linjc16/ctgov huggingface dataset:
Caustic Esophageal Burns in Children and High Doses of Methylprednisolone

Study Overview
=================
Brief Summary
-----------------
Corrosive substance ingestion in childhood is a public health issue in developing countries and several management protocols were proposed to prevent esophageal strictures. The role of corticosteroids in preventing corrosive-induced strictures is controversial. The investigators' aim is to study the influence of high doses of corticosteroids to prevent esophageal strictures.

Official Title
-----------------
High Doses of Methylprednisolone in the Management of Caustic Esophageal Burns in Children

Conditions
-----------------
Esophageal Diseases

Intervention / Treatment
-----------------
* Drug: methylprednisolon


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: -Corrosive substance ingested children with grade IIb esophageal burn Exclusion Criteria: Caustic substance ingested chldren grade I, IIa and grade III esophageal burns Caustic subtance ingested children with signs of perforation, mediastinitis, peritonitis, sespis Caustic substance ingested children with any chronic disease

Ages Eligible for Study
-----------------
Minimum Age: 12 Months
Maximum Age: 17 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: Single Group Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| No Intervention: Methylprednisolone, caustic burns<br> | Drug: methylprednisolon<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Evaluation of stricture development in children with caustic esophageal burns after high doses of methylprednisolone | stricture development was evaluated with endoscopic examination and upper gastrointestinal system series with barium swallow | three years | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
caustic, corticosteroid therapy, stricture, children
Expression of Toll-like Receptors 3 , 7 and 9 in Peripheral Blood Mononuclear Cells of COVID-19 Patients

Study Overview
=================
Brief Summary
-----------------
The aim of the study is to assess the expression of TLR 3, 7, and 9 in the population of peripheral blood mononuclear cells (PBMC) and in B lymphocytes (CD19+), T lymphocytes (CD4+ and CD8+) using flow cytometry in relation to the clinical parameters and outcome of COVID 19 patients .

Detailed Description
-----------------
Abnormal stimulation of innate immunity may have a great influence on the immunopathogenesis of COVID 19 disease .The involvement of innate immunity receptors-toll-like receptors (TLR)-in the pathogenesis of COVID 19 is not adequately studied. The activation of these receptors by specific ligands is thought to initiate autoimmune processes[1]. TLR stimulation leads to increased expression of proinflammatory cytokines (IL-6, IFN

Official Title
-----------------
Expression of Toll-like Receptors 3 , 7 and 9 in Peripheral Blood Mononuclear Cells of COVID-19 Patients

Conditions
-----------------
COVID-19 Respiratory Infection

Intervention / Treatment
-----------------
* Procedure: blood sample


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients ≥18 years old of both genders. Patients diagnosed as confirmed COVID-19 when they have a positive result of RT-PCR for SARS-CoV-2 RNA or confirmed diagnosis by typical clinical picture and radiological methods , according to the WHO and Egyptian Ministry of Health and Population (MOH) definitions, at Assiut University Hospital. Exclusion Criteria: Children less than 18 years. Patients refusal to participate in the study

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 100 Years

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

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

Arms and Interventions

| Intervention/Treatment |
| --- |
|Procedure: blood sample|5 cm blood sample from COVID-19 patients|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Cytokines storm occurrence in COVID-19 patients | To assess whether the expression of toll-like receptors 3,7 and 9 in peripheral blood mononuclear cells related to the clinical status of COVID-19 patients and probability of cytokines storm occurrence | Baseline |
A New Adaptive Feeding Plan for Newborns

Study Overview
=================
Brief Summary
-----------------
The purpose of this clinical trial is to identify the infant formula(s) for which the investigators get the closest gut maturation index compared to the one they get with breastfed babies.

Official Title
-----------------
A New Adaptive Feeding Plan for Newborns: Effects on Gut Maturity and Gut Microbiota

Conditions
-----------------
Infant Nutrition

Intervention / Treatment
-----------------
* Other: BSF
* Other: BSF + Lactoferrin + Probiotics
* Other: BSF + Lactoferrin + Probiotics + OS


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Healthy newborn infant Full term infant (≥ 37 weeks gestation; < 42 weeks gestation) Birth weight from 2500g to 4500g For the formula-fed groups: babies whose mothers elected not to breastfeed at all For the breastfed group: babies whose mothers elected to exclusively breastfeed for at least 2 months Newborn whose parents / caregivers can be expected to comply with the protocol Study explained and written information given Informed consent signed Exclusion Criteria: Mother who had antibiotics in the 7 days preceding delivery Caesarian section Multiple birth Congenital illness or malformation that may affect normal growth Significant pre-natal and/or post-natal disease Newborn participating in another clinical trial

Ages Eligible for Study
-----------------
Minimum Age: 1 Day
Maximum Age: 3 Days

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

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

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

Design Details

Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| No Intervention: Breastfeeding (Reference)<br> | |
| Active Comparator: Basic starter formula: BSF<br> | Other: BSF<br>* feeding amount according to individual baby need<br>|
| Experimental: BSF + Lactoferrin + Probiotics + OS<br> | Other: BSF + Lactoferrin + Probiotics + OS<br>* feeding amount according to individual baby need<br>|
| Experimental: BSF + Lactoferrin + Probiotics<br> | Other: BSF + Lactoferrin + Probiotics<br>* feeding amount according to individual baby need<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| gut maturation : Specific proteins in stools |  | 3rd day, at 1 week, 2 weeks and 1 month of age | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Growth and gut microbiota |  | At 1 month and 2 months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Infant Formula, Gut
Cone Beam CT for Diagnosis of Select Otorhinolaryngology (ENT) Indications at Lower Dose

Study Overview
=================
Brief Summary
-----------------
The study objective is to compare the CBCT images generated by the CS 9300 to those generated by conventional CT.

Detailed Description
-----------------
The study objective is to compare the CBCT images generated by the CS 9300 to those generated by conventional CT. It proposes a direct comparison of diagnostic image quality between the CS 9300 and CT for the ability to view and confirm ENT disorders.

Official Title
-----------------
Cone Beam CT (CS 9300) for Diagnosis of Select Otorhinolaryngology (ENT) Indications at Lower Dose

Conditions
-----------------
CerebroSpinal Fluid (CSF) Leak, Chronic Otitis Media, Otospongiosis, Otosclerosis, Pulsatile Tinnitus, Cholesteatoma

Intervention / Treatment
-----------------
* Radiation: Radiation


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Subject must be 18-80 years of age Subjects has provided informed consent Subjects must present with symptoms and/or pathology of the sinus or temporal bone region. Subject scheduled for additional radiological follow-up and/or endoscopy/surgery. CBCT exam performed within a maximum of 2 days of the conventional CT. Exclusion Criteria: Subjects under the age of 18 years, or over the age of 80 years Unable to collect all required case information Subjects not willing to consent, or consent is withdrawn Women in pregnancy or suspected of being pregnant confirmed by pregnancy test

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 80 Years

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

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

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

Design Details

Primary Purpose: Diagnostic
Intervention Model: Single Group Assignment
Interventional Model Description: Predicate CT Scan and Investigational Cone Beam Scan
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: Investigational CBCT<br>Radiation | Radiation: Radiation<br>* Subjects to receive standard of care CT scan and additional Cone Beam CT scan.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percentage of Participants With >=3 Diagnostic Rating Using Radlex Scale | Percentage of Participants with >=3 Diagnostic Rating Using Radlex Scale. Five radiologists participated in reader study using Radlex scale below to analyze and rate participant images. They determined if they could make a medical diagnosis for ENT patients. Used Radlex Scale - 1-Non-diagnostic, Unacceptable for diagnostic purposes. 2-Limited Acceptable, with some technical defect. 3-Diagnostic, Image quality that would be expected routinely when imaging cooperative patients. 4-Exemplary, Good most adequate for diagnostic purposes. | 11 months |
Outcomes After Parastomal Hernia Repair

Study Overview
=================
Brief Summary
-----------------
The aim of the current study is to evaluate the overall outcomes after parastomal hernia repairs in Denmark from 2007-2017 using data from the Danish Hernia Database and Danish Patients Registry. Specifically, the readmission and reoperation rates will be evaluated.

Detailed Description
-----------------
The Danish Hernia Database covers about 80% of all ventral hernia repairs performed in Denmark. Data on size of hernia, type of surgery, type of mesh and fixation method is available from the Danish Hernia Database. All healthcare services in Denmark are registered in the Danish National Patients Registry and data on 30-day readmission rate, readmission diagnosis and reoperation is found here. Each Danish citizen has a unique personal identification number and by merging data from the Danish Hernia Database and National Patients Registry, nationwide data on parastomal hernia repairs is available. The aim of the current study is to evaluate the overall outcomes after parastomal hernia repairs in Denmark from 2007-2017 focusing on readmission and reoperation rates.

Official Title
-----------------
Outcomes After Parastomal Hernia Repair

Conditions
-----------------
Parastomal Hernia

Intervention / Treatment
-----------------
* Procedure: Complication


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: All patients undergoing parastomal hernia repair in Denmark from 2007-2017 Exclusion Criteria: If data is not fully registered in the Danish Hernia Database

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 |
| --- | --- |
| Parastomal hernia<br>Patients undergoing parastomal hernia repair in Denmark between 2007 and 2017 | Procedure: Complication<br>* Readmission, reoperation<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Reoperation | Number of patients re-operated for a complication after a parastomal hernia repair | 30 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Readmission | Number of patients readmitted after parastomal hernia repair | 90 days | 
| Recurrence | Number of patients operated for recurrence after a parastomal hernia repair | 10 years |
MK0457 (an Aurora Kinase Inhibitor) Study in Patients With Advanced Colorectal Cancer and Other Advanced Solid Tumors (0457-001)

Study Overview
=================
Brief Summary
-----------------
Study with an investigational drug in patients with recurrent or non-responsive colorectal cancer or other advanced solid tumors. This is an early phase trial and some specific protocol information is proprietary and not publicly available at this time. (Full information is available to trial participants).

Official Title
-----------------
A Phase I/IIa Study Evaluating the Safety/Tolerability, Pharmacokinetics, and Efficacy of MK0457 Administered as a 5-Day Continuous Infusion in Patients With Advanced Colorectal Cancer and Other Solid Tumors

Conditions
-----------------
Colorectal Cancer, Advanced Solid Tumors

Intervention / Treatment
-----------------
* Drug: MK0457, VX-680 (Aurora Kinase Inhibitor)


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: In Part I, patients who are at least 18 years of age with advanced solid tumors and colorectal cancer will be eligible for the first part of this study. Patient must have recovered from and be at least 3 weeks from previous cancer treatment. In Part II, only patients with colorectal cancer will be eligible to participate. The patients may have received up to 3 prior treatments for their colorectal cancer. Patients must have recovered from and be at least 3 weeks from previous therapy. Exclusion Criteria: Patients who have had treatment with any investigational drug within the past 30 days. Patients who have certain types of blood cancers such as leukemia or lymphoma. Patients who have uncontrolled congestive heart failure (CHF), chest pain, or heart attack within the past 3 months. Patient is pregnant or nursing.

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


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: MK0457, VX-680 (Aurora Kinase Inhibitor)|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
Hepatic Steatosis and Fibrosis in Rheumatoid Arthritis Patients

Study Overview
=================
Brief Summary
-----------------
studying the prevalence of hepatic steatosis and fibrosis in a large scale of patients with RA and healthy controls

Official Title
-----------------
Evaluation of Hepatic Steatosis and Fibrosis in Rheumatoid Arthritis Patients: a Cross-sectional Case-control Study

Conditions
-----------------
Hepatic Steatosis and Fibrosis in Rheumatoid Arthritis Patients

Intervention / Treatment
-----------------
* Diagnostic Test: ultrasonography


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: RA according to the American College of Rheumatology (ACR)/EULAR 2010 criteria (Aletaha et al., 2010) Age≥18 years Exclusion Criteria: History of hepatitis B and C virus infection. Receiving hepatotoxic drugs other than RA-specific drugs. Alcohol abuse (i30 g/day in men and ⩾20 g/day in women). Diagnosis of Wilson's disease, α1-antitrypsin deficiency or hemochromatosis. Autoimmune liver disease. Cancer. Pregnancy.

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 |
| --- | --- |
| Rheumatoid arthritis patients<br> | Diagnostic Test: ultrasonography<br>* studying degree of steatosis<br>|
| control<br> | Diagnostic Test: ultrasonography<br>* studying degree of steatosis<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| degree of hepatic steatosis | degree of hepatic steatosis by ultrasonography and Hepatic Steatosis Index. | 1 day during examination | 
| degree of hepatic fibrosis | degree of hepatic fibrosis by FIB-4 and APRI tests | 1 day during examination | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
hepatic steatosis, rheumatoid arthritis
Validation of Sodergren Score for Haemorrhoids in Malaysia

Study Overview
=================
Brief Summary
-----------------
To validate the ability of the Sodergren score in guiding the management of symptomatic haemorrhoids in a Malaysian population.

Detailed Description
-----------------
All participating, consented subjects will be scored with the Sodergren score prior to receiving a standardized ambulatory treatment regime. The questionnaire will be self-administered by the subjects. Subjects whom are not able to self-administer the questionnaire will be assisted by the investigator or research assistant. The nature and severity of the subject's haemorrhoidal symptoms are considered as the pre-treatment baseline. A follow up period of 12 months will be carried out post treatment for failure or success of treatment. The data collected will be compared to pre-treatment scores and analyzed statistically.

Official Title
-----------------
Validating the Ability of the Sodergren Score to Guide Management of Symptomatic Haemorrhoids in a Malaysian Population

Conditions
-----------------
Hemorrhoids

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: 18 years of age and older Male and female genders Previous ambulatory treatment Internal Haemorrhoids Exclusion Criteria: Presence of external haemorrhoids Prior haemorrhoidal surgery Anti-coagulant therapy Anal fissure Inflammatory bowel disease Underlying colon-rectal malignancy

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 |
| --- | --- |
| Symptomatic Hemorrhoid<br>Consecutive patients with symptomatic hemorrhoids presenting to our clinic | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Method of treatment | Surgery or ambulatory treatment of hemorrhoid | 12 months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Hemorrhoids, Sodergren score, Validation
A Prospective Evaluation of Clinical Equivalence Between iX and PID

Study Overview
=================
Brief Summary
-----------------
Patients with chronic wounds will be imaged using 2 imaging devices. Two types of images will be acquired with each device, a standard photograph (ST-image) and a fluorescence image (FL-image). The images captured with the 2 imaging devices will be compared off-line by many interpreters to assess for any differences in the images that would alter a clinical decision.

Detailed Description
-----------------
Patients (n = 50) with chronic wounds will be imaged using 2 imaging devices. Two types of images will be acquired with each device, as standard photograph (ST-image) and a fluorescence image (FL-image). The images captured with the 2 imaging devices will be compared off-line by many interpreters to assess for any differences in the images that would alter a clinical decision.

Official Title
-----------------
A Prospective Evaluation of Clinical Equivalence Between i:X and PID

Conditions
-----------------
Wound

Intervention / Treatment
-----------------
* Device: MolecuLight PID


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Male and female subjects presenting at an advanced outpatient wound care clinic with wound(s) of unknown infection status 18 years of age or older Exclusion Criteria: Treatment with an investigational drug within 1 month before study enrollment Subjects with recent (<30 days) biopsy or curettage of target wound Subjects with wounds that cannot be completely imaged by study device due to anatomic location Unable or unwilling to consent

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

| Intervention/Treatment |
| --- |
|Device: MolecuLight PID|Hand-held, real-time fluorescence imaging device|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Concordance | The inter-reader concordance of the iX and PID FL-images together is not less than the inter-reader concordance of the iX FL-images alone. | 2 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Sensitivity and Specificity | Sensitivity and specificity for detection of moderate/heavy bacterial load of PID FL-images to be equal to or greater than that of i:X FL-images when validated by microbiology gold truth | 2 months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Wound, Imaging