louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT06796634: Effects of Cold Atmospheric Plasma (CAP) on Peritoneal Tumor Tissue
Official title: Effects of Cold Atmospheric Plasma (CAP) on Peritoneal Tumor Tissue
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Cold Atmospheric Plasma (CAP)
J-Plasma
Peritoneal Tumor
Lead sponsor: University Hospital, Ghent
Sponsor class: OTHER
First posted: 2025-01-28
Enrollment: 5
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: BASIC_SCIENCE

Brief summary: There are to date no studies available that have examined the effects of CAP on tumor tissue in patients. The aim of this study is to investigate these effects in patients undergoing surgery for peritoneal metastases. Tumor nodules will be treated with different durations and intensities of CAP before being surgically removed. The resected nodules will be analyzed for tumor vitality.


Eligibility criteria: Inclusion criteria:

* Patients with peritoneal metastases undergoing surgery (CRS, debulking), irrespective of the origin. Potential cancer types include ovarian cancer, colorectal cancer, and malignant peritoneal mesothelioma
* Written informed consent
* Age ≥ 18 years.

Primary outcomes:
measure: - Histology:
timeFrame: 1 year
Secondary outcomes:
Other outcomes:
Locations:
city: Ghent
country: Belgium
facility: UZ Ghent
state: East-Flanders
Study officials:
References:
Clinical trial NCT06765434: Effects of Personalized Music Listening in Advanced Alzheimer's
Official title: The Effects of Personalized Music Listening on Functional and Cognitive Status in Advanced-Stage Alzheimer's Disease
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Alzheimer Disease, Late Onset
Cognitive Impairment
Lead sponsor: Okan University
Sponsor class: OTHER
First posted: 2025-01-09
Enrollment: 54
Sex: ALL
Minimum age (years): 65
Maximum age (years): 90
Standard ages: OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Recent functional imaging studies have facilitated a better understanding of the neuroplasticity mechanisms underlying the strong and multifaceted effects of music on brain development. For this reason, music is considered a significant factor in improving recall and mood in individuals with dementia.

A review investigating the cognitive and behavioral effects of music listening in Alzheimer's disease (AD) reported that personalized (individualized) music listening yielded the best outcomes.

This study aims to examine the effects of personalized music activities on functional and cognitive status in individuals with advanced-stage AD.


Eligibility criteria: Inclusion Criteria:

* Aged 65 and over
* Patients diagnosed with advanced-stage Alzheimer's type dementia according to the diagnostic criteria of the American Psychiatric Association's Diagnostic and Statistical Manual of Mental Disorders (DSM-V)

Exclusion Criteria:

* Patients with hearing impairments that could interfere with music listening
* Individuals who have received music education and are able to play an instrument
* Patients with a history of heart disease, hypertension, or diabetes will be excluded from the study.

Primary outcomes:
measure: Standardized Mini-Mental State Examination (SMMSE)
timeFrame: baseline and 12 week later
measure: Functional Independence Measure (FIM)
timeFrame: baseline and 12 week later
measure: Frontal Assessment Battery (FAB)
timeFrame: baseline and 12 week later
Secondary outcomes:
measure: Clock Drawing Test (CDT)
timeFrame: baseline and 12 week later
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT06627634: Radical Surgery for Advanced Gastric- or GEJ-cancer With Oligometastatic Dissmination to the Liver
Official title: Gastric Cancer and Oligometastatic Liverinvolvement. Metastatectomy and Impact on Survival
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Survival
Lead sponsor: Aarhus University Hospital
Sponsor class: OTHER
Collaborators: name: Rigshospitalet, Denmark
name: Aalborg University Hospital
name: Odense University Hospital
First posted: 2024-10-04
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: Offering treatment with potential to cure for participants with no such offer in today's standard treatment options, by offering metastatectomia and standard treatment with intention to cure i.e., neoadjuvant chemotherapy and gastrectomy for participants with gastric- og gastroeusofageal junction cancer. Including 20 participants from all 4 centres in Denmark able to perform the surgical procedures in question.

Endpoints: 2-year overall survival.


Eligibility criteria: Inclusion Criteria:

* Age \> 18.
* Presence of primary T1-T4N0-N3M1 adenocarcinoma of the stomach or GEJ and max. 30% liver involvement.
* Primary tumour resectable, based on imaging workup.
* Surgical operable patients with ASA-score36 ≤ III and WHO performance status37 0-1.
* Patients eligible for treatment with systemic chemotherapy by FLOT regimen.
* Informed consent is obtained.

Exclusion Criteria:

* Patient with non-resectable cancer.
* Direct growth involving adjacent organs, i.e., pancreas, colon, blood vessels or bones.
* Other malignant disease diagnosed or treated up to 2 years prior to inclusion, except non-aggressive cancers such as non-melanoma sin cancer.
* Altered anatomy of the upper gastrointestinal tract due to previous surgery of the oesophagus, stomach, and duodenum.
* BMI ≤ 18
* The patient is unable to understand and/or read the consent form.
* Other serious illness or acute infections.
* Pregnant or breastfeeding.

Primary outcomes:
measure: Survival
timeFrame: 2 years
Secondary outcomes:
Other outcomes:
Locations:
city: Aarhus
country: Denmark
facility: Aarhus Univercity hospital
state: Jylland
Study officials:
affiliation: Aarhus University Hospital
name: Daniel Willy Kjaer, MD, PhD
role: STUDY_DIRECTOR
References:
Clinical trial NCT03815734: Effects of Motor Imagery on Trapeziometacarpal Osteoarthritis in Women During the Postoperative Immobilization Period
Official title: Effects of Motor Imagery on Trapeziometacarpal Osteoarthritis in Women During the Postoperative Immobilization Period
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Osteoarthritis Thumb
Immobilization
Keywords: Mental practice
motor imagery
trapeziometacarpal osteoarthritis
Lead sponsor: Universidad de León
Sponsor class: OTHER
First posted: 2019-01-24
Enrollment: 44
Sex: FEMALE
Minimum age (years): 50
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The aim of this study is to verify whether after trapeziometacarpal osteoarthrosis surgery and during the period of immobilization immediately after it, applying motor imagery, improvements are achieved on pain, strength, edema and / or inflammation, function and the joint range, accelerating the recovery process.

Detailed description: Motor imagery (IM) consists of a complex cognitive operation by which an action is simulated without doing it physically.

Many studies support the usefulness of motor imaging in rehabilitation after manual surgery.

An approach based on motor imagery may be useful in trapeziometacarpal osteoarthritis, and may be used to promote motor recovery after surgical treatment.

Eligibility criteria: Inclusion Criteria:

* The participants on the surgical waiting list of the Hospital of León

Exclusion Criteria:

* Other hand pathologies

Primary outcomes:
measure: Change from Preoperative pain to postoperative pain
timeFrame: 2 weeks before the surgery/5, 7 and 11 weeks after surgery
Secondary outcomes:
measure: Mobility of hand
timeFrame: 2 weeks before the surgery/5, 7 and 11 weeks after surgery
measure: Joint mobility
timeFrame: 2 weeks before the surgery/5, 7 and 11 weeks after surgery
measure: Strength
timeFrame: 2 weeks before the surgery/5, 7 and 11 weeks after surgery
measure: Edema/inflammation
timeFrame: 2 weeks before the surgery/5, 7 and 11 weeks after surgery
measure: Quality of life and function
timeFrame: 2 weeks before the surgery/5, 7 and 11 weeks after surgery
measure: Manual function
timeFrame: 2 weeks before the surgery/5, 7 and 11 weeks after surgery
Other outcomes:
Locations:
city: León
country: Spain
facility: Eva
Study officials:
affiliation: Universidad de León
name: Jesús Seco Calvo
role: STUDY_DIRECTOR
References:
citation: Stenekes MW, Geertzen JH, Nicolai JP, De Jong BM, Mulder T. Effects of motor imagery on hand function during immobilization after flexor tendon repair. Arch Phys Med Rehabil. 2009 Apr;90(4):553-9. doi: 10.1016/j.apmr.2008.10.029.
Clinical trial NCT00190034: Acetylcysteine Against Acute Renal Insult During Cardiopulmonary Bypass.
Official title: N-Acetylcysteine Protects Against Acute Renal Insult in Patients With Abnormal Renal Function Undergoing Cardiopulmonary Bypass.
Study type: INTERVENTIONAL
Overall status: SUSPENDED
Phase: PHASE4
Conditions: Cardiovascular Disease
Renal Insufficiency, Acute
Cardiopulmonary Bypass
Keywords: Acetylcysteine
cardiac surgery
cardiopulmonary bypass
acute renal insufficiency
Lead sponsor: Far Eastern Memorial Hospital
Sponsor class: OTHER
Collaborators: name: Synmosa Biopharma Corp.
First posted: 2005-09-19
Enrollment: 60
Sex: ALL
Minimum age (years): 16
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: The purpose of this study is to determine whether N-acetylcysteine is effective in the prophylaxis of post-cardiopulmonary bypass acute renal impairment.

Detailed description: BACKGROUND Reactive oxygen species have been shown to cause contrast-induced nephrotoxicity (CIN). According to previous studies, the N-acetylcysteine has been proved to be advantageous in the avoidance of CIN. We seek to evaluate the efficacy of the antioxidant N-acetylcysteine in limiting the nephrotoxicity after cardiovascular surgery with cardiopulmonary bypass.

METHODS We will prospectively study 60 patients who will receive a cardiovascular surgery with cardiopulmonary bypass. Patients will be randomly assigned to receive either N-acetylcysteine (600 mg orally twice daily for 4 doses) with 0.45% saline intravenously, before and after cardiopulmonary bypass, or placebo with 0.45% saline. Serum creatinine and blood urea nitrogen will be measured before, 48 h and 5 days after the operation procedure.

Expected results Prophylactic oral administration of the antioxidant N-acetylcysteine, along with hydration, will significantly reduce the acute renal damage induced by CPB in patients with chronic renal insufficiency that need cardiovascular procedures.

Eligibility criteria: Inclusion Criteria:

* All patients who will received cardiac surgery with cardiopulmonary bypass

Exclusion Criteria:

1. Dialyzed patients
2. Acute renal failure
3. Advanced left ventricular systolic dysfunction defined as left ventricular ejection fraction ≦ 35%.
4. Acute chronic obstructive lung disease or asthma exacerbation
5. Allergy to N-acetylcysteine

Primary outcomes:
measure: Serum creatinine and blood urea nitrogen: before, 48 h and 5 days after the operation procedure.
Secondary outcomes:
Other outcomes:
Locations:
city: Pan-Chiao
country: Taiwan
facility: Far Eastern Memorial Hospital
state: Taipei
Study officials:
affiliation: Far Eastern Memorial Hospital
name: Shao-jung Li, M.D.
role: STUDY_CHAIR
References:
Clinical trial NCT03079934: Vascular Healing After BVS-implantation
Official title: Vascular Healing After Implantation of Bioresorbable Vascular Scaffold in Different Clinical Settings and Follow-up Time Points
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Coronary Heart Disease
Keywords: Bioresorbable vascular scaffold
Optical coherence tomography
strut coverage
acute coronary syndrome
Lead sponsor: LMU Klinikum
Sponsor class: OTHER
Collaborators: name: Deutsches Zentrum für Herz-Kreislauf-Forschung (DZHK)
First posted: 2017-03-15
Enrollment: 26
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Data of patients who undergo OCT examination at different time points after BVS implantation will be analysed.

Brief summary: Evaluation of coronary artery vessel wall healing at different time points in patients undergoing implantion of bioresorbable vascular scaffold by using intravascular imaging.

In addition long-term clinical follow-ups are planned for all patients treated with Absorb in the institution

Detailed description: OCT-guided evalutation of the coronary vessel wall, endovascular healing and bioresorbable vascular scaffolds at different time points. These results will be analysed in terms of clinical presentation, gender and age.

Eligibility criteria: Inclusion Criteria:

* optical coherence tomography examination after BVS-implantation

Exclusion Criteria:

* None

Primary outcomes:
measure: the amount of tissue coverage per strut level analysis at OCT
timeFrame: 7 weeks
Secondary outcomes:
measure: amount of diameter stenosis per strut in OCT examination
timeFrame: 7 weeks
measure: amount of diameter stenosis per strut in OCT examination
timeFrame: 24 months
measure: healing score in OCT examination
timeFrame: 7 weeks
measure: healing score in OCT examination
timeFrame: 24 months
measure: proportion of malapposed and protruding struts per stent in OCT examination
timeFrame: 7 weeks
measure: proportion of malapposed and protruding struts per stent in OCT examination
timeFrame: 24 months
Other outcomes:
Locations:
city: Munich
country: Germany
facility: Munich University Clinic
state: Bavarian
Study officials:
affiliation: Munich University Clinic
name: Julinda Mehilli, MD
role: STUDY_CHAIR
References:
citation: Baquet M, Brenner C, Wenzler M, Eickhoff M, David J, Brunner S, Theiss H, Massberg S, Guagliumi G, Mehilli J. Impact of Clinical Presentation on Early Vascular Healing After Bioresorbable Vascular Scaffold Implantation. J Interv Cardiol. 2017 Feb;30(1):16-23. doi: 10.1111/joic.12359. Epub 2016 Nov 28.
Clinical trial NCT05789134: Mycoplasma Genitalium Infection and Associated Antimicrobial Resistance Among HIV-infected Male in Hong Kong
Official title: Mycoplasma Genitalium Infection and Associated Antimicrobial Resistance Among HIV-infected Male in Hong Kong
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: STI
Mycoplasma Genitalium Infection
Keywords: chlamydia trachomatis
Mycoplasma Genitalium Infection
Neisseria gonorrhoeae
men who have sex with men
heterosexual men
people living with HIV
Lead sponsor: Chinese University of Hong Kong
Sponsor class: OTHER
First posted: 2023-03-29
Enrollment: 750
Sex: MALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_ONLY
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: HIV-infected male who are attending the HIV specialist clinic in Hong Kong

Brief summary: Worldwide, Mycoplasma genitalium (MG) is increasingly reported as an emerging cause of sexually transmitted infections. Internationally, the prevalence of MG is higher in male with urethritis and community groups especially among people living with HIV (PLHIV). While MG is treatable, antimicrobial resistance is a rising concern. This cross-sectional study aims to determine the prevalence of MG infection and the antimicrobial resistance pattern in HIV-infected male in Hong Kong.

A total of 750 HIV-infected male attending HIV specialist clinic in Hong Kong would be recruited. The main outcome measures include prevalence of MG and resistance mutations to macrolide/fluoroquinolone in HIV-infected male; prevalence of MG/STI co-infections, as defined by concurrent detection of MG and one or more other bacterial STI.

Detailed description: A total of 750 HIV-infected male attending HIV specialist clinic in Hong Kong would be recruited. An online questionnaire would be self-administered. The participants would self-collect urine sample, rectal and pharyngeal swabs for MG, Chlamydia trachomatis (CT) and Neisseria Gonorrhoeae (NG) screening by nucleic acid amplification tests, and MG genotypic resistance mutations detection. Clinical data would be transcribed from medical records of recruited subjects.

Eligibility criteria: Inclusion Criteria:

* aged 18 or older, male, HIV-infected, and are attendees of the HIV specialist clinic, and can communicate in written and spoken English or Chinese

Exclusion Criteria:

* not able to provide consent

Primary outcomes:
measure: prevalence of MG infection
timeFrame: 1 year
measure: prevalence of MG resistance mutations
timeFrame: 1 year
Secondary outcomes:
measure: prevalence of CT infection
timeFrame: 1 year
measure: prevalence of NG infection
timeFrame: 1 year
measure: prevalence of syphilis
timeFrame: 1 year
measure: prevalence of HCV infection
timeFrame: 1 year
measure: prevalence of overall STI
timeFrame: 1 year
Other outcomes:
Locations:
city: Hong Kong
country: Hong Kong
facility: The Chinese University of Hong Kong
state: Hong Kong, China
Study officials:
References:
Clinical trial NCT03129334: Preventing Prescription Drug Abuse in Middle School Students
Official title: Preventing Prescription Drug Abuse in Middle School Students
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Prescription Drug Abuse (Not Dependent)
Substance Use
Substance Abuse
Lead sponsor: National Health Promotion Associates, Inc.
Sponsor class: INDUSTRY
First posted: 2017-04-26
Enrollment: 4500
Sex: ALL
Minimum age (years): 11
Maximum age (years): 14
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: This project is designed to test a primary prevention approach to the problem of prescription drug misuse and abuse (PDA) among middle school students. The intervention uses both online e-learning and small group facilitator-led intervention modalities. Middle schools will be randomized to receive the intervention or serve as controls.

Detailed description: While there are a number of drug abuse prevention programs for middle school age youth, relatively few programs focus on preventing prescription drug abuse. Furthermore, due to growing constraints on classroom time, new evidence-based prevention programs are needed that flexibly incorporate the use of online digital technology and classroom/small-group components. The present study is developing and testing an adaptation of the evidence-based substance abuse and violence prevention approach called Life Skills Training (LST). The proposed preventive intervention for middle school PDA will (1) utilize both online digital and face-to-face intervention modalities to address PDA and concurrent ATOD use; (2) positively change social norms and challenge positive expectancies regarding PDA and ATOD use; (3) discourage diversion of prescription medications; and (4) enhance protective factors by building social and self-regulation skills through interactive learning and behavioral rehearsal scenarios. Middle schools will be randomized into either an intervention group that will receive the new intervention or a treatment-as-usual control group that will receive existing health education programming. At the end of the intervention period, and at a 12-month follow-up assessments, we will compare both groups with respect to changes in behaviors, norms, attitudes, and knowledge regarding PDA and substance use.

Eligibility criteria: Inclusion Criteria:

* Middle school aged-youth

Exclusion Criteria:

* Significant cognitive impairment or severe learning disabilities, as screened by field staff at participating sites

Primary outcomes:
measure: Change in any prescription drug use in the past year
timeFrame: Post-test (within 2 weeks of completing final session/module of the intervention), 6-month followup, 12-month followup
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT01417234: Post-Market Clinical Evaluation of the Spiracur SNaP Wound Care System for Treatment of Acute Trauma and Acute Surgical Excision Wounds
Official title: Post-Market Clinical Evaluation of the Spiracur SNaP Wound Care System for Treatment of Acute Trauma and Acute Surgical Excision Wounds
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Trauma-related Wound
Surgical Wound, Recent
Lead sponsor: 3M
Sponsor class: INDUSTRY
First posted: 2011-08-16
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Study population will be selected from exisiting investigator patient population.

Brief summary: The purpose of this study is to evaluate the efficacy of the Spiracur SNaP® Wound Care System for the treatment of acute trauma and acute surgical excision wounds. The secondary purpose will be to compare the prospective patients to retrospectively treated acute trauma wounds to further evaluate efficacy and safety.


Eligibility criteria: Inclusion Criteria:

* Trauma wound, pressure ulcer, post operative wound, colostomy take-down site, or other acute wound deemed appropriate by study investigator(s) as the source of the wound on any part of the body including head and neck, torso, and extremities
* Wound \< 16 cm in greatest diameter
* Subject ≥ 18 years of age
* Exudate \< 25 ml/ day (estimate)
* Female subjects of child-bearing potential must be willing to take a urine pregnancy test prior to starting study
* Subject is willing and able to sign informed consent

Exclusion Criteria:

* Wound \> 45 days old
* Wound-related cellulitis
* Wound located in an area not amenable to forming an air-tight seal
* Subject has untreated osteomyelitis
* Subject is allergic to wound care products
* Wound has exposed blood vessels not suitable for negative pressure therapy
* Subject is pregnant
* Subject is actively participating in other clinical trials that conflict with current study
* Subject has fistulas

Primary outcomes:
measure: Wound Closure
timeFrame: 12 weeks
Secondary outcomes:
measure: Percent Wound Size Change
timeFrame: Baseline and 4 weeks
measure: Percent Wound Size Change
timeFrame: 4 weeks and 8 weeks
measure: Percent Wound Size Change
timeFrame: 8 weeks and 12 weeks
Other outcomes:
Locations:
city: Cleveland
country: United States
facility: Cleveland Clinic
state: Ohio
Study officials:
References: