pankajmathur/National_Library_of_Medicine_Studies_data huggingface dataset:
Exploration of Dalpiciclib + Tucidinostat in HR+/HER2- Advanced Breast Cancer After Failure of CDK4/6 Inhibitor
NCT Number: NCT06556862
Status: NOT_YET_RECRUITING
Study Type: INTERVENTIONAL
Phases: PHASE2
Conditions: HR+/HER2- Advanced Breast Cancer
Interventions: DRUG: Dalpiciclib|DRUG: Tucidinostat
Sponsor: Beijing 302 Hospital
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 155
Study Design: Allocation: NA|Intervention Model: SINGLE_GROUP|Masking: NONE|Primary Purpose: TREATMENT
Start Date: 2024-10-01
Completion Date: 2028-12-31
Locations: The Fifth Medical Center of PLA General Hospital, Beijing, Beijing, 100071, China

Summary:
A phase II study to explore the efficacy and safety of dalpiciclib + tucidinostat in HR+/HER2- advanced breast cancer after the failure of CDK4/6 inhibitor therapy.

Primary Outcome Measures: PFS, Progression-free survival: The time to the date of first documented progression or date of death from any cause, whichever came first, 1 Year
Secondary Outcome Measures: ORR, Objective response rate, 2 months|CBR, Clinical benefit rate: CR+PR+SD≥6 months, 2 Years|DCR, Disease Control Rate: CR+PR+SD, 2 Years|DoR, The time from the beginning of CR or PR to the time when the tumor was first evaluated as PD or any cause of death., 2 Years|OS, The time from the beginning of treatment to the time of death caused by any cause, 2 Years|Safety, Adverse events (AE), serious adverse events (SAE), and immune-related adverse events (irAE), in accordance with the NCI-CTC AE version 5.0 criteria. AE recorded from infromed consent to 28 days after treatment completion., AE recorded from infromed consent to 28 days after treatment completion
Effectiveness of DIMS Spectacle as a Function of the Age
NCT Number: NCT06556849
Status: COMPLETED
Study Type: OBSERVATIONAL
Conditions: Myopia
Interventions: DEVICE: Defocus Incorporated Multiple Segments (DIMS)
Sponsor: Luca Buzzonetti
Sex: ALL
Age: CHILD
Enrollment: 80
Study Design: Observational Model: |Time Perspective: p
Start Date: 2020-12-01
Completion Date: 2024-06-30
Locations: Luca Buzzonetti, Rome, Italy

Summary:
Purpose: To evaluate the effectiveness of Defocus Incorporated Multiple Segments (DIMS) in slowing myopia progression as a function of age in pediatric patients.

Methods: This was a non-randomized experimenter-masked retrospective controlled observational study of European individuals aged 6 -16 years with progressive myopia but no ocular pathology. The charts of the participants allocated to receive DIMS spectacles (Hoya® MiyoSmart®) or single vision spectacle lenses (control group) were retrospectively reviewed. The key outcome variables, cycloplegic spherical equivalent (SE) and axial length (AL), were measured at baseline and at 36 month follow up. The results were stratified by age into four groups: patients that wore DIMS spectacles oldest or youngest than 10 years (respectively, group A, 20 patients mean age 13.6±2.2 and group C, 20 patients mean age 9.0±1.2) and age matched control groups (group B, 18 patients mean age 13.2±2.5 and group D, mean age 8.5±0.9).

Primary Outcome Measures: SE, spherical equivalent, 36 months
Secondary Outcome Measures: AL, axial lenght, 36 months
Contralateral Leg Neuro-dynamic and Spine Mobilization With Leg Movement in Patients With Sciatica
NCT Number: NCT06556823
Status: RECRUITING
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Sciatic Radiculopathy
Interventions: OTHER: CLNDT+ Conventional PT in Diabetic Population):|OTHER: CLNDT+ Conventional PT in non Diabetic Population):|OTHER: SMWLM+ Conventional PT in Diabetic Population)|OTHER: SMWLM+ Conventional PT in non Diabetic Population)
Sponsor: Riphah International University
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 52
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: NONE|Primary Purpose: TREATMENT
Start Date: 2024-07-01
Completion Date: 2025-01
Locations: Railway General Hospital, Rawalpindi, Punjab, 46000, Pakistan

Summary:
The aim of this randomized clinical trial is to find the comparison of CLNDT and SMWLM technique in diabetic and non-diabetic sciatica patients on reducing back pain and improving range of motion of knee

Primary Outcome Measures: Goniometer, It is a tool used to measure the range of motion of joint (0-180). Positioning plays a vital part in goniometry because it helps to place the joints in a zero starting or neutral position. The examiner stabilizes the proximal joint component and then carefully moves the distal component of the joint through its entire available range of motion until reaching the end feel. By using universal goniometer ROM of knee will be assessed, patient will be in supine lying with both legs on the table, fulcrum of goniometer will be aligned with lateral epicondyle while stationary arm is in align with lateral epicondyle and midline of femur. While moving arm is with lateral malleolus and fibula border, while maintaining same position flexion and extension will be performing and measure., three weeks|Numeric Pain Rating Scale, The NPRS is an eleven-point pain impression scale: the patient rates pain from 0 (no aggravation) to 10 (most exceedingly terrible possible pain). Numeric Pain Rating Scale (NPRS), which was used to survey respondents' impression of the degree of pain that they felt. NPRS has been utilized in different examinations for low back pain., three weeks|Modified Oswestry low back pain Disability Index, The Modified Oswestry Low back pain disability index is widely used standardized questionnaires used by health professional to evaluate patient disability level in patient with low back pain that how patients low back pain affect daily life activities. ODI consists of 10 different questions each score range from 0-5 from minimum to maximum. The score of each section is summed and then divided into total and multiply by 100., three weeks
Proof-of-concept Study on Dyspnea Analysis Via GapCO2
NCT Number: NCT06556797
Acronym: MicroDys
Status: NOT_YET_RECRUITING
Study Type: OBSERVATIONAL
Conditions: Acute Dyspnea|Dyspnea
Sponsor: Assistance Publique - Hôpitaux de Paris
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 45
Study Design: Observational Model: |Time Perspective: p
Start Date: 2024-09
Completion Date: 2025-04

Summary:
Patients presenting to the emergency department with acute dyspnea undergo arterial blood gas measurement and monitoring of transcutaneous capnography using the TCM5 monitor. The aim of this study is to determine whether GapCO2, the difference between transcutaneous and arterial pCO2 (PaCO2 - PtcCO2), is correlated with the congestive or non-congestive origin of dyspnea.

Primary Outcome Measures: GapCO2, PaCO2 measured via arterial blood gas analysis - PtcCO2 measured via TCM5 monitor, at 37°C, Within 1 hour after enrolment
Secondary Outcome Measures: Diagnostic performance of GapCO2 at 37°C, Within 1 hour after enrolment|Proportion of patients who underwent GapCO2 measurement among those who presented to the emergency department for dyspnea on the days of inclusion, Feasibility of measuring GapCO2 in the emergency department, up to 28 days
Comparison of Gongs and Kaltenborn Mobilization on Neck Pain
NCT Number: NCT06556771
Status: RECRUITING
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Mechanical Neck Pain
Interventions: OTHER: Gongs mobilization + conventional physical therapy|OTHER: Kaltenborn mobilization along with traction + conventional therapy
Sponsor: Riphah International University
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 44
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: SINGLE (PARTICIPANT)|Primary Purpose: TREATMENT
Start Date: 2024-08-09
Completion Date: 2025-01-10
Locations: Alam Hospital Attock, Attock City, Punjab, 43350, Pakistan

Summary:
The aim of this randomized controlled trial is to find the effect of Gongs mobilization in comparison with Kaltenborn mobilization on mechanical neck pain , range of motion and proprioception.A randomized control trial that will include total 44 participants. The first group will receive Gongs mobilization along with conventional therapy and 2nd group will receive Kaltenborn mobilization along with conventional therapy.

Primary Outcome Measures: Numeric Pain Rating Scale NPRS, The NPRS is a segmented numeric version of the visual analog scale which is used to assess pain. It scores ranges from 0-10, 0 means No pain and 10 means Severe pain. Patient will be asked to verbally report the pain score., 4 weeks
Secondary Outcome Measures: : Goniometer, : It is an instrument that measures the available range of motion at a joint., 4 weeks|Cervical Joint Position Error, The patient is sitting 90 cm from the wall, and the starting point (center of target or reference point) of the laser projection is marked. The patient (blindfolded or closed) performs active neck movement and then returns to the starting position as accurately as possible. The final laser position is measured relative to the starting position (distance or angle). The errors are measured after cervical extension and flexion., 4 weeks
Stripping Massage on Rhomboid Major and Minor Active Trigger Points in Upper Thoracic Pain
NCT Number: NCT06556758
Status: RECRUITING
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Upper Thoracic Pain Due to Active Trigger Points
Interventions: OTHER: stripping massage + conventional therapy|OTHER: Conventional therapy
Sponsor: Riphah International University
Sex: FEMALE
Age: ADULT
Enrollment: 44
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: SINGLE (PARTICIPANT)|Primary Purpose: TREATMENT
Start Date: 2024-08-09
Completion Date: 2025-01-10
Locations: Railway General Hospital, Rawalpindi, Punjab, 44000, Pakistan

Summary:
Aim of this randomized controlled trial is to see the effects of stripping massage on rhomboids major and minor active trigger points in patients with upper thoracic pain for reducing pain, enhancing thoracic range of motion and physical functioning

Primary Outcome Measures: Numeric Pain Rating Scale NPRS, The NPRS is a segmented numeric version of the visual analog scale which is used to assess pain. It scores ranges from 0-10, 0 means No pain and 10 means Severe pain. Patient will be asked to verbally report the pain score., 4 weeks
Secondary Outcome Measures: Bubble inclinometer, It is an instrument that measures the available range of motion at a joint., 4 weeks
Other Outcome Measures: Functional rating index, The Functional Rating Index (FRI) is an instrument specifically designed to quantitatively measure the subjective perception of function and pain of the spinal musculoskeletal system in a clinical environment, 4 weeks
Pharmacokinetics of Butyrate Tablet BKR-017
NCT Number: NCT06556745
Status: NOT_YET_RECRUITING
Study Type: OBSERVATIONAL
Conditions: Hypercholesterolemia
Interventions: DRUG: BKR-017
Sponsor: BioKier Inc.
Collaborators: National Heart, Lung, and Blood Institute (NHLBI)
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 10
Study Design: Observational Model: |Time Perspective: p
Start Date: 2024-09
Completion Date: 2025-03

Summary:
The purpose of this study is to evaluate the pharmacokinetic profile and systemic exposure of BKR-017 in individuals on statin therapy after a single dose and at steady state after seven days repeated twice daily dosing.

Primary Outcome Measures: Peak Plasma Concentration (Cmax) of butyrate, Changes, from pre-dosing levels, in levels of butyrate in plasma after a single dose and after seven days of dosing., 8 days|Area under the plasma concentration versus time curve (AUC), AUC after 7 days of dosing will be compared to AUC after a single dose to determine if butyrate eaccumulates in the plasma., 8 days
Secondary Outcome Measures: Incidence of Treatment-Emergent Adverse Events as assessed by blood pressure, An assessment of safety will be made using blood pressure at screening, after single dose, and after 7 days repeat dosing., 8 days|Incidence of Treatment-Emergent Adverse Events as assessed by heart rate, An assessment of safety will be made using heart rate at screening, after single dose, and after 7 days repeat dosing., 8 days|Incidence of Treatment-Emergent Adverse Events as assessed by a hematology panel, Hematology (CBC) will be performed at screening, after single dose, and after 7 days repeat dosing., 8 days|Incidence of Treatment-Emergent Adverse Events as assessed by chemistry laboratory safety parameters, An assessment of chemistry laboratory safety parameters will be performed at screening, after single dose, and after 7 days repeat dosing., 8 days
Role of Eplerenone in Reducing Recurrence of Atrial Fibrillation in Patients With Structural Heart Disease
NCT Number: NCT06556732
Status: RECRUITING
Study Type: INTERVENTIONAL
Phases: PHASE1
Conditions: Atrial Fibrillation
Interventions: DRUG: Eplereone
Sponsor: Assiut University
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 100
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: SINGLE (PARTICIPANT)|Primary Purpose: PREVENTION
Start Date: 2024-08-10
Completion Date: 2024-08-31
Locations: Assiut University Heart Hospital, Assiut, 71526, Egypt

Summary:
This is a prospective comparative study, conducted at Cardiology Department, Aswan University Hospital on AF patients with structural heart disease. Eplerenone 25 mg daily will be given and searching for AF recurrence among study population.

Primary Outcome Measures: AF recurrence, 6 months
Impact of Urolithin A (Mitopure) on Mitochondrial Quality in Muscle of Frail Older Adults
NCT Number: NCT06556706
Acronym: MitoEM
Status: RECRUITING
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Frailty|Sarcopenia|Aging|Muscle Atrophy
Interventions: DIETARY_SUPPLEMENT: Mitopure (Urolithin A)|DIETARY_SUPPLEMENT: Placebo
Sponsor: Amazentis SA
Collaborators: Université du Québec a Montréal|McGill University Health Centre/Research Institute of the McGill University Health Centre
Sex: ALL
Age: OLDER_ADULT
Enrollment: 26
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: QUADRUPLE (PARTICIPANT, CARE_PROVIDER, INVESTIGATOR, OUTCOMES_ASSESSOR)|Primary Purpose: BASIC_SCIENCE
Start Date: 2024-08-15
Completion Date: 2025-12-31
Locations: McGill University Health Center, Montréal, Canada

Summary:
The study is a single-center, randomized, placebo-control double-blind study in frail older adults over 65yrs. to investigate the impact of Mitopure (Urolithin A) supplementation on muscle mitochondrial quality in frail older adults after 8-weeks of supplementation

Primary Outcome Measures: Change in mitochondrial area between placebo and active treated groups assessed via Electron Microscopy, 8-weeks|Change in mitochondrial cristae density between placebo and active treated groups assessed via Electron Microscopy, 8-weeks
Secondary Outcome Measures: change between groups on the following: maximal mitochondrial O2 consumption assessed via via respirometry on permeabilized myofibers, 8-weeks|change between groups in mitochondrial calcium retention capacity measured by mitochondrial permeability transition pore (mPTP) sensitivity to calcium, 8-weeks|mitochondrial DNA (mtDNA) over nuclear DNA ratio (mtDNA/nDNA) via qPCR, 8-weeks|Changes in body composition via Dual X-ray Absorptiometry (DXA) scan of total and appendicular lean mass, 8-weeks|Changes in composition via Peripheral quantitative computed tomography (pQCT) of muscle tissue, 8-weeks|Changes in the timed up and go test (time needed to stand from an armchair, walk a distance of 3 meters, turn around and sit back down in the chair), 8-weeks|Changes in grip strength measured by a hand dynamometer, 8-weeks|Changes in Berg balance test: Participant will be asked to maintain a given position or perform a task, 8-weeks|Changes in distance walked during the six-minute walk test, 8-weeks|Changes in the 30-second stand test: Participant will stand as many times as s/he can from a seated position for 30-seconds., 8-weeks|Changes in Four-square step test: To assess balance, participant will step over small sticks placed in an X on the floor, 8-weeks|Changes in Unipedal stance test (UPST): First a ball will be kicked to determine dominant leg, then participant will be asked to stand on one leg (barefoot) with eyes open and again with eyes closed, 8-weeks|Recording of adverse events, 8-weeks|Quantification of muscle fiber type (type I/II) via Myosin Heavy Chain immunolabeling, 8-weeks|Analysis of markers of neuromuscular junction integrity (NCAM biomarker staining), 8-weeks|Changes in knee extension strength measured by a hand dynamometer, 8-weeks
Janus II Feasibility
NCT Number: NCT06556693
Status: NOT_YET_RECRUITING
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Sleep Apnea
Interventions: DEVICE: Dual Channel Stimulation
Sponsor: Zoll Medical Corporation
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 40
Study Design: Allocation: NA|Intervention Model: SINGLE_GROUP|Masking: NONE|Primary Purpose: TREATMENT
Start Date: 2024-10
Completion Date: 2034-12

Summary:
The objectives of this study are to evaluate the feasibility of the remedē® Dual Channel System at implant and overnight sleep studies and to assess chronic safety.

Primary Outcome Measures: Safety through 12 months, Serious adverse event related to implant procedure, device, or stimulation, 12 Months post implant|Successful Implantation, Successful Implantation of dual channel system, implant procedure|Improvement in sleep disordered breathing, Demonstration of the acute prevention of sleep disordered breathing events during attended sleep study., 12 months post implant
EB-OCT Biopsy Guidance of Lung Cancer
NCT Number: NCT06556680
Status: NOT_YET_RECRUITING
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Lung Cancer
Interventions: DEVICE: Optical coherence tomography
Sponsor: Massachusetts General Hospital
Collaborators: National Heart, Lung, and Blood Institute (NHLBI)
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 200
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: DOUBLE (PARTICIPANT, INVESTIGATOR)|Primary Purpose: OTHER
Start Date: 2024-09
Completion Date: 2027-01

Summary:
Our objective is to develop, test, and validate a clinically robust polarization-sensitive optical coherence tomography (PS-OCT) biopsy guidance and diagnosis platform that is compatible with standard bronchoscopy techniques.

Primary Outcome Measures: Diagnostic yield of bronchial biopsy, EB-OCT guided bronchial biopsy changes the diagnostic yield when compared to traditional biopsy., 2 years
Secondary Outcome Measures: Determine the accuracy of OCT diagnosis of lung cancer in vivo by blinded reviewers., As a secondary outcome the EB-OCT images will be reviewed by blinded readers following the completion of the study to determine the accuracy for the in vivo diagnosis of lung cancer by OCT images alone., 2 years
MAX - SHOCK Clinical Trial
NCT Number: NCT06556667
Acronym: MAX-SHOCK
Status: NOT_YET_RECRUITING
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Cardioversion|Atrial Fibrillation
Sponsor: Ottawa Heart Institute Research Corporation
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 379
Study Design: Allocation: RANDOMIZED|Intervention Model: CROSSOVER|Masking: SINGLE (PARTICIPANT)|Primary Purpose: TREATMENT
Start Date: 2024-09-01
Completion Date: 2027-09-01

Summary:
Can Electrical Cardioversion (ECV) for AF be improved. It is the preferred method to restore sinus rhythm in patients with AF in whom a rhythm-control strategy is pursued.

Hypothesis:

ECV success rates will be greater with a biphasic defibrillator with maximum energy of 360J (® Physio-Control) compared to a biphasic defibrillator with maximum energy of 200J (® Zoll)

Primary Outcome Measures: ECV success, ECV success defined as \>_2 consecutive sinus beats, or captured atrial-paced beats in patients with implanted cardiac devices, after shock delivery, 2 seconds
Secondary Outcome Measures: First shock success, Cardioversion is successful without crossover, 2 seconds|sustained success, sustained sinus or atrial paced rhythm documented on 12-lead electrocardiogram, 4 hours
Tissue Reinforcement for Breast Reconstruction (TRBR) Pivotal Clinical Study (REDEFINE)
NCT Number: NCT06556654
Status: NOT_YET_RECRUITING
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Breast Reconstruction Surgery
Interventions: DEVICE: TRBR Device
Sponsor: W.L.Gore & Associates
Collaborators: Avania
Sex: FEMALE
Age: ADULT, OLDER_ADULT
Enrollment: 180
Study Design: Allocation: NA|Intervention Model: SINGLE_GROUP|Masking: NONE|Primary Purpose: TREATMENT
Start Date: 2024-09
Completion Date: 2029-09

Summary:
The GORE Tissue Reinforcement for Breast Reconstruction (TRBR) research study will look at breast reconstruction during mastectomy procedures. There will be two arms in this study, a Prospective Arm, where data will be collected for a new medical device called the Tissue Reinforcement for Breast Reconstruction (TRBR) Device and a Retrospective Arm where data will be collected from subjects who have previously had surgery and received no additional tissue reinforcement in their breast reconstruction surgery. This research study will look at the safety of the Study Device and the success of the participants breast reconstruction. The Study Device is investigational, which means it has not yet been used nor approved by the FDA for this treatment. The data collected in this study will be compared to the data collected in the Retrospective Arm.

Primary Outcome Measures: Absence of device- or procedure-related major adverse events (MAEs), Require rehospitalization or reoperation through, 1 year post index procedure
Secondary Outcome Measures: BREAST-Q Physical Well Being, Chest Score change from baseline (pre-index procedure). The maximum value pre-operatively is 30, and the minimum pre-operatively is 10. The maximum value post-operatively is 33, and the minimum pre-operatively is 11. A higher score indicates a worse outcome., 1-year post-index procedure.
A Clinical Study of GZR33 and GZR101 in Healthy Subjects
NCT Number: NCT06556641
Status: COMPLETED
Study Type: INTERVENTIONAL
Phases: PHASE1
Conditions: Healthy Subjects
Interventions: DRUG: GZR33 Injection|DRUG: GZR101 Injection|DRUG: Placebo|DRUG: Insulin Degludec
Sponsor: Gan and Lee Pharmaceuticals, USA
Sex: MALE
Age: ADULT
Enrollment: 28
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: DOUBLE (PARTICIPANT, INVESTIGATOR)|Primary Purpose: TREATMENT
Start Date: 2022-12-17
Completion Date: 2023-02-03
Locations: Study Site, Xingtai, Hebei, China

Summary:
This study evaluates the safety, tolerability, pharmacokinetics, and pharmacodynamics of GZR33 and GZR101 in healthy adult male subjects.This study consists of Part A and Part B.

Part A is a randomized, open-label, single-dose, two-sequence, two-period, cross-over design comparative study evaluating the PD and PK characteristics of GZR33 and Insulin Degludec Injection.

Part B is a randomized, double-blind, placebo-controlled, multiple-dose, parallel-group design study evaluating the safety, tolerability, immunogenicity, and PK of GZR33 and GZR101.

Primary Outcome Measures: AUC0-24h, Area under the plasma concentration-time curve from time 0 to 24 hours, From 0 to 24 hours|Incidence of adverse events (AE), Any changes or abnormal results in the following safety variables: incidence of adverse events (AE), including but not limited to hypoglycemic reactions, injection site reactions, clinical laboratory tests, 12-lead ECG, vital signs, physical examination, and local tolerability at the injection site., From Predose to Day12
Secondary Outcome Measures: Cmax, Maximum plasma concentration, From Predose to Day7|tmax, Time to reach maximum plasma concentration, From Predose to Day7|AUC0-last, Area under the plasma concentration-time curve from time 0 to the last blood sampling time point, From Predose to Day7
Tympanic Thermometer Study
NCT Number: NCT06556628
Status: ACTIVE_NOT_RECRUITING
Study Type: OBSERVATIONAL
Conditions: Body Temperature Changes|Fever
Interventions: DEVICE: Increased Body Temperatures
Sponsor: Baxter Healthcare Corporation
Sex: ALL
Age: CHILD, ADULT, OLDER_ADULT
Enrollment: 1000
Study Design: Observational Model: |Time Perspective: p
Start Date: 2022-04-11
Completion Date: 2025-05-31
Locations: Baxter, Skaneateles, New York, 13153, United States

Summary:
The goal of this study is to collect febrile, healthy, and in some instances cold temperature data from human subjects ranging from newborns to geriatrics. This data will be used to develop a new thermometer.

Primary Outcome Measures: Clinical Bias, The mean difference between output temperatures of the clinical thermometer under test, Immediately after the diagnostic test
Secondary Outcome Measures: Repeatability, Pooled standard deviation (over a selected group of subjects) of changes in multiple output temperatures taken from the same subject at the same measuring site with the same clinical thermometer by the same operator within a relatively short time, Immediately after the diagnostic test|Limits of Agreement, The magnitude of a potential disagreement between outputs of two clinical thermometers equal to double the standard deviation of output temperature differences when used on the same human subject., Immediately after the diagnostic test
Health Related Quality of Life (HrQoL) in Classical Homocystinuria (CBS Deficiency)
NCT Number: NCT06556615
Acronym: CBS_HrQoL
Status: NOT_YET_RECRUITING
Study Type: OBSERVATIONAL
Conditions: Homocystinuria
Interventions: BEHAVIORAL: Interview
Sponsor: University Children's Hospital, Zurich
Sex: ALL
Age: CHILD, ADULT, OLDER_ADULT
Enrollment: 80
Study Design: Observational Model: |Time Perspective: p
Start Date: 2024-08-15
Completion Date: 2025-09

Summary:
Patients, parents of young / handicapped patients, and experts will be interviewed to collect contents relevant for HrQoL in CBS deficiency. Based on these data, a questionnaire will be developed and tested for comprehensibility in patients and parents of young / handicapped patients. A final questionnaire version will be tested for psychometric criteria including validity and reliability.

Primary Outcome Measures: HrQol, Hrqol, through study completion, an average of 6 months
Methadone Patient Access to Collaborative Treatment
NCT Number: NCT06556602
Acronym: MPACT
Status: NOT_YET_RECRUITING
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Opioid Use Disorder|Staff|Patients
Interventions: OTHER: MPACT
Sponsor: University of Arizona
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 1080
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: NONE|Primary Purpose: HEALTH_SERVICES_RESEARCH
Start Date: 2026-04
Completion Date: 2030-08
Locations: University of Arizona College of Medicine, Tucson, Arizona, 85714, United States

Summary:
The trial of Methadone Patient Access to Collaborative Treatment (MPACT) will establish the impact of the intervention on patient outcomes of methadone treatment retention and in treatment overdose.

It will also establish the impact of patient and staff trauma symptoms and clinic practice change on MPACT intervention implementation.

Primary Outcome Measures: Days in Treatment to treatment interruption, Time (days) to treatment interruption, 18 months|Time to treatment cessation, Time to treatment cessation (tolerance of 30 days), 18 months|In Treatment- Point in time, Point in time in treatment (0 day, 30 day, 60, day, 90 day), 18 months|Number of patients reporting opioid overdoses while in methadone treatment, Reported overdoses by patients in methadone treatment during the trial period by survey measured at 5 points during the study period., 18 months
Secondary Outcome Measures: Number of staff experiencing vicarious (work related) stress, Post traumatic stress symptoms and vicarious (work related) trauma symptoms measured by the Vicarious Trauma Scale (VTS). Total scores can be grouped into three categories to represent low (8-28), moderate (29-42) and high (43-56) levels of vicarious trauma symptoms, 18 months|Number of patients and staff experiencing post traumatic stress symptoms, Post traumatic stress symptoms measured by the 8-item PCL-5 measuring post traumatic stress symptoms. Scores range from 0-80, with higher scores representing greater levels of traumatic stress symptomatology., 18 months
Collaborative Care for Treatment of Depression and Anxiety
NCT Number: NCT06556589
Status: RECRUITING
Study Type: OBSERVATIONAL
Conditions: Depression|Anxiety
Interventions: BEHAVIORAL: Collaborative Care
Sponsor: Kaiser Permanente
Collaborators: Garfield Memorial Fund
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 200
Study Design: Observational Model: |Time Perspective: p
Start Date: 2023-03-01
Completion Date: 2025-03-31
Locations: Kaiser Permanente Colorado, Aurora, Colorado, 80011, United States

Summary:
The goal of this project is to evaluate the effectiveness of a collaborative care model for primary care patients at Kaiser Permanente Colorado (KPCO) with depression and/or anxiety. Collaborative care uses evidence-based short-term treatments delivered to patients over the phone. We will explore the use of cost-efficient automated processes for patient outreach and follow-up, such as care pools of patients and using patient portal messaging, risk-based results routing to providers, and electronic health record (EHR) tools for patient tracking and outcome assessment. Using a cluster randomized design, we will compare results between clinics that are offering collaborative care to those that are not.

Primary Outcome Measures: Patient Health Questionnaire 9-item (PHQ-9) score, Change in Patient Health Questionnaire 9-item (PHQ-9) scores before and after Collaborative Care intervention. The score ranges from 0 to 27, with lower numbers indicating improvement in depression symptoms., Baseline and up to 24 weeks|Generalized Anxiety Disorder 7-item (GAD-7), Generalized Anxiety Disorder 7-item (GAD-7) questionnaire scores before and after Collaborative Care intervention. The score ranges from 0 to 21, with lower numbers indicating improvement in anxiety symptoms., Baseline and up to 24 weeks
EF-41/KEYNOTE D58: Phase 3 Study of Optune Concomitant With Temozolomide Plus Pembrolizumab in Newly Diagnosed Glioblastoma
NCT Number: NCT06556563
Acronym: EF-41
Status: NOT_YET_RECRUITING
Study Type: INTERVENTIONAL
Phases: PHASE3
Conditions: Glioblastoma
Interventions: DEVICE: Optune® device|DRUG: Temozolomide|DRUG: Pembrolizumab|DRUG: Placebo
Sponsor: NovoCure GmbH
Collaborators: Merck Sharp & Dohme LLC
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 741
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: QUADRUPLE (PARTICIPANT, CARE_PROVIDER, INVESTIGATOR, OUTCOMES_ASSESSOR)|Primary Purpose: TREATMENT
Start Date: 2024-10
Completion Date: 2029-04

Summary:
This is a multicenter, two-arm, randomized, double-blind, placebo-controlled study of Optune® (Tumor Treating Fields at 200 kHz) together with maintenance Temozolomide (TMZ) chemotherapy agent and pembrolizumab compared to Optune® together with maintenance TMZ and placebo in newly diagnosed Glioblastoma (GBM) patients. The primary objective of the study is to evaluate the Overall Survival (OS).

Primary Outcome Measures: Overall survival, Overall survival (OS) is defined as the time from randomization to death due to any cause, 24 months
Secondary Outcome Measures: Progression-Free Survival (PFS) per mRANO assessed by investigator, PFS is defined as the time interval, in months, between randomization and the first documented disease progression per mRANO assessed by investigator or death due to any cause, whichever occurs first.

Note: mRANO = Modified Radiographic Response Assessment in Neuro-Oncology, 24 months|Progression-Free Survival (PFS) per RANO assessed by investigator, PFS is defined as the time interval, in months, between randomization and the first documented disease progression per RANO assessed by investigator or death due to any cause, whichever occurs first.

Note: RANO = Response Assessment in Neuro-Oncology, 24 months
The Effect of Live Subject on the Anxiety Level and Perceived Competence Level
NCT Number: NCT06556524
Status: COMPLETED
Study Type: OBSERVATIONAL
Conditions: Anxiety Level
Interventions: BEHAVIORAL: observation
Sponsor: Gazi University
Sex: ALL
Age: ADULT
Enrollment: 2
Study Design: Observational Model: |Time Perspective: p
Start Date: 2022-12-01
Completion Date: 2022-12-31
Locations: Gazi University, Ankara, 06560, Turkey

Summary:
This study was carried out to examine the effect of training on the proficiency and anxiety levels of Paramedic students in a realistic, simulated environment of the pre-hospital scene. A total of 72 second-year students in the Paramedic program participated in this study with an interventional approach. The data collection form used in the study consisted of sociodemographic characteristics, a self-efficacy form for approaching trauma patients, and the worry and anxiety scale. Within the framework of the research, a competition named "trauma rally" was organized for university Paramedic students, which consisted of the pre-hospital approach of injured live subjects. Through face-to-face interviews, the data collection form was filled out with the participants before, immediately after and one month after the competition.

Primary Outcome Measures: anxiety level and trauma cases, As a result, it was determined that simulation training with a live subject did not change the anxiety level of paramedic candidates, but increased their self-efficacy against trauma cases, and that there was a negative relationship between anxiety scores and self-efficacy scores. Considering that interventions on patients and injured people in the pre-hospital scene are critical, it is recommended that simulation methods be combined with traditional methods in paramedic training., fifteen days
Efficacy Of Zinc Towards The Outcome on Children With Sepsis
NCT Number: NCT06556511
Status: COMPLETED
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Sepsis
Interventions: DRUG: Zinc Sulfate|DRUG: Placebo
Sponsor: dr. Aldora Jesslyn Oentari
Collaborators: Hasanuddin University
Sex: ALL
Age: CHILD, ADULT
Enrollment: 140
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: NONE|Primary Purpose: OTHER
Start Date: 2024-02-01
Completion Date: 2024-05-31
Locations: Hasanuddin University, Makassar, South Sulawesi, 90245, Indonesia

Summary:
Sepsis is a life-threatening organ failure induced by a compromised immune response to infection. Sepsis is a leading cause of morbidity and mortality (50-60%) in children treated in inpatient and critical care units. Children suffering from immunodeficiency have a higher mortality rate. Several studies in recent years have revealed that zinc homeostasis may be a significant role in the prevention of sepsis. It was important to conduct this study to determine the efficacy of zinc in children suffering from sepsis.

Primary Outcome Measures: This study was to compare the effectiveness of standard therapy with zinc in children with sepsis, Comparing the level of awareness, used of a mechanical ventilator, P/F ratio, Mean Arterial Pressure (MAP), serum leukocytes and platelets, C-Reactive Protein (CRP) and procalcitonin levels, lactate levels, sepsis progression, and patient mortality between zinc group and placebo group on day 0, 8, and 11, 10 days
Secondary Outcome Measures: Comparing the mean changes in clinical and laboratory parameters, 1. Comparing the difference of level of awareness, used of a mechanical ventilator, P/F ratio, Mean Arterial Pressure (MAP), serum leukocytes and platelets, C-Reactive Protein (CRP) and procalcitonin levels, lactate levels, sepsis progression, and patient mortality after treatment between zinc group and placebo group
2. Comparing the difference of level of awareness, used of a mechanical ventilator, P/F ratio, Mean Arterial Pressure (MAP), serum leukocytes and platelets, C-Reactive Protein (CRP) and procalcitonin levels, lactate levels, sepsis progression, and patient mortality before and after treatment in the zinc group
3. Comparing the difference of level of awareness, used of a mechanical ventilator, P/F ratio, Mean Arterial Pressure (MAP), serum leukocytes and platelets, C-Reactive Protein (CRP) and procalcitonin levels, lactate levels, sepsis progression, and patient mortality before and after treatment in the zinc group, 10 days
Preventive Catheter Ablation for Ventricular arrhythmiaS in Patients With End-sTage Heart faiLure
NCT Number: NCT06556485
Acronym: CASTLE-VT
Status: NOT_YET_RECRUITING
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Heart Failure|Arrhythmia, Ventricular|Cardiomyopathy Ischemic|Catheter Ablation|Heart Transplantation|Left Ventricular Assist Device
Interventions: PROCEDURE: Catheter ablation|DRUG: Medical therapy
Sponsor: Heart and Diabetes Center North-Rhine Westfalia
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 160
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: NONE|Primary Purpose: TREATMENT
Start Date: 2024-08-15
Completion Date: 2027-01-01

Summary:
CASTLE-VT is a randomized evaluation of prophylactic ablative treatment of arrhythmogenic ventricular scar in patients referred for HTx evaluation and diagnosed with ICM. Ablation will be performed with the use of a substrate-based approach in which the myocardial scar is mapped and ablated while the heart remains predominantly in sinus rhythm. The primary end point is the composite of all-cause mortality, worsening of HF requiring prioritized transplantation or LVAD implantation. The main secondary study end points are all-cause mortality, cardiovascular mortality, incidence of implantable cardioverter-defibrillator (ICD) therapy, hospitalizations, Quality of life, time to first ICD therapy, number of device-detected ventricular tachycardia/ventricular fibrillation episodes, LV function, and exercise tolerance. CASTLE-VT will randomize 160 patients with a follow up period of 2 years.

Primary Outcome Measures: Primary end point, Composite of all-cause mortality, worsening of HF requiring prioritized transplantation or LVAD implantation, through study completion, an average of 2 years
Secondary Outcome Measures: Secondary end point 1, all-cause mortality, cardiovascular mortality, through study completion, an average of 2 years|Secondary end point 2, incidence of implantable cardioverter-defibrillator (ICD) therapy, hospitalizations, number of device-detected ventricular tachycardia/ventricular fibrillation episodes, through study completion, an average of 2 years|Secondary end point 3, Quality of life, time to first ICD therapy, through study completion, an average of 2 years|Secondary end point 4, LV function, exercise tolerance, through study completion, an average of 2 years
Safety and Efficacy of Continuous Infusion of Terlipressin With Norepinephrine Versus Norepinephrine Alone in Improving Outcomes of Acute Kidney Injury in Acute on Chronic Liver Failure With Septic Shock
NCT Number: NCT06556472
Status: NOT_YET_RECRUITING
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Acute on Chronic Liver Failure
Interventions: DRUG: Terlipressin|DRUG: Norephrine
Sponsor: Institute of Liver and Biliary Sciences, India
Sex: ALL
Age: ADULT
Enrollment: 126
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: NONE|Primary Purpose: TREATMENT
Start Date: 2024-08-15
Completion Date: 2025-08-31
Locations: Institute of Liver & Biliary Sciences (ILBS), New Delhi, Delhi, 110070, India

Summary:
ACLF is defined differently in APASL,EASL and AASLD.APASL talks of reversibility in ACLF as per its definition and constitution of Homogenous population with ACLF.The definition of ACLF as per APASL is an acute hepatic insult manifesting as jaundice (serum bilirubin ≥ 5 mg/dL (85 micromol/L) and coagulopathy (INR ≥ 1.5 or prothrombin activity \< 40%) complicated within 4 weeks by clinical ascites and/or encephalopathy in a patient with previously diagnosed or undiagnosed chronic liver disease/cirrhosis, and is associated with a high 28-day mortality.

At the onset of septic shock there is initially an increased secretion of Arginine vasopressin. However, this initial rise is short lasting, and the vasopressin levels come back to normal or low serum levels with continued hypotension. However, even normal levels are too low for the degree of hypotension in septic shock. This causes a relative deficiency of vasopressin in septic shock. The exact time when this fall happens is not known and it is likely to be variable. Vasopressin was therefore tried as an agent in septic shock. Terlipressin is a synthetic analogue of vasopressin. It has a greater selectivity for the V1 receptor.

Currently, Norepinephrine is recommended as the first vasopressor to be started in general in septic shock population.(3) Catecholamines are the clinically used vasopressor agents of choice for supporting arterial blood pressure and ensuring adequate organ perfusion.

Development of adrenergic hyposensitivity with loss of catecholamine presser effects is seen in advanced stages of Vasodilatory Shock. Progressively increasing catecholamine therapy frequently enters into a vicious cycle of major adverse side effects resulting in continuous clinical deterioration necessitating further catecholamine excess.

Primary Outcome Measures: Proportion of patients developing 1 stage improvement in Acute kidney injury stage with resolution of shock at day 4 in both groups, Day 4
Secondary Outcome Measures: Outcome of acute kidney injury at day 4,7, Outcome in terms of resolution, persistence or progreession, Day 4 and 7|Incidence of adverse events in both groups, 1 year|Need of renal replacement therapy at day 7, Day 7|Duration of ICU and hospital stay, 1 year|Mortality, Day 7 and 28
Family-Based Financial Incentives Intervention for Smoking Cessation
NCT Number: NCT06556433
Acronym: Aniqsaaq-RCT
Status: NOT_YET_RECRUITING
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Smoking Cessation
Interventions: BEHAVIORAL: Financial Incentive Rewards
Sponsor: Mayo Clinic
Collaborators: National Institute on Drug Abuse (NIDA)|Alaska Native Tribal Health Consortium
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 1312
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: NONE|Primary Purpose: TREATMENT
Start Date: 2024-09-01
Completion Date: 2027-12-31
Locations: Alaska Native Tribal Health Consortium, Anchorage, Alaska, 99508, United States

Summary:
The current study will conduct an RCT to evaluate the effectiveness of a family-based incentive intervention with Alaska Native/American Indian families. The experimental arm will be compared to a control arm on biochemically-confirmed smoking abstinence at 6- and 12-months post-intervention.

Primary Outcome Measures: Change in smoking status, Number of participants to have biochemically verified, prolonged smoking abstinence., 6 months, 12 months
A Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of RAG-17 in Subjects With Amyotrophic Lateral Sclerosis (ALS) With Superoxide Dismutase Type 1 (SOD1) Gene Mutation
NCT Number: NCT06556394
Status: NOT_YET_RECRUITING
Study Type: INTERVENTIONAL
Phases: PHASE1
Conditions: Amyotrophic Lateral Sclerosis
Interventions: DRUG: RAG-17|DRUG: Placebo
Sponsor: Ractigen Therapeutics.
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 32
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: DOUBLE (PARTICIPANT, INVESTIGATOR)|Primary Purpose: TREATMENT
Start Date: 2024-08
Completion Date: 2026-04

Summary:
This is a Phase 1, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of RAG-17 in Subjects with Amyotrophic Lateral Sclerosis (ALS) with Superoxide Dismutase Type 1 (SOD1) Gene Mutation

Primary Outcome Measures: Adverse Events(AEs), Assesment of Safety and Tolerability: Incidence and severity of treatment-emergent Adverse Events(AEs) and Serious Adverse Events(SAEs), Before treatment and within 57 days after treatment
Secondary Outcome Measures: Plasma Pharmacokinetic (PK) Parameter: AUC0-last, Area Under the Plasma Concentration-Time Curve from Time 0 to the Last Measurable Non-zero Concentration, Before treatment and within 48 hours after treatment|Plasma Pharmacokinetic (PK) Parameter: AUC0-inf, Area Under the Plasma Concentration-Time Curve from Time 0 Extrapolated to Infinity, Before treatment and within 48 hours after treatment|Plasma Pharmacokinetic (PK) Parameter: Cmax, Peak Plasma Concentration, Before treatment and within 48 hours after treatment|Plasma Pharmacokinetic (PK) Parameter: Tmax, Time to reach Cmax. If the maximum value occurs at more than one time point, Tmax is defined as the first time point with this value, Before treatment and within 48 hours after treatment|Plasma Pharmacokinetic (PK) Parameter: λz, Elimination Rate Constant, Before treatment and within 48 hours after treatment|Plasma Pharmacokinetic (PK) Parameter: T½, Apparent Terminal Elimination Half-life of Study Drug, Before treatment and within 48 hours after treatment|Plasma Pharmacokinetic (PK) Parameter: CL/F, Apparent Clearance, Before treatment and within 48 hours after treatment|Plasma Pharmacokinetic (PK) Parameter: Vz/F, Apparent Volume of Distribution, Before treatment and within 48 hours after treatment|Plasma Pharmacokinetic (PK) Parameter: MRT, Mean Residence Time, Before treatment and within 48 hours after treatment|CSF Pharmacokinetic (PK) Parameter: Concentration, Concentration in Cerebrospinal Fluid(CSF), Before treatment and within 29 days after treatment|CSF Pharmacokinetic (PK) Parameter: T½, Half-life in Cerebrospinal Fluid(CSF), Before treatment and within 29 days after treatment
Efficacy of Trans Abdominis Plane Block for Post Cesarean Delivery Analgesia
NCT Number: NCT06556381
Status: RECRUITING
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Analgesia
Interventions: PROCEDURE: TAP block
Sponsor: Qassim University
Sex: FEMALE
Age: ADULT
Enrollment: 100
Study Design: Allocation: NON_RANDOMIZED|Intervention Model: PARALLEL|Masking: NONE|Primary Purpose: TREATMENT
Start Date: 2024-04-01
Completion Date: 2024-08-30
Locations: Qassim University Medical City, Buraidah, Qassim, 51411, Saudi Arabia

Summary:
Relief from pain is part of the fundamental human right to health. (1) However, available evidence indicates an increasingly detailed understanding of the pathophysiology of pain and general inadequacy of its treatment.

Primary Outcome Measures: Pain Score, NRS, 24 hours
A Study to Evaluate the Efficacy and Safety of Tarcocimab Tedromer and Tabirafusp Tedromer Compared to Aflibercept in Participants With Neovascular (Wet) Age-related Macular Degeneration (wAMD) - DAYBREAK
NCT Number: NCT06556368
Acronym: DAYBREAK
Status: RECRUITING
Study Type: INTERVENTIONAL
Phases: PHASE3
Conditions: Wet Age-related Macular Degeneration
Interventions: DRUG: Tarcocimab tedromer|DRUG: Tabirafusp tedromer|DRUG: Aflibercept
Sponsor: Kodiak Sciences Inc
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 675
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: QUADRUPLE (PARTICIPANT, CARE_PROVIDER, INVESTIGATOR, OUTCOMES_ASSESSOR)|Primary Purpose: TREATMENT
Start Date: 2024-08
Completion Date: 2026-01
Locations: Global Research Management, Inc. - Lugene Eye Institute, Glendale, California, 91204, United States|Retina Research Institute of Texas, Abilene, Texas, 79606, United States|Texas Retina Associates, Plano, Texas, 75075, United States

Summary:
A Study to Evaluate the Efficacy and Safety of Tarcocimab Tedromer and Tabirafusp Tedromer Compared to Aflibercept in Participants with Neovascular (Wet) Age-related Macular Degeneration (wAMD)

Primary Outcome Measures: Best corrected visual acuity (PCVA, Mean change in BCVA from Day 1 to Year 1, Week 48