linjc16/ctgov huggingface dataset:
Effect of Tourniquet on UKA

Study Overview
=================
Brief Summary
-----------------
There is obviously a lack of evidence regarding the risk-benefit ratio of a thigh tourniquet in unicondylar knee arthroplasty (UKA). This refers to many possible outcome criteria like operating time, blood loss, quality of prosthesis fixation in the bone, adverse events, radiographic result, clinical score outcome, easy of rehabilitation etc. It is not appropriate to rely on findings from the field of total knee arthroplasty. It is the aim of the current study, to clarify the role of a thigh tourniquet during UKA with regard to component fixation quality, component positioning and sizing, clinical outcome and rehabilitation process. Patients scheduled for routine UKA implantation due to osteoarthritis or osteonecrosis in the medial compartment will be considered for participation. Patients are then randomized for surgery with or without tourniquet. After an anteromedial Quad-Sparing approach the UKA procedure itself is then carried out, as suggested by the manufacturer. For both groups puls lavage and meticulous drying is applied before cementing. The following outcome parameters are assessed: 1)radiographic cement mantle thickness, 2)component position & sizing, 3)diolucencies, 4)score outcome and 5)parameters of early Rehab.

Official Title
-----------------
The Role of a Thigh Tourniquet in Unicondylar Knee Arthroplasty: a Randomized Controlled Trial

Conditions
-----------------
Tourniquets, Arthroplasty

Intervention / Treatment
-----------------
* Procedure: unicondylar knee arthroplasty


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: waiting list for unicondylar knee arthroplasty Exclusion Criteria: failed upper tibial osteotomy, insufficiency of the collateral or anterior cruciate ligaments, a fixed varus or valgus deformity (not passively correctable) above 15°, a flexion deformity greater than 15° and 5) rheumatoid arthritis. In addition - with regard to the scope of the current study - further exclusion criteria will be intake of medicinal anticoagulation prior to surgery liver dysfunction / coagulation dysfunction peripheral arterial obstructive disease.

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: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: tourniquet<br>UKA surgery with tourniquet | Procedure: unicondylar knee arthroplasty<br> <br> |
| Experimental: no tourniquet<br>UKA without tourniquet | Procedure: unicondylar knee arthroplasty<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| cement mantle thickness |  | 1 week |
Recognizing and Preventing Burnout

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to prevent burnout and offer the hospital staff a space for processing the emotional experiences.

Official Title
-----------------
Recognizing and Preventing Burnout: A Pilot Randomized Controlled Trial

Conditions
-----------------
Burnout, Professionals

Intervention / Treatment
-----------------
* Behavioral: Psychological Intervention


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Doctors, physiotherapists, nurses and care workers Be a Professional Worker at the Rehabilitation Respiratory Unit Age > 18 years old Exclusion Criteria: Refusal at the Informed 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?
-----------------

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Psychological Intervention<br>All the professionals workers involved in the experimental group will attend three intensive psychological meetings about emotional exhaustion, depersonalisation, low personal accomplishment and how to improve coping skills. | Behavioral: Psychological Intervention<br> <br> |
| No Intervention: Control Group<br>There is not any intervention. | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Changes in burnout, as assessed by the Maslach Burnout Inventory (MBI) (Maslach C., 1981) between baseline (T0), 6 months (T1) and 12 months (T2) |  | At the baseline (T0), 6 months (T1) and 12 months (T2) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Changes in coping strategies as assessed by the Coping Orientation to Problems Experienced (COPE) (Carver et al., 1989) between baseline (T0), 6 months (T1) and 12 months (T2) |  | At the baseline (T0), 6 months (T1) and 12 months (T2) | 
| Changes in psychological symptoms as assessed by the Symptom Checklist-90-R (Prunas et al., 2012) between baseline (T0), 6 months (T1) and 12 months (T2) |  | At the baseline (T0), 6 months (T1) and 12 months (T2) | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Burnout, Health Care Workers, Coping Skills, Clinical Trial
Treatment of Philadelphia-Positive Acute Lymphocytic Leukemia (Ph+ ALL) in the Elderly With Imatinib Mesylate (STI571) and Chemotherapy.

Study Overview
=================
Brief Summary
-----------------
ALL patients aged 55 years or older were treated with steroids during one week and Ph+ve cases were then offered a specific therapy including an induction treatment with steroids, cyclophosphamide, daunorubicin and vincristine, followed, irrespective of response to induction chemotherapy, by imatinib, 600 mg daily, combined with intermittent steroids during 2 months. Patients in complete response (CR) were then given 10 blocks of alternating chemotherapy, including 2 additional two-month blocks of imatinib, for a total treatment duration of 2 years. Therapy of occult central nervous system leukemia included 5 intrathecal injections of methotrexate and cranial irradiation. Duration of therapy : 2 years.

Official Title
-----------------
Evaluation of Imatinib (GLIVEC) After Induction Therapy in Patients Aged More Than 55 Years With Philadelphia Positive Acute Lymphoblastic Leukaemia (Ph+ ALL) : a Non Randomised, Controlled, Open, Multicentric, International Phase II Clinical Study (CSTI 571 AFR09 Trial)

Conditions
-----------------
Acute Lymphocytic Leukemia

Intervention / Treatment
-----------------
* Drug: imatinib


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Ph+ ALL patients 55 years or older Signed written informed consent Exclusion Criteria: CML in transformation Concomitant malignancy Previous treatment by Imatinib Severe organ condition

Ages Eligible for Study
-----------------
Minimum Age: 55 Years
Maximum Age: 90 Years

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

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

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

Design Details

Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

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

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Impact of Imatinib on survival in elderly patients with Ph+ALL |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Tolerance of Imatinib |  |  | 
| Complete remission rate |  |  | 
| Minimal Residual Disease after Imatinib treatment |  |  | 
| Leukemia free survival |  |  | 
| Impact of steroids given before starting chemotherapy |  |  | 
| Study of potential resistance mechanisums to Imatinib |  |  | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Acute Lymphocytic Leukemia,, Ph+,, elderly patients,, Imatinib
Renal Sympathetic Denervation for Reduction of Pain and Improvement of Insulin Sensitivity in Adult Polycystic Kidney Disease

Study Overview
=================
Brief Summary
-----------------
In patients with polycystic kidney disease, pain may be resistant to drug therapy and may reduce quality of life. This study investigate the effect of renal denervation on this pain.

Conditions
-----------------
Adult Polycystic Kidney Disease

Intervention / Treatment
-----------------
* Procedure: renal denervation


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Pain limiting daily activities in spite of pain killers, ADPKD Exclusion Criteria: Pregnancy

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: Crossover Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: immediate renal denervation<br>immediate renal denervation | Procedure: renal denervation<br> <br> |
| Active Comparator: delayed renal denervation<br>delayed renal denervation | Procedure: renal denervation<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pain | Pain from VAS | 6 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Quality of Life (QoL) | SF-12v2 | 6 months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
ADPKD, denervation, renal denervation
Development of an Epileptic Seizure Detection Algorithm by Continuous Analysis of the Electrocardiogram

Study Overview
=================
Brief Summary
-----------------
The aim of our project is to develop an epileptic seizure detection algorithm based on the the continuous analysis of the Electrocardiogram

Detailed Description
-----------------
In a first step, the team will build a multi-parametric algorithm on existing records issued from the Epilepsy Monitoring Units. Each selected record will be analyzed by EMU medical team in order to detect seizure on the EEG. The algorithm will adapt in order to obtain the best sensitivity and specificity regarding seizure detection. in a second step,algorithm will validate on a cohort of other recordings in patients with epilepsy

Official Title
-----------------
Development of an Epileptic Seizure Detection Algorithm by Continuous Analysis of the Electrocardiogram

Conditions
-----------------
Seizures, Epilepsy, Electrocardiography

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: patients with epilepsy with a long-term video-EEG recording 1 (or more) seizure (s) recorded onset seizure clearly defined on the basis of the EEG Exclusion Criteria: bad quality of the Electrocardiogram recording pace-maker non sinus rhythm

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 |
| --- | --- |
| Construction<br>100 recordings that will be used for the algorithm development | |
| Validation<br>100 recordings for the validation of the algorithm | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| ROC curve for seizure detection | ROC curve gives the relation between detection probability and false alarm probability of the algorithm that will be developped | 24 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Time of detection of seizures | Time of detection of seizures by the algorithm | 24 months | 
| ROC curve for Psychogenic seizure detection | ROC curve for Psychogenic seizure detection | 24 months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
seizure detection
Korean Post-marketing Surveillance for Orencia®

Study Overview
=================
Brief Summary
-----------------
The purpose of this post-marketing surveillance is to investigate and confirm the type and incidence of newly identified adverse events and any other factors affecting safety and efficacy of Orencia® so that the regulatory authority can manage the marketing approval properly.

Detailed Description
-----------------
Time Perspective: Prospective / Retrospective(On-treatment)

Official Title
-----------------
Korean Post-marketing Surveillance for Orencia®

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

Intervention / Treatment
-----------------
* Drug: No Intervention (subjects were previously treated with Orencia®)


Participation Criteria
=================
Eligibility Criteria
-----------------
For more information regarding BMS clinical trial participation, please visit www.BMSStudyConnect.com Inclusion Criteria: Patients must be diagnosed with: Adult Rheumatoid arthritis (RA): adult patients with moderate-to-severe active RA Or Juvenile idiopathic RA: juvenile patients aged 6 years and older with moderate-to-severe active RA Exclusion Criteria: Children aged <6 years Pregnant or lactating women Patients who are participating in another study Patients known to be hypersensitive to the active component of the surveillance drug or any other component of the surveillance drug Patients who had a positive tuberculosis screening test but were not treated with standard therapy before participating in the study Patients who have a positive hepatitis virus test Patients who were given a live vaccine concurrently with the surveillance drug or are expected to be given a live vaccine again within 3 months after discontinuation of the surveillance drug
Sexes Eligible for Study
-----------------
All

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Patients with active rheumatoid arthritis<br>Patients aged 6 years and over who have moderate-to-severe active rheumatoid arthritis | Drug: No Intervention (subjects were previously treated with Orencia®)<br>* No Intervention<br>* Other names: Abatacept;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Adverse events occurrence |  | 30 days after last dose of study drug | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of Adverse Events and Serious Adverse Events |  | 30 days after last dose of study drug | 
| Efficacy of Orencia® measured by swollen joint counts and tender joint counts in the subject treated with the surveillance drug, patient-assessed pain, APR, patient-assessed global health, physician-assessed global disease activity | * APR = acute phase reactants | 24 weeks of registration |
Clinical Management of Antiplatelet Drug Resistance in Patients With Drug Eluting Coronary Stents

Study Overview
=================
Brief Summary
-----------------
It is recommended that patients who have drug-eluting stents placed in their coronary arteries take aspirin and Plavix (Clopidogrel) for at least a year. Patients who stop taking these antiplatelet drugs or who have resistance to the antiplatelet effects of these drugs are at a higher risk of clots occurring inside the stents which may result in a heart attack. At the present time, it is unknown if increasing the doses of the antiplatelet agents is effective in overcoming this resistance. The purpose of this project is to identify patients with antiplatelet drug resistance and to test whether an increase in the Plavix (Clopidogrel) dose overcomes antiplatelet drug resistance.

Conditions
-----------------
Coronary Artery Disease

Intervention / Treatment
-----------------
* Drug: Plavix (Clopidogrel)


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Required Coronary Artery Angioplasty with a drug-eluting stent deployment Exclusion Criteria: The last drug-eluting stent placed greater than 2 weeks prior Aspirin or Plavix (Clopidogrel) allergy or contraindication

Ages Eligible for Study
-----------------
Minimum Age: 19 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: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 1<br> | Drug: Plavix (Clopidogrel)<br>* 150 mg tablet of Plavix (Clopidogrel) per day for 12 months if resistance is identified<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| to evaluate the frequency of aspirin and Plavix (Clopidogrel) resistance (as measured by a percent inhibition of platelet aggregation) in patients undergoing coronary drug-eluting stent deployment |  | 3 month intervals up to 12 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| to assess if a Plavix (Clopidogrel) dose increase in patients with resistance to both aspirin and Plavix (Clopidogrel) is effective in overcoming antiplatelet drug resistance |  | 3 month intervals up to 12 months | 
| to evaluate the frequency of major adverse cardiovascular events in patients with and without antiplatelet resistance and following a dose increase in Plavix (Clopidogrel). |  | 3 month intervals up to 12 months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Drug Eluting Stents, Clopidogrel Resistance, Aspirin Resistance
Ropivacaine Hypobaric Spinal Anaesthesia in Traumatic Hip Surgery

Study Overview
=================
Brief Summary
-----------------
This is a prospective, monocentric, randomized study, comparing the effectiveness and tolerance of four different dosages of hypobaric ropivacaine for unilateral spinal anaesthesia during traumatic femoral neck surgery in the elderly.

Official Title
-----------------
Determining the Minimum Effective Ropivacaine Dose for Unilateral Hypobaric Spinal Anaesthesia During Traumatic Femoral Neck Surgery in the Aged Person: Prospective Comparative Randomized Study

Conditions
-----------------
Femoral Neck Fracture

Intervention / Treatment
-----------------
* Drug: 6 mg of ropivacaine
* Drug: 8 mg of ropivacaine
* Drug: 10 mg of ropivacaine
* Drug: 12 mg of ropivacaine


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: older than 70 dorsal decubitus surgery ASA score 1, 2, 3 MMS score > or equal to 25 Exclusion Criteria: local anesthetic allergy spinal anaesthetic exclusion MMS score lower than 25

Ages Eligible for Study
-----------------
Minimum Age: 70 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: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 6 mg of ropivacaine<br>6 mg of ropivacaine are used for the spinal anaesthesia | Drug: 6 mg of ropivacaine<br>* 6 mg of ropivacaine are used for the spinal anaesthesia<br>|
| Experimental: 8 mg of ropivacaine<br>8 mg of ropivacaine are used for the spinal anaesthesia | Drug: 8 mg of ropivacaine<br>* 8 mg of ropivacaine are used for the spinal anaesthesia<br>|
| Experimental: 10 mg of ropivacaine<br>10 mg of ropivacaine are used for the spinal anaesthesia | Drug: 10 mg of ropivacaine<br>* 10 mg of ropivacaine for the spinal anaesthesia<br>|
| Experimental: 12 mg of ropivacaine<br>12 mg of ropivacaine are used for the spinal anaesthesia | Drug: 12 mg of ropivacaine<br>* 12 mg of ropivacaine for the spinal anaesthesia<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Determine the minimum effective ropivacaine dose for unilateral hypobaric spinal anaesthesia during traumatic femoral neck surgery. |  | 1 hour (surgery intervention) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Spinal anaesthesia characteristics |  | 1 hour (surgery intervention) | 
| Hemodynamics consequences |  | 1 hour (surgery intervention) | 
| Patient and surgeon satisfaction |  | 1 hour (surgery intervention) | 
| Morbidity and mortality |  | During 3 days after surgery | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Unilateral spinal anaesthesia, Hypobaric anaesthesia, Ropivacaine, Traumatic hip surgery