linjc16/ctgov huggingface dataset:
Study Evaluating the Bioavailability of Naproxen 500 mg in Three Formulations

Study Overview
=================
Brief Summary
-----------------
We will evaluate the bioavailability of naproxen 500 mg administered as three dfferent formulations.

Official Title
-----------------
An Open-Label, Randomized, 3-Way Crossover Study to Evaluate the Relative Bioavailability of a Single Oral Dose of Naproxen 500 mg Administered as PN 400 (Naproxen / Esomeprazole), as the [Active Comparator 1], or as [Active Comparator 2] in Healthy Volunteers

Conditions
-----------------
Arthritis

Intervention / Treatment
-----------------
* Drug: PN400
* Drug: naproxen
* Drug: naproxen


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Healthy male or non-pregnant female subjects between 18-55 years of age as well as other standard inclusion criteria for a study of this nature Exclusion Criteria: Standard exclusion criteria for a study of this nature

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

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

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: A<br>PN400 (naproxen/esomeprazole) | Drug: PN400<br>* naproxen 500 mg /esomeprazole 20 mg<br>|
| Active Comparator: B<br>naproxen 500 mg | Drug: naproxen<br>* naproxen 500 mg tablet<br>|
| Active Comparator: C<br>naproxen 500 mg | Drug: naproxen<br>* naproxen 500 mg<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To assess and compare the pharmacokinetics and relative bioavailability of a single oral dose of naproxen 500 mg administered in 3 formulations |  | 72-hour PK | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To evaluate the safety of the 3 treatments |  | entire study duration |
Analysis of Specimens From Patients With Orthopaedic Implants

Study Overview
=================
Brief Summary
-----------------
The investigators aim to determine the cause of failure of orthopaedic implants using multi-disciplinary analysis of data from patients who have undergone revision.

Detailed Description
-----------------
The following tests will then be arranged: Tribological assessment. The investigators will measure the wear of the explants using: 1) 'out of roundness'; and 2) Coordinate measuring. Semi-quantitative assessment of damage to the explants will also be conducted Histological assessment. Tissue sent in formalin may determine the biomarker of diagnosis of metal ion synovitis where applicable Metal ion measurement in body fluids where applicable (in patients with metal implants) Diamond Light Source (this was approved in the 1st amendment). The tests will involve subjecting formalin fixed tissue to the high energy electron beam of the Diamond Light Source Destructive testing of the implant is allowed by the patient (after all non-destructive tests have been performed) Protein analysis of fluid and tissue if provided Titanium levels from blood samples if provided Gene expression testing to assess and understand mechanism of inflammation where applicable

Official Title
-----------------
Analysis of Specimens From Patients With Orthopaedic Implants

Conditions
-----------------
Implants

Intervention / Treatment
-----------------
* Procedure: Implant


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: All patients undergoing revision of an orthopaedic implant (previously this was limited to metal hips but this has now expanded to other orthopaedic implants) Exclusion Criteria: Patients not consenting to the study

Ages Eligible for Study
-----------------
Minimum Age: 11 Years
Maximum Age: 70 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 |
| --- | --- |
| Failed implants<br>All patients undergoing revision of an orthopaedic implant (previously this was limited to metal hips but this has now expanded to other orthopaedic implants) | Procedure: Implant<br>* orthopaedic implant<br>|
| Controls with different failure modes<br>We will compare findings with different types of orthopaedic implants and categories of failure mode. | Procedure: Implant<br>* orthopaedic implant<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Cause of failure |  | At time of failure which is likely to be an average of 5 years post operative |
GR Defect in Peripheral Blood Mononuclear Cells in COPD

Study Overview
=================
Brief Summary
-----------------
T.to investigate a possible mechanism of the glucocorticosteroid receptors (GR) defect in patients with severe COPD by studying the effect of dexamethasone (Dex) on GR- binding, interleukin production (IL-6/IL-8) and MKP-1 expression in peripheral blood mononuclear cells blood (PBMC)

Official Title
-----------------
GR Defect in Peripheral Blood Mononuclear Cells in COPD

Conditions
-----------------
Chronic Obstructive Pulmonary Disease

Intervention / Treatment
-----------------
* Procedure: blood test


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients with severe (stage III, Gold) to very severe (stage IV, GOLD) COPD or subjects who are healthy smokers or subjects who are non-smokers Written informed consent Exclusion Criteria: Current upper respiratory tract infections Any significant disease or disorder (e.g. cardiovascular, pulmonary (other than asthma), gastrointestinal, liver, renal, neurological, musculoskeletal, endocrine, metabolic, malignant, psychiatric, major physical impairment) which, in the opinion of the investigator, may either put the subject at risk because of participation in the study, or may influence the results of the study, or the subjects ability to participate in the study Subjects not considered capable, as judged by the investigator, of following instructions of the study, e.g. because of a history of alcohol or drug abuse or any other reason

Ages Eligible for Study
-----------------
Minimum Age: 35 Years
Maximum Age: 85 Years

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

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

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

Arms and Interventions

| Intervention/Treatment |
| --- |
|Procedure: blood test|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
Prone Positioning Short-term Effects on Tissue Oxygen Saturation in Critical COVID-19 Patients

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to monitor short-term changes in tissue oxygen saturation and local blood flow as results of changing from supine to prone position in ARDS COVID-19 patients

Detailed Description
-----------------
After obtaining consent to participate in the study, the subjects included in the study will undergo a baseline 15-minute measurement of tissue oxygen saturation (StO2) measured non-invasively on the forearm by means of near-infrared spectroscopy (NIRS). Once a baseline stable StO2 value is obtained, a provocative test, consisting of a transient vascular occlusion, will be performed. The test will allow the obtention of a local metabolic rate, and a StO2 recovery rate after the ischemic stimulus. Tissue oxygenation measurements will be performed in supine position, immediately before changing to prone positioning, and repeated after 20 minutes of stabilization, once in prone position.

Official Title
-----------------
Short-term Effects of Prone Positioning on Tissue Oxygen Saturation, Measured by Near-infrared Spectroscopy, in COVID-19 Patients With Acute Respiratory Distress Syndrome

Conditions
-----------------
ARDS, Human, Covid19

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: COVID-19 patients admitted in the ICU receiving invasive mechanical ventilation and requiring prone positioning for severe hypoxemia management, as decided by the medical team Exclusion Criteria: Severe peripheral vasculopathy Raynaud's syndrome Skin lesions/trauma in upper limbs interfering the placement of the NIRS probe and/or the occlusion tourniquet Deep venous thrombosis in the upper limbs

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 |
| --- | --- | --- |
| Change in tissue oxygenation (StO2) | Tissue oxygenation is measured as percent of oxyhemoglobin over total hemoglobin content in the sensed area (skeletal muscle) | 20 minutes | 
| Change in local hemoglobin content (THC) | THC is measured as microMols | 20 minutes | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Compare changes in tissue oxygenation (StO2) and arterial oxygenation (SaO2) | Arterial oxygenation (SaO2) is obtained from blood gas analysis, from an arterial blood sample, while StO2 is derived from the sensed tissue, by means of NIRS/DCS technology | 20 minutes | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
COVID-19, Tissue oxygenation, ARDS, Prone position
Vitamin D Inadequacy is Associated With Incidence of Type 2 Diabetes

Study Overview
=================
Brief Summary
-----------------
Emerging evidence suggests that vitamin D [25-hydroxyvitamin D; 25(OH)D] may play a role in the etiology of type 2 diabetes. Vitamin D levels are lower in those with type 2 diabetes and impaired glucose tolerance (IGT) compared with those with normal glucose tolerance (NGT). In addition, a few prospective studies have shown a significant inverse association of baseline serum 25(OH)D with incident diabetes. To date, however, the exact mechanisms through which vitamin D affects diabetes risk are not yet fully known, particularly whether vitamin D plays a role in insulin resistance (IR) and/or b-cell dysfunction, the main pathophysiological disorders underlying type 2 diabetes. So, the investigators plan to examine the prospective associations of baseline vitamin D [25-hydroxyvitamin D; 25(OH)D] with insulin resistance (IR), b-cell function, and glucose homeostasis in subjects at risk for type 2 diabetes.

Official Title
-----------------
Vitamin D Inadequacy is Associated With Incidence of Type 2 Diabetes

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

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: one or more risk factors for diabetes, including: obesity hypertension dislipidemia a family history of diabetes Exclusion Criteria: previous diagnosed diabetes vitamin D supplement.

Ages Eligible for Study
-----------------
Minimum Age: 30 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 |
| --- | --- |
| Diabetes high risk group<br> | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Incidence of diabetes | Incidence of diabetes defined by American Diabetes Association criteria | 5 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pancreatic beta cell function | Pancreatic beta cell function assessed by homeostasis model | 5 years | 
| Insulin resistance | Insulin resistance assessed by homeostasis model | 5 years | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Vitamin D, Diabetes, pancreas beta cell function, insulin resistance, Deficiency of Vitamin D3
Evaluation of a Pro-Active Dynamic Accommodating Socket

Study Overview
=================
Brief Summary
-----------------
The primary objective of this study is to assess the effectiveness of the pro-active dynamic socket (PADS) on increasing socket comfort and fit for transfemoral and transtibial amputees during ambulation and rest, addressing residual limb volume fluctuations with a controlled flow bladder system.

Detailed Description
-----------------
The purpose of this study is to compare a pro-active dynamic socket to each user's everyday ischial containment socket in above-knee amputees, or transtibial socket in below-knee amputees. It is the goal for the pro-active dynamic socket to alleviate high pressure on the residual limb and improve socket fit and comfort. The pro-active dynamic socket contains bladders that can inflate and deflate throughout the gait cycle to appropriate levels of pressure to improve socket fit. These improvements will be confirmed by pressure measurements on the distal end of the residual limb, the ischium, and the bladders located around the socket walls.

Conditions
-----------------
Amputation

Intervention / Treatment
-----------------
* Device: Pro Active Dynamic Accommodating Socket


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: transfemoral or transtibial amputation unilateral or bilateral amputation stable residual limb volume read, write, and speak English for proper consent and responding to questionnaire Exclusion Criteria: evidence or history of residual limb skin conditions such as irritation or sores presence of phantom limb pain

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?
-----------------

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| lower limb amputees<br> | Device: Pro Active Dynamic Accommodating Socket<br>* Socket with bladders that instantaneously adjusts to volume fluctuations in the residual limb<br>|

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
-----------------
prosthetic socket, residual limb volume fluctuation, instantaneous bladder
The Importance of Lateral Internal Sphincterotomy Incision: Parallel or Vertical

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to determine effective incision type for the treatment of chronic anal fissures.

Detailed Description
-----------------
The lateral internal sphincterotomy (LIS) technique is considered the optimal surgical treatment for chronic anal fissures (CAFs); however, questions remain regarding the best technique. The present study investigated whether the type of anoderm incision (vertical or parallel to the anus) affected wound healing, wound-related complications, incontinence and recurrence rates in CAF patients undergoing open LIS.

Official Title
-----------------
Incision Type for Lateral Internal Sphincterotomy

Conditions
-----------------
Anal Fissure

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients undergoing open lateral internal sphincterotomy for chronic anal fissure Exclusion Criteria: Younger than 18 and older than 65 years of age, patients who had undergone no previous medical treatment, patients with a history of perianal interventions, patients with inflammatory bowel disease, diabetic patients, patients on steroids and immunosuppressives, patients with collagen tissue diseases, mentally retarded patients and patients with malignant disorders.

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 65 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 |
| --- | --- |
| Chronic anal fissures<br>Group A: with vertical incision Group B: with parallel incision | |
| Parallel incision, vertical insicion<br> | |

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
-----------------
Lateral internal sphincterotomy, Anal fissure, Surgical technique, Incision, Wound healing
Gastric Swab for Helicobacter Pylori Detection

Study Overview
=================
Brief Summary
-----------------
A randomized controlled trial for comparing the Helicobacter pylori test using the swap method and the method using the conventional biopsy.

Detailed Description
-----------------
The aim of this study is to conduct a prospective study under the hypothesis that a cotton swab method in the rapid urease test is not inferior to the conventional biopsy.

Official Title
-----------------
A Prospective Comparison of Cotton Swab Method and Conventional Biopsy Sampling in Rapid Urease Test for Helicobacter Pylori Detection

Conditions
-----------------
Helicobacter Pylori Infection

Intervention / Treatment
-----------------
* Diagnostic Test: swab RUT


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Adults aged 20-80 Patients who undergo esophagogastroduodenoscopy and need for investigation of Helicobacter pylori infection. Exclusion Criteria: Surgical history of any kind of gastrectomy Patients with contraindication of esophagogastroduodenoscopy

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?
-----------------

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: Tissue<br>conventional RUT using biopsied tissue | Diagnostic Test: swab RUT<br>* rapid urease test using swab instead of biopsied tissue<br>|
| Experimental: Swab<br>RUT using swab | Diagnostic Test: swab RUT<br>* rapid urease test using swab instead of biopsied tissue<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Accuracy | Accuracy of diagnosis for Helicobacter pylori infection | the same day wtih EGD | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| sensitivity, false positive, false negative rate, etc. |  | the same day wtih EGD | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Helicobacter Pylori, rapid urease test, swab
Resistance on Antithrombotic Drugs in Ischemic Heart Disease

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to determine whether aspirin and clopidogrel resistance measured with Multiplate function analyser has a good correlation with incidence of major adverse cardiac events in patients with coronary artery disease (CAD).

Detailed Description
-----------------
Our plan is to enroll 180 patients with diagnosed CAD who electively undergo percutaneous coronary intervention (PCI). Blood samples will be taken just before the procedure and one day after the procedure and analysed on Multiplate function analyser. Assessing aspirin and clopidogrel resistance incidence using Multiplate platelet function analyzer we will also try to find resistance correlation with the incidence of major adverse cardiac events in a one year follow up.

Official Title
-----------------
Assessment of Aspirin and Clopidogrel Resistance in Ischemic Heart Disease Using Multiplate Function Analyser and it's Correlation With Major Adverse Cardiac Events

Conditions
-----------------
Coronary Artery Disease

Intervention / Treatment
-----------------
* Procedure: PCI


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Elective PCI > 7 days on aspirin 100mg therapy before the intervention > 7 days on clopidogrel 75mg therapy before the intervention Exclusion Criteria: Loading dose of clopidogrel < 7 days on aspirin therapy before the intervention Myocardial infarction less than 30 days before the intervention Cerebrovascular incident less that three months before the intervention Haemorrhagic diathesis Trc < 100 Htc < 30% Creatinine > 140
Sexes Eligible for Study
-----------------
All

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Resistant<br>patients who are resistant to standard antithrombotic drugs | Procedure: PCI<br>* percutaneous coronary intervention in stable coronary artery disease<br>* Other names: balloon dilatation;|
| Nonresistant<br>patients who are not resistant to standard dual antithrombotic drugs | Procedure: PCI<br>* percutaneous coronary intervention in stable coronary artery disease<br>* Other names: balloon dilatation;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Major adverse coronary event |  | 12 months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
aspirin resistance, coronary artery disease, clopidogrel resistance, major adverse cardiac events, multiplate platelet function analyser, percutaneous coronary intervention