linjc16/ctgov huggingface dataset:
Prize Reinforcement Contingency Management for Cocaine Dependence: a 24-week Randomized Controlled Trial

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to determine whether prize-based contingency management (prizeCM) combined with cognitive behavioral therapy (CBT) is more effective in the treatment of of cocaine-dependent patients compared to CBT only. Patients were randomized to prizeCM + CBT (experimental group) or to CBT (control group) an treated over 24 weeks. It is the first trial of this type in Europe.

Official Title
-----------------
Prize Reinforcement Contingency Management for Cocaine Dependence: a 24-week Randomized Controlled Trial

Conditions
-----------------
Cocaine-related Disorders

Intervention / Treatment
-----------------
* Behavioral: Cognitive behavioral therapy (CBT)


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: cocaine dependence, aged 18 or older, other dependences Exclusion Criteria: severe somatic, brain, or psychiatric disease, attention deficit disorders with medication methylphenidate

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 60 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: 1<br>Cognitive behavioral therapy (CBT) + prize-based contingency management (prizeCM) | Behavioral: Cognitive behavioral therapy (CBT)<br> <br> |
| Active Comparator: 2<br>Cognitive behavioral therapy (CBT) | Behavioral: Cognitive behavioral therapy (CBT)<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| retention in treatment, cocaine abstinence | cocaine abstinence: at least 3 consecutive weeks of cocaine abstinence, the maximum number of weeks of continous abstinence and proportions of cocaine-free urine samples during the entire 24-week and at 6-month follow-up. | 24 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| patients' satisfaction with the therapy, clinical measures | patients' satisfaction with prize-based contingency management and with CBT | 24 weeks |
Clinical Implication of the Tunable Crack Sensor

Study Overview
=================
Brief Summary
-----------------
[Development of diagnosis algorism for paroxysmal arrhythmia using ultra-thin resistive membrane: a pilot study] Comparison of blood pressure via tunable crack sensor and invasive pressure wire

Detailed Description
-----------------
To develop a diagnosis algorism for paroxysmal arrhythmia using ultra-thin resistive membrane, we will compare the blood pressure measured via a tunable crack sensor and that measured by a invasive pressure wire

Official Title
-----------------
Development of Diagnosis Algorism for Paroxysmal Arrhythmia Using Ultra-thin Resistive Membrane: a Pilot Study

Conditions
-----------------
Blood Pressure

Intervention / Treatment
-----------------
* Device: tunable crack sensor


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: A case of suspected coronary artery disease at Seoul National University Hospital for the purpose of coronary angiography At least 19 years old If he/she hears enough explanation about clinical research and intends to participate in clinical research himself Exclusion Criteria: Under 19 years old Refusal to participate in clinical studies If the cognitive function is weak enough not to understand the explanation of the clinical study and to make voluntary decisions accordingly

Ages Eligible for Study
-----------------
Minimum Age: 19 Years

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

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

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

Arms and Interventions

| Intervention/Treatment |
| --- |
|Device: tunable crack sensor|blood pressure monitoring via crack sensor|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Blood pressure monitoring using tunable crack sensor | Systolic blood pressure and diastolic blood pressure by using tunable crack sensor | immediately | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
blood pressure, crack sensor
Injection Technique Assessment of Restylane Silk With Lidocaine for Lip Augmentation

Study Overview
=================
Brief Summary
-----------------
This is a multi-center, open-label, single-arm study to assess the safety of an injection technique with Restylane Silk in lip augmentation and correction of perioral rhytids .

Conditions
-----------------
Lip Augmentation and Correction of Perioral Rhytids

Intervention / Treatment
-----------------
* Device: Restylane Silk with Lidocaine


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Subjects willing to comply with the requirements of the study and providing written informed consent including release of copyright of photography images. Males or females, 22 years of age or older Subjects seeking augmentation therapy for the lips. Exclusion Criteria: History of allergy or hypersensitivity to injectable HA gel or to gram positive bacterial proteins. History of allergy or hypersensitivity to lidocaine, other amide type anesthetics, or topical anesthetics or nerve blocking agents Previous surgery to the upper or lower lip, lip piercing or tattoo, or history of facial trauma.

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

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

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

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

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: Restylane Silk with Lidocaine<br> | Device: Restylane Silk with Lidocaine<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of Participants With Adverse Events With the Use of Restylane Silk With Lidocaine |  | 12 weeks |
Study Evaluating the Safety and Pharmacokinetics (PK) of Ascending Single IV Doses of ERB-257 in Healthy Japanese Males

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to evaluate the safety, tolerability, and pharmacokinetics of IV administered ERB-257 as single ascending doses to healthy Japanese male subjects

Official Title
-----------------
Ascending Single-Dose Study of the Safety, Tolerability, and Pharmacokinetics of ERB-257 Administered Intravenously as a 30-Minute Infusion to Healthy Japanese Male Subjects

Conditions
-----------------
Healthy Subjects

Intervention / Treatment
-----------------
* Drug: ERB-257
* Other: placebo


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Healthy Japanese men between the ages of 20 and 50. Body mass index (BMI) in the range of 17.6 to 26.4 kg/m2 and body weight greater than or equal to 45 kg2. Have a high probability for compliance with and completion of the study. Exclusion Criteria: Presence or history of any disorder that may prevent the successful completion of the study. Acute disease state (eg, nausea, vomiting, infection, fever, or diarrhea) within 7 days before study day 1.

Ages Eligible for Study
-----------------
Minimum Age: 20 Years
Maximum Age: 50 Years

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

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

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

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: ERB-257<br>7 IV single doses of ERB-257 will be given to 6 healthy subjects per group - 1, 4, 15, 45, 90, 180, and 300 mg | Drug: ERB-257<br> <br> |
| Placebo Comparator: placebo<br>2 placebo subjects per group | Other: placebo<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To evaluate the safety and tolerability of ERB-257 as a single IV dose |  | 4 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To evaluate the pharmacokinetics of ERB-257 as a single IV dose |  | 4 days |
INFLUENCE OF TOPICAL INDOMETHACIN ON HYPOTHENSIVE EFFECT OF BRIMONIDINE

Study Overview
=================
Brief Summary
-----------------
Purpose: To evaluate the influence of the nonsteroidal anti-inflammatory indomethacin on the brimonidine intraocular pressure (IOP) lowering effect. Methods: A randomized double-masked study was carried out. Patients medicated with timolol maleate 0,5% and needed complementary medication were random allocated into two groups: (a) brimonidine tartarate 0,15% and indomethacin 1% or (b) brimonidine tartarate and placebo (balanced saline solution). If patient's both eyes were eligible, they were allocated to the same group. IOP was measured at two weeks, one month and two months after study beginning. The mean IOP of the eyes was used for analyzes, in the case of two eligible eyes. For statistical analyzes repeated measures analysis was used.

Official Title
-----------------
INFLUENCE OF TOPICAL INDOMETHACIN ON HYPOTHENSIVE EFFECT OF BRIMONIDINE

Conditions
-----------------
Glaucoma

Intervention / Treatment
-----------------
* Drug: brimonidine


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: primary open-angle glaucoma or ocular hypertension patients with the following criteria: 18 years of age or older, insufficient response to monotherapy with timolol maleate 0,5%, and adequate compliance in follow-up treatment Exclusion Criteria: hypersensitivity to eyedrop solutions, insufficient compliance in follow-up treatment, pregnancy or childbearing potential.

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

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

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

Design Details

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


Arms and Interventions

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

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
Renal Tolerance of Amoxicillin and Cloxacillin Combination

Study Overview
=================
Brief Summary
-----------------
2015 European Society of Cardiology Guidelines have proposed the combination of Ampicillin and Cloxacillin for initial empirical treatment of infective endocarditis in acute severely ill patients (before pathogen identiﬁcation). Yet this combination has never been studied in clinical trials. High dose penicillin treatments are associated with a risk of nephrotoxicity. The investigator's primary purpose is to describe patients treated with high dose Amoxicillin and Cloxacillin combination and to evaluate its renal tolerance.

Official Title
-----------------
Incidence of Actue Kidney Injury in Patients Treated With Amoxicillin and Cloxacillin Combination Therapy

Conditions
-----------------
Endocarditis, Acute Kidney Injury

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion criteria: Adult patient (≥18 years old) Hospitalized at the Strasbourg University Hospital and treated concomitantly with Amoxicillin IV and Cloxacillin IV for ≥48 hours between January 1, 2016 and December 31, 2020. Patient not having expressed his opposition, after information, to the reuse of his data for scientific research purposes. Exclusion criteria: Subject having expressed opposition to participating in the study Subject under guardianship, curatorship or safeguard of justice

Ages Eligible for Study
-----------------
Minimum Age: 18 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 |
| --- | --- | --- |
| Description of patients treated with dual IV therapy combining cloxacillin and amoxicillin in high doses at Strasbourg University Hospital |  | Files analysed retrospectively from January 01, 2016 to December 31, 2020 will be examined] | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Endocarditis, Acute kidney injury, Amoxicillin, Cloxacillin
Cross-sectional Study of Use of Speckle Method in Early Diagnosis of Cardiovascular Dysfunction

Study Overview
=================
Brief Summary
-----------------
Speckle tracking (STE) is a novel echocardiographic technique which permits calculation of myocardial velocities and deformation parameters such as strain and strain rate (SR). It is demonstrated that these parameters provide important insights into systolic and diastolic function, ischaemia, myocardial mechanics and many other pathophysiological processes of the heart. In this preliminary study, we investigated the role of STE in detection of early ventricular dysfunction in patients with Sjogren Syndrome, focusing on cardiorespiratory fitness.

Official Title
-----------------
Cross Sectional Study of Use of Speckle Tracking Echocardiography in the Early Diagnosis of Cardiovascular Dysfunction and Performance in Sjogren Patients

Conditions
-----------------
Sjogren Syndrome

Intervention / Treatment
-----------------
* Procedure: Speckle tracking echocardiography


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Diagnosis of Sjogren Syndrome Exclusion Criteria: previous cardiovascular events unstable angina stroke diagnosis of heart failure incapacity to provide an informed consent

Ages Eligible for Study
-----------------
Minimum Age: 40 Years
Maximum Age: 75 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 |
| --- | --- |
| Sjogren<br>Sjogren Patients evaluated with Speckle tracking echocardiography | Procedure: Speckle tracking echocardiography<br> <br> |
| Control<br>Controls Speckle tracking echocardiography | Procedure: Speckle tracking echocardiography<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Longitudinal Myocardial Strain reduction in Sjogren Patients | Longitudinal Myocardial Strain reduction could be an early marker of cardiac dysfunction in patients with Sjogren Syndrome, significantly better than common measurement (such as ejection fraction) | Baseline, 24 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Association between 6minute-walking-test and Longitudinal strain reduction | Longitudinal strain reduction could be linked to decrease in cardiorespiratory fitness, especially in 6-minute-walking-test | baseline, 24 weeks |
OraVescent Fentanyl (OVF) for the Treatment of Breakthrough Pain in Opioid Tolerant Cancer Patients

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to evaluate the long-term safety and efficacy of OraVescent fentanyl to treat breakthrough pain episodes in cancer patients who are already opioid tolerant.

Detailed Description
-----------------
The objective of this study is to determine the tolerability and safety of OraVescent fentanyl when used long term to relieve breakthrough pain in opioid tolerant cancer patients.

Official Title
-----------------
Multi-center, Open Label, Long-term Study of OraVescent Fentanyl Citrate for the Treatment of Breakthrough Pain in Opioid Tolerant Cancer Patients

Conditions
-----------------
Pain, Cancer

Intervention / Treatment
-----------------
* Drug: OraVescent fentanyl citrate


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: 18-80 years of age Average of 1-4 breakthrough pain episodes per day Opioid tolerant Histologically documented diagnosis of a malignant solid tumor or hematological malignancy Exclusion Criteria: Primary breakthrough pain is not related to cancer in any way Opioid or fentanyl intolerance Chronic obstructive pulmonary disease (COPD) or heart disease Sleep apnea or active brain metastases with increased cranial pressure

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 80 Years

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

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

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

Design Details

Primary Purpose: Treatment
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: OraVescent fentanyl citrate|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Tolerability and safety of OraVescent fentanyl when used long-term |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Assess the effectiveness of OraVescent fentanyl |  |  | 
| Assess the development of incremental tolerance |  |  | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Cancer, Pain
The Biosonographic Index

Study Overview
=================
Brief Summary
-----------------
In this exploratory study we explore the use of Shear Wave Elastography to differentiate between Acute Kidney Injury after vascular surgery and among the healthy population.

Official Title
-----------------
The Biosonographic Index - A Novel Index for the Early Detection of Acute Kidney Injury After Vascular Surgery - an Exploratory Study.

Conditions
-----------------
Acute Kidney Injury

Intervention / Treatment
-----------------
* Diagnostic Test: Shear Wave Elastography


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: No history of diabetes or hypertension Estimated Glomerular Filtration Rate > 60 ml/min/m^2 Structurally normal kidney on renal ultrasound BMI < 27 kg/m^2 Exclusion Criteria: Prisoners directly admitted from a correctional facility Children < 19 years or under 50 kg body weight if age is unknown Patients with end stage renal disease or preexisting glomerular filtration rate less than or equal to 30 mL/min/1.73 m^2 or need for dialysis Patients with end stage heart disease on the cardiac transplant list Patients undergoing procedures without vascular surgery All transplant patients Patients on ventricular assist devices Patients undergoing emergency procedures Patients with body mass index > 27kg/m^2 Any condition that would impede visualization of the kidneys by ultrasound

Ages Eligible for Study
-----------------
Minimum Age: 19 Years

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

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

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

Design Details

Primary Purpose: Diagnostic
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: Healthy Controls<br> | Diagnostic Test: Shear Wave Elastography<br>* Advanced ultrasound technique<br>|
| Other: Vascular Surgery Subjects<br> | Diagnostic Test: Shear Wave Elastography<br>* Advanced ultrasound technique<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Diagnostic factor of Shear Wave Elastography | Shear wave Elastography-derived Young's Elastic Modulus factor differentiating patients with Acute Kidney Injury post vascular surgery from healthy controls. | From the time of Informed Consent being given to 96 hours after consent being given |