linjc16/ctgov huggingface dataset:
Study Using Eculizumab in Transfusion Dependent Paroxysmal Nocturnal Hemoglobinuria (PNH) Patients

Study Overview
=================
Brief Summary
-----------------
The primary objective is to evaluate the safety and efficacy of eculizumab in transfusion dependent patients with hemolytic PNH.

Official Title
-----------------
Randomized, Double-Blind, and Placebo-Controlled Study Using Eculizumab in Transfusion Dependent PNH Patients

Conditions
-----------------
Hemoglobinuria, Paroxysmal

Intervention / Treatment
-----------------
* Drug: eculizumab


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Must have required at least 4 transfusions in the past 12 months PNH type III red blood cell (RBC) clone by flow cytometry of >10% Lactate dehydrogenase (LDH) level > 1.5 x upper limit of normal Platelet count > 100,000/mm3 Patient taking erythropoietin must be on a stable dose for at least 26 weeks Patient taking immunosuppressants must be on a stable dose for at least 26 weeks Patient taking corticosteroids must be on a stable dose for at least 4 weeks Patient taking coumadin must be at a stable INR for at least 4 weeks Patient taking iron supplements or folic acid must be on a stable dose for 4 weeks Willing and able to give written informed consent Must avoid conception Exclusion Criteria: Mean hemoglobin level prior to transfusion over the previous 12 months is >10.5 gm/dl Absolute neutrophil count <500/ul Active bacterial infection Hereditary complement deficiency Participation in any other investigational drug trial or exposure to other investigational agent, device, or procedures within 30 days Pregnant, breast-feeding, or intending to conceive History of meningococcal disease History of bone marrow transplantation

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: Educational/Counseling/Training
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

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

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
Optimised Fluoride Prevention by Double Rinse With Fluoride and Calcium

Study Overview
=================
Brief Summary
-----------------
Aim: to determine the optimal Ca2+ concentration with 905 ppm F as NaF. Study design: Experimental study in 10 volunteers. Single blind mouth rinse with calcium lactate solution (150; 75; 0 mM Ca-lactate) is immediately followed by a standard fluoride rinse. Procedure: Rinses are performed in the evening. The rinse combinations are given in a random order, and the subjects are unaware of the sequence. At least 3 days separates the use of each rinse. Dosage: 20 mL and 1 minute rinse with each solution. Saliva samples: Twelve hours after rinsing, unstimulated saliva samples are collected by expectoration. Analysis: The fluoride concentration in saliva samples are analysed Statistics and data handling: Fluoride in saliva 12 hours after rinsing are examined by one-way ANOVA, repeated measures design.

Official Title
-----------------
A Double Blind, Randomized, Cross Over Designed Trial of Fluoride Prevention by Double Rinse With Calcium and Fluoride

Conditions
-----------------
Dental Caries

Intervention / Treatment
-----------------
* Drug: calcium lactate solution


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: 18 years or older 10 natural teeth or more willing to refrain from use of fluoride containing products signed informed consent Exclusion Criteria: less than 10 natural teeth reduced cognitive skills does not speak and/or understand Swedish ongoing oral or systemic infections pregnancy breast feeding

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: Prevention
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: calcium lactate solution 75 mM<br> | Drug: calcium lactate solution<br>* Calcium lactate solution 75 mM, 150 mM, 175 mM and placebo<br>|
| Active Comparator: calcium lactate solution 150 mM<br> | Drug: calcium lactate solution<br>* Calcium lactate solution 75 mM, 150 mM, 175 mM and placebo<br>|
| Placebo Comparator: placebo<br> | Drug: calcium lactate solution<br>* Calcium lactate solution 75 mM, 150 mM, 175 mM and placebo<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Fluoride concentration in resting saliva |  | 12 hours after rinse | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Discomfort by calcium lactate rinse |  | 12 hours after rinse | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
dental caries/prevention and control, oral health, cariostatic agents
High Definition Endoscopy and Optic Enhancement Endoscopy in Gastric Neoplasia: A Prospective Study

Study Overview
=================
Brief Summary
-----------------
The aim of the study is to evaluate the diagnostic value of high definition endoscopy and optic enhancement in gastric neoplasia.

Conditions
-----------------
Gastric Neoplasia

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: patients with dyspeptic symptoms and aged 40 years or older or patients with Helicobacter pylori infection, or histologically verified gastric intestinal metaplasia or atrophic gastritis or patients with family history of gastric cancer Exclusion Criteria: presence of gastrectomy, acute gastrointestinal bleeding, or known gastric neoplasia presence of conditions unsuitable for endoscopy procedure including coagulopathy, impaired cardiopulmonary function , pregnancy or breastfeeding inability to provide informed consent

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| High definition endoscopy and optic enhancement<br>All the patients underwent routine preparation before the procedure. The detected lesions in high definition endoscopy were observed with optic enhancement mode. The endoscopist was required to give the real-time descriptions of surface pit patterns of the lesions, based on surface pattern classification. After that, biopsy specimens will be obtained respectively by forceps from each detected lesion recorded for histologic diagnosis. | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Sensitivity of optical enhancement endoscopy in diagnosis of gastric neoplasia |  | 8 months | 
| Specificity of optical enhancement endoscopy in diagnosis of gastric neoplasia |  | 8 months | 
| Positive predictive value of optical enhancement endoscopy in diagnosis of gastric neoplasia |  | 8 months | 
| Negative predictive value of optical enhancement endoscopy in diagnosis of gastric neoplasia |  | 8 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The inter-observer and intra-observer agreement of optic enhancement endoscopy in gastric neoplasia |  | 8 months |
Treating Alcohol Use In Older Adults With Depression

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to test the efficacy combining a treatment for depression with a treatment for alcohol dependence.

Detailed Description
-----------------
This study aims to study 80 patients with comorbid alcohol dependence and a depressive syndrome. After appropriate detoxification, patients are started on either naltrexone 50 mg or placebo. After one week, sertraline is added in an open label fashion. It is hypothesized that those patients receiving combination therapy will last 3 months with follow-up tracking lasting 1 year.

Official Title
-----------------
The Treatment of Late Life Major Depression Complication by Alcohol

Conditions
-----------------
Alcoholism, Depression

Intervention / Treatment
-----------------
* Drug: NALTREXONE
* Drug: Placebo


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Age > 55 Current depressive syndrome Current alcohol dependence No psychosis No opioid or cocaine abuse or dependence Exclusion Criteria:

Ages Eligible for Study
-----------------
Minimum Age: 55 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: Single Group Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 1<br>Naltrexone | Drug: NALTREXONE<br> <br> |
| Placebo Comparator: 2<br>Placebo | Drug: Placebo<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Alcohol use' |  | 12 weeks |
Evaluation of the Neural Therapy Effect on Long Term Postoperative Discomforts in Patients Who Undergo Bilateral Tubal Ligation

Study Overview
=================
Brief Summary
-----------------
The aim of this study was to explore the effect of neural therapy on postoperative pain and discomfort such as abdominal swelling; and gynecologic symptoms such as dysmenorrhea, dyspareunia, amount of menstrual bleeding and vaginitis. It also aimed to find out any possible links between the clinical changes and pathophysiologic mechanisms. One hundred and thirteen patients were randomly divided into two groups (neural therapy and control). Postoperative first day, neural therapy was applied to the T10 to S4 dermatomes and utero-vaginal ganglion in random with local anesthetic agent. All patients were recalled one year after the treatment. The visual analog scale (VAS) were noted in both groups, also discomfort and gynecologic symptoms are recorded.

Official Title
-----------------
Evaluation of the Neural Therapy Effect on Long Term Postoperative Discomforts and Gynecologic Symptoms in Patients

Conditions
-----------------
Pain, Postoperative, Neural Therapy of Huneke, Dysmenorrhea, Dyspareunia, Sterilization, Tubal

Intervention / Treatment
-----------------
* Procedure: Neural Therapy


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients who undergo bilateral tubal ligation Exclusion Criteria: Previous abdominal surgery Patients with diseases that could have neurologic complications (DM, SLE ...)
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 |
| --- | --- |
| Control<br>The control group with bilateral tubal ligation | Procedure: Neural Therapy<br>* Neural therapy is a form of alternative medicine in which local anesthetic is injected into certain locations of the body in an attempt to treat chronic pain and illness.<br>|
| Neural Therapy<br>The treatment group | Procedure: Neural Therapy<br>* Neural therapy is a form of alternative medicine in which local anesthetic is injected into certain locations of the body in an attempt to treat chronic pain and illness.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pain scores | Visual Analog Scale was used as the pain scale.1 to 10 points are given here. High score (8- 10) indicates severe pain. | 1 year later |
Observational Study of Patients With Duchenne Muscular Dystrophy Theoretically Treatable With Exon 53 Skipping

Study Overview
=================
Brief Summary
-----------------
PreU7-53 is a natural history study. The objective is to monitor the clinical and radiological course of upper limb muscle impairment in patients with Duchenne Muscular Dystrophy (DMD), potentially treatable with AAV-mediated exon 53 skipping.

Official Title
-----------------
Study of Clinical and Radiological Changes in Patients With Duchenne Muscular Dystrophy Theoretically Treatable With Exon 53 Skipping

Conditions
-----------------
Duchenne Muscular Dystrophy

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Diagnosis of Duchenne muscular dystrophy confirmed by at least genetic testing, theoretically treatable by exon 53 skipping. Age between ≥ 12 and <20 years old. Non ambulant patients (i;e; inability to walk more than 10 meters without any of assistance). Patients covered by a national health insurance scheme. Signed informed consent. Exclusion Criteria: Patient incapable of sitting upright in a wheelchair for at least one hour. Patients with severe intellectual impairment preventing them from fully understanding the exercises to be performed. Recent (less than 6 months ago) upper limb surgery or trauma This criteria is however no definitive. Patients who have undergone upper limb surgery or trauma may nonetheless be enrolled once the 6 month period is over. Known immune deficiency. Contraindications to NMR exams

Ages Eligible for Study
-----------------
Minimum Age: 12 Years
Maximum Age: 20 Years

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

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 |
| --- | --- | --- |
| PreU7-53 is a natural history study | The objective is to monitor the clinical and radiological course of upper limb muscle impairment in patients with DMD, potentially treatable with AAV-mediated exon 53 skipping. | Every year | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Duchenne Muscular Dystrophy, strength and function tests, MRI
Altaire Gel Forming Solution Versus Refresh Tears for the Treatment of Dry Eye Signs and Symptoms

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to evaluate and compare the effects of Altaire Gel forming solution and Refresh Tears in mild-moderate dry eye patients.

Official Title
-----------------
A Randomized Masked Evaluation of Altaire Gel Forming Solution Versus Refresh Tears for the Treatment of Dry Eye Signs and Symptoms

Conditions
-----------------
Dry Eye Syndromes

Intervention / Treatment
-----------------
* Drug: Altaire Gel forming solution
* Drug: Refresh Tears


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients 18 years or older. Males or females. Patient reported dry eye symptoms (episodic, annoying, activity limiting). Physician assessment of mild-moderate dry eye. Patient willing to instill drops TID and complete entire length of protocol. TBUT _< 10 seconds. At least Grade 6 Corneal Staining. Exclusion Criteria: Current topical cyclosporine use (Restasis) Current Refresh use. Refractive surgery within the last 6 months. Oral or topical corticosteroid use. Severe dry eye patients by physician assessment. Current active blepharitis. Oral doxycycline use. Oral antihistamine use.

