pankajmathur/National_Library_of_Medicine_Studies_data huggingface dataset:
Mechanistic Insights From Temporary Pacing in HFpEF
NCT Number: NCT06467266
Status: NOT_YET_RECRUITING
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Heart Failure Preserved Ejection Fraction|Pacing
Interventions: DIAGNOSTIC_TEST: Acute Haemodynamic Study
Sponsor: Guy's and St Thomas' NHS Foundation Trust
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 10
Study Design: Allocation: NA|Intervention Model: SINGLE_GROUP|Masking: NONE|Primary Purpose: BASIC_SCIENCE
Start Date: 2024-07-01
Completion Date: 2026-10-31

Summary:
Heart failure with preserved ejection fraction (HFpEF) is characterised by impaired diastolic function. A recent clinical trial has demonstrated multiple beneficial outcomes in HFpEF patients receiving personalised accelerated pacing from indwelling permanent pacemakers, including symptomatic improvement, objective reductions in NT-proBNP level and AF-burden.

The investigators aim to determine the underlying mechanisms behind these documented effects, to investigate the acute intracardiac haemodynamic response to temporary multisite pacing in HFpEF participants and to gain further mechanistic insight with additional haemodynamic, electrical and echocardiographic data collection during temporary pacing in this cohort. This will all provide valuable information towards new potential targets of therapy.

Primary Outcome Measures: Number of participants with changes in left ventricular end diastolic pressure upon accelerated right atrial pacing and conduction system pacing, Measurement of the absolute left ventricular end diastolic pressure (in mmHg) and volume (in milliliter) at real-time during each pacing mode, heart rate and AV delay with a pressure volume loop catheter, 30 months
Secondary Outcome Measures: Number of participants with leftward, downward shift in the LV P-V loop during accelerated RA pacing and CSP, not reproduced by RV pacing, Qualitative assessment of the leftward, downward shift in the left ventricular P-V loop during accelerated right atrial pacing and conduction system pacing, not reproduced by right ventricular pacing, 30 months|Number of participants with changes in Echo measures of diastology upon right atrial pacing and conduction system pacing, Measurement of the absolute left ventricular tissue velocity (measured in centimeter/second) with the use of a pulse wave tissue doppler imaging (TDI) signal in the apical four chamber view, 30 months
Evaluation of the Hybrid Rapid Maxillary Expander Assisted With Micro-osteo Perforation (MOPs) in Adult.
NCT Number: NCT06467240
Status: NOT_YET_RECRUITING
Study Type: OBSERVATIONAL
Conditions: Maxillary Anomaly
Interventions: PROCEDURE: hybrid rapid maxillary expander assisted with Micro-osteo perforation (MOPs)
Sponsor: Al-Azhar University
Sex: ALL
Age: CHILD, ADULT
Enrollment: 14
Study Design: Observational Model: |Time Perspective: p
Start Date: 2024-07-01
Completion Date: 2025-07-20
Locations: Dental Medicine Al-Azhar University, Cairo, Naser City, 4450113, Egypt

Summary:
This study will be directed for Evaluation of the hybrid rapid maxillary expander assisted with Micro-osteo perforation (MOPs) in adults

Primary Outcome Measures: CBCT measurment, amount of skeletal and dental expansion, 3 weeks|suture opening, amount of skeletal and dental expansion, 3 weeks
Exposure to the Aerobic Training Stimulus in Healthy Individuals
NCT Number: NCT06467227
Acronym: O2MVPaA
Status: RECRUITING
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Healthy
Interventions: OTHER: exercise modality
Sponsor: West Park Healthcare Centre
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 10
Study Design: Allocation: NA|Intervention Model: SINGLE_GROUP|Masking: NONE|Primary Purpose: TREATMENT
Start Date: 2024-06-01
Completion Date: 2025-03-01
Locations: Westpark Health Care Centre, Toronto, Ontario, M6M 2J5, Canada

Summary:
Fitness is an important determinant for health and influenced by using large muscles. Muscles respond to training. We want to know if adding arm exercise to leg exercise can provide a better training session for healthy individuals. If the strategy shows promise for healthy people then it might work for people with lung disease who have trouble training because of difficulty breathing. The purpose of this first study is to evaluate, in healthy people, a unique approach to training by determining if adding arm exercise to leg exercise can be endured longer than leg exercise alone.

Primary Outcome Measures: cycling endurance time, tolerance (time) of an individualized constant power endurance test, 30 minutes
SAD Study to Evaluate Safety, Tolerability, and Pharmacokinetic Profile of KSHN001126 in Healthy Post-Menopausal Females
NCT Number: NCT06467201
Status: NOT_YET_RECRUITING
Study Type: INTERVENTIONAL
Phases: PHASE1
Conditions: Healthy Postmenopausal Women
Interventions: DRUG: KSHN001126 150mg|DRUG: KSHN001126 300mg|DRUG: KSHN001126 600mg
Sponsor: Shivanka Research, LLC
Collaborators: Eric Solutions LLC|Clinexcel Research, Ahmedabad, India
Sex: FEMALE
Age: ADULT
Enrollment: 18
Study Design: Allocation: NON_RANDOMIZED|Intervention Model: SEQUENTIAL|Masking: NONE|Primary Purpose: BASIC_SCIENCE
Start Date: 2024-06
Completion Date: 2025-03
Locations: Advanced Pharma CR, Miami, Florida, 33147, United States|Health1 Superspeciality Hospital, Ahmedabad, Gujarat, 380058, India

Summary:
This is an Open-label, Sequential dosing, Single Ascending Dose (SAD) Study to Determine the Safety, Tolerability, and Pharmacokinetic (PK) Profile of KSHN001126 in Healthy Human Post-Menopausal Female Volunteers. The primary objective of the study is to evaluate the safety and tolerability of increasing single doses of KSHN001126 while the secondary objective is to evaluate the plasma PK profile of KSHN001126 and its metabolites (KSHN001167, KSHN001168 and Fulvestrant) following ascending single oral doses of KSHN001126.

Primary Outcome Measures: Type, incidence, severity, seriousness, and relatedness of Adverse Events (AEs), Adverse events reported after dosing will be evaluated, Upto Day 15 after dosing|Number of participants with abnormal laboratory tests results, Laboratory abnormalities after dosing will be evaluated, Upto Day 15 after dosing|Number of participants with abnormal vital signs, Upto Day 15 after dosing|Number of participants with abnormal Electrocardiogram readings, Impact on QTc interval will be evaluated, Upto Day 15 after dosing
Secondary Outcome Measures: Evaluate the Peak Plasma Concentration (Cmax) of KSHN001126 and its metabolites (KSHN001167, KSHN001168 and Fulvestrant) following ascending single oral doses of KSHN001126, 72 hours after dosing|Evaluate the Area under the plasma concentration versus time curve (AUC) of KSHN001126 and its metabolites (KSHN001167, KSHN001168 and Fulvestrant) following ascending single oral doses of KSHN001126, 72 hours after dosing|Evaluate the Time to maximum concentration (Tmax) of KSHN001126 and its metabolites (KSHN001167, KSHN001168 and Fulvestrant) following ascending single oral doses of KSHN001126, 72 hours after dosing|Evaluate the half life (T1/2) of KSHN001126 and its metabolites (KSHN001167, KSHN001168 and Fulvestrant) following ascending single oral doses of KSHN001126, 72 hours after dosing
Turkish Validity and Reliability of the Haptotherapeutic Well-Being Scale
NCT Number: NCT06467188
Status: COMPLETED
Study Type: OBSERVATIONAL
Conditions: Therapeutic Agalactia
Interventions: OTHER: Validity and reliability
Sponsor: Trakya University
Sex: FEMALE
Age: ADULT, OLDER_ADULT
Enrollment: 252
Study Design: Observational Model: |Time Perspective: p
Start Date: 2023-10-20
Completion Date: 2023-12-20
Locations: Trakya University, Edirne, 22030, Turkey

Summary:
Objectives: Haptotherapy fosters a sense of unity between the body, mind, and emotions. In addition, it contributes to expanding the woman's perception of her pregnancy and developing a more positive attitude towards pregnancy and childbirth. The study aims to examine the Turkish validity and reliability of the Haptotherapeutic Well-Being Scale, which will be used to evaluate the well-being levels of haptonomy and haptotherapy practices in women.

Design: The study was methodological type. Methods: The study conducted between October 20 and December 20, 2023, with 242 women who volunteered to participate by sharing forum pages on social media (Facebook, Instagram) via the web. Data were collected using a personal information form, including sociodemographic and obstetric characteristics and the Haptotherapeutic Well-Being Scale.

Primary Outcome Measures: Haptotherapeutic Well-Being Scale, Scale consists of 14 items and five sub-dimensions. High scores obtained from the scale mean that the level of haptotherapeutic well-being is also good. There are are received that the minimum 4, maximum 20 points from the psychological well-being sub-dimension, minimum 2, maximum 10 points from the physical health sub-dimension, minimum 3, maximum 15 points from the autonomy, relationships with others and touching and being touched sub-dimensions., 1 day
Usage of Spacers and the Relationship With Symptoms Severity in COPD Elderly Patients
NCT Number: NCT06467162
Status: COMPLETED
Study Type: OBSERVATIONAL
Conditions: Pulmonary Disease|Chronic Obstructive
Sponsor: Ai-Ling Chang
Sex: ALL
Age: OLDER_ADULT
Enrollment: 164
Study Design: Observational Model: |Time Perspective: p
Start Date: 2023-04-06
Completion Date: 2023-06-30
Locations: Wan-Ting Huang, Changhua, 51591, Taiwan

Summary:
The goal of this observational study is to investigate the usage of spacers and their relationship with symptom severity in chronic obstructive pulmonary disease elderly patients. Patients with chronic obstructive pulmonary disease aged 65 years or over at thoracic medicine outpatient clinics were recruited in this study. Research participants were interviewed using structured questionnaires, including demographic characteristics information, clinical characteristics information, and the chronic obstructive pulmonary disease assessment test.

Primary Outcome Measures: Symptoms severity, The severity and impacts of the COPD symptoms were measured by using the chronic obstructive pulmonary disease assessment test, Immediately after the outpatient department visit
Comparison of Frailty Screening Performance and Predictive Validity of Adverse Health Outcomes in Breast Cancer Patients Using Frailty Screening Tools
NCT Number: NCT06467149
Acronym: frailty
Status: RECRUITING
Study Type: OBSERVATIONAL
Conditions: Frailty Syndrome
Sponsor: Ju Qiu
Collaborators: Ministry of Education, China
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 500
Study Design: Observational Model: |Time Perspective: p
Start Date: 2023-08-12
Completion Date: 2025-12-30
Locations: Ju Qiu, Chongqing, China

Summary:
This study uses the Physical Frailty Phenotype (PFP) as the diagnostic criterion for frailty and aims to explore the frailty screening scale FRAIL (The FRAIL Scale), Tilburg Frailty Index (TFI) and geriatric screening. Screening performance of Tool-8 (Geriatric-8, G-8) in breast cancer patients, to compare the predictive validity of different frailty screening scales for adverse health outcomes in breast cancer patients, and to select appropriate frailty screening methods for breast cancer patients in my country Screening scale.

Primary Outcome Measures: Falls, one or more falls due to various reasons between the diagnosis of breast cancer and the second follow-up period.Does not use any scale, is a dichotomous variable with a fall score of "1" and a no fall score of "0"., From 2023.8~2025.12.|Unplanned hospitalisation, hospitalisation after doctor's diagnosis and hospitalisation for more than one day after diagnosis of breast cancer up to the second follow-up period, except for treatment nodes such as surgery and chemotherapy.No scale is used, it is a dichotomous variable with a score of "1" for unplanned hospitalisation and a score of "0" for non-occurrence., 2023.8~2025.12.|Disability, Activities of daily living (ADL) were assessed using the Barthel Index (BI).The present study defined the development of disability as a decrease in scores on at least one scale entry in the BI scale from six months earlier, From 2023.8~2025.12.|Depression, Depression screening was performed using the Geriatric Depression Scales-5 (GDS-5). The options for each entry were "yes" or "no". Entry 1 was scored 0 points for "yes" and 1 point for "no", and entries 2 to 5 were scored 1 point for "yes" and 0 points for "no". The answer "yes" for entries 2 to 5 is 1 point, and the answer "no" is 0 points. The total score ranged from 0 to 5, with a score of ≥2 indicating the presence of depression., From 2023.8~2025.12.
A Pilot Study Comparing Two Rehabilitation Approaches for Individuals With Irritable Shoulder Pain
NCT Number: NCT06467123
Status: RECRUITING
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Shoulder Pain
Interventions: OTHER: Tissue Intervention|OTHER: Biopsychosocial Intervention
Sponsor: University of Central Florida
Sex: ALL
Age: ADULT
Enrollment: 24
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: NONE|Primary Purpose: TREATMENT
Start Date: 2024-06-28
Completion Date: 2025-05-30
Locations: University of Central Florida, Orlando, Florida, 32765, United States

Summary:
This pilot study will assess feasibility and obtain preliminary effects of a tissue based intervention to a biopsychosocial intervention in individuals with shoulder pain.

Primary Outcome Measures: Report rate of adherence and adverse effects, Number of participants who complete the study and adverse events will be reported, through study completion, 4 weeks|Report preliminary outcomes of treatment effects, Shoulder pain intensity measured with the numeric pain rating scale will be compared between groups., through study completion, 4 weeks
Safety and Effectiveness Study of SQ-Kyrin TMVr System for Degenerated Mitral Regurgitation
NCT Number: NCT06467110
Status: ENROLLING_BY_INVITATION
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Degenerated Mitral Regurgitation
Interventions: DEVICE: transcatheter mitral valve clip delivery system and steerable guide catheter (Shenqi Medical)
Sponsor: Shanghai Shenqi Medical Technology Co., Ltd
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 118
Study Design: Allocation: NA|Intervention Model: SINGLE_GROUP|Masking: NONE|Primary Purpose: TREATMENT
Start Date: 2021-10-15
Completion Date: 2028-12-15
Locations: General Hospital of Northern Theater Command, PLA, Shenyang, Liaoning, 123005, China

Summary:
To verify the safety and effectiveness of transcatheter mitral valve clip delivery system and steerable guide catheter produced by Shanghai Shenqi Medical Technology Co., Ltd.in patients with moderate-severe or severe degenerated mitral regurgitation (DMR).

Primary Outcome Measures: 1. Incidence of composite endpoint of no death, no surgical mitral valve-related procedures due to mitral valve dysfunction, and no moderate-severe or severe MR (MR>2+) at 12 months after surgery, Incidence of composite endpoint of no death, no surgical mitral valve-related procedures due to mitral valve dysfunction, and no moderate-severe or severe MR (MR\>2+) at 12 months after surgery, 12 months after surgery
Systemic Treatment Alone Versus Systemic Treatment Plus Radiotherapy in Oligometastatic Renal Cell Carcinoma
NCT Number: NCT06467097
Acronym: SABLOR
Status: RECRUITING
Study Type: INTERVENTIONAL
Phases: PHASE3
Conditions: Kidney Neoplasm
Interventions: RADIATION: SBRT(Stereotatic Body Radiation Therapy)
Sponsor: Samsung Medical Center
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 88
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: NONE|Primary Purpose: TREATMENT
Start Date: 2024-04-16
Completion Date: 2031-02-13
Locations: Samsung Medical Center, Seoul, 06351, Korea, Republic of

Summary:
To evaluate whether incorporating locoregional radiotherapy in the treatment of oligometastatic renal cell carcinoma, including inductive oligometastases, along with standard systemic therapy, contributes to improved progression-free survival rates for patients.

Primary Outcome Measures: 1-year progression-free survival rate, Compare free survival between the standard systemic therapy alone group and systemic therapy combined with radiotherapy group, One year after completion of enrollment
Secondary Outcome Measures: Local control rate for radiation therapy site at one year, Compare Local control rate between the standard systemic therapy alone group and systemic therapy combined with radiotherapy group, One year after radiation completion of each participant|Grade 3 acute adverse event, Compare acute adverse events according to CTCAE V5.0 between the standard systemic therapy alone group and systemic therapy combined with radiotherapy group, three to six months after study treatment|Grade 3 chronic adverse event, Compare chronic adverse events according to CTCAE V5.0 between the standard systemic therapy alone group and systemic therapy combined with radiotherapy group, one year to three years after radiation completion|Overall survival rate, Compare Overall survival rate between the standard systemic therapy alone group and systemic therapy combined with radiotherapy group, From date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 36 months
Open-Label Safety, PK, and Efficacy Trial of Sebetralstat (KVD900) in Pediatric Patients (Ages 2-11) With HAE Type I or II
NCT Number: NCT06467084
Acronym: KONFIDENT-KID
Status: RECRUITING
Study Type: INTERVENTIONAL
Phases: PHASE3
Conditions: Hereditary Angioedema
Interventions: DRUG: KVD900 75 mg|DRUG: KVD900 150 mg|DRUG: KVD900 300 mg
Sponsor: KalVista Pharmaceuticals, Ltd.
Sex: ALL
Age: CHILD
Enrollment: 24
Study Design: Allocation: NON_RANDOMIZED|Intervention Model: PARALLEL|Masking: NONE|Primary Purpose: TREATMENT
Start Date: 2024-06-24
Completion Date: 2027-08-31
Locations: KalVista Investigative Site, Birmingham, Alabama, 35209, United States|KalVista Investigative Site, Scottsdale, Arizona, 85251, United States|KalVista Investigative Site, San Diego, California, 92123, United States|KalVista Investigative Site, Santa Monica, California, 90404, United States|KalVista Investigative Site, Wheaton, Maryland, 20902, United States|KalVista Investigative Site, Saint Louis, Missouri, 63141, United States

Summary:
KVD900-303 is an open-label, multicenter clinical trial in patients aged 2 to 11 years old with HAE Type I or II.

Primary Outcome Measures: The proportion of pediatric patients with HAE Types I or II who take any sebetralstat dose, who experience any AE(s) (including fatal AEs) during the study, irrespective of uses of other medications and sebetralstat discontinuations for any reason., Throughout the duration of the trial, up to 1 year.
Secondary Outcome Measures: Caregiver Global Impression of Change (CaGI-C): Time to beginning of symptom relief defined as at least "a little better" (2 time points in a row), Within 12 hours of the first IMP administration.|Caregiver Global Impression of Severity (CaGI-S): Time to first incidence of decrease from baseline (2 time points in a row), Within 12 hours of the first IMP administration.|CaGI-S: Time to HAE attack resolution defined as "none", Within 24 hours of the first IMP administration
Effectiveness and Tolerance of Cicaplast Baume B5 After Superficial CO2 Laser Resurfacing
NCT Number: NCT06467032
Status: COMPLETED
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Wound Heal
Interventions: OTHER: superficial CO2 laser resurfacing|OTHER: Laser untreated side
Sponsor: Cosmetique Active International
Sex: ALL
Age: ADULT
Enrollment: 25
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: QUADRUPLE (PARTICIPANT, CARE_PROVIDER, INVESTIGATOR, OUTCOMES_ASSESSOR)|Primary Purpose: OTHER
Start Date: 2023-01-16
Completion Date: 2023-04-21
Locations: CPCAD, Nice, France

Summary:
This monocentric, double-blinded, randomized with intra-individual comparisons study is an interventional cosmetic study.

The objective is to evaluate the effectiveness of a new formulation on the re-epithelialization kinetic after superficial CO2 laser dermabrasion in comparison to an untreated area.

Primary Outcome Measures: wound healing assessment by the Investigator (number of days for complete re-epithelialization), assessment on a 6-point scale: 0 (No healing); 1 (Weak healing: \<25% of the lesion area); 2 (Partial healing: between 25 and 50% of the lesion area); 3 (Significant healing: between 50 and 75% of the lesion area); 4 (Almost complete healing: \>75% of the lesion area); 5 (Complete healing)., from baseline to Day19
Secondary Outcome Measures: wound healing assessment by the Investigator (number of days for 25%, 50% and 75% re-epithelialization), assessment on a 6-point scale: 0 (No healing); 1 (Weak healing: \<25% of the lesion area); 2 (Partial healing: between 25 and 50% of the lesion area); 3 (Significant healing: between 50 and 75% of the lesion area); 4 (Almost complete healing: \>75% of the lesion area); 5 (Complete healing)., from baseline to Day19
Informative Exhibition for Deprescribing Benzodiazepines
NCT Number: NCT06467019
Acronym: ESUB
Status: RECRUITING
Study Type: OBSERVATIONAL
Conditions: Benzodiazepine-Related Disorders
Interventions: OTHER: Informative Session
Sponsor: Consorci Sanitari de l'Alt Penedès i Garraf
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 6410
Study Design: Observational Model: |Time Perspective: p
Start Date: 2024-06-13
Completion Date: 2025-07
Locations: Centro de Salud Vilanova i la Geltrú 3 Baix A Mar, Vilanova I La Geltrú, Barcelona, Spain

Summary:
The goal of this trial is to determine if an interactive and informative exhibition in the waiting room of a Primary Care Clinic can reduce the use of benzodiazepines in adults. The main question it aims to answer is:

• Does an interactive and informative exhibition reduce the number of participants using benzodiazepines? Researchers will compare benzodiazepine consumption before and after the interactive and informative exhibition implementation at study center.

Participants will receive an informative and interactive exhibition on the risks of chronic benzodiazepine use. A single informative session on the same topic will be conducted for health professionals.

Primary Outcome Measures: Chronic treatment with benzodiazepines, Percentage of patients treated chronically with benzodiazepines, based on electronic prescription data., 1 year
AI PREDICTION FOR PROXIMAL HUMERAL FRACTURES
NCT Number: NCT06467006
Acronym: Orthopredict
Status: NOT_YET_RECRUITING
Study Type: OBSERVATIONAL
Conditions: Proximal Humeral Fracture
Interventions: OTHER: Use of IA for proximal humeral fracture prognosis
Sponsor: Consorci Sanitari de l'Anoia
Collaborators: Parc de Salut Mar|Parc Taulí Hospital Universitari
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 500
Study Design: Observational Model: |Time Perspective: p
Start Date: 2024-09
Completion Date: 2027-09

Summary:
Our smartphones can recognize the pictures of our family, loved ones and friends. Face recognition software leverages artificial intelligence (AI), image recognition and other advanced technology to map, analyze and confirm the identity of a face.

We humans do a poor job when classifying the injury related to a patient sustaining a proximal humeral fracture. In consequence, there is great heterogeneity in the treatment of proximal humerus fractures. Moreover, offering relevant information to patients regarding the risk of complications or fracture sequelae is challenging, given that the current series are based on obsolete classifications, and the published series bring together just over hundreds of patients analyzed. With these limitations, patients have few opportunities to participate in decision-making about their injury.

The present project aim is to integrate new technologies for the prediction of relevant clinical results for the patients presenting a proximal humeral fracture. In brief, AI can help identify similar fracture patterns without human inference, while humans can feed the algorithm with variables of interest such as the functional outcomes and complications related to this particular type of fracture.

Primary Outcome Measures: Constant-Murley Score, Functional outcome, 1 year
Influence of Relaxing Breathing Before Each Station of an Objective Structured Clinical Examination
NCT Number: NCT06466993
Acronym: ZENECOS
Status: NOT_YET_RECRUITING
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Performance Anxiety|Stress|Coping Skills
Interventions: BEHAVIORAL: Intervention of standardized relaxing breathing
Sponsor: Claude Bernard University
Sex: ALL
Age: CHILD, ADULT, OLDER_ADULT
Enrollment: 400
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: DOUBLE (INVESTIGATOR, OUTCOMES_ASSESSOR)|Primary Purpose: OTHER
Start Date: 2024-09-05
Completion Date: 2024-12-17

Summary:
SObjective and Structured Clinical Examinations (OSCEs) has been incorporated recently in the certification process as a final national undergraduate ranking examination. This exam is an additional major stressor for medical students.

The aim of this study was to compare the efficiency on stress reduction of a standardized relaxing breathing occuring during rotation of the OSCE stations just before the start of the next upcoming OSCE station, in medical student, during the OSCE.

Primary Outcome Measures: PERFORMANCE, Score at the objectif structured clinical examination exam from 0 minimum to 200 points maximum, obtained seven days after the objectif structured clinical examination
Secondary Outcome Measures: Mean Difference of Inner Resource, Numerical Visual analog score on inner resource available perceived (from 0 to 100 : maximum), Two times : 10 minutes before objectif structured clinical examination (before training of intervention) and just 2 minutes after training of the intervention)|Mean difference of perceived impact of the intervention on performance, Numerical Visual analog scales on perceived impact of the intervention on performance (from zero: negative to 100: positive), Just five minutes after the objectif structured clinical examination
Study of Ventilator Associated Event During Intensive Care After Resuscitated Cardiac Arrest.
NCT Number: NCT06466980
Acronym: VAE-ACR
Status: RECRUITING
Study Type: OBSERVATIONAL
Conditions: Cardiac Arrest With Successful Resuscitation|Mechanical Ventilation
Interventions: OTHER: Ventilator associated event
Sponsor: Centre Hospitalier Sud Francilien
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 150
Study Design: Observational Model: |Time Perspective: p
Start Date: 2024-06-27
Completion Date: 2024-12-31
Locations: Centre Hospitalier Sud Francilien, Corbeil-essonnes Cedex, 91106, France

Summary:
The aim is to describe the incidence, characteristics, risk factors and outcome of complications acquired under mechanical ventilation (called ventilator-associated events) according to the new CDC criteria, in a population of patients admitted in intensive care unit after cardiac arrest.

Primary Outcome Measures: number, Incidence of ventilator associated event, at day 28
Secondary Outcome Measures: Associated factors, Associated factors of ventilator associated event, at day 28|number of pneumonias, Ventilator associated pneumonia according to the American Thoracic Society definition, at day 28|time, Mechanical ventilation duration, at day 28|number of deaths, In-hospital mortality, at day 28
Understanding the Acute Pain Phenotype in Patients Undergoing Surgery
NCT Number: NCT06466941
Status: RECRUITING
Study Type: OBSERVATIONAL
Conditions: Acute Pain|Chronic Post Operative Pain|Opioid Use
Interventions: PROCEDURE: regional anesthesia|PROCEDURE: no regional anesthesia|OTHER: acute pain consultation|OTHER: no acute pain consultation
Sponsor: Brigham and Women's Hospital
Collaborators: National Institute of General Medical Sciences (NIGMS)
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 1000
Study Design: Observational Model: |Time Perspective: p
Start Date: 2024-07-03
Completion Date: 2027-07-01
Locations: Brigham and Women's Hospital, Boston, Massachusetts, 02115, United States

Summary:
The goal of this observational study is to learn about how regional anesthesia (numbing medication) affects pain in patients with different psychosocial phenotypes such as different levels of concern about pain, sleep issues, and anxiety, who are having surgery.

The main questions are:

1. Do psychosocial factors such as concerns about pain, sleep, anxiety affect the effectiveness of regional anesthesia?
2. Do psychosocial factors and regional anesthesia affect the amount of opioids used after surgery?
3. Do psychosocial factors and regional anesthesia affect development of chronic postsurgical pain?

Primary Outcome Measures: Maximum pain score over the first 24 hours after surgery, Maximum pain score (numerical pain rating score 0-10) over the first 24 hours after surgery, 0-24 hours
Secondary Outcome Measures: Worst pain score over the first 24 hours after surgery, Worst pain score (numerical pain rating score 0-10) over the first 24 hours after surgery, 0-24 hours|Average pain score over the first 24 hours after surgery, Average pain score (numerical pain rating score 0-10) over the first 24 hours after surgery, 0-24 hours|Least pain score over the first 24 hours after surgery, Least pain score (0-10) over the first 24 hours after surgery, 0-24 hours|Daily pain scores, Comparison of pain scores (numerical pain rating score 0-10) over the first 7 days after surgery, 0-7days|Longitudinal pain scores, Comparison of pain scores (numerical pain rating score 0-10) at 1 month, 3 months, 6 months, and 12 months, 1-12 months|Postoperative opioid consumption, Comparison of amount of opioids used after surgery (morphine milliequivalents), 0-7 days|Incidence of chronic postsurgical pain, Comparison of persistent pain in the surgical area \> 3 months after surgery, 3-12 months
Total Pancreatectomies in Germany - Epidemiology, Trends,
NCT Number: NCT06466928
Acronym: ToPaGe
Status: COMPLETED
Study Type: OBSERVATIONAL
Conditions: Pancreas Disease
Interventions: PROCEDURE: Total pancreatectomy
Sponsor: Medizinische Hochschule Brandenburg Theodor Fontane
Collaborators: Margarete-Ammon-Stiftung
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 12938
Study Design: Observational Model: |Time Perspective: p
Start Date: 2010-01-01
Completion Date: 2024-06-05

Summary:
The purpose of this study was to evaluate the real-world mortality rates of total pancreatectomy across Germany and to understand the impact of hospital caseload on surgical outcomes.

Primary Outcome Measures: In-hospital mortality, Death, 30 days
Propofol vs. Nasal Dexmedetomidine in Pediatric Agitation and Delirium
NCT Number: NCT06466915
Status: COMPLETED
Study Type: INTERVENTIONAL
Phases: PHASE4
Conditions: Comparison of the Effects of Propofol and Nasal Dexmedetomidine
Interventions: DRUG: Dexmedetomidine|DRUG: Propofol
Sponsor: Baskent University Ankara Hospital
Sex: ALL
Age: CHILD
Enrollment: 162
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: DOUBLE (PARTICIPANT, INVESTIGATOR)|Primary Purpose: PREVENTION
Start Date: 2023-06-01
Completion Date: 2024-04-30
Locations: Ahmed Uslu, Ankara, Çankaya, 06490, Turkey

Summary:
Dental pain and anxiety are quite common in pediatric patients. However, due to children's inability to express their fears and lack of knowledge about the procedures to be performed, these symptoms have often been misunderstood and inadequately treated in pediatric settings. Children have consistently experienced high rates of emergence anxiety during the recovery process after general anesthesia. Emergence anxiety can be harmful to the patient, leading to bleeding at the surgical site, displacement of intravenous catheters, parental anxiety, additional care needs, and delays in hospital discharge. Inhalation anesthetics are preferred for pediatric surgeries because they promote faster recovery. However, inhalation anesthetics often lead to a high rate of emergence anxiety, ranging from 25% to 80% depending on the scoring scale used, the child's age, and the type of surgery performed. Additional sedative or analgesic drugs, such as midazolam, dexmedetomidine, or propofol, have been used to prevent emergence anxiety.

Dexmedetomidine is a selective α2-agonist with sedative and analgesic effects, but it can cause mild respiratory depression. Numerous studies have shown that intranasal dexmedetomidine is more effective than other adjunctive drugs. It has been found to be beneficial in reducing emergence anxiety during pediatric anesthesia with minimal blood pressure or respiratory depression. However, although intranasal dexmedetomidine initially has relatively rapid absorption, the absorption process may take longer compared to intravenous administration, implying that the child's hemodynamic status is more stable and a longer effective absorption time may have a clinical advantage in preventing emergence anxiety.

The aim of this study is to compare and investigate the effectiveness of nasal dexmedetomidine and intravenous propofol applications used to reduce agitation in pediatric cases following extubation in clinical practice.

Primary Outcome Measures: Agitation-Delirium, It will be evaluated with a Pediatric Anesthesia Emergence Delirium Scale., 0, 5, 10, 15, 20, 25, 30. minutes after extubation.|Behavioral pain assessment, It will be evaluated with a The Face, Legs, Activity, Cry, and Consolability Scale., 0, 5, 10, 15, 20, 25, 30. minutes after extubation.
Secondary Outcome Measures: Nausea-vomiting, It will be evaluated by visual analogue scale., 0, 5, 10, 15, 20, 25, 30. minutes after extubation.|Rapid recovery, It will be evaluated with a Modified Aldrete Score., 30 minutes after extubation.
Mastocytosis Registry (of Zurich)
NCT Number: NCT06466889
Acronym: MastoR
Status: RECRUITING
Study Type: OBSERVATIONAL
Conditions: Mastocytosis|Hypertryptasemia
Sponsor: University of Zurich
Sex: ALL
Age: CHILD, ADULT, OLDER_ADULT
Enrollment: 400
Study Design: Observational Model: |Time Perspective: p
Start Date: 2024-06-06
Completion Date: 2035-12-31
Locations: University Hospital of Zurich, Zurich, 8091, Switzerland

Summary:
The study aims to summarize patients with mastocytosis and hypertryptasämia (without underlying mastocytosis or no bone marrow biopsy) in relation to demographic information, clinical progress and treatment courses. Biologic samples are collected from available routine diagnostics (serum, skin tissue, gut mucosa, bone marrow, and others) for further use in experimental research.

Primary Outcome Measures: Demographics, In the registry we collect patient's demographic data e.g. age, gender, comorbidities, smoking, preexisting atopic disease and other to look for associations to mast cell diseases., 2010-2025|Disease progression, Patients will followed up over time to get more insight in disease progression.If there is progression detected (e.g. cutaneous mastocytosis to systemic mastocytosis or ISM to advanced forms) those cases will be carefully looked at to identify triggering factors and biomarkers., 2010-2025
Turkish Cultural Adaptation, Validity and Reliability Study of Youth Activity Profile
NCT Number: NCT06466863
Acronym: YAP-Turkey
Status: NOT_YET_RECRUITING
Study Type: OBSERVATIONAL
Conditions: Physical Activity|Children
Interventions: OTHER: Validity and Reliability
Sponsor: Istanbul University - Cerrahpasa (IUC)
Sex: ALL
Age: CHILD
Enrollment: 150
Study Design: Observational Model: |Time Perspective: p
Start Date: 2024-07-01
Completion Date: 2025-07-01

Summary:
Aim: The aim of this study is to conduct a Turkish cultural adaptation, validity, and reliability study of the Youth Activity Profile (YAP), developed to assess physical activity and sedentary behavior in a sample of individuals aged 12-17 years of Turkish descent.

Method: Online surveys will be distributed to participants through social media platforms, messages, and emails. Participants' demographic information will be obtained using an online assessment form prepared by the researchers. Subsequently, the Physical Activity Questionnaire for Adolescents (PAQ-A) will be used to determine the levels of physical activity. This survey will be completed by participants at a time convenient for them during the academic term. Following this, questions from the Youth Activity Profile (YAP) will be administered. Once the targeted number of participants is reached, the data collection process will be concluded, and the survey link will be deactivated.

Potential Outcomes: It is expected that this study will contribute to a better understanding of the health behaviors and physical activity trends of adolescents aged 12-17 years, thereby informing health policies.

Primary Outcome Measures: Youth Activity Profile (YAP), The Youth Activity Profile (YAP) is a 15-item questionnaire developed to evaluate physical activity and sedentary behavior in children and adolescents aged 8 to 17 years. It operates on a recall basis, covering activities over the previous week (7 days) and includes assessments of both school and out-of-school activities, as well as time spent in sedentary behaviors., Change from baseline to 7 day
Secondary Outcome Measures: Physical Activity Questionnaire for Adolescents (PAQ-A), The scale consisting of 10 questions is calculated with a 5-point Likert system. The 1st question is divided into 15 items. In the calculation of the 1st question, the result obtained by dividing each score given for 15 items by the number of items is used. The scores given for each of the questions 2-8 are totalled. The 9th question consists of 7 items in total, Baseline
Mesenchymal Stem Cells Derived Exosomes in Osteoarthritis Patients
NCT Number: NCT06466850
Status: RECRUITING
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Osteoarthritis, Knee
Interventions: BIOLOGICAL: Exosome
Sponsor: Isfahan University of Medical Sciences
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 20
Study Design: Allocation: NA|Intervention Model: SINGLE_GROUP|Masking: NONE|Primary Purpose: SUPPORTIVE_CARE
Start Date: 2024-01-01
Completion Date: 2025-01-25
Locations: Leila Dehghani, Isfahan, Iran, Islamic Republic of

Summary:
Present research focuses on the potential of exosomes, which are small vesicles secreted by mesenchymal stem cells (MSCs), as a therapeutic approach for osteoarthritis (OA).

OA is a degenerative joint disorder characterized by the destruction of cartilage and loss of extracellular matrix. It's associated with pro-inflammatory cytokines and increased expression of matrix metalloproteinase (MMP) and "a disintegrin and metalloproteinase with thrombospondin motifs" (ADAMTS).

MSCs have been explored as a new treatment for OA over the last decade1. It's suggested that the paracrine secretion of trophic factors, in which exosomes play a crucial role, contributes to the mechanism of MSC-based treatment of OA.

Exosomes derived from MSCs may suppress OA development. They carry bioactive molecules of the parental cells, including non-coding RNAs (ncRNAs) and proteins and anti-inflammatory factors. These exosomes have shown a significant impact on the modulation of various physiological behaviors of cells in the joint cavity.

This research provides hope for developing more effective and predictable methods of using MSC-derived exosomes for OA treatment.

Primary Outcome Measures: Western Ontario and McMaster University Osteoarthritis index (WOMAC), Filling out the WOMAC questionnaire, evaluating the measures related to knee function, 1, 3, and 6 months. The second injection is repeated in day 90 after first injection.
Just-In-Time Adaptive Interventions for Diabetic Patients
NCT Number: NCT06466837
Status: NOT_YET_RECRUITING
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Diabetes|Self-Control|Telemedicine
Interventions: BEHAVIORAL: Just-in-time intervention|BEHAVIORAL: Active control
Sponsor: The Hong Kong Polytechnic University
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 184
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: SINGLE (OUTCOMES_ASSESSOR)|Primary Purpose: HEALTH_SERVICES_RESEARCH
Start Date: 2024-09-01
Completion Date: 2026-03-01

Summary:
The addition of proactive nurse consultations was useful to older adults with diabetes mellitus in facilitating their chronic disease self-management. However, the service is time and resource-intensive. With the support of advanced technology, mhealth App seems to be a convenient way to support patients in managing diabetes.

Primary Outcome Measures: Change in HbA1c, Measured using the A1C Now device, with blood drawn from the subjects' finger, baseline, three-month, and six-month|Diabetic self-management behaviour, measured using the Summary of Diabetes Self-care. Total scores range from 0 to 42, with higher scores representing better self-management performance. Activities questionnaire, baseline, three-month, and six-month
Secondary Outcome Measures: Change in quality of life, By using the Chinese version of the 12-item Short Form Health Survey. Total score ranges from 0 to 100, higher the better.

version 2, baseline, three-month, and six-month|Change in medication adherence, Measure this by using the Adherence to Refills and Medications Scale. Scores from 12 to 48, higher score better medication adherence., baseline, three-month, and six-month|Change in health service utilization, Measure the total number of unscheduled visits to general out-patient departments, general practitioners, emergency departments, and hospitals, and the total frequency of health service attendance, baseline, three-month, and six-month|Cost, The cost of the app, including development of new features and maintenance costs, will be estimated from the provider and societal perspectives, including the subjects' travelling costs and time. An ingredient approach will be adopted to estimate the cost., three-month, and six-month|satisfaction with the JITAIs, as well as usability and technical problems, using semi-structured group interviews with the intervention group participants, three-month
Observational Study on the Outcome of Patients With ITP Who Underwent Splenectomy After 2010
NCT Number: NCT06466824
Status: NOT_YET_RECRUITING
Study Type: OBSERVATIONAL
Conditions: Primary Immune Thrombocytopenia
Sponsor: Gruppo Italiano Malattie EMatologiche dell'Adulto
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 157
Study Design: Observational Model: |Time Perspective: p
Start Date: 2024-09
Completion Date: 2025-03

Summary:
Retrospective data collection on ITP patients who underwent splenectomy from 01/01/2010 to 12/31/2022. The expected enrollment period is 6 months. The observation period of the enrolled patients is at least 1 year.

Primary Outcome Measures: evaluation of complications' incidence after splenectomy, Determine the percentage and incidence of thrombotic, hemorrhagic and infectious complications occurring during the patient's follow-up, at 90 days
Fourth Ventricular Administration of Immune Checkpoint Inhibitor (Nivolumab) and Methotrexate or 5-Azacytidine for Recurrent Medulloblastoma, Ependymoma, and Other CNS Malignancies
NCT Number: NCT06466798
Status: RECRUITING
Study Type: INTERVENTIONAL
Phases: PHASE1
Conditions: Recurrent Ependymoma|Recurrent Medulloblastoma|CNS Malignancies
Interventions: DRUG: Nivolumab|DRUG: Methotrexate|DRUG: 5-Azacytidine
Sponsor: David Ilan Sandberg
Sex: ALL
Age: CHILD, ADULT, OLDER_ADULT
Enrollment: 10
Study Design: Allocation: NON_RANDOMIZED|Intervention Model: PARALLEL|Masking: NONE|Primary Purpose: TREATMENT
Start Date: 2024-07-15
Completion Date: 2027-07-01
Locations: The University of Texas Health Science Center at Houston, Houston, Texas, 77030, United States

Summary:
The goal of this clinical trial is to assess the safety, toxicity, and antitumor activity of fourth ventricular infusions of nivolumab plus 5-azacytidine for recurrent ependymoma and nivolumab plus methotrexate for recurrent medulloblastoma and other CNS malignancies.

Additionally, the study will explore immunologic responses to nivolumab.

The hypothesis is that local administration of nivolumab, an immune checkpoint inhibitor, is safe and will lead to even more robust treatment responses when administered following 5-azacytidine in patients with recurrent ependymoma or methotrexate in patients with medulloblastoma or other CNS tumors.

Primary Outcome Measures: Safety as assessed by the number of participants with a new neurological toxicity that is graded as Grade 3 or higher and that is probably or definitely related to infusions [that is, classified as dose-limiting toxicity (DLT)], Adverse events will be graded according to the NCI common terminology criteria version 5.0. Adverse events not included in the Common Terminology Criteria for Adverse Events (CTCAE) chart will be graded as follows:

* Grade 1: Mild: discomfort present with no disruption of daily activity, no treatment required beyond prophylaxis
* Grade 2: Moderate: discomfort present with some disruption of daily activity, require treatment.
* Grade 3: Severe: discomfort that interrupts normal daily activity, not responding to first line treatment.
* Grade 4: Life Threatening: discomfort that represents immediate risk of death., from start of treatment to end of treatment (about 12 weeks)
Secondary Outcome Measures: Number of participants who responded to therapy as determined by MRI imaging, baseline, within 7 days of completing final infusion (about 12 weeks)
A Phase 3 Study of Efepoetin Alfa for Treatment of Anemia in Patients With Chronic Kidney Disease on Dialysis
NCT Number: NCT06466785
Status: RECRUITING
Study Type: INTERVENTIONAL
Phases: PHASE3
Conditions: Anemia of Chronic Kidney Disease
Interventions: DRUG: Efepoetin Alfa|DRUG: Darbepoetin Alfa
Sponsor: Genexine, Inc.
Collaborators: PT Kalbe Genexine Biologics
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 429
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: SINGLE (INVESTIGATOR)|Primary Purpose: TREATMENT
Start Date: 2024-01-25
Completion Date: 2027-09
Locations: Batumi Dialysis and Nephrology Center, Batumi, Georgia|Clinical Center for Nephrology Development, Tbilisi, Georgia|L.Managadze National Center of Urology, Tbilisi, Georgia|Tbilisi Heart And Vascular Clinic, Tbilisi, Georgia|Korea University Ansan Hospital, Ansan, Korea, Republic of|St Mary's Incheon Hospital, Incheon, Korea, Republic of|Kangdong KyungHee University Hospital, Seoul, Korea, Republic of|St Mary's Seoul Hospital, Seoul, Korea, Republic of|St Mary's Yeouido Hospital, Seoul, Korea, Republic of

Summary:
An investigator-blinded, randomized, multicenter, active-controlled Phase III study for the treatment of anemia in patients with CKD on hemodialysis

Primary Outcome Measures: Mean change in hemoglobin (Hb), Mean change from Baseline in Hb averaged over Week 20 to Week 28 without the use of rescue therapy (i.e., transfusion, or any approved ESA for all patients) within 6 weeks prior to and during the 8-week evaluation period., Over Week 20 to Week 28