linjc16/ctgov huggingface dataset:
RCT Comparing Invisalign and Traditional Orthodontic Treatment

Study Overview
=================
Brief Summary
-----------------
Comparison of orthodontic patients treated with aligners and traditional (clear braces)

Detailed Description
-----------------
Patients were selected based on being adults and having mild Class I malocclusion. They were randomly allocated into either the aligner group and the traditiona (clear braces group).. The aligner group was treated with invisalign, with up to two adjustments at the end of treatment. The traditional group had clear braces placed on their teeth. The outcome variables including the following: 1) pain and discomfort related to treatment, 2) posttreatment occlusal status, and 3) postretention occlusal status.

Official Title
-----------------
A Randomized Controlled Trial Comparing the Effectiveness of Invisalign and Traditional Orthodontic Treatments

Conditions
-----------------
Malocclusion, Angle Class II

Intervention / Treatment
-----------------
* Other: Aligners
* Other: Clear braces


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Class I molar and canine relationships Non-extraction treatments Mandibular crowding of 4 mm or less No missing tooth (from second to second molar) Exclusion Criteria: Anterior or posterior crossbites Anterior or lateral open bites Maxillary overjet exceeding 3mm Impacted tooth

Ages Eligible for Study
-----------------
Minimum Age: 17 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
Interventional Model Description: Randomized RCT
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Aligners<br>Invisalign treatment | Other: Aligners<br>* Clear aligners<br>* Other names: Invisalign;|
| Active Comparator: Traditional braces<br>Clear braces | Other: Clear braces<br>* Clear braces<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Occlusal changes | Differences in occlusion between the two groups | up to 6 months |
The Effect of Breastfeeding on the Development of Appendicitis in Adults

Study Overview
=================
Brief Summary
-----------------
Appendectomy is the most common emergent operative procedure performed worldwide. In this study investigators will investigate if there is a relationship between breast feeding and appendicitis in adults.

Detailed Description
-----------------
Acute appendicitis accounts for the commonest indication for emergency visits during daily surgical practice. Breast feeding is very important both mother and the child. For the infant, breast feeding has an important role on the maturity of immune system. In the literature search, there are a little studies about the relationship between the breast feeding and appendicitis. In the literature, some studies suggests that the breast feeding may possibly give protection against the development of appendicitis. But the number of the patients and the control groups are limited. Because of that the investigators have planned to make this study with a lot of number of patients.

Conditions
-----------------
Appendicitis

Intervention / Treatment
-----------------
* Other: Breastfeeding


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Subjects has pathologically proven appendicitis for appendicitis group. Exclusion Criteria: Subjects has American Society of Anesthesiologists Physical Status classification 4, Subject has pregnancy, Subject has malignity, Subject has chronic illness, Subjects who won't accept to join the study Subjects who don't have family members

Ages Eligible for Study
-----------------
Minimum Age: 20 Years
Maximum Age: 40 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 |
| --- | --- |
| Appendicitis<br>The patients with appendicitis | Other: Breastfeeding<br>* All of the participants and patients will have a questionnaire about their breastfeeding<br>|
| Control<br>The participants without appendicitis | Other: Breastfeeding<br>* All of the participants and patients will have a questionnaire about their breastfeeding<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The breastfeeding status questionnaire in the appendicitis patients and participants without appendicitis | 500 patients who have pathologically proven appendicitis and 1000 controls without appendicitis will be asked the question which is How long did you had breast feeding?. The patients and the participants will be in the same age groups. Also the same question will be asked to at least one of the family member (mother, father, older brother or older sister). The breastfeeding status will be in three group ( 0-2 months, 2-6 months and >6 months) | 2 days | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Appendix, Breastfeeding, Adult
Comparison of Surgical Outcomes Between Pre Sympathetic Plexus and Post Sympathetic Plexus Approach

Study Overview
=================
Brief Summary
-----------------
There would be no difference in the risk of sympathetic plexus damage between the pre sympathetic plexus approach and the post sympathetic plexus approach.

