linjc16/ctgov huggingface dataset:
Pharmacokinetics of Anacetrapib (MK0859) in Patients With Hepatic Insufficiency (MK-0859-039)

Study Overview
=================
Brief Summary
-----------------
This study will evaluate the Area Under the Curve (AUC(0 to infinity)) of anacetrapib.

Official Title
-----------------
A Single Dose Study to Investigate the Pharmacokinetics of MK0859 in Patients With Hepatic Insufficiency

Conditions
-----------------
Dyslipidemia

Intervention / Treatment
-----------------
* Drug: anacetrapib


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Female subjects of reproductive potential test negative for pregnancy and agree to use two acceptable methods of birth control throughout the study Subject is in good health Subject agrees to refrain from consumption of red wine, grapefruit, orange and apple juices throughout the study Exclusion Criteria: Patient has a history of cancer Patient is a nursing mother Patient is unable to refrain from or anticipates the use of any prescription or non-prescription medication during the study Patient consumes excessive amounts of alcohol or caffeine Patient has had major surgery, donated blood or participated in another investigational study within the past 4 weeks

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 70 Years

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

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

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 |
| --- | --- |
| Experimental: Part 1 - Group 1<br>Moderate Hepatic Patients | Drug: anacetrapib<br>* single dose administration of anacetrapib (MK0859) 100 mg oral tablet<br>|
| Experimental: Part 1 - Group 2<br>Healthy Subjects | Drug: anacetrapib<br>* single dose administration of anacetrapib (MK0859) 100 mg oral tablet<br>|
| Experimental: Part 2 - Group 1<br>Mild Hepatic Patients | Drug: anacetrapib<br>* single dose administration of anacetrapib (MK0859) 100 mg oral tablet<br>|
| Experimental: Part 2 - Group 2<br>Healthy Subjects | Drug: anacetrapib<br>* single dose administration of anacetrapib (MK0859) 100 mg oral tablet<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Area Under the Curve (AUC(0 to infinity)) of anacetrapib |  | through 168 hours post dose | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Tolerability of a single dose administration of 100mg anacetrapib, measured by the number of clinical and laboratory adverse events |  | through 14 days post dose | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Hepatic Insufficiency
The Effect of Esmolol on Patients With Sepsis

Study Overview
=================
Brief Summary
-----------------
The investigators conduct an RCT to explore the efficacy of esmolol in patients with septic shock and sepsis.

Detailed Description
-----------------
Severe sepsis, septic shock, and their complications have become the major healthcare problem that affects millions of people each year, resulting in high mortality rates. Septic responses have an extremely complex chain of events including inflammatory and anti-inflammatory processes, humoral and cellular reactions, and cardiocirculatory abnormalities. Esmolol may have some potential in treating septic shock and sepsis. The investigators conduct an RCT to explore the efficacy of esmolol in patients with septic shock and sepsis.

Official Title
-----------------
The Effect of Esmolol on Patients With Sepsis

Conditions
-----------------
Sepsis

Intervention / Treatment
-----------------
* Drug: Esmolol
* Drug: Placebo


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: sepsis patients HR>100bpm 6h after admission with CVC and ScvO2>65% Exclusion Criteria: age <18 years, used β-blocker before, cardiac dysrhythmias, need for an inotropic agent, valvular heart disease, hemoglobin>6g/L pregnancy.

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 75 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: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: ES group<br>Patients randomly assigned to the ES group were treated with esmolol to control the heart rate to the target range. | Drug: Esmolol<br>* The protocol required a titrated esmolol infusion commenced at 25 mg/ h, with an upper dose limit of 2000 mg/h, to maintain the HR between 75 and 90 bpm in ES group. The control group were treated with placebo.<br>|
| Placebo Comparator: control group<br>Patients randomly assigned to the control group were treated with placebo. | Drug: Placebo<br>* Placebo<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| REE | Resting energy expenditure | Day 7 after enrollment | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 28-day mortality rate | 28-day mortality rate | Day 28 after enrollment | 
| HR control rate | target heart rate control rate | 24 hours after enrollment | 
| Vasoactive drug administration dose | Vasoactive drug administration dose | Day 1/3/7 after enrollment | 
| Concentration of Lac | Concentration of lactic acid | Day 1/3/7 after enrollment | 
| O2ER | oxygen extraction rate | Day 1/3/7 after enrollment | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
sepsis, septic shock, esmolol
Reliability of Pupil Response to Acute Pain

Study Overview
=================
Brief Summary
-----------------
The purpose of this research study is to test whether researchers can reliably measure the response pupils have when an acute painful stimulus is experienced. Changes in the size of the pupil of the eye can be an indicator of brain activity in a region of the brain that is important for feeling pain.

Detailed Description
-----------------
There is strong rationale to support a role for locus coeruleus (LC) responsivity to acute painful stimuli in regulating speed of recovery after surgery and for LC responsivity as a mechanistic link explaining the risks for slow recovery from weak Conditioned Pain Modulation (CPM), catastrophizing cognitive style, and low enzyme activity catecholamine-O-methyltransferase (COMT) genotype. Preliminary data show feasibility to perform the proposed study. Primary Hypothesis: An observational study of pupil responses to noxious stimuli shows strong intra-individual reliability over 8 weeks. Key secondary hypotheses: Compared to individuals homozygous for val at the val158met site of the catecholamine-O-methyltransferase (COMT) gene, those homozygous for met will show smaller pupil responses to noxious stimuli and weaker CPM.

Official Title
-----------------
Reliability of Pupil Response to Acute Pain

Conditions
-----------------
Pain, Osteoarthritis

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Adult (18-70) Pain from hip or knee arthritis of moderate intensity American Society of Anesthesiologists physical status 1-3 Exclusion Criteria: Inability to complete study questionnaires Pregnancy Litigation or workers compensation related to hip or knee pain Taking > 50 mg morphine equivalents/day History of Raynaud's disease of the feet Psychotic disorder or a recent psychiatric hospitalization History of eye surgery or topical eye medications that would would directly affect pupil diameter

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Osteoarthritis<br>Study population to include adult men and women with osteoarthritis. | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percentage of change in pupil diameter | pupil diameter in response to 5 second presentation of noxious heat stimuli | 8 weeks | 
| Change from Baseline Verbal Pain Scores | Verbal pain scores will be obtained during stimulus presentation | 8 weeks |
Pain Relief in the Emergency Department Waiting Room: a Prevalence Study

Study Overview
=================
Brief Summary
-----------------
Pain in the emergency room is under documented and pain relief suboptimal. Data on nurse driven analgesia in emergency department waiting rooms is lacking. The primary objective of this study is to determine the proportion of patients in pain receiving pain therapy administered by the triage nurse (prevalence study). The secondary objectives are to 1) describe nursing practices in analgesia and adherence to the dedicated protocol; 2) to determine the factors associated with the non administration of painkillers and for these factors, to estimate the strength of the association

Official Title
-----------------
Antalgie à l'Accueil Des Urgences- étude de prévalence

Conditions
-----------------
Acute Pain

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Documented pain score on arrival by the triage nurse and Patients having to wait in the ER waiting room Exclusion Criteria: patients directly admitted to the consultation room patients for whom pain was not recorded

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

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

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Proportion of patients receiving pain medicine in the ER waiting room by the triage nurse after pain documentation |  | 3 month |
Health Status of Workers in Photocopier Units

Study Overview
=================
Brief Summary
-----------------
Photocopiers are indispensable in today's working environment. However, photocopiers emit a number of harmful chemicals during their operation. Photocopier toners also contain a number of potentially toxic substances. Chronic exposure to these substances may compromise the health of photocopier operators. This study is aimed to understand if chronic exposure to photocopier emissions is harmful to human health.

Official Title
-----------------
Correlation Between Pulmonary Function and Selected Serum/Sputum Biomarkers of Pulmonary Damage Among Workers in Photocopier Units

Conditions
-----------------
Exposure to Photocopiers on a Professional Basis

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Exposure to photocopier emissions for minimum 2 years professionally Exclusion Criteria: Any clinical abnormality

Ages Eligible for Study
-----------------
Minimum Age: 20 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 |
| --- | --- |
| photocopier exposure<br> | |
| control<br> | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To assess if photocopier emissions are toxic to human health |  | 2 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To assess the best biomarker for pulmonary damage in serum |  | 2 years |
A Long Term Follow-Up Study of Fabry Disease Subjects Treated With FLT190

Study Overview
=================
Brief Summary
-----------------
Fabry disease is a rare, X-linked inborn error of glycosphingolipid metabolism caused by an abnormal gene encoding the α-galactosidase A (αGLA) enzyme. The αGLA enzyme is ubiquitously expressed throughout the body and is responsible for the breakdown of glycosphingolipids, deficiency of which results in the accumulation of specific glycosphingolipids that are associated with the pathophysiology of the disease. Current treatment for Fabry disease is limited to the symptomatic management of pain, conventional management of complications, and methods to increase the availability of functional αGLA. This clinical study aims to investigate the long-term safety and durability of αGLA in patients who have been dosed with a new gene therapy product (FLT190) in earlier clinical studies.

Official Title
-----------------
A Multicenter, Long-term, Follow-up Study to Investigate the Safety and Durability of Response Following Dosing of an Adeno-associated Viral Vector (FLT190) in Subjects With Fabry Disease

Conditions
-----------------
Fabry Disease, Lysosomal Storage Diseases

Intervention / Treatment
-----------------
* Genetic: FLT190


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Subjects who have previously received FLT190 Provision of full informed consent and able to comply with all requirements of the study including long-term follow-up for 60 months (5 years) post-treatment. Exclusion Criteria: N/A

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

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

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

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

Design Details

Primary Purpose: Other
Intervention Model: Single Group Assignment
Interventional Model Description: A Multicenter, Long-term, Follow-up Study to Investigate the Safety and Durability of Response Following Dosing of an Adeno-associated Viral Vector (FLT190) in Subjects with Fabry Disease
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Participants who have received gene therapy vector (FLT190)<br> | Genetic: FLT190<br>* FLT190 is a recombinant adeno-associated viral (AAV) vector (AAVS3) containing the human αGLA gene as a single stranded (ss) deoxyribonucleic acid (DNA).<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Safety endpoint will be assessed by the reporting of adverse events (AEs) according to Common Terminology Criteria for Adverse Events (CTCAE) version 5.0. |  | Entry to 5 years post dosing | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Gene Therapy
Bioequivalence of a New Sublingual and a Reference Alprazolam Immediate Release Tablet Formulation

Study Overview
=================
Brief Summary
-----------------
This study tests the assumption that the bioavailability of alprazolam from a new sublingual formulation is the same as that from an existing commercial immediate release tablet formulation.

Official Title
-----------------
Open-Label, Randomized, Single-Dose, 2-Way Crossover Bioequivalence Study Comparing A New Alprazolam Sublingual Tablet Formulation To A Reference Alprazolam Immediate Release Tablet

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

Intervention / Treatment
-----------------
* Drug: alprazolam commercial immediate release oral tablet
* Drug: alprazolam test sublingual tablet


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Healthy male or female subjects BMI 17.5 - 30.5 Must provide informed consent Exclusion Criteria: Clinically significant disease Narrow angle glaucoma Positive drug screen

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 |
| --- | --- |
| Active Comparator: Alprazolam commercial immediate release oral tablet<br> | Drug: alprazolam commercial immediate release oral tablet<br>* 1 mg tablet, single dose<br>* Other names: Xanax;|
| Experimental: Alprazolam test sublingual tablet<br> | Drug: alprazolam test sublingual tablet<br>* 1 mg tablet, single dose<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Alprazolam bioavailability assessed as area under the concentration-time curve (AUC) and maximum concentration (Cmax) |  | 11 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Alprazolam time of maximum concentration (Tmax) and half life |  | 11 days | 
| Adverse events, clinical laboratory tests, vital signs |  | 11 days | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
alprazolam, bioequivalence, sublingual
Cognitive Behavioral Treatment of Posttraumatic Stress Disorder Enhanced by Virtual Reality for Individuals With PTSD and Substance Abuse

Study Overview
=================
Brief Summary
-----------------
This study is exploring the use of an intervention designed to treat PTSD in individuals with comorbid PTSD and substance abuse resulting from the attacks of September 11 or from military service in Iraq. A cognitive behavioral treatment protocol will be used to treat PTSD. The exposure component of the protocol will be enhanced with the use of virtual reality in which the client will view a virtual environment while describing their trauma.

Official Title
-----------------
Cognitive Behavioral Treatment of Posttraumatic Stress Disorder Enhanced by Virtual Reality for Individuals With PTSD and Substance Abuse

Conditions
-----------------
Posttraumatic Stress Disorder, Substance Abuse

Intervention / Treatment
-----------------
* Other: Cognitive behavioral treatment enhanced by virtual reality


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: English-speaking Between the ages of 18 and 70 Exposed to the WTC Attacks (were in towers or in the immediate area) or veterans of the Iraq War Diagnosed with PTSD symptoms Current substance abuse disorder or history of substance abuse disorder Exclusion Criteria: Presence of current organic mental disorder Presence or history of schizophrenia, bipolar disorder or depression with psychotic features, delusional disorder Active suicidal ideation, intent, or plan Active homicidal ideation, intent, or plan Use of pacemaker Medically unstable History of seizures

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


Arms and Interventions

| Intervention/Treatment |
| --- |
|Other: Cognitive behavioral treatment enhanced by virtual reality|A cognitive behavioral protocol with cognitive and behavioral techniques will be used to treat symptoms. The exposure part of the treatment will be enhanced with the use of a virtual environment.|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| posttraumatic stress symptomatology |  | prior to treatment, during the treatment, immediately following treatment and 6 months after the completion of treatment | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| substance use symptomatology |  | prior to treatment, during treatment, immediately following treatment, and 6 months after the completion of treatment | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
PTSD, Substance Abuse, WTC attacks, Iraq War
Estimation of Functional Liver Reserve Using Cholinesterases

Study Overview
=================
Brief Summary
-----------------
Estimation of functional liver reserve in patients with hepatocellular carcinoma (HCC) in cirrhosis is of paramount importance to properly select candidates for surgical resection. Together with the value of bilirubin, the presence/absence of ascites and esophageal varices, and the rate of residual liver volume, which are our current parameters to measure functional liver reserve, the investigators sought to investigate the value of preoperative cholinesterases (CHE) in predict postoperative adverse outcome after hepatic resection for HCC.

Official Title
-----------------
Estimation of Functional Liver Reserve in Patients With Hepatocellular Carcinoma in Cirrhosis: the Value of Preoperative Cholinesterases

Conditions
-----------------
Hepatocellular Carcinoma, Cirrhosis, Liver Neoplasm, Liver Disease

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Total bilirubin < 2 mg/dl No ascites No esophageal varices, or esophageal varices eradicated by endoscopy Liver volume: residual liver volume > or = 40% if total bilirubin < 1 mg/dl residual liver volume > or = 50% if total bilirubin between 1 and 1.5 mg/dl only limited resection if total bilirubin > 1.5 mg/dl Portal vein embolization was selected in any case in whom RLV did not fit the previous requirements. Exclusion Criteria: Total bilirubin > 2 mg/dl Refractory ascites Esophageal varices

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The primary outcome was to investigate the value of preoperative cholinesterases in predict postoperative adverse outcome after hepatic resection for hepatocellular carcinoma in cirrhosis. |  |  | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
hepatocellular carcinoma, liver tumor, cirrhosis, liver resection, tumor staging, liver disease staging