louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT02705443: Early Identification of Suspected Deep Tissue Injury (sDTI)
Official title: Early Identification of Suspected Deep Tissue Injury (sDTI) Utilizing Long-Wave Thermographic Imaging (LWIT)
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Pressure Ulcer
Bed Sore
Lead sponsor: Wound Vision
Sponsor class: INDUSTRY
First posted: 2016-03-10
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Subjects admitted to a long-term acute care hospital (LTACH).

Brief summary: The purpose of this study is to further clarify existing research on the early identification and documentation of suspected deep tissue injury (sDTI). Basic principles of physiology along with prior research suggests that sDTI has quantifiable amounts of heat (or lack thereof) relative to surrounding tissue that will exhibit characteristic thermal signatures (temperature). These signatures will be measured and quantitatively recorded using long-wave infrared thermography (LWIT) to not only identify sDTI, but to also learn more about their pathophysiological evolution. Additionally, the LWIT physiological data will be cross-compared to the gold standard of visual assessment and other current standards of wound evaluation.


Eligibility criteria: Inclusion Criteria:

* 18 years of age or older
* Can tolerate position changes ≥ 10 minutes
* Non-pregnant

Exclusion Criteria:

* Therapies/treatments cannot be safely suspended to for an imaging session
* Non-English speaking

Primary outcomes:
measure: Number of anatomical areas with intact skin and a thermographic anomaly that progress to a stageable pressure ulcer
timeFrame: Up to 25 days
measure: Number of anatomical areas with intact skin and a thermographic anomaly that do not progress to a stageable pressure ulcer
timeFrame: Up to 25 days
Secondary outcomes:
measure: Temperature change associated with anatomical areas after a stageable pressure ulcer occurs
timeFrame: Up to 25 days
Other outcomes:
Locations:
city: Dayton
country: United States
facility: Kindred Hospital Dayton
state: Ohio
Study officials:
References:
Clinical trial NCT01755338: Effect of Steroids on Cerebral Inflammation and Neuronal Damage After Surgical Aortic Valve Replacement
Official title: Effect of Steroids on Cerebrospinal Fluid Markers of Inflammation and Neuronal Damage After Surgical Aortic Valve Replacement
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Aortic Stenosis
Keywords: cerebrospinal fluid
inflammatory markers
heart surgery
neuronal damage
blood brain barrier
Lead sponsor: Sahlgrenska University Hospital
Sponsor class: OTHER
First posted: 2012-12-24
Enrollment: 30
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: TREATMENT

Brief summary: The purpose of this study is to investigate if methylprednisolone is effective in reducing the cerebral inflammatory response after open heart surgery with cardiopulmonary bypass.

Detailed description: In a previous study we found that patients undergoing aortic valve surgery had elevated cerebrospinal inflammatory markers. In this study we aim to investigate if this inflammatory response can be reduced after treatment with steroids.

30 patients will be randomized to intraoperative treatment with either placebo or methylprednisolone 15mg/kg. CSF and blood will be collected the day before and the day after surgery, analyzed for markers of inflammation (IL-6, IL-8), neuronal damage (S-100) and blood brain barrier function (alb).

Eligibility criteria: Inclusion Criteria:

* elective aortic surgery +/- coronary artery bypass grafting (CABG)

Exclusion Criteria:

* coagulopathy
* preoperative neurologic deficit
* uncontrolled hypertension

Primary outcomes:
measure: Changes in cerebrospinal fluid (CSF) levels of IL-6, IL-8, S100B, alb
timeFrame: 24h after surgery
Secondary outcomes:
measure: Postoperative/intraoperative insulin demand
timeFrame: 24h after surgery
Other outcomes:
Locations:
city: Göteborg
country: Sweden
facility: Sahlgrenska University Hospital
state: VGR
Study officials:
affiliation: Sahlgrenska University Hospital
name: Sven-Erik Ricksten, Professor
role: STUDY_CHAIR
References:
citation: Danielson M, Reinsfelt B, Westerlind A, Zetterberg H, Blennow K, Ricksten SE. Effects of methylprednisolone on blood-brain barrier and cerebral inflammation in cardiac surgery-a randomized trial. J Neuroinflammation. 2018 Sep 27;15(1):283. doi: 10.1186/s12974-018-1318-y.
Clinical trial NCT02813538: Major Liver Resection: Early Clotting Disorders and Functional Impairment.
Official title: Hypercoagulability and Liver Function After Major Liver Resection
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Hepatic Insufficiency
Blood Coagulation Disorders
Keywords: Thrombelastography
Antithrombin proteins
Liver surgery
Liver function tests
Lead sponsor: Hospital General Universitario Gregorio Marañon
Sponsor class: OTHER
First posted: 2016-06-27
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients undergoing major liver surgery defined as resection of 3 or more hepatic segments

Brief summary: The aim of this study is to evaluate early clotting disorders through thromboelastogram and anticoagulant proteins levels (maybe also endothelial markers) and liver function by indocyanine green clearance after major liver resection and search for a potential relationship between them.

Detailed description: We are prospectively recording data from patients undergoing major liver resection. We obtain a full procoagulant and anticoagulant profile preoperatively and, at first, second and sixth day after surgery. We also measure indocyanine green (ICG) clearance preoperatively and in the first two postoperative days. We are also recording clinical data, focusing on medical and surgical complications. We aim to establish the potential value of ICG clearance and or coagulation profile to predict clinical complications

Eligibility criteria: Inclusion Criteria:

* Patients undergoing major liver surgery defined as resection of 3 or more hepatic segments

Exclusion Criteria:

* Indocyanin green allergy
* Thyrotoxicosis
* Thrombophilia
* Lupus anticoagulant
* Coagulation factor deficiency
* Venous thromboembolism in the last 3 years
* Pulmonary thromboembolism in the last 3 years

Primary outcomes:
measure: Establish a relationship between ICG and MCF
timeFrame: 1 week
measure: Establish a relationship between pro and anticoagulant proteins levels and endothelial markers
timeFrame: 1 week
Secondary outcomes:
measure: Study blood coagulation disorders after major liver surgery resection
timeFrame: 2 years
measure: Study liver function after major liver surgery
timeFrame: 2 years
Other outcomes:
Locations:
city: Madrid
country: Spain
facility: Gregorio Marañon Hospital
Study officials:
affiliation: Gregorio Marañon Hospital
name: Luis Olmedilla, PhD
role: STUDY_DIRECTOR
References:
Clinical trial NCT06899438: Does Botulinum Toxin Type-A Injection an Effective Way of Relieving Pain in Myofascial Pain Syndrome Patients or Not
Official title: Does Botulinum Toxin Type-A an Effective Way of Relieving Pain in Myofascial Pain Syndrome or Not
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Myofacial Pain Syndromes
Keywords: Myofascial pain
Botulinum toxin
Prilocaine
İnjection
Lead sponsor: Bursa City Hospital
Sponsor class: OTHER_GOV
First posted: 2025-03-28
Enrollment: 38
Sex: ALL
Minimum age (years): 20
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: In this research prilocaine and botulinum toxin (BoNT-A) interventions prospectively compared to find out the effect of BoNT-A injection on myofascial pain syndrome (MPS).

The main question it aims to answer is: Does Botulinum Toxin Type-A an Effective Way of Relieving Pain in Myofascial Pain Syndrome or not?

For this purpose thirty-eight patients randomly assigned into two study groups. While BoNT-A injection group (BIG group n=19) treated with 20 units of toxin to each trigger point (TP), remaining treated with 2 ml prilocaine (PIG group n=19) with same procedure.

Pre-treatment, 2nd and 6th weeks findings were clinically recorded.

Detailed description: Visual Analog Scale (VAS), 4-Point Verbal Rating Scale (VRS), Pain Pressure Threshold (PPT), Short Form-36 (SF-36) and Beck Depression Inventory (BDI) tools were used to evaluate findings of the research.

Eligibility criteria: Inclusion Criteria:

Thirty eight patients (27 female, 11 male) admitted to the PM\&R (physical medicine and rehabilitation) department with at least one TP identified at neck, upper back and lower back muscles were included to the study.

Exclusion Criterias:

Recent any injection to TP within the last 2 months, Diagnosed with fibromyalgia syndrome, Having respiratory or cardiovascular diseases, Allergies, Having psychiatric disorders, History of shoulder or cervical intervention within the last year, Cervical myelopathy, radiculopathy, Failure of cooperation.

Primary outcomes:
measure: Visual analog scale, 4-point verbal rating scale, Pressure pain threshold
timeFrame: Pre-treatment, 2nd and 6th week scores were recorded.
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: LHU Ankara Hospital Department of Rheumatology
name: Baki Özdemir, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00658138: Clinical Evaluation of 3M™ ESPE™ Adper™ Scotchbond™ SE Self-Etch Adhesive in Class I and Class II Restorations in Adults
Official title: Clinical Evaluation of 3M™ ESPE™ Adper™ Scotchbond™ SE Self-Etch Adhesive in Class I and Class II Restorations in Adults
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Dental Caries
Lead sponsor: Solventum US LLC
Sponsor class: INDUSTRY
Collaborators: name: 3M
First posted: 2008-04-14
Enrollment: 61
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to evaluate the performance of a new dental adhesive system in the restoration of Class I and Class II cavities in adult teeth.


Eligibility criteria: Inclusion Criteria:

* Must be at least 18 years of age
* Must have 2 or 4 qualifying Class I or Class II cavities
* Must be willing to sign consent form
* Must be willing to return to University dental clinic for 4 study appointments
* Must be in good medical health and able to tolerate dental procedures

Exclusion Criteria:

* Current participation in other restorative product studies
* Known allergies to dental products
* Unacceptable level of oral hygiene
* Chronic periodontitis (gum disease)
* Rampant caries (cavities)
* Severe salivary gland problems
* Inability or unwillingness to attend study appointments

Primary outcomes:
measure: Percentage of Restorations Scoring Alpha
timeFrame: 12 months
Secondary outcomes:
Other outcomes:
Locations:
city: Bologna
country: Italy
facility: University of Bologna, Clinica Odontoiatrica
Study officials:
affiliation: University of Bologna
name: Giovanni Dondi dall'Orologio, Professor
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03730038: Effects of Pitavastatin Treatments on the Plasma Lgi3 Level in the Patients With Dyslipidemia
Official title: Effects of Pitavastatin Treatments on the Plasma Lgi3 Level in the Patients With Dyslipidemia: A Randomized Crossover Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Dyslipidemias
Keywords: Dyslipidemia
Lead sponsor: Yonsei University
Sponsor class: OTHER
First posted: 2018-11-05
Enrollment: 50
Sex: ALL
Minimum age (years): 20
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Intervention model description: Patients who assigned to the pitavastatin treatment first group will be given the pitavastatin, followed by wash-out period and life-style modification treatment. Patients who assigned to the life-style modification treatment first group, will be treated with life-style modification treatment first, followed by wash-out period and pitavastatin treatment.
Primary purpose: OTHER

Brief summary: Leucine-rich glioma inactivated 3(Lgi3) has been postulated to have a pro-inflammatory adipokine that inter-plays with other adipokines in adipogenesis and metabolic inflammation according to recent investigations. Thus, in this study, we sought to demonstrate that the treatment of statin can decrease Lgi3 level along with the decrease of the atherosclerosis to further evaluate the role of Lgi3 in atherosclerosis.

Detailed description: Patients who assigned to the pitavastatin treatment first group will be given the pitavastatin 4 mg qd treatment for 12 weeks after randomization, followed by wash-out period of 3 weeks and life-style modification treatment for 12 weeks. Similarly, patients who assigned to the life-style modification treatment first group, will be treated with life-style modification treatment for 12 weeks after randomization, followed by wash-out period of 3 weeks and pitavastatin treatment for 12 weeks.

Eligibility criteria: Inclusion Criteria:

* Age 20-80 years
* Patients with intermediate or low cardiovascular risks needing the statin treatment
* Patients with intermediate or low cardiovascular risks treating the statin treatment

Exclusion Criteria:

* Patients without signed informed consent
* Patients with myopathy
* Pregnant women or women with potential childbearing
* Patients with diabetes
* Patients with established coronary artery disease
* Patients with heart failure
* Life expectancy less than 1 year

Primary outcomes:
measure: Changes in Lgi3 level
timeFrame: At 12 weeks after intervention
Secondary outcomes:
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Division of Cardiology, Severance Cardiovascular Hospital, Yonsei University College of Medicine
Study officials:
References:
Clinical trial NCT05871138: Prognostic Value of Delta LUS Score of Patients Hospitalized for Acute Heart Failure
Official title: Prognostic Value of Delta LUS Score of Patients Hospitalized for Acute Heart Failure Within 30 Days of Discharge
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Emergencies
Acute Heart Failure
Keywords: Delta-lus score
heart failure
Lead sponsor: University of Monastir
Sponsor class: OTHER
First posted: 2023-05-23
Enrollment: 500
Sex: ALL
Minimum age (years): 18
Maximum age (years): 99
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: This is a prospective observational study that will be conducted in the emergency department of CHU Fattouma Bourguiba Monastir over a period from March 2023 to December 2023.

Will be included in this study patients aged over 18 years, hospitalized in the emergency department for dyspnea having as etiology an acute heart failure and in whom will be performed two pulmonary ultrasound examinations (at entry and exit). These patients will be contacted after one month of their discharge from the hospital

Brief summary: prognostic value of delta LUS score of patients hospitalized for acute heart failure within 30 days of discharge.

Detailed description: The aim of our study is to evaluate the contribution of the variation of the LUS score performed at the time of admission (LUS1) and at discharge (LUS2) in predicting the clinical course of patients admitted for acute cardiac decompensation 30 days after discharge.

Delta LUS score=((LUS2-LUS1) \*100)/LUS1

Eligibility criteria: Inclusion Criteria:

* Patients aged over 18 years,
* Patients hospitalized in the emergency department for dyspnea having as etiology an acute heart failure and in whom will be performed two pulmonary ultrasound examinations (at entry and exit).

Exclusion Criteria:

* Age less than 18 years
* Dyspnea of non-cardiac etiology (cause: pulmonary, traumatic, toxic...)
* Altered state of consciousness (Glasgow score\<14)
* Hemodynamic instability: presence of peripheral signs of shock, use of vasoactive drugs
* Mechanical ventilation from the outset
* Cardiorespiratory arrest
* Inability to give consent to the study
* Missing one of two ultrasound examinations
* Unable to make telephone contact after one month.

Primary outcomes:
measure: Delta lus
timeFrame: 30 days
measure: Readmission
timeFrame: 30 days
Secondary outcomes:
Other outcomes:
Locations:
city: Monastir
country: Tunisia
facility: Semir Nouira
state: Monastur
city: Monastir
country: Tunisia
facility: Emergency Departement
Study officials:
affiliation: University of Monastir
name: Nouira Semir, Pr
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01163838: Multiple-Dose Safety Study Of RN316 For TheTreatment Of Hypercholesterolemia
Official title: A Phase 1, Placebo-Controlled, Randomized Study To Assess The Safety, Tolerability, Pharmacokinetics, And Pharmacodynamics Following Multiple Intravenous Doses Of RN316 In Healthy Adult Subjects With Hypercholesterolemia
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: PHASE1
Conditions: Hypercholesterolemia
Dyslipidemia
Keywords: Hypercholesterolemia
Dyslipidemia
LDL
Cholesterol
High Cholesterol
Lead sponsor: Pfizer
Sponsor class: INDUSTRY
First posted: 2010-07-16
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The primary objective of this study is to evaluate the safety and tolerability of repeated doses of RN316 in eligible healthy volunteers. RN316 is an investigational drug that is currently being studied as a cholesterol lowering therapy.


Eligibility criteria: Inclusion Criteria:

* LDL-C must be greater or equal to 130 mg/dl
* BMI must be between 18.5 and 40 kg/m2

Exclusion Criteria:

* History of cardiovascular or cerebrovascular event during the past year.
* Poorly controlled type 1 or type 2 diabetes mellitus
* Subjects who have taken lipid lowering therapies within the last 3 months of screening.

Primary outcomes:
measure: Incidence of dose limiting or intolerable treatment related adverse events (AEs).
timeFrame: Every Scheduled Visit
measure: Incidence, severity and causal relationship of treatment emergent AEs (TEAEs).
timeFrame: Every Scheduled Visit
measure: Incidence of abnormal and clinically relevant safety laboratories.
timeFrame: Screening and Days 29, 57, 85, 113, 135, 141, 169 and 197
measure: Abnormal and clinically relevant changes in vital signs, BP, and ECG parameters.
timeFrame: Every Scheduled Visit
measure: Incidence of anti-drug-antibodies.
timeFrame: Baseline and Day 15 and monthly thereafter
Secondary outcomes:
measure: PK parameter estimates including but not be limited to: AUC, Tmax, Cmax terminal elimination half life (t1/2), Clearance (CL), volume of distribution at steady state (Vss), and accumulation ratio (R) of RN316.
timeFrame: Day 1 and every scheduled visit thereafter
measure: Absolute and percentage change in LDL C from baseline.
timeFrame: Every scheduled visit except Day 1
measure: Proportion of subjects who achieve a target LDL C of <100 mg/mL.
timeFrame: Every scheduled visit except Day 1
measure: Proportion of subjects who achieve a target LDL C of <70 mg/dL.
timeFrame: Every scheduled visit except Day 1
measure: Proportion of subjects achieving 50% decrease in LDL C from baseline.
timeFrame: Every scheduled visit except Day 1
Other outcomes:
Locations:
Study officials:
affiliation: Pfizer
name: Pfizer CT.gov Call Center
role: STUDY_DIRECTOR
References:
Clinical trial NCT02622243: Duration of Long Acting Muscarinic Antagonist (LAMA) Bronchoprotection Against Methacholine Challenge
Official title: Duration of Bronchoprotection of the Long Acting Muscarinic Antagonists Tiotropium and Glycopyrronium Against Methacholine Induced Bronchoconstriction
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Asthma
Lead sponsor: University of Saskatchewan
Sponsor class: OTHER
First posted: 2015-12-04
Enrollment: 13
Sex: ALL
Minimum age (years): 19
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: The study will assess the duration of protection of single doses of 2 different long acting muscarinic antagonists against methacholine induced bronchoconstriction.


Eligibility criteria: Inclusion Criteria:

* male or female asthmatics \> 19 years of age
* baseline methacholine PC20 less than or equal to 4mg/ml
* baseline lung function \>65% predicted
* non-smoker and less than 10 pack year smoking history

Exclusion Criteria:

* use of anticholinergic within 30 days of Visit 1
* poorly controlled asthma
* pregnant or nursing
* respiratory illness within 4 weeks of Visit 1
* exposure to an agent that triggered asthma worsening (e.g. allergen) within 4 weeks of Visit 1

Primary outcomes:
measure: Change from baseline methacholine bronchoprotection at 96 hours
timeFrame: pre treatment versus 96 hour post treatment
Secondary outcomes:
measure: Change from baseline methacholine bronchoprotection at 1 hour
timeFrame: pre treatment versus 1 hour post treatment
measure: Change from baseline methacholine bronchoprotection at 24 hours
timeFrame: pre treatment versus 24 hours post treatment
measure: Change from baseline methacholine bronchoprotection at 48 hours
timeFrame: pre treatment versus 48 hours post treatment
measure: Change from baseline methacholine bronchoprotection at 72 hours
timeFrame: pre treatment versus 72 hours post treatment
Other outcomes:
Locations:
city: Saskatoon
country: Canada
facility: Asthma Research Lab
state: Saskatchewan
Study officials:
affiliation: University of Saskatchewan
name: Don Cockcroft, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Blais CM, Davis BE, Cockcroft DW. Duration of bronchoprotection of the long-acting muscarinic antagonists tiotropium & glycopyrronium against methacholine-induced bronchoconstriction in mild asthmatics. Respir Med. 2016 Sep;118:96-101. doi: 10.1016/j.rmed.2016.07.017. Epub 2016 Jul 30.