louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT00382941: Study of LED Phototherapy for Musculoligamentous Lesions
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Tendinopathy
Sprains and Strains
Muscle Spasm
Epicondylitis
Fasciitis
Lead sponsor: Hermano Miguel Foundation
Sponsor class: OTHER
First posted: 2006-10-02
Sex: ALL
Minimum age (years): 16
Standard ages: CHILD
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 whether LED phototherapy using combined red and near infrared light (approved: Ministry of Health of Russian Federation No. 29/06070997/1080-00, EUROCAT Certificate No. CP033321-IV) is effective in the treatment of musculoligamentous lesions in physiotherapy practice


Eligibility criteria: Inclusion Criteria:

* Clinical diagnosis of acute or chronic musculoligamentous lesion
* Must be able to understand instructions and fill in auto administered questionnaires
* Informed consent

Exclusion Criteria:

* Use of oral corticosteroids or corticosteroid injections
* Systemic diseases
* General contraindications for phototherapy

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Quito
country: Ecuador
facility: CAID, Hermano Miguel Foundation
state: Pichincha
city: Quito
country: Ecuador
facility: Health Service, UDV Quito Centro Occidente, National Police of Ecuador
state: Pichincha
city: Quito
country: Ecuador
facility: Rehabilitation Department, A.B.E.I. Foundation
state: Pichincha
Study officials:
affiliation: Hermano Miguel Foundation
name: Sergiy Voznesenskyy, PhD, BPT
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04254341: Dilator Muscle Activity in Health and Sleep Apnea
Official title: Upper Airway Dilator Muscle Activity in Healthy Subjects and Patients With Obstructive Sleep Apnea During Wakefulness and Sleep
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Obstructive Sleep Apnea
Lead sponsor: Bnai Zion Medical Center
Sponsor class: OTHER_GOV
First posted: 2020-02-05
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: OTHER
Sampling method: NON_PROBABILITY_SAMPLE
Study population: adult subjects with and without sleep apnea

Brief summary: The role of control of peri-pharyngeal muscle tone in the pathogenesis of obstructive sleep apnea (OSA) is obvious: pharyngeal obstruction occurs only during sleep; and pharyngeal collapse occurs in almost all healthy subjects during anesthesia. Better understanding of these control mechanisms may help identifying the central components of the pathogenesis of OSA.

Detailed description: Study plan: Subjects will be studied first during wakefulness, while breathing against external resistors, to evaluate how are the peri-pharyngeal muscles recruited and activated to prevent pharyngeal collapse in the presence of negative intra-pharyngeal pressures. Thereafter, the same parameters will be evaluated during sleep, to assess muscle recruitment during intra-pharyngeal obstruction. The investigaors will record the electromyogram (EMG) of several dilator muscles, as well as the pressures above and below the area of pharyngeal collapse, and airflow.

Eligibility criteria: Inclusion Criteria:

1. subjects that underwent regular sleep studies and found to have either moderate/severe OSA, or no OSA.

-

Exclusion Criteria:

1. hemophilia
2. use of anti-coagulants -

Primary outcomes:
measure: EMG activity of peri-pharyngeal muscles during wakefulness and sleep
timeFrame: 4 hours
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: Bnai Zion
name: Arie Oliven, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Dotan Y, Pillar G, Schwartz AR, Oliven A. Asynchrony of lingual muscle recruitment during sleep in obstructive sleep apnea. J Appl Physiol (1985). 2015 Jun 15;118(12):1516-24. doi: 10.1152/japplphysiol.00937.2014. Epub 2015 Mar 26.
citation: Dotan Y, Pillar G, Tov N, Oliven R, Steinfeld U, Gaitini L, Odeh M, Schwartz AR, Oliven A. Dissociation of electromyogram and mechanical response in sleep apnoea during propofol anaesthesia. Eur Respir J. 2013 Jan;41(1):74-84. doi: 10.1183/09031936.00159611. Epub 2012 May 3.
Clinical trial NCT02169141: Pharmacokinetics of Levofloxacin and Capreomycin in Multidrug-Resistant Tuberculosis Patients
Official title: Pharmacokinetics of Levofloxacin and Capreomycin in MDR-TB Patients
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Tuberculosis
Keywords: pharmacokinetics
pharmacodynamics
MDR-TB
Levofloxacin
Capreomycin
Lead sponsor: University Medical Center Groningen
Sponsor class: OTHER
Collaborators: name: Republican Scientific and Practical Centre for Pulmonology and TB
name: National Institute for Public Health and the Environment (RIVM)
First posted: 2014-06-23
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: MDR-TB patients

Brief summary: This is an open label observational pharmacokinetic drug study to evaluate Levofloxacine and Capreomycin in patients with Multidrug-Resistant Tuberculosis (MDR-TB).

Detailed description: Patients receive MDR-TB treatment with o.a. Levofloxacin and Capreomycin. At least one week after start of treatment, the PK samples samples will be obtained via an intravenous catheter at 0, 1, 2, 3, 4, 7, and 12 hours after intake.

Eligibility criteria: Inclusion Criteria:

* age\> 18yrs
* culture positive
* diagnosis of MDR-TB

Exclusion Criteria:

* DM2
* Pregnancy
* allergy to IV canula material
* insertion of IV canula not possibele

Primary outcomes:
measure: AUC/MIC ratio of Levofloxacin
timeFrame: after day 8 of treatment
measure: Cmax/MIC ratio of Capreomycin
timeFrame: after day 8 of treatment
Secondary outcomes:
measure: Volume of Distribution
timeFrame: after day 8 of treatment
measure: Clearance
timeFrame: after day 8 of treatment
Other outcomes:
measure: PK-model
timeFrame: after day 8 of treatment
measure: Limited sampling strategy
timeFrame: after day 8 of treatment
Locations:
city: Minsk
country: Belarus
facility: Republican Scientific and Practical Center for TB and Pulmonology
Study officials:
affiliation: UMCG
name: JW C Alffenaar, PhD PharmD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Van't Boveneind-Vrubleuskaya N, Seuruk T, van Hateren K, van der Laan T, Kosterink JGW, van der Werf TS, van Soolingen D, van den Hof S, Skrahina A, Alffenaar JC. Pharmacokinetics of Levofloxacin in Multidrug- and Extensively Drug-Resistant Tuberculosis Patients. Antimicrob Agents Chemother. 2017 Jul 25;61(8):e00343-17. doi: 10.1128/AAC.00343-17. Print 2017 Aug.
citation: Velasquez AMA, Ribeiro WC, Venn V, Castelli S, Camargo MS, de Assis RP, de Souza RA, Ribeiro AR, Passalacqua TG, da Rosa JA, Baviera AM, Mauro AE, Desideri A, Almeida-Amaral EE, Graminha MAS. Efficacy of a Binuclear Cyclopalladated Compound Therapy for Cutaneous Leishmaniasis in the Murine Model of Infection with Leishmania amazonensis and Its Inhibitory Effect on Topoisomerase 1B. Antimicrob Agents Chemother. 2017 Jul 25;61(8):e00688-17. doi: 10.1128/AAC.00688-17. Print 2017 Aug.
Clinical trial NCT00620841: Gene Polymorphisms in Tacrolimus Drug Interactions
Official title: Gene Polymorphisms in Tacrolimus Drug Interactions in Renal Transplant Patients
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Renal Transplantation
Keywords: Tacrolimus
Renal Transplantation
genetic polymorphisms
Drug drug interactions
Lead sponsor: KU Leuven
Sponsor class: OTHER
Collaborators: name: Fund for Scientific Research, Flanders, Belgium
First posted: 2008-02-22
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Renal transplant recipients treated with a calcineurin-inhibitor

Brief summary: A retrospective analysis of the influence of gene polymorphisms on drug interactions between calcineurin-inhibitors and concomitant drugs in renal transplant patients.


Eligibility criteria: Inclusion Criteria:

* Treatment with calcineurin-inhibitor
* Renal transplantation

Exclusion Criteria:

* Drug, alcohol addiction

Primary outcomes:
measure: Tacrolimus exposure parameters
timeFrame: weeks
Secondary outcomes:
measure: Tacrolimus daily dosing
timeFrame: weeks
Other outcomes:
Locations:
city: Leuven
country: Belgium
facility: University Hospitals Leuven
state: Brabant
Study officials:
affiliation: Universitaire Ziekenhuizen KU Leuven
name: Dirk R Kuypers, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03864341: ED-Home Pilot Study
Official title: ED-Home: A Pilot Feasibility Study of a Homelessness Prevention Intervention for Substance Using Emergency Department Patients
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Housing Problems
Drug Use
Alcohol; Use, Problem
Lead sponsor: NYU Langone Health
Sponsor class: OTHER
Collaborators: name: National Institute on Drug Abuse (NIDA)
First posted: 2019-03-06
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Maximum age (years): 99
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief summary: This is a single-arm pilot study to test the feasibility of homelessness prevention and substance use interventions to be delivered to at-risk patients in the Bellevue Hospital emergency department (ED). ED patients (n=40) found eligible for the study will complete a baseline assessment and receive referrals to appropriate services, with a final six-month follow-up assessment.

Detailed description: ED patients found eligible for the study will complete a baseline survey and receive one-time, in person services at the time of the baseline/enrollment ED visit including referrals to homelessness prevention and substance use services, with a final six-month follow-up survey. Interim contacts at 7-10 days, 3 months, and 5 months will be used to assure intervention components were received and to confirm participant contact information.

Eligibility criteria: Inclusion Criteria:

* Be a patient in the Bellevue Hospital Center ED.
* Be ≥18 years old.
* Screen positive for homelessness risk using a homelessness risk screening tool (HRST).
* Screen positive for unhealthy alcohol or drug use.
* Able to provide consent.

Exclusion Criteria:

* Medically (e.g., critically ill) or psychiatrically unstable.
* Unable to provide informed consent for other reason (e.g., cognitive deficit, profound intoxication).
* Incarcerated or in police custody.
* Unable to understand and speak English.
* Lives outside NYC and/or cannot give a NYC ZIP code.
* Already homeless (residing in a shelter or on the streets).
* Does not have a telephone where can be reached for follow-up.
* Has already received specialized peer navigator/addiction social worker services during current ED visit.
* Has already participated in the study.

Primary outcomes:
measure: Percentage of Potential Participants Approached Who Were Eligible for the Study
timeFrame: Month 6
measure: Percentage of Eligible Participants Who Agreed to Participate in the Study
timeFrame: Month 6
measure: Number of Participants Who Received Referrals for Homelessness Prevention and/or Substance Use Services
timeFrame: Month 6
Secondary outcomes:
Other outcomes:
Locations:
city: New York
country: United States
facility: New York University School of Medicine
state: New York
Study officials:
affiliation: New York Langone Medical Center
name: Kelly Doran, MD, MHS
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02602041: Knowledge and Attitudes Regarding Healthy Lifestyle and Health Behavior Change in Cancer Patients and Their Partners; A Pilot Study
Official title: Knowledge and Attitudes Regarding Healthy Lifestyle and Health Behavior Change in Cancer Patients and Their Partners
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Breast Cancer
Testicular Cancer
Lead sponsor: University Medical Center Groningen
Sponsor class: OTHER
First posted: 2015-11-11
Enrollment: 38
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: The investigators will invite 10 women with early stage breast cancer (BC) and 10 men with disseminated testicular cancer (TC) and their partners (20 couples in total).

Brief summary: The investigators will perform a pilot study to gain insight into attitudes, barriers and facilitators for health behavior change in cancer patients and their partners. Results of this pilot will be used to design suitable questionnaires to investigate health behavior change in a larger cohort of patients and their partners. It will also direct future interventions to adequately target patients and, potentially, their partners to improve their lifestyle following a cancer diagnosis.

Detailed description: The investigators will perform semi-structured interviews with cancer patients and their partners in order to explore knowledge, attitudes, barriers and facilitators regarding health behavior change following cancer treatment.

Eligibility criteria: Inclusion Criteria:

* between 18 and 65 years of age
* have completed adjuvant or curative chemotherapy (in BC and TC patients, respectively) or started adjuvant hormonal therapy alone (in BC patients) between 6 and 24 months previously
* have no signs or symptoms of recurrent disease
* be in follow-up at the Department of Medical Oncology of the UMCG.

Exclusion Criteria:

* signs or symptoms of recurrent disease
* mental disability

Primary outcomes:
measure: Gain insight into barriers and facilitators for health behavior change
timeFrame: 12 months
Secondary outcomes:
Other outcomes:
Locations:
city: Groningen
country: Netherlands
facility: University Medical Center Groningen
Study officials:
affiliation: University Medical Center Groningen
name: J. Nuver, MD, PHD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06421441: The Effect of Self-Management Skills Training Given to Nursing Students According to Peer Education Module on Problematic Internet Use and Academic Procrastination Behavior
Official title: The Effect of Self-Management Skills Training Given to Nursing Students According to Peer Education Module on Problematic Internet Use and Academic Procrastination Behavior
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Problem Behavior
Problematic Internet Use
Academic Procrastination Behavior
Lead sponsor: Istanbul Aydın University
Sponsor class: OTHER
Collaborators: name: The Scientific and Technological Research Council of Turkey
First posted: 2024-05-20
Enrollment: 175
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Group 1: Experimental group (Education group) Goup 2: Control group
Primary purpose: OTHER

Brief summary: The aim of the study is to evaluate the effect of self-management skills training given with the peer education module on the problematic internet use and academic procrastination behavior of nursing students. .

Detailed description: A total of 12 hours of self-management skills training will be given to the peer groups, two days a week for three weeks, two lesson hours a day (60 min. + 60 min.).The effect of self-management skills training on problematic internet use and academic procrastination behavior of nursing students will be evaluated.

Eligibility criteria: Research Inclusion Criteria;

* Being 18 years or older,
* Volunteering to participate in the study,
* Using the internet for an average of 2 hours or more per day,
* Not having any communication problems,
* To continue self-management skills training.

Criteria for Exclusion from the Research;

* Having any communication barrier,
* Not continuing self-management skills training.

Primary outcomes:
measure: Problematic Internet Use Scale
timeFrame: Before training, immediately in the first and third months after training
measure: Academic Procrastination Scale
timeFrame: Before training, immediately in the first and third months after training.
Secondary outcomes:
Other outcomes:
Locations:
city: Istanbul
country: Turkey
facility: Istanbul Aydın Üniversity
Study officials:
References:
Clinical trial NCT06336941: "Ultra-High Frequency intraOral UltraSonography of the TONgue" (HOUSTON)
Official title: Intraoral Ultra-High Frequency Ultrasound of Oral Soft Tissue Lesions
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Oral Squamous Cell Carcinoma
Keywords: oral neoplasm
ultrasonography
depth of invasion
Lead sponsor: University of Pisa
Sponsor class: OTHER
First posted: 2024-03-29
Enrollment: 400
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

Brief summary: Oral diseases are currently diagnosed by means of clinical examination and supported by surgical biopsy procedures. In particular, daily oral medicine practice is lacking the use of a routine diagnostic support to the visualization of anatomical structures located beyond the mucosal surface. Considering the growing interest in minimally invasive diagnosis, the possibility of having an imaging technique dedicated to the investigation of oral soft tissues and their alterations may be instrumental to support the clinical diagnosis. Therefore, attempts to introduce conventional ultrasonography (US) to the diagnostic work-up of pathological conditions of the head and neck have been done, exploiting the unique features of this technique in terms of limited invasive- ness, repeatability, and cost efficiency.

In the literature, both extraoral and intraoral applications of US have been reported. Extraoral applications mainly focus on the characterization of oral and maxillofacial swellings of various origin, while intraoral applications mostly involve the study of malignant lesions in terms of tumor thickness and depth of invasion. The aim of the present protocol is to evaluate the role of intraoral ultra-high frequency ultrasonography in the study of oral mucosal lesions.


Eligibility criteria: Inclusion Criteria:

* Clinical diagnosis of oral squamous cell carcinoma
* Eligibility for surgical treatment
* Acceptance to be included in the study

Exclusion Criteria:

* Oral lesions other than oral squamous cell carcinoma
* Pregnant or breastfeeding patients
* Uncontrolled chronic diseases and/or conditions hindering the participation in the study
* Denial of inclusion in the study

Primary outcomes:
measure: Depth of invasion
timeFrame: measured preoperatively
Secondary outcomes:
Other outcomes:
Locations:
city: Pisa
country: Italy
facility: Università di Pisa
Study officials:
References:
Clinical trial NCT03543241: MyoStrain CMR Testing of Ischemia With Low Levels of Stress
Official title: MyoStrain CMR Testing of Ischemia With Low Levels of Stress
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Coronary Artery Disease
Myocardial Ischemia
Myocardial Dysfunction
Keywords: Strain
Lead sponsor: Myocardial Solutions
Sponsor class: INDUSTRY
First posted: 2018-06-01
Enrollment: 13
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients with known or suspected coronary artery disease scheduled for cardiac catheterization.

Brief summary: This prospective, observational study evaluates the accuracy of stress testing with the MyoStrain SENC CMR Imaging System to detect myocardial ischemia and viability in patients with suspected coronary artery disease using low levels of stress.

Detailed description: This prospective, single center study evaluates the MyoStrain SENC CMR Imaging System for the detection of myocardial ischemia and viability during conventional Cardiac Magnetic Resonance (CMR) wall motion stress testing. Patients with known or suspected coronary artery disease and scheduled for cardiac catheterization will be consented for inclusion in the study and evaluated during stress testing with low dose Dobutamine as the stressor agent. Data obtained with the MyoStrain SENC CMR Imaging System will be for observational purposes and will not be used to alter patient management.

Eligibility criteria: Inclusion Criteria:

* Known or suspected Coronary Artery Disease
* Symptoms potentially due to CAD; stable angina
* Positive imaging stress test or negative stress test but typical angina or anginal equivalent
* Negative Troponin with unstable angina
* Invasive coronary angiography planned within 3 months of CMR
* Provided written consent

Exclusion Criteria:

* Pregnancy
* Contraindication to Magnetic Resonance Imaging
* Prior allergy to Dobutamine
* Severe aortic stenosis
* Hypertrophic Cardiomyopathy
* Clinically significant Ventricular Tachycardia that would prohibit Dobutamine administration

Primary outcomes:
measure: Sensitivity of Ischemic CAD Detection
timeFrame: Up to coronary angiography within 1 month of standard CMR stress testing
Secondary outcomes:
measure: Specificity of Ischemic CAD Detection
timeFrame: Up to coronary angiography within 1 month of standard CMR stress testing
Other outcomes:
Locations:
city: Raleigh
country: United States
facility: WakeMed
state: North Carolina
Study officials:
affiliation: WakeMed Health and Hospitals
name: Frances Wood, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00442741: Evaluate the Effects of Patupilone on the Pharmacokinetics of Midazolam and Omeprazole in Patients With Advanced Malignancies (Extension)
Official title: An Open Label Phase I Study to Evaluate the Effects of Patupilone on the Pharmacokinetics of Midazolam and Omeprazole in Patients With Advanced Malignancies (Extension)
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: PHASE1
Conditions: Solid Tumors
Keywords: Cancer
EPO906
Patupilone
Lead sponsor: Novartis
Sponsor class: INDUSTRY
First posted: 2007-03-02
Enrollment: 0
Sex: ALL
Minimum age (years): 18
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 extension study is to evaluate the potential inhibitory effects of patupilone on metabolism using midazolam and omeprazole as the respective probe drugs.


Eligibility criteria: Inclusion criteria:

* Male or female patients 18 years or older
* Histologically documented advanced solid tumor, who have failed standard systemic therapy, or for whom standard systemic therapy does not exist
* Completed the Core study
* Completed all sampling in the core and not dose reduced Patients with adequate hematologic parameters

Exclusion criteria:

* Female patients who are pregnant or breast-feeding.
* Patients with a severe and/or uncontrolled medical disease
* Patients with a known diagnosis of human immunodeficiency virus (HIV) infection
* Patients having received an investigational agent within 30 days prior to study entry

Other protocol-defined inclusion/exclusion criteria may apply

Primary outcomes:
measure: To evaluate the safety, tolerability and potential activity of patupilone once every 21 days in patients that completed the core study
Secondary outcomes:
measure: Assessment of objective response and tumor evaluation will be based on the response evaluation criteria in solid tumors (RECIST)
Other outcomes:
Locations:
Study officials:
affiliation: Novartis Pharmaceuticals
name: Novartis Pharmaceuticals
role: STUDY_DIRECTOR
References: