linjc16/ctgov huggingface dataset:
Can Fish Oil and Phytochemical Supplements Mimic Anti-Aging Effects of Calorie Restriction?

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to determine if a combination of 10 nutritional supplements provide health benefits that are consistent with protection against age-related disease. All supplements have been shown in previous studies to have health benefits when administered alone. The hypothesis is that 6 months of taking 10 nutritional supplements each day will provide beneficial changes in healthy related measures.

Official Title
-----------------
Can Fish Oil and Phytochemical Supplements Mimic Anti-Aging Effects of Calorie Restriction?

Conditions
-----------------
Healthy Volunteers

Intervention / Treatment
-----------------
* Dietary Supplement: Supplement


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: age 40-60 yr body mass index of 21 - 30 kg/m2 sedentary to moderately active eating a typical US diet Exclusion Criteria: history of any chronic disease other than mild osteoarthritis use of medications other than occasional use of non-steroidal anti-inflammatory drugs, antihistamines, antacids or laxatives use of nutritional supplements smoking alcohol intake greater than two drinks per day for women and three drinks per day for men

Ages Eligible for Study
-----------------
Minimum Age: 40 Years
Maximum Age: 60 Years

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

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

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

Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: supplement<br> | Dietary Supplement: Supplement<br>* Participants in this group will take the following nutritional supplements on a daily basis: curcumin, fish oil, resveratrol, sesamin, Acetyl-L-carnitine, lipoic acid, green and black teas, quercetin, pomegranate, cinnamon bark.<br>|
| No Intervention: control<br> | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Carotid-femoral pulse wave velocity |  | Baseline and 6 months |
Sun Protection Factor Assay (SPF Assay 200/2016)

Study Overview
=================
Brief Summary
-----------------
To evaluate the Sun Protection Factor efficacy on human skin.

Official Title
-----------------
Sun Protection Factor (SPF) Assay: UVA Protection Factor Assay Minimal Persistent Pigment-Darkening Dose

Conditions
-----------------
Sunscreening Agents

Intervention / Treatment
-----------------
* Drug: BAY987516


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Fitzpatrick Skin Type l, ll and/or lll for UVB testing. Fitzpatrick Skin Type ll, lll and/or lV for UVA testing. Male and female. Aged between 18-70 years old. Good health as determined from the HRL SHF (Subject History Form). Signed and dated Informed Consent Form. Signed and dated HIPAA (Health Insurance Portability and Accountability Act) form. An unambiguous MED (Minimal Erythema Dose) or MPPD (Minimal Persistent Pigment Darkening Dose). Exclusion Criteria: Subjects on test at any other research laboratory or clinic. Known allergy or sensitivity to sunscreens, cosmetics and toiletries, topical drugs and/or ultraviolet light. Pre-existing dermatologic conditions which have been diagnoses by a medical professional (e.g. psoriasis, eczema, etc.) which would interfere with this study. Pre-existing other medical conditions (e.g. adult asthma, diabetes). Treatment with antihistamines or corticosteroids within one week prior to initiation of the test. Treatment with antibiotics within two weeks prior to initiation of the test. Chronic medication which could affect the results of the study. Known pregnant or nursing women.

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

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

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

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

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: BAY987516<br>Each test site area is divided into test sub site areas that are approximately at least 0.5 cm*2. The application of test material is 2 mg/cm*2. Thus, each 50 cm*2 test site area of a subject requires 100 mg of a test material to obtain a standard 2 mg/cm*2 test application. | Drug: BAY987516<br>* Each 50 cm*2 test site area of a subject requires 100 mg of a test material to obtain a standard 2 mg/cm*2 test application. (Formulation Code: Z46-096)<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Minimal Erythema Dose (MED) |  | Up to 15 minutes | 
| Minimal Persistent Pigment Darkening Dose (MPPD) |  | Up to 15 minutes |
Median and Paramedian Anesthesia in Cesarean Section

Study Overview
=================
Brief Summary
-----------------
The number of cesarean sections worldwide has markedly been increasing since 1985.Intrathecal anesthesia is preferred by most anesthesiologists over general anesthesia

Detailed Description
-----------------
Complications with spinal anesthesia are not common which makes it difficult to detect its incidence and one of the most serious complications is nerve injury.

Official Title
-----------------
Assessment of Different Routes Median and Paramedian Anesthesia in Cesarean Section

Conditions
-----------------
Anesthesia

Intervention / Treatment
-----------------
* Procedure: median anesthesia
* Procedure: paramedian anesthesia


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Age 18-42 years Scheduled for elective cesarean section ASA II Exclusion Criteria: -Age <18 years or >42 years ASA >II Emergency cesarean section

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 42 Years

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

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

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

Design Details

Primary Purpose: Other
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: anesthesia with median route versus paramedian route
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Giving median anesthesia<br> | Procedure: median anesthesia<br>* giving median anesthesia<br>|
| Active Comparator: Giving paramedian anesthesia<br> | Procedure: paramedian anesthesia<br>* giving paramedian anesthesia<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| the number of women who will have less pain | the number of women who will have less pain post procedure | 3 days |
Coronary and Structural Interventions Ulm - Coronary Chronic Total Occlusions

Study Overview
=================
Brief Summary
-----------------
To evaluate the long-term results after recanalization of coronary chronic total occlusions.

Detailed Description
-----------------
Patients with successful recanalization of coronary chronic total occlusions are followed during a period of 5 years to demonstrate safety and efficacy.

Official Title
-----------------
Coronary and Structural Interventions Ulm - Coronary Chronic Total Occlusions

Conditions
-----------------
Coronary Artery Disease, Ischemic Heart Disease, Stable Angina

Intervention / Treatment
-----------------
* Device: stent or scaffold


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: coronary artery disease chronic total occlusion Exclusion Criteria: no written informed 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?
-----------------

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: stent or scaffold<br>implantation of stents or scaffolds after recanalization of coronary chronic total occlusions | Device: stent or scaffold<br>* implantation of a CE certified drug-eluting stent, bare-metal stent or scaffold<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Major adverse cardiac events |  | 1-5 years |
The Prognostic Impact of Extracapsular Lymph Node Involvement in Ductal Pancreatic Adenocarcinoma

Study Overview
=================
Brief Summary
-----------------
Extracapsular lymph node involvement (ECLNI) has been identified as a pathological variable associated with worse outcome in esophageal, gastric and colorectal cancer. No studies so far have studied its prognostic impact in ductal pancreatic adenocarcinoma (DPAC). The goal of the investigators is to determine the prognostic value of ECLNI in a prospective consecutive series of 145 patients with DPAC, who underwent resection of their primary tumor between 1998 and 2005.

Detailed Description
-----------------
Presence and extent of extracapsular lymph node involvement (ECLNI) will be scored by reviewing all original pathological slides. ECLNI is defined as metastatic adenocarcinoma extending through the nodal capsule into the perinodal fatty tissue. Observers: 1 experienced board-certified GI pathologist, blinded for follow-up results. Follow-up data are obtained by reviewing patients charts and by a telephone survey of the patient's GP/gastroenterologist in November 2007. Statistical analysis: Common closing date: 1/11/2007 Kaplan-Meier survival analysis (Log-Rank, Wilcoxon) Cox logistic regression (uni/multivariate)

Official Title
-----------------
The Prognostic Impact of Extracapsular Lymph Node Involvement (ECLNI) in Ductal Pancreatic Adenocarcinoma (DPAC).

Conditions
-----------------
Pancreatic Neoplasms, Pancreatic Adenocarcinoma

Intervention / Treatment
-----------------
* Procedure: Pancreatic resection


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: DPAC Primary resection Exclusion Criteria: Positive section margins non DPAC, other tumor Postoperative mortality Neoadjuvant chemo/radiotherapy
Sexes Eligible for Study
-----------------
All

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Resected DPAC<br>145 consecutive resections for primary ductal pancreatic adenocarcinoma (DPAC)performed between 1998 and 2005. | Procedure: Pancreatic resection<br>* PPPD, Whipple, Total pancreatectomy or left pancreatectomy.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Overall cancer-specific survival |  | 11/2007 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Disease-free survival (DFS)& Correlation of ECLNI with other pathological variables |  | 11/2007 | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Prognosis, Extracapsular lymph node involvement
Study to Test an Approved Product in the Early Treatment of Migraine (0462-066)

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to test the effectiveness of an approved drug in the early treatment of migraine.

Official Title
-----------------
A Multicenter, Double-Blind, Randomized, Parallel, Placebo-Controlled Study to Examine the Efficacy of Rizatriptan 10 mg Tablet Administered Early During a Migraine Attack While the Pain is Mild

Conditions
-----------------
Migraine

Intervention / Treatment
-----------------
* Drug: MK0462, rizatriptan benzoate / Duration of Treatment: 1day
* Drug: Comparator: placebo / Duration of Treatment: 1 day


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Six month history of migraine; attacks typically mild when they begin with 1-4 migraine attacks per month. Exclusion Criteria: Heart disease High blood pressure

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: Double


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: MK0462, rizatriptan benzoate / Duration of Treatment: 1day|nan|
|Drug: Comparator: placebo / Duration of Treatment: 1 day|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percentage of patients who are pain free at 2 hours postdose |  |  | 
| Tolerability as measured by subjective adverse experience reporting |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percentage of patients with 24 hour sustained pain freedom |  |  | 
| Percentage of patients pain free at 30/45/60/90 minutes post dose |  |  | 
| Percentage of patients with associated symptoms at 2 hours |  |  | 
| Percentage of patients requiring rescue medication between 2 & 24 hours |  |  | 
| Percentage of patients with functional disability at 2 hours |  |  |
Primary Lymphedema and Mutation CELSR1 (Cadherin EGF LAG Seven-pass G-type Receptor 1)

Study Overview
=================
Brief Summary
-----------------
The investigators will describe the expression of mutation CELSR1 with codon stop and amino acids substitution mechanism in primary lymphedema, in both clinical examination and imaging exploration

Detailed Description
-----------------
According to the literature, it seems that the mutation of the CELSR1 gene is associated with primary lymphedema. Thus, the investigators have identified families with CELSR1 mutation with codon stop or animo acid substitution mechanisms among patients followed up in vascular medicine department, at Montpellier University hospital for primary lymphedema of lower limbs. Among the mutation carriers, the investigators have collected the clinical examinations and imaging exploration results, realized systematically during the follow up of all the patient with primary lymphedema (venous Doppler, MRI of the lymphatic system, lymphoscintigraphy of the lower limbs, abdominal ultrasound), in order to search for a morphological and functional pattern associated with the mutation.

Official Title
-----------------
Clinical and Functional Expression Associated With CELSR1 Mutations in Primary Lymphedema of Lower Limbs

Conditions
-----------------
Primary Lymphedema

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion criteria: Patient followed up in vascular medicine departement at Montpellier University Hospital for primary lymphedema of lower limbs, who carries the CELSR1 mutation with codon stop or amino acids substitution mechanism. Relatives to the index case who carry the mutation for the segregation study. Exclusion criteria: Patients who carry another mutation than CELSR1 responsible for primary lymphedema Syndromic form of primary lymphedema Patient not followed up at Montpellier University Hospital.
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 |
| --- | --- | --- |
| Presence of unilateral lymphedema of lower limbs | Describe the clinical examination of all CELSR1 mutation carriers: with ISL classification and perimeter measurement and Stemmer sign. | day 1 | 
| type of the morphological and functional pattern with imaging exploration. | Describe the morphological and functional pattern of the CELSR1 mutation with the imaging exploration | day 1 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| determine if deactivator mutation of CELSR1 | determine if deactivator mutation of CELSR1 is associated with : Great saphenous vein anatomical variation kidney's anomalies | day 1 | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
CELSR1, primary lymphedema of lower limbs, lymphedema
Prevalence of Aspirin Resistance in Chronic Kidney Disease Patients

Study Overview
=================
Brief Summary
-----------------
The primary objective of the study is to determine the prevalence of aspirin resistance in chronic kidney disease patients. The secondary objectives are to determine possible risk factors contributing to aspirin resistance in this population.

Detailed Description
-----------------
A cross-sectional of aspirin resistance in hemodialysis patients previously done in our institution showed that 23/66 (34.7%) hemodialysis patients were aspirin resistant. In a recent systematic review, renal impairment was associated with aspirin resistance . This association was seen in only two out of the twenty studies used in this meta-analysis . Both these studies are from the same center with a predominant Asian population. In this study we will try to evaluate the prevalence of aspirin resistance in CKD patient without being limited to a specific ethnicity.

Official Title
-----------------
Prevalence of Aspirin Resistance in Chronic Kidney Disease Patients

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

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients with known structural kidney disease as evident by history or by urinalysis and CKD stage III or IV determined by MDRD formula and who are taking aspirin. Exclusion Criteria: Younger than 18 years of age. Bleeding disorder or myeloproliferative disorders. Thrombocytopenia with platelets < 100.000. Malignancy. Acute hemorrhagic disease. A recent history of receipt of platelet glycoprotein IIb/IIIa blockers. Liver disease as evident by abnormal liver function and total bilirubin > 2mg/dl. use of anticoagulation.

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 |
| --- | --- | --- |
| prevalence of aspirin resistance in chronic kidney disease patients | Blood drawn for the Accumetric test | 2 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| risk factors contributing to aspirin resistance in this population. | risk factors | 2 years | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
aspirin, Chronic kidney disease
The Value of PET/CT in Diagnosing Residual Disease in Patients With Spinal Infection

Study Overview
=================
Brief Summary
-----------------
MRI has shoved little correlation with the clinical finding during treatment of spondylodiscitis (infection in the vertebrae and/or discs). Since PET/CT is almost as good as MRI in diagnosing spondylodiscitis the hypothesis and this study is that PET/CT is better in predicting residual disease in patients with spondylodiscitis. Preliminary study.

Detailed Description
-----------------
In the last years there has been reported increasing incidence of spondylodiscitis. The increase is mainly thought to be caused by the increasing elderly population and the increasing amount of spinal instrumentation in this population. The symptoms range from backache to severe neurological deficits. Up to 1/3 of cases are reported to be culture negative and cases can therefore be difficult to diagnose. MRI is thought to be the main imaging technique to visualise infection. But with the increasing availability of 18-F FDG PET/CT, it is reported to be nearly as efficient to diagnose spinal infection. During the long antibiotic treatment of spondylodiscitis, the clinicians have no real good imaging technique to predict residual disease since MRI during the remodelling fase of the spine will mimic no difference or worsening. Since 18-F-FDG PET marks areas with a high amount of inflammatory cells it may also be faster in returning to normal images and therefore correlates better to actual status than MRI. Some of the purposes of this study are therefore: To describe changes on PET/CT and MRI at index and after 4, 8 12 and 26 weeks and compare these to the clinical findings as well as inflammatory biomarkers. To investigate the correlation between normalisation of inflammatory biomarkers and changes on MRI and PET/CT.

Official Title
-----------------
Preliminary Study. The Value of 18F-FDG PET/CT Compared to MRI in Diagnosing Residual Disease in Patients With Spondylodiscitis

Conditions
-----------------
Spondylodiscitis

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: first case of infectious spondylodiscitis MRI or 18-F-FDG PET/CT compatible with spondylodiscitis overall assessment compatible with spondylodiscitis Exclusion Criteria: previous spinal infection (e.g. spondylodiscitis; epidural abscess) spinal operation in the previous 6 months spinal foreign body current malignant disease

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 |
| --- | --- | --- |