pankajmathur/National_Library_of_Medicine_Studies_data huggingface dataset:
Video-recOrded hospItal dischaRge (VOIR)
NCT Number: NCT06512272
Acronym: VOIR
Status: NOT_YET_RECRUITING
Study Type: INTERVENTIONAL
Phases: NA
Conditions: ALL, Adult
Interventions: OTHER: Video recorded shared using a mobile application
Sponsor: Anglia Ruskin University
Collaborators: Basildon and Thurrock Hospitals NHS FoundationTrust|Southend NHS Foundation Trust
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 60
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: NONE|Primary Purpose: OTHER
Start Date: 2024-08-01
Completion Date: 2024-10-31

Summary:
This study evaluates the suitability and acceptability of video-recorded discharge via the Patient Knows Best app. Through a randomized control trial, patients receive either standard discharge care or standard care supplemented with video-recorded discharge. Clinical teams record briefings covering medication and wound care, which patients can access multiple times on their smart devices. Patients and clinical staff complete questionnaires to assess acceptance and feasibility. Feasibility is determined by recruitment, retention, and completion rates, with patient engagement and viewing habits also analyzed. The study aims to enhance patient understanding and continuity of care through accessible discharge information.

Primary Outcome Measures: Acceptability of video-discharge, Questionnaire with close ended and open ended question based on validated questionnaire, 7 days and 30 days post-discharge
Secondary Outcome Measures: Patient satisfaction, Brief questionnaire on patient satisfaction, 7 and 30 days post discharge|Care of Transitions, Three questions measuring validated tool, 7 and 30 days post discharge|Staff satisfaction of video recorded discharge, Close and opened questionnaire, within 7 days of post-discharge experience
AlloMend Acellular Dermal Matrix Allograft in Pre-Pectoral Breast Reconstruction
NCT Number: NCT06512259
Status: RECRUITING
Study Type: OBSERVATIONAL
Conditions: Pre-Pectoral Breast Reconstruction Following Single or Double Mastectomy
Interventions: OTHER: AlloMend® Acellular Dermal Matrix allograft
Sponsor: AlloSource
Sex: FEMALE
Age: ADULT, OLDER_ADULT
Enrollment: 200
Study Design: Observational Model: |Time Perspective: p
Start Date: 2023-10-19
Completion Date: 2024-12-31
Locations: Alan H. Chen Surgical Associates, PC, Joliet, Illinois, 60435, United States

Summary:
This is a single-center, retrospective study which will be used to describe and evaluate the effectiveness of AlloMend® Acellular Dermal Matrix allograft for patients that have undergone Pre-Pectoral Breast Reconstruction surgery following a single or double mastectomy.

Primary Outcome Measures: Descriptive Data Collection, The primary objective is to obtain descriptive data and surgical intervention and post operative surgical outcome data on AlloMend® Acellular Dermal Matrix allograft for patients that have undergone Pre-Pectoral Breast Reconstruction surgery following a single or double mastectomy., Up to 6- months post-operatively
Secondary Outcome Measures: Physical Function and Quality of Life, Secondary Objectives will identify changes in physical function and quality of life as assessed for a period of 6-months post-operatively., Up to 6- months post-operatively
Other Outcome Measures: Qualitative Data, Qualitative data such as return to wound healing, pain, discomfort, physicial deformity, and revision surgeries will also be collected., Up to 6- months post-operatively
Failure Factors of ERCP After Gastrointestinal Reconstruction and Effectiveness Analysis of Remedial Measures
NCT Number: NCT06512246
Status: COMPLETED
Study Type: OBSERVATIONAL
Conditions: Endoscopic Retrograde Cholangiopancreatography
Sponsor: Beijing Friendship Hospital
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 195
Study Design: Observational Model: |Time Perspective: p
Start Date: 2024-04-01
Completion Date: 2024-07-01
Locations: Beijing Friendship Hospital, Beijing, Beijing, 100050, China

Summary:
This is a retrospective study, including 195 patients with gastrointestinal reconstruction, who treated with Endoscopic Retrograde Cholangiopancreatography (ERCP) at Beijing friendship hospital. The investigators assessed the outcomes of failure factors of ERCP and effectiveness of remedial measures.

Primary Outcome Measures: Rate of Reaching Duodenal Papilla, successfully reaching duodenal papilla during the endoscopic procedure, during the operation
Secondary Outcome Measures: Successful Intubation Rate, successful intubation during the ERCP procedure, during the operation|Successful Endoscopic Treatment Rate, successful endoscopic treatment during the ERCP procedure, during the operation|Effective Rate of Remedial Measures, remedial measures successfully relief symptom, during the operation|ERCP-related complication rate, The complications include pancreatitis, hemorrhage, perforation, pneumonia, etc. The results of intraoperative endoscopic observation, postoperative symptoms and signs, blood routine examination, amylase, lipase, and imaging and endoscopic examination were measured., during the operation
Heparin Alone vs. Heparin-Aspirin Combo in Free Flap Survival
NCT Number: NCT06512233
Status: NOT_YET_RECRUITING
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Complication,Postoperative
Interventions: DRUG: LMW Heparin 5000 U/ML-Aspirin 75 MG|DRUG: LMW Heparin 5000 U/ML
Sponsor: Aga Khan University
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 126
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: SINGLE (OUTCOMES_ASSESSOR)|Primary Purpose: TREATMENT
Start Date: 2025-01
Completion Date: 2025-12
Locations: Aga Khan University, Karachi, Sindh, 72000, Pakistan

