pankajmathur/National_Library_of_Medicine_Studies_data huggingface dataset:
Comparative Evaluation Of Two Bone-Anchored Maxillary Molar Distalization Appliances: Direct Versus Indirect Anchorage
NCT Number: NCT06507319
Status: RECRUITING
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Maxillary First Molar Distalization
Interventions: DEVICE: Direct bone anchored pull distal slider|DEVICE: Indirect bone anchored dual force distalizer.
Sponsor: Mansoura University
Sex: ALL
Age: CHILD
Enrollment: 20
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: SINGLE (PARTICIPANT)|Primary Purpose: TREATMENT
Start Date: 2023-06-08
Completion Date: 2024-10
Locations: Faculty of Dentistry, Mansoura, Egypt

Summary:
Aim of study: this study will be conducted for Comparative Evaluation Of Two Bone-Anchored Maxillary Molar Distalization Appliances: Direct Versus Indirect Anchorage.

Material and methods: The study will consist of two groups, each group has 10 Patients. The patients will be selected from the outpatient clinic of the orthodontic department at Mansoura University.

Patients will be divided into 2 groups, group 1 will be treated by direct bone anchored pull distal slider, and group 2 by indirect bone anchored dual force distalizer.

Primary Outcome Measures: Anteroposterior skeletal measurements, From the lateral cephalometric, the maxillary and mandibular sagittal positions will be measured according to the SN plane, before and after distalization., 8 months|Vertical skeletal measurements, From the lateral cephalometric, mandibular plane angle according to the SN plane and Frankfort horizontal plane, will be measured before and after distalization., 8 months|Dental angular measurements, From the lateral cephalometric, the angle between teeth (maxillary central incisor, first premolar, second premolar, first molar) and the SN plane will be measured before and after distalization to measure the amount of tipping., 8 months|Amount of distalization, From the lateral cephalometric, the distance between teeth (maxillary central incisor, first premolar, second premolar, first molar) and the pterygoid vertical (PTV) plane will be measured before and after distalization to calculate the amount of distalization in mm., 8 months|Amount of intrusion, From the lateral cephalometric, the distance between teeth (maxillary central incisor, first premolar, second premolar, first molar) and the palatal plane (PP) will be measured before and after distalization to calculate the amount of intrusion in mm.

., 8months|Amount of expansion, From the study model, the maxillary inter-canine, inter-first premolar, inter-second premolar, inter-first molar, and inter-second molar widths will be measured before and after distalization to calculate the amount of expansion in mm., 8 months|Amount of rotation, From the study model, the angle between buccopalatal axis of teeth (maxillary first premolar, second premolar, first molar) and the midpalatal suture will be measured before and after distalization to calculate the amount of rotation., 8 months
A Study to Investigate the Safety and Efficacy of KQB198 as Monotherapy and in Combination in Participants With Advanced Solid Malignancies
NCT Number: NCT06507306
Status: RECRUITING
Study Type: INTERVENTIONAL
Phases: PHASE1
Conditions: Solid Tumor, Adult
Interventions: DRUG: KQB198|DRUG: osimertinib
Sponsor: Kumquat Biosciences Inc.
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 100
Study Design: Allocation: NON_RANDOMIZED|Intervention Model: SEQUENTIAL|Masking: NONE|Primary Purpose: TREATMENT
Start Date: 2024-06-03
Completion Date: 2027-01-31
Locations: The Lindner Center for Research and Education at The Christ Hospital, Cincinnati, Ohio, 45219, United States|NEXT Oncology, San Antonio, Texas, 78229, United States|NEXT Oncology, Fairfax, Virginia, 22031, United States

Summary:
The goal of this clinical trial is to learn if KQB198 works to treat advanced solid tumor cancer in adults. It will also learn about the safety of KQB198. The main questions it aims to answer are:

* What is the safe dose of KQB198 by itself or in combination with other anti-cancer drugs?
* Does KQB198 alone or in combination with other anti-cancer drugs decrease the size of the tumor?
* What happens to KQB198 in the body?

Participants will:

* Take KQB198 daily, alone or in combination with another anti-cancer drug
* Visit the clinic about 8 times in the first 8 weeks, and then once every 4 weeks after that

Primary Outcome Measures: Number of patients who experience treatment-emergent adverse events, serious adverse events, and dose-limiting toxicities (Part 1), Safety characterized by type, incidence, severity, timing, seriousness and relationship to study treatment of AEs, SAEs, and DLTs, from first dose of study treatment to 28 days after last dose of study treatment., 28 Days|Recommended Phase 2 Dose (RP2D) (Part 1), Evaluate safety and assess number of patients with dose-limiting toxicity to determine the RP2D., up to 30 months|Efficacy and Optimal Biologic Dose of study treatment, as measured by Objective Response Rate (ORR) (Parts 2 and 3), Objective response is the proportion of subjects that experience confirmed complete response (CR) or partial response (PR) based on RECIST v1.1 during the time period from 1st dose of study treatment until last dose., up to 30 months
Secondary Outcome Measures: Concentration-time curve (AUC), up to 30 months|Maximum plasma concentration (Cmax), up to 30 months|Time to maximum plasma concentration (tmax), up to 30 months|Overall survival (OS), up to 30 months|Progression-free survival (PFS), up to 30 months|Overall response rate (ORR), up to 30 months|Duration of response (DOR), up to 30 months|Time to response (TTR), up to 30 months
The Effects of Periodontal Therapy on Gingival Crevicular Fluid NLRP3,Caspase-1,IL-1β Levels in Children With Gingivitis
NCT Number: NCT06507280
Status: RECRUITING
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Gingivitis
Interventions: PROCEDURE: Periodontal theraphy
Sponsor: Aydin Adnan Menderes University
Sex: ALL
Age: CHILD
Enrollment: 60
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: NONE|Primary Purpose: SCREENING
Start Date: 2024-02-01
Completion Date: 2025-01-01
Locations: Sultan Keles, Aydın, 09100, Turkey

Summary:
This study aims to determine the levels of NLRP3, caspase-1 and IL-1β concentrations in the gingival crevicular fluid of paediatric patients with gingivitis and their changes after periodontal treatment.

Primary Outcome Measures: NLRP3, NOD-, LRR- and pyrin domain-containing protein 3 level, Baseline|Caspase-1, Caspase-1 level, Baseline|IL-1 Beta, Interleukin-1 Beta level, Baseline
Secondary Outcome Measures: NLRP3, NOD-, LRR- and pyrin domain-containing protein 3 level, 7. days - 30. days|Caspase-1, Caspase-1 level, 7. days -30. days|IL-1 Beta, Interleukin-1 Beta level, 7. days-30. days
Pain and Clinical Reflections in Pelvic Congestion Syndrome
NCT Number: NCT06507267
Status: RECRUITING
Study Type: OBSERVATIONAL
Conditions: Pain, Chronic Primary
Interventions: OTHER: Pain and Clinical Reflections in Pelvic Congestion Syndrome
Sponsor: Kanuni Sultan Suleyman Training and Research Hospital
Sex: FEMALE
Age: ADULT
Enrollment: 54
Study Design: Observational Model: |Time Perspective: p
Start Date: 2024-06-10
Completion Date: 2024-09-30
Locations: Kanuni Sultan Süleyman Training and Research Hospital, Istanbul, 34000, Turkey

Summary:
Pelvic congestion syndrome (PKS) occurs as a result of dysfunction of the veins in the pelvic area. It is currently called pelvic venous disease. This definition also includes some diseases of the pelvic region such as May-Thurner and Nutcracker syndrome. Dilatation and reflux are usually observed in the para-uterine or ovarian veins. PCS is one of the important causes of chronic pelvic pain (CPA). Pain in PCS is unrelated to the menstrual cycle. PCS is frequently seen in multiparous women in the reproductive period. Pregnancy worsens the clinical condition of patients with PCS due to mechanical pressure on the pelvic region vessels in pregnant women. Although the underlying cause of PCS is thought to be hormonal factors related to progesterone and estrogen, its etiology has not been fully elucidated and is thought to be multifactorial.GnRH analogues and medroxyprogesterone, which have side effects such as menstrual irregularity, osteoporosis and weight gain, were previously used in the medical treatment of PCS. Combined oral hormonal contraceptives, vasoactive flavonoid fraction drugs, nonsteroidal anti-inflammatory (NSAID) drugs for pain relief, Gabapentin, and Amiltriptyline are still used in the treatment of PCS. In the past, traditional hysterectomy and oophorectomy were performed surgically. Laparoscopic ovarian vein ligation has been performed since the early 2000s, but its popularity has decreased due to potential complications such as retroperitoneal hematoma, ureteral injury, and thrombosis. Endovascular intervention is more preferred today due to its low complications and high success in treatment.

Primary Outcome Measures: onset of pain and application time for endovascular intervention,, numerical rating scala - 11, 'four months'
North West London Pebble Pathway: Automated OSA Diagnosis
NCT Number: NCT06507228
Acronym: PEBBLE
Status: RECRUITING
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Obstructive Sleep Apnea|Sleep Apnea
Interventions: DIAGNOSTIC_TEST: NWL PEBBLE STT
Sponsor: Patrik Bachtiger
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 200
Study Design: Allocation: NA|Intervention Model: SINGLE_GROUP|Masking: NONE|Primary Purpose: DIAGNOSTIC
Start Date: 2024-07-07
Completion Date: 2025-12-01
Locations: Charing Cross Hospital, London, W12 0HS, United Kingdom

Summary:
Patients with obstructive sleep apnoea (OSA) wait up to two years for a diagnostic test. Early diagnosis enables optimal treatment, mitigating risks including heart failure, lung disease, and stroke. Current diagnostic approaches are expensive (£391), time-consuming (\>1-hour interpretation), uncomfortable (cables/tubes/wires), and inequitable (multiple hospital visits). Overcoming all these limitations, we have designed and will investigate a straigh-to-test automated diagnostic pathway for OSA. This will use the AcuPebble, a miniature wearable acoustic sensor and the first regulated technology for automated, at-home diagnosis. The test is cheap (\< £100); time-saving; endorsed by patients, and accessible (posted directly to patients). This project will measure the impact of a potentially transformative, innovative, and scalable diagnostic pathway using AcuPebble technology.

