louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT03390699: Microbial Profile Among Patients Before and After Partial Maxillectomy
Official title: The Microbial Profile Among Patients Before and After Partial Maxillectomy
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Microbiology, Maxilla
Lead sponsor: Rambam Health Care Campus
Sponsor class: OTHER
First posted: 2018-01-04
Enrollment: 15
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: Microbial profile among patients before partial maxillectomy
Primary purpose: DIAGNOSTIC

Brief summary: Patients after maxillecotmy develop gum disease and teeth decay often. these two diseases are caused by bacteria. In addition, these patients may have oral infections such as candida . The therapeutic approach now days to these diseases (dental decay and periodontal disease) can change following the results of the study.

the purpose of the study is to examine whether the connection between the oral cavity and anatomical structures exposed by maxillectomy procedure causes a change in the level of microbes examined. To the best of our knowledge, there are not yet studies examined the clinical and microbiological changes in the oral cavity before and after surgery.

Detailed description: This study will include 15 patients who are scheduled to undergo partial maxillectomy as part of a prescribed treatment program prior to their eligibility for the study. The patients will undergo the surgery at the Department of Otolaryngology or Oral and Maxillofacial Surgery and will be given an obturator during surgery by a physician from the Internal and Maxillofacial Rehabilitation Department of the School of Dentistry .

demographic data on the patient's age and gender, general medical history, smoking habits, oral and periodontal and clinical examination (presence of periodontal disease) and microbiological testing will be preformed.

Eligibility criteria: Inclusion Criteria:

1. signed Consent form
2. Patients who are supposed to undergo Maxilla removal without closing the defect using a tissue implant and will need to complete the missing area by an obturator.
3. Men and women aged 18 and over

Exclusion Criteria:

1. Allergy to substances from which the obturator is made.
2. Pregnant women
3. Taking antibiotic drugs that affect bacterial flora 4 weeks before taking the saliva sample.
4. Psychiatric problem

Primary outcomes:
measure: microbial types
timeFrame: 6 months
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: Rambam Health Care Campus
name: Zvi Gutmacher, DMD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05239299: Treatment Options for Pediatric Chronic Pain: How do we Best Disseminate Our Scientific Findings
Official title: Dissemination of Scientific Findings: Wishes and Realities in the Field of Pediatric Chronic Pain
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Pediatric Chronic Pain
Lead sponsor: University Hospital, Basel, Switzerland
Sponsor class: OTHER
First posted: 2022-02-14
Enrollment: 19
Sex: ALL
Minimum age (years): 13
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Adolescents with chronic pain, one of their parents and health care professionals working with adolescents with chronic pain

Brief summary: Pediatric chronic pain is a prevalent condition with manifold treatment options. However, knowledge of targeted dissemination of intervention research findings is currently lacking.

The aim of this project is to determine satisfaction with current knowledge transfer from science to clinical practice amongst health care professionals, adolescents with CPP and their parents and to understand what treatment options have been offered to patients in Swiss pain centers Three focus groups, one with health care professionals, one with adolescent patients, and one with their parents, will be conducted to determine how the dissemination of scientific evidence to clinical practice can be improved and what hurdles exists when gathering information about pain interventions. In addition, patients will be asked about the treatment options offered to them and health care professionals about which treatments they routinely prescribe and why.


Eligibility criteria: Inclusion Criteria:

Adolescent group:

* Adolescents suffering from chronic pain (i.e., persistent or recurrent pain for three months or more)
* Able to read and speak German

Parent group:

* Parents of an adolescent with chronic pain
* Able to read and speak German

Health care professionals group:

* Health care professional working with adolescents with chronic pain
* Able to read and speak German

Exclusion Criteria:

* no chronic pain or experience with chronic pain

Primary outcomes:
measure: Information seeking behavior
timeFrame: immediattely after the focus group
Secondary outcomes:
Other outcomes:
Locations:
city: Basel
country: Switzerland
facility: Faculty of Psychology, University of Basel
Study officials:
affiliation: University of Basel
name: Helen Koechlin, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02900599: Predicting Treatment and Care Difficulties Among HIV Infected Patients
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: HIV
Keywords: HIV
Behavior
Lead sponsor: Centre Hospitalier de Cayenne
Sponsor class: OTHER
First posted: 2016-09-14
Enrollment: 111
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: HIV Cohort