Detailed Description
-----------------
Compare the incidence of sympathetic chain injury between front and back of sympathetic approach in oblique lumbar interbody fusion

Official Title
-----------------
Comparison of Surgical Outcomes Between Pre Sympathetic Plexus and Post Sympathetic Plexus Approach

Conditions
-----------------
Fusion of Spine, Sympathetic Nervous System

Intervention / Treatment
-----------------
* Procedure: Lateral lumbar interbody fusion


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients with lumbar degenerative disease needs a lateral lumbar interbody fusion of 1-2 segments between L2 to S1. Exclusion Criteria: Patients who had previously had lumbar surgery Patients with muscle weakness of motor grade III or lower Patients with neuropsychiatric diseases such as depression Patients with musculoskeletal disease, inflammatory musculoskeletal disease, or infection Patients with cancerous disease Patients who do not want to participate in the study

Ages Eligible for Study
-----------------
Minimum Age: 20 Years
Maximum Age: 80 Years

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

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

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

Arms and Interventions

| Intervention/Treatment |
| --- |
|Procedure: Lateral lumbar interbody fusion|oblique lumbar interbody fusion or direct lateral interbody fusion|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The rate of sympathetic plexus injury | The number of patiensts with sympathetic symptom such as edema of the lower extremity, change of skin temperature, pain, or paresthesia without other medical conditions | Postoperative day one | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Other complications | the number of patients with any other complication such as Injury of vascular structure, ureter, peritoneum, or bowel. | Postoperative 6 month |
SGS742 in Patients With Mild to Moderate Alzheimer's Disease (AD)

Study Overview
=================
Brief Summary
-----------------
The purpose of this trial is to determine the effect of a new drug, SGS742, on memory and cognition in patients with mild to moderate Alzheimer's disease.

Detailed Description
-----------------
SGS742 is a GABA(B) receptor antagonist. It is an orally active drug and possesses neurochemical and psychopharmacologic features that suggest it could improve memory and cognition in humans. The primary objective of the SGS742 clinical trial will be to determine the effect of SGS742 on memory and cognition in individuals diagnosed with mild to moderate Alzheimer's disease. The duration of the study is 3 months with 5 clinic visits.

Official Title
-----------------
A Multicenter, Randomized, Double-Blind, Placebo-Controlled, Phase II Study of the Efficacy and Safety of SGS742 in Subjects With Mild to Moderate Alzheimer's Disease

Conditions
-----------------
Alzheimer's Disease

Intervention / Treatment
-----------------
* Drug: SGS742


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: 55 to 90 years of age Diagnosed with mild to moderate Alzheimer's disease Willing caregiver In general good health Exclusion Criteria: Call 1-877-MY-MEMORY and ask to be referred to a study center located near you for entry criteria information. Prohibited Meds: Alzheimer's medications (Aricept, Exelon, Remydl, Nemenda)

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

Primary Purpose: Treatment
Allocation: Randomized
Masking: Double


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: SGS742|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
-----------------
Alzheimer disease, memory, cognition, GABA(B)receptor antagonist
Validation of a High-Quality Low-Cost Open-Source Electrocardiograph

Study Overview
=================
Brief Summary
-----------------
The high price of electrocardiograph (ECG) devices - with most hospital-grade devices costing thousands of dollars - is one of the barriers to access of this vital technology. There is a shortage of ECG devices in underserved areas and the devices available on the market currently are not adequate to solve this problem. Our solution is a low-cost high-quality open-access ECG device. This study intends to validate the study ECG device in human patients by demonstrating equivalence between the study ECG device and a gold standard device.

Official Title
-----------------
Validation of a High-Quality Low-Cost Open-Source Electrocardiograph (ECG)

Conditions
-----------------
Open Access, Medical Devices, Low Cost, Electrocardiograph

Intervention / Treatment
-----------------
* Device: Medical device validation


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: - All study participants must be able to provide written informed consent prior to study procedure. This study has 2 Phases. Phase 1: Healthy > 18 years of age Phase 2: > 18 years of age non critical patients presenting to the emergency department (Victoria Hospital and University Hospital) with cardiac complaint Exclusion Criteria: < 18 years old Unable to consent Phase 1: > 70 years of age Previous history of cardiac disease (e.g., atrial fibrillation, myocardial infarction, congestive heart failure) current status of non-sinus heart rhythm Phase 2: - Critical patients in the ED where consent would inappropriately delay investigations or treatment

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 70 Years

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

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

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

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Study device<br> | Device: Medical device validation<br>* The medical devices will both record electrical signals for comparison<br>|
| Active Comparator: Control device<br> | Device: Medical device validation<br>* The medical devices will both record electrical signals for comparison<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Equivalence of Electrical Signals between 3D printed ECG device and Gold Standard ECG | Comparing electrical signals from ECG electrodes with tested device and gold standard device by collecting the following data from both devices: rate, QR interval, PR interval, QT interval, and rhythm. | 60 seconds | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Open Access, Medical Devices, Low Cost
Safety and Efficacy Study of Rebamipide 2% Ophthalmic Suspension in Subjects With Dry Eye - Effects on Central Cornea

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to evaluate the safety and efficacy of 2% rebamipide compared to placebo in clearing of fluorescein staining of the central cornea in subjects with dry eye disease.

Official Title
-----------------
A Phase II, Prospective, Randomized, Double-masked, Parallel Group, Multi-center Study Assessing the Safety and Efficacy of 2% Rebamipide (OPC-12759) Compared to Placebo in Clearing of Fluorescein Staining of the Central Cornea in Subjects With Keratoconjunctivitis Sicca (Dry Eye)

Conditions
-----------------
Dry Eye, Keratoconjunctivitis Sicca

Intervention / Treatment
-----------------
* Drug: rebamipide 2% ophthalmic suspension
* Drug: placebo eye drops


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Age 18 years and older Diagnosis of dry eye as defined by the protocol Central corneal staining Exclusion Criteria: Ongoing ocular disease that may interfere with study parameters Inability to stop using topical ophthalmic medications throughout the duration of the study Inability to stop the use of contact lenses for the duration of the study

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 |
| --- | --- |
| Experimental: rebamipide 2% ophthalmic suspension<br> | Drug: rebamipide 2% ophthalmic suspension<br>* Instill one drop in each eye four times daily for 12 weeks.<br>|
| Placebo Comparator: placebo eye drops<br> | Drug: placebo eye drops<br>* Instill one drop in each eye four times daily for 12 weeks.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Central corneal clearing as measured by fluorescein staining |  | 12 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Ocular staining |  | 12 weeks | 
| Dry eye symptoms |  | 12 weeks |
Clinical-immunological Features of Anti-NMDAR Encephalitis

Study Overview
=================
Brief Summary
-----------------
Using a retrospective cohort of 501 patients with anti-NMDAR encephalitis to assess clinical and immunological prognostic biomarkers

Official Title
-----------------
Clinical-immunological Features of Anti-NMDAR Encephalitis

Conditions
-----------------
Anti NMDA Receptor Encephalitis

Intervention / Treatment
-----------------
* Other: Description of clinical characteristic


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patient with neurological disorder Patient with NMDAR antibodies in sera or CSF Exclusion Criteria: - No available clinical data Patient without NMDAR antibodies or neurological disorder

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Anti-NMDAR encephalitis<br>Patients with well-characterized anti-NMDAR encephalitis. | Other: Description of clinical characteristic<br>* This is a non-interventional study involving clinical data and biological samples (blood, DNA, CSF). Clinical data are collected for the center and samples are already stored in biobank repositories and collected as part of good clinical practice in the diagnostic process of patients with suspected autoimmune encephalitis, meaning that the standard diagnostic and therapeutic approaches will not be altered in the selected study population. Patients have already gave explicit written consent for biological specimens sampling and storage at the Centre de Ressources Biologiques des Hospices Civils de Lyon (CRB-HCL) (including tissue, cells or biological fluids) and genetic analysis for research purposes. Additionally, patients will be informed about the present study.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Modified Rankin scale (mRS) | Scale for measuring the degree of dependence in the daily activities of people who have suffered of neurological disability. 0 - No symptoms. - No significant disability. Able to carry out all usual activities, despite some symptoms. - Slight disability. Able to look after own affairs without assistance, but unable to carry out all previous activities. - Moderate disability. Requires some help, but able to walk unassisted. - Moderately severe disability. Unable to attend to own bodily needs without assistance, and unable to walk unassisted. - Severe disability. Requires constant nursing care and attention, bedridden, incontinent. - Dead. | Baseline | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Anti NMDA Receptor Encephalitis, antibodies, relapses, outcomes
Open Label, 4 Week Study of ITCA 650 in Adults With Type 2 Diabetes

Study Overview
=================
Brief Summary
-----------------
evaluate the safety and tolerability of ITCA 650 in subjects with type 2 diabetes mellitus.

Official Title
-----------------
A Phase Ib, Randomized, Open-Label, Multi-Center, 4-Week Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of ITCA 650 in Subjects With Type 2 Diabetes Mellitus

Conditions
-----------------
Type 2 Diabetes

Intervention / Treatment
-----------------
* Drug: ITCA 650 (exenatide in DUROS)


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: type 2 diabetes >6 months stable diet & exercise, metformin, TZD or met + TZD HbA1c >6.5% <10.0% Exclusion Criteria: prior treatment with exenatide history of pancreatitis history of medullary thyroid cancer or multiple endocrine neoplasia 2

Ages Eligible for Study
-----------------
Minimum Age: 30 Years
Maximum 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: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 10 mcg./day<br>ITCA 650 (exenatide in DUROS) | Drug: ITCA 650 (exenatide in DUROS)<br> <br> |
| Experimental: 20 mcg/day<br>ITCA 650 (exenatide in DUROS) | Drug: ITCA 650 (exenatide in DUROS)<br> <br> |
| Experimental: 40 mcg/day<br>ITCA 650 (exenatide in DUROS) | Drug: ITCA 650 (exenatide in DUROS)<br> <br> |
| Experimental: 80 mcg/day<br>ITCA 650 (exenatide in DUROS) | Drug: ITCA 650 (exenatide in DUROS)<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of Subjects With Study Drug-Related Adverse Events |  | 4 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To Characterize the Pharmacokinetic Profile of ITCA 650 in Subjects With Type 2 Diabetes Mellitus | Change in HbA1c from baseline | 4 weeks | 
| Change in Fasting Plasma Glucose (FPG) 4 Weeks From Baseline |  | 4 weeks | 
| Change in Weight From Baseline to 4 Weeks |  | 4 weeks |
Local Effects of Epinephrine on Lactate, Glucose, Lipid and Protein Metabolism in Bilaterally Perfused Human Legs

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to define the local metabolic effects of epinephrine in the bilaterally perfused human leg.

Official Title
-----------------
Local Effects of Epinephrine on Lactate, Glucose, Lipid and Protein Metabolism in Bilaterally Perfused Human Legs

Conditions
-----------------
Healthy

Intervention / Treatment
-----------------
* Drug: Epinephrine


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Male Exclusion Criteria: Comorbidity Females

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 50 Years

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

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

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

Design Details

Primary Purpose: Basic Science
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Single


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: Epinephrine|unilateral leg infusion of Epinephrine 0.4 micrograms/m2/min|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Arterio-Venous balances of metabolites | Acute regional effect of epinephrine infusion in the femoral artery | 6 hours infusion | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Phenylalanine, Palmitate, hyperinsulinemic-euglycemic-clamp, Effects of epinephrine in healthy volunteers