linjc16/ctgov huggingface dataset:
Evaluate Relative Bioavailability of PA32540 (Asa/Omeprazole), Its Aspirin Component, and Ecotrin® in Healthy Volunteers

Study Overview
=================
Brief Summary
-----------------
Study to determine a single dose bioavailablity of PA32540 is similar to EC aspirin 325 mg with respect to salicylic acid.

Official Title
-----------------
A Phase 1, Open-Label, Randomized, 3-Way Crossover Study to Evaluate the Relative Bioavailability of a Single Oral Dose of Aspirin Administered as PA32540 (Aspirin/Omeprazole) or as the Aspirin Component of PA32540 or as Ecotrin® 325 mg in Healthy Volunteers

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

Intervention / Treatment
-----------------
* Drug: PA32540
* Drug: aspirin component of PA32540
* Drug: Ecotrin


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Standard for PK Ages 18-55 years old Males and females Exclusion Criteria: Standard for PK

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

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 1<br>Single oral dose of 325 mg aspirin administered as PA32540 | Drug: PA32540<br> <br> |
| Experimental: 2<br>aspirin core | Drug: aspirin component of PA32540<br>* The 325 mg aspirin component of PA32540<br>|
| Active Comparator: 3<br>active | Drug: Ecotrin<br>* 325 mg Ecotrin<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
-----------------
PK
Brain Natriuretic Peptide (BNP) Levels in Patients in Non Invasive Mechanical Ventilation

Study Overview
=================
Brief Summary
-----------------
The purpose of the study is to evaluate variation of BNP in non invasive mechanical ventilated patients with severe acute respiratory failure.

Detailed Description
-----------------
The aim of the study is to evaluate in patients with severe acute respiratory failure requiring non invasive mechanical ventilation BNP levels at admission and during the following 24 hours during non invasive mechanical ventilation (Non Invasive Positive Pressure Ventilation or Continuous positive airway pressure). Because in patients affected by acute respiratory failure it is often difficult to distinguish if the disease precipitating the respiratory failure is a cardiac disease or a lung disease, aim of the present study is to evaluate the discriminating role that BNP could have in this group of patients; evaluation will be completed, once obtained clinical stabilisation, with an echocardiography and respiratory functional test.

Official Title
-----------------
Evaluation of BNP in Patients With Severe Acute Respiratory Failure Requiring Non Invasive Mechanical Ventilation

Conditions
-----------------
Respiratory Insufficiency

Intervention / Treatment
-----------------
* Procedure: Non invasive mechanical ventilation


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Severe respiratory distress (use of respiratory accessory muscles); Respiratory rate > 25 per minute; Respiratory acidosis (pH < 7.35 and PaCO2 > 45 mmHg); PaO2/FiO2 < 250 Exclusion Criteria: Age < 18 years; Facial deformities; Pneumothorax; Shock or systolic arterial pressure below 90 mmHg with amine infusion; Life-threatening arrhythmias; Need for immediate endotracheal intubation (PaO2/FiO2 < 100 with FiO2 100%, respiratory rate < 10, GCS < 8); Lack of co-operation from the patient; Recent esophageal-gastric surgery; Inability to clear secretions; Drugs that may interfere with BNP secretion; Severe obesity; Hepatic cirrhosis with ascitis; Endocrine disease.

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 90 Years

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

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

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

Arms and Interventions

| Intervention/Treatment |
| --- |
|Procedure: Non invasive mechanical ventilation|nan|

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
-----------------
Natriuretic peptide brain, Continuous positive airway pressure, Intermittent positive pressure breathing, Respiratory insufficiency
The Neuropsychiatric Evaluation of HIV-Positive and Negative Drug Using Individuals: Study 215

Study Overview
=================
Brief Summary
-----------------
The lack of success in treating substance abuse may be contributed to by a limited understanding of the clinical neurobiology of drug abuse. A better understanding of such deficits might aid in the development of more relevant pharmacological and psychosocial treatment approaches. Thus, the purpose of this study is to test the hypothesis that repetitive illicit drug use may be associated with cortical and subcortical structural abnormalities, vascular abnormalities, as well as neuropsychological decrements. Additionally, a battery of psychological tests are administered to provide information about demographics, drug use, neurocognitive measures, and personality structures....

Detailed Description
-----------------
The lack of success in treating substance abuse may be contributed to by a limited understanding of the clinical neurobiology of drug abuse. A better understanding of such deficits might aid in the development of more relevant pharmacological and psychosocial treatment approaches. Thus, the purpose of this study is to test the hypothesis that repetitive illicit drug use may be associated with cortical and subcortical structural abnormalities, vascular abnormalities, as well as neuropsychological decrements. Additionally, a battery of psychological tests are administered to provide information about demographics, drug use, neurocognitive measures, and personality structures.

Official Title
-----------------
The Neuropsychiatric Evaluation of HIV-Positive and Negative Drug Using Individuals: Study 215

Conditions
-----------------
HIV Infections

Participation Criteria
=================
Eligibility Criteria
-----------------
Data analysis protocol
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
-----------------
HIV Positive
The Need for Luteal Support in NC-FET

Study Overview
=================
Brief Summary
-----------------
The investigators are going to examine prospectively the need of luteal support after NC-FET.

Detailed Description
-----------------
The investigators are going to examine retroprospectively the need of luteal support after NC-FET in IVF cycle. One arm will receive luteal support after NC FET with vaginal tablet of Endometrin 100 mg twice a day after ET. The second arm will not. We are going to evaluate the pregnancy and implantation rate.

Official Title
-----------------
The Use of Luteal Support After NC-FET

Conditions
-----------------
Abnormal Menstrual Cycle

Intervention / Treatment
-----------------
* Drug: Vaginal tablet Endometrin twice a day


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Women under 39 years old, regular menstruation going through IVF NC-FET Exclusion Criteria: NO

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 39 Years

Sexes Eligible for Study
-----------------
Female

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

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

Design Details

Primary Purpose: Supportive Care
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: Vaginal tablet Endometrin twice a day|Endometrin 100 mg twice a day|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pregnancy rate | We would like to investigate whether there is need for luteal support in NC-FET cycle. | 4 weeks |
Elimination of CD4+CD25+ Regulatory T Cells in Patients With Hepatocellular Carcinoma

Study Overview
=================
Brief Summary
-----------------
It has been shown that patients with advanced HCC have an increased frequency of CD4+CD25+ regulatory T cells. These cells might suppress tumor-specific immune responses. Cyclophosphamide has been shown to reduce the frequency of CD4+CD25+ regulatory T cells. The aim of this study is to test if the treatment with cyclophosphamide leads to a decrease in the frequency of CD4+CD25+ regulatory T cells and to increase tumor specific immune responses in patients with advanced HCC.

Official Title
-----------------
Elimination of CD4+CD25+ Regulatory T Cells in Patients With Advanced HCC After Treatment With Cyclophosphamide

Conditions
-----------------
Advanced HCC

Intervention / Treatment
-----------------
* Drug: Cyclophosphamide


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: adequate WBC adequate liver and kidney function no immunodeficiency ECOG < 2 Exclusion Criteria: advanced liver cirrhosis severe cardiopulmonary diseases

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: Cyclophosphamide|150 - 250 - 350 mg|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Frequency of CD4+CD25+regulatory T cells |  | within 8 weeks | 
| Tumor specific immune responses |  | within 12 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Toxicity |  | within 8 weeks | 
| Function and Phenotype of CD4+CD25+ regulatory T cells |  | within 12 weeks | 
| Tumor response |  | within 12 weeks | 
| Survival |  | 6 months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
HCC, T cell
An Observational Study on the Prevalence of Human Papillomavirus Types in Women in the Kingdom of Bahrain

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to determine the Human Papillomavirus (HPV) prevalence and HPV type distribution among women ≥ 20 years of age attending routine cervical screening and among women ≥ 16 years of age presenting for post-natal check up in the Kingdom of Bahrain.

Official Title
-----------------
An Observational, Epidemiological Study on the Prevalence of Human Papillomavirus (HPV) Types in Women in the Kingdom of Bahrain

Conditions
-----------------
Human Papillomavirus Infection

Intervention / Treatment
-----------------
* Procedure: Endocervical samples


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Women ≥ 20 years of age attending a clinic for routine cervical screening OR Women ≥ 16 years of age presenting for post-natal check-ups Women providing a cervical sample Written informed consent or oral-witnessed thumb printed informed consent obtained from the subject Exclusion Criteria: Referral for abnormal cervical sample at the current visit Abundant menstrual bleeding or vaginal discharge not allowing appropriate screening to be performed (Note: Enrolment can be delayed until this condition is resolved) Pregnant women History of hysterectomy Known diagnosis of immunosuppression, or patient on immunosuppressives Having received one or more doses of human papillomavirus vaccine prior to participating in the study

Ages Eligible for Study
-----------------
Minimum Age: 16 Years

Sexes Eligible for Study
-----------------
Female

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Assessed Cohort<br>Subjects attending out-patient health services for routine cervical screening or presenting for post-natal check up | Procedure: Endocervical samples<br>* Endocervical samples collection during routine gynaecological examinations<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Prevalence of any Human Papillomavirus (HPV) deoxyribonucleic acid (DNA) and HPV type distribution among women undergoing cervical sample testing and post-natal check up. |  | Average time frame: 12 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Prevalence of any HPV DNA and HPV type distribution among women of different age strata undergoing cervical sample testing and post-natal check up. |  | Average time frame: 12 months | 
| Behavioural risk factors |  | During visit 1 (day 0) | 
| Awareness of HPV in relation to transmission and cause of cervical cancer |  | Average time frame: 12 months |
Immune Checkpoint Inhibitors and Atherosclerotic Plaque Volume

Study Overview
=================
Brief Summary
-----------------
In this study, investigators plan to test whether Immune Checkpoint Inhibitor (ICI) treatment leads to an accelerated progression of atherosclerosis in patients with lung cancer. Atherosclerosis is an immune-mediated inflammatory disease and these same checkpoints being targeted for cancer are critical negative regulators of atherosclerosis in animal and cellular models. Aortic plaque progression will be compared between cases (on ICI) and controls from pre-ICI to post-ICI among patients with non-small cell lung cancer. Groups will be matched for age, cancer type and stage and cardiovascular risk factors. Traditional markers of cardiovascular (CVD) risk and cancer-specific factors (ICI mono- and combination therapy, number of cycles, occurrence of immune-related adverse events, chest radiation, steroid use) will be associated with the change in aortic plaque volume.

Official Title
-----------------
Immune Checkpoint Inhibitors and Atherosclerotic Plaque Volume in Patients With Non-Small Cell Lung Cancer: A Case-Control Study

Conditions
-----------------
Non-small Cell Lung Cancer

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Cases: Subjects with non-small cell lung cancer treated with Immune Checkpoint Inhibitors. Available contrast enhanced CT scans of the chest both immediately pre-ICI (< 1 month) and latest follow-up. Controls: Subjects with non-small cell lung cancer, age, cancer stage and cardiovascular risk factor matched to cases. Available contrast enhanced CT scan of the chest at two time-points at a similar interval between scans as the cases. Exclusion Criteria: none

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 aortic plaque volume | The change of plaque burden after starting ICIs will be calculated and compared with the pre-ICI study. The change in plaque burden in controls will be calculated and compared from two studies at a similar median interval as ICI cases. | Three years | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Non-small Cell Lung Cancer, Immune Checkpoint Inhibitor, Atherosclerosis
Tissue Sectioning by Electro-Dissociation

Study Overview
=================
Brief Summary
-----------------
Currently there is no technique to produce thin (0.004-0.01 mm) serial sections of large fresh tissue specimens that are suitable for high-resolution in situ protein/gene expression studies without ice artifact or fixation-induced molecular damage. Traditional frozen sectioning preserves protein and nucleic acid structure, but the inherent ice artifact precludes reconstruction of protein and mRNA expression patterns in 3-dimensions. Since the limitations of the existing sectioning techniques result from the fact that they rely on mechanical cutting which in turn require the tissue to be stiff, we suggest a new approach to cut tissue via an electro erosion process that utilizes focus radio frequency (RF).

Official Title
-----------------
Tissue Sectioning by Electro-Dissociation

Conditions
-----------------
Thin Sections, Fresh Unfixed Tissues, Fresh Unfrozen Tissues

Intervention / Treatment
-----------------
* Other: Tissue Sectioning via Electro Erosion Process


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Fresh Tissue Unfrozen Tissue Unfixed Tissue Exclusion Criteria: Unfresh Tissue Frozen Tissue Fixed Tissue
Sexes Eligible for Study
-----------------
All

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

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

Arms and Interventions

| Intervention/Treatment |
| --- |
|Other: Tissue Sectioning via Electro Erosion Process|Focused RF energy can be used to produce consecutive thin sections of fresh tissue for immunohistochemical and nucleic acids analysis by electro-dissociation without thermal damage, ultimately allowing high resolution reconstruction of gene and protein expression patterns of large tissue specimens in 3D.|

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
-----------------
Histology, Immunohistochemical, Gene Expression, Tissue Sectioning
ReSure Sealant Post Approval Study

Study Overview
=================
Brief Summary
-----------------
This is a prospective multicenter observational post-approval registry study that will collect post-approval data relative to the incidence of pre-specified Adverse Ocular Events for cataract surgery patients treated with the FDA-approved ReSure Sealant when used by a broad group of physicians under commercial use conditions.

Official Title
-----------------
ReSure Sealant Post-Approval Study: A Registry Evaluation of ReSure Sealant for Specified Adverse Ocular Events After Sealing Corneal Incisions in Patients Undergoing Clear Corneal Cataract Surgery

Conditions
-----------------
Adverse Events

Intervention / Treatment
-----------------
* Device: ReSure Sealant


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Subject has a cataract and is expected to undergo clear corneal cataract surgery with intraocular lens placement Exclusion Criteria: ReSure Sealant is not applied to the operative eye

Ages Eligible for Study
-----------------
Minimum Age: 22 Years

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

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

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

Arms and Interventions

| Intervention/Treatment |
| --- |
|Device: ReSure Sealant|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Anterior chamber cells greater than level 1+ persisting at Visit 2 (≥ Day 20) |  | Post operative days 20 to 40 | 
| Hypotony (≤ 5 mmHg) |  | Post operative days 20 to 40 | 
| Ocular discomfort | Ocular Comfort Index score greater than 51.7 or a within-person increase from baseline of greater than 37.8 | Post operative days 20 to 40 | 
| Surgical reintervention | Surgical reintervention for management of a wound leak - Yes or No | Post operative days 20 to 40 |
Comparison of Doubled Quadrupled Versus Quadrupled Allograft Tissue Constructs for Anterior Cruciate Ligament (ACL) Reconstruction

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to compare two different soft tissue allografts, double bundle tibialis anterior allograft or quadruple bundle hamstring allograft, used in repairing a torn anterior cruciate ligament (ACL) of the knee.

Official Title
-----------------
A Prospective Randomized Comparison of Doubled Versus Quadrupled Allogenic Tissue Constructs for Anterior Cruciate Ligament Reconstruction

Conditions
-----------------
Anterior Cruciate Ligament, Injury

Intervention / Treatment
-----------------
* Procedure: ACL reconstruction


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: ACL injury is the primary limitation to activities of daily living. Exclusion Criteria: Multiple current ligamentous injuries to the knee. Revision reconstruction of the ACL. Uncorrected instability of the ACL on the opposite knee.

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: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Quadrupled Hamstring Allograft<br> | Procedure: ACL reconstruction<br>* Randomized comparison of two different allogenic tissue types, quadrupled hamstring or doubled tibialis anterior, for anterior cruciate ligament repair.<br>|
| Active Comparator: Doubled Tibialis Anterior Allograft<br> | Procedure: ACL reconstruction<br>* Randomized comparison of two different allogenic tissue types, quadrupled hamstring or doubled tibialis anterior, for anterior cruciate ligament repair.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Knee outcome scores | The change of physical function and pain as evaluated by patient reported outcome measures (Knee injury and Osteoarthritis Outcome Score (KOOS), International Knee Documentation Committee (IKDC) score). | One year | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
anterior cruciate ligament tear, ACL, ligament, knee, allograft