pankajmathur/National_Library_of_Medicine_Studies_data huggingface dataset:
A Pilot Clinical Study to Evaluate the Feasibility of Using the SPC Test
NCT Number: NCT06521528
Status: ACTIVE_NOT_RECRUITING
Study Type: OBSERVATIONAL
Conditions: Gastric Cancer
Interventions: DEVICE: nProfiler I Stomach Cancer Assay Kit
Sponsor: Novomics. Co., Ltd.
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 237
Study Design: Observational Model: |Time Perspective: p
Start Date: 2019-09-01
Completion Date: 2025-12-31
Locations: Novomics. Co., Ltd., Seoul, 07217, Korea, Republic of

Summary:
Precision medicine approaches emphasize the importance of reliable prognostic tools for guiding individualized therapy decisions. In this study, we evaluated the clinical feasibility of the Single Patient Classifier (SPC) test, a new clinical-grade prognostic assay, in stage II-III gastric cancer patients.

Primary Outcome Measures: Timely delivered proportion, the proportion of the cases in which the test results were timely delivered before selecting postoperative treatment, 14 days
Secondary Outcome Measures: 3-year disease free survival of the enrolled patients., Statistical significance (P value of \<0.05), 3-years after the enrollment completion|5-year overall survival of the enrolled patients., Statistical significance (P value of \<0.05), 5-years after the enrollment completion
SIMPLAAFY Clinical Trial
NCT Number: NCT06521463
Acronym: SIMPLAAFY
Status: NOT_YET_RECRUITING
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Atrial Fibrillation|Stroke|Bleeding
Interventions: DEVICE: WATCHMAN FLX Pro LAAC Device
Sponsor: Boston Scientific Corporation
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 1857
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: SINGLE (OUTCOMES_ASSESSOR)|Primary Purpose: PREVENTION
Start Date: 2024-09
Completion Date: 2026-09

Summary:
The primary objective is to demonstrate the safety and effectiveness of two monotherapy regimens versus dual antiplatelet (DAPT) therapy following post-implant with the WATCHMAN FLX Pro device in a commercial clinical setting.

Primary Outcome Measures: Reduced dose NOAC Arm Primary Endpoint: Composite rate of all death, all stroke, systemic embolism, and ISTH major bleeding at 6-months after randomization in the reduced dose NOAC arm tested for non-inferiority compared to the DAPT arm, Non Inferiority, 6 months after randomization|Aspirin Arm Primary Endpoint: Composite rate of all death, all stroke, systemic embolism, and ISTH major bleeding at 6-months after randomization in the Aspirin arm tested for non-inferiority compared to the DAPT arm., Non Inferiority, 6 months after randomization
Concurrent Surgery for Prolapse and Stress Urinary Incontinence to Reduce Further Surgery for Incontinence
NCT Number: NCT06521450
Status: NOT_YET_RECRUITING
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Stress Urinary Incontinence
Interventions: PROCEDURE: anti incontinence surgery
Sponsor: Shalamar Institute of Health Sciences
Sex: FEMALE
Age: ADULT, OLDER_ADULT
Enrollment: 130
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: NONE|Primary Purpose: TREATMENT
Start Date: 2024-10
Completion Date: 2025-03

Summary:
Urinary incontinence is a common and distressing medical condition which affects 26% of women in developing countries.Globally upto 54% women suffer from pelvic organ prolapse and stress urinary incontinence concomitantly.Women with coexisting stress incontinence have a 40% risk of undergoing subsequent surgery for postoperative stress incontinence and woem with occult incontinence have a 15% risk.Overall,there is sufficient evidence that for women who are symptomatic of stress incontinence and prolapse,concomitant vaginal surgery for both problems is beneficial for reducing postoperative incontinence.However,it must be borne in mind that in woen undergoing vaginal prolapse surgery alone,almost 1/3 may experience cure of incontinence symptoms and despite concomitant continence surgery,stress urinary incontinence persist in approximately 1/3 of women.This study will be conducted to assess whether women with polpase and stress urinary incontinence could benefit from combined surgery in regards of requiring further surgery for stress incontinence.

Primary Outcome Measures: symptomatic stress urinary incontinence requiring surgery at six months, at six months after surgery
Secondary Outcome Measures: quality of life parameters.It will be assessed using ICIQ-UI short form questionnaires, 0-12 score will show improved quality of life while 13-21 will show impaired quality, 1 week,6 week and six month after surgery
Hippocampal Network Function in Epilepsy
NCT Number: NCT06521437
Status: ENROLLING_BY_INVITATION
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Mesial Temporal Lobe Epilepsy
Interventions: DEVICE: TMS targeting the hippocampus indirectly via its network
Sponsor: University of Chicago
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 34
Study Design: Allocation: NA|Intervention Model: SINGLE_GROUP|Masking: NONE|Primary Purpose: BASIC_SCIENCE
Start Date: 2024-07-01
Completion Date: 2028-12
Locations: University of Chicago, Chicago, Illinois, 60637, United States

Summary:
The aim of this pilot study is to understand hippocampal network function in mesial temporal lobe epilepsy (MTLE) and to test whether transcranial magnetic stimulation (TMS) targeting the network of the hippocampus can change hippocampal-dependent memory task performance and epileptic activity in people with (MTLE). Positive findings would implicate the hippocampal network as a source of these typical primary MTLE symptoms.

Subjects with a primary diagnosis of MTLE will be enrolled in a non-randomized, non-blinded pilot experiment to test target engagement and preliminary efficacy of a novel neurostimulation approach targeting the hippocampal network. At baseline, subjects will undergo neurocognitive testing for hippocampal-dependent memory and functional magnetic resonance imagining (fMRI) neuroimaging assessment of brain structure and task-dependent activity. They will also receive scalp-electroencephalography (EEG) to measure interictal epileptiform discharge (IED) frequency at baseline, and will complete a seizure diary for one month. They will then receive high-frequency repetitive TMS targeting an area of parieto-occipital cortex defined based on fMRI connectivity with the hippocampus measured at baseline. The baseline assessments will then be repeated, using an alternate form of the memory test. The investigators will analyze changes from baseline in memory task performance, fMRI activity of the hippocampal network, IED frequency, and reported seizure frequency.

Primary Outcome Measures: Epileptic activity (IEDs), Scalp EEG is used to measure IEDs, identified via clinical assessment and quantified, Measured at baseline and 1 day after stimulation
Secondary Outcome Measures: Memory task performance, Subjects memorize word pairs and then attempt to recall the missing word given one item from each pair after a delay. Total number of words pairs recalled will be measured., The memory task is administered at baseline and 1 day after the last stimulation session. Recall will be measured approximately 15 minutes after seeing the word pairs.|fMRI connectivity of the hippocampal network, Subjects will undergo MRI neuroimaging assessment of brain structure and resting-state function. The correlation between the hippocampus and parietal cortex will be measured., First day of study (baseline session) and 1 day after last stimulation session.|Seizure frequency reported in seizure diary, Subjects will complete an online seizure diary daily. Number of daily seizures reported will be measured., From the baseline session to 30 days following the post-treatment sessions
The Effects of a Novel Nutritional Product on Nutrient Gaps and Gut Health in Active Adults
NCT Number: NCT06521424
Status: RECRUITING
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Gastrointestinal Microbiome|Nutrition, Healthy|Exercise
Interventions: DIETARY_SUPPLEMENT: AG1 - Nutritional Supplement|DIETARY_SUPPLEMENT: Placebo
Sponsor: Athletic Greens International
Sex: ALL
Age: ADULT
Enrollment: 20
Study Design: Allocation: RANDOMIZED|Intervention Model: CROSSOVER|Masking: TRIPLE (PARTICIPANT, INVESTIGATOR, OUTCOMES_ASSESSOR)|Primary Purpose: OTHER
Start Date: 2024-08-01
Completion Date: 2024-12-31
Locations: Hofstra University, Hempstead, New York, 11549, United States

Summary:
This study is a randomized, double-blind, placebo-controlled study of N=20 active men and women. This study to assess the effect of a novel dietary supplement on improving nutrient gaps and the gut microbiome.

Primary Outcome Measures: Gut Microbiome, Examine changes in the gut microbiome via fecal polar metabolomics measured by LC/MS, 14 days|Nutrient Gaps, Assess nutrient gaps by dietary record assessment utilizing The Automated Self-Administered 24-hour (ASA24®) Dietary Assessment Tool, 14 days
Secondary Outcome Measures: Exploratory Digestive Measures, A Digestive Quality of Life Questionnaire (DQLQ) will be utilized to assess the effect of the interventions on participant's digestive health. Scores range from 0 to 9 with a higher score indicating worse digestion associated with quality of life, 14 days
Pilot Subsidized and Culturally-adapted Community Supported Agriculture (CSA) Program
NCT Number: NCT06521411
Status: COMPLETED
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Diet Habit
Interventions: BEHAVIORAL: CSA model
Sponsor: NYU Langone Health
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 38
Study Design: Allocation: NA|Intervention Model: SINGLE_GROUP|Masking: NONE|Primary Purpose: PREVENTION
Start Date: 2022-05-24
Completion Date: 2022-11-01
Locations: NYU Langone Health, New York, New York, 10016, United States

Summary:
This study aims to apply community-engaged methods to refine and implement a culturally adapted systems-level program for improving diet in low income, Chinese American immigrants. Guided by the regular partner engagement, The researchers have organically developed a systems-level program to bring a subsidized community-supported agriculture (CSA) model to the community in a way that is aligned with cultural values, and that includes culturally appropriate produce and nutrition education.

This is a single-site proof of concept pilot program that will be evaluated using a pre-post-design.

Primary Outcome Measures: Change in Number of Different Vegetables Consumed, Diet quality will be self-reported via a follow-up survey. The participant is presented with a list of 29 different vegetables - he/she is asked to select all of the vegetables in the list that was consumed in the past month., Baseline, Week 20|Change in Diet Quality - Frequency, Diet quality will be self-reported via a follow-up survey. Frequency (how often vegetables were consumed in the past month) is reported on a Likert scale: 1 = once a month, 2 = two or three times a month, 3 = once a week, 4 = more than once a week., Baseline, Week 20|Change in Diet Quality - Quantity of Serving, Diet quality will be self-reported via a follow-up survey. Quantity of Serving (how much is consumed at a time) is reported on a Likert Scale: 1 = less than ¼ cup, 2 = ¼ to ½ cup, and 3 = more than ½ cup., Baseline, Week 20
Secondary Outcome Measures: Change in Food Insecurity Score, Food insecurity will be self-reported via a follow-up survey. The survey consists of 2 questions, reported on a Likert scale: 1 = often true, 2 = sometimes true, 3 = never true. The total range of score is 2-6; the higher the score, the lesser the insecurity., Baseline, Week 20|Change in Social Cohesion Score, Social cohesion will be self-reported via a follow-up survey. The survey consists of 3 questions, reported on a Likert scale: 0 = often, 1 = some of the time, 2 = hardly ever, 3 = never. The total score range is 0-9; the higher the score, the greater the sense of social cohesion., Baseline, Week 20
Postpartum Care in the NICU (PeliCaN) Transitions
NCT Number: NCT06521398
Acronym: PeliCaN
Status: NOT_YET_RECRUITING
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Stress Disorders, Post-Traumatic|Premature Birth|Postpartum Depression|Postpartum Anxiety
Interventions: OTHER: Doula Support
Sponsor: University of Pennsylvania
Sex: FEMALE
Age: CHILD, ADULT, OLDER_ADULT
Enrollment: 20
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: NONE|Primary Purpose: SUPPORTIVE_CARE
Start Date: 2024-08
Completion Date: 2027-08
Locations: Hospital of the University of Pennsylvania, Philadelphia, Pennsylvania, 19104, United States

