linjc16/ctgov huggingface dataset:
The Metabolic Effect of Walnut Consumption in Healthy Men and Healthy Postmenopausal Women

Study Overview
=================
Brief Summary
-----------------
The objectives of the proposed study are to assess the effect of walnut consumption on parameters of lipid metabolism, glucose metabolism, incretins and adipokines, endothelial function and blood pressure in healthy men and healthy postmenopausal women

Official Title
-----------------
The Metabolic Effect of Walnut Consumption in Healthy Men and Healthy Postmenopausal Women

Conditions
-----------------
Healthy

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


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Postmenopausal healthy women and healthy men Age > 50 yrs Exclusion Criteria: Evidence of alcohol, tabacco or drug abuse Obesity ≥ 35 kg/m2 Diabetes mellitus Hypertension LDL-cholesterol > 190 mg/dl, Triglycerides > 350 mg/dl History of atherosclerotic disease

Ages Eligible for Study
-----------------
Minimum Age: 50 Years
Maximum Age: 90 Years

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

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

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

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: walnut<br>western type diet with 48 g walnut per day | Dietary Supplement: walnut<br>* walnut consumption 48 g/d<br>|
| No Intervention: control<br> | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Fasting non-HDL-cholesterol |  | 8 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| area under the triglyceride curve (AUC-TG) | area under the plasma triglyceride concentration curve following a standardized oral fat challenge | 8 weeks | 
| incremental area under the triglyceride curve (iAUC-TG) | incremental area under the plasma triglyceride concentration curve following a standardized oral fat challenge | 8 weeks | 
| LDL-cholesterol | fasting plasma LDL-cholesterol concentration | 8 weeks | 
| HDL-cholesterol | fasting plasma HDL-cholesterol concentration | 8 weeks | 
| triglyceride | fasting plasma triglyceride concentration | 8 weeks | 
| glucose | fasting plasma glucose concentration | 8 weeks | 
| HOMA |  | 8 weeks | 
| insulin |  | 8 weeks | 
| HbA1c |  | 8 weeks | 
| area under the glucose curve (AUC-glucose) | area under the plasma glucose concentration curve following a standardized oral challenge | 8 weeks | 
| area under the insulin curve (AUC-insulin) | area under the plasma insulin concentration curve following a standardized oral challenge | 8 weeks | 
| endothelial function | Postprandial (mixed meal challenge) endothelial function (flow mediated dilatation, flow-independent dilatation) | 8 weeks |
EASY: Extended Access to Sollpura Over Years

Study Overview
=================
Brief Summary
-----------------
Liprotamase consists of 3 soluble, non-porcine digestive enzymes, lipase, protease, and amylase, combined in a fixed ratio. Liprotamase is stable in the stomach and can be formulated without enteric coating for administration either as a capsule or as a dosing solution dissolved in water or juice.

Detailed Description
-----------------
The purpose of the present study is to evaluate the safety of long-term use of liprotamase in the management of cystic fibrosis-related exocrine pancreatic insufficiency

Official Title
-----------------
An Open-Label Study Evaluating the Efficacy and Safety of Liprotamase in Subjects With Exocrine Pancreatic Insufficiency Due to Cystic Fibrosis

Conditions
-----------------
Exocrine Pancreatic Insufficiency, Cystic Fibrosis

Intervention / Treatment
-----------------
* Drug: Liprotamase


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Male or female subjects with cystic fibrosis-related exocrine pancreatic insufficiency who received liprotamase and completed Study AN-EPI3331 (SOLUTION: Study of Oral Liprotamase Unit-Matched Therapy Of Non-Porcine Origin in Patients With Cystic Fibrosis) Exclusion Criteria: Any medical, psychological, or social condition that may put the subject at increased risk by participating in this study. Females who are nursing, pregnant, intending to become pregnant, or intending to nurse during the time of the study.

Ages Eligible for Study
-----------------
Minimum Age: 7 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: Liprotamase<br>Oral, soluble, non-enterically coated, non-porcine, pancreatic enzyme replacement | Drug: Liprotamase<br>* Oral, soluble, non-enterically coated, non-porcine, pancreatic enzyme replacement<br>* Other names: Sollpura;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Safety, as Measured by Number of Participants With Adverse Events Including Clinical or Laboratory Abnormalities | Descriptive analysis | 12 months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
exocrine pancreatic insufficiency, cystic fibrosis, pancreatic enzyme replacement therapy
Occipital Transcranial Direct Current Stimulation in Fibromyalgia

Study Overview
=================
Brief Summary
-----------------
The aim of this study is to investigate whether transcranial direct current stimulation is effective in the treatment of fibromyalgia related pain. The study provides a placebo arm and the design is a cross-over design.

Official Title
-----------------
Occipital Transcranial Direct Current Stimulation in Fibromyalgia

Conditions
-----------------
Fibromyalgia

Intervention / Treatment
-----------------
* Device: Transcranial direct current stimulation


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients suffering from Fibromyalgia, diagnosed according to the criteria of the ACR-90, with exclusion of other pathologies mimicking the FMS related symptoms by a M.D. of the department of Physical Medicine and Rehabilitation (UZA, Belgium) Dutch speaking Stability of medication during the study Exclusion Criteria: History of substance abuse, unless treated and in remission during 6 months Cardiac disease, implanted pace-maker or defibrillator History of epileptic insults Severe organic comorbidity Psychiatric comorbidity with psychotic symptoms Pregnancy

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 65 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: Crossover Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Placebo Comparator: Placebo stimulation<br>Placebo stimulation at the occipital head area for 1800 seconds at 0 mA, three times a week, during one week (with seconds of stimulation to get onset tingling sensation) | Device: Transcranial direct current stimulation<br>* Transcranial Direct current stimulation<br>|
| Experimental: Effective transcranial stimulation<br>Effective stimulation at the occipital head are for 1800 seconds at 2 mA, 3 times a week for 1 week | Device: Transcranial direct current stimulation<br>* Transcranial Direct current stimulation<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Decrease on Visual Analogue Scale (VAS) score for Fibromyalgia related pain and pain scales of the Fibromyalgia Impact Questionnaire |  | baseline, directly after treatment, 3 weeks after treatment | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Changes in scores of the pain vigilance and awareness questionnaire, pain catastrophizing scale, fibromyalgia impact questionnaire and modified Fatigue Impact Scale |  | base line, directly after treatment and 3 weeks after treatment | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Fibromyalgia, Neuromodulation, Transcranial Direct Current Stimulation, Occipital
Interventional Sonography Guided by Image Fusion

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to register the precision of image fusion between live sonography and CT, MRI or PET/CT of liver lesions and other focal lesions in the abdomen. To test whether it will be possible to biopsy guided by image fusion.

Official Title
-----------------
Interventional Sonography Guided by Image Fusion

Conditions
-----------------
Focal Liver Lesions, Focal Lesions in the Abdomen

Intervention / Treatment
-----------------
* Procedure: biopsy


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Focal liver lesion seen on CT, MRI or PET/CT

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 |
| --- | --- |
| biopsy<br> | Procedure: biopsy<br>* ultrasound guided biopsy of tumors.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Verification of the tumor by sonography |  | baseline only |
Clinical Analysis of Recurrence Patterns Following Conjunctival Autografts for Pterygium Surgery

Study Overview
=================
Brief Summary
-----------------
This study is conducted to evaluate its morphologic reproliferating patterns in patients with pterygium treated with the excision and conjunctival autograft.

Detailed Description
-----------------
The medical records of 116 eyes of 116 patients with pterygium who had pterygium excision and conjunctival autograft between February 2009 and May 2011 were reviewed. Using consecutively recorded photographs, we evaluated preoperative morphologic characteristics and its growth patterns.

Official Title
-----------------
Retrospective Study of Recurrence Patterns Following Conjunctival Autografts for Pterygium Surgery

Conditions
-----------------
Recurrent Pterygium

Intervention / Treatment
-----------------
* Procedure: recurrent pterygium excision and following grafting


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Recurrent pterygium Unilateral or bilateral pterygium Both male and female Consenting to participate in study Exclusion Criteria: Fibrovascular proliferation secondary to injury Severe dry eye syndrome Pseudopterygium Signs of malignancy on pterygium Corneoscleral trauma or corneo-limbal scars

Ages Eligible for Study
-----------------
Minimum Age: 21 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 |
| --- | --- |
| Pterygium,recurrent<br>Consecutively recorded photographs of recurrent pterygium excision and following grafting were analyzed. | Procedure: recurrent pterygium excision and following grafting<br>* The excision of recurrent pterygial tissue and autograft of conjunctiva was done.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pterygium recurrence pattern | Morphologic recurrence pattern of pterygium using consecutively recorded photographs. | 12 months |
Rasburicase in Tumor Lysis Syndrome

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to determine whether rasburicase is effective and safety in correcting hyperuricemia.

Official Title
-----------------
Program of Rasburicase in the Treatment of Hyperuricemia in Children and Adolescent Patients With or at Risk of Tumor Lysis Syndrome.

Conditions
-----------------
Hyperuricemia

Intervention / Treatment
-----------------
* Drug: Rasburicase


Participation Criteria
=================
Eligibility Criteria
-----------------
List of inclusion Criteria: Acute hyperuricemia patients(uric acid>8.0 mg/dl) before/during chemotherapy for hematologic malignancies. List of exclusion Criteria: Hypersensitivity to uricases or any of the excipients. Known history of hemolytic anemia (G6PD deficiency). 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
-----------------
Maximum 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: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 1<br>Rasburicase 0,20mg/Kg/Day once a day 3-7 days | Drug: Rasburicase<br>* Rasburicase 0,20mg/Kg/Day once a day 3-7 days<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percentage of patients with uric acid greater-than-normal laboratory levels (hyperuricemia) |  | 24-48 hours after last dose of rasburicase | 
| Percentage of patients with uric acid greater-than-normal laboratory levels (hyperuricemia) |  | 28 (+- 3) days after the last dose of rasburicase | 
| Adverse events occurrence |  | During the study |
Validation of King's Sarcoidosis Questionnaire in a Danish Population

Study Overview
=================
Brief Summary
-----------------
The King's Sarcoidosis Questionnaire (KSQ) is a brief questionnaire assessing health status in patients with sarcoidosis. The KSQ was previously validated in English German and Dutch. KSQ will be translated into Danish and validated in a Danish sarcoidosis population.

Official Title
-----------------
Validation of King's Sarcoidosis Questionnaire in a Danish Population

Conditions
-----------------
Sarcoidosis

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Diagnosed with sarcoidosis Signed informed consent Exclusion Criteria: Inability or unwillingness to adhere to the study Inability to give 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?
-----------------
What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| KSQ validity in Danish |  | 2 year |
Descriptive Pharmacoepidemiological Study of Patients Treated With Iressa

Study Overview
=================
Brief Summary
-----------------
The aim of the study is to describe the characteristics of patients treated with Iressa (particularly age, gender, phenotype, histology and stage of disease, line of treatment and previous treatments, smoking history, conditions of initiation of treatment (presence of an EGFR-activating mutation) and to evaluate the impact of treatment on the health of the population concerned in terms of morbidity and mortality (clinical benefit, safety,...) and quality of life

Detailed Description
-----------------
Descriptive pharmacoepidemiological study of patients treated with Iressa

Official Title
-----------------
Descriptive Pharmacoepidemiological Study of Patients Treated With Iressa

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

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients treated with Iressa Exclusion Criteria: Patient included in a therapeutic trial comprising protocol use of Iressa Patient included in a therapeutic trial (Huriet-Serusclat Act) Patient refusing to participate in the study

Ages Eligible for Study
-----------------
Maximum Age: 130 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 |
| --- | --- | --- |
| The Overall survival |  | 24 months | 
| The progression free survival |  | 24 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Description of Quality of life by Functional Assessment of Cancer Therapy - Lung including Life Stressor Checklist (FACT-L including LSC) |  | baseline | 
| Description of Quality of life by Functional Assessment of Cancer Therapy - Lung including Life Stressor Checklist (FACT-L including LSC) |  | From baseline to 3 months | 
| Description of Quality of life by Life Stressor Checklist - Lung (LSC-L) |  | From 3 months to 6 months | 
| Description of Quality of life by Life Stressor Checklist - Lung (LSC-L) |  | From 6 months to 12 months | 
| Description of Quality of life by Life Stressor Checklist - Lung (LSC-L) |  | From 12 months to 18 months | 
| Description of Quality of life by Life Stressor Checklist - Lung (LSC-L) |  | From 18 months to 24 months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Lung cancer, France
The Study on Profile and Genetic Factors of Aspirin Resistance (ProGEAR Study)

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to determine the clinically meaningful definition and prevalence of aspirin resistance based on data linking aspirin-dependent laboratory tests to recurrent vascular events in cardiovascular patients taking aspirin.

Detailed Description
-----------------
Primary Outcomes: The primary endpoint is the composite outcomes of cerebral infarction, transient ischemic attack, myocardial infarction, unstable angina, percutaneous coronary angiography, thromboembolism, and death caused by cardiovascular disease. Secondary Outcomes: Platelet aggregation induced by collagen and arachidonic acid, serum thromboxane B2, urine 11-dehydrothromboxane B2, platelet thrombus formation under flow conditions (sub-study only at the National Cardiovascular Center) The primary objective of this study is to determine the markers for aspirin resistance. To achieve this objective, platelet aggregation, serum thromboxane B2, and urine 11-dehydrothromboxane B2 are measured in patients receiving usual therapeutic doses of aspirin, who experienced acute coronary syndrome, cerebral infarction, or transient ischemic attack occurred in a period between the past 1 month and the past 2 years. This is a multi-center, prospective study.

Official Title
-----------------
The Study on Profile and Genetic Factors of Aspirin Resistance (ProGEAR Study)-A Prospective Multicenter Cohort Study-

Conditions
-----------------
Coronary Disease, Cerebral Infarction, Ischemic Attack, Transient

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Adult males or females who met the criteria listed below: Patients who had acute coronary syndrome, cerebral infarction (except cardioembolic stroke), or transient ischemic attack between past 28 days and the past 2 years patients who receive long-term aspirin therapy (at least 28 days) Patients who are >=20 years of age Patients willing and able to give written informed consent Exclusion Criteria: Malignancy or suspected malignancy Patients who showed platelet counts less than 100,000/uL or more than 450,000/uL Congenital bleeding tendency Patients who receive other antiplatelet drugs or warfarin Patients with atrial fibrillation Patients who received surgical operation or catheter intervention within the past 2 weeks Patients who received anticoagulation drug therapy including heparin ( low-molecular weight heparin) and danaparoid. Patients with more than modified Rankin scale 4

Ages Eligible for Study
-----------------
Minimum Age: 20 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 |
| --- | --- | --- |

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Aspirin, Platelet Aggregation Inhibitors
Evaluation of a New Oral Contrast Agent for MR Enterography in the Assessment of Crohn Disease in the Small Bowel

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to assess the exam quality and accuracy of MR using a new oral contrast agent for the evaluation of Crohn Disease in the small bowel.

Detailed Description
-----------------
Crohn Disease is an inflammatory condition that involves the small bowel. Patients usually undergo multiple imaging exams in the diagnosis and surveillance of the disease. CT has been shown to have excellent results for detecting active inflammation. In the United States MR has lagged behind CT in utilization for imaging the small bowel. An advantage of MR over CT is the lack of radiation exposure to the patient. A new oral contrast agent is available that provides good distension of the small bowel and allows improved identification of active inflammation. The purpose of this study is to compare the accuracy of MR to CT using this new oral contrast agent and to assess exam quality.

Official Title
-----------------
Evaluation of a New Oral Contrast Agent for MR Enterography in the Assessment of Crohn Disease in the Small Bowel

Conditions
-----------------
Crohn Disease

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Known or suspected Crohn Disease Undergoing colonoscopy and CT enterography Exclusion Criteria: Contraindication to MR

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 |
| --- | --- |
| Suspected or known Crohn Disease<br>Suspected or known Crohn Disease | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| exam quality |  | one time point | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Crohn Disease, Inflammatory Bowel Disease