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Altaire Gel forming solution<br> | Drug: Altaire Gel forming solution<br>* Three times a day for two months<br>|
| Placebo Comparator: Refresh Tears<br> | Drug: Refresh Tears<br>* Three times a day for two months<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| TBUT | Test performed that measures how long the tears take to break up | 2 months | 
| Conjunctival and Corneal staining | Dye that will be placed inside the eye to evaluate the surface of the ey | 2 months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
dry eye signs and symptoms
A Trial on the Opportunity and Treatment of Residual Deformity After Reduction in Developmental Dislocation of the Hip

Study Overview
=================
Brief Summary
-----------------
Developmental dislocation of the hip is a common disease in children, and its incidence in China is about 9 ‰.The pathological changes of it is complex. The reluxation , subluxation and residual deformity and other complications are relatively common after treatment. The X-ray appears great acetabular index and wide medial gap , small central-edge angle. As there is no effective methods for treating such complications , investigators conducted this trial to find and prove optimal intervention time and treatment programs.

Official Title
-----------------
A Multi-center Study on the Opportunity and Treatment of Residual Deformity After Reduction in Developmental Dislocation of the Hip

Conditions
-----------------
Reduction, Developmental Dislocation of the Hip, Congenital Dislocation of Hip, Residual Deformity

Intervention / Treatment
-----------------
* Procedure: Pelvic osteotomy


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: The inclusion criteria consists of patients with large acetabular index ,small central-edge angle after reduction in developmental dislocation of the hip Exclusion Criteria: Age >14 years Patients are complicated with mental, neurological disorders (such as hypoxic-ischemic encephalopathy, epilepsy and dementia) or significant barriers to growth. Patients are complicated with cerebral palsy, multiple joint contractures disease. Children are complicated with dysfunction of liver and kidney , blood disorders, immune deficiency disease and ECG abnormalities. Parents refused further treatment.

Ages Eligible for Study
-----------------
Minimum Age: 1 Year
Maximum Age: 14 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 |
| --- | --- |
| Pelvic osteotomy<br> | Procedure: Pelvic osteotomy<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Early treatment can achieve good results in the residual deformity after reduction in developmental dislocation of the hip | Acetabular index of all ages were measured ，and the acetabular index of patients getting early treatment (pelvis osteotomy ) is normal in all ages according to The measurements of normal acetabular index and Sharp acetabular angle in Chinese hips publised on Chinese Journal of Orthopaedics in 2010. | 3 years |
Study of Tapering and Discontinuing Biological DMARDs in Rheumatoid Arthritis Patients

Study Overview
=================
Brief Summary
-----------------
This study aims to analyses time to disease relapse of RA patients if TNF-α inhibitors are being tapered, the predictive factors that are associated with successful taper of TNF-α inhibitors. Also, investigate the effects associated with dose tapering of TNF-α inhibitors.

Official Title
-----------------
Study of Tapering and Discontinuing Biological DMARDs in Rheumatoid Arthritis Patients

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

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion criteria: Diagnosed of RA based on the 1987 American College of Rheumatology (ACR) criteria and/or 2010 ACR/EULAR classification criteria of RA depending on the time of diagnosis Age ≥ 20 years old TNF-α inhibitors was prescribed for RA patients refractory to csDMARDs (defined as csDMARD therapy for over 6 months) during 2003/5/2 - 2017/4/30 Dose reduction or discontinuation use of TNF-α inhibitors (2011/1/1-2019/4/30) Exclusion criteria: TNF-α inhibitors were discontinued or tapered due to adverse events such as infection, liver transaminase elevation, malignancy and neutropenia.

Ages Eligible for Study
-----------------
Minimum Age: 20 Years
Maximum Age: 90 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 |
| --- | --- |
| Tapering<br>TNF-α inhibitors | |
| Discontinuing<br>TNF-α inhibitors | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| time to disease relapse | me to relapse after tapering or discontinuing TNF-α inhibitors | hrough study completion, an average of 10 year | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
biological DMARDs