louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT05739149: A Study to Evaluate Microvessel Ultrasound Imaging of Wound Healing in Patients With Chronic Ulcers
Official title: Microvessel Ultrasound Imaging of the Skin and Subcutaneous Tissues to Evaluate Wound Healing in Patients With Chronic Ulcers
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Non-Healing Ulcer of Skin
Non-healing Wound
Lower Extremity Wound
Lead sponsor: Mayo Clinic
Sponsor class: OTHER
First posted: 2023-02-22
Enrollment: 10
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: SUPPORTIVE_CARE

Brief summary: The purpose of this research is to explore the use of high-resolution microvessel ultrasound imaging system to look for scarring and to monitor wound healing and to see if treatment affects the amount of tiny vessels and circulation around the wound.


Eligibility criteria: Inclusion Criteria:

* Chronic wound in the course of diabetic foot ulcers and/or lower extremity venous ulcers with duration of at least 6 weeks and the wound surface not less than 2 sq. cm and not greater than 15 sq. cm, without evidence of active infection of the wound at the time of qualification to participate in the study
* Meets criteria for stalled chronic wound defined as less than 50% reduction in wound size after 30 days of standard of care management.
* For chronic venous ulcers, ultrasound demonstrates venous reflux \>0.5 seconds
* Satisfactory blood glucose control - fasting not more than 110 mg%, HbA1c \<6.5%
* Satisfactory blood supply to the wound verified by the measurement of the oxygen level of the foot tissue (TCPO2 \> 30mmHg) in patients with neuropathic etiology of diabetic foot syndrome
* In the case of the patients with the wounds of ischemic component, the condition for qualification is a clinical improvement of the limb's blood supply as a result of the revascularization procedure documented by ultrasound.
* Ankle-brachial index (ABI) ≥ 0.8

Exclusion Criteria:

* Acute wound with duration less than 6 weeks
* Evidence of active infection or on antibiotics
* Smoker
* For chronic venous ulcers, ultrasound demonstrates venous reflux \<0.5 seconds
* Unsatisfactory blood glucose control - fasting more than 110 mg%, HbA1c \<6.5%
* Poor blood supply to the wound verified by the measurement of the oxygen level of the foot tissue (TCPO2 \< 30mmHg) in patients with neuropathic etiology of diabetic foot syndrome
* Ankle-brachial index (ABI) \< 0.
* Pregnancy
* Known allergy to lidocaine

Primary outcomes:
measure: Microvessel imaging
timeFrame: 3 months
Secondary outcomes:
Other outcomes:
Locations:
city: Rochester
country: United States
facility: Mayo Clinic Minnesota
state: Minnesota
Study officials:
affiliation: Mayo Clinic
name: Michael Moynagh, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03339349: Weight-Based Enoxaparin Dosing and Real-Time Dose Adjustment in Orthopaedic Trauma
Official title: Weight-Based Enoxaparin Dosing and Real-Time Dose Adjustment in Orthopaedic Trauma
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Venous Thromboembolism
Deep Vein Thrombosis
Pulmonary Embolus
Lead sponsor: University of Utah
Sponsor class: OTHER
First posted: 2017-11-13
Enrollment: 80
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: OTHER

Brief summary: The rates of Venous thromboembolism (VTE) after orthopedic surgery are as high as 40-60% without prophylactic measures. Enoxaparin, a low-molecular-weight heparin, produces an anticoagulant effect by binding antithrombin, thereby accelerating antithrombin's inactivation of coagulation factor Xa (FXa), thus decreasing the likelihood of clot formation. Despite standard dosing enoxaparin prophylaxis, VTE rates in post-operative orthopedic trauma patients remain as high as 12.2%.The investigators will examine enoxaparin pharmacokinetics and test whether a clinical protocol for real-time enoxaparin dose adjustment can favorably alter the proportion of patients with in-range anti-Factor Xa (aFXa) levels. Outcomes will include peak and trough steady-state aFXa levels in response to standard and escalated doses of enoxaparin and the incidence of venous thromboembolism and bleeding events post-surgery. In the trauma and orthopaedic populations, patients with low initial aFXa levels are significantly more likely to develop deep venous thrombosis. Thus, this study has important implications for appropriate enoxaparin dose magnitude and frequency, and may ultimately help to decrease the substantial morbidity and mortality associated with post-operative VTE.


