linjc16/ctgov huggingface dataset:
Effects of Stimulant Dependence on Human Striatal Dopamine System - 15

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to determine whether DAT availability, assessed by WIN binding, in the striatum is altered in cocaine or methamphetamine dependence. To determine whether DA synthesis capacity, assessed by FDOPA uptake, in the striatum is altered in Coc or Meth dependence. To determine whether the PET tracers, WIN or FDOPA, will differentiate Meth induced alterations from those induced by Coc use. To determine whether the PET characterization of striatal alterations observed at 3-5 days since last drug use persists at least 3 months after last drug use.

Detailed Description
-----------------
4-5 Day inpatient study. Participant will have scanned pictures (MRI & PET scans) taken of their brain after being injected with a small amount of WIN, a radioactive substance. Participants give daily urine samples and fill out health related questionnaires. It is important to determine whether the alterations characterized within one week of last drug use persist over a longer time period. Based on results of the studies from aims 1 & 2, we will decide which of the 2 probes, WIN or FDOPA-PET is the more sensitive index of stimulant-dependency-induced changes.

Official Title
-----------------
Effects of Stimulant Dependence on Human Striatal Dopamine System

Conditions
-----------------
Amphetamine-Related Disorders, Tobacco Use Disorder

Intervention / Treatment
-----------------
* Procedure: radioactive substance


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: M/F, ages 21-50. Meet DSM-IV criteria for methamphetamine and nicotine dependence. Agree to conditions of the study and sign informed consent. Exclusion Criteria: Psychiatric disorder that requires medication therapy. History of seizures. Pregnant and/or nursing women. Dependence on ETOH or benzodiazepines or other sedative/hypnotics. Acute hepatitis. Other medical conditions that deem participation to be unsafe.

Ages Eligible for Study
-----------------
Minimum Age: 21 Years
Maximum Age: 50 Years

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

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

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

Design Details

Primary Purpose: Treatment
Masking: None (Open Label)


Arms and Interventions

| Intervention/Treatment |
| --- |
|Procedure: radioactive substance|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
-----------------
amphetamine dependence
Measurement of Jugular Venous Pulse in Critically Ill Patients.

Study Overview
=================
Brief Summary
-----------------
To assess the utility of clinical bedside examination for the measurement of jugular venous pulse in critically ill patients.

Detailed Description
-----------------
Procedures: All patients with central venous catheters (CVP) will undergo physical examination of the jugular veins, while blinded to the actual CVP measured from the catheter. Clinicians with various experience levels (attending physician, fellow, resident physician, 4th year medical student) will participate. The following clinical data will be obtained: Demographic data such as age, sex, weight and diagnosis will be collected. Each clinician's bedside CVP will be recorded from the bedside monitor. Clinicians will be blinded to bedside monitor.

Official Title
-----------------
An Evaluation of the Utility of Clinical Examination for the Measurement of Jugular Venous Pulse in Critically Ill Patients.

Conditions
-----------------
Jugular Venous Pulse Measurement in Critically Ill Patients

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: All patients admitted to the ICU who have existing central venous catheters. Exclusion Criteria: Patients admitted to the ICU who do not have existing central venous catheters

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 |
| --- | --- | --- |

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
jugular venous pulse
A Single Dose Study to Evaluate the Pharmacokinetics of Acoramidis Modified Release Formulations in Healthy Subjects

Study Overview
=================
Brief Summary
-----------------
This is a single centre, open-label, 5-period study in healthy male and non-pregnant and non-lactating healthy female subjects.

Detailed Description
-----------------
It is planned to enroll 14 subjects who will receive single oral doses of active IMP in a sequential manner over 5 periods, with a minimum of 7days between dosing in each period.

Official Title
-----------------
A Single Dose Study to Evaluate the Pharmacokinetics of Acoramidis Modified Release Tablet Formulations in Healthy Subjects

Conditions
-----------------
Amyloidosis

Intervention / Treatment
-----------------
* Drug: acoramidis


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Healthy males or non-pregnant, non-lactating healthy females Body mass index (BMI) of 18.0 to 32.0kg/m² and a body weight>50kg as measured at screening Must be willing and able to communicate and participate in the whole study Must provide written informed consent Must agree to adhere to the contraception requirements Exclusion Criteria: Subjects who have received any IMP formulation in a clinical research study within the 90 days prior to Period 1, Day 1 History of any drug or alcohol abuse in the past 2 years Subjects with pregnant or lactating partners Clinically significant abnormal clinical chemistry, haematology or urinalysis as judged by the investigator. Subjects with Gilbert's Syndrome are allowed. History of clinically significant cardiovascular, renal, hepatic, dermatological, chronic respiratory or gastrointestinal disease, neurological or psychiatric disorder, as judged by the investigator Presence or history of clinically significant allergy requiring treatment, as judged by the investigator. Hay fever is allowed unless it is active Subjects who are taking, or have taken, any prescribed or over-the-counter drug or herbal remedies (other than up to 4g of paracetamol per day or HRT/hormonal contraception) in the 14 days before first IMP administration.

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 65 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 |
| --- | --- |
| Experimental: acoramidis<br> | Drug: acoramidis<br>* acoramidis<br>* Other names: AG10;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pharmacokinetic Assessments: Cmax | Maximum Concentration (Cmax) | 72 hours | 
| Pharmacokinetic Assessments: AUC | Area under the plasma concentration-time curve (AUC) | 72 hours | 
| Pharmacokinetic Assessments: Tmax | Time to maximum concentration (Tmax) | 72 hours |
An Extension Study of an Investigational Drug, Lumasiran (ALN-GO1), in Patients With Primary Hyperoxaluria Type 1

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to evaluate the long-term safety and tolerability of lumasiran in patients with Primary Hyperoxaluria Type 1.

Official Title
-----------------
A Phase 2, Multicenter, Open-Label, Extension Study to Evaluate the Long-Term Administration of ALN-GO1 in Patients With Primary Hyperoxaluria Type 1

Conditions
-----------------
PH1, Primary Hyperoxaluria, RNAi Therapeutic, siRNA, AGT

Intervention / Treatment
-----------------
* Drug: Lumasiran


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Enrollment within 12 months of completion of Study ALN-GO1-001 In the opinion of the investigator tolerated the study drug If taking Vitamin B6 (pyridoxine), willing to remain on a stable regimen for the study duration Women of child-bearing potential must have a negative pregnancy test, cannot be breast feeding, and must be willing to use a highly effective method of contraception Willing to provide written informed consent and to comply with study requirements Exclusion Criteria: Clinically significant health concerns (with the exception of PH1) Clinically significant cardiovascular abnormality Abnormal for AST/ALT and any other clinical safety laboratory result considered clinically significant Requirement for chronic dialysis

Ages Eligible for Study
-----------------
Minimum Age: 6 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 |
| --- | --- |
| Experimental: Lumasiran (ALN-GO1)<br> | Drug: Lumasiran<br>* Multiple doses of lumasiran by subcutaneous (sc) injection<br>* Other names: ALN-GO1;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Incidence of Adverse Events |  | Up to approximately 1600 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in 24-hour Urinary Oxalate Corrected for Body Surface Area (BSA) Over Time |  | Up to approximately 1600 days | 
| Change in 24-hour Urinary Oxalate:Creatinine Ratio Over Time |  | Up to approximately 1600 days | 
| Change in Estimated Glomerular Filtration Rate (eGFR) Over Time |  | Up to approximately 1600 days | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Hyperoxaluria, Primary, Hyperoxaluria, Kidney Diseases, Urologic Diseases, Metabolism, Inborn Errors, Genetic Diseases, Inborn, Metabolic Diseases
Pretreatment Group Consultation for Patients With Colorectal Cancer

Study Overview
=================
Brief Summary
-----------------
An explorative study of the patients' experience of participating at a group consultation, together with other patients with newly diagnosed colon or rectal cancer

Detailed Description
-----------------
The group consultation is planned to be on the Friday of the same week as the patient recieved a suggested treatment plan i.e. after MDT, at a personal consultation with his/her colorectal surgeon. During the group consultation the steps necessary for the patient to take responsability for in connection with the operation. Ample time for questions, clarifications and discussions. Appropriate clinical trials are presented

Official Title
-----------------
Pretreatment Group Consultation for Patients With Colorectal Cancer

Conditions
-----------------
Colorectal Neoplasm

Intervention / Treatment
-----------------
* Other: Pretreatment group consultation


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients participating in the pretreatment group consultation Exclusion Criteria: Not able to answer questionnaire

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 120 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 |
| --- | --- |
| Patients participating in the pretreatment group consultation<br>Patients who chosse to participate in a group consultation (with other patients also in the process of undergoing surgery for colorectal cancer). | Other: Pretreatment group consultation<br>* A consultation in group with several patients and one surgeon<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The patient's experience of participating in a pretreatment group consultation | A questionnaire with questions on the patient's experience of the information received and their experience of participating in the pretreatment group consultation will be used to collect descriptive data. Some of the questions have been developed through semi-structured interviews with patients with colon or rectal cancer other are standardized questionnaires used in other studies. The questionnaire includes questions on which information resources the patients have used (such as social media, patient organizations).Their experience of the pretreatment group consultation will be assessed by Would you recommend someone in the same situation as you to attend the pretreatment group consultation?. Possible answering options are Yes, No and Don't know. The EuroQol's EQ-5D-5L for assessment of health related quality of will be included mainly as a tool for assurance of external validity, and not as an outcome measure. Both the indices and the VAS-scale may be used. | Before start of treatment |
The Study of Ropivacaine Median Effective Concentration in Ultrasound-guided Supraclavicular Brachial Plexus Block

Study Overview
=================
Brief Summary
-----------------
To determine the median effective concentration of ropivacaine hydrochloride for ultrasound-guided supraclavicular brachial plexus block. The result can provide reference for choosing appropriate drug concentration in clinical anesthesia.

Official Title
-----------------
The Study of Ropivacaine Median Effective Concentration in Ultrasound-guided Supraclavicular Brachial Plexus Block

Conditions
-----------------
Anesthesia

Intervention / Treatment
-----------------
* Drug: ropivacaine


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: ASA I or II Exclusion Criteria: upper limb paresthesia allergic to local anesthetics surgery history of clavicle BMI>30kg/m^2

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 64 Years

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

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

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

Design Details

Intervention Model: Single Group Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: ropivacine<br> | Drug: ropivacaine<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| the affection of nerve block | The anesthetic efficacy of five nerves, respectively named lateral antebrachial cutaneous nerve, medial cutaneous nerve of the forearm, radial nerve, median nerve, and ulnar nerve was assessed within 30 min after anesthesia. The next concentration of ropivacaine was adjusted according to the response of the previous patient using up-down sequential allocation. | 30 minutes | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Dose-response relationship, Drug
Type 2 Diabetes Secondary Prevention

Study Overview
=================
Brief Summary
-----------------
Three hundred and ninety height diabetic patients were educated during a week of hospitalisation (nutritional and physical-activity advices). After that, they were randomized in two groups : frequent follow-up (each three month) by educational nurses and dieteticians, versus no follow-up (control group). All patients were evaluated one year after their inclusion,by HbA1c (primary outcome), anthropometry, other cardiovascular risk factors, nutritionnal and physical-activity behaviours.

Official Title
-----------------
Type 2 Diabetes Secondary Prevention Trial at the Reunion Island

Conditions
-----------------
Type 2 Diabetes

Intervention / Treatment
-----------------
* Behavioral: Secondary prevention intervention trial
* Behavioral: standard follow up


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: type 2 diabetes patient aged >=18 years Exclusion Criteria: incapacity to a moderate physical activity

Ages Eligible for Study
-----------------
Minimum Age: 18 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 |
| --- | --- |
| close follow-up by nurse<br>close follow-up by nurse : patients were visited each tree months | Behavioral: Secondary prevention intervention trial<br>* Close follow-up by nurses, exercise physiologist and dieteticians<br>* Other names: Rédia-prev2;|
| standard follow up<br>stantdard follow up at one year | Behavioral: standard follow up<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| %HbA1c | measure of % HbA1c at inclusion and at one year and comparison between intervention and control groups | at inclusion and at one year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| anthropometry | BMI, waist, %fat mass and comparison between intervention and control groups | at inclusion and at one year | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Type 2 diabetes, Secondary prevention, Physical activity, Nutritional education, HbA1c, Reunion island, diabetic patients, both female and male, age >=18 years, able to practise a physical activity, in Saint Pierre (GHSR) and Saint Denis (CHD)
Thromboprophylaxis and Bariatric Surgery

Study Overview
=================
Brief Summary
-----------------
This trial is an assessment of the efficacy of three thromboprophylaxis regimens in two types of bariatric surgery. - gastric banding and gastric bypass on anti-Xa activity levels The study includes two groups of 150 patients scheduled for gastric banding or gastric bypass. Assessment of anti-Xa levels before and 4 hours after the injections from day 0 to 2 in order to determine the best prophylactic regimen allowing expected values ranged between 0.3 and 0.5 IU / ml.

Official Title
-----------------
Thromboprophylaxis During Bariatric Surgery

Conditions
-----------------
Thromboembolism

Intervention / Treatment
-----------------
* Drug: Enoxaparin


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: BMI over 40 Gastric banding or gastric bypass Exclusion Criteria: Renal insufficiency Thrombopenia Long term anticoagulant treatment Pregnancy Allergy to heparin

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


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: Enoxaparin|injection of enoxaparin a few time|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Anti-Xa activity level measured 4 hours before and after enoxaparin injection at different doses |  | 48 heures | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Microparticles |  | day 0, 1, 9,30 | 
| Thrombotic events until D30 |  | day 30 | 
| Bleeding events |  | day 30 | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Thromboprophylaxis, Bariatric surgery, prevention of venous thromboembolism in bariatric surgery
A Prospective Trial to Study the Evolution of Clonal Architecture of Tumors From Patients Treated With Molecular Targeted Agents

Study Overview
=================
Brief Summary
-----------------
This is a prospective study to identify molecular mechanisms of acquired resistance to targeted therapies in patients with unresectable or metastatic cancer. This is a protocol to study clinical characteristics and biopsy tissue of patients with oncogene-driven cancer who have had previous clinical response to targeted therapy and subsequently experience progression of disease. The tissues and other specimens will be used to carry out laboratory studies to explore the molecular basis of acquired resistance to targeted therapies.

Official Title
-----------------
A Prospective Trial to Study the Evolution of Clonal Architecture of Tumors From Patients Treated With Molecular Targeted Agents

Conditions
-----------------
Metastatic Oncogen-driven Cancer

Intervention / Treatment
-----------------
* Procedure: Biopsy


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients diagnosed with confirmed cancer and who fulfill the following eligibility criteria will be considered eligible for this study: Patient affiliated to a social security regimen Patients scheduled to receive anticancer agents or currently receiving anticancer agents Tumor lesion accessible to core biopsies (malignant effusions can represent an alternative) Patient who is fully informed, able to comply with the protocol and who signed the informed consent. Availability of initial tumor material (ideally frozen, or non-Bouin fixed paraffin embedded material) acquired before exposure to the targeted therapy Note: Patients may have received other treatments since treatment with targeted therapies including radiation or chemotherapy, before undergoing the study biopsy. Exclusion Criteria: 1. Coagulation abnormality prohibiting a biopsy

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Patients with metastatic oncogen-driven cancer<br> | Procedure: Biopsy<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Type and frequency of molecular alterations in resistant tumors using whole exome sequencing |  | 30 days after inclusion |