linjc16/ctgov huggingface dataset:
Value of Percutaneous Cholangioscopy After Placement of a Percutaneous Transhepatic Biliary Drainage

Study Overview
=================
Brief Summary
-----------------
In a prospective study the investigators perform repeated cholangioscopies in all patients that received percutaneous transhepatic biliary drainage (PTBD) for a variety of malignant and benign diseases. Endoscopic findings and their correlation with clinical features will be recorded prospectively. The impact on clinical decision will be evaluated.

Official Title
-----------------
Percutaneous Cholangioscopy After Placement of a Percutaneous Transhepatic Biliary Drainage (PTBD) - a Prospective Study on Endoscopic Findings and Clinical Impact

Conditions
-----------------
Bile Duct Stricture Not Treatable by ERC

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: PTBD with at least 14 French in diameter Exclusion Criteria: missing informed consent

Ages Eligible for Study
-----------------
Minimum Age: 1 Year

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
-----------------
percutaneous, transhepatic, biliary, drainage, cholangioscopy
Multiple Ascending Dose Study for AZD 7268 in Japanese Healthy Male Volunteers

Study Overview
=================
Brief Summary
-----------------
This is a multiple ascending dose study (MAD) in the Japanese population with AZD7268. This MAD study will evaluate the safety, tolerability and pharmacokinetics of orally administered AZD7268 after multiple ascending doses.

Official Title
-----------------
A Phase I, Single-Centre, Randomised, Double-Blind, Placebo-controlled, Study to Assess the Safety, Tolerability and Pharmacokinetics of AZD7268 When Given in Multiple Ascending Oral Doses in Japanese Healthy Male Subjects

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

Intervention / Treatment
-----------------
* Drug: AZD7268
* Drug: Placebo


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Provision of Informed Consent Healthy male subjects, with suitable veins for cannulation or repeated venipuncture Exclusion Criteria: Inability to understand or cooperate with given information Any positive result on screening for human immune deficiency virus (HIV), Hepatitis B, Hepatitis C and syphilis test History of seizure (including infant febrile seizures) or family history of seizure

Ages Eligible for Study
-----------------
Minimum Age: 20 Years
Maximum Age: 45 Years

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

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

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

Design Details

Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: AZD7268<br> | Drug: AZD7268<br>* Capsule, Oral, BID<br>|
| Placebo Comparator: Placebo<br> | Drug: Placebo<br>* Capsule, Oral, BID<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Investigate the safety and tolerability of AZD7268 by Adverse Events. |  | From first dosing throughout the treatment period and including the follow-up period | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Characterize the PK parameters(Cmax, AUC,t1/2) of AZD7268 by assessment of drug concentrations in plasma |  | Blood samples will be taken from pre-dose until 48 hours post last dose | 
| Characterize the PK parameters (CLr, Ae) of AZD7268 by assessment of drug concentrations in urine |  | Urine samples will be taken from post first dose until 48 hours post last dose. | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Phase I, Japanese Healthy volunteer
Peri-operative Assessment of Coagulopathy in Neonates and Infants Undergoing Cardiac Surgery

Study Overview
=================
Brief Summary
-----------------
This prospective study will aim to globally assess the coagulopathy induced during cardiac surgery with cardiopulmonary bypass (CPB) in a large pediatric population. The investigators primary objective will be the understanding of CPB-induced coagulopathy based on demographic and surgical characteristics, and coagulation assays. Secondary objective will aim at determining the relationship between coagulation assays, postoperative blood loss, and transfusion requirements. The ultimate goal will be to design an algorithm using point-of-care monitoring that could be used to guide hemostatic therapies in neonates and children undergoing cardiac surgery.To do this, investigators will examine the coagulation in the laboratory based setting.

Official Title
-----------------
Peri-operative Assessment of Coagulopathy in Neonates and Infants Undergoing Cardiac Surgery

Conditions
-----------------
Congenital Heart Disease

Intervention / Treatment
-----------------
* Other: Perioperative blood samples collection


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Neonates weighing greater than 2.5 kg Patients equal to or less than 12 months of age Undergoing elective cardiac surgery with cardiopulmonary bypass Exclusion Criteria: Emergent procedure The patient is deemed to be in a moribund condition (American Society of Anesthesiology (ASA 5))

Ages Eligible for Study
-----------------
Maximum Age: 12 Months

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

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Study Group<br>Three blood samples will be collected intra-operatively from each subject enrolled | Other: Perioperative blood samples collection<br>* Collect blood samples at 3 different points intra-operatively. Each blood sample will be run using rotational thromboelastometry to assess intraoperative coagulation<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Evidence of CPB-induced coagulopathy confirmed by coagulation assays |  | Over 6 months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Congenital Heart Disease, Point-of-care coagulation monitoring, Rotaional Thromboelastometry
Alternate Day Buprenorphine Administration, Phase X - 15

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to determine how subjects will make changes in the amount of medication received when given a monetary alternative to buprenorphine.

Official Title
-----------------
Alternate Day Buprenorphine Administration, Phase X

Conditions
-----------------
Opioid-Related Disorders

Intervention / Treatment
-----------------
* Drug: Buprenorphine


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

Ages Eligible for Study
-----------------
Minimum Age: 34 Years
Maximum Age: 51 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: Buprenorphine|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Opioid withdrawal |  |  | 
| Subjective dose estimate |  |  | 
| Drug effect characteristics: ARCI |  |  | 
| Money choice |  |  |
Diffusion Tensor Imaging Magnetic Resonance Imaging (DTI MRI) as a Correlate to Pain Relief and Facial Numbness in Patients Following Stereotactic Radiosurgical Rhizotomy for Trigeminal Neuralgia

Study Overview
=================
Brief Summary
-----------------
Trigeminal neuralgia or tic douloureux is severe, often debilitating, facial pain that significantly impairs the patient's quality of life and health. Stereotactic radiosurgery has been shown to provide pain relief in majority of patients treated. However, a common side effect of radiosurgery is facial numbness. To better understand how radiosurgery can bring about pain relief and facial numbness, we are conducting a study in which brain MRI scans will be done following stereotactic radiosurgery to learn if there are any changes in the MRI scans that correlate with symptoms.

Official Title
-----------------
Investigation of Diffusion Tensor Imaging Magnetic Resonance Imaging (DTI MRI) as a Correlate to Pain Relief and Facial Numbness in Patients Following Stereotactic Radiosurgical Rhizotomy for Trigeminal Neuralgia

Conditions
-----------------
Trigeminal Neuralgia

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: All patients age 18 years and older with typical trigeminal neuralgia, as determined by diagnostic criteria set by the International Headache Society, who are 1) intolerant of or refractory to medical management and 2) not candidates for or refusing a surgical micro-vascular decompression, will be evaluated for treatment with SRS. ECOG or Karnofsky Performance Status will not be employed, but patients must be sufficiently healthy to tolerate all study procedures. Patient must exhibit the ability to understand and the willingness to sign a written informed consent. Exclusion Criteria: Exclusion criteria Patients who present with pre-existing facial numbness. Patients MRI contraindications (e.g., pacemaker or defibrillator, cochlear implant, brain aneurysm clip, etc.) Patients who have previously been treated with MVD. Patients who have previously had an ablative treatment, including prior SRS. Pediatric patients (age <18), pregnant women, and patients who are unable to give informed consent will be excluded.

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 |
| --- | --- | --- |
| DTI MRI findings | DTI MRI will be performed before and after radiosurgery to determine if there is a correlation between pain relief, facial numbness, and imaging changes. | 6 months |
Atherosclerotic Plaque Characterization

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to utilize high-resolution CMR carotid imaging for the characterization of carotid wall volumes and plaque content in patients with clinical significant carotid atherosclerosis. Patients who are scheduled to undergo an imaging procedure will be recruited from the cath lab. Upon enrollment, blood samples conventional and genetic profiling will be collected. For patients undergoing a carotid endarterectomy, tissue from the carotid vessel will be collected during their procedure. Comparison of the MR images with tissue and/or blood samples will be made. Length of time in the study will be approximately 1 day. There will be no study-related patient follow-up.

Official Title
-----------------
Atherosclerotic Plaque Characterization Using Multispectral, Multicontrast High Resolution Cardiovascular Magnetic Resonance Imaging

Conditions
-----------------
Atherosclerosis

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Age range >17 years of age Surgical carotid artery disease Provide written informed consent and Authorization for Use/Disclosure of PHI Exclusion Criteria: History of carotid trauma History of middle or large vessel vasculitis Refusal to provide written informed consent and Authorization for Use/Disclosure of PHI

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 |
| --- | --- | --- |
| Characterization of plaque that is found in the carotid walls of patients who have atherosclerosis |  | 2 years post study initiation | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To evaluate the effectiveness of MR imaging in identifying these plaque characteristics |  | 2 Years Post Study Initiation | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Atherosclerosis, Subjects diagnosed with atherosclerosis
Evaluation of Microcirculation of Peripheral Vascular Disease in Diabetes

Study Overview
=================
Brief Summary
-----------------
The main aim of the present study was to evaluate the microcirculation of peripheral vascular disease in diabetes.

Official Title
-----------------
Evaluation of Microcirculation of Peripheral Vascular Disease in Diabetes

Conditions
-----------------
Peripheral Vascular Disease in Diabetes

Intervention / Treatment
-----------------
* Diagnostic Test: Five points test of Tongji university


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: 1.Patients with Peripheral vascular disease with or without diabetes. 2.Rutherford class 2-6. 3.Target lesions with a diameter reduction of at least 50% on angiography, and without past history of any intervention. 4.Target vessel with 2.0--10.0mm in diameter and having a lesion of about 4cm-20cm in length. 5.Written informed consent signed by the patients or representatives Exclusion Criteria: 1.Previous bypass surgery or stent placement at the ipsilateral lower limb 2.History of intolerance to antiplatelet therapy, heparin, or contrast media. 3.Bleeding diathesis; 4.Active systemic bacterial infection; 5.Severely impaired renal function (serum creatinine level > 2.5 mg/dL. Expected survival time of less than 24 months

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: Diagnostic
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: Five points test of Tongji university<br>We established the evaluatation and follow-up system of diabetes vascular disease based on the method called Five points test of Tongji university . | Diagnostic Test: Five points test of Tongji university<br>* In each group, we will evaluate the microcirculation of diabetic foot using the newly-established Five points test of Tongji university before or after the operation, and then compare the temperature of the five points with the other data.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Coincidence rate of 5 points test of Tongji university | The primary study endpoint was that the coincidence rate of evaluating the microcirculation by the newly-established 5 points test of Tongji university attains over 95% before and after operations as assessed by digital substraction angiography (DSA). | 12 months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Diabetes, Peripheral Vascular Disease, Microcirculation
Drug Use Investigation for Cervarix®

Study Overview
=================
Brief Summary
-----------------
This post-marketing study was designed to assess safety and efficacy of Cervarix® vaccine in Japanese female subjects under conditions of actual use.

Official Title
-----------------
Drug Use Investigation for Cervarix®

Conditions
-----------------
Infections, Papillomavirus

Intervention / Treatment
-----------------
* Biological: Cervarix®


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Subject must be female Subject must be aged 10 and over Exclusion Criteria: Subject with obvious fever Subject with obvious severe acute disease Subject with hypersensitivity to any component of Cervarix® Other than above, subject who is in inappropriate conditions for vaccination

Ages Eligible for Study
-----------------
Minimum Age: 10 Years

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

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Female subjects<br>Subjects received Cervarix® as per routine practice | Biological: Cervarix®<br>* Administered according to the prescribing information in the locally approved label by the authorities.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The number of subjects with solicited local adverse events | Local adverse events: pain, redness, swelling at the vaccination site | 7 days after vaccination | 
| The number of subjects with solicited general adverse events | General adverse events: fatigue, fever, gastrointestinal symptoms (nausea, vomiting, diarrhea, abdominal pain, etc.), headache, arthralgia, myalgia, urticaria, and rash | 7 days after vaccination | 
| The number of subjects with unsolicited adverse events | Any symptoms other than specified (local/systemic) symptoms | 30 days after vaccination | 
| The number of subjects with serious adverse events |  | 30 days after vaccination |
Optimal Feeding Tube Placement

Study Overview
=================
Brief Summary
-----------------
A randomized controlled trial comparing current standard blind method to CORTRAK enteral access system (CEAS), an FDA approved electromagnetic device to place enteric tubes.

Detailed Description
-----------------
Patient population would include patients in pediatric intensive care unit, pediatric cardiac unit, intermediate medical care unit and pediatric floor who receives postpyloric feeding tube placements. The study team are going to monitor total time and number attempts required for each successful placement, correlation of findings on x-ray versus CEAS, cost-effectiveness of this new equipment with standard blind method and decrease in radiation exposure with CEAS.

Official Title
-----------------
A Randomized Controlled Trial for Optimal Feeding Tube Placement

Conditions
-----------------
Enteral Feeding Intolerance

Intervention / Treatment
-----------------
* Device: Enteric Tube
* Device: CORTRAK enteral access system


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patient admitted to pediatric floor, intermediate care unit, pediatric intensive care unit, or congenital care unit requiring post-pyloric feeding tube placement of size eight french or more and not meeting any of exclusion criteria Exclusion Criteria: Under three kilograms, Open chest wall, Open abdominal wall

Ages Eligible for Study
-----------------
Maximum Age: 18 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 |
| --- | --- |
| Active Comparator: Standard Blind Technique of Tube placement<br>FDA approved technique of enteral nutrition tube placement | Device: Enteric Tube<br>* A post pyloric feeding tube used in patients requiring enteral nutrition<br>* Other names: Enteral nutrition tube;|
| Active Comparator: CORTRAK enteral access system (CEAS) placement<br>An electromagnetic device used to enable enteral nutrition tube placement | Device: CORTRAK enteral access system<br>* Electromagnetic guidance system for enteric feeding tube placement<br>* Other names: CEAS;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Duration of Time | Time taken for placement of enteral tube | Baseline to End of procedure up to 30 minutes | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of X-Rays | Number of X-rays required to achieve correct tube placement | Baseline to End of procedure up to 30 minutes | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
enteral nutrition, radiation exposure, nursing care, pediatrics, radiation, non-ionizing
Clinical Application of 18F-labeled RD2 PET/CT Imaging in the Diagnosis and Treatment of Small Liver Carcinoma

Study Overview
=================
Brief Summary
-----------------
This is a single arm study to evaluate the safety and biodistribution of 18F-labeled RD2 PET/CT Imaging in patients with small liver carcinoma.

Official Title
-----------------
Clinical Application of 18F-labeled RD2 PET/CT Imaging in the Diagnosis and Treatment of Small Liver Carcinoma

Conditions
-----------------
Liver Carcinoma

Intervention / Treatment
-----------------
* Radiation: 18F-RD2


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients with highly suspected tumor； Patients underwent PET/CT examination within 1 week; Patients voluntarily signed informed consent; Over 18 years old, male or female. Exclusion Criteria: Pregnant women; Lactating women; Patients with impaired renal function.

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 18F-RD2<br> | Radiation: 18F-RD2<br>* Patients will receive 5-10 mCi 18F-RD2<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Evaluation of tissue distribution of 18F-RD2 | Biodistribution of 18F-RD2 evaluated by radioactive uptake values (standardized uptake values, SUVs) in various organs during repeated 18F-RD2 scans will be reported. | 2 hours |