Eligibility criteria: Inclusion Criteria:

* Receiving orthopedic trauma surgery
* Able to have enoxaparin initiated within 36 hours after procedure

Exclusion Criteria:

* Intracranial bleeding/stroke
* bleeding disorder
* heparin-induced thrombocytopenia
* creatinine clearance \< 30 mL/minute
* epidural catheter
* serum creatinine \> 1.6 mg/dL

Primary outcomes:
measure: Number of Participants With Venous Thromboembolism Events
timeFrame: 90 days
measure: Number of Participants With Bleeding Events
timeFrame: 90 days
Secondary outcomes:
Other outcomes:
Locations:
city: Salt Lake City
country: United States
facility: University of Utah
state: Utah
Study officials:
References:
Clinical trial NCT00938249: Effects of Monascus Garlic Fermented Extract on Serum Triglyceride Level
Official title: Effects of Monascus Garlic Fermented Extract on Serum Triglyceride Level: a Double-Blind, Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Hypertriglyceridemias
Keywords: Moderately Elevated Serum Triglyceride
Lead sponsor: Hiroshima University
Sponsor class: OTHER
Collaborators: name: Wakunaga Pharmaceutical Co., Ltd.
First posted: 2009-07-13
Enrollment: 55
Sex: ALL
Minimum age (years): 20
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: The purpose of the study is to determine the effect of monascus garlic fermented extract on serum lipid concentrations in subjects with moderately elevated serum triglyceride.


Eligibility criteria: Inclusion Criteria:

* Healthy as based on medical history and physical examination
* Fasting serum triglyceride 120 to 200mg/dl
* Willing not to serve as blood donor during the study
* Informed consent signed

Exclusion Criteria:

* Female subjects who are pregnant or nursing a child
* Participation in any clinical trial up to 90 days before Day 1 of this study
* Renal or hepatic dysfunction
* Heart disease
* Under medication
* Subjects who are taking functional food designed for weight loss or serum lipid reduction

Primary outcomes:
measure: Fasting triglyceride level
timeFrame: Every 4 weeks (Overall 20 weeks)
Secondary outcomes:
measure: Abdominal circumference
timeFrame: Every 4 weeks (Overall 20 weeks)
measure: Visceral fat area by CT scan
timeFrame: Week 0 and Week 12
measure: Serum total cholesterol and LDL cholesterol levels
timeFrame: Every 4 weeks (Overall 20 weeks)
measure: Serum adiponectin level
timeFrame: Week 0 and Week 12
Other outcomes:
Locations:
city: Hiroshima
country: Japan
facility: Hiroshima University
Study officials:
References:
citation: Higashikawa F, Noda M, Awaya T, Ushijima M, Sugiyama M. Reduction of serum lipids by the intake of the extract of garlic fermented with Monascus pilosus: a randomized, double-blind, placebo-controlled clinical trial. Clin Nutr. 2012 Apr;31(2):261-6. doi: 10.1016/j.clnu.2011.10.008. Epub 2011 Oct 29.
Clinical trial NCT00861549: Bioavailability, Pharmacokinetics and Safety Evaluation of Phencynonate Hydrochloride in Healthy Volunteers
Official title: Bioavailability, Pharmacokinetics and Safety Evaluation of Phencynonate Hydrochloride in Healthy Volunteers
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Healthy
Keywords: Bioavailability
Pharmacokinetics
Safety Evaluation
Lead sponsor: PhytoHealth Corporation
Sponsor class: INDUSTRY
First posted: 2009-03-13
Enrollment: 32
Sex: MALE
Minimum age (years): 18
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: BASIC_SCIENCE

Brief summary: The purpose of this study is to evaluate the bioavailability of two formulations (Taiwan and China mainland) of phencynonate hydrochloride tablets and to generate pharmacokinetic and safety profiles of phencynonate hydrochloride in healthy volunteers.


Eligibility criteria: Inclusion Criteria:

1. Subjects must have signed and dated informed consent form.
2. Subjects must be ≧ 18 and ≦ 40 years old, healthy, non-smoking male.
3. Subjects with body weight within ± 20% ideal body weight
4. Subjects with urinalysis data within acceptable range, including pH, blood, glucose and protein
5. Subjects with laboratory evaluations data within acceptable range, including serum chemistry examinations (glucose, total cholesterol, TG, SGOT, SGPT, GSP, alkaline phosphatase, total bilirubin, total protein, albumin, r-GT, BUN, creatinine, uric acid) and hematology (complete blood count and platelets)
6. Subjects with acceptable ECG and chest x-ray

Exclusion Criteria:

1. Subjects had taken any drugs within 14 days prior to screening.
2. Subjects with history of glaucoma
3. Subjects with history of ileus
4. Subjects with history of benign prostate hypertrophy with urine retention
5. Subjects with history of myasthenia gravis
6. Subjects with history of asthma
7. Subject with history of any other medical conditions that, in the opinion of the investigator, compromised subject safety or ability to comply with study procedures
8. Subjects with history of drug or alcohol addiction or abuse within 1 year prior to screening
9. Subjects with hypersensitivity to phencynonate hydrochloride or other drugs with similar chemical structure
10. Subjects had donated blood more than 250 mL within the pervious 3 months prior to study
11. Subjects had received any investigational drugs within 1 month prior to screening

Primary outcomes:
measure: PK parameters(1)Cmax,Tmax,Elimination half-life,AUC,Vd/F,Clt/F,MRT,relative BA and percentage of protein binding of plasma PCNH and its metabolite (2) D∞(u)and Clr of urine PCNH and its metabolite
timeFrame: 5 or 10 days
measure: Safety Variables:AE/lab. exam./PE/Vital signs/ECG
timeFrame: 5 to 10 days
Secondary outcomes:
Other outcomes:
Locations:
city: Taipei
country: Taiwan
facility: General Clinical Research Center for New Drug Trial, Tri-Service General Hospital
Study officials:
affiliation: Tri-Service General Hospital
name: Yaoh S Lin, M.D.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02364349: A Comparative Study on Local Allergic Responses of Bee Venom and Essential Bee Venom Pharmacopuncture
Official title: A Comparative Study on Local Allergic Responses of Bee Venom and Essential Bee Venom Pharmacopuncture
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Healthy Volunteers
Lead sponsor: Jaseng Hospital of Korean Medicine
Sponsor class: OTHER
First posted: 2015-02-18
Enrollment: 20
Sex: ALL
Minimum age (years): 20
Maximum age (years): 39
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: SUPPORTIVE_CARE

Brief summary: This double-blinded randomized clinical trial investigates any differences in allergic responses elicited by Bee Venom (BV) and Essential Bee Venom (eBV).

Detailed description: This double-blinded randomized clinical trial investigates difference in allergic responses elicited by Bee Venom (BV) and Essential Bee Venom (eBV). Twenty healthy volunteers aged 20-40 years were randomly allocated to the 2 groups and administered eBV and BV on left and right forearm, respectively, in accordance with group allocation. Physician, participant, and outcome assessor were blinded to group allocation. Local pain, swelling, itching, redness, wheals and adverse reactions were recorded by timepoint before and after treatment.

Eligibility criteria: Inclusion Criteria:

* Individuals with no prior exposure to bee venom treatment
* Healthy individuals of both genders, 20 to 39 years old
* Individuals able to communicate their thoughts
* Voluntary participants who have provided written consent

Exclusion Criteria:

* Individuals on medications for chronic diseases (i.e. hypertension, hyperlipidemia)
* Individuals with past history of allergic dermatitis
* Individuals with past history of adverse events following bee stings
* Individuals with symptoms of common cold
* Individuals with fear of bee venom intervention or those who refuse to participate

Primary outcomes:
measure: Visual Analog Scale(VAS) on Pain
timeFrame: 0.5 hours after intervention
measure: Wheal and erythema
timeFrame: 24 hours after intervention
measure: Visual Analog Scale(VAS) on Pain
timeFrame: 48 hours after intervention
Secondary outcomes:
measure: Visual Analog Scale(VAS) on Pain
timeFrame: 0, 2, 6, 24, 72, 96, 120, 144 hours after intervention
measure: Visual Analog Scale(VAS) for Wheal response
timeFrame: 0,0.5, 2, 6, 24, 48, 72, 96, 120, 144 hours after intervention
measure: Visual Analog Scale(VAS) for Skin irritation
timeFrame: 0,0.5, 2, 6, 24, 48, 72, 96, 120, 144 hours after intervention
measure: Wheal and erythema
timeFrame: 0, 0.5, 6, 24, 72 hours after intervention
measure: Adverse events
timeFrame: 0, 6, 24, 72 hours after intervention
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Jaseng Hospital of Korean Medicine
state: Gangnam-Gu
Study officials:
affiliation: Jaseng Hospital of Korean Medicine
name: Joon-Shik SHIN, MD
role: STUDY_CHAIR
References:
Clinical trial NCT02324049: Safety, Pharmacokinetics, and Pharmacodynamics/Efficacy of SBC-103 in Mucopolysaccharidosis III, Type B (MPS IIIB)
Official title: A Phase I/II Open Label Study in MPS IIIB Subjects to Investigate the Safety, Pharmacokinetics, and Pharmacodynamics/Efficacy of SBC-103 Administered Intravenously
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
PHASE2
Conditions: Mucopolysaccharidosis IIIB
Keywords: MPS IIIB
Mucopolysaccharidosis
Mucopolysaccharidosis type IIIB
Sanfilippo Syndrome
Metabolism, Inborn Errors
Metabolic Diseases
Genetic Diseases, Inborn
Carbohydrate Metabolism, Inborn Errors
Connective Tissue Diseases
Lysosomal Storage Diseases
Mucinoses
Mucopolysaccharidoses
Pathologic Processes
Lead sponsor: Alexion Pharmaceuticals, Inc.
Sponsor class: INDUSTRY
First posted: 2014-12-24
Enrollment: 11
Sex: ALL
Minimum age (years): 2
Maximum age (years): 12
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: Study to evaluate the safety and tolerability of intravenous (IV) administration of SBC-103 in participants with mucopolysaccharidosis III, type B (MPS IIIB, Sanfilippo B) with evaluable signs or symptoms of developmental delay.

Detailed description: This study was designed as a 3-part study to evaluate the safety and tolerability of IV administration of SBC-103. Participants enrolled in Part A (0.3, 1.0, or 3.0 milligrams \[mg\] per kilogram \[kg\] of SBC-103 administered every other week \[QOW\] for 24 consecutive weeks). Participants who completed Part A were eligible for Part B (an increase to 1.0 or 3.0 mg/kg QOW). Participants who completed Part B were eligible for Part C (5.0 and/or 10.0 mg/kg to continue through Week156; no participants received both 5.0 and 10.0 mg/kg). Due to the early termination of the SBC-103 development program, including this study, all participants withdrew from Part C at the sponsor's decision. As a result of the early termination of this program, this report provides only safety data.

Eligibility criteria: Key Inclusion Criteria:

* A participant was greater than or equal to 2 years of age but less than 12 years of age at the time of informed consent.
* Definitive diagnosis of MPS IIIB.
* Documented developmental delay.

Key Exclusion Criteria:

* Received treatment with gene therapy at any time.
* Previous hematopoietic stem cell or bone marrow transplant.
* Had any internal or non-removable external metal items that presented a safety risk for study assessments that utilized magnetic fields, or any other medical condition or circumstance in which magnetic resonance imaging was contraindicated according to local institutional policy.
* Known hypersensitivity to eggs.

Primary outcomes:
measure: Number Of Participants Who Experienced Severe Treatment-emergent Adverse Events (TEAEs)
timeFrame: Baseline to Week 142
Secondary outcomes:
Other outcomes:
Locations:
city: Minneapolis
country: United States
state: Minnesota
city: Pittsburgh
country: United States
state: Pennsylvania
city: Barcelona
country: Spain
city: Birmingham
country: United Kingdom
Study officials:
References:
Clinical trial NCT02957149: Platelet Rich Plasma During Radical Prostatectomy
Official title: A Study Evaluating Intraoperative Application of Platelet-Rich Plasma to the Neurovascular Bundles During Nerve-Sparing Radical Prostatectomy: Initial Technical Description and Prospective Early Postoperative Outcomes Analysis
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Prostate Cancer
Lead sponsor: Mayo Clinic
Sponsor class: OTHER
First posted: 2016-11-06
Enrollment: 24
Sex: MALE
Minimum age (years): 50
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: SUPPORTIVE_CARE

Brief summary: Can platelet rich plasma applied to nerve bundles at time of surgery help the nerve bundles heal? Subjects undergoing a Radical Prostatectomy who meet study inclusion/exclusion criteria will be consented to receive an intraoperative application of platelet-rich plasma, made from their own blood at the time of surgery, for application onto their neurovascular bundles in an effort to improve the healing process. Subjects will be followed for an additional 18 months to determine the efficacy and safety of this procedure.


Eligibility criteria: Inclusion Criteria:

* Newly diagnosed, clinically localized prostatic adenocarcinoma
* Age 50 - 60 years
* Male gender
* Normal preoperative sexual function
* Normal urinary continence

Exclusion Criteria:

* Unable or unwilling to provide informed consent
* Vulnerable study populations
* Active systemic infection
* Diabetes mellitus diagnosis
* Preexisting Erectile Dysfunction or urinary incontinence
* Metastatic or locally advanced prostatic adenocarcinoma on preoperative evaluation
* Men found grossly or pathologically to have locally advanced or metastatic disease at the time of radical prostatectomy
* An estimated blood loss of \> 750 mL at the time of radical prostatectomy
* Treatment prior to surgery with any form of hormones, anti-androgens or androgen deprivation therapy
* Use of an antidepressant, beta blocker or erectile dysfunction medication at the time of study screening
* Men without a regular sexual partner
* Use of aspirin or heparin 2 weeks before radical prostatectomy
* Need for use of aspirin or heparin for 2 weeks or more after radical prostatectomy

Primary outcomes:
measure: Safety of Using Platelet Rich Plasma (PRP) on the Neurovascular Bundle (NVB)
timeFrame: 18 months
Secondary outcomes:
measure: Change in Sexual Function Using International Index of Erectile Function (IIEF-5)
timeFrame: Baseline; every 3 months up to 18 months.
measure: Change in Urinary Function (UF) Using the Expanded Prostate Cancer Index Composite (EPIC)
timeFrame: Baseline; 3 months; 6 months; 9 months; 12 months; 18 months
Other outcomes:
Locations:
city: Rochester
country: United States
facility: Mayo Clinic in Rochester
state: Minnesota
Study officials:
affiliation: Mayo Clinic
name: Matthew T. Gettman, M.D.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04381949: Interest of Tracheal Extubation in Positive Pressure on Postoperative Oxygenation in Adult Digestive Surgery: Prospective Randomized Study ExPress
Official title: Interest of Tracheal Extubation in Positive Pressure on Postoperative Oxygenation in Adult Digestive Surgery: Prospective Randomized Study
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Patients Undergoing Digestive Surgery With Orotracheal Intubation
Lead sponsor: University Hospital, Rouen
Sponsor class: OTHER
First posted: 2020-05-11
Enrollment: 208
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: Evaluation of a postoperative tracheal extubation protocol under positive pressure in accordance with international recommendations.

Two arms: the first with "classic" extubation with disconnection of the respirator and the second with extubation without disconnection of the respiratory, as recommended.

Computer Randomization with a 1: 1 ration


Eligibility criteria: Inclusion Criteria:

* Age\> 18 and \<80
* Patient going to benefit from general anesthesia with orotracheal intubation for surgery lasting more than 60 minutes at the visceral surgery unit of the Rouen University Hospital.
* Person affiliated to a social security scheme
* Person who has read and understood the newsletter and signed the consent form

Exclusion Criteria:

* Minor patients or age\> 80 years
* History of Obstructive Sleep Apnea Syndrome
* Chronic respiratory failure / History of chronic obstructive pulmonary disease
* Surgery \< 60 minutes
* Use of methylene blue intraoperatively
* Extubation finally performed in the operating room
* orotracheal intubation difficult to induce general anesthesia
* Suspected inhalation during orotracheal intubation
* Pneumothorax per operative
* Heart failure authenticated by trans thoracic ultrasound \<50%
* Neuromuscular pathologies (myasthenia gravis, myopathies)
* Body mass index\> 35
* Emergency surgery
* Patient with an ASA IV score (ie according to the definition of the American Society of Anesthesiology)
* Major surgical complications (hemorrhagic shock)
* Major anesthetic complications (anaphylactic shock, bronchospasm)
* Pregnant or parturient or lactating woman or woman of childbearing age without proven contraception
* Person deprived of their liberty by an administrative or judicial decision or person placed under the protection of justice / guardianship or curatorship

Primary outcomes:
measure: Desaturation rate
timeFrame: within one hour of tracheal extubation
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References: