linjc16/ctgov huggingface dataset:
Median Nerve Strain and Applied Pressure Measurement in the Carpal Tunnel Syndrome Patients

Study Overview
=================
Brief Summary
-----------------
The aim of this study is to investigate diagnostic accuracy of median nerve strain and applied pressure measurement . Idiopathic carpal tunnel syndrome patients and healthy controls will be evaluated by ultrasound. Median nerve strain, pressure applied to the skin will be measured at the proximal part of the carpal tunnel. The parameters will be compared between patients and controls, and before and after the open carpal tunnel release in the patients.

Detailed Description
-----------------
The aim of this study is to investigate diagnostic accuracy of median nerve strain and applied pressure measurement . Idiopathic carpal tunnel syndrome patients and healthy controls will be evaluated by ultrasound. Median nerve strain, pressure applied to the skin, and ratio of pressure-strain will be measured at the proximal part of the carpal tunnel. In addition, distal latencies in the motor and sensory nerve conductions studies and cross-sectional area of median nerve will be measured. The parameters will be compared between patients and controls, and before and after the open carpal tunnel release in the patients.

Official Title
-----------------
Median Nerve Strain and Applied Pressure Measurement in the Carpal Tunnel Syndrome Patients

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

Intervention / Treatment
-----------------
* Diagnostic Test: strain and applied pressure measurement


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: carpal tunnel syndrome patients and asymptomatic control Exclusion Criteria: Patients were excluded if there was a history of cervical radiculopathy, rheumatoid arthritis, gout, hemodialysis, sarcoidosis, amyloidosis, or traumatic injuries to the arm. Written consent was obtained from all study participants
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 |
| --- | --- |
| Carpal tunnel syndrome<br>group of carpal tunnel syndrome patients | Diagnostic Test: strain and applied pressure measurement<br>* Measurement of median nerve strain and applied pressure at proximal carpal tunnel level<br>|
| Control group<br>group of healthy controls | Diagnostic Test: strain and applied pressure measurement<br>* Measurement of median nerve strain and applied pressure at proximal carpal tunnel level<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| median nerve strain | Change of the median nerve strain from the initial measurement at 3, 6, 12 months after the treatment | through study completion, an average of 1 year | 
| applied pressure | Change of the applied pressure from the inital measurement at 3, 6, 12months after the treatment | through study completion, an average of 1 year |
Effect of CAUTI Prevention Alert - A Randomized Control Trial

Study Overview
=================
Brief Summary
-----------------
This study proposes to expand upon previous research by studying the effects of a urinary-catheter removal alert on duration of urinary catheter use and frequency of CAUTIs with a large, randomized controlled trial within a three-hospital academic medical center. Hypothesis The proposed urinary-catheter removal alerts will decrease the number of catheter days and decrease the number of catheter associated urinary tract infections (CAUTIs), but will not affect the catheter re-insertion rate.

Detailed Description
-----------------
Primary Objectives Specific Aim 1: Investigate the effect of a urinary-catheter removal alert on the rate of catheter associated urinary tract infections (CAUTIs). Specific Aim 2: Investigate the effect of a urinary-catheter removal alert on the number of catheter days. Specific Aim 3: Evaluate the effect of a urinary-catheter removal alert on the rate of catheter re-insertion. Specific Aim 4: Evaluate the effect of a urinary-catheter removal alert on overall mortality in patients with indwelling catheters.

Official Title
-----------------
Effect of CAUTI Prevention Alert - A Randomized Control Trial

Conditions
-----------------
Infection Due to Indwelling Urinary Catheter

Intervention / Treatment
-----------------
* Other: CAUTI Decision Support


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: All admissions with an indwelling urinary catheter will be randomly assigned to intervention vs. control (usual care) conditions. Exclusion Criteria: Neonatal Intensive Care Unit and pediatric patients

