louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT04313140: Virtual Biopsy Development to Identify Patient's Glioma Grade at the CHU of Poitiers Using Magnetic Resonance Imaging
Official title: Virtual Biopsy Development to Identify Patient's Glioma Grade at the CHU of Poitiers Using Magnetic Resonance Imaging
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Development of the Virtual Biopsy
Tumor Grade
Artificial Intelligence Algorithms
Clinical
Radiological
Lead sponsor: Poitiers University Hospital
Sponsor class: OTHER
First posted: 2020-03-18
Enrollment: 500
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

Brief summary: Glioma is a tumor of the central nervous system. These lesions are sorted with the WHO ranking regarding the tumoral oncotype. The tumoral MRI assessment is the first step before any medical decision. Currently, only anatomical biopsy can give the tumor grade definition and help to define the most adapted treatment.


Eligibility criteria: Inclusion Criteria:

* Age≥ 18 years,
* Patient with suspected glioma with prior imaging
* Subject free, with legal protection guardianship or curatorship;
* Enrollment in the French Social Security system;
* Informed consent signed by the patient

Exclusion Criteria:

* Any contraindication to an MRI examination
* Legal protection, namely minors, persons deprived of their liberty by a judicial or administrative decision, persons residing in a health or social establishment, adults under legal protection and finally patients in emergency situations
* Pregnant or lactating women, women of childbearing age who do not have effective contraception

Primary outcomes:
measure: Validation of the virtual biopsy in the context of gliomas through the use of statistical learning algorithms (artificial intelligence) compared to the biopsy.
timeFrame: The MRI examination (for 2 hours 30 minutes)
Secondary outcomes:
Other outcomes:
Locations:
city: Poitiers
country: France
facility: CHU De Poitiers
Study officials:
References:
Clinical trial NCT05445440: A Study to Assess the Effects of BMS-986371 on the Drug Levels of Methotrexate in the Presence and Absence of Sulfasalazine
Official title: A Phase 1, Two-part, Open-label, Drug-drug Interaction Study in Healthy Male Adult Participants to Evaluate the Effects of BMS-986371 on the Pharmacokinetics of Methotrexate in the Presence and Absence of Sulfasalazine
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Healthy Participants
Lead sponsor: Bristol-Myers Squibb
Sponsor class: INDUSTRY
First posted: 2022-07-06
Enrollment: 30
Sex: MALE
Minimum age (years): 18
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: SEQUENTIAL
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to evaluate the effects of BMS-986371 on the drug levels of methotrexate, sulfasalazine and their main metabolites in healthy male adult participants.

Detailed description: This study will allow investigation of potential drug-drug interaction mediated through drug transporter proteins. During each part, blood samples will be collected at prespecified times for pharmacokinetic assessments. Subject safety will be monitored throughout the study. There will be approximately 16 subjects enrolled into each part.

Eligibility criteria: Inclusion Criteria:

* Participant has physical exam, vital signs, clinical laboratory safety and other medical test results that are within normal limits, considered not clinically significant by the Investigator, or within other parameters specified in the protocol
* Body mass index of 18 to 32 kg/m\^2, inclusive

Exclusion Criteria:

* Any significant acute or chronic medical illness
* Current or recent (within 3 months of study intervention administration) gastrointestinal disease that could possibly affect the absorption, distribution, metabolism and excretion of study drug
* Any other medical, psychiatric and/or social reason as determined by the Investigator

