pankajmathur/National_Library_of_Medicine_Studies_data huggingface dataset:
Advanced Imaging for Pulmonary Fibrosis
NCT Number: NCT06532071
Status: NOT_YET_RECRUITING
Study Type: INTERVENTIONAL
Phases: PHASE2
Conditions: Pulmonary Fibrosis
Interventions: DRUG: [68Ga]CBP8
Sponsor: Peter Caravan
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 60
Study Design: Allocation: NA|Intervention Model: SINGLE_GROUP|Masking: NONE|Primary Purpose: DIAGNOSTIC
Start Date: 2024-09-01
Completion Date: 2028-12-31

Summary:
The purpose of this study is to determine if measurements of active collagen deposition using \[68Ga\]CBP8 positron emission tomography (PET) and tissue injury using dynamic contrast-enhanced magnetic resonance imaging (DCE-MRI) can predict an individual patient's pace of disease progression in non-idiopathic pulmonary fibrosis interstitial lung disease (non-IPF ILD) and identify which individuals will develop progressive pulmonary fibrosis.

Primary Outcome Measures: Development of progressive pulmonary fibrosis, Defined by the 2022 ATS guideline definition of progressive pulmonary fibrosis (PPF) which defines PPF as satisfying 2 of 3 criteria over 12 months: worsening symptoms, physiologic progression (absolute decline in FVC ≥ 5% or absolute decline in DLCO ≥ 10%), or radiologic evidence of disease progression., Up to 24 months
Secondary Outcome Measures: Decline of forced vital capacity (FVC) ≥ 5% from baseline, FVC will be measured at baseline, 6, 12, 18, and 24 months, Up to 24 months|Decline of forced vital capacity (FVC) ≥10% from baseline, FVC will be measured at baseline, 6, 12, 18, and 24 months, Up to 24 months|Decline of diffusing capacity for carbon monoxide (DLCO) ≥15% from baseline, DLCO will be measured at baseline, 6, 12, 18, and 24 months, Up to 24 months
Effect of TENS on Patients With Palmar Hyperhidrosis
NCT Number: NCT06532045
Status: TERMINATED
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Hyperhidrosis Primary Focal Palms
Interventions: DEVICE: Transcutaneous electrical nerve stimulation
Sponsor: Cairo University
Sex: ALL
Age: ADULT
Enrollment: 56
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: SINGLE (PARTICIPANT)|Primary Purpose: TREATMENT
Start Date: 2023-07-01
Completion Date: 2024-05-16
Locations: Mahmoud, Cairo, Cairo Government, 3753450, Egypt

Summary:
To investigate the effectiveness of Transcutaneous Electrical Nerve Stimulation on Hyperhidrosis Severity on patients with primary Palmar Hyperhidrosis.

Primary Outcome Measures: Change the severity of hyperhidrosis, Measure the rate sweating by iodine starch testin unit of score, 2 weeks
Secondary Outcome Measures: Change the quality of life, Measure Quality of life by questionnaire in unit of grade, 2 weeks
Clinical Study of Active Intervention in High-risk HFpEF Patients
NCT Number: NCT06532019
Status: NOT_YET_RECRUITING
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Heart Failure With Preserved Ejection Fraction
Interventions: OTHER: Targeted intervention based on risk factors
Sponsor: Xiangtan Central Hospital
Collaborators: The First People's Hospital of Xiangtan City|The Xiangtan People's Hospital|The Xiangxiang People's Hospital
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 924
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: DOUBLE (PARTICIPANT, INVESTIGATOR)|Primary Purpose: OTHER
Start Date: 2024-08-01
Completion Date: 2028-08-01

Summary:
Based on inclusion and exclusion criteria, this experiment plans to include 924 Heart Failure with Preserved Ejection Fraction(HFpEF) patients with increased risk of all-cause death. The enrolled patients will divided into usual care group (n=462) and targeted intervention group (n=462) in a 1:1 ratio. The usual care patients will receive routine heart failure treatment. Patients in targeted intervention group, on top of routine therapy for heart failure, will receive further therapy targeting therapy to correct hypoalbuminemia, anemia or hyponatremia, and try to enhance medication to lower N-terminal pro brain natriuretic peptide (NT-proBNP), C-reactive protein(CRP), New York Heart Association(NYHA )Classification, to add diuretics for patients with higher right ventricular diameters(RADs),multidiscipline intervention for patients complicating chronic obstructive pulmonary disease(COPD), and actively reperfusion for ischemic HFpEF patients. The incidence of all-cause death will be compared after 3 years follow-up.The primary endpoint is the occurrence of all-cause mortality events during the follow-up period.

Primary Outcome Measures: all-cause mortality, follow-up by clinical visit, telephone call or community visit, The patients will be followed up for 3 years after they were enrolled.
A Phase Ⅲ Clinical Study of HLX22 in Combination With Trastuzumab and Chemotherapy for the Treatment of Gastroesophageal Junction and Gastric Cancer
NCT Number: NCT06532006
Status: NOT_YET_RECRUITING
Study Type: INTERVENTIONAL
Phases: PHASE3
Conditions: Gastroesophageal-junction Cancer|Monoclonal Antibody|Gastric Cancer|HER2-positive Gastric Cancer
Interventions: DRUG: HLX22|DRUG: Pembrolizumab|DRUG: Trastuzumab|DRUG: Oxaliplatin|DRUG: Capecitabine
Sponsor: Shanghai Henlius Biotech
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 550
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: QUADRUPLE (PARTICIPANT, CARE_PROVIDER, INVESTIGATOR, OUTCOMES_ASSESSOR)|Primary Purpose: TREATMENT
Start Date: 2024-11-01
Completion Date: 2028-09-01
Locations: Beijing Cancer Hospital, Beijing, Beijing, 100142, China

Summary:
This is a double-blind, randomized, multiregion, comparative phase Ⅲ clinical study designed to evaluate the efficacy and safety of HLX22 in combination with trastuzumab and chemotherapy as first-line treatment in patients with HER2-positive locally advanced/metastatic adenocarcinoma of the gastric and/or gastroesophageal junction (G/GEJ).Eligible subjects will be randomized to the two groups based on a 1:1 ratio. Enrolled subjects shall be treated with the study drug until the loss of clinical benefit, death, intolerable toxicity, withdrawal of informed consent, or other reasons specified by the protocol (whichever occurs first).

Primary Outcome Measures: PFS per RECIST 1.1 assessed by IRRC(Independent Radiology Review Committee), PFS is defined as the time from randomization to the first documented disease progression per RECIST 1.1 or death due to any cause, whichever occurs first. PFS will be determined for each treatment arm, Up to 5 years|OS, OS is defined as the time from randomization to death due to any cause. OS will be determined for each treatment arm., Up to 5 years
Secondary Outcome Measures: PFS per RECIST 1.1 assessed by investigator, PFS is defined as the time from randomization to the first documented disease progression per RECIST 1.1 or death due to any cause, whichever occurs first. PFS will be determined for each treatment arm, Up to 5 years|ORR assessed by IRRC and investigator per RECIST v1.1, ORR is defined as the percentage of participants who have a Complete Response (\[CR\], disappearance of all evidence of disease) or Partial Response (\[PR\], regression of measurable disease and no new sites) per RECIST 1.1. ORR will be determined for each treatment arm., Up to 5 years|Adverse events, An AE is any untoward medical occurrence in a participant that is temporally associated with the use of study treatment, whether or not considered related to the study treatment. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of a study treatment. The number of participants who experience an AE will be reported for each treatment arm., Up to 5 years
Effect of Pectin in Chronic Kidney Disease Patients ( Stage 3 and 4 )
NCT Number: NCT06531993
Status: NOT_YET_RECRUITING
Study Type: INTERVENTIONAL
Phases: PHASE2
Conditions: Chronic Kidney Diseases
Interventions: DRUG: Pectin
Sponsor: Assiut University
Sex: ALL
Age: ADULT
Enrollment: 98
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: SINGLE (PARTICIPANT)|Primary Purpose: TREATMENT
Start Date: 2024-08
Completion Date: 2025-08

Summary:
Effect of pectin in chronic kidney disease patients

Primary Outcome Measures: effect of pectin in GFR improvement in ckd patients, Measure eGFR using CKD epi equation,, 6 month
Predicting Mortality in Kidney Transplant Recipients
NCT Number: NCT06531967
Acronym: mBox
Status: ENROLLING_BY_INVITATION
Study Type: OBSERVATIONAL
Conditions: Death
Interventions: OTHER: No intervention
Sponsor: Paris Translational Research Center for Organ Transplantation
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 13000
Study Design: Observational Model: |Time Perspective: p
Start Date: 2004-01-01
Completion Date: 2024-08-01
Locations: Department of Medicine, Mayo Clinic, Phoenix, Arizona, 85054, United States|Bakar Computational Health Sciences Institute, University of California, San Francisco, California, 94158, United States|Penn Transplant Institute, Hospital of the University of Pennsylvania, Philadelphia, Pennsylvania, 19104, United States|Department of Nephrology and Renal Transplantation, University Hospitals Leuven, Leuven, Belgium|Division of Nephrology, University Hospital Liège (CHU), Liège, Belgium|Necker hospital, Paris, France|Saint-Louis hospital, Paris, France|Tenon hospital, Paris, France|Department of Nephrology and Organ Transplantation, Toulouse University Hospital, Toulouse, France|Department of Nephrology and Clinical Immunology, University Hospital of Tours, Tours, France|Leiden Transplant Center, Leiden University Medical Center, Leiden, Netherlands

Summary:
Accurately predicting kidney recipient risk of death has a crucial interest because of the organ shortage, the need to optimize allograft allocation by identifying high-risk patients who may not benefit from a transplant and improve the clinical decision-making after transplant to ensure that each patient survives as long as possible.

However, according to a literature review the investigators performed, studies attempting to develop a kidney recipient death prediction model suffer from many shortcomings, including the lack of key risk factors, use of biased registry data, small sample size, lack of external validation in different countries and subpopulations, and short follow-up.

The present study thus aimed to address these limitations and develop a robust, generalizable kidney recipient death prediction model.

Primary Outcome Measures: Patient death, Patient death, Up to 10 years after kidney transplantation
Extension Study to Evaluate the Long-Term Safety and Tolerability of MBX 2109 in Patients With Hypoparathyroidism
NCT Number: NCT06531941
Status: NOT_YET_RECRUITING
Study Type: INTERVENTIONAL
Phases: PHASE2
Conditions: Hypoparathyroidism
Interventions: DRUG: 400 µg of MBX 2109 once-weekly by subcutaneous injection|DRUG: 200-1600 µg of MBX 2109 once-weekly by subcutaneous injection
Sponsor: MBX Biosciences
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 48
Study Design: Allocation: NON_RANDOMIZED|Intervention Model: CROSSOVER|Masking: NONE|Primary Purpose: TREATMENT
Start Date: 2024-10
Completion Date: 2027-05-27
Locations: MBX Biosciences Investigational Site, Jacksonville, Florida, 32204, United States|MBX Biosciences Investigational Site, Jacksonville, Florida, 32216, United States|MBX Biosciences Investigational Site, Jackson, Mississippi, 39202, United States|MBX Biosciences Investigational Site, Las Vegas, Nevada, 89148, United States|MBX Biosciences Investigational Site, Albany, New York, 12203, United States|MBX Biosciences Investigational Site, Greenville, North Carolina, 27834, United States|MBX Biosciences Investigational Site, Dallas, Texas, 75208, United States|MBX Biosciences Investigational Site, El Paso, Texas, 79935, United States|MBX Biosciences Investigational Site, Fort Worth, Texas, 76132, United States|MBX Biosciences Investigational Site, Round Rock, Texas, 78681, United States|MBX Biosciences Investigational Site, San Antonio, Texas, 78231, United States|MBX Biosciences Investigational Site, Weslaco, Texas, 78596, United States

Summary:
The purpose of this study is to evaluate the long-term safety and tolerability of MBX 2109 in patients with hypoparathyroidism who completed the 12-week treatment period in the Phase 2 study, MBX-2H1002.

Primary Outcome Measures: To evaluate the long-term safety and tolerability of weekly MBX 2109 in patients with hypoparathyroidism., Incidence of treatment-emergent adverse events (TEAEs) and serious adverse events (SAEs)., 104 weeks
Effect of Chest Tube Withdrawal on Patients' Anxiety Levels After Thoracic Surgery
NCT Number: NCT06531928
Status: NOT_YET_RECRUITING
Study Type: OBSERVATIONAL
Conditions: Chest Tube Withdrawal|Video-assisted Thoracoscopic Surgery
Interventions: OTHER: chest tube withdrawal
Sponsor: Ankara Ataturk Sanatorium Training and Research Hospital
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 60
Study Design: Observational Model: |Time Perspective: p
Start Date: 2024-08-15
Completion Date: 2025-06-30

Summary:
Since the removal of the chest tube is a painful procedure, it can cause serious anxiety in patients. Patients state that chest tube removal is among the bad memories they experience. The source of the anxiety may be related to fear and anxiety about the pain caused by the upcoming chest tube removal procedure, or it may be the words they have heard from other patients who have had this experience before. There are a limited number of studies in the literature on anxiety that may occur in patients due to chest tube withdrawal. In addition, studies in the literature did not focus on whether there was a difference between pre-procedure and post-procedure anxiety levels. In this study, it was aimed to investigate the anxiety levels before and after the procedure and the pain levels felt in the patients due to the procedure due to chest tube withdrawal in patients who underwent VATS. In addition, it aimed to investigate whether there is any correlation between pre-procedure anxiety and pain experienced during the procedure. If a correlation is detected, the importance of pre-procedural anxiety management will be better understood, the necessity of interventions such as psychological and pharmacological treatment for anxiety will come to the fore, and new research on this subject will be needed.

Primary Outcome Measures: visual analog scale -Anxiety, Investigation of pre-procedure and post-procedure anxiety levels due to chest tube removal in patients undergoing VATS and pain felt by patients due to the procedure. The VAS-anxiety is a segmented numerical version of the visual analog scale (VAS), in which the respondent chooses an integer (0-100 mm) that best reflects the intensity of his anxiety. It is considered a one-dimensional measure of anxiety intensity in adults. It ranges from "0 mm" representing no anxiety to "100 mm" representing extreme anxiety., 24 hours
Secondary Outcome Measures: visual analog scale-Pain, It was aimed to investigate whether there is any correlation between pre-procedure anxiety and pain experienced during the procedure. The VAS-pain is a segmented numerical version of the visual analog scale (VAS), in which the respondent chooses an integer (0-100 mm) that best reflects the intensity of his pain. It is considered a one-dimensional measure of pain intensity in adults. It ranges from "0 mm" representing no pain to "100 mm" representing extreme pain., 24 hours
Comparison of Efficacy and Safety Between Ciprofol and Remimazolam During Fiberoptic Bronchoscopy
NCT Number: NCT06531915
Status: NOT_YET_RECRUITING
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Fiberoptic Bronchoscopy
Interventions: DRUG: Ciprofol|DRUG: Remimazolam
Sponsor: Anhui Provincial Hospital
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 190
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: DOUBLE (PARTICIPANT, OUTCOMES_ASSESSOR)|Primary Purpose: TREATMENT
Start Date: 2024-12-01
Completion Date: 2025-03-31

Summary:
Both ciprofol and remimazolam have been found to be potential alternatives to propofol (a commonly used anesthesia) during fiberoptic bronchoscopy, while the efficacy and safety between ciprofol and remimazolam have not been reported. This study aims to compare the efficacy and safety between ciprofol and remimazolam in patients undergoing fiberoptic bronchoscopy.

Primary Outcome Measures: The success rate of fiberoptic bronchoscopy, 24 hours after fiberoptic bronchoscopy
Secondary Outcome Measures: Induction time, 24 hours after fiberoptic bronchoscopy|Procedure time, 24 hours after fiberoptic bronchoscopy|Awake time, 24 hours after fiberoptic bronchoscopy|Recovery time, 24 hours after fiberoptic bronchoscopy|Stay time in PACU, 24 hours after fiberoptic bronchoscopy|Supplemental times of experimental drugs (ciprofol or remimazolam), 24 hours after fiberoptic bronchoscopy|Doses of experimental drugs (ciprofol or remimazolam), 24 hours after fiberoptic bronchoscopy|Times of using rescue sedative drug, 24 hours after fiberoptic bronchoscopy|Doses of using rescue sedative drug, 24 hours after fiberoptic bronchoscopy|Incidence of adverse events, 24 hours after fiberoptic bronchoscopy|Patients' satisfaction, Patients' satisfaction is assessed using the Satisfaction Scale reported by Luo et al. The Satisfaction Scale ranges from 0 to 10 points and contains five items. The higher score indicates better satisfaction., 24 hours after fiberoptic bronchoscopy|Heart rate, 6 minutes after fiberoptic bronchoscopy|SBP, 6 minutes after fiberoptic bronchoscopy|Diastolic blood pressure, 6 minutes after fiberoptic bronchoscopy|SpO2, 6 minutes after fiberoptic bronchoscopy
LncRNA Nicotinamide Nucleotide Transhydrogenase-Antisense RNA1 NNT-AS1 in CRC
NCT Number: NCT06531902
Status: COMPLETED
Study Type: OBSERVATIONAL
Conditions: Colorectal Cancer
Sponsor: Ain Shams University
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 88
Study Design: Observational Model: |Time Perspective: p
Start Date: 2020-10-01
Completion Date: 2021-06-01
Locations: Faculty of Pharmacy, Ain Shams University, Advanced Biochemistry Research Lab, Cairo, 11566, Egypt

Summary:
The current study will compare the blood expression level of lncRNA NNT-AS1 and hsa-miR-485-5p, as well as heat shock protein 90 (HSP90) serum levels in both healthy and CRC Egyptian patients' cohort peripheral blood samples. Second, examine if lncRNA NNT-AS1/hsa-miR-485 5p/HSP90 axis, or individually investigated, would be used as a non-invasive molecular precision biomarker in liquid biopsy for better diagnostic utility for CRC patients. Also, based on CRC patients' group stratification by histologic grades 1-3. Finally, investigate the probable link/correlation between lncRNA NNT-AS1/hsa-miR-485-5p/HSP90 as an axis or individually in CRC Egyptian patients' cohort in relation to demographic data or clinicopathological characteristics. All findings will be confirmed or ruled out by in silico means as well.

Primary Outcome Measures: determination ofncRNA Expression pattern in CRC patients' in comparison to the control group, 9 months|determination of HSP90 protein concentration in control and CRC cases, 12 months|assigning Correlation coefficient between ncRNA, HSP90 protein, CEA, and CA19-9, 10 months|carry out hsa-miR-485-5p target analysis, 3 months
Efficacy of the Dreem 3S Ambulatory Sleep Monitoring Device for the Evaluation of Narcolepsy
NCT Number: NCT06531876
Status: RECRUITING
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Narcolepsy Type 1|Hypersomnia|Sleep Disorder
Interventions: DEVICE: Dreem 3S recording
Sponsor: Beacon Biosignals
Collaborators: Kaiser Permanente|Stanford University|Intrepid Research|Sleep Insights|Sleep Management Institute
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 78
Study Design: Allocation: NON_RANDOMIZED|Intervention Model: SINGLE_GROUP|Masking: NONE|Primary Purpose: DIAGNOSTIC
Start Date: 2024-07-01
Completion Date: 2025-06-01
Locations: Kaiser Permanente Fontana Medical Center, Fontana, California, 92335, United States|Stanford University, Redwood City, California, 94063, United States|Sleep Insights Medical Associates PLLC, Rochester, New York, 14623, United States|Intrepid Research, Cincinnati, Ohio, 45245, United States

Summary:
This study intends to examine the utility of a home-use EEG-based sleep monitor for the diagnosis and evaluation of disorders of excessive sleepiness, specifically the neurological disorder Narcolepsy Type 1.

Primary Outcome Measures: Compliance with Dreem 3S, The primary outcome of this study is the ability of subjects with hypersomnia to utilize the Dreem 3S system over multiple nights., 1 week|Consensus sleep staging, Positive percent agreement (PPA) for WAKE stage for human adjudicated automated sleep staging from the Dreem 3S data (test method) as compared to consensus human sleep staging of synchronouslly recorded PSG data (reference method)., Days 9-10 (est)
Secondary Outcome Measures: Usability, Subject assessment of usability of the Dreem device, as measured by the System Usability Scale, Days 1-7|24-hour usability, Percent of a 24 hour period during which subjects will be asked to wear and operate the Dreem 3S Headband device during which interpretable data is collected., Day 7 (est)|Detailed comparison between adjudicated Dreem derived sleep stages and PSG derived sleep stages, Examination of Positive Predictive Agreement (PPA) for REM, N1, N2, N3 when comparing adjudicated labels derived from Dreem 3S recorded EEG and sleep stages from human adjudicated PSG data., Days 9-10 (est)|Comparison of Dreem derived hypnogram based sleep metrics with in-lab PSG, Percentage of REM in the first 120 minutes of the night (starting after unambiguous sleep onset) will be compared from human adjudicated Dreem sleep labels and human adjudicated PSG data., Days 9-10 (est)|Agreement of Dreem derived sleep stages to PSG derived sleep stages, Cohen's kappa of agreement will be calculated between human adjudicated automated sleep staging of Dreem 3S data and manual consensus sleep staging of PSG data collected during in-lab nocturnal monitoring., Days 9-10 (est)
Curcumin and EGCG Supplementation to Improve Serum BDNF and Mood Disturbance
NCT Number: NCT06531863
Status: NOT_YET_RECRUITING
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Mood Disturbance
Interventions: DIETARY_SUPPLEMENT: Curcumin|DIETARY_SUPPLEMENT: Epigallocatechin Gallate|OTHER: Placebo
Sponsor: Auburn University
Sex: ALL
Age: ADULT
Enrollment: 64
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: SINGLE (PARTICIPANT)|Primary Purpose: TREATMENT
Start Date: 2024-09-01
Completion Date: 2025-08-01

Summary:
The goal of this randomized placebo controlled trial is to examine mood disturbance and serum brain derived neurotrophic factor (BDNF) in people (age 18-50) with moderate depression. The main questions it aims to answer are:

Does curcumin and EGCG supplementation improve mood disturbance symptomology? Does curcumin and EGCG supplementation increase serum BDNF? Researchers will compare intervention versus placebo.

Participants will consume an 8-week supplement of both:

* 1,500mg/day curcumin
* 300mg/day epigallocatechin gallate (EGCG)

Primary Outcome Measures: Changes in total distress as measured via DASS-21 total score., The DASS-21 (Depression Anxiety and Stress Scale) Total ranges from 0 to 63, with lower numbers indicating less distress, 8-weeks|Changes in serum brain derived neurotrophic factor (BDNF)., Serum BDNF will be measured via commercial ELISA kits. Higher levels of serum BDNF are optimal., 8-weeks
Secondary Outcome Measures: Changes in DASS-21 subscales (depression, anxiety, stress)., The DASS-21 (Depression Anxiety and Stress Scale) subscales include Depression, Anxiety, and Stress, which range from 0 to 21, with lower numbers indicating less distress, 8-weeks|Changes in subjective sleep quality., Using Global Sleep Assessment Questionnaire includes 11 questions outlined with "During the PAST 4 WEEKS, how often" with answer choices ranging from "never, sometimes, usually and always", 8-weeks|Changes in subjective physical activity., Using International Physical Activity Questionnaire has 27 questions that span 5 activity domains from "job related physical activity, transportation physical activity, house work and maintenance, recreation and sport as well as time spent sitting" over the past 7-days., 8-weeks|Changes in diet quality., Using diet recalls over the past 24 hours., 8-weeks|Number of Participants who report daily adherence to supplementation intake, Number of participants that report consuming supplement \>80% of days via daily text messages, 8-weeks|Changes in fasting alanine aminotransferase (ALT), Phlebotomy will be obtained while fasted 8+ hours and alanine aminotransferase (ALT) will be measured as part of a comprehensive metabolic panel and reported in mg/dl. Lower concentrations are optimal., 8-weeks|Changes in fasting aspartate aminotransferase (AST), Phlebotomy will be obtained while fasted 8+ hours and aspartate transferase (AST) will be measured as part of a comprehensive metabolic panel and reported in mg/dl. Lower concentrations are optimal., 8-weeks
Prospective Study of Serum Marker LncRNA RP5-977B1 in Pulmonary Nodules
NCT Number: NCT06531850
Status: RECRUITING
Study Type: OBSERVATIONAL
Conditions: Tumor of Lung|Pulmonary Nodule
Sponsor: Affiliated Cancer Hospital & Institute of Guangzhou Medical University
Sex: ALL
Age: CHILD, ADULT, OLDER_ADULT
Enrollment: 200
Study Design: Observational Model: |Time Perspective: p
Start Date: 2024-01-01
Completion Date: 2026-01-01
Locations: Cancer Hospital & Affiliated Guangzhou Medical University, Guangzhou, Guangdong, 510095, China

Summary:
Based on previous studies, this project intends to use prospective studies to select patients identified by imaging as pulmonary nodules to explore the potential of RP5-977B1 in differentiating benign and malignant pulmonary nodules, construct diagnostic models combined with clinical protein tumor markers, compare the diagnostic efficacy of the two, and finally determine the sensitivity and specificity of markers through pathological results. It provides a new content for the diagnosis of benign and malignant pulmonary nodules.

Primary Outcome Measures: Benign nodule, Pathological findings determined that the nodules were benign in the patient, A week|Tumor, Pathological findings identified the nodules as malignant tumors in the patient, A week
Electroencephalographic Characteristics of Chronic Pain in Patients With Spinal Cord Injury
NCT Number: NCT06531837
Status: NOT_YET_RECRUITING
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Chronic Pain
Interventions: DRUG: Esketamine(Continuous infusion)|DRUG: Remifentanil (Target-Controlled Infusion)|DRUG: Flurbiprofen (Single intravenous injection)|DEVICE: Spinal Cord Stimulation|OTHER: No intervention
Sponsor: Beijing Tiantan Hospital
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 60
Study Design: Allocation: NON_RANDOMIZED|Intervention Model: PARALLEL|Masking: NONE|Primary Purpose: OTHER
Start Date: 2024-08-25
Completion Date: 2026-02-28
Locations: Beijing Tiantan Hospital, Beijing, 100070, China

Summary:
The diagnosis of chronic pain currently lacks objective and quantifiable biomarkers. This study aims to observe the EEG characteristics of patients with chronic pain following spinal cord injury and subsequently administer analgesic interventions with remifentanil, esketamine, flurbiprofen, and spinal cord stimulation. The correlation between EEG features and pain intensity will be examined. The research aims to advance the objectification of chronic pain diagnosis and treatment.

Primary Outcome Measures: EEG Spectral Characteristics, EEG power spectrum characteristics of chronic pain in patients with spinal cord injury under esketamine, remifentanil, flurbiprofen administration and spinal cord stimulation, including the δ, θ, α, β, and γ frequency bands.

administration, including the δ, θ, α, β, and γ frequency bands., During the trial(up to 3 hours for each subject).
Secondary Outcome Measures: Numeric Rating Scale(NRS), Numerical Rating Scale Assessment Pre- and Post-Analgesic Treatment. The NRS ranges from 0 to 10, with 0-3 indicating mild pain, 4-6 indicating moderate pain, and 7-10 indicating severe pain., During the trial(through study completion, 7 days)|Generalized Anxiety Disorder(GAD-7), The GAD-7 scale ranges from 0 to 21 points, with a higher score indicating a higher level of anxiety., During the trial(through study completion, 7 days)|Patient Health Questionnaire-9(PHQ-9), The PHQ-9 scale ranges from 0 to 27 points, with a higher score indicating a higher level of depression., During the trial(through study completion, 7 days)
Post-marketing Phase 4 Safety & Tolerability Study of Breztri aerosphereTM in Indian Patients With Chronic Obstructive Pulmonary Disease
NCT Number: NCT06531798
Acronym: INDOS-B
Status: NOT_YET_RECRUITING
Study Type: INTERVENTIONAL
Phases: PHASE4
Conditions: Moderate to Severe COPD
Interventions: DRUG: Breztri Aerosphere
Sponsor: AstraZeneca
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 150
Study Design: Allocation: NA|Intervention Model: SINGLE_GROUP|Masking: NONE|Primary Purpose: TREATMENT
Start Date: 2024-09-01
Completion Date: 2025-10-01

Summary:
The purpose of this study is to observe the safety and tolerability of Breztri aerosphereTM as maintenance treatment in Indian patients with moderate to severe COPD.

Primary Outcome Measures: To observe the safety and tolerability of Breztri aerosphereTM as maintenance treatment in Indian patients with moderate to severe COPD, Percentage, nature, intensity, seriousness and causal relationship of AEs, SAEs, and AEs leading to discontinuation of study drug will be assessed, 24 weeks
Role of Lung Ultrasound in Screening for Interstitial Lung Disease in Patients With Rheumatoid Arthritis
NCT Number: NCT06531785
Status: RECRUITING
Study Type: OBSERVATIONAL
Conditions: Interstitial Lung Disease|Rheumatoid Arthritis
Interventions: DEVICE: chest ultrasound
Sponsor: Assiut University
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 60
Study Design: Observational Model: |Time Perspective: p
Start Date: 2024-01-01
Completion Date: 2025-01-01
Locations: Faculty of Medicine, Assiut University, Assiut, 711111, Egypt

Summary:
The aim of this observational cross-sectional study is to assess accuracy of Lung Ultrasound to early diagnose ILD among Rheumatoid arthritis patients. Rheumatoid arthritis patients with suggestive history of chest troubles will be evaluated using chest ultrasound and high resolution CT chest to evaluate ability of chest ultrasound to early diagnose ILD among rheumatoid arthritis patients.

Primary Outcome Measures: Number of rheumatoid arthritis patients that can be diagnosed early with Interstitial lung disease., early diagnosis of Interstitial lung disease among rheumatoid arthritis patients using chest ultrasound versus high resolution computed tomography, 1 month
Characteristics and Outcomes of TB and HIV Co-infections
NCT Number: NCT06531772
Status: RECRUITING
Study Type: OBSERVATIONAL
Conditions: Human Immunodeficiency Virus|Mycobacterium Tuberculosis
Interventions: DRUG: Antitubercular Agents
Sponsor: Assiut University
Sex: ALL
Age: CHILD, ADULT, OLDER_ADULT
Enrollment: 100
Study Design: Observational Model: |Time Perspective: p
Start Date: 2023-09-01
Completion Date: 2025-03-01
Locations: Faculty of Medicine, Assiut University, Assiut, 711111, Egypt

Summary:
People Living with HIV (PLHIV) are prone to several opportunistic infections depending on the degree of immunosuppression as well as infections prevalent in their geographic area/country. These include a wide variety of mycobacterial diseases, fungal infections, bacterial pneumonias, pneumocystis jirovecii pneumonia, cryptococcal infections, toxoplasmosis etc.

Tuberculosis remains the most common opportunistic infection in the developing countries like South Africa and India.

HIV and tuberculosis (TB) are two of the most challenging infections faced by the humanity. HIV is the most important risk factor for progression of latent Mycobacterium tuberculosis (MTB) to active disease. The most common cause of death among PLHIV is tuberculosis. These two infections place immense burden on health care systems worldwide. During the last two decades, sustained research and public health initiatives on prevention and therapeutic advances have allayed morbidity and mortality due to HIV and TB to a large extent, however more needs to be done.

Globally, an estimated 10 million people fell ill with TB and an estimated 1.4 million people died of TB in 2018 (1.2 million among HIV negative and 251 000 among HIV positive people). There were around 37.9 million PLHIV worldwide in 2018.

In the pre-antiretroviral therapy (ART) era, nearly one-third of HIV/AIDS (acquired immune deficiency syndrome) related deaths were due to TB. Wider availability of ART has reduced the mortality of HIV-associated TB significantly, but it still remains high compared to HIV-uninfected individuals. The mortality risk with HIV TB coinfection accounts for approximately 25% of global HIV/AIDS deaths every year.

This study aims to investigate characteristics and outcomes of TB and HIV co-infections in Upper Egypt.

Primary Outcome Measures: Cure rate for tuberculosis infection, complete cure from tuberculosis infection assessed by sputum conversion, general condition improvement and radiological improvement., 6 months
Secondary Outcome Measures: pulmonary complications associated with tuberculosis in both groups, Superimposed pneumonia, opportunistic infection, pneumothorax, respiratory failure, 1 year
Efficacy of Fentanyl Soaked Nasal Packs on Postoperative Pain in Nasal Surgeries.
NCT Number: NCT06531759
Status: NOT_YET_RECRUITING
Study Type: INTERVENTIONAL
Phases: PHASE2
Conditions: Postoperative Pain
Interventions: DRUG: Fentanyl
Sponsor: Assiut University
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 100
Study Design: Allocation: NA|Intervention Model: SINGLE_GROUP|Masking: NONE|Primary Purpose: TREATMENT
Start Date: 2024-09-01
Completion Date: 2025-11

Summary:
Efficacy of fentanyl soaked nasal packs on postoperative pain in nasal surgeries.

Primary Outcome Measures: Efficacy of fentanyl soaked nasal packs on postoperative pain in nasal surgeries, Assessment of pain intensity will be done using The 11-point Numeric pain rating scale, subjects will be asked to give a pain score ranging from 0 to 10 interpreted as 0 is no pain and 10 is the worst pain they ever felt at intervals of 3, 6, 12 and 24 hours postoperatively., 24 hours postoperatively
Effect of Extracorporeal Shock Wave on Electrophysiological Changes and Pain in Patients With Lower Cross Syndrome
NCT Number: NCT06531746
Status: RECRUITING
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Lower Cross Syndrome
Interventions: OTHER: Extracorporeal shock wave|OTHER: Selected physical therapy program
Sponsor: Ahmed Alshimy
Sex: ALL
Age: ADULT
Enrollment: 44
Study Design: Allocation: RANDOMIZED|Intervention Model: FACTORIAL|Masking: DOUBLE (PARTICIPANT, INVESTIGATOR)|Primary Purpose: TREATMENT
Start Date: 2024-08-10
Completion Date: 2024-09-30
Locations: Al Ryada University for Science and Technology, Sadat, Menoufia, Egypt

Summary:
Lower Cross Syndrome happens when there is muscular imbalance between weak and tight muscles. The tight muscles are generally the hip flexors and erector spinae, and weak muscles are the abdominals and gluteal muscles. Shortening occurs in the hip flexors while weakening occurs in the abdominals and gluteal muscles.

Primary Outcome Measures: Visual Analog Scale, Assess pain intensity, 4 weeks|Electromyograph, Assess activity of iliopoas and lower back muscles, 4 weeks
Artemis Sleep Countermeasures
NCT Number: NCT06531733
Acronym: ASCM
Status: RECRUITING
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Fatigue
Interventions: DEVICE: Sleep Promoting (pink noise)|DEVICE: Wake Promoting (blue enriched light plus a nap)
Sponsor: National Aeronautics and Space Administration (NASA)
Sex: ALL
Age: ADULT
Enrollment: 24
Study Design: Allocation: RANDOMIZED|Intervention Model: SINGLE_GROUP|Masking: NONE|Primary Purpose: TREATMENT
Start Date: 2024-06-22
Completion Date: 2025-06-01
Locations: NASA Ames Research Center, Mountain View, California, 94043, United States

Summary:
Purpose. The purpose of this study is to test sleep and wake-promoting countermeasures to evaluate their effectiveness in helping individuals fall asleep quickly, maintain sleep during a nap, and maintain alertness during waking.

Protocol Overview. The proposed study involves two laboratory visits separated by at least one week. Participants are required to complete all procedures in the companion screening and at-home protocol in order to qualify for this laboratory protocol. The at-home protocol involves keeping a regular schedule for 2-3 weeks. Participants will need to maintain a regular schedule with at least 8.5 hours in bed for at least one week prior to the first laboratory visit. They will then continue the at-home protocol, maintaining at least 8.5 hours in bed each night for at least a week before completing the second laboratory visit.

There are two interventions that participants will experience during the study, sleep promoting (pink noise) and wake promoting (blue enriched lighting plus a nap). These will be delivered separately and together depending on randomization.

Participants will first be randomized to one of three conditions sleep promoting + wake placebo, sleep placebo + wake promoting, or sleep promoting + wake promoting. All participants will complete a sleep placebo + wake placebo condition. The order of the full placebo condition versus the intervention (i.e., lab visit 1 vs. lab visit 2) will be randomized after the condition randomization occurs. Each participant will complete one of the interventions and one placebo for a total of two visits.

Primary Outcome Measures: Karolinska Sleepiness Scale (KSS), Subjective alertness as measured by the 9-point Likert-type Karolinska Sleepiness Scale (KSS)., Up to 120 minues|Psychomotor Vigilance Task (PVT), Objective cognitive performance as measured by the psychomotor vigilance task (PVT), a simple reaction time task with outcome measures including number of lapses (reaction time \>500ms) and speed (1/reaction time)., up to 560 minutes|Electroencephalography (EEG), Sleep architecture as measured by electroencephalography (EEG) including sleep stage at awakening, total sleep time, time in each sleep stage, sleep efficiency, and sleep onset latency., up to 48 hours
Comparison of the Effects of Oral Ulceration Healing in Patients Wearing a Removable Denture
NCT Number: NCT06531720
Acronym: MUCOSA HEALING
Status: COMPLETED
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Oral Mucosa; Ulcer
Interventions: DRUG: Chlorhexidine Gluconate|DRUG: Choline Salicylate 8.7 % Oral Gel|OTHER: control group
Sponsor: Medical University of Silesia
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 27
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: TRIPLE (PARTICIPANT, CARE_PROVIDER, INVESTIGATOR)|Primary Purpose: TREATMENT
Start Date: 2023-01-01
Completion Date: 2023-12-31
Locations: Department of TMD Silesian Medical University, Zabrze, 41-800, Poland

Summary:
The aim of the study was comparing the effectiveness of oral mucosa healing properties of different preparations: CHX=0,2% chorhexidine digluconate, CHS=8,7% choline salicylate, CON=control group, in patients with delivered removable dentures, during the adaptation period.

Primary Outcome Measures: Comparing the effectiveness of oral mucosa lesion healing of different preparations, Using a transparent millimeter grid superimposed on the oral mucosa lesion, the Wound Surface Area (WSA) was measured in mm\^2., From baseline assessment up to 2 weeks.
Unravelling the Interplay of Weight Stigma and Pregnancy Outcomes: A Prospective Cohort Study
NCT Number: NCT06531694
Status: NOT_YET_RECRUITING
Study Type: OBSERVATIONAL
Conditions: Weight Stigma|Pregnancy Outcomes|Overweight and Obesity
Sponsor: Monash University
Sex: FEMALE
Age: ADULT, OLDER_ADULT
Enrollment: 800
Study Design: Observational Model: |Time Perspective: p
Start Date: 2026-06
Completion Date: 2028-12

Summary:
The goal of this prospective cohort study is to investigate the contribution of stigma and discrimination due to body size to adverse pregnancy outcomes. We also aim to explore the role of psychological and social factors in this relationship. The specific objectives of this study are:

Objective 1: Explore weight stigma as a mediator of the association between BMI ≥30 kg/m2 and adverse pregnancy outcomes.

Objective 2: Explore confounding factors not previously considered such as weight cycling, trauma, eating disorders, and internalised weight bias as mediators in the relationship between obesity and adverse pregnancy outcomes.

Primary Outcome Measures: Proportion of women diagnosed with gestational diabetes mellitis by 34 weeks gestation, Measuring the number of women reporting a diagnosis of gestational diabetes mellitis by 34 weeks gestation as assessed via self-reported measures and chart review., 34 weeks
Secondary Outcome Measures: Proportion of women experiencing induction of labour, Identifying whether the woman's labour was spontaneous or induced measured via a self-reported questionnaire., 6 weeks postpartum|Proportion of women reporting each mode of birth (i.e., vaginal birth, caesarean section, assisted vaginal birth, or other), Identifying the mode of birth assessed via a self-reported questionnaire. Options are: vaginal birth, caesarean section, assisted vaginal birth (e.g., with forceps), or other., 6 weeks postpartum|Proportion of women who reported experiencing gestational hypertension in their most recent pregnancy, Identifying the proportion of women who reported a diagnosis of gestational hypertension during their most recent pregnancy via a self-reported questionnaire., 6 weeks postpartum|Infant birth weight (in grams) reported by mothers for their most recent infant, Infant birth weight (in grams) reported by mothers based on their most recent baby's birth certificate or hospital discharge summary information., 6 weeks postpartum|Proportion of women currently breastfeeding their infant reported by mothers at 6-weeks postpartum, The proportion of women currently breastfeeding their infant (yes/no) reported by mothers at 6-weeks postpartum, 6 weeks postpartum
A Clinical Trial to Examine the Efficacy of a Supplement to Support Hormone Regulation in Women
NCT Number: NCT06531668
Status: ACTIVE_NOT_RECRUITING
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Hormone Regulation
Interventions: DIETARY_SUPPLEMENT: Beyond Hormone|OTHER: Placebo
Sponsor: Scale Media Inc
Collaborators: Citruslabs
Sex: FEMALE
Age: ADULT
Enrollment: 50
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: TRIPLE (PARTICIPANT, INVESTIGATOR, OUTCOMES_ASSESSOR)|Primary Purpose: TREATMENT
Start Date: 2024-06-07
Completion Date: 2024-09-07
Locations: Citruslabs, Santa Monica, California, 90404, United States

Summary:
This randomized, triple-blind, placebo-controlled trial will evaluate the efficacy of Live Conscious's Beyond Hormone supplement in regulating hormone production in women. The study involves 50 generally healthy female participants aged 25-45 who are not menopausal. The trial spans three menstrual cycles and assesses both objective hormone levels and subjective well-being through blood tests and questionnaires, respectively.

Primary Outcome Measures: Hormone Levels Blood Panel (estradiol, testosterone, DHEA, insulin, and progesterone), Measurement of hormone levels. Blood tests will be conducted to evaluate these levels at Baseline (Day 2-5 of the first menstrual period), Midline (Day 2-5 of the second menstrual period), and Endline (Day 2-5 of the third menstrual period)., Baseline (Day 0), Midline (Day 45), and Endline (Day 90)
Secondary Outcome Measures: Participants' Perceptions of Quality of Life, Evaluation of participants' perceptions of the product's effects on quality of life with a self-reported questionnaire., Baseline (Day 0), Midline (Day 45), and Endline (Day 90)|Participants' Mood and Energy Levels using the Visual Analog Scale (VAS), Assessment of participants' mood and energy levels using the Visual Analog Scale (VAS). These assessments will be conducted at Baseline (Day 2-5 of the first menstrual period), Midline (Day 2-5 of the second menstrual period), and Endline (Day 2-5 of the third menstrual period)., Baseline (Day 0), Midline (Day 45), and Endline (Day 90)|Participants' Monthly Cycle Symptoms using the Menstrual Cycle Symptom Diary (MCSD), Evaluation of participants' monthly cycle symptoms using the Menstrual Cycle Symptom Diary (MCSD). These assessments will be conducted at Baseline (Day 2-5 of the first menstrual period), Midline (Day 2-5 of the second menstrual period), and Endline (Day 2-5 of the third menstrual period)., Baseline (Day 0), Midline (Day 45), and Endline (Day 90)|Participants' Libido using a Libido Questionnaire, Assessment of participants' libido using a Libido Questionnaire. These assessments will be conducted at Baseline (Day 2-5 of the first menstrual period), Midline (Day 2-5 of the second menstrual period), and Endline (Day 2-5 of the third menstrual period)., Baseline (Day 0), Midline (Day 45), and Endline (Day 90)
Intradetrusor Botox at the Time of Transurethral Resection of the Prostate for Mixed Lower Urinary Tract Symptoms
NCT Number: NCT06531655
Status: WITHDRAWN
Study Type: OBSERVATIONAL
Conditions: Transurethral Resection of the Prostate
Sponsor: Benaroya Research Institute
Sex: MALE
Age: ADULT, OLDER_ADULT
Enrollment: 0
Study Design: Observational Model: |Time Perspective: p
Start Date: 2024-08
Completion Date: 2026-08
Locations: Virginia Mason Medical Center, Seattle, Washington, 98101, United States

Summary:
Patients with longstanding obstructive lower urinary tract symptoms (LUTS) due to benign prostatic hypertrophy (BPH) can also develop symptoms of overactive bladder syndrome (OAB). Transurethral resection of the prostate (TURP) is the gold standard treatment for BPH. However, in the immediate post-operative period, TURP can also include OAB-like symptoms, including urinary frequency and urgency. For men with baseline OAB symptoms, this initial worsening of symptoms can be distressing.

Botox is an FDA approved medication with on-label indications to treat overactive bladder. According to AUA guidelines, it is considered a third-line treatment therapy.

The purpose of this study is to evaluate the outcomes of men who have Botox concurrent with their TURP.

Primary Outcome Measures: To identify whether concurrent Botox and TURP are effective at reducing post-operative irritative voiding symptoms., At the post-operative visit: Trial of Void assessment will be used to assess for rates of postoperative urinary retention., 1 week
Secondary Outcome Measures: To identify whether concurrent Botox and TURP lead to higher rates of urinary retention using the American Urological Association symptom score, Post-op visits when AUA symptom score: (0 to 7 (Mild), 8 to 19 (Moderate), 20 to 35 (Severe)), Four and twelve-week|To identify whether concurrent Botox and TURP lead to rates of urinary retention using internal Virginia Mason Post-Procedure questionnaire, At the post-operative visit the VM Post Procedure Questionnaire will be administered., Four and twelve-week|To identify whether concurrent Botox and TURP lead to higher rates of urinary retention using the Patient Global Impression of Improvement (PGI-I) to assess patient observed improvement in urinary incontinence., Administer the Patient Global Impression of Improvement (PGI-I), Four and twelve-week|To identify whether concurrent Botox and TURP lead to higher rates of urinary retention using the Urinary Distress Inventory, Short Form (UDI-6), Administer the short 6 question form of the Urinary Distress Inventory at the post-operative visits, Four and twelve-week|To identify whether concurrent Botox and TURP lead to higher rates of urinary retention using a bladder scan to assess the amount of residual urine in bladder post trial of void., Post void residual obtained via bladder scan., Four and twelve-week