louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT06000514: Topical Sm29 in Combination With Meglumine Antimoniate in the Treatment of Cutaneous Leishmaniasis.
Official title: Association of Topical Sm29 in Gold Nanoparticles With Intravenous Meglumine Antimoniate in the Treatment of Cutaneous Leishmaniasis Caused by Leishmania Braziliensis: A Randomized Controlled Trial.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
PHASE2
Conditions: Cutaneous Leishmaniasis, American
Keywords: Cutaneous Leishmaniasis
Sm29
L. braziliensis
Lead sponsor: Hospital Universitário Professor Edgard Santos
Sponsor class: OTHER
Collaborators: name: Conselho Nacional de Desenvolvimento Científico e Tecnológico
name: Oswaldo Cruz Foundation
First posted: 2023-08-21
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Randomized and controlled
Primary purpose: TREATMENT

Brief summary: This project is composed of a phase I study with the purpose of evaluating adverse reactions and the best dose to be used of Sm29 and a phase II randomized controlled study with 3 arms with the purpose of comparing the efficacy of meglumine antimoniate associated with Sm29, with meglumine antimoniate plus placebo and meglumine antimoniate alone in the treatment of cutaneous leishmaniasis.

Detailed description: The phase I study was performed in 10 healthy subjects and 10 patients with CL. In healthy individuals (N=5) Sm29 was applied to healthy skin at a concentration of 5ug and in another 5 Sm29 was used at a dose of 10ug applied twice a day for 20 days. A phase I study was also carried out in 10 patients with CL to assess the occurrence of adverse reactions to Sm29 applied to the ulcerated lesion and to compare the use of two doses of Sm29. In 5 patients, Sm29 was used at a dose of 5ug and applied twice a day, and in 10 patients, a dose of 10ug of Sm29 was used, also applied twice a day. The 10 patients were also treated with glucantime at a dose of 20mg/kg/weight with a maximum dose of 1200mg/day intravenously for 20 days. Patients were evaluated on days 10, 20 and 30 for adverse reactions.

Eligibility criteria: Inclusion Criteria:

- Clinical diagnosis of cutaneous leishmaniasis (typical ulcerated lesion); 1 to 2 ulcers; ulcer size ranging from 10-40mm; disease duration between 20-90 days.

Exclusion Criteria:

* Diabetes; Cardiovascular or kidney disease; HIV seropositivity; use of immunosupressive drugs; pregnancy.

Primary outcomes:
measure: Cure
timeFrame: 90 days
Secondary outcomes:
Other outcomes:
Locations:
city: Presidente Tancredo Neves
country: Brazil
facility: Corte de Pedra Health Post
state: Bahia
Study officials:
affiliation: Federal University of Minas Gerais
name: SERGIO C OLIVEIRA, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01902914: Effectiveness of P02 Digital Hearing Aids
Official title: Effectiveness of NECTEC Model, Body-worn, Digital Hearing Aids and Cost of Screening and Hearing Aids Service in Elders
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE1
PHASE2
Conditions: Hearing Loss, Bilateral
Sensorineural Hearing Loss
Keywords: hearing aids
hearing disability
community
hearing aids service
Lead sponsor: Khon Kaen University
Sponsor class: OTHER
First posted: 2013-07-18
Enrollment: 100
Sex: ALL
Minimum age (years): 60
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief summary: To test the effectiveness of body-worn, digital hearing aids, model 02 which is developed by the National Electronics and Computer Technology Center, Thailand.

Detailed description: Hearing aids distribution and service system are limited accessed in hearing disabled people in developing countries. The local-made, body-worn, digital hearing aids is developed by the National Electronics and Computer Technology Center, Thailand. The effectiveness of this model will be compares with other standard body-worn, hearing aids in community elders. The functional gain, quality of sound, customers' satisfaction, and quality of life (EQ-5D, HHIE, HUI-3, IOI-HA) are main outcomes.The cost of Screening and hearing aids will be also investigated. The validity and reliability of several tools used such as the Thai-Hearing Handicap Inventory for elderly (HHIE) questionnaire, Music Test, Thai-Five Minute Hearing Test, and Khon Kaen Hearing Aids Evaluation are also studied.

Eligibility criteria: Inclusion Criteria:

* older than 60 years
* bilateral sensorineural hearing loss
* PTA (0.5-2 KHz) of better ear \> 40 DB but \<75 dB
* no deformity of pinna and ear canal
* new or unexperienced hearing aids user
* can communicate with Thai or local language

Exclusion Criteria:

* speech discrimination \<40%
* suspected of retrocochlear lesion

Primary outcomes:
measure: functional gain
timeFrame: Immediate after hearing aids fitting
Secondary outcomes:
measure: Satisfaction
timeFrame: immediate after hearing aids fitting
Other outcomes:
Locations:
city: Khon Kaen
country: Thailand
facility: Phu Wieng district
Study officials:
affiliation: Khon Kaen University
name: Kwanchanok Yimtae, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Kasemsiri P, Yimtae K, Thanawirattananit P, Israsena P, Noymai A, Laohasiriwong S, Vatanasapt P, Siripaopradith P, Kingkaew P. Effectiveness of a programable body-worn digital hearing aid for older adults in a developing country: a randomized controlled trial with a cross-over design. BMC Geriatr. 2021 Jul 23;21(1):437. doi: 10.1186/s12877-021-02325-4.
Clinical trial NCT00023114: p450 Mediated Lung Toxicity
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Pulmonary Disease
Keywords: lung function
smoking
metabolism
Lead sponsor: National Institute of Environmental Health Sciences (NIEHS)
Sponsor class: NIH
First posted: 2001-08-24
Enrollment: 10
Sex: ALL
Minimum age (years): 0
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no

Brief summary: The purpose of this project is to do cross species comparisons of the metabolism and toxicity of a number of toxicants which require metabolism for toxicity. All of the toxicants in question are encountered by humans in the workplace, through lifestyle choices (cigarette smoking) and as a result of environmental contamination. The high incidence of pulmonary diseases in the human population means that it will be difficult if not impossible to determine whether humans are at risk from exposure to these chemicals without solid mechanistic data. Recent rodent bioassays suggest that these compounds have oncogenic potential further supporting the need to test the potential for injury in primates. As part of this testing, we intend to establish in vitro methods for assessing critical steps in the metabolism of these agents and their interaction with cellular macromolecules. Once this is done, similar studies can be conducted in Rhesus or in human lung tissue that is available because it cannot be used for transplant purposes.


Eligibility criteria: All available organ donors in the Sacramento area

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT06036914: A Study of Ultra High Dose Diuretics to Treat Heart Failure
Official title: Ultra High Dose Diuretic Strategy for Management of Acute Decompensated Heart Failure - A Randomized, Double-Blind Pilot Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Heart Failure; With Decompensation
Lead sponsor: Mayo Clinic
Sponsor class: OTHER
First posted: 2023-09-14
Enrollment: 20
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 determine the safety and effectiveness of ultrahigh dose diuretics compared to standard dose diuretics over 24 hours in patients with decompensated heart failure.


Eligibility criteria: Inclusion Criteria:

* Diagnosis of decompensated heart failure receiving intravenous diuretics
* Ability to provide informed consent

Exclusion Criteria:

* Patients on home inotrope medications
* Patients with Chronic Kidney disease stage V and end stage renal failure on dialysis
* Patients lacking the capacity to consent for themselves
* Known pregnancy or breastfeeding mothers
* Complex congenital heart disease
* Allergy to furosemide or bumetanide
* Respiratory failure requiring non-invasive ventilation (CPAP/BiPAP) or invasive mechanical ventilatory support at the time of randomization
* Hypotension with systolic blood pressure \<80 mm Hg at the time of randomization
* Acute coronary syndrome
* Sustained Ventricular tachycardia requiring treatment in the last 48 hours
* Patients weighing ≤ 40 kg

Primary outcomes:
measure: Urine Output
timeFrame: 24 hours
Secondary outcomes:
measure: Change in Body Weight
timeFrame: Baseline, 24 hours
measure: Change in NT-proBNP
timeFrame: Baseline, 24 hours
measure: Change in Urine Sodium Excretion
timeFrame: Baseline, 24 hours
measure: Change in apnea-hypopnea index
timeFrame: Baseline, 24 hours
measure: Change in Iohexol glomerular filtration rate (GFR)
timeFrame: Baseline, 24 hours
measure: Change in Peripheral Vein Pressure
timeFrame: Baseline, 24 hours
measure: Change in Cardiac Output
timeFrame: Baseline, 24 hours
measure: Change in estimated Right Ventricular (RV) systolic pressure
timeFrame: Baseline, 24 hours
measure: Change in Right Atrial (RA) pressure
timeFrame: Baseline, 24 hours
measure: Change in Left Atrial (LA) strain
timeFrame: Baseline, 24 hours
measure: Change in Left Ventricular (LV) global longitudinal strain
timeFrame: Baseline, 24 hours
measure: Change in Right Ventricular (RV) global longitudinal strain
timeFrame: Baseline, 24 hours
measure: Change in E/e'
timeFrame: Baseline, 24 hours
Other outcomes:
Locations:
city: Rochester
country: United States
facility: Mayo Clinic in Rochester
state: Minnesota
Study officials:
affiliation: Mayo Clinic
name: Yogesh Reddy, M.B.B.S
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05688514: TVMR With the Innovalve System Trial - First In Human Israel
Official title: TVMR With the Innovalve System Trial - First In Human Israel
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Mitral Valve Regurgitation (Degenerative or Functional)
Lead sponsor: Edwards Lifesciences
Sponsor class: INDUSTRY
First posted: 2023-01-18
Enrollment: 1
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: Study to evaluate the safety and performance of the Innovalve mitral valve replacement system

Detailed description: The study is a multi-center, First-In-Human, prospective, single arm early feasibility study to evaluate the safety and performance of the Innovalve mitral valve replacement system

Eligibility criteria: Inclusion Criteria:

* Clinically significant, symptomatic mitral regurgitation
* High risk for open-heart surgery
* Meets anatomical criteria

Exclusion Criteria:

* Unsuitable anatomy
* Patient is inoperable
* EF\<25%

Primary outcomes:
measure: Absence of implant or delivery related serious adverse events at 30 days
timeFrame: 30 days
Secondary outcomes:
measure: Technical success
timeFrame: Procedure
measure: Procedural success
timeFrame: 30 days
measure: NYHA functional class
timeFrame: 30 days, 6, 12 months and annually up to 5 years
measure: Six-minute walk test
timeFrame: 30 days, 6, 12 months and annually up to 5 years
measure: Quality of life improvement (KCCQ-12) Kensas City Cardiomyopathy Questionnaire
timeFrame: 30 days, 6, 12 months and annually up to 5 years
measure: Reduction in Mitral Regurgitation grade
timeFrame: 30 days, 6, 12 months and annually up to 5 years
Other outcomes:
Locations:
city: Ramat Gan
country: Israel
facility: The Chaim Sheba Medical Center
Study officials:
References:
Clinical trial NCT05321914: Resistance Exercise, Metabolism and Time of Day
Official title: The Impact of the Time of Day on Metabolic Responses to Resistance Exercise in Adults Who Are Obese or Overweight: a Randomised Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Metabolic Disease
Keywords: exercise
muscle
metabolism
circadian
Lead sponsor: University of Glasgow
Sponsor class: OTHER
First posted: 2022-04-11
Enrollment: 36
Sex: ALL
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: BASIC_SCIENCE

Brief summary: The aim of the current study is to determine the effect of time of day on the muscle and metabolic responses to resistance exercises in obese or overweight adults. To achieve this aim we have the following objectives:

1. Compare the effects of resistance exercise training performed in the morning vs the evening on insulin sensitivity
2. Compare the effects of resistance exercise training performed in the morning vs the evening on gains in muscle mass and strength
3. Compare the acute glucose responses to resistance exercise performed in the morning vs the evening


Eligibility criteria: Inclusion Criteria:

* pass the physical activity readiness questionnaire
* body mass index (BMI) \>27kg/m² and limited to 40 kg/m².

Exclusion Criteria:

* Prior surgery for weight loss
* Prior history of heart, lung, cancer, endocrine or liver disease
* Participating in more than 1 hour structured exercise training per week

Primary outcomes:
measure: Change in insulin sensitivity
timeFrame: Change from baseline to 6 weeks
Secondary outcomes:
measure: Change in vastus lateralis muscle thickness
timeFrame: Change from baseline to 6 weeks
measure: Change in whole body lean mass
timeFrame: Change from baseline to 6 weeks
measure: Change in whole body fat mass
timeFrame: Change from baseline to 6 weeks
measure: Change in one-repetition maximum muscle strength
timeFrame: Change from baseline to 6 weeks
measure: Change in knee extensor maximal isometric torque
timeFrame: Change from baseline to 6 weeks
measure: Change in grip strength
timeFrame: Change from baseline to 6 weeks
measure: Change in mean glucose levels
timeFrame: Change from baseline to 6 weeks
measure: Change in glucose variability
timeFrame: Change from baseline to 6 weeks
Other outcomes:
Locations:
city: Glasgow
country: United Kingdom
facility: Stuart Robert Gray
Study officials:
References:
Clinical trial NCT04402814: IgG/IgM Antibody Test in Patients Who Have Tested Negative or Positive for COVID-19 With the Standard Method of COVID19 Testing.
Official title: Evaluation and Correlation of SARS-Cov2 Virus IgG/IgM Rapid Test Cassette Clungene Test With the Standard Method of COVID19 Testing in Inpatients With or Without COVID19
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: SARS-CoV 2
Keywords: Coronavirus
COVID-19
Clungene
IgG/IgM antibodies
Lead sponsor: Sharp HealthCare
Sponsor class: OTHER
First posted: 2020-05-27
Enrollment: 90
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: Hospitalized (or recently discharged) subjects who have been previously tested for COVID-19 with the standard method of testing.

Brief summary: The purpose of this study is to evaluate point of care SARS-Cov2 Virus IgG/IgM rapid test cassette Clungene test and correlate it with the standard method of testing in inpatients who have tested positive or negative for COVID19.

Detailed description: This is a laboratory testing study using the SARS-Cov2 Virus IgG/IgM rapid test cassette Clungene test to determine the presence of IgM and IgG antibodies in subjects who have tested negative or positive for COVID-19. The study is observational and subjects will be assigned to one of two arms depending on the results of their nCOVID-19 test.

Eligibility criteria: Inclusion Criteria:

* Received confirmed COVID-19 positive or negative test from Sharp HealthCare's standard method of testing.
* Age \>/=18 years old.
* Access to a phone in the hospital room or an electronic device that is capable of receiving phone calls and/or video calls and/or e-mail.
* Able to read/write/speak English or Spanish fluently.
* Subjects must have the ability to understand the requirements of the study, provide informed consent, and provide authorization of use and disclosure of personal health information.
* Hospitalized at the time of consent or recently discharged with leftover blood stored at hospital laboratory

Exclusion Criteria:

* Impaired cognitive or decision-making capacity (based on the clinical judgment of the PI or designee)

Primary outcomes:
measure: IgG/IgM antibodies
timeFrame: from date of consent to date of test completion, up to 40 days
Secondary outcomes:
Other outcomes:
Locations:
city: La Mesa
country: United States
facility: Fadi A. Haddad MD Inc.
state: California
city: La Mesa
country: United States
facility: Sharp Grossmont Hospital
state: California
city: San Diego
country: United States
facility: Sharp Memorial Hosptial
state: California
Study officials:
affiliation: Sharp HealthCare
name: Fadi Haddad, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00354614: Validation of the ApneaLink Sleep Screener for Obstructive Sleep Apnea (OSA)
Official title: Validation of the ApneaLink Sleep Screener in a Suspected Sleep Disordered Breathing Population
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Obstructive Sleep Apnea
Lead sponsor: ResMed
Sponsor class: INDUSTRY
First posted: 2006-07-20
Enrollment: 81
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Pts. with suspected OSA.

Brief summary: The primary endpoints for this study are that the AL validation will 1) achieve a sensitivity of greater than 80% for AHI values greater than or equal to 15, and 2) demonstrate a correlation coefficient of r=0.75 indicating strong correlation between the AHI of diagnostic PSG and AL.

Detailed description: All subjects with suspected Sleep Disordered Breathing (SDB) scheduled for diagnostic polysomnography (PSG) will be invited to participate in the study to be tested to determine if they have Sleep Disordered Breathing (SDB), using the ApneaLink (AL) Sleep Screener. Subjects initially will be tested for SDB in the home environment. Following an AL home test, subjects will undergo a simultaneous, attended diagnostic polysomnography (PSG) sleep study and ApneaLink test for the purpose of confirming and comparing the results between diagnostic PSG and the AL device.

Eligibility criteria: Inclusion Criteria:

* Adult subjects ( greater than 18 years of age) of either gender or any race
* Suspected sleep disordered breathing
* Untreated sleep disordered breathing
* Willingness to use AL at home within 2 days of receipt and instruction on the AL
* Willingness to use AL at home and undergo PSG within 2 to 4 weeks of completing the at home AL test

Exclusion Criteria:

* Any subject requiring home oxygen therapy
* Any subject currently receiving positive airway pressure therapy

Primary outcomes:
measure: Sensitivity and Specificity
timeFrame: Simultaneous single night recording
Secondary outcomes:
Other outcomes:
Locations:
city: Pittsburgh
country: United States
facility: University of Pittsburgh Medical Center
state: Pennsylvania
Study officials:
affiliation: Associate Professor of medicine and Medical Director, UPMC Sleep Medicine
name: Patrick J Strollo, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Oktay B, Rice TB, Atwood CW Jr, Passero M Jr, Gupta N, Givelber R, Drumheller OJ, Houck P, Gordon N, Strollo PJ Jr. Evaluation of a single-channel portable monitor for the diagnosis of obstructive sleep apnea. J Clin Sleep Med. 2011 Aug 15;7(4):384-90. doi: 10.5664/JCSM.1196.
Clinical trial NCT01298414: Biomarkers in Bone Marrow Samples From Young Patients With Acute Myeloid Leukemia
Official title: Pediatric Myeloid Leukemia-Specific miRNA Expression Profiles Induced by the Leukemic Stem Cell Niche
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Leukemia
Keywords: childhood acute myeloid leukemia/other myeloid malignancies
Lead sponsor: Children's Oncology Group
Sponsor class: NETWORK
Collaborators: name: National Cancer Institute (NCI)
First posted: 2011-02-17
Enrollment: 20
Sex: ALL
Maximum age (years): 30
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Diagnosis of acute myeloid leukemia

Brief summary: RATIONALE: Studying samples of bone marrow from patients with cancer in the laboratory may help doctors identify and learn more about biomarkers related to cancer.

PURPOSE: This research study is looking at biomarkers in bone marrow samples from young patients with acute myeloid leukemia.

Detailed description: OBJECTIVES:

* To study the effect of niche mesenchymal stromal cells (MSC) exposure on microRNAs (miR) expression in pediatric AML at different time points and compare those profiles to the miR profiles at baseline.
* To focus on four pediatric AML-specific miRs (miR34a, miR538e, miR193e, and miR198) which show the most significant differential expression after in vivo niche exposure at four months (hematogenous spread).
* To determine whether altered miR expression reflects or causes the metastatic invasion pattern of AML.

OUTLINE: Bone marrow-derived mesenchymal stromal cell (MSC) samples are implanted subcutaneously in NOD/SCID mice. Cells are then harvested at day 0, 1 month, and 4 months post-implantation. miRNA is isolated and analyzed by Ilumina MicroRNA Expression Profiling single Beadchip. The obtained data is then analyzed by the Illumina Genome Studio Analysis Software.

Eligibility criteria: DISEASE CHARACTERISTICS:

* Diagnosis of acute myeloid leukemia
* Fresh human bone marrow samples obtained from orthopedic surgery at the Tissue Donation Program of The Feinstein Institute and the Children Oncology Group (COG) Myeloid Disease Biorepository

PATIENT CHARACTERISTICS:

* Not specified

PRIOR CONCURRENT THERAPY:

* Not specified

Primary outcomes:
measure: miR expression patterns in pediatric AML are regulated by the niche MSC-associated microenvironment
measure: Exposure of AML cells to the niche MSCs generate changes in pediatric AML miR expression profiles
measure: Correlation between changes in pediatric AML miR expression profiles and changes in biological behavior of AML cells (dormant versus invasive)
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: Feinstein Institute for Medical Research
name: Sarah R.I. Vaiselbuh, MD
role: PRINCIPAL_INVESTIGATOR
References: