pankajmathur/National_Library_of_Medicine_Studies_data huggingface dataset:
To Validate Point Mini User Needs
NCT Number: NCT06504667
Status: NOT_YET_RECRUITING
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Amputation; Traumatic, Hand|Amputation, Congenital
Interventions: DEVICE: Point Mini
Sponsor: Point Designs
Collaborators: University of Colorado, Denver
Sex: ALL
Age: CHILD
Enrollment: 5
Study Design: Allocation: NA|Intervention Model: SINGLE_GROUP|Masking: NONE|Primary Purpose: DEVICE_FEASIBILITY
Start Date: 2024-11-15
Completion Date: 2025-03-15
Locations: University of Colorado Denver | Anschutz Medical Campus, Aurora, Colorado, 80045, United States|Point Designs, Lafayette, Colorado, 80026, United States

Summary:
The objective of the device feasibility study will be to validate the user needs of the Point Mini system. This study will be a single group intervention model where one group of 5 children with partial-hand upper limb loss will be asked to perform several tasks. Successful completion of a task results in a fulfilled user need. Failure to complete a task results in an unfulfilled user need.

Primary Outcome Measures: VAL-1, User wears Point Mini(s) for a entire session without discomfort (Pass/Fail), Day 1 (8 hours)|VAL-2, User flexes and extends the Point Mini(s) without using contralateral hand ten times (Pass/Fail), Day 1 (10 minutes)|VAL-3.1, User lifts a 10-25 lb bag with Point Mini(s) depending on age (Pass/Fail), Day 1 (10 minutes)|VAL-3.2, User grips a hammer with Point Mini(s) and makes indentations into the wood (Pass/Fail), Day 1 (10 minutes)|VAL-4, User releases Point Mini(s) while performing an active grasp by pressing the dorsal button ten times sequentially (Pass/Fail), Day 1 (10 minutes)|VAL-5, User positions Point Mini(s) into each of the locking positions without binding (Pass/Fail), Day 1 (10 minutes)|VAL-6, User activates spring-back mechanism ten times without failure by using (1) contralateral hand, (2) tabletop, and (3) side or thigh (Pass/Fail), Day 1 (10 minutes)|VAL-7, User grips a 5 lb cylindrical smooth object using Point Mini(s) for 10 seconds (Pass/Fail), Day 1 (10 minutes)|VAL-8, User picks up 4 coins from a smooth tabletop within 30 seconds (Pass/Fail), Day 1 (10 minutes)|VAL-9, User performs VAL-1 through VAL-8 without Point Mini releasing from mounting system (Pass/Fail), Day 1 (8 hours)
Interoception and Eating Behaviors in Children
NCT Number: NCT06504654
Acronym: I-EAT
Status: NOT_YET_RECRUITING
Study Type: OBSERVATIONAL
Conditions: Obesity, Childhood|Eating Behavior
Sponsor: Penn State University
Sex: ALL
Age: CHILD, ADULT, OLDER_ADULT
Enrollment: 60
Study Design: Observational Model: |Time Perspective: p
Start Date: 2024-10
Completion Date: 2026-06

Summary:
The purpose of this study is to examine how individual differences in interoception (the ability to sense, interpret, and act on bodily feelings like hunger, fullness, thirst, hot, cold, etc.) relate to eating behaviors in children ages 7-10 years. Findings will inform whether interventions targeting interoceptive awareness may be helpful for prevention of obesity and related chronic diseases.

Primary Outcome Measures: Kcal consumed in the Eating in the Absence of Hunger protocol, Children will be provide with an array of snacks following a meal and will have 10 minutes to consume any snacks that they'd link. Intake will be measured by pre- and post-weighing snacks, Visit 2 (1-3 weeks after enrollment at Visit 1)
Secondary Outcome Measures: Salivary ghrelin, Children will provide saliva samples which will be analyzed for active ghrelin, Visit 2 - fasting, +30 min, +60 min, and +90 min from start of a meal|Salivary leptin, Children will provide saliva samples which will be analyzed for leptin, Visit 2 - fasting, +30 min, +60 min, and +90 min from start of a meal|Heart beat counting accuracy, Participants will be fitted with a heart rate monitor and will be asked to count their heartbeat over several time intervals. Reported counts will be compared to measured heart rate to determine percent accuracy, Visit 1|Gastric interoception, Children will be asked to drink plain water until their stomach feels 'just right', and then will be asked to drink further water until their stomach feels maximally full. The amount of water consumed in each phase will be measured by changes in weight of the water bottle. The ratio of the two volumes is a measure of gastric interoception that is not confounded by stomach capacity, Visit 1|Multidimensional Assessment of Interoceptive Awareness (MAIA)-youth version, Children will complete a questionnaire via interview to assess their perception of their interoceptive awareness, Visit 1
Falls Among the Older Patients Treated for Cancer in Normandy's Outclinics: Screening and Prevention
NCT Number: NCT06504628
Acronym: CHUPACHOUP
Status: NOT_YET_RECRUITING
Study Type: OBSERVATIONAL
Conditions: Aged Patients Treated for Cancer in Outclinics
Interventions: DIAGNOSTIC_TEST: screening risk for falling and identifiy the risk level low-intermediate-high|DIAGNOSTIC_TEST: 3 mnth-follow-up
Sponsor: University Hospital, Caen
Sex: ALL
Age: OLDER_ADULT
Enrollment: 400
Study Design: Observational Model: |Time Perspective: p
Start Date: 2024-09-16
Completion Date: 2024-12-27
Locations: Caen UH, Caen, Normandie, 14000, France|Centre de radiothérapie de la Baie, Avranches, France|Centre de radiothérapie Maurice Tubiana/Polyclinique Parc, Caen, France|CLCC François Baclesse, Caen, France|Centre Hospitalier Public du Cotentin, Cherbourg, France|Centre Hospitalier Jacques Monod, Flers, France|Centre Hospitalier Avranches-Granville, Granville, France|Hôpital Privé de l'Estuaire, Le Havre, France|Centre Hospitalier Robert Bisson, Lisieux, France|Becquerel Cancer CEnter, Rouen, 76000, France|CHU de Rouen Charles Nicolle, Rouen, France|Centre Hospitalier d'Evreux-VErnon, Évreux, France

Summary:
The French Plan National AntiChute (published on February 21, 2022) and international recommendations on falls prevention (Age Ageing,September 2022) recommend identifying the risk of falling in people aged 65 and over, at least once a year during a follow-up consultation. The presence of chronic illness such as cancer increases the risk for falling. Recommendations suggest targeted preventive interventions according to the risk level, and early reassessment at 3 months in case of high risk.

This study consists of a cross-sectional survey conducted during a week dedicated to patient safety (September 16-20, 2024), to identify the prevalence of patients at high risk for falling, requiring enhanced care. The relation between high risk for falling and social and oncological characteristics will be studied. A 3-month telephone follow-up will identify any obstacles to implementing the recommendations in this high-risk group.

This multicenter cross-sectional prospective study is exploratory.

Primary Outcome Measures: prevalence of each of the three levels of fall-risk, describe the distribution of patients in mild, intermediate and high risk for falling, Day 1
Secondary Outcome Measures: look for association between high-risk categorization and rural place of residence, gender, age bracket (65-74 and 75 and over), investigating center, type of cancer (location)., Day 1|Describe the rate of high-risk patients who will have benefited from (full or partial) implementation of recommended interventions according to 3-month follow-up., 3 mnths|among high-risk patients followed up at 3 months, look for an association between the absence ofimplementation of recommendations and social, medical characteristics and motive, 3 mnths|describe the Average number of STOPPFALL medications per patient. Rate of patients with at least one oncologydrug listed as a fall risk (CIPN), in the 3 fall risk categories, Day 1
Observational Study of Patients Treated With Nivolumab and Chemotherapy for Advanced or Metastatic Esophageal, Gastroesophageal or Gastric Cancer in France
NCT Number: NCT06504615
Acronym: METAGIO
Status: NOT_YET_RECRUITING
Study Type: OBSERVATIONAL
Conditions: Gastric Adenocarcinoma|Gastro-esophageal Junction Adenocarcinoma|Esophageal Adenocarcinoma (EAC)|Esophageal Squamous Cell Carcinoma (ESCC)
Interventions: DRUG: nivolumab + chemotherapy
Sponsor: Bristol-Myers Squibb
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 500
Study Design: Observational Model: |Time Perspective: p
Start Date: 2024-08-31
Completion Date: 2028-08-31
Locations: Kappa Santé, Paris, France

Summary:
A study to estimate the overall survival in real-life conditions in France of adult participants treated with nivolumab in combination with chemotherapy as first-line treatment for gastric and gastroesophageal junction cancer.

Primary Outcome Measures: Overall survival (OS), Day 0 and months 2-3, 4-6, 8-9, 12, 18, 24, 30 and 36
Secondary Outcome Measures: Cause of death (where available), Day 0 and months 2-3, 4-6, 8-9, 12, 18, 24, 30 and 36|Disease progression, As assessed by the Site Investigator, Day 0 and months 2-3, 4-6, 8-9, 12, 18, 24, 30 and 36|Progression-free survival (PFS), Day 0 and months 2, 3, 4-6, 8-9, 12, 18, 24, 30 and 36|Time to treatment discontinuation (TTD), Day 0 and months 2-3, 4-6, 8-9, 12, 18, 24, 30 and 36|Time to failure of strategy (TFS), Day 0 and months 2-3, 4-6, 8-9, 12, 18, 24, 30 and 36|Time to next Treatment (TTNT), Day 0 and months 2-3, 4-6, 8-9, 12, 18, 24, 30 and 36|Second progression-free survival (PFS2), Day 0 and months 2-3, 4-6, 8-9, 12, 18, 24, 30 and 36|Treatment Free Interval (TFI), Day 0 and months 2-3, 4-6, 8-9, 12, 18, 24, 30 and 36|Overall tumor response (ORR), Day 0 and months 2-3, 4-6, 8-9, 12, 18, 24, 30 and 36|Response rate, Day 0 and months 2-3, 4-6, 8-9, 12, 18, 24, 30 and 36|Duration of response (DOR), Day 0 and months 2-3, 4-6, 8-9, 12, 18, 24, 30 and 36|Participant socio-demographics, Baseline|Participant clinical characteristics, Baseline|Participant treatment history, Baseline|Nivolumab treatment regime, Day 0 and months 2-3, 4-6, 8-9, 12, 18, 24, 30 and 36|Chemotherapy treatment regime, Day 0 and months 2-3, 4-6, 8-9, 12, 18, 24, 30 and 36|Reason for treatment discontinuation, Day 0 and months 2-3, 4-6, 8-9, 12, 18, 24, 30 and 36|Subsequent non-systemic treatment received post first-line treatment, Day 0 and months 2-3, 4-6, 8-9, 12, 18, 24, 30 and 36|Subsequent systemic treatment received post first-line treatment, Day 0 and months 2-3, 4-6, 8-9, 12, 18, 24, 30 and 36|Subsequent systemic treatment effectiveness, Day 0 and months 2-3, 4-6, 8-9, 12, 18, 24, 30 and 36|Participant adverse events (AEs), Up to 3 years|Participant health related quality of life as assessed by 5-level EuroQoL-5 dimension version (EQ-5D-5L), Day 0 and months 2-3, 4-6, 8-9, 12, 18, 24, 30 and 36
Pain Elimination and Anxiety Control Through Experiential Virtual Reality
NCT Number: NCT06504602
Status: NOT_YET_RECRUITING
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Procedural Pain|Procedural Anxiety
Interventions: DEVICE: Active Virtual Reality|DEVICE: Passive Virtual Reality
Sponsor: Children's Hospital Los Angeles
Sex: ALL
Age: CHILD, ADULT
Enrollment: 96
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: SINGLE (CARE_PROVIDER)|Primary Purpose: TREATMENT
Start Date: 2024-09-01
Completion Date: 2025-03-15

Summary:
The goal of this clinical trial is to determine if active virtual reality is more effective than passive virtual reality and standard of care distraction in decreasing pain in children, from 8 to 21 years old, undergoing intravenous placement in emergency department. The main question\[s\] it aims to answer \[is/are\]:

* Will active virtual reality reduce pain score on Faces Pain Scale - revised and measure of heart rate during intravenous placement for children ages 8 years old to 21 years old more than passive virtual reality and standard of care?
* Will active virtual reality reduce anxiety score on Visual Analog Scale - revised and measure of heart rate during intravenous placement for children ages 8 years old to 21 years old more than passive virtual reality and standard of care?

If there is a comparison group: Researchers will compare active group to passive group and standard of care.

Participants will randomized into active virtual reality, passive virtual reality or standard of care arms.

Primary Outcome Measures: Mean Change from Baseline in Pain Scores on Faces Pain Scale - Revised after IV Placement, Pain score on Faces Pain Scale - Revised will be assessed 5 minutes before and immediately after procedure. The minimum score is 0, and the maximum score is 10. Higher scores correlate to a worse outcome (more pain)., 5 minutes before, immediately after procedure
Secondary Outcome Measures: Mean Change from Baseline in Anxiety Scores on Visual Analog Scale after IV Placement, Anxiety score on Visual Analog Scale will be assessed 5 minutes before and immediately after procedure. The minimum score is 0, and the maximum score is 100. Higher scores correlate to a worse outcome (more anxiety)., 5 minutes before, immediately after procedure|Mean Change from Baseline in Heart Rate after IV Placement, Heart Rate will be measured 5 minutes before, during, and immediately after procedure, 5 minutes before, during, and immediately after procedure
Relationship Between Kinesthetic Perception, Motor Competence, Physical Fitness and Emotional Intelligence in Children
NCT Number: NCT06504563
Status: COMPLETED
Study Type: OBSERVATIONAL
Conditions: Children
Sponsor: Riphah International University
Sex: ALL
Age: CHILD
Enrollment: 97
Study Design: Observational Model: |Time Perspective: p
Start Date: 2024-05-14
Completion Date: 2024-07-28
Locations: Riphah International University, Lahore, Pakistan

Summary:
The benefits of an active lifestyle and physical fitness extend to physical, mental, and social aspects of well-being, including improved cardiopulmonary health, concentration, and self-confidence. The World Health Organization recommends 60 minutes of daily activity to combat childhood obesity, which is influenced by factors like lack of exercise, poor diet, and sedentary behaviors. Obesity negatively impacts children's kinesthetic perception, motor skills, and emotional resilience, crucial for their nervous system development. This study aims to explore the relationship between these factors in obese school-age children.

Primary Outcome Measures: Kinesthetic Perception, Kinesthetic perception will be assessed by Nelson hand reaction. The term Reaction time is the interval of time between the presentation of the stimulus and the initiation of response. Motor competence will be assessed using the pictorial scale of Perceived Movement Skill Competence (PMSC) for young children. Emotional intelligence will be assessed by using PANAS tool. Affect indicates people's positive and negative emotions and is composed of Positive Affect (PA) or pleasant emotions and Negative Affect (NA) or unpleasant emotions., 8 weeks|Physical fitness, endurance will be measured, 8 weeks
A Study to Compare the Effects of Elranatamab (PF 06863135) Versus Standard of Care (SOC) in Patients With Multiple Myeloma (MM) in Germany and US
NCT Number: NCT06504524
Status: COMPLETED
Study Type: OBSERVATIONAL
Conditions: Multiple Myeloma
Interventions: DRUG: Elranatamab|DRUG: Standard of Care
Sponsor: Pfizer
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 2
Study Design: Observational Model: |Time Perspective: p
Start Date: 2023-09-01
Completion Date: 2024-05-31
Locations: Pfizer, New York, New York, 10001, United States|Pfizer, Berlin, Germany

Summary:
The purpose of the study is to understand how well elranatamab (PF-06863135) may be used for relapsed refractory multiple myeloma (RRMM). MM is a type of cancer that begins in plasma cells (white blood cells that produce antibodies). Sometimes MM might improve at first, but then gets resistant to the treatment and starts growing again (known as relapsed refractory).

This study medicine will be compared with standard-of-care (SOC) therapies. SOC are treatments that are accepted by medical experts as a proper treatment for a certain type of disease and that are widely used by doctors in real world.

For people receiving elranatamab, the study doctors will use data from the other clinical trial (MagnetisMM-3). The study doctors will also use data from multiplemany real-world sources (TherapyMonitor MM Germany and Flatiron Health), for SOC in clinical practice. This study does not seek any participants for enrollment.

The study doctors will compare the experiences of people receiving elranatamab to people receiving SOC therapies. This way, it will help the study doctors to know how well elranatamab can be used for RRMM treatment.

Primary Outcome Measures: Overall Survival, Time from initiation of the index Line of therapy until death due to any cause . Patients are censored at loss to follow-up or end of the study period., up to 402 weeks
Secondary Outcome Measures: Progression-free Survival, Time from initiation of the index line of therapy (index date) to either the date of progression (proxy in TM-MM dataset: initiation of the next treatment line) or death due to any cause. Patients are censored at loss to follow-up or end of the study period., up to 402 weeks
Effectiveness of Clear Aligners in Different Thicknesses
NCT Number: NCT06504498
Status: COMPLETED
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Angle's Class I Malocclusion|Crowding, Tooth
Interventions: DEVICE: 0.5 mm-thick Duran® clear aligner|DEVICE: 0.75 mm-thick Duran® clear aligner
Sponsor: Mersin University
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 28
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: SINGLE (OUTCOMES_ASSESSOR)|Primary Purpose: TREATMENT
Start Date: 2021-05-10
Completion Date: 2022-05-20
Locations: Mersin University Faculty of Dentistry Department of Orthodontics, Mersin, 33110, Turkey

Summary:
This study aimed to evaluate the effectiveness, pain, and satisfaction levels between patients treated with different thicknesses of clear aligners among Class I maxillary mild crowding cases. Two types of clear aligners with thicknesses of 0.5 and 0.75 mm were used. The null hypotheses were as follows: There is no clinical difference in effectiveness, pain, and satisfaction levels between different thickness of clear aligners. The alternate hypotheses were as follows: The thicker the clear aligner, the greater orthodontic force applied to tooth which affects the amount of orthodontic tooth movement, pain, and satisfaction levels of patients. The primary aim was to evaluate pre- and post-treatment changes in amount of orthodontic tooth movement. Maxillary cephalometric parameters were measured on lateral cephalograms and maxillary dental parameters were measured using OrthoAnalyzer, and compared before and after treatment. Visual Analogue Scale and Patient Satisfaction Evaluation Form were used in order to assess the pain and satisfaction levels of patients. Pain and satisfaction levels were measured before the aligner insertion (T0), at the 4th hour (T1), 2nd day (T2), 1st week (T3), 1st month (T4) and at the end of the treatment (T5).

Primary Outcome Measures: Radiographic tooth movement, Changes in the amount of maxillary cephalometric parameters using lateral cephalometric radiographs after 6 months., At 6th months|Orthodontic tooth movement, Changes in intercanine, interpremolar, intermolar arch expansions and dental arch perimeter (maxillary dental parameters) using OrthoAnalyzer® software after 6 months., At 6th months
Secondary Outcome Measures: Patients' pain level, Changes in patients' pain level using a 10-cm VAS using ''no pain'' and ''severe pain'' as anchor descriptions at the 4th hours, 2nd days, 1st week, 1st month, and 6th months., At the 4th hours, 2nd days, 1st week, 1st month, and 6th months|Patients' satisfaction level, Changes in patients' satisfaction level using ''Patient Satisfaction Evaluation Form 1'' at the 4th hours, 2nd days, 1st week, 1st month; and using ''Patient Satisfaction Evaluation Form 2'' at the 6th months., At the 4th hours, 2nd days, 1st week, 1st month, and 6th months
A Randomized Triple-Blind Placebo-Controlled Study to Evaluate the Effects of a Supplement on Lower Urinary Tract Symptoms in Men.
NCT Number: NCT06504472
Status: COMPLETED
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Lower Urinary Tract Symptoms|Benign Prostatic Hyperplasia|Erectile Dysfunction
Interventions: DIETARY_SUPPLEMENT: ProstaThrive™ Supplement|DIETARY_SUPPLEMENT: Placebo
Sponsor: Optimale
Collaborators: Citruslabs
Sex: MALE
Age: ADULT, OLDER_ADULT
Enrollment: 80
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: TRIPLE (PARTICIPANT, INVESTIGATOR, OUTCOMES_ASSESSOR)|Primary Purpose: TREATMENT
Start Date: 2024-02-07
Completion Date: 2024-06-24
Locations: Citruslabs, Santa Monica, California, 90404, United States

Summary:
This study aims to evaluate the effects of the ProstaThrive™ supplement on lower urinary tract symptoms (LUTS) in men. It is a 90-day virtual, randomized, placebo-controlled trial with 80 male participants aged 40 and above. The primary endpoint is the reduction in LUTS, while secondary endpoints include changes in sexual function and performance.

Primary Outcome Measures: Change in Lower Urinary Tract Symptoms (LUTS), Measured by urinary urgency, nighttime urination frequency (nocturia), perceived urinary flow, and perceived bladder emptying at Baseline, Day 30, Day 60, and Day 90 via questionnaires, including questions adapted from the International Prostate Symptom Score (IPSS)., Baseline, Day 30, Day 60, and Day 90
Secondary Outcome Measures: Change in Sexual Function and Performance, Measured by the ability to get and maintain an erection at Baseline, Day 30, Day 60, and Day 90 via study-specific questionnaires., Baseline, Day 30, Day 60, and Day 90
The Safety and Efficiency of Sirolimus in Primary Antiphospholipid Syndrome: A Randomized Control Study
NCT Number: NCT06504420
Status: NOT_YET_RECRUITING
Study Type: INTERVENTIONAL
Phases: PHASE2
Conditions: Primary Antiphospholipid Syndrome
Interventions: DRUG: Sirolimus|DRUG: Placebo
Sponsor: Peking University People's Hospital
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 70
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: TRIPLE (PARTICIPANT, INVESTIGATOR, OUTCOMES_ASSESSOR)|Primary Purpose: TREATMENT
Start Date: 2024-08-15
Completion Date: 2027-12-30

Summary:
This study is an Investigator initiated, randomized, multicenter, double-blind, placebo-control study. The aim of this study is to evaluate the safety and efficiency of Sirolimus for primaty antiphospholipid syndrome patients at week 24 and week 48.

Primary Outcome Measures: Complete response(CR) rate at week 24, CR will be defined as follows: 1.No thrombosis events; 2.PLT ≥100 and with nobleeding; 3. No persistent autoimmnune haemolytic anaemia; 4. No skin ulcer; 5.No renal thrombotic microangiopathy; 5.Normal cognitive function (MoCA score ≥26）., week 24|Partial response (PR) rate at week 24, PR will be defined as one of follows: 1.superficial thrombotic events;2. PLT ≥30 or increased at least 2 times of baseline and with no bleeding;3.haemoglobulin concentration normal or increased 20g/L compared to baseline; 4.50% improvement; 5. a serum creatinine level 15% abov baseline, RBCs per high-power field 50% above baseline with no casts, 50% improvement in the urinary prt:cr; 6. milde cognitive diysfunction (MoCA 9\~25)., week 24
Secondary Outcome Measures: Complete response(CR) rate at week 48, CR will be defined as follows: 1.No thrombosis events; 2.PLT ≥100 and with nobleeding; 3. No persistent autoimmnune haemolytic anaemia; 4. No skin ulcer; 5.No renal thrombotic microangiopathy; 5.Normal cognitive function (MoCA score ≥26）., week 48|Partial response (PR) rate at week 48, PR will be defined as one of follows: 1.superficial thrombotic events;2. PLT ≥30 or increased at least 2 times of baseline and with no bleeding;3.haemoglobulin concentration normal or increased 20g/L compared to baseline; 4.50% improvement; 5. a serum creatinine level 15% abov baseline, RBCs per high-power field 50% above baseline with no casts, 50% improvement in the urinary prt:cr; 6. milde cognitive diysfunction (MoCA 9\~25)., week 48|Rate of Participants with adverse effects and serious adverse effects during treatment, Adverse effects include fever, rash, abnormal liver function, rate of new-onset infections and any abnormal measures after recivede study drug., baseline to week 48
BINGO: Bridging Knowledge, Increasing Awareness
NCT Number: NCT06504407
Status: NOT_YET_RECRUITING
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Cancer Education|Health Equity
Interventions: BEHAVIORAL: Bingo Educational Game
Sponsor: Milton S. Hershey Medical Center
Sex: FEMALE
Age: ADULT, OLDER_ADULT
Enrollment: 90
Study Design: Allocation: NA|Intervention Model: SINGLE_GROUP|Masking: NONE|Primary Purpose: SCREENING
Start Date: 2024-10-01
Completion Date: 2026-04-01

Summary:
The U.S. population is becoming more diverse, but minority groups are still significantly underrepresented in cancer clinical trials. This disparity limits our understanding of how treatments work across different populations. Efforts like the 21st Century Cures Act aim to improve inclusion, but challenges persist due to historical mistrust and complex barriers in healthcare.

To address these issues, Penn State Health is using a fun and educational approach called "BINGO" to engage the African American/Black community in Dauphin and surrounding counties. Led by the PSCI Diversity Navigator, these BINGO games will provide information about cancer and clinical trials in a relaxed setting. The goal is to build trust, increase awareness, and ultimately improve participation of underrepresented groups in clinical trials.

Through this initiative, they hope to connect participants with needed healthcare services and gather feedback to tailor future trials to community needs. This approach aims to foster collaboration between minority communities and the healthcare system, ensuring that clinical trials reflect the diversity of the population they aim to serve.

Primary Outcome Measures: Feasibility Measure, Percentage of Participants Attending a Complete Bingo Game Session and Completing Pre- and Post-Test Surveys., one year|Utility Measure, Pre- and post-test scores on knowledge-based questions will be compared to measure the effectiveness of the educational content., one year|Engagement Measure, Participant engagement will be evaluated using a 5-point Likert scale, with the percentage of participants who "strongly agree or agree" that Bingo game was engaging being the primary measure., one year
Resistive Action Video Games Enhance Functional Fitness of Disabled Workers in Sheltered Workshops
NCT Number: NCT06504355
Status: COMPLETED
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Mental Disorder
Interventions: BEHAVIORAL: Training program incorporating video aerobic exercise, action video game and resistive action video game
Sponsor: National Taiwan Normal University
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 32
Study Design: Allocation: NON_RANDOMIZED|Intervention Model: PARALLEL|Masking: SINGLE (PARTICIPANT)|Primary Purpose: SUPPORTIVE_CARE
Start Date: 2021-08-01
Completion Date: 2023-12-31
Locations: National Taiwan Normal University, Taipei, 106, Taiwan

Summary:
Aims: Investigating the efficacy of resistive action video games on functional fitness (FF) of disabled workers in sheltered workshops (DWSWs).

Methods: Thirty-two DWSWs participated in this study and were allocated as either experimental group (EG) or control group (CG). DWSWs in EG underwent three 60-minute sessions each week for 12 weeks; those in CG maintained daily routine. The outcomes included all components FF and were measures at pre-, mid- and post-training.

Primary Outcome Measures: Body weight, On the counter Omron four-point bluetooth transmission weight and body fat meter HBF 702T was used, One week before training, 6 weeks of training, 12 weeks of training.|Body mass index, On the counter Omron four-point bluetooth transmission weight and body fat meter HBF 702T was used, One week before training, 6 weeks of training, 12 weeks of training.|Body fat percentage, On the counter Omron four-point bluetooth transmission weight and body fat meter HBF 702T was used, One week before training, 6 weeks of training, 12 weeks of training.|Skeletal muscle rate, On the counter Omron four-point bluetooth transmission weight and body fat meter HBF 702T was used, One week before training, 6 weeks of training, 12 weeks of training.|Muscle strength, Bicep arm curl test, One week before training, after 6 weeks of training, after 12 weeks of training.|Muscle strength, Counts of strand-up in the 30-second chair stand test., One week before training, after 6 weeks of training, after 12 weeks of training.|Cardiopulmonary endurance, Counts of steps in the 2-minute step test, One week before training, 6 weeks of training, 12 weeks of training.|Flexibility, The distance in centimeters between two middle fingers in the Back scratch test., One week before training, 6 weeks of training, 12 weeks of training.|Flexibility, The distance in centimeters between the middle fingers and the big toe in sit and reach test., One week before training, 6 weeks of training, 12 weeks of training.|Balance, Seconds to maintain one-leg stance stability, One week before training, 6 weeks of training, 12 weeks of training.|Agility, Timed-Up-and-Go test, One week before training, 6 weeks of training, 12 weeks of training.
OXiris for Abdominal SEptic Shock (OASES Study)
NCT Number: NCT06504316
Acronym: OASES
Status: NOT_YET_RECRUITING
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Septic Shock|Abdominal Sepsis|Multi Organ Failure|Blood Purification|AKI - Acute Kidney Injury
Interventions: DEVICE: CRRT filter
Sponsor: RenJi Hospital
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 192
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: NONE|Primary Purpose: TREATMENT
Start Date: 2024-08-15
Completion Date: 2027-05-31
Locations: Renji Hospital, School of Medicine, Shanghai Jiaotong University, Shanghai, 200127, China

Summary:
This study innovatively utilizes multi-modal hemodynamic monitoring (Norepinephrine equivalence, NEE+Pulse indicator Continuous Cariac output, PiCCO) to investigate the optimal timing of initiation of oXiris in abdominal infection-associated septic shock patients and to investigate prognosis on sepsis phenotypes undergoing oXiris therapy.

Primary Outcome Measures: The dose of vasopressor agents, Decrease range of NEE after initiation of CRRT, CRRT 0, 6, 12, 24, 48, 72 hours
Secondary Outcome Measures: The value of PiCCO parameters, Increase range of cardiac index (CI) and systemic vascular resistance index (SVRI) after initiation of CRRT, CRRT 0, 6, 12, 24, 36, 48, 72 hours|The level of inflammatory markers, Decrease range of serum procalcitonin (PCT), interleukin-6 (IL-6) level after initiation of CRRT, CRRT 0, 12, 24, 48, 72 hours|The severity of illness score Severity of illness score, Decrease range of Acute Physiology and Chronic Health Evaluation II (APACHE II) and Sequential Organ Failure Assessment (SOFA) score during the first 72 hours, CRRT 0, 24, 48, 72 hours|The time of hospital stay, Length of hospital and ICU stay, From date of randomization until the date of end of followup|The number of subjects of survival and kidney recovery, Survival and kidney recovery, Day 28, 60, 90
Other Outcome Measures: The nmber of subjects of survival in phenotypes of septic shock, The survival of various phenotypes of septic shock, Day 28, 60, 90|Filter lifespan, Duration of oXiris filter using and timing of changing filter, From time of filter initiation using until the time of filter changed or CRRT stop (if filter no changed)
The Effect of Articulatory Gestures on Early Literacy Skills in 4-year Olds
NCT Number: NCT06504264
Status: NOT_YET_RECRUITING
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Early Literacy|Articulatory Gestures|Phonemic Awareness
Interventions: BEHAVIORAL: phonemic segmentation
Sponsor: Montclair State University
Sex: ALL
Age: CHILD
Enrollment: 9
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: SINGLE (PARTICIPANT)|Primary Purpose: TREATMENT
Start Date: 2024-09-01
Completion Date: 2025-06-30

Summary:
This study will use an experimental design to explore if articulatory gestures (with letters and phonemic awareness training) enhance early literacy skills more than general mouth awareness training (with letters and phonemic awareness training) or letter/phonemic awareness training alone.

Primary Outcome Measures: number of words correctly phonemically segmented from primary investigator created list, will tell the sounds in 9 words presented orally, immediately after the intervention
Secondary Outcome Measures: number of words read correctly from primary investigator created list, will read phonemically 6 spelled words, immediately after the intervention|number of nonwords read correctly from primary investigator created list, will read 7 nonwords, immediately after the intervention
Validity and Reliability of the Modified Delirium Diagnostic Tool - Provisional (DDT-Pro) (Thai Version) in Peri-operative Fragility Hip Fracture Patient
NCT Number: NCT06504251
Status: COMPLETED
Study Type: OBSERVATIONAL
Conditions: Old Age|Hip Fractures|Delirium
Interventions: DIAGNOSTIC_TEST: Delirium Diagnostic Tool-Provisional ( DDT-Pro )
Sponsor: Mahidol University
Sex: ALL
Age: OLDER_ADULT
Enrollment: 110
Study Design: Observational Model: |Time Perspective: p
Start Date: 2022-09-09
Completion Date: 2024-02-27
Locations: Siriraj hospital, Bangkok, Bangkoknoi, 10700, Thailand

Summary:
Nowadays, the number of hip fracture patients is increasing. As Thailand enters into an aging society, hip fractures are becoming more common. They are typically treated with surgery. Complications, such as urinary tract infections, pressure sores, and acute confusion, are often observed. These various complications contribute to an increased rate of illness and death.

Delirium is a common problem among hip fracture patients. Currently, diagnosis is typically made using the Diagnostic and Statistical Manual of Mental Disorders (DSM-V), which is a standard tool. However, utilizing it effectively requires expertise. Additionally, other tools such as the Confusion Assessment Method (CAM) and the Memorial Delirium Assessment Scale (MDAS) are available. Nonetheless, training is necessary for their proper use, and they may be more suitable for specific patient groups.

The Delirium Diagnostic Tool-Provisional (DDT-Pro) is another tool created to aid in diagnosing delirium. Unlike other tools, it does not require specialized training. It can assess the main symptoms of delirium, including cognitive ability, higher-level thinking skills, and the sleep-wake cycle. This tool has been utilized in foreign countries such as Spain. The tool was found to have good accuracy and reliability and is useful in aiding the diagnosis of delirium. However, it has never been translated and tested for use in elderly Thai patients with fragility hip fractures.

Primary Outcome Measures: To evaluate the accuracy and reliability of the revised Thai language version of the Delirium Diagnostic Tool-Provisional (DDT-Pro)., Accuracy and reliability of the revised Thai language version of the Delirium Diagnostic Tool-Provisional (DDT-Pro) compared with the gold standard tool (DSM V), 3 day
Secondary Outcome Measures: The incidence of delirium in patients with fragility hip fractures before and after surgical treatment., Number of delirium in peri-operative fragility hip fracture in Siriraj hospital, 3 day
EVEROLD LONG TERM FOLLOW-UP
NCT Number: NCT06504225
Acronym: EVEROLD FUP
Status: NOT_YET_RECRUITING
Study Type: OBSERVATIONAL
Conditions: Transplant; Complication, Failure
Sponsor: University Hospital, Brest
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 260
Study Design: Observational Model: |Time Perspective: p
Start Date: 2024-08-01
Completion Date: 2025-08-01
Locations: Chu Amiens, Amiens, France|CHU Bordeaux, Bordeaux, France|Chu Brest, Brest, France|CHU Lille, Lille, France|CHU Limoges, Limoges, France|CHU Nice Pasteur 2, Nice, France|CHU Nice, Nice, France|Hôpital Necker, Paris, France|Chu Poitiers, Poitiers, France|CHU Rennes, Rennes, France|CHU Rouen, Rouen, France|CHU Strasbourg, Strasbourg, France|CHU Toulouse Rangueil, Toulouse, France|CHU Tours, Tours, France

Summary:
Long Term Follow up of EVEROLD study

Primary Outcome Measures: Patient survival, Patient survival at last follow-up, up to 12 years|Graft survival, Graft survival at last follow-up, up to 12 years
Secondary Outcome Measures: Rejection rate, Biopsy proven rejection, up to 12 years|Infection rate, All infections requiring hospitalization, up to 12 years|Major cardiovascular events, up to 12 years|Cancer rate, Skin cancer, solid organ tumor and hematological cancer, up to 12 years|Hospitalization, Number of hospitalization, hospital stay, reason for hospitalization, up to 12 years|eGFR, estimated GFR (MDRD and CKD-EPI), up to 12 years
Validity and Reliability of a New Mobile Application
NCT Number: NCT06504212
Status: RECRUITING
Study Type: OBSERVATIONAL
Conditions: Proprioception
Interventions: OTHER
Sponsor: Inonu University
Sex: ALL
Age: ADULT
Enrollment: 4
Study Design: Observational Model: |Time Perspective: p
Start Date: 2024-07-12
Completion Date: 2024-11-12
Locations: Gulfem Ezgi, Malatya, Inonu University, 11000, Turkey

Summary:
In this study, we aimed to study the validity and reliability of the Angle Meter, a Smartphone application for elbow joint position sense.

Primary Outcome Measures: universal goniometer, Joint position sense measurement with universal goniometer ., [Time Frame: 3 days]|mobile application, The elbows will be photographed in 3 different angles, in open and kinetic chain position. The elbow photograph of healthy individuals measured with the Angle meter will be evaluated simultaneously but independently with the Angle meter by 2 different evaluators., [Time Frame: 3 days]
Obinutuzumab, Zanubrutinib, and Lenalidomide Followed Short-Cycle of Obinutuzumab and Cytarabine in Newly Diagnosed Mantle Cell Lymphoma
NCT Number: NCT06504199
Acronym: ZGR
Status: RECRUITING
Study Type: INTERVENTIONAL
Phases: PHASE2
Conditions: Mantle Cell Lymphoma
Interventions: DRUG: Obinutuzumab|DRUG: Zanubrutinib|DRUG: Lenalidomide|DRUG: Cytarabine|BIOLOGICAL: CAR-T
Sponsor: Institute of Hematology & Blood Diseases Hospital, China
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 39
Study Design: Allocation: NA|Intervention Model: SINGLE_GROUP|Masking: NONE|Primary Purpose: TREATMENT
Start Date: 2024-07-18
Completion Date: 2028-12-31
Locations: Institute of Hematology & Blood Diseases Hospital, Tianjin, Tianjin, 300020, China|Institute of Hematology and Blood Diseases Hospital ,Chinese Academy of Medical Sciences, Tianjin, Tianjin, 300020, China

Summary:
This study aims to preliminarily explore the efficacy and safety of the combination of Obinutuzumab and Zanubrutinib plus Lenalidomide (ZGR) followed by a short cycle of cytarabine and Obinutuzumab in the induction treatment of newly diagnosed mantle cell lymphoma (MCL) . The investigators propose ZGR followed by a short cycle of Obinutuzumab and cytarabine could be an effective first-line treatment for MCL.

Primary Outcome Measures: Complete response rate (CRR), defined as the proportion of patients with complete response as assessed by response to induction therapy using the 2014 Lugano criteria., up to the end of 9 cycles of treatment(each cycle is 28 days)
Secondary Outcome Measures: overall response rate (ORR), defined as the proportion of patients with complete or partial response as assessed by response to induction therapy., up to the end of 9 cycles of treatment(each cycle is 28 days)|Minimal residual disease (MRD) negative rate of, defined as the proportion of patients with MRD negative (less than 10-4) in bone marrow by flow cytometry after induction therapy in newly diagnosed patients with bone marrow invasion., up to the end of 9 cycles of treatment(each cycle is 28 days)|Progress-free survival (PFS), defined as the time from the start of treatment to disease progression or death due to any cause., up to 5 years|Duration of tumor remission (DoR), defined as the time from the first treatment response (including complete response and partial response) to the last assessment of response., up to 5 years|Overall survival (OS), defined as the time from enrollment to death for any cause., up to 5 years
The Use of Blinatumomab in Patients With NGS-MRD Relapsed B-ALL After Autologous/Allogeneic Transplantation
NCT Number: NCT06504186
Status: NOT_YET_RECRUITING
Study Type: INTERVENTIONAL
Phases: NA
Conditions: B-ALL
Interventions: DRUG: Blinatumomab
Sponsor: Institute of Hematology & Blood Diseases Hospital, China
Sex: ALL
Age: CHILD, ADULT, OLDER_ADULT
Enrollment: 20
Study Design: Allocation: NA|Intervention Model: SINGLE_GROUP|Masking: NONE|Primary Purpose: PREVENTION
Start Date: 2024-07
Completion Date: 2026-10

Summary:
To explore the efficacy and safety ofblinatumomab± TKI in B-ALL patients aged ≥ 14 years with NGS-MRD relapse (sensitivity: 10-6) after auto/allo HSCT, and to observe the disease-free survival (DFS), recurrence rate and toxicity after transplantation.

Primary Outcome Measures: disease-free survival (DFS), disease-free survival (DFS), Follow-up until 3 years after transplantation|recurrence rate, recurrence rate, Follow-up until 3 years after transplantation
Secondary Outcome Measures: NGS-MRD response rate, Bone marrow was collected from patients at 3 and 6 months after transplantation and at 15 days after treatment with blinatumomab, and immunoglobulin rearranged IGH-VDJ sequences were monitored using high-throughput sequencing (NGS) to identify significant clonal sequences to regularly determine changes in MRD levels before and after treatment., 3 and 6 months after transplantation and at 15 days after treatment|overall survival (OS), overall survival (OS), Follow-up until 3 years after transplantation|incidence of acute and chronic GVHD, The frequency and severity of acute GVHD of the intestine, skin, and liver were observed until 100 days after transplantation, and all episodes of GVHD were graded using the clinical grading criteria for acute GVHD. The changes of skin, liver function, eyes, and oral cavity of patients after 100 days after transplantation were observed to assess the incidence of localized and extensive chronic GVHD., 100 days after transplantation
Diced Cartilage in Breast Reconstruction
NCT Number: NCT06504173
Status: COMPLETED
Study Type: OBSERVATIONAL
Conditions: Mammaplasty|Microsurgery|Rip Reconstruction Cartilage
Interventions: PROCEDURE: diced cartilage
Sponsor: ISAR Klinikum
Collaborators: Breast Imaging Division, Radiologie Augsburg Friedberg / Breast Center Augsburg, Augsburg, Germany
Sex: FEMALE
Age: ADULT, OLDER_ADULT
Enrollment: 173
Study Design: Observational Model: |Time Perspective: p
Start Date: 2024-01-01
Completion Date: 2024-07-01
Locations: ISAR Klinikum - Department Plastic Surgery, Munich, Bavaria, 80331, Germany|ISAR Klinikum, Munich, Bavaria, 80331, Germany

Summary:
Exposure of internal mammary vessels in autologous breast reconstruction often requires removal of a rib cartilage segment, which can lead to contour deformity in the craniomedial breast pole. This study evaluated the use of diced cartilage (DC) to counteract substance loss in the microvascular anastomosis area, and investigated safety and suitability of the procedure to avoid postoperative deformities.

Primary Outcome Measures: Magnetic resonance imaging (MRI) scans: soft tissue sinking of the recipient vessels area, the sinking depth of epicostal soft tissue into the space of rib segment resection on axial planes in Magnetic resonance imaging (MRI) scans performed at least 6 months postoperatively, October 2021 to June 2023
Secondary Outcome Measures: Visual contour deficit of the recipient vessels area, Postoperative photographic images were examined by two investigators (blinded to group assignments) for IMVES-associated deformities using standardized photographic images of the reconstructed breasts at the 6-month follow-up., October 2021 to June 2023
A Study of Radspherin® in Patients With Primary Advanced Epithelial Cancer, With Peritoneal Metastasis That Are Homologous Recombination Proficient Scheduled to Undergo Neoadjuvant Chemotherapy and Interval Debulking Surgery
NCT Number: NCT06504147
Status: RECRUITING
Study Type: INTERVENTIONAL
Phases: PHASE2
Conditions: Peritoneal Carcinomatosis|Ovarian Cancer
Interventions: DRUG: Radspherin
Sponsor: Oncoinvent AS
Sex: FEMALE
Age: ADULT, OLDER_ADULT
Enrollment: 114
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: NONE|Primary Purpose: PREVENTION
Start Date: 2024-06-15
Completion Date: 2031-02-28
Locations: Moffitt Cancer Center, Tampa, Florida, 33612, United States|UZ Leuven, Leuven, Belgium|The Norwegian Radiumhospital, Oslo, Norway|Clinica Universidad de Navarra, Madrid, Spain|Clinica Universidad de Navarra, Pamplona, Spain|Imperial College Healthcare NHS Trust, London, United Kingdom

Summary:
This is a Phase 2, controlled, randomised, parallel assignment, open label, multicentre study to evaluate efficacy and safety of a single intraperitoneal injection of Radspherin® in patients with primary advanced high-grade serous or high-grade endometrioid epithelial ovarian cancer, fallopian tube, or primary peritoneal cancer, with peritoneal metastasis that are HR proficient and scheduled to undergo NACT and IDS. The study will be conducted in 2 parts; first, a Safety Lead-in Cohort will be recruited followed by the randomised part of the study. For both parts of the study, patients must be scheduled to undergo NACT and IDS and complete resection to no residual tumour (R0) should be deemed to be achievable during diagnostic work-up. Patients in both parts of the study will undergo the same procedures and assessments.

Primary Outcome Measures: Progression free survival, To compare PFS in patients with primary advanced high-grade serous or high-grade endometrioid epithelial ovarian, fallopian tube, or primary peritoneal cancer1 with peritoneal metastasis that are HR proficient following Radspherin® treatment versus no treatment., 24 months
Secondary Outcome Measures: Peritoneal progression free survival, To compare peritoneal PFS (PPFS) in patients with primary advanced epithelial cancer with peritoneal metastasis that are HR proficient following Radspherin® treatment versus no treatment., 24 months