linjc16/ctgov huggingface dataset:
A Validation of the Functional Low-Vision Observer Rated Assessment (FLORA-20) for Profoundly Blind Individuals

Study Overview
=================
Brief Summary
-----------------
This study aims to validate an observer-rated assessment titled Functional Low-Vision Observer Rated Assessment (FLORA-20), which comprises 20 functional vision tasks commonly performed in or around a blind individual's home environment. This study shall be carried out with individuals who have an implanted visual prosthesis device. There are no new implantations or changes to the original implant or external wearables being studied or tested. Additionally, data from the study shall not be used alter standard of care or the user's treatment options.

Official Title
-----------------
A Validation of the Functional Low-Vision Observer Rated Assessment (FLORA-20) for Profoundly Blind Individuals

Conditions
-----------------
Blindness, Acquired

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Subjects implanted with the Argus II or Orion device Subjects able to understand the written informed consent and willing to participate as evidenced by signing the informed consent Subject is able to follow instructions and comply with FLORA-20 scheduling and completion of tasks Subject is willing to be filmed while performing the FLORA-20 tasks during the study Exclusion Criteria: Subject is unsuitable for study participation as determined by Investigator's clinical judgment (with Sponsor's final input).

Ages Eligible for Study
-----------------
Minimum Age: 22 Years
Maximum Age: 74 Years

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

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

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Inter-observer reliability | Intraclass correlation coefficient (ICC) of the overall FLORA-20 scores provided by each of the assessors (in-person and remote) | Single 1 day visit | 
| Intra-observer reliability | ICC of the overall FLORA-20 scores provided by the same assessor, assessed and re-assessed at two different time points | Single 1 day visit | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Improvement in Average Performance, ON vs. OFF | Paired t-test to determine if there is a statistically significant improvement in average performance from ON vs. OFF | Single 1 day visit | 
| Clinical Meaningfulness (Effect Size) | Cohen's d calculation of overall FLORA-20 scores between device ON vs. OFF | Single 1 day visit | 
| Internal consistency - Cronbach's alpha | Cronbach's alpha of the individual FLORA-20 task scores | Single 1 day visit | 
| Internal consistency - item-total correlations | Item-total correlations for each FLORA-20 task | Single 1 day visit | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Observer-rated instrument
Sustain, A.S.P.E.N. HPN Registry 2011

Study Overview
=================
Brief Summary
-----------------
The American Society for Parenteral and Enteral Nutrition (A.S.P.E.N.) developed a Web-based registry for nutrition care launched in early 2011, initially focusing on the home parenteral nutrition (HPN) patient population. The purpose of Sustain is to collect information regarding the patients and populations who require HPN in the United States, measure outcomes associated with HPN, allow institutional benchmarking against the aggregate data, and publish the findings to improve the quality of care for patients receiving HPN. The registry is open to all sites (hospital and home based) who care for new or existing HPN patients.

Official Title
-----------------
SustainTM,LLC: A.S.P.E.N.'s National Patient Registry for Nutrition Care- Home Parenteral Nutrition

Conditions
-----------------
Patients Requiring Home Parenteral Nutrition

Intervention / Treatment
-----------------
* Other: all patients on Home Parenteral Nutrition


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria:must receive PN at home - Exclusion Criteria:patients receiving PN in long-term care or as IDPN -
Sexes Eligible for Study
-----------------
All

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Home PN - pediatric<br>Pediatric patients (under 18) on Home PN | Other: all patients on Home Parenteral Nutrition<br> <br> |
| Adult patients on Home PN<br>Adult patients on Home PN | Other: all patients on Home Parenteral Nutrition<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| catheter infection rate | catheter infection rate normalized per 1000 PN days | per 1000 PN days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| rehospitalization rate | rehospitalization rate per 1000 PN days | ongoing |
Carpal Tunnel Syndrome Treated With 830nm Diode Laser

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to determine that 830nm diode laser directly above the transverse carpal ligament (between the pisiform and navicular bone) on subjects' wrists, and test this therapeutic effect.

Detailed Description
-----------------
The low level laser instrument (Painless Light PL-830, Advanced Chips & Products Crop., USA) emitted two light beams with a distance of 2.5cm between them by two laser diodes.

Official Title
-----------------
Instiutional Review Board of Chung Shan Medical University Hospital

Conditions
-----------------
Carpal Tunnel Syndrome

Intervention / Treatment
-----------------
* Device: diode laser


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: no operation of the wrist first onset of CTS more than 1 year ago with repeated episodes never having laser treatment before. Exclusion Criteria: patients with any rheumatoid arthritis history of metabolic disease or paralyzed limbs caused by stroke taking any anti-inflammatory drug with other treatments, such as acupuncture, physical therapy and wearing orthosis

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 70 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: Single Group Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: A<br>low level laser instrument (Painless Light PL-830, Advanced Chips & Products Crop., USA) | Device: diode laser<br>* wavelength at 830nm, 9.7J/cm2 for 10 min<br>* Other names: Low-level laser;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| treatment effect |  | two weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| EMG, Jamar dynamometer, Carpal tunnel function disability form |  | two weeks |
An Observational Real-world Study Evaluating Severe Tricuspid Regurgitation Patients Treated With the Abbott TriClip™ Device (bRIGHT)

Study Overview
=================
Brief Summary
-----------------
The bRIGHT EU PAS study is an observational real-world study evaluating severe tricuspid regurgitation patients treated with the Abbott TriClip™ device (bRIGHT EU Post-Approval Study).

Detailed Description
-----------------
The TriClip™ bRIGHT EU post-approval study (PAS) study is designed to confirm the safety and performance of the TriClip™ device in a contemporary real-world setting. The bRIGHT PAS study is a prospective, single arm, open-label, multi-center, post market registry, conducted to satisfy condition of CE Marking for the TriClip™.

Official Title
-----------------
An Observational Real-world Study Evaluating Severe Tricuspid Regurgitation Patients Treated With the Abbott TriClip™ Device

Conditions
-----------------
Tricuspid Valve Regurgitation

Intervention / Treatment
-----------------
* Device: Transcatheter heart valve procedure


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Subjects (>=18 years age) have severe tricuspid regurgitation and are symptomatic despite medical therapy. Subjects eligible to receive the TriClip™ per the current approved Indications for Use. Subject must provide written informed consent prior to study procedure. Exclusion Criteria: 1. Subjects participating in another clinical study that may impact the follow-up or results of this study.

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: Transcatheter heart valve procedure|Transcatheter treatment of TR with Abbott TriClip™.|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Acute Procedural Success (APS) | The primary endpoint is Acute Procedural Success (APS) defined as successful implantation of the TriClip™ device with resulting TR reduction at least 1 grade at discharge (30-day echocardiogram will be used if discharge is unavailable or uninterpretable). Subjects who die or undergo tricuspid valve surgery before discharge are considered to be an APS failure. | up to 30 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Composite endpoint of all-cause mortality or TR re-intervention | The secondary endpoint is a composite endpoint of all-cause mortality or tricuspid valve re-intervention/re-operation at 1 year. | at 1 year follow-up |
Effects of Creatine Supplementation in Women With Knee Osteoarthritis and Fibromyalgia

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to determine whether creatine associated or not to exercise training can improve physical performance in patients with knee osteoarthritis and fibromyalgia.

Conditions
-----------------
Knee Osteoarthritis, Fibromyalgia

Intervention / Treatment
-----------------
* Dietary Supplement: Creatine supplementation
* Dietary Supplement: Dextrose supplementation


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Fulfill ACR criteria of knee osteoarthritis Fulfill ACR criteria of fibromyalgia Exclusion Criteria: Athletes Drugs stable for at least three months before entering the study No limitations to resistance training

Ages Eligible for Study
-----------------
Minimum Age: 25 Years
Maximum Age: 80 Years

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

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

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

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 1<br>creatine intake | Dietary Supplement: Creatine supplementation<br> <br> |
| Placebo Comparator: 2<br>placebo (dextrose) intake | Dietary Supplement: Dextrose supplementation<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Physical function | Assessed by the timed-stands test | 12 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Strength | Assessed by the 1-repetition maximum test | 12 weeks | 
| Quality of life | health-related questionaires | 12 weeks | 
| Body composition | Assessed by DXA | 12 weeks | 
| Renal function | Assessed by 51Cr-EDTA | 12 weeks |
Biological Effects of Citrate-buffered Solutions on Dialysis Efficiency and Systemic Inflammation

Study Overview
=================
Brief Summary
-----------------
In this study 45 patients undergoing weekly dialysis for chronic end stage renal disease will be enrolled. The patients will be treated with a standard dialysis solution, containing acetate buffer, for 3 months; subsequently the acetate will be substituted with citrate anion for the 3 following months and then, the last 3 months, the standard acetate-solution will be restarted. The aim of the study is to assess if acetate-to-citrate switch in the dialysis solution influences dialysis efficiency and patient inflammatory state.

Official Title
-----------------
Biological Effects of Citrate-buffered Solutions on Dialysis Efficiency and Systemic Inflammation

Conditions
-----------------
Renal Insufficiency, Chronic, Inflammation

Intervention / Treatment
-----------------
* Drug: Dialysis Solutions


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: age >18 years creatinine clearance <5ml/min treatment with bicarbonate HD (BIC-HD) or on-line hemodiafiltration (OL-HDF) 3 times per week for at least 6 months prior to study start treated at Dialysis unit of: Città della Salute e della Scienza University Hospital, Torino, Italy Exclusion Criteria: known neoplastic disease active chronic inflammatory disease active acute inflammatory disease

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
Intervention Model: Sequential Assignment
Interventional Model Description: 45 patients with end stage renal disease will be treated with dialysis solution A (standard of care: acetate-buffered) for 3 months then with solution B (acetate-free, citrate buffered, otherwise identical to solution A) for 3 months and then with solution A for the final 3 months
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Single arm<br> | Drug: Dialysis Solutions<br>* Solution A: 3mmol/L of acetate anion; Solution B: 1mmol/L of citrate anion<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in serum CRP (C-reactive protein) | Change in serum CRP during the 3 months of citrate-buffered dialysis | Months 4th to 6th | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in dialysis efficiency | Dougirdas formula will be used to estimate dialysis efficiency at the beginning and completion of each study interval | Every 3 months (month 0, 6, 3 and completion - 9) | 
| Change in serum CRP (C-reactive protein) | Variation of serum CRP at the beginning and completion of each study interval | Every 3 months (month 0, 6, 3 and completion - 9) |
Autologous Fresh Whole Blood and Coagulation Following Cardiopulmonary Bypass in Infants

Study Overview
=================
Brief Summary
-----------------
Dilution of blood caused by cardiopulmonary bypass (the heart-lung machine) during open heart surgery is associated with decreased concentrations in the blood of coagulation factors. This can be extreme in infants because of their small blood volumes and can lead to impairment of the normal blood clotting mechanism and excessive bleeding after the operation. Transfusion of fresh whole blood has been shown to be an effective treatment because fresh blood is rich in coagulation factors. However, it is difficult to obtain truly fresh blood from a blood bank. We hypothesized that fresh blood drawn from the patient and given back after cardiopulmonary bypass would improve the clotting mechanism. In our study, the infants in the treatment group have some of their own fresh blood removed after they are anesthetized for the operation and before they are placed on cardiopulmonary bypass. This blood is then given back to them after completion of cardiopulmonary bypass. Infants in the control group will not have their own blood removed but will undergo cardiopulmonary bypass. We will compare the two groups by drawing blood samples that measure coagulation tests.

Conditions
-----------------
Congenital Heart Defects

Intervention / Treatment
-----------------
* Procedure: Autologous fresh whole blood


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Undergoing non-complex open heart surgery Diagnosis of congenital heart disease No previous open heart surgery Weight 15 kg or less

Ages Eligible for Study
-----------------
Minimum Age: 1 Month

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: Single


Arms and Interventions

| Intervention/Treatment |
| --- |
|Procedure: Autologous fresh whole blood|nan|

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
-----------------
dilutional coagulopathy
Population Based Evaluation of the Use of TNFα Antagonists in Pregnant Women With Inflammatory Bowel Diseases

Study Overview
=================
Brief Summary
-----------------
: Inflammatory bowel diseases (IBD), such as Crohn's disease (CD) and ulcerative colitis (UC) need long term treatments which can conflict with a desire of pregnancy in women. Uncontrolled IBD increases the risk of poor pregnancy outcomes [1]. Antitumor Necrosis Factor α (antiTNFα) are commonly used, off-label, in pregnancy but with the risk of treatment-related complications. Existing recommendations on the use of antiTNFα during pregnancy are conflicting and only rely on expert opinions. This study was aimed to assess appropriateness and risk to benefit ratio of antiTNFα treatment during pregnancy in women with IBD, for both the mother and the baby until the end of the first year.

Official Title
-----------------
Evaluation of Adherence to Guidelines, and of the Risk to Benefit Ratio, in the Use of TNFα Antagonists in Pregnant Women With Inflammatory Bowel Diseases. Study on the French National PMSI Database

Conditions
-----------------
Inflammatory Bowel Diseases

Intervention / Treatment
-----------------
* Other: treated by antiTNFα
* Other: not treated by antiTNFα


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: pregnancy between 01/01/2011 and 31/12/2014 Diagnosis of IBD (Crohn's disease or Ulcerative Colitis) Exclusion Criteria: Non IBD indication of antiTNFα treatment

Ages Eligible for Study
-----------------
Minimum Age: 15 Years

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

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| pregnant IBD women treated<br>pregnant IBD women treated by antiTNFα | Other: treated by antiTNFα<br>* pregnant IBD women treated by antiTNFα<br>|
| pregnant IBD women not treated<br>pregnant IBD women not treated by antiTNFα | Other: not treated by antiTNFα<br>* pregnant IBD women not treated by antiTNFα<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Overall complications | composite criteria composed by: Disease related complications Treatment related complications Pregnancy related complications | 9 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Infectious Complications in the children born from IBD mothers | Occurrence of infectious complications during the first year of life | The first year of life |
Immune Response in the SAPHO Syndrome

Study Overview
=================
Brief Summary
-----------------
The aetiology of SAPHO syndrome seems to involve genetic, infectious and immunological components. The investigators examined innate and adaptative immune responses in SAPHO syndrome as compared with psoriatic arthritis and rheumatoid arthritis.

Official Title
-----------------
Immune Mechanisms During SAPHO Syndrome and Treatment by Etarnecept

Conditions
-----------------
SAPHO Syndrome

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Clinical diagnosis of SAPHO syndrome Must have bone lesions Exclusion Criteria: Infliximab treatment

Ages Eligible for Study
-----------------
Minimum Age: 1 Year
Maximum Age: 70 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 |
| --- | --- | --- |
| IL-8 production by PMN |  | 24 h | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| TNFalpha production by PMN |  | 24 h | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
SAPHO syndrome, Innate immunity, TNF alpha, Polymorphonuclear neutrophils, Propionibacterium acnes, Interleukin-8