pankajmathur/National_Library_of_Medicine_Studies_data huggingface dataset:
A Study to Evaluate the Pharmacodynamics and Safety of ARCT-810 in Participants With OTCD
NCT Number: NCT06488313
Status: RECRUITING
Study Type: INTERVENTIONAL
Phases: PHASE2
Conditions: OTC Deficiency|Ornithine Transcarbamylase Deficiency|OTCD
Interventions: BIOLOGICAL: ARCT-810
Sponsor: Arcturus Therapeutics, Inc.
Sex: ALL
Age: CHILD, ADULT, OLDER_ADULT
Enrollment: 9
Study Design: Allocation: NA|Intervention Model: SEQUENTIAL|Masking: NONE|Primary Purpose: TREATMENT
Start Date: 2024-06-10
Completion Date: 2026-09-01
Locations: Uncommon Cures, Chevy Chase, Maryland, 20815, United States

Summary:
Evaluate the safety and pharmacodynamics of multiple doses of ARCT-810 in adolescent and adult participants with OTC deficiency.

Primary Outcome Measures: Incidence, severity and dose-relationship of adverse events (AEs), Safety and tolerability of ARCT-810 assessed by incidence, severity, and dose-relationship of AEs, Day 85
Secondary Outcome Measures: Stable isotope ureagenesis assay values (AUC of first isotope), Change from Baseline in stable isotope ureagenesis assay values (AUC of first isotope) following multiple doses of ARCT-810, Up to Day 85|Stable isotope ureagenesis assay values (AUC of second isotope), Change from Baseline in stable isotope ureagenesis assay values (AUC of second isotope) following mulitple doses of ARCT-810, Up to Day 85|Fasting plasma ammonia, Proportion of participants maintaining normal morning fasting plasma ammonia, Up to Day 85|Plasma Glutamine, Change from Baseline in plasma glutamine and labeled glutamine as available, Up to Day 85|Plasma pharmacokinetics, The noncompartmental plasma pharmacokinetics of ARCT-810 will be assessed based on the observed plasma concentration of ARCT-810 mRNA and lipid, Up to Day 57
Long Term Follow-Up for Safety of AVR-RD-02
NCT Number: NCT06488261
Status: ACTIVE_NOT_RECRUITING
Study Type: OBSERVATIONAL
Conditions: Gaucher Disease
Interventions: BIOLOGICAL: AVR-RD-02
Sponsor: John Bernat
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 2
Study Design: Observational Model: |Time Perspective: p
Start Date: 2024-02-21
Completion Date: 2037-10
Locations: University of Iowa Hospitals and Clinics, Iowa City, Iowa, 52242, United States

Summary:
The goal of this observational study is to assess the safety and tolerability of AVR-RD-02 treatment in subjects who previously received AVR-RD-02 treatment (single dose administration).

Primary Outcome Measures: Incidence of newly diagnosed malignancy, hematologic disorder, and/or autoimmune or rheumatologic disorder, Baseline to Year 14|Change from baseline over time in hemoglobin concentration, Baseline to Year 14|Chane from baseline over time in platelet count, Baseline to Year 14
Secondary Outcome Measures: Change from baseline over time in glucocerebrosidase (GCase) enzyme activity in whole blood, Baseline to Year 14|Average vector copy number (VCN) from whole blood using quantitative polymerase chain reaction (qPCR) analysis, Baseline to Year 14|Change from baseline over time in anti-GCase total antibodies and subsequent titers, Baseline to Year 14|Identification of potential aberrant clonal expansion(s) assessed by performing insertional site analysis (ISA) from whole blood, Baseline to Year 14|Presence of replication competent lentivirus (RCL), Baseline to Year 14
Qualitative Evaluation of Pediatric Obesity Therapeutic Education Programs
NCT Number: NCT06488235
Acronym: QUALIPOP
Status: NOT_YET_RECRUITING
Study Type: OBSERVATIONAL
Conditions: Pediatric Obesity
Sponsor: University Hospital, Angers
Sex: ALL
Age: CHILD, ADULT
Enrollment: 32
Study Design: Observational Model: |Time Perspective: p
Start Date: 2024-10
Completion Date: 2026-11

Summary:
Obesity concerns almost the entire planet and is considered in France as a major public health issue: 17% of children are overweight and 4% obese.

Because of this situation, the public authorities have set up programs in order to overcome obesity. Accompanying the child and its family in a process of change through Educational care program seems to be the most suitable. Unfortunately, the abandonment rate of these programs is often high.

Primary Outcome Measures: Categorization of the reasons given by children and parents, Description and categorization of the reasons given by children and parents, during the data analysis, either 6 months following the focus group period
Secondary Outcome Measures: Mirroring of the respective experiences of attrition by children, Description and mirroring of the respective experiences of attrition by children, during the data analysis, either 6 months following the focus group period
Intravesical Gemcitabine and Docetaxel for Low Grade Intermediate Risk Bladder Cancer
NCT Number: NCT06488222
Status: NOT_YET_RECRUITING
Study Type: INTERVENTIONAL
Phases: PHASE2
Conditions: Bladder Cancer
Interventions: DRUG: Docetaxel|DRUG: Gemcitabine
Sponsor: University of Florida
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 34
Study Design: Allocation: NA|Intervention Model: SINGLE_GROUP|Masking: NONE|Primary Purpose: TREATMENT
Start Date: 2024-10
Completion Date: 2027-08
Locations: University of Florida, Gainesville, Florida, 32608, United States

Summary:
Bladder cancer is the 8th most common cancer in the UF Health Cancer Center catchment area and the 7th most common cancer presenting to UFHealth. Most newly diagnosed cases are stage I bladder cancer, which is defined by having no deep muscle invasion and no evidence of disease beyond the bladder. The current use in BCG (Bacillus Calmette-Guerin) refractory disease and the ongoing evaluation in BCG naïve high-risk disease support evaluation of intravesical gemcitabine and docetaxel in decreasing disease recurrence in intermediate risk stage I bladder cancer.