Brief summary: Much of HIV is related to behaviour: sexual risk taking, late diagnosis, adherence to antiretroviral therapy, follow up, disclosure of one's HIV status. The project aimed to use various psychometric tools to determine if these scores have a predictive value on late testing, treatment succes, quality of follow up, and disclosure of HIV to sex partners. The expected outcomes would be to be able to stratify patients using a behavioural risk score and allocate targeted ressources to improve the quality of care for the most at risk patients.


Eligibility criteria: Inclusion Criteria:

* HIV Infected outpatient

Exclusion Criteria:

* Refusal to participate

Primary outcomes:
measure: CD4 Count
timeFrame: 1 year after interview
Secondary outcomes:
measure: viral load
timeFrame: 1 year after interview
measure: hiv disclosure to partner
timeFrame: at the time of interview
measure: loss to follow up
timeFrame: one year after interview
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT06368999: Neurophysiological and Neuropsychological Evalution in Healthcare Workers
Official title: Neurophysiological and Neuropsychological Evalution in Healthcare Workers of Stress Condition
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Stress Disorders, Post-Traumatic
Lead sponsor: Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico
Sponsor class: OTHER
First posted: 2024-04-16
Enrollment: 40
Sex: ALL
Minimum age (years): 21
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: study of brain EEG activity
Primary purpose: SCREENING

Brief summary: The goal of this observational study is to compare in participant population the effect of stress condition on cerebral EEG activity Participants will do an 8 minutes EEG registration. Researchers will compare EEG activity of heathcare workers.


Eligibility criteria: Inclusion Criteria:

* healthcare workers

Exclusion Criteria:

* neurological disorders

Primary outcomes:
measure: EEG activity
timeFrame: immediately after the outbreak of the pandemic (first session) and almost 6 months later (second session).
Secondary outcomes:
Other outcomes:
Locations:
city: Milan
country: Italy
facility: Fondazione IRCCS Cà Granda Ospedale Maggiore Policlinico
Study officials:
References:
Clinical trial NCT03502499: Half-normal Saline in Idiopathic Left Ventricular Outflow Tract Arrhythmias Ablation
Official title: Half-normal Saline vs Normal Saline for Irrigation of Open-irrigated Radiofrequency Catheters in Idiopathic Left Ventricular Outflow Tract Arrhythmias Ablation
Study type: INTERVENTIONAL
Overall status: SUSPENDED
Phase: NA
Conditions: Ventricular Arrythmia
Lead sponsor: Texas Cardiac Arrhythmia Research Foundation
Sponsor class: OTHER
First posted: 2018-04-18
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

Brief summary: The study evaluates the use of half-normal saline as an irrigant for open-irrigated catheters during left ventricular outflow tract ventricular arrhythmias ablation. By increasing the efficacy of radiofrequency energy-mediated lesion formation, half-normal saline has the potential to reduce procedural times and improved acute and long-term outcomes.


Eligibility criteria: Inclusion criteria

* male or female between 18 and 75 years of age at the time of enrollment
* undergoing first-time radiofrequency ablation for left ventricular outflow tract ventricular arrhythmias
* written informed consent obtained from subject or subject's legal representative and ability for subject to comply with the requirements of the study

Exclusion criteria

* ventricular arrhythmias originating from the right ventricular outflow tract according to the ventricular arrhythmia ECG morphology (i.e., precordial R wave transition at V3 or later)
* ventricular arrhythmias not originating from cardiac outflow tracts
* baseline hyponatremia (serum sodium level \< 135 mEq/L)
* pregnant, breastfeeding, or unwilling to practice birth control during participation in the study
* presence of a condition or abnormality that in the opinion of the Investigator would compromise the safety of the patient or the quality of the data

Primary outcomes:
measure: total radiofrequency ablation time, and total procedure time
timeFrame: intraprocedural
measure: acute success
timeFrame: intraprocedural
measure: long-term success
timeFrame: 1 year
Secondary outcomes:
Other outcomes:
measure: procedure-related complications
timeFrame: periprocedural (at the time of the procedure and up to 1 month)
measure: hyponatremia
timeFrame: periprocedural (at the time of the procedure and up to 1 month)
Locations:
city: Aurora
country: United States
facility: University of Colorado Hospital
state: Colorado
city: Austin
country: United States
facility: Texas Cardiac Arrhythmia Institute, St. David's Medical Center
state: Texas
Study officials:
affiliation: Texas Cardiac Arrhythmia Institute, St. David's Medical Center
name: Andrea Natale, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06059599: Active Informed Consent: a New Solution to Improve and Objectively Test the Patient Understanding of Complex Surgical Procedures Proposals
Official title: Active Informed Consent: a New Solution to Improve and Objectively Test the Patient Understanding of Complex Surgical Procedures Proposals
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Spine Disease
Urologic Diseases
Lead sponsor: Istituto Ortopedico Rizzoli
Sponsor class: OTHER
First posted: 2023-09-28
Enrollment: 300
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief summary: This is an interventional, non-pharmacological, randomized controlled superiority study (RCT), multicenter, open label, parallel group.

The aim is to evaluate the effectiveness of a new preoperative information method, based on multimedia tools and on the objective control of understanding by the patient candidate for spinal or urological surgery.


Eligibility criteria: Inclusion Criteria:

* Age ≥ 18 years
* Presence on waiting list for planned spinal (instrumented vertebral arthrodesis) and urological (radical prostatectomy) surgeries
* Understanding of the Italian language (in fact, it is believed that the percentage of non
* Italian mother-tongue patients is minimal and therefore not impacting the study)
* Ability to access computer tools -

Exclusion Criteria:

* Age \< 18 years
* Inability to self-determine
* Urgency/emergency of intervention

Primary outcomes:
measure: Client Satisfaction Questionnaire
timeFrame: at baseline (day 0)
Secondary outcomes:
Other outcomes:
Locations:
city: Bologna
country: Italy
facility: Istituto Ortopedico Rizzoli
Study officials:
References:
citation: Kinnersley P, Phillips K, Savage K, Kelly MJ, Farrell E, Morgan B, Whistance R, Lewis V, Mann MK, Stephens BL, Blazeby J, Elwyn G, Edwards AG. Interventions to promote informed consent for patients undergoing surgical and other invasive healthcare procedures. Cochrane Database Syst Rev. 2013 Jul 6;2013(7):CD009445. doi: 10.1002/14651858.CD009445.pub2.
citation: Glaser J, Nouri S, Fernandez A, Sudore RL, Schillinger D, Klein-Fedyshin M, Schenker Y. Interventions to Improve Patient Comprehension in Informed Consent for Medical and Surgical Procedures: An Updated Systematic Review. Med Decis Making. 2020 Feb;40(2):119-143. doi: 10.1177/0272989X19896348. Epub 2020 Jan 16.
citation: Nathe JM, Krakow EF. The Challenges of Informed Consent in High-Stakes, Randomized Oncology Trials: A Systematic Review. MDM Policy Pract. 2019 Mar 28;4(1):2381468319840322. doi: 10.1177/2381468319840322. eCollection 2019 Jan-Jun.
citation: Luhnen J, Muhlhauser I, Steckelberg A. The Quality of Informed Consent Forms-a Systematic Review and Critical Analysis. Dtsch Arztebl Int. 2018 Jun 1;115(22):377-383. doi: 10.3238/arztebl.2018.0377.
Clinical trial NCT00620399: A Study on the Use of a Brace Following Low Back Surgery
Official title: Lumbar Fusion With and Without Postoperative Bracing: A Randomized Prospective Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Lumbar Fusion
Keywords: lumbar fusion
Lead sponsor: Sunnybrook Health Sciences Centre
Sponsor class: OTHER
Collaborators: name: Medtronic Sofamor Danek
First posted: 2008-02-21
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Primary purpose: TREATMENT

Brief summary: This study evaluated the hypothesis that bracing following lumbar spinal fusion surgery improves functional outcome following surgery


Eligibility criteria: Inclusion Criteria:

* Age 18-80
* Undergoing posterior lumbar fusion surgery for degenerative conditions

Exclusion Criteria:

* Unable to complete questionnaires due to language or cognitive barrier
* Declined study participation

Primary outcomes:
measure: functional outcome scores
timeFrame: 2 years following surgery
Secondary outcomes:
Other outcomes:
Locations:
city: Cleveland
country: United States
facility: University Hospitals of Cleveland
state: Ohio
Study officials:
References:
Clinical trial NCT03471299: Association of Survival in Impact of Ultrafiltration Rates in Hemodialysis Patients
Official title: Impact of Ultrafiltration Rates on Mortality in Maintenance Hemodialysis Patients
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Hemodialysis
Keywords: Ultrafiltration rate
Lead sponsor: University of Hyogo
Sponsor class: OTHER
First posted: 2018-03-20
Enrollment: 759
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_ONLY
Time perspective: RETROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: In this study, 759 patients who had undergone maintenance HD for \>1 year at Tojinkai Hospital, kyoto, Japan. The present study examined data from all individual with regular thrice weekly maintenance HD treatment.

Brief summary: This study assesses retrospectively the association of mortality on UFR assessments in our study population undergoing HD.


Eligibility criteria: Inclusion Criteria:

Patients with stable undergoing hemodialysis for \>1 year.

Exclusion Criteria:

Patients with combined therapy with peritoneal dialysis and HD. Patients without records of laboratory investigations during this period. Patients with transferred hospital and those lost to follow-up.

Primary outcomes:
measure: Ultrafiltration rate (ml/hr/kg)
timeFrame: 7 years
Secondary outcomes:
Other outcomes:
Locations:
city: Kobe
country: Japan
facility: Graduate School of Applied Informatics, University of Hyogo
state: Hyogo
Study officials:
affiliation: Graduate School of Applied Informatics, University of Hyogo
name: Yuko Mizuno-Matsumoto, Ph.D
role: STUDY_DIRECTOR
References:
Clinical trial NCT01461499: Shiga Microalbuminuria Reduction Trial-2
Official title: Clinical Investigation on the Effects of Reducing Microalbuminuria in Hypertensive Patients With Type 2 Diabetes - SMART2
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Type 2 Diabetes Mellitus
Hypertension
Keywords: Hypertension
Albuminuria
Direct renin inhibitor
Angiotensin receptor blocker
Type 2 diabetes
Lead sponsor: Shiga University
Sponsor class: OTHER
First posted: 2011-10-28
Enrollment: 237
Sex: ALL
Minimum age (years): 20
Maximum age (years): 75
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 compare the effects of a direct renin inhibitor (DRI), aliskiren, on the urinary albumin excretion in hypertensive patients with type 2 diabetes under strict blood pressure control with angiotensin receptor blocker (ARB).


Eligibility criteria: Inclusion Criteria:

* Segment: outpatients
* Hypertension: taking an anti-hypertensive treatment or indicating mean sitting SBP/DBP more than130/80 mmHg
* Type 2 diabetes: diagnosed by ADA criteria or under an anti-diabetic drug treatment
* Microalbuminuria: 10 \< and \< 300 mg/gCr
* Informed consent: patients who understand well about this study based on own voluntary will and can give a written consent

Exclusion Criteria:

* Sever hypertension (over 180/110 mmHg), malignant hypertension and secondary hypertension
* Type 1 diabetes
* Patients whose investigator regards as difficult to comply with study protocol in reference to the package insert of aliskiren
* Patients who have history of operation in gastrointestinal tract surgery, and anamnestic or concurrent gastrointestinal disorders, which may interfere with drug absorption
* Serum potassium \> 5.6 mEq/L (hyperkalemia)
* Urinary microalbumin \< 10 or \> 300 mg/gCr
* Patients who participated in another clinical study within three months

Primary outcomes:
measure: Reduction in Albuminuria
timeFrame: baseline and 24 weeks
Secondary outcomes:
measure: Change in the Urinary Angiotensinogen Level
timeFrame: baseline and 24 weeks
measure: Change in the Plasma Renin Activity
timeFrame: baseline and 24 weeks
measure: Change in the Serum Insulin Level
timeFrame: baseline and 24 weeks
Other outcomes:
Locations:
city: Otsu
country: Japan
facility: Shiga University of Medical Science
state: Shiga
Study officials:
affiliation: Shiga University of Medical Science
name: Hiroshi Maegawa, M.D.
role: STUDY_CHAIR
References:
Clinical trial NCT02709499: Effects of the Low-level Laser Therapy on Inflammatory Profile of the Patients With Coronary Artery Bypass Surgery
Official title: Effects of the Low-level Laser Therapy on Inflammatory Profile on Patients With Coronary Artery Bypass Surgery: A Randomized, Controlled Clinical Trail
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Cardiovascular Diseases
Lead sponsor: Federal University of Health Science of Porto Alegre
Sponsor class: OTHER
First posted: 2016-03-16
Enrollment: 38
Sex: ALL
Minimum age (years): 45
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Cardiovascular diseases are the leading causes of morbidity and mortality in Brazil and surgical procedures to treat these disorders have grown dramatically in recent years. Since the first heart surgery in successful open field in humans, conducted in 1953 by John Lewis, many techniques have been used to improve the outcome of surgery and reduce their side effects. The low-level laser therapy (LBP) has been widely used in clinical practice for pain relief purposes, reducing inflammation and stimulating tissue healing. However, the effect of this therapy has been little elucidated in patients with cardiac disease. The objective of this study is to evaluate the effect of low level laser therapy on the inflammatory profile and cardiac tissue healing markers of patients in the postoperative period of CABG surgery.

Detailed description: This study will be conducing in a large hospital that is reference in Cardiovascular diseases treatments. 38 patients will be randomized for placebo or 6J low-level laser therapy (LLLT). The inflammatory profile and cardiac tissue will be assessment before and after de LLLT.

Eligibility criteria: Inclusion Criteria:

* Patients after elective coronary artery bypass surgery, hemodynamically stable, without ischemic changes and / or complex arrhythmias on the electrocardiogram, between 45 and 75 years of age, who have performed the first surgery

Exclusion Criteria:

* Patients with decompensated heart failure; other associated surgery; presence of any comorbidity such as: unstable angina; sequel of stroke; photosensitivity; use of cardiac pacemaker; Diabetes mellitus (due to the negative effect of diabetes on wound healing).

Primary outcomes:
measure: cytokine IL-10
timeFrame: six days
measure: cytokine IL-6
timeFrame: six days
measure: cytokine TNF-α
timeFrame: six days
Secondary outcomes:
measure: Troponin
timeFrame: six days
measure: Creatine phosphokinase (CK)
timeFrame: six days
measure: Lactate dehydrogenase (LDH)
timeFrame: six days
measure: Complete blood count
timeFrame: six days
measure: Visual Analog scale
timeFrame: six days
measure: Hospital stay
timeFrame: six days
measure: Pulmonary complications
timeFrame: six days
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT01417299: The Impact of RPh201 on CVS Patients: Clinical and fMRI Measurements
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: PHASE1
PHASE2
Conditions: Chronic Vegetative State
Keywords: chronic vegetative state
RPh201
functional MRI
Lead sponsor: Hadassah Medical Organization
Sponsor class: OTHER
First posted: 2011-08-16
Enrollment: 0
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 investigators are studying the impact of RPh201 on chronic vegetative patients. RPh201 has been reported to induce neuronal regeneration in animal models. Evaluation will be done by combining clinical /behavioral assessment with fMRI studies.


Eligibility criteria: Inclusion Criteria:

* Chronic vegetative patients

Exclusion Criteria:

* Inability to go through an MRI scans (i.e. metal implants, neurotransmitters)and pregnancy

Primary outcomes:
measure: change in the awareness status of the patients.
timeFrame: 3-6 months
Secondary outcomes:
measure: change in the awareness status of the patients.
timeFrame: 1 month following the end of the trial
Other outcomes:
Locations:
Study officials:
affiliation: Hadassah Medical Organization
name: Tamir Ben-Hur, MD PhD
role: PRINCIPAL_INVESTIGATOR
References: