linjc16/ctgov huggingface dataset:
A Study to Investigate the Possible Causes of Secondary Effects During Use of Peripheral Midline Type Catheter in Patients Hospitalized in Different Care Settings

Study Overview
=================
Brief Summary
-----------------
Although the use of peripheral venous catheters (CVP) with brachial insertion with echo-guide (Midline) has increased significantly over the last 5-10 years, there are no sensitive data concerning complications in the literature during their use, particularly as regards incidence of thrombotic complication.The prospective observational study will enroll all the patients admitted to Home Health Hospitalization service, Geriatric Department and Intermediate Care service, to whom a Midline-type CVP will be placed for infusional therapy and who will give their consent to participate.

Official Title
-----------------
Safety and Efficiency oh the Use of Midline Peripheral Venous Catheter (MIDES)

Conditions
-----------------
Upper Extremity Deep Vein Thrombosis, Secondary

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Subjects admitted to wards adhering to the study (Home Health Hospitalization service, Geriatric Department and Intermediate Care service) Subjects submitted to Midline type venous catheter insertion Exclusion Criteria: History of deep venous thrombosis or pulmonary embolism Be hospitalized for less than a week

Ages Eligible for Study
-----------------
Minimum Age: 45 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 |
| --- | --- | --- |
| Number of participants with Peripheral deep venous thrombosis (DVP) suspected with Compression ultrasound (CUS) and confirmed by echodoppler | Deep vein thrombosis is investigated with Compression ultrasound (CUS) technique, scheduled once a week from the implant day or performed at the time of occurrence of device malfunctions or at the onset of symptoms resulting from thrombotic complications; echodoppler tecnique is used to confirm diagnosis of thrombosis. | Once a week from the implant day until CVP removal or patient discharge, whichever came first, assessed up to 40 days | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Midline, peripheral venous catheter, vascular access device, deep venous thrombosis
Random Trial for Elderly Patients With NSCLC

Study Overview
=================
Brief Summary
-----------------
Recently a radomized trial of vinorelbine versus best supportive care in patients at 70 years of age or older demonstrated a definite improvement in overall survival rate and quality of life with chemotherapy. The role of combination therapy containing the platinum compound, which is the standard therapy for the young patients is still vague. Gemcitabine and carboplatin have favorable toxicity profile.

Official Title
-----------------
A Randomized Phase III Trial of Vinorelbine Versus Gemcitabine and Carboplatin for Elderly Patients With Advanced Non-Small Cell Lung Cancer

Conditions
-----------------
Non-Small Cell Lung Cancer

Intervention / Treatment
-----------------
* Drug: vinorelbine, gemcitabine and carboplatin


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients with pathologically confirmed, advanced(clinical stage IIIB or IV) NSCLC No previous chemotherapy history Age ≥ 65 years ECOG performance status ≤ 2 Adequate marrow function (ANC ≥ 2,000/mm3, platelet ≥ 100,000/mm3), renal and liver function (total bilirubin < 2.0 mg/dL, AST/ALT levels < 3 × the upper limit of normal, serum creatinine < 2.0 mg/dL) Patients with informed written consent Exclusion Criteria: Patients with other major illness(active infection, severe heart disease, concomitant malignancy, etc)

Ages Eligible for Study
-----------------
Minimum Age: 65 Years

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

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

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

Design Details

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


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: vinorelbine, gemcitabine and carboplatin|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
Fixation of Thoracic Epidurals Influencing Catheter-related Infections and Dislocation

Study Overview
=================
Brief Summary
-----------------
Major interest in our investigation is to find out whether distinct fixation techniques influence catheter dislocation and/ or incidence of local inflammation. A systematic comparison of two different fixation techniques with regard to catheter location, analgetic potential and signs of local inflammation will be conducted. To ensure identical patients groups allocation will be strictly randomized. Furthermore, both patient groups will receive identical pain medication via the peridural catheter in situ. All catheter tips will be screened microbiologically after removal.

Official Title
-----------------
Fixation of Thoracic Epidural Catheters Influencing Catheter-related Infections and Dislocation

Conditions
-----------------
Dislocation, Infection, Line Colonisation, Line Insertion Site

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients aged > 18 years and operation with thoracic epidural Exclusion Criteria: Refusal of 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?
-----------------

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Cather fixation by tunneling and suture<br> | |
| Catheter fixation by adhesive tape<br> | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Changes in catheter position | Difference in catheter position between day of insertion and day of removal, measured in mm between catheter tip and skin niveau | 4-6 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Secondary variables | Analgetic quality, incidence of catheter contamination, signs of local inflammmation and microbiological eamination of the catheter after removal | 4-6 days |
Post Marketing Surveillance Study in Rehabilitation Clinics (Cardio, Nephro, Diabetes, Pulmo)

Study Overview
=================
Brief Summary
-----------------
Study to obtain long-term data on effects, safety and tolerability in routine medical practice and to investigate the potential of telmisartan to prevent secondary organ damage

Official Title
-----------------
Post Marketing Surveillance Study in Rehabilitation Clinics (Cardio, Nephro, Diabetes, Pulmo)

Conditions
-----------------
Hypertension

Intervention / Treatment
-----------------
* Drug: Micardis®
* Drug: MicardisPlus®


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Adult patients of both gender aged >=18 admitted to a hospital due to insufficiently controlled essential hypertension. No additional selection criteria have to be considered. Treatment was at the discretion of the physician following the summary of product information for Micardis® and MicardisPlus® Exclusion Criteria: not applicable

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 |
| --- | --- |
| Hypertension patients - Pneumology<br> | Drug: Micardis®<br> <br> Drug: MicardisPlus®<br> <br> |
| Hypertension patients - Cardiology<br> | Drug: Micardis®<br> <br> Drug: MicardisPlus®<br> <br> |
| Hypertension patients - Nephrology<br> | Drug: Micardis®<br> <br> Drug: MicardisPlus®<br> <br> |
| Hypertension patients - Diabetology<br> | Drug: Micardis®<br> <br> Drug: MicardisPlus®<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of patients with adverse events |  | up to 1 year | 
| Number of patients with abnormal changes in laboratory parameters |  | up to 1 year | 
| Number of patients with clinically significant changes in vital signs |  | up to 1 year | 
| Change in systolic blood pressure |  | up to 1 year | 
| Change in diastolic blood pressure |  | up to 1 year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Global assessment of efficacy by investigator on a 4-point scale |  | 2 weeks, after 1 year | 
| Global assessment of tolerability by investigator on a 4-point scale |  | 2 weeks, after 1 year |
Metformin/Rosuvastatin Combination Therapy With in Patients With Type 2 Diabetes and Dyslipidemia

Study Overview
=================
Brief Summary
-----------------
Compare the Efficacy and Safety of Metformin/Rosuvastatin Combination Therapy With Metformin or Rosuvastatin Monotherapy in Patients With Type 2 Diabetes and Dyslipidemia

Detailed Description
-----------------
Multi-center, Randomized, Double-blind, Phase III clinical trial

Official Title
-----------------
A Multi-center, Randomized, Double-blind, Phase III Clinical Trial to Compare the Efficacy and Safety of Metformin/Rosuvastatin Combination Therapy With Metformin or Rosuvastatin Monotherapy in Patients With Type 2 Diabetes and Dyslipidemia

Conditions
-----------------
Type 2 Diabetes, Dyslipidemia

Intervention / Treatment
-----------------
* Drug: Metformin + Rosuvastatin
* Drug: Metformin + placebo
* Drug: placebo + Rosuvastatin


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Over 19 years Type II DM with Dyslipidemia 6.5% ≤ HbA1c < 11% Triglyceride < 350mg/dL 100mg/dL ≤ LDL-C ≤ 250mg/dL FPG ≤ 270mg/dL Exclusion Criteria: Type I DM Unstable angina, MI, Stroke, CABG with 6 month from screening SBP ≥ 180mmHg, DBP ≥ 110mmHg TSH > UNL Heart failure (NYHA class III/IV) Serum Creatinine > UNL or CLCr < 60 mL/min CK ≥ 2x UNL HIV positive BMI > 40 kg/m^2