This study will investigate the efficacy and subject compliance with treatment of low grade intermediate risk bladder cancer with intravesical gemcitabine and docetaxel.

Primary Outcome Measures: Recurrence free survival, Evaluate the recurrence free survival, as measured by cystoscopy, 12 months after start of induction
Secondary Outcome Measures: Progression rate, Determine the progression rate at 12 months, for tumor grade and stage, based on pathologic assessment of tumors in patients with disease recurrence. Development of the following will be considered progression: high grade disease, ≥ T1 disease, CIS., 12 months after start of induction|Treatment compliance, Determine treatment compliance, as measured by how many planned study treatments were given. This will be measured by documented administration of study treatments in the subject's medical record., 12 months after the start of induction
Feasibility, Acceptability, and Fidelity of Motivational Interviewing to Increase Maternal NICU Presence
NCT Number: NCT06488196
Status: COMPLETED
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Neonatal Intensive Care
Interventions: BEHAVIORAL: Motivational Interviewing|OTHER: Treatment As Usual
Sponsor: Johns Hopkins All Children's Hospital
Sex: FEMALE
Age: ADULT, OLDER_ADULT
Enrollment: 95
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: NONE|Primary Purpose: SUPPORTIVE_CARE
Start Date: 2018-11-02
Completion Date: 2021-04-09
Locations: Johns Hopkins All Children's Hospital, Saint Petersburg, Florida, 33701, United States

Summary:
Maternal presence in the NICU during an infant's hospitalization is critical for the infant's medical recovery and overall neurodevelopmental trajectory. However, despite the importance of maternal presence in these settings, the current literature shows that families are often absent at bedside. To date, no behavioral interventions have been conducted to promote increased maternal visitation patterns in NICU settings. This project will aim to fill this gap in the literature by conducting a pilot study that uses a motivational interviewing intervention with the aim of increasing maternal visitation rates to a level IV NICU.

Primary Outcome Measures: Feasibility, as assessed by >75% of MI-randomized mothers receiving at least one MI session, Feasibility as assessed by \>75% of MI-randomized mothers receiving \> one MI session, 3 years
Secondary Outcome Measures: Acceptability as assessed by the number of mothers' open to completing additional MI session/s, MI acceptable, as evidenced by mothers reporting willingness (yes/no) to receive a second MI session after completing their first MI session., 3 years
Laparoscopic Preperitoneal Local Anesthetic Infiltration Versus Ultrasound Guided Quadratus Lumborum Block in Laparoscopic Bariatric Surgery
NCT Number: NCT06488183
Status: RECRUITING
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Pain Management
Interventions: PROCEDURE: preperitoneal local anesthetic infiltration in group p , quadratus lamborum block in group Q
Sponsor: sarah mohamed
Sex: ALL
Age: ADULT
Enrollment: 44
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: DOUBLE (PARTICIPANT, OUTCOMES_ASSESSOR)|Primary Purpose: OTHER
Start Date: 2024-05-12
Completion Date: 2024-08
Locations: Alexandria University, Alexandria, Egypt

Summary:
preperitoneal local anesthetic infiltration is effective for relief of postoperative pain in patients undergoing laparoscopic bariatric surgery.

Primary Outcome Measures: postoperative pain score, VAS score, postoperative day 1
Secondary Outcome Measures: postoperative morphine requirements, mg, postoperative day 1|postoperative nausea and vomiting, number, postoperative day1|length of stay in pacu, minutes, postoperative day 1|Length of hospital stay, days, postoperative day 3
Adapting and Implementing the I-HoME Intervention in Caregivers of Patients With ADRD
NCT Number: NCT06488157
Status: RECRUITING
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Caregiver Burden
Interventions: OTHER: I-HoME
Sponsor: Weill Medical College of Cornell University
Collaborators: National Institute on Aging (NIA)
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 15
Study Design: Allocation: NA|Intervention Model: SINGLE_GROUP|Masking: NONE|Primary Purpose: SUPPORTIVE_CARE
Start Date: 2024-07-10
Completion Date: 2024-12-30
Locations: Weill Cornell Medicine, New York, New York, 10065, United States

Summary:
The purpose of this study is to pilot test the adapted Improving Home hospice Management of End-of-life issues through technology (I-HoME) intervention with family caregivers of patients with advanced Alzheimer's Disease and related dementia. Data will be collected regarding intervention feasibility and acceptability.

Primary Outcome Measures: Feasibility, as measured by the percentage of caregivers who enroll in the study, Day 1|Feasibility, as measured by the percentage of participants who complete their telehealth visits, At the end of the intervention or at 12 weeks, whichever is earlier
Secondary Outcome Measures: Change in behavioral and psychosocial symptoms of dementia (BPSD) in the patient, as measured by the Neuropsychiatric Inventory Questionnaire, Change in behavioral and psychosocial symptoms of dementia (BPSD) in the patient, as measured by the Neuropsychiatric Inventory Questionnaire. Scale is from 0 to 36, with higher scores indicating more severe BPSD., Baseline, 2, 4, 6, 8, 10, 12 weeks|Change in caregiver depression, as measured by Patient Health Questionnaire-8, Change in caregiver depression, as measured by Patient Health Questionnaire-8. Scale is from 0 to 24, with higher scores indicating more severe depression., Baseline, 2, 4, 6, 8, 10, 12 weeks|Change in caregiver anxiety, as measured by General Anxiety Disorder-7, Change in caregiver anxiety, as measured by General Anxiety Disorder-7. Scale is from 0 to 21, with higher scores indicating more severe anxiety., Baseline, 2, 4, 6, 8, 10, 12 weeks|Change in caregiver burden, as measured by the Zarit Burden Interview - short version, Change in caregiver burden, as measured by the Zarit Burden Interview - short version. Scale is from 0 to 48, with higher scores indicating higher caregiver burden., Baseline, 2, 4, 6, 8, 10, 12 weeks|Change in caregiver perception of patient's pain, as measured by the Doloplus 2 Scale behavioral assessment, Change in caregiver perception of patient's pain, as measured by the Doloplus 2 Scale behavioral assessment. Scale is from 0 to 30, with higher scores indicating greater pain., Baseline, 2, 4, 6, 8, 10, 12 weeks
Comparing MTA Pulpotomy to Root Canal Treatment in Management of Permanent Molars With Irreversible Pulpitis in Children
NCT Number: NCT06488131
Status: NOT_YET_RECRUITING
Study Type: INTERVENTIONAL
Phases: PHASE4
Conditions: Irreversible Pulpitis
Interventions: PROCEDURE: MTA Pulpotomy|PROCEDURE: Root Canal Treatment
Sponsor: Ain Shams University
Sex: ALL
Age: CHILD
Enrollment: 62
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: DOUBLE (PARTICIPANT, OUTCOMES_ASSESSOR)|Primary Purpose: TREATMENT
Start Date: 2024-07
Completion Date: 2025-06

Summary:
Dental caries, highly prevalent amongst children, can cause pulpitis. Coronal pulpotomy provides an easier, cost-effective, conservative and biologically-driven treatment option compared to endodontic treatment in mature permanent teeth with irreversible pulpitis.

The aim of the current study is to evaluate postoperative pain, clinical and radiographic outcomes of MTA pulpotomy compared to root canal treatment in children's first permanent molars suffering from irreversible pulpitis.

Primary Outcome Measures: Pain Relief, A 10 cm visual analogue scale will be used to record pain, preoperatively, immediately postoperatively and every 24 hours for 7 days after the first appointment.
Secondary Outcome Measures: Clinical Evaluation, * Absence of pain or discomfort
* Tooth is functional, with no tenderness to palpation or percussion
* Normal mobility and probing depth
* Soft tissues surrounding the tooth are normal, with no swelling or inflammation, 3, 6, 12 and 18 months postoperatively|Radiographic Evaluation, * No evident radiographic periapical or furcal pathosis
* No evident root resorption
* Normal lamina dura, 6, 12 and 18 months postoperatively
Emergency Medicine Cardiovascular Risk Assessment for Lipid Disorders Trial
NCT Number: NCT06488105
Acronym: EMERALD RCT
Status: RECRUITING
Study Type: INTERVENTIONAL
Phases: PHASE2
Conditions: Lipid Disorder|Hypercholesterolemia|Cardiovascular Diseases|Atherosclerosis
Interventions: DRUG: Statin (rosuvastatin 10 or 40 mg daily, depending on risk)|BEHAVIORAL: Healthy Lifestyle Counseling|OTHER: Outpatient Followup
Sponsor: Wake Forest University Health Sciences
Collaborators: National Institutes of Health (NIH)|National Heart, Lung, and Blood Institute (NHLBI)
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 130
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: NONE|Primary Purpose: PREVENTION
Start Date: 2024-08-05
Completion Date: 2029-03-31
Locations: Wake Forest University Health Sciences, Winston-Salem, North Carolina, 27517, United States

Summary:
Emergency Medicine Cardiovascular Risk Assessment for Lipid Disorders (EMERALD) is a protocolized intervention based on American College of Cardiology/American Heart Association and US Preventive Services Task Force guidelines designed to initiate preventive cardiovascular care for emergency department patients being evaluated for acute coronary syndrome. The overarching goals of this proposal are to (1) determine the efficacy of EMERALD at lowering low-density lipoprotein cholesterol (LDL-C) and non high-density lipoprotein cholesterol (non-HDL-C) among at-risk Emergency Department (ED) patients who are not already receiving guideline-directed outpatient preventive care and (2) inform our understanding of patient adherence and determinants of implementation for ED-based cardiovascular disease prevention strategies.

Primary Outcome Measures: Percent change in low-density lipoprotein cholesterol (LDL-C) at 30 days, Percent change in LDL-C from the index Emergency Department (ED) encounter through 30 days, Index ED encounter through 30 days (-3, +11 days)
Secondary Outcome Measures: Percent change in LDL-C at 180 days., Percent change in LDL-C from the index ED encounter through 180 days, Index ED encounter through 180 days (+/- 15 days)|Percent change in non high-density lipoprotein cholesterol (non-HDL-C) at 30 days, Percent change in non-HDL-C from the index ED encounter through 30 days, Index ED encounter through 30 days (-3, +11 days)|Percent change in non-HDL-C at 180 days, Percent change in non-HDL-C from the index ED encounter through 180 days, Index ED encounter through 180 days (+/- 15 days)|Proportion of patients with outpatient clinic follow-up at 30 days, Did the patient follow-up with the recommended outpatient care team?, Index ED encounter through 30 days (-3, +8 days)|Proportion of patients with statin prescription pick-up, Did the patient pick-up their statin prescription from the pharmacy?, Index ED encounter through 10 days|Qualitative barriers and facilators, Qualitative interviews to determine facilitators and barriers to the Emergency Medicine Cardiovascular Risk Assessment for Lipid Disorders (EMERALD) program, 30 days (+30 days) after the index ED encounter
IC-CS Risk: Patient Outcomes
NCT Number: NCT06488092
Status: NOT_YET_RECRUITING
Study Type: OBSERVATIONAL
Conditions: Cesarean Delivery
Interventions: OTHER: Cesarean Risk Calculator
Sponsor: University of Pennsylvania
Collaborators: Eunice Kennedy Shriver National Institute of Child Health and Human Developement
Sex: FEMALE
Age: CHILD, ADULT, OLDER_ADULT
Enrollment: 20000
Study Design: Observational Model: |Time Perspective: p
Start Date: 2024-09
Completion Date: 2027-09
Locations: University of Michigan, Ann Arbor, Michigan, 48109, United States|Henry Ford Macomb Hospital, Clinton Township, Michigan, 48038, United States|Henry Ford Hospital, Detroit, Michigan, 48202, United States|E.W. Sparrow Hospital, Lansing, Michigan, 48912, United States|Princeton Medical Center, Plainsboro, New Jersey, 08536, United States|Akron General, Akron, Ohio, 44307, United States|Fairview Hospital, Cleveland, Ohio, 44111, United States|Hillcrest Hospital, Mayfield Heights, Ohio, 44124, United States|Lancaster General Health, Lancaster, Pennsylvania, 17602, United States|Chester County Hosptial, West Chester, Pennsylvania, 19380, United States|Logan Regional Hospital-Intermountain Healthcare, Logan, Utah, 84341, United States|McKay-Dee Hospital, Ogden, Utah, 84403, United States|Riverton Hospital-Intermountain Healthcare, Riverton, Utah, 84065, United States|University of Utah Hospital, Salt Lake City, Utah, 84132, United States

Summary:
This study is looking at the impact of the implementation of a cesarean risk calculator on cesarean delivery and maternal morbidity rates.

Primary Outcome Measures: Cesarean delivery rate (for any indication), at time of delivery|Maternal morbidity, one or more of the following: endometritis, postpartum hemorrhage greater than or equal to one liter, wound infection requiring antibiotics, venous thromboembolism, hysterectomy, intensive care unit admission, readmission within 30 days, and death, from delivery to 30 days postpartum
Secondary Outcome Measures: Neonatal morbidity, one or more of the following: severe respiratory distress, neonatal resuscitation outside of delivery room, and sepsis, delivery admission
Clinical Outcomes of Patients Implanted With the RxSight Light Adjustable Lens (LAL)
NCT Number: NCT06488066
Status: WITHDRAWN
Study Type: OBSERVATIONAL
Conditions: Cataract|Pseudophakia
Interventions: OTHER: Data collection
Sponsor: Vance Thompson Vision
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 0
Study Design: Observational Model: |Time Perspective: p
Start Date: 2021-08-13
Completion Date: 2022-01-01
Locations: Vance Thompson Vision, Sioux Falls, South Dakota, 57108, United States

Summary:
The objective of this investigator initiated study (IIT-002) is to collect data on commercial patients implanted with the RxSight Light Adjustable Lens (LAL).

Primary Outcome Measures: Manifest refraction, A qualified ophthalmologist, optometrist, or a trained ophthalmic technician should obtain the refraction, in 0.25D steps, in a calibrated refraction lane. If the subject has a current pair of glasses for distance vision, they can be measured with a lensometer, and these measurements are used as the beginning approximate refraction, Pre operatively and immediately post operatively
DAO DEFICIENCY SCREENING AMONG PATIENTS with INSOMNIA SYMPTOMS
NCT Number: NCT06488027
Status: COMPLETED
Study Type: OBSERVATIONAL
Conditions: Insomnia|Insomnia Disorder
Sponsor: AB Biotek
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 200
Study Design: Observational Model: |Time Perspective: p
Start Date: 2023-05-05
Completion Date: 2023-11-27

Summary:
Insomnia is prevalent in the global population. Diamino oxidase (DAO) is an enzyme that degrades histamine. When there is not enough DAO enzyme activity in the body, histamine accumulates and it can lead to symptoms in the nervous system, among others. In this study we wanted to study the prevalence of DAO deficiency in pacients with insomnia symptoms.

Primary Outcome Measures: number of patients with insomnia symptoms and DAO deficiency, number (absolute and percentage) of patients with insomnia symptoms and DAO deficiency, at the time of enrollment
Comparison of the Effect of Preoperative and Postoperative Erector Spina Plan Block and Paravertebral Block on Postoperative Pain in Video Assisted Thoracic Surgery (VATS)
NCT Number: NCT06488014
Status: NOT_YET_RECRUITING
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Anesthesia|Nerve Block|Pain, Postoperative|Thoracic Surgery, Video Assisted
Interventions: PROCEDURE: Erector spina plan block (ESP)|PROCEDURE: Paravertebral block
Sponsor: Ankara University
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 78
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: NONE|Primary Purpose: TREATMENT
Start Date: 2024-09-01
Completion Date: 2025-03-30
Locations: Ankara University, Ankara, Altındağ, 06340, Turkey

Summary:
The aim of this prospective controlled randomised clinical trial was to identify the analgesic method that is more effective than two different regional analgesia techniques routinely used for pain control after video-assisted thoracic surgery (VATS).

The effects of paravertebral block and erector spina plan (ESP) block on acute pain, need for additional analgesics and incidence of chronic pain after video-assisted thoracic surgery (VATS) will be compared before surgical incision (pre-emptive) and at the end of surgery.

It is aimed to show that ESP block, which is a newer method in the literature, provides equivalent / more effective analgesia with paravertebral block.

Primary Outcome Measures: Acute postoperative pain, Lower pain scores with erector spina plan block in pain control after acute thoracoscopy (using visual analogue scale, lowest value (no pain): 0, highest value (most severe pain): 10, lower values are considered as good results), 4 month
Secondary Outcome Measures: Chronic postoperative pain, Less chronic pain with erector spinae block (using visual analogue scale, lowest value (no pain): 0, highest value (most severe pain): 10, lower values are considered as good results), 6 month
Preoperative Use of Pantoprazole for Prevention of Post Operative Nausea and Vomiting in Gynecologic Surgery
NCT Number: NCT06488001
Status: RECRUITING
Study Type: INTERVENTIONAL
Phases: PHASE2
Conditions: Postoperative Nausea and Vomiting
Interventions: DRUG: pantoprazole|DRUG: Placebo
Sponsor: United States Naval Medical Center, Portsmouth
Sex: FEMALE
Age: ADULT, OLDER_ADULT
Enrollment: 132
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: TRIPLE (PARTICIPANT, CARE_PROVIDER, INVESTIGATOR)|Primary Purpose: PREVENTION
Start Date: 2022-08-26
Completion Date: 2025-03
Locations: Naval Medical Center Portsmouth, Portsmouth, Virginia, 23708, United States

Summary:
The goal of this clinical trial is to see if pantoprazole (a proton pump inhibitor used for acid reflux/heart burn) can reduce nausea and vomiting after gynecologic surgery in women between the ages of 18 and 79.

Researchers will compare a placebo to the active medication.

Participants will be asked to take three pills around their surgery, two taken before and one taken the night after.

Primary Outcome Measures: Postoperative Nausea and Vomiting, Postoperative nausea and vomiting compared between two groups using Visual Analog Scale, From enrollment until their postoperative visit at 6 weeks
Secondary Outcome Measures: Time to Oral Intake, Measure the time from surgery until patients can tolerate oral intake., From surgery until first meal, usually within a few hours.
Asleep Fiberoptic vs Direct Laryngoscopy Effect on Hemodynamic Stability Using Opioid Free Anesthesia Induction
NCT Number: NCT06487988
Status: NOT_YET_RECRUITING
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Analgesics, Opioid|Anesthesia, General|Heart Rate|Blood Pressure
Interventions: DEVICE: direct conventional laryngoscopy|DEVICE: fiberoptic guided intubation
Sponsor: American University of Beirut Medical Center
Sex: ALL
Age: ADULT
Enrollment: 90
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: DOUBLE (PARTICIPANT, INVESTIGATOR)|Primary Purpose: OTHER
Start Date: 2024-09-01
Completion Date: 2025-11-01

Summary:
The goal of this clinical trial is to compare blood pressure and heart rate between the fiberoptic and direct oral intubation using opioid free anesthesia induction. Secondary objectives include comparing the time needed for intubation and the incidence of postoperative sore throat, hoarseness, and upper airway trauma in adults aging between 18 to 55 years, scheduled for elective surgery under general anesthesia.

The main question it aims to answer is:

Does fiberoptic intubation cause less hemodynamic instability than direct oral intubation using opioid free anesthesia induction?

Primary Outcome Measures: Heart rate, Heart rate (bpm), baseline and up to 5 mins upon intubation|Blood pressure, Blood pressure (mm Hg), baseline and up to 5 mins upon intubation
Secondary Outcome Measures: time needed for intubation, time (between face mask removal and first ETCO2 reading in minutes), between face mask removal and first ETCO2 reading in minutes|incidence of postoperative sore throat, Sore throat pain (0-10), after 24 hrs|incidence of upper airway trauma, incidence of upper airway trauma (Yes or No), during intubation
Pilot RCT: FQHC Intervention for Uptake of CGM in Hispanic Adults with T1D
NCT Number: NCT06487962
Status: RECRUITING
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Type 1 Diabetes
Sponsor: University of Connecticut
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 30
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: NONE|Primary Purpose: OTHER
Start Date: 2024-05-28
Completion Date: 2026-08-01

Summary:
Hispanics adults with type 1 diabetes (T1D), despite their disproportionate burden of acute complications (hypoglycemia and diabetes ketoacidosis) and related emergency department visits, hospitalizations, and death, remain largely disenfranchised from continuous glucose monitoring (CGM), an efficacious technology to mitigate these inequities. To increase CGM uptake in low-income, Hispanic adults with T1D receiving diabetes management in federally qualified health centers (FQHCs), this pilot randomized control trial (RCT), will assess the feasibility of our study protocol, including our multi-level intervention informed by the Socio-Ecological Model.

Primary Outcome Measures: Number of days CGM worn, The total number of days CGM worn. Data will be collected from Ambulatory Glucose Profile Reports., 3 months and 6 months|Percentage of time the CGM is active, The percentage of time the CGM is active. Data will be collected from Ambulatory Glucose Profile Reports., 3 months and 6 months
Secondary Outcome Measures: A1C, Measure of glycemic control over the past 3 months, Baseline, 3 months, and 6 months|CGM time in range (TIR), TIR is measured by CGM. Data will be collected from Ambulatory Glucose Profile Reports., 3 months and 6 months|CGM time below range (TBR), TBR is measured by CGM. Data will be collected from Ambulatory Glucose Profile Reports., 3 months and 6 months|CGM time above range (TAR), TAR is measured by CGM. Data will be collected from Ambulatory Glucose Profile Reports., 3 months and 6 months|Number of hypoglycemic-related emergency department (ED) visits over past 3 months, 1-item measure, Baseline, 3 months, and 6 months|Number of hypoglycemic-related hospitalizations, 1-item measure, Baseline, 3 months, and 6 months|Number of hyperglycemic-related ED visits, 1-item measure, Baseline, 3 months, and 6 months|Number of hyperglycemic-related hospitalizations, 1-item measure, Baseline, 3 months, and 6 months|Medical Outcomes Survey Short Form-36, Quality of Life, Baseline, 3 months, and 6 months|Multidimensional Scale of Perceived Social Support, Social Support, Baseline, 3 months, and 6 months|Interpersonal Processes of Care Survey: Short Form, Disparities in Interpersonal Care (communication, decision-making, and interpersonal style), Baseline, 3 months, and 6 months
Valsartan and Amlodipine in Blood Pressure Management: Fixed-Dose vs. Free Drug Therapy
NCT Number: NCT06487949
Status: COMPLETED
Study Type: INTERVENTIONAL
Phases: PHASE4
Conditions: Hypertension
Interventions: DRUG: valsartan-amlodipine 80/5 mg FDC|DRUG: valsartan 80 mg and amlodipine 5 mg as free combination
Sponsor: Shiraz University of Medical Sciences
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 114
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: QUADRUPLE (PARTICIPANT, CARE_PROVIDER, INVESTIGATOR, OUTCOMES_ASSESSOR)|Primary Purpose: TREATMENT
Start Date: 2022-12-01
Completion Date: 2023-12-01
Locations: Shiraz University of Medical Sciences, Shiraz, Fars, 713481433, Iran, Islamic Republic of

Summary:
Patients aged 35 to 70 years with newly diagnosed stage 1 or 2 hypertension ( HTN) was randomized to receive either Valsartan 80 mg/Amlodipine 5 mg fix dose combination (FDC) or a free equivalent combination. Ambulatory blood pressure monitoring at baseline and 8 weeks post-treatment initiation was performed.

Primary Outcome Measures: Mean 24 hours systolic blood pressure, The average systolic blood pressure over 24 hours, during the day and at night, 8 weeks|Mean 24 hours diastolic blood pressure, The average diastolic blood pressure over 24 hours, during the day and at night, 8 weeks|Mean 24 hours mean blood pressure, The average mean blood pressure over 24 hours, during the day and at night, 8 weeks
Secondary Outcome Measures: Dipping, Drop of Mean systolic pressure more than 10% during nights compare to mean systolic pressure at days, 8 weeks
Real-World Registry Study on Patient Satisfaction With TransLoc 3D SI Joint Fusion
NCT Number: NCT06487936
Acronym: RELIEF
Status: RECRUITING
Study Type: OBSERVATIONAL
Conditions: Sacroiliac Joint Dysfunction|Sacroiliac; Fusion
Interventions: DEVICE: TransLoc 3D SI Joint Fusion System
Sponsor: CornerLoc
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 120
Study Design: Observational Model: |Time Perspective: p
Start Date: 2024-08-15
Completion Date: 2024-12-15
Locations: Advanced Orthopedic Center, Port Charlotte, Florida, 33948, United States

Summary:
This is a multi-center, consecutive enrollment registry study to evaluate patient satisfaction post SI Fusion with the TransLoc 3D SI Fusion System.

Primary Outcome Measures: Patient Satisfaction Survey, Patient satisfaction survey administered greater than 1 year post-op: satisfaction, functional improvement, and disability as it relates to their SI joint, Prospective 12 to 18 months post surgery
Secondary Outcome Measures: Visual Analogue Scale (VAS) of pain, Retrospective analysis of VAS pre and post surgery, if available, Baseline up to 1 year post surgery|Oswestry Disability Index (ODI), Retrospective analysis of ODI pre and post surgery, if available, Baseline up to 1 year post surgery|SAEs, Retrospective capture of Serious Adverse Events (SAEs) from the time of SI Fusion up to 90 days post operatively that required re-operation or in-patient hospitalization., Time of surgery up to 90 days post surgery|CT Scan Second Read (Radiological Overread), CT scan for placement and fusion, 12 to 18 months post fusion surgery
Differential Pressure Distribution Orthosis by 3D Printing Process in the Treatment of Post-burn Hypertrophic Scarring
NCT Number: NCT06487910
Acronym: EPIDERM
Status: NOT_YET_RECRUITING
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Burns|Hypertrophic Scar
Interventions: DEVICE: 3D scan measurment
Sponsor: Centre Hospitalier Régional Metz-Thionville
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 25
Study Design: Allocation: NA|Intervention Model: SINGLE_GROUP|Masking: NONE|Primary Purpose: OTHER
Start Date: 2024-09-01
Completion Date: 2026-09-01
Locations: CHR Metz-Thionville/Hopital Félix Maréchal, Metz, 57000, France

Summary:
This is a pilot, single-center, feasibility study to evaluate a new 3D printing method for ORDP design.

To our knowledge, there is no technical or clinical evaluation of ORDPs, particularly in the treatment of hypertrophic scars. The aim of our study is therefore to assess the feasibility of an innovative method of designing ORDPs for the curative treatment of post-burn hypertrophic scars, using a 3D printing process, and to describe the procedures (production time and cost).

Primary Outcome Measures: Sucess of the manufacture process of the orthosis, Defined as the compliance with all three of the following specifications: 1) oval shapes are approximately 2 mm thick, 2) absence of wounding areas (prickly or sharp), 3) a satisfactory morphological match with the area to be treated., 2 to 3 hours after inclusion
Secondary Outcome Measures: Time of conception, Total time to make the orthosis (minutes), 2 to 3 hours after inclusion|Total time to design the orthosis, Total time to design the orthosis (minutes), 2 to 3 hours after inclusion|Total cost of the orthosis fabrication, Total cost of the orthosis fabrication (minutes), 2 to 3 hours after inclusion
Phase III Presbyopia Correction Using the VIS Opti-K™ System
NCT Number: NCT06487897
Acronym: Opti-K™
Status: RECRUITING
Study Type: INTERVENTIONAL
Phases: PHASE3
Conditions: Presbyopia
Interventions: DEVICE: Optimal laser keratoplasty
Sponsor: VIS, Inc.
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 75
Study Design: Allocation: NA|Intervention Model: SINGLE_GROUP|Masking: NONE|Primary Purpose: TREATMENT
Start Date: 2024-09-30
Completion Date: 2027-12
Locations: Cohen Laser & Vision Center, Boca Raton, Florida, 33431, United States|Claris Vision Eye Health, South Dartmouth, Massachusetts, 02747, United States|The Cornea & Laser Eye Institute, Teaneck, New Jersey, 07666, United States|OCLI Vision - Oceanside, Oceanside, New York, 11572, United States

Summary:
The goal of this clinical trial is to evaluate the safety and efficacy of using the VIS Opti-K System to enable monovision by providing temporary improvement in near vision through the treatment of the non-dominant eye of low myopic, emmetropic and low hyperopic presbyope subjects. The main questions it aims to answer are determining uncorrected near visual acuity at 40cm in the treated eye and subjective improvement as measured by the patient satisfaction questionnaire.

Primary Outcome Measures: Uncorrected near visual acuity 2 or more lines or better, • The proportion of treated eyes (target: at least 50%) that achieve an uncorrected near visual acuity (UNVA) that is 2 or more lines better than Screening following treatment, 3 months
Secondary Outcome Measures: Binocular uncorrected near visual acuity, The proportion of eyes (target: at least 50%) that achieve a binocular uncorrected near visual acuity (UNVA) of 20/40 or better after the treatment, 3 months
Other Outcome Measures: Percentage of eyes that achieve UNVA, Percentage of eyes that achieve UNVA of 20/40 or better and 20/20 or better, 3 months|Subjective improvement in vision, • Subjective improvement in visual experience as measured by subject satisfaction questionnaire related to near vision, distance vision, visual symptoms and overall satisfaction., 3 months
INTRAVENOUS DRUG APPLICATIONS THROUGH ESCAPE GAMES
NCT Number: NCT06487884
Status: RECRUITING
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Nursing Students|Drug Application|Game Based Learning
Interventions: OTHER: escape games
Sponsor: Ataturk University
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 80
Study Design: Allocation: RANDOMIZED|Intervention Model: CROSSOVER|Masking: NONE|Primary Purpose: OTHER
Start Date: 2024-04-30
Completion Date: 2024-12
Locations: Asena KÖSE, Erzurum, Palandöken, 25070, Turkey

Summary:
Nursing students must have sufficient competence in medication safety before starting to work in clinics. Most nursing students want to actively participate in education. Active and interesting learning activities attract more attention than lecture and instructor-oriented approaches. One of the learning methods that has attracted attention recently is the escape games technique. This study aims to determine the knowledge and skill levels and learning experiences of nursing students regarding intravenous drug administration skills using the escape games method.

Primary Outcome Measures: Intravenous Drug Administration Knowledge Test, This test was prepared by the researchers in line with the literature. It consists of questions regarding the achievements that students are expected to achieve within the scope of the relevant subject. The knowledge test includes 20 multiple choice questions. After these questions are created by the researchers participating in the study, they will be sent to experts in the relevant field and their opinions will be taken and their final form will be given. In terms of scope, the knowledge test created by the researchers will be sent to expert faculty members in the Department of Nursing Principles and to experts on the subject for evaluation and opinions in terms of Turkish Language. The test will be finalized in line with the recommendations from experts., 6 weeks|Intravenous Drug Administration Checklist, Intravenous Drug Administration Checklist consists of application steps that question the procedure steps in detail, prepared in line with the objectives of the course content. This form, prepared by the researchers, was prepared in the form of a rubric and in line with the literature in order to observe the students objectively. Intravenous Drug Administration Checklist consists of three sub-checklists titled "Application Steps of Withdrawing Medicine from Ampoule", "Application Steps of Withdrawing Medicine from Vial" and "Practice Steps of Initiating Intravenous Drug Administration", 6 weeks
Effect of GLP1 Receptor Agonist on Brain Insulin Responsiveness
NCT Number: NCT06487832
Status: RECRUITING
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Normal Weight|Overweight and Obesity|Insulin Sensitivity|Insulin Resistance
Interventions: OTHER: Subcutaneous GLP1-RA|OTHER: Subcutaneous placebo
Sponsor: University Hospital Tuebingen
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 60
Study Design: Allocation: RANDOMIZED|Intervention Model: CROSSOVER|Masking: SINGLE (PARTICIPANT)|Primary Purpose: BASIC_SCIENCE
Start Date: 2024-07-01
Completion Date: 2027-12-31
Locations: University Clinic Tubingen, Department of Internal Medicine IV, Tübingen, 72076, Germany

Summary:
The overarching goal of the current study is to investigate the effect of GLP-1 on brain insulin responsiveness in a randomized, single-blinded, within subject cross-over study design. To this end, investigators will compare the effect of the administration of semaglutide versus placebo, followed by an fMRI with administration of intranasal insulin or placebo.

Primary Outcome Measures: Cerebral response after insulin compared to placebo nasal spray, Resting-state cerebral blood flow and BOLD-fMRI response from before to 30 min after nasal spray administration, 24 hours after semaglutide or placebo administration
Secondary Outcome Measures: Neural food-cue reactivity after insulin compared to placebo nasal spray, BOLD-fMRI response to food cues 30 min after nasal spray administration, 24 hours after semaglutide or placebo administration|Diffusion-weighted imaging (DWI), Diffusion weighted parameter based on MRI measurements, 24 hours after semaglutide or placebo administration|Heart rate variability (HRV), HRV based on ECG measurements, 24 hours after semaglutide or placebo administration|Change in subjective feeling of hunger and food craving, On a visual analogue scale, subjective feeling of hunger and food craving will be assessed using questionnaires., 24 hours after semaglutide or placebo administration|Change in mood, Using a questionnaire, positive and negative affect state will be assessed., 24 hours after semaglutide or placebo administration|Performance during cognitive tests, Cambridge Cognition Tests Battery, 24 hours after semaglutide or placebo administration
Evaluation of Temporomandibular Joint Condition Post Longstanding Mouth Opening by Rubber Dam
NCT Number: NCT06487819
Status: NOT_YET_RECRUITING
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Temporomandibular Joint Condition Post Longstanding Mouth Opening During Dental Procedure Using Rubber Dam|TMJ Disc Disorder|Osteoarthritis|Myofacial Pain
Interventions: PROCEDURE: Application of a rubber dam during dental treatments for varying durations.
Sponsor: Al-Azhar University
Sex: ALL
Age: ADULT
Enrollment: 300
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: QUADRUPLE (PARTICIPANT, CARE_PROVIDER, INVESTIGATOR, OUTCOMES_ASSESSOR)|Primary Purpose: SCREENING
Start Date: 2024-09-10
Completion Date: 2026-07-01
Locations: ‪Ahmed Sabry‬, Assiut, Assuit, Egypt

Summary:
This Clinical and radiographic study will be designed to evaluate the temporomandibular joint condition post longstanding mouth opening during dental procedure using rubber dam. primary outcome : preoperative and postoperative assessment of interincisal distance , occlusal biting force , visual analogue scale , lateral excursion movement and Magnetic resonance imaging (MRI).

Secondary outcome: investigator will try to answer the question of what is the best duration of time could the dentist use rubber dam isolation in dental procedures without harmful effect on TMJ and its supporting structures?

Primary Outcome Measures: Interincisal Distance, Measurement of the distance from the incisal edge of upper incisors to the incisal edge of lower incisors when the mouth is opened maximally in mm., Preoperative, immediately postoperative, 2 weeks postoperative.|Occlusal Biting Force, measurement of the biting force exerted by the patient's occlusion. This will be measured using a bite force gauge or similar instrument at the specified time points., Preoperative, immediately postoperative, 2 weeks postoperative.|Visual Analogue Scale (VAS), A subjective measure of pain intensity experienced by the patient. Patients will mark their pain level on a scale from 0 (no pain) to 10 (worst pain imaginable)., Preoperative, immediately postoperative, 2 weeks postoperative.|Magnetic Resonance Imaging (MRI), MRI scans will be done for patients who exhibit signs and symptoms of TMD postoperatively., 2 weeks postoperative (for symptomatic patients).|Lateral Excursion Movement, The maximum amount of lateral excursion on each side will be measured in mm., Preoperative, immediately postoperative, 2 weeks postoperative.
Secondary Outcome Measures: Optimal Duration for Rubber Dam Use, measure the duration of time for rubber dam application from the beginning of rubber dam application till the dentist remove rubber dam from the mouth of patient ., immediately postoperative
SmokefreeSGM Español Pilot, Beta Testing a Text-based Smoking Cessation Intervention for Sexual and Gender Minority(SGM) Groups Preferring Spanish Language
NCT Number: NCT06487806
Status: NOT_YET_RECRUITING
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Smoking Cessation
Interventions: BEHAVIORAL: SmokefreeSGM
Sponsor: The University of Texas Health Science Center, Houston
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 20
Study Design: Allocation: NA|Intervention Model: SINGLE_GROUP|Masking: NONE|Primary Purpose: TREATMENT
Start Date: 2024-09-01
Completion Date: 2025-05-31
Locations: The University of Texas Health Science Center at Houston, Houston, Texas, 77030, United States

Summary:
The purpose of this study is to test the usability, engagement and acceptability of SmokefreeSGM Español, a culturally and linguistically tailored version of SmokefreeSGM, among Spanish-speaking SGM smokers.

Primary Outcome Measures: Perceived Usability as Assessed by the System Usability Scale (SUS), This is a 10-item questionnaire. Total score ranges from 0 to 100, with a higher score indicating greater usability and a score above 75 indicating better outcome, end of intervention (1month after quit date)|Engagement with the text-messaging program as assessed by number of text messages a participant sends, including replies to the bidirectional texts messages of SmokefreeSGM Español program, end of intervention (1month after quit date)|Acceptability at 1 month as Assessed by the System Usability Scale (SUS), This is a 10-item questionnaire. Total score ranges from 0 to 100, with a higher score indicating greater acceptability, end of intervention (1month after quit date)
Mobile App Intervention for Sleep Problems and Alcohol Use Among Veterans
NCT Number: NCT06487793
Status: NOT_YET_RECRUITING
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Alcohol Use Disorder|Insomnia
Interventions: BEHAVIORAL: Enhanced Insomnia Coach|BEHAVIORAL: Sleep hygiene comparator
Sponsor: University of Southern California
Collaborators: RAND|Palo Alto Veterans Institute for Research|University of Missouri-Columbia
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 130
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: SINGLE (PARTICIPANT)|Primary Purpose: TREATMENT
Start Date: 2024-09-01
Completion Date: 2027-08-31

Summary:
The goal of this clinical trial is to test the preliminary efficacy of a brief mobile app targeting insomnia symptoms among veterans. In this study, we will enhance the mobile app, Insomnia Coach, with content from brief alcohol interventions to help veterans reduce both insomnia symptoms and alcohol use behaviors. We will compare those veterans who are randomly assigned to receive this brief mobile app intervention to those who receive a control condition. This will help us determine if veterans randomly assigned to receive the intervention experience greater improvement on outcomes compared to those who do not receive the intervention. The study involves a beta-test phase of the app to ensure feasibility and acceptability by veterans, followed by a randomized controlled trial with 130 veterans who meet criteria for insomnia and alcohol use disorder.

Primary Outcome Measures: Insomnia symptoms, 7-item Insomnia Severity Index (ISI). The ISI is a measure of insomnia symptoms including difficulty falling/staying asleep, sleep problems interfering with daily life, and concern about sleep problems., Past 30 days|Alcohol use frequency, Days used in past 30 days, Past 30 days|Alcohol use quantity, Number of drinks per drinking occasion, Past 30 days
Secondary Outcome Measures: Sleep quality, The 19-item Pittsburgh Sleep Quality Index will assess nuanced sleep behaviors at each time point (e.g., sleep latency, sleep duration, subjective sleep quality), Past 30 days|Alcohol-related consequences, 15-item Short Inventory of Alcohol Problems assesses problems from alcohol use across multiple domains such as interpersonal, intrapersonal, and physical., Past 30 days
Other Outcome Measures: Treatment initiation, Affirmative responses regarding whether participants initiated more formal treatment since starting the study, Past 30 days