linjc16/ctgov huggingface dataset:
Prevalence of Eosinophilic Esophagitis in Children With Celiac Disease

Study Overview
=================
Brief Summary
-----------------
Celiac disease (CD) and eosinophilic esophagitis (EE) are distinct diseases of the gastrointestinal tract with specific clinico-pathological characteristics. In recent years, in the literature, several children who underwent upper gastrointestinal endoscopy for suspected CD, which was confirmed histologically, were also found to have coexistent EE. There are reports of coexistent CD and EE. We would like to see the prevalence of EE in children with CD and the prevalence of CD in children with EE in our population, and to do so would like to review medical records. Our objectives are to determine if children with celiac disease have a high prevalence of eosinophilic esophagitis.and to determine if children with eosinophilic esophagitis have increased risk of developing celiac disease.

Official Title
-----------------
Prevalence of Eosinophilic Esophagitis in Children With Celiac Disease and Prevalence of Celiac Disease in Children With Eosinophilic Esophagitis in a Tertiary Community Hospital

Conditions
-----------------
Celiac Disease, Eosinophilic Esophagitis

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Seen in the Pediatric Gastroenterology clinic at St. John Hospital & Medical Center during study time frame Age 2-21 years old Diagnosed with CD or EE or both based on the endoscopic and histopathological findings . Exclusion Criteria: Gastroesophageal reflux diagnosed by PH probe. History of chemical ingestion

Ages Eligible for Study
-----------------
Minimum Age: 2 Years
Maximum Age: 21 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 |
| --- | --- | --- |
| Review of histopathology reports of esophageal biopsies to record the number of eosinophils per high power field. |  | Retrospective chart review study, no contact made with patients, so no patient time is required, expected average of 2 years |
Oxycodone-naloxone in Relieving Opioid-related Constipation

Study Overview
=================
Brief Summary
-----------------
The primary objective of this study is to demonstrate that subjects with moderate to severe non-malignant pain taking oxycodone/naloxone prolonged release tablets have improvement in symptoms of constipation compared to subjects taking oxycodone prolonged release tablets alone.

Detailed Description
-----------------
Patients with a documented history of moderate to severe non-malignant pain that require around the clock opioid therapy will be randomised to an oxycodone or an oxycodone-naloxone treatment arm to assess the safety and efficacy of oxycodone/naloxone prolonged release compared to oxycodone prolonged-release in relieving opioid-related constipation.

Official Title
-----------------
A Randomised, Double-blind, Parallel-group, Multicentre Study to Demonstrate Improvement in Symptoms of Constipation in Subjects With Non-malignant Pain Taking Oxycodone Equivalent of >20 mg/Day and <50 mg/Day as Oxycodone/Naloxone Prolonged Release Compared to Subjects Taking Oxycodone Prolonged Release Tablets Alone.

Conditions
-----------------
Pain

Intervention / Treatment
-----------------
* Drug: Oxycodone nalaxone prolonged release tablets (OXN)


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Male or female subjects at lest 18 years or older with pain. Subjects must report constipation caused or aggravated by opioids. Exclusion Criteria: Females who are pregnant or lactating. Subjects with evidence of significant structural abnormalities of the gastrointestinal (GI) tract (e.g. bowel obstruction, strictures).

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: Quadruple


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: Oxycodone nalaxone prolonged release tablets (OXN)|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To demonstrate that subjects with moderate to severe non-malignant pain taking oxycodone/naloxone prolonged release tablets have improvement in symptoms of constipation compared to subjects taking oxycodone prolonged release tablets. |  | 12 weeks with a 6 month open label extension | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
A randomised, double blind, parallel group, multicentre study to demonstrate improvement in symptoms of constipation in subjects with non malignant pain, Moderate to severe chronic non-malignant pain
A Single and Low Dose of Recombinant Factor VIIa in Patients With Severe Factor XI Deficiency Undergoing Surgery

Study Overview
=================
Brief Summary
-----------------
Lately the investigators found that patients with severe factor XI deficiency and inhibitors could undergo major surgery with a single low dose of recombinant factor VIIa and tranexamic agent. These results encourage us to apply this treatment in clinical trial setting to patients with severe factor XI deficiency undergoing surgery instead of blood product.

Detailed Description
-----------------
Eligible patients will be those with severe factor XI deficiency who agree to participate in the study . The treatment does not apply to patients requiring coronary artery bypass or other vascular surgery.

Conditions
-----------------
Hemophilia C

Intervention / Treatment
-----------------
* Drug: recombinant factor VIIa


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: patients with severe factor XI deficiency who will give informed consent to participate in the study Exclusion Criteria: patients with atherosclerosis disease i.e. unstable angina pectoris or recent stroke Patients who required aorto-coronary bypass or any vascular surgery

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 70 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

| Intervention/Treatment |
| --- |
|Drug: recombinant factor VIIa|single dose of 20ug/kg of recombinant factor VIIa along with tranexamic acid of 4 gram a day for 7 days following surgery|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Improvement in prophylactic treatment by using single and low dose recombinant FVIIa in patients with severe FXI deficiency | End point to be assessed the degree of bleeding following major operation under rFVIIa | 1 week | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
recombinant factor VIIa, factor XI deficiency
South China Prospective Cohort Study of Chronic Disease

Study Overview
=================
Brief Summary
-----------------
To investigate the risk factors and prediction biomarkers of chronic disease in adults aged 35-74 years.

Detailed Description
-----------------
To investigate the risk factors and prediction biomarkers of chronic disease within adults aged 35-74 years in South China. Following up the incidence of major chronic disease including stroke, coronary heart disease, cancer, chronic obstructive pulmonary disease, diabetes and hypertension.

Official Title
-----------------
South China Prospective Cohort Study of Chronic Disease

Conditions
-----------------
Chronic Disease

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: aged 35-74 years local residents or lived in local for 5 years more Exclusion Criteria: Malignancy Cognitive impairment that can not cooperate with investigation

Ages Eligible for Study
-----------------
Minimum Age: 35 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 |
| --- | --- | --- |
| Incidence of chronic disease | Incidence of chronic disease, including stroke, coronary heart disease, cancer, chronic obstructive pulmonary disease, diabetes and hypertension | 4 years or more | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Outcome of chronic disease | Outcome and development of chronic disease | 4 years or more | 
| Death | Death caused by chronic disease | 4 years or more | 
| Incidence of other disease | Incidence of other disease,including hyperuricaemia,fatty liver disease and so on | 4 years or more |
FMT in the Treatment of IBS

Study Overview
=================
Brief Summary
-----------------
52 adult IBS patients were recruited. 50% were given a fecal microbiota transplantation in colonoscopy and 50% were given an FMT made of their own feces as placebo. follow up time was 1 year after FMT.

Detailed Description
-----------------
52 adult IBS patients of any subgroup(IBS-D, IBS-C or IBS-M), were recruited and given an FMT in colonoscopy. Neither the patient nor the care taking personnel did know in which group the patients belonged to. The patients were screened with fecal samples for 16RNA sequencing and they were repeatedly done IBS-SSS questionnaire and questionnaires for quality of life and psychical condition. Follow up time was 1 year after the colonoscopy.

Official Title
-----------------
FECAL MICROBIOTA TRANSPLANTATION IN THE TREATMENT OF IRRITABLE BOWEL SYNDROME

Conditions
-----------------
Irritable Bowel Syndrome

Intervention / Treatment
-----------------
* Other: Fecal Microbiota Transplantation (FMT)
* Other: Placebo


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Diagnosis of IBS based on Rome III criteria Having received traditional treatment for at least 1 month Availability of consecutive fecal samples over one year. Compliance to attend ileocolonoscopy and FMT procedure. 18-75 years Exclusion Criteria: Unable to provide informed consent Antibiotic therapy in past 3 months Inflammatory bowel disease (IBD)

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

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Placebo controlled trial. 50% of patients received autologous FMT as placebo and 50% received FMT from a healthy donor.
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: FMT<br>IBS patients randomized to receive FMT from a healthy donor. | Other: Fecal Microbiota Transplantation (FMT)<br>* Fecal suspension administered in colonoscopy into the cecum of the patient.<br>|
| Placebo Comparator: Placebo<br>IBS patients randomized to receive autologous FMT (fecal suspension made of their own feces) as a placebo. | Other: Placebo<br>* As a placebo a fecal suspension made of patients own feces is administered into the cecum of the patient in colonoscopy.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| IBS symptom relieve | Reduction IBS-SSS by 50 points, The irritable bowel severity score system in which the maximum achievable score is 500. Mild, moderate and severe cases are indicated by scores of 75 to 175, 175 to 300 and > 300.( Aliment Pharmacol Ther. 1997 Apr;11(2):395-402.) | 52 weeks |
PictureRx: An Intervention to Reduce Latino Health Disparities

Study Overview
=================
Brief Summary
-----------------
The purpose of this randomized controlled trial is to evaluate the effect of Spanish-language illustrated medication instructions (PictureRx cards), compared to traditional medication instructions, on Latinos' understanding of their medication regimens. The study will also assess the effect on self-reported medication adherence. Patients with diabetes who attend participating clinics are eligible. The target sample size is 200.

Official Title
-----------------
PictureRx: An Intervention to Reduce Latino Health Disparities

Conditions
-----------------
Medication Adherence, Diabetes

Intervention / Treatment
-----------------
* Behavioral: PictureRx card


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Diabetes Latino, Spanish speaker Be at least 18 years old Must be taking at least 1 chronic medication Exclusion Criteria: Too ill to participate in an interview Do not have a telephone Having visual acuity worse than 20/50 via Rosenbaum Visual Acuity exam (eyechart) Inability to communicate in either Spanish or English Overt psychiatric illnesses, overt delirium or dementia

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: Health Services Research
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: PictureRx cards<br>Illustrated format of medication instructions that includes pictures of pills and icons to show their purpose | Behavioral: PictureRx card<br>* An illustrated format of medication instructions that includes pictures of the medications and icons to illustrate their purpose<br>|
| No Intervention: Control<br>Usual care | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Patient Understanding of their Medication Regimen | The primary outcome will be patients' understanding of their medication regimen, as assessed by an interviewer-administered questionnaire. | Approximately 1 week after enrollment | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Self-reported Adherence | As a secondary outcome, patients will report their self-reported adherence using a validated instrument. | Approximately 1 week after enrollment | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
PictureRx, Health Literacy, Limited English Proficiency, Latinos, Spanish
MRI in Assessing Tumor Size in Women With Ductal Carcinoma In Situ

Study Overview
=================
Brief Summary
-----------------
RATIONALE: Diagnostic procedures, such as MRI, may help find ductal carcinoma in situ and find out how far the disease has spread. PURPOSE: This clinical trial is studying how well MRI works in assessing tumor size in women with ductal carcinoma in situ.

Detailed Description
-----------------
OBJECTIVES: Primary Assess the contribution of MRI in accurately determining tumor size in women with ductal breast carcinoma in situ (DCIS). Secondary Evaluate the sensitivity of MRI in detecting DCIS. Evaluate the contribution of mammography in accurately determining tumor size. Compare the contribution of MRI vs mammography in assessing tumor extension. Compare the contribution of MRI vs mammography in assessing dense breasts. Evaluate the morphology of DCIS by MRI. Evaluate the curve of dynamic MRI in assessing DCIS. Evaluate the impact of nuclear grade of DCIS by MRI. Evaluate the rate of revision surgery. OUTLINE: Patients undergo clinical examination, mammography, ultrasound imaging, unilateral breast MRI, and tissue sampling.

Official Title
-----------------
Ductal Carcinoma in Situ: Protocol Evaluating the Assessment of Extension of Disease by MRI

Conditions
-----------------
Breast Cancer

Intervention / Treatment
-----------------
* Procedure: magnetic resonance imaging
* Procedure: radiomammography
* Procedure: ultrasound imaging


Participation Criteria
=================
Eligibility Criteria
-----------------
DISEASE CHARACTERISTICS: Diagnosis of ductal breast carcinoma in situ Any grade disease allowed Unifocal disease by mammography No history of breast cancer Hormone receptor status not specified PATIENT CHARACTERISTICS: Menopausal status not specified WHO performance status 0-2 Glomerular filtration rate ≥ 30 mL/min Not pregnant or nursing Fertile patients must use effective contraception No allergy or contraindication to contrast MRI No pacemaker or vascular clip PRIOR CONCURRENT THERAPY: No prior or concurrent liver transplantation

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

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

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

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

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: MRI<br> | Procedure: magnetic resonance imaging<br> <br> Procedure: radiomammography<br> <br> Procedure: ultrasound imaging<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Correlation of tumor extension by MRI with surgical histology |  | up to 1 year | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
ductal breast carcinoma in situ
Perfusion Index in the Success of Peripheral Nerve Block

Study Overview
=================
Brief Summary
-----------------
After a successful peripheral nerve block, blockade of sympathetic nerve fibers results in local vasodilatation, increased local blood flow, and increased skin temperature.Increased permeability index; Can be used as a reliable tool for evaluating block activity.

Official Title
-----------------
Evaluation of Perfusion Index in the Success of Peripheral Nerve Block in Advanced Age Patients

Conditions
-----------------
Perfusion Index, Peripheral Nerve Block Success

Intervention / Treatment
-----------------
* Device: perfusion index


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Over 65 years old ASA I-III Exclusion Criteria: Patients under 65 years old Patients contraindicated in regional anesthesia Patients with local anesthetic allergy Patients with injection site infection Patients who do not accept the procedure

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

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

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

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

Arms and Interventions

| Intervention/Treatment |
| --- |
|Device: perfusion index|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| patient's perfusion index |  | nine month | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Perfusion index, Peripheral nerve block success, older age
A Study of Genetic Variation Influencing Pain and Response to Opioid Medications

Study Overview
=================
Brief Summary
-----------------
The investigators will be collecting saliva DNA samples from chronic back pain patients. The investigators hope to find candidate genes associated with response to opioid medication by correlating molecular genetics data with pain measurement and opioid responsiveness data including opioid hyperalgesia and opioid analgesic tolerance.

Detailed Description
-----------------
The investigators hope to find a genetic association with various physiologic responses to opioid medication in patients who suffer from chronic pain (e.g. OIH vs. analgesic tolerance, baseline pain sensitivity, etc.). This has never been done before, and if it proves successful, it could provide physicians a greater understanding of why some chronic opioid users continue needing increased doses of opioids. This data may also help predict which patients will do well with chronic opioid therapy and which ones may not. Initial data with OPRM1 gene analysis in humans already implicates certain SNPs with opioid responsiveness and there have been suggestions for screening patients for OPRM1 prior to initiating opioid therapy in order to optimize their treatment response (Reynolds et al., 2008). Clin Lab Med. 2008 Dec;28(4):581-98. The value of CYP2D6 and OPRM1 pharmacogenetic testing for opioid therapy. Reynolds KK, Ramey-Hartung B, Jortani SA.

Official Title
-----------------
A Study of Genetic Variation Influencing Pain and Response to Opioid Medications in Patients With Chronic Pain

Conditions
-----------------
Pain

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Adult patient, aged 18-71 Recipient of chronic opioid therapy Patient is able to produce a saliva sample If a past study participant, patient will have agreed to be contacted for future studies. Exclusion Criteria: a. not meeting inclusion criteria

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 71 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 |
| --- | --- | --- |
| Genetic association with various physiologic responses to opioid medication in patients |  | Up to 5 years | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Chronic Pain, Genetic Variation, Opioid Medications, Pain