pankajmathur/National_Library_of_Medicine_Studies_data huggingface dataset:
Weight Variation on Cop
NCT Number: NCT06458634
Status: COMPLETED
Study Type: OBSERVATIONAL
Conditions: Adolescent Overweight
Sponsor: Amira Hussin Hussin Mohammed
Sex: ALL
Age: CHILD, ADULT
Enrollment: 200
Study Design: Observational Model: |Time Perspective: p
Start Date: 2023-11-01
Completion Date: 2024-04-30
Locations: Amira Hussin Mohammed, Gamasa, 35712, Egypt

Summary:
This study will be conducted to investigate the impact of variant weights in adolescents during unperturbed standing conditions.

Primary Outcome Measures: Sway length (mm), The force platform was positioned in the middle of the test-taking silent room. In the static standing trial, each participant had the freedom to converse with their partner at any moment, provided that companion was either sitting or stood in front of them at a distance of roughly two meters. The AP and ML direction COP will be investigated using the data collected during the trial's eighty seconds. Depending on which of the six test trials was being given, the participant was advised to stand quietly and unperturbed throughout the test procedure, with their eyes either open or closed., through study completion, an average of 6 months|The Maximum (peak) Oscillation of COP, The force platform was positioned in the middle of the test-taking silent room. In the static standing trial, each participant had the freedom to converse with their partner at any moment, provided that companion was either sitting or stood in front of them at a distance of roughly two meters. The AP and ML direction COP will be investigated using the data collected during the trial's eighty seconds. Depending on which of the six test trials was being given, the participant was advised to stand quietly and unperturbed throughout the test procedure, with their eyes either open or closed., through study completion, an average of 6 months|The minimum Oscillation of COP, The force platform was positioned in the middle of the test-taking silent room. In the static standing trial, each participant had the freedom to converse with their partner at any moment, provided that companion was either sitting or stood in front of them at a distance of roughly two meters. The AP and ML direction COP will be investigated using the data collected during the trial's eighty seconds. Depending on which of the six test trials was being given, the participant was advised to stand quietly and unperturbed throughout the test procedure, with their eyes either open or closed., through study completion, an average of 6 months
Weight Categories and Center of Pressure Sway
NCT Number: NCT06458621
Status: COMPLETED
Study Type: OBSERVATIONAL
Conditions: Body Weight
Sponsor: Delta University for Science and Technology
Sex: ALL
Age: CHILD, ADULT
Enrollment: 200
Study Design: Observational Model: |Time Perspective: p
Start Date: 2023-11-10
Completion Date: 2024-05-01
Locations: Delta university, Gamasa, El Dakahlia, 35511, Egypt

Summary:
This study will be conducted to investigate the impact of different weight categories of adolescents on the center of pressure displacement throughout posturographic analysis test

Primary Outcome Measures: Delta (Y)AP sway /mm, The anteroposterior COP sway length is the total distance traveled by COP in AP axis during the test time . The smaller the delta (y) , the better is the postural stability. It is an effective evaluation index in numerous populations and balance condition., Through study completion an average of 5 months|Delta (X)ML sway /mm, Mediolateral COP sway is the total distance traveled by COP in ML axis during the test time . The smaller the delta (x) , the better is the postural stability. It is an effective evaluation index in numerous populations and balance conditions., Through study completion an average of 5 months|Average COP speed /mm.s, is calculated by dividing the COP path length by testing time. In addition to the total COP average velocity, the average COP velocity components in the AP and ML directions can also be calculated. COP speed is an indicator of the efficiency of the postural control system. The average COP speed value is small, which is considered a good performance of posture control, Through study completion an average of 5 months
Hemodiasis Patients Using Virtual Reality Video
NCT Number: NCT06458608
Status: COMPLETED
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Hemodialysis|Symptoms|Virtual Reality|Comfort
Interventions: DEVICE: virtual reality glasses
Sponsor: Dilan aktepe coşar
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 50
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: NONE|Primary Purpose: SUPPORTIVE_CARE
Start Date: 2024-05-30
Completion Date: 2024-06-01
Locations: Gümüşhane Üniversitesi, Gümüşhane, Kelkit, 2900, Turkey

Summary:
VR, with its developing technology, is a new technique used in the healthcare industry combined with cognitive technology to reduce the symptoms experienced by patients and to relieve the patient. This study investigates whether virtual tour environments created using virtual reality glasses have an effect on patients\&#39; vital signs, symptoms and comfort during the hemodialysis session. It is aimed to evaluate the effect of Virtual Reality Based Videos applied during hemodialysis treatment on Hemodialysis Symptoms, vital signs and Comfort.

Primary Outcome Measures: Hemodialysis Comfort Scale Version II (HDCS Version II), The scale consists of a total of 26 items and a 5-point Likert type. HDCS Version II has six subscales (physical relaxation, physical comfort, psychospiritual comfort, psychospiritual transcendence, environmental transcendence, and sociocultural comfort)., 8 week
Secondary Outcome Measures: Dialysis Symptom Index (DSI) (Appendix 2), It consists of a total of 30 items that evaluate the emotional and physical symptoms of dialysis patients and the severity of these symptoms., 8 week|Vital Signs Monitoring Form, It is a form in which patients' BP, respiratory rate, pulse, temperature and oxygen saturation values are measured and recorded once a week before and after the HD procedure., 8 week
Safety and Tolerability of KH658 Gene Therapy in Subjects With Neovascular Age-related Macular Degeneration (nAMD)
NCT Number: NCT06458595
Status: NOT_YET_RECRUITING
Study Type: INTERVENTIONAL
Phases: PHASE1|PHASE2
Conditions: Age-related Macular Degeneration
Interventions: DRUG: KH658
Sponsor: Chengdu Origen Biotechnology Co., Ltd.
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 44
Study Design: Allocation: NA|Intervention Model: SEQUENTIAL|Masking: NONE|Primary Purpose: TREATMENT
Start Date: 2024-06-28
Completion Date: 2026-12-28
Locations: Tianjin Medical University General Hospital, Tianjin, China

Summary:
KH658 is a adeno-associated virus (AAV) vector-based gene therapy for suprachoroidal space injection. The long-term, stable therapeutic protein after one time injection for nAMD could potentially reduce the treatment burden and maintain vision.

Primary Outcome Measures: Tolerability and safety of KH658 in different dose levels, Week 4， Week 26|Change in BCVA letter, Week 26
Secondary Outcome Measures: Incidence of adverse events and adverse reactions, Week 4， 26， 38， 54|Efficacy (BCVA, CRT), Week 38， 54|Number of supplemental injections, Week 54|Annualized rate of supplemental injections, Week 54|Percentage of subjects free of rescue IVT therapy, Week 54
High Flow Nasal Cannula Is Appropriate Alternative for Stabilization of Very Premature Infants: A Prospective Observational Study
NCT Number: NCT06458582
Acronym: SIMPLSAFE
Status: COMPLETED
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Premature; Infant
Interventions: DEVICE: High-Flow Nasal Cannula
Sponsor: Charles University, Czech Republic
Sex: ALL
Age: CHILD
Enrollment: 65
Study Design: Allocation: NA|Intervention Model: SINGLE_GROUP|Masking: NONE|Primary Purpose: OTHER
Start Date: 2021-02-01
Completion Date: 2022-12-31
Locations: Charles University in Prague, Praha, Czech, 12808, Czechia

Summary:
A prospective observational study evaluates the safety and efficacy of using High-Flow Nasal Cannula to stabilize very preterm infants immediately after birth. Following placental transfusion, high flow nasal cannula at 8 l/min is administered along with intermittent tactile stimulation. Criteria for switching to other interventions like continuous positive airway pressure or positive pressure ventilation are set for cases of persistent bradycardia or low SpO2.

Primary Outcome Measures: HFNC slabilization, Number of infants who were stabilized after birth on high flow nasal cannula exclusively without any other use of artificial external pressures., 10 minutes after delivery
NK-ORB Expression of Mu Receptor on Lymphocytes in Rehabilitation
NCT Number: NCT06458569
Acronym: NK-ORB
Status: RECRUITING
Study Type: OBSERVATIONAL
Conditions: Fibromyalgia
Interventions: OTHER: Rehabilitation
Sponsor: IRCCS San Raffaele Roma
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 50
Study Design: Observational Model: |Time Perspective: p
Start Date: 2023-10-03
Completion Date: 2026-04-29
Locations: IRCCS San Raffaele, Roma, 00163, Italy

Summary:
Chronic pain is a serious disorder that causes physical suffering and emotional distress.

NK cells are cytotoxic granular cells playing a crucial role in innate immunity.

Recent studies described modulation of the percentage of B lymphocytes and NK cells expressing the μ opioid receptor as a potential marker for measuring pain. Neuropathic pain sufferers have decreased NK cell function, highlighting the need of further investigating the effect of opioid receptor expression on lympoid cells defining their potential relevance as a pain monitor marker. Opioid receptors expressed on NK, B and T cells are a possible candidate for objective monitoring of pain in patients.

Primary Outcome Measures: Identification of percentage of Mu-positive NK cells as predictive markers of pain in suffering patients, Peripheral blood of pain suffering patients who have entered a neurorehabilitation program will be investigated to confirm the modulation of the percentage of Mu-positive NK cells and to evaluate if they could be eligible as predictive markers of chronic pain by correlating it to the level of pain calculated with Numeric Pain Rating Scale., 3 weeks
Examining the Effects of Vivo on Physical Function and Glycemic Level in Sedentary Older With Prediabetes.
NCT Number: NCT06458530
Status: RECRUITING
Study Type: INTERVENTIONAL
Phases: NA
Conditions: PreDiabetes|Older Adult|Muscle Loss|Muscle Weakness
Interventions: BEHAVIORAL: Vivo
Sponsor: Impactiv, Inc.
Collaborators: Duke University
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 90
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: SINGLE (INVESTIGATOR)|Primary Purpose: PREVENTION
Start Date: 2024-07-09
Completion Date: 2025-08-31
Locations: Duke University Medical Center, Durham, North Carolina, 27710, United States

Summary:
This is a 12-week randomized, controlled trial that seeks to examine the effect of Vivo on 1) change in lower extremity strength defined as number of chair stands done in 30 seconds and 2) change in average glycemic level (HbA1c) compared to a wait list control.

Primary Outcome Measures: Lower body strength, Lower body strength measured by the 30-second chair stand, baseline and 12 weeks
Secondary Outcome Measures: Hemoglobin A1C (HbA1C), Hemoglobin A1C (HbA1C) measure during clinic assessment, baseline and 12 weeks|Balance, Static Balance Score of the SPPB. Sore 0-4 depending on the combined results of side by side, semi-tandem, and tandem stand tests., baseline and 12 weeks|Physical Activity Level, Average step count using Garmin Fitness Tracker, baseline and 12 weeks|Aerobic Endurance, Measured by the 2-minute step test for aerobic endurance, baseline and 12 weeks
Evaluation of Two Methods of Administration of Photobiomodulation in the Context of the Prevention and Treatment of Mucositis Induced by Radiotherapy, During the Treatment of Head and Neck Cancers
NCT Number: NCT06458517
Acronym: RADIO-PBM
Status: NOT_YET_RECRUITING
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Head and Neck Neoplasms
Interventions: DEVICE: Photobiomodulation session - intraoral|DEVICE: Photobiomodulation session - transcutaneous
Sponsor: Institut de cancérologie Strasbourg Europe
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 60
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: NONE|Primary Purpose: PREVENTION
Start Date: 2024-09-02
Completion Date: 2026-05-02
Locations: Institut de cancérologie Strasbourg Europe, Strasbourg, 67033, France

Summary:
The aim of this feasibility, prospective, single-center trial is to compare an intra-oral Photobiomodulation (PBM) via the Caremin650TM device (NeoMedLight) and a transcutaneous PBM via the ATP 38® device (Swiss Bio Innov) in patients treated with radiotherapy or chemoradiotherapy for cancer of the oropharynx or oral cavity. PBM session will be carried out first at the rate of two sessions per week for preventive purposes, and then, in case of occurence of grade 1 mucositis, three sessions per week with curative purpose.

Primary Outcome Measures: Cumulative incidence of oral mucositis (grade ≥ 2) in both group (intraoral and transcutaneous PBM), Oral mucositis will be graded according to NCI-CTCAE V5.0 criteria, Until OM resolution, up to 12 weeks
Secondary Outcome Measures: Radiotherapy treatment interruption in both group (intraoral and transcutaneous PBM), Number of cancelled radiotherapy sessions in comparison to initial treatment plan, Until OM resolution, up to 12 weeks|Duration of oral mucositis in both group (intraoral and transcutaneous PBM), Number of days, Until OM resolution, up to 12 weeks|Number of hospitals stays in both group (intraoral and transcutaneous PBM), Number of unscheduled hospitalizations, Until OM resolution, up to 12 weeks|Number of introductions of parenteral nutrition in both group (intraoral and transcutaneous PBM), Number of days from radiotherapy initiation until artificial nutrition introduction, Until OM resolution, up to 12 weeks|Infection rate in both group (intraoral and transcutaneous PBM), Infections graded according to NCI-CTCAE V5.0 criteria, Until OM resolution, up to 12 weeks|Food intake in both group (intraoral and transcutaneous PBM), Measured on a weekly basis with the Simple Evaluation of Food Intake (SEFI) tool, Until OM resolution, up to 12 weeks|Pain level in both group (intraoral and transcutaneous PBM), Measured with a visual analogic scale (VAS), graded from 0 to 10, Until OM resolution, up to 12 weeks|Quality of life of patients in both group (intraoral and transcutaneous PBM), Questionnaire from EORTC: QLQ-C30 with organ specific QLQ-HN35 module, Until OM resolution, up to 12 weeks|Dry mouth rate in both group (intraoral and transcutaneous PBM), Graded according to NCI-CTCAE V5.0 criteria, Until OM resolution, up to 12 weeks
Viral Infection of HSPC Impacts Hematopoiesis
NCT Number: NCT06458504
Acronym: MEGAHOST
Status: NOT_YET_RECRUITING
Study Type: OBSERVATIONAL
Conditions: HIV-1|SARS-CoV-2
Sponsor: Assistance Publique - Hôpitaux de Paris
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 45
Study Design: Observational Model: |Time Perspective: p
Start Date: 2024-06
Completion Date: 2026-02
Locations: Hematology and interne medicine department, Ambroise Paré hospital - APHP, Boulogne-Billancourt, 92100, France

Summary:
We propose to demonstrate that HIV-1 and SARS-CoV-2 are capable of targeting long-lived HSPC with self-renewal capacities. These progenitors, thus transformed into host cells, can give rise to a durable source of infected cells with an impact on hematopoiesis.

Primary Outcome Measures: Evaluate if infected HSPC would modulate the bone marrow environment, Evaluate whether these infected HSPC would modulate the bone marrow environment by upregulating inflammatory cytokines detrimental to lymphopoiesis., at 1 year
Urinary Symptoms After Posterior Tibial Nerve Stimulation
NCT Number: NCT06458491
Acronym: TENSI
Status: COMPLETED
Study Type: OBSERVATIONAL
Conditions: Posterior Tibial Nerve Stmulation
Interventions: DEVICE: Evolution of urinary symptoms
Sponsor: Hospices Civils de Lyon
Sex: FEMALE
Age: ADULT, OLDER_ADULT
Enrollment: 100
Study Design: Observational Model: |Time Perspective: p
Start Date: 2024-03-01
Completion Date: 2024-05-31
Locations: Department of obstetrics, Femme Mère Enfant Hospital, Lyon, France, Bron, 69677, France

Summary:
Overactive bladder (OAB) is a common syndrome affecting 7 million people in France, very often of idiopathic origin.

Current therapeutic management of OAB primarily involves hygiene and diet rules, patient education, behavioral measures with bladder reprogramming or even perineo-sphincter rehabilitation. However, the modalities of this conservative non-drug treatment are poorly defined and there is uncertainty as to their effectiveness.

In the event of persistent symptoms, the management of OAB is essentially based on the prescription of an anticholinergic medication. The effectiveness of anticholinergics has been established through numerous randomized clinical trials and meta-analyses. But the side effects of anticholinergics are known and some are very common (particularly dry mouth and constipation).

The principle of the posterior tibial nerve stimulation (TNS) by implanted (percutaneous) or adhesive (transcutaneous) electrode is to stimulate the sensory afferent pathways and to ensure negative feedback on the bladder. Posterior tibial nerve stimulation is a non-invasive therapeutic alternative that has demonstrated its effectiveness through numerous clinical studies mainly using a device for percutaneous use with a weekly stimulation session.

TNS is also possible transcutaneously (TENS) with daily 20-minute stimulation of the ankle, in the form of a self-administered treatment at home, over a period of 3 months. This treatment modality seems equivalent to the percutaneous approach.

Given its numerous advantages, the use of TENS is therefore expanding, and is currently recommended by many learned societies (SIFUD, AFU).

In this study, we wish to evaluate the TENSI+ medical device which uses transcutaneous posterior tibial nerve stimulation and which is offered in routine practice to patients with idiopathic or neurological overactive bladder.

Primary Outcome Measures: Evolution of urinary symptoms, change in the "overactive bladder" score obtained by the USP questionnaire, 3 months after the start of treatment
Effects of the Application of a Hyper-oxygenated Gel After Oral Surgery
NCT Number: NCT06458478
Status: RECRUITING
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Molar, Fourth|Extracting Own Teeth|Edema Face|Pain|Trismus
Interventions: OTHER: Hyper-oxygenated gel|OTHER: glycerin based gel
Sponsor: Azienda Ospedaliera di Perugia
Sex: ALL
Age: ADULT
Enrollment: 72
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: QUADRUPLE (PARTICIPANT, CARE_PROVIDER, INVESTIGATOR, OUTCOMES_ASSESSOR)|Primary Purpose: TREATMENT
Start Date: 2024-07-01
Completion Date: 2025-02-01
Locations: Ospedale Santa Maria della Misericordia, Perugia, 06156, Italy

Summary:
The goal of this clinical trial is to evaluate whether the topical application of Novox® Drop on surgical wounds after the extraction of lower third molars can have a clinical advantage.

The primary objective of the study is to evaluate the possible reduction of masseteric trismus (masticatory muscle spasm - primary outcome) and of post-operative pain and facial edema (swelling - secondary outcomes) after the extraction of impacted third molars compared to those who do not use it (placebo=glycerin-based gel).

Primary Outcome Measures: Masseteric trismus., Masseteric trismus will be assessed by measuring the width of the mouth opening. Precisely, the distance in cm between the mesial corners of the incisal edges of the upper central incisors and the lower right incisors at maximum mouth opening, before surgery and on the seventh postoperative day, using a caliper. Measurements will be taken twice to determine the average score. The difference between the average of each postoperative measurement and the preoperative one will indicate the trismus for that day., seven days
Secondary Outcome Measures: Post-operative pain, The intensity of postoperative pain will be assessed with a Visual Analog Scale (VAS). The patient will be able to express the degree of pain perceived at both time one and time two on a scale of ten intervals. Grade 1 on the scale indicates no pain, grade ten indicates very intense pain., seven days|Facial swelling, The swelling of the face in cm will be determined by measuring the distance from the corner of the mouth to the attachment of the earlobe following the curvature of the cheek and the distance from the outer canthus of the eye to the corner of the jaw. The arithmetic mean of the two measurements will be considered as reference. The difference between each postoperative measurement and baseline will indicate facial swelling for that day., seven days
Impact of Curcumin and Pentoxiphylline on Chronic Kidney Disease Patients
NCT Number: NCT06458465
Acronym: CKD
Status: RECRUITING
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Chronic Kidney Disease
Interventions: DIETARY_SUPPLEMENT: Curcumin|DRUG: Pentoxifylline 400 MG
Sponsor: Alexandria University
Collaborators: Tanta University
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 60
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: NONE|Primary Purpose: TREATMENT
Start Date: 2023-10-01
Completion Date: 2024-10-01
Locations: Nada Mustafa Kamel, Alexandria, 21648, Egypt

Summary:
The aim of the study is to evaluate the impact of turmeric and pentoxiphylline on serum levels of protein-bound uremic toxin (p-cresyl sulfate), oxidative stress biomarker level (Malonaldehyde), inflammatory biomarker level (Highly sensitive C-reactive protein). In addition to the evaluation of its effect on metabolic profile and disease progression in chronic kidney disease patients.

Primary Outcome Measures: The change in p-cresyl sulphate biomarker, the change in biological markers (pCS)., 6 Months|The change in high senstive c-reactive protiem biomarker, the change in biological marker (hs-CRP), 6 Months|The change in malonaldehyde biomarker, the change in biological marker (MDA), 6 Months|The change in estimated glomerular filtration rate, the change in eGFR, 6 Months|The change in serum creatinine and BUN, the change in values of serum creatinine and BUN, 6 Months|The change in proteinuria, the change in value of proteinuria, 6 Months
Secondary Outcome Measures: Number of participants losing the follow up, Non-adherence to study medications, loss of follow-up, existence of intolerable side effects, shifting of patients to dialysis, changing of standard care medications and death., 6 Months
Enhancing Immersion in Virtual Reality Based Advanced Life Support Training
NCT Number: NCT06458452
Status: RECRUITING
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Advanced Cardiac Life Support|Artificial Intelligence
Interventions: OTHER: Using Virtual Reality based serious gaming module for Advanced Cardiac Life Support
Sponsor: Acibadem University
Sex: ALL
Age: ADULT
Enrollment: 67
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: SINGLE (PARTICIPANT)|Primary Purpose: OTHER
Start Date: 2024-05-31
Completion Date: 2024-07-31
Locations: Acibadem Mehmet Ali Aydinlar University CASE Simulation Center, Istanbul, Turkey

Summary:
Virtual Reality based training modulues have become a part of simulation based medical education and are nowadays used for undergraduate and postgraduate level training of healthcare professionals.In parallel to the advancements in Artificial Intelligence technology voice regotnition has the potential to be used as an interfeace during game play .The aim of this study is whether game interface with Artificial Intelligence based voice regognition may elevate the level of immersion during the use of Virtual Reality based serious gaming for Advanced Cardiac Life Support Training.

Primary Outcome Measures: Comparison of two groups' performance scores, The participants of two groups will complete a Virtual Reality based exam for performance scoring, Up to 4 weeks
Secondary Outcome Measures: Level of immersion during game play, The participants of two groups will answer a questionnaire about the level of immersion, Up to 4 weeks
Thermoregulation in Individuals With a Leg Amputation
NCT Number: NCT06458426
Status: ENROLLING_BY_INVITATION
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Amputation|Diabetes
Interventions: DEVICE: shock-absorbing prosthesis
Sponsor: University of Utah
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 60
Study Design: Allocation: RANDOMIZED|Intervention Model: SINGLE_GROUP|Masking: NONE|Primary Purpose: BASIC_SCIENCE
Start Date: 2024-05-07
Completion Date: 2027-07-31
Locations: University of Utah, Salt Lake City, Utah, 84112-0920, United States

Summary:
The goal of this project is to understand the factors that affect skin temperature (e.g., tissue above amputation site, and opposite foot) in people with amputation and diabetes. This project will also test the effects of 'shock-absorbing' prosthesis on skin temperature responses.

Primary Outcome Measures: Walking mechanics, Mechanics of walking will be collected using a high-speed motion capture system and force-sensing platforms, which will quantify the motion of the legs and forces acting on the legs, respectively., during the intervention/procedure/surgery|Vascular physiology - macrocirculation, Macrocirculation of the legs (i.e.,blood flow) will be recorded using a Doppler ultrasound probe secured over the thigh during walking, during the intervention/procedure/surgery|Vascular physiology - microcirculation, Microcirculation of the legs (i.e.,oxygen utility) will be recorded using near-infrared spectroscopy sensors placed on the thighs, calf, and top surface of the foot., during the intervention/procedure/surgery|Temperature in lower limb, Temperatures of the skin above the amputation site and the opposite intact foot will be recorded using thermistors and a thermal imaging camera., during the intervention/procedure/surgery|Comfort, Participants will complete a self-reported questionnaire to indicate comfort while walking with a prosthesis., during the intervention/procedure/surgery
Utidelone Capsule Plus Capecitabine (CAP) for Metastatic Breast Cancer
NCT Number: NCT06458413
Status: RECRUITING
Study Type: INTERVENTIONAL
Phases: PHASE2
Conditions: Breast Cancer Recurrent
Interventions: DRUG: Utidelone Capsule Plus Capecitabine
Sponsor: Min Yan, MD
Collaborators: Beijing Biostar Pharmaceuticals Co., Ltd.
Sex: FEMALE
Age: ADULT, OLDER_ADULT
Enrollment: 40
Study Design: Allocation: NA|Intervention Model: SINGLE_GROUP|Masking: NONE|Primary Purpose: TREATMENT
Start Date: 2024-06-05
Completion Date: 2025-12-05
Locations: Henan Cancer hospital, Zhengzhou, Henan, China

Summary:
This study aims to investigate the efficacy and safety of utidelone capsule plus Capecitabine in the treatment of advanced breast cancer , and thus provides a new systemic treatment strategy for those patients.

This study was a single-arm, phase II study of patients with recurrent or metastatic HER2-negative breast cancer who had previously received chemotherapy regimens containing taxanes and/or anthracyclines were treated with a combination of utidelone capsules and capecitabine. The main objective was to explore the efficacy and safety of the combined regimen.

Primary Outcome Measures: Objective Response Rate （ORR）, ORR is defined as the percentage of participants in the analysis population who have CR or PR per RECIST 1.1., 18 months
Secondary Outcome Measures: Progression-Free Survival（PFS）, time from the first dose to disease progression or any-cause death, 18 months|Disease Control Rate （DCR）, DCR is defined as the percentage of participants in the analysis population who have CR or PR or SD per RECIST 1.1., 18 months|Duration of response (DoR), DOR is defined as the interval from response initiation (when either CR or PR is first determined) to progression or death, whichever occurs first., 18 months|Overall survival (OS), time from the first dose of study drug to any-cause death, 18 months|Treatment-related Adverse Event-TRAE, Number of participants with treatment-related adverse events as assessed by CTCAE v5.0, Until 28 days after the last dose of treatment
To Evaluate the Efficacy and Safety of Tegileridine and Oliceridine Injections in the Treatment of Postoperative Pain
NCT Number: NCT06458400
Status: NOT_YET_RECRUITING
Study Type: INTERVENTIONAL
Phases: PHASE4
Conditions: Analgesia
Interventions: DRUG: Tegileridine|DRUG: Oliceridine|DRUG: Morphine
Sponsor: Yuwei Qiu
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 75
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: NONE|Primary Purpose: TREATMENT
Start Date: 2024-06-06
Completion Date: 2024-12-31

Summary:
This was a single-center, randomized, open-label, controlled exploratory study conducted in Chinese patients. The study planned to enroll Chinese patients to evaluate the efficacy and safety of tegileridine and oliceridine injection in the treatment of postoperative pain.

Primary Outcome Measures: Time-weighted sum of differences of resting pain score within 24 hours after starting a loading dose of test drug infusion, "resting pain score" is assessed by Numeric Rating Scale, range 0-10, 0=no pain and 10 = worst imaginable pain, from 0 to 0 means worse pain, during the first 24 hours after starting a loading dose of test drug infusion
Secondary Outcome Measures: Resting-state pain and exercise-state pain intensity, Resting-state pain and exercise-state pain intensity are assessed by Numeric Rating Scale, range 0-10, 0=no pain and 10 = worst imaginable pain, from 0 to 0 means worse pain, Pain scores are evaluated at 10 minutes、30 minutes、6 hours、12 hours、24 hours after the first loading dose|Time-weighted sum of differences of exercise-state pain score within 24 hours after starting a loading dose of test drug infusion, "exercise-state pain score" is assessed by Numeric Rating Scale, range 0-10, 0=no pain and, Pain scores are evaluated at 10 minutes、30 minutes、6 hours、12 hours、24 hours after the first loading dose|total pain relief (TOTPAR) scores, Time-weighted sum of resting and moving state pain relief scores, 10 minutes、30 minutes、6 hours、12 hours、24 hours after the first loading dose|the percentage of patients receiving rescue analgesia, the percentage of patients receiving rescue analgesia, from 0-24 hours after the first loading dose|length of bed stay, length out of bed, From date of randomization until the date of hospital discharge or date of death from any cause, whichever came first, assessed up to 1 months.|Length of hospital stay, postoperative length of hospital stay, From date of randomization until the date of hospital discharge or date of death from any cause, whichever came first, assessed up to 1 months.|incidence of Postoperative nausea and vomiting, incidence rate of PONV, the first 24 hours after surgery|incidence rate of respiratory depression, respiratory depression is defined as respiratory rate \< 8 and/or SpO2\<90%, the first 24 hours after surgery|analgesia satisfaction, satisfaction evaluation using 0-100 scale, the first 24 hours after surgery|pressing times of postoperative analgesic pump, the first 24 hours after surgery|total doses of postoperative analgesic pump, the first 24 hours after surgery
Comparison of Clinical Outcomes According to High-protein Provision in Critically Ill Patients After Abdominal Surgery
NCT Number: NCT06458387
Status: NOT_YET_RECRUITING
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Protein Malnutrition
Interventions: DIETARY_SUPPLEMENT: Active protein supplementation|DIETARY_SUPPLEMENT: Conventional protein supplementation
Sponsor: Seoul St. Mary's Hospital
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 152
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: SINGLE (PARTICIPANT)|Primary Purpose: TREATMENT
Start Date: 2024-07
Completion Date: 2027-06
Locations: Division of Trauma and Surgical Critical Care, Department of Surgery, Seoul St. Mary's Hospital, Seoul, Seocho-gu, Banpo-dong Banpodaero 222, 137-701, Korea, Republic of

Summary:
Protein malnutrition in critically ill patients is a global concern due to its association with prolonged hospital stays, and higher morbidity rates. Patients who undergo abdominal surgery are particularly vulnerable due to alterations in gastrointestinal function and prolonged fasting. Despite the significance of proper nutrition, the optimal target of protein supplementation remains controversial.

The investigators aimed to evaluate the effects of high protein provision, targeting a protein intake of at least 1.5 g/kg/day for the first 3 days after abdominal surgery, on 6-month mortality.

Primary Outcome Measures: 6-month mortality rate, Proportion of patients who died within 6 months after surgery among participants, Participants were followed up to 180 days immediately after the surgery
Secondary Outcome Measures: 30-day mortality rate, Proportion of patients who died within 30 days after surgery among participants, Participants were followed up to 30 days immediately after the surgery|90-day mortality rate, Proportion of patients who died within 90 days after surgery among participants, Participants were followed up to 90 days immediately after the surgery|Incidence of postoperative complications, Proportion of patients who developed any complications during postoperative hospitalization among participants, Participants were followed during hospitalization (up to 14 days)
ATTR Cardiac Amyloidosis in a Selected Population
NCT Number: NCT06458374
Status: NOT_YET_RECRUITING
Study Type: OBSERVATIONAL
Conditions: ATTR Amyloidosis Wild Type|ATTR Gene Mutation|Carpal Tunnel Syndrome|Cardiac Amyloidosis
Sponsor: Helse Møre og Romsdal HF
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 180
Study Design: Observational Model: |Time Perspective: p
Start Date: 2024-06-17
Completion Date: 2039-02-28

Summary:
Patients operated for carpal tunnel syndrome (CTS) at Ålesund Hospital (200 patients) will have a biopsy to diagnose ATTR amyloidosis. Patients with positive biopsy will be examined to decide wether they have cardiac amyloidosis. All patients with positive biopsy will be followed closely for 10 years wit echocardiography an clinically.

Primary Outcome Measures: Frequency of ATTR in CTS, Biopsy proven ATTR, 2 years|Cardiac involvement in patients with biopsy proven ATTR, Scintigraphic and echocardiographic cardiac involvement possibly cMRI, 10 years
Identification of Risk Factors and Construction of Prediction Model for Postoperative Intestinal Anastomotic Leakage in Ovarian Cancer
NCT Number: NCT06458361
Status: RECRUITING
Study Type: OBSERVATIONAL
Conditions: Ovarian Cancer
Interventions: PROCEDURE: Type of bowel resection, surgical complexity score, intraoperative blood loss, perioperative erythrocyte transfusion, type of anastomosis
Sponsor: Zhongda Hospital
Sex: FEMALE
Age: CHILD, ADULT, OLDER_ADULT
Enrollment: 300
Study Design: Observational Model: |Time Perspective: p
Start Date: 2018-01-01
Completion Date: 2024-11-01
Locations: Zhongda Hospital, Nanjing, Jiangsu, 210000, China

Summary:
This study was a multicenter, retrospective cohort study. Although advancements in surgical techniques have mitigated the incidence of intestinal anastomotic fistula, complete avoidance remains elusive. Anastomotic leakage (AL) complications directly impinge on postoperative quality of life and pose life-threatening risks if inadequately managed. Given AL's adverse prognostic implications and the financial strain on patients' families, identifying its risk factors aids in perioperative risk assessment, enabling timely clinical decisions on interventions to enhance prognosis and curtail adverse outcomes and economic investments.

Primary Outcome Measures: Risk Factors and a Prediction Model for Postoperative Intestinal Anastomotic Leakage in Ovarian Cancer, Risk Factors, 1 month after surgery
Opioids and Loneliness
NCT Number: NCT06458335
Status: NOT_YET_RECRUITING
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Opioid Use Disorder|Loneliness|Social Isolation
Interventions: BEHAVIORAL: Cognitive-Behavioral Therapy for Perceived Social Isolation|BEHAVIORAL: Health Education
Sponsor: University of Rochester
Collaborators: National Institute on Drug Abuse (NIDA)|Medical University of South Carolina|Ohio State University
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 300
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: DOUBLE (INVESTIGATOR, OUTCOMES_ASSESSOR)|Primary Purpose: TREATMENT
Start Date: 2024-08-15
Completion Date: 2029-06-30

Summary:
This study aims to enroll 300 participants who will be assigned to one of three 3 groups. Each group will receive an intervention lasting 6, weekly sessions of 40-60 minutes. Eligibility include having an opioid use disorder and reporting loneliness or feeling alone or disconnected.

Primary Outcome Measures: Mean change in loneliness, Loneliness will be measured using the UCLA Loneliness Scale. A 20-item scale designed to measure one's subjective feelings of loneliness as well as feelings of social isolation. Participants rate each item as 1 (never), 2 (rarely), 3 (sometimes) or 4 (often). The scores range from 20-80 with higher scores indicating worse outcome., Baseline to 6 months|Mean change in number of days of opioid use, Participants will complete a calendar indicating the type and frequency of drug use., Baseline to 6 months
Secondary Outcome Measures: mean change in social interactions, Duke Social Support Index assesses several domains of perceived social support, including social network size, social interaction, social satisfaction, and instrumental social support. Higher scores indicate a higher quality of social interactions. Scores range from 0 to 37., Baseline to 6 months|Mean change in depression, Depression will be measured using the PROMIS tool. The scores range from 4-20 with higher scores indicating worse outcome., Baseline to 6 months|Mean change in anxiety, Anxiety will be measured using the PROMIS tool. The scores range from 4-20 with higher scores indicating worse outcome., Baseline to 6 months
Quality of Life in Patients Transitioning to Home or In-Center Dialysis (QUALIFY CKD-to-HOME)
NCT Number: NCT06458322
Status: RECRUITING
Study Type: OBSERVATIONAL
Conditions: Chronic Kidney Diseases
Interventions: OTHER: Home dialysis or In-Center dialysis
Sponsor: Ciusss de L'Est de l'Île de Montréal
Collaborators: The Kidney Foundation of Canada
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 350
Study Design: Observational Model: |Time Perspective: p
Start Date: 2022-07-01
Completion Date: 2025-12-31
Locations: Hôpital Maisonneuve-Rosemont, Montréal, Quebec, H1T 2M4, Canada

Summary:
The goal of this study is to evaluate quality of life (QoL) and frailty trajectories from advanced chronic kidney disease (CKD) to after dialysis initiation, specifically comparing patients choosing home dialysis and in-center hemodialysis.

The main questions it aims to answer are:

1. What is the trajectory of QoL in patients transitioning from advanced CKD to dialysis (up to 12 months after initiation) and how does these changes differ for patients oriented towards home dialysis and in-center hemodialysis?
2. Is the development of frailty after dialysis initiation less likely in patient pursuing home dialysis?
3. What is the variation in other PROMs and health outcomes (fatigue, anxiety \& depression, general assessment, cognitive function) form advanced CKD to the first 12 months after dialysis initiation?
4. What are the predictors of severe decline in QoL, frailty and other important health outcomes (fatigue, cognition, anxiety \& depression) during CKD G5 follow-up and after 12 months post dialysis initiation?

Participants will be ask to:

* Answer some questions and complete questionnaires each 3 months;
* Do a a grip test and a walking test each 6 months to evaluate their frailty;

Primary Outcome Measures: Change in Kidney Disease Quality of Life - 36, Patients Scale from 0-100 (0 = poor, 100 = excellent)., From study inclusion until 12-months after dialysis start.
Secondary Outcome Measures: Change in Fried Frailty phenotype, 5 components (slowness, weakness, weight loss, low physical activity, exhaustion) with classification as no-frail, pre-frail or frail., From study inclusion until 12-months after dialysis start.|Change in Clinical Frailty Scale, Scale 1 (very fit) to 9 (terminally ill), From study inclusion until 12-months after dialysis start|Change in Hospital Anxiety and Depression, 14 items scale (7 anxiety, 7 depression) with score \>8 as cut-off for increased risk of depression and anxiety., From study inclusion until 12-months after dialysis start|Change in Fatigue, 3 items questionnaire to assess fatigue and energy., From study inclusion until 12-months after dialysis start|Change in Cognitive Function (MoCa), 8 cognitive domains: attention and concentration, executive functions, memory, language, visuo-constructional skills, conceptual thinking, calculations, and orientation with a possible score of 30 points., From study inclusion until 12-months after dialysis start
Mangement of Spine Fracture
NCT Number: NCT06458309
Status: RECRUITING
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Spine Fracture
Interventions: PROCEDURE: spine surgery
Sponsor: Sohag University
Sex: ALL
Age: CHILD, ADULT, OLDER_ADULT
Enrollment: 60
Study Design: Allocation: NA|Intervention Model: SINGLE_GROUP|Masking: NONE|Primary Purpose: TREATMENT
Start Date: 2024-05-15
Completion Date: 2025-09-25
Locations: Sohag university Hospital, Sohag, Egypt

Summary:
Each year, there are approximately 5 million new vertebral fractures worldwide1. Most of these fractures involve the thoracolumbar or lumbar spines. The thoracolumbar junction, due to its mechanical transition zone, and the lumbar spine, due to its absence of stabilizing articulations with the ribs, lordotic posture and more sagittal oriented facet joints, are vulnerable for involvement in spinal injuries2.

Burst fractures occurs frequently in high-energy traumas which are most commonly associated with falls and traffic accidents.3

Primary Outcome Measures: AO Spine Injury Score, * injury morphology
* integrity of the PLC
* neurological status, 1 year
Evaluating the Efficacy of AI-Guided (GenAIS TM) vs. Standard Physician-Guided Dietary Supplement Prescriptions for Weight Loss in Obese Patients
NCT Number: NCT06458296
Status: COMPLETED
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Obesity
Interventions: OTHER: Control Group|OTHER: AI-Guided Group
Sponsor: S.LAB (SOLOWAYS)
Collaborators: Center of New Medical Technologies
Sex: ALL
Age: ADULT
Enrollment: 80
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: TRIPLE (PARTICIPANT, CARE_PROVIDER, OUTCOMES_ASSESSOR)|Primary Purpose: TREATMENT
Start Date: 2024-02-02
Completion Date: 2024-06-03
Locations: Center of New Medical Technologies, Novosibirsk, Novosibisk Region, 630090, Russian Federation

Summary:
Obesity, a chronic disease characterized by excessive fat accumulation, significantly impacts health. Genetic factors influence the development of obesity by affecting behavioral, dietary habits, and metabolic processes. This study investigated whether dietary supplements (DS), personalized through genetic and metabolic profiling, could enhance weight loss when combined with physical activity and dietary changes. The objective was to compare the efficacy of standard physician-guided DS prescriptions with AI-guided DS prescriptions in promoting weight loss in obese patients. The hypothesis was that AI-guided DS prescriptions, utilizing detailed genetic and metabolic data, would be more effective in promoting weight loss than standard physician-guided DS prescriptions. This was a 6-month randomized, controlled pilot clinical trial with an additional 6-month follow-up. Participants were healthy individuals aged 40-60 years with a BMI of 25 or greater. Participants were excluded if they had significant medical conditions or recent changes in medication or supplements. They were randomly assigned to either the control group (physician-guided DS prescriptions) or the AI-guided group (AI-determined DS prescriptions). The AI system developed by Triangel Scientific analyzed genetic, metabolic, and biochemical data to personalize treatment. Baseline measurements included comprehensive metabolic panels, genetic testing, metabolomic profiling, and detailed patient history

Primary Outcome Measures: percentage change in body weigh, 180 days
Secondary Outcome Measures: Change in BMI, 180 days|Percent change in high-sensitivity C-reactive, 180 days|Percent change in fasting glucose, 180 days|Percent change in insulin, 180 days|Percent change in total cholesterol, 180 days|Percent change in Low density lipoproteids, 180 days|Percent change in high density lipoprodeids, 180 days|Percent change in triglycerides, 180 days|Appetite ratings using visual analogue scale change, The scale has minimum of 0 - no appetite and 10 as a good appetite, 180 days
The Efficacy of Allogeneic Hematopoietic Stem Cell Transplantation in Newly Diagnosed High-relapse-risk CEBPA Mutant Acute Myeloid Leukemia
NCT Number: NCT06458257
Status: NOT_YET_RECRUITING
Study Type: OBSERVATIONAL
Conditions: Acute Myeloid Leukemia
Interventions: PROCEDURE: Allogeneic Hematopoietic Stem Cell Transplantation|DRUG: Chemotherapy
Sponsor: Ruijin Hospital
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 50
Study Design: Observational Model: |Time Perspective: p
Start Date: 2024-06
Completion Date: 2028-12
Locations: Ruijin Hospital Affiliated to Shanghai Jiaotong University School Of Medicine, Shanghai, Shanghai, 200025, China

Summary:
For newly diagnosed high-relapse-risk CEBPA mutant acute myeloid leukemia patients, we aim to perform allogeneic hematopoietic stem cell transplantation after patients finished one cycle of induction and two cycles of consolidation. To access whether the therapeutic regimen is effective for high-relapse-risk CEBPA mutant acute myeloid leukemia, the disease-free-survival (DFS), overall survival (OS), non-relapse-mortality of patients is evaluated.

Primary Outcome Measures: disease-free-survival, disease-free-survival, from data of AML diagnosis until the data of AML relapse, assessed up to 3 years|The relation of CEBPA Mutant AML genetics subgroup with MRD negativity rate after chemotherapy and DFS after transplantation, The relation of CEBPA Mutant AML genetics subgroup with MRD negativity rate after chemotherapy and DFS after transplantation, from enrollment to study completion, a maximum of 3 years
Secondary Outcome Measures: non-relapse-mortality, non-relapse-mortality, from enrollment to study completion, a maximum of 3 years|overall survival, overall survival, from enrollment to study completion, a maximum of 3 years|adverse events, adverse events, from enrollment to study completion, a maximum of 3 years