linjc16/ctgov huggingface dataset:
Anti-reflux Mucosectomy (ARMS) is a Useful Therapy for Refractory Gastroesophageal Reflux Disease (RGERD)

Study Overview
=================
Brief Summary
-----------------
Anti-reflux mucosectomy (ARMS) may be a new therapy for refractory gastroesophageal reflux disease (RGERD). The aim of the present study is to explore the safety and efficacy of ARMS.

Official Title
-----------------
Department of Gastroenterology, Zhongda Hospital

Conditions
-----------------
Refractory Gastroesophageal Reflux Disease

Intervention / Treatment
-----------------
* Procedure: anti-reflux mucosectomy


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Full sufficiency in literacy Be off proton pump inhibitor, antacids and prokinetics ≥ 2 weeks Refractory gastroesophageal reflux disease Exclusion Criteria: Severe heart, lung, and cerebrovascular disease Severe hematopoietic system disease Abnormal blood coagulation function Oropharyngeal abnormalities Severe spine malformation In pregnancy and lactation at present, or plan to become pregnant within 2 years Severe inflammation or huge ulcers in stomach Mental and psychological disorde
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 |
| --- | --- |
| Other: completely circumferential ARMS<br> | Procedure: anti-reflux mucosectomy<br>* Anti-reflux mucosectomy (ARMS) may be a new therapy for refractory gastroesophageal reflux disease (RGERD). The aim of the present study is to explore the safety and efficacy of ARMS.<br>|
| Other: semi-circumferential ARMS<br> | Procedure: anti-reflux mucosectomy<br>* Anti-reflux mucosectomy (ARMS) may be a new therapy for refractory gastroesophageal reflux disease (RGERD). The aim of the present study is to explore the safety and efficacy of ARMS.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Improvement of symptoms | Improvement of all the symptoms related with RGERD. | 1 month, 3 months, 6 months, 12 months, 18 months, 24 months, 30 months, 36 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Complications of ARMS | Complications of ARMS,such as esophageal stenosis and dysphagia. | 1 month, 3 months, 6 months, 12 months, 18 months, 24 months, 30 months, 36 months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Anti-reflux mucosectomy,refractory gastroesophageal reflux disease,safety,efficacy
Study of the Safety and Efficacy of Desvenlafaxine Succinate for Vasomotor Symptoms in Postmenopausal Women

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to evaluate the efficacy and safety of 100 mg and 150 mg of DVS SR, an extended release form of desvenlafaxine succinate, in comparison to placebo for the treatment of Vasomotor Symptoms (VMS) associated with menopause in a population of postmenopausal women.

Detailed Description
-----------------
To assess the efficacy and safety of 100 mg and 150 mg of DVS SR in comparison to placebo for the treatment of moderate to severe VMS associated with menopause, as well as additional outcome indicators such as sleep disruptions, overall climacteric symptoms, mood changes, somatic symptoms, and overall satisfaction with DVS SR in postmenopausal women.

Official Title
-----------------
A Double-Blind, Randomized, Placebo-Controlled, Efficacy and Safety Study of DVS SR for Treatment of Vasomotor Symptoms Associated With Menopause

Conditions
-----------------
Menopause, Vasomotor System

Intervention / Treatment
-----------------
* Drug: Desvenlafaxine succinate sustained-release (DVS SR)


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Generally healthy, postmenopausal women who seek treatment for hot flushes Body Mass Index (BMI) less than or equal to 40 kg/m2 Other inclusions apply. Exclusion Criteria: Hypersensitivity to Venlafaxine Myocardial infarction and/or unstable angina within 6 months of screening History of seizure disorder Other exclusions apply.
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: Double


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: Desvenlafaxine succinate sustained-release (DVS SR)|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The number and severity of hot flushes collected throughout the study after 12 weeks of therapy. |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The number of awakenings due to VMS and the total mood disturbance score (Profile of Mood States [POMS]). |  |  | 
| The scores on the Greene Climacteric Scale (GCS), the Visual Analog Scale-Pain Intensity (VAS-PI), and the Satisfaction Survey (SS). |  |  |
Effect of 0.5% vs 0.375% Ropivacaine on Autonomous Nervous System

Study Overview
=================
Brief Summary
-----------------
It is established that the local anesthetic that is administered during an interscalene block affects the autonomic outflow to the heart. This is very well seen during shoulder surgery when the patient is positioned in beach chair pasition. The investigators want to study the different effect of the two concentrations (0.5% and 0.375%) of ropivacaine on the autonomic nervous system through blood pressure and heart rate measurements.

Official Title
-----------------
Comparison of the Effect of Ropivacaine 0.5% vs 0.375% on the Autonomous Nervous System During Shoulder Surgery in Beach Chair Position

Conditions
-----------------
Ropivacaine, Shoulder Surgery, Interscalene Nerve Block

Intervention / Treatment
-----------------
* Procedure: Interscalene nerve block


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Elective shoulder surgery Age 18- 80 years old ASA I - IV Beach chair position Exclusion Criteria: Coagulopathy disorders Infection at the puncture site for the interscalene block Neurological deficit on the side to be operated Allergy to local anesthetics Psychiatric disorders Patient's refusal Problems with patient communication Failure of the interscalene block

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 80 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 |
| --- | --- |
| Active Comparator: Ropivacaine 0.5%<br>Ultrasound guided Intercalene nerve block with ropivacaine 0.5 % | Procedure: Interscalene nerve block<br> <br> |
| Active Comparator: Ropivacaine 0.375 %<br>Ultrasound guided Intercalene nerve block with ropivacaine 0.375 % | Procedure: Interscalene nerve block<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Blood pressure fluctuations |  | Completion of the surgery | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Heart rate fluctuations |  | Completion of surgery |
Thoracic Paravertebral Blocks Using a Combination of Ropivacaine and Dexmedetomidine

Study Overview
=================
Brief Summary
-----------------
The investigators designed a study to assess whether thoracic paravertebral blocks using a combination of ropivacaine and dexmedetomidine prolong nerve block duration.

Detailed Description
-----------------
The investigators designed a study to assess whether thoracic paravertebral blocks using a combination of ropivacaine and dexmedetomidine prolong nerve block duration. The effects of dexmedetomidine have only been compared at lower doses. This trial examined the effect of greater dose of dexmedetomidine on thoracic paravertebral block analgesia duration.

Official Title
-----------------
Thoracic Paravertebral Blocks Using a Combination of Ropivacaine and Dexmedetomidine

Conditions
-----------------
Thoracic Paravertebral Blocks

Intervention / Treatment
-----------------
* Drug: Dexmedetomidine


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients were included in the study if they were ethnic Chinese, American Society of Anesthesiologists (ASA) physical status I or II, candidates for general anesthesia undergoing thoracic surgery Exclusion Criteria: Patients were excluded if they do not want to cooperate with the test, had a history of radial artery puncture or coronary artery bypass grafting, had acute vessel trauma,or had been diagnosed with Raynaud' disease, had suffered from mental or neurological disorders

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?
-----------------

Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Interventional Model Description: a single-dose thoracic paravertebral analgesia for postoperative pain control after thoracoscopic lobectomy
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: dexmedetomidine group<br>a combination of ropivacaine and dexmedetomidine | Drug: Dexmedetomidine<br>* combination of ropivacaine and dexmedetomidine 20 ug every time<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change of analgesia duration | Change of thoracic paravertebral block analgesia duration | Change from Baseline to 3 days after surgery |
A Study of OPC-262 in Patients With Type 2 Diabetes

Study Overview
=================
Brief Summary
-----------------
The purpose of this clinical study is to evaluate the superiority of the efficacy of OPC-262 (2.5 mg, and 5 mg) to placebo in patients with type 2 diabetes after 24 week treatment in a double-blind fashion and to evaluate the safety of OPC-262 to placebo.

Official Title
-----------------
A Multicenter, Randomized, Double-blind, Placebo-controlled, 3-arms Parallel Group Comparative Study of OPC-262 in Patients With Type 2 Diabetes (Phase 2/3 Study)

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

Intervention / Treatment
-----------------
* Drug: OPC-262 2.5 mg
* Drug: OPC-262 5 mg
* Drug: Placebo


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Type 2 diabetes patients with HbA1C above 6.5% and below 10% Patients who are capable of giving informed consent Patients who are able to take contraceptive measures to avoid pregnancy of the patient or the patient's partner for the entire study period and for 4 weeks after the study (end of the post-observation period) Exclusion Criteria: Patients with type 1 diabetes mellitus, patients with diabetes mellitus due to other specified drugs, mechanisms or diseases, and patients with gestational diabetes mellitus Patients with a medical history of diabetic coma Patients with poorly-controlled hypertension Patients with heart failure Patients with a complication of active hepatitis or hepatic cirrhosis Patients undergoing treatment of glomerular diseases other than diabetic nephropathy Patients with a history or complication of malignant tumor

Ages Eligible for Study
-----------------
Minimum Age: 20 Years
Maximum Age: 74 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: OPC-262 2.5 mg<br>orally administered once daily for 24 weeks | Drug: OPC-262 2.5 mg<br>* orally administered once daily for 24 weeks<br>|
| Experimental: OPC-262 5 mg<br>orally administered once daily for 24 weeks | Drug: OPC-262 5 mg<br>* orally administered once daily for 24 weeks<br>|
| Placebo Comparator: Placebo<br>orally administered once daily for 24 weeks | Drug: Placebo<br>* orally administered once daily for 24 weeks<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Changes in HbA1C from baseline |  | Week 24 (LOCF) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Changes in fasting blood glucose (FBG) from baseline |  | Week 24 | 
| Changes in 2 hour postprandial blood glucose (PPG) from baseline |  | Week 24 | 
| Changes in 3 hour PPG AUC from baseline |  | Week 24 |
Effects of a Nutraceutical Preparation on Cognitive Impairment in Hypertensive Patients

Study Overview
=================
Brief Summary
-----------------
Aim of this randomized, double-blind clinical study is to evaluate the efficacy of a nutraceutical preparation on early markers of cognitive impairment, in patients affected by arterial hypertension.

Official Title
-----------------
Effects of a Nutraceutical Preparation on Cognitive Impairment in Hypertensive Patients

Conditions
-----------------
Hypertension

Intervention / Treatment
-----------------
* Dietary Supplement: Nutraceutical compound
* Dietary Supplement: Placebo


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Written informed consent; Males or females between 40 and 65 years of age; Hypertensive patients classified according to their SBP (Systolic Blood Pressure) and DBP (Diastolic Blood Pressure) values. Included patients will be those with stage 1 hypertension (SBP 140-159 mmHg; DBP 90-99 mmHg) and with stage 2 hypertension (SBP 160-179 mmHg; DBP 100-109 mmHg). Exclusion Criteria: Previous acute myocardial infarction (AMI); Previous stroke and/or transient ischemic attack (TIA); Diabetes mellitus; History of atrial fibrillation or other severe arrhythmias; Severe cardiovascular diseases; Renal pathologies (creatinine > 1.4 mg/dL); Preexisting psychiatric pathologies; Neurodegenerative diseases, such as multiple sclerosis, lateral amyotrophic sclerosis, Parkinson, Alzheimer, neuromuscular pathologies, epilepsy; Diagnosis of dementia; Depression; Long-term regular use of anxiolytics drugs, antidepressant drugs, antipsychotic drugs, hypnoinducing drugs, cognitive stimulators.

Ages Eligible for Study
-----------------
Minimum Age: 40 Years
Maximum Age: 65 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: Nutraceutical<br>Treated with nutraceutical compound | Dietary Supplement: Nutraceutical compound<br> <br> |
| Placebo Comparator: Placebo<br>Treated with placebo | Dietary Supplement: Placebo<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Cognitive function assessed by neuropsychological tests | Patients will be subjected to Montreal Cognitive Assessment (MoCA), Verbal fluency test, Word coupling test, Stroop test, and Instrumental Activities of Daily Living - IADL test. Assessments of cognitive functions will be performed by using unique score measurements defined in Units on a Scale. | 6 months |
Serum Fetuin Level in Polycystic Ovary Syndrome

Study Overview
=================
Brief Summary
-----------------
polycystic ovary syndrome is a common gynecological problem

Detailed Description
-----------------
Understanding the pathophysiology and the cause is of much importance for proper management of this problem

Official Title
-----------------
Serum Fetuin Level as a Marker in Polycystic Ovary Syndrome

Conditions
-----------------
Polycystic Ovary

Intervention / Treatment
-----------------
* Diagnostic Test: measurement of Fetuin-A level in serum


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: women who have PCOS in group 1 and who donnot have PCOS in group 2 with age between 20 -42 years Exclusion Criteria: women above 42 years old

