louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT06083740: A Postmarket Clinical Follow Up Study (PMCF) to Evaluate the Safety and Performance of VERIFORTE/Granudacyn® Med Wound Irrigation Solution.
Official title: A Postmarket Clinical Follow Up Study (PMCF) to Evaluate the Safety and Performance of VERIFORTE/Granudacyn® Med Wound Irrigation Solution.
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Wounds
Keywords: Acute wounds, chronic wounds, burns
Lead sponsor: P.G.F. Industry Solutions GmbH
Sponsor class: INDUSTRY
Collaborators: name: WPM - Wund Pflege Management Ges.m.b.H
First posted: 2023-10-16
Enrollment: 104
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: One treatment group (single-arm): All subjects participating in the study will be treated with Granudacyn/VERIFORTE med wound irrigation solution. People with a completed treatment of an acute or chronic wound participated in the study.

Brief summary: In the course of this clinical trial, it was shown that the use of Granudacyn/VERIFORTE med wound irrigation solution in the course of adjuvant therapy supports wound healing through mechanical irrigation and moistening of the wound. No risks have been reported. The benefits of using Granudacyn/VERIFORTE med wound irrigation solution therefore outweigh the potential risks.

Detailed description: Aim of this clinical trial was to collect clinical data on the performance and safety of the use of Granudacyn/VERIFORTE med as a wound irrigation solution, for cleansing and irrigation of acute, chronic or contaminated wounds.

The evaluation of the safety of the use of Granudacyn/VERIFORTE med wound irrigation solution within the scope of use was based on the frequency of adverse events (AEs) and, in particular, treatment-emergent adverse events (ADEs).

Study Design:

* Open-label, retrospective, monocentric, PMCF, non-interventional, observational study.
* One treatment group (single arm): All subjects participating in the study will be treated with Granudacyn/VERIFORTE med wound irrigation solution.
* The study will be conducted in Austria. The participating trial centre is in Lower Austria: WPM Ges.m.b.H

Eligibility criteria: Inclusion Criteria:

* Presence of a documented case report within the indication, which enables a retrospective evaluation of the target variables.
* Subjects are ≥ 18 years of age.
* Gender: All.

Exclusion Criteria:

* Vulnerable persons

Primary outcomes:
measure: Evaluation of safety: • AES: 0,00%, 95% CI: (0,00% - 4,16%) • ADEs: 0,00%, 95% CI: (0,00% - 4,16%)
timeFrame: 9 months
Secondary outcomes:
Other outcomes:
Locations:
city: Salzburg
country: Austria
facility: PGF Industry Solutions GmbH
Study officials:
References:
Clinical trial NCT04241640: Nefopam for Post Video-Assisted Thoracoscopic Lobectomy
Official title: Nefopam for Post Video-Assisted Thoracoscopic Lobectomy Pain Management and the Improvement of Enhanced Recovery After Surgery (ERAS): a Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Pain, Postoperative
Lead sponsor: Mahidol University
Sponsor class: OTHER
First posted: 2020-01-27
Enrollment: 72
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Video-assisted thoracoscopic (VATs) lobectomy is mild to moderately pain procedure. For conventional thoracotomy, there are many invasive pain control such as epidural analgesia, paravertebral block. However, for VATs, the invasive pain control somehow are too invasive. Nefopam is non-opioid painkilling medication, Serotonin, norepinephrine, dopamine reuptake inhibitor. Many study were demonstrated positive outcome of nefopam usage in many operation such as abdominal surgery, laparocopic surgery, orthopedic surgery. Nevertheless, nefopam for VATs is not well studied yet.


