pankajmathur/National_Library_of_Medicine_Studies_data huggingface dataset:
Study of Therapeutic Efficacy of Anti-CD19 CAR-T Cells in Children With Refractory Refractory AAV
NCT Number: NCT06508346
Status: RECRUITING
Study Type: OBSERVATIONAL
Conditions: ANCA Associated Vasculitis|CAR-T Cell Therapy
Interventions: BIOLOGICAL: anti-CD19-CAR-T cells
Sponsor: The Children's Hospital of Zhejiang University School of Medicine
Collaborators: Children's Hospital of Chongqing Medical University
Sex: ALL
Age: CHILD, ADULT
Enrollment: 12
Study Design: Observational Model: |Time Perspective: p
Start Date: 2024-08-01
Completion Date: 2027-07-31
Locations: Children's Hospital, Zhejiang University School of Medicine, Hangzhou, Zhejiang, China

Summary:
This is an investigator-initiated trial aimed at assessing the safety and efficacy of anti-CD19 CAR-T cells in the treatment of childhood-onset refractory ANCA-Associated Vasculitis.

Primary Outcome Measures: The safety of CAR-T cell in refractory childhood-onset ANCA-Associated Vasculitis, The number of occurrence and proportion of adverse events and serious adverse events that occurred, 3 months and 6 months
Secondary Outcome Measures: The efficiency of CAR-T cell in refractory childhood-onset AAV, Percentage of patients achieving 50% response 100% response by the 3-month time, 3 months and 6 months|The efficiency of CAR-T cell in refractory childhood-onset AAV, the assessment of disease activity using PVAS/BVAS 3.0 ,the asseeement of the Irreversible damage by PVDI/VDI,and the changes in laboratory values, 3 months|Cellular kinetics, CAR transgene levels by quantitative polymerase chain reaction (qPCR) in peripheral blood., 6 months|Autoantibody detection, Autoantibody detection up after CD19 CAR-T cells infusion., 24 months|Duration of disease response (DOR), the time between the first investigator assessment of remission and the first investigator assessment of progression or death from any cause, 24 months
Efficacy and Safety of Vitamin D Supplementation Combined With Alarm Therapy in Treating Nocturnal Enuresis
NCT Number: NCT06508333
Status: NOT_YET_RECRUITING
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Enuresis
Interventions: BEHAVIORAL: alarm therapy|DRUG: Vitamin D3
Sponsor: Xing Liu
Sex: ALL
Age: CHILD, ADULT
Enrollment: 180
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: DOUBLE (INVESTIGATOR, OUTCOMES_ASSESSOR)|Primary Purpose: TREATMENT
Start Date: 2024-08-01
Completion Date: 2026-10-01
Locations: Children's Hospital of Chongqing Medical University, Chongqing, Chongqing, 400000, China

Summary:
This prospective, randomized, two-arm, parallel-design controlled clinical trial aims to determine whether high-dose vitamin D supplementation combined with alarm therapy improves outcomes in children with nocturnal enuresis compared to alarm therapy alone.

Primary Outcome Measures: Change in enuresis frequency, Change in enuresis frequency from baseline to follow-up, 8 week
Secondary Outcome Measures: Change in quality of life score, The quality of life was assessed using a scale ranging from 0 to 3, where a score of 0 indicated no impact on family, social, or academic life, a score of 1 indicated occasional impact, a score of 2 indicated significant impact, and a score of 3 indicated severe impact on family, social, or academic life., 8 week|Change in vitamin D level, Change in vitamin D level from baseline to follow-up, 8 week|Global perception of improvement, Global perception of improvement (much better; better; about the same; worse), 8 week|Wish to receive another form of treatment?, Wish to receive another form of treatment? (YES; No), 8 week|Change in mean nocturia frequency, episodes/night, Change in mean nocturia frequency from baseline to follow-up, 8 week|Treatment adherence, The extent to which a patient adheres to their medication schedule, including both timing and dosage, or follows the prescribed treatment regimen, 8 week|Incidence of side effects, Type and frequency of side effects during treatment, 8 week
8-Week Artificial Intelligence Based Structured Exercises
NCT Number: NCT06508294
Status: RECRUITING
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Health Behavior
Interventions: BEHAVIORAL: 8 week artificial intelligence based posture exercises
Sponsor: Hacettepe University
Collaborators: Gulhane Training and Research Hospital
Sex: ALL
Age: ADULT
Enrollment: 36
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: SINGLE (PARTICIPANT)|Primary Purpose: SUPPORTIVE_CARE
Start Date: 2024-05-01
Completion Date: 2025-08-30
Locations: University of Health Science, Ankara, Kecioren, 06018, Turkey

Summary:
Posture is defined as the arrangement or orientation of body parts in relation to each other.In this study, it was aimed to examine the effect of an 8-week artificial intelligence-based structured exercise program in healthy adults. It performs measurements on frontal and lateral images of the individual in normal posture Photo of a participant showing how the Posture Screen Mobile app evaluates the horizontal tilt and inclination of the head, shoulders and hips from a frontal view.The craniovertebral angle (CVA) is a measurement of upper cervical posture obtained by calculating the angle between the ear tragus and a horizontal line passing through the spinous process of C7). KVA will be done with Posture Screen Mobile Phone application.Thoracic kyphosis is the anteroposterior curve of the thoracic spine in the sagittal plane and is defined using the Cobb angle.Thoracic kyphosis is the hunching of the spine in the upper back into an extreme external curve due to deformity.An artificial intelligence application called "Musclewiki" will be used for healthy adults to continue their exercise training at home. For 8 weeks, exercise will be practiced 3 times a week in the company of a physiotherapist, accompanied by a physiotherapist through artificial intelligence.

Primary Outcome Measures: craniovertebral angle measurement, angle degree measurement with telephone application, before- after 8 week
Secondary Outcome Measures: thoracal kyphosis angle, angle degree measurement with telephone application, before-after 8 week|lumbal lordosis angle, lumbal lordosis angle degree measurement with telephone application, before-after 8 week
Model Video Activity in Anatomy Education
NCT Number: NCT06508281
Status: COMPLETED
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Anatomy|Medical Students|Education
Interventions: OTHER: experimental group
Sponsor: Giresun University
Sex: ALL
Age: CHILD, ADULT
Enrollment: 148
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: SINGLE (PARTICIPANT)|Primary Purpose: BASIC_SCIENCE
Start Date: 2024-04-04
Completion Date: 2024-05-25
Locations: Giresun University, Faculty of Medicine, Department of Anatomy, Giresun, Turkey

Summary:
During Anatomy education and training at medical school; In addition to theoretical lecture presentations, visual alternative methods such as videos can be used to better understand, learn and keep in mind anatomical structures, to help reinforce knowledge and to increase students' motivation in anatomy lessons. Model videos can be an alternative to visual anatomy education in order to provide a better understanding of the subjects so that people can watch model videos wherever and whenever they want, in addition to the theoretical lesson.

Primary Outcome Measures: The effects of model video activity in anatomy education on the anatomy education of medical faculty students were measured with the 'Anatomy theoretical questions test' prepared by the researchers., A randomized controlled study with pre-test-post-test design with experimental and control groups. 'Anatomy theoretical questions test' prepared for pre-test and post-test was given to students before and after watching anatomy model videos. 'Anatomy theoretical questions test' prepared by researchers consists of 25 questions, each with five options., The duration of watching anatomy model videos for each subject is 1 week. The time to complete the 'Anatomy theoretical questions test' pre-tests and post-tests is 1 week each.
Language, Speech and Motor Function in MCI Due to AD and Alzheimer's Disease
NCT Number: NCT06508268
Status: RECRUITING
Study Type: OBSERVATIONAL
Conditions: Alzheimer's Disease|MCI Due to AD|Dementia Alzheimers
Interventions: BEHAVIORAL: GAITRite walkway system OR 4-meter walking speed test|BEHAVIORAL: Jamar hand dynamometer|BEHAVIORAL: Picture description task|BEHAVIORAL: Autobiographical semi-structured conversation|BEHAVIORAL: Verbal fluency
Sponsor: Hanze University of Applied Sciences Groningen
Collaborators: University of Groningen
Sex: ALL
Age: CHILD, ADULT, OLDER_ADULT
Enrollment: 208
Study Design: Observational Model: |Time Perspective: p
Start Date: 2024-07-12
Completion Date: 2025-02-09
Locations: Hanze University, Groningen, 9714CA, Netherlands

Summary:
The goal of this observational cross-sectional study is to explore the characteristics of language, speech, and motor function in persons with Mild Cognitive Impairment due to Alzheimer's disease ("MCI due to AD") and persons with mild and moderate Alzheimer's disease ("AD"). This study aims to:

* Explore motor, speech, and language functions in MCI due to AD and mild and moderate AD.
* Combine the characteristics of motor, language, and speech functions to gain more insight into the association of language, speech, and motor changes during MCI due to AD and mild and moderate AD.

Researchers will compare the outcomes to an age-matched control group without cognitive impairment.

Participants will undergo:

* Two motor function tests to assess gait and hand grip strength.
* Four language and speech function tests to assess spontaneous speech and verbal fluency..

Primary Outcome Measures: Language and speech characteristics of spontaneous speech, Autobiographical semi-structured interview and a picture description task ("The Cookie Theft Picture (Berube et al., 2019)), 4 months|Verbal fluency, Naming animals and professions, 4 months|Letter fluency, Naming letters starting with the letters D and A, 4 months|Temporal and spatial parameters of gait, Gaitrite walkway system (GAITRite) or 4-meter walking speed test, 4 months|Hand grip strength, Jamar hand dynamometer, 4 months
Adebrelimab Combined With Albumin Paclitaxel and Nedaplatin as Neoadjuvant Therapy for Locally Advanced Resectable ESCC
NCT Number: NCT06508229
Status: NOT_YET_RECRUITING
Study Type: INTERVENTIONAL
Phases: PHASE2
Conditions: Esophageal Squamous Cell Carcinoma
Interventions: DRUG: Adebrelimab|DRUG: albumin paclitaxel|DRUG: Nedaplatin
Sponsor: Harbin Medical University
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 65
Study Design: Allocation: NA|Intervention Model: SINGLE_GROUP|Masking: NONE|Primary Purpose: TREATMENT
Start Date: 2024-07-30
Completion Date: 2028-05-30

Summary:
This is a multi-center, single-arm, phase II clinical study designed to observe and evaluate the effectiveness and safety of adebrelimab combined with albumin paclitaxel and nedaplatin as neoadjuvant therapy for locally advanced resectable esophageal squamous cell carcinoma.

Primary Outcome Measures: pathological complete remission rate, After neoadjuvant therapy and surgery, there were no residual surviving tumor cells in the tumor bed in the postoperative specimens (% RVT=0), up to 24 months
Secondary Outcome Measures: R0 resection rate, The tumor lesion was completely removed, and no residual cancer cells were found on the cutting edge under the microscope, up to 24 months|Main pathological remission, After neoadjuvant therapy and surgery, the proportion of tumor cells remaining alive in the tumor bed in the postoperative specimen is less than or equal to 10% (% RVT ≤ 10), up to 24 months|objective response rate, The proportion of patients whose tumors have shrunk to a certain amount and remained in remission for a certain period of time, including complete response (CR) and partial response (PR)., up to 24 months|Disease-free survival, It was calculated from the time of first administration of study drug until disease progression or death., up to 24 months|overall survival, The time is calculated from the first administration of the study drug until death due to any cause (patients who were lost to follow-up are the last follow-up time; patients who are still alive at the end of the study are the end of follow-up date)., up to 24 months|Number of participants with treatment related adverse events asassessed by CTCAE v5.0, Proportion of patients with treatment-related adverse events recorded using CTCAE 5.0 criteria, up to 24 months|Changes in the patient's mood, Use PHQ-9 and GAD-7 to record the changes in patients' emotions during treatment, up to 24 months|The patient's nutritional status, Use PNI, CNI and mCONUT scoring standards to record changes in the patient's nutritional status during treatment, up to 24 months|The pain level of patients, NRS and VAS pain rating scales were used to assess changes in patients' pain levels during treatment., up to 24 months
Free Walking Exercise in Obstructive Sleep Apnea Patients With Non-alcoholic Fatty Liver
NCT Number: NCT06508190
Status: RECRUITING
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Obstructive Sleep Apnea|Non-alcoholic Fatty Liver
Interventions: BEHAVIORAL: continuous positive airway pressure|BEHAVIORAL: free walking exercise and continuous positive airway pressure
Sponsor: Ahram Canadian University
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 40
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: SINGLE (OUTCOMES_ASSESSOR)|Primary Purpose: TREATMENT
Start Date: 2024-07-12
Completion Date: 2024-12-01
Locations: Ahram canadian university, Giza, Egypt

Summary:
Research evaluating the impact of continuous positive airway pressure (CPAP) \& walking exercise on fatigue severity, liver enzymes and sleeping quality in patients with non-alcoholic fatty liver disease who also have obstructive sleep apnea. Forty patients are divided into two groups: twenty patients CPAP and other twenty patients for CPAP and walking program .

Primary Outcome Measures: Alanine tranaminase, serum hepatic enzyme, it will be measured after 12 weeks
Secondary Outcome Measures: Asparatate transamianse, serum hepatic enzyme, it will be measured after 12 weeks|Body mass index, it will be masusured on empty stomach and bladder, it will be measured after 12 weeks|triglycerodes, it will be meausred in plasma, it will be assessed after 12 weeks|Pittsiburg sleeping quality index, a questionnaire that wil be used for assessing sleeping quality, it will be assessed after 12 weeks|fatigue severity scale, a questionnaire that wil be used for assessing fatigue, it will be assessed after 12 weeks|Epworth sleepness scale, a questionnaire that wil be used for daytime sleepness, it will be assessed after 12 weeks
CPK Levels After LC and Association With Analgesic Modalities
NCT Number: NCT06508177
Status: RECRUITING
Study Type: OBSERVATIONAL
Conditions: Myotoxicity
Interventions: OTHER: İnterfascial plane block|OTHER: Standart analgesia plan
Sponsor: Samsun University
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 80
Study Design: Observational Model: |Time Perspective: p
Start Date: 2024-08-05
Completion Date: 2024-10-10
Locations: Samsun University, Samsun, Turkey

Summary:
Regional anesthesia and analgesia technics are widely and securely used during general surgery procedures. Interfascial plane blocks are the latest used ones for analgesia. There are studies in literature indicating that bupivacaine cause myotoxicity. The investigators aimed to examine plasma creatine phosphokinase (CPK) levels to see whether myotoxicity occurs or not after fascial plane blocks are applied to patients undergoing laparoscopic cholecystectomy.

Primary Outcome Measures: CPK levels, Serum creatine phosphokinase levels at 24th hour, at postoperative 24th hour
International CRDS Registry
NCT Number: NCT06508164
Acronym: CRDS Registry
Status: NOT_YET_RECRUITING
Study Type: OBSERVATIONAL
Conditions: Calcium Release Deficiency Syndrome
Sponsor: Population Health Research Institute
Collaborators: Canadian Institutes of Health Research (CIHR)
Sex: ALL
Age: CHILD, ADULT, OLDER_ADULT
Enrollment: 500
Study Design: Observational Model: |Time Perspective: p
Start Date: 2024-08-01
Completion Date: 2050-12-31
Locations: Boston Children's Hospital, Boston, Massachusetts, 02115, United States|Mayo Clinic, Rochester, Minnesota, 55905, United States|University of Washington, Seattle, Washington, 98195, United States|Antwerp University Hospital (UZA), Edegem, Antwerp, Belgium|Universitair Ziekenhuis Brussel (UZB), Brussels, Belgium|BC Children's Hospital, Vancouver, British Columbia, Canada|The University of British Columbia, Vancouver, British Columbia, Canada|Hamilton General Hospital, Hamilton, Ontario, L8L 2X2, Canada|London Health Sciences Centre - University Hospital, London, Ontario, Canada|Ottawa Heart Institute, Ottawa, Ontario, Canada|Toronto General Hospital, Toronto, Ontario, Canada|Montréal Heart Institute, Montréal, Quebec, Canada|Institut Universitaire de Cardiologie et de Pneumologie de Québec-Université Laval, Québec City, Quebec, Canada|Aarhus University Hospital, Aarhus, Denmark|Hopital Cardiologique du Haut-Leveque, Pessac, France|Shaare Zedek Medical Center, Jerusalem, Israel|Amsterdam University Medical Centre, Amsterdam, Netherlands|Oxford Heart Centre, John Radcliffe Hospital, Oxford, Oxfordshire, United Kingdom

Summary:
Calcium Release Deficiency Syndrome (CRDS) is a newly discovered genetic arrhythmia syndrome that confers a risk of life-threatening arrhythmias secondary to RYR2 loss-of-function. The International CRDS registry has been designed to facilitate large-scale evaluation of CRDS, including its phenotypic spectrum, approaches to risk stratification, and optimal treatment strategies.

Primary Outcome Measures: Malignant Ventricular Arrhythmia, Composite of malignant syncope, ICD shock, cardiac arrest, and sudden cardiac death, 5 years
Neovaginoplasty Using Photoinduced-imine-crosslink Hydrogel in MRKH Patients
NCT Number: NCT06508151
Status: NOT_YET_RECRUITING
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Mayer Rokitansky Kuster Hauser Syndrome
Interventions: PROCEDURE: neovaginoplasty and vaginal mold spreaded with photoinduced-imine-crosslink hydrogel|PROCEDURE: neovaginoplasty and vaginal mold
Sponsor: Obstetrics & Gynecology Hospital of Fudan University
Sex: FEMALE
Age: ADULT
Enrollment: 20
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: DOUBLE (PARTICIPANT, OUTCOMES_ASSESSOR)|Primary Purpose: TREATMENT
Start Date: 2024-08-01
Completion Date: 2026-06-30

Summary:
Evaluating the effectiveness and safety of neovaginoplasty using photoinduced-imine-crosslink hydrogel in patients with MRKH syndrome by comparing the differences in the degree of squamous epithelialization, vaginal length and width, and sexual life quality.

Primary Outcome Measures: Degree of vaginal squamous epithelialization, Percentage of squamous epithelialization of neovagina, 1 month|Degree of vaginal squamous epithelialization, Percentage of squamous epithelialization of neovagina, 3 months|Degree of vaginal squamous epithelialization, Percentage of squamous epithelialization of neovagina, 6 months
Secondary Outcome Measures: length of neovagina, length in centimetre, measured by a ruler, 1 month|length of neovagina, length in centimetre, measured by a ruler, 3 months|length of neovagina, length in centimetre, measured by a ruler, 6 months|width of neovagina, width in centimetre, measured by ruler, 1 month|width of neovagina, width in centimetre, measured by ruler, 3 months|width of neovagina, width in centimetre, measured by ruler, 6 months|Sexual life quality, Female Sexual Function Index, a self-reported questionnaire to measure sexual life quality, 6 months|Sexual life quality, Female Sexual Function Index, a self-reported questionnaire to measure sexual life quality, 1 year
Clinical Trial Assessing the Safety and Immunologic Correlates of Heterologous Prime-Boost With pNGVL4a-Sig/E7(Detox)/HSP70 and TA-HPV in Healthy Donors Followed by Peripheral Blood Collection
NCT Number: NCT06508138
Acronym: J21112LINKED
Status: ENROLLING_BY_INVITATION
Study Type: INTERVENTIONAL
Phases: PHASE1
Conditions: HPV 16 Infection|HPV-Related Carcinoma|Recurrence|Metastatic Cancer
Interventions: BIOLOGICAL: pNGVL4a-Sig/E7(detox)/HSP70 plasmid DNA; TA-HPV vaccinia virus
Sponsor: Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
Collaborators: PapiVax Biotech, Inc.|National Cancer Institute (NCI)
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 24
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: NONE|Primary Purpose: OTHER
Start Date: 2023-10-18
Completion Date: 2025-10-18
Locations: Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins, Baltimore, Maryland, 21287, United States

Summary:
This healthy related donor clinical trial is linked to a recipient clinical trial protocol for therapeutic purposes. In this healthy donor protocol, haploidentical relatives of a patient with recurrent or metastatic human papilloma virus (R/M HPV) 16-associated malignancy will be invited to be vaccinated with a therapeutic HPV vaccine series (PVX1) to generate HPV-specific white blood cells. In the linked recipient phase 1 clinical trial protocol, patient with incurable, locally recurrent or metastatic HPV 16-associated head and neck cancer will be randomized to one of two arms:

Arm A: non-myeloablative (NMA) allogeneic bone marrow transplant (alloBMT) OR Arm B: CD8-depleted donor lymphocyte infusion (DLI) on Day 0 of a dose escalation scheme

These two clinical trials are separated so that the healthy donor trial deals exclusively with issues of safety and immunological efficacy of the HPV vaccine series and this companion recipient trial examines the safety, feasibility and clinically efficacy of the allogeneic bone marrow graft and CD8-depleted DLI. The central hypothesis of the clinical trial is that patients with R/M HPV-associated malignancies can be safely and effectively treated by allogeneic bone marrow transplantation and/or CD8-depleted DLI from a healthy related donor that has been vaccinated against HPV16 E6 and E7 proteins.

Primary Outcome Measures: Safety of Vaccine series as assessed by number of adverse events, Safety of the vaccine series will be assessed by counting number of adverse events, 3 months
Cross-linked and Non-cross-linked Hyaluronic Acid in Subdeltoid Bursitis
NCT Number: NCT06508125
Status: NOT_YET_RECRUITING
Study Type: INTERVENTIONAL
Phases: PHASE4
Conditions: Subdeltoid Bursitis|Hyaluronic Acid
Interventions: DRUG: cross-linked hyaluronic acid|DRUG: non-cross-linked hyaluronic acid
Sponsor: Taipei Medical University
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 52
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: TRIPLE (PARTICIPANT, INVESTIGATOR, OUTCOMES_ASSESSOR)|Primary Purpose: TREATMENT
Start Date: 2024-07-25
Completion Date: 2024-12-31
Locations: Shin Kong Wu Ho-Su Memorial Hospital, Taipei, 111-01, Taiwan

Summary:
This study aims to compare the efficacy of different structures of hyaluronic acid, namely cross-linked and non-cross-linked hyaluronic acid, in treating subdeltoid bursitis.

Primary Outcome Measures: Shoulder pain and disability index, measure shoulder pain and disability, ranges from 0-100, higher scores indicate more pain or disability, score change from baseline to 1 week, 1 month and 3 months after treatment
Secondary Outcome Measures: Disabilities of the arm, shoulder, and hand, measure sports/music and work related to shoulder pain, ranges from 0-100, higher scores indicate more pain or disability, score change from baseline to 1 week, 1 month and 3 months after treatment|Visual analog scale, measure shoulder pain, ranges from 0-10, higher score indicate more pain, score change from baseline to 1 week, 1 month and 3 months after treatment|range of motion, measure shoulder range of motion, higher score indicate higher range of motion, score change from baseline to 1 week, 1 month and 3 months after treatment|Brief version of the World Health Organization Quality of Life Scale, measure quality of life, ranges from 0-100, higher scores indicate better quality of life, score change from baseline to 1 week, 1 month and 3 months after treatment
Pleth Variability Index in Pulmonary Embolism
NCT Number: NCT06508112
Status: COMPLETED
Study Type: OBSERVATIONAL
Conditions: Pulmonary Embolism
Interventions: DEVICE: Masimo Radical-7® Pulse CO-Oximeter
Sponsor: Suleyman Demirel University
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 1
Study Design: Observational Model: |Time Perspective: p
Start Date: 2023-04-01
Completion Date: 2024-06-01
Locations: Suleyman Demirel University Faculty of Medicine, Isparta, 32260, Turkey

Summary:
Pulmonary embolism(PE) is a ventilation/perfusion disorder caused by obstruction of the pulmonary artery, usually by a thrombus. The Pleth Variability Index(PVI) is a continuous, noninvasive indicator of dynamic perfusion index changes in photoplethysmography that occur in at least one respiratory cycle. The aim of this study is to evaluate the prognostic and mortality indicator role of PVI in patients with PE, hypothesizing that PVI could serve as a valuable guide in this disease where perfusion impairment is fundamental.

Based on our study, we determined that PVI could be a non-invasive, rapid, and objective tool for predicting disease progression and mortality in PE patients in the emergency department. Our study is the first to evaluate the PVI in PE.

Primary Outcome Measures: Pleth Variability Index: A Potential New Marker for Predicting the Mortality of Pulmonary Embolism?, PVI can be considered a noninvasive, rapid, and objective tool for predicting the course and mortality of the disease in PE patients in the emergency department., 1 year
Vitamin A and D Supplementation in Allogeneic HCT
NCT Number: NCT06508099
Acronym: VitaStem
Status: RECRUITING
Study Type: INTERVENTIONAL
Phases: PHASE2
Conditions: Acute Lymphoblastic Leukemia|Acute Myeloid Leukemia|Biphenotypic Acute Leukemia|Lymphoblastic Lymphoma|Chronic Myeloid Leukemia|Myelodysplastic Syndromes|Myeloprolipherative Neoplsm|Non-hodgkin Lymphoma
Interventions: DRUG: Vitamin A|DRUG: Vitamin D3
Sponsor: St. Petersburg State Pavlov Medical University
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 220
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: NONE|Primary Purpose: TREATMENT
Start Date: 2024-05-15
Completion Date: 2027-05
Locations: RM Gorbacheva Research Institute, Saint Petersburg, 197022, Russian Federation

Summary:
The therapy under investigation is the addition of 300 000 IU of vitamin A and 100 000 IU of vitamin D before conditioning. The study will include patients with malignant diseases in hematologic response with indications for allogeneic transplantation with matched related or matched unrelated donor.

Primary Outcome Measures: Cumulative incidence of gastrointestinal acute GVHD, Cumulative incidence of patients with acute GVHD II-IV grade, competing risk is death, relapse and primary graft failure, 125 days
Secondary Outcome Measures: Incidence of HSCT-associated adverse events, Toxicity assessment is based on presence of NCI CTC AE 5.0 event grades 3-5. Veno-occlusive disease incidence and severity assessment is based on EBMT criteria 2020. Transplant-associated microangiopathy incidence assessment is based on Harmonization criteria. All toxicity measurements will be aggregated as severity scores, 125 days|Infectious complications, Incidence of infections, including analysis of severe bacterial, fungal and viral infections incidence, 125 days|Overall survival, Kaplan-Meier estimate of either relapse, primary or secondary graft failure or death from all causes, 2 years|Event-free survival, Kaplan-Meier estimate of either relapse, primary or secondary graft failure or death from all causes, 2 years|Overall cumulative incidence of acute GVHD grade II-IV, Cumulative incidence of patients with acute GVHD II-IV grade, competing risk is death, relapse and primary graft failure, 125 days|Incidence of moderate and severe chronic GVHD, Cumulative incidence of patients with moderate and severe chronic GVHD according to NIH 2015 criteria, competing risk is death, relapse and primary graft failure, 2 years|Non-relapse mortality analysis, Cumulative incidence of patients with mortality without hematological relapse of malignancy, 2 years|GVHD-relapse-free survival analysis, Kaplan-Meier estimate of death, acute GVHD grade III-IV, severe chronic GVHD or relapse, 2 years|Cumulative incidence of primary and secondary graft failure, Cumulative primary and secondary graft failure, competing risk is death and relapse, 125 days
Pilonidal Sinus Disease
NCT Number: NCT06508086
Status: RECRUITING
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Pilonidal Sinus
Interventions: PROCEDURE: laser ablation technique in the treatment of pilonidal sinus|PROCEDURE: Karydakis technique in the treatment of pilonidal sinus
Sponsor: Sohag University
Sex: ALL
Age: CHILD, ADULT, OLDER_ADULT
Enrollment: 30
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: NONE|Primary Purpose: TREATMENT
Start Date: 2024-06-10
Completion Date: 2025-06-01
Locations: Sohag University Hospital, Sohag, Egypt

Summary:
The aim of this study is to compare the outcomes of Karydakis technique versus sinus tract ablation procedure using 1470 nm Diode laser for the treatment of pilonidal sinus and provide evidence-based guidance to select the most appropriate operative procedure.

Primary Outcome Measures: recurrence rate in the treatment of pilonidal disease, the patients undergo follow up at the outpatient clinic for manifestations of recurrence eg. discharge, multiple pits, 6 months after the operation
Neural Therapy in Notalgia Paresthetica
NCT Number: NCT06508073
Status: COMPLETED
Study Type: OBSERVATIONAL
Conditions: Notalgia Paresthetica
Interventions: OTHER: Neural Therapy
Sponsor: Sisli Hamidiye Etfal Training and Research Hospital
Sex: ALL
Age: ADULT
Enrollment: 12
Study Design: Observational Model: |Time Perspective: p
Start Date: 2024-06-26
Completion Date: 2024-07-10
Locations: University of Health Sciences, Şişli Hamidiye Etfal Training and Research Hospital, Istanbul, Turkey

Summary:
Patients diagnosed with Notalgia paresthetica and who received neural therapy within the last year were retrospectively screened. In the evaluations before treatment and at the 3rd month after treatment; Numerical rating scale for pain, PainDETECT questionnaire for neuropathic pain, SF-12 for quality of life and 5-D itch scale for itch level were used.

Primary Outcome Measures: Numeric Rating Scale for Pain, A scale between 0 and 10 was used to question the pain level., 12 weeks after treatment|PainDETECT Questionnaire for assessing Neuropathic pain, The questionnaire consists of 9 items and is completed by the patient (no clinical examination is required)\[1\]\[3\]. There are 7 weighted sensory descriptor items (never to very strongly) and 2 items relating to spatial and temporal pain characteristics\[3\]. A total score of 19 or more is indicative of likely neuropathic pain., 12 weeks after treatment|Short Form-12 for Quality of life, The SF-12 is a self-reported outcome measure assessing the impact of health on an individual's everyday life. It is often used as a quality of life measure., 12 weeks after treatment|5-D Itch Scale, The 5-D itch scale is a 5-domain disease-specific instrument evaluating the duration, degree (severity), direction (improving, unaltered or worsening), disability (impact on sleep, leisure/social, housework/errands and school/work activities) and distribution (body part affected), 12 weeks after treatment
Bimodal Stimulation Using Auditory and Vibrotactile Stimuli for the Mitigation of Tinnitus
NCT Number: NCT06508060
Status: NOT_YET_RECRUITING
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Tinnitus
Interventions: DEVICE: Neosensory Wristband|OTHER: Tones only
Sponsor: Neosensory
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 200
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: SINGLE (PARTICIPANT)|Primary Purpose: TREATMENT
Start Date: 2024-08
Completion Date: 2024-11

Summary:
The goal of this clinical trial is to learn if a bimodal stimulation device that combines auditory tones with vibrotactile stimulation to the wrist works to treat moderate to severe tinnitus in adults. It will also learn about the safety of the device. The main questions it aims to answer are:

1. Does a bimodal stimulation device that combines auditory tones with vibrotactile stimulation to the wrist decrease the severity of tinnitus symptoms in adults with moderate to severe tinnitus?
2. What medical problems do participants report when using a bimodal stimulation device that combines auditory tones with vibrotactile stimulation to the wrist?

Researchers will compare a bimodal stimulation device that combines auditory tones with vibrotactile stimulation to the wrist to a control condition in which only auditory tones are used, without the device, to see if the bimodal stimulation device works to treat moderate to severe tinnitus.

Participants will:

1. Use the bimodal stimulation device for 10 minutes every day for a period of 8 weeks
2. Have one-on-one calls with the research team at the beginning and end of the study
3. Complete baseline and final tinnitus functional index assessments to track progress as a result of the intervention.

Primary Outcome Measures: Tinnitus Functional Index, The Tinnitus Functional Index (TFI) is a self-report questionnaire that measures the severity and negative effects of tinnitus. It's used to assess how tinnitus affects a person in multiple domains, and can also be used to measure changes in tinnitus related to treatment., From the first day of treatment to the final day of treatment at 8 weeks
Respiratory Rate Validation Study - Mindset Medical Informed Vital Core Application
NCT Number: NCT06508047
Status: COMPLETED
Study Type: OBSERVATIONAL
Conditions: Vital Sign Evaluation
Interventions: DEVICE: Informed Vital Core App
Sponsor: Mindset Medical
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 65
Study Design: Observational Model: |Time Perspective: p
Start Date: 2024-07-16
Completion Date: 2024-08-22
Locations: Element Materials Techonology, Louisville, Colorado, 80027, United States

Summary:
Evaluating the Accuracy of a Web-Based Application - Vital Sign Measurement Platform. This single-arm cohort, open-label study is designed to evaluate the accuracy of a web-based application designed for measurements of vital signs including respiratory rate (RR). The purpose of the study is to conduct accuracy validation when compared to a FDA-cleared/approved vital sign monitoring device (reference device).

Primary Outcome Measures: Respiratory Rate Accuracy, The primary outcome measure is a Respiratory Rate accuracy validation comparing the Mindset Medical Application to the Reference, an FDA cleared End Tidal Carbon Dioxide monitor (GE Datex-Ohmeda) by manually scoring the collected waveform for data analysis., 60 seconds
Rapid and Safe Sputum Suction Method Validation
NCT Number: NCT06508008
Status: RECRUITING
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Sputum
Interventions: PROCEDURE: continuous negative pressure suction|PROCEDURE: Intermittent negative pressure sputum suction through oral pharyngeal airway
Sponsor: Affiliated Hospital of Nantong University
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 900
Study Design: Allocation: RANDOMIZED|Intervention Model: CROSSOVER|Masking: SINGLE (PARTICIPANT)|Primary Purpose: SUPPORTIVE_CARE
Start Date: 2024-02-18
Completion Date: 2024-08-18
Locations: Affiliated Hospital of Nantong University, Nantong, Jiangsu, 226001, China

Summary:
600 comatose patients admitted to the hospital in China from June 2024 to June 2028 were randomly divided into groups A and B. Group A used intermittent negative pressure suction through oral and pharyngeal ventilation, while group B used continuous negative pressure suction through regular oral and nasal suction.

Primary Outcome Measures: Blood oxygen saturation before and after sputum aspiration, The degree of binding between oxygen and hemoglobin (Hb) in arterial blood, Not exceeding 1 day|Suctioning time, All time required for sputum suction process, Not exceeding 2 minute|Degree of airway bleeding, Use a disposable sputum collection device to aspirate sputum for patients and differentiate the blood content under a blue LED light., Not exceeding 30 minute
Secondary Outcome Measures: Patient family satisfaction, After suctioning, use a satisfaction questionnaire to survey the operating nurses, with a minimum score of 1 and a maximum score of 5. The higher the value, the higher the satisfaction., Not exceeding 1 day
Simultaneous Working Length Detection Methods
NCT Number: NCT06507982
Status: COMPLETED
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Irreversible Pulpitis|Root Canal Treatment
Interventions: DEVICE: EWL|DEVICE: SWL|DEVICE: RWL
Sponsor: Istanbul Medipol University Hospital
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 100
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: TRIPLE (PARTICIPANT, INVESTIGATOR, OUTCOMES_ASSESSOR)|Primary Purpose: TREATMENT
Start Date: 2022-06-01
Completion Date: 2024-03-01
Locations: Istanbul Medipol University, Faculty of Dentistry, Istanbul, Turkey

Summary:
Precise knowledge of the apical construction, which determines the end of the area for canal preparation and filling, is essential for the success of root canal treatment and the management of postoperative pain. For this purpose, devices based on various methods that determine the working length are used. However, it is still controversial which method provides the most accurate measurements.In this study, the compatibility of the electronic apex locator (EAL) and simultaneous working length determination (SWL) methods in single-root teeth was investigated in comparison with the radiographic working length determination method (RWL) method, and to determine which one produced more effective results in terms of postoperative pain.A hundred patients applied for endodontic treatment with a diagnosis of irreversible pulpitis (IP) were included in the study, which was planned as a single-center prospective cohort. Patients were divided into three groups according to the method used to determine the root canal working length (WL). 35 patients in whom the WL with EAL method (EWL) was used were included in Group 1; 35 patients in whom the SWL method was used were included in Group 2; 30 patients in whom the RWL method was used were assigned to Group 3. Patient groups were randomly selected from people similar in age and gender. Age, gender, simplified oral hygiene index (OHI-S), oral and dental examinations and Visual Analogue Scale (VAS) results of all participants were recorded.

Primary Outcome Measures: postoperative pain evaluation by VAS scale, during first week after root canal treatment, postoperative pain was evaluated. From start of endodontic treatment up to 1 week, pain was evaluated using VAS scale VAS scale was used, which has 1 to 10 number Number 10 in VAS indicates severe pain, while 0 indicates no pain, Baseline, 24 hour postoperatively, 48hour postoperatively, 72 hour postoperatively, Day 3 and Day 7
The COMPASSION Study
NCT Number: NCT06507930
Status: NOT_YET_RECRUITING
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Breast Cancer|Metastatic Breast Cancer|Advanced Breast Cancer|Unresectable Breast Carcinoma
Interventions: OTHER: Telehealth Hospice Visits
Sponsor: Dana-Farber Cancer Institute
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 200
Study Design: Allocation: NON_RANDOMIZED|Intervention Model: SEQUENTIAL|Masking: NONE|Primary Purpose: HEALTH_SERVICES_RESEARCH
Start Date: 2025-01
Completion Date: 2026-03-01
Locations: Dana-Farber Cancer Institute, Boston, Massachusetts, 02215, United States

Summary:
The aim of this research study is to better understand the in-home hospice experience for participants, caregivers, hospice nurses, and oncology providers by conducting telehealth check-ins between participants and caregivers and oncology care teams.

Primary Outcome Measures: Proportion of Participant Intervention Completion, Feasibility of the telehealth intervention is defined as greater than or equal to 80% of enrolled participants (18 out of 25) completing greater than or equal to 66% of the planned telehealth check-ins while the participant remains alive., Up to 4 weeks
Global Real World Data in Patients With Advanced Thyroid Cancer on Standard of Care and Specialized Interventions- Registry of Oncologic Outcomes With Testing and Treatment.
NCT Number: NCT06507878
Acronym: GRASSROOT
Status: NOT_YET_RECRUITING
Study Type: OBSERVATIONAL
Conditions: Thyroid Cancer
Sponsor: M.D. Anderson Cancer Center
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 459
Study Design: Observational Model: |Time Perspective: p
Start Date: 2024-09-01
Completion Date: 2034-07-01
Locations: MD Anderson Cancer Center, Houston, Texas, 77030, United States

Summary:
The goal of this clinical research study is to learn about the barriers in the real world to accessing treatments for ATC. And to learn about how patients with ATC tolerate and respond to the commercially available medications for treatment of this disease, outside of a clinical study.

Primary Outcome Measures: Overall Survival, Prospective real-world, large-scale, comprehensive data on these patients who are unable to access traditional clinical trials but are treated with MDA regimens, assigned by stage and BRAF-status., Through study completion; an average of 1 year.
Study to Assess the Safety, Tolerability, Pharmacokinetic of Thrv-1268
NCT Number: NCT06507839
Status: RECRUITING
Study Type: INTERVENTIONAL
Phases: PHASE1
Conditions: Atrial Fibrillation
Interventions: DRUG: THRV-1268|OTHER: Placebo
Sponsor: Thryv Therapeutics, Inc.
Sex: ALL
Age: ADULT
Enrollment: 74
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: DOUBLE (PARTICIPANT, INVESTIGATOR)|Primary Purpose: OTHER
Start Date: 2024-06-06
Completion Date: 2025-02-01
Locations: Altasciences, Montreal, Quebec, H3P 3P1, Canada

Summary:
This is a single-center, randomized, double-blind, placebo-controlled study to be conducted in 2 parts: single ascending dose (SAD) incorporating a food effect arm and multiple ascending dose (MAD). Potential participants for each part will undergo screening procedures within 28 days of enrollment.

Primary Outcome Measures: Safety and Tolerability: Number of Participants with Adverse Events, Number of Participants with Adverse Events, SAD: Day 7; Food Effect: Day 15; MAD: Day 16
Secondary Outcome Measures: Pharmacokinetic LQT-1268 AUC0-t, Area under the concentration-time curve (AUC) from time 0 to the time of the last, SAD: Day 1; Food Effect: Serially on Day 1 and Day 8; MAD: Serially on Day 1 and 7|Pharmacokinetic LQT-1268 Cmax, Maximum observed plasma drug concentration, SAD: Day 1; Food Effect: Serially on Day 1 and Day 8; MAD: Serially on Day 1 and 7|Pharmacokinetic LQT-1268 Tmax, Time to maximum observed plasma drug concentration, SAD: Day 1; Food Effect: Serially on Day 1 and Day 8; MAD: Serially on Day 1 and 7|Pharmacokinetic LQT-1268 t1/2, Time to maximum observed plasma drug concentration, SAD: Day 1; Food Effect: Serially on Day 1 and Day 8; MAD: Serially on Day 1 and 7|Urine Pharmacokinetics of LQT-1268: Ae, Amount of the administered dose recovered over the entire 24-hour interval, SAD: Day 1; MAD: Serially on Day 1 and 7|Urine Pharmacokinetics of LQT-1268: Fe, Percentage of the administered dose recovered over the entire 24-hour interval, SAD: Day 1; MAD: Serially on Day 1 and 7|Urine Pharmacokinetics of LQT-1268: Ae0-t, Amount excreted unchanged in urine over a given time interval, SAD: Day 1; MAD: Serially on Day 1 and 7|Plasma Pharmacokinetics of LQT-1268: Ctrough, Concentration of drug in the blood immediately before the next dose is administered, MAD: Days 3-6|Plasma Pharmacokinetics of LQT-1268: Rac(AUC), Drug accumulation ratio, MAD: Day 7|Plasma Pharmacokinetics of LQT-1268: Rac(Cmax), Drug accumulation ratio, MAD: Day 7
Self-Compassionate Writing for Caregivers of Older Adults
NCT Number: NCT06507826
Status: COMPLETED
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Self-Compassion|Control
Interventions: BEHAVIORAL: Self-Compassionate Writing for Caregivers of Older Adults
Sponsor: Farah Wiita
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 652
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: SINGLE (PARTICIPANT)|Primary Purpose: SUPPORTIVE_CARE
Start Date: 2022-02-18
Completion Date: 2022-11-15
Locations: University of Reading, Reading, Berkshire, RG6 6AL, United Kingdom

Summary:
The goal of this study was to test an online writing intervention to encourage a self-compassionate mindset in family caregivers of older adults. The main aims were to answer the questions:

* Writing with self-compassion would increase self-compassion.
* Writing with self-compassion would improve mood. Researchers compared self-compassion components (self-kindness, which involves a gentle and non-judgemental approach to oneself at times of difficulty; common humanity, which includes recognising one's difficulties as part of a shared human experience; mindfulness, which includes noticing difficult feelings without becoming overwhelmed by them) to see which combinations achieved the best outcomes.

Participants wrote with different combinations of self-compassion components together, such as mindfulness and common humanity or mindfulness and self-kindness. Participants also wrote with self-kindness, common humanity, or mindfulness separately.

Primary Outcome Measures: Self-kindness measured with the State Self-Compassion Scale (Neff et al., 2021), Scores closer to 5 expected on a scale of 1 to 5, State measured immediately after intervention|Common humanity measured with the State Self-Compassion Scale (Neff et al., 2021), Scores closer to 5 expected on a scale of 1 to 5, State measured immediately after intervention|Mindfulness measured with the State Self-Compassion Scale (Neff et al., 2021), Scores closer to 5 expected on a scale of 1 to 5, State measured immediately after intervention
Secondary Outcome Measures: Guilt measured using the Positive and Negative Affect Schedule (Watson and Clark, 1999), Scores closer to 1 expected on a scale of 1 to 5, State measured immediately after intervention|Sadness measured using the Positive and Negative Affect Schedule (Watson and Clark, 1999), Scores closer to 1 expected on a scale of 1 to 5, State measured immediately after intervention|Serenity measured using the Positive and Negative Affect Schedule (Watson and Clark, 1999), Scores closer to 5 expected on a scale of 1 to 5, State measured immediately after intervention