Oxygen Therapy in Patients With Acute Heart Failure

Study Overview
=================
Brief Summary
-----------------
The HILO-HF Registry is a single centre registry that will be performed to provide information on the usual baseline oxygen saturation (SpO2) in patients presenting to ED with a primary ED diagnosis of AHF

Official Title
-----------------
High Versus Low SpO2 Oxygen Therapy in Patients With Acute Heart Failure

Conditions
-----------------
Acute Heart Failure

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients >40 years of age presenting to the ED with AHF With or without tested BNP With or without admission to hospital for treatment of HF\ Patients must be recruited within the first 24 hours of presenting to the ED. Exclusion Criteria: Patients on home oxygen Patients with known prior hypercapnic failure (PaCO2>50 mmHg) Asthma Primary pulmonary hypertension Patients requiring urgent positive pressure ventilation or intubation or on >10 L/min oxygen

Ages Eligible for Study
-----------------
Minimum Age: 40 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 |
| --- | --- |
| Observational Cohort<br>All patients will receive usual standard of care with the heart failure management including the routine supplemental oxygen therapy. | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in blood oxygen saturation levels from baseline to 72 hours |  | 72 hours | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Dyspnea on visual analogue scale (VAS) to 72 hours |  | 72 hours | 
| Change in global symptoms using Patient Global Assessment (PGA) measure to 72 hours |  | 72 hours | 
| Change in Peak Expiratory Flow |  | 72 hours | 
| Rate of patients with Worsening Heart Failure |  | 7 days | 
| 30-day composite clinical event (all-cause mortality, HF readmission, days alive and out of hospital) |  | 30days |
Evaluation of the Cost of a Nosocomial Infection With Clostridium Difficile

Study Overview
=================
Brief Summary
-----------------
Clostridium difficile is the first cause of nosocomial infectious diarrhea, due to its mode of transmission and its resistance in the environment. Nosocomiality is defined by the apparition of an infection 48 hours after the patient's hospitalization. Clostridium difficile contamination occurs oro-fecally and is transmitted directly through the hand or from the contaminated environment (during care or not). By implementing prevention and optimal treatment, nosocomial infections are preventable. A clostridium difficile infection causes an additional cost of patient care for the hospital. This additional cost is principally due to the increase of the length of the stay. It varies according to patient risk factors,and also according to the reason of the hospitalization and can vary from 300 euros ( 317$) to more than 25.000 euros (26.460$). By determining the increase in the length of the stay and the additional cost due to a clostridium difficile infection in the GHICL (Groupement des Hôpitaux de l'Institut Catholique de Lille), prevention will be valued and measures against those infections should be easier to set up. The main objective of this study is to evaluate the additional cost of an infection by clostridium difficile.

Conditions
-----------------
Cross Infection, Clostridium Difficile Infection

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients that have stayed in an hospital of the GHICL between January 2013 and September 2015. Exclusion Criteria: none
Sexes Eligible for Study
-----------------
All

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| clostridium difficile<br>Patients that have been infected by clostridium difficile during their stay in hospital | |
| no clostridium difficile<br>Patients that have not been infected during their stay in hospital. | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Difference between patient cost and income for the hospital based on the PMSI rate. | The difference between the real cost of the patient stay, included the additional costs due to clostridium difficile infection, and the public funding (calculated using the PMSI) for this stay will be computed. | Day 1 |
Sonazoid-enhanced Ultrasound for the Detection of Colorectal Liver Metastases Less Than 2 cm

Study Overview
=================
Brief Summary
-----------------
Preoperative chemotherapy is often used for patients with colorectal cancer liver metastasis (CLM). Many small CLMs (<=2cm) may disappear after chemotherapy, while most of these are still alive. Ultrasonography (US) is a common imaging modality for the intraoperative detection tumor. Sonazoid is new echo-contrast agent, which is more stable and sensitive for detecting of small tumor. Investigators initially this prospective study to compare the detection performance before and after using sonazoid.

Official Title
-----------------
Evaluation of Contrast Sonazoid-enhanced Ultrasound for the Detection of Colorectal Liver Metastases Less Than 2 cm

Conditions
-----------------
Liver Metastasis Colon Cancer

Intervention / Treatment
-----------------
* Diagnostic Test: After sonazoid


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Pathology confirmed colorectal adenocarcinoma One or more liver metastases less than 2 cm Multidisciplinary team recommend to perform preoperative chemotherapy Have baseline EOB-MR before chemotherapy Exclusion Criteria: Could not fulfill the criteria of no evidence of disease (NED) after hepatic resection/ablation/radiotherapy With other malignancies

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 85 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 |
| --- | --- |
| Before sonazoid<br>US detection liver metastases before sonazoid | |
| After sonazoid<br>US detection liver metastases after sonazoid | Diagnostic Test: After sonazoid<br>* 0.015ml/mg sonazoid enhanced US to detection of liver metastases.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| sensitive of detection tumor | Change of the sensitivity detection liver tumors when using sonazoid enhanced ultrasound | 6 months |
Optimization of Music Compression

Study Overview
=================
Brief Summary
-----------------
Hearing impaired persons suffer from inferior music perception with and without hearing aids. Hearing aids, however, are primarily designed to improve speech intelligibility not music enjoyment. This study investigates the potential benefit of signal processing strategies that are optimized for music. The purpose of this study is to improve music compression for hearing impaired people.

Official Title
-----------------
Optimization of Music Compression for People With Hearing Impairment

Conditions
-----------------
Hearing Loss

Intervention / Treatment
-----------------
* Other: Audio signal processing (applied offline before playback)


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Female and male adults between 18 and 99 years German-speaking Symmetric, mild to severe, ski-slope hearing loss Binaural hearing aid user without frequency lowering Informed Consent as documented by signature Exclusion Criteria: Have taken part in a study at Phonak within 4 months prior to the first session People with mental-health problems People whose audiogram is older than 12 months and it is not possible make a reliable measurement Very limited motor activity or mobility

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 99 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: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Compressive signal processing algorithm<br>Participants compare music signals with preprocessing to the same music signals without compressive preprocessing. | Other: Audio signal processing (applied offline before playback)<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Benefit of signal processing for music perception | Participants rate the enjoyment of music in 4 separate sessions, spread over an anticipated time frame of 3 months. | 3 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Performance in music discrimination tests | Participants perform an adaptive music discrimination test in which their discrimination thresholds are measured. | 3 months |
Study of the Prevalence of Iron Deficiency in Patients With Chronic Inflammatory Bowel Disease

Study Overview
=================
Brief Summary
-----------------
Despite its known prevalence in IBD, a recent study conducted with Prof. Cacoub (unpublished) on the national health insurance database showed that iron deficiency was an under-diagnosed and under-treated co-morbidity. In chronic diseases including IBD, Transferrin Saturation Factor is only performed in approximately 10% of cases, whereas it is recommended in inflammatory situations including IBD patients (HAS 2011). The objective of this study is therefore to obtain updated French data on the prevalence of iron deficiency in patients with IBD by applying the recommendations of ECCO and French Health High Authority (determination of ferritinemia and Transferrin Saturation Factor)

Official Title
-----------------
Study of the Prevalence of Iron Deficiency in Patients With Chronic Inflammatory Bowel Disease

Conditions
-----------------
Intestinal Disease

Intervention / Treatment
-----------------
* Diagnostic Test: Iron status testing


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patient, male or female, over 18 years old Patient present at the hospital on the day of the study Diagnosis of IBD on international criteria Patient giving written consent Exclusion Criteria: Protected patient: major under guardianship, curatorship or other legal protection, deprived of liberty by judicial or administrative decision; pregnant, lactating or parturient woman; Patient hospitalized without consent

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: IBD<br> | Diagnostic Test: Iron status testing<br>* Iron status testing<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Ferritinemia according to inflammatory status | Ferritinemia will be assessed from blood sample (iron status) | One day |