Summary:
This is a randomized controlled trial of a dyad-centered, doula support and healthcare coordination model of care in a large urban neonatal intensive care unit (NICU), which serves a high-risk, low-income, majority Black population. In addition to doula support and coordination of care in the NICU, there will be a warm handoff to a community doula to continue the support once infants leave the Hospital of the University of Pennsylvania (HUP) NICU.

Primary Outcome Measures: Difference in Post Traumatic Stress Disorder Scores at 6 months postpartum, This will measured by the PTSD Checklist for DSM-5 (PCL-5) is a 20-item self-report measure that assesses the 20 DSM-5 symptoms of PTSD. The symptom severity score ranges from 0-80 with 80 being a worse score., 6 months|Number of participants who have attendance with a primary care provider by 6 months postpartum, This will be assessed using the electronic health record and via survey and medical record review of outsider records., 6 months
Secondary Outcome Measures: Difference in Depression scores at 6 months postpartum, Edinburgh Postnatal Depression Scale, higher scores reflect higher risk of depression, ranges from 0-30. A score of 13 is indicative of high risk for depression., 6 months|Receipt of ACOG-recommended postpartum care by patient's designated provider, Comparison between two groups, this will be coded as a Yes or No variable, 12 weeks postpartum
Comparison of Non-invasive Respiratory Monitoring System (RMS) to Capnography for Respiratory Rate (RR)
NCT Number: NCT06521385
Status: COMPLETED
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Respiratory Monitoring
Interventions: DEVICE: Makani Science Respiratory Monitoring System
Sponsor: Makani Science
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 32
Study Design: Allocation: NA|Intervention Model: SINGLE_GROUP|Masking: NONE|Primary Purpose: BASIC_SCIENCE
Start Date: 2024-05-17
Completion Date: 2024-07-02
Locations: Illumination Foundation, Fullerton, California, 92833, United States

Summary:
The goal of this clinical trial is to compare the performance of a novel non-invasive respiratory monitoring system against the gold standard methods (capnography) in human subjects. The main question it aims to answer is whether the novel monitoring system comparable to the current standards.

Primary Outcome Measures: Respiratory Rate Accuracy Compared Between Experimental and Reference Devices, Accuracy (mean absolute error) of the subject respiratory rate (breaths/minute) measured by the Makani Science system (experimental device) compared against respiratory rate measured by capnography (reference device) for minute long segments., 1 hour
Secondary Outcome Measures: Respiratory Rate Bias Compared Between Experimental and Reference Devices, Bias of the subject respiratory rate (breaths/minute) measured by the Makani Science system (experimental device) compared against respiratory rate measured by capnography (reference device) for minute long segments., 1 hour|Makani Science System Performance after Simulated Breathing Artifacts, Accuracy (mean absolute error) of the subject respiratory rate (breaths/minute) measured by the Makani Science system (experimental device) compared against respiratory rate measured by capnography (reference device) after subject performed simulated breathing maneuvers., 15 minutes|Makani Science System Performance after Position Change, Accuracy (mean absolute error) of the subject respiratory rate (breaths/minute) measured by the Makani Science system (experimental device) compared against respiratory rate measured by capnography (reference device) after the subject shifts position., 15 minutes
The Aim of This Study is to Determine if Oocyte Sorting for Group Culture Using an Artificial Intelligence Image Analysis Tool (MagentaTM) Increases the Usable Blastocyst Yield and Subsequent Pregnancy in Patients Undergoing IVF
NCT Number: NCT06521372
Acronym: NiOS
Status: RECRUITING
Study Type: OBSERVATIONAL
Conditions: Infertility Primary
Interventions: OTHER: Magenta AI image analysis tool
Sponsor: Ovation Fertility
Collaborators: Future Fertility
Sex: ALL
Age: CHILD, ADULT, OLDER_ADULT
Enrollment: 450
Study Design: Observational Model: |Time Perspective: p
Start Date: 2024-01-01
Completion Date: 2027-01-02
Locations: Ovation Fertility Las Vegas, Las Vegas, Nevada, 89113, United States|Ovation Fertility Cincinnati, Cincinnati, Ohio, 45209, United States|Ovation Fertility - Nashville, Nashville, Tennessee, 37203, United States

Summary:
The aim of this study is to determine if oocyte sorting for group culture using an artificial intelligence image analysis tool (MagentaTM) increases the usable blastocyst yield and subsequent pregnancy in patients undergoing IVF.

Primary Outcome Measures: Compare blastocyst development rate, Blast Development rates between oocytes (and resulting embryos) that are group cultured according to MagentaTM scores versus oocytes (and resulting embryos group) cultured as per the standard of care following random sorting. Blastocyst development is defined by an embryologist's grading, according to the laboratory's grading system., 5 to 7 days
Secondary Outcome Measures: Fertilization Rate, within each MagentaTM score group and random sorting groups., 1Day|Morphological Blastocyst Quality, within each MagentaTM score group and random sorting groups., 7 days|Euploidy Rate, within each MagentaTM score group and random sorting groups., 14 days|Pregnancy Rate, Positive pregnancy test, 6 weeks
Role of Follicular T Cells in Hashimoto's Thyroiditis
NCT Number: NCT06521359
Status: NOT_YET_RECRUITING
Study Type: OBSERVATIONAL
Conditions: Hashimoto's Thyroiditis
Interventions: DEVICE: flow cytometry
Sponsor: Omnia Ahmed Nafea Mohamed
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 90
Study Design: Observational Model: |Time Perspective: p
Start Date: 2025-05
Completion Date: 2026-06

Summary:
Measure the frequency of Follicular helper Tcells and Follicular regulatory T cells in peripheral blood samples in Hashimoto's pts in comparison with control.

Primary Outcome Measures: Measure the frequency of Follicular helper Tcells and Follicular regulatory T cells in peripheral blood samples in Hashimoto's pts in comparison with control., Measure changes in number of surface markers CD4 , ICOS, CXCR5 and FOXP3. Follicular helper Tcells and Follicular regulatory T cells in peripheral blood samples in Hashimoto's pts in comparison with control., Baseline
Active Cycle Breathing Technique (ACBT) on Respiratory Parameters and Pain
NCT Number: NCT06521346
Acronym: (ACBT)
Status: NOT_YET_RECRUITING
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Respiratory Complication|Cardiac Disease
Interventions: PROCEDURE: Active cycle breathing technique|PROCEDURE: Routine care
Sponsor: Damanhour University
Sex: ALL
Age: ADULT
Enrollment: 120
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: SINGLE (PARTICIPANT)|Primary Purpose: TREATMENT
Start Date: 2024-12-01
Completion Date: 2026-01-01
Locations: Faculty of nursing Damanhour university, Damanhūr, Egypt

Summary:
This study aims to improve pulmonary function impairment is associated with a reduction in chest expansion, lung volume, pain perception and an impairment of the Post cardiac surgery patient's ability to cough effectively. The technique of active cycle breathing consisted of three parts to the ACBT, which are:

* breathing control
* deep breaths
* huff or cough

Primary Outcome Measures: Respiratory parameters, increase or decrease in respiratory rate, Three observation days|Pain perception, Using visual analogue scale score 0 mean no pain while score 10 means sever pain, Three observation days|Dyspnea (modified Borg scale), Zero (better outcome) refers to 'No difficulty in breathing at all 'and 10 (worse outcome) refers to 'maximal difficulty ', Three observation days
Secondary Outcome Measures: Reintubation, Three observation days|Deterioration in clinical parameters such as vital signs, Tachypnea, tachycardia, hypotension, Three observation days
Resveratrol-Based Gel Application in a Palatal Wound Following Free Gingival Graft Surgery
NCT Number: NCT06521333
Status: RECRUITING
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Mucogingival Defects
Interventions: DRUG: Resveratrol-Based gel|DRUG: Hyaluronic acid gel 0.2%|DEVICE: Stent
Sponsor: Cairo University
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 30
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: TRIPLE (PARTICIPANT, CARE_PROVIDER, OUTCOMES_ASSESSOR)|Primary Purpose: TREATMENT
Start Date: 2024-05-14
Completion Date: 2025-11-01
Locations: Faculty of dentistry, Cairo University, Cairo, Egypt

Summary:
Aim of the study to compare the effect of Resveratrol- Based gel versus 0.2% Hyaluronic acid gel applied to the palatal donor site and acrylic resin stent only in post-operative pain reduction after free gingival graft harvesting.

Primary Outcome Measures: Postoperative Pain, direct measure by using Visual Analog Scale (VAS) pain scores (ranging from 0 to 10, where 0 indicates no pain 1: minimal pain and 10 signifies severe pain) will be recorded daily for one week as the pain is expected to reach its maximum level during the initial healing phase (0-3 days), at (0--7 days)
Secondary Outcome Measures: Indirect Postoperative Pain by analgesic consumption consumption Postoperative, Pain Indirect measurement by analgesic consumption Postoperative for 7 days postoperatively, at (0-7) days|Wound size, measure by using UNC-15 periodontal probe., at surgery day, day 3, day 7, day 14 and day 21|patient satisfaction with the healing process, measure by using Visual analogue scale.

a Visual Analog Scale (VAS) specifically designed for measuring patient satisfaction with medical care. This type of scale allows patients to express their level of satisfaction by marking a point along a continuous line, which is typically 10 cm long, representing a range from complete dissatisfaction (0) to full satisfaction (10)., completed 1 week after the surgery|Color match.., measure by using Visual analogue scale. Colour match (CM) of the donor site was also assessment by using VAS scores (between 0 and 10. 0: no CM, 10: excellent CM) in comparison with adjacent and contra-lateral palatal mucosa., on day 3, day 7, day 14, day 21, and day 42
Speaking Valve Combined With Airway Pressure Predicts Upper Airway Patency in Adult Tracheotomized Patients
NCT Number: NCT06521320
Status: ACTIVE_NOT_RECRUITING
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Tracheotomy
Interventions: DIAGNOSTIC_TEST: speaking valve combined with airway pressure|DIAGNOSTIC_TEST: Bronchoscopy
Sponsor: Capital Medical University
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 300
Study Design: Allocation: NON_RANDOMIZED|Intervention Model: PARALLEL|Masking: NONE|Primary Purpose: DIAGNOSTIC
Start Date: 2021-10-01
Completion Date: 2024-07-31
Locations: Beijing Rehabilitation Hospital of Capital Medical University, Beijing, China

Summary:
This study was aimed to evaluate whether speaking valve combined with airway pressure could predict upper airway patency non-invasively in prolonged tracheostomized patients, identify candidates who need following endoscopy examination.

Primary Outcome Measures: Upper airway patency, Speaking valve combined with airway pressure protocol: After suction of oral and nasal secretion, the cuff was deflated. Then the speaking valve was placed. Supplement oxygen could be provided from nose. Connect a pressure measuring device for airway pressure. Then the tracheostomy tube was downsized according to patient's status (This decision was decided by a multidisciplinary team through consultation). Patients who could tolerate speaking valve and airway pressure\<10cmH2O were assumed Upper airway patency group. Patients who cannot tolerate the speaking valve or whose airway pressure is ≥10cmH2O even after downsizing the tracheostomy are in the Upper airway obstruction group.

Bronchoscopy protocol: Use bronchoscopy through nose to observe the upper airway through the glottis and around the cuff. Patients with bilateral vocal cord distance \<3 mm or Cotton grade II or above were considered to have upper airway obstruction during bronchoscopy evaluation., The patients started using the speaking valve combined with airway pressure measurement on the day of enrollment. After that, bronchoscopy should be performed within 48 hours.
Impact of Nicotinamide Riboside (NR) on Kidney Function in Patients Undergoing Cardiac Surgery
NCT Number: NCT06521307
Acronym: AKI-RCT
Status: NOT_YET_RECRUITING
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Acute Kidney Injury|Cardiac Valve Disease
Interventions: DIETARY_SUPPLEMENT: Nicotinamide riboside|OTHER: Placebo
Sponsor: Instituto Nacional de Cardiologia Ignacio Chavez
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 100
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: TRIPLE (PARTICIPANT, CARE_PROVIDER, INVESTIGATOR)|Primary Purpose: TREATMENT
Start Date: 2024-07-24
Completion Date: 2026-07-24
Locations: Insituto Nacional de Cardiología Ignacio Chávez, Mexico, 14080, Mexico

Summary:
Acute kidney injury (AKI) associated with cardiac surgery is the most important complication in adult patients undergoing open heart surgery and is associated with increased mortality and morbidity. In patients in intensive care units, it is the second most common type of AKI after AKI secondary to sepsis. There is currently no specific treatment for AKI. Supportive measures include renal support therapy for patients with severe AKI, and mortality in this subgroup of patients exceeds 50%. Increasing NAD+ with niacinamide has been shown to prevent various etiologies of experimental AKI in mice, and an early pilot study has shown both increased NAD levels following administration of nicotinamide riboside with pterostilbene NPRT and the safety of niacinamide in patients undergoing cardiac surgery.

Primary Outcome Measures: Impact of nicotinamide riboside (NR) on kidney function in patients undergoing cardiac surgery., The NAD+ and NADH will be measured with the quantitation of the cofactor SIRT1 with a human SIRT1 ELISA kit (novus, NBP2-80300) and a fluorogenic assay SIRT1 CS1040 and flow cytometry., 2 years
Mulligan SNAG Technique in Individuals With Lumbar Intervertebral Disc Protrusion
NCT Number: NCT06521294
Status: NOT_YET_RECRUITING
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Intervertebral Disc Protrusion
Interventions: OTHER: Mulligan SNAG mobilization tecnique|OTHER: Conventional Physiotherapy
Sponsor: Biruni University
Sex: ALL
Age: ADULT
Enrollment: 38
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: SINGLE (PARTICIPANT)|Primary Purpose: TREATMENT
Start Date: 2024-07-16
Completion Date: 2025-05-15
Locations: Faculty of Health Sciences in Biruni University, İ̇stanbul, Zeytinburnu, 34010, Turkey

Summary:
This study aimed to examine the effects of the Mulligan SNAG mobilization technique, applied in addition to conventional physiotherapy on the structure of the intervertebral disc and physical functioning in patients diagnosed with low back pain due to lumbar intervertebral disc protrusion. 38 volunteer patients will participate in the study. The participants will be randomized as an interventional and control gropus.

Primary Outcome Measures: Magnetic Resonance Imaging, to measure protrusion (bigger amount means worse outcome), baseline and iafter the intervention (in the 5th week)|Visual Analog Scale-VAS, to measure pain intensity (min. score is 0 and max. score is 10- higher score means worse outcome), baseline and immediately after the intervention (in the 5th week)
Secondary Outcome Measures: Oswestry Disability Index-ODI, to describe disabilty level resulting from pain (min. score is 0 and max. score is 50- higher score means worse outcome), baseline and immediately after the intervention (in the 5th week)|Functional Independence Measure- FIM, to measure independency in daily living activities (min. score is 18 and max score is 156- higger score means better independency in daily living activities), baseline and immediately after the intervention (in the 5th week)|Tampa Kinesiophobia Scale- TKS, to measure anxiety-avoidance state (min. score is 17 and max. score is 68- higher score means worse outcome), baseline and immediately after the intervention (in the 5th week)|One Leg stand Test- OLST, to measure static balance ability (min. score 0 and max. score is 60- Higher score means better balance), before and after the intervention (in the 5th week)|Sit-Stand Test-SST, to measure lower extremity performance (min. score is 0 and max. score is 30- higher score means better outcome), before and after the intervention (in the 5th week)|10-m Walking test and cadance measurement, to measure walking speed (in second- higher score means worse outcome) and cadance (number of steps during the test- higher score means better outcome), before and after the intervention (in the 5th week)|Nottingham Health profile-NHP, to describe level of quality of life (min. score is 38 and max. score is 3800 - higher score means poor health), before and after the intervention (in the 5th week)
Effects of Inspiratory Muscle Training on Lymphedema
NCT Number: NCT06521268
Status: NOT_YET_RECRUITING
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Lymphedema
Interventions: OTHER: Inspiratory muscle training|OTHER: Decongestive treatment
Sponsor: Biruni University
Sex: FEMALE
Age: ADULT
Enrollment: 24
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: SINGLE (PARTICIPANT)|Primary Purpose: TREATMENT
Start Date: 2024-07-16
Completion Date: 2025-05-15
Locations: Faculty of Health Sciences in Biruni University, İ̇stanbul, Zeytinburnu, 34010, Turkey

Summary:
The aim of this study is to examine the effect of inspiratory muscle training on lymphedema volume, subcutaneous tissue thickness, upper extremity functionality and sleep quality in the treatment of upper extremity lymphedema. Two groups included 24 patients with lymphedema will be divided into gropus (intervetion and control) and they will compare each other.

Primary Outcome Measures: Volumetric Measurement, to measure volume of the upper extremity in milliliter (increased volume compared to the normal upper extremity- increased score means worse outcome), baseline and immediately after the intervention (in the 5th week)|Measurement of Subcutaneous Tissue Thickness with Ultrasound (US), to measure thickness of the tissue (increased thickness compared to the normal upper extremity- increased score means worse outcome), baseline and immediately after the intervention (in the 5th week)
Secondary Outcome Measures: VISUAL ANALOG SCALE-VAS, to measure swelling feel, heaviness of edema, and tension of edema (min. score is 0- max.score is10: higher score means worse outcome), baseline and immediately after the intervention (in the 5th week)|HAND DYNAMOMETER, to measure hand grip (in Newton- higher score means better score), baseline and immediately after the intervention (in the 5th week)|Quick Disabilities Of the Arm,Shoulder And Hand (Quick DASH), to measure physical functioning of upper extremities (min. scorre is 0-max.score is 100- higher score means worse outcome), baseline and immediately after the intervention (in the 5th week)|Respiratory Function Test, to measure respiratory parameters (FEV1, FVC- higher score means better), before and after the intervention (in the 5th week)|Intraoral pressure measure, to measure Intraoral Pressure parameters (MEP and MIP- higher score means better), before and after the intervention (in the 5th week)|Lymphedema Life Impact Scale - LLIS, to measure impact of lymphedema on the survivors with lymphedema (min. score is 18 and max. score is 90- higher score means worse outcome), before and after the intervention (in the 5th week)|Lymph-ICF, to describe Lymphoedema Functioning, Disability And Health status of the partifcipants (min. score is 0 and max. score is 290- higher score means worse outcome), before and after the intervention (in the 5th week)|Pittsburgh Sleep Quality Index (PSQI), to measure sleep quality (min. score is 0 and max.score is 21 - higher score means worse outcome), before and after the intervention (in the 5th week)
The Effect of Training Given to With Hypertension
NCT Number: NCT06521242
Status: COMPLETED
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Hypertension|Train Sickness
Interventions: OTHER: Patient Education
Sponsor: Kader ÖZTÜRK
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 110
Study Design: Allocation: NON_RANDOMIZED|Intervention Model: PARALLEL|Masking: NONE|Primary Purpose: SUPPORTIVE_CARE
Start Date: 2021-07-01
Completion Date: 2022-12-26
Locations: Turkey, Erzurum, Yakutiye, 25100, Turkey

Summary:
The study was conducted to examine the effects of the training given according to the Roy Adaptation Model on the sleep and quality of life of individuals with hypertension.

Primary Outcome Measures: Pittsburg Sleep Quality Index (PSQI), The index was developed by Buysse et al. in 1989 to evaluate the sleep duration and intensity of individuals. The scale has 11 items and 7 sub-dimensions. These items are scored between 0-3. The scores that can be obtained from the scale range from "0" to "21" points. The Turkish validity and reliability of the scale was conducted by Ağargün et al. in 1996. A high total scale score indicates poor sleep quality. A reliable, valid, and standard measurement of sleep quality is made with PSQI. The Cronbach Alpha Internal Consistency Coefficient of the scale is 0.80., up to eight weeks
Secondary Outcome Measures: SF-36 Quality of Life Scale, The scale, which is widely used in health-related quality-of-life studies, was developed by Ware and Sherbourne. A high score on the scale indicates a good quality of life. The scores that can be obtained from the sub-dimensions and the sum of the scale vary between 0-100. A score approaching zero indicates poor health and 100 indicates good health. The Turkish validity and reliability of the scale was conducted by Pınar in 1995., up to eight weeks
Different Oral Iron Dosing Regimens in Treatment of Iron Deficency Anemia in Patients With Chronic Kidney Disease
NCT Number: NCT06521216
Status: NOT_YET_RECRUITING
Study Type: OBSERVATIONAL
Conditions: CKD
Interventions: DRUG: Ferrous sulfate
Sponsor: Assiut University
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 150
Study Design: Observational Model: |Time Perspective: p
Start Date: 2024-08-01
Completion Date: 2025-08-01

Summary:
Comparing between the efficacy of alternate day oral iron dose, once daily and thrice daily dose in improving anemia in CKD patients

Primary Outcome Measures: Change in Hemoglobin level by gm/dl, Follow up Hemoglobin level in 3 groups, 6 months
Periapical Lesions and Immediate Implants
NCT Number: NCT06521203
Status: COMPLETED
Study Type: OBSERVATIONAL
Conditions: Dental Implant Failure Nos|Periapical Granuloma|Osseointegration Failure of Dental Implant
Sponsor: Akdeniz University
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 25
Study Design: Observational Model: |Time Perspective: p
Start Date: 2016-01-01
Completion Date: 2023-12-01
Locations: Akdeniz University, Antalya, 07070, Turkey

Summary:
The aim of this case-control study is to evaluate the success and survival rates of dental implants immediately placed into extraction sites in the presence of periapical pathology.

The main questions it aims to answer are:

What were the survival and success rates of implants immediately placed into extraction sockets of teeth with chronic periodical lesions.

A retrospective analysis was performed based on the evaluation of certain clinical and radiographic parameters 12 months after prosthetic function of these implants.

Primary Outcome Measures: Survival of the implants, Pain on palpation, percussion, or function (Yes/No) Implant mobility (Yes/No) Radiographic crestal bone loss (\<4.0 mm) Absence of pain and mobility and crestal bone loss up to 4 mm were regarded as survive., Immediately after the implant placement and after 12 months of prosthesis function.|Success of the implants, Pain on palpation, percussion, or function (Yes/No) Implant mobility (Yes/No) Radiographic crestal bone loss (\<2mm) Gingival index score (1-2-3) Probing depth (mm) Absence of pain and mobility, crestal bone loss \<2mm, GI score less than 2, probing depth \<5mm were regarded as success., Immediately after the implant placement and after 12 months of prosthesis function.
ACOU085 for Hearing Loss Prevention in Testicular Cancer Patients Receiving Cisplatin
NCT Number: NCT06521190
Acronym: PROHEAR
Status: RECRUITING
Study Type: INTERVENTIONAL
Phases: PHASE2
Conditions: Cisplatin-induced Hearing Loss
Interventions: DRUG: ACOU085 (bimokalner)|DRUG: Placebo
Sponsor: Acousia Therapeutics GmbH
Sex: MALE
Age: ADULT
Enrollment: 40
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: QUADRUPLE (PARTICIPANT, CARE_PROVIDER, INVESTIGATOR, OUTCOMES_ASSESSOR)|Primary Purpose: PREVENTION
Start Date: 2023-12-15
Completion Date: 2025-09-30
Locations: Dept. of Otolaryngology of Tuebingen University, Tuebingen, Baden-Wuerttemberg, 72070, Germany

Summary:
Randomized, double-blind, placebo-controlled, multicenter phase IIa clinical trial in adult male TCa patients with the risk to suffer from sensorineural hearing loss (SNHL) due to cisplatin therapy within a chemotherapeutic regimen of testicular cancer. Patients will have an indication for a cisplatin-containing chemotherapy according to current guidelines and trial site tumor board recommendations. The trial is designed to show efficacy, safety, and tolerability of ACOU085 administered into the middle ear using 3 transtympanic injections per ear prior to 3 planned and corresponding 3-week chemotherapeutic cycles. The intra-individual control will be done by placebo injection into the respective contralateral middle ear.

Primary Outcome Measures: PTA air, Proportion of patients showing a difference of ≥10 dB between the ears in at least two frequencies for air conduction in PTA focused on high (4, 6, 8 kHz) and extended high frequencies (10, 12, 14, 16 kHz) between baseline (V1; prior to first initiation of cis-Pt-containing chemotherapy) and end of chemotherapeutic cycle 3 (V4), Visit 4 at 9 weeks
Secondary Outcome Measures: Distortion Product Otoacoustic Emissions (DPOAE), Intraindividual differences between the ears at Visits 2-5, 150 days|PTA bone, Intraindividual differences between the ears at Visits 2-5, 150 days|Oldenburger Test (speech understanding), Intraindividual differences between the ears at Visits 2-5, 150 days|Freiburger Test, Intraindividual differences between the ears at Visits 2-5, 150 days
Clinical Genetics and Screening for Idiopathic Pulmonary Fibrosis
NCT Number: NCT06521125
Acronym: GENESI
Status: NOT_YET_RECRUITING
Study Type: OBSERVATIONAL
Conditions: Familial Pulmonary Fibrosis|Idiopathic Pulmonary Fibrosis
Interventions: DIAGNOSTIC_TEST: High resolution Computed Tomography (HRCT) scans of the Chest|DIAGNOSTIC_TEST: Pulmonary Function Testing (PFTs)|DIAGNOSTIC_TEST: Digital lung sounds auscultation|DIAGNOSTIC_TEST: Laboratory Assessments|GENETIC: DNA sequencing
Sponsor: Fondazione Policlinico Universitario Agostino Gemelli IRCCS
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 600
Study Design: Observational Model: |Time Perspective: p
Start Date: 2024-09-01
Completion Date: 2026-09-01

Summary:
Background:

Idiopathic pulmonary fibrosis (IPF) is the most common and severe form of interstitial lung disease. Between 2% and 20% of patients with IPF have a family history of the disease, which is considered the strongest risk factor. Therefore, genetic testing has been increasingly considered as a potential tool to identify patients at risk of developing IPF.

According to some studies, genetic testing (particularly of MUC5B and TERT mutations) could be useful to rapidly identify unidentified and/or asymptomatic individuals (in families as well as in the general population) who have interstitial lung anomalies (ILA) that may indicate a initial stage of pulmonary fibrosis. Finding efficient screening methods and associated targeted treatments for IPF may be essential to improving the prognosis and quality of life of those suffering from this disease.

Objectives of the study:

The study involves two populations of study subjects:

* patients with FPF and sporadic IPF
* first-degree relatives of patients with FPF and sporadic IPF (biological relatives, not spouses)

The primary objective is to determine the prevalence rates of interstitial lung abnormalities in at-risk relatives of patient with IPF and FPF.

Study design:

Multicenter, cross-sectional study without drug and without device conducted in two major Italian tertiary referral hospitals.

The entire project is expected to last 24 months.

Primary Outcome Measures: Prevalence of ILA, The prevalence of ILA in first-degree relatives of patients with IPF, expressed as proportion of subjects with ILAs in the overall relatives population, At subject enrollment
Secondary Outcome Measures: Association between ILA and genetic variants, To assess the risk of ILA in first-degree relatives of patients with FPF and sporadic IPF associated with clinically relevant mutations.

Univariate and multivariate logistic regression analysis will be utilized to assess the association between genetic variants and ILA, At subject enrollment
A Novel Conditioning Approach to Counter Loneliness in Adults
NCT Number: NCT06521099
Status: NOT_YET_RECRUITING
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Loneliness
Interventions: BEHAVIORAL: Evaluative Conditioning with positive stimuli|BEHAVIORAL: Conditioning with neutral stimuli
Sponsor: Education University of Hong Kong
Collaborators: The University of Hong Kong
Sex: ALL
Age: ADULT
Enrollment: 136
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: SINGLE (PARTICIPANT)|Primary Purpose: TREATMENT
Start Date: 2024-07
Completion Date: 2026-06

Summary:
This study aims to test the efficacy of a 6-session conditioning paradigm by investigating the conditioning-induced change in the socio-affective processing, loneliness, depressive symptoms, and neural correlates of lonely adults.

Primary Outcome Measures: Changes in perceived valence of social stimuli, For each stimuli, they are required to indicate their immediate perceived valence (between negative to positive) of the scenes on a 7-point Likert scale (1 = strongly positive, 7 = strongly negative)., From baseline to immediately after; from baseline to 3 months after.|Changes in perceived degree of social engagement of social stimuli, For each stimuli, they are required to indicate their immediate perceived degree of social engagement (between none to high) of the scenes on a 7-point Likert scales (1 = no social engagement, 7 = very high social engagement)., From baseline to immediately after; from baseline to 3 months after.|Changes in perceived frequency of experience of social stimuli, For each stimuli, they are required to indicate their immediate perceived frequency of experiences of the scenes (never to always) on a 7-point Likert scales (1 = never, 7 = always)., From baseline to immediately after; from baseline to 3 months after.|Changes in self-reported loneliness, Loneliness is assessed based on the UCLA loneliness scale (Version 3), a 20-item 4-point Likert scale (score range 20 - 80) in which higher scores indicate greater degrees of loneliness., From baseline to immediately after; from baseline to 3 months after.|Changes in depressive symptoms, Depressive symptoms are assessed based on the Hospital Anxiety and Depression Scale, a 14-item scale assessing severity of depressive and anxiety symptom (score range 0 - 21 for both subscale), with a higher scores indicating higher severity, From baseline to immediately after; from baseline to 3 months after.|Changes in loneliness-related activation patterns and connectivity in neural networks, Neural activities and connectivity in Ventral Attention Network, Frontoparietal Network, and Default Mode Network are assessed by fMRI, From baseline to immediately after; from baseline to 3 months after.
Secondary Outcome Measures: Changes in daily loneliness, Daily loneliness is assessed based on a 5-minute self-report on a Likert scale, Through study completion, on average of 4 months
Optimizing Recovery in Trauma Patients by Integrating Enhanced Nutrition Delivery
NCT Number: NCT06521086
Status: NOT_YET_RECRUITING
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Trauma|Critical Illness
Interventions: DIETARY_SUPPLEMENT: Nutrition Supplements - Fresubin KCAL Drinks
Sponsor: Duke University
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 60
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: NONE|Primary Purpose: PREVENTION
Start Date: 2024-09-01
Completion Date: 2024-12-31
Locations: Duke University Hospital, Durham, North Carolina, 27710, United States

Summary:
This is a prospective, randomized, controlled trial designed to evaluate the impact of enhanced protein supplementation compared to a standard of care nutrition delivery in critically ill older adult trauma patients. Subjects will be randomized 1:1 to either enhanced nutrition or control arm. Subjects randomized to the enhanced nutrition arm will receive oral nutrition supplements (ONS) up to 3 times per day while in the hospital and for 4 weeks after discharge. Subjects in the standard of care arm will receive normal nutrition recommendations from their clinical providers. Participants in both groups will undergo non-invasive tests that measure how much energy (calories) they are using, body composition, and muscle mass.

Primary Outcome Measures: Change in muscle mass as a measure of muscle quality, Baseline to one month post-discharge (approximately six weeks)|Change in glycogen stores as a measure of muscle quality, Baseline to one month post-discharge (approximately six weeks)|Change in body composition (percentage of a body's weight that is fat tissue) as a measure of muscle quality, Body composition is the percentage of a body's weight that is fat tissue., Baseline to one month post-discharge (approximately six weeks)
Secondary Outcome Measures: Change in six minute walk test (6MWT) distance, The 6MWT assesses distance walked over 6 minutes as a sub-maximal test of aerobic capacity/endurance., Baseline to one month post-discharge (approximately six weeks)|Change in four meter gait speed, Four meter gait speed is the time one takes to walk four meters on a level surface., Baseline to one month post-discharge (approximately six weeks)|Change in 30-second sit to stand test, This test measures the number of times an individual can stand from a chair with no assistance in 30 seconds. This test is used to assess functional lower body strength., Baseline to one month post-discharge (approximately six weeks)|Change in grip strength, Grip strength is a measure of muscular strength or the maximum force/tension generated by one's forearm muscles. It can be used as a screening tool for the measurement of upper body strength and overall strength., Baseline to one month post-discharge (approximately six weeks)|Change in quadriceps strength, ED (electromechanical dynamometry) can be used in either isometric or isokinetic mode. Quadriceps strength is expressed as peak knee extensor torque, which is produced at around 60° knee flexion., Baseline to one month post-discharge (approximately six weeks)