linjc16/ctgov huggingface dataset:
Improvement of Compliance for High Doses of EPA Amongst Patients With Colorectal Cancer

Study Overview
=================
Brief Summary
-----------------
Several studies indicate beneficial effects of eicosapentanoic acid (EPA) on cancer cachexia. However, compliance is generally low. This case control study is conducted in order to investigate if compliance depends upon the physical properties of the supplement (capsules vs. drinks). In order to further investigate how compliance can be improved, a possible correlation between sideeffects and rate of increased polyunsaturated fatty acid concentration in blood is also tested

Detailed Description
-----------------
Patients with abdominal cancer in active chemotherapeutic were allocated to either EPA in an oral nutritional drink (commercial) or capsules with fish oil. The dose of EPA was the same in both groups, and diets were adjusted as iso-caloric. Compliance to the fish oil treatment was the primary outcome. Blood concentrations of EPA secondary.

Official Title
-----------------
Fish Oil Supplementation in Cancer Patients - Capsules or in Nutritional Supplements. A Controlled Trial of Compliance.

Conditions
-----------------
Compliance, Abdominal Cancer

Intervention / Treatment
-----------------
* Dietary Supplement: Möllers Omega-3 Ekstra Sterk
* Dietary Supplement: Nutrifriend Cachexia


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients receiving chemotherapy on Rigshospitalet due to colorectal cancer Not terminally ill Subjects must be18 years of age (or older) Exclusion Criteria: Subjects who do not read/speak/understand Danish Familial hypercholesterolemia Predialytic patients (GFR < 15 ml/min/1,73 m2 or creatinine ≥ 500 mmol/L) Use of blood thinners Bleeder's 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?
-----------------

Design Details

Primary Purpose: Supportive Care
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Allocation, not randomized
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Capsules<br>Dietary Supplement: Möllers Omega-3 Ekstra Sterk | Dietary Supplement: Möllers Omega-3 Ekstra Sterk<br> <br> |
| Active Comparator: Drink<br>Dietary Supplement: Nutrifriend Cachexia | Dietary Supplement: Nutrifriend Cachexia<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Compliance | Number of Capsules and bottles counted | 4 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Erythrocyte concentration of EPA | Concentration measured on isolated erythrocytes | 4 weeks |
Clinical Significance of Circulating Tumour Cells in Resectable Lung Cancer Patients

Study Overview
=================
Brief Summary
-----------------
To determine whether the presence of circulating/disseminated tumour cells (CTCs/DTCs) in the blood and bone marrow of the resectable lung cancer (NSCLC) patients is a negative prognostic factor, and to find correlations with other clinical/pathological disease characteristics.

Official Title
-----------------
Clinical Significance of Circulating Tumour Cells in Resectable Lung Cancer Patients

Conditions
-----------------
Non Small Cell Lung Cancer, Circulating Tumor Cell

Intervention / Treatment
-----------------
* Diagnostic Test: Device for CTC/DTC detection


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Non-small cell lung cancer, non-metastatic Exclusion Criteria: Prior neoadjuvant chemoradiotherapy Prior lung cancer Cancer duplicity

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

| Intervention/Treatment |
| --- |
|Diagnostic Test: Device for CTC/DTC detection|The CTCs/DTCs will be detected and counted in peripheral blood, tumour draining blood and bone marrow samples.|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| CEA, EGFR, LunX, c-met and EpCAM mRNA positive circulating tumour cells in lung cancer patients | The absolute gene expression of CEA, EGFR, LunX, c-met and EpCAM mRNA positive circulating tumour cells(CTCs) isolated from peripheral blood, tumour draining blood and bone marrow samples of lung cancer patients will be measured using real-time RT-PCR method. The gene expression will be normalized per microgram of total mRNA. | 30 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Cancer specific survival in CTC positive NSCLC patients | The cancer specific survival, overall survival and disease free survival will be measured from the time of diagnosis to the time of event. Two groups of patients will be compared: A: Patients with the presence of CTCs in peripheral blood, tumour draining blood and bone marrow before NSCLC surgery as described in primary outcome measure. B: Patients with the absence e of CTCs in peripheral blood, tumour draining blood and bone marrow before NSCLC surgery as described in primary outcome measure. | 5 years |
Observational Safety Study in Subjects With Type 2 Diabetes Mellitus Starting or Switching to Biphasic Insulin Aspart 30 Treatment

Study Overview
=================
Brief Summary
-----------------
This study is conducted in Europe. The aim of this study is to investigate safety and efficacy in subjects with type 2 diabetes mellitus starting or switching to biphasic insulin aspart 30 (NovoMix® 30) treatment.

Official Title
-----------------
A Multicentre, Open Label, Non-randomised, Non-interventional, Observational Safety Study in Subjects With Type 2 Diabetes Mellitus, Starting or Switching to NovoMix® 30 Treatment

Conditions
-----------------
Diabetes, Diabetes Mellitus, Type 2

Intervention / Treatment
-----------------
* Drug: biphasic insulin aspart 30


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Subjects with type 2 diabetes
Sexes Eligible for Study
-----------------
All

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| BIAsp 30 users<br> | Drug: biphasic insulin aspart 30<br>* Prescribed biphasic insulin aspart 30 as part of routine care. Starting dose, dose titration and injection frequency determined individually by each physician.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Incidence of SADR (serious adverse drug reactions) including major hypoglycaemia |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change from baseline in HbA1c (glycosylated haemoglobin) |  |  | 
| Mean FPG (fasting plasma glucose) |  |  | 
| Overall, daytime and nocturnal frequency of hypoglycaemic events |  |  |
Uses of Irradiated Human Amniotic Membrane in the Treatment of Dystrophic Epidermolysis Bullosa Patients

Study Overview
=================
Brief Summary
-----------------
To evaluate the effect of human amniotic membrane as a weekly dressing on chronic wounds in Epidermolysis Bullosa (EB) patients.

Detailed Description
-----------------
Dried human amniotic membrane dressing were obtained from National center for radiation research and technology, Egypt (NCRRT), under commercial name REGE pro.

Official Title
-----------------
Uses of Irradiated Human Amniotic Membrane in the Treatment of Dystrophic Epidermolysis Bullosa Patients

Conditions
-----------------
Epidermolysis Bullosa, Chronic Skin Ulcer

Intervention / Treatment
-----------------
* Biological: REGE pro dressing


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: 1- Patients diagnosed as EB wounds must be chronic Exclusion Criteria: Patients Must stop other line of treatment Exclude patients have: Autoimmune diseases Diabetes

Ages Eligible for Study
-----------------
Minimum Age: 12 Years
Maximum Age: 45 Years

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

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

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: Treated<br>Patients who received REGE pro dressing on EB wounds lesion weekly for 10 weeks | Biological: REGE pro dressing<br>* REGE pro is a dressing of dried human amniotic membrane sterilized by gamma radiation<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Lesion area | The lesion area from the first treatment is greater than 2 cm^2 (grade 3, according to CTCAE v4.0), to the complete healing (= 0 cm^2). | 6 weeks | 
| Clinical progression sings | After the first application time: White transperent color of granulation tissue appeared. After the second application time: color dense of granulation tissue increased and covered all over the wound. After the third application time: granulation tissue thickness increased and appeared as a complete homogenous layer. After the fourth application time: depending on lesion depth and size, granulation tissue turned to be pink to red color. After the fifth and sexth application time: Skin layers development appeared. | 6 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Patient complain (upon the weekly questionnaire) | The quality of life is scored 0 (minimum) -100 (maximum), the pain reduction is scored 0-100 (as previous) from the first visit till 6 weeks. | 6 weeks | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Epidermolysis Bullosa, Amniotic membrane
Characteristics of Patients With Thymoma in Chulalongkorn Hospital

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to study characteristics of patients with thymoma in Chulalongkorn hospital between 2003-2007.

Detailed Description
-----------------
To study characteristics of patients with thymoma undergone thymectomy in Chulalongkorn hospital between 2003-2007 in terms of clinical manifestations, associated diseases, and laboratory findings.

Official Title
-----------------
Characteristics of Patients With Thymoma Undergone Thymectomy in Chulalongkorn Hospital Between 2003-2007

Conditions
-----------------
Thymoma Staging, Clinical Presentations, Associated Disorders, Laboratory Findings

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients with histocytological proved thymoma undergone thymectomy in Chulalongkorn hospital between 2003-2007 Exclusion Criteria: None
Sexes Eligible for Study
-----------------
All

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Thymoma<br>Patients with thymoma | |
| Control<br>Normal controls | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Thymoma staging and clinical manifestations |  | 5 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Associated diseases and laboratory findings Immunological data |  | 4 months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Thymoma, Autoimmune diseases, Immunodeficiency
A Multi-Site Clinical Evaluation of the ARIES Flu Assay in Symptomatic Patients

Study Overview
=================
Brief Summary
-----------------
The ARIES Flu Assay is a real-time PCR based qualitative assay for the direct detection and differentiation of respiratory viral nucleic acid in nasopharyngeal swabs specimens. The objective of this study is to establish the diagnostic accuracy of ARIES Flu Assay.

Detailed Description
-----------------
The ARIES Flu Assay is a real-time polymerase chain reaction (PCR) based qualitative in vitro diagnostic test for the direct detection and differentiation of respiratory viral nucleic acid in nasopharyngeal swabs specimens from patients with signs and symptoms of respiratory tract infection in conjunction with clinical and laboratory findings. The objective is to establish the diagnostic accuracy of ARIES Flu Assay through a multi-site, method comparison on prospectively collected, left-over, and de-identified, nasopharyngeal swab specimens. Diagnostic accuracy will be expressed in terms of clinical sensitivity (or positive agreement) and specificity (or negative agreement).

Official Title
-----------------
A Multi-Site Clinical Evaluation of the ARIES Flu Assay in Symptomatic Patients

Conditions
-----------------
Respiratory Tract Infection, Bronchitis, Pneumonia

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: The specimen is from a patient suspected of having respiratory tract infection for whom a requisition has been made for viral testing The specimen is from a male of female subject who was either hospitalized, admitted to a hospital emergency department or visiting an outpatient clinic. The specimen is a nasopharyngeal swab Exclusion Criteria: The specimen is NOT a nasopharyngeal swab The specimen was not properly collected, transported or stored according to the instructions provided by the sponsor.
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 |
| --- | --- | --- |
| Diagnostic accuracy will be expressed in terms of clinical sensitivity (or positive agreement) and specificity (or negative agreement). | Accuracy determinations (diagnostic sensitivity and specificity, positive and negative agreement) were based on the fraction of comparator positive (or negative) results which were also positive (or negative) by ARIES Flu assay. | Within the first year of sample collection | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
ARIES Flu
Study Evaluating Multiple Doses Of GSI-953 Within The Elderly Population

Study Overview
=================
Brief Summary
-----------------
To assess the safety and tolerability of ascending, multiple, oral doses of GSI-953 in healthy elderly subjects.

Official Title
-----------------
An Ascending Multiple Dose Study Of The Safety, Pharmacokinetics, And Pharmacodynamics Of GSI-953 Administered Orally To Healthy Elderly Subjects

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

Intervention / Treatment
-----------------
* Drug: GSI-953


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Men or women, greater than or equal to 65 years of age. Women of nonchildbearing potential (WONCP) may be included if they are either surgically sterile (hysterectomy and/or oophorectomy) or postmenopausal for greater than or equal to 1 year (with FSH greater than or equal to 38 mIU/mL) and must have a negative pregnancy test result within 48 hours before administration of test article. Women who are surgically sterile must provide documentation of the procedure by an operative report or by ultrasound. Body mass index (BMI) in the range of 18.0 to 30.0 kg/m2 and body weight >50 kg. Exclusion Criteria: n/a

Ages Eligible for Study
-----------------
Minimum Age: 65 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: Single Group Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: GSI+Placebo<br> | Drug: GSI-953<br>* Oral capsule, 10- and 50-mg, either once a day for 14 days or twice a day for 14 days, depending on cohort assignment.<br>* Other names: Begacestat, WAY-210953, PF-05212362;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The pharmacokinetic and pharmacodynamic profile for the elderly subjects. |  | 6 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pharmacokinetics (PK) |  | 6 months | 
| Pharmacodynamics (PD) |  | 6 months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Alzheimer Disease
Metabolomic Profiling of Novel Mediators of Vascular Function

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to identify and characterize specific chemicals and metabolic pathways that change with forearm ischemia. These changes will be compared with forearm blood flow and flow-mediated vasodilation of the brachial artery.

Official Title
-----------------
Metabolomic Profiling of Novel Mediators of Vascular Function

Conditions
-----------------
Type 2 Diabetes Mellitus

Intervention / Treatment
-----------------
* Procedure: blood sampling and brachial artery ultrasound


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Adults age 18 or older Type 2 diabetes mellitus Exclusion Criteria: Type 1 diabetes mellitus Type 2 diabetics taking insulin, thiazolidinediones (rosiglitazone or pioglitazone), an amylin analog (Symlin [pramlintide]), or incretin mimetics (Byetta [exenatide]) Pregnancy Uncontrolled hypertension, > 180/100 mmHg

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

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

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| 1<br>Blood sampling and brachial artery ultrasound | Procedure: blood sampling and brachial artery ultrasound<br>* Intravenous blood sampling will be performed before and 15 seconds, 30 seconds, 1,2,5,10,and 30 minutes following an ischemic stimulus (inflation of a blood pressure cuff to suprasystolic pressure for 5 minutes) Brachial artery ultrasound imaging will be performed before and 1 minute after a 5 minute ischemic stimulus, to assess endothelium-dependent vasodilation of the brachial artery. Following completion of blood sampling, an additional resting image of the brachial artery will be obtained. Sub-lingual nitroglycerin will be administered, and the artery will be imaged again after 3 minutes, to assess endothelium-independent vasodilation.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| change from baseline (pre-forearm ischemia) in circulating metabolites compared with post-ischemic forearm measurements |  | pre/post 5 minute ischemic stimulus | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
metabolomics, flow-mediated vasodilation
Repeat Ablation Procedure in Patients With Relapse of Atrial Fibrillation

Study Overview
=================
Brief Summary
-----------------
Catheter ablation with isolation of the pulmonary veins has proven to be an effective treatment option in patients with paroxysmal atrial fibrillation. In patients who have a relapse of paroxysmal atrial fibrillation after one ablation procedure the investigators compare the reisolation of all pulmonary veins to reisolation plus an anterior left atrial line.

Detailed Description
-----------------
Catheter ablation with isolation of the pulmonary veins has proven to be an effective treatment option in patients with paroxysmal atrial fibrillation. In patients who have a relapse of paroxysmal atrial fibrillation after one ablation procedure we compare the reisolation of all pulmonary veins to reisolation plus an anterior left atrial line.

Official Title
-----------------
Repeat Ablation Procedure in Patients With Relapse of Paroxysmal Atrial Fibrillation Using Reisolation of Pulmonary Vein Versus Reisolation of Pulmonary Vein With Additional Anterior Line

Conditions
-----------------
Ablation, Paroxysmal Atrial Fibrillation

Intervention / Treatment
-----------------
* Procedure: Ablation


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: relapse of atrial fibrillation Exclusion Criteria: contraindication for ablation

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 80 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: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: reisolation of all PV and additional anterior line<br> | Procedure: Ablation<br>* Ablation of atrial fibrillation<br>|
| Placebo Comparator: reisolation of all pulmonary veins<br> | Procedure: Ablation<br>* Ablation of atrial fibrillation<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Freedom of atrial arrhythmias |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Quality of life, number of reconnected pulmonary veins, safety |  |  |