linjc16/ctgov huggingface dataset:
Transversus Abdominis Plane Block Versus Rectus Sheath Block After Cesarean Delivery

Study Overview
=================
Brief Summary
-----------------
Importance of effective postoperative pain management is well known. The undesired effects of pain can be prevented with multimodal analgesia for the patient. Overall, for cesarean delivery, interaction between the mother and her newborn baby can be provided earlier. Many regional anesthesia techniques can be prefferred after cesarean delivery. Aim of the study is to compare the postoperative analgesia effects of transversus abdominis plane block and rectus sheath block after elective cesarean delivery.

Official Title
-----------------
Transversus Abdominis Plane Block Versus Rectus Sheath Block for Postoperative Pain After Cesarean Delivery: A Randomized Controlled Trial

Conditions
-----------------
Postoperative Pain

Intervention / Treatment
-----------------
* Procedure: Transversus abdominis plane block
* Procedure: Rectus sheath block


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: ASA I-II patients Patients undergo elective cesarean delivery Gestation period between 37-40 weeks Exclusion Criteria: obesity (body mass index >35 kg/m2) infection of the skin at the site of needle puncture area patients with known allergies to any of the study drugs coagulopathy

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

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

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

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

Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| No Intervention: Control group<br> | |
| Active Comparator: TAP group<br>Transversus abdominis plane block administered group | Procedure: Transversus abdominis plane block<br>* Transversus abdominis plane block will be performed bilaterally after the surgery.<br>|
| Active Comparator: RS group<br>Rectus sheath block administered group | Procedure: Rectus sheath block<br>* Rectus sheath block will be performed bilaterally after the surgery.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Morphine consumption | Morphine consumption (mg) of patients with patient controlled device | Postoperative 24th hour. | 
| NRS score | Numerating rating scale of patients | Postoperative 24th hour | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Postoperative pain, Transversus abdominis plane block, Rectus sheath block, Cesarean delivery
Model 4296 Left Ventricular (LV) Lead Study

Study Overview
=================
Brief Summary
-----------------
This study is designed to show that a new lead, which paces the left bottom chamber (left ventricle) of the heart, is safe. Using a lead on the left side of the heart has been shown to potentially improve heart failure symptoms. The shape and size of this new lead may make it a good choice for patients or physicians.

Detailed Description
-----------------
This study is a prospective, multi-center, non-randomized design trial. All consented patients who meet all inclusion and no exclusion criteria may receive the investigational lead. The study design has statistical power to show safety at one-month after implant.

Official Title
-----------------
Model 4296 Left Ventricular Lead Study

Conditions
-----------------
Heart Failure

Intervention / Treatment
-----------------
* Device: Pacing Lead (Model 4296 LV Lead)


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Cardiac Resynchronization Therapy (CRT)/Cardiac Resynchronization Therapy-Defibrillator (CRT-D) indications according to the European Society of Cardiology/American College of Cardiology/American Heart Association (ESC/ACC/AHA) guidelines On optimal medical treatment according to investigator opinion Indicated for implantable cardioverter defibrillator (ICD) if CRT-D is implanted Patient consent Geographically stable Exclusion Criteria: Left Ventricular (LV) lead implant attempt in last 30 days Unstable angina or acute myocardial infarction (MI) in past 30 days Coronary artery bypass graft (CABG) or percutaneous transluminal coronary angioplasty (PTCA) in past 90 days Contraindicated for transvenous pacing Heart transplant Contraindicated for less than 1 milligram (mg) dexamethasone acetate Enrolled or intends to participate in concurrent drug and/or device study which would confound results Life expectancy shorter than duration of the study Exclusion criteria required by local law Unable to tolerate urgent thoracotomy
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: Model 4296 LV Lead<br>Non-randomized study | Device: Pacing Lead (Model 4296 LV Lead)<br>* Implant and follow-up of study device<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of Participants With Left Ventricular (LV)Lead Related Complications | A LV lead related complication occurs when an invasive procedure is needed to correct an adverse event related to the LV lead. | Implant to one-month post implant | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
heart failure, cardiac pacing, cardiac resynchronization therapy, left ventricular lead
Video Capsule Endoscopy to Investigate the Safety and Tolerability of Lumiracoxib in the Small Bowel

Study Overview
=================
Brief Summary
-----------------
This study is designed to investigate the potential differences in GI safety and tolerability in the small bowel between lumiracoxib, conventional non-selective NSAID (naproxen) with a proton pump inhibitor (omeprazole), or placebo.

Official Title
-----------------
A 16-Day, Randomized, Double-Blind, Double-Dummy, Placebo-Controlled, Parallel-Group Trial Comparing Lumiracoxib 100mg o.d. With Naproxen 500 mg b.i.d. Plus Omeprazole 20mg o.d. and Placebo in Healthy Volunteers to Investigate on the Safety and Tolerability of Lumiracoxib in the Small Bowel.

Conditions
-----------------
Healthy Volunteers

Intervention / Treatment
-----------------
* Drug: Lumiracoxib


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Healthy male or female subjects Exclusion Criteria: Evidence of cardiovascular, hepatic, gastrointestinal or renal disorders Hereditary problems of galactose intolerance, a severe lactase deficiency or glucose-galactose malabsorption syndrome Smokers Other protocol-defined inclusion/exclusion criteria may apply

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

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

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: Lumiracoxib|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percentage of subjects with one or more small bowel mucosal breaks (with or without hemorrhage) detected by video capsule endoscopy |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Total number of small bowel mucosal breaks (with or without hemorrhage) detected by video capsule endoscopy |  |  | 
| Percentage of subjects with one or more small bowel lesion detected by video capsule endoscopy |  |  | 
| Total number of small bowel lesions detected by video capsule endoscopy |  |  | 
| Value of small bowel inflammation (as measured by calprotectin test) |  |  | 
| Value of lower GI permeability for lumiracoxib (as measured by differential urinary excretion of sugars) |  |  | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Video capsule endoscopy, healthy volunteers, naproxen, omeprazole, lumiracoxib, small bowel
Clinical Study to Evaluate of The Whitening Efficacy and Safety of REMEWHITE

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to determine the effect of REMEWHITE on tooth whitening.

Detailed Description
-----------------
This study intended to establish the efficacy of REMEWHITE after using the product under controlled conditions at the hospital. The efficacy of the product was assessed at the end of the study; clinical examination by the dentist.

Official Title
-----------------
A Randomized, Double-blind, Placebo-controlled Clinical Study to Evaluate of The Whitening Efficacy and Safety of REMEWHITE

Conditions
-----------------
Tooth Whitening

Intervention / Treatment
-----------------
* Drug: Hydrogen Peroxide


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: ability to understand and provide informed consent general good health male and female adults, were 20 years or older no pregnant woman had six caines-free maxillary anterior teeth without restorations on the labial surfaces Exclusion Criteria: had severe internal discoloration (tetracycline stains, fluorosis, pulpless teeth) evidence of fracture or major cracks on tooth were pregnant or nursing had tooth sensitivity smokers had teeth shade A1, A2

Ages Eligible for Study
-----------------
Minimum Age: 20 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: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: whitening<br>30% Hydrogen peroxide | Drug: Hydrogen Peroxide<br>* Whitening product syringe type<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| colorimeter |  | 12 weeks after treatment | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| colorimeter |  | 24 weeks after treatment |
Differential Effects of Protein Quality on Postprandial Lipemia in Response to a Fat-Rich Meal in Type 2 Diabetes: Comparison of Whey, Casein, Gluten, and Cod Protein

Study Overview
=================
Brief Summary
-----------------
Enhanced and prolonged postprandial triglyceride responses involve increased cardiovascular risk in type 2 diabetes. It has been demonstrated that dietary fat and carbohydrates profoundly influence postprandial hypertriglyceridemia in type 2 diabetes, whereas little information exists about the effect of proteins. The purpose of this study is to compare the effects of the proteins casein, whey, cod, and gluten on postprandial lipid and incretin responses to a high-fat meal in type 2 diabetes.

Official Title
-----------------
Differential Effects of Protein Quality on Postprandial Lipemia in Response to a Fat-Rich Meal in Type 2 Diabetes: Comparison of Whey, Casein, Gluten, and Cod Protein

Conditions
-----------------
Type 2 Diabetes, Postprandial Lipemia

Intervention / Treatment
-----------------
* Dietary Supplement: Casein
* Dietary Supplement: Whey
* Dietary Supplement: Cod
* Dietary Supplement: Gluten


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Diabetes Exclusion Criteria: Liver, Kidney- and/or Heart Disease Serious Hypertension (160/110 mmHg)

Ages Eligible for Study
-----------------
Minimum Age: 40 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: Prevention
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Casein<br> | Dietary Supplement: Casein<br> <br> |
| Active Comparator: Whey<br> | Dietary Supplement: Whey<br> <br> |
| Active Comparator: Cod<br> | Dietary Supplement: Cod<br> <br> |
| Active Comparator: Gluten<br> | Dietary Supplement: Gluten<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Triglyceride levels |  | 0h- 2h- 4h- 6h- 7h- 8h postprandial | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Incretin levels |  | 0h- 0.5h- 1h- 2h- 4h- 6h- 8h postprandial | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
chylomicrons, Whey protein, gluten, casein, cod protein, GLP-1, postprandial, triglyceride, free fatty acids, retinyl palmitate, type 2 diabetes, GIP, Postprandial incretins
Clinical Trial to Evaluate the Efficacy and Safety of 'GLA5PR GLARS-NF1 Tab.' in Peripheral Neuropathic Pain

Study Overview
=================
Brief Summary
-----------------
A multi-center, randomized, double-blind, parallel, active-controlled phase III clinical trial to evaluate the efficacy and safety of 'GLA5PR GLARS-NF1 Tab.' and 'Pregabalin' in peripheral neuropathic pain

Official Title
-----------------
A Multi-center, Randomized, Double-blind, Parallel, Active-controlled Phase III Clinical Trial to Evaluate the Efficacy and Safety of 'GLA5PR GLARS-NF1 Tab.' and 'Pregabalin' in Peripheral Neuropathic Pain

Conditions
-----------------
Pain of Mononeuropathy

Intervention / Treatment
-----------------
* Drug: GLA5PR GLARS-NF1
* Drug: GLA5PR GLARS-NF1 placebo
* Drug: Pregabalin
* Drug: Pregabalin placebo


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: both male and female who are over 19-year-old patient whose pain scale is 4 9 patient who has pain of mononeuropathy Exclusion Criteria: patient whose CCr is <60ml/min patient who has other pain which is not from mononeuropathy patient who is going to have an operation during this study patient who has abnormal ECG

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: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: GLA5PR GLARS-NF1 & Pregabalin placebo<br>GLA5PR GLARS-NF1 150mg, 300mg tablet by mouth, every after dinner for about 3 months Pregabalin placebo 75mg, 150mg, 300mg capsules by mouth, every after breakfast and dinner for about 3 months | Drug: GLA5PR GLARS-NF1<br>* Pregabalin tablet<br>Drug: Pregabalin placebo<br>* tablet manufactured to mimic pregabalin capsule<br>* Other names: placebo (for pregablin);|
| Active Comparator: GLA5PR GLARS-NF1 placebo & Pregabalin<br>GLA5PR GLARS-NF1 placebo 150mg, 300mg tablet by mouth, every after dinner for about 3 months Pregabalin 75mg, 150mg, 300mg capsules by mouth, every after breakfast and dinner for about 3 months | Drug: GLA5PR GLARS-NF1 placebo<br>* tablet manufactured to mimic GLA5PR GLARS-NF1<br>* Other names: placebo (for GLA5PR GLARS-NF1);Drug: Pregabalin<br>* Pregabalin capsule<br>* Other names: Lyrica;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Daily Pain Rating Scale |  | 12-week |
Attachment and Prognostic Factor: the Implicit Approach

Study Overview
=================
Brief Summary
-----------------
This is a prospective longitudinal study aimed at better understanding the determinants of the prognosis of patients with substance dependence. 5 visits are planned during the study : the inclusion visit : during this visit the patient's non-opposition is obtained and then the patient answer to self-administered questionnaires online 4 telephone interviews for follow-up by investigator.

Official Title
-----------------
Place of Attachment as a Post-weaning Prognostic Factor: Interest of the Implicit Approach

Conditions
-----------------
Dependence Addictive

Intervention / Treatment
-----------------
* Behavioral: Questionnaires


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients between 18 and 65 years old Patients with a use-related disorder as defined by DSM5 Patients weaning for a substance, supported within the addictology sector of Henri Laborit Hospital Having expressed non-opposition to participating in the study after receiving written information. Exclusion Criteria: Person who cannot read or write Simultaneous participation in a therapeutic trial involving oxytocin Patients protected by law Patients who do not have French as their native language Patients who, in the opinion of the investigator, are unable to complete the questionnaires

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 65 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 |
| --- | --- |
| Patients with a use-related disorder weaning for a substance<br> | Behavioral: Questionnaires<br>* 5 visits are planned during the study : the inclusion visit : during this visit the patient's non-opposition is obtained and then the patient answer to self-administered questionnaires online 4 telephone interviews for follow-up by investigator<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Implicit attachment and onsumption | Assessment of the link between implicit attachment and changes in consumption after a 12-month follow-up | 12 months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
implicit approach, post-weaning prognostic factor
Morning Light Treatment for Traumatic Stress: The Role of Amygdala Reactivity

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to determine the effect of different amounts of time of morning light on brain emotional processing.

Official Title
-----------------
Morning Light Treatment for Traumatic Stress: The Role of Amygdala Reactivity

Conditions
-----------------
Stress

Intervention / Treatment
-----------------
* Device: Light therapy A via the Re-Timer®
* Device: Light therapy B via the Re-Timer®
* Device: Light therapy C via the Re-Timer®


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Meets criteria for traumatic stress Normal or corrected to normal vision Right-handed Fluency in English Physically able to travel for study visit attendance Exclusion Criteria: Significant chronic uncontrolled disease (e.g. uncontrolled diabetes, advanced liver disease, cancer, etc.) Severe hearing problem Intellectual disability or serious cognitive impairment Inability to tolerate enclosed spaces (e.g. the MRI machine) Ferrous-containing metals within the body Pregnant, trying to get pregnant, or breastfeeding Epilepsy Other research participation Frequent number of special events during study period (weddings, concerts, exams, etc.)

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: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Light therapy A via the Re-Timer®<br>-15 minutes/day | Device: Light therapy A via the Re-Timer®<br>* Subjects will conduct light treatment in the mornings at home.<br>* Other names: Re-Timer®;|
| Experimental: Light therapy B via the Re-Timer®<br>-30 minutes/day | Device: Light therapy B via the Re-Timer®<br>* Subjects will conduct light treatment in the mornings at home.<br>* Other names: Re-Timer®;|
| Experimental: Light therapy C via the Re-Timer®<br>-60 minutes/day | Device: Light therapy C via the Re-Timer®<br>* Subjects will conduct light treatment in the mornings at home.<br>* Other names: Re-Timer®;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in amygdala reactivity as measured by whole-brain oxygen-level dependent functional magnetic resonance imaging (fMRI) signal |  | Baseline and treatment week 2 and treatment week 4 | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Circadian timing, Mood, Light