linjc16/ctgov huggingface dataset:
The Efficacy and Tolerability of 12-weeks Treatment With Almond and Buckwheat Based Formula in Pediatric Patients With Active EoE

Study Overview
=================
Brief Summary
-----------------
Eosinophilic esophagitis (EoE) is a chronic, relapsing, immune-mediated esophageal disease. Clinical manifestations in infants and toddlers generally include vomiting, food refusal, choking with meals and, less commonly, failure to thrive. The management of the disease includes dietary and pharmaceutical interventions, and the goal of the treatment should ideally be both the resolution of symptoms and the normalization of the macroscopic and microscopic abnormalities. Milk is the most common food trigger identified, followed by wheat, soy, and eggs. The aim of the study is to examine the tolerability of a new plant based formula made of minimally processed almond and buckwheat and enriched with vitamins and minerals.

Official Title
-----------------
An Open Label, Pilot Study Assessing the Efficacy and Tolerability of 12-weeks Treatment With Almond and Buckwheat Based Formula in Pediatric Patients With Active Eosinophilic Esophagitis (EoE)

Conditions
-----------------
Eosinophilic Esophagitis

Intervention / Treatment
-----------------
* Dietary Supplement: Else nutrition formula


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Pediatric patients with active EoE (naïve and experienced) Ages 1-18 years Exclusion Criteria: Change in dosing of Proton pump inhibitors (PPI) medication Local steroid treatment < 1 month Refusal to comply with study protocol Known allergy to almonds and buckwheat Use of dairy during the study

Ages Eligible for Study
-----------------
Minimum Age: 1 Year
Maximum Age: 18 Years

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

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

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

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Plant based nutrition<br>Plant based nutritional formula based on almond and buckwheat | Dietary Supplement: Else nutrition formula<br>* Plant based nutrition from almond and buckwheat<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Improvement in Pediatric Eosinophilic Esophagitis Symptom Severity Module (PEESS), endoscopic and histological scoring | Improvement in PEESS, endoscopic and histological scoring (assessed at week 0 and week 12) | 12 weeks |
ZIMURA in Combination With Eylea in Patients With Idiopathic Polypoidal Choroidal Vasculopathy (IPCV)

Study Overview
=================
Brief Summary
-----------------
To asses the safety of intravitreal Zimura™ (complement factor C5 inhibitor) administered in combination with Eylea® in treatment experienced subjects with idiopathic polypoidal choroidal vasculopathy

Official Title
-----------------
A Phase 2A Open-Label Trial to Assess the Safety of ZIMURA™ (Anti-C5) in Combination With EYLEA® in Treatment Experienced Subjects With Idiopathic Polypoidal Choroidal Vasculopathy

Conditions
-----------------
Idiopathic Polypoidal Choroidal Vasculopathy

Intervention / Treatment
-----------------
* Drug: Zimura
* Drug: Eylea


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Diagnosis of IPCV Patients must have had 3 sequential Eylea injections within the previous 4 months Exclusion Criteria: Intravitreal treatment in the study eye prior to screening, regardless of indication, except 3 prior injections of Eylea History or evidence of severe cardiac disease Any major surgical procedure within one month of trial entry Subjects with a clinically significant laboratory value Any treatment with an investigational agent in the past 60 days for any condition Women who are pregnant or nursing Known serious allergies to the fluorescein dye, ICG dye, iodine, povidone iodine, or to the components or formulation of either Zimura or Eylea

Ages Eligible for Study
-----------------
Minimum 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: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Cohort 1<br>Zimura dosage 1 + Eylea 2 mg | Drug: Zimura<br>* Zimura in combination with Eylea<br>* Other names: avacincaptad pegol;Drug: Eylea<br>* Zimura in combination with Eylea<br>* Other names: aflibercept;|
| Experimental: Cohort 2<br>Zimura dosage 2 + Eylea 2 mg | Drug: Zimura<br>* Zimura in combination with Eylea<br>* Other names: avacincaptad pegol;Drug: Eylea<br>* Zimura in combination with Eylea<br>* Other names: aflibercept;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Adverse Events (AEs) | AEs | 9 months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
ARC1905, Eylea, Zimura, aflibercept, IPCV, avacincaptad pegol, complement factor C5 inhibitor
Study of Colorectal Procedures With the Levita Magnetic Surgical System

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to evaluate the safety and effectiveness of the Levita Magnetic Surgical System in patients undergoing colorectal procedures.

Detailed Description
-----------------
Prospective, multicenter, single-arm, open label study designed to assess the safety and effectiveness of the Levita Magnetic Surgical System in colorectal procedures.

Official Title
-----------------
Prospective Study of Colorectal Procedures With the Levita Magnetic Surgical System

Conditions
-----------------
Colorectal Procedures

Intervention / Treatment
-----------------
* Device: Levita Magnetic Surgical System


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Subject is at least 18 years of age Subject is scheduled to undergo elective colorectal surgery Exclusion Criteria: Significant comorbidities Subjects with pacemakers, defibrillators, or other electromedical implants Subjects with ferromagnetic implants Clinical history of impaired coagulation Subject has an anatomical abnormality noted after initiation of index procedure that would prevent device use Subject is not likely to comply with the follow-up evaluation schedule Subject is participating in another clinical trial

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Levita Magnetic Surgical System<br>Levita Magnetic Surgical System | Device: Levita Magnetic Surgical System<br>* Levita Magnetic Surgical System<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number and types of tools required to retract the colon or peri-colorectal tissues | Ability to adequately retract the colon, peri-colorectal tissues or adjacent organs to achieve an effective exposure of the target tissue. Adequate retraction is achieved if it is not necessary to replace the Levita Magnetic Surgical System with another instrument to retract these tissues during the procedure. | During planned colorectal procedure | 
| Device related Adverse events | All adverse events will be recorded and allocated as to relatedness to device, procedure or other. | Through 30 days post colorectal procedure/study completion. |
MK0767 and Metformin Combination Study (0767-028)

Study Overview
=================
Brief Summary
-----------------
A study to test the effects of MK0767 when added to Metformin in patients with inadequately controlled Type 2 Diabetes Mellitus. This is an early phase trial and some specific protocol information is in progress and not publicly available at this time. (Full information is available to trial participants).

Conditions
-----------------
Diabetes Mellitus

Intervention / Treatment
-----------------
* Drug: MK0767


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: All women of childbearing potential must have a negative urine pregnancy test prior to starting the study Patients must be on a stable dose of metformin for at least 2 weeks prior to visit 2 Exclusion Criteria: Patients with a history of type 1 diabetes mellitus and/or history of ketoacidosis Patients on estrogen replacement therapy regimen or SERM Patients with history of, allergy to, intolerance or hypersensitivity to statins or fibric acid derivatives, including history of elevated muscle and liver function tests, jaundice, hepatoxicity, or myopathy associated with these treatments Patient is on a weight loss program with ongoing weight loss or starting an intensive exercise program within 4 weeks from starting the study Have active liver or gall bladder disease HIV positive

Ages Eligible for Study
-----------------
Minimum Age: 21 Years
Maximum Age: 78 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: MK0767|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
Extracorporeal Membrane Oxygenation (ECMO): Blood Cells

Study Overview
=================
Brief Summary
-----------------
The objective of the study is to predict outcomes of patients on extracorporeal membrane oxygenation (ECMO) therapy by correlating cytokines and inflammatory cell patterns to clinical outcomes using data collected in the ECMO Registry at Spectrum Health.

Official Title
-----------------
Extracorporeal Membrane Oxygenation: Blood Cells

Conditions
-----------------
Extracorporeal Membrane Oxygenation

Intervention / Treatment
-----------------
* Other: Blood specimen collection


Participation Criteria
=================
Eligibility Criteria
-----------------
ECMO group: Inclusion Criteria: Greater than or equal to 18 years of age Subject presents to the CTICU at Butterworth Campus, Spectrum Health and is critically ill in the ICU needing ECMO therapy. Exclusion Criteria: Subject is less than 18 years of age Known prisoner Control Subjects: Inclusion Criteria Greater than 18 years of age Without any known cardiovascular, lung, or autoimmune disease. Exclusion Criteria: Less than or equal to 18 years of age Known cardiovascular, lung, or autoimmune disease

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 |
| --- | --- |
| ECMO<br>No intervention. Blood specimen collection. | Other: Blood specimen collection<br> <br> |
| Control<br>No intervention. Blood specimen collection. | Other: Blood specimen collection<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| All cause mortality |  | 1 year |
Effect of Quadratus Lumborum Block in C/S

Study Overview
=================
Brief Summary
-----------------
to compare postoperative analgesic effects of USG guided QLB-2 and QLB-3 blocks after C/S. We hypothesized that QLB-3 may be more effective for pain relieving than QLB-2 after C/S.

Official Title
-----------------
Comparison of Ultrasound Guided Quadratus Lumborum Block-2 and Quadratus Lumborum Block-3 for Postoperative Pain in Cesarean Section

Conditions
-----------------
Postoperative Pain, Cesarean Section Complications, Block, Patient Satisfaction

Intervention / Treatment
-----------------
* Procedure: ultrasound guıded quadratus lumborum block


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: pregnancy with a gestation of 37-41 weeks parturients who were scheduled for elective cesarean delivery under general anesthesia obtained patients informed consent Exclusion Criteria: inability to comprehend bleeding diathesis allergy to the study agents localized infection block failure

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 45 Years

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

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

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

Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: randomized controlled
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: quadratus lumborum-2<br> | Procedure: ultrasound guıded quadratus lumborum block<br>* Administering local aneshtetic agent with a block needle using the in-plane technique, bilaterally. Lumbar interfascial triangle, where the middle lumbar fascia joins the deep lamina of the posterior layer on the lateral border of the erector spinae was targeted as the optimal point of injection.<br>|
| Active Comparator: quadratus lumborum-3<br> | Procedure: ultrasound guıded quadratus lumborum block<br>* Administering local aneshtetic agent with a block needle using the in-plane technique, bilaterally. Lumbar interfascial triangle, where the middle lumbar fascia joins the deep lamina of the posterior layer on the lateral border of the erector spinae was targeted as the optimal point of injection.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Assesment of postoperative pain | measure of the visual analog scale at rest and dynamic after surgery | during 24 hour after surgery | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| need of analgesic | total number of PCA demands | during 24 hour after surgery |
Lifestyle and Dietary Pattern in Relation to Precursor Lesions of Colorectal Cancer

Study Overview
=================
Brief Summary
-----------------
The association between lifestyle and dietary pattern with precursor lesions of colorectal cancer is still unclear. This study is conduced in Jinhua, a city with a high prevalence of colorectal cancer in China, to assess relations between precursor lesions of colorectal cancer and lifestyle and dietary factors.

Detailed Description
-----------------
Investigations of precursor lesions of colorectal cancer are limited and studies in China are still lacking. The investigators aim to collect basic characteristics of participants at baseline, including sex, age, smoking, exercise, marriage, education level, dietary factors and so on, to assess the associations between lifestyle and dietary pattern and precursor lesions of colorectal cancer. Results from this study will be valuable for colorectal cancer prevention in China.

Official Title
-----------------
Lifestyle and Dietary Pattern in Relation to Precursor Lesions of Colorectal Cancer Among Urban and Rural Residents in Lanxi, China

Conditions
-----------------
Polyps

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Subject aged ≥45 and ≤74 years old Subject has complete data on diet and follow-up time Exclusion Criteria: Colorectal cancer Severe intestines problems

Ages Eligible for Study
-----------------
Minimum Age: 45 Years
Maximum Age: 74 Years

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

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

Study Plan
=================
How is the study designed?
-----------------
What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Numbers of participants with polyps | All polyps | From entry into the study (baseline:2018-2022) until 2022 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Numbers of participants with different subtypes of polyps | Subtypes of polyps, including serrated polyps, hyperplastic polyps, sessile serrated polyps/adenoma | From entry into the study (baseline:2018-2022) until 2022 | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Dietary factors, Precursor lesions of colorectal cancer, Lifestyle, Polyps
Obtain Additional Information on Use of CorMatrix ECM (Extracellular Matrix)

Study Overview
=================
Brief Summary
-----------------
The objective of the study is to actively gather additional information on the use of CorMatrix ECM for pericardial reconstruction.

Detailed Description
-----------------
Up to 100 clinical sites will enroll subjects who have received CorMatrix ECM for pericardial reconstruction. The following clinical data will be collected at a single post-operative visit: Demographic information Pre-operative risk factors Surgical procedure Blood transfusion information, if applicable Chest tube placement information Surgical complications Use of anticoagulation medication Cardiac related procedures since surgical procedure Device related adverse events

Official Title
-----------------
A Post Market Observational Study to Obtain Additional Information on the Use of CorMatrix ECM for Pericardial Reconstruction

Conditions
-----------------
Coronary Disease

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Subjects who have received CorMatrix ECM for pericardial reconstruction Sign an Informed Consent Exclusion Criteria: None
Sexes Eligible for Study
-----------------
All

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| CorMatrix ECM<br>Data collection for information on the use of CorMatrix ECM for pericardial reconstruction | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Proportion of Subjects With Device Related Adverse Events. | Data will be collected at the initial post-operative visit. This is a single visit study. | Post-op visit, after an average of 30 days | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Open heart surgery, cardiac repair
Identification of Null Allelic Variant of CYP2C8 In A Korean Population

Study Overview
=================
Brief Summary
-----------------
The genotype profile of CYP2C8 was analyzed in a Korean population. Frequency in multi-ethnic population and in vivo functionality of novel null allelic CYP2C8 variant were evaluated.

Detailed Description
-----------------
Whole blood samples from 50 unrelated Korean subjects were genotyped for 3kb of 5' upstream region, all exon-intron boundaries, exons, and UTR regions of CYP2C8 gene by direct sequencing. Genotyping of CYP2C8 has been addressed only for null allelic variant, CYP2C8*11 using pyrosequencing in the 447 Koreans, 93 African-Americans, 100 Caucasians, 348 Chineses and 100 Vietnameses. Then, in-vivo single PK study of CYP2C8 probe, rosiglitazone(4mg), was conducted in 7 healthy subjects with CYP2C8*1/*1 and 2 with CY2C8*1/*11.

Official Title
-----------------
The Effect of CYP2C8 E274Q, a Novel 23452 G>T SNP, on the Disposition of Rosiglitazone in Healthy Subjects: The Genetic Polymorphisms of CYP2C8 in a Korean Population

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

Intervention / Treatment
-----------------
* Drug: Rosiglitazone
* Genetic: CYP2C8 genotype


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Healthy volunteer Exclusion Criteria: Medical problems in taking probe drug

Ages Eligible for Study
-----------------
Minimum Age: 20 Years
Maximum Age: 65 Years

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

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

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

Design Details

Primary Purpose: Basic Science
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: rosiglitazone<br>avandia | Drug: Rosiglitazone<br>* single oral administration of 4mg of rosiglitazone<br>* Other names: Avandia;Genetic: CYP2C8 genotype<br>* CYP2C8*11.<br>* Other names: avandia;|
| Active Comparator: genetic polymorphism<br>avandia CYP2C8 genotype | Drug: Rosiglitazone<br>* single oral administration of 4mg of rosiglitazone<br>* Other names: Avandia;Genetic: CYP2C8 genotype<br>* CYP2C8*11.<br>* Other names: avandia;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| AUC | 0h,0.33h,0.66h,1h,1.5h,2h,3h,4h,6h,8h,12h,24h | 12hr | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Cmax | 0h,0.33h,0.66h,1h,1.5h,2h,3h,4h,6h,8h,12h,24h | 12hr | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
CYP2C8, genetic polymorphism, rosiglitazone, Korean