pankajmathur/National_Library_of_Medicine_Studies_data huggingface dataset:
Clinical Study to Compare the Effect of an Oral Rehydration Solution on the Rate of Absorption of Functional Ingredients
NCT Number: NCT06524674
Status: COMPLETED
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Absorption|Pharmacokinetic
Interventions: DIETARY_SUPPLEMENT: Hydration Multiplier + Energy|DIETARY_SUPPLEMENT: Hydration Multiplier + Sleep|DIETARY_SUPPLEMENT: Energy Comp|OTHER: Sleep Comp
Sponsor: Liquid I.V.
Collaborators: Princeton Consumer Research
Sex: ALL
Age: ADULT
Enrollment: 37
Study Design: Allocation: RANDOMIZED|Intervention Model: CROSSOVER|Masking: SINGLE (PARTICIPANT)|Primary Purpose: BASIC_SCIENCE
Start Date: 2023-10-01
Completion Date: 2024-05-31
Locations: Princeton Consumer Research, Raritan, New Jersey, 08869, United States

Summary:
The objective of this study was to compare the individual pharmacokinetics of functional ingredients included in an oral rehydration solution (ORS) with or without the inclusion of active base ingredients (carbohydrate and electrolytes). The functional ingredients included in both the control and test solutions were Melatonin in conjunction with L-theanine (Arm 1), Caffeine in conjunction with L-theanine (Arm 2), and Vitamin C in conjunction with Zinc (Arm 3), across two study periods.

The primary outcomes of this study included the relative pharmacokinetics of each functional ingredient. These included: maximum observed concentration (C max), time of maximum observed concentration (T max), cumulative Area Under the Curve (AUC) for each timepoint, (including AUC from the time of dosing to the time of last observation) and the concentration at each timepoint for the corresponding functional ingredients included in the specific study arm (i.e., melatonin, L-theanine, caffeine, vitamin C and zinc).

Primary Outcome Measures: Relative pharmacokinetics, The primary outcomes of this study included the relative pharmacokinetics of each functional ingredient. This included maximum observed concentration (C max) for the corresponding functional ingredients included in the specific study arm (i.e., melatonin, L-theanine, caffeine, vitamin and zinc)., 6 weeks|Relative pharmacokinetics, The primary outcomes of this study included the relative pharmacokinetics of each functional ingredient. This included time of maximum observed concentration (T max) for the corresponding functional ingredients included in the specific study arm (i.e., melatonin, L-theanine, caffeine, vitamin C and zinc)., 6 weeks|Relative pharmacokinetics, The primary outcomes of this study included the relative pharmacokinetics of each functional ingredient. This included: cumulative Area Under the Curve (AUC) for each timepoint, (including AUC from the time of dosing to the time of last observation) and the concentration at each timepoint for the corresponding functional ingredients included in the specific study arm (i.e., melatonin, L-theanine, caffeine, vitamin C and zinc)., 6 weeks
Anterior Segment Changes After Pars Plana Vitrectomy With SO Using AS-OCT
NCT Number: NCT06524661
Status: COMPLETED
Study Type: OBSERVATIONAL
Conditions: Glaucoma
Interventions: DEVICE: AS-OCT after vitrectomy
Sponsor: Minia University
Sex: ALL
Age: CHILD, ADULT, OLDER_ADULT
Enrollment: 30
Study Design: Observational Model: |Time Perspective: p
Start Date: 2023-04-15
Completion Date: 2024-04-15
Locations: Faculty of medicine ,Minia university, Minya, 61519, Egypt

Summary:
To evaluate changes in ACA induced by pars plana vitrectomy with SO 1000cs injection in vitreo-retinal surgery in phakic eyes using AS-OCT and changes in the IOP preoperatively, post-operatively and post-silicone oil evacuation.

Primary Outcome Measures: Assessement of the changes in anterior chamber angle after vitrectomy with silicone oil injection, Evaluation of changes in the anterior chamber angle parameters after vitrectomy with silicone oil 1000cs injection.

The measures include AOD 500, TISA 500, ACA and CCT The measuring tool is AS-OCT (anterior segment optical coherent topography), postoperative evaluation for 3 months duration (5 visits pre-ppv then one week, one month, three months )
A Study to Assess Molecular Changes in Adult Participants With Moderate to Severe Hidradenitis Suppurativa or With Moderate to Severe Atopic Dermatitis Receiving Subcutaneous Injections of Lutikizumab
NCT Number: NCT06524635
Status: RECRUITING
Study Type: INTERVENTIONAL
Phases: PHASE2
Conditions: Hidradenitis Suppurativa|Atopic Dermatitis
Interventions: DRUG: Lutikizumab
Sponsor: AbbVie
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 60
Study Design: Allocation: NON_RANDOMIZED|Intervention Model: PARALLEL|Masking: NONE|Primary Purpose: BASIC_SCIENCE
Start Date: 2024-08-14
Completion Date: 2027-02-23
Locations: Physioseq, LLC /ID# 267266, Sacramento, California, 95825, United States

Summary:
Hidradenitis suppurativa (HS) and atopic dermatitis (AD) are chronic inflammatory skin diseases that lead to the development of skin lesions and symptoms such as pain and discomfort. The purpose of this study is to assess molecular changes in adult participants with moderate to severe HS or with moderate to severe AD.

Lutikizumab (ABT-981) is an investigational drug being developed for the treatment of HS and AD. This study will consist of 2 sub-studies: Sub-Study 1 moderate to severe hidradenitis suppurativa and Sub-Study 2 moderate to severe atopic dermatitis. Approximate 60 participants will be enrolled in the study at approximately 2 sites in the US.

In Sub-Study 1 HS participants will receive subcutaneous (SC) injections of lutikizumab for up to week 15 with a 70-day follow-up period. In Sub-Study 2 AD, participants will receive subcutaneous (SC) injections of lutikizumab for up to week 14 with a 70-day follow-up period. The study duration for Sub-Studies 1 and 2 is expected to last up to 30 weeks.

There may be higher treatment burden for participants in this trial compared to their standard of care. Participants will attend regular visits during the study at a hospital or clinic and may require frequent medical assessments, blood tests, and biomarker collections.

Primary Outcome Measures: Number of Participants With Adverse Events (AEs), An AE is defined as any untoward medical occurrence in a patient or clinical investigation participant administered a pharmaceutical product which does not necessarily have a causal relationship with this treatment., Up to Approximately 30 weeks
VExUS Combined With CVP to Predict Clinical Outcomes in Sepsis Participants
NCT Number: NCT06524622
Status: RECRUITING
Study Type: OBSERVATIONAL
Conditions: Sepsis|Acute Kidney Injury
Interventions: DEVICE: Point-of-care ultrasound (POCUS)
Sponsor: The Second People's Hospital of Yibin
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 120
Study Design: Observational Model: |Time Perspective: p
Start Date: 2024-07-01
Completion Date: 2025-01-31
Locations: Point-of-care ultrasound (POCUS), Yibin, Sichuan, 610000, China

Summary:
Introduction:

Sepsis is a life-threatening organ dysfunction caused by a dysregulated host immune response to infection, and it is a common critical condition in the ICU. Early and timely fluid resuscitation is the cornerstone of sepsis treatment. However, excessive fluid loading can lead to interstitial edema and iatrogenic organ damage, particularly acute kidney injury (AKI). The VExUS grading system is a recently developed system that measures venous congestion through bedside ultrasound by assessing the blood flow waveforms of the portal vein, hepatic vein, and intrarenal veins, as well as the diameter of the inferior vena cava. Similarly, CVP is a commonly used indicator of venous congestion. The objective of this study is to Investigate the association between Venous Excess Ultrasound Score (VExUS), Central Venous Pressure (CVP) during the first three days of ICU admission, and the composite clinical outcome of major adverse kidney events within 30 days (MAKE 30) in sepsis participants.

Methods:

This study is a prospective, multicenter, observational study that will recruit at least 120 participants across multiple centers. Based on the definition of sepsis3.0, Participants with sepsis who are older than 18 years. Using Doppler ultrasound, Investigator will measure the IVC, HV, PV, and IRV, as well as lung ultrasound scores and cardiac-related parameters at 0-24 hours, 24-48 hours, and 48-72 hours after enrollment. Investigator will receive web-based educational courses, and image acquisition and interpretation will be adjudicated. The primary outcome is the relationship between VExUS score combined with CVP and MAKE 30 in sepsis participants.

Primary Outcome Measures: Clinical outcomes on MAKE30, MAKE30 is : in-hospital mortality, receipt of new RRT, or persistent renal dysfunction defined as a final inpatient serum creatinine value ≥2 time baseline serum creatinine, Day 30
Secondary Outcome Measures: occurrence of AKI within 7 days, Incidence of AKI from enrollment to 7 days post-enrollment, DAY 7|length of ICU stay and in-hospital stay, average length of ICU stay and in-hospital stay will be compared, DAY30|VExUS score, difference of the VExUS score at day 1, 2, 3 day between groups.Higher score means more illness., DAY3|CVP value, difference of the CVP value at day 1, 2, 3 day between groups.Higher score means more illness., DAY3|All-cause mortality within 30 days, All-cause mortality within 30 days, DAY30
EGCG for the Prevention and Treatment of TIPN
NCT Number: NCT06524609
Status: RECRUITING
Study Type: INTERVENTIONAL
Phases: PHASE1|PHASE2
Conditions: Chemotherapy-induced Peripheral Neuropathy
Interventions: DRUG: Epigallocatechin-3-Gallate|DRUG: Alcohol
Sponsor: Han Xi Zhao
Collaborators: The Fourth People's Hospital of Jinan
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 36
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: DOUBLE (PARTICIPANT, OUTCOMES_ASSESSOR)|Primary Purpose: TREATMENT
Start Date: 2023-11-30
Completion Date: 2025-01-30
Locations: Shandong First Medical University Affiliated Cancer Hospital (Shandong Academy of Medical Sciences), Jinan, Shandong, 250117, China

Summary:
Patients treated with paclitaxel analogs and experiencing Taxane-induced peripheral neurotoxicity (TIPN) of degree I or higher were treated with EGCG solution. The safety of topical EGCG solution for the treatment of TIPN and the optimal drug concentration were also verified by a phase I trial. The efficacy and safety of the optimal EGCG concentration obtained in the phase I trial were further analyzed in a randomized controlled phase II trial. Meanwhile, the predictive molecules of TIPN efficacy were initially explored by detecting patients' hematological related indexes. The optimal dose concentration, safety and efficacy of EGCG to ameliorate the neurotoxicity caused by paclitaxel-related drugs were clarified.

Primary Outcome Measures: sensory nerves and motor nerves of CTCAE, CTCAE（Common Terminology Criteria for Adverse Events）: A minimum of 1 grade and maximum of 5 grades., 42 days|TNS（Total Neuropathy Score）, TNS（Total Neuropathy Score）: Including sensory nerves, motor nerves and tendon reflexes, etc., 10 indicators, with a minimum of 1 grade and maximum of 5 grades each, and the scores of the 10 indicators were added together for a total., 42 days|EORTC Scale（European Organization for Research and Treatment of Cancer TIPN-specific Quality of Life Quality of Life Questionnaire for CIPN）, The scale consists of 9 scales for sensory, motor, and autonomic nerves, same grading and calculation method as the TNS scale., 42 days
Study on Gynecological Laparoscopy Under Total Intravenous Anesthesia
NCT Number: NCT06524596
Status: COMPLETED
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Butorphanol
Interventions: DRUG: tartaric acid butorphanol|DRUG: normal saline|DRUG: propofol and remifentanil
Sponsor: Wuhan Children's Hospital
Sex: FEMALE
Age: ADULT
Enrollment: 59
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: SINGLE (PARTICIPANT)|Primary Purpose: TREATMENT
Start Date: 2022-01-01
Completion Date: 2023-05-01
Locations: Wuhan Children's hospital, Wuhan, China

Summary:
To investigate the effect of preemptive analgesia with tartaric acid butorphanol on postoperative pain in gynecological laparoscopy under total intravenous anesthesia with remifentanil.This randomised, double-blind, placebo-controlled trial enrolled 60 patients undergoing elective gynaecological laparoscopy. The patients were divided into two groups: the butorphanol group (n = 30) and the control group (n = 29). Both groups received TIVA with propofol and remifentanil. Observing two groups of patients on the visual analog scale, the total consumption of rescue analogies, and the confidence of postoperative nausea and vomiting (PONV), and the patient satisfaction score.

Primary Outcome Measures: Visual analogue scale ( VAS ) scores for pain, Pain was assessed at 1 hour to evaluate immediate postoperative pain while allowing time to recover from anaesthesia., at 1 hour after surgery|Visual analogue scale ( VAS ) scores for pain, Pain was assessed at 2 hours after surgery., at 2 hours after surgery|Visual analogue scale ( VAS ) scores for pain, Pain was assessed at 4 hours after surgery., at 4 hours after surgery|Visual analogue scale ( VAS ) scores for pain, Pain was assessed at 6 hours after surgery., at 6 hours after surgery|Visual analogue scale ( VAS ) scores for pain, Pain was assessed at 12 hours after surgery., at 12 hours after surgery|Visual analogue scale ( VAS ) scores for pain, Pain was assessed at 24 hours after surgery., at 24 hours after surgery
Secondary Outcome Measures: the total rescue analgesic consumption (mg), The total rescue analgesic consumption was calculated by adding the amount of morphine delivered by PCA and any supplemental tramadol given by the nurse for inadequate pain control (VAS \>4) or at the patient's request, ensuring that the total opioid dose was within safe limits., within 24 hours after surgery|the incidence of postoperative nausea and vomiting(PONV), The incidence of postoperative nausea and vomiting(PONV) was defined as any nausea, vomiting or both, within 24 hours after surgery|the nausea severity of postoperative nausea and vomiting(PONV), The nausea severity was rated on a 4-point scale (0 = none, 1 = mild, 2 = moderate and 3 = severe), within 24 hours after surgery|patient satisfaction score, Patient satisfaction was assessed using a 5-point scale (1 = very dissatisfied, 2 = dissatisfied, 3 = neutral, 4 = satisfied and 5 = very satisfied)., at 24 hours after surgery
Exploration of Noninvasive Differential Diagnosis of Benign and Malignant Liver Tumors
NCT Number: NCT06524557
Status: RECRUITING
Study Type: OBSERVATIONAL
Conditions: Liver Tumor
Interventions: DIAGNOSTIC_TEST: with chronic liver disease
Sponsor: Xijing Hospital
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 200
Study Design: Observational Model: |Time Perspective: p
Start Date: 2018-01-01
Completion Date: 2025-12-30
Locations: Xijing Hosptial, Xi'an, Xi'an, 710032, China

Summary:
To explore an effective noninvasive method for differential diagnosis of liver tumors.

Primary Outcome Measures: The differential diagnosis of liver tumors, Multimodal ultrasound is of great value in the differential diagnosis of liver tumors, 2018.01-2025.12
Pulsed RF Neuromodulation and Leukocyte-Rich PRP for Refractory Low Back Pain
NCT Number: NCT06524531
Acronym: Multifidus
Status: RECRUITING
Study Type: INTERVENTIONAL
Phases: EARLY_PHASE1
Conditions: Multi-Organ Disorder
Interventions: PROCEDURE: Pulsed RF Neuromodulation|BIOLOGICAL: Leukocyte-Rich PRP Injection|PROCEDURE: Physiotherapy Alone
Sponsor: Iffat Anwar Medical Complex
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 100
Study Design: Allocation: RANDOMIZED|Intervention Model: CROSSOVER|Masking: SINGLE (PARTICIPANT)|Primary Purpose: TREATMENT
Start Date: 2024-07-10
Completion Date: 2025-12-30
Locations: Iffat Anwar Medical Complex, Lahore, Punjab, 54000, Pakistan

Summary:
This clinical trial aims to check the safety and efficacy profile of pulsed radiofrequency (RF) neuromodulation combined with leukocyte-rich platelet-rich plasma (PRP) injections for the treatment of refractory low back pain due to multifidus dysfunction. The trial will compare two groups: one receiving standard physical therapy and the other receiving pulsed RF neuromodulation and physiotherapy.

Primary Outcome Measures: Pain Visual Analog Scale (0-10), Change in pain intensity from baseline, 2 Weeks|Pain Visual Analog Scale (0-10), Change in pain intensity from baseline, 3 Months|Pain Visual Analog Scale (0-10), Change in pain intensity from baseline, 6 Months|Pain Visual Analog Scale (0-10), Change in pain intensity from baseline, 1 Year|Oswestry Disability Index (0-50), Change in disability index from baseline, 2 Weeks|Oswestry Disability Index (0-50), Change in disability index from baseline, 3 Months|Oswestry Disability Index (0-50), Change in disability index from baseline, 6 Months|Oswestry Disability Index (0-50), Change in disability index from baseline, 1 Year|Hospital Anxiety and Depression Scale (0-14), Change in anxiety and depression levels from baseline, 2 Weeks|Hospital Anxiety and Depression Scale (0-14), Change in anxiety and depression levels from baseline, 3 Months|Hospital Anxiety and Depression Scale (0-14), Change in anxiety and depression levels from baseline, 6 Months|Hospital Anxiety and Depression Scale (0-14), Change in anxiety and depression levels from baseline, 1 Year|Quality of Life (0-100), Change in Quality of life from baseline, 2 Weeks|Quality of Life (0-100), Change in Quality of life from baseline, 3 Months|Quality of Life (0-100), Change in Quality of life from baseline, 6 Months|Quality of Life (0-100), Change in Quality of life from baseline, 1 Year
A Multicenter Randomized Controlled Study of Interventional Treatment for Operable Stage Ⅱ-Ⅲ Non-small Cell Lung Cancer With Potential Recurrence as Minimal Residual Disease(MRD) Positive
NCT Number: NCT06524518
Status: NOT_YET_RECRUITING
Study Type: INTERVENTIONAL
Phases: PHASE2
Conditions: DFS
Interventions: DRUG: Chemotherapy combined with immunization
Sponsor: Xuanwu Hospital, Beijing
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 213
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: SINGLE (INVESTIGATOR)|Primary Purpose: PREVENTION
Start Date: 2024-08
Completion Date: 2029-12
Locations: Xuanwu Hospital, Beijing, Eijing, 100043, China

Summary:
A prospective, multicenter clinical study designed to explore the efficacy of adaptive therapy based on MRD status in patients with stage II-III non-small cell lung cancer(NSCLC) after treatment. Primary endpoints include 3-year Disease-Free Survival rate (3y-DFS) and median disease-free survival (mDFS).

Primary Outcome Measures: DFS, 3 years, MRD-positive patients were treated 3 years after intervention
Efficacy, Tolerability, and Cognitive Effects of Deep Transcranial Magnetic Stimulation for Bipolar Depression
NCT Number: NCT06524505
Status: RECRUITING
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Bipolar Depression
Interventions: DEVICE: deep Transcranial Magnetic Stimulation (dTMS) -active|DEVICE: deep Transcranial Magnetic Stimulation (dTMS) -sham
Sponsor: Tianjin Anding Hospital
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 100
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: QUADRUPLE (PARTICIPANT, CARE_PROVIDER, INVESTIGATOR, OUTCOMES_ASSESSOR)|Primary Purpose: TREATMENT
Start Date: 2021-11-01
Completion Date: 2024-11-30
Locations: Tianjin Anding Hospital, Tianjin, China

Summary:
The aim of this study is to evaluate the feasibility and efficacy of deep transcranial magnetic stimulation (dTMS) as an add-on treatment for bipolar depression. Meanwhile, we aim to evaluate the effect of dTMS on cognitive function of bipolar depressive patients. we hypothesize dTMS would improve depressive symptoms and cognitive function in bipolar disorder.

Primary Outcome Measures: The change over time in the score of Hamilton Depression Rating Scale (HDRS-17)., The aim is to explore whether dTMS combined with Pharmacological treatment could alleviate the severity of depressive symptoms as measured with HDRS-17 in bipolar depression after 4-week treatment. Hamilton Depression Rating Scale (HDRS-17) was used to evaluate the severity of symptoms of depression. Higher total score of the scale means more severe depressive symptoms., baseline, week 2, week 4, week 8
Secondary Outcome Measures: The change over time in the score of Hamilton Anxiety Rating Scale (HAMA), The aim is to explore whether dTMS combined with Pharmacological treatment could alleviate the severity of anxious symptoms as measured with HAMA in bipolar depression after 4-week treatment. Hamilton Anxiety Rating Scale (HAMA) was used to evaluate the severity of symptoms of anxiety. Higher total score of the scale means more severe anxious symptoms., baseline, week 2, week 4, week 8|The change of scores in MATRICS Consensus Cognitive Battery(MCCB), The aim is to observe whether active-stimuli in addition to pharmacological treatment will improve the cognitive function as measured with the MATRICS Consensus Cognitive Battery (MCCB) after 4 weeks of treatment compared to sham-stimuli, and investigators assess the scale at baseline, week 4 and week 8., baseline, week 4, week 8|The changes of levels of Brain Derived Neurotrophic Factor in peripheral blood, The aim is to investigate the change of Brain Derived Neurotrophic Factor level in peripheral blood as active stimuli in addition to regular medical treatment after 4 weeks of treatment compared to sham stimuli, and EDTA tubes were used to collect 5ml of peripheral blood at baseline, weeks 4, and 8 before feeding. The plasma was extracted after centrifugation, and the concentration of BDNF in plasma was detected by ELISA., baseline, week 4, week 8|The change of scores of Adverse events scale from baseline to week 4, The aim is to evaluate the adverse effects during the treatment., baseline, week 4
Flow Measurements in Functional CSF Shunts and Off-Shunt Locations With a Second-Generation Thermal Device
NCT Number: NCT06524492
Status: NOT_YET_RECRUITING
Study Type: OBSERVATIONAL
Conditions: Hydrocephalus
Interventions: DEVICE: FlowSense
Sponsor: Rhaeos, Inc.
Sex: ALL
Age: CHILD, ADULT, OLDER_ADULT
Enrollment: 40
Study Design: Observational Model: |Time Perspective: p
Start Date: 2024-07-25
Completion Date: 2024-12-31
Locations: Tampa Marriott Water Street, Tampa, Florida, 33602, United States|Rhaeos, Inc., Chicago, Illinois, 60654, United States|Northwest Special Recreation Association, Rolling Meadows, Illinois, 60008, United States

Summary:
This study compares the performance of two generations of non-invasive cerebrospinal fluid (CSF) shunt flow assessment devices. Measurements of functional implanted shunts and off-shunt locations will assess the diagnostic non-inferiority of the second-generation device to the first-generation device.

Primary Outcome Measures: Study Device Sensitivity, Study device sensitivity will be calculated as TP / (TP + FN)., Approximately 1 hour|Study Device Specificity, Study device specificity will be calculated as TN / (TN + FP), Approximately 1 hour
Investigating the Functional Characteristics of White Matter Fibers During Wakefulness and Sleep Based on SEEG
NCT Number: NCT06524479
Status: RECRUITING
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Refractory Epilepsy|Sleep
Interventions: PROCEDURE: SEEG recording and CCEP
Sponsor: Xuanwu Hospital, Beijing
Sex: ALL
Age: CHILD, ADULT, OLDER_ADULT
Enrollment: 20
Study Design: Allocation: NA|Intervention Model: SINGLE_GROUP|Masking: NONE|Primary Purpose: BASIC_SCIENCE
Start Date: 2024-07-08
Completion Date: 2027-10-08
Locations: Xuanwu Hospital, Beijing, Beijing, Beijing, 100000, China

Summary:
This study aims to include electrophysiological and clinical data from patients aged 14-65 with drug-resistant epilepsy who underwent SEEG electrode contacts traversing the brain's white matter. The collected data will be analyzed to investigate the functional characteristics of white matter fibers during wakefulness and sleep.

Primary Outcome Measures: SEEG recordings using cortico-cortical evoked potentials during daytime and sleeptime, The cortico-cortical evoked potential (CCEP) is a dynamic marker used to assess the functional connectivity or integrity of white matter. It is measured through the onset, peak latency, and amplitude of the N1., Hospital discharge (maximum one month from SEEG implantation)
Hypertensive Heart Disease in DR Congo
NCT Number: NCT06524440
Status: RECRUITING
Study Type: OBSERVATIONAL
Conditions: Hypertensive Heart Disease
Sponsor: Association of Future African Neurosurgeons, Yaounde, Cameroon
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 400
Study Design: Observational Model: |Time Perspective: p
Start Date: 2024-07-26
Completion Date: 2024-07-29
Locations: Monkole Mother and Infant Hospital Center, Kinshasa, Congo, The Democratic Republic of the

Summary:
In this Cross-sectional study, we will analyzed data from a tertiary referral Congolese hospital to find whether or not Congolese patients with hypertensive heart disease have multiple comorbid conditions. Will report on the management and outcomes of the patients.

Primary Outcome Measures: High Systolic Blood Pressure, The study will use high systolic blood pressures as a measure for hypertensive heart disease., 1 month
Novel Post-Surgical Incision Management to Prevent Ostomy Complications
NCT Number: NCT06524401
Status: NOT_YET_RECRUITING
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Ostomy|Enterocutaneous Fistula
Interventions: DEVICE: Limpet|DEVICE: Control
Sponsor: HealthPartners Institute
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 92
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: NONE|Primary Purpose: SUPPORTIVE_CARE
Start Date: 2024-08
Completion Date: 2025-09

Summary:
The goal of this clinical trial is to evaluate the safety and effectiveness of the Limpet, as compared to standard of care ostomy pouches, in reducing complications for ostomy and fistula patients. Secondary objectives include evaluating dressing leak rates and causes of complications (e.g., edema, tissue oxygen saturation, and poor stoma eversion). The main questions it aims to answer are:

Primary Hypothesis 1: Peristomal Skin Complications will decrease

Primary Hypothesis 2: Dressing Leak Rates will decrease

Participants will:

* Receive either the Limpet device or standard of care adhesive ostomy pouch dressing
* Return every 7 days for study visits for 30 days to receive device replacement, wound imaging, blood tests, and quality of life surveys.

Primary Outcome Measures: Peristomal Skin Complications (PSCs), We hypothesize that the Limpet will demonstrate a significant improvement in PSCs compared to standard of care adhesive ostomy pouches. Specifically, we anticipate a raw difference of 35% in PSCs for the pooled cohorts, with a complication rate of 50% in the control group and 15% in the Limpet group., 30 days|Dressing Leak Rates, We hypothesize that the Limpet will demonstrate a significant improvement in dressing leak rates compared to standard of care adhesive ostomy pouches. Specifically, we anticipate a raw difference of 15% in leak rates for the pooled cohorts, with a leak rate of 30% in the control group and 15% in the Limpet group., 30 Days
Secondary Outcome Measures: Total Complications (PSCs and Stomal Complications), We hypothesize that the Limpet will exhibit a raw difference of 35% in total complications (comprising PSCs and stomal complications like mucocutaneous separation and stoma retraction) for the ileostomy cohort. Stoma complication rates vary widely in the literature, and we plan to conduct sub analyses to evaluate the Limpet's effect on stoma complications independent of PSCs., 30 Days
A Randomized, Double-blinded, Self-controlled Clinical Study of Intralesional Injection of 5-fluorouracil Plus Triamcinolone for the Treatment of Refractory Nodular Prurigo
NCT Number: NCT06524323
Status: NOT_YET_RECRUITING
Study Type: INTERVENTIONAL
Phases: PHASE3
Conditions: Nodular Prurigo
Interventions: DRUG: 5-fluorouracil Injection|DRUG: Triamcinolone Acetonide
Sponsor: Second Affiliated Hospital, School of Medicine, Zhejiang University
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 60
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: DOUBLE (PARTICIPANT, OUTCOMES_ASSESSOR)|Primary Purpose: TREATMENT
Start Date: 2024-09-01
Completion Date: 2026-08-31
Locations: 2nd Affiliated Hospital, School of Medicine, Zhejiang University, Hangzhou, Zhejiang, 310000, China

Summary:
Nodular pruritus is a chronic inflammatory skin disease manifested as individual or multiple highly keratotic nodules with severe itching. The goal of this clinical trial is to compare the efficacy and safety of treating refractory nodular pruritus with intralesional injections of 5-fluorouracil alone or 5-fluorouracil plus triamcinolone acetonide.

Primary Outcome Measures: Clearance rate, The proportion of subjects with a clearance rate of ≥ 90%, Week 12 after administration|NRS score, The proportion of subjects whose NRS score improved by ≥ 4 points from baseline, Week 12 after administration
The Training of Resident Surgeons in Single-Port Thoracoscopic Surgery Wound Position Selection
NCT Number: NCT06524297
Acronym: OpVerse
Status: NOT_YET_RECRUITING
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Surgical Education
Interventions: OTHER: Metaverse system (Patients)|OTHER: Metaverse system (Resident Physician)
Sponsor: National Taiwan University Hospital
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 80
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: SINGLE (PARTICIPANT)|Primary Purpose: OTHER
Start Date: 2024-08-15
Completion Date: 2025-12-31

Summary:
the metaverse system applied to the training of wound location selection for singleport thoracoscopic surgery. The experimental design is two groups of 40 computer tomography located superficially less than 2 cm lung nodule patients, one group uses the metaverse system to let resident physicians simulate the wound position on the digital twin organs of each patient, and the other group does not use it. The investigators will evaluate the surgeon's satisfaction with the surgical wound position and urgicalrelated results (such as surgery time, blood loss, etc.). The investigators expect that the system will help improve the appropriateness of resident physicians' choice of wound location for high-difficulty single-port thoracoscopic surgery, help them cross the first threshold necessary to familiarize themselves with the surgery faster, and accelerate learning.

Primary Outcome Measures: Operation time, Compare the length of operation time between the experimental group (trained using the Metaverse surgical simulation system for 15 minutes pre-operatively) and the control group. This analysis will assess whether pre-operative simulation training reduces operation time for residents., 24 hours
Secondary Outcome Measures: Satisfaction Questionnaire for Attending Physicians, To improve the residents selection of wound locations during single-port thoracoscopic surgery, the attending physician will complete a post-operative questionnaire regarding the residents' pre-operative simulation training., Through study completion, an average of 1 year.
Feasibility of Self-treatment of Painful Diabetic Neuropathy Using Electrical Vasomotor Nerve Stimulation
NCT Number: NCT06524284
Acronym: HOME-EVNS
Status: RECRUITING
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Painful Diabetic Neuropathy
Interventions: DEVICE: Releaf
Sponsor: Neurecon BV
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 40
Study Design: Allocation: NA|Intervention Model: SINGLE_GROUP|Masking: NONE|Primary Purpose: TREATMENT
Start Date: 2024-07-22
Completion Date: 2024-12
Locations: Neurecon, Vught, Netherlands

Summary:
Electrical stimulation with EVNS (Electrical Vasomotor Neuro Stimulation), a methodology used by a specific group of neurostimulators known under various names, has proven its benefit in Painful Diabetic Neuropathy (PDN). However, due to the impaired mobility from Diabetic Neuropathy, a part of subjects did not finish the 10 days treatment in the outpatient clinic. Another part of the target group decided not to participate at all for the same reason.

The current study investigates the feasibility, safety and performance of a newly developed EVNS device, called Releaf™, optimised for HOME treatment,

Primary Outcome Measures: Side-effects, The number and severity of reported side-effects of HOME-EVNS, gathered via telephonic consulting on treatment day 1,3 and 8 and via user-initiated incoming calls to the PI, Day 1-10|Successful treatment cycles, The successful treatment cycles applied at home, defined as cycles with at least 8/10 successful (full 35 minutes) treatment sessions, derived from the adherence determined by recording device usage and intensity setting which is downloaded from device after its retrieval, Day 11|Reported usability, Usability by the User Questionnaire, Day 10|Use of helpdesk, The number of help requests to service desk., Day 1-10
Secondary Outcome Measures: Neuropathic pain, Neuropathic Pain Symptom Inventory (NPSI) filled in by subject, Before start, after 1 month, after 3 months|Quality of life score, EuroQol 5 Dimension 5 Level (EQ-5D-5L) QoL filled in by subject, Before start, after 1 month, after 3 months
Effect of Fermented Soybean (FSB) Supplementation on Gas-troesophageal Reflux Disease (GERD)
NCT Number: NCT06524271
Status: COMPLETED
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Gastro Esophageal Reflux
Interventions: DIETARY_SUPPLEMENT: Fermented Soybean|DIETARY_SUPPLEMENT: Supplement without fermented soybean
Sponsor: NATTOME SDN BHD
Collaborators: UCSI University
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 110
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: DOUBLE (PARTICIPANT, INVESTIGATOR)|Primary Purpose: TREATMENT
Start Date: 2023-11-01
Completion Date: 2024-05-31
Locations: UCSI University, Cheras, Kuala Lumpur, 56000, Malaysia

Summary:
Gastroesophageal reflux disease (GERD) is a prevalent chronic condition affecting the well-being of both adults and children in general medical practice. Research on the effects of fermented soy-bean (FSB) supplementation in managing GERD is relatively new, with limited studies available. Existing research often lacks sufficient dosing regimens and study durations to differentiate be-tween transient placebo effects and sustained benefits. In this study, the beneficial effects of FSB supplementation were investigated in 50 voluntary participants. Participants were required to take 1g of FSB supplement once daily for twelve weeks. GERD symptoms were evaluated using the Reflux Disease Questionnaire (RDQ), while inflammatory markers, including interleukin-4 (IL-4), interleukin-6 (IL-6), and interleukin-8 (IL-8), were measured to assess inflammation. The Quality of Life in Reflux and Dyspepsia (QOLRAD) questionnaire was used to evaluate partici-pants' quality of life. Results indicated that FSB supplementation significantly (P\<0.05) alleviated heartburn and regurgitation symptoms and reduced levels of IL-4, IL-6, and IL-8, indicating a notable anti-inflammatory effect. Additionally, significant (P\<0.05) improvements were observed in QOLRAD scores, particularly in vitality, emotional distress, and physical/social functioning. Collectively, our findings support the use of FSB as an adjuvant approach in managing GERD, with notable improvements in patients' quality of life.

Primary Outcome Measures: Reflux Disease Questionnaire (RDQ), The RDQ assessed six symptoms across three domains (heartburn, regurgitation, and upper abdominal pain) using a 6-point Likert scale to measure frequency and severity over the preceding weeks, 4 weeks|Quality of Life in Reflux and Dyspepsia (QOLRAD), This questionnaire comprised 25 questions in five subdomains: emotional distress (questions 12, 14, 15, 17, 19, and 22), sleeping disorders (questions 8, 10, 11, 18, and 21), eating/drinking disorders (questions 3, 5, 9, 13, 16, and 20), physical/social function (questions 2, 6, 23, 24, and 25) and vitality (questions 1, 4, and 7). Participants rated each question on a 7-point Likert scale., 4 weeks|Inflammatory Markers, Three markers were assessed, namely IL-4, IL-6 and IL-8, 4 weeks
A Predictive Model for Recurrence of Colorectal Cancer Based on Multi-omics of Portal Vein Blood
NCT Number: NCT06524245
Acronym: PVMRD
Status: RECRUITING
Study Type: OBSERVATIONAL
Conditions: Colorectal Cancer
Sponsor: Peking University Shougang Hospital
Collaborators: Beijing Tiantan Hospital|Peking University Third Hospital|Peking University First Hospital|Chinese PLA General Hospital
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 350
Study Design: Observational Model: |Time Perspective: p
Start Date: 2020-01-01
Completion Date: 2026-12
Locations: Peking University Shougang Hospital, Beijing, Beijing, 100144, China

Summary:
This multi-center study aims to develop a precise predictive model for colorectal cancer (CRC) recurrence and metastasis based on multi-omics analysis of portal vein blood. Despite advances in surgical treatments, approximately 40% of CRC patients experience tumor recurrence or metastasis post-surgery, with 80-90% of metastases being unresectable. The study will include stage I-IV CRC patients and will be conducted in two phases: a nested case-control study and a bidirectional cohort study. Comprehensive multi-omics sequencing will be performed on samples from primary tumors, adjacent tissues, normal intestinal tissues, portal vein blood, and peripheral blood. The goal is to identify specific biomarkers in the portal vein and peripheral blood associated with CRC recurrence and metastasis, and to compare the predictive accuracy of models based on these biomarkers. The ultimate objective is to provide a more effective method for early prediction and intervention of CRC recurrence and metastasis, thereby improving patient outcomes.

Project Information:

Project Title: A predictive model for recurrence of colorectal cancer based on multi-omics of portal vein blood: a multi-center study Project Duration: January 2020 to December 2026 Lead Institution: Peking University Shougang Hospital Principal Investigator: Gu Jin Contact: Hong Haopeng, 18059211195@163.com

Primary Outcome Measures: Colorectal Cancer Recurrence or Metastasis, The primary outcome measure is the occurrence of colorectal cancer (CRC) recurrence or metastasis within 24 months post-surgery. This will be monitored through clinical evaluations, imaging studies (CT, MRI), and blood tests (CEA levels). Recurrence or metastasis will be defined by persistent elevation in CEA, and/or detection of local recurrence or distant metastases through imaging and biopsy confirmation., 24 months post-surgery
Secondary Outcome Measures: Overall Survival, Overall survival (OS) will be measured from the date of surgery to the date of death from any cause. This outcome will help determine the effectiveness of the predictive model and intervention strategies developed from the study. Survival status will be monitored through regular follow-up visits and patient records., 24 months post-surgery
Comparison of Nerve-sparing Techniques in Radical Prostatectomy for Oncological Outcome and Functional Recovery.
NCT Number: NCT06524219
Status: NOT_YET_RECRUITING
Study Type: OBSERVATIONAL
Conditions: Prostate Cancer
Interventions: PROCEDURE: unilateral intrafascial resection|PROCEDURE: bilateral intrafascial resection|PROCEDURE: bilateral extrafascial resection
Sponsor: The First Affiliated Hospital with Nanjing Medical University
Sex: MALE
Age: ADULT, OLDER_ADULT
Enrollment: 150
Study Design: Observational Model: |Time Perspective: p
Start Date: 2024-10-01
Completion Date: 2029-10-01

Summary:
To evaluate the difference among three nerve-sparing techniques(unilateral intrafascial resection, bilateral intrafascial resection, bilateral extrafascial resection) of oncological outcome and functional recovery.

Primary Outcome Measures: biochemical recurrence-free rates, the rate of patients who do not have biochemical recurrence, 3 years|urinary control rate, the rate of patients who do not have incontinence, day 0, 3 month, 6 month, 1 year|sexual function, the rate of patients who do not lose sexual function, 6 month, 1 year
Secondary Outcome Measures: perioperative complications, the complications that occur in perioperation, perioperation|positive rate of incisal margin, the rate of patients who have positive incisal margin after the operation, day 0|prostate cancer-specific survival, the survival for prostate cancer, 3 years
RW Study of Adjuvant Radiotherapy in Locally Advanced Thyroid Cancer
NCT Number: NCT06524167
Status: RECRUITING
Study Type: OBSERVATIONAL
Conditions: Thyroid Cancer
Interventions: RADIATION: adjuvant radiotherapy
Sponsor: Fudan University
Sex: ALL
Age: CHILD, ADULT, OLDER_ADULT
Enrollment: 80
Study Design: Observational Model: |Time Perspective: p
Start Date: 2024-07-02
Completion Date: 2031-06-30
Locations: Fudan University Shanghai Cancer Center, Shanghai, 200032, China

Summary:
This study is a real-world study to observe the role of adjuvant radiotherapy in locally advanced recurrent high-risk thyroid cancer. The study included thyroid cancer that requires adjuvant radiotherapy to increase local control rate, excluding undifferentiated cancer. Local-regional recurrence free survival is the primary endpoint of the study.

Primary Outcome Measures: LRRFS, Local-regional Recurrence Free Survival, 5 years
Secondary Outcome Measures: DCR, Disease Control Rate, 5 years|PFS, Progression Free Survival, 5 years|OS, Overall Survival, 5 years|AE, Adverse Events, 5 years|QoL, Quality of Life, 5 years
Effect of Verbal Positive Reinforcement, Contingent Escape and Rewarding on Behaviour of Children Undergoing Primary Molar Pulpotomy: a Randomized Clinical Study
NCT Number: NCT06524154
Status: ACTIVE_NOT_RECRUITING
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Dental Anxiety
Sponsor: Mansoura University
Sex: ALL
Age: CHILD
Enrollment: 42
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: NONE|Primary Purpose: OTHER
Start Date: 2024-01-24
Completion Date: 2025-03-03

Summary:
The purpose of this study to evaluate the effect of verbal positive reinforcement, contingent escape and rewarding on behaviour of children undergoing primary molar pulpotomy.

Primary Outcome Measures: RMS Pictorial Scale (RMS-PS), The pictorial Scale (RMS) compromise's a row of five faces ranging from very happy very unhappy. The children will be asked to choose the face they feel like about themselves at that moment. The scale will be scored by giving a value of one to the very happy face and five to the very unhappy face, 12 weeks
Secondary Outcome Measures: Frankl Behavior Rating Scale, classified child's behavior into four groups according to the child's attitude and cooperation or lack of cooperation during dental treatment, 12 weeks
Other Outcome Measures: Pulse oximeter, To measure heart rate, 12 weeks
Review of the Follow-up of Difficult Airway Guidelines
NCT Number: NCT06524141
Status: NOT_YET_RECRUITING
Study Type: OBSERVATIONAL
Conditions: Anesthesia|Airway Management
Sponsor: Kocaeli City Hospital
Sex: ALL
Age: CHILD, ADULT, OLDER_ADULT
Enrollment: 50
Study Design: Observational Model: |Time Perspective: p
Start Date: 2024-08-01
Completion Date: 2025-01-31

Summary:
This questionnaire study aimed to ask the participants selected questions from the recommendations of the main guidelines on airway management. Thus, the compliance rate of anesthesiologists with the guidelines in different difficult airway management situations will be investigated. Secondarily, it was aimed to raise awareness about the recommendations of the guidelines.

Primary Outcome Measures: Anesthesiologists' adherence to current guidelines in difficult airway management situations., The study aims to ask the participants questions selected from the recommendations of the main guidelines on airway management. The compliance rate of anesthesiologists with guidelines in difficult airway management situations will be investigated., 5 months
Optimization of a Photoretinoscopy Method for Determining the Objective Refraction of Children With a Smartphone/add-on Device in India
NCT Number: NCT06524115
Status: NOT_YET_RECRUITING
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Ametropia
Interventions: DEVICE: Comparator device, Closed-field autorefractometer without cycloplegia|OTHER: Distance visual acuity check using objective refraction without cycloplegia|DEVICE: Comparator device, Closed-field autorefractometer with cycloplegia|OTHER: Distance visual acuity check using objective refraction with cycloplegia
Sponsor: Essilor International
Sex: ALL
Age: CHILD
Enrollment: 114
Study Design: Allocation: NA|Intervention Model: SINGLE_GROUP|Masking: NONE|Primary Purpose: SCREENING
Start Date: 2024-08
Completion Date: 2025-02
Locations: Sankara Nethralaya, Unit of Medical Research Foundation, Chennai, Tamil Nadu, 600 006, India

Summary:
The objective is to compare the refractive parameters of the photorefraction prototype device without cycloplegia with the refractive parameters of reference device, an autorefractometer with and without cycloplegia.

Primary Outcome Measures: Objective refractive error, The refractive error is collected in sphere power (D), cylinder power (D) and cylinder axis (°) and converted in equivalent sphere, J0, J45 (power vector in D), One day (all measurements are taken during the single visit)
The Aim of This Study is to Determine the Incidence of Alterations in Fluorescent In Situ Hybridisation (FISH) of Spermatozoa and to Evaluate the Efficacy of the Use of Annexin Columns (MACS®) in Patients With Altered FISH Undergoing In Vitro Fertilisation Techniques
NCT Number: NCT06524102
Status: COMPLETED
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Infertility, Male
Interventions: DEVICE: Magnetic Activated Cell Sorting
Sponsor: Instituto de Investigación Sanitaria y Biomédica de Alicante
Sex: ALL
Age: ADULT
Enrollment: 10
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: TRIPLE (PARTICIPANT, CARE_PROVIDER, OUTCOMES_ASSESSOR)|Primary Purpose: TREATMENT
Start Date: 2018-01-01
Completion Date: 2022-03-31
Locations: ISABIAL, Alicante, 03010, Spain

Summary:
250 petitions for FISH of spermatozoa were requested, determining the total and particular incidence in each of the indications collected. The effect of annexin columns was evaluated in 10 couples with altered FISH. In each of the couples, oocytes were pseudo-randomised to the control group and MACS®. All couples received experimental treatment. Mixed logistic regression model were adjusted to evaluate the effect of MACS® on the response variables studied.

Primary Outcome Measures: Euploid embryo rate, Embryos without chromosomal alterations in relation to the total number of those that were informative., This variable was taken 2 days after obtaining the genetic result of the embryo biopsy.
Secondary Outcome Measures: Fertilization rate, Number of correctly fertilized zygotes among the total number of mature oocytes inseminated, This variable was taken 17-20 hours after oocyte insemination.|Biopsiable embryo rate, Number of biopsied embryos versus the total number of correctly fertilized zygotes, This variable was taken on the 3rd day of embryonic development, at the time of the embryo biopsy. .