Ages Eligible for Study
-----------------
Minimum Age: 21 Years

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

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

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

Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| No Intervention: Control<br>Normal care conditions, no computer-based physician alert. | |
| Experimental: CAUTI Decision Support<br>Decision support aimed at preventing Catheter Associated Urinary Tract Infections (CAUTIs) | Other: CAUTI Decision Support<br>* Decision support used to prevent Catheter Associated Urinary Tract Infections<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of CAUTIs |  | One Year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of catheter days |  | One year | 
| Rate of catheter re-insertion |  | One Year | 
| Patient mortality due to CAUTI |  | One year | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Urinary Catheter, urinary tract infection
Study of Enfuvirtide in HIV-Positive Subjects

Study Overview
=================
Brief Summary
-----------------
A total of 26 patients will be admitted to the clinic where they will be dosed with each injection device. There will be a 7-day washout between doses and a 7-10 day follow-up period.

Official Title
-----------------
An Open-label, Randomized, Cross-over Study in HIV-Positive Subjects to Determine and Compare the Single-dose Pharmacokinetics of Enfuvirtide after a Single 90 mg SC Administration

Conditions
-----------------
HIV Infections, AIDS

Intervention / Treatment
-----------------
* Drug: Fuzeon


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: - Exclusion Criteria: -

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 64 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: Crossover Assignment
Masking: None (Open Label)


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: Fuzeon|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
Effects of Romadan Fasting on Variability in Blood Pressure in Healthy and Hypertensive Subjects

Study Overview
=================
Brief Summary
-----------------
Included participants who have a stable HT who intend to practice RJ

Detailed Description
-----------------
Stable patients with or without diagnosed hypertension that intend to fast ramadan. Each participant is examined during three planned visits. The first takes place during the month preceding Ramadan. The second during the last week of Ramadan and the third thirty days after the end of Ramadan. Participants that miss one appointement or more are exluded from the study. Patient recrutement is conducted in primary care centers of the state of Monastir, out-patients clinic (Cardiology, Endocrinology) at the emergency department of Fattouma Bourguiba university hospital after a clarified written consent.

Official Title
-----------------
Effects of Romadan Fasting on Variability in Blood Pressure in Healthy and Hypertensive Subjects

Conditions
-----------------
Hypertension

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Adult patient with or without diagnosed hypertension intending to fast Ramadan. Exclusion Criteria : Age < 18 years old Adult patient with or without diagnosed hypertension not intending to fast Ramadan.

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 |
| --- | --- | --- |
| Blood Pressure Variability | Values are registered during 24 hours. Diurnal measures are defined as measures conducted during 6 am and 10 pm, whereas nocturnal measures are defined as those registered during the remaining hours. Mean systolic blood pressure and diastolic blood pressure are calculated for the 24 hours for both diurnal and nocturnal period. | 60 days | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Hypertension, Ramadan fasting
Phase III Randomized Trial of Adjuvant Chemotherapy With S-1 vs S-1/Oxaliplatin ± Radiotherapy for Completely Resected Gastric Adenocarcinoma : The ARTIST II Trial

Study Overview
=================
Brief Summary
-----------------
The optimal regimen for adjuvant treatment has not been established in GC yet. We plan to compare TS-1, TS-1/oxaliplatin with or without RT in D2 resected gastric cancer.

Conditions
-----------------
Gastric Cancer

Intervention / Treatment
-----------------
* Drug: TS-1, oxaliplatin


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Histologically proven gastric or gastroesophageal adenocarcinoma ≥ D2 lymph node dissection, curative gastrectomy Stage II, III (AJCC 2010) with any N (any stage with N0 will be excluded) Age > 19 ECOG 0-2 No distant metastasis Adequate bone marrow functions (ANC ≥ 1,500/ul, blood platelet ≥ 100,000/ul, haemoglobin ≥ 10g/dl, transfusion allowed) Adequate renal functions(serum creatinine ≤ 1.5mg/dl) liver functions (serum bilirubin ≤ 1.5mg/dl, AST/ALT ≤ 3 times(normal value) Written informed consent Possible oral intake (food, drug) Exclusion Criteria: Subjects presenting with any of the following will not be included in the study Active infection requiring antibiotics Pregnant, lactating women Concurrent systemic illness not appropriate for chemotherapy Resection margin (+) at permanent pathology Pathologic stage I or IV (Ia or Ib according to AJCC 2010) Inadequate surgery including D0, D1 resection, dissected LNs less than 12 Paraaortic lymph node (+), pathologically proven women of potential childbearing not employing adequate contraception

