pankajmathur/National_Library_of_Medicine_Studies_data huggingface dataset:
Clinical Outcome of Dentsply Sirona Profile Implants
NCT Number: NCT06534034
Status: COMPLETED
Study Type: OBSERVATIONAL
Conditions: Dental Implants
Interventions: PROCEDURE: Dental implant placement
Sponsor: Aula Dental Avanzada
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 50
Study Design: Observational Model: |Time Perspective: p
Start Date: 2024-01-01
Completion Date: 2024-01-03
Locations: Clínica Dental Esteve, Alicante, 03001, Spain|Clinica Dental Amigó, Valencia, 46021, Spain

Summary:
This is a retrospective observational study of 50 implants placed between 2013 and 2023 from the same dental implant system (Osseospeed Profile, Dentsply Implants, Mölndal, Sweden).

Primary Outcome Measures: Success Rate, Number of dental Implants in function with no complications events, through study completion, a maximum of 5 years|Survival Rate, Number of dental Implants in function with any complications events, through study completion, a maximum of 5 years
Secondary Outcome Measures: Biological complications rate, Number os dental implant treatment with some biological complication, through study completion, a maximum of 5 years|Mechanical complications rate, Number of dental implant treatment with some mechanical complication, through study completion, a maximum of 5 year
IASO-782 in Autoimmune Hematological Diseases
NCT Number: NCT06534021
Status: NOT_YET_RECRUITING
Study Type: INTERVENTIONAL
Phases: PHASE1
Conditions: Autoimmune Thrombocytopenia|Warm Autoimmune Haemolytic Anaemia
Interventions: DRUG: IASO-782 injection|DRUG: placebo
Sponsor: Shanghai IASO Biotechnology Co., Ltd
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 16
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: QUADRUPLE (PARTICIPANT, CARE_PROVIDER, INVESTIGATOR, OUTCOMES_ASSESSOR)|Primary Purpose: TREATMENT
Start Date: 2024-08-01
Completion Date: 2025-11-01

Summary:
This study is a randomized, double-blinded, and placebo-controlled phase Ia clinical study in subjects with autoimmune hematological diseases. The study is designed to assess the safety and tolerability of IASO-782 for the treatment of autoimmune haematological diseases (ITP and wAIHA).

Primary Outcome Measures: Number of participants with adverse events as assessed by CTCAE v5.0, The safety and tolerability of IASO-782 will be assessed primarily by summarizing treatment-emergent AEs and SAEs., up to 12 weeks
Gait Training Program With Blood Flow Restriction in Children With Cerebral Palsy - EMBRIN: Pilot Study
NCT Number: NCT06533956
Acronym: EMBRIN
Status: NOT_YET_RECRUITING
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Cerebral Palsy
Interventions: OTHER: 10-week gait training program combined with simultaneous blood flow restriction (BFR).
Sponsor: University Hospital, Angers
Sex: ALL
Age: CHILD, ADULT
Enrollment: 10
Study Design: Allocation: NA|Intervention Model: SINGLE_GROUP|Masking: NONE|Primary Purpose: TREATMENT
Start Date: 2024-09
Completion Date: 2027-05
Locations: Les Capucins, Angers, France|University Hospital, Angers, Angers, France

Summary:
This is a single-center prospective experimental pilot study to assess the feasibility, tolerability and effect of a 10-week gait training program combined with simultaneous blood flow restriction (BFR) on the walking speed of children, aged 8 to 18, with bilateral spastic cerebral palsy.

The children will receive a 10-week intervention (1 week of habituation without BFR + 9 weeks with BFR) comprising 3 30-minute treadmill sessions per week. At each session, the first 5 minutes will enable a gradual increase in speed, and then the maximum tolerated walking speed will be sought. Maximum speed corresponds to the walking speed maintained by the child for an effort of between 5 and 7 on Borg's 10-point VAS. The rehabilitator will encourage the child to maintain this speed and provide feedback on performance. The BFR setting will maintain an occlusion, at the root level of both lower limbs, of 60% of the total occlusal pressure.

Children receiving the 10-week EMBRIN program are expected to improve their walking ability and muscular strength, two targets recognized as priorities for individuals with CP by the HAS. In this population, a major limitation of implementing rehabilitation programs is the large amount of practice required to bring about significant changes. This large amount of practice requires a major investment on the part of the individual, as well as significant rehabilitation resources. Muscle-strengthening programs are also particularly repetitive and therefore not very motivating for children. The EMBRIN program could reduce the training load and duration required to impact functional performance in children with CP. It could also help reduce the cost of rehabilitation interventions and reduce physical therapy time for individuals with CP in favor of their social participation.

Primary Outcome Measures: Comparison of changes in walking speed with standard rehabilitation and with gait training associated with BFR., The evaluation criterion is the change in walking speed between D-70-J0 and D0-J+70., Patients' walking speed will be compared between Day -70 to Day 0 (standard rehabilitation) and Day 0 to Day +70 (gait training program + BFR)
Blue-green Space Physical Activity: the "Parco Del Mare" Study
NCT Number: NCT06533943
Status: RECRUITING
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Healthy Adults|Natural Outdoor Environment|Health Promotion
Interventions: OTHER: Exercise program
Sponsor: Università degli Studi 'G. d'Annunzio' Chieti e Pescara
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 30
Study Design: Allocation: NON_RANDOMIZED|Intervention Model: PARALLEL|Masking: SINGLE (OUTCOMES_ASSESSOR)|Primary Purpose: TREATMENT
Start Date: 2022-02-01
Completion Date: 2024-12-20
Locations: Parco del Mare, Rimini, 47921, Italy

Summary:
This study protocol, describe the innovative study intervention which will be performed in a green-blue space in Italy in order to investigate on the improvements in wellbeing following participation in the study. This will be significant because it will provide evidence on the effectiveness of the supervised physical activities carried out in green-blue space in improving health, quality of life, physical performance, anthropometric outcomes and physiological parameters in adults, indicating the reasonableness for public health authorities to developing such activities.

Primary Outcome Measures: 12-Item Short Form Survey (SF-12), Quality of Life measurement (higher scores indicate better physical and mental components), through study completion, an average of 1 year
Evaluation of the Relationship Between OND and ONSD Measured by TOS With Clinical, Radiological, and Electrophysiological Parameters in MS Patients
NCT Number: NCT06533930
Status: COMPLETED
Study Type: OBSERVATIONAL
Conditions: Multiple Sclerosis
Interventions: OTHER: Transorbital Sonography|OTHER: Orbita Magnetic Resonance Imaging|OTHER: Visual Evoked Potentials|OTHER: Optical Coherence Tomography
Sponsor: Kutahya Health Sciences University
Sex: ALL
Age: ADULT
Enrollment: 136
Study Design: Observational Model: |Time Perspective: p
Start Date: 2023-10-01
Completion Date: 2024-04-01
Locations: Kutahya Health Sciences University, Faculty of Medicine, Kütahya, 43100, Turkey

Summary:
The primary aim of this study is to evaluate the reliability of optic nerve diameter (OND) and optic nerve sheath diameter (ONSD) measurements made with transorbital sonography (TOS) and magnetic resonance imaging (MRI) in patient groups that may progress with subclinical optic atrophy over time, such as those with multiple sclerosis (MS). The secondary aims of this study are to compare the relationship of TOS with visual evoked potentials (VEP) and optical coherence tomography (OCT) parameters used in the assessment of the afferent visual pathway in MS and its clinical subtypes and to evaluate the potential of TOS as a diagnostic and monitoring tool for detecting optic nerve atrophy, subclinical axonal loss, and clinical disability in MS.

Primary Outcome Measures: Transorbital Sonography, OND and ONSD of participants in the MS patient group and healthy control group were measured by TOS., 2 minutes|Orbita Magnetic Resonance Imaging, OND and ONSD of participants in the MS patient group were measured by orbita MRI., 30 minutes
Secondary Outcome Measures: Visual Evoked Potentials, Visual Evoked Potentials, 20 minutes|Optical Coherence Tomography, pRNFL thickness of participants in the MS patient group were measured by OCT., 15 minutes|Expanded Disability Status Scale, Disability Status Evaluation. A score of 0 on the scale indicates normal neurological status, while a score of 10 means MS-related death., 30 minutes
Spinal Cord Stimulation for Chronic Abdominal Pain Patients
NCT Number: NCT06533917
Status: RECRUITING
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Pain
Interventions: DEVICE: Main Group
Sponsor: The Leeds Teaching Hospitals NHS Trust
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 10
Study Design: Allocation: NA|Intervention Model: SINGLE_GROUP|Masking: NONE|Primary Purpose: DEVICE_FEASIBILITY
Start Date: 2024-01-18
Completion Date: 2025-06-04
Locations: Leeds Teaching Hospitals NHS Trust, Leeds, United Kingdom

Summary:
Chronic abdominal pain is a common disorder that can have significant impact on the lives of patients. Treatment options include medication which can have limited effectiveness, be associated with side effects and may lead to tolerance and dependency. Spinal cord stimulation (SCS) is a minimally invasive, therapeutic option for managing chronic abdominal pain. This involves implanting a device that delivers mild electrical signals to the spinal cord to reduce pain. Conventional SCS has been shown to improve abdominal pain caused by different disorders, but it causes feelings of unpleasant tingling in the tummy area. This feasibility study aims to explore relief from chronic abdominal pain symptoms when using a device that does not cause uncomfortable tingling feelings in the tummy area.

Primary Outcome Measures: To evaluate the safety and feasibility of ECAP-controlled closed-loop SCS in treating patients with CAP.treating patients with CAP, To evaluate the safety and feasibility of ECAP-controlled closed-loop SCS in treating patients with CAP.Visual Analogue Scale (VAS) in the last week.

• Incidence rates of study related adverse events will be collected and characterized., 12 MONTHS|• Changes in average pain intensity, in the primary region of pain on the Visual Analogue Scale (VAS) in the last week., • Changes in average pain intensity, in the primary region of pain on the Visual Analogue Scale (VAS) in the last week., 12 MONTHS|• Incidence rates of study related adverse events will be collected and characterized., • Incidence rates of study related adverse events will be collected and characterized., 12 MONTHS
Romosozumab as an Adjunct to Physiologic Estrogen Replacement in Functional Hypothalamic Amenorrhea
NCT Number: NCT06533865
Status: NOT_YET_RECRUITING
Study Type: INTERVENTIONAL
Phases: PHASE3
Conditions: FHA (Functional Hypothalamic Amenorrhea)
Interventions: DRUG: Romosozumab|DRUG: Placebo|DRUG: Zoledronic acid
Sponsor: Massachusetts General Hospital
Sex: FEMALE
Age: CHILD, ADULT
Enrollment: 114
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: TRIPLE (PARTICIPANT, CARE_PROVIDER, INVESTIGATOR)|Primary Purpose: TREATMENT
Start Date: 2024-10-01
Completion Date: 2029-06-01

Summary:
The goal of this study is to determine whether romosozumab will improve bone density in girls and women with functional hypothalamic amenorrhea (cessation of the menstrual period due to intense exercise, stress, or an eating disorder) who have low bone density. Participants will be randomly assigned to receive romosozumab or placebo for 6 months. All participants will receive one IV infusion of zoledronate at the 6 month visit. All participants will also receive transdermal estradiol and cyclic progesterone. We will investigate whether participants who receive active romosozumab will demonstrate greater improvements in bone density at one year than those who receive placebo. We will also compare bone density over a year with healthy controls (girls and women of similar age who have regular menstrual periods).

Primary Outcome Measures: Lumbar spine bone density, 6-month change in lumbar spine bone density, 0 and 6 months|Tibial cortical thickness, 6-month change in tibial cortical thickness, 0 and 6 months|Tibial failure load, 6-month change in tibial failure load, 0 and 6 months
Secondary Outcome Measures: Femoral neck and total hip bone density, 6- and 12-month change in femoral neck and total hip bone density, 0, 6, and 12 months|Lumbar spine bone density, 12-month change in lumbar spine bone density, 0 and 12 months|Radial cortical thickness, 6- and 12-month change in radial cortical thickness, 0, 6, and 12 months|Tibial cortical thickness, 12-month change in tibial cortical thickness, 0 and 12 months|P1NP and CTX, 1-, 6-, and 12-month change in P1NP and CTX, 0, 1, 6, and 12 months|Radial failure load, 6- and 12-month change in radial failure load, 0, 6, and 12 months|Tibial failure load, 12-month change in change in tibial failure load, 0 and 12 months|Lumbar spine, femoral neck, and total hip bone density, 6- and 12-month in lumbar spine, femoral neck, and total hip bone density, 0, 6, and 12 months|P1NP and CTX, 1-, 6- and 12-month change in markers of bone metabolism, 0, 1, 6 and 12 months|Tibial and radial cortical thickness, 6- and 12-month change in tibial and radial cortical thickness, 0, 6 and 12 months|Tibial and radial failure load, 6- and 12-month change in tibial and radial failure load, 0, 6 and 12 months
Prevention of Parastomal Hernias With a Preformed Three-dimensional, Funnel-shaped Mesh
NCT Number: NCT06533839
Acronym: PREVEMAC
Status: NOT_YET_RECRUITING
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Parastomal Hernia
Interventions: PROCEDURE: Permanent colostomy
Sponsor: Consorci Sanitari Integral
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 58
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: SINGLE (PARTICIPANT)|Primary Purpose: TREATMENT
Start Date: 2024-08-01
Completion Date: 2029-08-01
Locations: Hospital Sant Joan Despí Moisès Broggi, Sant Joan Despí, Barcelona, 08970, Spain

Summary:
Parastomal hernia (PH) remains a significant complication following stoma creation, boasting a considerable prevalence in the range of 30 to 50% within the first year post-surgery, a figure that climbs even higher when considering radiological evidence irrespective of clinical symptoms. A noteworthy one-third of these cases necessitate subsequent surgical interventions, yielding suboptimal outcomes both in the short and long term. The clinical manifestations of PH are diverse, ranging from mild inconveniences like fecal leakage and dermatitis to more severe and potentially life-threatening complications such as intestinal obstruction, hernia incarceration, and ischemia.

Various systematic reviews and meta-analyses have advocated for the adoption of prophylactic meshes, although defining precise incidence and recurrence rates has proven challenging due to methodological disparities across studies. Keyhole and modified Sugarbaker techniques dominate laparoscopic and robotic approaches, yet none offer ideal outcomes.

The aim of this study is to evaluate the decrease of postoperative parastomal hernia using this three-dimensional, funnel-shaped mesh.

Primary Outcome Measures: Postoperative parastomal hernia prevention, proportion of Postoperative parastomal hernias, up to one year post-intervention
Secondary Outcome Measures: Postoperative parastomal hernia prevention, proportion of Postoperative parastomal hernias, 5 years after surgery|readmissions for complications, proportion of hospital readmissions, up to one year post-intervention|morbidity, Comprehensive Complication Index (CCI) 20, up to one year post-intervention
Evaluation of Gut Microbiota and Its Associated Resistome in FMT Donors and Recipients Due to Recurrent Clostridiodes Difficile Infection
NCT Number: NCT06533800
Acronym: MICROFMT
Status: NOT_YET_RECRUITING
Study Type: OBSERVATIONAL
Conditions: CDI
Sponsor: Fondazione Policlinico Universitario Agostino Gemelli IRCCS
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 24
Study Design: Observational Model: |Time Perspective: p
Start Date: 2024-09-15
Completion Date: 2026-08-15

Summary:
Caratterizzazione della composizione microbica intestinale nei donatori di FMT e nei pazienti affetti da rCDI al tempo basale e a seguito del trapianto di microbiota fecale. Negli stessi time point valutare il resistoma associato alla comunità microbica rilevata.

Primary Outcome Measures: Assessment of gut microbiota e associated resitome, Characterization of intestinal microbial composition in FMT donors and patients with rCDI at baseline time and following fecal microbiota transplantation. In the same time points evaluate the resistance associated with the microbial community detected., 24 months
Impact of Echocardiography on Management of Critically Ill Neonates
NCT Number: NCT06533787
Status: NOT_YET_RECRUITING
Study Type: OBSERVATIONAL
Conditions: Critical Illness|Echocardiography|Neonatology
Interventions: DEVICE: Echocardiography
Sponsor: Sahar Abozkaly Mahmoud
Sex: ALL
Age: CHILD
Enrollment: 200
Study Design: Observational Model: |Time Perspective: p
Start Date: 2024-08
Completion Date: 2025-08

Summary:
The goal of the study was to estimate the outcome (mortality and morbidity) among hemodynamically unstable neonates, as well as the time to return to hemodynamic stability following the use of ECHO in the management of hemodynamically unstable neonates.

Primary Outcome Measures: Functional echocardiography ( ejection fraction using M mode echocardiography), Repeat echocardiographic assessment on a daily basis ( 24 hours interval)|Functional echocardiography fraction shortening by M mode echocardiography, Repeat echocardiographic assessment on a daily basis ( 24 hours interval)|Assessment of ductus arteriosus ( diameter, shunt directionality ) by 2D and color doppler echocardiography, Repeat echocardiographic assessment 5 days after the first echo assessment|Assessment of pulmonary hypertension, Using peak tricuspid regurgitation velocity by colour doppler, Repeat echocardiographic assessment on a daily basis ( 24 hours interval) following proposed treatment of pulmonary hypertension|Assessment of LV cardiac index, Assessment of LV outflow tract diameter by 2D/M mode echocardiography in parasternal long axis view and assessment of Velocity-time integral of PW in LV outflow tract by PW doppler in apical five-chamber view, Repeat echocardiographic assessment on a daily basis ( 24 hours interval)|Assessment of RV cardiac index, Assessment of RV outflow tract diameter by 2D echocardiography and Velocity-time integral of PW in RV outflow tract, Repeat echocardiographic assessment on a daily basis ( 24 hours interval)|Assessment of SVC flow, Assessment of SVC diameter (mean of systolic and diastolic diameter) by M mode echocardiography in high parasternal view, Repeat echocardiographic assessment on a daily basis ( 24 hours interval)|Assessment of RV function, Measurement of Tricuspid annular plane systolic excursion (TAPSE) using M mode echocardiography in apical four chamber view, Repeat echocardiographic assessment on a daily basis ( 24 hours interval)
Speech Locator_Benefits in Pediatric Popluations
NCT Number: NCT06533774
Status: TERMINATED
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Hearing Loss
Interventions: DEVICE: Phonak Audéo Lumity 90-R
Sponsor: Sonova AG
Sex: ALL
Age: CHILD
Enrollment: 27
Study Design: Allocation: NA|Intervention Model: SINGLE_GROUP|Masking: NONE|Primary Purpose: TREATMENT
Start Date: 2023-06-08
Completion Date: 2023-10-31
Locations: Hearts for Hearing, Oklahoma City, Oklahoma, 73120, United States

Summary:
The study seeks to evaluate the impact of SpeechSensor and StereoZoom 2.0 on speech understanding in noise in dynamic listening conditions in pediatric hearing aid users.

Primary Outcome Measures: Speech intelligibility using AZBio sentences Verbal response accuracy based on percent of words correctly repeated on an open-set sentence recognition in noise task., Verbal response accuracy based on percent of words correctly repeated on an open-set sentence recognition in noise task.

1. Initial - Personalized Signal-to-Noise-Ratio (SNR) is determined for each participant by finding the point where the participant scores 50% correct individual words within sentences. The personalized SNR is determined from the average of two list for a given condition. (SpeechSensor and SZ2.0 objectives)
2. For comparison conditions - Speech as noise will be presented at the participant's personalized SNR. Speech intelligibility will be determined by accuracy of individual words within sentences. The total words correct is determined for a single list for each condition. (Aided versus unaided, intended use objective)., 3 hours
Secondary Outcome Measures: Speech Focus Slider Usability - Performance on a modified PHAST (Practical Hearing Aid Skills Test) tool will be used to document whether participants can successfully modify the Speech Focus slider., 1. Ability to use slider in the app will be determined on the basis of successfully or not successfully completing a single task, "In a situation when you want to use the app, show me what you would do." The child will be reinstructed one time and must successfully perform the desired task to be eligible for the home trial.
2. Ability to successfully use slider in the app will be determined based on successful execution of all of the following tasks correctly):

i. Show me what you would do to better hear a person in front; ii. Show me what you would do to hear more of the sounds around you. iii. Demonstrate what you should do when you leave the situation., 3 hours|Preference for having slider, Preference for having the Speech Focus slider accessible via the app will be documented with a Yes/ No question on a subjective questionnaire administered post-home trial., Up to 4 weeks|Confidence and Anxiety, The possible impact of having access to the Speech Focus slider on confidence and anxiety will be measured using subjective ratings on a post-home trial questionnaire (i.e., Likert scale)., Up to 4 weeks
Eganelisib as Monotherapy and in Combination With Cytarabine in Relapsed/Refractory AML
NCT Number: NCT06533761
Status: NOT_YET_RECRUITING
Study Type: INTERVENTIONAL
Phases: PHASE1
Conditions: AML, Adult|MDS
Interventions: DRUG: Eganelisib|DRUG: Eganelisib in combination with cytarabine
Sponsor: Stelexis BioSciences
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 125
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: NONE|Primary Purpose: TREATMENT
Start Date: 2025-01-15
Completion Date: 2028-03-15

Summary:
This is a Phase 1b open-label, multicenter, dose-escalation and dose-optimization study designed to evaluate the safety, tolerability, pharmacokinetics (PK), pharmacodynamics (PD), and anti-tumor efficacy of eganelisib as monotherapy and in combination with cytarabine in patients with relapsed/refractory (r/r) acute myeloid leukemia (AML) or r/r higher-risk myelodysplastic syndromes (HR-MDS).

The study consists of 2 parts:

* Part 1: Dose Escalation (DE) in both monotherapy and in combination.
* Part 2: Dose Optimization

Primary Outcome Measures: Incidence and severity of adverse events (AEs), graded according to the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE), Version 5.0, 12 months|Incidence and severity of dose-limiting toxicities (DLTs) in DLT evaluable patients during Cycle 1, 28-35 days|Preliminary clinical activity as evaluated per European LeukemiaNet (ELN) 2022 criteria for AML and International Working Group (IWG) 2023 criteria for HR-MDS, 12 months
Secondary Outcome Measures: Area under the plasma concentration time curve extrapolated to the last measurable time point [AUClast] of eganelisib and cytarabine, 112 days|Maximum concentration [Cmax] of eganelisib and cytarabine, 112 days|Time of maximum concentration [Tmax] of eganelisib and cytarabine, 112 days|Plasma half-life [t1/2] of eganelisib and cytarabine, 112 days|Measure plasma concentrations of eganelisib and determine model-based PK parameters, 112 days
Adaptive Therapy for Post-Second-Line Advanced Breast Cancer
NCT Number: NCT06533722
Status: RECRUITING
Study Type: INTERVENTIONAL
Phases: PHASE2
Conditions: HER2-negative Metastatic Breast Cancer
Interventions: DRUG: Gemcitabine, Vinorelbine, or Eribulin
Sponsor: Sun Yat-sen University
Sex: FEMALE
Age: ADULT, OLDER_ADULT
Enrollment: 10
Study Design: Allocation: NA|Intervention Model: SINGLE_GROUP|Masking: NONE|Primary Purpose: TREATMENT
Start Date: 2024-08-04
Completion Date: 2025-07-07
Locations: Sun Yat-sen University Cancer Center, Guangzhou, Guangdong, 510060, China

Summary:
The primary objective of this study is to explore the efficacy and safety of adaptive therapy in the treatment of post-second-line metastatic breast cancer.

Primary Outcome Measures: progression-free survival (PFS), The interval time from the date of initiation treatment after recruit to the date of the first documented disease progression or death due to any cause., 12 months
Secondary Outcome Measures: Occurrence and severity of adverse events (AEs), Occurrence and severity of AEs by NCI-CTCAE v5. Changes in laboratory parameters (hematology and serum chemistry), vital signs and ECG parameters. Grade 3 or 4 abnormalities in serum chemistry laboratory parameters, 12 months
Satisfactory Debulking Prediction Model for Advanced Ovarian Cancer Based on PET-CT Image Data
NCT Number: NCT06533709
Status: RECRUITING
Study Type: OBSERVATIONAL
Conditions: Ovarian Cancer|Image|Predation
Interventions: DIAGNOSTIC_TEST: Radio-score
Sponsor: Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University
Sex: FEMALE
Age: ADULT, OLDER_ADULT
Enrollment: 146
Study Design: Observational Model: |Time Perspective: p
Start Date: 2024-06-01
Completion Date: 2026-05-31
Locations: The Sun Yat-sen Memorial Hospital of Sun Yat-sen University, Guangzhou, Guangdong, 520120, China

Summary:
This project intends to conduct a multicenter retrospective study to evaluate the satisfactory reduction of advanced ovarian cancer using PET-CT images, and explore the correlation between molecular biological characteristics and clinical characteristics of ovarian cancer through high-throughput sequencing genomics combined with radiomics.

Primary Outcome Measures: R0 resection, In patients with advanced ovarian cancer, the residual status after initial cytoreductive surgery is defined as follows: complete resection is defined as R0 resection, whereas visible residual tumor lesions during surgery are defined as non-R0 resection, yes or not
Secondary Outcome Measures: 5-year progression-free survival (PFS), PFS was calculated from the date of the last chemotherapy until disease progression or death due to any cause., 5 years|5-year overall survival (OS), OS was calculated from the date of the primary debulking surgery until death due to any cause., 5-year|Response to platinum-based chemotherapy, After the last chemotherapy, treatment efficacy was assessed according to NCCN guidelines. For primary tumor, patients who relapsed 6 months or more after initial chemotherapy were termed platinum-sensitive. In contrast, patients whose disease recurred in less than 6 months were classified as platinum-resistant., At least 6 months after the last chemotherapy
A Comparison of Microscopy and Enzyme Linked Immunosorbent Assay for Diagnosis of Giardia Lamblia in Children, Sohag
NCT Number: NCT06533696
Status: NOT_YET_RECRUITING
Study Type: OBSERVATIONAL
Conditions: Giardia Lamblia Infection
Sponsor: Sohag University
Sex: ALL
Age: CHILD, ADULT, OLDER_ADULT
Enrollment: 94
Study Design: Observational Model: |Time Perspective: p
Start Date: 2024-07
Completion Date: 2025-12

Summary:
The present study was done to evaluate the efficacy of Human anti Giardia lamblia antibody (ELISA) kitst in comparison to direct microscopy in the diagnosis of G. lamblia in stool specimens from immunocompetent and immunocompromised children with diarrhea and other gastrointestinal symptoms.

Primary Outcome Measures: A Comparison of Microscopy and Enzyme Linked Immunosorbent Assay for Diagnosis of Giardia lamblia in Children, Sohag, evaluate the efficacy of Human anti Giardia lamblia antibody (ELISA) kitst in comparison to direct microscopy in the diagnosis of G. lamblia in stool specimens from immunocompetent and immunocompromised children with diarrhea and other gastrointestinal symptoms., 1 year
Effects of Kinesio Taping and Extracorporeal Shock Wave Therapy in the Calcaneal Spur
NCT Number: NCT06533683
Status: COMPLETED
Study Type: OBSERVATIONAL
Conditions: Calcaneal Spur|Plantar Fasciitis|Heel Pain
Sponsor: Sisli Hamidiye Etfal Training and Research Hospital
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 60
Study Design: Observational Model: |Time Perspective: p
Start Date: 2023-09-01
Completion Date: 2024-03-01
Locations: Şişli Hamidiye Etfal Training and Research Hospital, İstanbul, Turkey

Summary:
The term \&#34;heel pain\&#34; is used to describe a common, painful condition that is localized in the plantar part of the heel and worsens when weight is placed on the heel. Patients with heel pain are more likely to have thickened plantar fascia, abnormal plantar fascia tissue, thicker plantar heel fat pad, and calcaneal spur. Calcaneal spurs are bony protrusions that typically occur just in front of the medial calcaneal tuberosity. Systemic medical treatments, physical therapy agents, exercise and local injections are often applied for heel pain caused by plantar fasciitis and calcaneal spur.

This study is to examine the effects of ESWT and kinesio taping on pain and other clinical outcomes in patients with calcaneal spurs.

Primary Outcome Measures: Pain level before treatment and 3rd month after treatment, Pain level will be evaluated with the Numerical Rating Scale. (minimum: 0, maximum: 10), From enrollment to the end of treatment at 3rd month
Secondary Outcome Measures: Assessment of heel sensitivity, It will be evaluated with the Heel Tenderness index. (0=no pain; 1=painful; 2=painful and whines; 3=painful, whines, and withdraws), From enrollment to the end of treatment at 3rd month|Assessment of functionality, Foot Function Index was used. The FFI consists of 23 items divided into 3 subscales that quantify the impact of foot pathology on pain, disability, and activity limitation in patients. Pain, disability, and activity limitation subscale scores range from 0 to 100., From enrollment to the end of treatment at 3rd month|Assessment of quality of life, The 12-item short-form health survey (SF-12) quality of life scale was used to evaluate general quality of life. It was presented as a physical component score (PCS) and mental component score (MCS). Scores range from 0 to 100, with higher scores indicating better physical and mental health functioning., From enrollment to the end of treatment at 3rd month
TME Alteration in HER2 Positive Breast Cancer
NCT Number: NCT06533670
Status: RECRUITING
Study Type: OBSERVATIONAL
Conditions: Breast Cancer|HER2-positive Breast Cancer|Chemotherapy Effect
Sponsor: Seoul National University Hospital
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 30
Study Design: Observational Model: |Time Perspective: p
Start Date: 2024-07-19
Completion Date: 2026-07-19
Locations: Seoul National University Hospital, Seoul, Korea, Republic of

Summary:
Evaluate for changes in the tumor microenvironment before/during neoadjuvant chemotherapy and after treatment in patients diagnosed with HER2-positive advanced breast cancer and receiving neoadjuvant cancer therapy and surgery for curative purposes.

Primary Outcome Measures: tumor microenvironment alteration, tumor microenvironment changes during neoadjuvant chemotherapy (NAC) for HER2-positive breast cancer., 6 months
Measuring Brain Health Using Low-Field Portable MRI
NCT Number: NCT06533631
Acronym: MR SCREEN
Status: NOT_YET_RECRUITING
Study Type: OBSERVATIONAL
Conditions: White Matter Hyperintensity
Interventions: DEVICE: Portable low-field MRI (pMRI)|DEVICE: 3T MRI
Sponsor: Yale University
Collaborators: National Institute of Neurological Disorders and Stroke (NINDS)
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 100
Study Design: Observational Model: |Time Perspective: p
Start Date: 2024-08
Completion Date: 2025-08
Locations: Yale Magnetic Resonance Research Center (MRRC) at The Analyn Center (TAC), New Haven, Connecticut, 06520, United States

Summary:
The purpose of this study is to develop a new grading scale and utilize automated segmentation for measurement of White Matter Hyperintensity (WMH) volume using a low field MRI.

Primary Outcome Measures: WMH graded on a low-field WMH scale, Each pMRI scan will be evaluated by two readers experienced in the adjudication of WMH and the high-field 3T MRI will be adjudicated by a board certified neuroradiologist. WMH will be graded on a low-field WMH scale as minimal, moderate, or severe. The low-field WMH scale will be derived by an expert panel consisting of the study investigators and two more neurologists, a neuroradiologist, and neuropsychologist. Investigators will employ the Delphi method to harness the collective expertise of this panel in developing the novel grading scale., 2 hours
Secondary Outcome Measures: WMH lesion load (in mm3), WMH lesion load will be assessed both global and per white matter region of interest (ROI). These ROIs are defined by FreeSurfer, which maps cortical parcels into corresponding WM segments using geodesic distances. Using the high-field MRI as ground truth, investigators will use two metrics to evaluate the WMH in pMRI. The first, and main validation criterion, is the Spearman correlation coefficient between lesion loads (both global and per ROI) estimated from pMRI (by the neural network) and from high-field MRI (obtained via manual delineation). And second, the Dice score between the predicted WMH mask in pMRI and the corresponding ground truth from the high-field MRI., 2 hours
Characterization of the "Transfusion-dependent Prediabetes" Using Continuous Glucose Monitoring
NCT Number: NCT06533618
Status: COMPLETED
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Prediabetic State
Interventions: DIAGNOSTIC_TEST: Continuous glucose monitoring system
Sponsor: University of Campania "Luigi Vanvitelli"
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 29
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: NONE|Primary Purpose: SCREENING
Start Date: 2023-07-01
Completion Date: 2023-10-30
Locations: Centro di Diabetologia Pediatrica "G.Stoppoloni", Naples, 80100, Italy

Summary:
Dysglycemia is a frequent finding in transfusion-dependent thalassemia (TDT). The oral glucose tolerance test (OGTT) remains the only validated screening test, but the procedure is complex and time-consuming. Continuous glucose monitoring (CGM) systems are simple to use, and could have a role in the diabetes mellitus diagnosis. This study involved 39 participants (19 cases and 20 healthy controls) using CGM for the analysis of the glucose metrics. Participants resulted negative for diabetes mellitus screening tests. Patients' clinical data were compared with glucose metrics.

Primary Outcome Measures: Number of participants with pre diabetes in Transfusion dependent patients, Transfusion dependent patients were studied using a continuous glucose monitoring system with the aim to show condition of dysglicemia (prediabetes), Seven days
Phase I Clinical Study to Evaluate the Safety and Efficacy of SSGJ-706 Monotherapy for Patients With Advanced Solid Tumors
NCT Number: NCT06533605
Status: NOT_YET_RECRUITING
Study Type: INTERVENTIONAL
Phases: PHASE1
Conditions: Advanced Solid Tumors Patients
Interventions: DRUG: SSGJ-706
Sponsor: Sunshine Guojian Pharmaceutical (Shanghai) Co., Ltd.
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 60
Study Design: Allocation: NON_RANDOMIZED|Intervention Model: SINGLE_GROUP|Masking: NONE|Primary Purpose: TREATMENT
Start Date: 2024-08
Completion Date: 2025-08-31

Summary:
This study includes two parts, different part has different administration frequencies of SSGJ-706.

Primary Outcome Measures: DLTs, Dose limiting toxicity, 12 months|MTD or MAD, maximum tolerated dose or the maximum administered dose if MTD is not reached, 12 months
Secondary Outcome Measures: The blood concentration of SSGJ-706, PK characteristics, 12 months
Gene Therapy for B-Cell Acute Lymphoblastic Leukemia
NCT Number: NCT06533579
Status: NOT_YET_RECRUITING
Study Type: INTERVENTIONAL
Phases: PHASE1|PHASE2
Conditions: B-cell Acute Lymphoblastic Leukemia
Interventions: GENETIC: Dose Level 1, VNX-101|GENETIC: Dose Level 2, VNX-101|GENETIC: Dose Level 3, VNX-101|GENETIC: Dose Level 4, VNX-101
Sponsor: Vironexis Biotherapeutics Inc.
Sex: ALL
Age: CHILD, ADULT, OLDER_ADULT
Enrollment: 26
Study Design: Allocation: NA|Intervention Model: SINGLE_GROUP|Masking: NONE|Primary Purpose: TREATMENT
Start Date: 2024-09
Completion Date: 2031-09

Summary:
This is a Phase 1/2, first-in-human, open-label, dose-escalating trial designed to assess the safety and efficacy of VNX-101 in patients with relapsed or refractory CD19+ B-cell acute lymphoblastic leukemia (ALL).

Primary Outcome Measures: Treatment emergent adverse events (TEAEs) and treatment-emergent serious events (TESAEs), Change from Baseline to Year 5 post dosing
Secondary Outcome Measures: Change from baseline in B-cell counts, Change from baseline to year 5 post dosing|Change baseline in immunoglobulin levels, Change from baseline to year 5 post dosing|Change baseline in antitumor activity, Change from baseline to year 5 post dosing|Proportion/duration of subjects achieving hematological response, progression free survival, and disease free survival., Change from baseline to year 5 post dosing
Other Outcome Measures: Exploratory Measure: Change in VNX-101 gene product levels, Change from baseline to year 5 post dosing|Exploratory Measure: Change in VNX-101 vector shedding, Change from baseline to year 5 post dosing
Erector Spinae Plane Block Versus Local Wound Infiltration After Modified Radical Mastectomy
NCT Number: NCT06533566
Status: RECRUITING
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Post Operative Pain|Erector Spinae Plane Block|Local Infiltration
Interventions: PROCEDURE: Erector spinae plane block|PROCEDURE: local wound infiltration
Sponsor: Tanta University
Sex: FEMALE
Age: ADULT
Enrollment: 37
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: DOUBLE (PARTICIPANT, OUTCOMES_ASSESSOR)|Primary Purpose: SUPPORTIVE_CARE
Start Date: 2024-08-10
Completion Date: 2025-08-01
Locations: Faculty of medicine, Tanta university, Tanta, El Gharbyia, 31111, Egypt

Summary:
This randomized prospective double blinded study will aim to evaluate the postoperative analgesic effect of ultrasound guided Erector Spinae plane block and local wound infiltration (drain block) for patients scheduled for modified radical mastectomy surgery.

Primary Outcome Measures: total morphine consumption, total morphine amount which will be consumed in the first postoperative day, first postoperative day after modified radical mastectomy surgery
A Study to Assess the Effects of Dexpramipexole in Participants With Eosinophilic COPD
NCT Number: NCT06533553
Acronym: SUSPIRE-1
Status: RECRUITING
Study Type: INTERVENTIONAL
Phases: PHASE2
Conditions: Chronic Obstructive Pulmonary Disease
Interventions: DRUG: Dexpramipexole Dihydrochloride
Sponsor: Areteia Therapeutics
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 30
Study Design: Allocation: NA|Intervention Model: SINGLE_GROUP|Masking: NONE|Primary Purpose: TREATMENT
Start Date: 2024-07-09
Completion Date: 2025-06
Locations: Research Site 10001-008, Newport Beach, California, 92663, United States|Research Site 10001-022, Northridge, California, 91324, United States|Research Site 10001-016, Westminster, California, 92683, United States|Research Site 10001-001, Saint Louis, Missouri, 63110, United States|Research Site 10001-007, Gastonia, North Carolina, 28054, United States|Research Site US-10001-004, Columbus, Ohio, 43215, United States|Research Site 10001-002, DuBois, Pennsylvania, 15801, United States|Research Site 10001-013, Philadelphia, Pennsylvania, 19140, United States|Research 10001-010, Charleston, South Carolina, 28277, United States|Research Site 10001-012, Rock Hill, South Carolina, 29732, United States|Research Site 10001-009, Corsicana, Texas, 75110, United States

Summary:
This is an open-label Phase II study assessing the PD of dexpramipexole 150 mg twice daily (BID) in participants with eosinophilic COPD. This study will help characterize the profile and duration of reductions of blood absolute eosinophil counts (AEC).

Primary Outcome Measures: Geometric mean change in the blood AEC from baseline to Week 16, Baseline, Week 16
Secondary Outcome Measures: Pre-BD FEV1, Change in pre-bronchodilator forced expiratory volume in 1 second (pre-BD FEV1) from baseline to Week 16, Baseline, Week 16|Post-BD FEV1, Change in post-bronchodilator forced expiratory volume in 1 second (Pre-BD FEV1) from baseline to Week 16, Baseline, Week 16|St George's Respiratory Questionnaire for COPD Patients (SGRQ-C), Change from baseline to Week 16. SGRQ-C total scores range from 0 to 100, with higher scores indicating more limitations., Baseline, Week 16|COPD Assessment Test (CAT), Change from baseline to Week 16, Baseline, Week 16
Safety Study of TPX-121 on Nasolabial Folds
NCT Number: NCT06533540
Status: NOT_YET_RECRUITING
Study Type: INTERVENTIONAL
Phases: PHASE1
Conditions: Nasolabial Fold, Hypoplastic
Interventions: BIOLOGICAL: TPX-115(allogeneic fibroblasts)
Sponsor: Tego Science, Inc.
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 18
Study Design: Allocation: NON_RANDOMIZED|Intervention Model: PARALLEL|Masking: NONE|Primary Purpose: TREATMENT
Start Date: 2024-12
Completion Date: 2026-12
Locations: Kyungpook National University, School of Medicine, Daegu, Jung-gu, 41944, Korea, Republic of

Summary:
Nasolabial folds augmentation is possible through dermal filler and botulinum toxin, however, safety issues are existed as well as efficacy. Therefore, there is a need for a safer procedure for nasolabial folds correction. This study (Project No. TPX-121) assesses the safety of allogeneic fibroblasts (TPX-115) on nasolabial folds. The safety endpoint is dose-limiting toxicity (DLT). In addition, exploratory endpoints are the improvement of nasolabial folds in Wrinkle Severity Rating Scale (WSRS) at week 4 and 12, change in WSRS and Wrinkle Severity Scale (WSS) at week 4 and 12, and overall appearance improvement rate in Global Aesthetic Improvement Scale (GAIS) at week 4 and 12.

Primary Outcome Measures: Dose-limiting toxicity, The number of subjects evaluated grade 3 or higher adverse drug reactions according to the NCI Common Terminology Criteria for Adverse Events (CTCAE) v5.0, Week 4
Other Outcome Measures: Improvement WSRS grade from baseline, Improvement Wrinkle Severity Rating Scale (WSRS) grade of nasolabial folds from baseline evaluated by an investigator based on pictures taken at week 4 and 12.

The WSRS ranges from 1 (absent) to 5 (Extreme). A negative change from baseline indicates improvement., Week 4 and Week 12|WSRS grade change from baseline, Wrinkle Severity Rating Scale (WSRS) grade change from baseline evaluated by an investigator based on pictures taken at week 4 and 12.

The WSRS ranges from 1 (absent) to 5 (Extreme). A negative change from baseline indicates improvement., Week 4 and Week 12|WSS grade change from baseline, Wrinkle Severity Scale (WSS) grade change from baseline evaluated by an investigator based on pictures taken at week 4 and 12.

The WSS ranges from 0 (absent) to 5 (Extreme). A negative change from baseline indicates improvement., Week 4 and Week 12|Overall appearance improvement percentage(%) using GAIS, Overall appearance improvement percentage(%) rated by subjects using Global Aesthetic Improvement Scale (GAIS) at week 4 and 12.

In the case of overall appearance improvement rate using GAIS being +3 point (Very much improved), +2 (Much improved), or +1 (Improved), Week 4 and Week 12
Rapid Diagnosis of Severe Respiratory Tract Infectious Diseases and Screening of Biomarkers for Stratified Diagnosis
NCT Number: NCT06533514
Status: NOT_YET_RECRUITING
Study Type: OBSERVATIONAL
Conditions: Severe Pneumonia|Biomarkers
Sponsor: Chinese PLA General Hospital
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 100
Study Design: Observational Model: |Time Perspective: p
Start Date: 2024-09-01
Completion Date: 2025-12-01

Summary:
The purpose of this study is to clarify the biomarkers for rapid diagnosis and stratified diagnosis of severe respiratory tract infectious diseases through clinical experiments.

Primary Outcome Measures: The relationship between the patient's specific biomarker levels and clinical outcomes., Treatment failure rate, Mortality rates, SOFA rating scale, 1 mounth
Leucine Requirements During the Menstrual Cycle
NCT Number: NCT06533501
Status: RECRUITING
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Menstrual Cycle
Interventions: OTHER: Dietary Leucine Intakes
Sponsor: University of British Columbia
Sex: FEMALE
Age: ADULT
Enrollment: 15
Study Design: Allocation: NA|Intervention Model: SINGLE_GROUP|Masking: NONE|Primary Purpose: BASIC_SCIENCE
Start Date: 2014-02-12
Completion Date: 2025-12
Locations: BC Children's Hospital Research Institute, Vancouver, British Columbia, V5Z 4H4, Canada

Summary:
The existing guidelines for dietary amino acid intake for women are set the same as those established for men. These recommendations might not be appropriate for women, as they do not take into consideration important differences between male and female physiology, like the menstrual cycle. This study aims to determine the leucine requirements during the phases of the menstrual cycle. Leucine is an essential amino acid (cannot be made naturally in the body) and is necessary for protein synthesis, and other important cellular functions. Consuming an adequate amount daily is crucial for maintaining overall health. An innovative, non-invasive technique utilizing pre-determined diets, safe stable isotopes, and a simple breath collection method will be used. Previous work done by Elango Lab investigators has applied this method to investigate other amino acids in pregnant, non-pregnant, and lactating women.

Primary Outcome Measures: Carbon 13 Oxidation, Urine and breath samples will be collected to measure the rate of L-\[1-13C\]phenylalanine oxidation., 8 hours