linjc16/ctgov huggingface dataset:
Flupenthixol and Haloperidol for Treating Cocaine Abuse Schizophrenics - 9

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to evaluate the safety and efficacy of flupenthixol and haloperidol for cocaine dependence in individuals with schizophrenia/schizoaffective illness.

Official Title
-----------------
Flupenthixol and Haloperidol for Treating Cocaine Abuse Schizophrenics

Conditions
-----------------
Cocaine-Related Disorders, Substance-Related Disorders

Intervention / Treatment
-----------------
* Drug: Flupenthixol


Participation Criteria
=================
Eligibility Criteria
-----------------
Please contact site for information.

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

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

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

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

Design Details

Primary Purpose: Treatment


Arms and Interventions

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

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Side effects |  |  | 
| Drug use |  |  | 
| Psychiatric symptoms |  |  | 
| Cocaine craving |  |  | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
cocaine dependence
A Trial Investigating the Effect of NN1250 in Japanese Subjects With Type 2 Diabetes

Study Overview
=================
Brief Summary
-----------------
This trial is conducted in Europe. The aim of this clinical trial is to investigate the pharmacodynamic (the effect of the investigated drug on the body) properties of NN1250 (insulin degludec) in Japanese subjects with type 2 diabetes.

Official Title
-----------------
A Trial Investigating the Pharmacodynamic Properties of NN1250 in Japanese Subjects With Type 2 Diabetes

Conditions
-----------------
Diabetes, Diabetes Mellitus, Type 2

Intervention / Treatment
-----------------
* Drug: insulin degludec


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Male or female Japanese subject aged 20-70 years (both inclusive) Japanese passport holder Japanese-born parents Type 2 diabetes mellitus (as diagnosed clinically) for at least 12 months Treated with insulin for at least 3 months Body Mass Index (BMI) maximum 33.0 kg/m^2 Glycosylated haemoglobin A1c (HbA1c) maximum 10.0% Fasting C-peptide below 1.0 nmol/L Exclusion Criteria: Use of oral antidiabetic drugs (OADs) and/or glucagon like peptide-1 (GLP-1) receptor agonists (exenatide, liraglutide) within 3 months prior to screening Subject who has donated any blood or plasma in the past month or more than 500 mL within 3 months prior to screening Not able or willing to refrain from smoking and use of nicotine gum or transdermal nicotine patches during the inpatient period Supine blood pressure at screening (after resting for 5 min) minimum 180 mmHg for systolic and/or minimum 100 mmHg for diastolic

Ages Eligible for Study
-----------------
Minimum Age: 20 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: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: NN1250<br> | Drug: insulin degludec<br>* Injected s.c. (under the skin) once daily for 6 days<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Area under the glucose infusion rate curve during one dosing interval at steady state |  | Within 0-24 hours after last dosing | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Maximum glucose infusion rate at steady state |  | Within 0-24 hours after last dosing | 
| Area under the serum insulin degludec concentration-time curve during one dosing interval at steady state |  | Within 0-24 hours after last dosing | 
| Maximum observed serum insulin degludec concentration at steady state |  | Within 0-24 hours after last dosing |
MAXOMAT ® in the Treatment of Severe Early Onset Intrauterine Growth Retardation on Pre-pubertal Children

Study Overview
=================
Brief Summary
-----------------
To test for equivalence in terms of catch-up growth between the 2 therapeutic regimens To specify the best period of treatment To assess the efficacy of treatment based on final adult height of these children

Official Title
-----------------
A Cohort of Pre-pubertal Children for the Study of Optimization of Methods of Administration of the Biosynthetic Growth Hormone MAXOMAT ® in the Treatment of Severe Early Onset Intrauterine Growth Retardation

Conditions
-----------------
Fetal Growth Retardation

Intervention / Treatment
-----------------
* Drug: somatropin
* Drug: somatropin


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Pre-pubertal children of either sex presenting with severe early onset intrauterine growth retardation (I.U.G.R.) Height Less Than or Equal to -3 SD Exclusion Criteria: Age less than 3 years The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.

Ages Eligible for Study
-----------------
Minimum Age: 3 Years
Maximum Age: 11 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 |
| --- | --- |
| Experimental: 1<br> | Drug: somatropin<br>* 0.2 IU/kg/day 7 days per week given sequentially (alternating periods of 6 months of treatment and 6 months of no treatment) for 3 years<br>|
| Active Comparator: 2<br> | Drug: somatropin<br>* 0.2 IU/kg/day 7 days per week given continuously for 3 years<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Efficacy data : measurement of height |  | at trimestrial visit | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| laboratory test assessment and evaluation of bone age |  | at every other visit | 
| measurement of anti-GH and anti-ECP antibodies |  | one visit out of four | 
| Tolerance data : undesirable events |  | throughout the study |
Investigating the Clinical Utility of the MDS

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to establish the clinical utility of the Melanoma Detection System (MDS).

Detailed Description
-----------------
The purpose of this study is to establish the clinical utility of the MDS while continuing to evaluate the safety and performance of the MDS in patients with skin lesions who are referred to secondary care clinics for evaluation, whose lesions (moles) are suspicious for melanoma.

Official Title
-----------------
Investigating the Clinical Utility of the MDS Test for the Oncogenic Activity in Nevi Suspected of Being Melanoma

Conditions
-----------------
Skin Lesion, Melanoma, Moles

Intervention / Treatment
-----------------
* Diagnostic Test: Melanoma Detection System -MDS


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Lesion has one or more of the ABCDE features and is recommended for excision. Lesion has at least 1 cm of skin around it that is accessible to the MDS. Patient is at least 18 years old. Patient is capable of giving written informed consent. Lesion is scheduled for primary excision. Exclusion Criteria: Lesion is less than one centimetre from the eyes. Lesion is on the palms of the hands or soles of the feet. Lesion is mucosal. Lesion is ulcerated. Patient is pregnant. Low patient study procedure compliance. Patient who is mentally or physically unable to comply with all aspects of the study. Patient is undergoing chemotherapy. Patient has known sensitivity to fluorescent dyes. Ink marking on or adjacent to lesion. Lesions larger than 20mm or too large to allow imaging.

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 99 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 |
| --- | --- |
| Urgent Excision<br>Subjects with moles suspicious of melanoma and are scheduled for an urgent excision. | Diagnostic Test: Melanoma Detection System -MDS<br>* Imaging of lesion using the MDS test.<br>* Other names: MDS;|
| Non-urgent Excision<br>Subjects with moles not-suspicious of melanoma and are scheduled for a non urgent excision. | Diagnostic Test: Melanoma Detection System -MDS<br>* Imaging of lesion using the MDS test.<br>* Other names: MDS;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Utility of the MDS in determining urgent or non-urgent excision of moles. | The MDS will provide a score that reflects the possibility for the presence of melanoma in moles. The score will be used together with clinical evaluation. | 1 day | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Does the MDS have an additive value to clinical evaluation of moles. | Does the MDS system provide superior results when compared to clinical evaluation. | 1 day |
Cicatricial Upper Eyelid Entropion Management

Study Overview
=================
Brief Summary
-----------------
Suture-less technique will be used in treatment for cicatricial upper eyelid entropion to detect its long-term efficacy

Official Title
-----------------
Suture-less Procedure for Management of Cicatricial Upper Eyelid Entropion

Conditions
-----------------
Entropion

Intervention / Treatment
-----------------
* Procedure: Suture-less surgical procedure


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Upper eyelid cicatricial entropion with no history of previous surgery. Cooperative patients older then 16 years old. Exclusion Criteria: Previous lid surgery. Senile and mechanical entropion.

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

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: Suture-less entropion technique<br>suture-less technique for cicatricial entropion | Procedure: Suture-less surgical procedure<br>* Suture-less technique will be used in treatment for cicatricial upper eyelid entropion<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Eyelid margin reposition to the normal position | posterior edge of eyelid opposed to eye globe using slit lamp examination of the inner margin of the upper lid | 1 month |
Clinical Verification Evaluation of VeinViewer® Device

Study Overview
=================
Brief Summary
-----------------
Measure accuracy of vein width using VeinViewer®, compared against ultrasound imaging as a gold standard

Official Title
-----------------
Clinical Verification Evaluation of VeinViewer® Device

Conditions
-----------------
Vein Width

Intervention / Treatment
-----------------
* Device: VeinViewer


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Must be 18 years of age or older Must be able to read and understand English to understand the consent letter Exclusion Criteria: Less than 18 years of age Unable to read and understand English to understand the consent letter

Ages Eligible for Study
-----------------
Minimum Age: 18 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 |
| --- | --- |
| Healthy Volunteers<br> | Device: VeinViewer<br>* VeinViewer® is designed to improve vascular access treatment standards and provide the highest possible quality in volunteer care. The device is a non-invasive handheld electronic visual aid device designed to project an image of superficial, subcutaneous vascular structures on the surface of the skin. VeinViewer's primary purpose is to assist in vascular visualization for IV starts and blood draws.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Device validation versus ultrasound | The focus of this study is to understand the clinical effectiveness of the device. | Immediately after assessment-Day 1 | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Veins, Vascular Access
Avatrombopag for the Treatment of Thrombocytopenia in Adults With Chronic Liver Disease Undergoing a Procedure

Study Overview
=================
Brief Summary
-----------------
Phase 4 observational cohort study to characterize the treatment patterns and effects of avatrombopag use in patients with thrombocytopenia associated with chronic liver disease who are either undergoing, or have already undergone, a procedure.

Detailed Description
-----------------
Data (e.g. type of procedure, platelet count, etc.) will be collected retrospectively or prospectively from patient visits occurring within approximately 7 calendar days prior to the first dose of avatrombopag, on Procedure Day, on Discharge Day, and from any clinic visit performed up to 30 days post-procedure. All treatment decisions and clinical assessments will be at the discretion of the treating physician per routine medical care and are not mandated by study design or protocol.

Official Title
-----------------
An Observational Cohort Study of the Use of Avatrombopag in Patients With Thrombocytopenia Associated With Chronic Liver Disease Undergoing a Procedure

Conditions
-----------------
Thrombocytopenia

Intervention / Treatment
-----------------
* Drug: Avatrombopag


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patient has thrombocytopenia associated with chronic liver disease and is planned for or underwent treatment with avatrombopag prior to a procedure Patient provides written informed consent Minimum Data for Retrospective Enrollment Platelet count from approximately 7 days prior to starting avatrombopag Platelet count on Procedure Day

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

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

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

Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: Avatrombopag|Avatrombopag dosing will be determined by the treating physician in conjunction with the FDA-approved package insert.|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in platelet count |  | Up to 8 days after the last dose of avatrombopag. | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Proportion of patients who received a platelet transfusion |  | From the first dose of avatrombopag to up to 15 days after the last dose of avatrombopag | 
| Occurrence of adverse events |  | From the first dose of avatrombopag to up to 30 days after the last dose of avatrombopag | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Chronic Liver Disease, Low Platelet Count
Comparative and Additive Diagnostic Performance of Magnetic Resonance Elastography (MRE) and Corrected-T1 (cT1) for Fibrosis and Inflammation in Nonalcoholic Steatohepatitis (NASH) Using Histology as Reference

Study Overview
=================
Brief Summary
-----------------
This pilot study will evaluate conventional and investigational MR imaging and spectroscopic sequences and collect data to help plan more definitive future studies.

Detailed Description
-----------------
This prospective pilot study evaluates the comparative and additive diagnostic performance of Magnetic Resonance Elastography (MRE) and corrected-T1 (cT1) for the detection and staging of fibrosis and inflammation in Nonalcoholic Steatohepatitis (NASH), using histology as the reference standard.

Official Title
-----------------
Comparative and Additive Diagnostic Performance of Magnetic Resonance Elastography (MRE) and Corrected-T1 (cT1) for Fibrosis and Inflammation in Nonalcoholic Steatohepatitis (NASH) Using Histology as Reference

Conditions
-----------------
Nonalcoholic Fatty Liver, Nonalcoholic Steatohepatitis, Liver Fibroses, Liver Inflammation

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Adult subjects of any gender and any ethnic group with known or suspected NASH Subject is willing and able to complete required research procedures (screening/enrollment, clinical evaluation, safety procedures, and research MRI exam), and is willing to allow the study team to review clinical data including but not limited to other clinical radiology reports and images and clinical or research biopsy results Subject has been fully informed and has personally signed and dated the written Informed Consent and Health Insurance Portability and Accountability Act (HIPAA) documents Subject has had or is expected to have a clinical or research biopsy within 150 days of the MR exam Exclusion Criteria: VA subject < 18 years of age Subject does not have a physician and does not wish to be contacted about possible incidental findings MRI contraindication(s) Subject knows that she is pregnant or states she is trying to become pregnant

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

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Single arm<br>This is a single arm study in which all participants have one MRI | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Accuracy of MRE and c-T1 to assess disease progress | The positive predictive value of quantitative imaging will be compared to histology for the assessment of NASH. | up to one year |
Cardiovascular and Metabolic Responses to a Mixed Meal

Study Overview
=================
Brief Summary
-----------------
The purpose is to determine whether regular endurance exercise and/or body weight influence the way our nervous and vascular systems respond during the metabolism of meals.

Detailed Description
-----------------
To begin to examine this question we recruited healthy endurance-trained (high fit, HF) and normally active (average fit, AF) subjects. It is well characterized that chronic endurance training results in enhanced peripheral insulin sensitivity. Therefore, our rationale was that inclusion of two healthy subject groups, with distinct differences in insulin sensitivity, would allow us to investigate how enhanced insulin sensitivity influences insulin-mediated changes in central sympathetic outflow. Direct measurements of central sympathetic outflow to skeletal muscle (i.e., MSNA) were recorded, and a mixed meal was used as a physiological method to evoke robust and sustained increases in MSNA, which have been primarily attributed to insulin. We hypothesized that HF subjects would have a greater MSNA response, for a given plasma insulin concentration, following consumption of a mixed meal (i.e., greater central insulin sensitivity).

Official Title
-----------------
Role of Exercise Training and Body Weight on Cardiovascular and Metabolic Responses to a Mixed Meal Tolerance Test

Conditions
-----------------
Insulin Resistance

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: healthy, not currently taking any medications Exclusion Criteria: unhealthy, taking medications

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| 1<br>Men with high fitness (above VO2max of 60) | |
| 2<br>Men with average fitness (below VO2max of 50) | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| insulin/glucose response to mixed meal ingestion |  | This study is cross-sectional. Primary and secondary measures will be assessed at a single timepoint. | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| MSNA |  | This is a cross-sectional study. Primary and seconardy measures will be assessed at a single visit lasting 4-6 hours. | 
| Blood flow |  | This is a cross-sectional study. Primary and seconardy measures will be assessed at a single visit lasting 4-6 hours. | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
insulin resistance