linjc16/ctgov huggingface dataset:
Parity and Serum Lipids in White and Hispanic Women

Study Overview
=================
Brief Summary
-----------------
To analyze the relationships between parity (childbirth) or gravidity (pregnancy) and measures of lipids in groups of women from the Hispanic Health and Nutrition Examination Survey (Hispanic HANES) and the Framingham Heart Study.

Detailed Description
-----------------
BACKGROUND: The relationships between parity or gravidity and measures of lipids in groups of women from the Hispanic Health and Nutrition Examination Survey (Hispanic HANES) and the Framingham Heart Study offered insights into the health of an important minority group in the United States and provided clues regarding hormonal mechanisms in lipoprotein metabolism. DESIGN NARRATIVE: In the Framingham cohort, the relationships among gravidity, LDL-cholesterol, HDL-cholesterol and total cholesterol were prospectively studied. Each of these serum lipids was tested as a potential mediator of associations between gravidity and various cardiovascular endpoints. In the Hispanic HANES, the associations among parity, gravidity, and lipid levels were examined in cross-sectional data on women of a different ethnic background in whom birth rates tended to be high. Secondary analysis of these two datasets was conducted, carefully considering aspects of the study designs. Bivariate analyses generated mean lipid levels within parity or gravidity groups. HDL, LDL, and total cholesterol were then stratified both by parity and other variables (such as age and smoking status) so that interactions could be considered. Multivariate analyses were used to analyze the effect of parity on lipids and cardiovascular disease events while controlling for a variety of potentially confounding factors (such as body mass index, subscapular/triceps, skinfold ratio, education, income, cigarette smoking, alcohol consumption, oral contraceptive use, estrogen replacement therapy, menopausal status and type of menopause). Interactions were also considered in multivariate models.

Conditions
-----------------
Atherosclerosis, Cardiovascular Diseases, Heart Diseases

Participation Criteria
=================
Eligibility Criteria
-----------------
No eligibility criteria

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

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

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 |
| --- | --- | --- |
Ultrasonography in Juvenile Idiopathic Arthritis

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to analyse the usability of ultrasonography together with biomarkers in the investigation of patients diagnosed with juvenile idiopathic arthritis. The investigators hypothesize that serum and urine markers of cartilage and bone synthesis and degradation, together with ultrasound measurements of joint cartilage thickness, are useful tools in the early evaluation of JIA patients, - as diagnostic, prognostic and monitoring methods.

Official Title
-----------------
Changes in Joint-Cartilage as a Measure of Outcome in Juvenile Idiopathic Arthritis - Assessed by Ultrasonography and Biomarkers

Conditions
-----------------
Juvenile Idiopathic Arthritis, Oligoarthritis, Polyarticular Juvenile Rheumatoid Arthritis, Systemic Juvenile Idiopathic Arthritis

Intervention / Treatment
-----------------
* Device: Ultrasonography


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Juvenile idiopathic arthritis: Oligoarticular, polyarticular or systemic onset type. Informed consent from parents between 5-15 years of age Exclusion Criteria: Other diagnoses that involves bones or cartilage Intraarticular steroid injections within 1 month of the trial investigation

Ages Eligible for Study
-----------------
Minimum Age: 5 Years
Maximum Age: 15 Years

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

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

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

Arms and Interventions

| Intervention/Treatment |
| --- |
|Device: Ultrasonography|Scanning 5 joints bilaterally with an ultrasound scanner|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Joint cartilage thickness | Joint catilage thickness measured by ultrasonography: knee, ankle, wrist, metacarpophalangeal and proximal interphalangeal joints by MRI: one knee by plain radiographs: knee, ankel and wrist | 1.5 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Level of different biomarkers in serum and urine | Level of bone- and cartilage-degradation biomarkers in serum and urine. COMP, CTX-II, RANKL/OPG, PYD/DPD | 1.5 years | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Juvenile idiopathic arthritis, Ultrasonography, Cartilage, Cartilage biomarkers, Bone biomarkers
Prospective Snapshot Audit of Distal Pancreatectomy in Spain

Study Overview
=================
Brief Summary
-----------------
Distal pancreatectomy is the surgical technique performed to treat many pancreatic diseases located in neck and tail of the pancreas. Laparoscopic approach is the gold standard but in many centres the percentage of laparoscopic approach is still low. This technique has low mortality but 30% morbidity mostly related to pancreatic fistula. Some new devices (linear stapler, energy devices and patches) seem to decrease pancreatic fistula but there is not evidence based medicine that confirm the results published usually in unicentric studies.

Detailed Description
-----------------
Snapshot observational study including most of the Spanish pancreatic units that perform distal pancreatectomy. One year consecutive cases. Main objectives. percentage of laparoscopic approach in Spain Morbidity at 90 days measured by CCI and Clavien Dindo Percentage of pancreatic fistula Impact of new device to decrease pancreatic fistula

Official Title
-----------------
SPAnish DIStal PANcreatectomy Snapshot Study

Conditions
-----------------
Surgery--Complications, Pancreas Disease, Pancreatic Fistula

Intervention / Treatment
-----------------
* Procedure: Distal pancreatectomy


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: -All distal pancreatectomies performed in involved Units Exclusion Criteria: No sign of informed consent for entering in the study Emergency procedures

Ages Eligible for Study
-----------------
Minimum Age: 18 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 |
| --- | --- |
| Distal pancreatectomy<br>All cases operated on performing distal pancreatectomy in involved Units | Procedure: Distal pancreatectomy<br>* We are going to collect all cases<br>* Other names: corporocaudal pancreatectomy;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Morbidity at 90 days | Morbidity measured with CCI and Clavien at 90 days | 90 days | 
| Laparoscopic approach | Laparoscopic or laparotomy approach | 1 year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pancreatic fistula | Percentage of pancreatic fistula | 90 days |
Effects of Losartan on Hepatic Fibrogenesis in Chronic Hepatitis C

Study Overview
=================
Brief Summary
-----------------
There is evidence on the beneficial effects of the administration of angiotensin II type 1 (AT1) receptors antagonists on liver fibrosis in hepatic stellate cells, experimental models of liver fibrosis in rodents and limited information in chronic hepatitis C with mild fibrosis. The purpose of this study is to investigate the effect of long-term administration of oral Losartan, an AT1 receptor antagonist, on liver fibrogenesis in patients with chronic hepatitis C and fibrosis F2-F3 (METAVIR score).

Official Title
-----------------
Effect of Long-Term Administration of Oral Losartan on Hepatic Fibrogenesis and Gene Expression in Chronic Hepatitis C With Significant Liver Fibrosis.

Conditions
-----------------
Chronic Hepatitis C, Liver Fibrosis

Intervention / Treatment
-----------------
* Drug: Losartan


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: age between 35 and 65 years chronic hepatitis C with intermediate fibrosis (F2-F3 in Metavir score). non-responder or contraindication to antiviral therapy. Exclusion Criteria: any other cause of liver disease HIV positive alcohol consumption arterial hypertension creatinine > 1.5mg/dL treatment with AT1 receptor antagonists or angiotensin converting enzyme inhibitors in the past 12 months. antiviral therapy in the past 12 months contraindications to oral losartan

Ages Eligible for Study
-----------------
Minimum Age: 35 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: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: Losartan|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Assessment of liver fibrogenesis by changes in gene expression of key mediators of liver fibrosis. |  |  | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Hepatitis C, Chronic
Identification of Sentinel Lymph Nodes With Methylene Blue and Isotope

Study Overview
=================
Brief Summary
-----------------
The aim of this study is to evaluate the performance of a double labelling method using isotope and methylene blue dye injection to localize precisely Sentinel Lymph Node (SLN) in a series of 100 patients with infiltrative breast cancer justifying SLN excision. Method and patients: SLN excision will be performed on 100 patients treated for infiltrative breast cancer. After preoperative methylene blue dye injection and lymphoscintigraphy, individual localization of the radioactive and stained nodes will be performed. After the surgery, SLN will be submitted to serial analysis and immunohistochemistry. A comparison of the two methods and an economical evaluation of the complete procedure will be performed.

Official Title
-----------------
Identification of Sentinel Lymph Node (SLN) in Breast Cancer Care: Clinical and Economical Evaluation of a Double Method Using Isotope and Methylene Blue Dye Injection.

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

Intervention / Treatment
-----------------
* Drug: Methylene blue (1%)
* Drug: Rhenium sulfure
* Procedure: Surgical procedure
* Procedure: Anatomo-pathologic procedure


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: patients with infiltrative breast cancer (diagnosed pre-operatively by core biopsy) approval and informed consent Exclusion Criteria: chemotherapy locoregional radiotherapy prevalent axillary lymph node

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


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: Methylene blue (1%)|nan|
|Drug: Rhenium sulfure|nan|
|Procedure: Surgical procedure|nan|
|Procedure: Anatomo-pathologic procedure|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Determination of an optimized protocol for SLN identification, with a double method using isotope and methylene blue dye injection. |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Comparison of the results of SLN serial sectioning, with H&E and IHC staining |  |  | 
| Economical evaluation of SLN procedure. |  |  | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
sentinel lymph node, SLN, probe, breast cancer, lymphoscintigraphy, methylene blue dye
Physiotherapy Program for Cluster Headache

Study Overview
=================
Brief Summary
-----------------
This study evaluates the effectiveness of physiotherapy program in the treatment of cluster headaches. Half of participants will receive a program of physiotherapy and usual drugs, while the other will receive an exercise program and usual drugs.

Detailed Description
-----------------
Previous studies have shown positive effects of physical therapy in patients with primary headache. However, so far no study that assessed the effect of a physiotherapy program combined with regular medication in patients with cluster headache.

Official Title
-----------------
Effectiveness of Physiotherapy Program in Patients With Cluster Headache

Conditions
-----------------
Cluster Headache

Intervention / Treatment
-----------------
* Behavioral: Physiotherapy
* Other: Home exercise program


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Cluster headache diagnosed Exclusion Criteria: Other types of headaches. Neurostimulator implanted. Other chronic pain processes

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: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Physiotherapy program<br>Physiotherapy program and usual drugs | Behavioral: Physiotherapy<br>* A program of physiotherapy including manual therapy, exercise, pain education.<br>* Other names: Manual Therapy, Physical Therapy;|
| Active Comparator: Home exercise program<br>Home exercise program and usual drugs | Other: Home exercise program<br>* Home exercise program<br>* Other names: Therapeutic exercise;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pain Scores on the Visual Analog Scale |  | 3 months |
Trichomonas Vaginalis Recurrence Among HIV+ Women

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to determine if the 2 gram single dose of metronidazole is as effective as the 7 day 500 mg BID dose for treatment of Trichomonas vaginalis (TV) among HIV-infected women.

Detailed Description
-----------------
This is a Phase IV equivalency trial as both doses of metronidazole are listed in the the Centers for Disease Control and Prevention Treatment Guidelines for the treatment of T vaginalis.

Official Title
-----------------
Randomized Phase IV Trial of Metronidazole Single Dose Versus 7 Day Dose for Treatment of Trichomonas Vaginalis Among HIV-infected Women

Conditions
-----------------
Trichomonas Infections, HIV Infections

Intervention / Treatment
-----------------
* Drug: Metronidazole


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Female 18 years or older HIV-positive TV positive by either wet preparation or culture ability to refrain from all alcohol use for 24 hours before and after taking oral metronidazole willing to take metronidazole treatment Exclusion Criteria: pregnant incarcerated previously enrolled currently taking disulfiram alcoholism or known liver damage medical contraindications to metronidazole treated with metronidazole within the previous 14 days requires treatment for B.V. per Amsel's criteria

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Single dose<br>Metronidazole 2 gm single dose | Drug: Metronidazole<br>* 2 gm single dose versus 7 day 500 mg BID dose<br>* Other names: Flagyl;|
| Active Comparator: 7 day dose<br>Metronidazole 500 mg dose x 7 days | Drug: Metronidazole<br>* 2 gm single dose versus 7 day 500 mg BID dose<br>* Other names: Flagyl;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| TV Culture Positive Result | At the participants' test of cure (TOC) visits they were screened for Trichomonas vaginalis using (InPouch) culture. Presence of parasite will yield a culture positive result. | test-of-cure visit at 6-12 days post-treatment completion | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| TV Culture Positive Result | Participants who returned for their follow up visits were tested for Trichomonas vaginalis using InPouch culture. If parasites are present, it will yield a culture positive result. | 3 months post-enrollment |
Double-blind, Placebo-controlled, Randomized Study of the Effectiveness of Escitalopram on Emotional Distress of Head and Neck Cancer Patients During Cancer Treatment

Study Overview
=================
Brief Summary
-----------------
Evaluation of the effectiveness of escitalopram on depressive symptoms after 3 months in patients with head and neck squamous cell carcinomas (oral cavity, larynx, oropharynx and hypopharynx) and with an HADS total score > 11

Conditions
-----------------
Carcinomas

Intervention / Treatment
-----------------
* Drug: Escitalopram


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Head and neck squamous cell carcinomas, stage I to IVb First-line curative cancer therapy : surgery and/or brachytherapy and/or chemotherapy HADS- T >11 Aged 18 to 75 yo, written consent required OMS>2 Exclusion Criteria: Palliative care Previous head and neck cancer Bipolar disorder or schizophrenia Severe major depressive disorder (DSM-IV TR) Expressed suicidal ideation Severe untreated organic disorder, especially acute infectious disorder ASAT/ALAT > 3N Clearance of creatinin < 30 ml/mn Hyponatremia Antecedent of delirium tremens or acute alcohol withdrawal disorder Antecedent of upper gastro-intestinal bleeding Antecedent of toxicity or inefficacy of a previous treatment with escitalopram Unauthorized treatments :- Antidepressant or antiepileptic (clonazepam authorized)- Hypnotic except zolpidem - Anxiolytic except clonazepam, clorazepate or diazepam- bupropion or varenicline Pregnancy or lactation

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
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Antidepressant treatment<br> | Drug: Escitalopram<br>* Escitalopram 10 mg once a day<br>|
| Placebo Comparator: Placebo<br> | Drug: Escitalopram<br>* Escitalopram 10 mg once a day<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Evaluation of the effectiveness of escitalopram on depressive symptoms after 3 months |  | 3 months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Patients with head and neck squamous cell carcinomas, head and neck squamous cell carcinomas
Sym004 in Metastatic Colorectal Cancer and ECD-EGFR Patients

Study Overview
=================
Brief Summary
-----------------
This is a single arm, phase 2, open-label, multicenter trial in patients with metastatic colorectal cancer (mCRC) and acquired resistance to anti-epidermal growth factor receptor (EGFR) monoclonal antibodies (mAbs) and documented mutation of extra cellular domain EGFR (ECD-EGFR).

Official Title
-----------------
An Open-label, Multicenter, Phase 2 Trial Investigating Sym004 in Patients With Metastatic Colorectal Cancer and Acquired Resistance to Anti-EGFR Monoclonal Antibodies and Documented Mutation of Extra Cellular Domain of EGFR (ECD-EGFR)

Conditions
-----------------
Metastatic Colorectal Cancer

Intervention / Treatment
-----------------
* Drug: Sym004


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion and Exclusion criteria have been removed due to Symphogen's business decision to no longer perform the clinical study.

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: Sym004<br>All patients will receive a loading dose of Sym004, followed by weekly (q1w) infusions | Drug: Sym004<br>* Sym004 is a 1:1 mixture of two monoclonal antibodies (mAbs) which bind to two non-overlapping epitopes of the Epidermal Growth Factor Receptor (EGFR).<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Best overall response (OR) assessed by Response Evaluation Criteria in Solid Tumors (RECIST) v1.1 |  | 1 year | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Resistance to anti-EGFR monoclonal antibodies, Mutation of ECD-EGFR