Eligibility criteria: Inclusion Criteria:

* Schedule to video-assisted thoracoscopic surgery : VATs lobectomy
* Can operate a patient-controlled analgesia (PCA) device
* No contraindication for nefopam

Exclusion Criteria:

* Epilepsy, on monoamine oxidase (MAO) inhibitors, glaucoma
* Creatinine clearance \< 60 ml/min
* Liver disease: child-pugh score B or C
* Allergy to nefopam
* Chronic opioid use

Primary outcomes:
measure: morphine consumption in first 24 hours post-operative
timeFrame: 24 hours
Secondary outcomes:
measure: numeric pain score
timeFrame: 24 hours
measure: side effect of nefopam
timeFrame: 24 hours
Other outcomes:
Locations:
city: Bangkok
country: Thailand
facility: faculty of medicine Siriraj hospital
Study officials:
References:
Clinical trial NCT03799640: Multidirectional Yoga for Cognition
Official title: Multidirectional Yoga Training to Improve in Healthy Older Participants
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Standard Yoga
Multi-directional Yoga
Educational Control
Lead sponsor: University of Miami
Sponsor class: OTHER
First posted: 2019-01-10
Enrollment: 40
Sex: ALL
Minimum age (years): 60
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Comparison of Yoga Interventions
Primary purpose: TREATMENT

Brief summary: Older individuals, 60-90, will be provided regular or cognitively based yoga training. They will then be evaluated using standard cognitive testing devices.

Detailed description: Reductions in executive function are common with age. Along with these declines come reductions in simple functional patterns of daily living such as crossing a street, walking in a crowded area, or performing any functions that occurs in an open (changing) environment. This study will use a newly developed yoga program incorporating multi-directional movements, cognitive challenges and visuomotor disturbances to improve executive function and associated movements in persons over 60 years of age.

Eligibility criteria: Inclusion Criteria:

* 60-90 years of age
* Capable of walking 50 feet with or without a walking aid-

Exclusion Criteria:

* Regularly participating in yoga or other balance training program
* Currently participating in another exercise study
* Unable to commit to study duration
* Uncontrolled neuromuscular or cardiovascular disease that prevents participation in an exercise study
* Advised not to exercise by their physician

Primary outcomes:
measure: NIH Toolbox: Picture Sequence Memory Test
timeFrame: 5 minutes
measure: NIH Toolbox Flanker test
timeFrame: 5 minutes
measure: NIH Toolbox List Sorting test
timeFrame: 5 minutes
measure: NIH Toolbox Pattern Comparison Processing Speed test
timeFrame: 5 minutes
measure: Walking Executive Function Tests
timeFrame: 10 minutes
measure: Timed up-and-go
timeFrame: 5 minutes
Secondary outcomes:
Other outcomes:
Locations:
city: Coral Gables
country: United States
facility: Max Orovitz Laboratories
state: Florida
city: Coral Gables
country: United States
facility: Laboratory of Neruomuscular Research and Active Aging
state: Florida
Study officials:
affiliation: University of Miami
name: Joseph Signorile, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06296940: Written Exposure in Substance Treatment
Official title: Project WEST (Written Exposure in Substance Treatment) Part 2
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Posttraumatic Stress Disorder
Substance Use Disorders
Keywords: Written Exposure Therapy
Lead sponsor: Potomac Health Foundations
Sponsor class: OTHER
Collaborators: name: University of Maryland, Baltimore County
First posted: 2024-03-06
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: We are conducting a randomized controlled trial of approximately 50 randomized subjects (up to 100 total enrollments) who will be assigned 1:1 to treatment as usual (TAU) or TAU+WET.
Primary purpose: TREATMENT

Brief summary: The purpose of this pilot randomized clinical trial is to test the feasibility and efficacy of written exposure therapy (WET) for posttraumatic stress disorder (PTSD) within the context of residential substance use disorder (SUD) treatment. All participants meet criteria for PTSD and are in a short term residential SUD treatment program (target residential treatment duration = 28 days) regardless of the research. The main questions the study aims to answer are: 1) Is the delivery of WET feasible in short term residential SUD treatment for individuals with severe SUD; 2) Do participants in the TAU+WET condition have greater reductions in PTSD symptoms pre/post treatment compared to participants in TAU alone?


Eligibility criteria: Inclusion Criteria:

* At least 18 years old
* Fluent in English
* Cognitively able to provide consent to the research
* Enrolled in inpatient treatment at the clinical site where the research takes place
* Meet criteria for probable PTSD based on PCL-5 score
* Be early enough in their residential stay to allow time to complete the WET protocol
* Have a clear memory of the traumatic event so they are able to write about itin detail

Exclusion Criteria:

* Reports significant suicidal or homicidal ideation with intent, untreated psychosis, or have other health limitations that may interfere with their ability to participate in the research

Primary outcomes:
measure: Efficacy of WET
timeFrame: Pre/post intervention window (approximately 3 weeks)
Secondary outcomes:
measure: Feasibility of WET delivered in residential SUD treatment context
timeFrame: Up to 4 weeks, or until the participant discharges from residential treatment (whichever comes first).
measure: Acceptability of WET delivered in residential SUD treatment context
timeFrame: Collected post intervention window (approximately 3 weeks from randomization)
Other outcomes:
Locations:
city: Baltimore
country: United States
facility: Maryland Treatment Centers
state: Maryland
Study officials:
References:
citation: Schacht RL, Wenzel KR, Meyer LE, Mette M, Mallik-Kane K, Rabalais A, Berg SK, Fishman M. A pilot test of Written Exposure Therapy for PTSD in residential substance use treatment. Am J Addict. 2023 Sep;32(5):488-496. doi: 10.1111/ajad.13442. Epub 2023 Jun 17.
Clinical trial NCT00427401: A Study To Evaluate PF-00915275 In Subjects With Type 2 Diabetes Mellitus For 4-Weeks
Official title: A Double Blind, Placebo Controlled, Parallel Group Study To Evaluate The Safety, Tolerability, Pharmacokinetics, And Pharmacodynamics Of PF-00915275 After Oral Administration To Subjects With Type 2 Diabetes Mellitus For 4-Weeks
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE2
Conditions: Diabetes Mellitus, Type 2
Lead sponsor: Pfizer
Sponsor class: INDUSTRY
First posted: 2007-01-29
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
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 safety, tolerability, pharmacokinetics (PK) and pharmacodynamics (PD) of PF-00915275 following administration to adult human subjects with T2DM for 4-weeks. The primary end point is glucose lowering (24 hour mean glucose concentration).


Eligibility criteria: Inclusion Criteria:

* Type 2 diabetes mellitus
* HbA1c \> 7.5%.

Exclusion Criteria:

* Recent (within the past 12 months) evidence or history of unstable concomitant disease.
* Treatment with any oral hypoglycemic agent within 3 months before enrollment.
* The exception to these criteria is that subjects who are currently taking metformin hydrochloride, in a stable dose (that is no changes in dose) for treatment of their diabetes within the past 3 months or longer of enrollment may participate.

Primary outcomes:
measure: The primary end point is glucose lowering (24 hour mean glucose concentration).
Secondary outcomes:
measure: Fasting blood glucose
Other outcomes:
Locations:
city: Bruxelles
country: Belgium
facility: Pfizer Investigational Site
Study officials:
affiliation: Pfizer
name: Pfizer CT.gov Call Center
role: STUDY_DIRECTOR
References:
Clinical trial NCT04146701: Metabolomics and Microbiomics in Cardiovascular Diseases
Official title: Metabolomics and Microbiomics in Cardiovascular Diseases
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Acute Heart Failure
NSTEMI - Non-ST Segment Elevation MI
STEMI - ST Elevation Myocardial Infarction
Myocardial Infarction, Acute
Sepsis
Cardiomyopathies
Dilated Cardiomyopathy
Ischemic Cardiomyopathy
Lead sponsor: Universitätsmedizin Mannheim
Sponsor class: OTHER
First posted: 2019-10-31
Enrollment: 750
Sex: ALL
Minimum age (years): 18
Maximum age (years): 100
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients suffering from acute cardiovascular diseases such as acute heart failure, STEMI, NSTEMI, ischemic and dilative cardiomyopathies and sepsis.

Brief summary: "MEtabolomics and MicrObiomics in caRdIovAscular diseases Mannheim (MEMORIAM) " is a single-center, prospective and observational study investigating to identify disease-specific metabolic, respectively microbiomic, patterns of patients with high-risk cardiovascular diseases. High-risk cardiovascular diseases comprise patients suffering from acute heart failure (AHF), ST-segment elevation myocardial infarction (STEMI), non-ST-segment elevation myocardial infarction (NSTEMI), sepsis, septic shock, ischemic and non-ischemic cardiomyopathy.

Detailed description: Scientific evidence about the metabolomic and microbiomic changes in high-risk cardiovascular patients is still lacking.

The acute, critical or progressive disease status predestinies to relevant changes in cardiovascular metobolism. High-risk patients in the present trial comprise those with acute heart failure, myocardial infarction (STEMI and NSTEMI), sepsis, septic shock, ischemic and non-ischemic cardiomyopathy with severely reduced left ventricular ejection fraction (LVEF \<35%).

Therfore this study investigates to identify disease-specific patterns of metabolic and microbiomic changes. These patterns may help to understand pathophysiology at the metabolic stages and find out those patients being at highest risk of adverse future outcome.

Eligibility criteria: Inclusion Criteria:

* above mentioned diseases, diagnosis according to respective guideline
* written informed consent

Exclusion Criteria:

* under 18 years
* cancer
* rheumatic diseases
* infections (except septic group)
* higher grade heart valve diseases

Primary outcomes:
measure: Disease-specific metabolic/microbiomic biomarker patterns.
timeFrame: Within 24h after disease onset
Secondary outcomes:
measure: All-cause and cardiovascular mortality.
timeFrame: 12 months after inclusion
measure: Cardiac rehospitalization.
timeFrame: 12 months after inclusion
Other outcomes:
Locations:
city: Mannheim
country: Germany
facility: University Medical Center Mannheim
Study officials:
affiliation: University Medical Center Mannheim
name: Michael Behnes, PD Dr.
role: STUDY_DIRECTOR
References:
Clinical trial NCT00314301: Motion Analysis of Sit-to-Stand Movements in Children With Spastic Diplegia
Official title: Motion Analysis of Sit-to-Stand Movements in Children With Spastic Diplegia Before and After Loaded Sit-to-Stand Training
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Cerebral Palsy
Keywords: cerebral palsy
resistance
movement
biomechanics
Lead sponsor: Far Eastern Memorial Hospital
Sponsor class: OTHER
Collaborators: name: National Taiwan University
First posted: 2006-04-13
Enrollment: 20
Sex: ALL
Minimum age (years): 5
Maximum age (years): 12
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: ECT

Brief summary: The purpose of this study is to compare movement variations before and after the loaded training, with kinematics, kinetics, and electromyography, in children with spastic diplegia and to further discuss mechanisms of the loaded training.

Detailed description: Subjects: This study will recruit twenty children who are aged between 5 and 12 years, with spastic diplegia, and without having major surgeries or botulinum toxin injection on lower extremities during the past 6 months prior to participate in this study.

Methods: The Vicon 250 motion analysis system, 3 AMTI force platforms and the EMG recording system will be used to collect data of sit-to-stand (STS) movements. Baseline, pre- and post-training evaluations will be carried out. The duration of the baseline and pre-training evaluations is 2 months. The training period will take about 6 weeks. Each evaluation will take two separate days to accomplish. On the first day, the STS1RM of individual children was determined. On the second day, kinematic and kinetic data of STS movements in natural and loaded (applying load of 50% STS1RM during STS movements) conditions were collected. Data of smoothness, maximal extension moment and around hip and knee joints, onset time of lower extremity muscles will then be calculated. Results of each evaluation will be used for further comparison.

Eligibility criteria: Inclusion Criteria:

* Diagnosed as spastic diplegia
* Aged between 5 and 12 years
* Able to perform the STS movements without assistance
* Able to cooperate and understand commands given

Exclusion Criteria:

* Severe musculoskeletal deformity or pain on lower extremities
* Botulism injection in the past 3 months or major operations in the preceding 6 months on lower extremities
* Uncontrolled epilepsy
* Major sensory deficits, such as blindness or deafness

Primary outcomes:
measure: kinematic measures of lower extremity and the whole body
measure: kinetic measures of lower extremity and the whole body
measure: electromyographic measures of lower extremity and the whole body
Secondary outcomes:
Other outcomes:
Locations:
city: Taipei
country: Taiwan
facility: National Taiwan University Hospital
Study officials:
affiliation: Research Ethics Review Committee of the Far Eastern Memorial Hospital
name: Yuh-Ting Lin, MSc
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06551701: ACHIEVE Pilot Statins for Vascular Protection
Official title: A Cluster-randomized Trial to Improve Use of High IntEnsity Statins for Vascular Protection
Study type: OBSERVATIONAL
Overall status: NOT_YET_RECRUITING
Conditions: ASCVD
Keywords: Statin
Lead sponsor: Duke University
Sponsor class: OTHER
Collaborators: name: Carelon Research
name: Harvard Pilgrim Health Care
name: National Heart, Lung, and Blood Institute (NHLBI)
First posted: 2024-08-13
Enrollment: 225
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: The study population includes patients who have an ASCVD diagnosis but are currently not treated with a moderate-high intensity statin.

Brief summary: ACHIEVE aims to increase statin usage among patients with ASCVD by having a pharmacist talk to patients and providers.

Detailed description: Atherosclerotic cardiovascular disease (ASCVD) is the leading cause of death in the United States (U.S.) Statins reduce the risk of cardiovascular events by 30% in those with prior history of ASCVD. Despite being inexpensive and well-tolerated, however, statins are underused in clinical practice, particularly in patients who identify as Black. A large-scale intervention to improve evidence-based statin initiation among individuals with ASCVD is needed, particularly for the Black population. To meet this need, we aim to conduct a multi-center, pragmatic, cluster randomized, controlled trial to assess the impact of a provider- and patient-directed intervention to increase the prescription of, and adherence to, appropriate statin therapy among those with ASCVD (ACHIEVE: A Controlled trial to improve use of High IntEnsity statins for Vascular protEction). The intervention will be pharmacist-led, embedded in commercial payer systems, partnering with the National Committee for Quality Assurance (NCQA), and with a particular emphasis on improving statin use in the Black population.

Eligibility criteria: Inclusion Criteria:

* Patients with a diagnosis of atherosclerotic cardiovascular disease currently not treated with a moderate- high intensity statin and the providers that care for them.
* Patient age 18-75

Exclusion Criteria:

* Hemodialysis
* History of rhabdomyolysis

Primary outcomes:
measure: Provider engagement as measured by recruitment
timeFrame: 2 years
measure: Patient engagement as measured by recruitment
timeFrame: 2 years
Secondary outcomes:
Other outcomes:
Locations:
city: Durham
country: United States
facility: Duke Clinical Research Institute
state: North Carolina
Study officials:
affiliation: Duke University
name: Christopher Granger, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02740101: The Role of Oxytocin in Modulating the Effects of Social Feedback on Achieving Personal Goals
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: EARLY_PHASE1
Conditions: Healthy
Keywords: oxytocin
social reward
social punishment
Lead sponsor: University of Electronic Science and Technology of China
Sponsor class: OTHER
First posted: 2016-04-15
Enrollment: 62
Sex: MALE
Minimum age (years): 18
Maximum age (years): 30
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: BASIC_SCIENCE

Brief summary: To examine potential differential effects of receiving various social feedback on achieving personal goals,and whether oxytocin would modulate these effects.

Detailed description: In the present study, 62 healthy male participants participated in the double-blind, placebo-controlled experiment. Investigators aimed to test the idea that whether oxytocin would modulate subjective responses during receiving various social reward and social punishment about the future outcomes of pursuing personal goals.

Eligibility criteria: Inclusion Criteria:

* Healthy subjects without past or current psychiatric or neurological disorders.

Exclusion Criteria:

* Taking oral contraceptives;
* No history of head injury and medical or psychiatric illness.

Primary outcomes:
measure: Rating of Encouragement after receiving specific social feedback
timeFrame: one hour
Secondary outcomes:
measure: Rating of Likeability after receiving specific social feedback
timeFrame: one hour
Other outcomes:
measure: Rating of Confidence after receiving a series of social feedback
timeFrame: one hour
Locations:
city: Chengdu
country: China
facility: school of life science and technology, University of Electronic Science and Technology of China
state: Sichuan
Study officials:
affiliation: University of Electronic Science and Technology of China
name: Keith Kendrick, Dr.
role: PRINCIPAL_INVESTIGATOR
References: