linjc16/ctgov huggingface dataset:
Role of the Peritoneal Microenvironment in the Pathogenesis and Spread of Colorectal Carcinomatosis

Study Overview
=================
Brief Summary
-----------------
The goal of this project is to investigate the extent and role of mesothelial - mesenchymal transition (MMT) and cancer associated fibroblasts (CAFs) in the pathogenesis of colorectal peritoneal carcinomatosis (PC).

Official Title
-----------------
Role of the Peritoneal Microenvironment in the Pathogenesis and Spread of Colorectal Carcinomatosis

Conditions
-----------------
Peritoneal Carcinomatosis

Intervention / Treatment
-----------------
* Procedure: Sampling peritoneal tissue


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: • Patients presenting with colorectal peritoneal carcinomatosis Exclusion Criteria: Pregnancy or breast feeding Psychiatric pathology capable of affecting comprehension and judgment faculty HIPEC (hyperthermic intraperitoneal chemotherapy) or PIPAC (pressurized intraperitoneal aerosol chemotherapy) in the past Abdominal radiation treatment

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 |
| --- | --- |
| Cytoreductive surgery (CRS)<br>In patients presenting with colorectal peritoneal carcinomatosis, peritoneal tissue will be sampled during surgery at 4 different locations. | Procedure: Sampling peritoneal tissue<br>* Resection specimen will be obtained during CRS from normal peritoneum at a distance, normal peritoneum close to a peritoneal metastasis, miliary peritoneal carcinomatosis, and established peritoneal carcinomatosis.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Immunohistochemistry (IHC) analysis | Extensive IHC analysis will be performed including CD44, integrins, ICAM-1, hyaluronate, and VCAM-1 (adhesion molecules); calretinin, mesothelin, WT1, cytokeratins and E-cadherin (mesothelial markers); α-SMA, FAP and podoplanin (CAF specific markers); PDGF, VEGF and EDGF (angiogenesis related markers) | Within 6 months after collection of the samples | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Intra-tumoral versus peritoneal vascularity | Vacularity will be assed using chalkley counts | Within 6 months after collection of the samples | 
| Laser capture microdisssection (LCM) followed by gene expression analysis | Different cell types (mesothelial cells, submesothelial resident fibroblasts, CAFs) will be isolated using LCM, followed by gene expression analysis | Within 12 months after collection of the samples |
Assessment Of Shivering With iSeismograph

Study Overview
=================
Brief Summary
-----------------
Shivering is a common side-effect of epidural anesthesia. In studies to date, the assessment of shivering has been based on a simple scale using descriptive words rather than actual measurements. We believe that we can assess shivering more scientifically by using a novel method to quantify arm movements during shivering.

Detailed Description
-----------------
This novel method will allow the investigators to quantitatively assess and measure shivering in obstetric parturients undergoing varying procedures under epidural anesthesia.

Official Title
-----------------
Assessment Of Shivering With iSeismograph In Parturients Undergoing Surgical Procedures Under Epidural Anesthesia

Conditions
-----------------
Shivering

Intervention / Treatment
-----------------
* Device: novel device


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: pregnancy epidural in situ Exclusion Criteria: non-cesarean delivery

Ages Eligible for Study
-----------------
Minimum Age: 19 Years

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

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| study group<br>patients undergoing cesarean under epidural anesthesia | Device: novel device<br>* novel device being used to measure shivering<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Comparison between physician-reported shivering and measured shivering | Quantifiable assessment of shivering data measured by novel device will be compared to subjective assessment of shivering made by attending anesthesiologist | During cesarean delivery |
HRCT in Prediction of Tumor Invasion in GGO Lung Adenocarcinoma (ECTOP-1008)

Study Overview
=================
Brief Summary
-----------------
This study is one of Eastern Cooperative Thoracic Oncology Projects (ECTOP-1008). It aims to evaluate the correlation between radiological diagnosis based on HRCT and pathological invasiveness.Investigators observe the radiological features and the correlation with the postoperative pathological findings.

Detailed Description
-----------------
Preoperative evaluation of pathologic tumor invasion of ground glass opacity (GGO) featured lung adenocarcinoma is important for selection of appropriate surgical extent. Whether thoracic high-resolution computed tomography (HRCT) scan could precisely predict pathologic tumor invasion remains unknown. Patients with peripheral GGO nodules (GGNs) would be enrolled, and HRCT with target scan would be performed preoperatively. Pathologic tumor invasion (invasive adenocarcinoma [IAD] versus adenocarcinoma in situ [AIS]/minimally invasive adenocarcinoma [MIA]) would be evaluated according to radiologic parameters of HRCT before surgery. Primary endpoint of this trial is the diagnostic sensitivity of pathologic tumor invasion evaluated by HRCT. Secondary endpoint is the diagnostic value of radiologic parameters of HRCT for pathologic tumor invasion of GGO featured lung adenocarcinoma.

Official Title
-----------------
Preoperative Evaluation of High-resolution Computed Tomography to Predict Pathologic Tumor Invasion in Ground-glass Opacity Featured Lung Adenocarcinoma

Conditions
-----------------
Adenocarcinoma of Lung

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: (1) GGNs on HRCT scan; (2) clinical stage IA; (3) simultaneously no more than three nodules; (5) Age ranging from 15 to 85 years. Exclusion Criteria: (1) pathologically confirmed non-adenocarcinoma; (2) patients who did not receive surgery.

Ages Eligible for Study
-----------------
Minimum Age: 15 Years
Maximum Age: 85 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<br>Patients with lung cancer who are candidates for surgery. | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Sensitivity | Diagnostic sensitivity of pathologic tumor invasion evaluated by HRCT | Pathologic reports were available, usually 1 month after surgery | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Value of radiologic parameters for tumor invasion | The receiver operating characteristic curve (ROC curve) and the area under the ROC curve (AUC) of the invasion prediction model based on radiologic parameters. | Pathologic reports were available, usually 1 month after surgery |
Comparative Study on the Effects of Sublingual Misoprostol in Addition to Standard AMTSL in Low Risk Parturients in LASUTH, Ikeja.

Study Overview
=================
Brief Summary
-----------------
Postpartum haemorrhage is the leading cause of maternal haemorrhage globally. With active management of labour 3 to 16.5% of parturients still experience postpartum haemorrhage. Hence the need for an effective oxytocic in third stage of labour.

Detailed Description
-----------------
This is a prospective randomized doubleblind controlled trial involving 660 consenting pregnant women. Eligible subjects will be ransomised into 2 groups of 330 participants. All patients will receive the standard oxytocin 10 units as part of the active management of third stage of labour. However, the study group will be administered sublingual 400 misoprostol while the control group will receive 2tablets of placebo (vitamin c). Measured mean blood loss will be comparee in the 2 groups using statistical analysis.

Official Title
-----------------
Comparative Study on Effects of Sublingual Misoprostol in Addition to Standard Active Management of Third Stage of Labour in Low Risk Parturients in Lagos State University Teaching Hospital, Ikeja.

Conditions
-----------------
Primary Postpartum Haemorrhage

Intervention / Treatment
-----------------
* Drug: Misoprostol
* Drug: vitamin c


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: singleton in longitudinal lie and cephalic presentation Exclusion Criteria: refusal of consents, multiple gestation

Ages Eligible for Study
-----------------
Minimum Age: 15 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: Single Group Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: study<br>Intramuscular oxytocin 10 units, 400 micrograms of misoprostol | Drug: Misoprostol<br>* experimental<br>* Other names: Cytotec;|
| Other: control<br>Intramuscular oxytocin 10 units, 2 tablets of placebo which will be vitamin c | Drug: vitamin c<br>* control<br>* Other names: ascorbic acid;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| mean blood loss |  | 1 hour of delivery | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| number of participants with untowards effects |  | 1 hour of delivery | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
uterine atony
Characterization of Low Density Lipoprotein and Mechanism of the Pro Aggregant Effect Through Oxidant Stress and Lipid Exchange

Study Overview
=================
Brief Summary
-----------------
Case control design: lipidomic study in 12 type 2 diabetics with metabolic syndrome, 12 metabolic syndrome without diabetes, 12 subjects with type 1 diabetes and 12 controls

Official Title
-----------------
Characterization of Low Density Lipoprotein and Mechanism of the Pro Aggregant Effect Through Oxidant Stress and Lipid Exchange

Conditions
-----------------
Diabetes, Metabolic Syndrome

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


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: statin and fibrate Wash out for one week HbA1c>7% and <12% (Arms 1 and 3) HbA1c<6% (Arms 2 and 4) Metabolic sd according NCEP III (3 out 4 criteria) (Arms 1 and 2) Exclusion Criteria: secondary CV prevention

Ages Eligible for Study
-----------------
Minimum Age: 30 Years
Maximum Age: 75 Years

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

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| type 2 diabetics with metabolic syndrome<br> | Procedure: Blood sample<br>* Blood sample for lipidomic study<br>|
| metabolic syndrome without diabetes<br> | Procedure: Blood sample<br>* Blood sample for lipidomic study<br>|
| type 1 diabetes<br> | Procedure: Blood sample<br>* Blood sample for lipidomic study<br>|
| control<br> | Procedure: Blood sample<br>* Blood sample for lipidomic study<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Level of plasma isoprostane and lipoperoxides |  | at baseline | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| TXA2 and PF4 levels after platelet activation of control platelet exposed to LDL |  | 2 hours | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Platelet function, diabetes, metabolic syndrome
Clinical Performance Evaluation of the Cholestech LDX Cardiac hsCRP Test (CLEAR)

Study Overview
=================
Brief Summary
-----------------
This is a multi-center study designed to assess the accuracy and precision of the Cholestech LDX Cardiac hsCRP test for the quantitative determination of C-reactive protein (CRP) in whole blood, serum and plasma from individuals being assessed for risk of cardiovascular disease. The Cholestech LDX Cardiac hsCRP test consists of the CRP cassette and LDX analyzer and measures CRP with high sensitivity on fingerstick or venous whole blood at the point-of-care (POC). The results of this study are intended to be used for regulatory 510k filings for use as an in vitro diagnostic test.

Conditions
-----------------
Cardiovascular Disease

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Adults (18 years of age or older) presenting to their physician's office or outpatient clinic for routine or pre-scheduled visits and a candidate for cardiovascular risk assessment. Willing and able to provide written informed consent and comply with study procedures. Exclusion Criteria: Known hematocrit <30% or > 52%; History of medical conditions - other than risk of cardiovascular disease - that may elevate CRP as listed in Appendix B (e.g., tissue damage, infection, inflammation, malignant neoplasia) Vulnerable populations deemed inappropriate for study by the site's principal investigator.

Ages Eligible for Study
-----------------
Minimum Age: 18 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 |
| --- | --- | --- |
Drug Management of Rheumatoid Arthritis in Covid-19 Context : Impact on Therapeutic De-escalation

Study Overview
=================
Brief Summary
-----------------
The current situation of Sars-Cov-2 pandemic generates fears in the general population. Among patients receiving long-term immunomodulatory drugs, especially in the context of auto-immune diseases, there may be legitimates interrogations about the appropriateness of continuing treatment, without modification, in the current context. Most patients with Juvenile Rheumatoid Arthritis benefit from long-term immunmodulatory therapy (DMARD - disease modifying anti-rheumatic drug), more or less combined with regular use of non-steroidal anti-inflammatory drugs (NSAIDs) or corticosteroids.The present study will characterize this issue by defining the proportion of patients whose usual treatment of Rheumatoid Arthritis has been modified in relation to the actual sanitary crisis.

Official Title
-----------------
Drug Management of Rheumatoid Arthritis in Covid-19 Context : Impact on Therapeutic De-escalation

Conditions
-----------------
Rheumatoid Arthritis, COVID

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Rheumatoid arthritis satisfying ACR/EULAR criteria Ongoing DMARD therapy Exclusion Criteria: Inhability 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?
-----------------
What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Reduction or discontinuation of the DMARD therapy in relation to the Covid-19 sanitary crisis | Reduction or discontinuation of treatment with sDMARD, bDMARD or tsDMARD | 1 Day |
A Long-term Follow-up Study Of Multiple Sclerosis Patients Who Participated In Genzyme-sponsored Studies of GZ402668

Study Overview
=================
Brief Summary
-----------------
Primary Objective: To assess the long-term safety of GZ402668 in patients with multiple sclerosis (MS) who received prior treatment during the TDU13475 or TDU14981 studies. Secondary Objectives: To assess the pharmacokinetics of GZ402668 in patients with MS. To assess the pharmacodynamics of GZ402668 in patients with MS. To assess the immunogenicity of GZ402668 in patients with MS.

Detailed Description
-----------------
The total study duration for a patient is approximately 47 months. There is no administration of GZ402668 in the LTS14120 study. Patients who already received investigational medicinal product (GZ402668 or placebo) in TDU13475 or TDU14981 will be followed up to 47 months in the LTS14120. Note: Patients from TDU14981 study (sanofi-sponsored) will participate in LTS14120 study. In order to keep consistent among all study related documents, the title of the LTS14120 study is not amended.

Official Title
-----------------
An Open-label, Long-term Follow-up Study Of Multiple Sclerosis Patients Who Participated In Genzyme-sponsored Studies of GZ402668

Conditions
-----------------
Progressive Multiple Sclerosis

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion criteria: Received investigational medicinal product (GZ402668 or placebo) in TDU13475 or TDU14981 The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 66 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 |
| --- | --- |
| GZ402668<br>Patient who received GZ402668 in prior study (TDU13475 or TDU14981) | |
| Placebo<br>Patient who received placebo in prior study (TDU13475 or TDU14981) | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of patients with adverse events |  | 4 years | 
| Safety, as assessed by clinical (physical examination), laboratory (hematology, creatinine, and urinalysis with microscopy), ECG, and vital sign events |  | monthly for up to 4 years | 
| Clinically significant changes in thyroid function tests from baseline |  | every 3 months for 4 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Time to lymphocyte repopulation |  | 4 years | 
| Number of patients with anti-drug antibodies |  | monthly for first 3 months then at 6 and 12 months for first 1 year | 
| Serum concentrations of GZ402668 |  | monthly for first 3 months |
Assessment of Metformin as Adjuvant Therapy in Patients With Ulcerative Colitis

Study Overview
=================
Brief Summary
-----------------
Brief Summary: This is a randomized, controlled study evaluating metformin tablets administered daily for 8 weeks. The purpose of the study is to evaluate the efficacy and safety of metformin in the treatment of mild to moderately active ulcerative colitis. Disease activity will be measured using Mayo score for ulcerative colitis activity. Calculation of the score requires patients to undergo colonoscopy at the start of the study and at week 8.

Official Title
-----------------
Assessment of Metformin as Adjuvant Therapy in Patients With Ulcerative Colitis

Conditions
-----------------
Ulcerative Colitis, Inflammatory Bowel Diseases

Intervention / Treatment
-----------------
* Drug: metformin 500 mg TID Oral Tablet
* Drug: Placebo


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients with mild or moderate ulcerative colitis newly diagnosed by colonoscopy and biopsy according to Mayo endoscopic scoring of ulcerative colitis. Adults (males and/or females) with age range from 18 to 65 years old. Patients on treatment with 5-aminosalisylic acid (5-ASA) Exclusion Criteria: Patients with severe ulcerative colitis according to Mayo endoscopic scoring of ulcerative colitis. Treatment with systemic or rectal steroids. Treatment with immunosuppressants. Previously failed treatment with a sulphasalazine. Known hypersensitivity to any of study drugs. Hepatic and renal dysfunction. Pregnancy and lactation. History of colorectal carcinoma. History of complete or partial colectomy. Current or previous treatment with metformin for females with polycystic ovarian syndrome. Patients with diabetes mellitus Patients with history of lactic acidosis Patients with disease states associated with hypoxemia including cardiorespiratory insufficiency Positive stool culture for enteric pathogens, positive stool ova and parasite exam.

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Placebo Comparator: Control group<br>participants will receive placebo for 8 consecutive weeks in addition to the standard therapy | Drug: Placebo<br>* Placebo<br>|
| Experimental: Metformin group<br>participants will receive 500 mg Metformin TID for 8 consecutive weeks in addition to the standard therapy | Drug: metformin 500 mg TID Oral Tablet<br>* biguanides derivatives<br>* Other names: Glucophage XR;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Difference between the two groups in the expression of colonic (NF)-κB proteins. |  | 8 weeks |