linjc16/ctgov huggingface dataset:
Endoscopic Ultrasound-guided Needle-based Confocal Laser Endomicroscopy in Solid Pancreatic Masses

Study Overview
=================
Brief Summary
-----------------
The differential diagnosis of solid pancreatic masses by endoscopic ultrasound-guided fine-needle aspiration (EUS-FNA) is currently suboptimal. Needle-based confocal laser endomicroscopy (nCLE) is a novel endoscopic technique, which is compatible with the 19-gauge FNA needle. Under endoscopic ultrasonography (EUS) guidance, nCLE enables real-time in vivo imaging of lesion tissues at cellular and subcellular levels. This study aimed to describe nCLE interpretation criteria for the characterization of pancreatic masses, with histopathological correlation, and to perform the validation of these criteria.

Conditions
-----------------
Solid Pancreatic Masses

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: patients with any pancreatic mass Exclusion Criteria: Patients aged <18 years or >80 years Known allergy to fluorescein dye Previous EUS-FNA performed within the past 3 months, and usualcontraindications to EUS-FNA 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?
-----------------
What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The nCLE interpretation criteria for the characterization of pancreatic masses with histopathological correlation |  | 20 months |
Effect of Omega-3 Fatty Acids on Oxidative Stress and Dyslipidemia in Pediatric Patients Undergoing Hemodialysis

Study Overview
=================
Brief Summary
-----------------
The purpose of the study is to evaluate the effect of omega-3 fatty acids supplementation on pediatric patients undergoing hemodialysis via the measurement of the following before and after omega-3 administration:oxidative stress markers, inflammatory markers and serum lipids.

Official Title
-----------------
Evaluation of the Effect of Omega-3 Fatty Acids Supplementation on Pediatric Patients Undergoing Hemodialysis

Conditions
-----------------
End Stage Renal Disease

Intervention / Treatment
-----------------
* Dietary Supplement: omega-3
* Other: empty soft gelatin capsules


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients between 8 and 18 years old Patients treated with HD for at least 6 months Exclusion Criteria: Patients with malignancy and active inflammatory disease. Patients who received vitamin E or any antioxidant treatment during the past 3 months.

Ages Eligible for Study
-----------------
Minimum Age: 8 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: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: omega-3 group<br>omega-3 soft gelatin capsules 1000 mg (500mg EPA+250mg DHA)once daily for four months | Dietary Supplement: omega-3<br>* dietary supplement<br>* Other names: NOW foods omega-3 softgels;|
| Placebo Comparator: placebo group<br>empty soft gelatin capsules with matched size, color and shape once daily for four months | Other: empty soft gelatin capsules<br>* empty softgels of matched size, shape and color<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| effect on oxidative stress status via measurement of superoxide dismutase and glutathione peroxidase and malondialdehyde |  | four months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| effect on serum lipid levels (HDL cholesterol, LDL cholesterol, total cholesterol, and triglycerides) |  | four months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
omega-3 fatty acids, hemodialysis, oxidative stress, dyslipidemia
Blood Pressure and Brain Blood Flow Regulation After Midodrine Administration in Those With Spinal Cord Injury

Study Overview
=================
Brief Summary
-----------------
This project aims to evaluate the physiological effects of Midodrine administration during orthostatic challenge in those with high level spinal cord injury. Midodrine has been shown to improve orthostatic symptoms in those with spinal cord injury but the physiological mechanisms influenced have not been identified. The investigators will examine key physiological components influencing orthostatic tolerance. The investigators will do this, by measuring the baroreflex, and brain blood flow autoregulation (the ability to maintain brain blood flow) before during and after the sit-up test. Two sit-up tests will occur; one before Midodrine administration, and one after administration of a 10mg dose of Midodrine.

Official Title
-----------------
Neural and Mechanical Baroreflex Sensitivity and Cerebral Blood Flow

Conditions
-----------------
Orthostatic Intolerance

Intervention / Treatment
-----------------
* Drug: Midodrine


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: To be included in the study, participants must have sustained a traumatic spinal cord injury within the ages of 18-49 years. Also, participants must have an injury level above the 6th thoracic vertebrae and be a non-smoker for a minimum of one year. Exclusion Criteria: Any participants with a history of cardiovascular disease, pulmonary disease or diabetes mellitus will not be eligible. Also, participants will not be eligible to take part in study if they experiences acute distress, or are taking medications known to influence cardiovascular function. Patient will be not eligible for the study if he/she has known adverse reaction to Midodrine.

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 49 Years

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

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

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

Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: Midodrine|Single 10 mg dose|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Baroreflex sensitivity |  | Immediately after drug administration (30 mins) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Cerebral autoregulation |  | Thirty minutes after administration | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Orthostatic intolerance in people with spinal cord injury
Regulatory B Cells and Chronic Immune Thrombocytopenia

Study Overview
=================
Brief Summary
-----------------
The chronic immune thrombopenia is an autoimmune disease caused by B cells. These cells produce anti platelets and megakaryocytes antibodies. Some B cells, named regulatory B cells, are known to control other cells. Their action in chronic immune thrombopenia is actually unknown.

Detailed Description
-----------------
The chronic immune thrombopenia is an autoimmune disease caused by B cells. These cells produce anti platelets and megakaryocytes antibodies. Some B cells, named regulatory B cells, are known to control other cells. Their action in chronic immune thrombopenia is actually unknown. In our cohort of chronic immune thrombopenia and controls, we realized a flow cytometry analyze of B and T cells and a co-culture to determine regulatory B cells functionality.

Official Title
-----------------
The Role of Regulatory B Cells in the Chronic Immune Thrombocytopenia

Conditions
-----------------
Purpura, Thrombocytopenic, Idiopathic, Regulatory B Cells

Intervention / Treatment
-----------------
* Biological: Biological tests


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Purpura, Thrombocytopenic, Idiopathic, chronic phase (>12 months) no treatment or thrombopoietin receptor agonists Exclusion Criteria: < 18 years Purpura, Thrombocytopenic, Idiopathic, acute phase pregnancy others causes of thrombopenia

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| patients group<br>Adults patients with chronic immune thrombocytopenia | Biological: Biological tests<br>* From the blood: B and T cells extraction then co-culture B and T cells and characterization of lymphocytes by flow cytometry<br>|
| control group<br>Adults without immune thrombocytopenia | Biological: Biological tests<br>* From the blood: B and T cells extraction then co-culture B and T cells and characterization of lymphocytes by flow cytometry<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Regulatory B cells functionality | inhibition of T cells proliferation with co-culture B and T cells | 1 week | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Cytometry immunophenotyping of B and T cells | characterization of B and T cells by flow cytometry | 1 week |
Nexium Dyspepsia/AST

Study Overview
=================
Brief Summary
-----------------
The aim is to evaluate if the resolution of upper abdominal symptoms (pain or burning) during an acid suppressive test trial of esomprazole given daily for 7 days predicts symptoms resolution at the end of a subsequent treatment period of 7 weeks.

Official Title
-----------------
Supportive Test for Acid-Related Symptoms (STARS II) With Esomeprazole and a Following 7-week, Double-blind, Randomized, Placebo Controlled Treatment Period in Uninvestigated Subjects With Upper Gastrointestinal Symptoms.

Conditions
-----------------
Gastrointestinal Disease, Signs and Symptoms, Digestive, Dyspepsia

Intervention / Treatment
-----------------
* Drug: Esomeprazole


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: At least 3 months of symptoms of pain or burning centered in the upper abdomen prior to enrollment. Helicobacter pylori test performed at enrollment must be negative (Helicobacter pylori is a bacterial infection of the stomach). Exclusion Criteria: Patients with symptoms of other gastrointestinal diseases, such as Gastroesophageal Reflux Disease (GERD), Irritable Bowel Syndrome (IBS) or Inflammatory Bowel Disease (IBD). Helicobacter pylori eradication treatment during the last 12 months prior to enrollment.

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

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

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

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

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

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

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The primary outcome is whether the patient is a responder or not after 8 weeks treatment. |  |  | 
| The primary efficacy outcome is based on symptom score recorded daily during the study in a patient diary. |  |  | 
| The patient will judge their symptoms of pain or burning centered in the upper abdomen on a four-graded scale (none, mild, moderate or severe). |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The secondary efficacy outcomes are whether the patient is a responder or not after 4 weeks, |  |  | 
| The average symptom score and the percentage of symptom-free days during the 7-week treatment period, |  |  | 
| Presence/absence of specific GI symptoms after 4 and 8 weeks of therapy |  |  |
Long-term Outcomes of Patients With Primary Amyloidosis After Stem Cell Transplantation

Study Overview
=================
Brief Summary
-----------------
This study examines the value of stem cell transplantation in managing light chain amyloidisis.

Detailed Description
-----------------
How does age at diagnosis affect prognosis in primary amyloidosis? How do lab values at diagnosis such as Creatinine, AST/ALT, total serum protein, serum gamma globulin/immunoglobulin levels affect prognosis in primary amyloidosis? How does degree of organ involvement/number of organs involved affect prognosis in primary amyloidosis? How does initial treatment affect prognosis in primary amyloidosis? 4. How do the specifics the stem cell transplant protocol affect prognosis in primary amyloidosis?

Official Title
-----------------
Reporting of Amyloidosis Stem Cell Transplantation Outcomes

Conditions
-----------------
Amyloidosis

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Eligible for Stem cell transplantation less than age 75 Exclusion Criteria: Creatinine > 3.0 BNP > 10000

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 75 Years

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

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 |
| --- | --- | --- |
| Survival |  | up to 8 years | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Amyloidosis
CDP323 Biomarker Study

Study Overview
=================
Brief Summary
-----------------
Comparison of the effects of different CDP323 doses given over a period of four weeks on blood biomarkers in subjects with relapsing forms of multiple sclerosis.

Official Title
-----------------
Double-blind, Placebo-controlled, Randomized, Parallel-group Study in Subjects With Relapsing Forms of Multiple Sclerosis to Evaluate the Effects of Different CDP323 Doses on Biomarker Patterns as Well as on Safety and Tolerability.

Conditions
-----------------
Relapsing Multiple Sclerosis

Intervention / Treatment
-----------------
* Drug: CDP323
* Drug: CDP323
* Drug: CDP323
* Drug: CDP323
* Drug: Placebo


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Female and male subjects aged 18-65 years Relapsing form of MS with at least one clinical relapse in the 24 months before screening; Screening EDSS score of 0-6.5; Must be fully immunocompetent Female subjects of childbearing potential must agree to practice contraception methods Exclusion Criteria: Any conditions that could interfere with the contrast-enhanced MRI; Any clinically significant disease state or findings other than MS; Any clinically significant deviation from the pre-defined ranges for laboratory tests; Concomitant treatment with MS disease modifying drugs

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: Basic Science
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 1<br> | Drug: CDP323<br>* 250mg capsules, 1000mg daily for 4 weeks<br>Drug: Placebo<br>* placebo capsules for 4 weeks<br>|
| Experimental: 2<br> | Drug: CDP323<br>* 50mg capsules, 100mg bid for 4 weeks<br>Drug: Placebo<br>* placebo capsules for 4 weeks<br>|
| Experimental: 3<br> | Drug: CDP323<br>* 250mg capsules, 500mg bid for 4 weeks<br>Drug: Placebo<br>* placebo capsules for 4 weeks<br>|
| Experimental: 4<br> | Drug: CDP323<br>* 250mg capsules, 1000mg bid for 4 weeks<br>Drug: Placebo<br>* placebo capsules for 4 weeks<br>|
| Placebo Comparator: 5<br> | Drug: Placebo<br>* placebo capsules for 4 weeks<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pharmacodynamic parameters related to leukocyte trafficking |  | 4 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Standard and disease-related safety variables |  | 4 weeks | 
| Class-related safety parameters |  | 4 weeks | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Blood biomarkers, CDP323, Relapsing multiple sclerosis
Alzheimer's Disease Long-term Follow-up Study (ALF Study)

Study Overview
=================
Brief Summary
-----------------
Open study for efficacy and safety of donepezil treatment during 48 weeks

Official Title
-----------------
Alzheimer's Disease Long-term Follow-up Study (ALF Study)

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

Intervention / Treatment
-----------------
* Drug: Donepezil Hydrochloride


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion criteria Men or women aged 40 to 90 Diagnosis of dementia according to DSM-IV Diagnosis of probable AD as defined by NINCDS-ADRDA criteria Mild to moderate AD at baseline, as defined by MMSE score of 10 to 26 Patients were generally healthy and ambulatory or ambulatory aided Patients did not take acetylcholinesterase inhibitor 4 weeks before screening Patients have useful MRI results 3 months before screening Exclusion If they have evidence of TIA or major infarction Epilepsy patients If they have evidence of other degenerative or psychiatric disorder, other serious disorder, alcoholism or drug abuse If they sensitive to acetylcholinesterase If they taken concomitant medication which were not allowed

Ages Eligible for Study
-----------------
Minimum Age: 40 Years
Maximum Age: 90 Years

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

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

Design Details

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


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: Donepezil Hydrochloride|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| ADAS-cog |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| MMSE, CDR, GDS, NPI, ADL, SSDQ |  |  |
Prospective Study of White Blood Cells

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to investigate white blood cells from volunteering donors to support the development of engineered regulatory T cell therapies.

Official Title
-----------------
Investigation of White Blood Cells to Support the Development of Engineered Regulatory T Cell (Treg) Therapies

Conditions
-----------------
Autoimmune Diseases, Inflammation, Rejection; Transplant, Liver

Intervention / Treatment
-----------------
* Other: White blood cell and blood collection


Participation Criteria
=================
Eligibility Criteria
-----------------
No additional inclusion/ exclusion criteria will be applied by Quell other than those specified by the consenting institutions.
Sexes Eligible for Study
-----------------
All

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Specimen collection to support development of engineering Treg<br> | Other: White blood cell and blood collection<br>* Mononucleocytes will be collected via apheresis<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| WBC characterisation to support the development of engineered regulatory T cells. | number, type and function of white blood cells in healthy controls and in patients | 5 years |
R2 in the Treatment of Follicular Lymphoma

Study Overview
=================
Brief Summary
-----------------
Lenalidomide Based Immunotherapy in the Treatment of FL

Detailed Description
-----------------
Lenalidomide Based Immunotherapy efficacy related molecular biomarker in follicular lymphoma

Official Title
-----------------
R2 in the Treatment of Follicular Lymphoma Grade 1-3A

Conditions
-----------------
Follicular Lymphoma

Intervention / Treatment
-----------------
* Drug: Revlimid


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients diagnose as de novo or relapse refractory FL grade 1-3A . No history of stem cell transplantation. Written informed consent. Exclusion Criteria: Chemotherapy or large field radiotherapy within 3 weeks prior to entering the study. Clinically significant active infection. Impaired liver, renal or other organ function not caused by lymphoma, which will interfere with the treatment schedule. Any significant medical or psychiatric condition that might prevent the patient from complying with all study procedures. Subject has ≥grade 2 peripheral neuropathy or grade 1 with pain within 14 days before enrollment. Patients who are pregnant or breast-feeding. HIV infection.

Ages Eligible for Study
-----------------
Minimum Age: 16 Years
Maximum Age: 75 Years

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

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

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

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Revlimd<br> | Drug: Revlimid<br>* Revlimid 25mg PO d1-10 Plus Rituximab 375 mg/m2 IV d0<br>* Other names: lenalidomide;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| CR | Complete response rate | 12 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| PFS | Progression free survival rate | 1 year | 
| OS | Overall survival rate | 1 year | 
| ORR | Overall response rate | 12 weeks |