linjc16/ctgov huggingface dataset:
Preconditioning With Sevoflurane and Propofol in Patients Undergoing Minimally Invasive Mitral Valve Surgery

Study Overview
=================
Brief Summary
-----------------
The main aim of this study is to compare markers of cardiac injury (Troponin I), inflammatory response and platelets function during minimally invasive mitral valve repair or replacement (MIMV) via right mini-thoracotomy in two standard anaesthetic regimes (sevo \propofol)

Detailed Description
-----------------
The main aim of this study is to compare markers of cardiac injury (Troponin I), inflammatory response and platelets function during minimally invasive mitral valve repair or replacement (MIMV) via right mini-thoracotomy in two standard anaesthetic regimes: Volatile conditioning (sevoflurane) used during induction (preconditioning) and during the operation as maintenance (perconditioning) and no propofol. Propofol induction and maintenance (TIVA) and no volatile anaesthetics. Outlet/residual blood samples coming from routine check will be collected at different time points. Study will be powered on Troponin I (primary statistical outcome). Original secondary outcome will be considered: platelets activation, left ventricle function, clinical figures (length of stay, inotrops requirements, ventilation times and other relevant).

Official Title
-----------------
A Single-center Observational Study Investigating the Effect of Volatile Conditioning (VC) With Sevoflurane on Myocardial Biomarkers and Platelets Function in Patients Having Minimally Invasive Mitral Valve Surgery (MIMV)

Conditions
-----------------
Myocardial Ischemia

Intervention / Treatment
-----------------
* Drug: sevofluorane


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Age ≥18 Patients undergoing elective (or urgent) first-time minimal invasive mitral valve surgery. Exclusion Criteria: Cardiogenic shock or cardiac arrest, emergent CABG Renal failure (with a GFR < 30 ml/min/1.73m2), Glibenclamide or nicorandil (as these medications may interfere with VC) Pregnancy Known intolerance/allergy to sevoflurane or propofol

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 |
| --- | --- |
| Sevofluorane<br>Patients preconditioned with Sevo | Drug: sevofluorane<br>* Continuous infusion of sevofluorane<br>* Other names: SEVO;|
| Propofol<br>Patients with no preconditioning | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Myocardial Injury assessed by changes in Troponin values | According to the routine post operative blood testing frame-time troponin sample will collected in the preoperative and postoperative period. | properatively-6, 12, 24, 48 and 72 hours after the end of ischaemic cardioplegic arrest |
Laboratory Studies Into the Pathology of Leukaemia

Study Overview
=================
Brief Summary
-----------------
Ongoing laboratory work into the pathology of Leukaemia:

Detailed Description
-----------------
The investigators will test AML samples sent to the diagnostic laboratory from participants with newly diagnosed or relapsed/refractory AML. Samples will be sent from district general hospitals and teaching hospitals. Results will be returned to referring clinicians in the same way investigators currently return results for samples sent for standard tests. The service will be advertised through the Royal Marsden Website with visibility to both participants and HCPs). The investigators will also inform all the clinicians involved in the AML working party (Dr Taussig is a member of the AML working group). In addition we are looking at diagnostic approaches to IDH 1 and 2 mutation identification. An initial comparison of 50 samples by three analysis methods will be conducted. IDH1 and IDH2 variant discovery will first be performed using an established standard in house SOP (SOP: SMD103) for CE-SSCA

Official Title
-----------------
Laboratory Studies Into the Pathology of Leukaemia

Conditions
-----------------
Leukemia

Intervention / Treatment
-----------------
* Procedure: Bone Marrow Aspirate


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: 18 & Over Diagnosis of AML Generic Research consent given Exclusion Criteria: Under 18 No generic research 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?
-----------------

Arms and Interventions

| Intervention/Treatment |
| --- |
|Procedure: Bone Marrow Aspirate|Diagnostic Bone Marrow aspirate|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pathology of Leukaemia cells | Pathology of Leukaemia cells | 15 years |
A Clinical Study of the Safety and Efficacy of MEBO Wound Ointment in Subjects With Diabetic Foot Ulcers

Study Overview
=================
Brief Summary
-----------------
The objective of this study is to evaluate the safety and efficacy of MEBO in the treatment of subjects with diabetic foot ulcers (DFUs).

Detailed Description
-----------------
This is a phase II, randomized, controlled, multi-center study designed to assess the safety and efficacy of MEBO in the treatment of subjects with DFUs. Subjects meeting entry criteria will be randomly assigned in a 1:1 ratio for up to 8 weeks of treatment with either MEBO or SOC.

Official Title
-----------------
A Phase II, Randomized, Controlled, Multi-Center Study of the Safety and Efficacy of Topically Applied MEBO Wound Ointment Compared to Standard of Care in Subjects With Diabetic Foot Ulcers

Conditions
-----------------
Diabetic Foot Ulcers

Intervention / Treatment
-----------------
* Drug: MEBO Wound Ointment (MEBO)
* Other: Standard of Care


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Male or female ≥18 years of age Able and willing to provide informed consent Able and willing to comply with protocol visits and procedures Target ulcer duration of ≥4 weeks Exclusion Criteria: Ulcer of a non-diabetic pathophysiology Known or suspected allergies to any of the components of MEBO Malignancy on target ulcer foot Non-compliance in the screening or run-in period

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: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: MEBO Wound Ointment (MEBO)<br>Topical application twice a day | Drug: MEBO Wound Ointment (MEBO)<br>* Topical application twice a day<br>* Other names: MEBO;|
| Active Comparator: Standard of Care<br>Topical application twice a day | Other: Standard of Care<br>* Topical application twice a day<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The incidence of complete healing of the target ulcer. |  | 8 week treatment period | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Time required to achieve complete healing (days). |  | 8 week treatment period | 
| Absolute and percentage change in ulcer surface area from baseline to endpoint. |  | 8 week treatment period | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Diabetic Foot Ulcers (DFUs)
High Field Magnetic Resonance Spectroscopy Imaging for Follow Up of Prostate Cancer Post Brachytherapy Implantation

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to establish the correct scanning parameters for obtaining good quality 3 Tesla (3T) magnetic resonance spectroscopy images (MRSI) of the prostate gland before and after brachytherapy implantation for prostate cancer. Three Tesla MRSI may be a valuable additional diagnostic and follow-up investigation for prostate cancer patients.

Official Title
-----------------
High Field (3 Tesla) Magnetic Resonance Spectroscopy Imaging for Follow Up of Prostate Cancer Post Permanent Iodine 125 Brachytherapy Implantation

Conditions
-----------------
Prostatic Neoplasm

Intervention / Treatment
-----------------
* Procedure: Magnetic Resonance Spectroscopy Imaging


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Suitable candidate for prostate brachytherapy to treat prostate cancer Patient signs a study consent form Exclusion Criteria: Have received other radiotherapy for prostate cancer or hormone treatments Has contraindication to MRSI scanning Does not sign study consent form

Ages Eligible for Study
-----------------
Minimum Age: 18 Years

Sexes Eligible for Study
-----------------
Male

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

| Intervention/Treatment |
| --- |
|Procedure: Magnetic Resonance Spectroscopy Imaging|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| pilot study meant to establish scanning parameters on 3T MRSI |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| safety/toxicity |  |  | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
brachytherapy, magnetic resonance spectroscopy
Quality of Life in Patients After Pharyngolaryngectomy

Study Overview
=================
Brief Summary
-----------------
Laryngeal cancer is an indication for a laryngectomy (separation of the airways and digestive tract). Laryngectomy causes a permanent disruption of self-perception. Communication, social interactions, diet andaesthetic appearance are altered. Its modifications disrupt the quality of life of patients and must be taken into account as soon as possible in patient cares.

Detailed Description
-----------------
The aim of the study is to describe quality of life in patients with laryngectomy.

Official Title
-----------------
Quality of Life in Patients After Pharyngolaryngectomy

Conditions
-----------------
Laryngectomy; Status

Intervention / Treatment
-----------------
* Other: Data collection


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: male or female with laryngectomy agreeing to participate in the study Exclusion Criteria: - less than 18 years old

Ages Eligible for Study
-----------------
Minimum Age: 18 Years

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| with laryngectomy group<br>with laryngectomy group: patients with laryngectomy for any type of cancer | Other: Data collection<br>* Description: quality of life assessment<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| EORTC QLQ-C30 | The QLQ-C30 is a generic questionnaire with 30 questions coded in 4 response modalities (not at all (1), a little (2), enough (3), a lot (4)) or in 7 response modalities (from very bad (1) to excellent ( 7)). Questions are summarized in five multiitem domains (physical, role, cognitive, emotional, and social functioning) and nine single item domains (fatigue, pain, nausea/vomiting, appetite loss, financial impact; diarrhea, constipation, sleep disturbance and quality of life). Each domain is scored between 0 and 100. For functional domains, a high score value represents a high level of quality of life. For symptom domains, a high score represents an important level of symptoms (a low level of quality of life). | Day 0 | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Laryngeal cancer - laryngectomy - quality of life
Seasonal Variation of Blood Cholesterol Levels

Study Overview
=================
Brief Summary
-----------------
To describe and delineate in a prospective study the nature and causes of seasonal variation of blood lipid levels in the general population.

Detailed Description
-----------------
BACKGROUND: Significant seasonal variation of blood cholesterol levels has been shown in a number of cross-sectional studies, with important implications for national screening and therapeutic guidelines. However, the phenomenon has not been well studied: little is known about etiology or about seasonal variation of lipid subfractions. DESIGN NARRATIVE: The investigators assessed the magnitude and timing of the seasonal effect for total cholesterol and the important lipoprotein subfractions (low-density lipoprotein, high-density lipoprotein, triglycerides, apolipoproteins AI and B, and lipoprotein (a)) in both sexes and at different ages. They also identified and quantified the effects of the main factors determining the variation and assessed the seasonal variation of other blood elements thought to play a role in the development of coronary heart disease, including hemostatic factors and antioxidants Finally, they explored the implications of the phenomenon for public health policy. Baseline and serial measures were repeated quarterly for one year. These included measures of: serum lipids and lipoproteins; antioxidant vitamins; platelets and hemostatic factors; demographic factors; weight, waist-hip ratio, height, body mass index (BMI) and blood pressure; dietary intake; physical activity; light exposure; and psychologic factors. Meteorologic data were also collected. Data were collected by written questionnaire and by the use of computer-assisted evening telephone interviews (CATI), which were used for the collection of dietary, physical activity and individual light-exposure and other lifestyle data. Activity and light data were verified in a subset of 80 patients by the use of a monitoring device. Analyses included methods to describe the seasonal variation in dietary, physical activity, psychologic, and light exposure data and repeated measures in linear regression models to determine the roles of specific dietary, physical activity, psychologic, and light-exposure related covariates in explaining variability in blood lipids, antioxidant vitamins, and hemostatic factors. The study completion date listed in this record was obtained from the End Date entered in the Protocol Registration and Results System (PRS) record.

Conditions
-----------------
Atherosclerosis, Cardiovascular Diseases, Heart Diseases, Coronary Disease

Participation Criteria
=================
Eligibility Criteria
-----------------
No eligibility criteria

Ages Eligible for Study
-----------------
Maximum Age: 100 Years

Sexes Eligible for Study
-----------------
Male

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 |
| --- | --- | --- |
Bioequivalency Study of Levetiracetam 1g Under Fasted Conditions

Study Overview
=================
Brief Summary
-----------------
The objective of this study was to prove the bioequivalence of Levetiracetam 1000 mg Tablets under fasted conditions

Official Title
-----------------
A Single Dose, 2-Period, 2-Treatment, 2-Way Crossover Bioequivalency Study of Levetiracetam 1g Tablets Under Fasting Conditions

Conditions
-----------------
Seizures

Intervention / Treatment
-----------------
* Drug: Levetiracetam


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: No clinically significant abnormal findings on the physical examination, medical history, or clinical laboratory results during screening Exclusion Criteria: Positive test for HIV, Hepatitis B, or Hepatitis C. Treatment with known enzyme altering drugs. History of allergic or adverse response to Levetiracetam or any comparable or similar product.

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 45 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: Crossover Assignment
Masking: None (Open Label)


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: Levetiracetam|1000 mg tablet|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| bioequivalence based on Cmax |  | 10 days |
Comparison of a Cemented, Polished Tapered Stem and an Anatomic Stem for Femoral Neck Fracture

Study Overview
=================
Brief Summary
-----------------
Postoperative periprosthetic femoral fracture after hip arthroplasty is associated with considerable morbidity and mortality. Recent cohort studies have demonstrated a high incidence of PPF in elderly patients treated with two commonly used polished, tapered, collarless stems in elderly patients. The aim of this study was to compare the rate and characteristics of PPF in a consecutive cohort of patients treated either the polished tapered CTP stem or the matte anatomic SP2 stem in an elderly population above 80 years of age with femoral neck fracture.

Conditions
-----------------
Hip Fracture, Femoral Neck Fracture, Periprosthetic Femoral Fracture

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Displaced femoral neck fracture Treated with a primary hip arthroplasty Exclusion Criteria: Secondary arthroplasty due to sequel after femoral fracture

Ages Eligible for Study
-----------------
Minimum Age: 80 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 |
| --- | --- |
| CPT stem<br>Patients treated with a polished, tapered femoral stem as a hip arthroplasty for a displaced femoral neck fracture | |
| SP2 stem<br>Patients treated with a anatomic femoral stem as a hip arthroplasty for a displaced femoral neck fracture | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Incidence of periprosthetic femoral fracture |  | 2 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Type of periprosthetic femoral fracture |  | 2 years | 
| Type of complications after surgery for periprosthetic femoral fracture |  | 2 years | 
| Mortality |  | 2 years | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
femoral neck fracture, hip arthroplasty, complication, periprosthetic femoral fracture
Rotation or Change of Biotherapy After First Anti-TNF Treatment Failure for Rheumatoid Arthritis

Study Overview
=================
Brief Summary
-----------------
Approximately 30% of patients with rheumatoid arthritis have an inadequate response to anti-TNF (primarily or loss of response), leaving two alternatives: rotation to a second anti-TNF or change of biologic, with a different mechanism of action, such as abatacept, rituximab and tocilizumab. No controlled trial compared these two strategies face to face. The present objective is to investigate the issue whether one of these strategies could have a better efficacy in a pragmatic trial in the setting of current practice.

Official Title
-----------------
Rotation or Change of Biotherapy After First Anti-TNF Treatment Failure for Rheumatoid Arthritis

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

Intervention / Treatment
-----------------
* Drug: infliximab, etanercept, adalimumab
* Drug: abatacept, rituximab or tocilizumab


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Active and erosive rheumatoid arthritis with a DAS28 equal or greater than 3.2 Inadequate response to a 1st anti-TNF Stable or no treatment with any DMARDs, or oral corticosteroids (< or = to 10 mg/day of prednisone equivalent)during the preceding month Exclusion Criteria: Counter-indication to other anti-TNF, abatacept, rituximab or tocilizumab Pregnancy Age < 18 years Impossibility to give informed consent Impossibility to be followed for 12 months

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: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: arm 1 (2d anti-TNF):<br>infliximab, etanercept, adalimumab | Drug: infliximab, etanercept, adalimumab<br> <br> |
| Active Comparator: arm 2 (other biotherapy)<br>abatacept, rituximab or tocilizumab | Drug: abatacept, rituximab or tocilizumab<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Proportion of EULAR responders |  | 6 months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Rheumatoid arthritis with inadequate response to 1 anti-TNF
Collagenase is a Common Treatment of MCP and PIP Joint Contractures in Dupuytrens Disease

Study Overview
=================
Brief Summary
-----------------
To evaluate the effect of collagenase clostridium histolyticum treatment at the Department of Orthopaedic surgery at Horsens Regional Hospital after minimum one-year follow-up (FU).

Official Title
-----------------
Collagenase Clostridium Histolytic is a Common Treatment of MCP and PIP Joint Contractures in Dupuytren Disease. A 1 to 4 Year Followup Study of 198 Joints

Conditions
-----------------
Dupuytren Contracture

Intervention / Treatment
-----------------
* Drug: Xiapex


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: dupuytrens disease xiapex treatment Exclusion Criteria: - demens/other psychiatric diseases

Ages Eligible for Study
-----------------
Minimum Age: 18 Years

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

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

Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: Xiapex|Follow-up of effect of treatment|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in extension deficit from baseline to FU in MCP and PIP joints after treatment |  | Minimum one year after treatment |