louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT00599079: Azithromycin in the Treatment of M. Avium Complex Lung Disease
Official title: Open, Noncomparative Trial of Azithromycin in the Treatment of M.Avium Complex (MAC) Lung Disease
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Mycobacterium Avium Complex Lung Disease
Keywords: MAC
Lead sponsor: The University of Texas Health Science Center at Tyler
Sponsor class: OTHER
Collaborators: name: Pfizer
First posted: 2008-01-23
Enrollment: 66
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: To determine the safety and efficacy of azithromycin in the treatment of lung infection with M.avium complex and M. abscessus lung disease.

Detailed description: To study the safety and efficacy of azithromycin in combination treatment for M. abscessus and MAC lung disease

Eligibility criteria: Inclusion Criteria:

* Meet American Thoracic Society criteria for nontuberculous lung disease: two or more AFB smear positive, culture positive sputums or bronchoscopic samples and/or two or more AFB smear negative respiratory samples with moderate to heavy growth (2+-4+); abnormal CXR consistent with M. avium lung disease; abnormal CXR consistent with M. avium lung disease; absence of other lung pathogens (except for the coexistence of M. abscessus).
* Age 18 and older
* Pretreatment isolate of M. avium complex available for MIC determination

Exclusion Criteria:

* History of macrolide allergy
* Received macrolide therapy in last two months
* Children less than 18 years of age
* If a menstruating female, not pregnant and on adequate birth control

Primary outcomes:
measure: Clinical and microbiological outcomes such as clinical symptoms and laboratory cultures
timeFrame: 6 months
Secondary outcomes:
measure: Microbiological cultures
timeFrame: 1yr
Other outcomes:
Locations:
city: Tyler
country: United States
facility: The University of Texas Health Science Center at Tyler
state: Texas
Study officials:
affiliation: The University of Texas Health Science Center at Tyler
name: Richard J Wallace Jr., M.D.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00873379: Melatonin Supplementation for Delirium Prevention in Acutely Hospitalized Elderly
Official title: Melatonin Supplementation for Delirium Prevention in Acutely Hospitalized Elderly: a Randomized, Double Blind, Placebo-Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Delirium
Lead sponsor: London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's
Sponsor class: OTHER
Collaborators: name: University of Western Ontario, Canada
First posted: 2009-04-01
Enrollment: 122
Sex: ALL
Minimum age (years): 65
Standard ages: OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: 122 people over 70 who were admitted to hospital were enrolled to the study. Half got .5 mg a night of melatonin, half got a placebo.


Eligibility criteria: Inclusion Criteria:

* Age over 65 admitted through the emergency department to an internal medicine service in London, Ontario, Canada.

Exclusion Criteria:

* Life expectancy less than 24 hours,
* Unable to communicate in English,
* Unable to take oral medications,
* Intracranial bleed or known seizure disorder,
* Markedly sub or supra-therapeutic INR while on warfarin, OR
* A known allergy to study tablet ingredients.

Primary outcomes:
measure: delirious using confusion assessment method (CAM)
timeFrame: days
Secondary outcomes:
measure: MDAS (memorial delirium assessment scale)
timeFrame: days
Other outcomes:
Locations:
city: London
country: Canada
facility: London Health Sciences Centre
state: Ontario
Study officials:
affiliation: Western University, Canada
name: Chris Brymer, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06900179: The Effectiveness of Augmented Reality Facilitated Education in Promoting Care Management of Malignant Fungating Wounds Among Oncology Nurses
Official title: The Effectiveness of Augmented Reality Facilitated Education in Promoting Care Management of Malignant Fungating Wounds Among Oncology Nurses
Study type: INTERVENTIONAL
Overall status: ENROLLING_BY_INVITATION
Phase: NA
Conditions: Nursing Education
Lead sponsor: Mackay Memorial Hospital
Sponsor class: OTHER
First posted: 2025-03-28
Enrollment: 188
Sex: ALL
Minimum age (years): 20
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: Malignant fungating wounds (MFWs) affect 5-14% of patients with advanced cancer, making them a common complication in this population. Characterized by symptoms such as foul odor, heavy exudate, bleeding, moderate to severe pain, and infection, MFWs cause significant physical discomfort and pose life-threatening risks while also leading to profound psychosocial issues, including shame and social isolation. These factors severely impact patients' quality of life, with half of those diagnosed surviving only six months on average.

However, clinical nursing staff often lack adequate knowledge and skills in managing MFWs, with an average accuracy rate of just 56.5%. Notable deficiencies exist in areas such as wound disinfection, odor control, and wound assessment, directly affecting the quality of patient care and highlighting an urgent need for specialized MFW training. Traditional MFW education often lacks real-life clinical scenarios and hands-on practice, resulting in a gap between learning and application and leaving learners ill-prepared for the complexities of clinical settings.

In contrast, augmented reality (AR) technology presents new possibilities for nursing education. AR can create highly simulated clinical environments where learners can safely practice complex clinical skills, enhancing clinical decision-making abilities. The implementation of AR-based training programs provides nursing staff with a more realistic and effective learning experience, allowing them to better address the challenges posed by MFWs and ultimately contributing to improvements in patient care and quality of life.


Eligibility criteria: Inclusion Criteria:

* Full-time nursing staff working in oncology wards at a teaching hospital in northern Taiwan
* Individuals willing to participate in the study and who have signed the informed consent form

Exclusion Criteria:

* Nursing staff not assigned to oncology-related wards
* Individuals expected to be unable to complete full participation in the study

Primary outcomes:
measure: MFWs care Knowledge scale
timeFrame: 6months
Secondary outcomes:
measure: Clinical Reasoning Scale
timeFrame: 6months
Other outcomes:
Locations:
city: Tamsui Dist
country: Taiwan
facility: MacKay Memorial Hosital
state: New Taipei City
Study officials:
References:
Clinical trial NCT05159479: Defining Robust Predictors of Chemotherapy Related Cardiotoxicity
Official title: Defining Robust Predictors of Chemotherapy Related Cardiotoxicity
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Cardiotoxicity
Gastrointestinal Neoplasms
Keywords: Fluoropyrimidine
Cardiotoxicity
Cardio-oncology
Lead sponsor: University College, London
Sponsor class: OTHER
Collaborators: name: British Heart Foundation
First posted: 2021-12-16
Enrollment: 600
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Participants will be recruited from secondary or tertiary care centres from oncology clinics. Participants included will be undergoing chemotherapy in the neoadjuvant, adjuvant and palliative setting.

Brief summary: Observational prospective cohort study designed for patients with gastrointestinal cancers receiving a fluoropyrimidine based chemotherapy regimen.

Detailed description: All enrolled participants will undergo baseline cardiovascular risk assessment (using QRISK3 and SCORE 2 risk calculators), cardiac, oncological and medication history. All participants will have serial cardiac symptom assessment, 12 lead ECG and cardiac biomarker assessments(high sensitivity troponin T and NT pro BNP) at baseline, on completion of the first cycle of treatment and post completion of treatment. Participants will be followed up for the development of cardiotoxicity.

Eligibility criteria: Inclusion Criteria:

* Age \>18
* Consented to receive fluoropyrimidine chemotherapy for GI malignancies (gastro-oesophageal, colorectal, pancreatic)
* Capacity to provide consent

Exclusion Criteria:

* Age \<18
* Lacking capacity to consent

Primary outcomes:
measure: Incidence of fluoropyrimidine induced cardiotoxicity (FIC)
timeFrame: 12 months
measure: Relationship of baseline cardiovascular risk with FIC
timeFrame: 12 months
measure: Relationship of baseline cardiovascular risk with FIC
timeFrame: 12 months
Secondary outcomes:
measure: Change in cardiac biomarkers (high sensitivity troponin T)
timeFrame: Assessed at baseline pre chemotherapy, after cycle 1 chemotherapy (46 hours for patients on 5-FU and day 14 for patients on capecitabine) and at end of treatment (at 6 weeks post completion)
measure: Change in cardiac biomarkers (NT pro BNP)
timeFrame: Assessed at baseline pre chemotherapy, after cycle 1 chemotherapy (46 hours for patients on 5-FU and day 14 for patients on capecitabine) and at end of treatment (at 6 weeks post completion)
measure: Cardiovascular symptom assessment
timeFrame: Assessed at baseline pre chemotherapy, after cycle 1 chemotherapy (46 hours for patients on 5-FU and day 14 for patients on capecitabine) and at end of treatment (at 6 weeks post completion)
Other outcomes:
Locations:
city: London
country: United Kingdom
facility: St Bartholomews Hospital
Study officials:
References:
Clinical trial NCT03938779: Stress Urinary Incontinence in Elite Athletes
Official title: Pelvic Floor Muscle Training and Stress Urinary Incontinence in Elite Athletes . Clinical Trial
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Pelvic Floor Disorders
Keywords: Elite Athletes
Volleyball
Pelvic Floor Muscle Training
Lead sponsor: University of Trás-os-Montes and Alto Douro
Sponsor class: OTHER
First posted: 2019-05-06
Enrollment: 15
Sex: FEMALE
Minimum age (years): 15
Maximum age (years): 30
Standard ages: CHILD
ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Intervention model description: Volleyball team will be evaluated in two moments, at the beginning and 4 months after the PFMT. After 4 months, to compare with the control group and to evaluate if there are differences between groups, namely muscle strength
Primary purpose: TREATMENT

Brief summary: A protocol of pelvic floor muscles training (PFMT) in elite athletes was applied. They will do it for 4 months. Then re-evaluated.

Detailed description: The athletes of the Portuguese national female's volleyball team were evaluated through perineometry, pad-test and Kings health questionnaire. They were taught a plan of pelvic floor muscles training (PFMT) to perform for 4 months. After this time they will be re-evaluated with the same measuring instruments.

Eligibility criteria: Inclusion Criteria:

* Elite female athletes
* Nulliparous
* Volleyball team.

Exclusion Criteria:

* Inability to contract the PFM, elderly
* Prolapse of the pelvic organs.

Primary outcomes:
measure: Pad-test (Short-term)
timeFrame: 2 hour 30 min
Secondary outcomes:
Other outcomes:
measure: Kings Health Questionnaire (KHQ)
timeFrame: 10 minutes
Locations:
city: Vila Real
country: Portugal
facility: Telma Filipa Rodrigues Pereira Pires
state: Trás-os-Montes E Alto Douro
Study officials:
References:
citation: Oliveira M, Ferreira M, Azevedo MJ, Firmino-Machado J, Santos PC. Pelvic floor muscle training protocol for stress urinary incontinence in women: A systematic review. Rev Assoc Med Bras (1992). 2017 Jul;63(7):642-650. doi: 10.1590/1806-9282.63.07.642.
citation: Morkved S, Bo K. Effect of pelvic floor muscle training during pregnancy and after childbirth on prevention and treatment of urinary incontinence: a systematic review. Br J Sports Med. 2014 Feb;48(4):299-310. doi: 10.1136/bjsports-2012-091758. Epub 2013 Jan 30.
citation: Da Roza T, de Araujo MP, Viana R, Viana S, Jorge RN, Bo K, Mascarenhas T. Pelvic floor muscle training to improve urinary incontinence in young, nulliparous sport students: a pilot study. Int Urogynecol J. 2012 Aug;23(8):1069-73. doi: 10.1007/s00192-012-1759-2. Epub 2012 May 3.
Clinical trial NCT05570084: Silodosin vs Tamsulosin as MET
Official title: Randomised Controlled Trial on Silodosin Versus Tamsulosin for Medical Expulsive Treatment of Ureteral Stones Size 5-10mm in Chinese
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE3
Conditions: Stone, Urinary
Lead sponsor: Princess Margaret Hospital, Hong Kong
Sponsor class: OTHER_GOV
First posted: 2022-10-06
Enrollment: 80
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The spontaneous passage rate for ureteral stone less than 1cm causing acute ureteral obstruction is about 50%. Previous Cochrane review has concluded that alpha blocker is likely to increase stone passage rate, reduce time to stone passage, analgesic use and hospitalisations. The European Association of Urology Guideline also recommends giving alpha blockers as Medical Expulsive Therapy to patients with distal ureteric stones \>5mm. However there is heterogeneity in different alpha blockers.

Silodosin is a recently introduced selective alpha blocker which has a much higher selectivity for the alpha-1-A receptor (17-fold compared with tamsulosin). From previous animal studies, ureteral contraction is mainly mediated by the alpha-1-A receptor, hence silodosin maybe more effective in increasing stone passage compared with tamsulosin.

Previous studies and meta-analysis has shown superiority of silodosin over tamsulosin on earlier stone passage and less pain. However, there is no data on Chinese population.

The investigators would like to compare the efficacy and side effect profile of Silodosin versus tamsulosin on improving stone passage rate and hence reduce rate of further intervention for stone clearance.


Eligibility criteria: Inclusion criteria:

* Presented with radio-opaque ureteric stone of size 5mm to 10mm on KUB
* Patients who can understand the study protocol and comply with the followup schedule

Exclusion criteria:

* Radiolucent stone
* Paper thin cortex
* Non-functioning kidney
* Renal insufficiency (serum creatinine greater than 1.8 mg/dl or 160umol/dL)
* Concurrent urosepsis
* Current \[alpha\]-blocker usage, Ca channel blocker, steroid
* Pregnancy
* Age \< 18
* History of ureteral stricture
* History of ureteric stone treatment within 2 years
* Allergic reaction to the study medication
* Unable to Consent
* Patient on JJ stent or PCN drainage

Primary outcomes:
measure: Stone free rate
timeFrame: FU at week 2
measure: Stone free rate
timeFrame: FU at week 4
Secondary outcomes:
measure: Pain control
timeFrame: FU at week 2
measure: Pain control
timeFrame: FU at week 4
Other outcomes:
Locations:
city: Hong Kong
country: Hong Kong
facility: Hong Kong
Study officials:
References:
Clinical trial NCT06436079: Evaluation of the Effectiveness of a Nursing Intervention Program in Reducing Anxiety in Users Who Perform Scheduled Sessions in the Hyperbaric Chamber
Official title: Evaluation of the Effectiveness of a Nursing Intervention Program in Reducing Anxiety in Users Who Perform Scheduled Sessions in the Hyperbaric Chamber
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Anxiety and Fear
Nurse's Role
Keywords: Anxiety
Nursing intervention
Hyperbaric chamber
Lead sponsor: Universitat de Girona
Sponsor class: OTHER
First posted: 2024-05-30
Enrollment: 42
Sex: ALL
Minimum age (years): 18
Maximum age (years): 100
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: The objective of this experimental study is to determine if the application of a nursing educational intervention reduces the anxiety of patients who are going to undergo treatment in the hyperbaric chamber.

The researchers will compare the nursing educational intervention with the usual practice that is currently carried out in the unit for patients who are going to begin treatment in the hyperbaric chamber.

Participants will:

* Receive explanatory information through a camera triptych when the treatment is indicated.
* Come half an hour before the first session to receive a nursing educational intervention, with audiovisual support, on the operation of the camera.

Detailed description: The objective of this experimental study is to determine if the application of a nursing educational intervention reduces the anxiety of patients who are going to undergo treatment in the hyperbaric chamber.

An educational intervention will be applied to the intervention group that will begin on the same day that the treatment is indicated. That day, you will be given an informative brochure about the most important aspects you should know about the hyperbaric chamber. On the first day of the session, you will be asked to come half an hour early to explain, in more detail, what the hyperbaric chamber consists of and important aspects that you should take into account.

The control group will receive the same intervention that is currently being carried out. Once treatment is prescribed in the chamber, they come on the first day and receive a brief explanation of how it works before entering.

Eligibility criteria: Inclusion Criteria:

* Results in the Pfeiffer questionnaire\<2.
* That they understand Spanish or Catalan

Exclusion Criteria:

* That feel fear inside the hyperbaric chamber.

Primary outcomes:
measure: Prevalence of anxiety measured with the STAI questionnaire.
timeFrame: First week of treatment in the hyperbaric chamber
Secondary outcomes:
Other outcomes:
Locations:
city: Palamós
country: Spain
facility: Hospital de Palamós
state: Girona
Study officials:
References:
Clinical trial NCT02070484: Human Amniotic Tissue-derived Allograft, NuCel, in Posteriolateral Lumbar Fusions for Degenerative Disc Disease
Official title: Efficacy of a Human Amniotic Tissue-derived Allograft, NuCel, in Patients Undergoing Posteriolateral Lumbar Fusions for Degenerative Disc Disease
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Lumbar Degenerative Disc Disease
Spinal Stenosis
Spondylolisthesis
Spondylosis
Intervertebral Disk Displacement
Intervertebral Disk Degeneration
Spinal Diseases
Bone Diseases
Musculoskeletal Diseases
Spondylolysis
Keywords: NuCel
Lumbar Spine
Degenerative Disease
Efficacy
Fusion
Lead sponsor: OhioHealth
Sponsor class: OTHER
Collaborators: name: NuTech Medical, Inc
First posted: 2014-02-25
Enrollment: 6
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: TREATMENT

Brief summary: The purpose of this study is to compare the effect and safety of NuCel to DBX on patients undergoing posteriolateral lumbar spinal fusions for degenerative disc disease.


Eligibility criteria: Inclusion Criteria:

* Between the ages of 18 and 75 years
* Symptomatic, single-level degenerative lumbar disc disease, spondylosis or spondylolisthesis
* Failed conservative treatments
* Low risk for non-union
* Must be candidates for single-level, posteriolateral lumbar spine fusion
* Must be able and willing to give Informed Consent
* English-speaking

Exclusion Criteria:

* Smoker (any smoking ≤3 months prior to consent); (Patel et al. 2013)
* Patients with poorly controlled diabetes mellitus (HgbA1c \> 7%)
* Documented osteoporosis
* Prior lumbar spinal surgery at the same spinal level, or immediately adjacent spine level, to the level being operated on
* Back pain due to infection, tumour, or metabolic bone disease
* Terminal disease, such as HIV infection, neoplasm
* Autoimmune disease, such as rheumatoid arthritis
* Morbid obesity (body mass index (BMI) of 35 kg/m2)
* Major psychiatric illness in the last year
* History of alcohol or drug abuse in the last year
* Pregnant women

Primary outcomes:
measure: Oswestry Disability Index
timeFrame: 12 months
measure: Oswestry Disability Index
timeFrame: Baseline
measure: Oswestry Disability Index
timeFrame: 1 month
measure: Oswestry Disability Index
timeFrame: 2 months
measure: Oswestry Disability Index
timeFrame: 3 months
measure: Oswestry Disability Index
timeFrame: 6 months
Secondary outcomes:
measure: Computed Tomography (CT) Scans to Assess Lumbar Bone Fusion
timeFrame: 6 and 12 months
Other outcomes:
Locations:
city: Columbus
country: United States
facility: Riverside Methodist Hospital
state: Ohio
city: Columbus
country: United States
facility: Grant Medical Center
state: Ohio
Study officials:
affiliation: OhioHealth
name: Joseph Shehadi, MD
role: PRINCIPAL_INVESTIGATOR
References: