linjc16/ctgov huggingface dataset:
Drug-Drug Interaction Study to Assess the Effects of Multi Dose Clopidogrel on the Pharmacokinetics of Single-Dose K-877 in Healthy Adult Volunteers

Study Overview
=================
Brief Summary
-----------------
The primary objective of this study is to assess the effects of clopidogrel on the PK of K-877 in healthy adult subjects.

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

Intervention / Treatment
-----------------
* Drug: K-877
* Drug: Clopidogrel


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Subject provides written informed consent before any study-specific evaluation is performed; Subject is a healthy adult male or female volunteer between the ages of 18 and 45 years, inclusive at screening; Subject has a BMI of 18 to 30 kg/m², inclusive; Subject has hematology, serum chemistry, and urinalysis test results within the reference ranges, or results that do not show clinically significant abnormalities, as judged by the Investigator at screening and check-in; Exclusion Criteria: Subject is a woman who is pregnant or breastfeeding; Subject has clinically significant abnormalities in the screening or check-in assessments; Subject has current or history of clinically significant coagulation, bleeding, or platelet disorders; Subject or a family member of the subject has a history of coagulation or bleeding disorders or reasonable suspicion of vascular malformations, including aneurysms;

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 45 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: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: K-877 & Clopidogrel<br>K-877 & Clopidogrel orally | Drug: K-877<br> <br> Drug: Clopidogrel<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Plasma exposure of K-877 by measuring Cmax when administered alone or with Clopidogrel |  | Up to 72 hours after dosing | 
| Plasma exposure of K-877 by measuring AUC when administered alone or with Clopidogrel |  | Up to 72 hours after dosing | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Evaluation of 20 participants with treatment emergent adverse events as assessed by the principle investigator | Subjects will be questioned in a general way by the investigator without specific symptoms suggested. | Through study completion up to 17 days. |
Safety of Cardiac Pacemakers in 3 Tesla MRI

Study Overview
=================
Brief Summary
-----------------
To evaluate short-term and long-term effects by MR imaging at 3T on the technical and functional status of cardiac pacemakers.

Detailed Description
-----------------
Recently, a shift could be observed from cardiac pacemakers being an absolute contraindication to being a relative contraindication for MR imaging at 1.5 Tesla, depending on a patient-per-patient risk-benefit-evaluation, which includes an urgent clinical need for MR imaging (other imaging modalities non-conclusive) and co-morbidities (especially cardiac co-morbidities). At the same time, MR imaging at 3 Tesla is evolving from a research application only to an important imaging modality today. Using the improved signal-to-noise-ratio, high field MR-Systems with a field strength of 3 Tesla offer a variety of diagnostic advantages to 1.5 Tesla systems. These advantages lead to a higher sensitivity and specificity in diagnosing, foremost neurological, disorders. In this study, we evaluate the safety of MR imaging of the brain in patients with cardiac pacemakers at 3T.

Official Title
-----------------
Study to Evaluate Safety of Cardiac Pacemakers in MR Imaging at 3T Tesla

Conditions
-----------------
Heart Diseases

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Urgent need for an MRI examination Stable pacemaker physical parameters Battery voltage > 2.7 V Battery impedance < 2000 Ohm Battery estimated remaining lifetime > 6 months Lead impedances 200-2000 Ohm Stable pacing parameters Pacing capture threshold <2.5V at a pulse duration of 0.4ms Sensing > 5mV Minimum 3 months since pacemaker and lead implantation Exclusion Criteria: History of ventricular tachycardia (VT) or ventricular fibrillation Unstable angina Myocardial infarction within the previous 3 months Cardiothoracic surgery within the previous 3 months Presence of an abdominal pacemaker with lead length > 70 cm Presence of MRI incompatible bioimplants or other MRI incompatible materials
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
-----------------
pacemaker, magnetic resonance imaging, safety
Reconstruction of the Bile Duct With the Round Ligament

Study Overview
=================
Brief Summary
-----------------
The investigators developed a new surgical technique in order to reconstruct the bile duct with the round ligament

Detailed Description
-----------------
Classically, the bile duct defect after bile duct injury or resection is achieved by bilioenteric reconstruction. However bilioenteric anastomosis is associated with long term complications including intrahepatic bile ducts infection, specific complications related to the Roux en Y jejunal loop and eliminate the endoscopic access to intrahepatic bile ducts. The investigators had recently developed a new surgical technique to reconstruct the veins with the parietal peritoneum with excellent results. Accordingly the investigators decided to develop a new surgical technique in order to reconstruct the bile duct defects with the vascularized round ligament.

Official Title
-----------------
Reconstruction of Postcholecystectomy Bile Duct Injury and Bile Duct Defects With the Round Ligament

Conditions
-----------------
Bile Duct Obstruction, Extrahepatic

Intervention / Treatment
-----------------
* Procedure: Reconstruction of the bile duct with the round ligament


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Radiological or operative diagnosis of bile duct Injury or defect Can underwent surgical procedure Exclusion Criteria: 1) The absence of the round ligament
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: Device: Round ligament and the bile duct<br>The investigators describe the safety and efficacy of the reconstruction of the bile duct with the Round ligament. | Procedure: Reconstruction of the bile duct with the round ligament<br>* In patients who had bile duct defect by injury or resection, the Round ligament will be used to reconstruct the defect. Surgical technique, the early and long term postoperative measures are detailed in the investigators protocol.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Safety - absence of any severe complication or mortality related to the new procedure | Safety is defined by the absence of any severe complication (necrosis or biliary fistula) or mortality related to the new procedure. | at 1 year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Bile buct patency | Secondary outcome include mainly the patency of the reconstructed bile duct. | at 3 year | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Bile duct injury, Bile duct defect, Round ligament, Reconstruction
Assessment of Skin Perfusion Pressure as an Indicator of Tissue Oxygenation in Cardiac Surgery Patients Undergoing Cardiopulmonary Bypass

Study Overview
=================
Brief Summary
-----------------
This study is aim to evaluate usefulness of the perioperative monitoring of skin perfusion pressure as an indicator of perpheral perfusion in patients undergoing on-pump cardiac surgery. Association of the intraoperative and postoperative 6hr skin perfusion pressure with perioperative serum lactate level is going to be assessed.

Conditions
-----------------
Peripheral Circulation During On-pump Cardiac Surgery

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: age > 20 yrs, scheduled for elective on-pump cardiac surgery Exclusion Criteria: known peripheral arterial occlusive disease, patients without swan ganz catheter insertion, heart transplantation, infective endocarditis, emergency surgery, hemodynamic instability requiring vasopressor, preoperative lactate > 2mmol/L, known liver cirrhosis, pregnant, cognitive dysfunction, being unable to communicate

Ages Eligible for Study
-----------------
Minimum Age: 20 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 |
| --- | --- |
| SPP<br>Patients undergoing cardiac surgery with perioperative monitoring of Skin Perfusion Pressure | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Assessment of skin perfusion pressure |  | From post induction to 6 hours | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Assessment of arterial lactate level |  | From post induction to 48 hours |
A Clinical Study of 6MW3211 in Patients With Renal Cancer

Study Overview
=================
Brief Summary
-----------------
single arm, non-randomized, multicenter, open label, phase 2 clinical trial in patients with advanced clear cell renal cacer

Detailed Description
-----------------
This study is a single arm, non-randomized, multicenter, open label, phase 2 clinical trial to evaluate preliminary efficacy and safety in patients with advanced clear cell renal cacer

Official Title
-----------------
A Phase 2, Multicenter, Open-Label Study to Evaluate the Preliminary Efficacy and Safety of 6MW3211 in Patients With Advanced Clear Cell Renal Cancer

Conditions
-----------------
Advanced Clear Cell Renal Cell Carcinoma

Intervention / Treatment
-----------------
* Drug: 6MW3211


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Voluntarily participate in the study and sign the informed consent. Advanced clear cell renal cancer. At least one measurable tumor target lesion. Life expectancy≥3 months. Suitable organ functions. Patients who had failed at least one line therapy. ECOG 0-1. The samples of tumor tissue should be provided Exclusion Criteria: Patients who had received anti-tumor therapy/radiotherapy/immunotherapy within 4 weeks. History of other malignant tumors within 5 years. Patients with CNS metastasis. History of active autoimmune diseases. Patients with poor-controlled systemic diseases after treatment. Patients with severe infection or requiring antibiotic treatment within 4 weeks before dosing. Adverse reactions related to previous treatments failed to recover to CTCAE 5.0 ≤1 Patients who had experienced immune-related adverse events (irAE) with grade 3 or above. Patients who were allergic to any composition of experimental drug. Subjects with poor treatment compliance. Pregnant or lactating woman. Live vaccination within 28 days before first dosing. History of drug abuse or addiction Patients with active HBV or HCV, or HIV antibody positive,or Tp-Ab positive.

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 6MW3211<br>6MW3211 injection, 30mg/kg | Drug: 6MW3211<br>* 6MW3211 injection, 30mg/kg, Q2W<br>* Other names: 6MW3211 injection;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| ORR | Objective response rate | up to 24 months |
Broxuridine Plus Surgery in Treating Patients With Stage I or Stage II Prostate Cancer

Study Overview
=================
Brief Summary
-----------------
Phase II trial to study the effectiveness of broxuridine in treating patients who are undergoing surgery for stage I or stage II prostate cancer. Broxuridine may help doctors determine the rate of growth of prostate tumors and help them plan effective treatment

Detailed Description
-----------------
OBJECTIVES: I. Measure the potential doubling times of multifocal adenocarcinomas of the prostate using broxuridine. II. Determine whether the doubling times of multifocal carcinomas occurring within a single prostate are consistent with a model in which low-volume carcinomas have slow doubling times and high-volume carcinomas have fast doubling times. OUTLINE: Patients receive broxuridine IV over 30 minutes on day -1. Approximately 12-96 hours later, patients undergo surgery to remove the prostate. Tumor tissue is examined by immunostaining for the presence of broxuridine to determine doubling times of the tumor.

Official Title
-----------------
Cell Kinetic Study of Bromodeoxyuridine (BrdU) in Prostate Cancer

Conditions
-----------------
Stage I Prostate Cancer, Stage IIA Prostate Cancer, Stage IIB Prostate Cancer

Intervention / Treatment
-----------------
* Drug: bromodeoxyuridine
* Procedure: conventional surgery
* Other: laboratory biomarker analysis


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Diagnosis of stage I or II (T1-2) carcinoma of the prostate PSA greater than 8 ng/mL Abnormal findings on digital rectal examination Eligible for radical prostatectomy Performance status - ECOG 0 or 1 No prior biologic therapy No prior chemotherapy No prior neoadjuvant hormonal therapy No prior radiotherapy See Disease Characteristics No prior therapy that would affect tumor growth rates or volume
Sexes Eligible for Study
-----------------
Male

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: Treatment (bromodeoxyuridine)<br>Patients receive broxuridine IV over 30 minutes on day -1. Approximately 12-96 hours later, patients undergo surgery to remove the prostate.Tumor tissue is examined by immunostaining for the presence of broxuridine to determine doubling times of the tumor. | Drug: bromodeoxyuridine<br>* Given IV<br>* Other names: broxuridine;Procedure: conventional surgery<br>* Undergo surgery<br>* Other names: surgery, conventional;Other: laboratory biomarker analysis<br>* Correlative studies<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Average doubling time between low and high volume tumors |  | Up to 3 years |
Evaluating the Psychophysiological Effects of a Smartphone-Based Mindfulness Task

Study Overview
=================
Brief Summary
-----------------
The aim of the present study is to evaluate the psychophysiological effects of a smart phone based mindfulness meditation app (MMA) for individuals with clinically significant symptoms of major depression and/or anxiety, or symptoms of chronic pain. Specifically, the study aims to examine parasympathetic tone using HRV (primary outcome), mind-wandering and present awareness, mood symptoms, and breath focus in groups of participants who self-report clinically significant symptoms of depression and/or anxiety (DA), chronic pain symptoms (CP), as well as control participants who do not meet our criteria for either (Controls (C). All study groups will be randomized to a mindfulness meditation app (MMA+) condition or a mindfulness meditation condition without the app (MMA-) after a brief stress-induction procedure.

Official Title
-----------------
Evaluating the Psychophysiological Effects of a Smartphone-Based Mindfulness Task on Individuals With Clinically Significant Symptoms of Chronic Pain, Depression and Anxiety

Conditions
-----------------
Chronic Pain, Depression, Anxiety

Intervention / Treatment
-----------------
* Behavioral: Mindfulness Meditation


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: York University students Exclusion Criteria: Individuals with diagnosed cardiac conditions (e.g. coronary artery disease, arrhythmias etc) will be excluded due to confounds with heart rate variability assessment

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Mindfulness Meditation App<br>Participants randomized to this arm will use a smartphone app to practice mindfulness meditation for 12 minutes. | Behavioral: Mindfulness Meditation<br>* A meditative practice involving paying attention to present moment experiences and focusing on breathing sensations.<br>|
| Active Comparator: Mindfulness Meditation No App<br>Participants randomized to this arm will not use a smartphone app, but will receive instructions to practice mindfulness meditation for 12 minutes. | Behavioral: Mindfulness Meditation<br>* A meditative practice involving paying attention to present moment experiences and focusing on breathing sensations.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Heart Rate Variability | A stress biomarker derived from heart rate recordings that reflects parasympathetic control of cardiac output | 22 minutes |
Clinical Validation of Boneview for FDA Submission

Study Overview
=================
Brief Summary
-----------------
The goal of this clinical validation is to assess comparative performances of physicians with and without the assistance of BoneView for the diagnosis of fractures on radiographs. The performances are evaluated in terms of accuracy (primary endpoint with the pair specificity/sensitivity and the secondary endpoint PPV/NPV) and in terms of time needed for diagnosis (secondary endpoint with the measurement of time on each case).

Official Title
-----------------
Clinical Validation of Boneview for FDA Submission: Evaluation of the Ability of the Artificial Intelligence Software, Boneview, to Improve Physicians' and Radiologists' Performances in Detecting Fractures on Bone X-Rays Radiographs.

Conditions
-----------------
Fracture

Intervention / Treatment
-----------------
* Device: Diagnosis of fracture on X-Ray Radiographs


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Anonymized standard X-ray exams of extremity/pelvis/rib cage/dorsolumbar spine not containing or containing fracture(s). Adult patient, with minimum age of 21 years old. Exclusion Criteria: Exams with one or more images including a body part not concerned by the intended use of BoneView (skull and cervical spine) Cases with one or more images being used for model design and development. Exams with one or more images being of poor quality (lossy), which prevent a proper interpretation by the readers. Cases not containing a medically relevant number of views for correct diagnosis.

Ages Eligible for Study
-----------------
Minimum Age: 21 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 |
| --- | --- |
| AI- Aided performances<br> | Device: Diagnosis of fracture on X-Ray Radiographs<br>* Diagnosis of fracture on X-Ray Radiographs with and without the assistance of Boneview Software<br>|
| AI- Unaided performances<br> | Device: Diagnosis of fracture on X-Ray Radiographs<br>* Diagnosis of fracture on X-Ray Radiographs with and without the assistance of Boneview Software<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| measurement of diagnosis performances via calculation of sensitivity, specificity, NPV, PPV | calculation of sensitivity, specificity, NPV, PPV and comparison between the two cohorts | 1 month | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Time needed for diagnosis via measurement of the time before submission of the diagnosis | measurement of the time and comparison between the two cohorts | 1 month | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
fracture, artificial intelligence, x-rays radiographs
French Observational Study With Colic Capsule

Study Overview
=================
Brief Summary
-----------------
colic capsule usings with patients without possible colic endoscopy

Official Title
-----------------
French Observational Study With Colic Capsule

Conditions
-----------------
Colic Capsule Interest

Intervention / Treatment
-----------------
* Device: colic capsule


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: anesthesia not possible incomplete colic endoscopy colic endoscopy refused Exclusion Criteria: none

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 |
| --- |
|Device: colic capsule|colic polyp diagnosis|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| number of polyps or lesions | number of polyps or lesions | 5 years |