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 42 Years

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

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| PCOS group<br>women who have PCOS | Diagnostic Test: measurement of Fetuin-A level in serum<br>* Fetuin A level will be measured in blood of the PCOS women<br>* Other names: Fwtuin A level;|
| control group<br>women who donnot have PCOS | Diagnostic Test: measurement of Fetuin-A level in serum<br>* Fetuin A level will be measured in blood of the PCOS women<br>* Other names: Fwtuin A level;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The number of women who will have high level of fetuin A and has PCOS | Evaluation of women who have PCOS in relation to fetuin A level | within a week |
Scleral Lens Fitting Using Wide-Field OCT

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to see if OCT technology can optimize scleral contact lens fittings. Subjects with keratoconus, post-penetrating keratoplasty (PK), post-LASIK ectasia, post-radial keratotomy (RK), or a variety of anterior surface disorders requiring scleral lens fittings will be considered for enrollment. For each study eye, a clinically-selected scleral lens fit will be compared against an OCT-selected lens fit. The quality of each lens fit will be determined by flourescein exam at the slit lamp. Apical clearance, limbal clearance, conjunctival compression, and lens edge lift will be assessed. A lens that satisfies all four criteria will be considered satisfactory.

Official Title
-----------------
Clinical Trial of OCT-based Scleral Lens Fitting With Wide-Field OCT

Conditions
-----------------
Keratoconus, Irregular; Contour of Cornea

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Eyes requiring fit for scleral lenses for KCN, post-PK, post-RK, post-LASIK ectasia, or various anterior surface disorders Exclusion Criteria: Inability to maintain stable fixation for OCT imaging Inability to commit to required visits to complete the study Eyes with concurrent retinal diseases, glaucoma, or other eye conditions that may limit visual outcome

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 |
| --- | --- |
| Clinically-Selected Scleral Lens<br>The clinically-selected lens is based on slit lamp assessment. This lens will be compared against an OCT-selected lens. | |
| OCT-Selected Scleral Lens<br>The OCT-selected lens is based on OCT measurements. This lens will be compared against a clinically-selected lens. | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Apical Clearance | Apical clearance of each lens (whether clinically-selected or OCT-selected) will be graded as acceptable, too high, or too low. | 5 years | 
| Limbal Clearance | Limbal clearance of each lens (whether clinically-selected or OCT-selected) will be graded as acceptable, too much, or too little. | 5 years | 
| Conjunctival Compression | Conjunctival compression of each lens (whether clinically-selected or OCT-selected) will be graded as acceptable or excessive. | 5 years | 
| Lens Edge Lift | Lens edge lift for each lens (whether clinically-selected or OCT-selected) will be graded as acceptable or excessive. | 5 years | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Keratoconus (KCN), Irregular Cornea, Optical Coherence Tomography (OCT)
A Clinical Study to Limit Physiologic Intestinal FDG Uptake Uptake on PET-CT Scans

Study Overview
=================
Brief Summary
-----------------
Patients who undergo PET-CT scans to look for cancer are given an intravenous contrast (FDG) that is taken-up by active cells such as cancer cells. This contrast can then be seen in the body using the PET-CT scanner. However, cells in the colon also take up the FDG, and can produce false positive signals from the colon. Our hypothesis is that much of this signal comes from bacteria that are present in high concentrations in the colon. If this is the case, using an antibiotic to suppress the activity of bacteria may improve the ability of PET-CT to distinguish abnormal cells from normal cells in the colon.

Official Title
-----------------
A Clinical Study to Limit Physiologic Intestinal FDG Uptake Uptake on PET-CT Scans

Conditions
-----------------
Intestinal FDG Uptake

Intervention / Treatment
-----------------
* Drug: Rifaximin


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients undergoing clinically-indicated PET-CT scan for non-GI lymphoma Exclusion Criteria: Patients with known Inflammatory Bowel Disease Patients with known colon cancer

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: Diagnostic
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Rifaximin<br> | Drug: Rifaximin<br>* 550mg BID for 2 days<br>* Other names: Xifaxan;|
| No Intervention: Control<br>Randomly-selected matched PET-CT scans performed on same day as intervention group. | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| SUVmax of FDG in Each Colonic Segment |  | Day 2 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| SUVavg in Each Colonic Segment |  | Day 2 |