linjc16/ctgov huggingface dataset:
Study Comparing Etanercept Plus Methotrexate to Either Etanercept or Methotrexate Alone in Rheumatoid Arthritis.

Study Overview
=================
Brief Summary
-----------------
To compare the therapeutic and radiographic effects and safety between etanercept, methotrexate, and the etanercept/methotrexate combination in patients with rheumatoid arthritis.

Detailed Description
-----------------
Etanercept is an injection administered under the skin twice weekly. Methotrexate is a tablet to be taken once weekly. Patients will not know which treatment they are on. Patients will need to meet the study criteria to be enrolled in the study and sign an informed consent.

Official Title
-----------------
A Double-blind Study Evaluating the Efficacy and Safety of the Combination of Etanercept and Methotrexate in Comparison to Etanercept Alone or Methotrexate Alone in Rheumatoid Arthritis Patients.

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

Intervention / Treatment
-----------------
* Drug: Etanercept


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion: - Generally healthy of at least 18 years of age with active rheumatoid arthritis. Exclusion: - A history or presence of clinically important medical disease.

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: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

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

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The objective of this study is to evaluate the therapeutic response including radiographic changes and safety of etanercept alone, methotrexate (MTX) alone, and the combination of etanercept and MTX in patients with rheumatoid arthritis (RA) |  |  | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Arthritis, Rheumatoid, Safety
Expanded Access to Telisotuzumab Vedotin

Study Overview
=================
Brief Summary
-----------------
This is an expanded access program (EAP) for eligible participants. This program is designed to provide access to Telisotuzumab vedotin prior to approval by the local regulatory agency. Availability will depend on territory eligibility. A medical doctor must decide whether the potential benefit outweighs the risk of receiving an investigational therapy based on the individual patient's medical history and program eligibility criteria.

Official Title
-----------------
Expanded Access to Telisotuzumab Vedotin

Conditions
-----------------
Non-Small Cell Lung Cancer (NSCLC)

Intervention / Treatment
-----------------
* Drug: Telisotuzumab vedotin


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: - The participant must not be eligible for a telisotuzumab vedotin clinical trial.

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


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

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

Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: Telisotuzumab vedotin|Intravenous Infusion|

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
-----------------
Non-Small Cell Lung Cancer (NSCLC), Telisotuzumab vedotin, ABBV-399, Expanded Access, Pre-approval Access, Compassionate Use, Special Access Program, Named Patient Basis, Special Access Scheme
Efficiency of Patellar Taping in Treatment of Patellofemoral Pain Syndrome

Study Overview
=================
Brief Summary
-----------------
Patellar subluxation is a common disorder that may cause patellofemoral pain syndrome. The efficiency of patellar taping in the treatment of patellofemoral pain syndrome has been reported good outcomes in most patients. However, some studies reported less effective in patients with higher body mass index, larger lateral patellofemoral angle, and smaller Q angle. The investigators hypothesized that femoral internal rotation is a negative factor to the patellar taping. The investigators enroll consecutive 100 patients with anterior knee pain and radiographic evidence of patellar subluxation. The investigators determine femoral rotation via physical examination. The visual analogue scale was evaluate to compare the result between the those with and without femoral internal rotation.

Detailed Description
-----------------
Consecutive 100 patients with anterior knee pain and compatible with inclusion criteria. Before treatment, an independent physiotherapist evaluates whether femoral internal rotation or not via physical therapy, and another studying nurse records the visual analog scale and measures Q angle. After evaluation, McConnell taping is applied to these patients. Two weeks later, outcomes are recorded including visual analog scale, satisfactory, and complication. The outcomes are compared between those with and without femoral internal rotation.

Official Title
-----------------
The Effects of Distal Femoral Rotation on Patellofemoral Pain Syndrome Treated With Patella Taping

Conditions
-----------------
Patellofemoral Pain Syndrome

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: anterior knee pain radiographic evidence of patellar subluxation Exclusion Criteria: history of patellar dislocation osteoarthritis of ipsilateral knee pregnancy history of knee injury BMI > 35 allergy to taping

Ages Eligible for Study
-----------------
Minimum Age: 20 Years
Maximum Age: 50 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 |
| --- | --- |
| femoral internal rotation<br> | |
| no femoral internal rotation<br> | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Knee pain | The visual analog scale are measured before and two weeks after taping. | two weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Satisfactory | The patients recorded the satisfactory score by theyself from 0 to 10. Ten degree means most satisfactory. | 2 weeks |
Selective Unilateral Spinal Anesthesia Versus Selective Sensory Spinal Anesthesia for Knee Arthroscopy Surgery

Study Overview
=================
Brief Summary
-----------------
Background: Selective unilateral spinal anesthesia is the gold standard spinal anesthesia technique for knee arthroscopy. Selective sensory spinal anesthesia has recently been validated for this surgery. Both selective techniques are specially indicated for ambulatory surgery because of PACU fast track, low discharge home time and high patient satisfaction. This study compares both spinal techniques for knee arthroscopy surgery.

Official Title
-----------------
Selective Unilateral Spinal Anesthesia Versus Selective Sensory Spinal Anesthesia for Knee Arthroscopy Surgery

Conditions
-----------------
Pain

Intervention / Treatment
-----------------
* Drug: hypobaric levobupivacaine with fentanyl
* Drug: hyperbaric bupivacaine 0,5%


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: adults scheduled to undergo knee arthroscopy Exclusion Criteria: a previous history of neurological impairment insulin-dependent diabetes mellitus intolerance to the study drug or related compounds and additives BMI > 38 kg/m2 height <155 cm or >180 cm any existing contraindications for spinal anaesthesia surgery in which a complete block of the lower limb

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: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: hyperbaric bupivacaine<br> | Drug: hyperbaric bupivacaine 0,5%<br>* SUSA with 4 mg hyperbaric bupivacaine 0.5%<br>* Other names: Marchaine;|
| Experimental: hypobaric levobupivacaine with fentanyl<br> | Drug: hypobaric levobupivacaine with fentanyl<br>* SSSA with 4 mg hypobaric levobupivacaine 0,13% with 10 mcg fentanyl<br>* Other names: Chirocane;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| time to discharge home | In Day Surgery Unit, patients will be assessed for home discharge every 30 minutes and will be followed an expected average of three hours. | every 30 minutes for an average of 3 hours | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Ambulation time after surgery | In PACU and in Day Surgery Unit, patients will be assessed for unassisted ambulation every 30 minutes and will be followed an expected average of three hours. | every 30 minutes for an average of 3 hours | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
knee arthroscopy, hyperbaric bupivacaine, hypobaric levobupivacaine plus fentanyl
Will Preoperative MRI Breast in Women Under 56 Years With Breast Cancer Change Primary Treatment

Study Overview
=================
Brief Summary
-----------------
The study is a prospective randomised multicenter trial assessing the additional value of breast MRI in women under 56 years of age with newly diagnosed breast cancer. Will preoperative breast MRI change treatment regimen? Will preoperative breast MRI reduce the number of primary surgeries? Will preoperative breast MRI increase the rate of mastectomies? Will preoperative breast MRI be cost effective?

Detailed Description
-----------------
Completed: the study has concluded normally; participants are no longer being examined or treated (i.e., last patient's last visit has occurred)

Official Title
-----------------
Randomized Multicenter Trial Assessing if Preoperative MRI Breast in Women Under 56 Years With Breast Cancer Will Change Primary Treatment

Conditions
-----------------
Breast Neoplasm

Intervention / Treatment
-----------------
* Device: MRI


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Women under 56 years of age Newly diagnosed breast cancer Swedish or English speaking Exclusion Criteria: Claustrophobia Pregnancy Renal failure Metal items in patients

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 56 Years

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

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

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

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: preoperative breast MRI<br>The intervention is that preoperative MRI breast will be performed in women under 56 years with newly diagnosed breast cancer | Device: MRI<br>* The intervention is that preoperative MRI breast will be performed in 220 women under 56 years with newly diagnosed breast cancer. Aims are to analyze if the intervention will affect primary management, decrease the number of reoperations and to analyze if the intervention leads to an increasing number of unnecessary mastectomies compared to the non intervention arm.<br>|
| No Intervention: no MRI breast<br>The arm type description implies that no MRI breast will be performed to women under 56 years with newly diagnosed breast cancer | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change of treatment plan | Did breast magnetic resonance imaging add information about the tumour that changed primary treatment plan | 14 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Did breast magnetic resonance imaging reduce the number of reoperation during primary management |  | 6 months | 
| Did breast magnetic resonance imaging increase the number of mastectomies |  | 6 months | 
| Did breast magnetic resonance imaging affect cost |  | 6 months |
Feasibility Study of Auditory Brainstem Implant in Young Children

Study Overview
=================
Brief Summary
-----------------
Current treatment options for bilateral profoundly deaf children, diagnosed with inner ear anatomical abnormalities are limited, and in the case of absent cochleas, non-existent. An auditory brainstem implant (ABI) places an electrode close to the auditory nucleus in the brainstem. Children aged 2 - 5 who are not candidates for a cochlear implant, or who did not demonstrate benefit from a cochlear implant, will be implanted with an ABI and followed for 1 year for safety and a total of 3 years for preliminary efficacy. This is a feasibility study to determine the safety of the ABI.

Official Title
-----------------
A Feasibility Study of the Placement, Use, and Safety of the Nucleus 24 Auditory Brainstem Implant in Non-Neurofibromatosis Type 2 (NF2) Pediatric Patients

Conditions
-----------------
Bilateral Cochlear Aplasia, Bilateral Cochlear Nerve Deficiency, Bilateral Cochlear Ossification Secondary to Meningitis

Intervention / Treatment
-----------------
* Device: Auditory brainstem implant


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Bilateral profound deafness due to cochlear aplasia, cochlear nerve deficiency, or ossification secondary to meningitis If previously received a cochlear implant, must demonstrate lack of benefit from that device Exclusion Criteria: Medical contraindication to craniotomy/intracranial surgery Severe cognitive or developmental delays

Ages Eligible for Study
-----------------
Minimum Age: 2 Years
Maximum Age: 5 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 |
| --- | --- |
| Experimental: Device implantation<br>Implantation of device | Device: Auditory brainstem implant<br> <br> * Other names: Cochlear Corporation Nucleus 24;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of Serious Adverse Events | Count of the number of expected serious adverse events must not exceed that known to occur in pediatric retrosigmoid craniotomy and Count of the number of unexpected serious adverse events must not exceed 2 in the first 5 children. | 12-month post-activation | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Access to sound at a level (dB) and within the frequency range (500-4000 Hz), known to be associated with speech | ability to detect sounds | 3 years post-activation |
VISIBILITY™ Iliac Study

Study Overview
=================
Brief Summary
-----------------
The VISIBILITY Iliac study is a prospective, multi-center, non-randomized study confirming the safety and effectiveness of stenting using the Visi-Pro™ Balloon Expandable Stent System for the treatment of stenotic, restenotic or occluded lesions in the common and external iliac artery.

Official Title
-----------------
Visi-Pro™ Balloon Expandable Iliac Study (VISIBILITY™ Iliac)

Conditions
-----------------
Peripheral Arterial Disease, Claudication

Intervention / Treatment
-----------------
* Device: Visi-Pro™ Balloon Expandable Stent System


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patient has claudication as defined by a Rutherford Clinical Category Score of 2, 3 or 4. Evidence of ≥ 50% stenosis, restenosis or occlusion of target lesion(s) located in the common iliac artery and/or external iliac artery. Willing to comply with all follow-up evaluations at the specified times. Provides written informed consent prior to enrollment in the study. Exclusion Criteria: Previous implantation of stent(s) in the target vessel. Received endovascular treatment of the target lesion within six months prior to the index procedure. Known hypersensitivity to contrast material that cannot be adequately pretreated. Known hypersensitivity to 316L stainless Steel. Life expectancy of less than 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
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Visi-Pro™ Balloon Expandable Stent System<br>The objective of the study is to confirm the safety and effectiveness of the Visi-Pro stent in the treatment of stenotic, restenotic or occluded lesions in the common and external iliac artery. | Device: Visi-Pro™ Balloon Expandable Stent System<br>* Implantation of one or more study devices in the common and/or external iliac artery.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Major Adverse Event Rate at 9 Months | The Major Adverse Event rate at 9 months is defined as a composite of periprocedural death, in-hospital MI, clinically-driven target lesion revascularization and amputation of the treated limb through 9 months postprocedure. | 9 months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Peripheral arterial disease, claudication, stent, VISI-Pro, Iliac artery
A Mentor-Based Approach to Long-Term Weight Loss

Study Overview
=================
Brief Summary
-----------------
The purpose of this study to examine the effect of having a weight loss mentor on long-term weight loss in overweight adults.

Official Title
-----------------
A Mentor-Based Approach to Long-Term Weight Loss

Conditions
-----------------
Weight Loss, Obesity

Intervention / Treatment
-----------------
* Behavioral: behavioral weight loss program


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Female 21-55 years of age BMI = 25-35 kg/m2 Ability to provide informed consent. Ability to provide consent from their personal physician to participate in this study. Exclusion Criteria: Reporting regular exercise participation of at least 20 minutes per day on at least 3 days per week during the previous six months. (This study is designed to recruit relatively sedentary adults.) Diabetes, hypothyroidism, or other medical conditions which would affect energy metabolism. Currently pregnant, pregnant within the previous six months, or planning on becoming pregnant within the next 12 months. (Pregnancy will be based on self-report and will be included on the detailed medical history that is completed by subjects.) Non-medicated resting systolic blood pressure >160 mmHg or non-medicated resting diastolic blood pressure >100 mmHg, or taking medication that would affect blood pressure. Taking medication that would affect resting heart rate or the heart rate response during exercise (e.g., beta blockade). Arrhythmia on resting or exercise electrocardiogram that would indicate that vigorous exercise was contraindicated. History of myocardial infarction or valvular disease. History of orthopedic complications that would prevent optimal participation in the exercise component (e.g., heel spurs, severe arthritis).

Ages Eligible for Study
-----------------
Minimum Age: 21 Years
Maximum Age: 55 Years

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

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: None (Open Label)


Arms and Interventions

| Intervention/Treatment |
| --- |
|Behavioral: behavioral weight loss program|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| weight loss |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| fitness |  |  | 
| dietary intake |  |  | 
| mediators |  |  |
Evaluation of the Technique LHP (Laser HemorrhoidoPlasty) in Haemorrhoidal Prolapse Mini Invasive Surgery

Study Overview
=================
Brief Summary
-----------------
Hemorrhoids surgery technics evolved during the past 20 years. Recently a new one using laser have been developped. It aims at reducing the blood flow towards hemorroïdal plexuses by photocoagulating with a fiber laser the terminal branches of the superior rectal artery. The aim is to evaluate the efficacy of this technic and note the post surgery pain and events

Official Title
-----------------
Evaluation of the Technique LHP (Laser HemorrhoidoPlasty) in Haemorrhoidal Prolapse Mini Invasive Surgery Grade II or III of Goligher

Conditions
-----------------
Hemorrhoids

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: age > 18 hemorrhoid prolapse grade 2 and 3 accepting participation Exclusion Criteria: hemorrhoid prolapse grade 1 and 4 other proctological pathology previous surgery of prolapsus with anti coagulant treatment Intestinal chronic inflammatory disease age < 18 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?
-----------------
What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Goligher score | score evaluating symptoms of haemorroidal pathology | 1 year |