louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT06087536: A Clinical Trial to Assess the Safety and PK of OMN6 in HABP or VABP Caused by Acinetobacter Baumannii Complex
Official title: A Prospective, Multinational, Multicenter, Randomized, Sequential, Double-blind, Placebo-controlled, Phase 2a Clinical Trial to Assess the Safety and Pharmacokinetics of OMN6 in HABP or VABP Caused by Acinetobacter Baumannii Complex (ABC).
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE2
Conditions: Hospital-acquired Bacterial Pneumonia
Ventilator-associated Bacterial Pneumonia
Keywords: HABP VABP ABC Acinetobacter baumannii pneumonia
Lead sponsor: Omnix Medical Ltd
Sponsor class: INDUSTRY
First posted: 2023-10-17
Enrollment: 54
Sex: ALL
Minimum age (years): 18
Maximum age (years): 99
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: SEQUENTIAL
Primary purpose: TREATMENT

Brief summary: This is a phase 2a, multinational, multicenter, double-blind, randomized, placebo-controlled, dose-ranging safety, tolerability and PK study in patients with HABP (Hospital Acquired Bacterial Pneumonia) or VABP (Ventilator Associated Bacterial Pneumonia) caused by ABC to identify safe and well-tolerated doses and to assess the PK profile of OMN6 in patients.


Eligibility criteria: Inclusion Criteria:

1. A signed informed consent form.
2. Male or female patients 18 years or older
3. A diagnosis of either a HABP or a VABP
4. ABC infection of the lower respiratory tract suspected based on a positive rapid testing of respiratory specimens
5. Women of childbearing potential (WOCBP) (i.e., not post-menopausal or surgically sterilized) must have a negative highly sensitive urine or serum pregnancy test before randomization.
6. Acute Physiology and Chronic Health Evaluation II (APACHE II) score between 10 and 24

Exclusion Criteria:

1. Moderate to severe reduction of renal function
2. Liver dysfunction
3. Evidence of septic shock
4. Acute respiratory distress syndrome.
5. Immunosuppressed patients (due to either immunosuppressant drugs or to any medical condition).
6. History of any known hypersensitivity to colistin or to carbapenems
7. Any condition or circumstance that, in the opinion of the investigator, would compromise the safety of the patient or the quality of the study data

Primary outcomes:
measure: To assess the safety of a single-day treatment with OMN6 vs. matching placebo when coadministered with a background therapy of meropenem and colistin
timeFrame: 28 day
measure: To asses the Cmax of OMN6 in patient population
timeFrame: 1 day
measure: To assess the Tmax of OMN6 in patient population
timeFrame: 1 day
measure: To assess the AUC of OMN6 in patient population
timeFrame: 1 day
measure: To assess the t1/2 of OMN6 in patient population
timeFrame: 1 day
Secondary outcomes:
Other outcomes:
Locations:
city: Be'er Ya'akov
country: Israel
facility: Omnix Medical Research Site
city: Holon
country: Israel
facility: Omnix Medical Research Site
city: Petah Tikva
country: Israel
facility: Omnix Medical Research Site
city: Rishon LeTsiyon
country: Israel
facility: Omnix Medical Research Site
Study officials:
References:
Clinical trial NCT05265936: Is it Safe to Advance a Guidewire Through a Previously Placed Double j Stent?
Official title: Is it Safe to Advance a Guidewire Through a Previously Deployed Double j Stent? A Prospective, Randomized, Controlled Study
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Kidney Stone
Ureter Obstruction
Stent Complication
Keywords: double j stent
guidewire
infection
Lead sponsor: Ankara Training and Research Hospital
Sponsor class: OTHER
First posted: 2022-03-04
Enrollment: 88
Sex: ALL
Minimum age (years): 18
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: In this prospective randomized controlled study, it is aimed to investigate the effects of guidewire advanced through a previously placed double j stent on postoperative complications, operation time and efficacy.


Eligibility criteria: Inclusion Criteria:

* Double J stent placed at least 2 weeks ago

Exclusion Criteria:

* Active urinary tract infection

Primary outcomes:
measure: Rate of postoperative complication
timeFrame: 3 months
Secondary outcomes:
Other outcomes:
Locations:
city: Ankara
country: Turkey
facility: Ankara Training and Research Hospital
state: Altindag
Study officials:
affiliation: Ankara Training and Resarch Hospital
name: Ali Kaan Yildiz
role: PRINCIPAL_INVESTIGATOR
References:
citation: Leslie SW, Sajjad H. Double J Placement Methods Comparative Analysis. 2023 May 30. In: StatPearls [Internet]. Treasure Island (FL): StatPearls Publishing; 2025 Jan-. Available from http://www.ncbi.nlm.nih.gov/books/NBK482453/
Clinical trial NCT00589836: Assessment of Left Ventricular Torsion by Echocardiography Study
Official title: Assessment of LV Torsion by Tissue Doppler Echocardiography
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Hypertrophic Cardiomyopathy
Keywords: HCM
HOCM
hypertrophic cardiomyopathy
tissue doppler echocardiography
myocardial torsion
Lead sponsor: The Cleveland Clinic
Sponsor class: OTHER
First posted: 2008-01-10
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients undergoing cardiac echocardiography testing in the outpatient department

Brief summary: The purpose of this study is to learn about the twisting or wringing motion of the heartbeat called Left Ventricular Torsion (LV Torsion) which can be seen on ultrasound.

Detailed description: This study is designed to characterize the myocardial torsional behavior in patients with a variety of cardiac pathologies.

Simple and inexpensive methods for measurement of LV torsion could facilitate more widespread investigation of LV torsion, which might reveal significant relationships between torsional alterations and clinical outcomes and eventually lead to routine clinical application. Recently, Doppler tissue imaging (DTI) has been shown to accurately reflect myocardial velocity24,25 with better temporal resolution than MRI.26 Investigators hypothesize therefore that DTI might be used for quantification of LV rotation and torsion of the human heart. The purpose of the present study was to examine the accuracy of a novel method with DTI for quantifying the LV torsion in humans and tagged MRI as the reference standard.

Eligibility criteria: Inclusion Criteria:

* Male and female patients age 18 to 70 years
* Patients with hypertrophic cardiomyopathy
* Patients with the ability to exercise using a supine bicycle
* Ability to provide informed consent

Exclusion Criteria:

* Aortic valve stenosis classified as moderate to severe
* Severe left ventricular obstruction at rest (high gradients \> 4m/second)
* Uncontrolled arrhythmias including atrial fibrillation, atrial flutter, frequent premature ventricular ectopic beats
* History of sustained ventricular tachyarrhythmia at any time

Primary outcomes:
measure: Accuracy of Doppler Tissue Imaging
timeFrame: 1 1/2 hours
Secondary outcomes:
Other outcomes:
Locations:
city: Cleveland
country: United States
facility: The Cleveland Clinic Foundation
state: Ohio
Study officials:
affiliation: The Cleveland Clinic
name: Zoran Popovic, M.D.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01316536: Music Therapy is Associated With Decreased Pain and Agitation in Intubated ICU Patients
Official title: Music Therapy is Associated With Decreased Pain and Agitation in Intubated ICU Patients
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Music Therapy for Pain and Sedation
Keywords: pain, agitation, music
Lead sponsor: University of California, San Francisco
Sponsor class: OTHER
First posted: 2011-03-16
Enrollment: 5
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: SUPPORTIVE_CARE

Brief summary: The study is designed to analyze the use of music therapy to decrease pain and agitation in intubated ICU patients.

Detailed description: This is a randomized, prospective single-blinded placebo-controlled study of consecutive intubated ICU patients requiring anxiolytics and analgesic medications. Patients will be randomized into two groups: one group will receive music (MUSIC), whereas the other group (CONTROL) will wear headphones, but hear an audio loop of recorded ICU sounds (vent alarms, ambient noise, talking, etc). The two groups will then be analyzed for sedation and analgesia requirements; Ramsay sedation score, ICP in brain injured patients, ventilator days, ICU length of stay, hospital length of stay, mean arterial blood pressure (MAP).

Eligibility criteria: Inclusion Criteria:

* between 18 and 70 years old, requiring intubation andmechanical ventilation, requiring sedation with propofol or benzodiazepines and/or analgesia with narcotics

Exclusion Criteria:

* hearing loss, psychiatric illness, hemodynamically unstable (requirement for vasopressor support)

Primary outcomes:
measure: Decreased sedation and pain requirements
timeFrame: maximum of 7 days from study entry while still intubated and sedated
Secondary outcomes:
measure: ICU length of stay
timeFrame: from admission date to ICU to discharge date from ICU while on study
Other outcomes:
Locations:
city: San Francisco
country: United States
facility: University of California, San Francisco at San Francisco General Hospital
state: California
Study officials:
affiliation: University of California, San Francisco
name: Julin Tang, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: University of California, San Francisco
name: Dante Yeh, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04084236: The Effects of Transcutaneous Electrical Nerve Stimulation on People With Knee Osteoarthritis (OA) and or Chronic Pain
Official title: The Effects of Transcutaneous Electrical Nerve Stimulation on People With Knee Osteoarthritis (OA) and or Chronic Pain
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Knee Pain
Lead sponsor: Omron Healthcare Co., Ltd.
Sponsor class: INDUSTRY
Collaborators: name: Western Michigan University
First posted: 2019-09-10
Enrollment: 30
Sex: ALL
Minimum age (years): 45
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to evaluate the effect of TENS at the knee pain.


Eligibility criteria: Inclusion Criteria:

* Male or Female between the ages of 45 years or older
* Ultrasonography scale of 0-3 for grading of primary Knee OA of the knee(s)
* Pain perceived as a minimum of 3/10 on a 0-10 pain scale with 24 hours of the each visit
* No phobia of electrical stimulation
* No pain or anti-inflammatory medication will be taken during study
* OA and or Chronic knee pain, Injury/pain that began minimum of 6- weeks before the beginning of the study.

Exclusion Criteria:

* Pregnancy
* Diabetes Mellitus
* Neuropathy
* Smoker
* Uncontrolled HTN
* Past surgery in the region to be treated by TENS or had received an intra-articular corticosteroid or hyaluronic acid injection within 6 months prior to enrollment
* Arthritis (RA) in the area to be treated by TENS
* Allergic to tape/electrodes
* Dementia
* History of knee joint replacement or tibial osteotomy
* Undergoing physical therapy
* Any major joint pain (e.g., back, hip, or ankle) that could limit functional ability
* Contraindications to TENS (pacemakers, dermatological conditions, and abnormal sensation in the knees)
* Severe medical or neurological conditions (e.g. Chronic obstructive pulmonary disease, cardiovascular disease, arteriosclerosis obliterans, cerebrovascular accident, lumber disc, herniation, and rheumatoid arthritis)
* The subject does not utilize stairs in daily living
* The subject is unable to walk without ambulatory assistive devices.

Primary outcomes:
measure: stair climb test
timeFrame: 2 hours
measure: timed Up and Go test (TUG)
timeFrame: 2 hours
measure: 6-minute walk test (6MWT)
timeFrame: 2 hours
measure: VAS(Visual Analog Scale score) for knee pain
timeFrame: 2 hours
measure: The Knee injury and Osteoarthritis Outcome Score (KOOS)
timeFrame: 2 hours
measure: Perceived Competence Scale (PCS) questionnaire
timeFrame: 2 hours
measure: The Hospital Anxiety and Depression Scale (HADS)
timeFrame: 2 hours
Secondary outcomes:
measure: 2-step test
timeFrame: 2 hours
measure: stand-up test
timeFrame: 2 hours
measure: Knee extensor strength
timeFrame: 2 hours
Other outcomes:
Locations:
city: Muko
country: Japan
facility: Omron healthcare Co.,Ltd.
Study officials:
References:
Clinical trial NCT03029936: Obesity-asthma Endophenotype and Diaphragm Mobility in Adolescence
Official title: Obesity-asthma Endophenotype: Assessment of Diaphragm Mobility and Muscle Inflammation Markers in the Adolescence
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Obesity
Asthma
Keywords: obesity
asthma
diaphragm excursion
pulmonary function test
Lead sponsor: Universidade Federal de Pernambuco
Sponsor class: OTHER
First posted: 2017-01-24
Enrollment: 100
Sex: ALL
Minimum age (years): 12
Maximum age (years): 21
Standard ages: CHILD
ADULT
Accepts healthy volunteers: yes
Observational model: OTHER
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: 108 adolescents aged 12 years to 21 years will be recruited, of all sexes

Brief summary: Obesity and asthma share changes that may begin in the fetal development phase. The endophenotype obesity-asthma presents as main characteristic a pattern of inflammatory response different from the habitual Th2 profile of cytokines. In these obese patients, possible changes in the diaphragm muscle can directly influence the dynamics of pulmonary ventilation significantly.

Due to the importance of the diaphragm in pulmonary ventilation, this study will be performed to verify possible alteration in the excursion and diaphragmatic thickness of adolescents with endophenotype obesity-asthma. In parallel, the possible underlying etiopathogenic substrate of this endophenotype will be explored through the dosing of muscle enzymes and inflammatory cytokines and obesity hormones.


Eligibility criteria: Inclusion Criteria:

* Adolescents of both sexes, aged 12-21 years;
* For the obesity groups, BMI for gender and age equal to or greater than the 97th percentile;
* Clinical diagnosis of persistent, moderate and severe asthma by a specialist physician and its severity classified according to the GINA (Global Initiative Against Asthma) criteria.

Exclusion Criteria:

* Adolescents with a diagnosis of cardiovascular, rheumatic, osteoarticular, neuromuscular or any other disease that limits the safe performance of the tests proposed by the protocol will be excluded; And those who do not agree to participate in the study.

Primary outcomes:
measure: Diaphragm mobility
timeFrame: 1 day
Secondary outcomes:
measure: Diaphragm thickness
timeFrame: 1 day
measure: Th1 Cytokine Levels
timeFrame: 1 day
measure: Th2 Cytokine Levels
timeFrame: 1 day
Other outcomes:
Locations:
city: Recife
country: Brazil
facility: Universidade Federal de Pernambuco
state: Pernambuco
Study officials:
affiliation: Universidade Federal de Pernambuco
name: Luis H Tenório, MsC
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03880136: Food Effect Study of CTP-543 in Healthy Volunteers
Official title: A Phase 1 Single Center, Open-Label, Randomized Two-Period, Two-Arm Crossover Study of the Relative Bioavailability of a Single Dose of CTP-543 in Fasted and Fed Conditions in Healthy Volunteers
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Healthy
Keywords: Safety
Bioavailability
Pharmacokinetics
Lead sponsor: Concert Pharmaceuticals
Sponsor class: INDUSTRY
First posted: 2019-03-19
Enrollment: 14
Sex: ALL
Minimum age (years): 18
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: BASIC_SCIENCE

Brief summary: Two period crossover study to assess the bioavailability of CTP-543 under fed and fasted conditions.

Detailed description: This open-label, single-dose study will assess in healthy subjects a solid oral dose formulation of CTP-543 under fasted and fed conditions.

Eligibility criteria: Inclusion Criteria:

* Healthy adults between 18 and 55 years of age, inclusive
* Body weight not less than 100 lbs and body mass index within the range of 18 to 32 kg/m2, inclusive, at screening

Exclusion Criteria:

* History of clinically significant central nervous system (e.g., seizures), cardiac, pulmonary, metabolic, renal, hepatic, or gastrointestinal conditions
* PR interval \> 220 msec or QRS duration \> 120 msec or QTcF interval \> 450 msec obtained at screening visit or prior to the first dose of study drug
* Positive blood screen for human immunodeficiency virus (HIV antibody), hepatitis B virus surface antigen, or hepatitis C virus antibody at screening
* Urinalysis positive for greater than trace blood, protein or glucose
* History of drug or alcohol abuse within 6 months of screening
* History of tobacco product use within 3 months prior to the study
* Inability to comply with dietary restrictions during study participation
* Blood donation or collection within 8 week prior to dosing
* Positive pregnancy test

Primary outcomes:
measure: Measurement of CTP-543 in plasma under fed and fasted conditions
timeFrame: 48 hours
Secondary outcomes:
Other outcomes:
Locations:
city: Tempe
country: United States
facility: Celerion, Inc.
state: Arizona
Study officials:
References:
Clinical trial NCT00323336: Markers of Bone Turnover in Saliva and How This Compares to Urine and Blood
Official title: Salivary Markers of Bone Turnover Compared to Urine and Blood
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Bone Turnover Markers
Osteoporosis
Lead sponsor: Mayo Clinic
Sponsor class: OTHER
First posted: 2006-05-09
Enrollment: 100
Sex: FEMALE
Minimum age (years): 25
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: The subject population will be limited to pre-menopausal and post-menopausal females who are in good systemic health in an attempt to determine whether salivary levels of bone turnover markers hold valuable promise as a replacement or partner biofluid for serum and/or urine. In addition, proper selection of the subject population will minimize the effect of confounding variables. The specific inclusion criteria and exclusion criteria are listed below.

Brief summary: Study is being done to determine if it is possible to use saliva to measure bone specific proteins and predict bone turnover which could be used in the treatment of osteoporosis.

Detailed description: Prevention and treatment of osteoporosis require sensitive and specific assays of bone turnover. Presently, serum or urinary assessments are used. However, the development of other procedures that are more patient-convenient, non-invasive and cost-efficient would significantly facilitate a clinician's ability to determine bone turnover. The objective of this application is to determine the feasibility of using saliva for this measurement. We will compare serum, urinary and salivary levels in 50 pre- and 50 post-menopausal women. Markers to be measured are bone alkaline phosphatase, osteocalcin, procollagen type propepties hydroxypyridinium crosslinks of collagen and crosslinked collagen telopeptides. Collection of saliva, serum and urine will be done at a single visit. We expect to observe reasonable good correlation between serum and saliva levels and poorer correlation between urine and saliva levels.

Eligibility criteria: Inclusion:

* 50 pre-menopausal females (25-40 yo)
* 50 post-menopausal females (55-70 yo)
* Good systemic health
* Good oral health

Exclusion:

* arthritis
* active periodontitis
* history or actively smoking
* diabetes
* HIV positive
* anti-coagulant therapy
* bone fracture within the past year
* pregnancy
* known metabolic bone disease

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Rochester
country: United States
facility: Mayo Clinic
state: Minnesota
Study officials:
affiliation: Mayo Clinic
name: Sreenivas Koka, D.D.S., Ph.D.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01778036: Neck Motion and Motor Control in Chronic Neck Pain and Associations With Clinical Symptoms
Official title: Neck Motion and Motor Control in Chronic Neck Pain and Associations With Clinical Symptoms
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Neck Pain
Keywords: Neck movement
motor control
disability
psychological variables
Head Movements
Physical therapy
Fear avoidance
Self Efficacy
Catastrophizing
Fly test
Postural sway
Lead sponsor: Norwegian University of Science and Technology
Sponsor class: OTHER
Collaborators: name: University of Oslo
First posted: 2013-01-29
Enrollment: 84
Sex: ALL
Minimum age (years): 18
Maximum age (years): 67
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Neck pain patients referred to physiotherapy treatment in primary health care

Brief summary: The primary purpose of this study is to investigate if there is altered motor control of head and neck in chronic neck pain patients compared with healthy persons. In addition, associations between neck pain, motor control, disability and function, and clinical symptoms will be studied in patients following physiotherapy treatment in primary health care.


Eligibility criteria: Inclusion Criteria:

* Idiopathic neck pain with duration \>2 weeks
* Normal or corrected vision
* Pain at or above 3 on Numeric Rating Scale, with "low pain" defined as 3-4 and "high pain" as 5 or higher.

Exclusion Criteria:

* Systemic or diagnosed chronic disease, including diabetes, stroke and neurological diseases, that may influence motor control and neck pain or ability to perform tests
* positive spurling test for neurological radiating arm pain
* pregnancy
* whiplash
* insufficient comprehension of Norwegian language

Primary outcomes:
measure: Conjunct motion
timeFrame: up to 8 weeks
Secondary outcomes:
measure: head motion smoothness
timeFrame: up to 8 weeks
measure: reposition accuracy
timeFrame: up to 8 weeks
measure: postural sway.
timeFrame: up to 8 weeks
measure: Head stabilization
timeFrame: up to 8 weeks
measure: pain
timeFrame: up to 24 weeks
measure: Head motion accuracy
timeFrame: up to 8 weeks
Other outcomes:
measure: Neck disability and function
timeFrame: up to 24 weeks
Locations:
city: Oslo
country: Norway
facility: University of Oslo
city: Trondheim
country: Norway
facility: Norwegian University of Science and Technology
Study officials:
affiliation: Norwegian University of Science and Technology
name: Ottar Vasseljen, prof
role: STUDY_DIRECTOR
References:
citation: Meisingset I, Stensdotter AK, Woodhouse A, Vasseljen O. Neck motion, motor control, pain and disability: A longitudinal study of associations in neck pain patients in physiotherapy treatment. Man Ther. 2016 Apr;22:94-100. doi: 10.1016/j.math.2015.10.013. Epub 2015 Nov 2.