linjc16/ctgov huggingface dataset:
Warwick Metal On Metal Study

Study Overview
=================
Brief Summary
-----------------
assess results of metal on metal hip replacements carried out at warwick hospital

Detailed Description
-----------------
Resurfacing and XL head hip replacements have not done as well as expected. The ASR implant has been withdrawn. Recent publications and media appearances by Tony Nargol, an orthopaedic surgeon, have suggested 36mm metal on metal replacements. I intend to report the results of this series.

Official Title
-----------------
Review of 750 36mm MOM Hip Replacements ( Pinnacle/Corail) With up to 6 Year Follow up

Conditions
-----------------
Metal Hip Replacement

Intervention / Treatment
-----------------
* Radiation: x ray


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: All patients with 36mm metal on metal hips Exclusion Criteria: -
Sexes Eligible for Study
-----------------
All

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| MOM total hip replacements<br>all patients with MOM 36mm hip replacements | Radiation: x ray<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Oxford hip score |  | 6 years | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
retrospective analysis
Complicated Outcome Prediction After Liver Resection

Study Overview
=================
Brief Summary
-----------------
Although mortality after liver surgery reduced during the last three decades to less than 2%, post-operative course is still complicated in a range of 20-50% of cases.The identification of one or few factors which could detect the real risk of complicated post-operative outcome, may help anesthesiologist to decide whether admit a patient to ICU or not.The primary aim of this study was to evaluate whether RRI, alone or along with other items, can predict post-operative complication after hepatic resection.

Official Title
-----------------
Complicated Outcome Prediction After Liver Resection: the Role of Renal Resistive Index

Conditions
-----------------
Liver Neoplasms

Intervention / Treatment
-----------------
* Procedure: Liver resection for primary and secondary disease


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients resectable and affected by primary and secondary liver disease Exclusion Criteria: Subjects affected by kidney disease and/or cirrhosis and pregnant patients were excluded from the trial. Patients who should have needed nephrectomy during the operation would be also excluded.

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 |
| --- | --- |
| Patients submitted to liver resection<br>Patients underwent liver resection for primary and secondary disease | Procedure: Liver resection for primary and secondary disease<br>* Liver resection in parenchyma-sparing setting for primary and secondary disease<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| renal resistive index (RRI) | the association between RRI and occurrence of hepatic complications during the first postoperative week. | up to 7 days after surgery |
Physical Work Capacity After Traumatic Brain Injury

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to determine whether body weight supported treadmill training is more effective than traditional physical therapy at restoring gait in persons recovering from traumatic brain injury.

Official Title
-----------------
Physical Work Capacity After Traumatic Brain Injury

Conditions
-----------------
Traumatic Brain Injury

Intervention / Treatment
-----------------
* Procedure: body weight supported treadmill training
* Procedure: traditional physical therapy


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: traumatic brain injury follow two step commands between 18 and 60 years old between 3 and 36 months post injury Exclusion Criteria: known cardiovascular disease uncooperative, behavioral challenges

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 60 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: 1<br>body weight supported treadmill training | Procedure: body weight supported treadmill training<br>* BWSTT for 12 weeks, 3 times per week<br>|
| Placebo Comparator: 2<br>traditional physical therapy | Procedure: traditional physical therapy<br>* traditional PT for 12 weeks, 3 times per week<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Overground gait speed |  | 12 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| aerobic capacity |  | 12 weeks | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
rehabilitation, head injury, 3 months post injury, require manual assistance or walking aids to walk, very slow walking speed, able to follow two step commands
PERCI- Medium Cut Off (MCO)

Study Overview
=================
Brief Summary
-----------------
The medium cut-off dialysis membrane has been developed to provide a significantly extended molecular cut-off compared to conventional high-flux membranes. The medium cut-off membrane allows for a high permeability of molecules up to a molecular weight of 45 kDa and has a still limited permeability for albumin (68 kDa). The main goal of this project is the evaluation of the new, highly porous and selective dialysis membrane (MCO-Ci 400) for the treatment of patients with end-stage renal disease in hemodialysis mode and to study its potential to improve chronic inflammation.

Official Title
-----------------
Permeability Enhancement to Reduce Chronic Inflammation _ Medium Cut Off (MCO) (Study no 1502)

Conditions
-----------------
Chronic Kidney Failure, Chronic Inflammation

Intervention / Treatment
-----------------
* Device: MCO-Ci 400
* Device: Revaclear 400


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: CKD5 ( GFR < 15ml/min/ 1.73m2) Dialysis treatment for ≥ 3 months Dialysis 3x weekly Vascular access by fistula or CVC Age > 18 and < 99 Years Ability to give written informed consent Exclusion Criteria: Missing informed consent form current clinically manifested infection or within the last two weeks current CRP-value > 50mg/L or within the last two weeks Intake of any medication applied for immunosuppressive purposes Pregnancy or lactation Participation in a different interventional study

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
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: MCO-Ci 400<br>MCO-Ci 400 is the investigational medical product applied in hemodialysis mode | Device: MCO-Ci 400<br>* hemodialysis<br>|
| Active Comparator: Revaclear 400<br>the standard high flux dialyzer Revaclear 400 is used as an comparator in hemodialysis mode | Device: Revaclear 400<br>* hemodialysis<br>* Other names: standard high flux dialyzer;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| TNF-alpha mRNA | Significant lower pre- dialytic TNF-α mRNA expression level in circulating peripheral blood mononuclear cells | 4 weeks treatment time | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| safety related events |  | 6 month | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
CKD5, dialysis, high porous membranes
Prospective, Multicenter Study of the Second Generation Antimicrobial Graft in the Abdominal Position

Study Overview
=================
Brief Summary
-----------------
The purpose of this prospective trial is to demonstrate the safety and performance of the Second Generation Anti-Microbial vascular graft in the treatment of aneurysmal and occlusive diseases of the abdominal aorta.

Official Title
-----------------
Multicenter Clinical Study Assessing the Performance and the Safety of the Second Generation Antimicrobial Graft in the Abdominal Position

Conditions
-----------------
Aneurysmal Disease of the Abdominal Aorta, Occlusive Disease of the Abdominal Aorta

Intervention / Treatment
-----------------
* Device: Second Generation Anti-Microbial bifurcated vascular graft (InterGard)


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Is 18 - 85 years of age Is presenting with an aorto-iliac occlusion (obstruction of flow) or stenosis, or aorto-iliac aneurysm and is eligible for a revascularization with a bifurcated graft Is affiliated with a social welfare organization system Is willing to participate in the clinical evaluation after signature of the informed consent Is able to attend all follow up visits and diagnostics and laboratory exams required by the present protocol Exclusion Criteria: Is treated as an emergency Is included in another investigation Is pregnant or lactating, or a woman of childbearing potential unwillint to use an effective form of contraception for the duration of the trial Has a known allergy to the material device used Has previous aorto-iliac bypass or replacement

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

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: Single Arm Study<br>Consecutive patients meeting the selection criteria | Device: Second Generation Anti-Microbial bifurcated vascular graft (InterGard)<br>* treatment of patients with aorto-iliac occlusion,stenosis, or aneurysm<br>* Other names: InterGard;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Graft patency at three years |  | three years | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Aneurysmal disease of the abdominal aorta, Occlusive disease of the abdominal aorta
A Randomized Controlled Study of Postoperative Adjuvant Chemotherapy of Uracil- Tegafur (UFT) Compared With Surgery Alone (NSAS-CC)

Study Overview
=================
Brief Summary
-----------------
This is a controlled study designed to compare relapse-free survival and overall survival in patients receiving UFT with those in patients receiving surgery alone. Patients will be randomly assigned to surgery alone or surgery followed by UFT within 6 weeks after curative resection. To assess treatment efficacy, data on recurrence and survival will be collected for 5 years after enrollment of the last patient. To evaluate safety, data on adverse events will be collected for 12 months after the start of treatment.Evaluations will be separately done for colon cancer and rectal cancer.

Official Title
-----------------
A Randomized Controlled Study of Postoperative Adjuvant Chemotherapy of UFT Compared With Surgery Alone in Patients With Dukes C Colorectal Cancer (NSAS-CC)

Conditions
-----------------
Colorectal Cancer

Intervention / Treatment
-----------------
* Drug: UFT (uracil, tegafur)
* Procedure: Surgery alone


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Age 20 to 75 Performance status 0 , 1, or 2 (ECOG) Hematopoietic WBC ≥ 4,000/mm^3 Platelet ≥ 100,000/mm^3 Hepatic AST and ALT ≤ 2 times upper limit of normal(ULN) Total bilirubin ≤ 1.2mg/dL Renal BUN ≤ 25mg/dL Creatinine ≤ 1.5mg/dL Exclusion Criteria: Prior anticancer treatment

Ages Eligible for Study
-----------------
Minimum Age: 20 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: 1<br>UFT (uracil, tegafur) | Drug: UFT (uracil, tegafur)<br>* to receive oral uracil-tegafur 400 mg square meter for one year<br>|
| Other: 2<br>Surgery alone | Procedure: Surgery alone<br>* Standardized mesorectal excision with selective lateral pelvic lymphadenectomy of stage III rectal cancer.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Relapse-free survival and overall survival |  | every course for first three courses, then every other course | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Adverse events |  | any time | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Colorectal Cancer
Continuous 7-day Detection of Arrhythmias in Dialysis Population

Study Overview
=================
Brief Summary
-----------------
The Carnation Ambulatory Monitor (CAM) is an innovative diagnostic patch device that allows to differentiate the different kinds of arrhythmias more precisely than any other ECG-monitoring device. It attaches on the sternum and can be carried for a week without any breaks. This allows a continuous rhythm monitoring without any gap for 7 days. This device will be used in dialysis patients to monitor arrhythmias during changes in volume and/or electrolyte balance due to dialysis, in the phases after dialysis as well as before dialysis in the short or long intervals between dialysis sessions.

Official Title
-----------------
Optimized Continuous 7-day Detection of Arrhythmias in Dialysis Population by a Patch With a High Resolution Differentiation of Atrial Activity

Conditions
-----------------
Arrythmia, Dialysis; Complications

Intervention / Treatment
-----------------
* Diagnostic Test: Carnation Ambulatory Monitor (CAM)


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Age 18 years. Written informed consent Exclusion Criteria: Participation in another study within 4 weeks before study begin Pacemaker ICD

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 99 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 |
| --- | --- |
| Hemodialysis patients<br> | Diagnostic Test: Carnation Ambulatory Monitor (CAM)<br>* 7-day detection of arrhythmias with Carnation Ambulatory Monitor (CAM)<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of dialysis patients with an arrhythmia | Detection of arrhythmias (including distribution of ventricular and atrial arrhythmias) by means of Carnation Ambulatory Monitor (CAM) in hemodialysis patients during an entire week, thus including all different phases: during/after/before dialysis sessions | ECG monitoring over 7 days (3 intermittent hemodialysis sessions) |
Gastroesophageal Reflux Disease Prospective Registry

Study Overview
=================
Brief Summary
-----------------
The purpose of this registry is to evaluate information to determine which operations and treatments for gastroesophageal reflux disease or similar diseases of the stomach, esophagus or digestive tract are providing the most benefit including the long-term effects of treatment (or no treatment) and the progression of the disease over time.

Detailed Description
-----------------
All patients in this registry will have a diagnosis of gastroesophageal reflux disease or a similar disease of the stomach, esophagus or digestive tract. Each patient undergoing anti-reflux surgery will be asked to participate in the registry to gather preoperative, intraoperative and postoperative outcomes. The data collected from the registry will be used to assess the outcome of various treatments, both standard and new: some specific areas of interest include the long-term effects of treatment (or no treatment), the progression of the disease over time, and the overall length of survival of the patient.

Official Title
-----------------
Gastroesophageal Reflux Disease Prospective Registry

Conditions
-----------------
GERD

Intervention / Treatment
-----------------
* Other: Diagnosed with GERD


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: - Any patient undergoing anti-reflux surgery Exclusion Criteria: - None

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 |
| --- | --- |
| Diagnosed with GERD<br>Collect data on GERD patients | Other: Diagnosed with GERD<br>* Recording of patient outcomes<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Postoperative patient reported sign and symptoms | Patient reported signs and symptoms as reported in Reflux scale and GERD questionnaire. | Up to 10 years after surgery |
Effects of Pepper Gas Exposure in Non-combatant Bystanders.

Study Overview
=================
Brief Summary
-----------------
Pepper sprays and pepper gas grenades are used by riot police at various places in the world for crowd control. Data about the acute effects based on human studies is extremely scarce. Kashmir valley in the northern Indian state of Jammu & Kashmir has witnessed political turmoil for the past 22 years and incidents of stone pelting are common wherein groups of youth indulge in stone pelting at the security personnel. While there have been previous episodes of fatalities associated with incidents of firing by the security personnel; non lethal methods are adopted routinely now. These include lathis, water cannons, tear gas and more recently the pepper gas grenades. The pepper grenades explode in the area and the adverse effects are perceived by the population in the area too who are even sitting in their homes. The study proposes to observe the health effects of the pepper gas exposure in non-combatant civilians.

Detailed Description
-----------------
Eligibility: History of exposure to a pepper grenade explosion. Exclusion: Participation in combat operation/ stone pelting/ demonstration.

Official Title
-----------------
Pepper Gas Exposure Study

Conditions
-----------------
Cough, Irritation in Throat, Irritation in Skin, Lacrimation

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: All participants with a history of exposure to pepper gas grenade explosion Exclusion Criteria: Combatant role while exposure
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 |
| --- | --- | --- |
| Development of cough, irritation in throat, nasal irritation, nasal discharge, wheezing, breathlessness, hemoptysis, chest pain upon exposure or worsening of already existing cough, breathlessness, wheezing of a previous respiratory illness. |  | 24 hours | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Duration of symptoms developed |  | 10 days | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Pepper spray, bronchospasm, lacrimation