pankajmathur/National_Library_of_Medicine_Studies_data huggingface dataset:
Role of Topical Steroid Injection With Refractory Benign Esophageal Stricture Endoscopic Dilatation in Children
NCT Number: NCT06514079
Acronym: ISIs
Status: RECRUITING
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Pediatric Disorder|Esophageal Diseases|Esophageal Stricture
Interventions: PROCEDURE: Esophageal dilatation with steroids injection
Sponsor: Mohammad Daboos
Sex: ALL
Age: CHILD
Enrollment: 21
Study Design: Allocation: NA|Intervention Model: SINGLE_GROUP|Masking: NONE|Primary Purpose: TREATMENT
Start Date: 2022-03-02
Completion Date: 2024-08-20
Locations: Mohammad Daboos, Cairo, Select, 115678, Egypt

Summary:
This clinical trial study included 21 children with refractory benign esophageal strictures. Upper GI endoscopy performed up to the area of stricture, esophageal dilatation done, endoscopy repeated, and steroid injected intralesional under direct endoscopic vision. The effect of the procedure was followed over a period of 12 months by evaluation of number of dilatation, maximum dilator size, periodic dilatation index (PDI) and dysphagia score.

Primary Outcome Measures: Maximum dilatation size, achieving a diameter of 11 mm for patients aged \<2 years, 12 mm for patients aged between 2 and 5 years, and 15 mm for children aged \>5 years with complete relief of symptoms without requiring endoscopic procedure or surgical intervention for at least 6 months, 12 months
Secondary Outcome Measures: dysphagia score, Dysphagia was graded into the following:

* Score 0 - No dysphagia: able to eat a normal diet.
* Score 1 - Moderate passage: able to eat some solid foods.
* Score 2 - Poor passage: able to eat only semi-solid foods.
* Score 3 - Very poor passage: able to swallow only liquids only.
* Score 4 - No passage: unable to swallow anything, 12 months
Prognostic Biomarkers for Pulpotomy Outcome
NCT Number: NCT06514053
Status: RECRUITING
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Pulpitis - Irreversible
Interventions: PROCEDURE: Full pulpotomy|PROCEDURE: Root canal treatment
Sponsor: The University of Hong Kong
Sex: ALL
Age: CHILD, ADULT, OLDER_ADULT
Enrollment: 192
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: NONE|Primary Purpose: TREATMENT
Start Date: 2024-01-01
Completion Date: 2026-12
Locations: Clinical Research Centre, Faculty of Dentistry, The University of Hong Kong, Hong Kong, Hong Kong

Summary:
This study will recruit 180 molars diagnosed with irreversible pulpitis. Full pulpotomy will be performed on 120 teeth, while RCT (root canal treatment) will be conducted on another cohort of 60 teeth as the control for assessing long-term outcomes. Additionally, 12 blood samples and pulp tissues from healthy teeth receiving elective RCT will be collected as the controls. The first pulpal blood sample will be collected after caries removal and pulp exposure. Subsequently, the entire coronal pulp tissue will be removed and collected for histological examination, image-based spatial and scRNA-seq analyses. A second pulpal blood sample will be collected from the radicular pulp tissue. Both blood samples will be used to profile the inflammation-related biomarkers through multiplex immunoassays. The remaining pulp tissue will be covered by Biodentine and restored with resin-based composite. Pulpotomy treatment outcomes will be evaluated clinically and radiographically at 6 and 12 months. The biomarkers identified in the pulpal blood and histology and the single-cell transcriptomes of the coronal pulp will be compared with the treatment "success" and "failure" groups upon one year. The outcome of RCT will be compared with that of full pulpotomy at 24 months.

Primary Outcome Measures: Success rate, Success rate of full pulpotomy and RCT in teeth with irreversible pulpitis, 2 years|Biomarkers, Quantitative descriptive analysis of the expression of biomarkers commonly found in tissue inflammation using multiplex immunoassay (Millipore, USA). The kits include targets as follows: sCD40L;EGF;Eotaxin;FGF-2;Flt-3 ligand;Fractalkine;G-CSF;GM-CSF;GROα;IFNα2;IFNγ;IL-1α;IL-1β;IL-1ra;IL-2;IL-3;IL-4;IL-5;IL-6;IL-7;IL-8;IL-9;IL-10;IL-12 (p40);IL-12 (p70);IL-13;IL-15;IL-17A;IL-17E/IL-25;IL-17F;IL-18;IL-22;IL-27;IP-10;MCP-1;MCP-3;M-CSF;MDC (CCL22);MIG;MIP-1α;MIP-1β;PDGF-AA;PDGF-AB/BB;RANTES;TGFα;TNFα;TNFβ;VEGF-A; MMP-1, -2, -7, -9, -10., 2 years
Secondary Outcome Measures: Correlation, Correlation of biomarkers' expression to the outcome of full pulpotomy in teeth with irreversible pulpitis to identify objective prognostic biomarkers for full pulpotomy; biomarkers to investigate are described in Outcome 2, 2 years
Study of BEBT-109 in Subjects With Non-Small Cell Lung Cancer Carrying EGFR Exon 20 Insertion Mutations
NCT Number: NCT06514027
Status: NOT_YET_RECRUITING
Study Type: INTERVENTIONAL
Phases: PHASE2
Conditions: Non Small Cell Lung Cancer
Interventions: DRUG: BEBT-109 Capsules|DRUG: Pemetrexed Disodium for Injection|DRUG: Carboplatin Injection|DRUG: Cisplatin Injection
Sponsor: BeBetter Med Inc
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 30
Study Design: Allocation: NON_RANDOMIZED|Intervention Model: PARALLEL|Masking: NONE|Primary Purpose: TREATMENT
Start Date: 2024-07
Completion Date: 2027-11
Locations: Sun Yat-sen University Cancer Center, Guangzhou, Guangdong, 510060, China

Summary:
This is a multicenter, open Phase II clinical study to evaluate the efficacy, safety, and pharmacokinetic characteristics of BEBT-109 combined with injectable pemetrexed disodium and carboplatin or cisplatin injection as first-line treatment for locally advanced, recurrent, or metastatic non-small cell lung cancer carrying EGFR exon 20 insertion mutations.

Primary Outcome Measures: ORR, Objective response rate, Every 6 weeks,assessed up to 24 months.|AE, Adverse event, From the first administration of the study drug to 28 days after the last administration of the study drug.
Secondary Outcome Measures: DCR, Disease control rate, Every 6 weeks,assessed up to 24 months.
Other Outcome Measures: DOR, Duration of response, Every 6 weeks,assessed up to 24 months.|PFS, Progression-free survival, Every 6 weeks,assessed up to 24 months.|OS, Overall survival, From date of administration until date of death from any cause, assessed up to 24 months.|TTR, Time to response, Every 6 weeks,assessed up to 24 months.|Tmax, Time of peak plasma concentration, From 1 hour before dosing on day 1 and day 20 of the first cycle to 48 hours after dosing, and from 1 hour before dosing on day 18 and day 19 of the first cycle (each cycle is 21 days).|Cmax, Peak plasma concentration, From 1 hour before dosing on day 1 and day 20 of the first cycle to 48 hours after dosing, and from 1 hour before dosing on day 18 and day 19 of the first cycle (each cycle is 21 days).|t1/2, Half-life of plasma drug concentrations, From 1 hour before dosing on day 1 and day 20 of the first cycle to 48 hours after dosing, and from 1 hour before dosing on day 18 and day 19 of the first cycle (each cycle is 21 days).|AUC0-t, Area under the plasma concentration time curve from 0 hour to last time of quantifiable concentration after administration, From 1 hour before dosing on day 1 and day 20 of the first cycle to 48 hours after dosing, and from 1 hour before dosing on day 18 and day 19 of the first cycle (each cycle is 21 days).|CL, Apparent plasma clearance, From 1 hour before dosing on day 1 and day 20 of the first cycle to 48 hours after dosing, and from 1 hour before dosing on day 18 and day 19 of the first cycle (each cycle is 21 days).
Transition From Donor Milk: a Feasibility Study
NCT Number: NCT06514014
Status: NOT_YET_RECRUITING
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Preterm Birth|Nutrition, Healthy
Interventions: DIETARY_SUPPLEMENT: Preterm Infant Formula
Sponsor: Augusta University
Sex: ALL
Age: CHILD, ADULT, OLDER_ADULT
Enrollment: 20
Study Design: Allocation: RANDOMIZED|Intervention Model: SINGLE_GROUP|Masking: NONE|Primary Purpose: TREATMENT
Start Date: 2024-11-01
Completion Date: 2026-06-30

Summary:
Preterm and very low birth weight (VLBW, \< 1,500g) infants who receive donor human milk (DHM) often experience slow postnatal growth and no clinical data is available to guide the duration of DHM for preterm infants. We hypothesize that transitioning from DHM to preterm infant formula after the first month of life is both safe and conveys improved weight and length gains and fat free mass accumulation.

Primary Outcome Measures: Weight Velocity, Weight velocity between birth and 36 weeks post menstrual age, 36 weeks post menstrual age|Fat free mass, Fat free mass at 36 weeks post menstrual age, 36 weeks post menstrual age
Secondary Outcome Measures: Bronchopulmonary dysplasia, 36 weeks post menstrual age|Retinopathy of prematurity, 36 weeks post menstrual age|Sepsis, 36 weeks post menstrual age|Necrotizing enterocolitis, 36 weeks post menstrual age
A Study of AMDX-2011P in Participants With Alzheimer's Disease
NCT Number: NCT06514001
Status: RECRUITING
Study Type: INTERVENTIONAL
Phases: PHASE2
Conditions: Alzheimer Disease
Interventions: DRUG: AMDX-2011P
Sponsor: Amydis Inc.
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 25
Study Design: Allocation: NA|Intervention Model: SINGLE_GROUP|Masking: NONE|Primary Purpose: DIAGNOSTIC
Start Date: 2024-07
Completion Date: 2025-03
Locations: Associated Retina Consultants, Phoenix, Arizona, 85020, United States|Global Research Management, Glendale, California, 91204, United States|Eye Research Foundation, Newport Beach, California, 92663, United States

Summary:
The purpose of this study is to assess safety, tolerability, plasma pharmacokinetics and biologic activity of a single intravenous dose of AMDX-2011P in participants with Alzheimer's Disease (AD).

Primary Outcome Measures: AMDX-2011P Adverse Events Profile, Incidence, nature and severity of adverse events/serious adverse events (AEs/SAEs), 8 days
Secondary Outcome Measures: Concentration of AMDX-2011P, Plasma Pharmacokinetic (PK) Concentration (CMax) AMDX-2011P to AMDX-2011, 2 hours|Pharmacokinetic Analysis of AMDX-2011P, Area under the plasma versus time curve (AUC), 2 hours|Biological Activity, Detection of amyloid deposits in the retina after intravenous AMDX-2011P administration, 8 days
Application of MI-BCI Combined With tDCS in Early Rehabilitation After Anterior Cruciate Ligament Reconstruction
NCT Number: NCT06513988
Status: COMPLETED
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Anterior Cruciate Ligament Injuries
Interventions: DEVICE: MI-BCI combined with tDCS treatment
Sponsor: Air Force Military Medical University, China
Sex: ALL
Age: ADULT
Enrollment: 1
Study Design: Allocation: NA|Intervention Model: SINGLE_GROUP|Masking: NONE|Primary Purpose: TREATMENT
Start Date: 2024-05-06
Completion Date: 2024-07-15
Locations: Air Force Medical Center of PLA, Beijing, Beijing, 100142, China

Summary:
To recover lower-limb motor function is a primary goal for rehabilitation after anterior cruciate ligament (ACL) reconstruction. Although quantitative testing and questionnaire evaluation provide a lot of valuable information, while functional magnetic resonance imaging (fMRI) provides a powerful method to assess functional connectivity (FC) involved in motor function recovery before and after receiving a novel combined rehabilitation training. However, our understanding of the FC changes during early rehabilitation after ACL reconstruction is partial and incomplete.

Primary Outcome Measures: resting-stage fMRI, Resting-stage fMRI images data acquisition was carried out in the Air Force Medical Center with a 3.0T MRI scanner (GE Discovery MR750, USA) using the echo planar imaging (BOLD) sequence for 6 min each time (TR/TE = 2000 ms/30 ms, matrix 64 × 64, FOV = 220×220mm2, number of slices = 36) with contiguous 3 mm slice thickness providing whole brain coverage. In addition, a series of anatomical images were also obtained during the first imaging session using T1-weighted 3D TFE sequence with 1×1×1mm resolution, before and after 4 weeks|IKDC, The IKDC score is a subjective knee assessment scale used to assess the level of knee function and severity of symptoms. The functional status of the knee joint is assessed by summing the scores for each item, converting the scores to a scale of 0 to 100, before and after 4 weeks
Validation Study of CART BP as a Wearable Cuffless Blood Pressure Monitor
NCT Number: NCT06513975
Status: NOT_YET_RECRUITING
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Blood Pressure|Hypertension|Blood Pressure, High|Blood Pressure, Low|Hypotension
Interventions: DEVICE: CART BP|DEVICE: sphygmomanometer
Sponsor: Sky Labs
Collaborators: Samsung Medical Center
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 50
Study Design: Allocation: NA|Intervention Model: SINGLE_GROUP|Masking: NONE|Primary Purpose: DIAGNOSTIC
Start Date: 2024-08-15
Completion Date: 2025-08-15

Summary:
This study aims to evaluate the accuracy of the CART BP, a medically approved ring-type blood pressure monitor, in comparison to the traditional auscultatory method using a dual-head stethoscope. The comparison is conducted in accordance with the 2023 European Society of Hypertension (ESH) Recommendations, focusing on patients with suspected hypertension or hypotension. The evaluation includes accuracy measurements across various postures and during different exercise periods.

Primary Outcome Measures: Mean error and standard deviations of differences between CART BP and Reference, The primary outcome measure is the mean error and standard deviation (SD) of the differences between the CART BP device and the reference device. This endpoint is determined based on the European Hypertension Society (ESH) recommendation, which states that the pass criteria are as per International Organization for Standardization (ISO) 81060-2:2018: a mean error within 5 mmHg and an standard deviation within ±8 mmHg., 1 hour
Anti-CD14 Treatment With IC14 in Hospitalized ARDS Patients
NCT Number: NCT06513949
Status: NOT_YET_RECRUITING
Study Type: INTERVENTIONAL
Phases: PHASE2
Conditions: Acute Respiratory Distress Syndrome|Adult Respiratory Distress Syndrome|Acute Lung Injury|Acute Lung Injury/Acute Respiratory Distress Syndrome (ARDS)
Interventions: BIOLOGICAL: Atibuclimab|OTHER: Placebo
Sponsor: Implicit Bioscience
Collaborators: University of Washington
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 56
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: QUADRUPLE (PARTICIPANT, CARE_PROVIDER, INVESTIGATOR, OUTCOMES_ASSESSOR)|Primary Purpose: TREATMENT
Start Date: 2024-08
Completion Date: 2026-08
Locations: University of Washington, Seattle, Washington, 98195, United States

Summary:
Hospitalized patients with ARDS will be randomized to intravenous treatment with a monoclonal antibody against CD14, called IC14, or placebo. They will be followed for 28 days.

The primary outcome is the day 4 oxygenation index assessed as a continuous measure.

Primary Outcome Measures: Day 4 Oxygenation Index, (mean airway pressure x fraction of inspired oxygen \[FiO2\] x100)/ partial pressure of oxygen \[PaO2\], Day 1 through Day 4
Secondary Outcome Measures: Biomarkers of injury and inflammation measured in bronchoalveolar lavage fluid, Interleukin(IL)-6, Day 4|Biomarkers of injury and inflammation measured in plasma, Interleukin(IL)-6, Day 4|Oxygenation index, (mean airway pressure x FiO2 x100)/PaO2, Days 7 and 14|Oxygen saturation index, (mean airway pressure x FiO2 x100)/peripheral oxygen saturation \[SpO2\], Days 4, 7, and 14|P:F ratio, Ratio of partial pressure of arterial oxygen (P) to fraction of inspired oxygen (F), Days 4, 7, and 14|S:F ratio, Ratio of the arterial oxygen saturation (S) to fraction of inspired oxygen (F), Days 4, 7, and 14|Sequential Organ Failure Assessment (SOFA) Score (range 0 [best] to 24 [worst]), Disease severity scale, Days 4, 7, and 14|Time to blood presepsin level, Time from study consent to measurement completion of blood presepsin level via the PATHFASTTM instrument, Days 0-4|Cumulative incidence of run failures, Defined as not completing presepsin measurement between consent and infusion of study drug, Days 0-1|Cumulative incidence of protocol-specified exempt serious events, protocol-specified exempt serious events, Days 1-28|Cumulative incidence of grade 3 and 4 clinical and laboratory adverse events, Common Toxicity Criteria for Adverse Events version 5.0, Days 1-28|Cumulative incidence of serious adverse events, Serious adverse events standard definition, Days 1-28|Cumulative incidence of adverse events of special interest, Adverse events of special interest for test article and bronchoalveolar lavage, Days 1-28
Other Outcome Measures: Ventilator-free Days, Days alive and free of invasive mechanical ventilation, Days 1-28|Mortality, All-cause mortality, Day 1-28
Nursing Interventions on Prevention Medical Device Related Pressure Injury (MDRPI)
NCT Number: NCT06513936
Acronym: MDRPI
Status: NOT_YET_RECRUITING
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Medical Device Site Erosion
Interventions: PROCEDURE: The skin care Bundle|PROCEDURE: Routine care
Sponsor: Damanhour University
Sex: ALL
Age: ADULT
Enrollment: 120
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: SINGLE (PARTICIPANT)|Primary Purpose: TREATMENT
Start Date: 2024-10-01
Completion Date: 2026-12-01

Summary:
This study aims to assess the effect of implementing nursing interventions on preventing medical device related pressure injury in critically ill patients.

Research hypothesis:

Critically ill patients who experienced nursing interventions have a significantly lower risk of developing medical device related pressure injury than those who do not.

Primary Outcome Measures: Pressure Ulcer occurrence, Pressure Ulcer Grading based on 6 stages stage. Score 1 refer to the better outcome, while score 6 is the worse outcome, 7 days
Secondary Outcome Measures: ICU length, until patient discharge, 30 days|Mechanical ventilator days, How many days on ventilator, 7 days
Comparison of Remimazolam and Propofol on Emergence in Elderly Orthopedic Patients Under General Anesthesia
NCT Number: NCT06513923
Status: COMPLETED
Study Type: INTERVENTIONAL
Phases: PHASE4
Conditions: Hip Fracture
Interventions: DRUG: Remimazolam|DRUG: Flumazenil|DRUG: Propofol
Sponsor: Central South University
Sex: ALL
Age: OLDER_ADULT
Enrollment: 136
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: TRIPLE (PARTICIPANT, CARE_PROVIDER, OUTCOMES_ASSESSOR)|Primary Purpose: PREVENTION
Start Date: 2023-02-01
Completion Date: 2023-10-31
Locations: Department of Anesthesiology, The Second Xiangya Hospital, Changsha, Hunan, 410011, China|The Second Xiangya Hospital, Changsha, Hunan, 410011, China

Summary:
Purpose: This study aims to compare the emergence time among three anesthesia regimens: remimazolam, remimazolam with flumazenil, and propofol in elderly patients undergoing hip replacement surgery.

Background: Previous studies have shown that flumazenil accelerates emergence time when used with remimazolam. Remimazolam and propofol have comparable emergence times, although remimazolam can be up to 5 minutes longer than propofol.

Primary Outcome Measures: Time to Emergence, Defined as the time from discontinuation of the anesthetic agent to the time the patient opens their eyes on verbal command., Within one day of surgery
Secondary Outcome Measures: Hemodynamic Parameters, Blood pressure measured at various time points including diastolic and systolic blood pressure., During operation|Hemodynamic Parameters, Heart rate measured at various time points., During operation|Post-Operative Recovery, Assessed using the Modified Aldrete Score.The modified Aldrete score is measured by evaluating five criteria, including the individual's activity level, respiration, circulation, consciousness, and oxygen saturation. A score of "0", "1", or "2" is given for each category, two representing the ideal condition.Given the five parameters, individuals can have a total score from zero to ten. A score lower than nine typically means the individual's status is suboptimal., Within one day of surgery|Adverse Events, Incidence and severity of adverse events related to anesthesia(injection pain, post-induction hypotension, bradycardia and body movement, postoperative nausea and vomiting, intraoperative awareness and delirium, sedation rescue and re-sedation)., Within one day of surgery
Evaluating the Impact of Social Music
NCT Number: NCT06513910
Status: RECRUITING
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Mental Health Issue|COVID-19
Interventions: BEHAVIORAL: Music
Sponsor: Yale University
Collaborators: National Institute of Mental Health (NIMH)
Sex: ALL
Age: CHILD, ADULT, OLDER_ADULT
Enrollment: 48
Study Design: Allocation: NA|Intervention Model: SINGLE_GROUP|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.

2b. Social Music Study: Investigators will assess the neural mechanisms of feelings of subjective connectedness during communal music listening and creating between dyads of subjects who are both familiar and unfamiliar with each other.

Primary Outcome Measures: EEG gamma and theta activity during music vs no music conditions, EEG gamma and theta activity measured by the Post Spectral Density measures in the gamma range (\>30Hz) and theta (4-8Hz) frequency ranges during music vs no music conditions., baseline measurements on day of study, during music vs no music conditions, and 30 minutes after music listening
Secondary Outcome Measures: Mean score subjective rating of social connection during session, Rating of subjective connectedness will be assessed using a Likert scale with total score range from 1-5, with higher scores indicating more connectedness., baseline measurements on day of study, during music vs no music conditions, and 30 minutes after music listening
The Effect of Acupressure and Father's Lap on Pain and Physiological Parameters During Heel Lancing
NCT Number: NCT06513897
Status: RECRUITING
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Infant Development|Nurse's Role|Pain, Acute
Interventions: OTHER: Acupressure|OTHER: Father's Lap
Sponsor: Baskent University
Collaborators: Mersin University
Sex: ALL
Age: CHILD
Enrollment: 90
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: DOUBLE (PARTICIPANT, OUTCOMES_ASSESSOR)|Primary Purpose: SUPPORTIVE_CARE
Start Date: 2024-08-01
Completion Date: 2024-09-15
Locations: Başkent University, Ankara, Turkey

Summary:
Neonatal heel blood collection is a common medical procedure to obtain blood samples from newborns for diagnostic purposes. Although necessary for clinical evaluation, this procedure causes discomfort and distress in infants. The pain experienced during heel prick is a major concern and warrants exploration of effective and compassionate interventions to alleviate associated discomfort and reduce crying time. Non-pharmacological approaches, such as acupressure and cuddling, are thought to have important contributions to improving the overall experience of newborns undergoing this procedure. . The aim of this study was to evaluate the efficacy of acupressure and paternal hugging interventions in relieving pain and reducing crying time during neonatal heel haemorrhage. The choice of these interventions was based on their potential to offer non-invasive and holistic approaches to pain management by addressing not only the physical but also the emotional dimensions of the neonatal experience.

Primary Outcome Measures: Pain Score, Pain will be assessed using the Neonatal Pain, Agitation, Sedation Scale. The minimum score of the scale is 0 and the maximum score is 10. Four points and below is considered as mild pain, five points and above is considered as moderate and severe pain., pre-intervention, immediately after the intervention|Pulse value, Pulse value will be assessed using the infant pulse oximeter., pre-intervention, immediately after the intervention|Crying time, Crying time will be recorded throughout the procedure., During the intervention|Saturation value, Saturation value will be assessed using the infant pulse oximeter., pre-intervention, immediately after the intervention
Evaluating Social Perception Dynamics
NCT Number: NCT06513871
Status: RECRUITING
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Mental Health Issue|COVID-19
Interventions: BEHAVIORAL: Social perception tasks
Sponsor: Yale University
Collaborators: National Institute of Mental Health (NIMH)
Sex: ALL
Age: CHILD, ADULT, OLDER_ADULT
Enrollment: 300
Study Design: Allocation: NA|Intervention Model: SINGLE_GROUP|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.

Component 2d. Social Perception Tasks: Participants may be asked to take part in social perception tasks in which they will be asked to indicate their social perception and connection felt with various partners.

Primary Outcome Measures: Mean score individual subjective rating of social connection during session, Rating of subjective connectedness will be assessed using a Likert scale with total score range from 1-5, with higher scores indicating more connectedness., baseline on day of study and 5 minutes after intervention
Secondary Outcome Measures: Mean score group subjective rating of social connection post session, Rating of subjective connectedness will be assessed using a Likert scale with total score range from 1-5, with higher scores indicating more connectedness., baseline on day of study and 5 minutes after intervention
Evaluating the Community Drum Circle
NCT Number: NCT06513858
Status: RECRUITING
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Mental Health Issue|COVID-19
Interventions: BEHAVIORAL: Communal Drumming|BEHAVIORAL: Communal drumming recordings
Sponsor: Yale University
Collaborators: National Institute of Mental Health (NIMH)
Sex: ALL
Age: CHILD, ADULT, OLDER_ADULT
Enrollment: 90
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|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 America due to disproportionate effects of social factors such as 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 Persons of African Descent(PAD) 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 community-based music mindfulness program on stress management in PAD community members with anxiety and depression during COVID19.

Component 2c. Drum Circle Study: Investigators will study the impact of participation in drum circles on anxiety and feelings of connectedness.

Primary Outcome Measures: Rating of Absorption in music pre vs post sessions, These ratings are classified on a scale from 0 to 1, with 0 indicating no absorption and 1 indicating complete absorption., Baseline on day of study visit before drum circle, during drum circle (45min), 30 min after music listening
Secondary Outcome Measures: Altered States of Consciousness Rating Scale, This scale has 94 statements and below each statement is a line with the endpoints "No, not more than usually" and "Yes, much more than usually." Each participant will rate to what extent the statements apply to their particular experience, compared to normal waking consciousness, by making a vertical mark on the line below the statements. Normal waking consciousness corresponds to a mark at the very left end of the scale, i.e.: "No, not more than usually.", Baseline on day of study visit before drum circle, during drum circle (45min), 30 min after music listening
Drum Circle Synchrony Study 2c.a.
NCT Number: NCT06513845
Status: RECRUITING
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Mental Health Issue|COVID-19
Interventions: BEHAVIORAL: Communal drumming recordings
Sponsor: Yale University
Collaborators: National Institute of Mental Health (NIMH)
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 30
Study Design: Allocation: NON_RANDOMIZED|Intervention Model: PARALLEL|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.

2c.a. Drum Circle Synchrony Study: This study will investigate the role that synchrony plays in subjective feelings of connection.

Primary Outcome Measures: Mean score connectedness rating, Mean connectedness rating survey assessed using a Likert scale total range of 1 (no connection) to 7 (maximum connection) for synchronous and asynchronous audio samples, measured during listening session (30minutes)|Mean score subjective rating of synchrony, Subjective ratings of synchrony will be assessed using a Likert scale with total score range from 1-5, with higher scores indicating more synchrony, for synchronous and asynchronous audio samples., measured during listening session (30minutes)
Asthma Navigator Intervention to Improve Health Equity in Children
NCT Number: NCT06513832
Status: NOT_YET_RECRUITING
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Asthma in Children
Interventions: BEHAVIORAL: The asthma navigator
Sponsor: Emory University
Collaborators: Georgia Clinical & Translational Science Alliance (CTSA)
Sex: ALL
Age: CHILD
Enrollment: 75
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: SINGLE (OUTCOMES_ASSESSOR)|Primary Purpose: PREVENTION
Start Date: 2024-08
Completion Date: 2026-08

Summary:
The goal of this study is to improve health equity in children aged 5-16.9 years admitted to the PICU for asthma. The objectives are:

* To identify the factors related to differential experiences of asthma self-management
* To pilot the effectiveness of an individualized asthma navigator intervention at PICU discharge.

Primary Outcome Measures: Future unscheduled healthcare utilization for asthma exacerbation, The occurrence of unscheduled healthcare utilization and the date and time of occurrence will be assessed through weekly screenings of each child's EMR at Children's (Epic system)., Baseline, end of study (average of 52 weeks)
Other Outcome Measures: Hospitalization occurrence, Number of hospitalizations would be measured., Baseline, end of study (average of 52 weeks)|Clinic follow-up, Number of clinic follow ups would be measured., Baseline, end of study (average of 52 weeks)
Granisetron Versus Pethidine in Treatment of Post Spinal Shivering in Cesarean Sections
NCT Number: NCT06513806
Status: NOT_YET_RECRUITING
Study Type: INTERVENTIONAL
Phases: PHASE4
Conditions: Anesthesia; Adverse Effect, Spinal and Epidural
Interventions: DRUG: Granisetron 1 Mg/mL Intravenous Solution|DRUG: Pethidin
Sponsor: Ain Shams University
Sex: FEMALE
Age: ADULT
Enrollment: 330
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: DOUBLE (PARTICIPANT, INVESTIGATOR)|Primary Purpose: TREATMENT
Start Date: 2024-08
Completion Date: 2024-09

Summary:
Granisetron Versus Pethidine in Treatment of Post Spinal Shivering in Cesarean Sections

Primary Outcome Measures: treating post spinal shivering, If shivering occurs the degree of Shivering will be classified as:

* 0: No shivering
* 1: Mild fasciculations of face or neck and ECG disturbances in the absence of voluntary activity of the arms
* 2: Visible tremor involving more than one muscle group
* 3: Gross muscular activity involving the entire body

assessment of tested drugs in treating post spinal shivering in patients who undergone cesarean delivery and have been treated with either granisetron or pethidine, perioperatively/periprocedurally
Secondary Outcome Measures: pain assessment, pain scores by VAS (visual analogue scale) which is from 0-10 , 0 no Pain and 10 worst pain, 12 hours postoperative|nausea, vomiting, incidence of postoperative complications: nausea, vomiting, 12 hours postoperative
A Study of the Correlation Between Portal Vein Thrombosis and Prognosis of Liver Transplantation
NCT Number: NCT06513780
Status: RECRUITING
Study Type: OBSERVATIONAL
Conditions: Portal Vein Thrombosis
Interventions: OTHER: Observation
Sponsor: Ru-zhou Cai
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 700
Study Design: Observational Model: |Time Perspective: p
Start Date: 2016-01-01
Completion Date: 2025-12-31
Locations: Beijing Friendship Hospital, Capital Medical University, Beijing, China

Summary:
The goal of this observational study is to investigate the correlation between portal vein thrombosis (PVT) and the prognosis of liver transplantation. The main questions it aims to address are:

What is the prevalence of PVT? What are the risk factors associated with PVT? What is the prognostic impact of preoperative PVT on liver transplantation?

Participants are divided into two groups: the PVT group and the non-PVT group. The investigators will comparatively analyze the data of both groups, estimate the prevalence and risk factors of PVT, construct a predictive model for PVT that is applicable in clinical settings, and clarify the prognostic effects of PVT.

Primary Outcome Measures: Death, Rate of death from various causes after liver transplant, 10 years|Postoperative portal vein thrombosis, Number of participants with portal vein thrombosis after liver transplant, 10 years|Postoperative portal vein stenosis, Number of participants with portal vein stenosis after liver transplant, 10 years
Secondary Outcome Measures: Postoperative complications, Rate of re-surgery, interventional operation, endoscopy, dialysis, etc., 1 year
Investigating Changes in Responses to Controlled Effective Doses of Ozone at Different Exercise Intensities
NCT Number: NCT06513754
Status: NOT_YET_RECRUITING
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Ozone|Exercise Intensity
Interventions: OTHER: Ozone|BEHAVIORAL: Heavy Intensity|BEHAVIORAL: Moderate Intensity|OTHER: Filtered Air
Sponsor: Michael Koehle
Collaborators: Natural Sciences and Engineering Research Council, Canada
Sex: ALL
Age: ADULT
Enrollment: 18
Study Design: Allocation: RANDOMIZED|Intervention Model: CROSSOVER|Masking: DOUBLE (PARTICIPANT, INVESTIGATOR)|Primary Purpose: BASIC_SCIENCE
Start Date: 2024-09
Completion Date: 2025-08
Locations: Environmental Physiology Laboratory, Vancouver, British Columbia, V6T 1Z1, Canada

Summary:
The project will look to investigate whether exercise during ozone exposure performed for a shorter duration at a higher intensity is more harmful than exercise performed for a longer duration at a lighter intensity. To assess this, participants will perform these exercise conditions with and without ozone exposure and researchers will assess changes in lung function, subjective symptoms, and breathing mechanics to determine which is more harmful.

Primary Outcome Measures: Pulmonary function, forced vital capacity, forced expiratory volume in 1 second, forced expiratory flow over the middle half of FVC., Measured before, during, and after exercise (before, 45th minute of exercise, immediately after, and every 30 minutes after for an hour)
Secondary Outcome Measures: Rating of perceived exertion, How hard does the exercise feel rated on a scale of 6-20 with each increase representing an increase in perceived exertion while exercising, Measured during and after exercise (every 15 minutes during, immediately after, and every 30 minutes after for an hour)|Sensations of Dyspnea, Sensations of breathlessness as measured by the multidimensional dyspnea profile. Increased scores represent worsened sensations or severities of dyspnea., Measured before, during, after exercise (before, every 15 minutes during, immediately after, and every 30 minutes after for an hour)|Subjective Symptoms, Subjective symptoms associated with ozone exposure using a questionnaire previously used by the Environmental Physiology Laboratory. This scale measures the presence and severity of eye, throat, lung irritation in response to ozone exposure. Higher scores indicate worsened symptoms., Measured before, during, after exercise (before, every 15 minutes during, immediately after, and every 30 minutes after for an hour)
Building Stronger Foundations: Exploring a Collaborative Faculty Mentoring Workshop for In-depth Growth
NCT Number: NCT06513741
Status: COMPLETED
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Behavior
Interventions: BEHAVIORAL: Mentoring Workshop
Sponsor: University of Lahore
Sex: ALL
Age: CHILD, ADULT, OLDER_ADULT
Enrollment: 37
Study Design: Allocation: NA|Intervention Model: SINGLE_GROUP|Masking: NONE|Primary Purpose: OTHER
Start Date: 2023-05-01
Completion Date: 2023-12-31
Locations: The University of Lahore, Lahore, Punjab, 54770, Pakistan

Summary:
Mentorship training programs demand a paradigm shift from theory-driven approach to hands-on practical approach. This requires prioritisation of preparation of mentors and mentees for their roles through self-awareness and targeted professional development. There is a lack of evidence form health professions education institutions of global south, regarding effectiveness of the workshops in fostering mentorship culture. A mixed method study with convergent parallel design is conducted through a collaborative mentoring workshop; "Faculty Mentoring-Building stronger by digging deeper" by Aga khan University Medical College, Karachi and University of Lahore, Punjab, Pakistan. Objective of the research is to emphasise the importance of faculty mentoring program, roles and responsibilities of mentors and mentees and collecting perceptions of the participants regarding the associated role of institutions. It aims to educate faculty members to develop personal development plans for becoming effective mentors and mentees. The designed intervention is a 12 hour workshop spanned over two days of six hours each with the focus on determining perception of the Medical faculty of two institutions regarding the importance and preparedness of faculty development programs and the focus on self through personal swot translating into a personal development plan. The demographic data of participants was collected before the workshop, during the workshop, and after workshop. Comparison between quantitative findings was done through ANOVA, while the qualitative data was subjected to thematic analysis.

Primary Outcome Measures: Personal Development Plan, Developing a personal development plan through SWOT analysis of self. The plan will identify the areas of mentoring that need improvement with the identified milestones and timelines, At the end of the workshop (Day 2)
Pilot Study of Methadone Patient Access to Collaborative Treatment
NCT Number: NCT06513728
Acronym: MPACT
Status: NOT_YET_RECRUITING
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Opioid Substitution Treatment Clinics|Patients|Staff
Interventions: OTHER: MPACT Intervention
Sponsor: University of Arizona
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 140
Study Design: Allocation: NA|Intervention Model: SINGLE_GROUP|Masking: NONE|Primary Purpose: HEALTH_SERVICES_RESEARCH
Start Date: 2024-10-01
Completion Date: 2025-08-31
Locations: University of Arizona College of Medicine, Tucson, Arizona, 85714, United States

Summary:
Examine the preliminary effect of the MPACT intervention on methadone treatment retention, in treatment overdose and patient trauma symptoms. The study will also explore the relationship between staff trauma symptoms and MPACT implementation.

Primary Outcome Measures: methadone treatment retention, Retention in methadone treatment (measured by 3 different indicators), 4 months (pilot study period)|In treatment overdose, Reported overdoses during methadone treatment (measured by study constructed algorithm), 4 months (pilot study period)
Secondary Outcome Measures: Trauma symptoms among patients and staff, Post traumatic stress symptoms (measured by 8-item Post Traumatic Stress Disorder Checklist or, PCL-5). Scores are 0-80. Higher scores mean greater PTSD symptom severity., pilot period of 4 months|Vicarious Trauma symptoms among staff, Vicarious trauma symptoms (measured by the Vicarious Trauma Scale (VTS). Scores are 0-190. Higher scores indicate more vicarious (work related) traumatization., pilot period of 4 months
Activity of Bioactive Natural Compounds as Potential Agonists of GLP1R
NCT Number: NCT06513715
Acronym: BIOBESICOM
Status: ACTIVE_NOT_RECRUITING
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Obesity|Overweight
Interventions: DIETARY_SUPPLEMENT: Control|DIETARY_SUPPLEMENT: Jubanine
Sponsor: Universidad Católica San Antonio de Murcia
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 100
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: TRIPLE (PARTICIPANT, INVESTIGATOR, OUTCOMES_ASSESSOR)|Primary Purpose: TREATMENT
Start Date: 2024-01-09
Completion Date: 2026-07-01
Locations: Faculty of Nursing. Catholic University of Murcia, Murcia, 30107, Spain

Summary:
The goal of this clinical trial is to learn if natural bioactive compound jubenine works to reduce appetite and to favour weight loss. It will also learn about the safety of natural bioactive compound jubenine. The main questions it aims to answer are:

Does natural bioactive compound jubenine reduce the hunger perception or increase the satiety perception, and, consequently, reduce food intake? What medical problems do participants have when taking natural bioactive compound jubenine? Researchers will compare natural bioactive compound jubenine to a placebo (a look-alike substance that contains no drug) to see if natural bioactive compound jubenine works to reduce food intake for obesity treatment.

Participants will:

Take natural bioactive compound jubenine or a placebo three times every day for 3 months.

Visit the clinic once every 1 week for checkups and tests. Keep a diary of their symptoms and potenital adverse effects.

Primary Outcome Measures: Weight loss, Percentage of weight loss from baseline weight, First evaluation will be made after 3 months of treatment, and a second evaluation will be made 12 months later.
To Determine the Effectiveness of Transesophageal Lung Ultrasound Guided Recruitment Maneuver in Cardiac Surgery
NCT Number: NCT06513702
Acronym: TELUS-REM
Status: NOT_YET_RECRUITING
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Coronary Artery Bypass Surgery
Interventions: PROCEDURE: Transesophageal lung ultrasound (TELUS) guided recruitment maneuver|OTHER: Manual bag lung reinflation
Sponsor: University of Malaya
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 60
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: DOUBLE (PARTICIPANT, OUTCOMES_ASSESSOR)|Primary Purpose: TREATMENT
Start Date: 2024-08-01
Completion Date: 2025-08

Summary:
This study is to evaluate the effectiveness of Transesophageal Lung ULtrasound (TELUS) guided recruitment maneuver to reduce lung atelelectasis in cardiac surgery. This is a RCT trial involving a cardiac patient that requiring used of cardiopulmonary bypass machine intraoperatively. These patient will be randomized into either intervention group or control group.

Primary Outcome Measures: Incidence of lung atelectasis intraoperatively after TELUS guided recruitment, assessed by TOE during sternal wiring after recruitment maneuver, intraoperatively
Secondary Outcome Measures: Severity of Postoperative pulmonary complications., Grade 0 - Absence of any complications Grade 1 - Cough, dry

* Microatelectasis: abnormal lung findings and temperature \> 37.5°C without other documented cause; normal CXR Grade 2 - Cough, productive
* Bronchospasm
* Hypoxemia (SpO2 ≤ 90%) at room air
* Atelectasis: gross radiological confirmation plus either temperature \> 37.5°C or abnormal lung findings
* Hypercarbia (PaCO2 \> 50 mmHg), requiring treatment Grade 3 - Pleural effusion, resulting in thoracentesis
* Pneumonia- requiring change of antibiotic
* Pneumothorax
* Noninvasive ventilation- Re-intubation , with period of ventilator dependence (non-invasive or invasive ventilation) ≤ 48 hours Garde 4 - Ventilatory failure: postoperative ventilator dependence exceeding 48 hours, or reintubation with ventilator dependence exceeding 48 hours Grade 5 Death before hospital discharge, 30 days