linjc16/ctgov huggingface dataset:
PK Study of Tacrolimus and Cyclosporine When Co-Administered With Adefovir Dipivoxil in Post-Liver Transplant Patients

Study Overview
=================
Brief Summary
-----------------
Open-label pharmacokinetic drug interaction study.

Detailed Description
-----------------
Multi-center, phase 2, open-label, sequential-cohort, drug interaction study. Cohort 1 subjects (tacrolimus and adefovir dipivoxil) were enrolled first. Based on the findings in Cohort 1, a decision was made on whether to enroll subjects in Cohort 2 (cyclosporine and adefovir dipivoxil)(i.e., if no interaction was observed in Cohort 1, Cohort 2 subjects would not be enrolled). Since no pharmacokinetic interaction was observed in Cohort 1, Cohort 2 was not enrolled.

Official Title
-----------------
A Multi-Center Phase 2, Open-Label Study to Evaluate the Pharmacokinetics of Tacrolimus and Cyclosporine When Co-Administered With Adefovir Dipivoxil 10 mg to Patients Post-Liver Transplantation

Conditions
-----------------
Hepatitis B

Intervention / Treatment
-----------------
* Drug: Adefovir Dipivoxil


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: 18-65 years of age Greater than or equal to 6 months post-liver transplantation Must be on a documented stable total daily dose of tacrolimus or cyclosporine for three months. Must have calculated creatinine clearance greater than or equal 50 mL/min (Cockcroft-Gault method).

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

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 |
| --- | --- |
| Other: Treatment Arm 1<br>Adefovir dipivoxil 10 mg once daily with tacrolimus or cyclosporine for 14 days | Drug: Adefovir Dipivoxil<br>* Adefovir dipivoxil 10 mg once daily for 14 days co-administered with tacrolimus or cyclosporine<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To evaluate pharmacokinetics of tacrolimus or cyclosporine when co-administered with adefovir dipivoxil 10 mg once daily to patients post-liver transplantation |  | 21 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To evaluate PK of ADV 10 mg once daily when co-administered with tacrolimus or cyclosporine in patients post-liver transplantation. To evaluate the safety of ADV 10 mg once daily, when co-administered with tacrolimus or cyclosporine for 14 days. |  | 21 days | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Hepatitis B, Post-Liver Transplantation, Adefovir Dipivoxil, Tacrolimus, Cyclosporine
Comparison of Foley Balloon With or Without Traction for the Cervical Ripening

Study Overview
=================
Brief Summary
-----------------
We will compare the use of foley bulb catheters placed in the cervix for ripening of the cervix for labor induction,.

Detailed Description
-----------------
One arm will have the foley balloon placed alone in the cervix. And one arm will have the foley balloon placed in the cervix and then attached to a weight (1000 cc Iv Bag of fluid). Our hypothesis is that the weighted balloon will be more effective than the non-weighted balloon in the ripening of the cervix for induction of labor

Official Title
-----------------
Comparison of Foley Balloon With or Without Traction for the Cervical Ripening

Conditions
-----------------
Pregnancy

Intervention / Treatment
-----------------
* Device: foley balloon only
* Device: foley balloon with weight attached


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Term pregnancy scheduled for induction of labor Exclusion Criteria: Preterm pregnancy that require induction for fetal indications

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 45 Years

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

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: FoleyBalloon<br>foley balloon placed in the cervix | Device: foley balloon only<br>* place foley balloon only in cervix<br>|
| Active Comparator: foley balloon with weight<br>foley balloon with weight attached | Device: foley balloon with weight attached<br>* foley balloon with 1000cc IV bag attached<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Time to effectively ripen cervix |  | to effective cervical ripening | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
pregnancy, induction of Labor, Cervical ripening, Foley balloon
Arteriovenous Fistula Tissue Bank for Pre- and Post-Fistula Placement Specimens

Study Overview
=================
Brief Summary
-----------------
This project will bank sera, DNA and vascular specimens from patients undergoing arteriovenous fistula creation and revision.

Detailed Description
-----------------
Hemodialysis patients utilizing an arteriovenous fistula (AVF) for hemodialysis access are 10 times less likely to develop bacteremia than those patients utilizing a hemodialysis catheter. Because of this, a great focus has been on placing AVF in all patients undergoing hemodialysis. While AVF are relatively simple to place from a surgical standpoint, 30-60% of AVF will not mature adequately to be used for hemodialysis. In order to be utilized for hemodialysis, the blood flow in the vein used to create the AVF will need to increase by over 100 fold. In order to do so, the vein will need to dilate by more than 150%. AVF which fail to mature do not dilate, and the major histologic finding in these AVF has been neointimal hyperplasia. The factors (both circulating and tissue) which contribute to AVF maturation or failure are poorly understood, and investigations in this area are limited. Current studies in the literature have either described pre-AVF vein characteristics, or have looked at serum or tissue specimens following AVF failure. To date, no studies have looked at specimens from patients both before and after fistula placement, or described factors associated with fistula maturation. This project will bank sera, DNA and vascular specimens from patients undergoing arteriovenous fistula creation and revision.

Official Title
-----------------
Arteriovenous Fistula Tissue Bank for Pre- and Post-Fistula Placement Specimens

Conditions
-----------------
Kidney Failure, Chronic

Intervention / Treatment
-----------------
* Other: Biologic specimens


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Age 19 years of age or greater Arteriovenous fistula placement for hemodialysis access scheduled within 30 days Exclusion Criteria: Incompetent to provide informed consent

Ages Eligible for Study
-----------------
Minimum Age: 19 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 |
| --- | --- |
| Arteriovenous Fistula<br>A tissue bank will be created to collect serum, whole blood, and vein specimens obtained from participants undergoing Arteriovenous Fistula (AVF) placement and revision. The planned specimen harvests will allow for both pre- and post-AVF placement specimens from both maturing and failing AVF. | Other: Biologic specimens<br>* Banking of serum, DNA and tissue<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
-----------------
Hemodialysis, Vascular access, Arteriovenous fistula
Characterization of the Microbiome in Cutaneous T Cell Lymphoma

Study Overview
=================
Brief Summary
-----------------
Investigators plan to perform a pilot study that aims to characterize the microbiome of human cutaneous T cell lymphoma patients and compare this to the microbiome of age and sex matched controls.

Official Title
-----------------
Characterization of the Microbiome in Cutaneous T Cell Lymphoma

Conditions
-----------------
Cutaneous T Cell Lymphoma

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Group 1: Patients with stage IA-IIA cutaneous T cell lymphoma Group 2: Patients with stage IIB and above cutaneous T cell lymphoma Group 3: Patients with CD30+ lymphoproliferative disorder including lymphomatoid papulosis and cutaneous anaplastic large cell lymphoma Group 4: Patients with plaque psoriasis with BSA>5% on routine phototherapy per standard of care Group 5: Patients with moderate to severe atopic dermatitis on routine bleach bath therapy per standard of care Group 6: Healthy individuals without the above skin conditions, similar age and sex distribution to the patients with cutaneous T cell lymphoma All Groups: subjects who are age 18-89 years of age at time of enrollment All Groups: Subjects who are able and willing to give informed consent for this study and the Dermatology Tissue Acquisition and Biorepository (STU00009443). Exclusion Criteria: All Groups: Subjects who are younger than 18 years of age or older than 90 years of age All Groups: Subjects who are unable to give consent Patients currently on systemic antibiotics or recent (within past 4 weeks) exposure to systemic antibiotics We will not recruit the following populations: adults unable to consent, individuals who are not yet adults (infants, children, teenagers), pregnant women, prisoners and other vulnerable populations.

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 89 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 |
| --- | --- |
| Stage IA-IIA cutaneous T cell lymphoma<br> | |
| Stage IIB and above cutaneous T cell lymphoma<br> | |
| CD30+ lymphoproliferative disorders<br> | |
| Plaque psoriasis with BSA>5% on routine phototherapy<br> | |
| Moderate to severe atopic dermatitis on routine bleach bath<br> | |
| Healthy controls<br> | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Bacterial diversity index | Diversity analysis of microbiome samples (measured by number of bacteria species/sample) | 3 months |
Effects of Smoking State on Decision Making

Study Overview
=================
Brief Summary
-----------------
Adult smokers will be tested using behavioral and neuroimaging measures after smoking as usual and after overnight abstinence.

Official Title
-----------------
Effects of Smoking State on Effort-based Decision Making

Conditions
-----------------
Behavior

Intervention / Treatment
-----------------
* Other: smoking abstinence
* Other: smoking satiety


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Aged 18-55 years Smokes cigarettes or e-cigarettes Negative urine drug screen Exclusion Criteria: Unstable or serious medical or mental health condition History of serious head trauma Pregnancy Unsuitable for MRI Weight > 350 pounds (maximum allowed for MRI)

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
Intervention Model: Single Group Assignment
Interventional Model Description: Participants will be instructed to smoke as usual before one fMRI study visit (satiated state) and to abstain from using all tobacco/nicotine for 12 hours before the other fMRI study visit (abstinence and/or withdrawn state). The order of the satiated and abstinence/withdrawn study visits will be randomized and counterbalanced across participants.
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: All Subjects<br>for the abstinence intervention, 12+ hours after smoking will be assessed before assessments following smoking as normal For the satiated intervention, smoking as normal will be assessed first before assessments following 12+ hours of abstinence from smoking | Other: smoking abstinence<br>* participants will be asked to not smoke for at least 12 hours<br>Other: smoking satiety<br>* participants will be asked to smoke as usual<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Effort based decision making | number of high effort selections | through study completion, an average of 1 year | 
| Distress tolerance behavior | duration on measures of distress tolerance | through study completion, an average of 1 year | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Decision making
Preoxygenation With Optiflow™ - the Effect of Speech on Lung Oxygenation.

Study Overview
=================
Brief Summary
-----------------
If a patient speaks during the process of preoxygenation with high-flow nasal oxygen via the Optiflow™ system, is the efficacy reduced as measured by end-tidal lung oxygen content?

Detailed Description
-----------------
This is a randomised controlled trial on 34 patients undergoing routine elective surgery at the Princess Anne Hospital, Southampton. The study will take place from September 2018 to January 2019 and involve preoxygenating all participants for three minutes using the Optiflow™ device. During this time, participants will be instructed to either read aloud a standardised text or to breathe through their nose with a closed mouth. At the end of 3 minutes, the primary outcome, ETO2, will be measured and recorded.

Official Title
-----------------
Preoxygenation With High Flow Nasal Oxygenation Using Optiflow - Does Speech Have an Effect on The End Tidal Oxygen Achieved When Compared to Closed Mouth Nasal Breathing?

Conditions
-----------------
Unrecognized Condition

Intervention / Treatment
-----------------
* Device: Optiflow


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: BMI 18-35, ASA category 1 or 2 Exclusion Criteria: Inability to read/ follow instructions, Heavily sedated

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 65 Years

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

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

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

Design Details

Primary Purpose: Health Services Research
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Patients were assigned to either the 'Speech' arm or 'Non-speech' arm of the study
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Speech<br>Participants were asked to read a standardised script aloud for 3 minutes whilst receiving oxygen from the Optiflow device. At the end of 3 minutes End Tidal Oxygen was measured and recorded. | Device: Optiflow<br>* 45l.min oxygen<br>* Other names: HFNO, High Flow Nasal Oxygen;|
| Active Comparator: Non-speech<br>Participants were asked to breathe in and out of their nose for 3 minutes, with a closed mouth, whilst receiving oxygen from the Optiflow device. At the end of 3 minutes End Tidal Oxygen was measured and recorded. | Device: Optiflow<br>* 45l.min oxygen<br>* Other names: HFNO, High Flow Nasal Oxygen;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| End Tidal Oxygen Fraction | Oxygen fraction in first expired breath post preoxygenation | At the end of 3 minutes preoxygenation | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Optiflow, High Flow Nasal Oxygen, Preoxygenation, Speech
Lung Ultrasound Signs and Patterns in COVID-19 Pregnant Women

Study Overview
=================
Brief Summary
-----------------
SARS-CoV-2 impact on pregnant women is not well known yet. Some authors demonstrated that lung ultrasound can give similar results if compared to chest computed tomography and better results if compared to chest x-rays without radiations and limited risks for mother and fetus. The Lung Ultrasound Score (LUS) can be used to asses the entity and monitor the evolution of lung impairment. Some authors described an artifact, the light beam, as a typical ultrasound sign in COVID-19 positive patients. With our study we hypothesize to understand the prevalence of this sign and other ultrasound signs in pregnant COVID-19 positive patients.

Official Title
-----------------
Lung Ultrasound Signs and Patterns in COVID-19 Pregnant Women - The PINK-CO Protocol

Conditions
-----------------
Pregnancy Complications, Covid19

Intervention / Treatment
-----------------
* Diagnostic Test: Lung ultrasound


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: All pregnant COVID 19 positive patients admitted at our institution who had lung ultrasound performed Exclusion Criteria: are < 18 years old history of rheumatic disease history of spontaneous pneumothorax fibrothorax history of thoracic surgery no consent given

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

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

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

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

Arms and Interventions

| Intervention/Treatment |
| --- |
|Diagnostic Test: Lung ultrasound|Lung ultrasound signs in Covid 19 positive pregnant patients|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Light Beam | Evaluate the prevalence of the light beam sign | 24 hours after admission | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Ultrasound patterns | Evaluate the prevalence of ultrasound signs and patterns during pregnancy | 24 hours after admission | 
| Lung ultrasound score | Evaluate if the Lung ultrasound score relates with the clinical presentation of the patient | 24 hours after admission | 
| Illness severity | Evaluate if the lung ultrasound score relates with the prognosis | 24 hours after admission | 
| Length of stay | Evaluate if the lung ultrasound score relates with the length of stay | 24 hours after admission |
Efficacy and Safety of Colistin for Therapy of Infections Caused by ESBL Producing K.Pneumoniae or E.Coli

Study Overview
=================
Brief Summary
-----------------
In patients with documented ESBL-producing E.coli and Klebsiella pneumoniae will be allocated to receive colistin or conventional antibiotic regimen.

Detailed Description
-----------------
In patients with documented ESBL-producing E.coli and Klebsiella pneumoniae will be allocated to receive colistin or conventional antibiotic regimen.The primary outcome is clinical response and secondary outcomes are microbiological response and adverse events.

Official Title
-----------------
Efficacy and Safety of Colistin for Therapy of Infections Caused by Extended Spectrum Beta-Lactamase(ESBL) Producing Klebsiella Pneumoniae or Escherichia Coli

Conditions
-----------------
Infections

Intervention / Treatment
-----------------
* Drug: Colistin


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Age > 18 yr. Hospitalized to Siriraj Hospital Infections with ESBL-producing E.coli or K.pneumoniae Consent informed consent Exclusion Criteria: Pregnancy or lactating mother Colistin allergy Neurologic diseases

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

| Intervention/Treatment |
| --- |
|Drug: Colistin|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Clinical response |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Microbiological response |  |  | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
ESBL-producing E.coli Infections, ESBL-producing Klebsiella pneumoniae Infections, Colistin