Summary:
This randomized clinical trial aims to compare the effectiveness of heparin alone versus combination therapy of Heparin- Aspirin in improving free flap survival in patients undergoing reconstructive surgery. Participants will be randomly assigned to receive either heparin or a combination therapy, and the primary outcome measure will be the survival rate of the free flap at various time points post-surgery

Primary Outcome Measures: Free Flap Survival Rate, Percentage of patients with successful survival of the free flap grafts at specified time points post-surgery, two hourly for 1st 24 hours and then three hourly for next 48 hours and four hourly for next 72 hours and onwards.
Secondary Outcome Measures: flap thrombosis, bleeding complications, re-operation in free flap surgeries and overall patient outcomes in both groups, Number of participants experiencing complications requiring medical or surgical intervention within the first 30 days post-surgery., 30 days post-surgery
Imaging the Effects of Serotonin 2A Receptor Modulation on Synaptic Density in Treatment-resistant Depression (SYNVEST)
NCT Number: NCT06512220
Acronym: SYNVEST
Status: NOT_YET_RECRUITING
Study Type: INTERVENTIONAL
Phases: PHASE2
Conditions: Treatment Resistant Depression
Interventions: DRUG: Psilocybin 25 mg|DRUG: Risperidone 1 MG
Sponsor: Centre for Addiction and Mental Health
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 12
Study Design: Allocation: NON_RANDOMIZED|Intervention Model: SEQUENTIAL|Masking: NONE|Primary Purpose: TREATMENT
Start Date: 2024-08
Completion Date: 2026-08
Locations: Centre for Addiction and Mental Health, Toronto, Ontario, M6J1H4, Canada

Summary:
Limit: 5000 characters. Psilocybin, the chemical component of "magic mushrooms", has been administered with psychotherapy in several randomized clinical trials (RCTs) showing large and sustained antidepressant effects. In healthy volunteers, the psychedelic effects of psilocybin have been shown to be blocked by administration of certain medications such as risperidone.

The purpose of this study is to use an established SV2A radiotracer produced at our Centre to determine the feasibility of integrating PET imaging in to psilocybin trials. The preliminary imaging data will assess whether psilocybin's antidepressant effects are related to changes in synaptic density in adults with TRD, and whether any changes in synaptic density are associated with psilocybin's actions on the 5-HT2AR.

Primary Outcome Measures: Feasibility of obtaining PET imaging scans before and after administration of psilocybin (25 mg) with and without risperidone (1 mg)., Percentage of participants recruited, enrolled, and retained., 24 Months
Secondary Outcome Measures: Obtain preliminary data on synaptic density (as measured by [18F] SynVesT-1 volume distribution, VT) in brain regions relevant to MDD (i.e., hippocampus, prefrontal cortex), as measured by \[18F\] SynVesT-1 volume distribution, VT, Before and 4 weeks after administration of psilocybin 25 mg with and without risperidone 1 mg
Other Outcome Measures: Change in the Montgomery-Åsberg Depression Rating Scale (MADRS) from Baseline to 1-week post-treatment., The Montgomery-Åsberg Depression Rating Scale (MADRS) is a 10-item clinician-rated scale that measures depression severity. Each item can be scored from 0-6. The minimum assessment score is 0 and the maximum score is 60. Higher composite scores represent a more severe condition., Baseline (Visit 2, Day 0) to 1-week post-treatment (Visit 4, Day 7).
Uterine Preservation in the Management of Placenta Accreta Spectrum Disorders
NCT Number: NCT06512181
Acronym: U-PRESERVE
Status: NOT_YET_RECRUITING
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Placenta Accreta Spectrum
Interventions: OTHER: Conservative/Expectant Management
Sponsor: University of Pennsylvania
Sex: FEMALE
Age: ADULT, OLDER_ADULT
Enrollment: 15
Study Design: Allocation: NA|Intervention Model: SINGLE_GROUP|Masking: NONE|Primary Purpose: TREATMENT
Start Date: 2024-09-01
Completion Date: 2030-12-31
Locations: Hospital of the University of Pennsylvania, Philadelphia, Pennsylvania, 19104, United States

Summary:
This study for the conservative management of placenta accreta spectrum disorders (PAS), which are a major cause of maternal morbidity and mortality. The most common management strategy for PAS in the United States is a preterm cesarean-hysterectomy. However, accumulating data show that conservative management is safer and is preferred by some patients. In selected participants (n=15) who desire uterine preservation, the investigators provide the option of conservative management, which will be defined as leaving the placenta in the uterus after delivery of the infant. This is a single-arm single-site pilot study where all participants will be carefully monitored during a standard postpartum inpatient stay and with outpatient follow-up until the uterus is empty.

Primary Outcome Measures: Hysterectomy rate, Percent of participants who undergo a hysterectomy, Delivery through 1 year
Secondary Outcome Measures: Endometritis rate, Percent of participants who have endometritis, Delivery through 1 year|Coagulopathy rate, Percent of participants who have coagulopathy, Delivery through 1 year|Frequency of vaginal bleeding, Percent of participants with vaginal bleeding at each time point, Delivery through 1 year|Frequency of pelvic pain, Percent of participants with pelvic pain at each time point, Delivery through 1 year
Measuring Aided Language Development
NCT Number: NCT06512168
Acronym: MALD
Status: NOT_YET_RECRUITING
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Down Syndrome|Cerebral Palsy|Apraxia of Speech|Speech Sound Disorder|Speech Disorders in Children|Speech and Language Disorder
Interventions: BEHAVIORAL: AAC Generative Language Intervention
Sponsor: University of Central Florida
Collaborators: National Institute on Deafness and Other Communication Disorders (NIDCD)|University of New Mexico|University of Wisconsin, Milwaukee
Sex: ALL
Age: CHILD
Enrollment: 60
Study Design: Allocation: NA|Intervention Model: SINGLE_GROUP|Masking: NONE|Primary Purpose: DIAGNOSTIC
Start Date: 2024-11-01
Completion Date: 2028-03-31

Summary:
The focus of the current study is to systematically investigate the psychometric properties of a range of aided language measures, which are based on the Graphic Symbol Utterance and Sentence Development Framework (Binger \& Kent-Walsh).

Primary Outcome Measures: Aided AAC Utterance Length, Aided AAC Sentence Length Measured in Morphemes, 24 Months
Using Artificial Intelligence for the Detection of Respiratory Diseases Associated With Pollution
NCT Number: NCT06512142
Acronym: SmartLungs
Status: ENROLLING_BY_INVITATION
Study Type: OBSERVATIONAL
Conditions: COPD Asthma|Lung Neoplasm|Emphysema
Sponsor: University of Medicine and Pharmacy "Victor Babes" Timisoara
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 30000
Study Design: Observational Model: |Time Perspective: p
Start Date: 2023-11-01
Completion Date: 2025-03-31
Locations: "Victor Babes" University Hospital, Timisoara, Timis, Romania

Summary:
Generating a picture at the city level, through geospatial and temporal grouping a lung diseases associated or exacerbated by pollution (COPD, AB and neoplasm pulmonary or pleural) and correlating this data with pollution data.

Development of an accurate and prognostic HRCT imaging diagnostic tool, computer assisted in the mentioned pathology, by generating an algorithm capable of to detect early the follow-up tomographic imaging lesions, as well as to evaluate objective their speed of evolution.

Validation of the proposed algorithm by comparison with medical diagnosis.

Primary Outcome Measures: Correlation between lung diseases and pollution, Establishing the relationship between the incidence and exacerbation of lung diseases (COPD, acute bronchitis, and pulmonary or pleural neoplasms) and pollution levels through geospatial and temporal analysis at the city /county level, December 2023 - December 2024|Development of a diagnostic algorithm, Creating an accurate, computer-assisted HRCT imaging diagnostic tool designed to detect early tomographic lesions and evaluate the progression speed of these lesions in patients with the mentioned pathologies., September 2024 - March 2024
Defining Volume Status in Sepsis With Extracellular Water Measurement.
NCT Number: NCT06512129
Status: NOT_YET_RECRUITING
Study Type: OBSERVATIONAL
Conditions: Sepsis
Sponsor: Uppsala University
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 20
Study Design: Observational Model: |Time Perspective: p
Start Date: 2024-09-01
Completion Date: 2026-12-01

Summary:
The goal of this observational study is to learn about the influence of extracellular water on volume status in adult sepsis patients presenting with hemodynamic instability. The main question it aims to answer is:

• Can measurement of extracellular water contribute to the description of hemodynamic instability in adult sepsis patients.

Patients with sepsis admitted to intensive care will receive standard care with the addition of measurement of extracellular water.

Primary Outcome Measures: Phenotypes in sepsis - extracellular water for volume status characterization., Can measurement of extracellular water contribute to the description of hemodynamic instability in adult sepsis patients during the first 72 hours?, 2 years
A Clinical Trial of SIBP-A17 Injection in the Treatment of Advanced Solid Tumor Patients.
NCT Number: NCT06512116
Status: NOT_YET_RECRUITING
Study Type: INTERVENTIONAL
Phases: PHASE1
Conditions: Advanced Solid Tumor
Interventions: DRUG: SIBP-A17
Sponsor: Shanghai Institute Of Biological Products
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 196
Study Design: Allocation: NA|Intervention Model: SINGLE_GROUP|Masking: NONE|Primary Purpose: TREATMENT
Start Date: 2024-07-30
Completion Date: 2025-12-30

Summary:
To evaluate the safety, tolerability, and pharmacokinetic characteristics of SIBP-A17 and determine the maximum tolerable dose (MTD) and phase II recommended dose (RP2D).

Primary Outcome Measures: Dose limiting toxicity (DLT), During the dose escalation phase, the first treatment cycle (21 days after the first dose) after the subject's administration was determined by the investigator to have occurred events related to the investigational drug as specified in the protocol., Day 126|Maximum tolerated dose (MTD), The maximum tolerated dose (MTD) refers to the highest dose at which DLT does not occur in \<1/3 of subjects or ≤ 1/6 of subjects during the DLT observation period., Day 260|Recommended Phase II Dose (RP2D), Recommended Phase II Dose The optimal dose for phase II clinical trial research obtained based on clinical trial results of phase I and literature review., Day 518|Adverse Events (AE), That is adverse events, any adverse events that occurred to the participant during the study period., 28 days
Secondary Outcome Measures: AUC (Area Under The Plasma Concentration Versus Time Curve), It shows the degree to which a drug is absorbed and used in the body., 15 days|Cmax (Peak Plasma Concentration), It shows the highest plasma concentration of a drug that can be achieved after administration., 15 days|ORR(Objective Response Rate), The proportion of participants whose tumor volume shrinks to a predetermined value and maintains the minimum time limit and is the sum of complete and partial responses., 5 months|DCR (Disease control rate), In clinical trials, the percentage of participants with advanced or metastatic cancer who responded fully to cancer treatment, partially responded, and had stable disease., 5 months|PFS(Progression-free survival), The time between the onset of randomization and the onset (of any aspect) of tumor progression or death (from any cause)., 5 months|OS (overall survival), From randomization to time of death due to any cause., 5 months|Δ QTcF, Changes in Δ QTcF (post administration QTcF baseline QTcF) at various time points after administration., 15 days
Sclerostin Regulation in Apical Periodontitis Lesions in Apical Periodontitis Lesions
NCT Number: NCT06512103
Status: COMPLETED
Study Type: OBSERVATIONAL
Conditions: Apical Periodontitis
Interventions: DIAGNOSTIC_TEST: Apical periodontitis group
Sponsor: Istanbul Medipol University Hospital
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 125
Study Design: Observational Model: |Time Perspective: p
Start Date: 2023-08-01
Completion Date: 2024-01-31
Locations: Istanbul Medipol University, Faculty of Dentistry, Istanbul, Turkey