Other protocol-defined inclusion/exclusion criteria apply

Primary outcomes:
measure: Area under the plasma concentration-time curve from time zero to the time of the last quantifiable concentration (AUC[0-T])
timeFrame: Up to 22 days
measure: Area under the plasma concentration-time curve from time zero extrapolated to infinite time (AUC[INF])
timeFrame: Up to 22 days
measure: Maximum observed plasma concentration (Cmax)
timeFrame: Up to 22 days
Secondary outcomes:
measure: AUC(0-T)
timeFrame: Up to 22 days
measure: AUC(INF)
timeFrame: Up to 22 days
measure: Cmax
timeFrame: Up to 22 days
measure: Number of participants with adverse events (AEs)
timeFrame: Up to 30 days post participant's last study treatment
Other outcomes:
Locations:
city: Miami
country: United States
facility: Quotient Sciences Miami
state: Florida
Study officials:
affiliation: Bristol-Myers Squibb
name: Bristol-Myers Squibb
role: STUDY_DIRECTOR
References:
Clinical trial NCT04216940: Pain Intensity After Root Canal Instrumentation
Official title: Assessment of Pain Intensity After Instrumentation by MPRo and Hyflex Rotatry Files in Molars With Irreversible Pulpitis
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Pain, Postoperative
Lead sponsor: Ain Shams University
Sponsor class: OTHER
First posted: 2020-01-03
Enrollment: 50
Sex: ALL
Minimum age (years): 25
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Assess the pain intensity in a two visit treatment of molars with irreversible pulpitis after instrumentation with two rotary systems Mpro and Hyflex files.


Eligibility criteria: Inclusion Criteria:

* mandibular molars with acute pulpitis

Exclusion Criteria:

* badly decayed non-restorable molars
* medically compromised patients

Primary outcomes:
measure: Pain felt after mechanical instrumentation in the first visit
timeFrame: up to 72 hours
Secondary outcomes:
Other outcomes:
Locations:
city: Cairo
country: Egypt
facility: Ain Shams University
Study officials:
References:
Clinical trial NCT02439840: Use of Bispectral Index Monitoring to Detect Deep Sedation in Mechanically Ventilated Patients: Validity Study
Official title: Use of Bispectral Index Monitoring to Detect Deep Sedation in Mechanically Ventilated Patients: Validity Study
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Disorder; Mental, Sedative
Depressed Level of Consciousness
Mechanical Ventilation Complication
Psychosis Associated With Intensive Care
Lead sponsor: Capital Medical University
Sponsor class: OTHER
First posted: 2015-05-12
Enrollment: 45
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Adult patients admitted to 3 ICUs in University Affiliated Hospital will be screened daily and enrolled consecutively.

Brief summary: In the previous study, the investigators obtained the cutoff value of Bispectral Index to detect early deep sedation in patients with mechanical ventilation. Bispectral Index monitoring can be used as an adjunct tool in screening and confirming deep sedation during the early period of mechanical ventilation. In present study, validation test will be carried out to clarify the sensitivity and specificity of obtained cutoff value in screening deep sedation in patients with mechanical ventilation.


Eligibility criteria: Inclusion Criteria:

* Adult patients are intubated and ventilated within the previous 24 hours, are administered with continuous or intermittent intravenous sedatives and/or analgesics, and are expected to receive mechanical ventilation and sedation for longer than 24 hours

Exclusion Criteria:

* Age under 18 or over 65 years;
* Continuously infusion of muscle relaxants;
* Diagnosed or suspected brain diseases, which including brain trauma, intracranial hemorrhage, stroke, brain tumors, hypoxic-ischemic encephalopathy, epilepsy and meningitis;
* Diagnosed conditions that resulted in a decrease level of consciousness, which including hypoxemia with partial pressure of oxygen in arterial blood less than 60 mmHg, hypotension with systolic blood pressure less than 90 mmHg, hypoglycemia with blood glucose concentration less than 4.1 mmol/L, anemia with hemoglobin concentration less than 70 g/L, and body temperature below 36 °C.

Primary outcomes:
measure: To determine the diagnostic accuracy of BIS monitoring for detecting deep sedation against the reference standard of RASS.
timeFrame: 15 minutes before and after RASS evaluation
Secondary outcomes:
measure: Incidence of deep sedation
timeFrame: 24 hours after establishing of BIS monitoring
Other outcomes:
Locations:
city: Beijing
country: China
facility: Department of Critical Care Medicine, Daxing Teaching Hospital, Capital Medical University
state: Beijing
Study officials:
affiliation: Capital Medical University
name: Jian-Xin Zhou, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02208440: InSpace™ System in Comparison to Best Repair of Massive Rotator Cuff Tear.
Official title: A Randomized, Two-arm, Prospective, Subject Blind Study to Assess the Safety and Efficacy of InSpace™ Device in Comparison to Full Thickness Massive Rotator Cuff Repair in Subjects Scheduled for a Repair Surgery.
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Full-thickness Rotator Cuff Tear
Keywords: Full-thickness/Massive Rotator Cuff Tear, Sub-acromial spacer
Lead sponsor: OrthoSpace Ltd.
Sponsor class: INDUSTRY
First posted: 2014-08-05
Enrollment: 14
Sex: ALL
Minimum age (years): 40
Maximum age (years): 95
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This is a post-marketing study to further assess the safety and effectiveness of the InSpace™ device implantation in comparison to surgical repair of full thickness Massive Rotator Cuff Tear .

Detailed description: This is a post-marketing study to further assess the safety and effectiveness of the InSpace™ device implantation in comparison to surgical repair of full thickness Massive Rotator Cuff Tear .

The effectiveness will be assessed by comparing the shoulder outcome scores of each treatment arm ( ASES, Constant and Quick DASH) from pre-operation (baseline) up to 2 years post-operation, with respect to pain reduction, improvement of activity of daily living (ADL) and improvement of range of motion (ROM).

The safety will be asses by comparing the Adverse event rate between the treatment arms.

Eligibility criteria: Main Inclusion Criteria:

* Age 40 or older.
* Positive diagnostic imaging of the affected shoulder indicating full thickness Massive RCT involving more than one tendon.
* Persistent pain and functional disability of the affected shoulder for at least 3 months.

Main Exclusion Criteria :

* Known allergy to the balloon material (copolymer of PLA and -θ-caprolactone).
* Evidence of significant osteoarthritis or cartilage damage in the shoulder
* Evidence of gleno-humeral instability
* Previous surgery of the shoulder in the past 2 years, excluding diagnostic arthroscopy
* Evidence of major joint trauma, infection, or necrosis in the shoulder
* Partial-thickness tears of the rotator cuff

Primary outcomes:
measure: The change in the Shoulder Score
timeFrame: baseline and 6 months
Secondary outcomes:
Other outcomes:
Locations:
city: Wigan
country: United Kingdom
facility: Wigan and Leigh NHS Foundation Trust: Upper Limb & Trauma Surgery
state: Hall Lane, Appley Bridge
Study officials:
References:
Clinical trial NCT01089140: Non-Idiopathic Scoliosis Treated With Tranexamic Acid
Official title: Blood Loss and Transfusion Requirement in Pediatric Patients With Non-Idiopathic Scoliosis Treated With Tranexamic Acid Undergoing Posterior Spinal Instrumentation and Fusion.
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE2
Conditions: Non-idiopathic Scoliosis
Keywords: pediatrics
scoliosis
tranexamic acid
Investigating non-idiopathic scoliosis
Lead sponsor: The Hospital for Sick Children
Sponsor class: OTHER
First posted: 2010-03-18
Enrollment: 2
Sex: ALL
Minimum age (years): 8
Maximum age (years): 17
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: FACTORIAL
Primary purpose: TREATMENT

Brief summary: Investigation of tranexamic acid (TXA) for reducing perioperative blood loss and transfusion requirement in pediatric patients with secondary scoliosis undergoing posterior spinal fusion.

Detailed description: To investigate whether tranexamic acid (TXA) reduces perioperative blood loss and transfusion requirement in pediatric patients with secondary scoliosis undergoing posterior spinal fusion.In addition determination of the optimal TXA dosing for perioperative reduction of blood loss and transfusion requirement as well as to evaluate use of thromboelastography (TEG) as a measure of coagulation and fibrinolysis in pediatric patients with secondary scoliosis undergoing posterior spinal fusion (this may help guide blood product therapy).

The investigation will determine the effects of TXA on the TEG profile and whether plasminogen activator inhibitor-1 (PAI-1) level affects bleeding and transfusion requirement during scoliosis surgery. Finally to investigate whether PAI-1 level affects bleeding in response to TXA during scoliosis surgery.

Eligibility criteria: Inclusion Criteria:

1. Children with secondary scoliosis undergoing posterior spinal fusion

Exclusion Criteria:

1. Known bleeding disorder as this may increase the risk of bleeding
2. Current antifibrinolytic therapy as these patients may bleed less
3. Patient or family history of thromboembolic disease as there may be potential risk of thrombosis
4. Use of NSAIDS within 5 days of surgery as this may increase the risk of bleeding
5. Known allergy to TXA
6. History of renal insufficiency as TXA is renally excreted
7. Colour vision disturbance

Primary outcomes:
measure: Perioperative blood loss and transfusion requirement
timeFrame: 8 hours
Secondary outcomes:
measure: Thromboelastography (TEG): TEG monitors coagulation of blood samples in vitro to produce a complete picture of clot formation, strength and dissolution (i.e. fibrinolysis).
timeFrame: After Induction- Prior to Drug Administration, Immediately after Bolus Dose
measure: Plasminogen Activator Inhibitor-1
timeFrame: Baseline -Immediately after induction and prior to administration of study drug
Other outcomes:
Locations:
city: Toronto
country: Canada
facility: Hospital for Sick Children
state: Ontario
Study officials:
affiliation: Hospital for SickkIds
name: Tara Der, M.sc. MD.,(FRCPC)
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06411340: Inflammation in Acute Cardiovascular Diseases - the CArdiovascular Inflammation Registry (CAIR)
Official title: An Observational-based Registry of Routinely Collected Clinical Parameters to Study Inflammation in Acute Cardiovascular Diseases - the CArdiovascular Inflammation Registry
Study type: OBSERVATIONAL
Overall status: NOT_YET_RECRUITING
Conditions: Inflammation
Cardiovascular Diseases
Myocarditis
Pericarditis
Myocardial Infarction
Heart Failure
Heart Diseases
Keywords: Inflammation
Acute cardiovascular disease
Myocarditis
Registry
Electronic health records
Pericarditis
Myocardial infarction
Lead sponsor: King's College London
Sponsor class: OTHER
First posted: 2024-05-13
Enrollment: 1000
Sex: ALL
Minimum age (years): 13
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients who are diagnosed with acute cardiovascular diseases can be included in the registry.

Brief summary: Following acute cardiovascular injury, inflammation is vital to activate reparative mechanisms. However, there is compelling evidence implicating excessive inflammation and dysregulated resolution in fibrosis, ventricular remodelling, and heart failure (HF). Recently, the anti-inflammatory agent colchicine reduced cardiovascular events after myocardial infarction (MI) compared to placebo, indicating that targeting inflammation in acute cardiovascular conditions is feasible. Several acute cardiovascular conditions are characterised by inflammation, including myocarditis, MI, and acute heart failure. However, there is large variability in definition, epidemiology, clinical presentation, pathophysiology, and natural history of acute inflammatory cardiovascular diseases. This relates, in part, to the difficulty in performing adequately powered studies. Clinical studies that include sufficient patients and extended observation periods are necessary to address some of these knowledge gaps. This registry aims to collate routinely collected clinical data on patients with acute cardiovascular diseases characterised by inflammation in an observational-based registry. By doing so, the investigators hope to understand the contribution of inflammation to the pathophysiology of acute cardiovascular disease, improve risk stratification, and identify potential novel therapeutic targets.


Eligibility criteria: Inclusion Criteria:

* Any patient 13 years of age or older with an acute cardiovascular condition requiring hospital admission is eligible.

Exclusion Criteria:

* \<13 years of age

Primary outcomes:
measure: All-cause mortality
timeFrame: 1 year
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT05351840: To Evaluate the Pharmacokinetic Interactions and Safety in Healthy Volunteers
Official title: An Open-label, Multiple-dose, Fixed-sequence, 3-Period Study to Evaluate the Pharmacokinetic Interactions and Safety in Healthy Volunteers
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Healthy
Lead sponsor: JW Pharmaceutical
Sponsor class: INDUSTRY
First posted: 2022-04-28
Enrollment: 31
Sex: ALL
Minimum age (years): 19
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: SEQUENTIAL
Intervention model description: open label, multiple dose, Fixed sequence, 3 Period design
Primary purpose: OTHER

Brief summary: To evaluate and compare the pharmacokinetic interactions and safety of multiple dose of Treatment A and Treatment B alone and in combination

Detailed description: The objective of this study was to evaluate pharmacokinetic characteristics and safety after oral concurrent administration of Treatment A and Treatment B compared to each single administration in Healthy volunteers.

Eligibility criteria: Inclusion Criteria:

* Healthy volunteers, aged between 19 to 45 years (both inclusive) at the screening.
* Subjects who are informed of the investigational nature of this study, and voluntarily agree to participate in this study and signs informed consent

Exclusion Criteria:

* Subjects who have a clinically significant past or present medical history of hepato-biliary, renal, gastrointestinal, respiratory, hematologic/neoplastic, endocrine, urologic, psychiatric, musculoskeletal, immunologic, Otorhinolaryngological, and cardiovascular diseases.
* Subjects who have a medical history and/or condition that is considered to be dangerous to take the study drug.

Primary outcomes:
measure: The Pharmacokinetics(PK) parameters AUCss,τ
timeFrame: 0~24 hours
measure: The Pharmacokinetics(PK) parameters Css,max
timeFrame: 0~24 hours
Secondary outcomes:
Other outcomes:
Locations:
city: Daejeon
country: Korea, Republic of
facility: Clinical Trial Center, Chungnam National University Hospital
Study officials:
affiliation: Clinical Trial Center, Chungnam National University Hospital
name: Jang Hee Hong, PI
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00409240: Multi-Targeted Cardiac Risk Intervention in Type 2 Diabetes
Official title: Multi-Targeted Cardiac Risk Intervention in Type 2 Diabetes
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Diabetes
Hypertension
Dyslipidemia
Keywords: Group Intervention
Pharmacotherapy
Behavioral Modification
Diabetes
Lead sponsor: Providence VA Medical Center
Sponsor class: FED
Collaborators: name: Sandra A. Daugherty Foundation
First posted: 2006-12-08
Enrollment: 103
Sex: ALL
Minimum age (years): 18
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Our study intends to test the efficacy of pharmacist-led group interventions on a weekly basis for 4-weeks, then on a monthly basis for 5 additional months to achieve concomitant reductions in hemoglobin A1c, lipids and blood pressure.

Detailed description: Our project intends to study the 6-month efficacy of a pharmacist-led group intervention program that simultaneously target diabetes, hypertension and dyslipidemia. We hypothesize that pharmacist-led group interventions on a weekly basis for 4-weeks then on a monthly basis for 5 additional months may achieve concomitant reductions in hemoglobin A1c, lipids and blood pressure. We are proposing a pilot randomized controlled study to test the efficacy and feasibility of this approach.

Eligibility criteria: Inclusion Criteria:

* type 2 diabetes mellitus,
* \>18 years old,
* with a documented HbA1c more than 7.0%,
* an LDL cholesterol \>100 mg/dl AND a blood pressure \>130/80 mm Hg documented at least once in the medical records within the last 6 months, and
* willing to comply with the study interventions will be eligible for the study.

Exclusion Criteria:

* pregnancy,
* unable to attend the group sessions,
* disease conditions such as psychiatric instability (acutely suicidal, psychotic) or organic brain injury that preclude them from performing diabetes self-care,
* enrolled in the Providence VAMC's Telehealth program

Primary outcomes:
measure: Percent of Patients Achieving Hemoglobin A1C Goal, LDL Cholesterol Goal, and Systolic Blood Pressure Goal From the Enrollment Until the End of the Study
timeFrame: 6 months
Secondary outcomes:
Other outcomes:
Locations:
city: PRovidence
country: United States
facility: Providence VAMC
state: Rhode Island
Study officials:
affiliation: Providence VAMC, Brown Medical School
name: Wen-Chih Wu, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Cohen LB, Taveira TH, Khatana SA, Dooley AG, Pirraglia PA, Wu WC. Pharmacist-led shared medical appointments for multiple cardiovascular risk reduction in patients with type 2 diabetes. Diabetes Educ. 2011 Nov-Dec;37(6):801-12. doi: 10.1177/0145721711423980. Epub 2011 Oct 21.