linjc16/ctgov huggingface dataset:
Randomised Controlled Trial of Unsolicited Occupational Therapy in Community-Dwelling Elderly

Study Overview
=================
Brief Summary
-----------------
In this study we aim to assess whether unsolicited occupational therapy compared to no therapy can decelerate the increase in disability in high-risk elderly.

Detailed Description
-----------------
Community-dwelling elderly, and particularly the oldest old, are generally viewed as highly susceptible to the 'inverse care law'. That is, those in greatest need for preventive assessment and surveillance have the highest potential benefit but are most likely to be missed. Hence, active case-finding and close follow-up might be an important strategy for maintaining the health, independence, and well-being of very elderly people who are at a particularly high risk. In this study we aim to assess whether unsolicited occupational therapy compared to no therapy can decelerate the increase in disability in high-risk elderly. Subjects in the intervention group will be visited by an occupational therapist who provides training and education about assistive devices that are already present and will give recommendations and information about procedures, possibilities, and costs of assistive devices and community-based services. Control subjects will not be visited by an occupational therapist. The primary outcome measure of the trial will be the score on the Groningen Activity Restriction Scale (GARS). Secondary outcome measures will be well-being and feelings of loneliness.

Official Title
-----------------
Randomised Controlled Trial of Unsolicited Occupational Therapy in Community-Dwelling Elderly

Conditions
-----------------
Disability, Occupational Therapy

Intervention / Treatment
-----------------
* Behavioral: occupational therapy


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: age 85 years living independently MMSE score > 18 points Exclusion Criteria: none

Ages Eligible for Study
-----------------
Minimum Age: 85 Years
Maximum Age: 85 Years

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

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

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

Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Intervention/Treatment |
| --- |
|Behavioral: occupational therapy|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Score on the Groningen Activity Restriction Scale (GARS) |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Well-being and feelings of loneliness. |  |  | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
disability, occupational therapy
Prospective, Non-interventional, Multi-center Post-authorization Safety Study of Eylea for Central Retinal Vein Occlusion (CRVO)

Study Overview
=================
Brief Summary
-----------------
This is a prospective, non-interventional, multi center post-authorization safety study that includes patients with a diagnosis of CRVO. The investigator will have made the choice of treatment (EYLEA) as well as the decision to use EYLEA according the Japanese Package Insert prior to enrolling the patient in this study. The observation period for each patient starts when therapy with EYLEA is initiated. The enrollment period is 2 years. Patients will be followed for a time period of 2 years or until it is no longer possible (e.g. lost to follow-up) within the 2 years. For each patient, data are collected as defined in the case report form at the initial visit, follow-up visits and final visit, either by routine clinical visits (as per investigators routine practice). There will interim analysis of study data: 6 months after last patient first visit and J-PSUR(Japanese-Periodic Safety Update Report )

Official Title
-----------------
Special Drug Use Investigation of EYLEA for CRVO

Conditions
-----------------
Retinal Vein Occlusion

Intervention / Treatment
-----------------
* Drug: Aflibercept (Eylea, VEGF Trap-Eye, BAY86-5321)


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients who start EYLEA treatment for CRVO Exclusion Criteria: Patients who have already received EYLEA treatment Patients who are contraindicated based on approved label
Sexes Eligible for Study
-----------------
All

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Group 1<br>Eylea treatment goup | Drug: Aflibercept (Eylea, VEGF Trap-Eye, BAY86-5321)<br>* 2 mg of Eylea will be treated per one injection at more than one months interval usually.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of episodes of adverse drug reactions and adverse events(serious or non-serious, related or not related, ocular or non ocular) |  | 6 months after start of treatment with the drug | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Effectiveness (visual acuity) |  | 6months after start of treatment with the drug | 
| Effectiveness (retina thickness) |  | 6months after start of treatment with the drug | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
CRVO, Macular edema, Aflibercept, anti-VEGF
Outcomes of Critically Ill Patients With Severe Acute Kidney Injury Requiring Renal Replacement Therapy

Study Overview
=================
Brief Summary
-----------------
This study assess the vital status, renal function and renal recovery of patients admitted to intensive care unit and requiring renal replacement therapy for acute kidney failure. Patient follow up is up to 3 years after ICU admission when possible.

Detailed Description
-----------------
Up to 50% of critically ill patients develop acute kidney injury and up to 10% require renal replacement therapy in the intensive care unit. This study aims to identify factors associated with mortality and to evaluate renal recovery of patients who had acute kidney failure requiring renal replacement therapy in intensive care unit at 1 and 3 years post intensive care unit admission.

Official Title
-----------------
Outcomes of Critically Ill Patients With Severe Acute Kidney Injury Requiring Renal Replacement Therapy

Conditions
-----------------
Critical Illness, Acute Kidney Injury

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Adults admitted to the intensive care Acute kidney failure requiring renal replacement therapy Exclusion Criteria: Patients suffering end stage renal failure requiring chronic renal replacement therapy Patients under 18 years

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 |
| --- | --- |
| critically ill patients<br>critically ill patients with acute kidney failure requiring renal replacement therapy | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| one-year mortality | vital status | year 1 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| hospital mortality |  | year 1 | 
| one year renal function |  | Year one | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
critically ill patients, acute kidney injury, renal replacement therapy, long term outcome
CytoSorb in Patients With Liver Failure

Study Overview
=================
Brief Summary
-----------------
Hemoadsorption has been demonstrated to improve liver functional tests in patients with liver failure. The present study investigates the effects of three consecutive sessions of hemoadsorption, performed in accordance to the local protocol for treating patients with acute liver failure, on liver functional tests, severity scores and 30-days mortality. Paraclinical results and severity scores were obtained before and after the three consecutive sessions.

Official Title
-----------------
Effects of Renal Replacement Therapy With Hemoadsoption in Patients With Liver Failure

Conditions
-----------------
Liver Dysfunction

Intervention / Treatment
-----------------
* Procedure: hemoadsorption


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: patients with acute liver failure or acute on chronic liver failure who require hemoadsorption in accordance with local guidelines Exclusion Criteria: unsigned informed consent duration of therapy under 12 hours death before the three consecutive sessions

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 |
| --- | --- |
| liver failure<br>patients diagnosed with acute liver failure or acute on chronic liver failure in accordance with national guidelines who require 3 consecutive sessions of hemoadsorption | Procedure: hemoadsorption<br>* three consecutive sessions of hemoadsorption in patients with liver failure<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 30 days mortality | 30 days mortality | 30 days |
Urine Sample Collection for Validation of the AnchorDx UriFind™ Bladder Cancer Assay

Study Overview
=================
Brief Summary
-----------------
The AnchorDx UriFind™ Bladder Cancer Assay is designed to detect 2 DNA methylation biomarkers in urine specimens from patients 22 years or older suspected of having bladder cancer. Results from the assay are intended for use, in conjunction with current standard diagnostic procedures, as an aid for initial diagnosis of bladder carcinoma in patients.

Official Title
-----------------
Urine Sample Collection for Validation of the AnchorDx UriFind™ Bladder Cancer Assay in Subjects Suspected of Having Bladder Cancer

Conditions
-----------------
Bladder Cancer

Intervention / Treatment
-----------------
* Diagnostic Test: UriFind Bladder Cancer Assay


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Clinical Validation Group: 55 years or older, gender is not limited Suspected of bladder cancer and are scheduled for bladder biopsy or trans-uretheral resection of bladder tumor (TUBRT) Can receive standard of care, including urine cytology, cystoscopy, or surgery for bladder cancer diagnosis Can provide at least of 75 ml of urine (prior to cystoscopy or surgery) Exclusion Criteria: History of urinary cancer Neoadjuvant therapy

Ages Eligible for Study
-----------------
Minimum Age: 55 Years
Maximum Age: 100 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 |
| --- | --- |
| Clinical Validation Group<br>Patients with suspected bladder cancer (including hematuria, inflammatory bladder, suspicious ultrasound results) | Diagnostic Test: UriFind Bladder Cancer Assay<br>* The AnchorDx UriFind™ Bladder Cancer Assay is designed to detect 2 DNA methylation biomarkers in urine specimens from patients 22 years or older suspected of having bladder cancer. Results from the Assay are intended for use, in conjunction with current standard diagnostic procedures, as an aid for initial diagnosis of bladder carcinoma in patients.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Sensitivity and Specificity of UriFind assay in detecting early stage Bladder Cancer | To evaluate the performance of the UriFind assay relative to the patient at diagnosis (cystoscopy or surgery followed by histology). | Baseline |
Olfaction Changes in Patients Undergoing Spine Surgery

Study Overview
=================
Brief Summary
-----------------
This observational prospective study evaluates perioperative olfaction alterations, comprising changes in threshold value, discrimination and identification, which occur in spine patients. The single group is subjected to a preoperative and a postoperative assessment.

Official Title
-----------------
Prospective Observational Pilot Study on Olfaction Alterations That Occur in Spine Patients After Surgery

Conditions
-----------------
Orthopedic Disorder of Spine, Smell Disorder

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Males or females Caucasian race Between 50 and 85 years of age Candidates to spine surgery Acceptance and signing of informed consent Exclusion Criteria: Past or present cancer Heart failure Kidney failure (III-IV) Past or present neuropsychiatric disorders Heavy smokers (over/equal 3 cigarettes per day) Smell disorders Rhinitis Allergies to the respiratory system

Ages Eligible for Study
-----------------
Minimum Age: 50 Years
Maximum Age: 85 Years

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

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

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Changes in olfaction threshold | Changes in the olfaction threshold evaluated with a series of solutions having different concentrations of aromas | Day before surgery and first day after surgery |
Serum Biomarkers Analysis in Patients With AR Treated With Anti-TMF

Study Overview
=================
Brief Summary
-----------------
Multicenter, prospective, observational study for evaluating if circulant rheumatoid factor, cyclic citrullinated anti-peptide anti-bodies and albumin can be used as potential predictors in the response to the treatment with anti-TNF in patients with rheumatoid arthritis after 24 weeks of treatment.

Official Title
-----------------
Analysis of Circulant Rheumatoid Factor, Cyclic Citrullinated Anti-peptide Anti-bodies and Albumin as a Potential Predictor in the Response to the Treatment With Anti-TNF in Patients With Rheumatoid Arthritis

Conditions
-----------------
Rheumatoid Arthritis

Intervention / Treatment
-----------------
* Drug: Anti-TNF


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Both genders Over 18 years old Diagnosis of rheumatoid arthritis according to ACR criteria Patients that initiate treatment with anti-TNF drugs according to clinical practice, both in naïve anti-TNF patients and patients after first anti-TNF failure Patients able to follow the protocol requirements Patients that signed the informed consent Exclusion Criteria: Patients with known hypersensitivity to investigational products Patients with tuberculosis, or severe infections like sepsis or opportunistic infections Patients with moderate/severe cardiac insufficiency (NHYA classification Class III/IV) Patients that according to the investigator criteria can not participate in the study or complete the study questionnaires Pregnant or fertile woman that does not use a contraception method

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 |
| --- | --- |
| Anti-TNF<br> | Drug: Anti-TNF<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Anti-TNF treatment response based on circulant rheumatoid factor |  | 24 weeks | 
| Anti-TNF treatment response based on circulant cyclic citrullinated anti-peptide antibodies. |  | 24 weeks |
Effect of a Third COVID-19 Booster Among Health Care Workers

Study Overview
=================
Brief Summary
-----------------
A new wave of COVID-19 infections, mainly caused by the Omicron/ Delta variant, has been sweeping the globe since the start of 2022. In response, the administration of a third dose of COVID-19 vaccine was considered to address potential waning immunity over time and reduced effectiveness against the Omicron/ Delta variant. The pandemic also resulted in many infections among health care workers (HCWs) and their households. In this study, a retrospective analysis would perform on risk of COVID-19 infection and their outcome in relation to their COVID-19 vaccination history by using the data repository from one of the Hong Kong private hospitals. HCWs were required to submit a standardized online self-declaration form for report of 1) demographic of the HCWs, 2) symptoms related history and 3) COVID-19 exposure history once they were COVID-19 confirmed by rapid antigen test against COVID-19 and/or polymerase chain reaction (PCR) test for COVID-19. Subsequent follow up such as contact tracing, COVID-19 PCR testing results of these HCWs and status of return to work were captured by the infection control team in a systematic manner.

Official Title
-----------------
Effect of a Third COVID-19 Booster on COVID-19 Infection Rate and Return to Works During Fifth Wave COVID-19 Among Health Care Workers

Conditions
-----------------
COVID-19 Vaccines

Intervention / Treatment
-----------------
* Biological: Third COVID-19 booster


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: All full time staff members of the private hospital Exclusion Criteria: History of COVID-19 before 2022

Ages Eligible for Study
-----------------
Minimum Age: 18 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 |
| --- | --- |
| Health care workers without third COVID-19 booster<br>Health care workers received less than 3 doses of COVID-19 vaccine | |
| HCWs with third COVID-19 booster<br>Health care workers received at least 3 doses of COVID-19 vaccine | Biological: Third COVID-19 booster<br>* Third COVID-19 booster<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| COVID-19 Infection | Number of participants with COVID-19 infected | During 1 February - 31 March 2022 | 
| Number of days return to work after COVID-19 infection | Number of days return to work after COVID-19 infection | During 1 February - 31 March 2022 |
Therapeutic Efficacy of Intense Pulsed Light in the Treatment of Chalazion

Study Overview
=================
Brief Summary
-----------------
Study method: This test screened the subjects first, and proposed to include 50 subjects with primary or recurrent eyelid plate gland cysts without obvious surgical indications. All subjects underwent three strong pulsed light therapy combined with eyelid plate gland massage, treatment of local anesthesia eye drops, and metal pads were placed in conjunctival sac protection. Eye protection, using the M22 strong pulsed light small optical treatment head of the medical company, energy selection 14-16J/cm2, laser position is selected on the upper and lower eyelids, 3mm away from the root of the eyelashes. Each interval is 3 weeks. Eye-related examinations were performed before treatment and 3 times after treatment. The evaluation content included: ocular surface, slit lamp observation, anterior segment photography, intraocular pressure, vision, corneal fluorescein staining, tear film rupture time, eyelid plate gland evaluation, eyelid plate gland cyst relief, eyelid plate gland cyst recurrence rate.

Official Title
-----------------
Therapeutic Efficacy of Intense Pulsed Light in the Treatment of Chalazion

Conditions
-----------------
Chalazion

Intervention / Treatment
-----------------
* Device: IPL
* Procedure: Conservative treatment or excision with curettage


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients had primary or recurrent eyelid plate gland cyst without obvious surgical indications Exclusion Criteria: (1) any intraocular inflammation, ocular infection, allergy, ocular surgery, or ocular trauma in the past 6 months; (2) any eyelid diseases or structural abnormality; (3) any systematic diseases may lead to dry eye or MGD; (4) skin cancer or pigmented lesion in the treatment zone.

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: Treatment
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Experimental group<br>Receiving IPL-MGD treatment. | Device: IPL<br>* intense pulsed light<br>|
| Active Comparator: Control group<br>Another set of age, sex and diagnosis matched consecutive cases of chalazion, who received conservative treatment or excision with curettage but without IPL-MGX treatment as a control (Non-IPL group). | Procedure: Conservative treatment or excision with curettage<br>* conservative treatment or excision with curettage but without IPL-MGX treatment as a control<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Recurrence rate of chalazia | The recurrence of the chalazia | An average of 1 year |