pankajmathur/National_Library_of_Medicine_Studies_data huggingface dataset:
Virtual Reality Exposure for Dental Fear
NCT Number: NCT06494176
Status: NOT_YET_RECRUITING
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Dental Fear
Interventions: BEHAVIORAL: neVR Fear the Dentist
Sponsor: New York University
Collaborators: Virtually Better, Inc.
Sex: ALL
Age: CHILD, ADULT, OLDER_ADULT
Enrollment: 250
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: NONE|Primary Purpose: TREATMENT
Start Date: 2024-08
Completion Date: 2026-12
Locations: New York University, New York, New York, 10010, United States

Summary:
The purpose of this study is to compare an intervention for dental fear to the usual approach (i.e., whatever your dentist typically does to help you manage fear) in reducing patient fear and making dentist appointments more tolerable. The dental fear intervention (called neVR Fear the Dentist™) has two separate steps. Step 1 involves using a mobile app that is based on research-backed approaches to handling dental fear on your smartphone or device. Step 2 is a 1-hour self-administered virtual reality intervention to be completed in the dental office.

This is a randomized study. Participants will be randomized to either the intervention group or an active control.

Investigators hypothesize that participants in the intervention condition will show greater declines in self-reported dental fear and improved oral health-related quality of life during post-treatment and follow-up period.

Primary Outcome Measures: Reduction in dental fear, Overall dental fear will be measured by the self-report Gatchel Dental Fear Item (Gatchel, 1987). This scale uses a one-item assessment of overall dental fear. Patients rate their dental fear on a scale of 0 = "None" to 10 = "High", with higher scores representing higher levels of fear., Measure will be collected at baseline, immediately post-treatment, and 1-, 3-, and 6-months post treatment.|Dental fear and anxiety, Dental fear and anxiety will also be measured using the Index of Dental Fear and Anxiety (IDAF; Armfield, 2010), an 8-item patient-report survey. Responses range from 1 = "Disagree" to 5 = "Strongly Agree." Total scores range from 5 to 40 with higher scores representing more dental anxiety/fear., Measure will be collected at baseline, immediately post-treatment, and 1-, 3-, and 6-months post treatment.|Anticipatory dental fear, Anticipatory dental fear will be measured via self-report using the Modified Dental Anxiety Scale (MDAS; Humphries et al., 1995), a 5-item scale. All items are rated on a 1-5 scale where 1 = "Not Anxious" and 5 = "Extremely Anxious," with total scores ranging from 5 to 25. Higher scores indicate higher dental anticipatory anxiety., Measure will be collected at baseline, immediately post-treatment, and 1-, 3-, and 6-months post treatment.
Nab-Sirolimus and Endocrine Therapy in Recurrent Low Grade Serous Ovarian Cancer (NARETO)
NCT Number: NCT06494150
Status: NOT_YET_RECRUITING
Study Type: INTERVENTIONAL
Phases: PHASE2
Conditions: Low Grade Ovarian Serous Adenocarcinoma
Interventions: DRUG: nab-Sirolimus|DRUG: Fulvestrant
Sponsor: University of Oklahoma
Collaborators: Aadi Bioscience, Inc.
Sex: FEMALE
Age: ADULT, OLDER_ADULT
Enrollment: 37
Study Design: Allocation: NA|Intervention Model: SINGLE_GROUP|Masking: NONE|Primary Purpose: TREATMENT
Start Date: 2024-08
Completion Date: 2029-09
Locations: OU Health Stephenson Cancer Center, Oklahoma City, Oklahoma, 73117, United States

Summary:
This single arm phase II study proposes to evaluate the efficacy and safety of nab-sirolimus + endocrine therapy (Fulvestrant) in patients with recurrent low grade serous ovarian cancer (LGSOC).

Primary Outcome Measures: The percentage of people in a treatment group who have a partial or complete response to the treatment within a certain period of time as measured by RECIST version 1.1., The primary analysis is preplanned to occur when the last patient enrolled has been treated for 6 months., 3 years|Incidence of patients with ≥ grade 3 adverse events., Review of adverse events that have occurred to determine the toxicity for the proposed treatment regimen., 3 years
Secondary Outcome Measures: Proportion of patients who have remained progression-free for 6-months., Proportion of patients on the proposed treatment combination who have not had any disease progression for at least 6 months., 3 years|Duration of response from a subjects first scan to disease progression or death., Determine the length of time from the date subjects have partial or complete response to treatment until the date the subjects have disease progression., Up to 3 years
Effect of Pre-dosing With Methylcellulose or Psyllium on Colonic Fermentation of Inulin
NCT Number: NCT06494137
Acronym: COCOA3
Status: NOT_YET_RECRUITING
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Irritable Bowel Syndrome
Interventions: OTHER: inulin
Sponsor: University of Nottingham
Collaborators: Quadram Institute Bioscience
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 35
Study Design: Allocation: RANDOMIZED|Intervention Model: CROSSOVER|Masking: TRIPLE (PARTICIPANT, INVESTIGATOR, OUTCOMES_ASSESSOR)|Primary Purpose: BASIC_SCIENCE
Start Date: 2024-10
Completion Date: 2025-03
Locations: Nottingham Digestive Disease Centre, Nottingham, Nottinghamshire, NG7 2UH, United Kingdom

Summary:
The aim for this pilot study is to test the hypothesis that pre-dosing with gel-forming dietary fibres (methylcellulose or psyllium) will alter the colonic fermentation of a model fermentable dietary fibre (Inulin) when delivered separately, in contrast to our previous trials where gel-forming and fermentable dietary fibres were co-administered. Performance of each gel-forming dietary fibre will be compared to placebo (water) to assess treatment effectiveness.

Primary Outcome Measures: Breath hydrogen AUC, Area under curve (AUC) from time 0-6 hours (AUC 0-6) of breath hydrogen (ppm.hour) after consumption of inulin intake., 0-6 hours
Secondary Outcome Measures: Breath hydrogen AUC, Area under curve (AUC) from time 0-24hours (AUC 0-24) of breath hydrogen (ppm.hour) after consumption of inulin intake., 0-24h|Whole gut transit, Time for blue colour to appear after ingesting muffin labelled with blue food colouring, 0-7days
Efficacy and Safety of tACS vs tDCS in Schizophrenia
NCT Number: NCT06494124
Status: RECRUITING
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Schizophrenia
Interventions: DEVICE: transcranial Alternating current stimulation (tACS)|DEVICE: transcranial Direct current stimulation (tDCS)|DEVICE: Sham controlled
Sponsor: All India Institute of Medical Sciences, Bhubaneswar
Collaborators: Indian Council of Medical Research
Sex: ALL
Age: ADULT
Enrollment: 90
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: DOUBLE (PARTICIPANT, OUTCOMES_ASSESSOR)|Primary Purpose: TREATMENT
Start Date: 2024-04-03
Completion Date: 2026-06
Locations: All India Institute of Medical Scinces - Bhubaneswar, Bhubaneswar, Odisha, 751019, India

Summary:
This clinical trial aims to compare the efficacy and safety of transcranial Alternating current stimulation (tACS) vs. transcranial Direct current stimulation (tDCS) vs. sham stimulation in chronic schizophrenia.

The main question it aims to answer is:

• In comparison to tDCS, can tACS improve the clinical outcome of patients with chronic schizophrenia?

Participants will be randomised into 3 groups receiving either tDCS, tACS or sham stimulation and changes in psychopathology and neuro-cognition with the interventions will be compared within and between the groups. The primary outcome measure is the Positive and Negative Syndrome Scale (PANSS), while secondary outcome measures are the Auditory Hallucination Rating Scale (AHRS), Brief Cognitive Assessment Tool for Schizophrenia (B-CATS), and Global Assessment of Functioning (GAF).

Primary Outcome Measures: Positive and Negative Syndrome Scale (PANSS), Measures psychopathology and illness severity in schizophrenia, Baseline, Day 5, Day 10
Secondary Outcome Measures: Auditory Hallucination Rating Scale (AHRS), Measures severity of auditory hallucinations in schizophrenia, Baseline, Day 5, Day 10|Brief Cognitive Assessment Tool for Schizophrenia (B-CATS), Measures neurocognitive deficits in schizophrenia, Baseline, Day 5, Day 10|Global Assessment of Functioning (GAF), Measures overall functioning of the patients with mental illness including schizophrenia, Baseline, Day 5, Day 10
Systemic Therapy of Open-label Prophylactic Pravastatin or Pentoxifylline/Tocopherol Prevention of Lymphedema Advancing to Eventual Fibrosis: an Interventional Registry-embedded Bayesian Randomized Trial for Radiation Sequelae (STOP4-LATE-FIBROSE)
NCT Number: NCT06494111
Status: NOT_YET_RECRUITING
Study Type: INTERVENTIONAL
Phases: PHASE2
Conditions: Lymphedema|Fibrosis
Interventions: DRUG: Pravastatin|DRUG: Pentoxifylline|DRUG: Tocopherol
Sponsor: M.D. Anderson Cancer Center
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 295
Study Design: Allocation: RANDOMIZED|Intervention Model: SINGLE_GROUP|Masking: NONE|Primary Purpose: TREATMENT
Start Date: 2024-11-29
Completion Date: 2031-03-01
Locations: MD Anderson Cancer Center, Houston, Texas, 77030, United States

Summary:
To learn if pentoxifylline and vitamin E or pravastatin can reduce radiation-induced lymphedema/fibrosis.

Primary Outcome Measures: Safety and adverse events (AEs), Incidence of Adverse Events, Graded According to National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) Version (v) 5.0, Through study completion; an average of 1 year.
Conventional Versus Modified Pre-surgical Naso-Alveolar Molding Treatment in Cleft Lip and Palate Infants
NCT Number: NCT06494098
Status: ACTIVE_NOT_RECRUITING
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Cleft Lip and/or Palate|Cleft Lip Bilateral
Interventions: PROCEDURE: Nasoalveolar Molding|DIAGNOSTIC_TEST: Addition silicone impression
Sponsor: Mansoura University
Sex: ALL
Age: CHILD
Enrollment: 20
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: DOUBLE (PARTICIPANT, OUTCOMES_ASSESSOR)|Primary Purpose: TREATMENT
Start Date: 2024-06-16
Completion Date: 2024-09-15
Locations: Mansoura University, Mansoura, Dakahliya, 35511, Egypt

Summary:
The aim of this study is to evaluate and compare clinically conventional Pre-surgical Naso-Alveolar Molding (PNAM) treatment versus Modified Naso-Alveolar Molding protocol (MPNAM) in cleft lip and palate patients in terms of:

1. Decreasing cleft gap.
2. Attaining columellar length.
3. Effect on maxillary growth.
4. Treatment Duration.
5. Parents acceptance.

Primary Outcome Measures: Attaining columellar length, 3 month
Secondary Outcome Measures: Treatment Duration, 3 month
Pressure Muscle Index and Threshold of Over-assistance During Pressure Support Ventilation
NCT Number: NCT06494085
Acronym: PUMA
Status: NOT_YET_RECRUITING
Study Type: OBSERVATIONAL
Conditions: Acute Hypoxemic Respiratory Failure
Interventions: OTHER: Measuring Respiratory Mechanics|OTHER: Randomized Pressure Support
Sponsor: Unity Health Toronto
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 20
Study Design: Observational Model: |Time Perspective: p
Start Date: 2024-08-30
Completion Date: 2025-02-28

Summary:
Pressure support ventilation (PSV) is used to assist the breathing of the intubated patient with some pressure from the ventilator. This support aims at avoiding excessive inspiratory effort, while ensuring a certain degree of training of the patient's inspiratory muscle. Avoiding both minimal and excessive assistance is thus important for the optimal care of the intubated patient ensuring a lung and diaphragm protective ventilation with the goal to liberate the patient from the ventilator as soon as possible.

Recently pressure-muscle-index (PMI), an index of inspiratory effort easy to be measured on the ventilator screen, has been proposed to avoid excessive assistance in PSV. This will be the first prospective study testing the effects of setting pressure support based on PMI to avoid excessive assistance on patients recovering from acute lung injury (acute hypoxemic respiratory failure).

Primary Outcome Measures: Inspiratory Occlusion, To investigate the role of the inspiratory occlusion as a diagnostic tool to understand the patient's desired tidal volume and minute ventilation in Pressure Support Ventilation (PSV),, 60 minutes|Pressure Muscle Index (PMI), To investigate the role of a PMI\>0 strategy to avoid over-assistance in Pressure Support Ventilation, 60 minutes
Secondary Outcome Measures: Pendelluft, To investigate the relationship between "active" and "passive" pendelluft measured over different levels of assistance in PSV., 60 minutes|Lung and Diaphragm Protective Ventilation, To measure indexes proposed by current literature to target a lung and diaphragm protective ventilation strategy with both inspiratory and expiratory occlusions in PSV, while applying a PMI\>0 strategy., 60 minutes
Short Versus Standard of Care Antibiotic Duration for Children Hospitalized for CAP
NCT Number: NCT06494072
Status: NOT_YET_RECRUITING
Study Type: INTERVENTIONAL
Phases: PHASE4
Conditions: Community Acquired Pneumonia in Children
Interventions: DRUG: Ampicillin for Injection|DRUG: Ceftriaxone for Injection|DRUG: Amoxicillin|DRUG: Ampicillin / Sulbactam Injection|DRUG: Amoxicillin-clavulanate|DRUG: Clindamycin|DRUG: Cefprozil|DRUG: Levofloxacin
Sponsor: Medical College of Wisconsin
Sex: ALL
Age: CHILD, ADULT
Enrollment: 236
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: NONE|Primary Purpose: TREATMENT
Start Date: 2024-07
Completion Date: 2027-05
Locations: Childrens Wisconsin, Milwaukee, Wisconsin, 53226, United States

Summary:
The goal of this open label, randomized, non-inferiority clinical trial is to compare the treatment success of a 5 day antibiotic course versus a standard antibiotic course (usually 7-14 days of antibiotics) in hospitalized children aged 3 months to 18 years, with uncomplicated community acquired pneumonia.

The main questions it aims to answer are:

* Does a 5 day course work as well as standard (longer) courses of antibiotics for treating community acquired pneumonia in children?
* Does a 5 day course cause less antibiotic side effects compared to a standard (longer) course of antibiotics in children with community acquired pneumonia?

Participants will

* be randomly assigned to either receive 5 total days or a total duration decided by the treating physician
* receive a brief follow up questionnaire regarding clinical symptoms, follow up care/antibiotics, and side effects via phone or email at days 5 and 14 from the start of antibiotics

Researchers will compare the experimental group (receiving 5 days duration) with the control group (standard duration) to see if 5 days is as successful as a standard duration.

Primary Outcome Measures: Treatment failure rate, Treatment failure is defined as the clinical need for additional antibiotic treatment, an emergency department (ED) visit, or readmission to the hospital for a suspected lower respiratory tract infection within 14 days of treatment initiation., 14 days from the first dose antibiotics
Secondary Outcome Measures: Adverse drug event rate, Adverse drug events include allergic reactions, skin rash, abdominal symptoms (such as vomiting, stomach pain, or diarrhea), or other plausible associated complaints described by the parent(s)/guardian., 14 days from the first dose antibiotics
A Novel Repetitive Synchronized Associative Stimulation Neuromodulation Approach for Spinal Cord Injury Patients
NCT Number: NCT06494059
Status: NOT_YET_RECRUITING
Study Type: INTERVENTIONAL
Phases: NA
Conditions: SCI - Spinal Cord Injury
Interventions: OTHER: Intermittent theta burst stimulation (iTBS)|OTHER: Functional electrical stimulation (FES)|OTHER: Transcutaneous spinal cord stimulation (TSCS)|OTHER: Sham Intermittent theta burst stimulation (iTBS)
Sponsor: University of Miami
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 25
Study Design: Allocation: NON_RANDOMIZED|Intervention Model: PARALLEL|Masking: NONE|Primary Purpose: BASIC_SCIENCE
Start Date: 2024-10-01
Completion Date: 2026-12-30
Locations: University of Miami, Miami, Florida, 33136, United States

Summary:
The purpose of this research is to explore the effect of magnetic stimulation to activate the brain, electrical spinal cord stimulation to activate spinal cord, and electrical muscle stimulation used to activate upper limb (arms), lower limb (legs) and trunk (stomach) muscles in people with spinal cord injury (SCI) and able-bodied subjects (without SCI).

Primary Outcome Measures: Change in nine-hole peg test, The Nine-Hole Peg Test assesses hand and finger dexterity. It is administered by asking the subject to take the pegs from a container, one by one, and place them into holes on the board as quickly as possible. Participants must then remove the pegs from the holes, one by one, and replace them back into the container. Scores are based on the time taken to complete the activity, recorded in seconds., baseline, up to 2 months|Change in foot tapping test (FTT), FTT assesses motor neuron function and mobility. Participants are seated with the foot on the floor and are asked to tap their foot on the ground as rapidly as possible for 10 seconds while keeping the heel on the ground. The number of taps are counted during the 10 seconds., baseline, up to 2 months|Change in Function in Sitting Test for people with SCI (FIST-SCI), FIST-SCI is a clinical test that will be used to test seated balance. FIST-SCI consists of 14 functional, everyday activities as test items. The items are scored on a 5 point ordinal scale ranging from 0 to 4, with 0 representing the lowest ability and 4 representing normal ability., baseline, up to 2 months|Change in Motor Evoked Potential (MEP), MEP evaluates corticospinal excitability (strength of the connections between the brain and the muscles). The excitability is measured as a peak-to-peak amplitude in millivolts (mV)., baseline, up to 2 months
Defining Musical Toxicity and Its Effect on Patient Well-being
NCT Number: NCT06494046
Status: NOT_YET_RECRUITING
Study Type: OBSERVATIONAL
Conditions: Breast Carcinoma|Esophageal Carcinoma|Head and Neck Carcinoma|Lung Carcinoma|Malignant Brain Neoplasm|Malignant Solid Neoplasm
Interventions: OTHER: Non-Interventional Study
Sponsor: Mayo Clinic
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 64
Study Design: Observational Model: |Time Perspective: p
Start Date: 2024-08-01
Completion Date: 2025-09-30
Locations: Mayo Clinic in Rochester, Rochester, Minnesota, 55905, United States

Summary:
This study evaluates the experience of musicians who are going through cancer treatment.

Primary Outcome Measures: Describe specific musical difficulties that arise during and after cancer treatments - MTQ 10-item, Assessed using the Musical Toxicity Questionnaire (MTQ 10-item), a survey with yes/no and open-ended questions (e.g., What musical instrument do you play, or do you sing?). The survey is designed to capture the participant's thoughts and feelings on how cancer treatments (before and after) has affected enjoyment and ability to play, teach, or perform music. The questionnaire will take about 15-30 minutes to complete. Qualitative analysis software will be utilized to code responses and organize themes. Themes will be organized into related groups and interpreted to generate conclusions., Baseline
Prophylaxis Guided by Cytomegalovirus-specific T Cell Immunity to Prevent Cytomegalovirus Disease in Lung Transplant Recipients
NCT Number: NCT06494033
Status: NOT_YET_RECRUITING
Study Type: OBSERVATIONAL
Conditions: Lung Diseases
Sponsor: University of Miami
Collaborators: Eurofins Viracor, LLC
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 100
Study Design: Observational Model: |Time Perspective: p
Start Date: 2024-09-01
Completion Date: 2026-06-30
Locations: University of Miami, Miami, Florida, 33136, United States

Summary:
The purpose of this study is to evaluate the clinical outcomes of Cytomegalovirus (CMV) virus in the participants' body. Therefore, the study team will follow the participants' immunological response based on the Cytomegalovirus (CMV) virus testing.

Primary Outcome Measures: Positive CMV Immunoglobulin (IgG) positive lung transplant, Positive CMV Immunoglobulin (IgG) measured by IU/ml, Up to 1 year
Secondary Outcome Measures: Graft Outcome status, Graft Outcome status measured by number of rejection based on forced expiratory volume in 1 second( FEV1) /Forced vital capacity (FVC) ratio. A calculated ratio that helps diagnose obstructive and restrictive lung diseases, Up to 1 year|Number of dead participants, Number of dead participants measured by numbers of death, Up to 1 year|Duration of CMV medication, Duration of CMV medication measured by treatment days, Up to 1 year|Number of patients with CMV-positive results, CMV disease measured by the number of patients with CMV-positive results, Up to 1 year|Severity of CMV Disease, Severity of CMV disease measured by CMV polymerase chain reaction (PCR) (IU/mL), Up to 1 year
Task Practice and Spinal Cord Stimulation
NCT Number: NCT06494020
Status: NOT_YET_RECRUITING
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Spinal Cord Injury Cervical|Spastic
Interventions: OTHER: Task Practice combined with Transcutaneous Spinal Cord Stimulation( TcSCS)
Sponsor: University of Miami
Collaborators: ONWARD Medical, Inc.
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 6
Study Design: Allocation: NA|Intervention Model: SINGLE_GROUP|Masking: NONE|Primary Purpose: OTHER
Start Date: 2024-10-01
Completion Date: 2027-10-01
Locations: University of Miami - Christine E. Lynn Rehabilitation Center, Miami, Florida, 33136, United States|University of Miami, Miller School of Medicine, The Miami Project To Cure Paralysis, Miami, Florida, 33136, United States

Summary:
The goal of this study is to understand the effects of combined task practice with transcutaneous cervical spinal cord stimulation. The study will explore the effect of higher stimulation frequencies on spasticity. Transcutaneous stimulation has been shown to improve motor function in some individuals with chronic spinal cord injury. The study intends to explore scientifically the association between higher stimulation frequencies and spasticity/hypertonicity.

Primary Outcome Measures: Change in motor performance as measured by The Graded Refined Assessment of Strength, Sensibility, and Prehension (GRASSP) test, GRASSP is a multimodal test that measures sensorimotor and prehension function in three domains that are important for the description of arm and hand functions, namely strength, sensation and prehension strength. It is an ordinal scale (minimum value = 0, maximum value = 100) with higher scores indicating better performance.

There is a sensation category ordinal scale (minimum value = 0 maximum value = 24) that measures sensation where higher scores indicate greater sensation.

The Prehension performance category has an ordinal scale (minimum value = 0 maximum value = 40) that measures prehension where higher scores indicate greater ability., baseline, up to 6 months
Secondary Outcome Measures: Change in Spasticity as measured by Modified Ashworth Scale (MAS), 6 category ordinal scale (minimum value = 0 maximum value = 4) that measures spasticity where higher scores indicate greater spasticity., baseline, up to 6 months
Role of IV Calcium to Prevent Diltiazem-related Hypotension
NCT Number: NCT06494007
Acronym: AFstd
Status: COMPLETED
Study Type: INTERVENTIONAL
Phases: PHASE4
Conditions: Atrial Fibrillation|Rapid Ventricular Response|Hypotension Drug-Induced
Interventions: DRUG: Sodium chloride|DRUG: 90 mg of calcium|DRUG: 180 mg Calcium
Sponsor: Haseki Training and Research Hospital
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 217
Study Design: Allocation: RANDOMIZED|Intervention Model: CROSSOVER|Masking: TRIPLE (PARTICIPANT, INVESTIGATOR, OUTCOMES_ASSESSOR)|Primary Purpose: PREVENTION
Start Date: 2023-01-01
Completion Date: 2024-07-01
Locations: Haseki Training and Research Hospital, Istanbul, Fatih, 34265, Turkey

Summary:
The objective of this study is to examine the efficacy and safety of IV calcium pretreatment at varying doses prior to weight-adjusted IV Diltiazem on the incidence of Diltiazem-related hypotension in adult patients presenting to the Emergency Department due to Atrial Fibrillation with Rapid Ventricular Response. Specifically, we tested the hypothesis that patients with Atrial Fibrillation who receive IV calcium pretreatment prior to IV Diltiazem suffer less hypotension than those receiving Diltiazem monotherapy.

Primary Outcome Measures: Change in Systolic blood pressure before and after treatment, We investigated the change in systolic blood pressure at 5, 10, and 15 minutes following the initial IV diltiazem administration comparatively among treatment groups., 5, 10, and 15 minutes following the initial administration.
Secondary Outcome Measures: Change in Heart Rate before and after treatment, We also investigated the change in Heart rate values at 5, 10, and 15 minutes following the initial IV diltiazem administration comparatively among treatment groups., 5, 10, and 15 minutes following the initial administration
Other Outcome Measures: Assessing the treatment-related complications, We also evaluated treatment-related adverse effects, hypotension, and hypercalcemia., 2 hours following the initial administration
Myval OCTACOR TransAXillary Transcatheter Aortic Valve Replacement Multicenter Clinical Registry
NCT Number: NCT06493994
Acronym: OCTACOR
Status: NOT_YET_RECRUITING
Study Type: OBSERVATIONAL
Conditions: Aortic Valve Stenosis
Interventions: OTHER: transaxillary (TAX) transcatheter aortic valve replacement
Sponsor: University of Luebeck
Collaborators: University Hopsital Schleswig Holstein Campus Lübeck
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 100
Study Design: Observational Model: |Time Perspective: p
Start Date: 2024-09-01
Completion Date: 2027-10-01
Locations: Universität zu Lübeck, Lübeck, Schleswig-Holstein, 23538, Germany

Summary:
Study goal is to determine the feasibility, procedural success, safety and potential benefit of the Myval Octacor transcatheter heart valve (THV) in patients undergone transaxillary (TAX) transcatheter aortic valve replacement (TAVR).

Primary Outcome Measures: Time until first occurrence, * Stroke including ischemic or hemorrhagic stroke,
* Systemic embolism,
* Major bleeding (BARC type 3-5), or Cardiovascular or unexplained death, 30 Days
Outcomes in Bone Marrow Aplasia.
NCT Number: NCT06493981
Status: NOT_YET_RECRUITING
Study Type: INTERVENTIONAL
Phases: PHASE3
Conditions: Aplastic Anemia Idiopathic
Interventions: DRUG: Eltrombopag
Sponsor: Assiut University
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 3
Study Design: Allocation: NA|Intervention Model: SINGLE_GROUP|Masking: NONE|Primary Purpose: TREATMENT
Start Date: 2024-07
Completion Date: 2030-07

Summary:
Bone marrow aplasia, also known as aplastic anemia (AA) is a potentially fatal bone marrow failure syndrome characterized by a paucity of hematopoietic stem cells (HSCs) and progenitor cells with varying degrees of cytopenia and fatty infiltration of the bone marrow space. Underlying mechanisms include immune-mediated attack, telomere defects, and inherent HSC compartment insufficiency. These events may occur individually or in concert, mostly involving effector T cells Historical treatment has included the use of high-dose chemotherapy and allogeneic stem cell transplantation as well as lymphotoxic immunosuppressive therapy (IST) Thrombopoietin (TPO) regulates platelet production, maturation, and release through binding of c-mpl on megakaryocytes.

Primary Outcome Measures: Determine hematological response after 6 months, Change in CBC elements after 6 months of treatment, 6 months to 5 years|Determine overall survival rate., Number if years estimated to survive after treatment, 5 years
Secondary Outcome Measures: Rate of relapse in patients deemed responsers at 6 months., Around 1 year|Clonal evolution to myeloid malignancy or new chromosomal abnormality, Around 2 years|Change in serum iron and ferritin over time of treatment, From 6 months to 5 years|Eltrombopag efficacy in increasing platelet count, After6 months|Adverse effects raelated to treatment, Within 2 years
Role of Uterotonics in Reducing Intraoperative Blood Loss in Patients With PASD Undergoing Cesarean Hysterectomy
NCT Number: NCT06493968
Status: RECRUITING
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Placenta Accreta Spectrum
Interventions: DRUG: oxytocin|OTHER: placebo
Sponsor: Cairo University
Sex: FEMALE
Age: ADULT
Enrollment: 70
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: TRIPLE (PARTICIPANT, INVESTIGATOR, OUTCOMES_ASSESSOR)|Primary Purpose: PREVENTION
Start Date: 2024-07-01
Completion Date: 2024-12-31
Locations: Cairo University, Cairo, Egypt

Summary:
Objectives: To evaluate the effect of oxytocin in reducing intraoperative blood loss in patients with PAS disorders planned for cesarean hysterectomy.

Primary Outcome Measures: Intraoperative blood loss, amount of intraoperative blood loss in patients with PAS disorders undergoing cesarean hysterectomy, during operation
Secondary Outcome Measures: operative time, during operation
Clinical Efficiency of Bioactive Pit and Fissure Sealant
NCT Number: NCT06493942
Status: NOT_YET_RECRUITING
Study Type: INTERVENTIONAL
Phases: PHASE2
Conditions: Pit and Fissure Sealant
Interventions: OTHER: BioCoat® by Premier®|OTHER: UltraSeal XT™ plus by Ultradent
Sponsor: Cairo University
Sex: ALL
Age: CHILD
Enrollment: 40
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: TRIPLE (PARTICIPANT, INVESTIGATOR, OUTCOMES_ASSESSOR)|Primary Purpose: PREVENTION
Start Date: 2024-08-01
Completion Date: 2025-09-30

Summary:
This study will compare the performance of newly introduced bioactive resin based pits and fissure sealant versus fluoride releasing filled resin based pits and fissure sealant in posterior molars prone to carious lesions of fissures in patients at risk of caries. Visual tactile examination and VistaCAM will be used for evaluation.

Primary Outcome Measures: Retention of sealant, rate of sealant loss, 1 year
Secondary Outcome Measures: Caries incidence, Rate of caries progression, 1 year
Mechanical Power as a Predictor for Weaning in Chronic Obstructive Pulmonary Disease Patients :Prospective Cohort Study.
NCT Number: NCT06493929
Status: NOT_YET_RECRUITING
Study Type: OBSERVATIONAL
Conditions: Mechanical Power
Interventions: OTHER: Chest ultrasound|OTHER: Calculation of Mechanical Power on the first day of intubation and before First trial of weaning:
Sponsor: Assiut University
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 84
Study Design: Observational Model: |Time Perspective: p
Start Date: 2024-08-01
Completion Date: 2026-08-01
Locations: Assiut University, Assiut, Egypt

Summary:
The primary objective is to evaluate the mechanical power as a predictor of weaning of mechanical ventilation in COPD patients hospitalized in the respiratory intensive care unit of Assiut University Hospital The secondary objective is to compare between mechanical power and diaphragmatic excursion (DE) assessed by ultrasound as a predictor of weaning in these patients. Also, to investigate the association between MP and DE and mortality in these patients

Primary Outcome Measures: 1. Evaluation the efficacy of MP as a predictor of weaning for COPD patients., Evaluation the efficacy of MP as a predictor of weaning for COPD patients., 2 years
Secondary Outcome Measures: 1-MP as a predictor of patient's mortality., MP as a predictor of patient's mortality., 2 years|2-MP and duration of hospital stay and ICU stay., MP and duration of hospital stay and ICU stay., 2 years|3-MP and ventilator induced lung injury., THE ASSOCIATION BETWEEN VALUE OF MP and ventilator induced lung injury., 2 years|4-Correlation analysis between mechanical power and other parameters of weaning: Respiratory rate, Rapid shallow breathing index, Heart Rate and Expiratory Tidal volume in evaluation of prognosis in COPD patients., Correlation analysis between mechanical power and other parameters of weaning: Respiratory rate, Rapid shallow breathing index, Heart Rate and Expiratory Tidal volume in evaluation of prognosis in COPD patients., 2 years
Measurement of Endotracheal Tube Cuff
NCT Number: NCT06493916
Status: ACTIVE_NOT_RECRUITING
Study Type: OBSERVATIONAL
Conditions: Endotracheal Tube Cuff Pressure Levels in Practice
Sponsor: Bozok University
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 37
Study Design: Observational Model: |Time Perspective: p
Start Date: 2024-06-03
Completion Date: 2024-10-03
Locations: Yozgat Bozok Üniversitesi Araştırma ve Uygulama Hastanesi, Yozgat, Merkez/Yozgat, 66100, Turkey

Summary:
The purpose of this study is to evaluate whether the endotracheal intubation practitioners accordance to the literature knowledge of cuff pressure limits.

Primary Outcome Measures: Endotracheal tube cuff pressure measurements, 3 months
Validation of the Dutch Translation of the Prosthesis Evaluation Questionnaire
NCT Number: NCT06493890
Status: RECRUITING
Study Type: OBSERVATIONAL
Conditions: Validation Studies
Interventions: OTHER: Validation PEQ-DLV
Sponsor: University Medical Center Groningen
Collaborators: Stichting Beatrixoord Noord-Nederland
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 84
Study Design: Observational Model: |Time Perspective: p
Start Date: 2022-11-01
Completion Date: 2025-12-31
Locations: University Medical Centre Groningen, Groningen, 9713GZ, Netherlands

Summary:
The aim of our research is to be able to use the questionnaire 'Prosthesis Evaluation Questionnaire' (PEQ) in Dutch. The PEQ is a validated and reliable questionnaire for research into the quality of life in adults with a lower limb prosthesis. The research consists of two phases. The first phase is the translation of the PEQ and the second phase is the validation of this questionnaire. To validate the questionnaire, we want to include 84 participants who have to complete questionnaires three times within a period of three months.

Primary Outcome Measures: Reliable and validated Dutch version of the PEC, Cultural adaptation and validation of the Dutch translation of the Prosthesis Evaluation Questionnaire, T0: Baseline; T1: two weeks; T2: three months
Clinical Efficacy of Prophylactic Intravenous Neostigmine and Atropine in Preventing Post-Dural Puncture Headache Among Parturient Undergoing Spinal Anesthesia for Cesarean Section: A Double-blind Randomized Placebo-controlled Trial
NCT Number: NCT06493838
Status: NOT_YET_RECRUITING
Study Type: INTERVENTIONAL
Phases: PHASE4
Conditions: Acute Pain
Interventions: DRUG: intravenous 50 mL of saline injection of 0.9% after umbilical cord clamping.|DRUG: Neostigmine 20μg/kg (Neostigmine Methylsulphate 0.5 mg, Amriya Pharm.Ind.) and atropine 0.01 mg/kg (diluted in 50 ml saline; 0.9% for 10 min) following umbilical cord clamping.
Sponsor: Minia University
Sex: FEMALE
Age: ADULT
Enrollment: 180
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: DOUBLE (PARTICIPANT, OUTCOMES_ASSESSOR)|Primary Purpose: PREVENTION
Start Date: 2024-07-15
Completion Date: 2025-01-16

Summary:
Post dural puncture headache is a distressing issue, many measures tried to treat symptoms but few delt with prevention.

Primary Outcome Measures: Incidence of patients with post dural puncture headache, Number of patients develop post dural puncture headache, first 5 days post-partum
Secondary Outcome Measures: Severity of post dural puncture headache, Visual analogue scale score for pain assessment. from 0 to ten. 0= no pain 1-3= mild pain....4-6= moderate pain ... 7-10= severe pain, first 5 days post-partum|onset and duration of post dural puncture headache, Time when visual analogue scale score increase and duration until return to 0. Visual analogue scale score for pain assessment. from 0 to ten. 0= no pain 1-3= mild pain....4-6= moderate pain ... 7-10= severe pain, 5 days post partum|Analgesic request, First time to analgesic request from block, 24 hours after operation|Analgesc requirements, Total analgesic requirements, 2 days after operation|frequency of analgesic doses, number of analgesic doses given to the patient, 5 days|incidence of complications related to the procedure, number of patients with adverse events as bradycardia, tachcardia, miosis,muscle cramps, twitches, colics, hypotension, 6 hours after procedure
Identification of Olfactory Biomarkers of Skin Cancer From Skin Odor Samples: a Pilot Study
NCT Number: NCT06493786
Acronym: SCENT-SKIN-001
Status: NOT_YET_RECRUITING
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Identify Volatile Biomarkers Specific to Malignant Melanoma, Basal Cell Carcinoma and Squamous Cell Carcinoma|Verify That the Volatile Biomarkers Identified Derive From Metabolic Changes in Body Odour and Not Just From Changes in the Surface of Cancerous Lesions
Interventions: OTHER: Collection of body odor samples
Sponsor: Association pour la Recherche Clinique et Immunologique
Collaborators: SenseBioTek Health-Care|ESPCI Paris
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 120
Study Design: Allocation: NA|Intervention Model: PARALLEL|Masking: NONE|Primary Purpose: OTHER
Start Date: 2024-07-25
Completion Date: 2025-07-31

Summary:
The aim of this research is to determine which volatile organic compounds (odors) are associated with different skin cancers.

To this end, odor samples will be taken from various parts of the body, from patients with skin cancers and from "healthy" subjects who have no skin cancer.

The various samples collected will be analyzed in the laboratory, and compared with each other, to determine whether there is a specific "smell" for the main types of skin cancer.

Primary Outcome Measures: Comparison of chromatographic profiles of skin VOCs, For each group of patients (MM, CBC\*, CE), the chromatographic profiles of cutaneous VOCs (nature of molecules and content) will be described and compared as follows:

healthy areas (excluding contralateral areas) versus healthy areas of matched healthy subjects, by area and overall.

\* For the BCC group, the same analyses will be performed for the 3 BCC categories: superficial BCC, nodular BCC, infiltrating BCC., 12 months
A Phase 2 Study of SSGJ-707 in Metastatic Colorectal Cancer Patients
NCT Number: NCT06493760
Status: NOT_YET_RECRUITING
Study Type: INTERVENTIONAL
Phases: PHASE2
Conditions: Metastatic Colorectal Cancer
Interventions: DRUG: SSGJ-707|DRUG: Bevacizumab|DRUG: Oxaliplatin|DRUG: Capecitabine|DRUG: Calcium Folinate|DRUG: 5-fluorouracil
Sponsor: Sunshine Guojian Pharmaceutical (Shanghai) Co., Ltd.
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 130
Study Design: Allocation: NON_RANDOMIZED|Intervention Model: SINGLE_GROUP|Masking: NONE|Primary Purpose: TREATMENT
Start Date: 2024-08
Completion Date: 2027-06
Locations: Liu Tianshu, Shanghai, Shanghai, China

Summary:
This study includes two parts:Part 1: SSGJ-707 (different dosing regimens) in combination with chemotherapy for first-line treatment of metastatic colorectal cancer.Part 2: SSGJ-707 in combination with chemotherapy versus bevacizumab in combination with chemotherapy for first-line treatment of metastatic colorectal cancer.

Primary Outcome Measures: ORR, Objective response rate, 12 months|Safety and tolerability, Safety and tolerability assessed by incidence and severity of adverse events, 12 months
Secondary Outcome Measures: PFS, The efficacy end points, 24 months
Stereotactic Body Radiation Therapy After Chemotherapy for Unresectable Perihilar Cholangiocarcinoma
NCT Number: NCT06493734
Acronym: STRONG II
Status: RECRUITING
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Klatskin Tumor
Interventions: RADIATION: Stereotactic body radiation therapy
Sponsor: Erasmus Medical Center
Collaborators: Dutch Cancer Society
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 30
Study Design: Allocation: NA|Intervention Model: SINGLE_GROUP|Masking: NONE|Primary Purpose: TREATMENT
Start Date: 2024-07-01
Completion Date: 2028-03-01
Locations: Antwerp University Hospital / Sint-Augustinus Gasthuiszusters, Wilrijk, Antwerp, 2610, Belgium|University Hospital Brussels / Jules Bordet Institute, Brussels, Brussels-capital, 1070, Belgium|Radboud University Medical Center, Nijmegen, Gelderland, 6525 GA, Netherlands|Maastricht University Medical Center+ / Maastro Clinic Maastricht, Maastricht, Limburg, 6229 ET, Netherlands|Amsterdam University Medical Center, Amsterdam, Noord-Holland, 1081 HV, Netherlands|Erasmus MC, Rotterdam, Zuid-Holland, 3015 CD, Netherlands|University Medical Center Groningen, Groningen, 9713 GZ, Netherlands|University Medical Center Utrecht, Utrecht, 3584 CX, Netherlands

Summary:
The objective of this study is to evaluate the efficacy of stereotactic body radiation therapy (SBRT) as additional treatment after standard chemotherapy regarding tumor local control, toxicity, progression-free survival (PFS), overall survival and quality of life. In addition, the objective is to explore the value of immunodynamics in peripheral blood for predicting PFS in patients undergoing chemotherapy.

Primary Outcome Measures: Local tumor control, Local tumor control is defined as time from inclusion to local radiological progression. Definition of progression is based on response evaluation criteria in solid tumors (RECIST) 1.1. In RECIST 1.1, response of a tumor to treatment is defined as either complete response (CR), partial response (PR), stable disease (SD), or progressive disease (PD)., 42 months (maximum follow-up time)
Secondary Outcome Measures: Progression-free survival (PFS), PFS is defined as time from inclusion until radiological progression. Definition of progression is based on RECIST 1.1., 42 months (maximum follow-up time)|Overall survival (OS), OS is defined as time from inclusion until death from any cause., 42 months (maximum follow-up time)|Adverse events, Adverse events assessed by the Common Toxicity Criteria for Adverse Events (CTCAE) V.5.0, 42 months (maximum follow-up time)|Quality of life (QoL) - EQ-5D-5L, Assessed by means of the EuroQol (EQ)-5D-5L (measure of health outcome in general population)., 36 months|Quality of life (QoL) - QLQ-C30, Assessed by means of the European Organisation for Research and Treatment of Cancer (EORTC) QLQ-C30 (QoL specific for patients with cancer)., 36 months|Quality of life (QoL) - QLQ-BIL21, Assessed by means of the supplementary module EORTC QLQ-BIL21 (specific for CCA and gallbladder cancer)., 36 months
Clear Aligner Treatment With and Without Low Level Laser Therapy for Upper Incisor Crowding
NCT Number: NCT06493721
Status: COMPLETED
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Crowding of Anterior Maxillary Teeth
Interventions: PROCEDURE: Clear Aligner Treatment|PROCEDURE: Low level laser
Sponsor: Faculty of Dental Medicine for Girls
Sex: ALL
Age: CHILD, ADULT
Enrollment: 22
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: SINGLE (PARTICIPANT)|Primary Purpose: TREATMENT
Start Date: 2022-12-15
Completion Date: 2024-06-28
Locations: Faculty of Dental Medicine for Girls Al-Azhar University, Cairo, 11787, Egypt

Summary:
The goal of this clinical trial is to assess the effect of Low Level Laser Therapy (LLLT) on Upper Incisor Crowding using Clear Aligner Treatment (CAT).

Primary Outcome Measures: Rate of tooth movement, Calculate rate of anterior incisor decrowding using digital measurement in millimetre, Initial alignment at the end of 3rd month during treatment planning of clear aligner
Secondary Outcome Measures: Pain level, Will Low Level Laser Therapy decrease pain levels during clear aligner treatment. Evaluated using Numerical Rating Scale, Initial alignment at the end of 3rd month phase during treatment planning of clear aligner
The Effect of Motivational Interviewing in Women's Health
NCT Number: NCT06493682
Status: NOT_YET_RECRUITING
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Procrastination|Health Behavior|Cancer
Interventions: BEHAVIORAL: Experimental (Motivational Interviews)
Sponsor: Amasya University
Sex: FEMALE
Age: ADULT, OLDER_ADULT
Enrollment: 104
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: NONE|Primary Purpose: SUPPORTIVE_CARE
Start Date: 2024-10-01
Completion Date: 2025-05-31

Summary:
The behaviour of healthcare demand procrastination constitutes an obstacle for individuals to lead a healthy life, and an example of this is the low participation rate of women in pap-smear screening programs compared to the target population. It is known that motivational interviews are frequently used and effective in studies planned to change health behavior. According to the results of the power analysis, at least 104 women, 52 experimental and 52 control, should be included in the study. Data will be collected with the "Personal Information Form", "Healthcare Demand Procrastination Scale", "Health Belief Model Scale for Cervical Cancer and Pap Smear Test" and "Evaluation Form for Cervical Cancer Screening Participation". Motivational interviews will be given to the women in the experimental group.

Primary Outcome Measures: Healthcare Demand Procrastination Scale, The minimum score that can be obtained from the scale is "11", the maximum score is "55", and as the score obtained from the scale increases, behaviour of healthcare demand procrastination also increase., At the end of the 4 weeks|Health Belief Model Scale for Cervical Cancer and Pap Smear Test, The scale consists of 35 items and 5 sub-dimensions. Each sub-dimension in the scale is scored separately. A high mean score is evaluated positively, except for the 'pap smear barriers' sub-dimension. A high 'pap smear barriers' score indicates that there are problems with having a pap smear., At the end of the 4 weeks|Cervical Cancer Screening Participation, Developed by the researcher. It is a two-question form that aims to evaluate women's cervical cancer screening behaviors in the last 6 months and the effectiveness of motivational interviewing on these behaviors., At the end of the 6 months
Study on the Correlation Between Treg Immune Cells on the Muscle Content and Cognitive Functions of the Elderly
NCT Number: NCT06493669
Status: RECRUITING
Study Type: OBSERVATIONAL
Conditions: Cognitive Disorder Patients and Cognitive Assessment
Interventions: DIAGNOSTIC_TEST: Cognitive assessment
Sponsor: Fifth Affiliated Hospital, Sun Yat-Sen University
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 100
Study Design: Observational Model: |Time Perspective: p
Start Date: 2023-05-01
Completion Date: 2024-12-31
Locations: The Fifth Affiliated Hospital of Sun Yat-sen University, Zhuhai, Guangdong, 519000, China

Summary:
In order to explore the impact of the level of the elderly Treg immune cells and the effects of different fat distribution and muscle content, the impact of the level of Treg immune cells on cognitive functions is explored. The correlation between visceral fat content, subcutaneous fat content and cognitive function.

Primary Outcome Measures: Cognitive function decline, MoCA score \<26, through study completion, an average of 1 year