Primary Outcome Measures: Time to diagnosis, Time to diagnosis vs. historical control group, 12 months
Secondary Outcome Measures: Cost saving per test, Cost saving per test in pounds sterling compared to control group, 12 months|Test completion rate, Completion rate as proxy for health equity, 12 months|Financial saving to patients from cutting journeys associated with appointments, Cost saved from averted journeys by per patient cost of public transport and time taken to travel; informed by mapping journey per patient post-code to sleep study centre., 12 months|Sustainability impacts by carbon footprint reduction, CO2 footprint from averted technologies (reduced plastic waste) and reduced patient journeys (CO2 footprint reduction from miles travelled, calculated using Echochain carbon footprint calculator)., 12 months|Time saving to patients from cutting journeys associated with appointments, Time saved from averted journeys by per patient cost of public transport and time taken to travel; informed by mapping journey per patient post-code to sleep study centre., 12 months
Dysferlinopathy Protein in Peripheral Blood Monocytes.
NCT Number: NCT06507215
Status: COMPLETED
Study Type: OBSERVATIONAL
Conditions: Muscular Dystrophies|Limb-Girdle Muscular Dystrophy Type 2B|Miyoshi Myopathy|Distal Myopathy With Anterior Tibial Onset
Interventions: DIAGNOSTIC_TEST: Protein analysis
Sponsor: Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 149
Study Design: Observational Model: |Time Perspective: p
Start Date: 2012-02-01
Completion Date: 2017-07-17
Locations: Eduard Gallardo Vigo, Barcelona, Cataluña, 08041, Spain

Summary:
The objective of the study is to answer the following important questions. Deficiency of the dysferlin protein is the cause of a very rare limb-girdle muscular dystrophy (LGMD-2B) that leads to significant disability. This disease is caused by mutations in the dysferlin gene. It is a recessive inherited disease, meaning that both copies of the gene must have mutations for the disease to develop. This study aims to analyze the frequency of carriers of a mutation in the DYSF gene in the Caucasian population. To achieve this, The investigator analyzed the blood of 100 healthy volunteers from their local area, quantifying the dysferlin protein in peripheral blood monocytes.

Primary Outcome Measures: Dysferlin Expression Levels by age and gender, Dysferlin expresion lels in monocytes by western blotting, 1 month
Secondary Outcome Measures: Identification of Carries by Protein Level, Identification of Carries by Protein Level, 1 month|Percentage of Predicted Carriers Showing Specific Genetic Mutations, Mutation Analysis of Predicted Carriers, 1 month|Percentage of DNA Methylation in Target Gene, DNA Methylation status of the DYSF locus in order to determine wether the reduced DYSF levels in carrier and disease range had an underlying epigenetic mechanism., 1 month
Comparison of Remimazolam and Propofol for Recovery of Ambulatory Upper Airway Surgery
NCT Number: NCT06507202
Status: RECRUITING
Study Type: INTERVENTIONAL
Phases: PHASE4
Conditions: Laryngeal Disease|Pharyngeal Diseases|Oral Cavity Disease|Nasal Disease
Interventions: DRUG: Remimazolam|DRUG: Propofol
Sponsor: Chung-Ang University Gwangmyeong Hospital
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 116
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: TRIPLE (PARTICIPANT, INVESTIGATOR, OUTCOMES_ASSESSOR)|Primary Purpose: TREATMENT
Start Date: 2024-01-22
Completion Date: 2025-03-22
Locations: ChungAng University Gwangmyeong Hospital, Gyeonggi-do, Gwangmyeon-si, 14353, Korea, Republic of

Summary:
The purpose of this study is to compare the effects of remimazolam and propofol on postoperative recovery time, complications, and safety in patients undergoing ambulatory upper airway surgery under general anesthesia.

Primary Outcome Measures: Fit-for-discharge time, Evaluated on a scale of 0 to 10 through the Modified Post Anesthetic Discharge Scoring System (MPADSS); a score of 9 or higher meets the discharge criteria., 15 minutes after surgery
Secondary Outcome Measures: Time to eye opening, time to extubate, time to postanesthetic care unit (PACU) transfer, Measured at operating room, using a timer from the end of surgery, 1 minute|postanesthetic care unit (PCAU) stay time, Day surgery center stay time, Measured from entering to exiting each units, 5 minutes|Incidence of adverse events, Including desaturation, laryngospasm, hypotension, bradycardia, hemodynamic agent administration, emergence agitation, headache, dizziness, somnolence, cough, shivering, postoperative nausea \& vomiting, 6 hours|Postoperative pain score, 11-point NRS (0-10); for the worst pain, 6 hours|modified Observer's Alertness/Sedation Scale (MOAA/S) at PACU arrival, Evaluated on a scale of 0 to 5, 30 minutes|modified Aldrete score at PACU arrival, Evaluated on a scale of 0 to 10, 30 minutes
Comparison of the Efficacy of Flexible Ureteroscope and Percutaneous Nephroscopic Surgery in the Treatment of 2-4cm Kidney Stones
NCT Number: NCT06507176
Status: RECRUITING
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Kidney Stone
Interventions: PROCEDURE: flexible ureteroscopic lithotripsy|PROCEDURE: percutaneous nephrolithotomy
Sponsor: The First Hospital of Jilin University
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 224
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: SINGLE (OUTCOMES_ASSESSOR)|Primary Purpose: TREATMENT
Start Date: 2024-07-21
Completion Date: 2026-11-15
Locations: Yanbowang, Ch'ang-ch'un, Jilin, 130000, China

Summary:
Urolithiasis is a common disease in urology. With the continuous progress of science and technology, the treatment of kidney lithiasis has undergone revolutionary changes, and the previously commonly used open surgical lithotomy method has been gradually eliminated, and replaced with less traumatic treatment methods. Percutaneous nephroscopy can theoretically treat the vast majority of kidney stones, especially in the treatment of kidney stones \> 2 cm, it is widely used. With the development of ureteroscopy technology, the adaptation of ureteroscopy for the treatment of kidney stones has been expanding, and people have gradually paid attention to it with less damage and higher safety. This study aims to evaluate whether the efficacy and safety of soft ureteral lithotomy in the treatment of 2-4cm kidney stones is equal to that of percutaneous nephrolithotomy through prospective randomized controlled clinical trials, so as to provide more choices for physicians and patients, and provide theoretical basis for the standardization of clinical practice and the rationality of treatment.