Ages Eligible for Study
-----------------
Minimum Age: 20 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: Factorial Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Arm A<br>S-1 40-60mg BID (4weeks - 2weeks off) x 8 cycles | Drug: TS-1, oxaliplatin<br> <br> |
| Active Comparator: Arm B<br>{S-1 40-60mg BID (2weeks - 1week off) + Oxaliplatin 130mg/m2 q 3 week} x 8 cycles | Drug: TS-1, oxaliplatin<br> <br> |
| Active Comparator: Arm C<br>{S-1 40-60mg BID (2weeks - 1week off) + Oxaliplatin 130mg/m2 q 3 weeks} x 2 cycles → S-1 40mg BID (2weeks - 1week off - 2weeks)+ RT 45 Gy (5weeks) → Rest for 4 weeks → {S-1 40-60mg BID (2weeks - 1week off) + Oxaliplatin 130mg/m2 q 3 weeks} x 4 cycles | Drug: TS-1, oxaliplatin<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The primary endpoint of the study is disease-free survival (DFS). |  | 3-year |
CAR-T Cell Therapy in Patients With Hematological Malignancies

Study Overview
=================
Brief Summary
-----------------
The prognosis of relapsed or refractory lymphoblastic leukaemia (ALL) and diffuse large B-cell lymphoma (DLBCL) is poor with conventional treatment with complete response rates around 25-30% with a median progression-free survival (PFS) of around 2 months and 7 months, respectively, despite the use of allogeneic and autologous haematopoietic stem cell transplantation. The recent introduction of CAR-T (Chimeric Antigen Receptor T-cells) therapy as a therapeutic option has been a breakthrough in the management of these entities.

Detailed Description
-----------------
Information on baseline patient characteristics, haematological disease, comorbidities and CAR-T therapy procedure (lymphodepletion schedule, infused product) will be collected. Early post-infusion toxicity and recurrence data will be collected. The grading of adverse effects will follow the EBMT and ASTCT guidelines. Finally, data will be collected to analyse survival and, in case of death, cause of death).

Official Title
-----------------
Retrospective Analysis of the Use of CAR-T Cell Therapy in Patients With Hematological Malignancies in Spain

Conditions
-----------------
CART Therapy

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Adult patients >18 y/o Patients receiving CAR-T cell therapy in Spain, since 2018. Exclusion Criteria: T Patients receiving CART therapy as part of a clinical trial.
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 |
| --- | --- | --- |
| Progression free survival | Patients who relapse or progress at 6 month after CART infussion. | 6 month | 
| Progression free survival | Patients who relapse or progress at 12 month after CART infussion. | 12 month | 
| Progression free survival | Patients who relapse or progress at 24 month after CART infussion. | 24 month | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Overall survival |  | 6 month,12 month and 24 month | 
| High relevance toxicity rates | Rate of grade 3 or more of CRS and neurotoxicity | During the firs month | 
| Progression free survival | Patients who relapse or progress at 6, 12, 24 months from apheresis | 6 month,12 month and 24 month |
Living Together With Dementia_Creation and Validation of a Training Program for Family Caregivers of People With Dementia to Live at Home

Study Overview
=================
Brief Summary
-----------------
This study aims to experimentally evaluate the training program for family caregivers of people with dementia_Living together with Dementia.

Detailed Description
-----------------
This study will begin in March 2016, with the initial assessment of family caregivers of people with dementia. These were recruited through hospital neurology clinic and must comply with a set of pre-established criteria. It is expected a total of 20 participants in the study (10 in the experimental group and 10 in control group). Interventions will take place over the months of March and April. The final evaluation is scheduled for late April and the follow up to July 2016. an evaluation document itself for this study was built.

Conditions
-----------------
Dementia

Intervention / Treatment
-----------------
* Other: psychoeducation


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Be primary caregiver of the person with dementia Be able to read and write Carers of peolpe with dementia in initial or moderate stage Exclusion Criteria: The person with dementia have severe mental pathologies associated

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?
-----------------

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Psychoeducation<br>Interventions: Give information Teach and train strategies | Other: psychoeducation<br>* Providing knowledge and skills development in family caregivers of people with dementia, through a structured psychoeducational programme<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Caregiver Overload Scale |  | 7 weeks | 
| Carers Assessment Satisfaction Index |  | 7 weeks | 
| Carers Assessment Difficulties Index |  | 7 weeks | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Family caregivers, training programme, dementia
Screening Patients With Sickle Cell Disease for Kidney Damage

Study Overview
=================
Brief Summary
-----------------
This study aims to study the temporal course of sickle nephropathy and assess novel biomarkers that can predict patients prone to nephropathy.

Detailed Description
-----------------
Sickle cell disease causes kidney damage that gets worse with increasing age, leading to chronic kidney disease and kidney failure in nearly one third of patients with sickle cell disease. Some patients develop kidney damage at a young age and others show mild kidney damage at older ages. We do not know the natural progression of kidney damage in sickle cell disease patients, nor do we know who is more prone to develop severe kidney damage. Therefore, currently, there are no preventative measures or treatments for sickle cell related kidney disease. The purpose of this research study is to collect data that will help in assessing the progression of kidney damage in sickle cell disease, develop novel urine and blood tests that can predict kidney damage early, and developing treatment ideas for intervention and prevention of kidney damage that eventually leads to kidney failure.

Official Title
-----------------
Screening Patients With Sickle Cell Disease for Kidney Damage

Conditions
-----------------
Sickle Cell Disease

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Sickle cell disease (i.e. Hgb SS, Hgb SC, Sβ-Thalassemia) Individuals at baseline/steady state (absence of fever or acute sickle event, defined as vaso-occlusive pain crises, acute chest syndrome, splenic sequestration, stroke, priapism) for three weeks. Adult Subjects > 18 years of age: ability to consent to donate blood and/or urine for research purposes only. Newborn to < 18 years of age: ability of parent/legal guardian to consent for peripheral blood and/or urine samples to be obtained for research purposes only. Exclusion Criteria: Hematologic malignancy Patients that either do not have the ability to undergo the informed consent process or whose parent/legal guardian does not have the ability to undergo the informed consent process
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 |
| --- | --- | --- |
| Rate of progression of microalbuminuria. |  | Baseline through 36 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Evaluation of novel urinary biomarkers. |  | baseline, year 1, year 2 and year 3 | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Sickle cell disease, Hgb SS, Hgb SC, Sβ-Thalassemia
Spironolactone After Liver Transplant

Study Overview
=================
Brief Summary
-----------------
To study spironolactone to prevent calcineurin inhibitor (CNI) kidney injury.

Detailed Description
-----------------
The aim of this study is to determine if spironolactone decreases nephrotoxicity from calcineurin inhibitors in liver transplant recipients and to determine the best study of renal function in liver transplant recipients.

Official Title
-----------------
Spironolactone to Prevent or Delay Calcineurin Inhibitor (CNI) Toxicity in Liver Transplant Recipients

Conditions
-----------------
Transplant, Liver

Intervention / Treatment
-----------------
* Drug: Spironolactone


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: liver transplant Exclusion Criteria: dual organ transplant

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 |
| --- | --- |
| No Intervention: SOC-Standard of care<br>standard of care, nontreatment | |
| Experimental: spironolactone<br>spironolactone | Drug: Spironolactone<br>* spironolactone 25 mg up to 50 mg<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Glomerular Filtration Rate (GFR) | The primary analyses were based on the difference between each estimated GFR measure and iothalamate scan. | 18 months |