louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT05765045: A Nursing Triage Protocol for Minor Orthopedic Traumata: the Effect on Flow Time, Quality of Care and Patient Satisfaction in an Emergency Department
Official title: A Nursing Triage Protocol for Minor Orthopedic Traumata: the Effect on Flow Time, Quality of Care and Patient Satisfaction in an Emergency Department
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Trauma Injury
Lead sponsor: Universiteit Antwerpen
Sponsor class: OTHER
Collaborators: name: Heilig Hartziekenhuis, Mol
First posted: 2023-03-13
Enrollment: 220
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Intervention group and control group
Primary purpose: DIAGNOSTIC

Brief summary: In 2019, nearly half of all hospital contacts in Belgium took place through the emergency department, and more than a third of patients arrived after an accident or trauma. In instances of overcrowding, patients with minor orthopedic injuries face prolonged waiting times. Previous studies have shown that implementing triage protocols for medical imaging conducted by a triage nurse can reduce the Total Length of Stay (TLOS) for this patient group.

This is a single-center, unblinded, randomized, controlled trial that aims to evaluate the impact of a nurse triage protocol on turnaround time (primary outcome), quality of care, and patient satisfaction. The study population consists of adults who present with minor orthopedic injuries below the elbow or knee and have an Emergency Severity Index (ESI) of 4 or 5. Participants are randomly assigned to either the 'nurse triage protocol' group (n=110) or the 'usual care' group (n=110).


Eligibility criteria: Inclusion Criteria:

* Adults (18 years old)
* ESI 4 or ESI 5 Recent trauma (\< 10 days after trauma)
* Accidental trauma mechanism
* Trauma below the elbow (forearm, wrist, hand, finger)
* Trauma below the knee (lower leg, ankle, foot, toe)

Exclusion Criteria:

* ESI 1 or ESI 2 or ESI 3
* Return visit after previous emergency department contact for the same injury (e.g. increased pain, tight cast, ...)
* Trauma resulting from underlying somatic pathology (e.g. syncope, epileptic attack, vertigo, vasovagal collapse, ...)
* Atraumatic (pain) complaints (e.g. pain in the calf, toe, foot, wrist, ... without a clear trauma mechanism)
* Additional, non-orthopedic injuries (e.g. laceration, signs of cerebral commotion, ...)
* Pregnancy or a suspicion of pregnancy

Primary outcomes:
measure: TLOS
timeFrame: 6-8 weeks
Secondary outcomes:
measure: Patient satisfaction
timeFrame: 6-8 weeks
measure: Treatment efficiency
timeFrame: 6-8 weeks
Other outcomes:
Locations:
city: Wilrijk
country: Belgium
facility: University of Antwerp
state: Antwerp
Study officials:
affiliation: Universiteit Antwerpen
name: Filip Haegdorens, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00897845: Studying Tumor Samples From Women Who Have Undergone Chemotherapy for Breast Cancer
Official title: Molecular Profiling of E2197 FFPE Samples Using a Custom 512 Breast Cancer Gene Set on the DASL Platform: Towards the Development of Predictive Gene Sets for Risk of Recurrence in Patients With Operable Breast Cancer Treated With Adjuvant Therapy
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Breast Cancer
Keywords: stage II breast cancer
stage IIIA breast cancer
stage IIIB breast cancer
Lead sponsor: Eastern Cooperative Oncology Group
Sponsor class: NETWORK
Collaborators: name: National Cancer Institute (NCI)
First posted: 2009-05-12
Enrollment: 2541
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 120
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Samples submitted for research from patients enrolled on E2197

Brief summary: RATIONALE: Studying samples of tumor tissue from patients with cancer in the laboratory may help doctors learn more about changes that occur in DNA and identify biomarkers related to cancer.

PURPOSE: This research study is looking at tumor samples from women who have undergone chemotherapy for breast cancer.

Detailed description: OBJECTIVES:

Primary

* To identify gene sets for risk of recurrence using molecular profiling in samples from women with lymph node-positive or high-risk lymph node-negative breast cancer on clinical trial ECOG-E2197.

Secondary

* To define a set of significant genes as prognostic markers of recurrence.
* To compare the prognostic value of the Oncotype DX™ (ODX) 21 gene assay of clinical trial with gene sets determined in this study.
* To compare the DASL™ assay of the ODX 21 genes with ODX assay results of clinical trial.
* To compare the prognostic value of selected genes with gene sets determined in this study.

OUTLINE: This is a multicenter study.

Samples are used in molecular profiling by applying a custom panel of breast cancer-related genes to a cDNA-mediated Annealing, Selection, Extension, and Ligation (DASL™) assay, immunohistochemistry, and other studies.

Eligibility criteria: DISEASE CHARACTERISTICS:

* Histologically confirmed breast cancer tumor samples collected on clinical trial ECOG-E2197
* Histologically lymph node-positive (N1-3) OR high-risk lymph node-negative disease
* Hormone receptor-positive or negative disease (status known)
* HER2 status known

PATIENT CHARACTERISTICS:

* Menopausal status not specified

PRIOR CONCURRENT THERAPY:

* See Disease Characteristics

Primary outcomes:
measure: Correlation of results with Outcome
timeFrame: 1 month
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: Emory University
name: Brian Leyland-Jones, MD
role: STUDY_CHAIR
References:
Clinical trial NCT06369545: Chronic Pelvic Pain Syndrome in Males
Official title: Examination of the Efficacy of ESWT (Extracorporeal Shock Wave Therapy) and TENS (Transcutaneous Electrical Nerve Stimulation) in Individuals Receiving Drug Treatment for Chronic Pelvic Pain Syndrome: Randomized Controlled Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Pelvic Pain Syndrome
Keywords: Chronic Pelvic Pain Syndrome
Male
ESWT
TENS
Lead sponsor: Biruni University
Sponsor class: OTHER
First posted: 2024-04-17
Enrollment: 38
Sex: MALE
Minimum age (years): 20
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Randomized Controled Trial
Primary purpose: TREATMENT

Brief summary: The aim of this study is to evaluate the effectiveness of ESWT (Extracorporeal Shock Wave Therapy) and TENS (Transcutaneous Electrical Nerve Stimulation) in individuals diagnosed with chronic pelvic pain syndrome and treated with medication. The study was organized as a randomized controlled trial. The sample size is 30 patients suffering from chronic pelvic pain syndrome.

Detailed description: Volunteers who are between the ages of 20-40, diagnosed with chronic pelvic pain syndrome, and who meet the inclusion criteria will be included in the study and will be randomized into 2 groups: Group I (TENS) and Group II (ESWT).

Eligibility criteria: Inclusion Criteria:

1. Aged between 20-40 years old males
2. Diagnosis of Chronic Pelvic Pain Syndrome

Exclusion Criteria:

1. Cancer
2. Surgery related to pelvic floor

2. Receiving drug treatment

Primary outcomes:
measure: VISUAL ANALOUGE SCALE
timeFrame: baseline and immediately after the intervention
measure: National Institutes of Health Chronic Prostatitis Symptom Index (NIH-CPSI)
timeFrame: baseline and immediately after the intervention
measure: ALGOMETER
timeFrame: baseline and immediately after the intervention
Secondary outcomes:
measure: Hospital Anxiety and Depression Scale- HAD
timeFrame: baseline and immediately after the intervention
measure: Nottingham Health Profile-NHP
timeFrame: baseline and immediately after the intervention
measure: Digital Muscle Testing
timeFrame: baseline and immediately after the intervention
measure: Flexibility Measurements
timeFrame: baseline and immediately after the intervention
measure: ROM Assessments
timeFrame: baseline and immediately after the intervention
measure: Lasegue Test
timeFrame: baseline and immediately after the intervention
Other outcomes:
Locations:
city: İ̇stanbul
country: Turkey
facility: Faculty of Health Sciences in Biruni University
state: Zeytinburnu
Study officials:
References:
citation: Schneider MP, Tellenbach M, Mordasini L, Thalmann GN, Kessler TM. Refractory chronic pelvic pain syndrome in men: can transcutaneous electrical nerve stimulation help? BJU Int. 2013 Jul;112(2):E159-63. doi: 10.1111/bju.12005. Epub 2013 Feb 22.
Clinical trial NCT04722445: Ultrasound Measurement of Quadriceps Shortening During Neuromuscular Electrical Stimulation in Critically Ill Patients
Official title: Diagnostic Accuracy of Early ulTrasound Measurement of Quadriceps Thickness During Neuromuscular EleCTrical Stimulation for the Diagnosis of ICU-acquired Weakness : an Observational Study (DETECT)
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: ICU Acquired Weakness
Quadriceps Muscle Atrophy
Lead sponsor: Groupe Hospitalier du Havre
Sponsor class: OTHER
First posted: 2021-01-25
Enrollment: 80
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: Critically ill patients admitted in ICU departement and mechanically ventilated for at least 24 hours without counterindications to provide NMES.

Brief summary: ICU-Aw is highly prevalent (50%) among critically ill patients. Its diagnosis is usually delayed as it requires patients' awakening and collaboration to provide accurate measurement.

This study aims to investigate the accuracy of an early ultrasound measurement of quadriceps shortening during neuromuscular electrical stimulation to diagnose future ICU-Aw in critically ill patients.


Eligibility criteria: Inclusion Criteria:

* Mechanical ventilation for at least 24 hours

Exclusion Criteria:

* Decision to withhold life-sustaining treatment
* Pregnancy
* Degenerative neurological pathology with disabling muscle weakness
* Pace Maker
* Inability to communicate
* Chronic loss of autonomy described by the patient's family
* Guardianship

Primary outcomes:
measure: ICU-Aw diagnosis
timeFrame: In the 24 hours following extubation
Secondary outcomes:
measure: Respiratory muscles strength
timeFrame: In the 30 minutes before extubation (during spontaneous breathing trial)
measure: Cough capacity
timeFrame: In the 30 minutes before extubation (during spontaneous breathing trial)
measure: Extubation failure/success
timeFrame: Within 48 hours after extubation
Other outcomes:
Locations:
city: Montivilliers
country: France
facility: Groupe Hospitalier du Havre
Study officials:
affiliation: Groupe Hospitalier du Havre
name: Yann Combret, PhD, PT
role: PRINCIPAL_INVESTIGATOR
References:
citation: Medrinal C, Combret Y, Hilfiker R, Prieur G, Aroichane N, Gravier FE, Bonnevie T, Contal O, Lamia B. ICU outcomes can be predicted by noninvasive muscle evaluation: a meta-analysis. Eur Respir J. 2020 Oct 1;56(4):1902482. doi: 10.1183/13993003.02482-2019. Print 2020 Oct.
Clinical trial NCT00852345: Treatment Protocol for Clofazamine in the Long Term Treatment of Leprosy
Official title: Clofazamine in the Long Term Treatment of Leprosy, Phase III
Study type: EXPANDED_ACCESS
Overall status: NO_LONGER_AVAILABLE
Conditions: Leprosy
Keywords: multibacillary leprosy
leprosy
clofazamine
Lead sponsor: Kaiser Permanente
Sponsor class: OTHER
Collaborators: name: Health Resources and Services Administration (HRSA)
First posted: 2009-02-27
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT

Brief summary: Clofazimine has shown effectiveness in the treatment of leprosy for many years. The World Health Organization and the National Hansen's Disease Program consider clofazamine to be standard therapy for treatment of multibacillary leprosy. In recent years, the availability of the drug has become limited and is currently available only under a research protocol and is considered "investigational." Use of Clofazamine in patients presenting with lepromatous leprosy is necessary for patients exhibiting nerve involvement or lesions resistant to other therapies. This drug will be used prospectively for patients who require treatment of leprosy as deemed appropriate by a Kaiser Permanente Southern California physician.

Detailed description: Treatment protocol objective is to treat patients with clofazamine who meet inclusion criteria stated above.

Eligibility criteria: Inclusion Criteria:

* Known or suspected leprosy confirmed by skin biopsy and/or slit skin smears.
* Multibacillary leprosy (lepromatous leprosy or borderline-lepromatous).
* Paucibacillary leprosy (borderline, borderline tuberculoid, or indeterminate) if there is involvement of the cranial nerves or active acute neuritis.
* Known or suspected ENL(erythema nodosum leprosum) (a specific immune reaction with painful skin nodules and fever)
* Known or suspected dapsone-resistant leprosy or relapsed leprosy.
* Intolerance of other antileprosy antibiotic (where clofazamine is substituted as apart of multidrug regimen)

Exclusion Criteria:

* Uncomplicated paucibacillary leprosy which would otherwise be treated with dapsone and rifampin only.
* Known prior intolerance of Clofazamine
* Any minor (even with parental consent)
* Any fertile woman who is pregnant a specific immune reaction with painful skin rash and fever)

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Irvine
country: United States
facility: Kaiser Permanente
state: California
Study officials:
affiliation: Kaiser Permanente
name: Arnold M Henson, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04580745: Study of MORF 057 to Evaluate Single and Multi Ascending Doses in Healthy Volunteers
Official title: A Phase 1a Randomized, Double-blind, Placebo-controlled Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of Single and Multiple Ascending Doses of Oral MORF-057 in Healthy Subjects
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Healthy Volunteers
Keywords: MORF-057
Lead sponsor: Morphic Therapeutic, Inc
Sponsor class: INDUSTRY
First posted: 2020-10-08
Enrollment: 67
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: SEQUENTIAL
Primary purpose: OTHER

Brief summary: Phase 1a randomized, double-blind, placebo-controlled study to evaluate single and multiple ascending doses of MORF-057 in healthy subjects.


Eligibility criteria: Inclusion Criteria:

* Healthy male and female subjects between 18 to 65 years old with a body mass index between 18 and 32 kg/m2
* Determined to be medically healthy by the Investigator.
* Use of acceptable methods of contraceptives.
* Ability to provide written informed consent and to understand and comply with the requirements of the study.

Exclusion Criteria:

* History of any malignancy, except basal or squamous cell carcinoma of the skin that resolved or in remission prior to Screening.
* Abnormal laboratory values at Screening.
* Any clinically significant major diseases.
* Female who is pregnant or breastfeeding, or planning to become pregnant during the course of the study.
* Unwilling or unable to comply with the requirements of the protocol.

Primary outcomes:
measure: Incidence of adverse events and safety signals observed during single and multiple ascending doses of MORF-057 administered orally to healthy adult subjects
timeFrame: Day -1 to Day 28
measure: Maximum Plasma Concentration (Cmax) of MORF-057 in a fed state
timeFrame: Day -1 to Day 28
measure: Time to Reach Cmax (Tmax) of MORF-057 in a fed state
timeFrame: Day -1 to Day 28
Secondary outcomes:
measure: Maximum Plasma Concentration (Cmax) during single and multiple ascending doses of MORF-057
timeFrame: Day -1 to Day 28
measure: Time to Reach Cmax (Tmax) during single and multiple ascending doses of MORF-057
timeFrame: Day -1 to Day 28
measure: Incidence of adverse events and safety signals observed during single dose of MORF-057 administered after a meal to healthy subjects.
timeFrame: Day -1 to Day 28
Other outcomes:
Locations:
city: Cincinnati
country: United States
facility: Medpace
state: Ohio
Study officials:
References:
Clinical trial NCT00149045: Follow up and Observation of Charcot Marie Tooth Disease in Families
Official title: Clinical and Genetic Features of Familial Neuropathy
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Charcot-Marie-Tooth Disease
Keywords: familial peripheral Neuropathy Anticipation
Lead sponsor: Hadassah Medical Organization
Sponsor class: OTHER
First posted: 2005-09-08
Sex: ALL
Minimum age (years): 8
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: DEFINED_POPULATION
Time perspective: OTHER

Brief summary: The study is aimed to test the hypothesis that there is anticipation in CMT


Eligibility criteria: Inclusion Criteria:Patients with Genetically confirmed CMT 1a disease -

Exclusion Criteria:

-

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Jerusalem
country: Israel
facility: Hadassah Medical Organization
Study officials:
affiliation: Hadssah University Hospital, Department of Neurology
name: Israel Steiner, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02647645: Cognitive Training With and Without tDCS to Improve Cognition in HIV
Official title: Cognitive Training With and Without tDCS to Improve Cognition in HIV
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: HIV
Mild Neurocognitive Disorder
Lead sponsor: Nova Southeastern University
Sponsor class: OTHER
First posted: 2016-01-06
Enrollment: 21
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 purpose of this study is to develop pilot data on the potential efficacy of computer-based cognitive training or the combination of computer-based cognitive training with transcranial direct current stimulation (tDCS) in improving cognitive function in persons with HIV-related mild neurocognitive disorder (MND).

Detailed description: The purpose of this study is to develop pilot data on the potential efficacy of computer-based cognitive training or the combination of computer-based cognitive training with transcranial direct current stimulation (tDCS) in improving cognitive function in persons with HIV-related mild neurocognitive disorder (MND). tDCS is a noninvasive brain stimulation technique in which a small direct current (1-2 mA) is applied to the scalp during a cognitive or motor activity, inducing a very small current that affects specific neural circuits related to the site at which electrodes are placed. tDCS has been judged safe and has shown significant treatment effects in studies with other populations, but has not been extensively studied in individuals with HIV infection. tDCS has been shown to facilitate learning in a number of studies, suggesting that it may improve or enhance learning in those with cognitive problems. As HIV infection is associated with decrements in a number of cognitive skills, including working memory, executive functions, and psychomotor speed that are related to individuals' functional status and medication adherence, the demonstration of a technique to enhance the effects of cognitive training in this population would have substantial clinical benefits as well as scientific value.

Eligibility criteria: Inclusion Criteria:

* 18 years of age or older
* Fluent in English
* Meets Frascati criteria for mild neurocognitive disorder

Exclusion Criteria:

* Left handed
* Presence of dementia
* Use of specific psychotropic medications including antidepressants, antipsychotics, and sleep-promoting medications

Primary outcomes:
measure: Working Memory: Participants' Rate of Improvement
timeFrame: 3 weeks
Secondary outcomes:
measure: Center for Epidemiological Studies Depression Scale (CES-D)
timeFrame: 3 weeks
measure: Patient's Own Assessment of Function (PAOF)
timeFrame: 3 weeks
Other outcomes:
Locations:
city: Fort Lauderdale
country: United States
facility: NSU Psychiatry Research Office
state: Florida
Study officials:
affiliation: Nova Southeastern University
name: Raymond L Ownby, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01715545: Availability of Poor Quality Embryos
Official title: Availability of Poor Quality Embryos in Frozen-thawed Embryo Transfer Cycles
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Infertility
Keywords: day-3 poor quality embryo
vitrification
clinical outcome
Lead sponsor: The Second Affiliated Hospital of Kunming Medical University
Sponsor class: OTHER
First posted: 2012-10-29
Enrollment: 481
Sex: FEMALE
Minimum age (years): 20
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: unfertile women

Brief summary: The purpose of this study is to explore a method to identify the viability of day-3 poor quality embryos

Detailed description: Day-3 poor quality embryos are related to significant lower clinical pregnancy,so freezing numerous poor quality embryos are clinical impractical. To ensure the successful pregnancy and to enhance the availability of the poor quality embryos, day-3 poor quality embryos are further cultured to different developmental stage and then cryopreserved. The viability of these embryos are tested in frozen-thawed transfer.

Eligibility criteria: Inclusion Criteria:

* unfertile women

Exclusion Criteria:

* women older than 40 years

Primary outcomes:
measure: pregnancy rate
timeFrame: 5 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Kunming
country: China
facility: The Second Affiliated Hospital of Kunming Medical University
state: Yunnan
Study officials:
affiliation: The Second Affiliated Hospital of Kunming Medical University
name: Jie Yang
role: PRINCIPAL_INVESTIGATOR
References:
citation: (1) Lu LI, Xiao-xi SUN, Jun-ling CHEN, et al. Analysis of Factors Influencing Pregnancy Rate in Frozen-thawed Embryo Transfer. Journal of Reproduction and Contraception (2004) 15 (4):239-244