pankajmathur/National_Library_of_Medicine_Studies_data huggingface dataset:
Exploring the Impact of Monocytes in Myeloproliferative Neoplasia (EMYNEM)
NCT Number: NCT06462664
Acronym: EMYNEM
Status: RECRUITING
Study Type: OBSERVATIONAL
Conditions: Myeloproliferative Neoplasm
Sponsor: University Hospital, Brest
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 10
Study Design: Observational Model: |Time Perspective: p
Start Date: 2024-06-01
Completion Date: 2028-01-31
Locations: Chu Brest, Brest, 29609, France

Summary:
Impact of monocytes on Myeloproliferative Neoplasm hematopoietic stem cell growth and differentiation in vitro

Primary Outcome Measures: Proliferation and differentiation of hematopoitic stem/progenitor cells, 2 years
Effect of Probiotic Limosilactobacillus Reuteri (L. Reuteri) on Crying and Fussing Time in Infants With Colic
NCT Number: NCT06462651
Status: NOT_YET_RECRUITING
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Infantile Colic
Interventions: DIETARY_SUPPLEMENT: L. reuteri|DIETARY_SUPPLEMENT: Placebo
Sponsor: BioGaia AB
Sex: ALL
Age: CHILD
Enrollment: 50
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: QUADRUPLE (PARTICIPANT, CARE_PROVIDER, INVESTIGATOR, OUTCOMES_ASSESSOR)|Primary Purpose: TREATMENT
Start Date: 2024-10
Completion Date: 2025-08

Summary:
This is a double-blind, randomized, placebo-controlled, parallel-group study in infants with colic with the primary objective to evaluate crying and fussing time.

Primary Outcome Measures: Crying and fussing time, To evaluate crying and fussing time after 7 days of supplementation with L. reuteri in infants with colic., [Time Frame: From baseline to Day 7]
Secondary Outcome Measures: Crying and fussing time, Change in mean daily crying and fussing time measured by Baby´s Day Diary, [Time Frame: From baseline up to Day 21]|Crying time, Change in mean daily crying time measured by Baby´s Day Diary, [Time Frame: From baseline up to Day 21]|Number of responders, Proportion of responders defined as reduction of daily average crying time with 50 % compared to baseline, [Time Frame: From baseline up to Day 21]|Family quality of life (family QoL), Change in family QoL measured by the PedsQL Family Impact Module (Acute) - Total Score, [Time Frame: From baseline up to Day 21]|Sleeping time, Change in mean sleeping time measured by Baby´s Day Diary, [Time Frame: From baseline up to Day 21]|Maternal depression, Change in maternal depression measured by the Edinburgh Postnatal Depression Scale Total Score, [Time Frame: From baseline up to Day 21]
Study of Lumateperone in the Treatment of Patients With Bipolar Mania
NCT Number: NCT06462612
Status: RECRUITING
Study Type: INTERVENTIONAL
Phases: PHASE3
Conditions: Bipolar Disorder, Manic
Interventions: DRUG: Lumateperone|DRUG: Placebo
Sponsor: Intra-Cellular Therapies, Inc.
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 350
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: TRIPLE (PARTICIPANT, INVESTIGATOR, OUTCOMES_ASSESSOR)|Primary Purpose: TREATMENT
Start Date: 2024-07-17
Completion Date: 2026-06
Locations: Clinical Site, Bentonville, Arkansas, 72712, United States|Clinical Site, Little Rock, Arkansas, 72211, United States|Clinical Site, Anaheim, California, 92805, United States|Clinical Site, Cerritos, California, 90703, United States|Clinical Site, Orange, California, 92868, United States|Clinical Site, Torrance, California, 90504, United States|Clinical Site, Hialeah, Florida, 33012, United States|Clinical Site, Miami Lakes, Florida, 33014, United States|Clinical Site, Miami Lakes, Florida, 33016, United States|Clinical Site, Miami, Florida, 33122, United States|Clinical Site, Miami, Florida, 33135, United States|Clinical Site, Miami, Florida, 33145, United States|Clinical Site, Tampa, Florida, 33629, United States|Clinical Site, West Palm Beach, Florida, 33407, United States|Clinical Site, Atlanta, Georgia, 30331, United States|Clinical Site, Stockbridge, Georgia, 30281, United States|Clinical Site, Chicago, Illinois, 60641, United States|Clinical Site, Glen Oaks, New York, 11004, United States|Clinical Site, Cincinnati, Ohio, 45219, United States|Clinical Site, Richardson, Texas, 75080, United States

Summary:
This is a multicenter, randomized, double-blind, placebo-controlled, study in the acute treatment of patients with a diagnosis of bipolar I disorder with manic episodes or manic episodes with mixed features (bipolar mania), with or without psychotic symptoms, according to criteria of the Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition (DSM 5).

Primary Outcome Measures: Young Mania Rating Scale (YMRS), The YMRS is an 11-item, clinician-administered mania rating scale designed to assess the severity of manic symptoms. Four of the YMRS items are rated on a 0 to 8 scale, with the remaining 7 items rated on a 0 to 4 scale. The total score ranges from 0 to 60 with a higher score indicating increased severity of manic symptoms., Week 3
Secondary Outcome Measures: Clinical Global Impression Scale-Severity (CGI-S), The CGI-S is a clinician-rated scale to assess a patient's overall mental health. The scale ranges from 1 (normal, not at all ill) to 7 (among the most extremely ill patients)., Week 3
Osteopontin Gene Polymorphism in Stroke Patients in Egypt
NCT Number: NCT06462599
Status: NOT_YET_RECRUITING
Study Type: OBSERVATIONAL
Conditions: Ischemic Stroke
Interventions: GENETIC: Gene polymorphism from blood samples
Sponsor: Assiut University
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 100
Study Design: Observational Model: |Time Perspective: p
Start Date: 2024-09
Completion Date: 2025-10

Summary:
This study aims to investigate the correlation of serum osteopontin level as a predictior and a prognostic factor in upper egyptian patients and correlation between Osteopontin Gene Polymorphisms and serum level of osteopontin in ischaemic stroke patients

Primary Outcome Measures: Measure osteopontin level in ischaemic stroke patients and different gene polymorphisms related to the disease, investigate the correlation of serum osteopontin level as a predictior and a prognostic factor in upper egyptian patients.

