linjc16/ctgov huggingface dataset:
Thoracolumber Oterfacial Plane Block for Spine Surgery

Study Overview
=================
Brief Summary
-----------------
The most commonly used technique to anesthetize patients scheduled for thoracic or lumbar spine surgery is general anesthesia. Analgesic techniques vary from the use of neuraxial techniques like epidural, intrathecal, or caudal analgesia, nerve root infiltration to the use of systemic opioids, Paracetamol, non-steroidal anti-inflammatory drugs (NSAID), steroids and gabapentinoids . In 2015, a promising regional analgesia technique was reported, that targets the dorsal, rather than ventral, rami of the thoracolumbar nerves as they pass through the paraspinal musculature, and called this a thoracolumbar interfacial plane block (TLIP).

Official Title
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Thoracolumbar Interfacial Plane Block for Analgesia After Spine Surgery

Conditions
-----------------
Spine Surgeries

Intervention / Treatment
-----------------
* Drug: Bupivacaine 0.5% injected in the thoraco-lumber inetrfacial plane block


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients scheduled for Spine surgery. Exclusion Criteria: Spine deformities, redo surgeries, patients refusing being enrolled in the study, and patients with a bleeding tendency (INR˃ 1.4 and or Platelet count ≤ 150 X103/ µl) will be excluded.

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 45 Years

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

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

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

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: T group<br>Ultrasound guided Bilateral TLIP Block will be performed 15 minute before the start of surgery Using 15 ml of bupivacaine 0.25 for each side. | Drug: Bupivacaine 0.5% injected in the thoraco-lumber inetrfacial plane block<br>* After attaching basic monitors (ECG, SpO2, NIBP), the patient will take the prone position. Using the superficial probe of the ultrasound machine, the probe will be placed in transversally in midline position at selected level. The spinous process and interspinalis muscles will be identified. The probe was then moved laterally to identify the mulifidus muscle (MF) and the longissimus muscles (LG) where the local anesthetic will be injected. The needle will be advanced under real-time in-plane ultrasound guidance till it reaches the interface between the two muscles then a 1-2 ml of saline will be inserted to confirm needle site. 15 ml of bupivacaine 0.25 will be injected each side.<br>|
| No Intervention: C group<br> | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| postoperative morphine consumption in milligrams | morphine consumption (mg)required to keep visual anlohue scale below 4 in the 1st 24 hours after surgery | for the 1st 24 hours after surgery |
Determinants of the Long-Term Success of Bariatric Surgery

Study Overview
=================
Brief Summary
-----------------
The management of obesity is based on a multidisciplinary approach and justifies the use of surgery in patients with the most severe forms. Surgery for obesity or bariatric surgery generally allows rapid and significant weight loss however it is associated with significant risks, and its long-term results remain heterogeneous and unpredictable. Long-term data will clarify the role of different types of bariatric surgery in surgical strategy, improve patient information and identify predictors of failure in order to provide personalised and tailored surgery for each candidate .

Detailed Description
-----------------
Currently, there is insufficient data to determine the persistence over time of the positive results of bariatric surgery on weight loss. Moreover, there is no consensus or criteria for choosing one surgical weight loss procedure over another. The best choice for one patient may not be the most appropriate for another. The results of this project will allow to better select obese patients likely to benefit from bariatric surgery, and to further personalise the management of severe obesity.

Official Title
-----------------
Determinants of the Long-Term Success of Bariatric Surgery - Multicenter Regional Observational Study: Regional Multicentre Prospective Study

Conditions
-----------------
Morbid Obesity, Bariatric Surgery Candidate

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients who received bariatric surgery 5 years ago. Exclusion Criteria: Refusal to participate in the study, Unable to receive informed information, Unable to participate in the study
Sexes Eligible for Study
-----------------
All

Study Plan
=================
How is the study designed?
-----------------
What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Success rate in terms of weight loss | Rate of patients who lost at least 20 of their initial body weight | at 5 years after bariatric surgery | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Success rate in terms of weight loss according to type of bariatric surgery | Rate of patients who lost at least 20 of their initial body weight at 1 year according to type of bariatric surgery (Gastric by-pass in Y or Omega, sleeve gastrectomy, and gastric band) | at 1 year after bariatric surgery | 
| Success rate in terms of weight loss according to type of bariatric surgery | Rate of patients who lost at least 20 of their initial body weight at 5 years according to type of bariatric surgery (Gastric by-pass in Y or Omega, sleeve gastrectomy, and gastric band) | at 5 years after bariatric surgery | 
| Rate of re- interventions related to bariatric surgery | Evaluation of re-interventions following bariatric surgery | 5 years | 
| Lost rate seen | Evaluation of lost to follow-up | at 5 years after bariatric surgery |
A Study of Xeloda (Capecitabine) as First-Line Chemotherapy in Patients With Advanced or Metastatic Gastric Cancer.

Study Overview
=================
Brief Summary
-----------------
This single arm study will assess the efficacy and safety of Xeloda in combination with oxaliplatin as first-line chemotherapy in patients with advanced and/or metastatic gastric cancer who have had no prior chemotherapy for advanced or metastatic disease. Eligible patients will receive Xeloda 1000mg/m2 po twice daily, D1-D10 every 2 weeks (10 days treatment followed by 4 days rest period) plus oxaliplatin 85 mg/m2/day iv, D1 every 2 weeks. The anticipated time on study treatment is until disease progression, and the target sample size is <100 individuals.

Official Title
-----------------
A Open Label Study of the Effect of First-line Therapy With Xeloda in Combination With Oxaliplatin on Overall Response Rate in Patients With Locally Advanced and/or Metastatic Gastric Cancer

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

Intervention / Treatment
-----------------
* Drug: Oxaliplatin
* Drug: capecitabine [Xeloda]


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: adult patients, >=18 years of age; gastric cancer with unresectable locally advanced and/or metastatic disease; >=1 measurable lesion; ambulatory, with ECOG Performance Status >=1. Exclusion Criteria: previous chemotherapy (except adjuvant or neoadjuvant treatment >=6 months prior to enrollment); clinically significant cardiac disease or myocardial infarction within last 12 months; CNS metastases; history of other malignancy within last 5 years, except for cured basal cell cancer of the skin, or in situ cancer of the cervix.

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 1<br> | Drug: Oxaliplatin<br>* 85mg/m2 iv on day 1 of each 2 week cycle<br>Drug: capecitabine [Xeloda]<br>* 1000mg/m2 po bid on days 1-10 of each 2 week cycle<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Overall response rate |  | Event driven | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Time to disease progression, overall survival, duration of response, time to response. |  | Event driven | 
| AEs, laboratory parameters. |  | Throughout study |
A Multiple-Dose Pharmacokinetic Interaction Study Between ABT-335, Atorvastatin and Ezetimibe

Study Overview
=================
Brief Summary
-----------------
The objective of this study is to evaluate the potential PK interaction between ABT-335, atorvastatin 80 mg and ezetimibe 10 mg when administered concurrently.

Conditions
-----------------
Pharmacokinetics

Intervention / Treatment
-----------------
* Drug: ABT-335
* Drug: Atorvastatin
* Drug: Ezetimibe


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Healthy male or female subjects Exclusion Criteria: Clinically significant diseases or disorders Positive screens for drug and alcohol Pregnant or breast-feeding females Any history of surgery(ies) that might interfere with the gastrointestinal motility, pH or absorption

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 55 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

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: A<br>ABT-335 135 mg | Drug: ABT-335<br>* One ABT-335 135 mg capsule QD for 10 days<br>* Other names: fenofibric acid;|
| Experimental: B<br>Atorvastatin 80 mg and Ezetimibe 10 mg | Drug: Atorvastatin<br>* One 80 mg tablet of atorvastatin QD for 10 days<br>* Other names: atovastatin;Drug: Ezetimibe<br>* One ezetimibe 10 mg tablet QD for 10 days<br>|
| Experimental: C<br>ABT-335 135 mg, Atorvastatin 80 mg and Ezetimibe 10 mg | Drug: ABT-335<br>* One ABT-335 135 mg capsule QD for 10 days<br>* Other names: fenofibric acid;Drug: Atorvastatin<br>* One 80 mg tablet of atorvastatin QD for 10 days<br>* Other names: atovastatin;Drug: Ezetimibe<br>* One ezetimibe 10 mg tablet QD for 10 days<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| PK interaction |  | Study duration approximately 62 days |
Patch Test Skin Irritation/Sensitization of Cetaphil Daily Advance Ultra Hydration Lotion

Study Overview
=================
Brief Summary
-----------------
Determine if Cetaphil Daily Advance Ultra Hydrating Lotion proves to be a contact sensitizer or irritant in certain individuals.

Official Title
-----------------
100 Human Subject Repeat Insult Patch Test Skin Irritation/Sensitization Evaluation (Occlusive Patch)

Conditions
-----------------
Determine Sensitivity of Skin to Cetaphil Daily Advance Ultra Hydrating Lotion

Intervention / Treatment
-----------------
* Other: Cetaphil Daily Advance Ultra Hydrating Lotion


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Not currently under a doctor's care Free of dermatological or systemic disorder which would interfere with the results Free of any acute or chronic disease Will complete a preliminary medical history form and are in general good health Can read, understand, and sign informed consent Exclusion Criteria: Under 18 years old Currently under doctor's care currently taking any medication History of acute or chronic disease Diagnosed with chronic skin allergies Pregnant or lactating

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

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

Accepts Healthy Volunteers
-----------------
Accepts Healthy Volunteers

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

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Cetaphil Daily Advance Ultra Hydrating Lotion<br>All subjects receive Cetaphil Daily Advance Ultra Hydrating Lotion | Other: Cetaphil Daily Advance Ultra Hydrating Lotion<br>* 0.2ml or 0.2g of Cetaphil on occlusive, hypoallergenic patch applied to skin for 24 hrs 9 times on Monday, Wednesday, and Friday for 3 weeks<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| area of erythema and edema is measured | 9 consecutive 24hr exposures for every Monday, Wednesday, and Friday for 3 consecutive weeks | 3 consecutive weeks |
A Combined Transvenous and Epicardial Lead Placement Procedure for Implantation of Cardiac Resynchronization Devices: a Feasibility Study.

Study Overview
=================
Brief Summary
-----------------
Cardiac resynchronization therapy has become one of the cornerstones of the treatment of heart failure. However, a large proportion of patients still fails to this type of therapy. This may be due to a suboptimal position of the left ventricular pacing lead, which may be caused by unfavorable cardiac venous anatomy. Implantation of the pacing lead using video assisted thoracic surgery is more flexible and evades the venous system altogether, resulting in a much more favorable position of the pacing lead, with better treatment results as e consequence.

Conditions
-----------------
Heart Failure With Intraventricular Conduction Delay

Intervention / Treatment
-----------------
* Device: Hybrid CRT-D/P implantation


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion criteria NYHA class II-III. Left ventricular ejection fraction ≤ 35%. QRS-duration of ≥ 120 ms (NYHA III) or ≥ 130 ms (NYHA II) and left bundle branch block morphology. No sidebranch of the coronary sinus near the posterolateral wall of the left ventricle and/or presence of a Thebesian valve which reduces coronary sinus diameter 50% or more (corresponding to a decrease in cross sectional area of 75% or more). On optimal medical therapy for heart failure, including beta-blockers, ACE-inhibitors, AT2-antagonists and aldosteron antagonists. Age ≥ 18 years. Signed informed consent. Exclusion criteria A potential subject who meets any of the following criteria will be excluded from participation in this study: Coronary ischemia or a recent myocardial infarction (< 6 months). Allready a CRT-device implanted. Venous thrombosis without options to reach the right heart. Presence of any other condition than HF with a life expectancy of < 1 year. History of intrathoracic surgery. Presence or suspected presence of a noncompliant left lung. Participation in another intervention trial. Unable to understand Dutch language. Pregnant women.

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: HYBRID<br>Hybrid transvenous/epicardial implantation of a CRT-(D) device. | Device: Hybrid CRT-D/P implantation<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of procedure related serious adverse events |  | 30 days after implantation of device |
Acupuncture Safety/Efficacy in Knee Osteoarthritis

Study Overview
=================
Brief Summary
-----------------
The goal of this research is to determine the efficacy and safety of Traditional Chinese Acupuncture (TCA) in patients with osteoarthritis of the knee. A three arm randomized controlled trial (RCT) using sham TCA, true TCA, and an education/attention comparison group with a total sample of 525 is proposed. Primary hypothesis to be tested is that patients randomized to true TCA will have significantly more improvement in pain and function as measured by the Womac Pain & Function Scales and patient global assessments than patients randomized to the sham acupuncture and education/attention control groups. Secondary aims of the study are to 1) determine if improvement with TCA differs between patients below age 65 vs. those aged 65 and above, 2) to determine if improvement with TCA differs by racial/ethnic group (ie., Caucasian, Black, Hispanic), and 3) to determine if improvement with TCA differs by stage of radiographic severity of knee OA at baseline (KL grade 2, 3 or 4)

Official Title
-----------------
Acupuncture Safety/Efficacy in Knee Osteoarthritis

Conditions
-----------------
Osteoarthritis, Knee

Intervention / Treatment
-----------------
* Procedure: Acupuncture


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Diagnosis of osteoarthritis of the knee (fulfilling ACR criteria) for at least 6 months duration At least moderate pain in the knee for most days in the last month Must be taking analgesic or nonsteroidal anti-inflammatory agents for control of pain Documented radiographic changes of osteoarthritis (Kellgren-Lawrence grade>2) at the time of rheumatological screening Signed informed consent

Ages Eligible for Study
-----------------
Minimum Age: 50 Years

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

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

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

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Masking: Single


Arms and Interventions

| Intervention/Treatment |
| --- |
|Procedure: Acupuncture|nan|

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
-----------------
acupuncture, osteoarthritis, elderly
WREX Outcome Study

Study Overview
=================
Brief Summary
-----------------
This study is to evaluate how the Wilmington Robotic Exoskeleton (WREX) is working for children who are using the WREX, or have used it in the past. The survey consists of a set of questions a) performed online and b) performed over the phone.

Detailed Description
-----------------
The WREX (Wilmington Robotic EXoskeleton) is being used by many children with neuromuscular conditions such as arthrogryposis and muscular dystrophy. Nemours/A.I. duPont Hospital for Children alone has provided a WREX for about 80 children in the last 3 years. This is being done through the orthopedic and muscle clinics in the hospital. We would like to perform a retrospective study to see how well the children are doing with the WREX. We propose getting this feedback through a survey administered to families using the WREX. The survey will be performed in two parts. 1) A phone survey will use the Canadian Occupational Performance Measure (COPM). 2) an online survey with additional questions. The parents are asked to submit answers on behalf of the children if they are unable to.

Official Title
-----------------
WREX Outcome Study

Conditions
-----------------
Muscular Dystrophy, Arthrogryposis, Spinal Muscular Atrophy

Intervention / Treatment
-----------------
* Device: WREX orthosis


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Neuromuscular disease Use the Wilmington Robotic Exoskeleton Exclusion Criteria: people who do not use the Wilmington Robotic Exoskeleton

Ages Eligible for Study
-----------------
Minimum Age: 2 Years
Maximum Age: 21 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: WREX orthosis<br>WREX Orthosis | Device: WREX orthosis<br>* Upper extremity exoskleton used to assist movement<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Activities of daily living |  | 6 months |