Primary Outcome Measures: Stone free-rate (SFR), Stone-free status is defined as the absence of any residual stone fragments or the presence of clinically meaningless residual stone fragments in the kidney, defined as ≤4mm, asymptomatic, non-obstructive, and non-infectious stone particles., All patients underwent a 2mm plain CT scan 1 month after surgery to assess final SFR.
Secondary Outcome Measures: Time of operation, Time of operation：From transurethral surgery to indwelling fistula or catheter., From transurethral surgery to indwelling fistula or catheter, assessed up to 6 hours.|Length of stay, Length of stay: from leaving the operating room to discharge, From leaving the operating room to discharge,assessed up to 1 month.|Postoperative complication, Postoperative complication：Any surgery-related adverse events that occurred during or less than one month after surgery, Any surgery-related adverse events that occurred during or less than one month after surgery.|Hospitalization costs, Hospitalization costs: Total costs during hospitalization, From admission to discharge,assessed up to 1 month.
The Effect of Breathing Exercise Applied With Incentive Spirometer
NCT Number: NCT06507163
Status: COMPLETED
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Breathing Exercises|Cardiac Surgery|Incentive Spirometry
Interventions: OTHER: The post-surgical breathing exercise group|OTHER: The pre- and post- surgical breathing exercise group
Sponsor: TC Erciyes University
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 75
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: NONE|Primary Purpose: SUPPORTIVE_CARE
Start Date: 2023-05-03
Completion Date: 2024-01-14
Locations: Sevda Korkut, Talas, Kayseri, 0(553) 310 49 51, Turkey

Summary:
It was conducted as a single-center, prospective, randomized controlled experimental study. Data were collected with the Introductory Information Form, Numerical Rating Scale, Physiological Parameters Follow-up Form and General Comfort Scale.

Primary Outcome Measures: Pain level, Evaluated with Numerical Rating Scale (NRS). NRS is a scale between 0 and 10., postop 1st and postop 5th day|Anxiety level, Evaluated with Numerical Rating Scale (NRS). NRS is a scale between 0 and 10., postop 1st and postop 5th day|Comfort level, It was evaluated with the General Comfort Scale. The scale is a four-point Likert type and contains a total of 48 items., postop 1st and postop 5th day|Partial oxygen pressure (PaO2), It is evaluated with a sample taken from arterial blood., postop 1st and postop 5th day|Forced Vital Capacity (FVC), It is measured with a device called spirometer., postop 5th day
AI-assisted Migraine Education: Efficacy, Safety and Patients' Acceptance
NCT Number: NCT06507150
Status: NOT_YET_RECRUITING
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Migraine
Interventions: OTHER: AI-assisted migraine education (AIME)
Sponsor: Ente Ospedaliero Cantonale, Bellinzona
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 140
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: NONE|Primary Purpose: OTHER
Start Date: 2024-09-01
Completion Date: 2026-08-31

Summary:
Migraine affects 1 in 7 people globally, significantly impacting quality of life and economic productivity. Despite its prevalence, limited awareness leads to misdiagnosis, inadequate treatment, and stigmatization. AI can enhance migraine management through improved diagnosis, prediction, and personalized education. The primary objective of this study is to determine if adding AI-assisted migraine education to standard education improves patients' understanding of their condition more effectively.

Primary Outcome Measures: The primary objective of this study is to ascertain if the addition of AI-assisted migraine education to standard migraine education yields a superior improvement in the patients' understanding of their condition., Difference in the proportion of correct responses to a set of 20 migraine-related questions via the Migraine Intel Quotient test score (MiQ score) between Standard Migraine Education (SME Group) and the AI-assisted migraine education added to Standard Migraine Education (AIME group) at 3 months after baseline., 3 months
Secondary Outcome Measures: Investigate if the two types of educations have persistent effect over time up to 6 months., To assess changes in the MiQ score from baseline to 3 months and to 6 months, and from 3 months to 6 months in the SME group and AIME group., 6 months|Evaluate the participants' subjective perception of each education experience, To report patients' evaluation of learning experience at 3 and 6 months after baseline in both SME and AIME groups by 10 Visual Analog Scale (VAS) scoring, and comparison between groups at each timepoint, 6 months|Investigate migraine clinical course following either education interventions, To assess changes in the number of monthly migraine days, migraine intensity, and migraine duration as well as the HIT-6 and MIDAS scores at 3 and 6 months after baseline in SME and AIME groups, and between SME and AIME groups at each time point., 6 months|Evaluate the frequency and the quality of adverse events (AEs) occurring during education interventions, To describe frequency and type of AEs occurring during the study period in SME and AIME groups.education interventions, 6 months
Rapid Examination of Acute CT
NCT Number: NCT06507124
Acronym: REACT
Status: RECRUITING
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Behavior
Interventions: OTHER: This is observational with no intervention
Sponsor: East Lancashire Hospitals NHS Trust
Collaborators: University of Central Lancashire
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 30
Study Design: Allocation: NA|Intervention Model: SINGLE_GROUP|Masking: NONE|Primary Purpose: HEALTH_SERVICES_RESEARCH
Start Date: 2024-03-01
Completion Date: 2025-03-01
Locations: East Lancashire Hospitals NHS Trust, Blackburn, BB23HH, United Kingdom

Summary:
CT scans are becoming increasingly prevalent in medicine. These are reviewed by radiologists and formal report provided. A recent survey suggests that non-radiologists are increasingly being expected to be able to interpret pathology on CT scans, however there is limited training provided in medical school and specialty training schemes.

This study aims to qualitatively analyse how non-radiologists of different seniority and specialties approach CT body scan interpretation. This will be done by recording participants as they look at a pre-selected CT scan.

The data will be reviewed with a thematic analysis. The eventual aim is to develop a CT interpretation system, which can be used by the non-radiologist to look for important pathology on a CT scan of the body

Primary Outcome Measures: Observe the difference in CT interpretation technique between traditionally trained radiology consultants and other clinicians of varying seniorities, Process of thematic analysis. The proposed study is using an inductive and latent level approach for the data analysis. This was selected as it allows the flexibility to look beyond what is being said. By combining the oral presentation with the manipulation of the image and the answering of key questions we feel there will be a better chance of appreciating the underlying cognitive approach being employed.

Open coding will be used for the transcript analysis. This allows them to be modified under the influence of more data.

Once preliminary themes have been proposed a review will be made to see which codes they address. Unlinked codes will prompt further analysis of the themes, considered of new themes or development of sub-themes. This iterative process continues with new data until a steady state is achieved and no new themes are being generated., 1 year
The Impact of Probiotics on Well-being in Women
NCT Number: NCT06507111
Acronym: ProWOME
Status: NOT_YET_RECRUITING
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Female|Healthy Aging
Interventions: DIETARY_SUPPLEMENT: Lab4P|OTHER: Placebo
Sponsor: Cultech Ltd
Collaborators: Comac Medical
Sex: FEMALE
Age: ADULT, OLDER_ADULT
Enrollment: 50
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: TRIPLE (PARTICIPANT, INVESTIGATOR, OUTCOMES_ASSESSOR)|Primary Purpose: SUPPORTIVE_CARE
Start Date: 2024-07
Completion Date: 2025-02
Locations: Comac Medical, Sofia, Bulgaria

Summary:
An exploratory study to determine whether daily supplementation with a probiotic product impacts the overall well-being of women aged between 45 - 65

Primary Outcome Measures: Quality of Life Questionnaire, Quality of life questionnaire to evaluate the participants quality of life post probiotic supplementation. This QoL questionnaire uses a non-numeric, 5-point scale, ranking the presence and severity of symptoms as "none, mild, moderate, severe, and extremely severe"., At Day 1, Day 56 and Day 112 ± 3 after trial start|Sleep Quality Questionnaire, Sleep quality questionnaire to measure the participants quality of sleep post probiotic supplementation. This sleep questionnaire uses the Athens Insomnia Scale and reports sleep quality using select phrases, and not a scored scale, such as "no problem, minor problem, considerable problems, serious problems". These phrases are question dependent., At Day 1, Day 56 and Day 112 ± 3 after trial start|Mood Questionnaire, Mood questionnaires to evaluate the participants mood post probiotic supplementation. This mood questionnaire is based off the Hospital Anxiety Depression Scale (HADS) and uses a four point scale for severity ranging from "0 - 3" with 0 being the lowest symptom severity and 3 being the highest symptom severity., At Day 1, Day 56 and Day 112 ± 3 after trial start
Secondary Outcome Measures: Weekly Well-being Diary, Weekly well-being diary to evaluate the participants general well-being post probiotic supplementation. This well-being diary records the frequency of days in the week that symptoms were experienced, this is between 1 - 7., Days 1, 7, 14, 21, 28, 35, 42, 49, 56, 63, 70, 77, 84, 91, 98, 105 and 112|Bacterial composition of faecal samples via sequencing, Shotgun metagenomic sequencing analysis to assess the bacterial composition of the faecal microbiome., At Day 1 and Day 112 ± 3 after trial start|Bacterial composition of vaginal samples via sequencing, Shotgun metagenomic sequencing analysis to assess the bacterial composition of the vaginal microbiome., At Day 1 and Day 112 ± 3 after trial start|Blood plasma analysis for plasma lipids, Blood plasma samples analysed for plasma lipids such as cholesterol and triglycerides., At Day 1 and Day 112 ± 3 after trial start|Blood plasma analysis inflammatory markers, Blood plasma samples analysed for plasma inflammatory markers such as IL-1B, TNFa, IL6, IL8, CCL2., At Day 1 and Day 112 ± 3 after trial start
Effectiveness of Telematic Instruction to Patients in the Correct Performance of Respiratory Polygraphy at Home
NCT Number: NCT06507098
Status: COMPLETED
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Obstructive Sleep Apnea of Adult
Interventions: OTHER: Video-assisted training|OTHER: Nurse training
Sponsor: Consorci Sanitari del Maresme
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 216
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: NONE|Primary Purpose: DIAGNOSTIC
Start Date: 2023-05-01
Completion Date: 2024-02-28
Locations: Mateu Serra-Prat, Mataró, Barcelona, 08304, Spain

Summary:
The objective of this trial is to evaluate the use of a video-assisted training for the use of a home-respiratory polygraph for the diagnosis of obstructive sleep apnea compared to standard training by a nurse.

A clinical trial is conducted to this effect. One arm is video-assisted training and the other arm is conventional training by a nurse.

Primary Outcome Measures: Number of valid respiratory polygraphies, Number of studies without recording errors, 1 day
Secondary Outcome Measures: Personal care time used in the training of the procedure, Minutes of caregiver's time spent in the instruction, 1 day|Satisfaction with the instruction, Satisfaction of the patients with the instruction measured by an analogic visual scale (0-10), 1 day
Adaptive Rock Climbing
NCT Number: NCT06507072
Status: NOT_YET_RECRUITING
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Congenital Upper Limb Differences
Interventions: BEHAVIORAL: Adaptive Rock Climbing Program
Sponsor: Children's Hospital Los Angeles
Sex: ALL
Age: CHILD
Enrollment: 20
Study Design: Allocation: NA|Intervention Model: SINGLE_GROUP|Masking: NONE|Primary Purpose: SUPPORTIVE_CARE
Start Date: 2024-08-31
Completion Date: 2026-05-31
Locations: Children Hospital Los Angeles, Los Angeles, California, 90027, United States

Summary:
The goal of this clinical trial is to assess changes in functional and psychosocial outcomes following a 12-week adaptive rock-climbing program for children with congenital upper limb differences. The main questions it aims to answer are

* Assess functional outcomes following a 12-week adaptive rock-climbing program.
* Assess psychosocial outcomes following a 12-week adaptive rock climbing program.
* Assess barriers to participation in adaptive sports.

Participants will complete 12-week adaptive rock climbing program.

Primary Outcome Measures: Change from Baseline in Range of Motion at 12 Weeks, An occupational therapist will measure the passive and active range of motion. These measurements will be conducted for the following: shoulder flexion, shoulder abduction, shoulder internal rotation, shoulder external rotation, elbow flexion/extension, forearm supination, forearm pronation, wrist extension, and wrist flexion. This will be measured in degrees., Baseline and 12 weeks|Change from Baseline in KINDL Scores at 12 Weeks, The KINDL questionnaire will be completed by both child and parent. It includes 24 Likert-scaled items associated with emotional well-being and self-esteem. Questionnaires will be scored according to instructions provided by KINDL., Baseline and 12 weeks|Change from Baseline in Muscle Testing at 12 Weeks., Manual muscle testing will be measured by an occupational therapist. This will be measured from grade 0 to 5., Baseline and 12 weeks|Change from Baseline in PROMIS Life Satisfaction Scores at 12 Weeks., To assess positive affect and well-being, children and parents will complete the PROMIS Pediatric Life Satisfactions v1.0 8-item Short Form. Patients will respond to statements such as "I was satisfied with my life," on a scale of 1 "Not at all" to 5 "Very much.", Baseline and 12 weeks|Change from Baseline in PROMIS Pediatric Global Health Scores at 12 Weeks, To gain a general view of participants' perception of their own physical, emotional, and relational health, children will also be asked to complete the PROMIS Pediatric Global Health v1.0 7-item Short Form. Participants will respond to 7 statements on a scale of 5 "Excellent" to 1 "Poor.", Baseline and 12 weeks
Secondary Outcome Measures: Assess Barriers to Participation in Adaptive Sports, Identify common transportation barriers through a demographic survey with transportation questions., At 12 weeks (post-intervention)
Health Education for Preventing Falls in Older Adults Living in the Community
NCT Number: NCT06507020
Status: NOT_YET_RECRUITING
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Accidental Falls|Older Adults
Interventions: BEHAVIORAL: Fall prevention knowledge education|BEHAVIORAL: Exercise education|BEHAVIORAL: Home hazard reduction education
Sponsor: Guangzhou Center for Disease Control and Prevention
Collaborators: Southern Medical University, China
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 888
Study Design: Allocation: RANDOMIZED|Intervention Model: FACTORIAL|Masking: DOUBLE (INVESTIGATOR, OUTCOMES_ASSESSOR)|Primary Purpose: PREVENTION
Start Date: 2024-08-01
Completion Date: 2025-08-01

Summary:
This clinical trial aims to evaluate the effectiveness of three health education intervention modules in preventing falls among older adults living in the community. The study is designed as a factorial randomized controlled trial, assessing the impact of three health education intervention modules: Fall prevention knowledge education，Exercise education, and Home hazard reduction education. Each module will have a 'yes' and 'no' version, resulting in eight experimental conditions.

The primary questions it seeks to address are: (1) What is the main effect of different health education intervention modules on preventing falls in older adults living in the community? (2)What is the interactive effect of different health education intervention modules on preventing falls in older adults living in the community?

The trial will be conducted in twenty four sub-district in Baiyun District, Guangzhou City. An estimated 37 participants will be recruited from each of the 24 sub-districts, with the sub-districts being randomly assigned to one of the eight experimental groups by a statistician independent of the research team using computer-generated random numbers.

Primary Outcome Measures: The rate of falling in each group, Falls will be monitored with supplied monthly fall diaries., Baseline, 6-month, 12-month
Secondary Outcome Measures: Fall efficacy in each group, Fall efficacy will be monitored with 'Falls Efficacy Scale International, FES-I', and each item is scored on a scale of 1 to 4 (from "not at all confident" to "very confident"), with a total score of 16 to 64, with higher scores indicating a greater sense of fall efficacy or self-confidence., Baseline, 6-month, 12-month|Quality of life in each group, Quality of life will be monitored with 'the 12-item MOS Short-form Health Survey version 2, SF-12 V.2'. All entries except 1, 8, 9 and 10 are positively scored and the total score is calculated by the scale's unique standardised method, with a minimum score of 0 and a maximum score of 100, Baseline, 6-month, 12-month
Genetic and Epigenetic Background of Inner Ear Dysfunction in Turner Syndrome
NCT Number: NCT06507007
Status: NOT_YET_RECRUITING
Study Type: OBSERVATIONAL
Conditions: Sensorineural Hearing Loss|Turner Syndrome|Inner Ear Disease
Sponsor: Gødstrup Hospital
Collaborators: University of Aarhus|Aarhus University Hospital
Sex: FEMALE
Age: ADULT
Enrollment: 150
Study Design: Observational Model: |Time Perspective: p
Start Date: 2024-09-01
Completion Date: 2027-07-30

Summary:
The goal of this case-control study is to pave the way for new revolutionary treatment measures within hearing loss that could either replace or delay the need for hearing aids. The study focuses on people with Turner syndrome (TS).

The aim is to find out if there are specific DNA methylation patterns and/or RNA expression profiles linked to sensorineural hearing loss (SNHL) in people with TS. Additionally, the structure and function of the inner ear in these individuals will be examined to see if there is a connection to their epigenetic profile.

The main question it aims to answer is: Does epigenetics constitute a common denominator for some of the unexplained SNHL cases?

Turner Syndrome (TS) represents an ideal model for studying epigenetics related to sensorineural hearing loss (SNHL).

Participants will undergo the following tests:

* Ear examinations
* Hearing tests
* Balance tests
* Blood tests
* MRI scans
* CBCT (cone-beam computed tomography) scans

Primary Outcome Measures: Epigenetic profile, DNA methylation analyses are conducted on the purified DNA. RNA expression analyses and ChIP-seq are performed on the purified RNA. Based on this, the epigenetic profile will be mapped to identify consistent differences associated with SNHL., 2024-2026
Secondary Outcome Measures: Hearing ability, Hearing level thresholds and bone conduction is assesed by pure tone audiometry., 2024-2026|Vestibular status, The vestibular function is assessed using the video head impulse test (vHIT), vestibular evoked myogenic potentials, and posturography., 2024-2026|Structural malformations, Anatomy and inner ear malformations are examined using Conebeam CT and MRI., 2024-2026
A Study of HRS-9057 in Patients With Heart Failure and Volume Overload
NCT Number: NCT06506994
Status: NOT_YET_RECRUITING
Study Type: INTERVENTIONAL
Phases: PHASE1
Conditions: Heart Failure With Volume Overload
Interventions: DRUG: HRS-9057|DRUG: HRS-9057|DRUG: Tolvaptan
Sponsor: Fujian Shengdi Pharmaceutical Co., Ltd.
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 24
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: NONE|Primary Purpose: TREATMENT
Start Date: 2024-07-15
Completion Date: 2024-10-20
Locations: The Second Affiliated Hospital of Guangzhou Medical University, Guangzhou, Guangdong, 510285, China

Summary:
The study is an open-label, Tolvaptan-controlled Phase I study to evaluate the safety, tolerability, PK/PD profile and efficacy of HRS-9057 in the treatment of heart failure with volume overload. A total of 24 subjects who experience volume overload due to heart failure despite diuretic treatment will be enrolled in the study and receive HRS-9057 injection or Tolvaptan tablets.

Primary Outcome Measures: The incidence and severity of any adverse events (AEs), baseline up to Day 14
Secondary Outcome Measures: Tmax for HRS-9057, Predose on Day 1 through Day 6|Cmax for HRS-9057, Predose on Day 1 through Day 6|Daily urine volume, Predose on Day 1 through Day 7|Daily fluid balance, Daily fluid balance is calculated by subtracting daily urine volume from daily fluid intake., Predose on Day 1 through Day 7|Serum sodium concentration, Predose on Day 1 through Day 6|Serum osmolality, Predose on Day 1 through Day 6|Urine osmolality, Predose on Day 1 through Day 7|Body weight, baseline to Day 8|Lower limb edema change from baseline, The severity of edema in the subject's tibial border or dorsum of the foot will be assessed in the sitting position using a 4-point scale (0-absent, 1-mild, 2-moderate and 3-severe) by the investigator. The percentage of subjects in whom the lower limb edema was improved or worsening at Day 8 will be evaluated., baseline to Day 8|Jugular venous distension change from baseline, Whether or not the subject has jugular venous distension will be documented. If distension is observed, the vertical height (in centimeters) from the sternal angle to the highest point of pulsation of the internal jugular vein will be documented and the change from baseline to Day 8 will be evaluated., baseline to Day 8|Pulmonary congestion change from baseline, The investigator will perform chest X-ray at baseline and Day 8 to assess the severity of pulmonary congestion using a 4-point scale (0-absent, 1-mild, 2-moderate and 3-severe). The percentage of subjects in whom pulmonary congestion was improved or worsening at Day 8 will be evaluated., baseline to Day 8|New York Heart Association (NYHA) classification change from baseline, baseline to Day 8
Ergonomics in the Cardiac Catheterization Laboratory
NCT Number: NCT06506968
Acronym: ERGO-CATH
Status: RECRUITING
Study Type: OBSERVATIONAL
Conditions: Ergonomics|Orthopedic Injury|Wellness
Sponsor: Brigham and Women's Hospital
Collaborators: Rampart ic, LLC
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 30
Study Design: Observational Model: |Time Perspective: p
Start Date: 2024-05-13
Completion Date: 2024-12
Locations: Brigham and Women's Hospital, Boston, Massachusetts, 02115, United States

Summary:
The goal of this observational study is to quantify ergonomic risk associated with traditional protective equipment in operators working in the cardiac catheterization laboratory as compared with a mobile protection system. The main questions it aims to answer is:

What is the mean time spent by operators in positions of high ergonomic postural risk during cases?

Participants will wear IMU, EMG, and radiation sensors, as well as complete baseline and discomfort surveys for several catheterization procedures.

Primary Outcome Measures: Mean time spent in positions of high ergonomic risk, This is a directly measurable endpoint utilizing the position and time data acquired from the IMU sensor system and this endpoint will be compared with and without the use of lead protective gear as well as across procedure category and physician reported case complexity. The investigators will report mean time spent in different ergonomic postures stratified by the Rapid Upper Limb Assessment scoring model (1-mild, 2-moderate, 3-high risk, 4-very high risk)., May 2024 - December 2024
Secondary Outcome Measures: Mean self-reported musculoskeletal discomfort, Participants will report discomfort after each case using a modified cornell muscular discomfort survey. Participants will rate their discomfort from slightly uncomfortable to very uncomfortable., May 2024 - December 2024
Futibatinib in Patients Previously Enrolled in an Antecedent Futibatinib as Monotherapy or Combination Therapy.
NCT Number: NCT06506955
Status: ENROLLING_BY_INVITATION
Study Type: INTERVENTIONAL
Phases: PHASE2|PHASE3
Conditions: Advanced/Metastatic Cancer
Interventions: DRUG: futibatinib|DRUG: futibatinib, fulvestrant
Sponsor: Taiho Oncology, Inc.
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 15
Study Design: Allocation: NON_RANDOMIZED|Intervention Model: SINGLE_GROUP|Masking: NONE|Primary Purpose: TREATMENT
Start Date: 2024-09-16
Completion Date: 2026-12-31
Locations: University of California, San Francisco (UCSF), San Francisco, California, 94143, United States

Summary:
This is a nonrandomized, open-label, multicenter rollover study for patients who received futibatinib as monotherapy or as combination therapy in a Taiho-sponsored futibatinib study.

Primary Outcome Measures: Number of participants with serious adverse events, treatment-related adverse events, and any AEs leading to treatment discontinuation graded according to NCI-CTCAE v5.0., To collect long term safety information in patients continuing to receive treatment with futibatinib as monotherapy or in combination with fulvestrant who participated in a Taiho-sponsored futibatinib study and who are deriving clinical benefit with no undue risk, through study completion, an average of 5 years
Tricuspid Heart Valve Replacement Study
NCT Number: NCT06506942
Acronym: TRICURE EFS
Status: NOT_YET_RECRUITING
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Tricuspid Valve Regurgitation|Heart Valve Diseases|Cardiovascular Diseases
Interventions: DEVICE: Transcatheter Tricuspid Valve Replacement
Sponsor: TRiCares
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 10
Study Design: Allocation: NA|Intervention Model: SINGLE_GROUP|Masking: NONE|Primary Purpose: TREATMENT
Start Date: 2024-10
Completion Date: 2030-10
Locations: University of Michigan Hospital and Health Systems, Ann Arbor, Michigan, 48109, United States|Columbia University Medical Center/ NewYork Presbyterian Hospital, New York, New York, 10032, United States

Summary:
Prospective, multi-center study to assess safety and performance of the TRiCares Topaz Tricuspid Valve Replacement System

Primary Outcome Measures: Composite of MAE, Composite rate of major adverse events (MAEs) at 30 days, including mortality, myocardial infarction, stroke and major complications., 30 day post-intervention|Device Success, Device success defined as a reduction in tricuspid regurgitation immediately post-intervention, immediately post-intervention
Secondary Outcome Measures: Six minute walk test, Change in distance (m) compared to baseline assessment, 30 days, 6 months, annual for five years post-intervention|Reduction in Tricuspid Regurgitation (TR) Grade, Number of patients presenting with reduction in TR grade compared to baseline assessment, 30 days, 6 months, annual for five years post-intervention|New York Heart Association (NYHA) Function Class, Number of patients presenting with improvement in NYHA classification, 30 days, 6 months, annual for five years post-intervention
Task Specific Training for Advanced Multiple Sclerosis
NCT Number: NCT06506929
Status: RECRUITING
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Multiple Sclerosis
Interventions: OTHER: Task specific physical therapy
Sponsor: Hunter College of City University of New York
Collaborators: Multiple Sclerosis Foundation
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 15
Study Design: Allocation: NA|Intervention Model: SINGLE_GROUP|Masking: NONE|Primary Purpose: TREATMENT
Start Date: 2024-07-10
Completion Date: 2026-01
Locations: Hunter College, Physical Therapy Department, City University of New York, New York, New York, 10010, United States

Summary:
The purpose of this study is to find effective physical therapy treatments for individuals who have severe multiple sclerosis. Physical therapy treatments for mild-to-moderate multiple sclerosis exists, however, very limited research has been done for physical therapy for severe multiple sclerosis (MS). In this study 10 participants diagnosed with severe MS will engage in 1-hour physical therapy sessions twice a week for 6 weeks to address limitations in standing, balancing, and bed mobility.

Primary Outcome Measures: Multiple Sclerosis Physical Frailty Functional Assessment (MSPFFA), Assessment of ability to perform functional mobility tasks. The MSPFFA is a 14 item ordinal scale; the maximum score is a 56, minimom score is 14. The higher the score, the better the function and the less physically frail the person being tested is considered to be., Will be administered twice, once at pre-intervention and once at post-intervention. The length of the intervention is 6 weeks.
Secondary Outcome Measures: Multiple Sclerosis Impact Scale-29 (MSIS29), Self report measure of the impact of MS on the participant. The MSIS-29 is 29 item self report measure. The higher the score, the greater the impact of MS on the person person reporting bleives they have.The score is rated from 0-100 with the higher score indicating a greater impact on the individual from MS., Will be administered twice, once at pre-intervention and once at post-intervention. The length of the intervention is 6 weeks.