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

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

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

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

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Group I<br>Metformin + Rosuvastatin, Dosing to Type II DM with Dyslipidemia | Drug: Metformin + Rosuvastatin<br>* Group I: Metformin + Rosuvastatin,<br>|
| Active Comparator: Group II<br>Metformin + placebo, Dosing to Type II DM with Dyslipidemia | Drug: Metformin + placebo<br>* Group II: Metformin + placebo,<br>|
| Active Comparator: Group III<br>Placebo + Rosuvastatin, Dosing to Type II DM with Dyslipidemia | Drug: placebo + Rosuvastatin<br>* Group III: placebo + Rosuvastatin<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| LDL-C (% change) |  | 16 weeks from baseline | 
| change of HbA1c |  | 16 weeks from baseline | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Metformin, Rosuvastatin, type 2 diabetes, dyslipidemia
Rapid Diagnosis of Myocardial Damage and Coronary Stenosis With Magnetic Resonance Imaging (MRI)

Study Overview
=================
Brief Summary
-----------------
The hypothesis is that single-shot imaging of myocardial infarction is possible in atrial fibrillation using MRI late enhancement technique

Detailed Description
-----------------
50 outpatients in Jonkoping County with a diagnosis of in-hospital myocardial infarction, are asked to participate in this study comparing segmented true FISP late enhancement with single-shot trueFISP late enhancement for the diagnosis of myocardial damage. The study does not intervene regarding treatment but is a comparison of the diagnostic power of the two MRI techniques.

Official Title
-----------------
Rapid Diagnosis of Myocardial Damage and Coronary Stenosis With MRI

Conditions
-----------------
Myocardial Infarction

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: in-hospital diagnosis of myocardial infarction Exclusion Criteria: pacemaker, not willing to participate, metallic objects in brain or eyes,

Ages Eligible for Study
-----------------
Minimum Age: 20 Years
Maximum Age: 80 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
-----------------
Myocardial infarction, MRI late enhancement, Atrial fibrillation
Changes of Right and Left Cerebral Oxygen Saturation and Blood Flow During Nephrectomy in Lateral Decubitus Position

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to determine changes of right and left cerebral oxygen saturation and blood flow during nephrectomy in lateral decubitus position.

Conditions
-----------------
Nephrectomy

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Adult patients (ASA physical status I and II) aged between 20-65 yrs Exclusion Criteria: Cardiovascular, renal, hepatic disease, or communication failure

Ages Eligible for Study
-----------------
Minimum Age: 20 Years
Maximum Age: 65 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 |
| --- | --- | --- |
| brain oximeter saturation(%) |  | 1 hour after operation | 
| blood flow |  | 1 hour after operation | 
| velocity of superficial temporal artery in right and left side |  | 1 hour after operation | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
To compare the change of cerebral oxygen saturation and blood flow between right and left side in lateral decubitus position during nephrectomy
Absorption, Metabolism and Excretion (AME) Study of [14C]EDP-305 in Healthy Male Subjects

Study Overview
=================
Brief Summary
-----------------
A Phase 1, Open-label Study of the absorption, metabolism, and excretion of a single oral dose of [14C]EDP-305 in healthy male subjects.

Official Title
-----------------
A Phase 1, Open-label Study of the Absorption, Metabolism, and Excretion of [14C]EDP-305 Following a Single Oral Dose in Healthy Male Subjects

Conditions
-----------------
NASH - Nonalcoholic Steatohepatitis

Intervention / Treatment
-----------------
* Drug: EDP-305


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Healthy male subjects aged between 18 and 55 years (inclusive) with a body mass index between 18.0 and 32.0 kg/m2 (inclusive) able to comprehend and willing to sign an Informed Consent Form In good health, determined by no clinically significant findings from medical history, physical examination, 12 lead ECG, vital signs measurements, and clinical laboratory evaluations. Exclusion Criteria: Significant history or clinical manifestation of any metabolic, allergic, dermatological, hepatic, renal, hematological, pulmonary, cardiovascular, gastrointestinal, neurological, respiratory, endocrine, or psychiatric disorder, as determined by the Investigator (or designee). History of stomach or intestinal surgery or resection that would potentially alter absorption and/or excretion of orally administered drugs (including gastrectomy and cholecystectomy; uncomplicated appendectomy and hernia repair will be allowed). Donation of blood from 56 days prior to Screening, plasma from 2 weeks prior to Screening, or platelets from 6 weeks prior to Screening.

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 55 Years

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

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

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

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Single arm EDP-305<br> | Drug: EDP-305<br>* [14C]EDP-305<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Cmax of EDP-305 in plasma |  | Up to 9 days | 
| AUC of EDP-305 in plasma |  | Up to 9 days | 
| AUC-inf in plasma |  | Up to 9 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Amount excreted in urine (Aeu) |  | Up to 9 days | 
| Amount excreted in feces (Aef) |  | Up to 9 days | 
| Safety measured by adverse events |  | Up to 9 days | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
AME Study
Study of Weight Loss Using Gastric Stimulation in Obese Patients With Type 2 Diabetes

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to test the effect of an implanted device that stimulates the stomach on weight loss in patients suffering from obesity and type 2 diabetes.

Official Title
-----------------
ASSIST: Appetite Suppression Induced by Stimulation Trial

Conditions
-----------------
Severe to Morbid Obesity and Type 2 Diabetes

Intervention / Treatment
-----------------
* Device: Enterra Therapy System (H9900014)


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Type 2 diabetes with HbA1c of 7.5 - 11% Willing to make behavior and lifestyle modifications No previous bariatric surgery (gastric bypass, gastric banding) Meet additional study criteria Exclusion Criteria: History of substance abuse or chemical dependency with in the last 3 years Prior GI surgery for morbid obesity or any gastric surgery for conditions other than obesity or diabetes Severe congestive heart failure Any underlying illness other than diabetes or obesity that affects gastrointestinal motility Currently taking medications for weight loss

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 70 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 |
| --- |
|Device: Enterra Therapy System (H9900014)|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Mean excess weight loss and percent excess weight loss |  | 12 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Diabetes status and use of diabetes medication |  | 12 months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Obesity, Morbid obesity, Diabetes
Inheritance of Osteosarcoma & Paget's Disease Through Chromosome 18:

Study Overview
=================
Brief Summary
-----------------
Researchers have previously demonstrated loss of heterozygosity in a region on chromosome 18q, associated with osteogenic sarcomas in bone affected by Paget's disease. The loci used in this study are specifically described by those authors as showing loss of heterozygosity in 6 of 7 affected families.

Detailed Description
-----------------
As above, no additional information

Official Title
-----------------
Inheritance of Osteosarcoma & Paget's Disease Through Chromosome 18: Examination of Osteosarcoma Tissue Samples From Two Family Members for Loss of Heterozygosity in the Chromosome 18 Region, Genetically Linked With Paget's Disease of Bone

Conditions
-----------------
Osteosarcoma, Paget's Disease

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: This is a familial study therefore the only inclusion/exclusion criteria would be that subjects must be a blood relative and over the age of 18. The subjects are proband and father along with unaffected blood relatives. Their peripheral blood will act as a control and provide information to delineate the inheritance from the father, as seen in the son. Exclusion Criteria: Not part of the family
Sexes Eligible for Study
-----------------
All

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| family members<br>family members of the proband and father identified | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Loss of heterozygosity | A loss of heterozygosity of a proposed tumor suppressor gene on chromosome 18 | January, 2000 through February 2009 | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Inheritance of Osteosarcoma & Paget's Disease through Chromosome 18