louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT05355844: Cutibacterium Acnes in Deep Tissues in Primary Spine and Shoulder Surgery
Official title: Can Benzoyl Peroxide Decrease the Burden of Cutibacterium Acnes in Primary Spine and Shoulder Surgery? Prospective Randomized Study
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Rotator Cuff Tear Arthropathy
Spine Degeneration
Lead sponsor: Hospital del Mar
Sponsor class: OTHER
First posted: 2022-05-02
Enrollment: 200
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: Obtain deep tissue samples from patients undergoing primary prosthetic surgery of the shoulder and patients undergoing primary instrumented surgery of the spine. Patients will be randomized to receive benzoyl peroxide 3 days prior to surgery.

Detailed description: Shoulder prosthetic surgery as well as interventional surgery on the spine are commonly contaminated by Cutibacterium Acnes. Although the significance of this contamination is unknown, it represents a cause for concern since in some patients, contaminating Cutibacterium Acnes from surgery may develop long-term infection of the implant. Unlike knee and hip surgeries, where the most common infection-causing germs are Staphylococcus aureus, in shoulder and spine surgery, Cutibacterium Acnes represents one of the germs most frequently associated with infections. peri implant. Skin preparation with chlorhexidine as well as antibiotic prophylaxis with cefazolin have been shown to be ineffective in eradicating Cutibacterium Acnes. Recently, different studies support the use of benzoyl peroxide in topical application, to reduce the load of Cutibacterium acnes on the skin. Despite this, it has not been shown to reduce the rate of infection, nor to reduce the phylotypes of Cutibacterium acnes associated with peri-implant infections (IA, IB and II).

Obtain deep tissue samples from patients undergoing primary prosthetic surgery of the shoulder and patients undergoing primary instrumented surgery of the spine. Patients will be randomized to receive benzoyl peroxide 3 days prior to surgery.

Eligibility criteria: Inclusion Criteria:

* patients \> 18 yrs.
* Primary prosthetic shoulder surgery.
* Instrumented primary surgery of the spine.

Exclusion Criteria:

* active infection.
* previous surgeries.
* interventionism prior to surgery in the last 6 months (infiltrations, arthro-CT, arthro-MRI)

Primary outcomes:
measure: Cutibacterium acnes
timeFrame: 2 weeks
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT01679444: MRS Probe Study of Alcohol
Official title: Magnetic Resonance Spectroscopy Probe Study of Alcohol Use
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Heavy Dose Drinkers
Keywords: MRS
Heavy dose drinkers
Alcohol
NIAAA
Lead sponsor: Mayo Clinic
Sponsor class: OTHER
First posted: 2012-09-06
Enrollment: 40
Sex: ALL
Minimum age (years): 21
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP

Brief summary: This protocol will investigate the neurobiological underpinnings of alcohol craving in recently detoxified alcoholic drinkers utilizing novel functional brain imaging. This clinical magnetic resonance spectroscopy (MRS) study will investigate whether glutamate and other brain metabolites correlate to measures of alcohol craving severity


Eligibility criteria: Inclusion Criteria: (Minimal or No Alcohol Group)

1. Male or female age 21-70
2. Consume less alcohol then what is described in this protocol as a "higher dose drinker", or consume no alcohol at all.
3. Able to complete a 60 min. MRS brain scan.

Exclusion Criteria:

1. Inability to speak English
2. Inability or unwillingness to provide written informed consent
3. Diagnosis of active substance dependence other than nicotine (e.g. alcohol, cannabis, caffeine, prescription use of barbiturates, benzodiazepines, opiates, or stimulants) this will be determined using a PRISM (Psychiatric Research Interview for Substance and Mental Disorders) interview.
4. Any unstable active medical or additional psychiatric condition as determined by the investigator
5. Active suicidal ideation as determined by the PHQ-9 question 9 indicating response #2 or higher (several days; more than half the days; or nearly every day).
6. History of encephalopathy, hepatic failure, or HIV seropositivity
7. History of claustrophobia
8. History of major head trauma with loss of consciousness \>5 minutes or skull fracture
9. History of previous neurological event (e.g. epilepsy, stroke, transient ischemic attack)
10. Implanted metal objects (e.g. pacemakers; aneurysm clips; metal prostheses, joints, rods, or plates)
11. Contraindication to MRI scanning
12. Pregnancy or breast-feeding

Primary outcomes:
measure: Utilizing Magnetic Resonance Spectroscopy at 3 Tesla, investigate the neurobiological underpinnings of alcohol craving
Secondary outcomes:
measure: Evaluate the relationship between these metabolites, each reported as a Cerebrospinal Fluid-corrected absolute concentration, and severity of alcohol cravings
Other outcomes:
Locations:
city: Rochester
country: United States
facility: Mayo Clinic in Rochester
state: Minnesota
Study officials:
affiliation: Mayo Clinic
name: Mark Frye, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01622244: Coordinated Access to Care From Hospital Emergency Departments
Official title: Coordinated Access to Care From Hospital Emergency Departments - Assessing Effectiveness and Cost-Effectiveness
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Mental Health
Lead sponsor: Unity Health Toronto
Sponsor class: OTHER
Collaborators: name: Ontario Ministry of Health and Long Term Care
First posted: 2012-06-19
Enrollment: 166
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: The study will assess the effectiveness and cost-effectiveness of providing brief, intensive case management for frequent users of hospital Emergency Departments who have mental health and/or addictions problems. The goals of the intervention are to support patients' transition to community-based health and social services and supports - including primary and urgent psychiatric care, peer support and other community services and supports - so as to improve patient wellbeing and reduce avoidable ED visits and hospitalizations.


Eligibility criteria: Inclusion Criteria:

* legal adult status (age 18)
* able to give informed consent
* have made 5+ visits to participating hospital Emergency Department in the previous 12 months
* One of these visits will have been for a mental health and/or addiction problem.

Exclusion Criteria:

-

Primary outcomes:
measure: Frequency of Emergency Department visits
timeFrame: Baseline, 6 and 12 months
Secondary outcomes:
measure: Changes in symptom severity
timeFrame: Baseline, 6 and 12 months
measure: Days in hospital
timeFrame: baseline, 6 and 12 months
measure: Changes in substance use
timeFrame: baseline 6 and 12 months
measure: Changes in health related quality of life
timeFrame: baseline, 6 and 12 months
Other outcomes:
Locations:
city: Toronto
country: Canada
facility: St. Michael's Hospital
state: Ontario
city: Toronto
country: Canada
facility: St. Michael's Hospital
state: Ontario
Study officials:
affiliation: Unity Health Toronto
name: Vicky Stergiopoulos, MD, MHSc
role: PRINCIPAL_INVESTIGATOR
References:
citation: Stergiopoulos V, Gozdzik A, Tan de Bibiana J, Guimond T, Hwang SW, Wasylenki DA, Leszcz M. Brief case management versus usual care for frequent users of emergency departments: the Coordinated Access to Care from Hospital Emergency Departments (CATCH-ED) randomized controlled trial. BMC Health Serv Res. 2016 Aug 24;16(1):432. doi: 10.1186/s12913-016-1666-1.
Clinical trial NCT01306344: Qualitative Descriptive Study of the Meaning of the Ward Round
Official title: Qualitative Descriptive Study of the Meaning of the Ward Round
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Teaching Rounds
Keywords: Qualitative Research
Interview, Psychological
Patients
Nurses
Physicians
Lead sponsor: Oslo University Hospital
Sponsor class: OTHER
Collaborators: name: Oslo University College
First posted: 2011-03-01
Enrollment: 12
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Time perspective: RETROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Inpatients at a hospital ward. Nurses and physicians working at the same hospital ward. Heterogeneous groups.

Brief summary: 1. A qualitative descriptive design.
2. A phenomenologic approach to investigate the meaning of the ward round.
3. Interviews of patients, nurses and physicians.
4. A Master thesis.


Eligibility criteria: Inclusion Criteria:

* Grown-ups, normal cognitive function, speaks norwegian.

Exclusion Criteria:

* Children, vulnerable patientgroups, students.

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Oslo
country: Norway
facility: Oslo University Hospital
Study officials:
affiliation: Oslo University College
name: Bjorg Christiansen, PhD
role: STUDY_DIRECTOR
References:
Clinical trial NCT04547244: CRTd Responders Optimization
Official title: Optimization of Cardiac Resynchronization Therapy and Its Effects in Patients With Type 2 Diabetes Mellitus: Automatic Optimization vs. Echocardiographic Guided Optimization.
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Heart Failure
Heart Failure With Reduced Ejection Fraction
Cardiac Death
Lead sponsor: University of Campania Luigi Vanvitelli
Sponsor class: OTHER
First posted: 2020-09-14
Enrollment: 200
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: Patients aged more than 18 and less than 75 affected by chronic heart failure in NYHA class II/III with reduced cardiac pump and indication to receive a CRTd.

Brief summary: Suboptimal optimization of atrio-ventricular (AV) and inter-ventricular (VV) timings could affect the clinical response of CRTd in T2DM patients. Thus, authors hypothesize that automatic sensor guided CRTd optimization could ameliorate clinical outcomes in patients with T2DM. However, authors will evaluate the effects of cardiac resynchronization therapy (CRTd) in patients with type 2 diabetes mellitus (T2DM) optimized via automatic vs. echocardiographic guided approach.Authors will conduct a prospective, multicenter study to recruit, from October 2016 to June 2019, patients with T2DM and heart failure (HF) candidate to receive a CRTd. After CRTd the patients will be optimized via automatic vs. echocardiographic guided approach.


Eligibility criteria: Inclusion Criteria:

* heart failure with reduced cardiac pump, NYHA class II/III, indication to receive a CRTd.

Exclusion Criteria:

* NYHA class IV, previous CRTD implantation, neoplastic disease, inflammatory chronic disease.

Primary outcomes:
measure: CRTd responders rate
timeFrame: 12 months
Secondary outcomes:
Other outcomes:
Locations:
city: Napoli
country: Italy
facility: Celestino Sardu
Study officials:
References:
citation: Sardu C, Paolisso P, Ducceschi V, Santamaria M, Sacra C, Massetti M, Ruocco A, Marfella R. Cardiac resynchronization therapy and its effects in patients with type 2 DIAbetes mellitus OPTimized in automatic vs. echo guided approach. Data from the DIA-OPTA investigators. Cardiovasc Diabetol. 2020 Nov 28;19(1):202. doi: 10.1186/s12933-020-01180-8.
Clinical trial NCT06615544: Clinical Evaluation of a New Dual-cure Universal Adhesive
Official title: Clinical Evaluation of a New Dual-cure Universal Adhesive for Indirect Restorative Treatment
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Class I Dental Restorations
Class II Dental Restorations
Insufficient Dental Restoration
Caries, Dental
Lead sponsor: Ivoclar Vivadent AG
Sponsor class: INDUSTRY
First posted: 2024-09-26
Enrollment: 45
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The overall aim of this study is to evaluate the clinical performance and safety of the new dental dual-cure adhesive for luting indirect ceramic restorations (inlays and onlays). The primary aim is to determine the rate of postoperative hypersensitivity occurrence after using the new adhesive for the placement of indirect restorations. The secondary objective of this study is to assess the long-term clinical performance of the new adhesive in terms of marginal quality, retention/fracture rate of the ceramic restorations, and vitality/fracture rate of the restored teeth.


Eligibility criteria: Inclusion Criteria:

* Age: 18-65 years
* Informed consent signed and understood by the subject
* Indication for indirect restorations (inlay, onlay) in molar or premolar
* The occlusal area of the restoration must cover at least 1/3 of the occlusal area of the tooth.
* visual analogue scale (VAS)\&lt;4 (0=no pain, 10=maximum conceivable pain)
* Max. 2 restorations per participant in different quadrants.
* Vital tooth
* Healthy periodontium, no active periodontitis
* Contact with adjacent teeth (at least at one side) and opposing teeth present with at least one contact point.
* Sufficient language skills

Exclusion Criteria:

* Insufficient isolation
* Participants with a proven allergy to one of the ingredients of the materials used
* Participants with proven allergy to local anaesthetics
* High caries activity/ poor oral hygiene
* Participants with severe systemic diseases
* Pregnancy
* Tooth with irreversible pulpitis
* Indication for direct pulp capping
* Bleaching of teeth within the last 14 days
* Usage of peroxide-based disinfectants within the last 14 days

Primary outcomes:
measure: Postoperative hypersensitivity
timeFrame: 1 month
Secondary outcomes:
measure: Fracture rate
timeFrame: 5 years
measure: Marginal quality
timeFrame: 5 years
Other outcomes:
Locations:
city: Schaan
country: Liechtenstein
facility: Ivoclar Vivadent AG
Study officials:
References:
Clinical trial NCT01923844: Effects of Bolus Surfactant Therapy on Peripheral Perfusion Index and Tissue Carbon Monoxide
Official title: Effects of Bolus Surfactant Therapy on Serial Peripheral Perfusion Index and Tissue Carbon Monoxide Measurements in Preterm Infants With Severe Respiratory Distress Syndrome
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Respiratory Distress Syndrome
Keywords: Newborn
perfusion index
pulsatility index
respiratory distress syndrome
surfactant
transcutaneous carbon monoxide
Lead sponsor: Ege University
Sponsor class: OTHER
First posted: 2013-08-16
Enrollment: 48
Sex: ALL
Maximum age (years): 1
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: BASIC_SCIENCE

Brief summary: Exogenous bolus surfactant administration may affect hemodynamic parameters and peripheral perfusion. Surfactant therapy is commonly used for respiratory distress syndrome in premature infants, which is also associated with inflammation. There are different types and doses of surfactant preparations available. With the help of new generation monitors, changes in peripheral perfusion and transcutaneous CO, a marker of inflammation, may be demonstrated.

Detailed description: Preterm infants with severe Respiratory Distress Syndrome (study group) were compared to preterm infants without Respiratory Distress Syndrome(control group). Infants in the study group were randomized to receive either poractantalfa or beractant.

Perfusion index (PI) and transcutaneous CO (TCO) values were measured before (Tp) and 0 (T0), 5 (T5), 30 (T30), 60 (T60), 360 (T360) minutes after surfactant administration in the first six hours of life.

Eligibility criteria: Inclusion Criteria:

* Gestational age between 26 and 36 weeks
* intubated for respiratory distress syndrome

Exclusion Criteria:

* cardiac defects,
* hemodynamically significant patent ductusarteriosus,
* congenital pneumonia,
* early sepsis
* unstable infants in need of inotropic support.

Primary outcomes:
measure: Change from baseline in perfusion index (PI)at 6 hours
timeFrame: before (Tp) and 0 (T0), 5 (T5), 30 (T30), 60 (T60), 360 (T360) minutes after surfactant administration in the first six hours of life
measure: Change from baseline in transcutaneous carbon monoxide (TCO)at 6 hours
timeFrame: before (Tp) and 0 (T0), 5 (T5), 30 (T30), 60 (T60), 360 (T360) minutes after surfactant administration in the first six hours of life
Secondary outcomes:
Other outcomes:
Locations:
city: Izmir
country: Turkey
facility: Ege University Children's Hospital Neonatal Intesive Care Unit
Study officials:
affiliation: Ege University Faculty of Medicine, Department of Pediatrics, Division of Neonatology
name: Mehmet Yalaz, M.D.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00081744: Study Comparing Tigecycline to Imipenem/Cilastatin in Complicated Intra-Abdominal Infections in Hospitalized Subjects
Official title: A Multicenter, Double-Blind, Randomized Comparison Study Of the Efficacy and Safety of Tigecycline to Imipenem/ Cilastatin to Treat Complicated Intra-Abdominal Infections in Hospitalized Subjects
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Gram-Positive Bacterial Infections
Cross Infection
Keywords: Bacterial Infections
Lead sponsor: Wyeth is now a wholly owned subsidiary of Pfizer
Sponsor class: INDUSTRY
First posted: 2004-04-21
Enrollment: 850
Sex: ALL
Minimum age (years): 8
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Primary purpose: TREATMENT

Brief summary: Purpose: To provide a mechanism for the emergency use of tigecycline in the appropriate clinical situations.


Eligibility criteria: Inclusion Criteria:

* Male or female subjects, ≥ 8 years of age and a weight of ≥ 35 kilograms
* Subjects with selected culture-positive infections caused by a multiple antibiotic-resistant pathogen presumed to be susceptible to tigecycline
* Subjects who have failed or are intolerant of other available appropriate antibiotic therapies or whose pathogens are resistant to other available antibiotics

Exclusion Criteria:

* Subjects who are moribund with an expected survival of less than 2 weeks.
* Subjects who have been designated as "Do Not Resuscitate", unless it is anticipated within a reasonable degree of medical certainty that they can achieve benefit from potentially curative antibiotic therapy
* Known or suspected hypersensitivity to tigecycline, tetracyclines, or other compounds related to this class of antibacterial agents

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: Wyeth is now a wholly owned subsidiary of Pfizer
name: Medical Monitor, MD
role: STUDY_DIRECTOR
References:
citation: Oliva ME, Rekha A, Yellin A, Pasternak J, Campos M, Rose GM, Babinchak T, Ellis-Grosse EJ, Loh E; 301 Study Group. A multicenter trial of the efficacy and safety of tigecycline versus imipenem/cilastatin in patients with complicated intra-abdominal infections [Study ID Numbers: 3074A1-301-WW; ClinicalTrials.gov Identifier: NCT00081744]. BMC Infect Dis. 2005 Oct 19;5:88. doi: 10.1186/1471-2334-5-88.
citation: Fomin P, Koalov S, Cooper A, Babinchak T, Dartois N, De Vane N, Castaing N, Tellado J; 301 And 306 Study Groups. The efficacy and safety of tigecycline for the treatment of complicated intra-abdominal infections - the European experience. J Chemother. 2008 Oct;20 Suppl 1:12-9. doi: 10.1179/joc.2008.20.Supplement-1.12.
Clinical trial NCT00278044: Clinical Study and Gene Mutation Analysis of Adrenoleukodystrophy in Taiwanese Children
Official title: Clinical Study and Gene Mutation Analysis of Adrenoleukodystrophy in Taiwanese Children
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Adrenoleukodystrophy
Keywords: Search as text words in Annotation & Scope Note
Lead sponsor: Far Eastern Memorial Hospital
Sponsor class: OTHER
Collaborators: name: National Taiwan University Hospital
name: Fu Jen Catholic University
First posted: 2006-01-18
Enrollment: 20
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

Brief summary: Study the clinical manifestations and gene mutation of Taiwanese ALD patients


Eligibility criteria: Inclusion Criteria:

* X-ALD patients and family

Exclusion Criteria:

-

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Taipei
country: Taiwan
facility: Far Eastern Memorial Hospital
Study officials:
affiliation: Far Eastern Memorial Hospital
name: Jao Shwann Liang, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02680444: Mindful Positive Reappraisal: a Daily Diary Randomized Controlled Trial
Official title: Exploring Daily Affective Changes in University Students With a Mindful Positive Reappraisal Intervention: a Daily Diary Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Mental Health Wellness 1
Keywords: Mindfulness
Primary Promotion
Mental Health
Well-being
Positive Reappraisal
Lead sponsor: University of Guelph
Sponsor class: OTHER
First posted: 2016-02-11
Enrollment: 129
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL

Brief summary: Brief and cost-effective interventions teaching emotion regulation techniques can be feasibly applied to promote mental health in University students. The tools of mindfulness (i.e., objective awareness and acceptance) and positive reappraisal (i.e., positive re-evaluation of negative events) can mutually benefit one another to promote well-being. The current study explored the effects of a randomly-assigned Mindful-Reappraisal intervention (n=36) compared to Reappraisal-Only (n=34) and an active control (n=36) on university students' daily affect over five days. Time by condition interactions were analyzed with planned contrasts and multilevel growth modelling.

Detailed description: The University student lifestyle can lead to heightened stress, anxiety, and burnout. To promote mental health, brief and cost-effective interventions teaching beneficial emotion regulation techniques can not only counteract the negative but also foster positive functioning. The tools of mindfulness (i.e., objective awareness and acceptance) and positive reappraisal (i.e., positive re-evaluation of negative events) can mutually benefit one another to promote well-being. However, there is currently little research testing the viability of brief, self-administered interventions combining training of mindfulness and positive reappraisal. The current study explored the effects of a randomly-assigned Mindful-Reappraisal intervention (n=36) compared to Reappraisal-Only (n=34) and an active control (n=36) on university students' daily affect over five days. Time by condition interactions were analyzed with planned contrasts and multilevel growth modelling.

Eligibility criteria: Inclusion Criteria:

* Undergraduate students

Exclusion Criteria:

* Not undergraduate students

Primary outcomes:
measure: Change in Daily Affect
timeFrame: Day 1 - Day 5 of the intervention practice days
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: University of Guelph
name: M. Gloria Gonzalez-Morales
role: PRINCIPAL_INVESTIGATOR
References: