pankajmathur/National_Library_of_Medicine_Studies_data huggingface dataset:
Music Mindfulness Study 2a.
NCT Number: NCT06505226
Status: RECRUITING
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Mental Health Issue|COVID-19
Interventions: BEHAVIORAL: in person meditation|BEHAVIORAL: in person meditation using headphones|BEHAVIORAL: virtual meditation
Sponsor: Yale University
Collaborators: National Institute of Mental Health (NIMH)
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 70
Study Design: Allocation: RANDOMIZED|Intervention Model: CROSSOVER|Masking: NONE|Primary Purpose: SUPPORTIVE_CARE
Start Date: 2024-08
Completion Date: 2025-08
Locations: BLOOM, New Haven, Connecticut, 06515, United States|Musical Intervention Studios, New Haven, Connecticut, 06520, United States

Summary:
Mental health vulnerability due to stress is increased in People of African Descent (PADs) in America due to disproportionate effects of racism, poverty, education, and criminal justice sentencing. Various meditation and mindfulness approaches have provided evidence of measured reductions in multiple negative dimensions of stress. However, the majority of these studies do not have an adequate representation of PADs or other marginalized groups and are not designed to be culturally relevant or community based. Music has been shown to alleviate multiple symptoms of stress and has been shown to be a preferred and effective support for meditation and mindfulness. However, its role in stress management in PADs engaged in meditation or mindfulness is seldom studied. This study aims to evaluate the effects of a virtual, community-based music mindfulness program on stress management in PAD community members with anxiety and depression during COVID19.

Music Mindfulness Study: Investigators will compare the effects of music-backed guided mindfulness mediation and guided mediation alone in alleviating anxiety and depression.

Primary Outcome Measures: Mean Score Perceived Stress Scale, The Perceived Stress Scale (PSS-10) is a 10-item, validated, self-report, questionnaire used to assess perceived control and confidence in managing stressful situations over the past month. Scores range from 0 to 40, with higher scores indicated higher levels of perceived stress., 8 weeks
Secondary Outcome Measures: Mean Score Social Connectedness Scale, The Social Connectedness Scale (SCS) is a self-report questionnaire that measures the extent to which individuals feel connected to others in their social environment. 20 items on a 6-point Likert scale, from 1 (strongly disagree) to 6 (strongly agree). Total score is achieved by summing all items with total score range from 20-120. Higher scores indicate a greater sense of social connectedness., 8 weeks
Multimodal Brain Monitoring as an Early Warning and Prognostic Tool for Acute Brain Injury
NCT Number: NCT06505213
Status: NOT_YET_RECRUITING
Study Type: OBSERVATIONAL
Conditions: Acute Brain Injury
Interventions: OTHER: no intervention
Sponsor: Xiangya Hospital of Central South University
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 490
Study Design: Observational Model: |Time Perspective: p
Start Date: 2024-07-30
Completion Date: 2028-06-30

Summary:
The primary aim of this study is to evaluate the effectiveness of multimodal brain monitoring technologies as both an early warning system and a prognostic tool in patients suffering from acute brain injuries. This research seeks to determine how effectively these tools can predict clinical outcomes and prevent complications by providing early alerts to healthcare professionals.

Primary Outcome Measures: Relation between multimodal brain monitoring parameters and outcome., Association between advanced multimodal brain monitoring parameters of the first 48h of admission and six months functional outcome (Glasgow Outcome Score Extended), 6 months
Secondary Outcome Measures: Neuromonitoring Pattern, Describe multimodal neuromonitoring parameters variation and identify trends., 3-5 days|Neuromonitoring and Short Term Outcome, Association between advanced multimodal brain monitoring parameters and 28 days functional outcome (Glasgow Outcome Score Extended), 28 days
Observational Cohort Study Renal Transplantation University Hospitals Leuven
NCT Number: NCT06505200
Status: ACTIVE_NOT_RECRUITING
Study Type: OBSERVATIONAL
Conditions: Kidney Transplant Rejection|Kidney Transplantation|Kidney Transplant Failure
Interventions: OTHER: No intervention
Sponsor: Universitaire Ziekenhuizen KU Leuven
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 1891
Study Design: Observational Model: |Time Perspective: p
Start Date: 2004-03-01
Completion Date: 2027-12-31
Locations: University Hospitals Leuven, Leuven, 3000, Belgium

Summary:
This retrospective observational cohort study aims to compile routinely collected clinical, histological and outcome data of kidney transplant recipients, to evaluate risk factors for post-transplant injury, phenotypes of injury, and impact on outcome of such injury, in order to provide clinicians more accurate, less biased and faster tools for diagnosis, clinical management and treatment decisions with regard to kidney transplant rejection.

Primary Outcome Measures: Kidney transplant failure, Graft failure, recipient death, 2004 - 2022
Secondary Outcome Measures: Kidney transplant rejection phenotypes, 2004 - 2022|Kidney transplant function, 2004 - 2022
Celecoxib for ENT Pain Management
NCT Number: NCT06505187
Status: NOT_YET_RECRUITING
Study Type: INTERVENTIONAL
Phases: PHASE2
Conditions: Parotidectomy
Sponsor: University of Wisconsin, Madison
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 84
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: SINGLE (PARTICIPANT)|Primary Purpose: SUPPORTIVE_CARE
Start Date: 2024-09
Completion Date: 2026-09

Summary:
The goal of this clinical trial is to find out whether pain can be managed after an operation with celecoxib instead of oxycodone. The main question it aims to answer is if use of celecoxib plus Tylenol reduces the need for oxycodone.

Researchers will compare the combination of celecoxib and Tylenol to a placebo to find out whether celecoxib works to manage pain.

Participants will:

* Take celecoxib, or a placebo, plus Tylenol with opioids as needed
* Keep a diary of their pain between visits
* Complete questionnaires

Primary Outcome Measures: Number of oxycodone pills taken, Total number of oxycodone pills taken during the first 7 days post-operative, 7 days
Secondary Outcome Measures: Change in pain scores, Numerical pain scores will be measured using a post-operative modified brief pain inventory. Participants will rate their pain on a scale of 0-10, where 0 = no pain and 10 = worst pain., Baseline (post-operative) to 7 days|Side effects from medications, Participants will self-report any side effects experienced from medications for the first 7 days post-operative, 7 days|Drain duration, Length of time participant retains the post-operative drain, 7 days|Number of post-operative complications, Participants will report any post-operative complications experienced during the first 7 days post-operative, 7 days
Effect of Treatment With Systane Ultra in Symptomatology and Visual Task Efficiency in Digital Device Users
NCT Number: NCT06505174
Status: COMPLETED
Study Type: OBSERVATIONAL
Conditions: Digital Eye Strain|Computer Vision Syndrome|OSDI
Interventions: OTHER: Hydroxypropyl Guar-based artificial tears four times per day
Sponsor: University of Valladolid
Sex: ALL
Age: ADULT
Enrollment: 34
Study Design: Observational Model: |Time Perspective: p
Start Date: 2023-01-10
Completion Date: 2023-07-31
Locations: IOBA Eye Institute, Valladolid, 47011, Spain

Summary:
This study assessed the effect of one month of use of preservative-free artificial tears (Systane Ultra UD, Alcon) on symptomatology related to digital eye strain (DES), visual task performance, and tear film stability in visual display terminal users.

Primary Outcome Measures: OSDI Score, Change in OSDI score, One month|CVSS17 Score, Change in CVSS17 score, One month
Dry Needling Versus Percutaneous Electrolysis in Lumbar Multifidus Muscles in Patients With Chronic Low Back Pain.
NCT Number: NCT06505161
Acronym: DN-PE-LBP
Status: NOT_YET_RECRUITING
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Chronic Low-back Pain
Interventions: OTHER: Dry needling|OTHER: Percutaneous electrolysis
Sponsor: University of Alcala
Sex: ALL
Age: ADULT
Enrollment: 40
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: DOUBLE (PARTICIPANT, OUTCOMES_ASSESSOR)|Primary Purpose: TREATMENT
Start Date: 2024-09-01
Completion Date: 2025-07-01
Locations: Campus Científico-Tecnológico UAH. Av. de León, 3A, Alcalá De Henares, Madrid, 28805, Spain

Summary:
The aim of this study is to evaluate the reduction of pain of two different treatments in patients with chronic low back pain. Patients were divided in two groups. The control group will receive DN treatment, and the experimental group will receive PE, both in the lumbar multifidus muscles.

Primary Outcome Measures: Pain intensity. Visual analogue scale., A 10-point Numerical Pain Scale (0: no pain, 10: maximum pain) assesses the intensity of pain, At baseline, at 1 week after the last intervention, and 6-month follow-up period
Secondary Outcome Measures: Disability. Oswestry Low Back Pain Disability Idex, It has 10 items associated to activities of daily living, each item has a punctuation from 0 to 5 points, At baseline, at 1 week after the last intervention, and 6-month follow-up period|Fear of Movement. Tampa Scale of kinesiophobia (TSK-11SV), Is a 11-item questionnaire that measures the fear of movement and (re)injury., At baseline, at 1 week after the last intervention, and 6-month follow-up period|Quality of life. SF-12 Health questionnaire., SF-12 Health questionnaire scores range from 0 to 100% and indicate the self-perceived health-related quality of life, At baseline, at 1 week after the last intervention, and 6-month follow-up period
Comparing the Difference in Pain Control in the Pediatric General Surgery Population: to Alternate or Combine Acetaminophen and Ibuprofen?
NCT Number: NCT06505148
Status: NOT_YET_RECRUITING
Study Type: INTERVENTIONAL
Phases: PHASE4
Conditions: Pediatric Disorder
Interventions: DRUG: Acetaminophen|DRUG: Ibuprofen
Sponsor: Baylor Research Institute
Collaborators: Baylor Scott and White Health
Sex: ALL
Age: CHILD, ADULT
Enrollment: 80
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: NONE|Primary Purpose: TREATMENT
Start Date: 2024-08-01
Completion Date: 2025-08-01
Locations: Baylor Scott & White Health Temple Market, Temple, Texas, 76508, United States

Summary:
To examine the difference in pain control in the pediatric general surgery population alternating acetaminophen and Ibuprofen q 3 hours vs giving them simultaneous combination therapy around the clock.

Primary Outcome Measures: Faces, Legs, Activity, Cry, and Consolability (FLACC) pain assessment scale., Pain will be assessed using an age-appropriate pain rating scale. The FLACC is an interval scale quantifying pain behavior with scores ranging from 0 no pain behaviors to 10 most possible pain behaviors. The five categories of behaviors assessed with the FLAC include facial expressions, leg movement, activity, crying, and consolability., 24, 48, and 72 hours after surgery|Pain Visual Analog Scale (VAS), This tool portrays a 10cm ruler visual and the patient selects the marker indicating their pain intensity, 0 indicating no pain to 10 indicating the worst pain possible., 24, 48, and 72 hours after surgery|Numeric Pain Rating Scale (NPRS), The NPRS is scored on an 11-point scale where the higher the number indicating severe more the pain., 24, 48, and 72 hours after surgery
Secondary Outcome Measures: Parent/ guardian adherence, Adherence will be assessed by asking the parent/guardian regarding their ability to follow pain regimen and the ease to follow the instructions., 72 hours after surgery
Stem Cell Treatment for Regeneration of the Rotator Cuff (Lipo-Cuff Study)
NCT Number: NCT06505135
Status: NOT_YET_RECRUITING
Study Type: INTERVENTIONAL
Phases: PHASE1
Conditions: Rotator Cuff Tears|Rotator Cuff Injuries|Rotator Cuff Tear Arthropathy
Interventions: BIOLOGICAL: Stem-cell treatment|OTHER: Standard care
Sponsor: University of Southern Denmark
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 52
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: NONE|Primary Purpose: TREATMENT
Start Date: 2024-09
Completion Date: 2026-09
Locations: Orthopaedic Research Unit, Department of Orthopaedics, Hospital Sønderjylland, Region of Southern Denmark., Sønderborg, Danmark, 6400, Denmark

Summary:
Treatment of rotator cuff tears with micro-fragmented adipose tissue is a minimal-invasive procedure with the potential to shorten and ease recovery, accelerate return to daily activity and work of thus with a potential capacity to improve the functional result compared to conventional surgery alone. The study will provide evidence whether the addition of micro-fragmented adipose tissue therapy can augment conventional rotator cuff tear treatment. The study will also reveal whether this treatment can be feasible for standard care of patients with rotator cuff tear as it will be simple to standardize. Moreover, besides providing a novel treatment for patients with rotator cuff tears, the project will based on data from muscle biopsies and scanning modalities, generate new knowledge, preparing for precision regenerative medicine in shoulder disease.

Primary Outcome Measures: Patient reported outcome of Oxford shoulder score, A difference in 8 points from the oxford shoulder score questionnaire, From inclusion and until 12 months after operation
Secondary Outcome Measures: Clinical healing of the shoulder, Defined as pain-free movement above shoulder level, 12 months post surgery|Radiological healing, Defined as closure of the gap between the tendon and the greater tuberosity that serves as the attachment for rotator cuff muscles assessed by MRI ., baseline, 6 and 12 months post-surgery|Functioning of the supraspinatus muscle with improved muscle strain, Recorded be speckle tracking ultrasonography., baseline, 3, 6 and 12 months post-surgery|Oxford shoulder score, Difference in points measured by the oxford shoulder score, baseline, 3, 6 and 12 months post-surgery|Quality of life (EQ5D), Difference in points measured by EQ5D questionnaire, baseline, 3, 6 and 12 months post-surgery
Dyadic Life Review Intervention for Older Patients With Advanced Cancer) and Their Caregivers
NCT Number: NCT06505122
Acronym: DLR RCT
Status: NOT_YET_RECRUITING
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Cancer
Interventions: BEHAVIORAL: Dyadic Life Review
Sponsor: University of Rochester
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 60
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: NONE|Primary Purpose: SUPPORTIVE_CARE
Start Date: 2024-08-30
Completion Date: 2026-07-31

Summary:
The purpose of this study is to test the feasibility of a pilot Randomized Controlled Trial (RCT) comparing Dyadic Life Review (DLR) intervention in older adults with advanced cancer and their caregivers to Care-as-Usual (CAU) group, which involves a referral to social work.

Primary Outcome Measures: DLR Intervention Enrollment Rate, Evaluate the feasibility of DLR in older patients and caregivers based on enrollment rate., 18 weeks|DLR Intervention Retention Rate, Evaluate the feasibility of DLR in older patients and caregivers based on retention rate., 18 weeks
Secondary Outcome Measures: Unidimensional Relationship Closeness Scale, Quality of relationship with care-receiver: assesses quality of relationship between participant and family member and has demonstrated valid scores across several relationship types, including spouses and other family members. This is a 12-item scale, rated from 1-7 (1=strongly agree, 7=strongly disagree), with a possible total of 84; a higher score indicates a higher level of closeness., 18 weeks|Communication Satisfaction Scale, The observation of each partner's level of satisfaction with various aspects of their communication. This is a 12-item scale, rated from 1-5 (1=not at all satisfied, 5=extremely satisfied), with a possible total of 60; a higher score indicates greater satisfaction with communication., 18 weeks|Distress Thermometer, A self-report measure to capture distress and identify a list of sources of that distress. This is a 10-item scale, rated from 0-10 (0=no distress, 10=severe distress), with a possible total of 10; a higher score indicates greater distress., 18 weeks
A Comparative Study of the Results of Dynamic and OPD Static Measurement of Pupil Diameter Before and After Cataract Surgery by Pupil Detectors
NCT Number: NCT06505096
Status: NOT_YET_RECRUITING
Study Type: OBSERVATIONAL
Conditions: Cataract
Interventions: PROCEDURE: cataract surgery
Sponsor: Shanghai Eye Disease Prevention and Treatment Center
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 60
Study Design: Observational Model: |Time Perspective: p
Start Date: 2024-08-01
Completion Date: 2026-01-01

Summary:
Age-related cataract remains the leading cause of blindness in developing countries. And, with the aging of the population in these countries, the number of cataract patients will continue to grow. With accurate biological measurements and the implantation of a suitable IOL, most cataract patients can achieve good distance vision after surgery. Studies have shown differences in pupil diameter and sensitivity in patients with different refractive states, with correlations to accommodation status as well as refractive error. The pupil is an important factor to be evaluated during the selection of an artificial lens (Intraocular lens, IOL), especially a functional IOL.

Among the various instruments used for preoperative cataract biological measurements, the light source is mostly a fixed parameter, and the static pupil diameter measurement by fixed illumination light source detection as an evaluation method is relatively rough. In this study, we are going to simulate different illumination states in daily life and set up two kinds of measurement instruments, namely, OPD and binocular pupil detector, so as to obtain more realistic research results and to explore the following: 1. The static and dynamic measurement of pupil diameter by people of different refractive states in different periods of preoperative and postoperative period. 2. Whether there is a difference between the static and dynamic pupil measurement results, 2. the change of pupil size under the stimulation of different light sources, and to compare the difference between the two detection methods, to provide objective pupil indexes for the more scientific selection of functional IOLs, to provide a basis for the selection of more accurate pupil measurement methods, to accurately screen the population of the use of functional IOLs, and to improve the patient's satisfaction after the operation.

Purpose of the study To simulate the difference between the preoperative and postoperative pupil diameters of cataract patients measured by static and dynamic methods under daily illumination, to select a more accurate pupil measurement method, and to make corrections for the evaluation of preoperative biometric indexes.

Primary Outcome Measures: pupil size, pupil size before and after cataract surgery, 1 week, 1 month, 3 months
Ovarian Tissue Cryopreservation and Subsequent Auto-Transplantation for Female Cancer Patients (HKCH)
NCT Number: NCT06505057
Status: RECRUITING
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Neoplasms
Interventions: OTHER: Ovarian Tissue Cryopreservation and Subsequent Auto-Transplantation
Sponsor: Chinese University of Hong Kong
Sex: FEMALE
Age: CHILD, ADULT
Enrollment: 100
Study Design: Allocation: NA|Intervention Model: SINGLE_GROUP|Masking: NONE|Primary Purpose: OTHER
Start Date: 2024-08-13
Completion Date: 2041-07-31
Locations: Hong Kong Children's Hospital, Hong Kong, Hong Kong

Summary:
Ovarian tissue freezing is an ideal option for these patients as it can be performed immediately and does not need any time for ovarian stimulation. We hope we can develop this service in our locality to allow more young female cancer patients to have their fertility preserved.

Primary Outcome Measures: Surgical complications, Surgical complications after ovarian tissue transplantation, 15 years
Secondary Outcome Measures: Pregnancy rate, Pregnancy rate after ovarian tissue transplantation, 15 years
Effect of Aerobic Exercise Versus Resistance Exercise on Bone Density in Postmenopausal Diabetic Women
NCT Number: NCT06505044
Status: ACTIVE_NOT_RECRUITING
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Osteoporosis
Interventions: PROCEDURE: aerobic exercise|PROCEDURE: resistance exercise
Sponsor: Deraya University
Sex: FEMALE
Age: ADULT
Enrollment: 50
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: DOUBLE (PARTICIPANT, INVESTIGATOR)|Primary Purpose: TREATMENT
Start Date: 2024-03-10
Completion Date: 2024-08-01
Locations: Soad A. Mohamad, Minya, 05673, Egypt

Summary:
Osteoporosis is a significant public health issue, especially among postmenopausal women with diabetes, and its prevalence is increasing. This trial aims to determine the influence of moderate intensity aerobic exercise vs resistance exercise on bone mineral density among postmenopausal diabetic women.

Primary Outcome Measures: The bone mineral density (BMD), • Dual Energy X-ray Absorptiometry (DEXA). It was used to measure the bone mineral density (BMD) of the lumbar spine for each woman in both groups before and after the study., 3 months
The Post Intensive Care Syndrome Follow-up and Management Study: The ICU Recovery Answers Project
NCT Number: NCT06504979
Acronym: ICURA
Status: NOT_YET_RECRUITING
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Post Intensive Care Syndrome|ICU Survivors|ICU Families
Interventions: OTHER: Telehealth follow-up of post-intensive care syndrome
Sponsor: Corporacion Parc Tauli
Collaborators: Universitat de les Illes Balears|Hospital Son Espases|Fundació La Marató de TV3
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 180
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: NONE|Primary Purpose: SUPPORTIVE_CARE
Start Date: 2024-09
Completion Date: 2026-08

Summary:
Critically ill survivors develop mental health, cognition, and mobility sequelae known as Post-Intensive Care Syndrome (PICS). Clinically significant symptoms of post-traumatic stress, depression, anxiety, and cognitive impairment are frequently observed at short- and long-term after ICU, impacting quality of life of the survivors and their relatives.

The main objective of the project is to optimize, implement and evaluate the impact in quality of life of a digital platform (ICURA) specifically designed for following-up and managing the mental health sequelae related to PICS in ICU survivors and their relatives during the one-year recovery phase.

Methods: Observational, prospective and multicenter study including two cohorts: 1) ICU patients' cohort (ICUcohort), and 2) ICU patients' family cohort (ICU-F-cohort). After ICU discharge, patients will be randomized to participate in a follow-up with ICURA vs. the standard follow-up.

Expected results: Critically ill survivors in the APPICS program after ICU will show better levels of functionality and quality of life than those participants in the usual follow-up. APPICS will contribute to enhancing the prognosis of emotional alterations during the 12 months after ICU both, in ICU survivors, and relatives. Analyzing risk factors, based on demographic and clinical data, will help to the early detection of long-term mental health difficulties in ICU survivors.

Primary Outcome Measures: Health-related quality of life, 12-Item Short Form Survey (SF-12) at 12 months after ICU discharge Scores range from 0 to 100, with higher scores indicating better physical and mental health functioning., 1 year|Functionality, WHO Short Disability Assessement Schedule (WHODAS 2.0) 12 months after ICU discharge. Scores range from 0 to 60, with higher scores indicating higher level of disability., 1 year
Study to Compare the Efficacy, Pharmacokinetics, Pharmacodynamics, Safety, and Immunogenicity of MAB-22 Versus Prolia®
NCT Number: NCT06504966
Status: NOT_YET_RECRUITING
Study Type: INTERVENTIONAL
Phases: PHASE3
Conditions: Osteoporosis
Interventions: DRUG: MAB-22|DRUG: Prolia®
Sponsor: Xentria, Inc.
Sex: FEMALE
Age: ADULT, OLDER_ADULT
Enrollment: 440
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: DOUBLE (PARTICIPANT, INVESTIGATOR)|Primary Purpose: OTHER
Start Date: 2024-10
Completion Date: 2026-10

Summary:
Double-blind, Parallel-group, Active-controlled Study to Compare the Efficacy, Pharmacokinetics, Pharmacodynamics, Safety, and Immunogenicity of MAB-22 Versus Prolia®

Primary Outcome Measures: To compare MAB-22 and Prolia® (EU-authorized) in postmenopausal women with osteoporosis to demonstrate biosimilarity and non-inferiority with respect to efficacy profile in terms of bone mineral density (BMD)., Efficacy coprimary endpoint: percentage change from baseline (%CfB) in lumbar spine bone mineral density (BMD) (LS-BMD), Day 1 to Week 52|To compare MAB-22 and Prolia® (EU-authorized) in postmenopausal women with osteoporosis to demonstrate biosimilarity and non-inferiority with respect to Pharmacodynamic (PD) profile in terms of serum cross-linked C telopeptide of type I collagen (sCTX)., PD coprimary endpoint: area under the effect curve (AUEC) of C telopeptide of type I collagen (sCTX) over the initial 6-month period, Day 1 to Week 26 [Predose]
Biomarker Discovery in Lung Cancer - Malaysia
NCT Number: NCT06504927
Status: RECRUITING
Study Type: OBSERVATIONAL
Conditions: Lung Cancer
Sponsor: University of Malaya
Collaborators: MiRXES Pte Ltd
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 400
Study Design: Observational Model: |Time Perspective: p
Start Date: 2024-01-16
Completion Date: 2026-12-31
Locations: University of Malaya Medical Centre, Kuala Lumpur, 59100, Malaysia

Summary:
This study aims to

1. Identify biomarkers and signatures to differentiate between high-risk and lung cancer patients.
2. Discover blood-based biomarkers that can be used as an adjunct test to imaging diagnosis to improve patient follow-up.

Primary Outcome Measures: To discover and validate RNA and methylated cell-free DNA cancer biomarkers that can discriminate between high-risk and lung cancer patients., To discover and validate RNA and methylated cell-free DNA cancer biomarkers that can discriminate between high-risk and lung cancer patients., 3 years
Preparing FIM-BCS - A Lifestyle Modification for African-American Breast Cancer Survivors
NCT Number: NCT06504914
Acronym: FIM-BCS
Status: RECRUITING
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Hypertension|Obesity|Nutrition, Healthy
Interventions: BEHAVIORAL: Assigned Interventions
Sponsor: University of Illinois at Chicago
Sex: FEMALE
Age: ADULT, OLDER_ADULT
Enrollment: 24
Study Design: Allocation: NA|Intervention Model: SINGLE_GROUP|Masking: NONE|Primary Purpose: TREATMENT
Start Date: 2024-02-05
Completion Date: 2025-01
Locations: University of Illinois Chicago, Chicago, Illinois, 60612, United States

Summary:
Hypertension and obesity are both major risk factors for cardiovascular disease (CVD), a leading cause of death for Black women in the United States. The investigators propose examining the feasibility and acceptability of the 12-week RN-CHeFRx (Real Nourishment and Cooking Healthy Food is Rx) intervention

- grocery delivery, cooking classes, and nutrition education - for Black women with hypertension and obesity to improve nutritious eating habits and blood pressure control.

Primary Outcome Measures: Number of participants who complete the 12 week intervention, Completion will be measured by class attendance, [Time Frame: Up to 12 weeks]
Evaluation of Efficacy and Safety of PD-1 Monoclonal Antibody in Combination With rhG-CSF, IL-2, and CapeOX in Initially Resectable Synchronous Colorectal Liver Metastases
NCT Number: NCT06504901
Status: NOT_YET_RECRUITING
Study Type: OBSERVATIONAL
Conditions: Colorectal Cancer
Interventions: DRUG: Tislelizumab|DRUG: Interleukin-2|DRUG: Capecitabine|DRUG: Oxaliplatin|DRUG: Neupogen
Sponsor: The First Affiliated Hospital with Nanjing Medical University
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 30
Study Design: Observational Model: |Time Perspective: p
Start Date: 2024-07-10
Completion Date: 2027-07-10

Summary:
This study attempts to employ a combination therapy using rhG-CSF, IL-2, and PD-1 inhibitors, aiming to overcome the limitations of monotherapy in immunotherapy through multi-faceted immune regulation. By modulating the immune microenvironment to enhance immune cell infiltration, and breaking through the physical and immunosuppressive barriers of tumors, it seeks to augment the efficacy of immunotherapy. This approach explores the effectiveness of a neoadjuvant treatment model in cases of liver metastasis.

Primary Outcome Measures: CR rate (cCR + local excision pCR), Complete Response rate," which includes both "complete clinical response" (cCR), 3 years
Secondary Outcome Measures: Event-Free Survival rates, Event-Free Survival (EFS) is the length of time after treatment during which the patient survives without any events of interest occurring, such as disease progression, recurrence, or death. Therefore, the 1/2/3-year EFS rates refer to the percentages of patients surviving without these events at 1, 2, and 3 years., 5 years|Overall Survival rates, Overall Survival (OS) is the most common endpoint in cancer clinical trials, measuring the proportion of patients still alive at specific time points after the start of treatment. Thus, the 1/2/3-year OS rates represent the percentages of patients still alive at 1, 2, and 3 years post-treatment., 5 years
Do Penicillin-allergic Patients Presents a High Risk of Sinus Lift Failure
NCT Number: NCT06504888
Status: RECRUITING
Study Type: OBSERVATIONAL
Conditions: Maxillary Sinus Disease
Interventions: DRUG: Penicillin
Sponsor: Universitat Internacional de Catalunya
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 400
Study Design: Observational Model: |Time Perspective: p
Start Date: 2004-07-01
Completion Date: 2024-12-31
Locations: Universitat Internacional de Catalunya, Sant Cugat Del Vallès, Barcelona, 08195, Spain

Summary:
This retrospective study aims to evaluate clinical histories to determine if there is a relationship between patients allergic to penicillin and sinus lift failure and the possible post-operative complications that may arise.

Primary Outcome Measures: Maxillary sinus lift procedure failure, "Inability to place the implant after sinus lift", 2 years
Secondary Outcome Measures: Implant survival rate, "The implant is still in mouth", 1 year after implant placement|Post-operative complications, Fistula, infection, unspecific failure, hemorrhage or healing by second intention, 1-2 weeks after surgery|Intra-operative complications, Schneider membrane's perforation: 1-2mm, 2-5mm, 5-10mm or \>10mm, In the surgery
Application of PD-1 Monoclonal Antibody in Combination With IL-2 and CapeOX in Organ Preservation Therapy for Ultra-Low Localized Advanced Rectal Cancer
NCT Number: NCT06504875
Status: NOT_YET_RECRUITING
Study Type: OBSERVATIONAL
Conditions: Rectal Cancer
Interventions: DRUG: Tislelizumab|DRUG: Interleukin-2|DRUG: Capecitabine|DRUG: Oxaliplatin
Sponsor: The First Affiliated Hospital with Nanjing Medical University
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 23
Study Design: Observational Model: |Time Perspective: p
Start Date: 2024-07-10
Completion Date: 2027-07-10

Summary:
The objective is to evaluate whether the neoadjuvant combination of PD-1 inhibitor tislelizumab and interleukin-2 (IL-2) can significantly enhance the complete response rate (cCR + local excision pCR) and organ preservation rate in patients with MSS/pMMR locally advanced rectal cancer.

Primary Outcome Measures: CR rate (cCR + local excision pCR), Complete Response rate," which includes both "complete clinical response" (cCR) and "pathologic complete response after local excision" (pCR), 1 years
Secondary Outcome Measures: organ preservation rates, The assessment of how different treatment strategies, determined by the Complete Response (CR) status post-neoadjuvant chemotherapy, affect the anal sphincter preservation in patients with locally advanced low rectal cancer., 1 month|Event-Free Survival rates, Event-Free Survival (EFS) is the length of time after treatment during which the patient survives without any events of interest occurring, such as disease progression, recurrence, or death. Therefore, the 1/2/3-year EFS rates refer to the percentages of patients surviving without these events at 1, 2, and 3 years., 5 years|Overall Survival rates, Overall Survival (OS) is the most common endpoint in cancer clinical trials, measuring the proportion of patients still alive at specific time points after the start of treatment. Thus, the 1/2/3-year OS rates represent the percentages of patients still alive at 1, 2, and 3 years post-treatment., 5 year
A Study in Healthy Men to Test Whether Zongertinib Influences the Amount of 4 Other Medicines (Dabigatran, Rosuvastatin, Metformin, and Furosemide) in the Blood
NCT Number: NCT06504862
Status: RECRUITING
Study Type: INTERVENTIONAL
Phases: PHASE1
Conditions: Healthy
Interventions: DRUG: Zongertinib|DRUG: Dabigatran-etexilate|DRUG: Rosuvastatin|DRUG: Metformin hydrochloride|DRUG: Furosemide
Sponsor: Boehringer Ingelheim
Sex: MALE
Age: ADULT
Enrollment: 32
Study Design: Allocation: NON_RANDOMIZED|Intervention Model: CROSSOVER|Masking: NONE|Primary Purpose: TREATMENT
Start Date: 2024-08-19
Completion Date: 2024-10-16
Locations: Humanpharmakologisches Zentrum Biberach, Biberach, 88397, Germany

Summary:
For Part 1 of the trial, the main objective is to assess the effect of a single dose of zongertinib on the pharmacokinetics of a single dose of dabigatran-etexilate. For Part 2 of the trial, the main objective is to assess the effect of zongertinib at steady-state on the pharmacokinetics of a single dose of rosuvastatin, metformin and furosemide (administered as a cocktail).

Primary Outcome Measures: Part 1: Area under the concentration-time curve of the analyte in plasma over the time interval from 0 extrapolated to infinity (AUC0-∞), Up to 3 days|Part 1: Maximum measured concentration of the analyte in plasma (Cmax), Up to 3 days|Part 2: Area under the concentration-time curve of the analyte in plasma over the time interval from 0 extrapolated to infinity (AUC0-∞), Up to 4 days|Part 2: Maximum measured concentration of the analyte in plasma (Cmax), Up to 4 days
Secondary Outcome Measures: Part 1: Area under the concentration-time curve of the analyte in plasma over the time interval from 0 to the last quantifiable data point (AUC0-tz), Up to 3 days|Part 2: Area under the concentration-time curve of the analyte in plasma over the time interval from 0 to the last quantifiable data point (AUC0-tz), up to 4 days
Kinematic Biofeedback on Gait Quality in Stroke
NCT Number: NCT06504836
Status: NOT_YET_RECRUITING
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Stroke
Interventions: OTHER: Gait training with biofeedback|OTHER: Gait training without biofeedback
Sponsor: National Yang Ming Chiao Tung University
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 40
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: SINGLE (OUTCOMES_ASSESSOR)|Primary Purpose: TREATMENT
Start Date: 2024-07-15
Completion Date: 2025-12-31

Summary:
Walking disorder is the most common and concerning issue for individuals with stroke. Previous studies have often used improvements in walking speed and distance as reference indicators for the advancement of gait performance in individuals with stroke. However, for individuals with chronic stroke, considering gait symmetry and variability to enhance gait quality as the primary intervention target may be more crucial. According to a literature review, it can be inferred that the application of biofeedback to detect gait quality may be an effective approach to improve gait symmetry and variability in individuals with stroke. However, there is still insufficient research evidence on this issue. Therefore, this study aims to investigate the effects of a kinematic biofeedback device system, which detects hip joint angles, on gait quality in individuals with chronic stroke.

Primary Outcome Measures: Gait symmetry, Using GAITRite system to measure the symmetry of spatiotemporal parameters, including step length, step width, single support time, and double support time. Calculate the gait symmetry using following formula:

Gait symmetry = affected side/ unaffected side., 1 day|Gait variability, Using GAITRite system to measure the coefficient of variation (CV). The mean and standard deviation will be used to calculate the coefficient of variation (CV).

CV = standard deviation / mean \* 100%, 1 day
Secondary Outcome Measures: Propulsive force, Using Force plate to measure the ground reaction force, 1 day
The Effect of Light Level Applied During Breastfeeding on Maternal Stress, Anxiety, Psychological Well-being and Breastfeeding Motivation
NCT Number: NCT06504823
Status: NOT_YET_RECRUITING
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Stress|Anxiety
Interventions: OTHER: Light level
Sponsor: Emine Yıldırım
Sex: FEMALE
Age: ADULT, OLDER_ADULT
Enrollment: 60
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: SINGLE (PARTICIPANT)|Primary Purpose: SUPPORTIVE_CARE
Start Date: 2024-07-22
Completion Date: 2024-08-02

Summary:
To determine the effect of the light level applied during breastfeeding on the mother's stress, anxiety, psychological well-being and breastfeeding motivation. This research was planned as a single-blind randomized controlled experimental type study comparing separate groups as intervention-placebo controlled. Data will be collected with the Introductory Information Form, Psychological Well-Being Scale, Perceived Stress Scale (ASÖ/PSÖ-14), State-Trait Anxiety Inventory (STAI) and Breastfeeding Motivation Scale (For Primiparous Mothers). The effect of two different light levels on mothers will be examined.

Primary Outcome Measures: stress, stress scale, 1 day
Secondary Outcome Measures: anxiety, anxiety scale, 1 day
Effect of Light Level on Stress, Anxiety, Psychological Well-being in Pregnant Women
NCT Number: NCT06504810
Status: NOT_YET_RECRUITING
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Stress|Anxiety|Pregnant Women
Interventions: OTHER: light
Sponsor: Emine Yıldırım
Sex: FEMALE
Age: ADULT, OLDER_ADULT
Enrollment: 60
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: SINGLE (PARTICIPANT)|Primary Purpose: SUPPORTIVE_CARE
Start Date: 2024-07-25
Completion Date: 2024-08-25

Summary:
To determine the effect of light level on stress, anxiety and psychological well-being in pregnant women. This research was planned as a single-blind, randomized controlled experimental type study by comparing separate groups as experiment-placebo control. Data will be collected using the Introductory Information Form, Psychological Well-Being Scale, Perceived Stress Scale (ASÖ/PSÖ-14), and State-Trait Anxiety Inventory (STAI). The effect of two different amounts of light on pregnant women will be evaluated.

Primary Outcome Measures: stress, stress scale, 1 day
Secondary Outcome Measures: anxiety, anxiety scale, 1 day
The Effect of Automatic Massage Applied to Healthcare Workers on Pain, Fatigue and Psychological Well-being
NCT Number: NCT06504797
Status: NOT_YET_RECRUITING
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Massage|Pain, Back
Interventions: DEVICE: automatic massage
Sponsor: Emine Yıldırım
Sex: ALL
Age: CHILD, ADULT, OLDER_ADULT
Enrollment: 25
Study Design: Allocation: NA|Intervention Model: SINGLE_GROUP|Masking: NONE|Primary Purpose: SUPPORTIVE_CARE
Start Date: 2024-07-25
Completion Date: 2024-08-02

Summary:
To determine the effect of automatic massage applied to healthcare workers on pain, fatigue and psychological well-being. This research is planned as a pretest-posttest type study. It will be held in the Osmaniye State Hospital maternity ward. The application will be applied by one person in the rest room. Data will be collected using the Introductory Information Form, Psychological Well-Being Scale, Perceived Stress Scale (ASÖ/PSÖ-14), State-Trait Anxiety Inventory (STAI), and Piper Fatigue Scale.

Primary Outcome Measures: pain perception, pain scale, 1 week
Clinical and Laboratory Patterns of Pediatric Gross Hematuria
NCT Number: NCT06504771
Status: NOT_YET_RECRUITING
Study Type: OBSERVATIONAL
Conditions: Hematuria
Sponsor: Sohag University
Sex: ALL
Age: CHILD
Enrollment: 60
Study Design: Observational Model: |Time Perspective: p
Start Date: 2024-08-01
Completion Date: 2025-02
Locations: Faculty of Medicine,Sohag University, Sohag, Egypt

Summary:
Study the demographic, clinical, laboratory and etiological profile of children with gross hematuria and trace the outcome of these patients for at least 3 months follow up.

Primary Outcome Measures: Investigate the creatinine level of the studied cases, follow up of creatinine level in mg/dl of the studied cases, three months
The Effects of Breathing Exercises and Postural Exercises in Young Adults With Asthma.
NCT Number: NCT06504758
Status: NOT_YET_RECRUITING
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Asthma
Interventions: OTHER: Breathing Retraining Program|OTHER: Postural Exerises Program (Stretching and Strengthening Exercises)
Sponsor: Yeditepe University
Sex: FEMALE
Age: ADULT
Enrollment: 12
Study Design: Allocation: NA|Intervention Model: SINGLE_GROUP|Masking: NONE|Primary Purpose: PREVENTION
Start Date: 2024-07-24
Completion Date: 2024-09-27
Locations: Yeditepe University, Istanbul, Ataşehir, 34758, Turkey

Summary:
The aim of this study was to investigate the effects of breathing exercises and postural exercises via telerehabilitation on respiratory parameters, posture, and quality of life in young adults with asthma.

Primary Outcome Measures: Mini - Asthma Quality of Life Questionnaire (AQLQ), It is a test that measures health related quality of life in adults., 5 weeks|New York Posture Scale, There are 13 body alignment sections to general postural alignment. Includes posterior views of the head, shoulders, spine, hips, feet, and arches, and lateral (left side) views of the chest, shoulders, upper back, torso, abdomen, and lower back. Ratings were given as 5 (correct posture), 3 (minor deviation), or 1 (minor deviation)., 5 weeks|Asthma Control Test, It is a questionnaire that consists of 5 topics referring to the daytime and nocturnal symptoms of past 4 weeks which are activity limitation, shortness of breath, awaking due to asthma symptoms, reliever medication and global judgment of asthma., 5 weeks|International Physical Activity Questionnaire - Short Form (IPAQ-SF), It aims to evaluate physical activity across different nations in adults aged 18-65 years., 5 weeks|Oxygen Saturation, It is important to monitor current oxygen saturation due to the nature of oxygen consumption in the body., 5 weeks|Respiratory Rate Per Minute, The normal value of respiratory rate is roughly 12-16 breaths per minute., 5 weeks|Sit to Stand Test, Quadriceps muscle endurance will be evaluated with this test., 5 weeks
Safety and Efficacy Real-world Data of Trastuzumab Deruxtecan and Sacituzumab Govitecan
NCT Number: NCT06504719
Status: ACTIVE_NOT_RECRUITING
Study Type: OBSERVATIONAL
Conditions: Breast Cancer|Metastatic Cancer
Interventions: DRUG: Antibody-Drug Conjugates
Sponsor: Hellenic Cooperative Oncology Group
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 312
Study Design: Observational Model: |Time Perspective: p
Start Date: 2023-01-01
Completion Date: 2024-08-01
Locations: Hellenic Cooperative Oncology Group, Athens, 11524, Greece

Summary:
The study aims to evaluate real-world efficacy and toxicity data of treatment with Trastuzumab deruxtecan (T-DXd), a HER2-targeting ADC and sacituzumab govitecan (SG), a TROP-2-targeting ADC in pretreated patients with advanced breast cancer.

Primary Outcome Measures: The primary endpoint was toxicity rate of each drug, Adverse events (AEs) were graded according to the Common Terminology Criteria for Adverse Events (CTCAE, version 5.0), From the initiation of ADC to the date of discontinuation (due to any reason), first documented progression, death from any cause or last contact, throughout study completion, up to 24 months
Secondary Outcome Measures: progression-free survival (PFS), From the date of disease progression to the date of death from any cause or last contact, throughout study completion,up to 24 months
Effect of Matcha Tea Versus Green Tea on Salivary pH and Flow Rate in High Caries Risk Patients
NCT Number: NCT06504706
Status: COMPLETED
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Salivary pH
Interventions: PROCEDURE: Matcha Tea|PROCEDURE: Green Tea
Sponsor: Cairo University
Sex: ALL
Age: CHILD, ADULT, OLDER_ADULT
Enrollment: 24
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: DOUBLE (PARTICIPANT, OUTCOMES_ASSESSOR)|Primary Purpose: PREVENTION
Start Date: 2024-01-01
Completion Date: 2024-07-01
Locations: Faculty of Dentistry Cairo University, Cairo, 12345, Egypt

Summary:
Objectives: To evaluate the effect of green tea versus matcha tea on the salivary pH in high caries risk patients. Materials and methods: Total number of high caries risk patients were randomized into two equal groups (n=). Group 1 (intervention group) was given Matcha Tea and Group 2 (control group) was given green tea. A portable digital pH meter was used to measure the salivary pH at baseline and after consumption tea immediately, after 5 mins and after 10 mins.

Primary Outcome Measures: salivary pH, pH of saliva to be measured, baseline before administration of tea, immediately after administration of tea, 5 minutes after administration of tea and 10 minutes after administration of tea
Iron Status in Children With ADHD
NCT Number: NCT06504693
Status: NOT_YET_RECRUITING
Study Type: OBSERVATIONAL
Conditions: Attention Deficit Hyperactivity Disorder
Interventions: DIAGNOSTIC_TEST: CBC
Sponsor: Assiut University
Sex: ALL
Age: CHILD
Enrollment: 44
Study Design: Observational Model: |Time Perspective: p
Start Date: 2024-09-01
Completion Date: 2025-10

Summary:
Evaluation of the status of iron deficiency in children with attention deficit hyperactivity disorder.

Primary Outcome Measures: Iron status in children with attention deficit hyperactivity disorder, To determine number of patients with ADHD who have associated iron deficiency, Baseline
Results of 8 Strand Repair of Flexor Tendon Injuries
NCT Number: NCT06504680
Status: NOT_YET_RECRUITING
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Cut Flexor Zone ll Using 8-strand
Interventions: PROCEDURE: Repair of flexor tendon injury zone ll using 8- strand
Sponsor: Assiut University
Sex: ALL
Age: CHILD, ADULT
Enrollment: 52
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: NONE|Primary Purpose: TREATMENT
Start Date: 2024-08-10
Completion Date: 2025-06

Summary:
Functional results of 8 strand repair of flexor tendon injuries zone II with and without splinting of the wrist

Primary Outcome Measures: range of motion, ROM using Strickland criteria by finger goniometer, Six month post operative
Secondary Outcome Measures: Hand function, Hand function using DASH score, 6 month post-operative|Complications, As rupture , adhesion, 6 month post-operative