linjc16/ctgov huggingface dataset:
N-acetyl Cysteine for the Prevention of Oral Mucositis After Autologous Hematopoietic Cell Transplantation.

Study Overview
=================
Brief Summary
-----------------
Oral mucositis (OM) is a major source of morbidity in patients undergoing hematopoietic cell transplantation (HCT). N-acetyl cysteine (NAC) is an antioxidant, widely used as mucolytic agent or antidote of acetaminophen overdose hepatotoxicity. we intend to explore the safety and efficacy of NAC in the prevention of OM after high-dose chemotherapy and autologous HCT in a phase III, randomized, open label and multi-center study.

Official Title
-----------------
Efficacy and Safety of N-acetyl Cysteine for the Prevention of Oral Mucositis After High-dose Chemotherapy and Autologous Hematopoietic Cell Transplantation: a Phase III, Randomized, Open Label, Multi-center Study.

Conditions
-----------------
Mucositis, Transplant-Related Disorder

Intervention / Treatment
-----------------
* Drug: N acetyl cysteine


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients with multiple myeloma and lymphoma in partial response and complete remission. Undergoing high-dose chemotherapy with autologous transplantation. Exclusion Criteria: • Known sensitivity to NAC

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: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Phase III, randomized, open label and multi-center study.
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: N acetyl cysteine<br>NAC dissolved in water at a dose of 600 mg three times per day from day of transplant until neutrophil engraftment, or upon resolution of OM, whichever appears later. | Drug: N acetyl cysteine<br>* N acetyl cysteine dissolved in water at a dose of 600 mg three times daily from day of transplant until neutrophil engraftment, or upon resolution of OM, whichever appears later.<br>|
| No Intervention: Control<br>No intervention | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Proportion of patients with grade 3-4 OM | Proportion of patients with grade 3-4 OM | day 14 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Proportion of patients with grade 1-4 OM | Proportion of patients with grade 1-4 OM | 14 days | 
| Time from transplantation to first hospital discharge | Time from transplantation to first hospital discharge | 30 days | 
| Non-relapse mortality | Non-relapse mortality | day 50 |
Retina Projection System Trials for Low Vision People

Study Overview
=================
Brief Summary
-----------------
Purpose a. Examination on Efficacy of Retina Projection System Patients a. Low vision patients Methods Vision aids Retina Projection System Face-mounted video display as control Comparison of Reading Speeds with both vision aids

Detailed Description
-----------------
Purpose a. Examination on efficacy of a new vision aid of Retina Projection System Patients Low vision patients Vision between 0.06 and 0.3 no exclusion on kinds of ocular diseases Methods Vision aids Retina Projection System Face-mounted video display as control Computer-aided measurement of reading speeds of individual characters Comparison of reading Speeds with the two vision aids

Official Title
-----------------
Multicenter Clinical Trials of Retina Projection System

Conditions
-----------------
Vision, Low

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: low vision patients vision between 0.06 and 0.3 Exclusion Criteria: light perception hand motion vision less than 0.06
Sexes Eligible for Study
-----------------
All

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| 1<br> | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Reading speeds with two different vision aids |  | Visits for measuring reading speeds | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Low vision
Pain Management After Shoulder Prosthesis: A Clinical Trial of Nerve Block and Local Infiltration

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to determine the efficacy of local infiltration analgesia as compared to 48-hour interscalene block in treating pain after shoulder arthroplasty. The investigators hypothesize a reduced pain score and use of supplemental analgesic medication during the first three postoperative days using local infiltration analgesia.

Official Title
-----------------
Pain Management After Shoulder Arthroplasty: A Randomised Clinical Trial of Interscalene Block and Local Infiltration Analgesia

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

Intervention / Treatment
-----------------
* Procedure: Local infiltration analgesia
* Procedure: Interscalene catheter


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: elective primary shoulder arthroplasty Exclusion Criteria: reverse or delta prosthesis recent fracture near the shoulder allergic to amid-type local analgesics operation not under general anaesthesia incompetent, pregnant, below 18 or above 90 years old severe chronic neurogenic pain or sensory disturbances in the shoulder

Ages Eligible for Study
-----------------
Minimum Age: 18 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
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Local infiltration analgesia<br> | Procedure: Local infiltration analgesia<br>* 150 ml ropivacaine, of which 100 ml is with adrenalin<br>* Other names: LIA;|
| Active Comparator: Interscalene catheter<br> | Procedure: Interscalene catheter<br>* 7 ml ropivacaine interscalene block via catheter, subsequently given 5 ml/h and possibility of 5 ml bolus for the first 48 hours.<br>* Other names: interscalene block;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Supplemental analgesics ingested |  | First 24 hours postoperatively | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pain score |  | First 72 hours postoperatively | 
| Supplemental analgesics ingested |  | First 72 hours postoperatively | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Shoulder Arthroplasty, Local infiltration analgesia
Immunogenicity of Cholera Vaccine in Children With IBD

Study Overview
=================
Brief Summary
-----------------
Assessment of the immunogenicity and safety of immunization against cholera in children with inflammatory bowel disease.

Official Title
-----------------
Evaluation of Immunogenicity of Cholera Vaccine in Children With Inflammatory Bowel Disease

Conditions
-----------------
Cholera, Inflammatory Bowel Diseases

Intervention / Treatment
-----------------
* Biological: Vaccination against cholera


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: diagnosis of Crohn's disease or ulcerative colitis based on standard clinical, endoscopic, histologic and radiographic criteria (Porto criteria), no vaccination against cholera in the past, written consent of the patient's legal guardians and the patient himself if he/she turns 16 years of age. Exclusion Criteria: serious exacerbation of inflammatory bowel disease defined as Paediatric Ulcerative Colitis Activity Index (PUCAI) > 65 points for patients with ulcerative colitis or Pediatric Crohn's Disease Activity Index (PCDAI) > 40 points for patients with Crohn's disease.

Ages Eligible for Study
-----------------
Minimum Age: 6 Years
Maximum Age: 18 Years

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

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

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

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Cholera vaccination<br>Two doses of the vaccine against cholera | Biological: Vaccination against cholera<br>* Participants will receive two doses of an oral cholera vaccine with an interval of 2-4 weeks.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Achieving seroprotective antibody concentration | Serum antibody concentration indicating protection against cholera. | 4-6 weeks after the second dose | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Adverse effects | Evaluation of adverse effects after vaccination. | 3 days after each dose | 
| Inflammatory bowel disease exacerbation occurrence. | Disease exacerbation assessed according to the Paediatric Ulcerative Colitis Activity Index (PUCAI) for patients with ulcerative colitis or Pediatric Crohn's Disease Activity Index (PCDAI) for patients with Crohn's disease. | 4-6 weeks after the second dose |
Clinical Study Evaluating Vildagliptin Versus Vildagliptin/Metformin on NAFLD With DM

Study Overview
=================
Brief Summary
-----------------
Clinical study evaluating vildagliptin versus vildagliptin/metformin on NAFLD with DM.

Detailed Description
-----------------
Clinical study evaluating vildagliptin versus vildagliptin/metformin on nonalcoholic fatty liver disease with DM.

Official Title
-----------------
Clinical Study Evaluating the Effectiveness of Vildagliptin Versus Vildagliptin/Metformin on NAFLD With DM

Conditions
-----------------
dm

Intervention / Treatment
-----------------
* Drug: Vildagliptin
* Drug: vildagliptin\metformin


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: NAFLD and type 2 DM Exclusion Criteria: Viral hepatitis. Child score more than 6. renal impairment.

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: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: vildagliptin<br>vildagliptin 50 mg twice daily | Drug: Vildagliptin<br>* vildagliptin twice daily<br>* Other names: dibavally;|
| Active Comparator: vildagliptin\metformin<br>vildagliptin\metformin twice daily | Drug: vildagliptin\metformin<br>* vildagliptin\metformin twice daily<br>* Other names: dibavally plus;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| number of patients with improved nafld and insulin resistance | number of patients showing improved nafld and insulin resistance | 6 months |
A Study to Evaluate the Safety and Efficacy of Clozapine in Patients With Treatment-resistant Schizophrenia

Study Overview
=================
Brief Summary
-----------------
Clozapine is an antipsychotic. This 24-week study will evaluate the safety and efficacy of clozapine in patients with treatment-resistant schizophrenia. This study is not recruiting in the United States.

Detailed Description
-----------------
Clozapine is an antipsychotic. This 24-week study will evaluate the safety and efficacy of clozapine in patients with treatment-resistant schizophrenia.

Official Title
-----------------
A 24-week, Multicenter, Open-label Study to Evaluate the Safety and Efficacy of Clozapine in Patients With Treatment-resistant Schizophrenia

Conditions
-----------------
Schizophrenia

Intervention / Treatment
-----------------
* Drug: Clozapine


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Diagnosed as schizophrenia Not responded to at least two atypical antipshychotics launched in Japan Inpatient Exclusion Criteria: Low white blood cell count Significant heart diseases Diabetes mellitus Other protocol-defined exclusion criteria may apply.

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 64 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: 1<br> | Drug: Clozapine<br> <br> * Other names: Clozaril;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Values of hematological tests during the 24 week treatment |  |  | 
| Incidence of hematological adverse events during the 24 week treatment |  |  | 
| Compliance to Clozapine Patient Monitoring System during the 24 week treatment |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Changes in the symptoms of psychosis every 4 weeks up to week 24 |  |  | 
| Global change in severity of psychosis at baseline and week 12 |  |  | 
| Global impression of change in the condition of patients at week 12 and 24 |  |  | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Schizophrenia, treatment-resistant, clozapine
Whole Body Vibration and Unstable Shoes on Balance in Healthy Young People

Study Overview
=================
Brief Summary
-----------------
Aim: To compare the effect of different type of shoes (unstable or stable) combined with a whole body vibration training on balance. Design: Randomized controlled trial. Setting: Laboratory of biomechanics. Population: Healthy young people.

Detailed Description
-----------------
Background: The use of whole body vibration to train strength and balance has increased in the last years. Last studies have shown that adding an unstable device increased electromyographic activity of the lower limb and the trunk muscles. However, no studies have investigated the effects of wearing unstable shoes during a whole-body vibration training on balance in healthy young people. Aim: To compare the effects of different type of shoes (unstable [Intervention group] or stable [Control group]) combined with a 12-weeks whole body vibration training on balance. Setting: Laboratory of biomechanics.

Official Title
-----------------
Effects of Combined Whole Body Vibration and Unstable Shoes on Balance in Healthy Young People: A Preliminary Randomized Controlled Trial

Conditions
-----------------
Balance

Intervention / Treatment
-----------------
* Other: Unstable shoes plus Whole-body vibration
* Other: Stable shoes plus Whole-body vibration


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Body mass index < 35. Exclusion Criteria: Cardiovascular disease, incapacity to practice a physical activity, musculoskeletal pathologies, neurologic diseases, previous experience with unstable shoes, previous experience with whole-body vibration.

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 40 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 |
| --- | --- |
| Experimental: Unstable shoes<br>Wearing unstable shoes during the whole-body vibration training | Other: Unstable shoes plus Whole-body vibration<br>* Wearing unstable shoes during the whole-body vibration training<br>|
| Active Comparator: Stable shoes<br>Wearing stable shoes during the whole-body vibration training | Other: Stable shoes plus Whole-body vibration<br>* Wearing stable shoes during the whole-body vibration training<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Balance | Velocity of the center of pressure assessed with a foot pressure sensitive walkway | 4 weeks | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Unstable Shoes, Whole Body Vibration
Changes in Physical Inactivity in Patients With Knee Osteoarthritis

Study Overview
=================
Brief Summary
-----------------
This is an objective cohort study using objective recording of physical activity (accelerometry) during and after the GLAiD intervention to investigate if a sedentary behavior change by participating in an 6-week physiotherapy-led exercise and education program (GLAiD) occurs. The GLAiD intervention is an education and exercise based intervention aiming at decreasing pain and improving function in patients with knee osteoarthritis. The primary outcome is change in objective recorded physical activity between baseline and follow-up.

Official Title
-----------------
Changes in Physical Inactivity Secondary to Exercise Therapy in Patients With Knee Osteoarthritis: A Prospective Cohort Study

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

Intervention / Treatment
-----------------
* Other: standardized exercise treatment for knee OA in Denmark (GLAiD)


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: ≥40 years Diagnosed with knee OA Willing and able to complete study visits and procedures Owner of a smartphone or tablet Eligible for participation in the GLAID treatment Speaks, reads and writes Danish language Exclusion Criteria: Any condition, which in the opinion of the Investigator, would put the subject at increased safety risk by participation, or otherwise make the subject unsuitable for this study.

Ages Eligible for Study
-----------------
Minimum Age: 40 Years

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

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

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

Arms and Interventions

| Intervention/Treatment |
| --- |
|Other: standardized exercise treatment for knee OA in Denmark (GLAiD)|objective measurement of physical activity before, during af after the GLAiD intervention|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Objectively measured physical activity | accelerometer recorded physical activity | 6 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Knee Injury and Osteoarthritis Outcome Score(KOOS) | KOOS questionnaire | baseline (day 1) and follow-up (after 6 weeks) |
Screening For Diabetic Macular Edema Among Diabetic Patients Using Optical Coherence Tomography

Study Overview
=================
Brief Summary
-----------------
Diabetic macular edema is one of the major causes of visual impairment in diabetic retinopathy patients especially in the working age group. The problem is likely to increase in the future with statistics showing a growing number of the diabetic population especially in the Middle East . .

Detailed Description
-----------------
The worldwide prevalence of diabetic macular edema was reported as 6.81% among patients with diabetes. Other research reported that the 10-year incidence of diabetic macular edema was 14% in individuals with type 2 diabetes, and progression to diabetic macular edema occurred in 29% of individuals with type 1 diabetes over 25 years if left untreated . Although diabetic macular edema resolves spontaneously in about 33% to 35% of patients, it tends to be chronic in most patients..Diabetic macular edema can occur at any stage of diabetic retinopathy . The symptoms of diabetic macular range from slight visual blurring to complete blindness if left untreated . Optical coherence tomography is an objective non-invasive method for high-resolution cross-sectional imaging of the retina .

Official Title
-----------------
Screening For Diabetic Macular Edema Among Diabetic Patients In Assiut University Hospital Using Optical Coherence Tomography

Conditions
-----------------
Diabetic Macular Edema

Intervention / Treatment
-----------------
* Device: Optical Coherence Tomography


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients with type 1or type 2 Diabetes Mellitus. Fundus examination and optical coherence tomography can be done with no significant hazy media Exclusion Criteria: Previous ocular surgery (e.g. vitreo-retinal surgery, glaucoma surgery). Presence of co-existing retinal or choroidal disease (e.g. high myopia, retinitis pigmentosa and Age-related macular degeneration) Other associated ocular conditions (ex. glaucoma & corneal opacity & iritis). Previous history of trauma. Pregnancy induced diabetes

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

| Intervention/Treatment |
| --- |
|Device: Optical Coherence Tomography|an objective non-invasive method for high-resolution cross-sectional imaging of the retina|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The prevalence of diabetic macular edema in diabetic patients | The prevalence of diabetic macular edema in diabetic patients using optical coherence tomography . | 5 minutes |