pankajmathur/National_Library_of_Medicine_Studies_data huggingface dataset:
Postbiotic as Adjunct Treatment for Vaginal Candidiasis
NCT Number: NCT06474247
Status: RECRUITING
Study Type: INTERVENTIONAL
Phases: PHASE2|PHASE3
Conditions: Vaginal Candidiasis
Interventions: DEVICE: Postbiotic|DEVICE: Placebo
Sponsor: Min-Tze LIONG
Collaborators: AIMST University|Sumita Hospital
Sex: FEMALE
Age: ADULT, OLDER_ADULT
Enrollment: 118
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: TRIPLE (PARTICIPANT, CARE_PROVIDER, INVESTIGATOR)|Primary Purpose: TREATMENT
Start Date: 2024-06-02
Completion Date: 2025-06-02
Locations: Sumita Hospital, Lucknow, Aliganj, 226024, India|AIMST University, Bedong, Kedah, Malaysia

Summary:
This project aims to study the efficacy of intravaginal administration of postbiotic at 1g/day as an adjunct treatment against vaginal candidiasis in women for 4-weeks compared to placebo.

Primary Outcome Measures: Microbiota profiles of vaginal samples of women with vaginal candidiasis upon administration of postbiotic or placebo as assessed via next generation sequencing, Differences in microbiota abundance of vaginal samples of women with vaginal candidiasis upon administration of postbiotic compared to placebo, 4-weeks
Secondary Outcome Measures: Pathogenic yeasts profiles of vaginal samples of women with vaginal candidiasis upon administration of postbiotic or placebo as assessed via real time PCR, Differences in pathogenic yeasts abundance of vaginal samples of women with vaginal candidiasis upon administration of postbiotic compared to placebo, 4-weeks|Quality of life profiles of women with vaginal candidiasis upon administration of postbiotic or placebo as assessed via questionnaires, Differences in quality of life parameters of women with vaginal candidiasis upon administration of postbiotic compared to placebo, 4-weeks
Modulation of Gut Microbiota by Probiotic in Children
NCT Number: NCT06474234
Status: RECRUITING
Study Type: INTERVENTIONAL
Phases: PHASE2
Conditions: Generally Healthy
Interventions: DIETARY_SUPPLEMENT: Probiotic|DIETARY_SUPPLEMENT: Placebo
Sponsor: Min-Tze LIONG
Collaborators: National University of Malaysia
Sex: ALL
Age: CHILD
Enrollment: 120
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: TRIPLE (PARTICIPANT, CARE_PROVIDER, INVESTIGATOR)|Primary Purpose: TREATMENT
Start Date: 2024-05-29
Completion Date: 2025-06-30
Locations: UKM Medical Centre, Cheras, Kuala Lumpur, 56000, Malaysia

Summary:
This project aims to study the benefits of probiotics namely Bifidobacterium infantis YLGB-1496 in modulating gut microbiota of healthy children, among pre-school children in Malaysia \<7 years old.

Primary Outcome Measures: Microbiota profiles of fecal samples in generally healthy children upon administration of probiotic as assessed via pyrosequencing, Differences in microbiota abundance in fecal sample of generally healthy children upon administration o probiotic compared to placebo, 12-weeks
Secondary Outcome Measures: Clinical respiratory symptoms duration and frequency in generally healthy children upon administration of probiotic as assessed using the Monthly Health Questionnaire (as used in ClinicalTrials.gov (identifier number NCT02434042), Changes in duration and frequency of respiratory illnesses symptoms from generally healthy children on probiotic or placebo after 12-weeks, via the use of questionnaire., 12-weeks|Clinical gastrointestinal symptoms in generally healthy children upon administration of probiotic as assessed using the Monthly Gastrointestinal Questionnaire as used in ClinicalTrials.gov (identifier number NCT02434042), Differences in duration and frequency of gastrointestinal symptoms upon administration of probiotic compared to placebo, 12-weeks|Immunity profiles in generally healthy children upon administration of probiotic via the use of oral swabs, Differences in concentrations of proteins such as interleukins (IL-10, IL-4, IL-6, Tumour Necrosis Factor-alpha, Interferon gamma) in swab samples (ug/mL) upon administration of probiotic compared to placebo, 12-weeks
Efficacy of EBPSI on Future Suicide Risk Among Adolescent Suicide Attempters
NCT Number: NCT06474221
Status: RECRUITING
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Suicide, Attempted
Interventions: BEHAVIORAL: Electronic Based Psychosocial Intervention (EBPSI)
Sponsor: University of Pittsburgh
Collaborators: Fogarty International Center of the National Institute of Health|St.John's Medical College and Hospital
Sex: ALL
Age: CHILD, ADULT
Enrollment: 168
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: SINGLE (OUTCOMES_ASSESSOR)|Primary Purpose: TREATMENT
Start Date: 2024-05-10
Completion Date: 2025-09-30
Locations: St John's Medical College and Hospital, Bengaluru, Karnataka, 560034, India|Kalinga Institute of Medical Sciences (KIMS),, Bhubaneswar, Odisha, 751024, India

Summary:
Our study is designed to study the efficacy of an Electronic based psycho-social intervention targeting healthy coping and problem solving skills to mitigate suicidal behaviour. This would integrate existing systems and bridge the gap in accessibility to care for suicidal behaviour.

Primary Outcome Measures: Persistent Suicide Ideation, Change in intervention arm as compared to TAU on persistent suicidal ideation using the Columbia Suicide Severity Rating Scale (C-SSRS). the ideation ranges from 0-5 on this scale., At baseline and 1,3, 6 and 12 months after the baseline intervention.|Suicide attempts, Change in intervention arm as compared to TAU on number of suicide attempts. Minimum attempts can be 0 and maximum can be infinity., At baseline and 1,3, 6 and 12 months after the baseline intervention.
Secondary Outcome Measures: Depression, Change in depression in intervention group as compared to TAU using Beck Depression Inventory (BDI). The minimum score is 0 and maximum is 63., At baseline and 1,3, 6 and 12 months after the baseline intervention.|Acceptability of Intervention Measure (AIM), To assess the acceptability of EBPSI By using acceptability of Intervention Measure and Intervention Appropriateness Measure (IAM). The minimum score is 0 and maximum is 16., At baseline and 1,3, 6 and 12 months after the baseline intervention.|Feasibility of Intervention Measure (FIM), To assess the feasibility of intervention by using Feasibility of Intervention Measure (FIM). The minimum score is 0 and maximum is 16., At baseline and 1,3, 6 and 12 months after the baseline intervention.|Attribution Style, To compare change in attribution styles of intervention and TAU group using Children's Attributional Style Questionnaire (Minimum score 5 and maximum score is 35)., At baseline and 1,3, 6 and 12 months after the baseline intervention.|Coping Mechanism, To study the change in coping mechanism in intervention group as compared to TAU using BRIEF - COPE - Brief Coping Questionnaire. Each strategy is scored separately and minimum score is 1 and maximum score is 8., At baseline and 1,3, 6 and 12 months after the baseline intervention.
Cue-based Intervention in Prospective Memory and Medication Adherence.
NCT Number: NCT06474195
Status: RECRUITING
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Schizophrenia
Interventions: BEHAVIORAL: Cue based intervention|BEHAVIORAL: Treatment as Usual
Sponsor: University of Pittsburgh
Collaborators: Fogarty International Center of the National Institute of Health|St.John's Medical College and Hospital
Sex: ALL
Age: ADULT
Enrollment: 104
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: NONE|Primary Purpose: SUPPORTIVE_CARE
Start Date: 2024-06-15
Completion Date: 2025-09-30
Locations: St. John's Medical College and Hospital, Bengaluru, Karnataka, India

Summary:
Medication adherence is a major challenge while treating patients with major mental illnesses like schizophrenia and schizoaffective disorder. This interventional study aims to assess the improvement in prospective memory and thus medication adherence by giving time and event-based cues to the participants.

Primary Outcome Measures: Prospective memory, Change in prospective memory in intervention arm as measured by compared to TAU The Memory for Intentions Screening Test(MIST) score as compared to TAU, Baseline, After 30days' intervention|Prospective memory (sustainability), Change in prospective memory in intervention arm as measured by compared to TAU The Memory for Intentions Screening Test (MIST) score as compared to TAU, Baseline, 90 days after baseline assessment|Medication adherence, Change in medication adherence in intervention arm as measured by Brief Adherence Rating Scale (BARS) score as compared to TAU, Baseline, After 30days' intervention|Medication adherence (Sustainability), Change in medication adherence in intervention arm as measured by Brief Adherence Rating Scale (BARS) score as compared to TAU, Baseline, 90 days after baseline assessment
Secondary Outcome Measures: Cognition, Change in cognition in intervention arm as measured by Trail Making Test (TMT) score as compared to TAU, Baseline, After 30days' intervention|Cognition (Sustainability), Change in cognition in intervention arm as measured by Trail Making Test (TMT) score as compared to TAU, Baseline, 90 days after baseline assessment|Independent living skills score, Change in Independent living skills score in intervention arm as measured by Independent living skills scale (ILSS) score as compared to TAU, Baseline, After 30days' intervention|Independent living skills score (Sustainability), Change in Independent living skills score in intervention arm as measured by Independent living skills scale (ILSS) score as compared to TAU, Baseline, 90 days after baseline assessment|Cognitive Insight, Change in Independent living skills score in intervention arm as measured by Cognitive Insight Scale (BCIS) score as compared to TAU, Baseline, After 30days' intervention|Cognitive Insight (Sustainabilty), Change in Independent living skills score in intervention arm as measured by Cognitive Insight Scale (BCIS) score as compared to TAU, Baseline,90 days after baseline assessment
Comparison of the Effects of Apixaban on Thrombin Generation in Patients With de Novo Multiple Myeloma
NCT Number: NCT06474182
Acronym: ProApix
Status: NOT_YET_RECRUITING
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Multiple Myeloma|Total Knee Replacement
Interventions: PROCEDURE: Blood sampling|DRUG: Apixaban
Sponsor: Centre Hospitalier Universitaire de Saint Etienne
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 32
Study Design: Allocation: NON_RANDOMIZED|Intervention Model: PARALLEL|Masking: SINGLE (PARTICIPANT)|Primary Purpose: OTHER
Start Date: 2024-09
Completion Date: 2026-12-31
Locations: CHU de Saint-Etienne, Saint-Étienne, 42055, France

Summary:
Patients with multiple myeloma (MM) are at high risk of venous thromboembolism (VTE) and these patients require adequate thromboprophylaxis. Following the publication of the AVERT clinical study, Apixaban is strongly recommended as a prophylactic treatment option for patients with cancer, based on high quality of evidence and a favorable efficacy/safety profile. A multicenter and ancillary study - APIXABOR - that measured the plasmatic concentration of Apixaban in patients with MM and treated with preventive dose has been conducted. The peak drug concentration was superior in MM plasma, as compared to non-myeloma patients under prophylaxis. Therefore, the present study evaluated whether differences in pharmacokinetics have an impact on pharmacodynamics (i.e. decrease in coagulability in MM patients as compared to non-MM patients undergoing a surgery for total knee replacement who also have VTE prophylaxis). In fine, this study may inform to better manage thromboprophylaxis in MM patients.

Primary Outcome Measures: Endogenous Thrombin potential (nM.min), Endogenous Thrombin potential (nM.min) as measured with MidiCAT method at the concentration peak 2 hours after 2.5mg Apixaban treatment, 2 hours after Apixaban Treatment
Secondary Outcome Measures: Apixaban concentration (ng/mL), Apixaban concentration (ng/mL) as measured by mass spectrometry during 12 hours following Apixaban treatment (2.5mg) in both groups, Kinetics of 12 hours following Apixaban treatment in both groups|Pharmacodynamics' kinetics of Endogenous Thrombin Potential, MidiCAT method measure : Endogenous Thrombin Potential (nM.min), Kinetics of 12 hours following Apixaban treatment in both groups|Pharmacodynamics' kinetics of Lagtime, MidiCAT method measure : Lagtime (min), Kinetics of 12 hours following Apixaban treatment in both groups|Pharmacodynamics' kinetics of Time to peak, MidiCAT method measure : Time to peak (min), Kinetics of 12 hours following Apixaban treatment in both groups|Pharmacodynamics' kinetics of Thrombin peak, MidiCAT method measure : Thrombin peak (M, Thrombin), Kinetics of 12 hours following Apixaban treatment in both groups
Assessment of T-cell Response and In-vitro Proof-of-concept of T-cell Engineering in Chronic ESKD Patients.
NCT Number: NCT06474169
Acronym: LYMPHOVIRCT
Status: NOT_YET_RECRUITING
Study Type: OBSERVATIONAL
Conditions: Chronic Kidney Diseases
Interventions: OTHER: 1 blood sample for each participant
Sponsor: Centre Hospitalier Régional d'Orléans
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 100
Study Design: Observational Model: |Time Perspective: p
Start Date: 2024-09
Completion Date: 2026-12

Summary:
This is a comparative, prospective, non-interventional study to evaluate immune response in patients with chronic kidney disease. The primary objective is to define immunodeficiency (phenotype and function of T cells) in patients with end-stage kidney disease. The second objective is to provide an in-vitro proof-of-concept of T-cell engineering in the context of end-stage kidney disease.

The study population was patients with chronic kidney disease.

Primary Outcome Measures: The primary outcome is to characterize T cell immunodeficiency in our cohort of end-stage kidney disease patients from a phenotypic and functional point of view., Identify T cells and perform extensive phenotype. This analysis will be performed on mononuclear cells with a clinical flow cytometry system (panel of specific fluorophores will be used)., Duration of blood collection (approximately 5 minutes in inclusion)|The primary outcome is to characterize T cell immunodeficiency in our cohort of end-stage kidney disease patients from a phenotypic and functional point of view., Perform a non-specific assessment of T-cell activation in measuring the production of ATP ( adenosine triphosphate) and cytokines., Duration of blood collection (approximately 5 minutes in inclusion)|The primary outcome is to characterize T cell immunodeficiency in our cohort of end-stage kidney disease patients from a phenotypic and functional point of view., Functional evaluation of T cells with specific viral assessment. Differents tests will be performed after peptidic stimulations: quantification of cytokines and proliferative capacities., Duration of blood collection (approximately 5 minutes in inclusion)
Secondary Outcome Measures: in-vitro proof-of-concept of T-cell engineering, Development of mRNA delivery system to restore T-cell function in ESKD patients through T-cell therapy., For each outcome, duration of blood collection (approximately 5 minutes in inclusion)
Assessing Cervical Sensorimotor Control With VR in Chronic Neck Pain
NCT Number: NCT06474130
Status: NOT_YET_RECRUITING
Study Type: OBSERVATIONAL
Conditions: Neck Pain|Virtual Reality|Sensorimotor
Sponsor: National Cheng Kung University
Collaborators: National Science and Technology Council
Sex: ALL
Age: ADULT
Enrollment: 80
Study Design: Observational Model: |Time Perspective: p
Start Date: 2024-07-15
Completion Date: 2027-07-31
Locations: National Cheng Kung University, Tainan, 701, Taiwan

Summary:
To develop a cervical SMC VR assessment system incorporating different SMC tests and to compare cervical SMC performance using this self-developed VR assessment system in individuals with and without CNP

Primary Outcome Measures: Cervical Range of Motion (ROM), Participants will follow the instructions that appeared in the VR HMD to perform active maximal neck flexion, extension, side bending and rotation. The maximal ROM in each direction will be calculated and obtained based on the IMU sensors embedded in the HMD., One day|Joint Position Error (JPE), There will be a virtual target displayed in the VR HMD. Participant will be instructed to remember this position, then close their eyes and move the head away from the target center, and then return to the initial starting position.

Difference between the starting position and final position in distance (mm) will be calculated., One day|Figure of Eight (FOE), The participant will be instructed to control the red dot moving along the path of the figure-of-eight as accurately as possible by moving their head., One day|Subjective Visual Vertical (SVV), A tilted white rod will be presented at different angles for 1-degree interval from 45 to 135 degrees randomly on the display as described above. The rod will be precisely controlled by using left and right arrow keys of a keyboard. Participants will be instructed to reposition the white rod so that the white rod will be positioned vertically while keeping the head and neck as still as possible., One day|Head Tile Response (HTR), A tilted white rod will be presented at different angles for 1-degree interval from 45 to 135 degrees randomly on the display as described above. Participants will be instructed to tilt their heads laterally so that the line will be re-positioned vertically., One day|Saccades, Two virtual white targets at 90 degrees of visual angle positioned 0.82 m apart from the participant will be displayed in the VR HMD. Participants will be asked to shift their gaze quickly between two targets without moving their heads for 10 secs., One day|Smooth Pursuit Neck Torsion (SPNT), A virtual red-dot target is displayed in the VR HMD. The target will move in a horizontal plane with a sinusoidal pattern (30 degrees per second) from left to right and back 10 times with a visual angle of 40 degrees. Participants will be requested to follow the moving target with their eyes and keep their heads still., One day|Postural Sway (PS), Participants will be asked to follow the instructions that appeared in the VR HMD and stand still for 30 seconds in EO or EC condition and in neck neutral or neck torsion 45-degree position, One day
Muscle-tendon Interaction in the Spastic Sural Triceps During Gait
NCT Number: NCT06474117
Acronym: GEcho
Status: NOT_YET_RECRUITING
Study Type: OBSERVATIONAL
Conditions: Spinal Cord Injuries|Stroke
Interventions: OTHER: Gait analysis coupled with ultrasound|OTHER: Isokinetic dynamometer with simultaneous ultrasound
Sponsor: Nantes University Hospital
Collaborators: Laboratoire Motricité, Interactions, Performance (MIP)|Société Française de Physiothérapie (SFP).
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 80
Study Design: Observational Model: |Time Perspective: p
Start Date: 2024-09-01
Completion Date: 2026-09-01
Locations: CHU de Nantes, Nantes, Loire Atlantique, 44093, France

Summary:
This project aims to study the mechanical behavior of the muscle-tendon unit (MTU) of the gastrocnemius medialis (GM) and the Achilles tendon (AT) in post-stroke and spinal cord injured (SCI) patients compared to a healthy population, focusing on the variations in muscle and tendon length during the stance phase of the gait cycle. The primary objective is to assess the respective contributions of the GM and AT lengthening in the MTU during walking. Inclusion criteria include adult post-stroke and post-SCI patients with voluntary motor function and some walking capacity. Methods include ultrasound measurements and 3D gait analysis.

Primary Outcome Measures: Length of the Achilles Tendon (AT), Muscle Fibers of the Gastrocnemius Medialis (GM), and the Muscle GM During the Single Support Phase of Walking, This measure involves the use of ultrasound to assess the lengths of the Achilles tendon, muscle fibers of the gastrocnemius medialis, and the entire muscle GM during the single support phase of the gait cycle in post-stroke and SCI patients compared to healthy controls. The primary goal is to determine the contributions of the muscle and tendon to the overall muscle-tendon unit during walking., 1 Day
Secondary Outcome Measures: Positioning of the Muscle Fibers on the Force-Length Curve During Different Phases of Walking, This outcome measure evaluates the positioning of the muscle fibers of the gastrocnemius medialis on the force-length curve during various phases of the gait cycle, including the single support phase and the double support phases (reception and propulsion). The measurements will be compared between post-stroke, SCI patients and healthy controls. The assessment will involve ultrasound measurements and isokinetic dynamometry to determine the force-length relationship., 1 Day
Collection of Blood and Skin Samples From Patients With Primary Mitochondrial Diseases and Healthy Volunteers
NCT Number: NCT06474104
Status: RECRUITING
Study Type: OBSERVATIONAL
Conditions: Primary Mitochondrial Diseases
Sponsor: Minovia Therapeutics Ltd.
Sex: ALL
Age: CHILD, ADULT, OLDER_ADULT
Enrollment: 100
Study Design: Observational Model: |Time Perspective: p
Start Date: 2024-05-12
Completion Date: 2026-05-30
Locations: Sheba Medical Center - Tel Ashomer, Ramat Gan, 5266202, Israel

Summary:
Mitochondrial diseases are a genetically diverse group of disorders, some of which are caused by mutations or deletions in the mitochondrial DNA (mtDNA) and which display a wide range of severity and phenotypes. Despite a prevalence of roughly 1 in 8500 in the population there is no effective treatments for the majority of mitochondrial diseases beyond supportive care (Gorman 2016, Elliott 2008). Many of these, such as Pearson syndrome and Kearns-Sayre syndrome, are early onset disorders, and may lead to mortality within the first decades of life. Importantly, mitochondria are selectively inherited from the mother. In addition, there are numerous diseases in which mitochondrial dysfunction plays an important role. Some examples are Alzheimer's and Parkinson's disease, both of which are known to have mitochondrial involvement.

Minovia therapeutics develops a therapeutic intervention called mitochondrial augmentation technology (MAT). For the development work, Minovia needs patients' cells with different mutations that will allow to study the baseline heteroplasmy and functionality of patient hematopoietic cells, identify potential biomarkers to assess mitochondrial content and function in liquid biopsies, and study the efficacy of MAT in different PMDs.

Primary Outcome Measures: mitochondrial function, Analysis on how different mitochondrial mutations (sequence / heteroplasmy) are related to mitochondrial function and quantity in the white cell line and their characteristics., 1 year
Liquid Biopsy MonitORing Of CholangioCarcinOma for Treatment Response and Prognostic Outcomes (MOROCCO)
NCT Number: NCT06474091
Status: ENROLLING_BY_INVITATION
Study Type: OBSERVATIONAL
Conditions: Cholangiocarcinoma
Interventions: OTHER: Non-Interventional Study
Sponsor: Mayo Clinic
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 500
Study Design: Observational Model: |Time Perspective: p
Start Date: 2024-05-08
Completion Date: 2029-05-08
Locations: Mayo Clinic in Rochester, Rochester, Minnesota, 55905, United States

Summary:
This study explores the potential value of a new blood test approach to detect measurable residual disease or early recurrence/progression in patients with cholangiocarcinoma.

Primary Outcome Measures: Associate of PUMA levels with short term progression, Proteins, mUtations, Methylated DNA, and Aneuploidy (PUMA) markers will be assessed pre- and post-treatment and will be associated with treatment response to therapy (short term progression; time to cholangiocarcinoma recurrence)., Up to 5 years|Associate of PUMA levels with progression free survival, Pre-surgical and post-surgical PUMA levels will be associated with progression free survival (time to death from cholangiocarcinoma)., Up to 5 years
Study To Evaluate The Efficacy Of Tofacitinib In Patients With SJS/TEN
NCT Number: NCT06474078
Status: RECRUITING
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Stevens-Johnson Syndrome|Toxic Epidermal Necrolysis
Interventions: DRUG: Tofacitinib
Sponsor: Chang Gung Memorial Hospital
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 20
Study Design: Allocation: NA|Intervention Model: SINGLE_GROUP|Masking: NONE|Primary Purpose: TREATMENT
Start Date: 2022-08-01
Completion Date: 2025-07-31
Locations: Chang Gung Memorial Hospital, Taoyuan, 333, Taiwan

Summary:
The goal of this study is to evaluate the effect of tofacitinib in patients with Stevens-Johnson Syndrome (SJS) and Toxic Epidermal Necrolysis (TEN). The primary outcome of the study is the time to complete re-epithelialization. The secondary outcomes are to determine mortality, length of hospitalization, adverse events, the time to beginning of epithelization, the time to halting of progression of SJS/TEN, ocular complications, and infections.

Primary Outcome Measures: Time to complete re-epithelialization of SJS/TEN, Definition of complete re-epithelialization as the absence of erosions on the skin., up to 4 weeks
Secondary Outcome Measures: Mortality, Number of participants with mortality at 30 days, 3 months and 1 year, up to 1 year|Length of hospitalization, Duration of hospital stay, up to 3 months|Adverse events, Adverse events related to the treatment with tofacitinib, up to 3 months
Pregnancy Outcomes Following Myomectomy
NCT Number: NCT06474065
Status: RECRUITING
Study Type: OBSERVATIONAL
Conditions: Uterine Fibroid|Pregnancy Complications|Reproductive Issues|Reproductive Sterility
Interventions: PROCEDURE: Myomectomy
Sponsor: Centro di Ricerca Clinica Salentino
Sex: FEMALE
Age: ADULT
Enrollment: 150
Study Design: Observational Model: |Time Perspective: p
Start Date: 2024-06-28
Completion Date: 2025-12-30
Locations: Andrea Tinelli, Lecce, Le, 73100, Italy

Summary:
The most prevalent genital pathology, uterine fibroids have a detrimental impact on the health of women. Fibroid symptoms are typically more impactful on females and frequently require uterine excision. Although contentious in terms of how it affects pregnancy outcomes, hysteroscopic, laparoscopic, or laparotomic myomectomy has always been a necessary and suitable procedure for the patient's health. Numerous studies have been conducted on the topic, but no clear findings have been reached.

The goal of this observational study is to investigate the pregnancy outcomes after hysteroscopic, laparoscopic, laparotomic myomectomies in female patients affected by fibroids. The main questions it aims to answer are:

To investigate pregnancy outcomes in relation to surgical approach used for myomectomy.

To investigate whether pregnancy outcome is different in relation to time when myomectomy was performed: on a pregnant uterus or on a non-gravid uterus.

If there is a comparison group: Researchers will compare a group of patients unsubmitted to surgery, to see the difference with the operated patients.

Participants will follow up, to evaluate the possible pregnancy complications, the intraoperative complications and other perinatal and post-operative complications.

Primary Outcome Measures: Pregnancy complications, placental pathology, intraoperative complications, other complications, 1 year
Secondary Outcome Measures: Intraoperative complications, intraabdominal adhesions/PAI score, surgical complications: Claven Dindo classification, 1 year
Other Outcome Measures: other complications, neonatal outcome, duration of maternal hospitalization, Primary or secondary PPH, relaparotomy, peripartum hysterectomy, ligation of major blood vessels, 1 year
Volume Kinetics of Gelofusine 4% During Vascular Surgery
NCT Number: NCT06474052
Status: COMPLETED
Study Type: OBSERVATIONAL
Conditions: Fluid Electrolyte Disorders
Interventions: DRUG: Gelofusine 4%
Sponsor: Institutul de Urgenţă pentru Boli Cardiovasculare Prof.Dr. C.C. Iliescu
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 15
Study Design: Observational Model: |Time Perspective: p
Start Date: 2024-01-01
Completion Date: 2024-04-15
Locations: Institutul de Urgenta de Boli Cardiovasculare Prof Dr CC Iliescu, Bucuresti, București, 022328, Romania

Summary:
The volume kinetics of the commercially available colloid fluid, Gelofusine 4%, have not been previously studied. Adult patients undergoing open vascular surgery, including femoral and carotid endarterectomy as well as bypass surgery, received general anesthesia. Following the induction of anesthesia, Gelofusine 4% was administered at a dosage of 10 ml/kg over a 30-minute period. Hemoglobin concentration was monitored for up to 180 minutes post-administration to construct a plasma hemodilution profile.

Primary Outcome Measures: Plasma Volume, Plasma volume was determined using a two-compartment kinetic model with three rate constants (k12, k21, and k10) and a scaling factor (Vc, central volume) that relates dilution to volume. This model was applied to the dependent variables, which included frequently measured plasma dilution and urinary excretion., 180 minutes after the start of the Gelofusine 4% infusion
The Efficacy of Fluticasone Furoate/Vilanterol/Umeclidinium Compared With Vilanterol/Umeclidinium in Reducing Air Trapping and Airway and Blood Cytokine Levels in COPD
NCT Number: NCT06474039
Status: NOT_YET_RECRUITING
Study Type: INTERVENTIONAL
Phases: PHASE3
Conditions: COPD
Interventions: DRUG: Trelegy or Anoro
Sponsor: Mahidol University
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 50
Study Design: Allocation: RANDOMIZED|Intervention Model: CROSSOVER|Masking: QUADRUPLE (PARTICIPANT, CARE_PROVIDER, INVESTIGATOR, OUTCOMES_ASSESSOR)|Primary Purpose: TREATMENT
Start Date: 2024-06
Completion Date: 2026-12

Summary:
This study aims to demonstrate the effects of triple therapy (ICS/LABA/LAMA) and dual bronchodilators (LAMA/LABA) on air trapping in the lungs' COPD patients and inflammatory mediators

Primary Outcome Measures: Changes in lung volume, TLC, RV, RV/TLC, IOS, 4 weeks
Secondary Outcome Measures: Inflammatory cytokines, FENO, hs-CRP, sputum cell counts and differential counts, 4 weeks
A Clinical Trial to Evaluate the Safety and Efficacy of Neuromodulation Using High Intensity Focused Ultrasound 'ExAblate 4000 Type 2.1' in Patients With Psychostimulant Use Disorder(PUD)
NCT Number: NCT06474026
Status: NOT_YET_RECRUITING
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Psychostimulant Use Disorder(PUD)
Interventions: DEVICE: ExAblate 4000 Type 2.1
Sponsor: Korea University Anam Hospital
Sex: ALL
Age: ADULT
Enrollment: 10
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: NONE|Primary Purpose: TREATMENT
Start Date: 2024-08-01
Completion Date: 2025-07-31

Summary:
The purpose of this clinical trial is to evaluate the initial safety and efficacy of the ExAblate Model 4000 Type 2.1 high-intensity focused ultrasound surgical device for nucleus accumbens (NAc) neuromodulation in patients with psychostimulant use disorder (PUD).

Primary Outcome Measures: Success rate of psychostimulant abstinence (%), Percentage of subjects with no detectable psychostimulants and other illicit drugs by urine toxicology screening after application, 7, 30, 90, and 180 days after ACTIVE device application
Secondary Outcome Measures: Time to recurrence (in days), Mean time to relapse for subjects with psychostimulants and other illicit drugs detected by urine toxicology screening after application of the ACTIVE device, 6 months|Visual Analog Scale rating of craving severity (mm), Change in substance craving visual analog scale (VAS, 0\~100mm) score after sham or active device application. 0 indicates no craving at all, while 100 indicates the maximum craving., Baseline to 7 days after SHAM device application, baseline to 7, 30, 90, and 180 days post ACTIVE device|Assessments related to mood/anxiety/attention/impulsivity, Change (in points) in assessments of mood/anxiety/attention/impulsivity, Baseline to 7 days after SHAM device application, baseline to 7, 30, 90, and 180 days post ACTIVE device|Assessment of cognitive function, Change in Cognitive Function Assessment (points) Post-ACTIVE Device application, Baseline to 180 days post-ACTIVE Device application|Evaluation of fMRI drug cue reactivity (FDCR) in neural signaling of drug craving (including striatum, orbitofrontal cortex, amygdala, and synapses), Change in fMRI drug cue reactivity after sham or active device application, Baseline to 7 days after SHAM device application, Baseline to 7 days and 180 days after active device application
A Phase Ⅰb Study on Autologous GC101 TIL Injection for the Treatment of NSCLC
NCT Number: NCT06473961
Acronym: MIZAR-005
Status: NOT_YET_RECRUITING
Study Type: INTERVENTIONAL
Phases: PHASE1
Conditions: Non Small Cell Lung Cancer Metastatic|Non Small Cell Lung Cancer
Interventions: BIOLOGICAL: Autologous Tumor Infiltrating Lymphocytes
Sponsor: Shanghai Juncell Therapeutics
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 20
Study Design: Allocation: NA|Intervention Model: SINGLE_GROUP|Masking: NONE|Primary Purpose: TREATMENT
Start Date: 2024-09-01
Completion Date: 2027-07-01

Summary:
20 participants are expected to be enrolled for the Phase Ib clinical trial，this trail is expected to be finished in 36 months.

Primary Outcome Measures: Adverse Events, Incidence of adverse events associated with GC101 TIL retransfusion, Up to Day 28|Objective Response Rate, Proportion of subjects in total cases in complete or partial response (RECIST v1.1 criteria), 18 weeks
Secondary Outcome Measures: Adverse Events, Incidence of adverse events associated with GC101 TIL retransfusion, Maximum 360 days|Objective Response Rate, Proportion of subjects in total cases in complete or partial response (RECIST v1.1 criteria) during the study, Maximum 36 months|Best overall response, Optimal efficacy recorded from the start of treatment until disease progression or relapse (RECIST v1.1 and iRECIST), Maximum 36 months|Disease Control Rate, Evaluate the efficacy endpoints of DCR by the investigator with RECIST v1.1 and iRECIST, Maximum 36 months|Progression-Free Survival, Evaluate the efficacy endpoints of PFS by the investigator with RECIST v1.1 and iRECIST, Maximum 36 months|Duration of Response, Evaluate the efficacy endpoints of DOR by the investigator with RECIST v1.1 and iRECIST, Maximum 36 months|overall survival, Evaluate the efficacy endpoints of OS, Maximum 36 months
To Assess the Effects of Single Dose of JMKX001899 on QTc Interval in Healthy Subjects
NCT Number: NCT06473948
Status: NOT_YET_RECRUITING
Study Type: INTERVENTIONAL
Phases: PHASE1
Conditions: Solid Tumor, Adult
Interventions: DRUG: JMKX001899|DRUG: JMKX001899|DRUG: JMKX001899|DRUG: Placebo
Sponsor: Jemincare
Sex: ALL
Age: ADULT
Enrollment: 27
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: DOUBLE (PARTICIPANT, INVESTIGATOR)|Primary Purpose: BASIC_SCIENCE
Start Date: 2024-07-10
Completion Date: 2025-02-27

Summary:
Study to assess the effect of JMKX001899 on QTc interval in healthy volunteers

Primary Outcome Measures: To evaluate the effect of a single dose of JMKX001899 on the change in time-matched QTc intervals compared with placebo, QTc interval was measured by electrocardiograms to evaluate the potential effect of JMKX001899 plasma concentrations on the QTc interval using linear mixed-effect exposure-response modeling, including the predicted ddQTc at Cmax values corresponding to exposure levels, 48 hours
Maternal Well-being in the Perinatal Period
NCT Number: NCT06473935
Status: RECRUITING
Study Type: OBSERVATIONAL
Conditions: Perinatal Depression|Anxiety|Loneliness|Mother-Child Relations
Interventions: OTHER: Questionnaires and focus groups
Sponsor: IRCCS San Raffaele
Sex: FEMALE
Age: CHILD, ADULT, OLDER_ADULT
Enrollment: 134
Study Design: Observational Model: |Time Perspective: p
Start Date: 2024-06-01
Completion Date: 2025-12-31
Locations: IRCCS San Raffaele, Milan, 20132, Italy

Summary:
The goal of this observation study is to investigate the mental health status of women experiencing their first pregnancy, with particular attention to anxiety and depression symptoms, feelings of loneliness, and the quality of defense mechanisms employed.

Primary Outcome Measures: Depression, Levels of perinatal depression and of pregnancy-related anxiety, June 1, 2024 - December 31, 2025|Anxiety, Levels of state and trait anxiety, June 1, 2024 - December 31, 2025|Loneliness, Feelings of loneliness during and after pregnancy, June 1, 2024 - December 31, 2025|Defense mechanisms, Nature of defense mechanisms during and after pregnancy, June 1, 2024 - December 31, 2025
Secondary Outcome Measures: Attachment bond, Quality of prenatal of attachment bond and in the postpartum period, June 1, 2024 - December 31, 2025|Women subjective experience, Subjective experience of pregnancy and postpartum, June 1, 2024 - December 31, 2025|Unmet needs of women, Unmet needs of women during the perinatal period, June 1, 2024 - December 31, 2025
Assessing Levels of Fear and Anxiety and Monitoring Wound Healing Among Patients Who Are About to Undergo Wisdom Tooth Extraction Surgery or Jaw Implant Surgery Under Local Anesthesia Versus General Anesthesia
NCT Number: NCT06473922
Status: RECRUITING
Study Type: OBSERVATIONAL
Conditions: Tooth Extraction
Interventions: PROCEDURE: Reginal anesthesia
Sponsor: Assaf-Harofeh Medical Center
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 46
Study Design: Observational Model: |Time Perspective: p
Start Date: 2024-07-01
Completion Date: 2026-08-30
Locations: Shamir (Asaf Harofe) Medical Center, Be'er Ya'aqov, 70300, Israel

Summary:
Tooth extraction is one of the most common surgical procedures in dentistry. Up to 15% of the world's adult population suffers from high anxiety about dental treatments. The stress resulting from this anxiety may cause a delay in the healing and fusion of the surgical wound. Therefore, it is possible to perform this surgical tooth extraction procedure under general anesthesia.

The purpose of the present study is to assess the level of anxiety/fear and to monitor the wound healing process among patients who are about to undergo surgery to remove wisdom teeth or no more than 3 jaw implants under local anesthesia in the dental clinic compared to patients who are about to undergo the same surgery under general anesthesia.

Primary Outcome Measures: Level of fear, Level of fear from pain and dental fear will be monitored by questionnaireד, From visit 1 which will be 5-7 days before surgery to visit 5 which will be 6 weeks after surgery|Wound healing, Will be monitored by the IPR questionnaire, From visit 3 which will be 5 days after surgery to visit 5 which will be 6 weeks after surgery
Combination of Steroid and Humanized CD25 Monoclonal Antibody as First-line Therapy for aGVHD
NCT Number: NCT06473909
Status: NOT_YET_RECRUITING
Study Type: INTERVENTIONAL
Phases: PHASE2
Conditions: Acute Graft Versus Host Disease
Interventions: DRUG: CD25 antibody combined glucocorticoid as first-line treatment
Sponsor: Institute of Hematology & Blood Diseases Hospital, China
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 20
Study Design: Allocation: NA|Intervention Model: SINGLE_GROUP|Masking: NONE|Primary Purpose: TREATMENT
Start Date: 2024-07-01
Completion Date: 2025-12-31

Summary:
The first-line treatment of acute graft-versus-host disease with humanized CD25 monoclonal antibody combined with glucocorticoid was used to study the remission rate of acute graft-versus-host disease, the cumulative incidence and remission rate of severe acute graft-versus-host disease, GVHD-free survival rate, all-cause mortality and quality of life evaluation, and safety evaluation for prevention programs.

Primary Outcome Measures: The remission rate of aGVHD, 28 days
Secondary Outcome Measures: Incidence rate of severe aGVHD, 24 weeks|overall survival, 24 weeks|infection rate, 24 weeks|relapse rate, 24 weeks|non-relapse mortality, 24 weeks
Effect of Ketalar or Dexmedetomidine on Increased Sensitivity to Pain Following Treatment With Remifentanil
NCT Number: NCT06473896
Status: RECRUITING
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Cholecystectomy
Interventions: DRUG: Ketalar|DRUG: Dexmedetomidine
Sponsor: Assaf-Harofeh Medical Center
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 90
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: SINGLE (PARTICIPANT)|Primary Purpose: TREATMENT
Start Date: 2024-04-18
Completion Date: 2026-08-30
Locations: Shamir (Asaf Harofe) Medical Center, Be'er Ya'aqov, 70300, Israel

Summary:
Analgesia is one of the pillars of anesthesia. One of the common opiates for pain relief, with a short half-life, is Remifentanil. However, following Remifentanil treatment an increased sensitivity to pain \[hyperalgesia\] appears. The aim of the study is to compare the effects between complementary treatments, like Ketalar and Dexmedetomidine, in preventing increased sensitivity to pain after Remifentanil treatment

Primary Outcome Measures: Pain Level, A record of pain level will be made using the Visual Analogue Scale. The score is determined by marking on 10-cm line between 0 - "no pain" to 10 - "the highest pain"., Up to two hours after the end of the anesthesia process|Pain killer consumption, Treatment with morphine for pain relief, Up to two hours after the end of the anesthesia process
SGLT2 Inhibitor and Sepsis
NCT Number: NCT06473844
Status: NOT_YET_RECRUITING
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Sepsis|Inflammation|SGLT2 Inhibitors|Critically Ill|Organ Dysfunction Syndrome
Interventions: DRUG: Empagliflozin 10 MG|DRUG: Placebo
Sponsor: Hospital Authority, Hong Kong
Collaborators: Chinese University of Hong Kong
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 60
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: DOUBLE (PARTICIPANT, INVESTIGATOR)|Primary Purpose: OTHER
Start Date: 2024-09-01
Completion Date: 2027-02-28
Locations: The University of Hong Kong, Hong Kong, 00, Hong Kong

Summary:
Goal of this clinical trial is to examine the safety and efficacy of SGLT2 inhibitors on the clinical outcomes in patients with sepsis. Main study outcomes are as follows:

(i) Primary objective is to examine the efficacy and safety of SGLT2 inhibitors on clinical outcomes in patients with sepsis.

(ii) Secondary objective is to examine the effect of SGLT2 inhibitors on inflammatory markers in patients with sepsis.

Primary Outcome Measures: Mortality, 28-day mortality|Change in Sequential Organ Failure Assessment (SOFA) score, Score is based on lab results and clinical data. Higher SOFA scores indicate higher risk of ICU mortality. Lower SOFA scores predicts lower risk of ICU mortality., Baseline and day 7 score
Secondary Outcome Measures: Interleukin-6, Interleukin-1 beta, TNF-a, IFN-gamma, Procalcitonin, C-reactive protein, Baseline and day 7
MagDI Australia Study
NCT Number: NCT06473831
Status: RECRUITING
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Obesity|Type 2 Diabetes
Interventions: DEVICE: Magnet System, DI Biofragmentable
Sponsor: GT Metabolic Solutions, Inc.
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 30
Study Design: Allocation: NA|Intervention Model: SINGLE_GROUP|Masking: NONE|Primary Purpose: TREATMENT
Start Date: 2024-06-06
Completion Date: 2025-09-30
Locations: St George Private Hospital, Sydney, New South Wales, 2217, Australia

Summary:
The objective of the MagDI Australia Study is to evaluate the feasibility / performance, safety, and initial efficacy of the MagDI System in eligible participants who are indicated for a duodeno-ileal (small bowel) side-to-side anastomosis procedure for partial intestinal diversion (e.g., one example of a small bowel clinical procedure requiring a side-to-side anastomosis).

Primary Outcome Measures: Feasibility and performance of the side-to-side anastomosis for duodeno-ileal diversion using the MagDI System., The duodeno-ileal diversion will be considered feasible if it results in successful:

* Placement of the Magnet System (≥ 90% alignment of magnets); and
* Creation of a patent anastomosis confirmed radiologically, and
* Passage of magnets without any surgical re-interventions.

The primary endpoint will be met if the feasibility/performance is confirmed in ≥ 80% of enrolled and treated subjects., From date of study index procedure through 90 days|Safety of the MagDI System, Freedom from serious adverse events related to the study device or study device procedure requiring additional emergency surgery or re-intervention, including:

* All-cause mortality
* Intestinal perforation and/or peritonitis
* Intestinal obstruction
* Life-threatening bleeding
* Incidence of device malfunctions, Procedure, Day 90, Day 180, Day 360
Non-invasive vs Invasive Cardiac Output Monitoring During Cesarean Section
NCT Number: NCT06473818
Status: NOT_YET_RECRUITING
Study Type: OBSERVATIONAL
Conditions: Hemodynamics
Interventions: DEVICE: Non-invasive monitoring|DEVICE: Invasive monitoring
Sponsor: General Hospital of Ningxia Medical University
Sex: FEMALE
Age: ADULT
Enrollment: 50
Study Design: Observational Model: |Time Perspective: p
Start Date: 2024-09-01
Completion Date: 2024-11-30

Summary:
This study aims to evaluate the consistency of hemodynamic monitoring between NICAP and NICCO technologies (T20A; Chongqing, China) and the traditional pulse wave analysis method (EV1000; USA).

Primary Outcome Measures: Cardiac output (CO), Monitoring data, 1-60 minutes after spinal anesthesia|Cardiac index (CI), Monitoring data, 1-60 minutes after spinal anesthesia|Stroke volume (SV), Monitoring data, 1-60 minutes after spinal anesthesia|Stroke volume variation (SVV), Monitoring data, 1-60 minutes after spinal anesthesia|Peripheral vascular resistance, Monitoring data, 1-60 minutes after spinal anesthesia
Secondary Outcome Measures: The incidence of post-spinal anesthesia hypotension, Systolic blood pressure (SBP) \< 80% of the baseline, 1-15 minutes after spinal anesthesia.|The incidence of severe post-spinal anesthesia hypotension, Systolic blood pressure (SBP) \< 60% of the baseline, 1-15 minutes after spinal anesthesia|The incidence of bradycardia, Heart rate \< 60 beats/min, 1-15 minutes after spinal anesthesia|The incidence of nausea and vomiting., Presence of nausea and vomiting in patients after spinal anesthesia, 1-15 minutes after spinal anesthesia|The incidence of hypertension, Systolic blood pressure (SBP) \>120% of the baseline, 1-15 minutes after spinal anesthesia