pankajmathur/National_Library_of_Medicine_Studies_data huggingface dataset:
ClearPetra™ Vacuum-assisted Ureteral Access Sheath vs Traditional Approach
NCT Number: NCT06547632
Acronym: VA-UAS vs trad
Status: NOT_YET_RECRUITING
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Nephrolithiasis|Kidney Stone
Interventions: DEVICE: ClearPetra Ureteral access sheath
Sponsor: University of Kansas Medical Center
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 150
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: NONE|Primary Purpose: TREATMENT
Start Date: 2024-09-01
Completion Date: 2025-06-01
Locations: University of Kansas Medical Center, Kansas City, Kansas, 66160, United States

Summary:
Ureteroscopy has been considered the best approach when treating renal stones smaller than 2 cm. This procedure is usually performed together with ureteral access sheaths, which helps protect the ureter mucosa and lowers intrarenal pressure.

Recently, a new vacuum-assisted ureteral access sheath called ClearPetra has entered US market and allows for continuous stone fragmentation and aspiration.

Because there is little information on comparing this device with traditional approach (no sheath or non-vacuum-assisted sheath) in American population, we aim to compare those devices in terms of their ability to clear the kidney from kidney stones, as well as reduce infection rates postoperatively.

Primary Outcome Measures: To compare Stone Free Status between ClearPetra and traditional approach, Stone free is defined as no residual stones \>2mm in post operative CT scan, 90 days
Secondary Outcome Measures: To compare Total operative time between ClearPetra and traditional approach, Time from scope insertion to scope removal from the patient, 1 day|To compare Urinary tract infection between ClearPetra and traditional approach, Data collection searching for urine tract infection signs, symptoms, antibiotic administration and culture, 30 days of procedure
Role of ET-1, Physical Activity, and Sedentary Behavior in Microvascular Dysfunction Following GDM
NCT Number: NCT06547619
Status: NOT_YET_RECRUITING
Study Type: INTERVENTIONAL
Phases: EARLY_PHASE1
Conditions: Gestational Diabetes|Endothelial Dysfunction|Physical Inactivity
Interventions: DRUG: Insulin aspart
Sponsor: Anna Stanhewicz, PhD
Sex: FEMALE
Age: ADULT
Enrollment: 40
Study Design: Allocation: NON_RANDOMIZED|Intervention Model: PARALLEL|Masking: NONE|Primary Purpose: BASIC_SCIENCE
Start Date: 2024-09
Completion Date: 2027-05

Summary:
Women with a history of gestational diabetes mellitus (GDM) are at a 2-fold greater risk for the development of overt cardiovascular disease (CVD) following the effected pregnancy. While subsequent development of type II diabetes elevates this risk, prior GDM is an independent risk factor for CVD morbidity, particularly, within the first decade postpartum. GDM is associated with impaired endothelial function during pregnancy and decrements in macro- and microvascular function persist postpartum, despite the remission of insulin resistance following delivery. Collectively, while the association between GDM and elevated lifetime CVD risk is clear, and available evidence demonstrates a link between GDM and vascular dysfunction in the decade following pregnancy, the mechanisms mediating this persistent dysfunction remain unexamined.

The purpose of this investigation is to examine the role of endothelin-1, a potent vasoconstrictor, in aberrant microvascular function in otherwise healthy women with a history of GDM and to identify whether this mechanism is influenced by physical activity and sedentary behavior.

Primary Outcome Measures: microvascular insulin-mediated dilation, cutaneous vascular vasodilator responses to insulin perfusion in lactated Ringer's, BQ 788 and BQ-123, and L-NAME treated microdialysis sites, at the study visit, an average of 4 hours
Effect of Resistive Inspiratory Muscle Training Optimizing Lung Function in Spinal Cord Injury
NCT Number: NCT06547606
Status: NOT_YET_RECRUITING
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Spinal Cord Injury (SCI), Respiratory Complication
Interventions: OTHER: Usual Care
Sponsor: University of Dhaka
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 60
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: DOUBLE (PARTICIPANT, OUTCOMES_ASSESSOR)|Primary Purpose: TREATMENT
Start Date: 2024-08-01
Completion Date: 2025-01-01

Summary:
The goal of this clinical trial is to evaluate the effectiveness of resistive inspiratory muscle training (RIMT) in optimizing lung function in individuals with spinal cord injury (SCI). It will also learn about the safety and impact of RIMT on health-related quality of life in this population. The main questions it aims to answer are:

Does RIMT improve respiratory function in individuals with SCI? What impact does RIMT have on the health-related quality of life of participants? What are the perceived exertion or dyspnoea levels in participants undergoing RIMT? Researchers will compare RIMT to conventional respiratory physiotherapy to see if RIMT works to enhance lung function and improve overall respiratory outcomes in individuals with SCI.

Participants will:

Perform resistive inspiratory muscle training along with conventional respiratory physiotherapy 5 days a week for 4 weeks.

Primary Outcome Measures: Lung function, The spirometer is a medical device used to measure lung function by assessing the volume of air inhaled and exhaled. During a spirometry test, the patient breathes into a mouthpiece connected to the spirometer, which records the amount and rate of air breathed in and out. Key measurements include forced vital capacity (FVC) and forced expiratory volume in one second (FEV1)., at baseline and after 4 week|Expiratory flow rate during forced expiration, The peak flow meter is a device used to measure how well air moves out of the lungs. It helps assess the peak expiratory flow rate (PEFR), which is the fastest rate at which a person can blow air out of their lungs after taking a deep breath., at baseline and after 4 week|Health-Related Quality of Life (HRQoL), The SF-12 is a validated and reliable health survey that measures health-related quality of life. It comprises 12 questions covering eight domains: physical functioning, role-physical, bodily pain, general health, vitality, social functioning, role-emotional, and mental health. Responses are used to calculate summary scores for physical and mental health., at baseline and after 4 week|Perceived exertion and dyspnoea, The Modified Borg Scale is a validated tool for measuring perceived exertion during physical activity, ranging from 0 (no exertion) to 10 (maximal exertion). It allows individuals to rate their effort intensity, serving as a subjective measure of physical strain., at baseline and after 4 week
Promoting the Development of Autonomous Health Behaviors in Children and Adolescents Through Motivational Interviewing
NCT Number: NCT06547567
Status: NOT_YET_RECRUITING
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Pediatric Obesity
Interventions: BEHAVIORAL: Motivational Interviewing
Sponsor: Peking University
Sex: ALL
Age: CHILD
Enrollment: 150
Study Design: Allocation: RANDOMIZED|Intervention Model: SINGLE_GROUP|Masking: NONE|Primary Purpose: HEALTH_SERVICES_RESEARCH
Start Date: 2024-08
Completion Date: 2027-01

Summary:
1. Study Population

1. Sample Size: 150 children.
2. Randomization: This study will employ a randomized controlled intervention design. Participants will be stratified based on factors such as gender and age, and within each stratum, they will be randomly assigned in a 1:1 ratio to either the intervention group receiving motivational interviewing or the control group. The randomization process will be centralized and conducted by personnel not involved in the project.
3. Inclusion Criteria (all of the following must be met for inclusion):

   Both children/adolescents and their parents are willing to participate and demonstrate good compliance.

   Children/adolescents have a weight classified as normal, overweight, or obese. Age range: 10 to 14 years. Informed consent is obtained from both the child and the parent.
4. Exclusion Criteria (meeting any one of the following will result in exclusion):

Pathological obesity (e.g., due to endocrine disorders). Underweight. Clinically diagnosed severe mental illness or psychiatric disorders. Clinically diagnosed eating disorders (e.g., binge eating disorder). Physical developmental abnormalities or disabilities that prevent normal physical activity.

History of or plans to undergo pharmacological or surgical weight loss interventions within the next two years.

Primary Outcome Measures: Stages of Behavior Change, The main survey indicators include personality traits, autonomous motivation, behavioral attitudes, subjective norms, perceived behavioral control, behavioral intentions, stages of behavior change, obesity-related behaviors, 2 years|Obesity Status (BMI), The main survey indicators include obesity status, such as BMI, 2 years
A DDI Study to Investigate PK and Safety of Cefiderocol in Combination With Xeruborbactam in Healthy Adult Participants
NCT Number: NCT06547554
Status: NOT_YET_RECRUITING
Study Type: INTERVENTIONAL
Phases: PHASE1
Conditions: Bacterial Infections
Interventions: DRUG: Xeruborbactam|DRUG: Cefiderocol|DRUG: Xeruborbactam/Cefiderocol|DRUG: Dextrose 5% in water
Sponsor: Qpex Biopharma, Inc.
Collaborators: Shionogi Inc.|Biomedical Advanced Research and Development Authority
Sex: ALL
Age: ADULT
Enrollment: 40
Study Design: Allocation: RANDOMIZED|Intervention Model: CROSSOVER|Masking: TRIPLE (PARTICIPANT, CARE_PROVIDER, INVESTIGATOR)|Primary Purpose: TREATMENT
Start Date: 2024-09
Completion Date: 2025-12
Locations: Nucleus Network Minneapolis Clinic, Minneapolis, Minnesota, 55114, United States

Summary:
A phase 1, randomized, double blind, placebo controlled drug-drug interaction, pharmacokinetics and safety study of cefiderocol in combination with xeruborbactam in healthy adult participants

Primary Outcome Measures: The incidence and nature of treatment emergent adverse events (TEAE), Number of patients with Treatment-Emergent Adverse Events by subject, by group, severity and relationship to treatment., 17 days|Number of patients with changes from baseline in safety parameters, Number of patients with changes in safety parameters before and after dosing by subject and group., 17 days|Peak plasma Concentration measurements by subject and by cohort (Cmax), Comparison will be performed between the groups for concentration measurements (Cmax). Mean graphical presentation of the data will be reported., 17 days|Time concentration data measurements by subject and by cohort (Tmax), Comparison will be performed between the groups for time concentration data measurements (Tmax)., 17 days|Area under the plasma concentration versus time curve (AUC) between cohorts, Comparison will be performed between the groups for area under the plasma concentration versus time curve (AUC) Mean graphical presentation of the data will be reported. Statistical analysis of exposure parameters will be performed., 17 days|Urine Pharmacokinetic (PK) amount excreted by subject and by cohort, Urine Pharmacokinetic (PK) parameters such as amount excreted will be calculated from urinary excretion data., 17 days|Urine Pharmacokinetic (PK) % dose excreted by subject and by cohort, Urine Pharmacokinetic (PK) parameters such as amount of % dose excreted will be calculated from urinary excretion data., 17 days
Pharmacokinetics and Safety Profile of a Single Dose GZR4 in Subjects With Renal Impairment
NCT Number: NCT06547502
Status: RECRUITING
Study Type: INTERVENTIONAL
Phases: PHASE1
Conditions: Diabetes
Interventions: DRUG: GZR4
Sponsor: Gan and Lee Pharmaceuticals, USA
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 28
Study Design: Allocation: NON_RANDOMIZED|Intervention Model: PARALLEL|Masking: NONE|Primary Purpose: TREATMENT
Start Date: 2024-07-03
Completion Date: 2024-10-23
Locations: Site 1, Suzhou, Jiangsu, China

Summary:
This study will be conducted to investigated the effect of decreased kidney function on PK and safety of GZR4 and to guide dosing recommendations in people with kidney impairment.

Primary Outcome Measures: AUC0-inf, Day1-Day29|AUC0-last, Day1-Day29|Cmax, Day1-Day29
Secondary Outcome Measures: Incidence of TEAE, Day1-Day29|AUC0-168h, Day1-Day29|Tmax, Day1-Day29|T1/2, Day1-Day29
GATE-251 or Placebo for the Reduction of Symptoms of Major Depressive Disorder
NCT Number: NCT06547489
Status: NOT_YET_RECRUITING
Study Type: INTERVENTIONAL
Phases: PHASE2
Conditions: Major Depressive Disorder
Interventions: DRUG: zelquistinel
Sponsor: Gate Neurosciences, Inc
Sex: ALL
Age: ADULT
Enrollment: 164
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: QUADRUPLE (PARTICIPANT, CARE_PROVIDER, INVESTIGATOR, OUTCOMES_ASSESSOR)|Primary Purpose: TREATMENT
Start Date: 2024-09-30
Completion Date: 2026-12-31

Summary:
The goal of this clinical trial is to learn if GATE-251 works to treat depression in adults. It will also learn about the safety of GATE-251. The main questions it aims to answer are:

Does GATE-251 reduce depression scores in participants compared to participants who take a placebo (a look-alike tablet that contains no GATE-251)?

What medical problems are observed in participants who take GATE-251?

Participants will take one tablet of GATE-251 or placebo every week for 6 weeks. Participants will visit the clinic every week of the 6 week period to have the severity of their depression evaluated.

Primary Outcome Measures: Change in the Hamilton Depression Rating Scale-17 score compared to placebo, A 17-item rating scale used to assess the severity of depression, Change in score from baseline 6 weeks
Secondary Outcome Measures: Change in the Clinical Global Impressions - Severity score compared to placebo, A 7-level rating scale used by a clinician to gauge depression severity, Change in score from baseline to 6 weeks
Chidamide and PD-1 Inhibitor Plus Anlotinib for HER2-low Breast Cancer That Has Spread or Cannot be Surgically Removed
NCT Number: NCT06547476
Status: NOT_YET_RECRUITING
Study Type: INTERVENTIONAL
Phases: PHASE2
Conditions: Breast Cancer
Interventions: DRUG: Tucidinostat (chidamide), PD-1 inhibitor (tislelizumab), anlotinib
Sponsor: Guangdong Provincial People's Hospital
Sex: FEMALE
Age: ADULT, OLDER_ADULT
Enrollment: 40
Study Design: Allocation: NA|Intervention Model: SINGLE_GROUP|Masking: NONE|Primary Purpose: TREATMENT
Start Date: 2024-09-01
Completion Date: 2026-12-31

Summary:
This Phase II study was designed to assess the efficacy and safety of the combination of PD-1 inhibitor, Tucidinostat (chidamide), a histone deacetylase inhibitor, and anlotinib in advanced breast cancer.

Participants must have HER2-low and PD-L1 positive （CPS≥1）breast cancer that has been treated before.

Participants' cancer:

Cannot be removed by an operation Has spread to other parts of the body

Primary Outcome Measures: Progression-free survival(PFS), Time from treatment until disease progression or death, 2 years
Secondary Outcome Measures: Objective Response Rate（ORR）, Objective Response Rate（ORR）by RECIST 1.1,the total proportion of patients with complete response（CR）, partial response（PR）, 2 years|Clinical Benefit Rate (CBR), the total proportion of patients with Partial Response (PR), Complete Response (CR) or Stable Disease (SD) ≥6 months, 2 years|Disease Control Rate （DCR）, the total proportion of patients with complete response（CR）, partial response（PR）and stable disease（SD）, 2 years|Overall survival (OS), Time from treatment until death from any cause, 2 years
Effects of Nasal Airflow on Sleep in Tracheotomized Patients
NCT Number: NCT06547463
Acronym: NASA
Status: NOT_YET_RECRUITING
Study Type: OBSERVATIONAL
Conditions: Patients With Prolonged Weaning
Interventions: OTHER: nasal oxygenation device
Sponsor: Assistance Publique - Hôpitaux de Paris
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 24
Study Design: Observational Model: |Time Perspective: p
Start Date: 2024-10-01
Completion Date: 2026-01-01

Summary:
The passage of air through the nasal cavities generates rhythmic oscillations transmitted by the olfactory bulb to the brain, which induces cerebral activation in functional brain areas and is associated with better cognitive performance compared to oral breathing. Consequently, the abolition of nasal ventilation - intrinsic in tracheotomized and ventilated patients - could have deleterious effects on brain activity. Besides the loss of olfaction, the abolition of nasal ventilation could affect brain activity and sleep.

The hypothesis of the present study is that the restoration of nasal stimulation by the passage of humidified nasal airflow in tracheotomized and ventilated patients improves sleep quality, notably with a greater proportion of time spent in REM sleep.

Primary Outcome Measures: Effects of nasal ventilation on sleep quality in ventilation-dependent tracheostomized patients., The proportion of time spent in REM sleep over the total sleep time, During the 12 hours duration of PSG
Secondary Outcome Measures: Effects of nasal ventilation on sleep duration, Total sleep time as determined by polysomnography, During the 12 hours duration of PSG|Effects of nasal ventilation on sleep architecture, Proportion of time spent in stage 1, stage 2 and stage 3 sleeping, During the 12 hours duration of PSG|Effects of nasal ventilation on the proportion of atypical sleep, Proportion of time spent in atypical sleep, During the 12 hours duration of PSG|Effects of nasal ventilation on minute ventilation, Measurement of transcutaneous PaCO2, During the 12 hours duration of PSG|Effects of nasal ventilation on night-time awakenings, Prevalence of night-time awakenings, During the 12 hours duration of PSG|Effects of nasal ventilation on patient-ventilator asynchrony, Asynchrony index (number of asynchronies/total number of respiratory cycles), During the 12 hours duration of PSG
Papaverine and Oxytocin vs Oxytocin Alone in Labor Induction
NCT Number: NCT06547437
Status: NOT_YET_RECRUITING
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Induced; Birth|Labor Onset and Length Abnormalities
Interventions: DRUG: Papaverine|DRUG: normal saline
Sponsor: Western Galilee Hospital-Nahariya
Sex: FEMALE
Age: ADULT
Enrollment: 126
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: QUADRUPLE (PARTICIPANT, CARE_PROVIDER, INVESTIGATOR, OUTCOMES_ASSESSOR)|Primary Purpose: TREATMENT
Start Date: 2024-09
Completion Date: 2025-12

Summary:
This study aims to evaluate the efficacy and safety of combining papaverine with oxytocin for labor induction compared to oxytocin alone

Primary Outcome Measures: time to active delivery, time from labor induction till dilatation of 6 cm, 24 HOURS AFTER DELIVERY
Secondary Outcome Measures: vaginal deliveries in 24 hours, rate of vaginal deliveries in 24 hours, 24 HOURS AFTER DELIVERY|total length of labor, time for induction to delivery, 24 HOURS AFTER DELIVERY|cesarean delivery rate, rate of emergent cesarean delivery during labor, ho24 HOURS AFTER DELIVERY|length of second stage of labor, second stage of labor in hours, 24 hours after delivery
Phase I Clinical Study of Chondroitin Sulfate for Treatment of NEC
NCT Number: NCT06547424
Status: NOT_YET_RECRUITING
Study Type: INTERVENTIONAL
Phases: PHASE1
Conditions: Necrotizing Enterocolitis|Intestinal Ischemia
Interventions: DRUG: Chondroitin sulfate
Sponsor: Indiana University
Sex: ALL
Age: CHILD
Enrollment: 20
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: TRIPLE (PARTICIPANT, CARE_PROVIDER, INVESTIGATOR)|Primary Purpose: TREATMENT
Start Date: 2025-01
Completion Date: 2029-03
Locations: Riley Hospital for Children, Indianapolis, Indiana, 46202, United States

Summary:
The goal of this phase 1 double blind, randomized controlled trial is to determine the safety of chondroitin sulfate supplementation in the neonates with necrotizing enterocolitis. The main questions the study aims to answer are:

Is chondroitin sulfate safe to administer in the neonatal NEC population, and will it have a beneficial profile in the short term intestinal and long term neurodevelopmental sequelae of NEC? Researchers will compare all cause mortality, progression to surgery, systemic inflammatory markers, and long term neurodevelopmental outcomes in those NEC patients who receive chondroitin sulfate compared to those who receive milk or formula placebo.

Primary Outcome Measures: Mortality, 14 and 28 days post intervention|Progression to need for surgery, Infants with Stage 2 NEC can progress to stage 3 NEC and require surgery to remove intestinal tissue. This rate will be compared in the intervention and placebo arms, 14 and 28 days post intervention
Secondary Outcome Measures: Systemic inflammatory markers, Blood will be assessed for common inflammatory markers, 14 and 28 days post intervention|Neurodevelopmental impairment (NDI), NDI will be assessed at 1 and 2 years post intervention. eurodevelopmental impairment will be defined as any of the following: moderate to severe cerebral palsy (CP) with Gross Motor Function Classification System level ≥ 2, Bayley-IV cognitive composite score \<85, severe bilateral visual impairment consistent with vision \<20/200, or permanent hearing loss despite amplification that prevents communication or understanding the examiner, 1 and 2 years post intervention
Study of ONO-4578 and XELOX/FOLFOX Plus Bevacizumab in Colorectal Cancer
NCT Number: NCT06547385
Status: ACTIVE_NOT_RECRUITING
Study Type: INTERVENTIONAL
Phases: PHASE1
Conditions: Colorectal Cancer
Interventions: DRUG: ONO-4578|DRUG: ONO-4538|DRUG: Capecitabine|DRUG: Oxaliplatin|DRUG: Fluorouracil|DRUG: Calcium Levofolinate Hydrateb|DRUG: Bevacizumab
Sponsor: Ono Pharmaceutical Co. Ltd
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 40
Study Design: Allocation: NON_RANDOMIZED|Intervention Model: SEQUENTIAL|Masking: NONE|Primary Purpose: TREATMENT
Start Date: 2021-01-13
Completion Date: 2027-10-31
Locations: National Cancer Center Hospital East, Kashiwa-shi, Chiba, Japan|Kobe City Hospital Organization Kobe City Medical Center General Hospital, Kobe-shi, Hyogo, Japan|Kanagawa Cancer Center, Yokohama-shi, Kanagawa, Japan|Saitama Cancer Center, Ina, Kitaadati-gun, Saitama, Japan|NHO Osaka National Hospital, Osaka-shi, Osaka, Japan|Osaka General Medical Center, Osaka-shi, Osaka, Japan|Osaka Medical and Pharmaceutical University Hospital, Takatsuki-shi, Osaka, Japan|Saitama Medical University International Medical Center, Hidaka-shi, Saitama, Japan|Cancer Institute Hospital of JFCR, Koto-Ku, Tokyo, Japan

Summary:
To evaluate the tolerability and safety of combination of ONO-4578 and ONO-4538 and the standard of care XELOX + bevacizumab or the safety of combination of ONO-4578 and ONO-4538 and the standard of care FOLFOX + bevacizumab as first-line therapy in patients with unresectable, advanced, or recurrent colorectal cancer.

Primary Outcome Measures: Incidence and severity of AEs and SAEs, up to 3years|Incidence and severity of clinical laboratory abnormalities, up to 3years|12-lead electrocardiography (Heart rate), up to 3years|12-lead electrocardiography (PR interval), up to 3years|12-lead electrocardiography (RR interval), up to 3years|12-lead electrocardiography (QRS width), up to 3years|12-lead electrocardiography (QT interval), up to 3years|Chest X-ray test, up to 3years|ECOG performance status, up to 3years
Secondary Outcome Measures: Objective response rate (ORR), up to 3years|Disease control rate (DCR), up to 3years|Overall survival (OS), up to 3years|Progression-free survival (PFS), up to 3years|Duration of response (DOR), up to 3years|Time to response (TTR), up to 3years|Best oveall response (BOR), up to 3years|Percentage of change in the sum of tumor diameters of target lesions, up to 3years|Maximum percent change in the sum diameters of the target lesions, up to 3years|Time course of tumor markers, up to 3years|Plasma ONO-4578 concentration, up to 3years|Serum ONO-4538 concentration, up to 3years|Anti-ONO-4538 antibody, up to 3years
A Study to Evaluate Drug-Drug Interactions of Obicetrapib Tablets and Ezetimibe Tablets in Healthy Adult Subjects
NCT Number: NCT06547359
Status: NOT_YET_RECRUITING
Study Type: INTERVENTIONAL
Phases: PHASE1
Conditions: Healthy Volunteers
Interventions: DRUG: Obicetrapib 10mg|DRUG: Ezetimibe 10mg
Sponsor: NewAmsterdam Pharma
Collaborators: Pharma Medica Research, Inc.
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 94
Study Design: Allocation: NON_RANDOMIZED|Intervention Model: SEQUENTIAL|Masking: NONE|Primary Purpose: TREATMENT
Start Date: 2024-09-16
Completion Date: 2024-11-12
Locations: PharmaMedica Research Inc., Toronto, Ontario, M1S 3V6, Canada

Summary:
A Study to Evaluate Drug-Drug Interactions of Obicetrapib Tablets and Ezetimibe Tablets in Healthy Adult Subjects

Primary Outcome Measures: Cmax (Obicetrapib, unconjugated ezetimibe, and ezetimibe glucuronide), Maximum measured analyte concentration, time zero (0) to the time of the last measurable analyte concentration (t), up to 18 days|AUCt (Obicetrapib, unconjugated ezetimibe, and ezetimibe glucuronide), The area under the analyte concentration versus time curve, time zero (0) to the time of the last measurable analyte concentration (t)|AUCinf (Obicetrapib, unconjugated ezetimibe, and ezetimibe glucuronide), The area under the analyte concentration versus time curve, m time zero to infinity
Secondary Outcome Measures: Tmax (Obicetrapib, unconjugated ezetimibe, and ezetimibe glucuronide), Time of the maximum measured analyte concentration, zero (0) to the time of the last measurable analyte concentration (t), up to 18 days|Kel (Obicetrapib, unconjugated ezetimibe, and ezetimibe glucuronide), The apparent first-order elimination rate constant, time zero (0) to the time of the last measurable analyte concentration (t), up to 18 days|Thalf (Obicetrapib, unconjugated ezetimibe, and ezetimibe glucuronide), The apparent elimination half-life, zero (0) to the time of the last measurable analyte concentration (t), up to 18 days|CL/F (Obicetrapib, unconjugated ezetimibe, and ezetimibe glucuronide), Total body clearance, time zero (0) to the time of the last measurable analyte concentration (t), up to 18 days|Vd/F (Obicetrapib, unconjugated ezetimibe, and ezetimibe glucuronide), Apparent volume of distribution, time zero (0) to the time of the last measurable analyte concentration (t), up to 18 days
Acceptability and Palatability Study of Paediatric Amino Acid Feed
NCT Number: NCT06547346
Status: RECRUITING
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Allergy
Interventions: DIETARY_SUPPLEMENT: Alfamino Junior
Sponsor: Société des Produits Nestlé (SPN)
Sex: ALL
Age: CHILD
Enrollment: 15
Study Design: Allocation: NA|Intervention Model: SINGLE_GROUP|Masking: NONE|Primary Purpose: BASIC_SCIENCE
Start Date: 2024-01-05
Completion Date: 2024-09-03
Locations: Paediatric allergy, Leeds Children's Hospital, Clarendon Wing, Leeds General Infirmary, Leeds,, Leeds, LS1 3EX, United Kingdom

Summary:
Product acceptability and palatability data from a minimum of 15 participants are required to submit an application to the Advisory Committee on Borderline Substances (ACBS) and the Health Service Executive (HSE) for Ireland for product registration

Primary Outcome Measures: Number of children reporting gastrointestinal tolerance using an online questionnaire., Number of patients reporting diarrhoea and / or constipation, Bloating and / or distension, Nausea and / or vomiting, Burping / flatulence / regurgitation, Abdominal discomfort/ pain, measured as symptoms and graded as none, mild moderate or severe, 7 days|Palatability, indicated via symbols of how much the product is liked using online questionnaire., Number of children who like the appearance, taste, smell graded as as 5 likert scale of an online questionnaire from really liked to really did not like using happy to sad images to correctly identify outcome., 7 days|Participant compliance, How many feeds and volume prescribed each day, How many feeds and volume taken, 7 days
Sensor-based Just-in Time Adaptive Interventions (JITAIs) Targeting Eating Behavior
NCT Number: NCT06547320
Status: RECRUITING
Study Type: INTERVENTIONAL
Phases: PHASE2
Conditions: Overweight and Obesity
Interventions: BEHAVIORAL: Eat Less Intervention|BEHAVIORAL: Eat Slower Intervention
Sponsor: The Miriam Hospital
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 90
Study Design: Allocation: NA|Intervention Model: SINGLE_GROUP|Masking: NONE|Primary Purpose: TREATMENT
Start Date: 2024-08-01
Completion Date: 2025-08-31
Locations: Boston University, Boston, Massachusetts, 02215, United States|The Miriam Hospital Weight Control and Diabetes Resarch Center, Providence, Rhode Island, 02903, United States

Summary:
The purpose of this study is to determine whether a sensor device called an Automatic Ingestion Monitor (AIM) that is worn on eyeglasses can be used with a smartphone to change eating behavior. Participants will wear the device for one week of no-intervention observation. They will then test behavioral interventions focused on eating for two weeks. The researchers hypothesize that messages sent to a smartphone that are based on information from the AIM can reduce the amount of food that is eaten and slow eating.

Primary Outcome Measures: Total energy intake, Total amount of energy consumed from foods and beverages, Daily average computed for the 7-day observation period and each 7-day intervention period
Secondary Outcome Measures: Energy intake per eating occasion, Amount of energy consumed from foods and beverages during each eating occasion, Average intake per eating occasion computed for the 7-day observation period and each 7-day intervention period|Rate of eating per eating occasion, Chews per minute during each eating occasion., Average intake per eating occasion computed for the 7-day observation period and each 7-day intervention period
CYP1A2 and ADORA2A Genotypes and Endurance Performance.
NCT Number: NCT06547307
Status: RECRUITING
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Healthy
Interventions: DIETARY_SUPPLEMENT: Caffeine 2 mg|DIETARY_SUPPLEMENT: Caffeine 4 mg|DIETARY_SUPPLEMENT: Caffeine 0 mg
Sponsor: Masaryk University
Sex: ALL
Age: ADULT
Enrollment: 60
Study Design: Allocation: RANDOMIZED|Intervention Model: CROSSOVER|Masking: TRIPLE (PARTICIPANT, INVESTIGATOR, OUTCOMES_ASSESSOR)|Primary Purpose: BASIC_SCIENCE
Start Date: 2024-08
Completion Date: 2025-03
Locations: Masaryk University, Brno, Czechia

Summary:
The aim of this randomized, double-blind, placebo-controlled experiment will be to assess the potential effect of the selected gene polymorphism (CYP1A2, ADORA2A) on performance after caffeine ingestion.

Primary Outcome Measures: Efficacy of caffeine to improve endurance performance (time to complete 10 km trial), To determine if caffeine intake improves endurance performance compared to placebo. Efficacy of caffeine doses (2 mg/kg and 4 mg/kg) to shorten the time needed to complete the 10 km time trial., 2 Hours
Secondary Outcome Measures: Caffeine ingestion and genotype interaction, To determine if different variants of selected genes affect the potential ergogenic effect of caffeine. A buccal mucosa smear will be taken to identify variants of CYP1A2 and ADORA2A genes to determine which genes/variants are associated with improvement in time trial performance after caffeine ingestion., 1 day
Does a Novel Needle Over Catheter Device Improve First Pass Success and Decrease Complications
NCT Number: NCT06547294
Status: NOT_YET_RECRUITING
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Vascular Access Device Complications|Catheterization, Peripheral
Interventions: DEVICE: Osprey IV|OTHER: Historical Controls
Sponsor: Community Medical Center, Toms River, NJ
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 200
Study Design: Allocation: NA|Intervention Model: SINGLE_GROUP|Masking: NONE|Primary Purpose: TREATMENT
Start Date: 2024-10
Completion Date: 2025-09
Locations: Robert Wood Johnson Barnabas Health Community Medical Center, Toms River, New Jersey, 08755, United States

Summary:
Emergency Department Patients who were to get intravenous (IV) access through routine medical care will receive it through trademarked catheter via convenience sample. Patient and clinician experience, including adverse events, will be recorded. A standardized data entry sheet will be collected at time of enrollment, and then daily thereafter while the subject has the IV. The data collected will remain anonymous.

Primary Outcome Measures: Number of Attempts, The number of attempts that operator needs to access vein and secure device for proper bidirectional flow, 10 minutes
Secondary Outcome Measures: Blood culture contamination rates, Proportion of blood culture specimens (when drawn) that are reported with contaminants, 1 week|Flushing characteristic, whether operator finds flow into patient to be impeded or unimpeded, 10 minutes|Patient discomfort, Patient's self assessment of level of pain experienced by insertion, 10 minutes|Time to removal, Total days device remained in place, 1 week|Removal reason, If removed for device failure vs cessation of therapy, 1 week|Edema, Presence of edema, 1 week|Redness, Presence of redness, 1 week|Drainage, Presence of drainage, 1 week|Site Pain, Presence of site pain, 1 week
Machine Learning Prediction of Multiple Infections in Elderly Surgical Patients
NCT Number: NCT06547281
Status: COMPLETED
Study Type: OBSERVATIONAL
Conditions: Postoperative Infection|Geriatrics|Prediction
Sponsor: Weidong Mi
Sex: ALL
Age: OLDER_ADULT
Enrollment: 42540
Study Design: Observational Model: |Time Perspective: p
Start Date: 2022-09-01
Completion Date: 2024-03-30
Locations: Depatment of Anesthesiology, The First Medical Center Affiliation: Chinese PLA General Hospital, Beijing, Beijing, 100853, China

Summary:
Utilizing machine learning techniques, investigators developed the geriatric infection assessment model, leveraging domestic databases to predict multiple postoperative infections in elderly patients. The model addresses the current gap in predictive tools tailored for elderly surgical patients in China, offering insights into both overall and specific infection risks.

Primary Outcome Measures: Machine Learning Prediction of Multiple Infections in Elderly Surgery Patients, Utilizing machine learning techniques, investigators developed the geriatric infection assessment model, leveraging domestic databases to predict multiple postoperative infections in elderly patients., January 2014 - August 2019
Advancing the Science of Pediatric Interstage Home Monitoring
NCT Number: NCT06547268
Acronym: Heart@Home
Status: RECRUITING
Study Type: OBSERVATIONAL
Conditions: Heart Defects, Congenital
Interventions: DEVICE: Wireless sensor and platform
Sponsor: Ann & Robert H Lurie Children's Hospital of Chicago
Collaborators: Sibel Health Inc.
Sex: ALL
Age: CHILD
Enrollment: 20
Study Design: Observational Model: |Time Perspective: p
Start Date: 2024-07-24
Completion Date: 2026-08
Locations: Ann & Robert H. Lurie Children's Hospital of Chicago, Chicago, Illinois, 60611, United States

Summary:
The overall goal of this study is to understand the feasibility of using a wireless sensor device (instead of a wired device) to collect information used to monitor children with heart conditions at home.

Primary Outcome Measures: Physiologic measurements, Physiologic data waveform morphology, up to 14 days per patient of data collection
Secondary Outcome Measures: Systems Usability Score, Score from 0 (min) to 100 (max) of usability with higher is better (100=perfect)., up to 14 days per patient of data collection|Utilization, Emergency departnment use, up to 14 days per patient of data collection
Exparel Versus Bupivacaine in Post-operative Pain Control
NCT Number: NCT06547255
Status: RECRUITING
Study Type: INTERVENTIONAL
Phases: PHASE4
Conditions: Liposomal Bupivacaine
Sponsor: Case Western Reserve University
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 100
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: SINGLE (PARTICIPANT)|Primary Purpose: TREATMENT
Start Date: 2024-08-21
Completion Date: 2024-12-31

Summary:
This is a prospective, randomized study to evaluate anaesthetic parameters, postoperative analgesia and oral analgesic consumption comparing exparel (liposomal bupivacaine) vs. standard bupivacaine

Primary Outcome Measures: post operative pain, At home questionnaire with a numerical scale (0 - 10), to be completed each morning and evening for four days post-operative, 96 hours post-operatively|Adverse effects, At home questionnaire including the presence or absence of any abnormal sensations, change in taste, nausea, constipation, fever, diaphoresis, vomiting, light-headedness, palpitations, or headache., 96 hours post-operatively|NSAID/Acetaminophen use, Ibuprofen 600mg \[Advil\], Tylenol) Use, 96 hours post-operatively|Norco 5/325 (Hydrocone-Acetaminophen) Use, At home questionnaire including the dosage, time, quantity and reason for use, 96 hours post-operatively
Levothyroxine-sodium Bioequivalence Trial With Oral Single Dose Administration
NCT Number: NCT06547242
Status: COMPLETED
Study Type: INTERVENTIONAL
Phases: PHASE1
Conditions: Healthy
Interventions: DRUG: Levothyroxin|DRUG: Levothyroxin
Sponsor: Berlin-Chemie AG Menarini Group
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 132
Study Design: Allocation: RANDOMIZED|Intervention Model: CROSSOVER|Masking: NONE|Primary Purpose: OTHER
Start Date: 2021-10-22
Completion Date: 2022-05-22
Locations: Phase I Unit, Erfurt, Thuringia, 99084, Germany

Summary:
Levothyroxine-sodium Bioequivalence Trial With Oral Single Dose Administration

Primary Outcome Measures: AUC0-72, AUC0-72 of levothyroxine (baseline corrected) after each treatment, 72 days|Cmax, Cmax of levothyroxine (baseline corrected) after each treatment, 72 days
Secondary Outcome Measures: AUC0-tlast, AUC0-tlast of levothyroxine (baseline corrected) after each treatment, 72 days|AUC0-∞, AUC0-∞ of levothyroxine (baseline corrected) after each treatment, 72 days|AUCexpol%, AUCexpol% of levothyroxine (baseline corrected) after each treatment, 72 days|tmax, tmax of levothyroxine (baseline corrected) after each treatment, 72 days|t1/2, t1/2 of levothyroxine (baseline corrected) after each treatment, 72 days|λz, λz of levothyroxine (baseline corrected) after each treatment, 72 days|tlag, tlag of levothyroxine (baseline corrected) after each treatment, 72 days
Clinicopathological Features and Genetic Susceptibility Screening of Recurrent Drug-induced Liver Injury
NCT Number: NCT06547229
Acronym: RDILI-GS
Status: ACTIVE_NOT_RECRUITING
Study Type: OBSERVATIONAL
Conditions: Recurrent Drug-induced Liver Injury
Sponsor: Beijing Friendship Hospital
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 60
Study Design: Observational Model: |Time Perspective: p
Start Date: 2024-07-15
Completion Date: 2028-06
Locations: Liver Research Center, Beijing Friendship Hospital, Key Laboratory on Translational Medicine on Cirrhosis, National Clinical Research Center for Digestive Disease, Capital Medical University, Beijing, China, Beijing, Beijing, 100050, China

Summary:
The goal of this observational study is to screening for clinical, pathological and HLA features in patients with recurrent drug-induced liver injury. The main question it aims to answer is: Which patients with drug-induced liver injury need to be more cautious when re-dosing?

Primary Outcome Measures: Death/Liver transplantation, DILI has a primary, contributory role for the death (liver-related mortality) or no role for the death (all-cause mortality) .

DILI is the primary indication for liver transplantation., 1 year|Acute Liver Failure, Acute liver failure is defined as elevated bilirubin and prolonged international normalized ratio (INR) ≥1.5 accompaniedby mental disturbance within 26 weeks after DILI onset without underlying chronic liver diseases., 1 year|Recovery, Recovery status is defined as clinical and biochemical resolution within 1 year after DILI onset, with alanineaminotransferase (ALT) or aspartate aminotransferase (AST) ≤40 U/L, alkaline phosphatase (ALP) ≤150 U/L, and totalbilirubin (TB) ≤1.5 upper limits of normal (ULN) (25.65 μmol/L)., 1 year
Secondary Outcome Measures: chronic DILI, Chronicity is defined as the presence of any one of the following: (i) persistently elevated liver biochemistry indexes; (ii)radiological or histological evidence of persistent liver injury at one year after DILI onset., 2 years
Phase 2 Open-label Extension Study of AOC 1020 in Adults With Facioscapulohumeral Muscular Dystrophy (FSHD)
NCT Number: NCT06547216
Acronym: FORTITUDE-OLE
Status: ENROLLING_BY_INVITATION
Study Type: INTERVENTIONAL
Phases: PHASE2
Conditions: FSHD|FSHD1|FSHD2|FMD|FMD2|Fascioscapulohumeral Muscular Dystrophy|Fascioscapulohumeral Muscular Dystrophy Type 1|Fascioscapulohumeral Muscular Dystrophy Type 2|Dystrophies, Facioscapulohumeral Muscular|Dystrophy, Facioscapulohumeral Muscular|Facioscapulohumeral Muscular Dystrophy 1|Facioscapulohumeral Muscular Dystrophy 2|Facio-Scapulo-Humeral Dystrophy|Atrophy, Facioscapulohumeral|Atrophies, Facioscapulohumeral|Facioscapulohumeral Atrophy|Muscular Dystrophies|Muscular Dystrophy, Facioscapulohumeral|FSH Muscular Dystrophy|Landouzy Dejerine Dystrophy|Landouzy-Dejerine Muscular Dystrophy|Dystrophies, Landouzy-Dejerine|Dystrophy, Landouzy-Dejerine|Landouzy-Dejerine Syndrome|Muscular Dystrophy, Landouzy Dejerine|Progressive Muscular Dystrophy|FSH
Interventions: DRUG: AOC 1020
Sponsor: Avidity Biosciences, Inc.
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 72
Study Design: Allocation: NON_RANDOMIZED|Intervention Model: PARALLEL|Masking: NONE|Primary Purpose: TREATMENT
Start Date: 2024-07-25
Completion Date: 2028-04
Locations: University of California Los Angeles, Los Angeles, California, 90095, United States|Stanford University, Palo Alto, California, 94304, United States|University of California San Diego, San Diego, California, 92093, United States|University of Colorado, Denver, Colorado, 80045, United States|University of Florida, Gainesville, Florida, 32608, United States|Rare Disease Research, Atlanta, Georgia, 30329, United States|Kansas University Medical Center, Kansas City, Kansas, 66205, United States|University of Rochester Medical Center, Rochester, New York, 14642, United States|Duke University, Durham, North Carolina, 27708, United States|Ohio State University, Columbus, Ohio, 43221, United States|University of Pennsylvania, Philadelphia, Pennsylvania, 19104, United States|University of Texas Southwestern, Dallas, Texas, 75390, United States|Virginia Commonwealth University, Richmond, Virginia, 23298, United States|University of Washington, Seattle, Washington, 98104, United States|University of Ottawa, Ottawa, Ontario, K1Y 4E9, Canada|University College London, London, WIT 7HA, United Kingdom|University of Sheffield, Sheffield, S10 2TN, United Kingdom

Summary:
A Phase 2 Open-label Extension Study to Evaluate the Long-Term Safety, Tolerability, Efficacy, and Pharmacokinetics of AOC 1020 Administered Intravenously to Adult Participants with Facioscapulohumeral Muscular Dystrophy (FSHD)

Primary Outcome Measures: Incidence of treatment-emergent adverse events, Through study completion, up to Day 729
Cetuximab, Irinotecan, Toripalimab in RAS/BRAF Wild-type Ultraselected Right-sided Colorectal Cancer Study
NCT Number: NCT06547203
Status: RECRUITING
Study Type: INTERVENTIONAL
Phases: PHASE2
Conditions: Colorectal Cancer Metastatic
Interventions: DRUG: Cetuximab|DRUG: Toripalimab|DRUG: Irinotecan
Sponsor: Sun Yat-sen University
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 34
Study Design: Allocation: NA|Intervention Model: SINGLE_GROUP|Masking: NONE|Primary Purpose: TREATMENT
Start Date: 2024-07-18
Completion Date: 2029-07-30
Locations: Sun Yat-sen University Cancer Center, Guangzhou, Guangdong, 510060, China

Summary:
The objective of this clinical trial is to evaluate the efficacy and safety of cetuximab combined with PD-1 inhibitor and irinotecan in negative ultraselection RAS/BRAF wild-type refractory right-sided metastatic colorectal cancer.

Primary Outcome Measures: Objective Response Rate, The proportion of patients who have achieved partial response (PR) plus complete response (CR), as assessed by the investigator using RECIST v1.1 criteria, Assessed after every 4 cycles (each cycle is 14 days) for up to 24 months
Secondary Outcome Measures: Disease Control Rate, The proportion of patients who have achieved complete response (CR), partial response (PR), or stable disease (SD) following treatment initiation., Assessed after every 4 cycles (each cycle is 14 days) for up to 24 months|Duration of Response, Length of time from the initial detection of a measurable response (complete response or partial response) to the treatment until the first documentation of disease progression or recurrence, Assessed after every 4 cycles (each cycle is 14 days) for up to 24 months|Progression-Free Survival, The length of time from the start of treatment until the disease progresses or the patient dies from any cause, whichever occurs first., Assessed up to 24 months|Overall Survival, Defined as the time from the start of study treatment to death due to any cause, Assessed throughout the study duration (5 years)|Adverse events (Treatment-related), Assessment of adverse events and their severity according to NCI CTCAE version 5.0 criteria., Assessed throughout the study duration (5 years)
Study on Treating by Eating: Role of AGEs on Mucosal Barrier and Microbiome.
NCT Number: NCT06547190
Acronym: STEAMM
Status: COMPLETED
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Healthy
Interventions: BEHAVIORAL: High AGEs diet|BEHAVIORAL: Low AGEs diet
Sponsor: Universitaire Ziekenhuizen KU Leuven
Collaborators: Vlaams Instituut voor Biotechnologie (VIB)
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 20
Study Design: Allocation: RANDOMIZED|Intervention Model: CROSSOVER|Masking: NONE|Primary Purpose: PREVENTION
Start Date: 2022-02-01
Completion Date: 2022-07-30
Locations: University Hospital of Leuven, Leuven, Belgium

Summary:
This is an exploratory study aimed at healthy volunteers to investigate the impact of differential cooking methods on global and gut inflammation, intestinal permeability, and the gut microbiota. The investigators hypothesize that a short dietary intervention of baking and grilling of food for 2 weeks as opposed to steaming and boiling of food for 2 weeks will result in measurable differences in blood, stool and urine samples that guide towards gut and overall health and disease. All food will be provided, together with detailed cooking instructions. Food logs including photographs will be used to check whether participants complied with the study.

The investigators aim to better understand the role of cooking methods in human health, so that this can be implemented in preventive strategies and dietary treatments for specific patient groups.

Primary Outcome Measures: Intestinal inflammation, Measurement of faecal calprotectin through stool samples (in mg/kg), 2 weeks|Gut microbial metabolism, Measurement of short chain fatty acids including acetic acid, propionic acid and butyric acid through stool samples (in mg/100g stool), 2 weeks|Gut microbial composition, Measurement of the composition of the gut microbiota using 16s rRNA sequencing of stool samples., 2 weeks|Intestinal transcellular permeability, Measurement of transcellular intestinal permeability using lipopolysaccharide binding protein in blood samples, 2 weeks|Intestinal paracellular permeability, Measurement of paracellular intestinal permeability using the lacultulose mannitol test using urine samples, 2 weeks|Systemic inflammation, serum inflammation through OLINK inflammatory panel (measurement of 92 proteins in blood), 2 weeks|Systemic inflammation, Every serum CRP in blood samples (in mg/l), 2 weeks|Systemic cardiometabolic health, serum cardiometabolic parameters through OLINK cardiometabolic panel (measurement of 92 proteins in blood), 2 weeks|Systemic lipid profile, Total, LDL- and HDL-cholesterol values in blood samples (in mg/dl), 2 weeks|Weight changes, weight (in kg), 2 weeks|Handgrip strength changes, Handgrip strength (in kg), 2 weeks