pankajmathur/National_Library_of_Medicine_Studies_data huggingface dataset:
RIC (Remote Ischemic Conditioning) in Older Individuals
NCT Number: NCT06476288
Status: NOT_YET_RECRUITING
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Old Age|Mobility Limitation|Debility
Interventions: OTHER: Low-intensity resistance exercise training|OTHER: Remote ischemic conditioning (RIC)
Sponsor: Duke University
Collaborators: National Institutes of Health (NIH)
Sex: ALL
Age: OLDER_ADULT
Enrollment: 20
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: SINGLE (PARTICIPANT)|Primary Purpose: SUPPORTIVE_CARE
Start Date: 2024-08
Completion Date: 2026-07
Locations: Duke University, Durham, North Carolina, 27710, United States

Summary:
The purpose of this study is to examine the feasibility and acceptability of a technique called remote ischemic conditioning (RIC) that aims to improve muscle strength, muscle mass, exercise tolerance, resilience (i.e. how well someone responds to a stressor), quality of life, physical activity, and physical function when added to rehabilitative exercise training in individuals over age 65 who have some difficulty with mobility.

Primary Outcome Measures: Feasibility of study intervention as measured by the number of participants who completed the study, Up to 6 weeks|Feasibility of study intervention as measured by the attrition rate, Attrition rate is expressed as a percentage and is calculated by dividing the number of non-completers by the total number of participants., Up to 6 weeks|Feasibility of study intervention as measured by the number of exercise visits attended per participant, Up to 6 weeks|Feasibility of study intervention as measured by the number of RIC home applications completed per participant, Up to 6 weeks|Acceptability of study intervention as measured by an Intervention Acceptability Questionnaire, Each participant will complete an Intervention Acceptability Questionnaire with responses on a 5-point Likert scale, where a higher score indicates greater acceptability., Up to 6 weeks
Secondary Outcome Measures: Feasibility of collecting blood samples during study as measured by the success rate of collection, Up to 6 weeks|Change in Short Physical Performance Battery (SPPB), The SPPB measures changes in physical function., Baseline to post-intervention visit (approximately 7 weeks)|Change in muscle strength as measured by dynamometry, Measurements made with isokinetic dynamometry, hand-held dynamometry and DXA scans completed at pre- and post-intervention., Baseline to post-intervention visit (approximately 7 weeks)|Change in exercise tolerance as measured by VO2peak testing, Baseline to post-intervention visit (approximately 7 weeks)|Change in quality of life as measured by PROMIS-29, Baseline to post-intervention visit (approximately 7 weeks)|Change in Brief Resilience 5-point Likert Scale, Higher score indicates greater resilience., Baseline to post-intervention visit (approximately 7 weeks)|Change in vascular function as measured by arterial tonometry, Baseline to post-intervention visit (approximately 7 weeks)
Single Dose Texas 2017 (H3N2) Challenge Study
NCT Number: NCT06476275
Status: NOT_YET_RECRUITING
Study Type: INTERVENTIONAL
Phases: PHASE1
Conditions: Influenza Viral Infections
Interventions: BIOLOGICAL: Influenza A/Texas/71/2017 (H3N2)|BIOLOGICAL: Sham placebo
Sponsor: Duke University
Collaborators: United States Department of Defense|Owlstone Ltd|Darwin Biosciences
Sex: ALL
Age: ADULT
Enrollment: 36
Study Design: Allocation: RANDOMIZED|Intervention Model: SINGLE_GROUP|Masking: QUADRUPLE (PARTICIPANT, CARE_PROVIDER, INVESTIGATOR, OUTCOMES_ASSESSOR)|Primary Purpose: BASIC_SCIENCE
Start Date: 2024-08
Completion Date: 2024-12

Summary:
The overall objective of the present study is to utilize the recombinant H3N2 (A/Texas/71/2017 (H3N2, clade 3C3a)) influenza virus for a controlled human infection model to study host responses to influenza virus with the aim of identifying volatile markers in exhaled breath and expression markers in saliva for early detection of infection after pathogen exposure. This study will aim to recruit up to 40 healthy volunteers between ages 18-45 who will receive a single dose of either intranasally administered placebo (sham inoculum) or the virus challenge strain at a concentration known to elicit a \~60-80% attack rate. The response to influenza challenge will be measured by clinical, laboratory, immunological, digital biomarker, on-breath volatile organic compound data and host RNA expression in both blood and saliva.

The study will enroll and challenge up to 34 healthy adult volunteers with live virus plus approximately 6 sham-inoculated controls who will be prescreened for study inclusion to have serological antibody titers of ≤1:40 against the challenge strain. Each participant will complete up to 3 weeks of follow-up post confinement.

Primary Outcome Measures: Number of participants with detectable viral shedding in nasopharyngeal (NP) swab(s) by qualitative RT-PCR over any 2 days and with symptomatic infection, 24 hours post challenge through Day 8|Number of participants with On-breath volatile markers that correlate with clinical symptoms, On-breath volatile markers that correlate with early, pre-symptomatic influenza viral infection, early asymptomatic influenza viral infection, clinical symptoms of infection throughout the confinement period and viral shedding. Captured by the Owlstone Medical Breath Biopsy Collection Station and identified and quantified by thermal-desorption gas chromatography mass spectrometry (TD-GC-MS)., Baseline (Day -1) through Day 8|Number of participants with Biomarker expression changes that correlate with clinical symptoms, Biomarker expression changes in saliva that correlate with early, pre-symptomatic influenza viral infection, early asymptomatic influenza viral infection, clinical symptoms of infection throughout the confinement period and viral shedding. Quantitative RNA expression levels at baseline and post challenge serial timepoints using next-level genomic sequencing (NGS) and RT-qPCR., Baseline (Day -1) through Day 8
Risk Factors for Postoperative Cough in Patients Undergoing Thoracoscopic Lung Resection
NCT Number: NCT06476249
Status: RECRUITING
Study Type: OBSERVATIONAL
Conditions: Lung Cancer
Interventions: OTHER: without
Sponsor: Hematology department of the 920th hospital
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 1000
Study Design: Observational Model: |Time Perspective: p
Start Date: 2024-03-01
Completion Date: 2027-05-01
Locations: the 920th Hospital of the Joint Logistics Support Force, Kunming, Yunnan, 223964, China

Summary:
Lung cancer, as the main cause of cancer-related deaths in both males and females, is a great risk to human health. Pulmonary resection is the most applicable to early-stage lung cancer diagnoses and considered the best curative options. Coughing is a prominent symptom among postoperative complications, with approximately 18%-50% of patients experiencing persistent coughing after surgery. This study is a prospective observational study and is expected to be carried out in a large tertiary hospital. This cohort is expected to include 1000 participants for three years.

Patients with pulmonary nodules on chest CT will be divided into two groups based on the presence or absence of cough symptoms on admission. The investigators decided whether to include patients in this cohort study strictly based on the inclusion and exclusion criteria. The severity of cough, the trajectory of cough change, and the physiological and social burden caused by cough will be reflected by the results of LCQ-MC, CSS, HARQ, and VAS. LCQ-MC, CSS, HARQ, and VAS are just a few of the questionnaires that are widely used to investigate the cough and severity of the respondent. The included variables included age, gender, Height, Weight, education level, smoking history, alcohol history, preoperative lung function, nodule size, preoperative and postoperative blood routine (such as white blood cell count, neutrophil count, etc.), blood biochemistry (such as C-reactive protein, PCT, etc.), liver and kidney function test results, surgical method, surgical site, operation duration, anesthesia method, anesthesia duration, lymph node dissection, pathological results, chest tube caliber, number of days of catheterization, use of cough drugs, use of non-steroidal anti-inflammatory drugs, Number of days in hospital and number of outpatient visits due to cough.

Primary Outcome Measures: The score value of Mandarin Chinese version of the Leicester Cough Questionnaire, Mandarin Chinese version of the Leicester Cough Questionnaire is a globally recognized questionnaire for assessing the severity of cough, On the 3rd,1 month and Half a year postoperatively|The score value of visual analogue scale, The score value of visual analogue scaleis a globally recognized questionnaire for assessing the severity of cough, On the 3rd, 7th, 11th, 15th, 1 month, and half a year after surgery, respectively
Secondary Outcome Measures: The score value of Hull airway reflux questionnaire, The score value of visual analogue scaleis a globally recognized questionnaire for assessing the severity of cough, On the 3rd,1 month and Half a year postoperatively
Artificial Saliva Containing Cumin and Ginger Extract in Hemodialysis Patients With Xerostomia
NCT Number: NCT06476223
Status: NOT_YET_RECRUITING
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Xerostomia
Interventions: DRUG: Artificial saliva containing cumin and ginger extract|DRUG: Placebo
Sponsor: Chulalongkorn University
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 26
Study Design: Allocation: RANDOMIZED|Intervention Model: CROSSOVER|Masking: QUADRUPLE (PARTICIPANT, CARE_PROVIDER, INVESTIGATOR, OUTCOMES_ASSESSOR)|Primary Purpose: TREATMENT
Start Date: 2024-07-01
Completion Date: 2025-01-31

Summary:
Hemodialysis patients with xerostomia are divided into 2 groups which are group A (start with artificial saliva containing cumin and ginger extract for 2 weeks, free periods 2 weeks, then placebo for 2 weeks) and group B (start with placebo for 2 weeks, free periods 2 weeks, then artificial saliva containing cumin and ginger extract for 2 weeks). Amount of saliva (g/min), xerostomia's questionnaire, Increase of saliva score, World Health Organization Oral Mucositis Grading Scale, acid and base of saliva, quality of life's questionnaire will measure before, after using the sample for 7 and 14 days.

Primary Outcome Measures: Xerostomia symptoms using Xerostomia Inventory Score, Patients give the score of Xerostomia Inventory questionnaire. The Xerostomia Inventory Score is graded 11 to 55 (Low score means low frequency xerostomia and high score means high frequency of xerostomia), 14 days
Secondary Outcome Measures: Salivary flow rate, Weigh the saliva amount from the patients in 5 mins and then calculate in g/min, 14 days|Amount of saliva score, Patients give the score of saliva amount (0 to 10, 0 means no saliva and 10 means high amount of saliva), 14 days|Quality of life score using the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-Head and Neck 35, Patients give the score of the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-Head and Neck 35. The score is graded 35 to 130 (Low score means high quality of life and high score means low quality of life), 14 days|World Health Organization Oral Mucositis, World Health Organization Oral Mucositis is graded 0 to 4 (0 means no mucositis to 4 means severe mucositis)., 14 days|Acid and base of saliva, Measure acid and base of saliva using acid and base standard paper, 14 days
Validation of Hematological Indices
NCT Number: NCT06476171
Status: RECRUITING
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Multiple Organ Dysfunction|Sepsis|Pneumonia|Wound Infection
Interventions: DIAGNOSTIC_TEST: Determination of the level of the studied biomarkers
Sponsor: Petrovsky National Research Centre of Surgery
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 200
Study Design: Allocation: NON_RANDOMIZED|Intervention Model: PARALLEL|Masking: NONE|Primary Purpose: DIAGNOSTIC
Start Date: 2023-06-19
Completion Date: 2024-12-30
Locations: Petrovsky National Reasearch Centre of Surgery, Moscow, 119991, Russian Federation

Summary:
The hypothesis of the study is that hematological indices (neutrophil to lymphocyte ratio, platelet to lymphocyte ratio and systemic index of inflammation) may be predictors of infectious complications and multiple organ dysfunction in patients after cardiac surgery.

Primary Outcome Measures: Number of patients with onset of complications of any type in the postoperative period, Recording by the attending physician of the occurrence of a complication, Up to 12 weeks
Secondary Outcome Measures: Changes in the levels of other biomarkers often used in clinical practice, neutrophil elastase; myeloperoxidase; lactoferrin; interleukins -1β,17,10,6; presepsin; endothelin; lipopolysaccharide; lipopolysaccharide binding protein; procalcitonin; lactoferrin; interleukins -1β,17,10,6; presepsin; endothelin; lipopolysaccharide; lipopolysaccharide binding protein; procalcitonin; ferritin ; lactate dehydrogenase, tumor necrosis factor - alpha; Endotoxin Activity Assay, Up to 1 week|Number of patients with nosocomial pneumonia, In accordance with national clinical guidelines, the diagnosis of pneumonia was made with the appearance of fresh focal infiltrative changes in the lungs according to X-ray examination data in combination with two or more clinical and laboratory signs (acute fever 38,0 ° C and higher; cough with sputum; physical signs - focus of crepitation/small bubbly wheezing, bronchial respiration, shortening of percussion sound; leukocytosis \> 10 x 109 /l and/or rod shift \> 10%)., Up to 12 weeks|Number of patients with wound infection, The diagnosis of wound infection is established jointly with surgeons on the basis of examination of the postoperative wound during dressing and bacteriological examination of the discharge from the wound., Up to 12 weeks|Number of patients with multiple organ dysfunction, With the dysfunction of two or more functional systems (cardiovascular, respiratory, renal-hepatic), the syndrome of multiple organ dysfunction was established, Up to 12 weeks|Number of patients with sepsis, If there is a focus of infection or suspected infection in combination with multiple organ dysfunction (+ 2 points on the SOFA scale), sepsis is diagnosed., Up to 12 weeks
Evaluating Adenoma Recurrence After Endoscopic Mucosal Resection With Margin Marking or Post Treatment With Snare Tip Soft Coagulation
NCT Number: NCT06476145
Acronym: ERADICATE
Status: RECRUITING
Study Type: OBSERVATIONAL
Conditions: Adenoma Colon Polyp
Sponsor: AdventHealth
Collaborators: Northwestern University|White River Junction Veterans Affairs Medical Center|Rush University|University Medical Centre Ljubljana|University of Kansas|Henry Ford Health System|Carilion Clinic|St. Paul's Hospital, Canada|Minneapolis Veterans Affairs Medical Center
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 342
Study Design: Observational Model: |Time Perspective: p
Start Date: 2023-12-08
Completion Date: 2026-03-08
Locations: AdventHealth, Orlando, Florida, 32804, United States

Summary:
Non-inferiority trial comparing the recurrence rate of adenomas in non-pedunculated colonic lesions following endoscopic mucosal resection with margin marking (EMR-MM) and endoscopic mucosal resection with thermal margin ablation (EMR-STSC)

Primary Outcome Measures: Adenoma Reocurrance, During Screening Colonoscopy (SC) 1, between 3 -12 post initial procedure. The post-EMR site will be assessed and biopsied for histology to assess for recurrence of adenoma., 3 - 12 (+/- 6 months)
Secondary Outcome Measures: EMR procedure time, Time from submucosal injection to completion of resection, including the time required to treat any intraprocedural adverse event, but not including time on prophylactic endoscopic closure., During procedure visit|Comparison of MM vs STSC procedure time, MM procedure time is defined as that required to complete placing cautery marks around the lesion prior to resection. STSC time is defined as that required to complete margin ablation around the entire resection margin., Index procedure visit|Incidence of overall severe adverse events: Bleeding, Severe bleeding (immediate or delayed): defined as the need for hospitalization, transfusion, repeat endoscopy, surgery or interventional radiology. Immediate complication is defined as an event at the time of ESD resection or immediately following colonoscopy (before patient has left the endoscopy unit or during the immediate post-procedural care). A delayed (post-procedure) bleed is defined as an event that occurs after the patient has left the endoscopy unit and within 30 days following the procedure, Index procedure, 1 - 3 days post, 30 days.|Incidence of overall severe adverse events: Perforation, Defined as complete hole, or full-thickness resection of the muscularis propria (Sidney classification of deep mural injury type IV or V)., Index procedure, 1 - 3 days post, 30 days.|Incidence of overall severe adverse events: Postpolypectomy Syndrome, Abdominal pain severe enough to warrant emergency room or hospital admission in the presence of fever, leukocytosis, peritoneal inflammation in the absence of frank perforation on CT, and/or required treatment with antibiotics., Index procedure, 1 - 3 days post, 30 days.
Human Research Program Flight Thigh Cuff
NCT Number: NCT06476106
Status: RECRUITING
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Healthy
Interventions: DEVICE: Venoconstrictive Thigh Cuff (VTC)
Sponsor: National Aeronautics and Space Administration (NASA)
Sex: ALL
Age: CHILD, ADULT, OLDER_ADULT
Enrollment: 10
Study Design: Allocation: NA|Intervention Model: SINGLE_GROUP|Masking: NONE|Primary Purpose: SUPPORTIVE_CARE
Start Date: 2023-03-24
Completion Date: 2030-05-14
Locations: Johnson Space Center, National Aeronautics and Space Administration, Houston, Texas, 77058, United States

Summary:
Venoconstrictive Thigh Cuffs (VTC) are being evaluated to determine the effectiveness at reversing the headward fluid shift that occurs during weightlessness. If successful, future studies may be done to implement these as a CM to SANS. To support this effort, participants will participate in 2 preflight study sessions consisting of a VTC fit check and a baseline data collection without and with the VTC donned. Participants will also participate in 3 inflight study sessions: a VTC fit check on flight day 30 (FD30) and two separate data collection sessions on flight day 45 (FD45) and 45 days before landing (R-45). During the two in-flight data collection days, participants will be studied before and for up to 6 hours after donning the VTC.

Primary Outcome Measures: Internal Jugular Vein (IJV) area, Measured using Ultrasound., Thigh Cuff Measures 90 days before mission, after 45 days in mission, and 45 days before return|IJV pressure, Measured using the VeinPres device during Ultrasound., Thigh Cuff Measures 90 days before mission, after 45 days in mission, and 45 days before return|Intraocular Pressure (IOP), Measured using the Pneumatonometer., Thigh Cuff Measures 90 days before mission, after 45 days in mission, and 45 days before return|stroke volume, Measured from data collected during Ultrasound., Thigh Cuff Measures 90 days before mission, after 45 days in mission, and 45 days before return
SRT Combined With Anlotinib for the Treatment of Brain Metastases From Non-small Cell Lung Cancer
NCT Number: NCT06476093
Status: RECRUITING
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Non-Small-Cell Lung Cancer|Brain Metastases
Interventions: DRUG: Anlotinib hydrochloride
Sponsor: The First People's Hospital of Lianyungang
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 46
Study Design: Allocation: NA|Intervention Model: SINGLE_GROUP|Masking: NONE|Primary Purpose: TREATMENT
Start Date: 2024-07-01
Completion Date: 2027-02-28
Locations: The First People's Hospital of Lianyungang, Lianyungang, Jiangsu, 222002, China

Summary:
To evaluate the efficacy and safety of SRT combined with anlotinib in the treatment of limited brain metastases from non-small cell lung cancer.

Primary Outcome Measures: intracerebral Progression-Free-Surviva（iPFS）, The time from the start of treatment to intracranial tumor progression or death for any reason

The time from the start of treatment to intracranial tumor progression or death for any reason

The time from the start of treatment to intracranial tumor progression or death for any reason, 20 months|intracerebral Objective Response Rate (iORR), The proportion of patients whose intracranial tumor volume has reduced to a predetermined value and can maintain the minimum time limit, 20 months
Secondary Outcome Measures: intracerebral Progression-Free-Survival rate at 6 months and 1 year, 12 months|Progression-Free-Survival（PFS）, 20 months|Objective Response Rate（ORR）, 20 months|intracerebral Disease Control Rate（iDCR）, 20 months|Disease Control Rate（DCR）, 20 months|Overall Survival（OS）, 20 months
Ultrasound Guided Serratus Anterior Versus Erector Spinae Block in Pain Alleviation in Acute Herpes Zoster
NCT Number: NCT06476080
Status: NOT_YET_RECRUITING
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Acute Herpes Zoster Neuropathy
Interventions: PROCEDURE: ultrasound guided erector spine block|PROCEDURE: Serratus anterior block
Sponsor: Minia University
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 120
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: DOUBLE (PARTICIPANT, OUTCOMES_ASSESSOR)|Primary Purpose: TREATMENT
Start Date: 2024-07-05
Completion Date: 2025-04-15

Summary:
Acute herpes zoster pain is very severe . Conventional analgesics may be of no value. Regional blocks may play a role

Primary Outcome Measures: pain score, Visual analogue scale from 0 to 10. 0= NO pain, 1-3=mild tolerable pain, 4-6= moderate pain, 7-10= severe untearable pain., immediate after injection, 1 week, 1, 3 months
Secondary Outcome Measures: Number of patients with pain recurrence, Number of patients in need for re-injection, 1 week, 1, and 3 months|analgesic consumption, total amount dose of analgesics used, 1 week, 1, and 3 months|Incidence of treatment related adverse events, hypotension, bradyarrhythmia, hematoma, immediately after injection
Predicting Early Tumor Recurrence in Patients With Esophageal Squamous Cell Carcinoma
NCT Number: NCT06476067
Status: RECRUITING
Study Type: OBSERVATIONAL
Conditions: Esophageal Cancer|Recurrence|DNA Methylation
Interventions: PROCEDURE: Surgery
Sponsor: City of Hope Medical Center
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 150
Study Design: Observational Model: |Time Perspective: p
Start Date: 2006-01-01
Completion Date: 2025-12-31
Locations: Nagoya University, Nagoya, Aichi, 4668560, Japan|Yamanashi Universiy, Chuo, Yamanashi, 4093898, Japan

Summary:
The prognosis of patients with esophageal squamous cell carcinoma (ESCC) who develop post-operative early tumor recurrence is often relatively poor. Therefore, biomarker that can detect micro metastases before the start of treatment is required. Epigenomic alterations such as DNA methylation have attracted attention as promising biomarkers. The investigators aim to predict early recurrence based on whole genome DNA methylation analysis of esophageal cancer.

Primary Outcome Measures: Recurrence-free Survival（RFS), Time from curative-intent resection to the development of recurrence (or death), Up to 60 months
Optimal Timing for Laparoscopic Cholecystectomy After Cholecystostomy in Acute Cholecystitis Tokyo II/III Setting
NCT Number: NCT06476054
Status: RECRUITING
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Cholecystitis, Acute
Interventions: PROCEDURE: Optimal timing for laparoscopic cholecystectomy
Sponsor: Hospital Arnau de Vilanova
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 146
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: SINGLE (OUTCOMES_ASSESSOR)|Primary Purpose: PREVENTION
Start Date: 2024-02-01
Completion Date: 2027-08-01
Locations: Hospital Universitari Arnau de Vilanova, Lleida, 25198, Spain

Summary:
Percutaneous drainage in acute cholecystitis has been recommended by the recent update of the Tokyo Guidelines for patients with grade II and III disease who are unable to undergo surgical treatment due to their condition or associated comorbidities.

There are no reports providing high-quality scientific evidence on the optimal timing for surgery after percutaneous transhepatic gallbladder drainage, so a consensus has not been reached. The grade III stage generates the most controversy; after percutaneous drainage, delaying the cholecystectomy can lead to new episodes of exacerbation during the waiting period or may limit the procedure to a specific group of patients with this pathology.

The economic impact, including the number of readmissions, increased length of stay, and associated morbidity and mortality, generates controversy regarding the subsequent therapeutic decisions after the medical management of cholecystitis in this special group of patients.

Primary Outcome Measures: recurrence tax of cholecystitis, % of recurrence of cholecystitis after cholecystostomy in acute cholecystitis, 6 months after cholecystostomy
Secondary Outcome Measures: Patient demographics, Data tracking related to patient demographics to evaluate if it affects to the recurrence tax. Age (years), BMI in kg/m\^2, Charlson and ASA classification., pre-operative and surgery day|Pre-operative patient comorbidities, Data tracking related to patient previous comorbidities to evaluate if it affects to the recurrence tax., pre-operative and surgery day|Collection of pre-operative patient treatment (includes antibiotic prophylaxis), Data tracking related to patient previous treatments or prophylaxis to evaluate if it affects to the recurrence tax., pre-operative and surgery day|Surgery details, Data tracking related to patient surgery issues to evaluate if it affects to the recurrence tax. Presence of: Technique difficulties, description of intra-operative complications., pre-operative and surgery day|Post-operative patient morbidity, Analysis of data related to morbidity according to the performed intervention.Clavien-Dindo classification., 30 and 90 days post-surgery|Post-operative patient mortality, Analysis of data related to mortality according to the performed intervention., 30 and 90 days post-surgery
Analysis of the Understanding of the French Version of the Vulvar Pain Assessment Questionnaire
NCT Number: NCT06476002
Acronym: VPAQ-Trad
Status: RECRUITING
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Vulvodynia
Interventions: OTHER: Questionnaire
Sponsor: Hopital Foch
Sex: FEMALE
Age: ADULT, OLDER_ADULT
Enrollment: 30
Study Design: Allocation: NA|Intervention Model: SINGLE_GROUP|Masking: NONE|Primary Purpose: OTHER
Start Date: 2024-05-06
Completion Date: 2024-08-06
Locations: Hopital Foch, Suresnes, 92150, France

Summary:
Prior to the current study, a translation into french of the screening version of the VPAQ (VPAQscreen) and its supplemental scales (VPAQdesc, VPAQcope, VPAQpartner) was performed according to the recommended process. The present study aims to evaluate the understanding of this translation on a panel of 30 women suffering from provoked or mixed vestibulodynia.

Primary Outcome Measures: understanding question, for each item of VPAQscreen (Vulvar Pain Assessment Questionnaire Screen) and the specific supplementary questionnaires (VPAQdesc, VPAQcope, VPAQpartner), answer to "Did you understand that question?", Day 1|understanding answer, for each item of VPAQscreen (Vulvar Pain Assessment Questionnaire Screen) and the specific supplementary questionnaires (VPAQdesc, VPAQcope, VPAQpartner), answer to "Did you understand the different possible answers?", Day 1|understanding, for each item of VPAQscreen (Vulvar Pain Assessment Questionnaire Screen) and the specific supplementary questionnaires (VPAQdesc, VPAQcope, VPAQpartner), answer to "Can you explain what went wrong?", Day 1
A Study of DM001 in Patients With Advanced Solid Tumors
NCT Number: NCT06475937
Status: NOT_YET_RECRUITING
Study Type: INTERVENTIONAL
Phases: PHASE1
Conditions: Breast Neoplasms|Carcinoma, Non-Small-Cell Lung|Solid Carcinoma
Interventions: DRUG: DM001
Sponsor: Xadcera Biopharmaceutical (Suzhou) Co., Ltd.
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 128
Study Design: Allocation: NA|Intervention Model: SINGLE_GROUP|Masking: NONE|Primary Purpose: TREATMENT
Start Date: 2024-08
Completion Date: 2027-02-13

Summary:
The goal of this clinical trial is to find out about the safety, efficacy, and tolerability of DM001 for patients with the advanced solid tumors. DM001 is an experimental drug which is not approved by health authorities for the treatment of advanced solid tumors.

Participants will have up to 17 visits during the study.There will be up to a 4-week Screening Period followed by a treatment period that will be divided into 3-week cycles/ Participants will have 5 study visits during Cycle 1, 3 visits during Cycles 2 and 3, and 1 visit during subsequent cycles. Participants will have an End of Treatment visit 21 days (+ 7 days) after last dose of study drug and then a follow-up visit 30 days (± 7 days) after the End of Treatment visit.

Primary Outcome Measures: Dose-limiting Toxicities (DLTs) of DM001, Incidence of DLTs of DM001 will be determined. A dose-limiting toxicity (DLT) was defined as grade 3 neurological toxicities (e.g. chemical meningitis) or other grade 4 toxicity., 12 months|Maximum tolerated dose (MTD) for DM001, The MTD of DM001 will be determined. The MTD was defined as the dose where 0/3 or 1/6 patients experienced a DLT with at least two patients encountering DLT at the higher dose., 12 months
Secondary Outcome Measures: Area under the plasma concentration-time curve (AUC(0-inf), ng*h/mL), Area under the plasma concentration-time curve from time zero extrapolated to infinity, calculated by linear up/log down trapezoidal summation., 12 months|Maximum (peak) plasma concentration (Cmax, ng/mL), Maximum concentration, obtained directly from the observed concentration versus time data., 12 months|Time to maximum (peak) concentration (Tmax, h), Time to Cmax, 12 months|Trough concentration (Ctrough, ng/mL), The lowest plasma concentration reached before the next dose., 12 months|Objective response rate (ORR), ORR is defined as the number of patients with at least a confirmed complete response (CR) or partial response (PR), based on the best objective response values while on treatment using RECIST version 1.1, 12 months
Impact of Peri-Operative Hyponatremia on Postoperative Outcomes in Major HPB Surgeries for Cancers
NCT Number: NCT06475911
Status: RECRUITING
Study Type: OBSERVATIONAL
Conditions: Carcinoma
Sponsor: Institute of Liver and Biliary Sciences, India
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 500
Study Design: Observational Model: |Time Perspective: p
Start Date: 2023-10-23
Completion Date: 2024-12-30
Locations: Institute of Liver and Biliary Sciences, New Delhi, Delhi, 110070, India

Summary:
The present study is being designed to study the impact and predictive nature of perioperative hyponatremia on post operative outcomes in patients undergoing Major HPB surgeries for cancers. Major hepatobiliary-pancreatic surgeries will be defined as follows-

* Pancreaticoduodenectomy,
* Hemihepatectomy or greater with or without caudate lobectomy
* Extrahepatic bile duct resection
* Extended cholecystectomy
* Distal Pancreatectomy with or without splenectomy The primary Objective of the study would be to compare post operative major morbidities and early mortality (\<90 day) in major HPB surgeries done for cancer patients with and without peri-operative hyponatremia. (\<135mmoL/L). Development of systemic complications and long term outcomes (overall survival and disease free survival) will also be evaluated.

It will be an observational study consisting of both, a retrospective arm and a prospective arm. All consecutive patients undergoing major HPB surgery from 2010 till 30th June 2024 will be included in the study.

Primary Outcome Measures: Post operative major morbidities and early mortality (<90 day)., Post operative major morbidities and early mortality (\<90 day) in major HPB surgeries done for cancer. in patients with and without peri-operative hyponatremia. (\<135mmoL/L)., Post operative day 90
Secondary Outcome Measures: Post operative Systemic complications., Post operative Systemic complications in patients with and without peri-operative hyponatremia., Post operative day 90|Overall Survival, Overall Survival defined as POD1 till death/last follow up in patients with and without peri-operative hyponatremia., Till 30th Sep 2024|Disease free survival, Disease free survival- Surgical resection till first detected recurrence of cancer or last follow-up without recurrence with and without peri-operative hyponatremia., Till 30th Sep 2024
Longitudinal Endpoint Assessment of Disease Burden in HD
NCT Number: NCT06475898
Acronym: LEAD-HD
Status: RECRUITING
Study Type: OBSERVATIONAL
Conditions: Huntington Disease
Sponsor: Huntington Study Group
Collaborators: University of Rochester Center for Health + Technology|Modality.AI, Inc|Neurotargeting LLC
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 600
Study Design: Observational Model: |Time Perspective: p
Start Date: 2024-06-25
Completion Date: 2026-12
Locations: Huntington Study Group, Rochester, New York, 14618, United States

Summary:
LEAD-HD is intended to collect and analyze self-reported health information from individuals with Huntington Disease (HD) or prodromal HD participating in a 24-month longitudinal natural history study using remote technologies.

Primary Outcome Measures: PRO natural history, Obtain PRO natural history data in HD., December 2026|Demographic characteristics, Identify demographic characteristics that are associated with faster or slower disease progression., December 2026|Assess the ability to consent and enroll, Assess the ability to consent and enroll participants in long-term longitudinal studies in HD using a direct-to-patient platform., December 2026
Effect of Baby Massage on Postnatal Maternal Attachment and Depression
NCT Number: NCT06475885
Status: COMPLETED
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Postpartum Period
Interventions: OTHER: Infant Massage Program
Sponsor: Gazi University
Sex: FEMALE
Age: CHILD, ADULT, OLDER_ADULT
Enrollment: 70
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: SINGLE (OUTCOMES_ASSESSOR)|Primary Purpose: PREVENTION
Start Date: 2022-12-25
Completion Date: 2023-06-18
Locations: Koru Hospital, Ankara, 06510, Turkey

Summary:
This study aims to examine the effects of providing infant massage training to mothers in the early postpartum period with the goal of preventing postpartum depression and enhancing maternal bonding.

Primary Outcome Measures: Edinburgh Postnatal Depression Scale, The Edinburgh Postnatal Depression Scale (EPDS) is a 10-item measure used as a screening tool to identify the risk of depression, but it is not intended for diagnostic purposes. Each question on the scale is scored from 0 to 3, with the maximum possible score being 30. The 1st, 2nd, and 4th questions are scored 0-1-2-3, while the 3rd, 5th, 6th, 7th, 8th, 9th, and 10th questions are scored 3-2-1-0. The cut-off point for the scale is 13, with scores of 13 and above indicating the presence of depression. In this study, the scale was administered to participants on the 14th and 45th days postpartum. The difference between the mean scores of the Edinburgh Postnatal Depression Scale in the experimental group and the mean scores in the control group was examined to determine if it is statistically significant (p\<0.05 indicates significance)., One month|Maternal Attachment Scale, The Maternal Attachment Inventory (MAI) is a unidimensional scale designed to measure the attachment between a mother and her baby. It consists of 26 items, each rated on a 4-point Likert scale ranging from "always" to "never." The scale is scored as follows: "Always = 4 points," "Frequently = 3 points," "Sometimes = 2 points," and "Never = 1 point." Higher total scores indicate higher levels of maternal attachment. The minimum possible score on the scale is 26, and the maximum possible score is 104. In this study, the scale was administered to participants on the 45th day postpartum. The difference between the mean scores of the Maternal Attachment Inventory in the experimental group and the mean scores in the control group was examined to determine if it is statistically significant (p\<0.05 indicates significance)., one day|he relationship between the Edinburgh Postnatal Depression Scale and Maternal Attachment Scale., The relationship between the mean scores of the Edinburgh Postnatal Depression Scale and the mean scores of the Maternal Attachment Scale administered to participants on the 45th day postpartum was examined to determine if it is statistically significant (p\<0.05 indicates significance)., one day
Study to Evaluate the Bioequivalence of "Crecheck Tablet 2.5 mg (Rosuvastatin Calcium)" and "Crestor Tablet 5 mg (Rosuvastatin Calcium)" in Healthy Adult Subjects
NCT Number: NCT06475872
Status: COMPLETED
Study Type: INTERVENTIONAL
Phases: PHASE1
Conditions: Primary Hypercholesterolemia|Combined Hyperlipidemia
Interventions: DRUG: Crecheck Tablet 2.5 mg|DRUG: Crestor Tablet 5 mg
Sponsor: Hanlim Pharm. Co., Ltd.
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 36
Study Design: Allocation: RANDOMIZED|Intervention Model: CROSSOVER|Masking: NONE|Primary Purpose: TREATMENT
Start Date: 2023-11-20
Completion Date: 2023-12-07
Locations: Seok Gyeong Medical Foundation Central Hospital, Gyeonggi-do, 15079, Korea, Republic of

Summary:
This clinical trial is an open, randomized, 2-group, 2-period, fasting, single-dose, crossover study to evaluate the bioequivalence of "Crecheck Tablet 2.5 mg (Rosuvastatin Calcium)" of Hanlim Pharm. Co., Ltd. and "Crestor Tablet 5 mg (Rosuvastatin Calcium)" of AstraZeneca Korea Co., Ltd. in healthy adult subjects.

Primary Outcome Measures: Area under the plasma concentration versus time curve (AUC), Concentration of rosuvastatin in plasma, 48 hours|Peak Plasma Concentration (Cmax), Concentration of rosuvastatin in plasma, 48 hours
Secondary Outcome Measures: Time to Maximum Plasma Concentration (Tmax), Concentration of rosuvastatin in plasma, 48 hours|Half Life (t1/2), Concentration of rosuvastatin in plasma, 48 hours|AUC∞, Concentration of rosuvastatin in plasma, 48 hours|AUCt/AUC∞(%), Concentration of rosuvastatin in plasma, 48 hours|Dissolution pattern by comparative dissolution test of Rosuvastatin, 48 hours
A Trial of HRS5580 in Prevention of Postoperative Nausea and Vomiting of Adults
NCT Number: NCT06475846
Status: NOT_YET_RECRUITING
Study Type: INTERVENTIONAL
Phases: PHASE2
Conditions: Preventing of Postoperative Nausea and Vomiting in Adults
Interventions: DRUG: HRS5580|DRUG: HRS5580|DRUG: HRS5580|DRUG: Ondansetron|DRUG: blank preparation
Sponsor: Fujian Shengdi Pharmaceutical Co., Ltd.
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 232
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: QUADRUPLE (PARTICIPANT, CARE_PROVIDER, INVESTIGATOR, OUTCOMES_ASSESSOR)|Primary Purpose: TREATMENT
Start Date: 2024-06
Completion Date: 2024-11
Locations: Beijing Friendship Hospital, Capital Medical University, Beijing, Beijing, 100050, China|Third Xiangya Hospital of Central South University, Changsha, Hunan, 410013, China

Summary:
The study is being conducted to evaluate the efficacy, and safety of HRS5580 for preventing of postoperative nausea and vomiting in adults. To explore the reasonable dosage of HRS5580 for postoperative nausea and vomiting.

Primary Outcome Measures: No vomiting rate within 72 hours after extubation, at 72 hours after extubation
Secondary Outcome Measures: Complete response rate (defined as the proportion of subjects without vomiting and receiving no rescue therapy) at 24, 48, 72, 96, and 120 hours after extubation, at24, 48, 72, 96, and 120 hours after extubation|No vomiting at 24, 48, 96, and 120 hours after extubation,, at 24, 48, 96, and 120 hours after extubation|Proportion of subjects who did not experience significant nausea within 24, 48, 72, 96, and 120 hours after extubation, at 24, 48, 72, 96, and 120 hours after extubation|Proportion of participants not receiving rescue medication within 24, 48, 72, 96, and 120 hours of extubation, at 24, 48, 72, 96, and 120 hours of extubation
Investigation of the Relationship Between Core Endurance and Awareness of Injury Prevention in Adolescent Basketball Players
NCT Number: NCT06475833
Status: NOT_YET_RECRUITING
Study Type: OBSERVATIONAL
Conditions: Sports Physical Therapy
Interventions: DIAGNOSTIC_TEST: Prone plank test, Side plank test, The Awareness of Sports Injuries Scales
Sponsor: Hacettepe University
Sex: ALL
Age: CHILD, ADULT
Enrollment: 50
Study Design: Observational Model: |Time Perspective: p
Start Date: 2024-06-30
Completion Date: 2024-08-30
Locations: Sakarya University of Applied Sciences, Sakarya, Akyazı, 54400, Turkey

Summary:
Injuries occurring during adolescence can lead to serious long-term problems. Such injuries can cause athletes to take breaks from their sports and physically strain themselves. Since athletes are in their adolescent period, the physiological development of the musculoskeletal system is ongoing. Awareness of injury prevention during this period is crucial. This study aims to investigate the relationship between core endurance and awareness of injury prevention in athletes. Objectively determining this relationship is important for providing support to protect athletes from injuries.

Primary Outcome Measures: The Awareness of Injury Prevention, To assess awareness of injury prevention, the Injury Prevention Awareness Scale will be conducted. The Sport Injury Prevention Awareness Scale is a measure with validated reliability and validity in Turkish. The 18-item four-factor (health status, environmental factors and equipment, exercise session, exercise program) Sports Injury Prevention Awareness Scale is valid and reliable for use with Turkish individuals aged 13-66 years., Baseline
Secondary Outcome Measures: Core endurance, To assess core endurance will be conduct prone bridge test and lateral plank test. Prone bridge test assess deep abdominal muscles. Lateral plank test assess side abdominal muscles. The prone bridge test, in the plank position, with the elbows under the shoulders and the body parallel to the ground, the athlete is asked to hold the position for as long as possible. In the lateral side plank test, the athlete is asked to hold the position with the elbow under the shoulder and the spine parallel to the ground for as long as possible., Baseline
Preventing of GVHD With Post-transplantation Cyclophosphamide, Abatacept, Vedolizumab and Baricitinib at Children and Young Adults With Hemoblastosis
NCT Number: NCT06475820
Status: ACTIVE_NOT_RECRUITING
Study Type: INTERVENTIONAL
Phases: PHASE2|PHASE3
Conditions: Acute Lymphoblastic Leukemia|Acute Myeloid Leukemia|Biphenotypic Acute Leukemia|Malignant Lymphoma|Myelodysplastic Syndromes
Interventions: DRUG: Baricitinib
Sponsor: Federal Research Institute of Pediatric Hematology, Oncology and Immunology
Sex: ALL
Age: CHILD, ADULT
Enrollment: 150
Study Design: Allocation: NA|Intervention Model: SINGLE_GROUP|Masking: NONE|Primary Purpose: TREATMENT
Start Date: 2023-12-01
Completion Date: 2027-04-01
Locations: Dmitry Rogachev National Medical Research Center Of Pediatric Hematology, Oncology and Immunology, Moscow, Samory-Mashela,1, 11198, Russian Federation

Summary:
GVHD prevention using a combination of post-transplantation cyclophosphamide in combination with abatacept, vedolizumab and and Baricitinib in children and young adults with hematoloblastosis after myeloablative conditioning regimen with treosulfan/TBI, cyclophosphamide/etoposide, fludarabine after HSCT from matched unrelated and haploidentical donors

Primary Outcome Measures: Estimate the probability of developing acute GVHD stage II-IV after HSCT, 100 days after HSCT|side effects of conditioning, Explore the safety based on an assessment of the frequency of occurrence of:

- severe (3-5 degrees) side effects of conditioning during 1 month, 100 days after HSCT|transplant-associated mortality, 100 days after HSCT
Secondary Outcome Measures: cumulative probability of relapse, Probability of developing a relapse of the primary disease, transplantation-associated mortality on the horizon of 100 days, after HSCT by day + 100|cumulative probability of relapse, Probability of developing a relapse of the primary disease, transplantation-associated mortality on the horizon up to 2 years, up to 2 years after HSCT|event-free survival, after HSCT by day + 100|event-free survival, up to 2 years after HSCT|Probability of engraftment of leukocyte, cumulative Probability of engraftment of leukocyte of donor origin, after HSCT by day + 100|Probability of engraftment of platelet, cumulative Probability of engraftment of platelet, after HSCT by day + 100|Probability of reactivation of CMV, cumulative Probability of reactivation CMV, 12 months after HSCT|Probability of reactivation of EBV, cumulative Probability of reactivation EBV, 12 months after HSCT|Probability of reactivation of AdV, cumulative Probability of reactivation ADV, 12 months after HSCT|Probability of reactivation BK, cumulative Probability of reactivation BK, 12 months after HSCT
Dietary Interventions in Cancer Patients Treated With Immune Checkpoint Inhibitors
NCT Number: NCT06475807
Status: NOT_YET_RECRUITING
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Cancer
Interventions: DIETARY_SUPPLEMENT: High-fermented food|DIETARY_SUPPLEMENT: High fiber supplementation
Sponsor: University of Pittsburgh
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 60
Study Design: Allocation: NA|Intervention Model: SINGLE_GROUP|Masking: NONE|Primary Purpose: SUPPORTIVE_CARE
Start Date: 2024-08
Completion Date: 2027-06
Locations: UPMC Hillman Cancer Center, Pittsburgh, Pennsylvania, 15232, United States

Summary:
This pilot trial will study the potential impact of two distinct dietary interventions with sequential use of high-fermented foods and high-fiber supplements on the gut microbiome and antitumor immunity in patients with melanoma and non-small cell lung cancer (NSCLC) treated with immune checkpoint inhibitors. The trial aims to understand how dietary changes affect the composition and function of the gut microbiome, together with immunological and metabolomic markers in serum in patients with melanoma and NSCLC who are undergoing standard-of-care treatment with neoadjuvant or adjuvant immune checkpoint inhibitors.

Primary Outcome Measures: Change in cell frequency of gut microbiota composition, Changes in gut microbiome diversity and function, evaluated with metagenomics, identify differentially abundant taxa and assess all genes in all organisms present in each fecal microbiota sample in pre- vs. post- each dietary using PERMANOVA. This will be measured as change of cell frequency and calculated as percentage change., Up to 14 weeks
Secondary Outcome Measures: Adverse Events and Serious Adverse Events, Incidence of anti-PD-1/PD-L1 therapy treatment-related grade 3 or more toxicities per CTCAE v5.0, Up to 14 weeks|Changes in cell frequency of circulating adaptive immune cells, Changes in the circulating adaptive and innate cells in the systemic circulation, evaluated with multiparameter flow cytometry, peripheral blood mononuclear cells will be used to evaluate cell frequency, phenotype, and function. This will be measured as change of cell frequency and calculated as percentage change., Up to 14 weeks