linjc16/ctgov huggingface dataset:
Ultrasound Determination of Needle Depth in Epidurals in Adult Patients

Study Overview
=================
Brief Summary
-----------------
The introduction of local anesthetics and other medications into the epidural space is a principal technique in provision of anesthesia in many procedures. Typically the anesthetist accesses the epidural space blindly using palpation and visualization of external landmarks and then uses a needle to get to the epidural space. The investigators propose a prospective study of use of ultrasound in a large heterogeneous group of surgical candidates to define the relationship between the actual needle depth (ND) to the epidural space and measured ultrasound depth (UD). Establishing correctly the depth to the epidural space via ultrasound is a component of ultrasound imaging that might improve current technique, and might lead to faster performance of the epidural. Use of ultrasound may also improve the efficacy and safety of epidural placement. The null hypothesis of this study is that ultrasound depth is similar to the needle depth in adult non parturient patients undergoing lumbar and thoracic epidurals. A parturient in this case is defined as a female currently near or going through labor.

Official Title
-----------------
Ultrasound Determination of Needle Depth in Lumbar and Thoracic Epidurals in Adult Non-Parturient Patients

Conditions
-----------------
Analgesia, Epidural, Surgery

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: The patient population will include all non parturients above the age of 18 who are candidates for epidural placement prior to surgery. Exclusion Criteria: Parturients, prisoners and patients younger than 18 years old will be excluded from this study.

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

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

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

Study Plan
=================
How is the study designed?
-----------------
What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Ultrasound depth | Depth to epidural space as determined by ultrasound probe | At time of exam | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
determination of depth to epidural space using ultrasound
Impact of Vitamin D on Endothelial Function and Blood Biomarkers Including CD28 Null Cells in CKD

Study Overview
=================
Brief Summary
-----------------
Vitamin D deficiency is common in CKD and assciated with CV complications. Endothelial dysfucntion is common in CKD and is a harbinger of atherosclerosis. The study investigated the impact of Vitamin D on endothelial fucntion and blood biomarkers in CKD.

Official Title
-----------------
Impact of Cholecalciferol on Endothelial Fucntion and Blood Biomarkers in Patients With Chronic Kidney Disease

Conditions
-----------------
CKd Patients With Stage 3 and 4

Intervention / Treatment
-----------------
* Drug: Cholecalciferol


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: CKD 3-4 Age 18-80 Exclusion Criteria: Recent MI, CVA, malignancy active infection active inflammation High calcium already on Viatmin D therapy

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Vitamin D<br>Cholecalciferol 300,000 twice | Drug: Cholecalciferol<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Flow mediated dilation |  | 16 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| CD28 null cell frequency |  | 16 weeks | 
| Blood biomarkers of endothelial function and inflammation |  | 16 weeks |
Cytokines and Sevoflurane During Surgery

Study Overview
=================
Brief Summary
-----------------
The aim of the present study was to evaluate the effects of anaesthesia with sevoflurane and surgery on cytokines response.

Official Title
-----------------
Effects of Inhalation Anaesthesia With Sevoflurane on Cytokine Response in Patients Submitted to Otorhinolaryngological Surgery

Conditions
-----------------
Cytokines, Inflammatory, Sevoflurane

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: both gender, ASA I physical status, 18-50 years old, tympanoplasty and septoplasty. Exclusion Criteria: Malignant or genetical diseases; diabetes; smoking; elicit drugs, recent RX radiation.

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 50 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 |
| --- | --- |
| Volunteers<br>Healthy volunteers not submitted to anesthesia nor surgery. | |
| Sevoflurane Group<br>This group was submitted to inhalational anesthesia with sevoflurane and otorhinolaryngological surgery. | |

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
-----------------
anaesthetic techniques, inhalation, sevoflurane, Cytokines, Immune response
A Open-label, Single-dose Study to Investigate The Pharmacokinetics Between a GL2907 XL and Oxycontin CR Tab. 10mg in Healthy Male Volunteers

Study Overview
=================
Brief Summary
-----------------
The purpose of this clinical trial is to compare the pharmacokinetic characteristics of GL2907 XL 20mg tablet and Oxycontin CR 10mg tablet. GL2907 XL 20mg tablet is controlled released formulation which is made by GL Pharm Tech.

Official Title
-----------------
A Randomized, Open-label, Single-dose, Crossover Study to Investigate The Pharmacokinetics Between a GL2907 XL and Oxycontin CR Tab. 10mg in Healthy Male Volunteers

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

Intervention / Treatment
-----------------
* Drug: Oxycodone
* Drug: Oxycodone
* Drug: Oxycodone


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: 20 45 years old, Healthy Adult Male Subject ≥ 50kg(Body Weight) and Ideal Body Weight ≤ ±20% Exclusion Criteria: ALT or AST > 1.25(Upper Normal Range) Total Bilirubin > 1.5 (Upper Normal Range) BUN or Creatinine > Normal Range Systolic BP > 160mmHg or < 80mmHg, Diastolic BP > 100mmHg or < 50mmHg

Ages Eligible for Study
-----------------
Minimum Age: 20 Years
Maximum Age: 45 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
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: GL2907 XL 20mg (Oxycodone 20mg, fasted)<br> | Drug: Oxycodone<br>* Oxycodone XL 20mg(20mg once a day, fasted)<br>|
| Experimental: GL2907 XL 20mg (Oxycodone 20mg, after high fat meal)<br> | Drug: Oxycodone<br>* Oxycodone XL 20mg/day(20mg once a day, after high fat meal)<br>|
| Active Comparator: Oxycontin CR 10mg (Oxycodone 10mg, fasted)<br> | Drug: Oxycodone<br>* Oxycodone 20mg/day (10mg twice a day, fasted)<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Cmax | Pharmacokinetic of Oxycodone | 48hr | 
| AUC(0-24h) | Pharmacokinetic of Oxycodone | 24 hr | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Tmax | Pharmacokinetic of Oxycodone | 48 hr | 
| t1/2 | Pharmacokinetic of Oxycodone | 48 hr | 
| Vz/F | Pharmacokinetic of Oxycodone | 48 hr | 
| CL/F | Pharmacokinetic of Oxycodone | 48 hr | 
| Safety Monitoring | Adverse Event, Vital sign, 12-lead ECG, Physical Exam, Laboratory test | 27 days | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Oxycodone, controlled release formulation
Individualized Molecular Profiling for Allocation to Clinical Trials (IMPACT) Project

Study Overview
=================
Brief Summary
-----------------
This study aims to screen tumor molecular profile for better selection of anticancer treatment, in particular, allocation to clinical trials if available.

Detailed Description
-----------------
Molecular profiling will be performed on archival tumor tissue or freshly collected tumor tissue from re-biopsy. Blood and/or saliva may be collected to study the genetic makeup and also to compare the tumor molecular profile. Personalized therapy will be given based on molecular profile.

Official Title
-----------------
Individualized Molecular Profiling for Allocation to Clinical Trials (IMPACT) Project

Conditions
-----------------
Solid Tumor

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Confirmed histological diagnosis of solid tumor Suitable for systematic treatment and clinical trials ECOG (Eastern cooperative oncology group) performance status < 2 Able to provide tumor tissue for molecular profiling Able to understand and sign the informed consent form Exclusion Criteria: None

Ages Eligible for Study
-----------------
Minimum Age: 21 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 |
| --- | --- |
| tumor tissue for molecular profiling<br> | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The molecular and clinical epidemiology for cancer patients being considered for novel therapeutics |  | 5 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The proportion of patients who have actionable alterations and enrol into clinical trials |  | 5 years | 
| The correlation of molecular profiles with clinical outcomes |  | 5 years |
ANASA (Patients' Satisfaction With Pulmonary Diseases' Treatment)

Study Overview
=================
Brief Summary
-----------------
The aim of the study is to compare patients' satisfaction from the use of three different inhalation devices by using the FSI-10 questionnaire

Detailed Description
-----------------
Patients are requested to reply to FSI-10 questionnaire regarding their satisfaction from inhalation devices. Patients are on 3 different asthma inhalation devices with combination treatment (Turbuhaler, Diskus, Elpenhaler)

Official Title
-----------------
Multicenter, Prospective, Non Interventional Observational Study in Treatments of Asthma and Chronic Obstructive Pulmonary Disease (COPD)

Conditions
-----------------
Asthma, Chronic Obstructive Pulmonary Disease

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients > 18 years old, both genders who are on their inhalation treatment at least two months before study enrollment, Who are able to be compliant to study procedures Exclusion Criteria: Patients < 18 years old, Patients who are on their inhalation treatment less than two months before study enrollment Patients who are not able to be compliant to study procedures

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 |
| --- | --- |
| Turbuhaler inhaler use<br> | |
| Discus inhaler use<br> | |
| Elpenhaler inhaler use<br> | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Patients' satisfaction | Patients' replies to FSI-10 questionnaire valid in Greek language | all study period (5 months) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Patients devices' use |  | all study period (5 months) | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
COPD
Analgesic Treatment Mediated by Arcoxia (0663-093)

Study Overview
=================
Brief Summary
-----------------
Allow physicians to test the efficacy of arcoxia in patients with acute pain.

Official Title
-----------------
Analgesic Treatment Mediated by Arcoxia

Conditions
-----------------
Pain

Intervention / Treatment
-----------------
* Drug: MK0663, Arcoxia, etoricoxib / Duration of Treatment: 3 Days


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Diagnosis of acute pain susceptible of pharmacological treatment Greater than 18 years of age Voluntary acceptance to participate in the study and signature of the informed consent form Exclusion Criteria: Allergy to etoricoxib or any of its components Less than 18 years old Patient is taking anticoagulants Patient that already has taken any drug as analgesic

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


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: MK0663, Arcoxia, etoricoxib / Duration of Treatment: 3 Days|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Evaluate pain using the verbal analog scale (evaluate pain before starting treatment and then evaluate pain every day after had taken arcoxia up to three days) |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Patient satisfaction with the drug therapy using PGART scale |  |  | 
| Patient satisfaction was obtained at the end of treatment(on third day) |  |  |
Long-Term Follow-up After Ventral Hernia Repair With Strattice Mesh

Study Overview
=================
Brief Summary
-----------------
This study will assess long-term outcomes (greater than 12 months) following ventral hernia repair with Strattice mesh reinforcement.

Detailed Description
-----------------
Subjects will be retrospectively identified as having undergone operative repair of ventral hernia with Strattice mesh reinforcement during the period January 1, 2013 - November 1, 2017. Follow-up data will be collected either at a postoperative clinic visit or via telephone interview.

Official Title
-----------------
Long Term Follow-up After Ventral Hernia Repair With Strattice Mesh

Conditions
-----------------
Ventral Hernia

Intervention / Treatment
-----------------
* Device: Strattice Mesh


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Hernia repair with Strattice Mesh Age 18 or older Exclusion Criteria: Under age 18 No history of hernia repair

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

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

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

Arms and Interventions

| Intervention/Treatment |
| --- |
|Device: Strattice Mesh|Subjects will be restrospectively identified has having undergone ventral hernia repair with Strattice mesh reinforcement. Once identified long term follow-up data will be collected.|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Hernia recurrence | Percentage of patients with recurrence at long-term (>12 months) follow-up. | 24 Months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Quality of LIfe Questionnaire | Percentage of patients with mean quality of life scores at long-term (>12 months) follow-up. | 24 Months |
GAPP 1 Survey: Global Attitudes of Patients and Physicians in Insulin Therapy for Diabetes Mellitus

Study Overview
=================
Brief Summary
-----------------
This study is conducted in Asia, Europe and in the United States of America. The aim of this study is to examine patient and physician beliefs regarding insulin therapy and the degree to which patients adhere to their insulin regimens.

Official Title
-----------------
GAPP 1 Survey: Global Attitudes of Patients and Physicians in Insulin Therapy for Diabetes Mellitus

Conditions
-----------------
Diabetes, Diabetes Mellitus, Type 1, Diabetes Mellitus, Type 2

Intervention / Treatment
-----------------
* Behavioral: No treatment given
* Behavioral: survey


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: PATIENTS WITH DIABETES: Age 18 years or older Treated with insulin Type 1 or Type 2 diabetes PHYSICIANS: In practice for more than 1 year since completing residency See a minimum number of patients with diabetes per week (primary care physicians 5, specialists 10) Initiate insulin treatment for patients with 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 |
| --- | --- |
| Patients with diabetes<br> | Behavioral: No treatment given<br>* Survey conducted through computer-assisted telephone interviewing.<br>|
| Physicians<br> | Behavioral: survey<br>* Survey conducted via the Internet.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Frequency of insulin omission/non-adherence |  | In the past 30 days prior to the day when responding to the survey (patient survey) | 
| Reasons for insulin omission/non-adherence reported by patient and physician |  | Day 1 (when responding to the survey) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Impact of insulin treatment on life domains (patient survey) |  | Day 1 (when responding to the online questionnaire) |
Extension Study of the Long-term Safety and Tolerability of Octreotide Acetate in Patients With Moderately Severe or Severe Non-proliferative Diabetic Retinopathy or Low Risk Proliferative Diabetic Retinopathy

Study Overview
=================
Brief Summary
-----------------
This multicenter, open-label extension study will evaluate the long-term tolerability and safety for patients completing study CSMS995 0802. During this extension study, all patients will receive open-label treatment of octreotide acetate in microspheres every 4 weeks for 2 years for the treatment of moderately severe to severe NPDR and low risk PDR.

Official Title
-----------------
An Open-label Extension Study to Evaluate the Long-term Safety and Tolerability of Octreotide Acetate in Microspheres in the Therapy of Patients With Moderately Severe or Severe Non-proliferative Diabetic Retinopathy (NPDR) or Low Risk Proliferative Diabetic Retinopathy (PDR)

Conditions
-----------------
Diabetic Retinopathy

Intervention / Treatment
-----------------
* Drug: Octreotide acetate in microspheres


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: written informed consent provided prior to participation in the extension study successful completion of study CSMS995 0804 willingness to comply with all study requirements Exclusion Criteria: more than 8 weeks interval since the completion of study CSMS995 0804 premature discontinuation from study CSMS995 0804 Other protocol-defined inclusion/exclusion criteria may apply.

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: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: Octreotide acetate in microspheres|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| long-term safety and tolerability |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| monitor long-term efficacy |  |  | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Diabetic retinopathy, Octreotide acetate in microspheres