Correlation between Osteopontin Gene Polymorphisms and serum level of osteopontin in ischaemic stroke patients, Baseline
Study of Lumateperone in the Acute Treatment of Patients With Bipolar Mania
NCT Number: NCT06462586
Status: RECRUITING
Study Type: INTERVENTIONAL
Phases: PHASE3
Conditions: Bipolar Disorder, Manic
Interventions: DRUG: Lumateperone|DRUG: Placebo
Sponsor: Intra-Cellular Therapies, Inc.
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 350
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: TRIPLE (PARTICIPANT, INVESTIGATOR, OUTCOMES_ASSESSOR)|Primary Purpose: TREATMENT
Start Date: 2024-06-19
Completion Date: 2026-04
Locations: Clinical Site, Rogers, Arkansas, 72758, United States|Clinical Site, Bellflower, California, 90706, United States|Clinical Site, Culver City, California, 90230, United States|Clinical Site, Garden Grove, California, 92845, United States|Clinical Site, Lemon Grove, California, 91945, United States|Clinical Site, Montclair, California, 91763, United States|Clinical Site, Hallandale Beach, Florida, 33009, United States|Clinical Site, Hialeah, Florida, 33016, United States|Clinical Site, Miami Gardens, Florida, 33056, United States|Clinical Site, Miami Lakes, Florida, 33016, United States|Clinical Site, Miami Springs, Florida, 33166, United States|Clinical Site, Miami, Florida, 33184, United States|Clinical Site, Orlando, Florida, 32807, United States|Clinical Site, Atlanta, Georgia, 30324, United States|Clinical Site, Atlanta, Georgia, 30338, United States|Clinical Site, Decatur, Georgia, 30030, United States|Clinical Site, Savannah, Georgia, 31405, United States|Clinical Site, Shreveport, Louisiana, 71101, United States|Clinical Site, Marlton, New Jersey, 08053, United States|Clinical Site, North Canton, Ohio, 44720, United States|Clinical Site, Austin, Texas, 78701, United States|Clinical Site, Austin, Texas, 78754, United States|Clinical Site, DeSoto, Texas, 75115, United States

Summary:
This is a multicenter, randomized, double-blind, placebo-controlled, study in the acute treatment of patients with a diagnosis of bipolar I disorder with manic episodes or manic episodes with mixed features (bipolar mania), with or without psychotic symptoms, according to criteria of the Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition (DSM 5).

Primary Outcome Measures: Young Mania Rating Scale (YMRS), The YMRS is an 11-item, clinician-administered mania rating scale designed to assess the severity of manic symptoms. Four of the YMRS items are rated on a 0 to 8 scale, with the remaining 7 items rated on a 0 to 4 scale. The total score ranges from 0 to 60 with a higher score indicating increased severity of manic symptoms., Week 3
Secondary Outcome Measures: Clinical Global Impression Scale-Severity (CGI-S), The CGI-S is a clinician-rated scale to assess a patient's overall mental health. The scale ranges from 1 (normal, not at all ill) to 7 (among the most extremely ill patients)., Week 3
Extra-Corporeal Shock Wave Lithotripsy for Renal and Upper Ureteral Stones in Adults Under Locally Infiltrate d Anaesthetics ; a Clinical Randomized Controlled Study
NCT Number: NCT06462573
Status: NOT_YET_RECRUITING
Study Type: INTERVENTIONAL
Phases: EARLY_PHASE1
Conditions: Stone Ureter
Interventions: DRUG: locally infilterating anaethesia like lidocaine|DRUG: general anaethesia
Sponsor: Assiut University
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 60
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: NONE|Primary Purpose: DIAGNOSTIC
Start Date: 2024-09-01
Completion Date: 2026-09-01

Summary:
There are many treatment modalities available for managing renal and upper ureteric stones. They range from completely non-invasive outpatient procedures to invasive procedures requiring hospital admission and increased risks of complications. Extracorporeal shockwave lithotripsy (ESWL) is a truly non-invasive procedure as opposed to other surgical treatments used, such as retrograde intrarenal surgery and percutaneous nephrolithotomy (1).

The choice between shockwave lithotripsy (SWL) and other treatment modalities depends on several factors, including stone site, stone burden, stone CT density, etc. Another compounding factor in choosing the treatment modality is patient preference and expectation (1).

Extracorporeal Shock Wave Lithotripsy is one of the treatment options for patients with renal and ureteral calculi. Even though the procedure is less invasive compared to others. Pain caused by the procedure is a major concern. Several studies recommended the use of either local or systemic analgesia with varying results (2).

As a truly non-invasive treatment option, ESWL has been widely used for treating renal, as well as ureteric, stones with satisfactory efficacy and minimal morbidity. However, the pain caused by ESWL is a major limitation of its efficacy, in addition to the associated patient dissatisfaction and negative experience that may result in the patient refraining from further sessions.

The relationship between pain and ESWL efficacy can be explained by multiple facts: firstly, the pain leads to inability to increase the energy delivered by the shockwaves to optimum levels; secondly, the pain usually leads to significant movement of the patient, as well as excessive respiratory movements, both of which move the stone away from the focus of shockwaves; lastly, the pain may be severe that the session is discontinued before delivery of effective number of shockwaves

Primary Outcome Measures: Comparison between local and systemic analgesia, Pain score during the session using visual analogue scale, Baseline
Secondary Outcome Measures: Comparison between local and systemic analgesia, 4. Two-month stone free rate (SFR), Baseline
Live and Interactive Fitness Training Program (Vivo Knee OA)
NCT Number: NCT06462560
Acronym: LIFT-OA
Status: RECRUITING
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Knee Osteoarthritis
Interventions: OTHER: Vivo Online Exercise Program|OTHER: Medbridge Home program
Sponsor: Intermountain Health Care, Inc.
Collaborators: Impactiv, Inc.
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 334
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: NONE|Primary Purpose: TREATMENT
Start Date: 2024-04-28
Completion Date: 2026-04
Locations: Intermountain Health, Murray, Utah, 84107, United States

Summary:
Potential participants will be screened at clinic. Patients who meet eligibility criteria will be considered for study. After written informed consent is obtained, participants will complete baseline testing and participants who meet eligibility criteria will be randomized 1:1 to 2 treatment arms: Vivo Arm: Vivo twice a week for 6 months and Usual Care Arm: meet with ATC and given Medbridge home exercise program for 6 months. All participants will be followed for 12 months, and will be assessed at 3-,6-, and 12-months. All participants will complete functional assessments, OA patient reported outcomes measures, quality of life, exercise self-efficacy, and fall risk questionnaires, and health care utilization report at each testing visit. A subset of Vivo participants will be asked satisfaction questions at the 3 and 6 month time points.

Primary Outcome Measures: Primary Endpoint 1, Changes from baseline in number of chair stands done in 30-seconds at 3 and 6 months., 6 months post intervention
Secondary Outcome Measures: Secondary Endpoint 1, Changes from baseline in WOMAC score at 3 and 6 months., 6 months post intervention|Secondary Endpoint 2, Changes from baseline in length of time (seconds) to do 1-leg balance stance at 3 and 6 months., 6 months post intervention|Secondary Endpoint 3, Changes from baseline in seconds to complete the 8-foot up and go at 3 and 6 months., 6 months post intervention|Secondary Endpoint 4, Changes from baseline in number of knee raises completed in 2-minute knee raise at 3 and 6 months, 6 months post intervention|Secondary Endpoint 5, Changes from baseline in number of arm-curls done in 30 seconds at 3 and 6 months, 6 months post intervention|Secondary Endpoint 6, Changes from baseline in PROMIS-Plus-Osteoarthritis of the Knee (OAK) score at 3 and 6 months, 6 months post intervention|Secondary Endpoint 7, Changes from baseline in exercise self-efficacy scale score at 3 and 6 months, 6 months post intervention|Secondary Endpoint 8, Changes from baseline in quality of life (SF-36 score) at 3 and 6 months, 6 months post intervention
ADAPT Study: Long-term Safety Study of INZ-701 in Patients With ENPP1 Deficiency and ABCC6 Deficiency
NCT Number: NCT06462547
Status: RECRUITING
Study Type: INTERVENTIONAL
Phases: PHASE2
Conditions: Gene Mutations|Pseudoxanthoma Elasticum|Arterial Calcification|Ectonucleotide Pyrophosphatase/phosphodiesterase1 Deficiency|Autosomal Recessive Hypophosphatemic Rickets Type 2
Interventions: DRUG: INZ-701
Sponsor: Inozyme Pharma
Sex: ALL
Age: CHILD, ADULT, OLDER_ADULT
Enrollment: 200
Study Design: Allocation: NA|Intervention Model: SINGLE_GROUP|Masking: NONE|Primary Purpose: TREATMENT
Start Date: 2024-06-19
Completion Date: 2030-12
Locations: Mayo Clinic, Rochester, Minnesota, 55905, United States|Clinilabs Drug Development Corporation, Eatontown, New Jersey, 07724, United States|Necker-Enfants Malades Hospital, Paris, France|Parexel Early Phase Clinical Unit, Berlin, Germany|Universitätsklinikum Hamburg-Eppendorf (UKE), Hamburg, Germany|VCTC, Oxford, United Kingdom

Summary:
The purpose of this study (Study INZ701-304 \[ADAPT\]) is to assess the long-term safety of INZ-701 in patients with ENPP1 Deficiency or ABCC6 Deficiency who have received INZ-701 in an existing clinical study and choose to continue dosing for the potential treatment of their condition.

Primary Outcome Measures: Number of Treatment Emergent Adverse Events (TEAEs), Treatment-emergent AEs are defined as any AE occurring from the first dose of INZ-701 through 30 days after the last dose of INZ-701., 6 years (long term safety assessment)|Incidence of Anti-Drug Antibodies (ADA), For each subject, the presence of ADAs will be assessed and, if present, further evaluation will determine specificity and subtypes., 6 years (long term safety assessment)
Secondary Outcome Measures: Time to maximum serum concentration (Tmax), For each subject, the time to reach maximum concentration of INZ-701 in the plasma will be measured via a series of blood samples obtained throughout the study, comparing the participant's baseline value over time., 6 years (long term safety assessment)|Maximum Plasma Concentration (Cmax) of INZ-701, For each subject, the maximum concentration of INZ-701 in the plasma will be measured via a series of blood samples obtained throughout the study, comparing the participant's baseline value over time.collected and assessed., 6 years (long term safety assessment)|Mean Change from Baseline in Plasma PPi Concentration, For each subject, their plasma PPi concentrations based on a validated assay will be collected and assessed throughout the study, comparing the participant's baseline value over time., 6 years (long term safety assessment)
The Band-Frail Study: A Provincial Intervention to Outweigh Diabetes and Frailty in New Brunswick
NCT Number: NCT06462534
Status: COMPLETED
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Type 2 Diabetes|Frailty
Interventions: BEHAVIORAL: Band-Frail Program
Sponsor: University of New Brunswick
Collaborators: Public Health Agency of Canada (PHAC)
Sex: ALL
Age: OLDER_ADULT
Enrollment: 203
Study Design: Allocation: NA|Intervention Model: SINGLE_GROUP|Masking: NONE|Primary Purpose: SUPPORTIVE_CARE
Start Date: 2021-03-01
Completion Date: 2022-12-31
Locations: University of New Brunswick- Faculty of Kinesiology, Fredericton, New Brunswick, E3B5A3, Canada

Summary:
The goal of this study is to test whether psychological, social, and physical health outcomes of older adults living with type 2 diabetes and frailty are improved when participating in the Band-Frail Program.

Primary Outcome Measures: Physical Functioning, Physical functioning will be measured using the Short Physical Performance Battery (SPPB). The SPPB is a three-part standardized test including balance, gait, and chair stand components each scored out of 4 points for a total possible score ranging from 0 to 12 points. A higher SPPB score suggests high levels of physical functioning, while a lower SPPB score suggests functional limitations., 16 weeks
Secondary Outcome Measures: Frailty Status, Frailty status will be measured using Fried's Frailty Scale. The scale includes five frailty criteria: unintentional weight loss, exhaustion, low physical activity, slowness, and weak grip strength.

Participants will be scored in each of the five criteria and then given a cumulative score ranging from 0 to 5 to represent their frailty status. Participants who score three or more criteria will be considered frail, individuals who score one or two criteria will be considered pre-frail, and those who score zero criteria will be considered robust (non-frail)., 16 weeks
Cold Snare Piecemeal Resection vs Cold Snare Endoscopic Mucosal Resection
NCT Number: NCT06462521
Acronym: CARDINAL
Status: ENROLLING_BY_INVITATION
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Colon Cancer|Colon Polyp|Colon Adenoma|Serrated Polyp
Interventions: PROCEDURE: Cold Snare Piecemeal Resection (CSPR)|PROCEDURE: Cold Snare Endoscopic Mucosal Resection (Cold EMR)
Sponsor: Indiana University
Collaborators: Rush University Medical Center|Minneapolis Veterans Affairs Medical Center|John D. Dingell VA Medical Center|Carilion Clinic|White River Junction Veterans Affairs Medical Center|The University of Kansas Medical Center|Vancouver Coastal Health|Université de Montréal
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 285
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: NONE|Primary Purpose: PREVENTION
Start Date: 2024-08-29
Completion Date: 2026-01
Locations: Indiana University, Indianapolis, Indiana, 46202, United States

Summary:
The study will compare the use of cold snare piecemeal resection (CSPR) vs cold endoscopic mucosal resection (Cold EMR). The study will include two cohorts: one cohort for conventional adenomas 10-19mm in size and one cohort for serrated lesions 10mm or larger.

Primary Outcome Measures: Efficacy of Resection (Central Post-Resection Biopsies), Efficacy of resection will be assessed by biopsies in four or six quadrants of the perimeter of the defect post-resection and two biopsies from the center of the defect post-resection. Comparison of the biopsy pathology results for polyps removed by Cold EMR vs CSPR., 1 day|Efficacy of Resection (Peripheral Post-Resection Biopsies), Efficacy of resection will be assessed by biopsies in four or six quadrants of the perimeter of the defect post-resection and two biopsies from the center of the defect post-resection. Comparison of the biopsy pathology results for polyps removed by Cold EMR vs CSPR., 1 day
Head-to-head Comparison of [18F]F-PSMA-N5 With [68Ga]Ga-PSMA-11 PET/CT in PCa Diagnosis, Recurrence, and Metastasis
NCT Number: NCT06462508
Status: RECRUITING
Study Type: INTERVENTIONAL
Phases: EARLY_PHASE1
Conditions: Prostate Cancer|PET/CT
Interventions: DRUG: [18F]F-PSMA-N5|DRUG: [68Ga]Ga-PSMA-11
Sponsor: Anhui Provincial Hospital
Sex: MALE
Age: ADULT, OLDER_ADULT
Enrollment: 30
Study Design: Allocation: NA|Intervention Model: SINGLE_GROUP|Masking: NONE|Primary Purpose: DIAGNOSTIC
Start Date: 2024-04-20
Completion Date: 2025-12-31
Locations: The First Affiliated Hospital of China University of Science and Technology（Anhui Provincial Hospital）, Hefei, Anhui, 230000, China

Summary:
To prospectively evaluate the radiodrug biodistribution of a novel PET imaging agent \[18F\]F-PSMA-N5 in different organs of prostate cancer patients and its diagnostic efficacy in the diagnosis, recurrence and metastasis of prostate cancer, and to compare with \[68Ga\]Ga-PSMA-11.

Primary Outcome Measures: Standard uptake value(SUV), Standard uptake value(SUV) of \[18F\]F-PSMA-N5 and \[68Ga\]Ga-PSMA-11 for each target lesion of subjects., 30 days
Secondary Outcome Measures: Diagnostic efficacy, The sensitivity, specificity and accuracy of \[18F\]F-PSMA-N5 and \[68Ga\]Ga-PSMA-11 PET/CT were calculated., 30 days|Number of lesions, The number of lesions detected by \[18F\]F-PSMA-N5 and \[68Ga\]Ga-PSMA-11 PET/CT., 30 days
Head-to-head Comparison of [18F]F-PSMA-N5 With [18F]F-PSMA-1007 PET/CT in PCa Diagnosis, Recurrence, and Metastasis
NCT Number: NCT06462495
Status: RECRUITING
Study Type: INTERVENTIONAL
Phases: EARLY_PHASE1
Conditions: Prostate Cancer|PET/CT
Interventions: DRUG: [18F]F-PSMA-N5|DRUG: [18F]F-PSMA-1007
Sponsor: Anhui Provincial Hospital
Sex: MALE
Age: ADULT, OLDER_ADULT
Enrollment: 30
Study Design: Allocation: NA|Intervention Model: SINGLE_GROUP|Masking: NONE|Primary Purpose: DIAGNOSTIC
Start Date: 2024-04-10
Completion Date: 2025-12-31
Locations: The First Affiliated Hospital of China University of Science and Technology（Anhui Provincial Hospital）, Hefei, Anhui, 230000, China

Summary:
To prospectively evaluate the radiodrug biodistribution of a novel PET imaging agent \[18F\]F-PSMA-N5 in different organs of prostate cancer patients and its diagnostic efficacy in the diagnosis, recurrence and metastasis of prostate cancer, and to compare with \[18F\]F-PSMA-1007.

Primary Outcome Measures: Standard uptake value(SUV), Standard uptake value(SUV) of \[18F\]F-PSMA-N5 and \[18F\]F-PSMA-1007 for each target lesion of subjects., 30 days
Secondary Outcome Measures: Diagnostic efficacy, The sensitivity, specificity and accuracy of \[18F\]F-PSMA-N5 and \[18F\]F-PSMA-1007 PET/CT were calculated., 30 days|Number of lesions, The number of lesions detected by \[18F\]F-PSMA-N5 and \[18F\]F-PSMA-1007 PET/CT., 30 days
Peri-Operative Testosterone Administration in Primary Hip Arthroscopy
NCT Number: NCT06462482
Status: NOT_YET_RECRUITING
Study Type: INTERVENTIONAL
Phases: PHASE4
Conditions: Femoro Acetabular Impingement
Interventions: DRUG: Nandrolone Decanoate|DRUG: Saline
Sponsor: American Hip Institute
Sex: MALE
Age: ADULT, OLDER_ADULT
Enrollment: 60
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: SINGLE (OUTCOMES_ASSESSOR)|Primary Purpose: TREATMENT
Start Date: 2024-08
Completion Date: 2026-12

Summary:
It is often observed that patients following hip surgery have a hard time with rehabilitation, as patients commonly lose muscle mass and strength around the surgical site. The goal of this study is to learn if giving patients testosterone around their hip surgery can prevent them from losing muscle mass, as well as to see if it will improve their outcomes after surgery. The main question this study aims to answer is: Will perioperative testosterone administration increase lean mass in addition to improving functional and clinical patient reported outcomes greater than placebo?

Researchers will compare patients who were administered testosterone to standard of care (no administration of testosterone) to see if there is a difference in their recovery and outcomes.

Participants will be given either testosterone or saline for eight weeks beginning two weeks prior to surgery. Participants will have to answer questionnaires on how they are doing, as well as will do other testing during this time.

Primary Outcome Measures: modified Harris Hip Score, Patient-reported outcome measure. Scale 0-100, 100 indicating optimal function outcome, 2 years
Secondary Outcome Measures: Total lean body mass, Measuring total lean body mass via Lunar IDXA, 2 years|Nonarthritic Hip Score, Patient-reported outcome measure. Scale 0-100, 100 indicating optimal function outcome, 2 years|HOS-SSS, Patient-reported outcome measure. Scale 0-100, 100 indicating optimal function outcome, 2 years|iHOT-12, Patient-reported outcome measure. Scale 0-100, 100 indicating optimal function outcome, 2 years|Age, Demographic information, Before surgery|Body mass index, Demographic information, Before surgery|Sex, Demographic information, Before surgery
Post-market Clinical Follow-up Study of Alcon PRECISION1™ Spherical and PRECISION1™ for Astigmatism Soft Contact Lenses
NCT Number: NCT06462456
Status: NOT_YET_RECRUITING
Study Type: OBSERVATIONAL
Conditions: Refractive Errors
Interventions: DEVICE: Verofilcon A spherical soft contact lenses|DEVICE: Verofilcon A toric soft contact lenses
Sponsor: Alcon Research
Sex: ALL
Age: CHILD, ADULT, OLDER_ADULT
Enrollment: 168
Study Design: Observational Model: |Time Perspective: p
Start Date: 2024-10
Completion Date: 2027-12

Summary:
The purpose of this study is to assess long term performance and safety of verofilcon A soft contact lenses in a real-world setting in a population of 7 years or older having at least 1 year of verofilcon A (sphere or toric) contact lens wear in a daily wear and daily disposable modality.

Primary Outcome Measures: Distance Visual Acuity with Study Lenses at Baseline, Visual acuity (VA) assessed per the investigator's standard of care with study lenses in place., Baseline|Distance Visual Acuity with Study Lenses at Year 1 Follow-Up, Visual acuity (VA) assessed per the investigator's standard of care with study lenses in place., Year 1|Incidence of Corneal Infiltrative Events, A corneal infiltrate is a single or group of inflammatory cells in the normally clear cornea., Up to Year 1|Incidence of Microbial Keratitis, Microbial keratitis is a sight-threatening infection of the cornea., Up to Year 1
A Prospective Study of RISE for Physicians
NCT Number: NCT06462443
Status: RECRUITING
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Stress|Burn Out
Interventions: BEHAVIORAL: RISE for Physicians Program
Sponsor: AdventHealth
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 36
Study Design: Allocation: NA|Intervention Model: SINGLE_GROUP|Masking: NONE|Primary Purpose: SUPPORTIVE_CARE
Start Date: 2024-06-03
Completion Date: 2024-12-31
Locations: AdventHealth, Orlando, Florida, 32804, United States

Summary:
The purpose of this study is to determine whether the RISE for Physicians program has a significant impact on physicians' burnout, resilience, insight, self-compassion, empowerment, and professional and personal mental health and well-being.

Primary Outcome Measures: Maslach Burnout Inventory - Human Services Survey, 22-item questionnaire with the following response categories: 0=never, 1=a few times a year or less, 2=once a month or less, 3=a few times a month, 4=once a week, 5=a few times a week, 6=every day, Baseline, 1-month follow-up, 3-month follow-up
Secondary Outcome Measures: Professional Quality of Life Scale, 30-item questionnaire with the following response categories: 1=never, 2=rarely, 3=sometimes, 4=often, 5=very often, Baseline, 1- and 3-month follow-up|Brief Resilience Scale, 6-item questionnaire with the following response categories: 1=strongly agree, 2=disagree, 3=neutral, 4=agree, 5=strongly agree, Baseline, 1- and 3-month follow-up|Self-Reflection and Insight Scale - Short Form, 12-item questionnaire with the following response categories: 1=strongly disagree, 2, 3, 4, 5, 6, 7=strongly agree, Baseline, 1- and 3-month follow-up|Self-Compassion Scale - Short Form, 12-item questionnaire with the following response categories: 1=almost never, 2, 3, 4, 5=almost always, Baseline, 1- and 3-month follow-up|General Self-Efficacy Scale, 10-item questionnaire with the following response categories: 1=not at all true, 2=barely true, 3=moderately true, 4=exactly true, Baseline, 1- and 3-month follow-up|Perceived Stress Scale, 10-item questionnaire with the following response categories: 0=never, 1=almost never, 2=sometimes, 3=fairly often, 4=very often, Baseline, 1- and 3-month follow-up|Work-Life Climate Scale, 7-item questionnaire with the following response categories: rarely or none of the time (\<1 day), some or a little of the time (1-2 days), occasionally or a moderate amount of time (3-4 days), all of the time (5-7 days), Baseline, 1- and 3-month follow-up|Moral Injury Outcomes Scale, 14-item questionnaire with the following response categories: 0=strongly agree, 1=disagree, 2=neither agree or disagree, 3=agree, 4=strongly agree, Baseline, 1- and 3-month follow-up|Generalized Anxiety Disorder - 2 item scale, 2-item questionnaire with the following response categories: 0=not at all, 1=several days, 2=more than half the days, 3=nearly every day, Baseline, 1- and 3-month follow-up|Patient Health Questionnaire - 2 item, 2-item survey with the following response categories: 0=not at all, 1=several days, 2=more than half the days, 3=nearly every day, Baseline, 1- and 3-month follow-up
PTEN Hamartoma Tumor Syndrome Pediatric Patient Registry
NCT Number: NCT06462430
Status: RECRUITING
Study Type: OBSERVATIONAL
Conditions: PTEN Hamartoma Tumor Syndrome|Macrocephaly Autism Syndrome
Sponsor: Acibadem University
Collaborators: Boston Children's Hospital|Ege University
Sex: ALL
Age: CHILD, ADULT, OLDER_ADULT
Enrollment: 100
Study Design: Observational Model: |Time Perspective: p
Start Date: 2022-11-01
Completion Date: 2026-01-02
Locations: Acibadem University, Istanbul, Turkey

Summary:
PtenTurkiye.org' is a national ( Turkish), web-based registry for PTEN Hamartoma Tumour ( PHTS) syndrome established in 2022. It is designed to increase awareness, gather scientific knowledge by collaboration and increase data accessibility, collect high-quality data on the epidemiology, genetic background and natural history of PHTS especially for pediatric patients so that more accurate follow up guidelines can be recommended.

Primary Outcome Measures: Genotype-phenotype correlations of pediatric patients with PTEN Hamartoma Tumor Syndrome (PHTS) and creation of patient registry, Longitudinal follow up of pediatric patients with PTEN Hamartoma Tumor syndrome ( PHTS) and their adult relatives with PHTS for 3 years to better understand this syndrome to be able to find better follow up guidelines., 3 years
Efficacy and Safety of Arbidol in the Treatment of Allergic Rhinitis
NCT Number: NCT06462417
Status: NOT_YET_RECRUITING
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Allergic Rhinitis
Interventions: DRUG: Arbidol
Sponsor: Zheng Liu
Collaborators: National Natural Science Foundation of China
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 15
Study Design: Allocation: NA|Intervention Model: SINGLE_GROUP|Masking: NONE|Primary Purpose: TREATMENT
Start Date: 2024-06-20
Completion Date: 2025-06-30
Locations: Department of ENT, Tongji Hospital, Tongji Medical College, Huazhong University of Science and Technology, Wuhan, Hubei, 430030, China

Summary:
The most important treatment for AR is topical nasal medications (including nasal corticosteroids, nasal antihistamines, nasal decongestants, and nasal saline irrigation etc.), which are still limited. Arbidol may inhibit molecular targets involved in the pathogenesis of AR. This study intends to explore the effect of Arbidol in the treatment of allergic rhinitis and evaluate its efficacy and safety.

Primary Outcome Measures: The protein level of molecular biomarkers in nasal epithelial cells, The level of molecular biomarkers in nasal epithelial cells at baseline (day 0, prior to treatment), day 14 will be measured by western blotting., 14 days|The mRNA level of inflammation molecular biomarkers in nasal epithelial cells, The relative mRNA level of inflammatory cytokines (including IL-4, IL-13, CCL11, CCL24, CCL26 etc.) in nasal epithelial cells at baseline (day 0, prior to treatment), day 14 will be measured by Real-time PCR., 14 days|The level of inflammation molecular biomarkers in nasal lavage fluid, Investigate the change of inflammation molecular biomarkers using sample of nasal lavage fluid. Biomarkers including IL-4, IL-13, CCL11, CCL24, CCL26 and IgE etc. in nasal lavage fluid at day 7 day 14 were detected to compare the changes of molecular indices relative to baseline at day 0., 14 days
Secondary Outcome Measures: Changes from baseline in daily total nasal symptom score (TNSS) during 2 weeks of treatment., The TNSS for allergic rhinitis was used to evaluate the rhinitis-related symptoms and quantity of life scores. Changes from baseline in daily total nasal symptom score (TNSS) during 2 weeks of treatment. The Total Nasal Symptom Score (TNSS) is the sum of four symptom scores, rhinorrhea, nasal congestion, nasal itching, and sneezing, where each symptom is scored on a scale of 0 to 3., 14 days
Proton Therapy for Locally Advanced Cervical Cancer
NCT Number: NCT06462378
Status: RECRUITING
Study Type: INTERVENTIONAL
Phases: PHASE2
Conditions: Cervical Cancer|Proton Therapy|Radiotherapy Side Effect
Interventions: RADIATION: Proton therapy
Sponsor: University of Aarhus
Collaborators: Aarhus University Hospital
Sex: FEMALE
Age: ADULT, OLDER_ADULT
Enrollment: 55
Study Design: Allocation: NA|Intervention Model: SINGLE_GROUP|Masking: NONE|Primary Purpose: TREATMENT
Start Date: 2024-05-20
Completion Date: 2034-05-20
Locations: Department of Oncology, Capital Region Denmark, Copenhagen, Denmark

Summary:
The purpose of this protocol is to determine toxicity and efficacy of proton therapy in combination with standard concomitant platinum-based chemotherapy and standard image-guided adaptive brachytherapy (IGABT) in patients with locally advanced cervical cancer (LACC). The over-all aim is to maintain a high disease control and at the same time reduce acute morbidity as well as late side effects after treatment.

Primary Outcome Measures: Acute Bone marrow toxicity, Grade 2+ Bone marrow toxicity, Worst recorded baseline to 3 months after RT
Secondary Outcome Measures: Late bone marrow toxicity, Grade 2+ Bone marrow toxicity, >3 month to 5 years after RT|Toxicity, Toxicity evaluated by NCI-CTCAE v. 5.0 (common terminology criteria for adverse events grade 0-5, 5 indicating worse outcome), baseline to 5 years after RT|Patient Reported outcomes, Patient reported outcomes (by EORTC QLQ-C30, grades 1-4 four indicating worse outcome), baseline to 5 years after treatment|Patient Reported outcomes, Patient reported outcomes (by European Organisation for Research and Treatment of Cancer (EORTC) (Quality of life Questionnaire) QLQ-CX24 grades 1-4 four indicating worse outcome), baseline to 5 years after treatment|cisplatin, Cummulative dose (mg), 3 month|Oncological outcomes, Progression free survival, 5-year|Dosimetrics outcomes, External Beam Radiotherapy dose volume to organs at risk (NCI-CTCAE) and comparison to (Image Guided intensity modulated external beam radiochemotherapy and MRI based adaptive brachy therapy in loaclly advanced cervical cancer) EMBRACE II cohort, 3 month
Other Outcome Measures: Local control, Local tumor control, 5-year|Overall survial, Overall survial, 5-year
Prevention of GvHD in Participants With Hematological Malignancies Undergoing Hematopoietic Stem Cell Transplant (HSCT)
NCT Number: NCT06462365
Status: RECRUITING
Study Type: INTERVENTIONAL
Phases: PHASE1
Conditions: Hematologic Malignancy|GvHD|GVHD,Acute|GVHD, Chronic|Hematopoietic Stem Cell Transplant|Acute Lymphoblastic Leukemia, Adult B-Cell|Acute Lymphoblastic Leukemia, Adult T-Cell|Acute Myeloid Leukemia in Remission|Myelodysplastic Syndromes|Chronic Myelomonocytic Leukemia, in Remission|Cancer Remission
Interventions: BIOLOGICAL: TRX103
Sponsor: Tr1X, Inc.
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 36
Study Design: Allocation: NA|Intervention Model: SEQUENTIAL|Masking: NONE|Primary Purpose: PREVENTION
Start Date: 2024-04-08
Completion Date: 2027-04-15
Locations: City of Hope, Duarte, California, 91010, United States|University of Minnesota, Minneapolis, Minnesota, 55455, United States|Fred Hutchinson Cancer Center, Seattle, Washington, 98109, United States

Summary:
The purpose of this Phase 1, first in human open-label study is to assess the safety and tolerability of TRX-103 in patients with hematological malignancies undergoing HLA-mismatched related or unrelated hematopoietic stem cell transplantation (HSCT). It is anticipated that up to 36 Subjects will be enrolled during a 18-24 month enrollment period. TRX-103 will be infused one time post HSCT.

Primary Outcome Measures: Safety and tolerability of TRX103 cell infusion through incidence of Adverse events., Up to a year|Safety of TRX103 determined by stem cell engraftment and donor chimerism after HSCT measured by absolute neutrophil counts and percent donor chimerism., Up to day 42|Safety of TRX103 determined by negative Replication Competent Lentivirus (RCL)., At 3-month, 6-month, and 1-year.
Secondary Outcome Measures: Incidence of Grade II-IV acute GvHD (aGvHD)., Day 0 to Day +100 day|Incidence of Grade III-IV acute GvHD (aGvHD)., Day 0 to Day +100 day|Incidence and severity of chronic GvHD (cGvHD), Day +100 through Day +365|Overall survival at Day +365., Up to a year
EFFECT OF A SUBSTANCE P ANTAGONIST ON THE SECRETION OF ALDOSTERONE IN PATIENTS WITH OBSTRUCTIVE SLEEP APNEA SYNDROME AND ARTERIAL HYPERTENSION
NCT Number: NCT06462287
Acronym: APHOS 3
Status: RECRUITING
Study Type: INTERVENTIONAL
Phases: PHASE2
Conditions: Apnea, Obstructive
Interventions: DRUG: Aprepitant 125 and 80Mg Oral Capsule|DRUG: Placebo
Sponsor: University Hospital, Rouen
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 24
Study Design: Allocation: RANDOMIZED|Intervention Model: CROSSOVER|Masking: SINGLE (PARTICIPANT)|Primary Purpose: TREATMENT
Start Date: 2024-03-05
Completion Date: 2026-04-19
Locations: CHU de Rouen, Rouen, 76000, France

Summary:
Obstructive sleep apnea syndrome (OSAS) is associated with hyperaldosteronism with elevated plasma aldosterone/renin ratio, the physiopathological mechanism of which remains uncertain. This hyperaldosteronism contributes to the development of arterial hypertension and cardiovascular complications observed in patients with OSA, in particular by increasing arterial stiffness and heart rate variability. The frequent association of OSA with obesity with metabolic syndrome suggests that excess weight could be responsible for stimulation of aldosterone secretion independent of the renin/angiotensin system. Several studies indicate in particular that the production of mineralocorticoids by the adrenals could be activated by various adipocyte secretion products such as leptin and certain fatty acids after oxidation in the liver. In addition, a recent study showed that basal aldosterone secretion is also controlled by substance P released within the adrenal tissue itself by nerve fibers belonging to the splanchnic contingent. Thus, the oral administration of aprepitant, an antagonist of the substance P receptor (NK1 receptor), to healthy volunteers induces a reduction of approximately 30% in the overall secretion of aldosterone assessed by measuring aldosteronemia and 24-hour aldosteronuria. To the extent that OSA causes sympathetic hypertonia, the hypothesis is that the associated hyperaldosteronism could result from activation of the nervous control of aldosterone secretion, involving substance P and the NK1 receptor. If this is indeed the case, the administration of aprepitant to patients with OSA should result in a significant reduction in aldosteronemia.

Primary Outcome Measures: Rate of aldosterone secretion, Measurement of 24-hour aldosteronuria before and after the administration of an NK1 receptor antagonist (aprepitant) or placebo in patients suffering from obstructive sleep apnea syndrome (OSAS) and arterial hypertension, Immediately after the intervention/procedure/surgery
Phenotypic and Genotypic Characterization of Escherichia Coli
NCT Number: NCT06462261
Status: NOT_YET_RECRUITING
Study Type: OBSERVATIONAL
Conditions: Antibiotic Sensitivity Testing and Genotypic Caharacterization of Ecoli
Sponsor: Sohag University
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 100
Study Design: Observational Model: |Time Perspective: p
Start Date: 2024-07-01
Completion Date: 2025-03

Summary:
Collection of urine samples Cultivation Antibiotic sensitivity test PCR

Primary Outcome Measures: Antibiotic sensitivity testing whether sensitive .intermediately sensitive and resistance, 6 month
Anti-CD19 Chimeric Antigen Receptor Modified T-cell (CAR-T) Therapy for Treatment of B-cell Hematological Malignancies
NCT Number: NCT06462248
Status: RECRUITING
Study Type: INTERVENTIONAL
Phases: PHASE2
Conditions: Lymphoma, Nonhodgkin|Leukemia, Lymphocytic
Interventions: DRUG: CUCART19
Sponsor: Chi Kong Li
Collaborators: Hong Kong Children's Hospital
Sex: ALL
Age: CHILD, ADULT, OLDER_ADULT
Enrollment: 20
Study Design: Allocation: NA|Intervention Model: SINGLE_GROUP|Masking: NONE|Primary Purpose: TREATMENT
Start Date: 2024-06-01
Completion Date: 2027-12-31
Locations: Prince of Wales Hospital, Hong Kong, China

Summary:
CAR-T therapy is now available as a commercial product for treatment of relapsed /refractory acute lymphoblastic leukaemia and B-lymphoma. There is limited access to this new treatment as the product is very expensive. It is imperative to develop cost effective, closed circuit manufacturing systems for CAR-T cells to make CAR-T cells a point-of care production option. Hong Kong Institute of Biotechnology has established a certified GMP facility and utilize the Prodigy system to manufacture CAR-T cells for clinical application. Prince of Wales Hospital and Hong Kong Children's Hospital will conduct the phase II clinical trial to confirm the efficacy and safety of local manufactured CAR-T cell product.

Primary Outcome Measures: Production efficiency of CAR-T cell manufacturing, At least 90% of patients enrolled should be able to achieve successful production of CAR T cells as deomonstrated by CAR-T cell proliferation and persisteance of CAR-T cells in recipients for at least one month after infusion, 18 months
Secondary Outcome Measures: survival outcome, Achieve a leukemia free survival at 3 months of 60% or higher, and overall survival of B cell ALL patients at 6 months of 50% or higher. Overall and progression free survival of patients with B cell NHL, 24 months
Immune Checkpoint Inhibitor Combined With Pemetrexed Intrathecal Injection for Leptomeningeal Metastasis From Solid Tumors
NCT Number: NCT06462222
Status: NOT_YET_RECRUITING
Study Type: INTERVENTIONAL
Phases: PHASE1|PHASE2
Conditions: Leptomeningeal Metastasis
Interventions: DRUG: Toripalimab, pemetrexed
Sponsor: Guangzhou Medical University
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 34
Study Design: Allocation: NA|Intervention Model: SINGLE_GROUP|Masking: NONE|Primary Purpose: TREATMENT
Start Date: 2024-06-20
Completion Date: 2026-06-20
Locations: Guangzhou Medical University, Huizhou, China

Summary:
This is an open-label, single-arm, phase I/II trial of immune checkpoint inhibitor combined with pemetrexed intrathecal injection for leptomeningeal metastasis from solid tumors, to evaluate the safety and efficacy.

Primary Outcome Measures: PR2D, The recommended phase II dose. The dose limiting toxicity was defined as ≥ grade 3 neurological toxicities (e.g., chemical meningitis) or other grade 4 toxicity., From date of treatment until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 6 months.]|Clinical response rate, The response assessment in neuro-oncology criteria (RANO) proposal for response criteria of leptomeningeal metastasis was used to assess the clinical response in this study., From date of treatment until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 6 months.|Incidence of treatment-related adverse events, The incidence of treatment-related adverse events were measured for determining tolerability and safety. Adverse events (AEs) are evaluated according to the Common Terminology Criteria for Adverse Events (CTCAE). Events of grade 3-5 are defined as moderate and severe adverse events., From date of treatment until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 6 months.
Secondary Outcome Measures: Neurological progression-free survival (NPFS), NPFS was defined as time from the start of treatment until neurological progression or death. The neurological progression was determined based on the RANO proposal evaluation criteria which have been established and published on Neuro Oncol., From date of treatment until the date of first documented neurological progression or date of death from any cause, whichever came first, assessed up to 6 months.|Overall survival(OS), Survival time was recorded since the date of patient enrollment. All patients were followed up until death or the end of the study., From the enrollment of this study until date of death from any cause, whichever came first, or the last follow-up (at least 7 months).