Summary:
Our aim was to examine the relationship between inflammatory bone resorption associated with the severity of AP and gingival crevicular fluid (GCF) and blood sclerostin and PGE2 levels in cases of AP. Additionally, the correlation of sclerostin regulation with RANKL and MMP-9 levels will be investigated.This single-centered cross-sectional analytical study included 90 patients with AP and 35 systemically and orally healthy volunteers as the control group, who applied for a control examination between September 2023 and February 2024. Demographic characteristics of the patients (age, body mass index (BMI) and oral hygiene index (OHI)) and dental examination findings (periapical index (PAI) score, root canal treatment, number of crowns, fillings and missing teeth, etc.) were recorded. According to the PAI score, the participants were divided into three groups: 35 healthy patients with a PAI score of 1-2 (Group 1: Control group), 35 patients with a PAI score of 3-4 (Group 2: mild-moderate AP), and 55 patients having at least one tooth with PAI score of 5, characterized by more severe bone resorption (Group 3: Severe AP). Sclerostin, RANKL and MMP-9 levels were measured in serum and GCF of all participants.

Primary Outcome Measures: levels of sclerostin, RANKL, MMP-9 and PGE2 in gingival crevicular fluid, correlation between periapical radiolucency and GCF levels will be evaluated, baseline
Secondary Outcome Measures: levels of sclerostin, RANKL, MMP-9 and PGE2 in serum, correlation between periapical radiolucency and serum levels will be evaluated, baseline
Effects of LGI Steam Bread on Glycemia Control in T2DM in China
NCT Number: NCT06512090
Status: NOT_YET_RECRUITING
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Diabete Type 2
Interventions: DIETARY_SUPPLEMENT: LGI steam bread|DIETARY_SUPPLEMENT: Diabetic diet
Sponsor: Shanghai Punan Hospital of Pudong New District
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 144
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: NONE|Primary Purpose: TREATMENT
Start Date: 2024-07-13
Completion Date: 2025-02-28

Summary:
This was a single-center, randomized, open, prospective, parallel-controlled, head-to-head comparison trial. To investigate the effects of low glycemic index（LGI）related steam bread on glycemic control，islet function in patients with type 2 diabetes.

Primary Outcome Measures: glucose at 120 mins, the blood glucose level at 120 mins after Standard meal test, 120 minutes
Secondary Outcome Measures: glucose at 60 mins, The blood glucose at 60 mins after standard meal test, 60 minutes|iAUC 120 minutes, 120-minute Area under the Curve (iAUC), 120 minutes
Clinical Validation of mμSORS for Non-invasive Blood Glucose Detection in Non-diabetic Subjects
NCT Number: NCT06512077
Status: NOT_YET_RECRUITING
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Diabetes Mellitus
Interventions: DEVICE: Multi-channel Microspatial Offset Raman Scattering Spectroscopy (mμSORS) for Noninvasive Blood Glucose Detection
Sponsor: Shanghai Jiao Tong University School of Medicine
Collaborators: Shanghai Photonic View Technology Co., Ltd.
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 34
Study Design: Allocation: NA|Intervention Model: SINGLE_GROUP|Masking: NONE|Primary Purpose: DIAGNOSTIC
Start Date: 2024-07-20
Completion Date: 2024-09-15

Summary:
This is a single-center, open-label, prospective study. Blood glucose is measured at different time points during oral glucose tolerance test and hypoglucose clamp test in healthy subjects, using both venous plasma and multi-channel microspatial offset Raman scattering spectroscopy (mμSORS). Venous plasma glucose was set as gold standard. The two measurements were collected synchronously so as to calculate the mean absolute relative difference (MARD) and the consensus error grid (CEG). Accuracy of non-invasive blood glucose testing by mμSORS will be in-depth validated specifically in the 3-10 mmol/l glucose range.

Primary Outcome Measures: Mean absolute relative deviation (MARD) of venous plasma glucose and glucose values measured by mμSORS at each time point of OGTT and hypoglucose clamp tests., Glucose will be measured using both intravenous sampling (plasma) and multi-channel microspatial offset Raman scattering spectroscopy (mμSORS) detection synchronously., 2 months|Consensus Error Grid (CEG) for venous plasma glucose and glucose values measured by mμSORS at each time point of OGTT and hypoglucose clamp tests., Glucose will be measured using both intravenous sampling (plasma) and multi-channel microspatial offset Raman scattering spectroscopy (mμSORS) detection synchronously., 2 months
Secondary Outcome Measures: MARD for two measurement methods in different blood glucose ranges., Plasma glucose ranges 3.9-10.0 mmol/L and \<3.9 mmol/L., 2 months|Incidence of Treatment-Emergent Adverse Events., Safety outcomes., 2 months
A Trial of SHR-A2102 With Adebrelimab With or Without Other Antitumor Therapy in Advanced or Metastatic Non-small Cell Lung Cancer
NCT Number: NCT06512051
Status: RECRUITING
Study Type: INTERVENTIONAL
Phases: PHASE1|PHASE2
Conditions: Advanced or Metastatic Non-small Cell Lung Cancer
Interventions: DRUG: SHR-A2102；Adebrelimab；Cisplatin/ Carboplatin
Sponsor: Shanghai Hengrui Pharmaceutical Co., Ltd.
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 248
Study Design: Allocation: NA|Intervention Model: SINGLE_GROUP|Masking: NONE|Primary Purpose: TREATMENT
Start Date: 2024-07-30
Completion Date: 2026-10
Locations: Chinese People's Liberation Army General Hospital, Beijing, Beijing, China

Summary:
The study is being conducted to evaluate the safety, tolerability and efficacy of SHR-A2102 with Adebrelimab with or without other Antitumor Therapy in Advanced or Metastatic Non-small cell lung Cancer.

To explore the reasonable dosage of SHR-A2102 for Advanced or Metastatic Non-small cell lung Cancer

Primary Outcome Measures: RP2D, RP2D will be determined on the basis of evaluation on safety, PK, efficacy data in Phase IB stages；, through phase IB completion, an average of 1 years|Incidence and severity of AE(DLT), According to NCI-CTCAE v5.0 evaluation criteria from Day 1 to 90 days after last dose；, from Day1 to 90 days after last dose|ORR, efficacy was assessed every 6 weeks within 48 weeks and every 9 weeks after 48 weeks s as determined by RECIST1.1, 18 months after the last subject was enrolled in the group
Secondary Outcome Measures: DCR, Since C1D1 every 6 weeks within 48 weeks and every 9 weeks after 48 weeks, and the proportion of subjects whose best response was PR or CR or SD as determined by RECIST1.1；, 18 months after the last subject was enrolled in the group|DOR, Since C1D1 every 6 weeks within 48 weeks and every 9 weeks after 48 weeks, and the proportion of subjects whose best response was PR or CR or SD as determined by RECIST1.1；, 18 months after the last subject was enrolled in the group|PFS(Investigator evaluation), Since C1D1 every 6 weeks within 48 weeks and every 9 weeks after 48 weeks, and the proportion of subjects whose best response was PR or CR or SD as determined by RECIST1.1；, 18 months after the last subject was enrolled in the group|OS(Investigator evaluation), Since C1D1 and death from any cause；, 18 months after the last subject was enrolled in the group
The Use of DXA in Scoliosis
NCT Number: NCT06512038
Status: RECRUITING
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Scoliosis Idiopathic
Interventions: RADIATION: DEXA Scan
Sponsor: Sheffield Children's NHS Foundation Trust
Collaborators: University of Sheffield
Sex: ALL
Age: CHILD
Enrollment: 20
Study Design: Allocation: NA|Intervention Model: SINGLE_GROUP|Masking: NONE|Primary Purpose: BASIC_SCIENCE
Start Date: 2024-05-08
Completion Date: 2025-05-31
Locations: Sheffield Children's NHS Foundation Trust, Sheffield, S10 2TH, United Kingdom

Summary:
This is a pilot study to look at image quality of iDXA AP supine spinal images to see if the investigators can accurately measure the size of the curve from iDXA images and to see how patients with scoliosis feel about iDXA imaging compared to normal x-rays. With normal x-rays being taken standing (or sitting if patients are in a wheelchair), it is important that the investigators understand how the lying down images compare to the standing images. Where there may be some clinical benefit, images will be taken standing (normal x-rays) and lying down (iDXA images). The investigators will see if the addition of iDXA images can help in brace design and brace monitoring.

Primary Outcome Measures: Radiation Dosage, DXA in comparison to X-Ray, Through study completion, an average of 6 months|Patient Satisfaction Questionnaire about the use of DXA in Scoliosis, This will be self reported questionnaire completed by patients. They will use a simple pictorial scale to report about their experiences having both a DXA and X-ray. The Scale ranges from 'Very Uncomfortable/ very unacceptable', 'Uncomfortable / unacceptable' to 'Okay'., through study completion, an average of 6 months|DXA Image Quality, Image quality as judged by 2 spinal surgeons and a consultant radiologist on a 4 point scale as:

1. Excellent - almost as good as an x-ray
2. Good - Good quality and easily able to see required anatomical landmarks for measurement
3. Adequate - Poor quality but just able to see required anatomical landmarks for measurement
4. Poor - Unable to see required anatomical landmarks for measurement, Through study completion, an average of 6 months|Imaging Angles, Cobb angle, apical vertebral translation and apical vertebral rotation will be measured from the x-rays and DXA scans for all the curves, Through study completion, an average of 6 months|Beighton Score for joint flexibility, Beighton score (flexibility) will be recorded by a clinician for all the patients with idiopathic scoliosis. The score will evaluate each patient's:

* Passive dorsiflexion and hyperextension of the fifth MCP joint beyond 90°
* Passive apposition of the thumb to the flexor aspect of the forearm
* Passive hyperextension of the elbow beyond 10°
* Passive hyperextension of the knee beyond 10°
* Active forward flexion of the trunk with the knees fully extended so that the palms of the hands rest flat on the floor, Through study completion, an average of 6 months
Technology-Assisted Yoga and Exercise on Neuropathy and Pain in Children With Leukemia
NCT Number: NCT06512012
Acronym: yogaCIPN
Status: COMPLETED
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Leukemia|Children With Cancer|Yoga Therapy|Excercise|Neuropathy;Peripheral|Pain
Interventions: BEHAVIORAL: yoga and exercise
Sponsor: Dokuz Eylul University
Sex: ALL
Age: CHILD, ADULT
Enrollment: 27
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: NONE|Primary Purpose: SUPPORTIVE_CARE
Start Date: 2021-10-30
Completion Date: 2024-06-30
Locations: Gülçin Özalp Gerçeker, İzmir, 35100, Turkey

Summary:
The study was planned to examine the effects of technology-supported yoga and exercise on chemotherapy-induced peripheral neuropathy and pain in children aged 5-18 years with leukemia.

Primary Outcome Measures: Pediatric Modified Total Neuropathy Scale and Total Neuropathy Score-Pediatric Vincristine (TNS-PV) for peripheral neuropathy, Pediatric Modified Total Neuropathy Scale and Total Neuropathy Score-Pediatric Vincristine (TNS-PV) assessment tools will be used. They determine Chemotherapy-induced Peripheral Neuropathy and its severity in children receiving cancer treatment. Each category is scored between 0-4. The highest 32 points are obtained from the scale. The higher the score, the worse the neuropathy. TNS-PV is based on adding constipation and hoarseness to the Pediatric Modified Total Neuropathy Scale., during 6 months (at the beginning of the study, 3rd month and 6th month)|Adolescent Pediatric Pain Scale for pain, Adolescent Pediatric Pain Scale: This scale consists of three independent parts;

1. body outline diagram where the child/adolescent can mark the location of the pain

   \*Assessment: The child can mark the anterior and posterior sides-upper extremity, lower extremity, head, neck, abdomen, chest, shoulder, back... so that the location and number of the pain area is evaluated
2. 10 cm long, where the pain can mark the severity as "no pain, mild pain, moderate pain, very pain and worst pain possible" word chart scale

   \* Evaluation: With a scale of 0-10 cm, the pain is evaluated by the child between 0-10 and the pain is defined as "no pain, mild pain, moderate pain, very pain".

   and defines its intensity by choosing one of the "worst pain possible"
3. word list under 4 dimensions (sensory, emotional, evaluative, time) to indicate the nature of pain., during 6 months (at the beginning of the study, 3rd month and 6th month)
Secondary Outcome Measures: Pediatric Symptom Screening Scale for chemotherapy related symptoms, Pediatric Symptom Screening Scale: It was developed to evaluate the symptoms experienced by children. The scale consists of a total of 15 items and is Likert type.

The scale score ranges from 0 to 60. The overall score increases as the symptoms worsen., during 6 months (at the beginning of the study, 3rd month and 6th month)
M-I/E for Preventing VAP in Post-neurosurgical Patients
NCT Number: NCT06511986
Status: RECRUITING
Study Type: OBSERVATIONAL
Conditions: Ventilator Associated Pneumonia|Brain Injuries|Mechanical Insufflation-exsufflation
Sponsor: Beijing Sanbo Brain Hospital
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 210
Study Design: Observational Model: |Time Perspective: p
Start Date: 2024-03-04
Completion Date: 2024-12-27
Locations: Beijing Sanbo Brain Hospital, Capital Medical University, Beijing, Beijing, 100090, China

Summary:
Ventilator-associated pneumonia (VAP) is a common infection in critically ill patients, especially those with acute brain injuries, leading to increased mortality and longer ICU stays.

The mechanical insufflation/exsufflation (M-I/E) cough assist device improves outcomes in patients with neuromuscular disorders but its effects on brain-injured patients are largely unknown.

This study is conducted at a tertiary neurosurgical medical center and consists of two substudies. The prospective physiological study assessed the impact of M-I/E on hemodynamics and ICP in mechanically ventilated neurosurgical patients. The combined retrospective-prospective clinical study was performed to investigate the efficacy of M-I/E on occurence of VAP and other clinical outcomes.

Primary Outcome Measures: Mean blood pressure, In study one, mean blood pressure will be recorded during the incremental pressure changes in the study one, during the process of physiological study, up to 2 hours|Heart rate, In study one, heart rate will be recorded during the incremental pressure changes in the study one, During the process of physiological study, up to 2 hours|Rate of ventilator associated pneumonia, In study two, ventilator associated pneumonia is defined as pneumonia occurring in patients who have been mechanically ventilated for at least 48 hours. Pneumonia was diagnosed by clinical features (e.g., cough, fever, pleuritic chest pain) and by lung imaging. To derived the diagnosis of pneumonia, patient electronical record, lab results, and images were extracted from the electronical system., Within 7 days after the onset of mechanical of ventilation
Secondary Outcome Measures: Intracranial pressure, In study one, intracranial pressure will be recorded during the incremental pressure changes in the study one, During the process of physiological study, up to 2 hours|Length of stay in ICU, Days of ICU Stay, Patients will be followed up until 28 days after surgery, discharged from hospital or dead, which ever came first,through study completion, an average of 1 year|Length of hospital stay, Days of hospital stay, Patients will be followed up until 28 days after surgery, discharged from hospital or dead, which ever came firstthrough study completion, an average of 1 year|Days of receiving mechanical ventilation, The duration from the start of mechanical ventilation to the weaning off from ventilator, Patients will be followed up until 28 days after surgery, discharged from hospital or dead, which ever came firstthrough study completion, an average of 1 year
Feasibility of the BrainGate2 Neural Interface System in Persons With Tetraplegia (BG-Tablet-01)
NCT Number: NCT06511934
Acronym: BG-Tablet-01
Status: RECRUITING
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Brainstem Stroke|ALS|Tetraplegia|Spinal Cord Injuries|Cervical Spinal Cord Injury
Interventions: DEVICE: BrainGate Neural Interface System
Sponsor: Leigh R. Hochberg, MD, PhD.
Collaborators: Brown University|Stanford University|National Institute on Deafness and Other Communication Disorders (NIDCD)
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 2
Study Design: Allocation: NA|Intervention Model: SINGLE_GROUP|Masking: NONE|Primary Purpose: DEVICE_FEASIBILITY
Start Date: 2024-08-01
Completion Date: 2026-07-30
Locations: Masssachusetts General Hospital, Boston, Massachusetts, 02114, United States

Summary:
People with brainstem stroke, advanced amyotrophic lateral sclerosis (ALS, also known as Lou Gehrig's disease), or other disorders can become unable to move or speak despite being awake and alert. In this project, the investigators seek to further translate knowledge about interpreting brain signals related to movement, and to further develop an intracortical brain-computer interface (iBCI) that could restore rapid and intuitive use of communication apps on tablet computers by people with paralysis.

Primary Outcome Measures: Sensor implant duration for at least one-year without any device-related Serious Adverse Events or explant, To determine the safety of the Sensor and overall safety of the System. Participants will be considered a success for this safety measure if they are successfully implanted with the Sensor(s) and:

1. the sensors are not explanted for safety reasons during the one-year post-implant evaluation period.
2. there are no device-related Serious Adverse Events that result in death or permanently increased disability during the one-year post-implant evaluation period., 1 year
Effect of Biologic Therapy on Surgical Outcomes for Perforated Crohn's Patients
NCT Number: NCT06511921
Status: ACTIVE_NOT_RECRUITING
Study Type: INTERVENTIONAL
Phases: EARLY_PHASE1
Conditions: Crohn Disease
Interventions: BIOLOGICAL: early biologic therapy|BIOLOGICAL: late biologic therapy
Sponsor: Zagazig University
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 60
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: TRIPLE (PARTICIPANT, CARE_PROVIDER, OUTCOMES_ASSESSOR)|Primary Purpose: TREATMENT
Start Date: 2024-07-09
Completion Date: 2025-07-09
Locations: Zagazig University Hospitals, Zagazig, 44519, Egypt

Summary:
crohn's disease patients who present by intestinal perforation as the first presentation are hard to deal with. Surgical techniques as anastmosis or diversion stoma and active course of the disease may greatly affect the quality of life. In post-operative period, is the priority to avoid the post operative complications and to improve surgical outcomes or to stop active course of the disease and to induce remission?. So, those patients were classified into two groups. one group will receive biological therapy early post operative and the other group will receive it 2 or 3 months later after surgery and the investigators will compare results between the two groups.

Primary Outcome Measures: size of intra-abdominal fluids or collection, size of peritoneal fluids will be measured by surface area in centimeter square ( weight x height) using ultrasound, from the first post-operative day to 2 months postoperatively|bowel function, bowel function will be assessed by hearing intestinal sound using Stethoscope, from the first post-operative day to 2 months postoperatively|fecal fistula, if found, its amount will be calculated per day using calibrated colostomy bag, from the first post-operative day to 2 months postoperatively|skin maceration, skin maceration surface area will be calculated by (weight x height) in centimeter square using a ruler, from the first post-operative day to 2 months postoperatively|body weight, weight gain or weight loss will be measured in kg, from the first post-operative day to 2 months postoperatively|age, age in years will be recorded, 2 hours before surgery|sex, sex of patients (male or female) will be recorded, 2 hours before surgery
FH ORTHO Shoulder Observatory
NCT Number: NCT06511856
Status: RECRUITING
Study Type: OBSERVATIONAL
Conditions: Trauma|Arthropathy Shoulder
Interventions: DEVICE: ARROW
Sponsor: FH ORTHO
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 500
Study Design: Observational Model: |Time Perspective: p
Start Date: 2022-09-08
Completion Date: 2035-09-08
Locations: Clinique VIA DOMITIA, Lunel, 34400, France|Clinique Bizet, Paris, 75116, France|Clinique de l'Union, Saint-Jean, 31243, France

Summary:
This study is a real-life observatory designed to collect long-term clinical data on patients who have undergone shoulder joint replacement or repair following shoulder trauma.

In this type of intervention, one or more medical devices distributed by FH ORTHO SAS may be used by surgeons.

This study meets the requirement for post-market clinical follow-up (PMCF) as defined in the European Medical Device Regulation (MDR 2017/745).

It therefore involves collecting in real life, i.e. under the usual conditions of surgery and short and long-term patient follow-up, minimal clinical data that will make it possible to document the continued benefit/risk of the medical devices concerned.

This study is designed as a permanent long-term observatory, of a non-interventional nature, with the objective of having long-term follow-up data (5 to 10 years depending on the devices concerned) for a maximum number of patients included.

Primary Outcome Measures: Performance of the medical devices over long term follow-up (maximum10 years), Functional performance measured by the Constant-Murley score, maximum 10 years
Secondary Outcome Measures: revision rate medical devices over long term follow-up (maximum10 years), maximum 10 years
Music for Pain in the Waiting Room
NCT Number: NCT06511843
Status: RECRUITING
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Pain, Acute
Interventions: BEHAVIORAL: Pain Coping Information|BEHAVIORAL: Lyrical Music|BEHAVIORAL: Instrumental Music
Sponsor: Florida State University
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 266
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: TRIPLE (PARTICIPANT, INVESTIGATOR, OUTCOMES_ASSESSOR)|Primary Purpose: TREATMENT
Start Date: 2024-07-23
Completion Date: 2024-10-30
Locations: Tallahassee Orthopedic Clinic (TOC), Tallahassee, Florida, 32308, United States

Summary:
This is a single-site, three-arm, parallel-group randomized clinical trial (RCT). The clinical effects of two, 4-minute, audio-recorded, music interventions (one with lyrics and the other without) for orthopedic patients will be investigated relative to a 4-minute audio-recoding about pain psychoeducation.

Primary Outcome Measures: Change in Pain Unpleasantness Numeric Rating Scale, Single Likert scale item ranging from 0-10, with 0 indicating no pain and 10 representing the most unpleasant pain imaginable., Immediately before to after 4-minute audio recording
Secondary Outcome Measures: Change in Pain Intensity Numeric Rating Scale, Single Likert scale item ranging from 0-10, with 0 indicating no pain and 10 representing the most intense pain imaginable., Immediately before to after 4-minute audio recording|Change in Anxiety Numeric Rating Scale, Single Likert scale item ranging from 0-10, with 0 indicating no anxiety and 10 representing severe anxiety,, Immediately before to after 4-minute audio recording
Other Outcome Measures: Change in Self-Transcendent State, Self-transcendent state will be measured by the three-item, state version of the validated Nondual Awareness Dimensional Assessment. These three items will be scored on a Likert scale ranging from 0-10, with higher scores representing greater self-transcendence., Immediately before to after 4-minute audio recording|Experience of Emotional Chills, Emotional chills and goosebumps will be measured with two items, each scored on a 0 to 10 Likert type scale. Higher score represent more chills/goosebumps., Immediately after 4-minute audio recording
Effectiveness of Plaque Score Detection Techniques
NCT Number: NCT06511830
Status: NOT_YET_RECRUITING
Study Type: OBSERVATIONAL
Conditions: Plaque, Dental
Interventions: DIAGNOSTIC_TEST: Dental Monitoring images
Sponsor: University of Nebraska
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 48
Study Design: Observational Model: |Time Perspective: p
Start Date: 2024-10
Completion Date: 2025-08
Locations: University of Nebraska Medical Center Dental College, Lincoln, Nebraska, 68583-0740, United States

Summary:
This study investigates the similarity between microbial plaque scores when assessing the entire dentition versus select teeth. The hypothesis posits that plaque buildup on single teeth mirrors that of the entire mouth, facilitating efficient plaque data collection and generalized deductions. Additionally, the research explores the potential of Dental Monitoring© photos in accurately identifying plaque indexes, aiming to enhance plaque evaluation efficiency in dental appointments. The null hypothesis suggests no significant difference between full dentition plaque scores and selected teeth. Results may streamline plaque tracking in patient appointments and enable remote monitoring, potentially detecting plaque accumulation issues earlier.

Primary Outcome Measures: Presence of Visibly Detectable Plaque, The presence of dental plaque will be determined by visual presence or absence of dental plaque at 6 sites per tooth. The presence of dental plaque is reported a percentage of tooth surfaces with visibly detectable plaque., Baseline
Correlation Between Noninvasive Blood Vessel Functionality Parameters and Cerebral Hemodynamics in Neurocritical Care Patients
NCT Number: NCT06511804
Acronym: Mespere ICP
Status: RECRUITING
Study Type: OBSERVATIONAL
Conditions: Brain Injuries|Intracranial Pressure Increase|Monitoring
Interventions: DEVICE: Intracranial Pressure Noninvasive Monitoring
Sponsor: University of Louisville
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 25
Study Design: Observational Model: |Time Perspective: p
Start Date: 2024-07-17
Completion Date: 2025-06-30
Locations: University of Louisville Health, Louisville, Kentucky, 40202, United States

Summary:
The purpose of this clinical research project is to employ Mespere LifeSciences NeurOs Cerebral Oximetry system, equipped with noninvasive sensors approved by the FDA, to monitor and investigate the correlation within a cohort of patients suffering from traumatic brain injury (TBI), stroke, brain tumor, and brain bleeding. This study aims to investigate and establish the correlation between blood vessel functionality parameters-specifically, Vasodilation/Constriction Index (VDC), Vascular Resistance Index (VR), and Volume Reactivity Index (VRx)-with the crucial physiological indicators, Intracranial Pressure (ICP) and Mean Arterial Pressure (MAP). By doing so, the investigators seek to address fundamental questions surrounding cerebral hemodynamics and autoregulation in various neurological conditions.

Primary Outcome Measures: cerebral hemodynamics and autoregulation as assessed by the noninvasive blood vessel functionality parameters-Vasodilation/Constriction Index (VDC), Vascular Resistance Index (VR), and Volume Reactivity Index (VRx), cerebral hemodynamics and autoregulation as assessed by the noninvasive blood vessel functionality parameters-Vasodilation/Constriction Index (VDC), Vascular Resistance Index (VR), and Volume Reactivity Index (VRx)-in patients with traumatic brain injury, stroke, brain bleeding, 1 hour