linjc16/ctgov huggingface dataset:
Methotrexate Polyglutamate Measurements in Patients With Inflammatory Bowel Disease

Study Overview
=================
Brief Summary
-----------------
There are currently no serum levels to help guide appropriate methotrexate therapy. Data from this study will assess the correlation between dosing and whole blood methotrexate(MTX) polyglutamate measurements in children and adolescents with IBD.

Detailed Description
-----------------
This is a cross-sectional study design. Subjects will be requested to provide one blood sample to be collected during the conduct of their routine clinical care. Data related to the diagnosis and interval assessment of enrolled subjects will also be collected.

Official Title
-----------------
Methotrexate Polyglutamate Measurements in Patients With Inflammatory Bowel Disease

Conditions
-----------------
IBD

Intervention / Treatment
-----------------
* Diagnostic Test: MTX Assessment


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: IBD Methotrexate Therapy Exclusion Criteria: Inability to provide relevant samples

Ages Eligible for Study
-----------------
Minimum Age: 1 Year
Maximum Age: 21 Years

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

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

Arms and Interventions

| Intervention/Treatment |
| --- |
|Diagnostic Test: MTX Assessment|Measurement of Methotrexate Polyglutamate levels.|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Methotrexate Polyglutamate Level | Measurement of Methotrexate Polyglutamate Levels | Samples will collected within 16 weeks of consent. | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The correlation between Methotrexate Polyglutamate Levels and Lab Parameters | Compare the relationship between Methotrexate Polyglutamage levels and ESR,CRP, Hemoglobin, and Albumin | Samples will collected within 16 weeks of consent. | 
| The correlation between Methotrexate Polyglutamate Levels and Clinical History | Do Methotrexate Polyglutamate Levels Predict Clinical Outcome as Measured by Disease Activity Indices, including PUCAI for ulcerative colitis and PCDAI for patients with Crohn Disease | Samples will collected within 16 weeks of consent. |
Cancer Predictive Score on Breast MRI

Study Overview
=================
Brief Summary
-----------------
Sometimes, breast ultrasound and mammographic can't be diagnose suspsious lesions ( no substratum). So a MRI-guided breast biopsy is perfomed and disclosed ultimately benign lesions. The aim of this retrospective study is to establish a predictive MRI score of occult breast lesions by mammography and ultrasound.

Official Title
-----------------
Malignity Predictive Factors on Breast MRI With Ultrasound and Mammography Occult Lesions

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

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion criteria: women aged 18 and more performed MRI-guided breast biopsy Exclusion criteria: - Not MRI-guided breast biopsy

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

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

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 |
| --- | --- | --- |
| Number of participants with MRI characteristics of breast lesions | MRI characteristics of breast lesions : shape, contours, size, enhancement, perileeal edema, enhancement curve | 1 day | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| predictive score for the benignity of lesions seen on MRI | predictive score for the benignity of lesions seen on MRI (and not on mammography and ultrasound) with the criteria which will emerge after multivariate analysis and which will be weighted . score out of 10, with 3 to 5 criteria rated from 0 to 2. 10 would be in favor of benignity and 0 in favor of malignancy. | 1 day | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Women imaging, Diagnostic Imaging, Magnetic Resonance Imaging, Breast biopsy, Breast cancer detection, predictive factors, Radiology, Breast lesion diagnosis
Pathological Characteristics of Basal Cell Carcinoma

Study Overview
=================
Brief Summary
-----------------
A hospital based cross-sectional study was conducted from 2017 to February 2021. Clinical history, examination and histopathological variants were collected from medical files and pathology reports. Confirmation of pathology was done in all the patients visiting skin and plastic surgery department with suspected lesions.

Detailed Description
-----------------
Some cases may be tested for immunohistochemistry on the tissue block

Official Title
-----------------
Basal Cell Carcinomas on Sun-protected Versus Sun-exposed Body Sites: a Clinicopathological Descriptive Study

Conditions
-----------------
Dermatological Tumors

Intervention / Treatment
-----------------
* Procedure: Excision


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Excised lesion Confirmed basal cell carcinoma pathologically Exclusion Criteria: Incision biopsy Incomplete follow up

Ages Eligible for Study
-----------------
Minimum Age: 10 Years
Maximum Age: 100 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 |
| --- | --- |
| sun-protected<br>All patients with basal cell carcinoma in a sun protected body site | Procedure: Excision<br>* Surgical excision of the lesion and histopathology evaluation using Hematoxylin and Eosin stains<br>|
| sun-exposed<br>All patients with basal cell carcinoma in a sun exposed body site | Procedure: Excision<br>* Surgical excision of the lesion and histopathology evaluation using Hematoxylin and Eosin stains<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Healing | Complete removal of the lesion | 1 day | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Recurrence | Occurrence of recurrence | 1 year |
The Effects of Polyunsaturated Fatty Acids (PUFA) on Allergic/Atopic Dermatitis

Study Overview
=================
Brief Summary
-----------------
This clinical trial will study the effects of PUFA supplementation during pregnancy and lactation period on fatty acid composition in human milk and plasma of the mothers and the clinical outcome of atopic dermatitis in infants at increased risk.

Official Title
-----------------
The Effects of Polyunsaturated Fatty Acids on Allergic/Atopic Dermatitis

Conditions
-----------------
Atopic Dermatitis

Intervention / Treatment
-----------------
* Dietary Supplement: DHA+EPA
* Dietary Supplement: High Olive Oil
* Dietary Supplement: DHA


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Woman is pregnant between 16 and 20 weeks Mother delivers after 36 weeks Mother is willing to breast-feed for four months Mother has potential to deliver a child with increased risk of atopic dermatitis Signed Informed Consent Exclusion Criteria: Mother is smoking Disease with influence on breast feeding Complicated pregnancy Allergic to seafood Allergic to soy Allergic to marine fish Mother has more than two salmon or tuna meals per week Mother is undergoing treatment with anticoagulants
Sexes Eligible for Study
-----------------
Female

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 |
| --- | --- |
| Experimental: Docosahexaenoic Acid (DHA)<br>infants receiving capsule containing DHA. | Dietary Supplement: DHA<br> <br> |
| Other: High Olive Oil<br>infants receiving capsule without DHA and EPA. | Dietary Supplement: High Olive Oil<br> <br> |
| Experimental: DHA+EPA<br>infants receiving capsule containing DHA and EPA. | Dietary Supplement: DHA+EPA<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Lipid Analysis |  | Baseline, Delivery, Within one week after delivery, 6 weeks postpartum, 4 months postpartum | 
| Metabolomics Study of PUFA |  | Baseline, Delivery, Within one week after delivery, 6 weeks postpartum, 4 months postpartum, 12 months postpartum | 
| Skin Prick Test to Common Allergens |  | 4 months postpartum, 12 months postpartum | 
| Clinical Assessment of IgE-mediated Allergic Eczema |  | 4 months postpartum, 12 months postpartum | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Fatty Acid Desaturase (FADS) Genotypes |  | Baseline | 
| immunoglobulin E immunoglobulin E Immunoglobulin E (IgE) Antibodies |  | Baseline | 
| Immunological Biomarkers |  | 4 months postpartum, 12 months postpartum | 
| Medically-confirmed adverse events collected throughout the study period |  | 12 months postpartum |
Calculating of Correlations Between ADR, PDR, MAP

Study Overview
=================
Brief Summary
-----------------
The aim of our study is to compare MAP (mean adenoma per colonoscopy) with ADR (adenoma detection rate) and PDR (polyp detection rate) of all colonoscopists in our department

Detailed Description
-----------------
ADR (adenoma detection rate) is generally accepted quality indicator. For possible gaming with ADR other indicators are needed. MAP (mean adenoma per colonoscopy) reflects the quality of examination of entire colon and is considered to be the most objective quality indicator. The aim of our study is to compare MAP with ADR and PDR (polyp detection rate) of all colonoscopists in our department. We want to retrospectively assess the quality indicators of all colonoscopies from January 2013 to December 2017. We want to calculate ADR, PDR and MAP of all our endoscopists for all colonoscopies in patients over 50 years of age excluding therapeutic, IBD, management of complications and sigmoidoscopies (screening, surveillance, diagnostic) and separately only for screening colonoscopies. Correlations between MAP/ADR and MAP/PDR will be performed using Pearson´s correlation coefficient.

Official Title
-----------------
Calculating of Correlations Between ADR, PDR, MAP

Conditions
-----------------
Colon Neoplasm

Intervention / Treatment
-----------------
* Device: Colonoscopy


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: people over 50 years of age coming for colonoscopic examination (screening, surveillance, diagnostic) Exclusion Criteria: age under 50 years indication for colonoscopy: therapeutic, IBD, management of complications and sigmoidoscopies

Ages Eligible for Study
-----------------
Minimum Age: 50 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 |
| --- | --- |
| Patients after colonoscopy over 50 years<br>All colonoscopies in patients over 50 years of age (screening, surveillance, diagnostic) excluding therapeutic, IBD, management of complications and sigmoidoscopies | Device: Colonoscopy<br>* Endoscopic examination of large bowel<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| correlation between MAP and ADR for all and screening colonoscopies | Pearson´s correlation coefficient | january 2013 - december 2017 | 
| correlation between MAP and PDR for all and screening colonoscopies | Pearson´s correlation coefficient | january 2013 - december 2017 | 
| correlation between ADR and PDR for all and screening colonoscopies | Pearson´s correlation coefficient | january 2013 - december 2017 |
Comparison of Sirolimus Alone With Sirolimus Plus Tacrolimus in Type 1 Diabetic Recipients of Cultured Islet Cell Grafts

Study Overview
=================
Brief Summary
-----------------
Proof of concept study in islet transplantation, two treatment arms (ATG SIR-TAC versus ATG SIR) each consisting of ten type 1 diabetic patients

Official Title
-----------------
Comparison of Sirolimus Alone With Sirolimus Plus Tacrolimus in Type 1 Diabetic Recipients of Cultured Islet Cell Grafts

Conditions
-----------------
Islet Transplantation, Type 1 Diabetes

Intervention / Treatment
-----------------
* Drug: ATG-Sirolimus-Tacrolimus


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Type 1 insulin-dependent diabetic patients C-peptide < 0.15 nmol/l (<0.45 µg/l) 6 min. after glucagon IV (1mg) (glycemia > 180 mg/dl) diabetic nephropathy hypoglycaemic unawareness Exclusion Criteria: smoker before transplantation plasma creatinine > 2 mg/dl albuminuria >1000 mg/24 hrs abnormal liver function history of thrombosis or pulmonary embolism history of malignancy, tuberculosis or chronic viral hepatitis history of any other serious illness which could be relevant for the protocol HLA antibodies EBV antibody negative HIV 1 & 2 antibody positive

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 65 Years


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

Design Details

Allocation: Non-Randomized
Intervention Model: Factorial Assignment
Masking: None (Open Label)


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: ATG-Sirolimus-Tacrolimus|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
S9925: Collecting and Storing Samples From Patients With Lung Cancer

Study Overview
=================
Brief Summary
-----------------
RATIONALE: Collecting and storing samples of tissue, blood, and sputum from patients with cancer to study in the laboratory may help the study of cancer in the future. PURPOSE: The purpose of this study is to collect and store tissue, blood, and sputum samples from patients with lung cancer to be tested in the laboratory.

Detailed Description
-----------------
OBJECTIVES: Establish a central lung cancer specimen repository to serve as a resource for current and future scientific studies. Correlate clinicopathologic information in the Southwest Oncology Group clinical data base with results of studies using the repository. Test new hypotheses with the specimens in the repository. OUTLINE: Peripheral blood, sputum, and biopsy specimens are collected from patients. Tissue samples are frozen and stored in a lung cancer specimen repository for later use in correlative studies. PROJECTED ACCRUAL: Not specified

Official Title
-----------------
Lung Cancer Specimen Repository Protocol, Ancillary

Conditions
-----------------
Lung Cancer

Intervention / Treatment
-----------------
* Other: biologic sample preservation procedure


Participation Criteria
=================
Eligibility Criteria
-----------------
DISEASE CHARACTERISTICS: Enrolled on one of the following Southwest Oncology Group protocols: SWOG-8805, SWOG-9019, SWOG-9416, SWOG-9509, SWOG-S9900, SWOG-S0003, SWOG-S0023, SWOG-S0126, SWOG-S0435, SWOG-S0220, SWOG-S0222, SWOG-S0327, SWOG-S0310, SWOG-S0339, SWOG-S0342, SWOG-S0341, SWOG-S0509, SWOG-S0429, or SWOG-S0124 PATIENT CHARACTERISTICS: Not specified PRIOR CONCURRENT THERAPY: Not specified
Sexes Eligible for Study
-----------------
All

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

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

Arms and Interventions

| Intervention/Treatment |
| --- |
|Other: biologic sample preservation procedure|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Establishment of a central lung cancer specimen repository to serve as a resource for current and future scientific studies |  | From date of study activation to consolidation of specimen banks | 
| Correlation of clinicopathologic information in the Southwest Oncology Group clinical data base with results of studies using the repository |  | From date of study activation to consolidation of specimen banks | 
| Test of new hypotheses with the specimens in the repository |  | From date of study activation to consolidation of specimen banks | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
non-small cell lung cancer, small cell lung cancer
Parental Feeding Styles and Child Dietary Quality

Study Overview
=================
Brief Summary
-----------------
In this study, the investigators will use an existing data set to examine the relationship between parent feeding styles and the quality of the dinner meal using the Healthy Eating Index.

Detailed Description
-----------------
Investigators will use an existing data set collected between 2007 and 2009. The purpose of the larger data set including 177 families was to examine parent - child interactions during dinner meals in low-income Hispanic and African-American families participating in Head Start programs. Data was collected on parent-child interactions and information regarding the food served and consumed by children during dinner meals. The specific aims included: 1) examining the overall diet quality using the Healthy Eating Index of Head Start preschool dinner meals by parent feeding styles, an 2) the diet quality of the dinner meal served to that of the meal consumed and within each of the parent feeding styles.

Official Title
-----------------
Parental Feeding Styles and Child Dietary Quality at Dinner Among Low-income Minority Families

Conditions
-----------------
Dietary Quality

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Parents who were responsible for feeding the child while the child was not in Head Start and their oldest child enrolled in Head Start. Exclusion Criteria: Any children who have dietary restraints or food allergies.

Ages Eligible for Study
-----------------
Minimum Age: 3 Years
Maximum Age: 5 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 |
| --- | --- | --- |
| Dietary Quality | The Healthy Eating Index was used to obtain the quality of the food served and consumed by the child at dinner. | 10 minutes | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
parent feeding styles, dietary quality, dinner meal, preschool, low-income
Transdermally Delivered Human Insulin Product

Study Overview
=================
Brief Summary
-----------------
An Early Feasibility Study of a device formulation to deliver human insulin across intact skin

Detailed Description
-----------------
An attempt was made to formulate an insulin product that would complex human insulin in a stable anhydrous solution and when applied to the skin enable the uptake and release of insulin in a brittle T1D patient. A series of formulations were produced at varing dose strengths and in conjunction with injected insulin products, applied and serum glucose measured to ascertain response and optimize a fomrula to be submitted for IND approval.

Official Title
-----------------
A Comparison of Injected Insulin Replacement Therapy With A Novel Transdermally Delivered Human Insulin Product

Conditions
-----------------
Hypoinsulinemia

Intervention / Treatment
-----------------
* Combination Product: TD Insulin


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Brittle T1D patient with poor insulin sensitivity requiring more than 3,000 IUs on insulin a day Exclusion Criteria: High insulin sensitivity well managed serum glucose

Ages Eligible for Study
-----------------
Minimum Age: 60 Years
Maximum Age: 61 Years

Sexes Eligible for Study
-----------------
Male

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| TD Insulin Pilot<br>Test of novel transdermal insulin (TD Insulin) formulations | Combination Product: TD Insulin<br>* Human Insulin USP formulated in a solution capable of transdermal delivery.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Insulin response | Measurement of down modulation of serum glucose as measured by a standard blood glucose meter not otherwise attributable to injected insulin | 8-24 hours | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Insulin, needle-less, transdermal