louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT04711499: Effect of Fatigue on Regional Anaesthesia Task
Official title: The Effect of Fatigue on Regional Anaesthesia Task Performance Among Anaesthetists: a Rater-blinded Randomised Controlled Crossover Trial
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Fatigue
Anesthesia
Keywords: regional anaesthesia
patient safety
nerve blockade
ultrasound guided needling
Lead sponsor: Nottingham University Hospitals NHS Trust
Sponsor class: OTHER
First posted: 2021-01-15
Enrollment: 32
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: SCREENING

Brief summary: The adverse effects of sleep related fatigue are significant, impacting on doctors' health, wellbeing, performance and ultimately their safety and that of their patients'.

Trainees are at an increased risk of fatigue because they routinely, and are increasingly, working long hours, and exposed to excessive and high intensity workloads. With increasing numbers of patient consultations, there is a higher risk of making poorer quality clinical decisions (i.e. decision fatigue). The excessive workloads experienced by doctors can cause fatigue through the requirement for sustained attention over long periods of time, particularly when performing complex and mentally demanding tasks. Our main objective is to study the difference between the fatigued and non-fatigued state of anaesthetists and on their ability to perform an ultrasound-guided peripheral nerve blockade task. We hypothesise that fatigue will result in a clinically significant reduction in the objective structured assessment scores of anaesthetists who are performing an ultrasound-guided peripheral nerve blockade task compared to their scores when they are non-fatigued.


Eligibility criteria: Inclusion Criteria:

1. Anaesthetists of ST3 grade and above with previous experience of performing an ultrasound guided peripheral nerve block.

Exclusion Criteria:

1. Previous experience of gaze control training or eye-tracking software applied to medical interventions.
2. No previous experience of performing an ultrasound guided peripheral nerve block.

Primary outcomes:
measure: composite error scoring within a regional anaesthesia performance task
timeFrame: 6 months
Secondary outcomes:
measure: Global rating score (GRS)
timeFrame: 6 months
measure: Task completion time
timeFrame: 6 months
measure: Reliability of the composite error score (CES) and global rating scale (GRS)
timeFrame: 6 months
measure: Eye tracking metrics
timeFrame: 6 months
Other outcomes:
Locations:
Study officials:
affiliation: University Hospitals of Nottingham
name: David Hewson, MBBS
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06433999: A 12-Week Open-Label Study to Investigate the Efficacy and Safety of Brepocitinib in Adults With Skin-Predominant Dermatomyositis
Official title: A 12-Week Open-Label Pilot Study to Investigate the Efficacy and Safety of Oral Brepocitinib in Adults With Skin-Predominant Dermatomyositis
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Dermatomyositis
Dermatomyositis, Adult Type
Keywords: skin-predominant dermatomyositis
dermatomyositis
Lead sponsor: Priovant Therapeutics, Inc.
Sponsor class: INDUSTRY
First posted: 2024-05-30
Enrollment: 5
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: This is a prospective, 12-week, open-label, single-arm study. The study population comprises individuals with refractory skin disease characteristic of dermatomyositis with no to minimal muscle involvement. After an up to 8-week Screening Period, eligible participants will receive brepocitinib 30 mg orally (PO) QD for 12 weeks.


Eligibility criteria: Inclusion Criteria:

* A diagnosis of dermatomyositis according to 2017 EULAR/ACR Classification Criteria for Idiopathic Inflammatory Myopathies
* Active cutaneous manifestations of dermatomyositis
* Adult subjects (18-75 years old)
* Weight \> 40 kg to \< 130 kg, and with a body mass index (BMI) \< 40 kg/m2.

Exclusion Criteria:

* Dermatomyositis with end-stage organ involvement
* Dermatomyositis with irreversible muscle involvement

History of:

* Any lymphoproliferative disorder
* Active malignancy;
* History of cancer within 5 years prior to randomization (exceptions for basal cell carcinoma, squamous cell carcinoma, ductal carcinoma in situ of the breast, carcinoma in situ of the uterine cervix, or thyroid carcinoma.) Cancer-associated dermatomyositis
* Overlap myositis/connective tissue disease (except for overlap with Sjögren's syndrome)
* Participants at a risk of thrombosis or cardiovascular disease
* Participants with a high risk for herpes zoster reactivation
* Participants with active or recent infections

Primary outcomes:
measure: The primary endpoint is the change in CDASI-A score from baseline through Week 12
timeFrame: 12 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Scottsdale
country: United States
facility: Clinical Trial Site
state: Arizona
Study officials:
affiliation: Mayo Clinic
name: Mangold, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00344799: Cytogenetic Study of Ocular Melanoma
Official title: Molecular and Cytogenetic Studies of Ocular Melanoma
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Choroidal Melanoma
Keywords: Choroidal Melanoma
Choroidal Malignant Melanoma
Ocular Melanoma
Uveal Melanoma
Lead sponsor: Jonsson Comprehensive Cancer Center
Sponsor class: OTHER
First posted: 2006-06-27
Enrollment: 95
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: Patients who have been diagnosed with ocular melanoma, and underwent melanoma treatment at our facility.

Brief summary: Patients who are diagnosed with choroidal melanoma and undergo I-125 plaque or enucleation surgery consent to participate in the study. A tumor sample taken during surgery is studied in the lab for genetic features. These features and features of subjects' clinical course are recorded. Analysis of the data may identify genetic features that are indicative of prognostic factors including risk of metastasis.

Detailed description: The Jules Stein Eye Institute Ocular Melanoma Research Group is conducting cytogenetic studies of choroidal melanoma to improve the screening of biopsy samples of choroidal melanoma through cytogenetic analysis. Our goal is to identify molecular probes that specifically target regions of chromosomes that undergo changes characteristic of metastatic choroidal melanoma.

Eligibility criteria: Inclusion Criteria:

1. Patient with diagnosis of ocular melanoma
2. Patient with local treatment plan for ocular melanoma- plaque brachytherapy or enucleation
3. Patient 18 years of age or older
4. Archival enucleation specimens with diagnosis of ocular melanoma

Exclusion Criteria:

1. Patient who refuses local melanoma treatment
2. Patient who refuses to participate in this study

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Los Angeles
country: United States
facility: Jules Stein Eye Institute
state: California
Study officials:
affiliation: Jules Stein Eye Institute, UCLA
name: Tara M McCannel, MD, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Jules Stein Eye Institute, UCLA
name: Bradley R Straatsma, MD, JD
role: STUDY_DIRECTOR
affiliation: Jules Stein Eye Institute, UCLA
name: Lynn Gordon, MD, PhD
role: STUDY_CHAIR
affiliation: Jules Stein Eye Institute, UCLA
name: Ben Glasgow, MD
role: STUDY_CHAIR
affiliation: UCLA Pathology and Laboratory Medicine
name: Nagesh P Rao, PhD
role: STUDY_CHAIR
References:
citation: McCannel TA, Burgess BL, Nelson SF, Eskin A, Straatsma BR. Genomic identification of significant targets in ciliochoroidal melanoma. Invest Ophthalmol Vis Sci. 2011 May 9;52(6):3018-22. doi: 10.1167/iovs.10-5864.
Clinical trial NCT00171899: Study Comparing Standard Dose and High-dose Imatinib Mesylate in Patients With Chronic Phase Philadelphia Chromosome Positive (Ph+) Chronic Myelogenous Leukemia (CML)
Official title: Study Comparing Standard Dose and High-dose Imatinib Mesylate in Patients With Chronic Phase Ph+ CML
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Chronic Myelogenous Leukemia
Keywords: Chronic Myelogenous Leukemia
Complete cytogenetic response
Imatinib mesylate
Major molecular response
Chronic phase Ph+ Chronic Myelogenous Leukemia
Lead sponsor: Novartis
Sponsor class: INDUSTRY
First posted: 2005-09-15
Enrollment: 80
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: The study will assess the role of high-dose imatinib mesylate, in patients who have taken imatinib mesylate for at least 1 year at the standard dose, in achieving a major molecular response (a measure of the level of chronic myelogenous leukemia) versus the standard dose.


Eligibility criteria: Inclusion Criteria:

* Chronic myelogenous leukemia with Philadelphia chromosome
* 18 years and older
* Patients must have been taking imatinib mesylate standard dose for at least 12 months and have achieved a complete cytogenetic response but not a major molecular response.

Exclusion Criteria:

* Patients with cardiac problems such as congestive heart failure, or myocardial infarction within the last 6 months
* Patients with an uncontrolled medical disease such as uncontrolled diabetes, chronic renal (kidney) disease or active uncontrolled infection.
* Patients with other current primary malignancy or malignancy requiring active intervention

Other protocol defined inclusion/exclusion criteria may apply.

Primary outcomes:
measure: Percent of patients achieving major molecular response at baseline and at last visit
Secondary outcomes:
measure: Complete cytogenetic response at baseline and at last visit
measure: Overall survival
measure: Disease progression-free survival
measure: Quality of Life assessment at baseline, last visit
measure: Safety: adverse events and lab parameters, vital signs, physical exam, electrocardiogram, concomitant medications
Other outcomes:
Locations:
city: Toronto
country: Canada
facility: Novartis Investigative Site
Study officials:
affiliation: Novartis Pharmaceuticals
name: Novartis Pharmaceuticals
role: STUDY_DIRECTOR
References:
Clinical trial NCT00530699: Safety, Tolerability and PK of AZD1152 in Patients With Relapsed Acute Myeloid Leukaemia (AML)
Official title: A Phase I, Open Label, Multi-centre Study to Assess the Safety, Tolerability, and Pharmacokinetics of AZD1152 in Japanese Patients With Acute Myeloid Leukaemia.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Acute Myeloid Leukaemia
Keywords: Acute Myeloid Leukaemia
Phase 1
AZD1152
Lead sponsor: AstraZeneca
Sponsor class: INDUSTRY
First posted: 2007-09-17
Enrollment: 30
Sex: ALL
Minimum age (years): 20
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to assess safety and tolerability of multiple ascending doses of AZD1152 and to assess effect of AZD1152 on the rate of complete remission in patients with relapsed acute myeloid leukaemia who are not considered to be suitable for standard chemotherapy.


Eligibility criteria: Inclusion Criteria:

* Patients with relapsed or refractory AML for which no standard therapies are anticipated to result in durable remission
* Newly diagnosed Acute Myeloid Leukemia who are not considered suitable for other treatments.

Exclusion Criteria:

* Administration of anticancer agents (other than hydroxyurea) within 2 weeks prior to first dose of study drug, and administration of hydroxyurea within 24 hours prior to first dose of study drug
* Participation in any other trial with an investigational product within the previous 30 days.
* Uncontrolled intercurrent illness including, but not limited to, active infection, symptomatic congestive heart failure, cardiac arrhythmia or psychiatric illness/social situations

Primary outcomes:
measure: To assess the safety and tolerability of AZD1152 in patients with AML by assessment of AEs, vital signs, ECG parameters, clinical chemistry, haematology (including clotting parameters) and urinalysis
timeFrame: assessed at each visit
Secondary outcomes:
measure: To examine the pharmacokinetics of AZD1152
timeFrame: assessed after dose administration
Other outcomes:
Locations:
city: Nagoya
country: Japan
facility: Research Site
state: Aichi
city: Yoshida-gun
country: Japan
facility: Research Site
state: Fukui
city: Maebashi-city
country: Japan
facility: Research Site
state: Gunma
city: Isehara
country: Japan
facility: Research Site
state: Kanagawa
city: Yokohama
country: Japan
facility: Research Site
state: Kanagawa
city: Chuo
country: Japan
facility: Research Site
state: Tokyo
city: Fukuoka
country: Japan
facility: Research Site
Study officials:
affiliation: AstraZeneca
name: Paul Stockman
role: STUDY_DIRECTOR
References:
Clinical trial NCT02055599: WEMR With Clinical Decision Support for All Wounds
Official title: Wound Research Database With Clinical Decision Support for Patients With All Wounds
Study type: OBSERVATIONAL
Overall status: WITHDRAWN
Conditions: Chronic Wounds
Keywords: Wound
Wound Healing
Pressure Ulcers
Chronic Wounds
Clinical Decision Support
Lead sponsor: Winthrop University Hospital
Sponsor class: OTHER
First posted: 2014-02-05
Enrollment: 0
Sex: ALL
Minimum age (years): 21
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Male or female patients at Winthrop University Hospital with any chronic wound (defined as a break in the integument).

Brief summary: The goal of this project to begin using a wound research database with clinical decision support features at Winthrop University Hospital. A research database is an electronic computer system that is used to collect patient information. Clinical decision support is the ability for a computer system to provide medical assistance to the doctor through alerts and recommendations based on the information entered. The investigators believe that use of a wound clinical decision support tool, much like a drug, will improve healing in patients with chronic wounds (wounds that fail to heal over the course of weeks) and ultimately lower the risk of death and illness caused by these wounds. In order to develop a useful clinical decision support tool, investigators first need to develop a large research database to determine the data points important for wound healing. The investigators will be using the data collected in this study for future research and publication. Data will be reviewed to answer questions important to wound healing and for the purpose of developing the clinical decision support alert system.

After providing informed consent, participants will be asked a series of questions related to their past medical history, and relevant wound data will be collected. Study staff will photograph the wound at baseline, and once per week until the wound is completely healed, or for a duration of six months.

Participants will be expected to return to Winthrop University Hospital for wound follow-up on a regular basis, or as determined by the Principal Investigator.


Eligibility criteria: Inclusion Criteria:

* 21 years or older
* Diagnosed with a wound (defined as a break in the integument)
* Must be willing and able to provide written informed consent

Exclusion Criteria:

* Patients with Diabetic Foot Ulcers

Primary outcomes:
measure: To answer questions relevant to wound healing.
timeFrame: up to 6 months
Secondary outcomes:
measure: Develop new parameters for clinical decision support based on wound data collected.
timeFrame: up to 6 months
Other outcomes:
Locations:
city: Mineola
country: United States
facility: Winthrop University Hospital
state: New York
Study officials:
affiliation: Winthrop University Hospital
name: Harold Brem, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06461299: Study to Evaluate the Efficacy, Safety, and Tolerability of Sarecycline for Treating Periorificial Dermatitis
Official title: A Single-Center Pilot Study to Evaluate the Efficacy, Safety, and Tolerability of Sarecycline for Treating Periorificial Dermatitis
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Perioral Dermatitis
Lead sponsor: The Dermatology Institute of Boston
Sponsor class: OTHER
First posted: 2024-06-17
Enrollment: 9
Sex: ALL
Minimum age (years): 18
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: This is a single-center, prospective, pilot study to evaluate the efficacy, safety, and tolerability of sarecycline (Seysara) for periorificial dermatitis. This will be a four-week open-label study using sarecycline to treat POD.
Primary purpose: TREATMENT

Brief summary: A Single-Center Pilot Study to Evaluate the Efficacy, Safety, and Tolerability of Sarecycline for Treating Periorificial Dermatitis

Detailed description: This pilot study's intended purpose is to evaluate the efficacy, safety, and tolerability of sarecycline for periorificial dermatitis. Sarecycline, a third-generation tetracycline, is currently only indicated to treat acne vulgaris. However, the investigator has used sarecycline to treat periorificial dermatitis and would like to capture and report on this efficacy in a pilot study. The investigator hypothesize's that not only will the subjects respond well to sarecycline treatment, but that it will be well-tolerated.

Eligibility criteria: Inclusion Criteria:

* Have a clinical diagnosis of POD by both the principal investigator and a blinded observer
* Have a PODSI score of 3.0 or greater at baseline by clinical investigator
* Must not be dysphagic.
* Patient is male or female, 18-55 years of age inclusive at Screening.

Exclusion Criteria:

* Allergy to tetracyclines.
* Immunocompromised.
* Pregnancy or planning a pregnancy during the study period.
* Lactating subjects.
* Ongoing use of any of the following treatments to the face throughout study; oral or topical steroids, oral or topical calcineurin inhibitors, topical retinoids, topical antibiotics, - oral or topical metronidazole, or topical azelaic acid.
* Facial hair or skin dermatoses that interfere with evaluation of the perioral dermatitis.

Primary outcomes:
measure: PODSI score
timeFrame: 4 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Boston
country: United States
facility: The Dermatology Institute of Boston
state: Massachusetts
Study officials:
References:
Clinical trial NCT02514499: Multiplex Testing for Evaluation of Breast Cancer Risk, Longitudinal Study
Official title: Multiplex Testing for Evaluation of Breast Cancer Risk, Longitudinal Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: BRCA1/2 Negative
Keywords: patients
Lead sponsor: Abramson Cancer Center at Penn Medicine
Sponsor class: OTHER
First posted: 2015-08-03
Enrollment: 350
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: SCREENING

Brief summary: The overall goal of the proposed research is to evaluate the uptake of testing and longitudinal risks and benefits of multiplex testing for cancer susceptibility in BRCA1/2 negative patients. This model will inform the selection of the outcomes and potential mediators and moderators of these outcomes, to inform the debate over utility, risks, and benefits of clinical incorporation of multiplex testing for breast cancer susceptibility.


Eligibility criteria: Inclusion Criteria:

* 1. Women and men (at least 18 YO) 2. English speaking AND 3. Negative for BRCA1 and BRCA2 mutations

Exclusion Criteria:

1. Non English speaking patients

Primary outcomes:
measure: Completion of questionnaires
timeFrame: 2 years
Secondary outcomes:
Other outcomes:
Locations:
city: Philadelphia
country: United States
facility: Abramson Cancer Center of the University of Pennsylvania
state: Pennsylvania
Study officials:
References:
Clinical trial NCT03720899: Comparing NicoBloc to Nicotine Lozenges
Official title: A Pilot Trial Comparing NicoBloc to Nicotine Lozenges: Initial Acceptability and Feasibility Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
PHASE3
Conditions: Smoking Cessation
Nicotine Dependence
Lead sponsor: University of Alabama at Birmingham
Sponsor class: OTHER
First posted: 2018-10-25
Enrollment: 45
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: participants will be randomized to one of two interventions
Primary purpose: TREATMENT

Brief summary: To examine the feasibility, acceptability, and preliminary impact of using NicoBloc compared to nicotine lozenges

Detailed description: Smoking remains the leading cause of preventable death in the U.S. with approximately 18% of the population continuing to smoke. However, smoking is concentrated in disadvantaged populations where the prevalence of smoking may be as high as 70-80 %. Participants will receive a sampling experience (use of nicotine lozenges or NicoBloc during sessions) with counseling focused around their experience of using these interventions, including side effects and smoking cessation expectancies.

Eligibility criteria: Inclusion Criteria:

1. 18 years or older
2. planning to live in the Birmingham Metro area for the next 3 months
3. Smoking at least 5 cigarettes per day for the past year and a Carbon Monoxide\>8ppm to ensure daily smoking. This relatively low cutoff was chosen due to the expectation of enrolling a large \>50% African-American average \<10 cigarettes per day compared to Whites who average \~15 cigarettes per day
4. exclusive use of filtered cigarettes
5. English speaking.

Exclusion Criteria:

1. Living in a restricted environment that does not allow smoking (e.g., prison or jail facility, etc.)
2. Pregnant or nursing (all women of childbearing potential will be required to use an acceptable form of contraception)
3. Currently enrolled in a smoking cessation treatment program, using nicotine replacement products, or prescribed bupropion or varenicline
4. Known allergy nicotine lozenge
5. Within one month post-myocardial infarction or untreated severe angina
6. Cognitive impairment or unstable psychiatric condition that interferes with the informed consent process (individuals stable on psychiatric medications will be included)
7. Daily or exclusive use of other tobacco products (e.g., electronic cigarettes, little cigars, etc.).

Primary outcomes:
measure: The Treatment Satisfaction Survey
timeFrame: 4 months
Secondary outcomes:
measure: Change in the Questionnaire of Smoking Urges-Brief Form, From Baseline to Week 4 Timepoint
timeFrame: Week 4
measure: Retention Rates
timeFrame: 4 months
Other outcomes:
Locations:
city: Birmingham
country: United States
facility: University of Alabama, Birmingham
state: Alabama
Study officials:
affiliation: University of Alabama at Birmingham
name: Karen L Cropsey, Psy.D.
role: PRINCIPAL_INVESTIGATOR
References: