pankajmathur/National_Library_of_Medicine_Studies_data huggingface dataset:
Effectiveness of SMS Nudging to Increase Coverage of Influenza Vaccination Among the Elderly
NCT Number: NCT06486766
Acronym: InfluSMS
Status: NOT_YET_RECRUITING
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Influenza
Interventions: BEHAVIORAL: Norwegian SMS|BEHAVIORAL: Polish/Ukrainian SMS
Sponsor: Norwegian Institute of Public Health
Collaborators: University of Oslo|Finnish Institute for Health and Welfare|University of Turku|University Hospital, Akershus
Sex: ALL
Age: OLDER_ADULT
Enrollment: 1000000
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: SINGLE (OUTCOMES_ASSESSOR)|Primary Purpose: HEALTH_SERVICES_RESEARCH
Start Date: 2025-10
Completion Date: 2026-07

Summary:
The trial will investigate to what extent SMS reminders for influenza vaccination increases coverage of influenza vaccination among elderly from the majority population, and among elderly from immigrant groups with low vaccination coverage

Primary Outcome Measures: Influenza vaccination coverage (%), The percent uptake of the influenza vaccine in the population of interest, Three months following the intervention, during the 2025/2026 influenza season
Other Outcome Measures: COVID-19 vaccination coverage (%), The percent uptake of the COVID-19 vaccine in the population of interest, Three months following the intervention, during the 2025/2026 influenza season
LSTR in Chevron Osteotomy
NCT Number: NCT06486753
Status: RECRUITING
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Bunion
Interventions: PROCEDURE: Chevron osteotomy bunion surgery with lateral soft tissue release
Sponsor: The Methodist Hospital Research Institute
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 200
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: NONE|Primary Purpose: TREATMENT
Start Date: 2021-06-24
Completion Date: 2028-03-09
Locations: Houston Methodist Research Institute, Houston, Texas, 77030, United States

Summary:
The goal of this clinical trial is to determine if performing a lateral soft tissue release during a Chevron osteotomy (or Akin osteotomy when appropriate) for bunions leads to better correction without added complications in 200 patients over the age of 18 years old with the capacity to consent and mild to moderate bunions that are determined to benefit from Chevron osteotomies by one of the IRB approved study physicians. The main questions it aims to answer are:

How does the addition of a lateral soft tissue release (LSTR) in a Chevron osteotomy bunion surgery affect hallux valgus alpha angle (HVA) correction? How does the addition of an LSTR in a Chevron osteotomy bunion surgery affect intermetatarsal angle (IMA) degrees of correction? Researchers will compare Chevron osteotomy bunion surgeries with and without LSTR to see if LSTRs lead to better correction without added complications.

Participants will:

* Be randomized to a control group where they receive a typical Chevron osteotomy bunion surgery or to the experimental group where they receive a Chevron osteotomy bunion surgery with an LSTR.
* Complete surveys preoperatively and at 3, 6, and 12 months after surgery.
* Receive routine x-rays pre and postoperatively to compare hallux valgus angle (HVA).

Primary Outcome Measures: Hallux valgus alpha angle correction, Pre-surgery, 6 weeks post surgery
Secondary Outcome Measures: Intermetasarsal angle (IMA) degrees of correction, 3 months, 6 months, and 12 months post surgery|Recurrence of hallux valgus deformity, 3 months, 6 months, and 12 months post surgery|Complications following surgery, We will be looking at complications including possible metatarsal head avascular necrosis (AVN) and over correction (hallux varus)., 3 months, 6 months, and 12 months post surgery
Efficacy and Safety of 675-nm Laser for Dorsal Hand Rejuvenation
NCT Number: NCT06486727
Status: NOT_YET_RECRUITING
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Wrinkle
Interventions: DEVICE: Redtouch
Sponsor: Mahidol University
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 26
Study Design: Allocation: NA|Intervention Model: SINGLE_GROUP|Masking: NONE|Primary Purpose: TREATMENT
Start Date: 2024-07-01
Completion Date: 2025-12-01

Summary:
This study aimed to evaluate efficacy and safety of 675-nm laser for dorsal hand rejuvenation in Thai patients. Twenty-six subjects aged 50 to 65 years diagnosed with wrinkle and solar lentigines on both dorsums of hands were included and treated with RedTouch for 3 times every 4 weeks. Then, they were follow up at 3 and 6 months after the final treatment. The measurement of 5-point Global Aesthetic Improvement Scale scores by physicians and subjects were conducted. Moreover, pigmentation level, wrinkle and texture were also recored using Antera. Elasticity was measured using Cutometer.

Primary Outcome Measures: The change in pigmentation level, wrinkle and texture, Using Antera®, Baseline, 4, 8, 12 weeks after the first treatment and 3, 6 months after the last treatment
Secondary Outcome Measures: The change in elasticity, Using Cutometer®, Baseline, 4, 8, 12 weeks after the first treatment and 3, 6 months after the last treatment|Overall improvement by physicians and patients, 5-point GAIS, 4, 8, 12 weeks after the first treatment and 3, 6 months after the last treatment|Adverse events, Side effects, 4, 8, 12 weeks after the first treatment and 3, 6 months after the last treatment|Pain score, Visual analog scale (0-10; no pain-worst pain possible), Baseline, 4, 8, 12 weeks after the first treatment
Mechanical Alignment Versus Kinematic Alignment Total Knee Arthroplasty
NCT Number: NCT06486714
Status: NOT_YET_RECRUITING
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Knee Osteoarthritis
Interventions: PROCEDURE: Total knee arthroplasty
Sponsor: Loyola University
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 96
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: SINGLE (PARTICIPANT)|Primary Purpose: TREATMENT
Start Date: 2024-09-01
Completion Date: 2024-12-31

Summary:
Historically, total knee arthroplasty (TKA) has been performed with the goal of restoring a neutral mechanical axis, eliminating the average 3 degrees of valgus and varus of the distal femur and proximal tibia joint lines respectively. This is thought to provide a more stable and neutral joint-bearing surface. Because of this shift to a 0-degree knee angle, soft tissue releases are frequently required to balance the knee after making the distal tibia and proximal tibia cuts. More recently and increasingly, TKAs have been performed with a goal of restoring kinematic, or anatomic, alignment of the knee. This is thought to provide a more normal native knee angle, with the hopes of precluding the necessity of soft tissue releases to balance the knee. While some studies are promising regarding kinematically aligned TKAs (KA-TKA), at present, it is unclear how these compare to mechanically aligned TKAs (MA-TKA) in terms of patient reported outcome measures (PROM) when compared head-to-head.

This study will randomize patients to receive either cemented MA-TKA or KA-TKA with the goal of assessing pain scores and PROMs at various time points following surgery.

Primary Outcome Measures: Knee Injury and Osteoarthritis Outcome Score (KOOS) Jr Score, The KOOS Jr Score is a patient-reported outcome measure, scaled from 0-28, with higher scores meaning worse outcomes., Baseline, 2 weeks post op, 6 weeks post op, 1 week post op
Secondary Outcome Measures: Patient Reported Outcome Measure Information System (PROMIS) Physical Function, The PROMIS Physical Function Score is a patient-reported outcome measure, scaled from 0-20, with higher scores meaning improved outcomes., Baseline, 2 weeks post op, 6 weeks post op, 1 week post op
Other Outcome Measures: Patient Reported Outcome Measure Information System (PROMIS) Pain Interference, The PROMIS Pain Interference Score is a patient-reported outcome measure, scaled from 0-20, with higher scores meaning worse pain., Baseline, 2 weeks post op, 6 weeks post op, 1 week post op|Forgotten Joint Score, The Forgotten Joint Score is a patient-reported outcome measure, scaled from 0-100, with higher scores meaning improved outcomes., Baseline, 2 weeks post op, 6 weeks post op, 1 week post op|Pain Visual Analogue Scale, Pain scale scaled from 0-10 with higher scores indicating more pain., Baseline, 2 weeks post op, 6 weeks post op, 1 week post op|Range of motion, Range of motion defined as degrees of knee extension and flexion, Baseline, 2 weeks post op, 6 weeks post op, 1 week post op
Effect of Singing in Abdominal Surgery Patients
NCT Number: NCT06486701
Acronym: singing
Status: COMPLETED
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Abdominal Pain|Anxiety
Interventions: BEHAVIORAL: have a sing
Sponsor: Istanbul Aydın University
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 60
Study Design: Allocation: RANDOMIZED|Intervention Model: CROSSOVER|Masking: SINGLE (PARTICIPANT)|Primary Purpose: HEALTH_SERVICES_RESEARCH
Start Date: 2024-01-01
Completion Date: 2024-02-09
Locations: Medicana Kadikoy Hospital, Istanbul, 34697, Turkey

Summary:
Patients who have undergone abdominal surgery are given a prompt in the postoperative period and asked to sing the song they remember. Vital signs, pain and anxiety levels are measured before and after singing.

Primary Outcome Measures: Vital signs, pain and anxiety: Measurement will be made with the Vital signs, pain and anxiety, It will be measure to sing a song after Abdominal Surgery, total of six month
Secondary Outcome Measures: Vital signs, pain and anxiety: Measurement will be made with the Vital signs, pain and Anxiety, No intervention, the control group abdominal surgery patients, total of six month
Breastfeeding Counseling Training on Breast Milk Perception and Baby Feeding Attitudes
NCT Number: NCT06486675
Acronym: EFFBCTBP
Status: NOT_YET_RECRUITING
Study Type: INTERVENTIONAL
Phases: NA
Conditions: MİDWİFERY STUDENT
Interventions: OTHER: education
Sponsor: Kahramanmaras Sutcu Imam University
Collaborators: Inonu University
Sex: FEMALE
Age: ADULT
Enrollment: 98
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: NONE|Primary Purpose: SUPPORTIVE_CARE
Start Date: 2024-07-15
Completion Date: 2024-10-30

Summary:
This research will be conducted to determine the effect of face-to-face breastfeeding counseling training on breast milk perception and infant nutrition attitudes.The population of this semi-experimental research consisted of students who took the Breastfeeding Consultancy course at Kahramanmaraş Sütçü İmam University Faculty of Health Sciences (n=49) and 3rd year students who did not take this course at İnönü University Faculty of Health Sciences (n=47). "Personal Introduction Form", "Adults' Perception Scale on Breast Milk (ASAÖ)" and "Infant Nutrition Attitude Scale (IOWA)" will be used to collect pre-test and post-test data. Pretest data were obtained in the first lesson of the semester in both groups. Participants in the experimental group were given training consisting of breastfeeding counseling course content for 14 weeks. The control group was not given any training on this subject. At the end of the semester, post-test measurements will be made to both groups simultaneously and with the same measurement tools.

Primary Outcome Measures: First Measurement: 1.602 / 5.000 First Measurement:Adult Perception Scale on Breast Milk, Adults' Perception Scale on Breast Milk is a five-point Likert-type, one-dimensional scale consisting of 30 items. The minimum total score to be obtained from the scale is 30 and the maximum is 150 points. As adults' ASAS score increases, it shows that their perception of breast milk is at a good level. C, 3 MONTH|Second Measurement:Baby Nutrition Attitude Scale (IOWA), Baby Nutrition Attitude Scale is a scale created by De La Moraave Russell (1999) to predict participants' attitudes towards breastfeeding and the duration of breastfeeding (De La Mora,2019). The scale consists of 17 items and is a 5-point Likert type scale. 8 items in the scale are about formula feeding, and 9 items are about breastfeeding. Scoring of items related to formula nutrition is done by reverse scoring. The total score to be received varies between 17 and 85, and a low score indicates that the participant has a positive attitude towards bottle feeding, and a high score indicates that the participant has a positive attitude towards breastfeeding., 3 month
A Clinical Study Investigating OM-85-IN Safety and Tolerability in Healthy Volunteers and Mild Allergic Asthma Patients
NCT Number: NCT06486662
Status: RECRUITING
Study Type: INTERVENTIONAL
Phases: PHASE1
Conditions: Allergic Asthma
Interventions: DRUG: OM-85-IN|DRUG: Placebo
Sponsor: OM Pharma SA
Sex: ALL
Age: ADULT
Enrollment: 41
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: TRIPLE (PARTICIPANT, INVESTIGATOR, OUTCOMES_ASSESSOR)|Primary Purpose: TREATMENT
Start Date: 2024-06-14
Completion Date: 2025-02-28
Locations: The Fraunhofer Institute For Toxicology And Experimental Medicine ITEM, Hanover, Nikolai-Fuchs-Strasse 1, 30625, Germany

Summary:
This study will assess the safety and tolerability of OM-85-IN compared to placebo in healthy volunteers and mild asthmatic patients

Primary Outcome Measures: Percentage of subjects with treatment-emergent adverse events (TEAEs) (including clinically relevant findings from nasal inspection), 28 days
Secondary Outcome Measures: Part II : Mean difference of Total Nasal Symptom Score (TNSS points) before and after treatment defined as the arithmetic mean of TNSS collected from pre-Nasal Allergen Challenge (NAC) to 6 hours post-NAC, 28 days|Part II : Area under the curve (AUC)0-6 hours of Total Nasal Symptom Score (TNSS points) after NAC before and after treatment, 28 days|Part II : Mean difference of nasal flow by rhinomanometry (Pascal) before and after treatment defined as the arithmetic mean of TNSS collected from pre-Nasal Allergen Challenge (NAC) to 6 hours post-NAC, 28 days|Part II : Area under the curve (AUC)0-6 of nasal flow by rhinomanometry (Pascal) after NAC before and after treatment, 28 days|Part II : Mean difference in fractional exhaled nitric oxide (FeNO) before and after treatment and NAC, 28 days|Part II : Mean difference on mannitol dose resulting in ≥15% fall in FEV1 from baseline or ≥10% incremental fall in FEV1 between consecutive mannitol doses after NAC before and after treatment, 28 days
Application of Multimodal Large Language Model in HFpEF
NCT Number: NCT06486649
Acronym: MeG-HFpEF
Status: RECRUITING
Study Type: OBSERVATIONAL
Conditions: Heart Failure With Preserved Ejection Fraction
Interventions: DIAGNOSTIC_TEST: Multimodal Large Language Model Diagnosis|DIAGNOSTIC_TEST: Routine diagnostic and therapeutic procedure
Sponsor: Peking University Third Hospital
Collaborators: Tianjin Medical University General Hospital|The First Hospital of Hebei Medical University|Central hospital Affiliated to Shandong First Medical University|Qingdao Municipal Hospital
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 80
Study Design: Observational Model: |Time Perspective: p
Start Date: 2023-12-20
Completion Date: 2024-12-20
Locations: Peking UniversityThird Hospital, Beijing, Beijing, China

Summary:
This study will validate the effectiveness of a multimodal large language model to screen for heart failure with preserved ejection fraction (HFpEF), comparing it with the traditional clinical standardized assessment process.

Primary Outcome Measures: dignostic specificity, dianostic specificity comparison between routine diagnosis and therapy and large language model diagnosis, through study completion, an average of 8 months|dignostic sensitivity, dianostic sensitivity comparison between routine diagnosis and therapy and large language model diagnosis, through study completion, an average of 8 months
Secondary Outcome Measures: consistency rate, consistency rate between routine diagnosis and therapy and large language model diagnosis, through study completion, an average of 8 months|time spent on diagnosis, comparison of time spent on diagnosis between routine diagnosis and therapy and large language model diagnosis, through study completion, an average of 8 months|patient satisfaction, comparison of patient satisfaction between routine diagnosis and therapy and large language model diagnosis by questionnaire, through study completion, an average of 8 months|economic cost analysis, comparison of economic cost between routine diagnosis and therapy and large language model diagnosis by the total cost of treatment, through study completion, an average of 8 months|false discovery rate, comparison of false discovery rate between routine diagnosis and therapy and large language model diagnosis, through study completion, an average of 8 months|physician workload assessment, comparison of physician workload between routine diagnosis and therapy and large language model diagnosis according to counting the number of participants with treatment-related, through study completion, an average of 8 months|diagnosis efficiency, The probability of accuracy compared to the final diagnosis of the patient's visit, through study completion, an average of 8 months
Effect of Inhalation Therapy on Children's Fear and Anxiety Levels and Physiological Parameters
NCT Number: NCT06486610
Status: RECRUITING
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Anxiety and Fear
Interventions: BEHAVIORAL: Fish-shaped nebulizer and fish-shaped toy|DEVICE: Silent nebulizer
Sponsor: Recep Tayyip Erdogan University
Sex: ALL
Age: CHILD
Enrollment: 90
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: DOUBLE (PARTICIPANT, OUTCOMES_ASSESSOR)|Primary Purpose: SUPPORTIVE_CARE
Start Date: 2024-05-01
Completion Date: 2024-12-30
Locations: Recep Tayyip Erdoğan University Faculty of Health Sciences, Rize, Güneysu, 53100, Turkey

Summary:
The research was planned as a randomized controlled study. Between July 2023 and July 2025, he was hospitalized in the pediatric emergency department of Recep Tayyip Erdogan University Training and Research Hospital and was treated with a nebulizer. It includes children aged 3-6 and their mothers receiving treatment. The sample of the research will consist of 120 children and their mothers who applied to the pediatric emergency department between the specified dates and met the inclusion criteria and volunteered to participate in the research. "Introductory Information Form", "Child Fear Scale", "Emotional Indicators Scale in Children", "Physiological Parameter Tracking Form" will be used to collect data. "Nebulizer with Toy Figure", "Sound Insulated (Silent) Nebulizer" and "Toy with Fish Figure" will be used as research materials.

Primary Outcome Measures: Child Fear Scale, This scale was developed to measure the anxiety levels in children. The facial muscle changes in expressions of fear have been illustrated by a graphic artist based on photographs of frightened faces. The scale can be used by families, children, or researchers to assess children. It presents a scale containing five facial expressions, scored between 0 and 4. A score of 0 indicates no fear or anxiety, while a score of 4 indicates the highest level of fear or anxiety. These are recognized as: "0" neutral expression (no anxiety), "1" very slight fear (very low anxiety), "2" mild fear (mild anxiety), "3" more fear (increased anxiety), "4" the most extreme fear (severe anxiety). This scale can be applied to measure fear and anxiety before and during medical procedures., one year|Emotional Indicators Scale for Children, This scale is an easily administered and evaluated tool used to objectively identify emotional responses of children to medical procedures. The emotional indicators on the scale are assessed based on five parameters: facial expression, voice, activity, interaction, and cooperation level. These five parameters are scored from 1 to 5, with the lowest possible score being 5 and the highest being 25. The scale has a Cronbach's alpha reliability coefficient of 0.88. In this study, the scale will be utilized to assess the emotional indicators of children during inhalation therapy., one year
Contingency Management for Problematic Behavior Reduction in the Community
NCT Number: NCT06486584
Status: ACTIVE_NOT_RECRUITING
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Schizophrenia|Bipolar Disorder|Anosognosia
Interventions: BEHAVIORAL: Contingency Management
Sponsor: Laureate Institute for Brain Research, Inc.
Collaborators: Tulsa Day Center
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 15
Study Design: Allocation: NA|Intervention Model: SINGLE_GROUP|Masking: NONE|Primary Purpose: OTHER
Start Date: 2023-06-20
Completion Date: 2024-12-15
Locations: Laureate Institute for Brain Research, Tulsa, Oklahoma, 74136, United States

Summary:
This study aims to determine the feasibility and effectiveness of implementing a contingency management program in a small group of mentally ill, unhoused individuals with schizophrenia or bipolar disorder and anosognosia (a lack of insight into their mental health) in the City of Tulsa. The primary objective of the study is to decrease disruptive or problematic behaviors (e.g. interactions with police, emergency services, hospitals, shelter staff, 911 calls) by unhoused individuals in the community through monetary incentives. Up to 15 participants will meet weekly for 30 minutes with their case manager to discuss progress on life goals ($10) and for having seven days with no disruptive behaviors (or "trouble-free days") per week at each visit, they will receive an additional baseline payment of $20, increasing with continued success in subsequent weeks by $1 per week.

Primary Outcome Measures: Reduction in disruptive behaviors, Participants will decrease the frequency of disruptive behaviors in comparison with the 6-month period immediately prior to recruitment, 6 months
Secondary Outcome Measures: Reduction in disruptive behaviors, Participants will decrease the frequency of disruptive behaviors in comparison with the 6-month period immediately prior to recruitment, 18 months
Strategies to Control Robotic Hand Prosthesis Via HD-sEMG and to Restore Sensory Feedback Via TENS
NCT Number: NCT06486571
Status: RECRUITING
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Upper Limb Amputees
Interventions: OTHER: Electromyography recording with HD-sEMG|OTHER: Transcutaneous Electrical Nerve Stimulation (TENS)
Sponsor: Istituto Nazionale Assicurazione contro gli Infortuni sul Lavoro
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 30
Study Design: Allocation: NA|Intervention Model: SINGLE_GROUP|Masking: NONE|Primary Purpose: BASIC_SCIENCE
Start Date: 2024-04-23
Completion Date: 2026-04-22
Locations: Centro Protesi Inail, Budrio, BO, 40054, Italy

Summary:
Upper limb amputation still causes severe disability today; prostheses currently on the market are able to restore partially to the amputee the lost functionality. In addition to the motor capacity of the limb, prosthetic systems should also aim to restore to the sensory information from the surrounding environment during contact with objects. Therefore, it is important to develop bidirectional prostheses. It is thus apparent that the development of new techniques for decoding the efferent channel, such as high-density surface electromyography, and for encoding of the afferent channel afferent, to return multimodal somatosensory sensations of mechanoception, nociception, and thermoception using TENS, isimportant to improve the patient's use of the prosthesis.

Primary Outcome Measures: Improve gestures decoding by means of HD-sEMG decoding algorithms, The performance of HD-sEMG classifiers with variable number of classes will be evaluated in the offline phase in terms of accuracy of classification and F1-Score., through study completion, an average of 2 year through study completion, an average of 2 year|Elicit somatic sensations in amputees, The performance of the stimulation strategy will be evaluated in terms of stimulus discrimination accuracy, a parameter that identifies the number of times the subject correctly reports the type of sensation elicited by the experimenter compared to the total number of stimulations performed., through study completion, an average of 2 year through study completion, an average of 2 year
Secondary Outcome Measures: Increase the number of hand grasps to be classfiied, To explore the possibility of increasing the number of gestures that can be classified by the developed classification system, compared to the number of gestures that can be reproduced by prosthetic control solutions traditional and to evaluate the intuitiveness in using classifiers to control a polyarticulated prosthesis., through study completion, an average of 2 year through study completion, an average of 2 year|Development of encoding strategies, Develop new algorithms for decoding motor intention from the myoelectric signal and new encoding algorithms for the sensory restitution by non-invasive stimulation and to evaluate the intuitiveness of the developed strategies., through study completion, an average of 2 year through study completion, an average of 2 year
Relative Bioavailability Study of HU6
NCT Number: NCT06486558
Status: RECRUITING
Study Type: INTERVENTIONAL
Phases: PHASE1
Conditions: Healthy
Interventions: DRUG: HU6 450 mg Tablet|DRUG: HU6 150 mg Capsules x 3 (Total dose = 450 mg)
Sponsor: Rivus Pharmaceuticals, Inc.
Sex: ALL
Age: ADULT
Enrollment: 40
Study Design: Allocation: RANDOMIZED|Intervention Model: CROSSOVER|Masking: NONE|Primary Purpose: TREATMENT
Start Date: 2024-07-24
Completion Date: 2024-10-31
Locations: Nucleus Network, Saint Paul, Minnesota, 55114, United States

Summary:
This is a 2-part study. Part 1 will assess the relative bioavailability of the new 450 mg tablet test formulation compared to the 150 mg capsule reference formulation (3 x 150 mg). Part 1 dosing will be conducted in the fasted state. Part 2 will assess the effect of food (and fat content) on the pharmacokinetics of the 450 mg tablet test formulation.

Primary Outcome Measures: Area under the plasma concentration-time curve (AUC) from time 0 to last quantifiable time point (AUC0-t),, 14 days|Maximum concentration (Cmax), 14 days
HeartBeet Clinic Pilot Trial
NCT Number: NCT06486532
Status: NOT_YET_RECRUITING
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Hyperlipidemia|Hypertension
Sponsor: HealthPartners Institute
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 60
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: NONE|Primary Purpose: PREVENTION
Start Date: 2024-11
Completion Date: 2025-01-31

Summary:
The goal of the current study is to conduct a pilot randomized controlled trial comparing the HeartBeet Clinic, a 16-week lifestyle medicine program with virtual, small-group coaching, to a self-paced, online education program. In this pilot study, the primary goals will be to assess acceptability and feasibility of the study and intervention procedures to prepare for a larger efficacy trial.

Primary Outcome Measures: Acceptability, Assess the acceptability using Client Satisfaction Questionnaire (CSQ-8; Larsen et al., 1979). Participants report the extent to which the intervention met their expectations on a 8-item scale. Participants rate the quality of the service and their satisfaction with the services provided on a 4-point Likert-type scale with varying response options (e.g., "How would you rate the quality of the service you received? 4 = Excellent, 3 = Good, 2 = Fair, or 1 = Poor). Items were summed for a total score ranging from 8 to 32, with higher scores corresponding to greater satisfaction with treatment., Within 2 weeks post-intervention
Secondary Outcome Measures: Recruitment and Retention feasibility, Assess feasibility of the intervention based on meeting recruitment and retention targets., End of study (5 months)|Cardiovascular health, Cardiovascular health will be measured by Life's Essential 8 (Lloyd-Jones et al., 2022), a composite measure that includes 8 domains: diet quality, physical activity, smoking, sleep, lipids, blood pressure, blood glucose, and body mass index. Each domain is scored on a scale from 0-100; a total cardiovascular health score is the average of the 8 domains., Within 2 weeks post-intervention
Collection of Vaginal Microbiota Samples (VAGINOTYPE)
NCT Number: NCT06486519
Acronym: VAGINOTYPE
Status: RECRUITING
Study Type: OBSERVATIONAL
Conditions: Vaginal Microbiota
Sponsor: Lallemand Health Solutions
Collaborators: BioFortis
Sex: FEMALE
Age: ADULT
Enrollment: 200
Study Design: Observational Model: |Time Perspective: p
Start Date: 2024-05-14
Completion Date: 2025-01
Locations: Biofortis, Unité d'Investigation Clinique, Paris, 75012, France|Biofortis, Unité d'Investigation Clinique, Saint-Herblain, 44800, France

Summary:
The aim of this study is to collect vaginal microbiota samples from healthy women who are subject to vaginal and urinary infections.

Primary Outcome Measures: Composition of the vaginal microbiome, Vaginal microbiota composition (α-diversity, β-diversity, and relative abundance at the genus and species level) at a single point in time via shotgun sequencing., 1 day
Proximal Femur Reconstruction Following Resection of Primary Bone Tumors: Analysis of the Clinical and Radiographic Results
NCT Number: NCT06486506
Acronym: ProFemuRe
Status: RECRUITING
Study Type: OBSERVATIONAL
Conditions: Bone Tumor|Bone Cancer
Interventions: OTHER: Analysis
Sponsor: Costantino Errani
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 150
Study Design: Observational Model: |Time Perspective: p
Start Date: 2024-04-29
Completion Date: 2024-12
Locations: IRCCS Itituto Ortopedico Rizzoli, Bologna, BO, 40136, Italy

Summary:
From the archives of the Rizzoli institute all the patients (approximately 150 patients) undergoing oncological reconstruction of proximal femur from 01/01/1991 to 31/12/2023.

A review will be made from the medical records, radiological imaging, and histological data of these patients

Primary Outcome Measures: longevity of the reconstruction, evaluation of the longevity of the reconstruction, meaning reconstruction failure-free survival after surgery, At baseline (Day 0)
Secondary Outcome Measures: Musculoskeletal tumour society (MSTS) functional evaluation, The MSTS questionnaire consists of six domains, each scored on a scale from 0 to 5, with a higher score indicating better function., at baseline (day 0)
Effect of Minimally Invasive Surgical Assisted by Robots on Intraventricular Hemorrhage
NCT Number: NCT06486480
Status: NOT_YET_RECRUITING
Study Type: INTERVENTIONAL
Phases: EARLY_PHASE1
Conditions: Clarify the Therapeutic Differences Between Robot Assisted Endoscopic Clearance and Traditional Puncture and External Drainag
Interventions: PROCEDURE: Using robot assisted endoscopy to clear intraventricular hemorrhage
Sponsor: Jin Hu
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 143
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: SINGLE (OUTCOMES_ASSESSOR)|Primary Purpose: TREATMENT
Start Date: 2025-01-01
Completion Date: 2026-12-31

Summary:
Clarify the therapeutic differences between robot assisted endoscopic clearance and traditional puncture and external drainage, and establish a new minimally invasive surgical diagnosis and treatment strategy for intraventricular hemorrhage

Primary Outcome Measures: 6-month mRS score, MRS Scores 6 months after onset, 180 days
Secondary Outcome Measures: 30 day mortality rate, Mortality at 30 days after onset, 0-30 days
Real-world Evaluation of the HistoSonics Edison System for Treatment of Liver Tumors Across Multidisciplinary Users (BOOMBOX: Master Study)
NCT Number: NCT06486454
Status: NOT_YET_RECRUITING
Study Type: OBSERVATIONAL
Conditions: Liver Neoplasms|Primary Liver Cancer|Secondary Liver Cancer|Tumor Liver|Benign Liver Tumor
Interventions: DEVICE: HistoSonics Edison System
Sponsor: HistoSonics, Inc.
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 5000
Study Design: Observational Model: |Time Perspective: p
Start Date: 2024-10
Completion Date: 2031-11

Summary:
The goal of this observational study is to collect information on the use of the HistoSonics Edison System for the treatment of liver tumors. The main aim is to understand how different patient characteristics and procedural characteristics may affect histotripsy success at 36 hours post-histotripsy procedure. Sub-studies to the BOOMBOX: Master Study will investigate specific populations and/or clinical questions with more stringent enrollment criteria, standardized testing criteria, and/or follow-up schedule. Any participant enrolled in the BOOMBOX: Master Study that also qualifies for a sub-study may enroll in the sub-study in parallel; sub-studies will be described in separate sub-study protocols. The BOOMBOX: Master Study will collect information about participants before, during, and after the histotripsy treatment procedure. All participants will be followed per standard clinical follow-up based on each site's clinical practice for up to 5 years after the initial histotripsy procedure or until completion of their follow-up in a sub-study, whichever is longer.

Primary Outcome Measures: Histotripsy Technical Success, Histotripsy technical success, defined as completion of histotripsy on the target tumor(s) according to the histotripsy treatment plan, assessed by the treating physician on CT or MR imaging at ≤36 hours post-histotripsy treatment procedure. The histotripsy treatment plan will include identification of the intended complete or partial treatment of the tumor(s). The histotripsy treatment zone must provide target tumor coverage greater than or equal to the degree of treatment intended., ≤36 hours post-histotripsy treatment procedure
Small Cell Lung Cancer Community Engagement to Eliminate Research Disparities
NCT Number: NCT06486428
Acronym: SUCCEED
Status: NOT_YET_RECRUITING
Study Type: OBSERVATIONAL
Conditions: Small-cell Lung Cancer
Sponsor: Addario Lung Cancer Medical Institute
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 30
Study Design: Observational Model: |Time Perspective: p
Start Date: 2024-10
Completion Date: 2026-06

Summary:
This pilot feasibility study will evaluate if a direct-to-patient, de-centralized, remote blood collection approach will improve outreach to SCLC patients and enable successful collection of samples for bio-banking (for future use). The study will also assess the ability of this patient population to adequately self-report medical information such as diagnoses, medical history and treatment history, as well as, to gather information on care and quality of life impacts and preferences through an initial and 4-month follow up survey.

Primary Outcome Measures: Feasibility of conducting trial in SCLC population, Percentage of SCLC eligible subjects enrolled. Percentage of tSCLC eligible subjects enrolled. Percentage of SCLC eligible subjects enrolled compared to percentage of tSCLC eligible subjects enrolled. Percentage of SCLC enrolled subjects completed. Percentage of tSCLC enrolled subjects completed. Percentage of SCLC enrolled subjects completed compared to percentage of tSCLC enrolled subjects completed. Reasons for early termination from trial in SCLC enrolled. Reasons for early termination from trial in tSCLC enrolled., 12 months
Other Outcome Measures: Bio-specimen collection, Percentage of blood collections during trial in SCLC enrolled compared to in tSCLC enrolled.

Reasons for failure to obtain blood collections. Percentage of successful blood collections during trial (SCLC compared to tSCLC).

Reasons for failure to obtain blood collections. Percentage of successful blood collections during trial (SCLC compared to tSCLC). Reasons for failure to obtain blood collections., 12 months|Subject Surveys (baseline and at 3 months), Percentage of successful Survey completions; at baseline; at Month 3. Reasons for failure to complete Survey(s)., 3 months
Novel Diagnosis of Ectopic Pregnancy
NCT Number: NCT06486415
Status: NOT_YET_RECRUITING
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Ectopic Pregnancy|hCG|Pregnancy of Unknown Location
Interventions: DIAGNOSTIC_TEST: serum BHCG testing
Sponsor: Acibadem University
Sex: FEMALE
Age: ADULT
Enrollment: 20
Study Design: Allocation: NON_RANDOMIZED|Intervention Model: PARALLEL|Masking: NONE|Primary Purpose: DIAGNOSTIC
Start Date: 2024-07-01
Completion Date: 2025-04-01

Summary:
In the project, the investigators aim to determine the Beta- human chorionic gonadotropin (BHCG) value with serial measurements on the same day in the diagnosis of ectopic pregnancy.

Primary Outcome Measures: Changes in Beta-hCG Levels Measured Every 2 Hours as a Discriminating Factor Between Ectopic and Normal Pregnancy, The primary outcome is how the changes in Beta-hCG levels measured every two hours differ between the ectopic pregnancy and the normal pregnancy., 10 hours
Secondary Outcome Measures: Increase pattern of BHCG levels in normal pregnancy, BHCG increase pattern every two hours in normal pregnancy, 10 hours
DISPARITY Study: An Observational Evaluation of Characteristics of Participants in Clinical Studies
NCT Number: NCT06486402
Acronym: DISPARITY
Status: ACTIVE_NOT_RECRUITING
Study Type: OBSERVATIONAL
Conditions: Participation Rate, Patient|Patient Participation
Interventions: OTHER: participation rate
Sponsor: Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
Sex: ALL
Age: CHILD, ADULT, OLDER_ADULT
Enrollment: 5000
Study Design: Observational Model: |Time Perspective: p
Start Date: 2023-03-15
Completion Date: 2024-12-01
Locations: Amsterdam UMC, Amsterdam, Noord-holland, 1105 AZ, Netherlands

Summary:
The aim of this study is to evaluate whether females are underrepresented in clinical studies in the Departments of Anaesthesia and Intensive Care, Amsterdam UMC, locations AMC and VUmc. The main outcome is Participation Prevalence Ratio (PPR), which means the representation of female/male patients in a study in relation to their representation in the disease population undergoing surgery.

To achieve this, we will use the average proportion of female participants enrolled per study and, in addition, data from the CBS for population benchmarking, determining the proportions of males and females undergoing surgery (elective cardiac and non-cardiac surgery) and the proportions of these populations in an academic hospital.

Primary Outcome Measures: Participation rate, Number of patients participating in a clinical trial, 5 year
The Impact of WASH on Handwashing Practices Among School Children in Nigeria.
NCT Number: NCT06486376
Acronym: WASHEDUP
Status: RECRUITING
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Hand Hygiene
Interventions: BEHAVIORAL: Water, Sanitation and Hygiene Education Against Diarrhoea, Undernutrition and Pneumonia
Sponsor: The Neo Child Initiative for Africa
Sex: ALL
Age: CHILD
Enrollment: 3500
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: SINGLE (OUTCOMES_ASSESSOR)|Primary Purpose: OTHER
Start Date: 2024-02-01
Completion Date: 2024-12-15
Locations: Kiddies Primary School, Somolu, Lagos, 10004, Nigeria

Summary:
Children are considered as the most vulnerable group of individuals affected by lack of water, sanitation and hygiene facilities which predisposes them to a wide range of enteric diseases particularly diarrhoeal and parasitic infections. School-based WASH interventions typically aim to reduce the incidence of hygiene related diseases, improve school outcomes for pupils and influence hygiene practices of families and the wider community. This study intends to investigate the impact and effectiveness of the teacher-led school- based hygiene intervention on handwashing practices and prevention of diarrhoea, undernutrition, and pneumonia among school children in primary schools in Lagos, Nigeria.

Primary Outcome Measures: Sanitation and hygiene-related knowledge, attitudes, and practices of handwashing, The incidence of diarrhoeal diseases and pneumonia among school children in primary schools in Lagos., 3 months
Secondary Outcome Measures: School absenteeism, The difference in school absence and the occurrence of self-reported diarrhoea, and pneumonia symptoms between children who attended schools that participated in the WASHED-UP campaign versus children who attended schools that did not receive WASHED-UP?, 3 months
Comparison of the Antiplatelet Efficacy of Aspirin Combined With Clopidogrel and Aspirin Combined With Half-dose Ticagrelor in Patients With Unruptured Intracranial Aneurysms With Normal CYP2C19 Metabolizer Phenotype
NCT Number: NCT06486363
Status: NOT_YET_RECRUITING
Study Type: INTERVENTIONAL
Phases: PHASE4
Conditions: Intracranial Aneurysms|Antiplatelet Drugs
Interventions: DRUG: Aspirin combined with clopidogrel|DRUG: Aspirin combined with half-dose ticagrelor
Sponsor: The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 196
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: NONE|Primary Purpose: TREATMENT
Start Date: 2024-08-01
Completion Date: 2027-07-31

Summary:
The goal of this clinical trial is to compare the antiplatelet efficacy of aspirin combined with clopidogrel and aspirin combined with half-dose ticagrelor in in patients with unruptured intracranial aneurysms with normal CYP2C19 metabolizer phenotype. The main questions it aims to answer are:

If aspirin combined with half-dose ticagrelor is comparable to or better than aspirin combined with clopidogrel? What medical problems do participants have when taking aspirin combined with half-dose ticagrelor? Researchers will compare aspirin combined with half-dose ticagrelor to aspirin combined with clopidogrel to see if aspirin combined with half-dose ticagrelor works to treat patients with unruptured intracranial aneurysms received endovascular treatment.

Participants will:

Take aspirin combined with half-dose ticagrelor or aspirin combined with clopidogrel every day for 6 months Visit the clinic 1 month and 6 months for checkups and tests

Primary Outcome Measures: Incidence rate of cerebral stroke, Incidence rate of cerebral stroke, including ischemic stroke and hemorrhagic stroke, The entire experimental process after endovascular treatment|Modified Rankin Scale, Modified Rankin Scale ( The scale runs from 0 to 6, 0 means perfect health and 6 means death), 6 months after endovascular surgery|Mini-mental state examination, The MMSE examination includes time and place orientation, registration, attention and calculation, recall, language, repitition, complex commands. Score excess 24 or more indicates a normal cognition, 19-23 points indicates mild cognitive impairment, score of 10-18 points indicates moderate cognitive impairment and score below 9 points indicates severe cognitive impairment, 6 months after endovascular surgery
Secondary Outcome Measures: Platelet inhibition rate/platelet aggregation rate, Platelet inhibition rate/platelet aggregation rate, 1 day before endovascular surgery/3 days after endovascular surgery/3 and 6 months after endovascular surgery
IL-6: A Marker for AML Chemo Sensitivity
NCT Number: NCT06486350
Status: RECRUITING
Study Type: OBSERVATIONAL
Conditions: AML, Adult
Sponsor: Fujian Medical University Union Hospital
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 72
Study Design: Observational Model: |Time Perspective: p
Start Date: 2023-10-01
Completion Date: 2025-06
Locations: Fujian Medical University Union Hospital, Fuzhou, Fujian, 350001, China

Summary:
Acute myeloid leukemia (AML) is a clonal malignancy that arises from the primitive hematopoietic cells within the hematopoietic system. According to SEER cancer statistics, the 5-year survival rate for AML patients stands at a concerning 30%. Despite therapeutic advancements, the development of chemotherapy resistance and the risk of disease relapse pose significant barriers to curative outcomes. Evidence has linked elevated interleukin-6 (IL-6) levels in plasma and bone marrow to a poorer prognosis in AML, with IL-6 potentially fostering chemotherapy resistance through the enhancement of fatty acid uptake and the induction of stromal-like morphological changes in AML cells. However, the role of IL-6 as a potential biomarker for monitoring chemotherapy sensitivity in AML has not been fully elucidated. This study seeks to investigate the correlation between IL-6 levels in bone marrow supernatant and the sensitivity to chemotherapy, offering a clinical perspective that could pave the way for improved prognostic markers and personalized treatment strategies.

Primary Outcome Measures: ORR, The primary endpoint of this study is the overall response rate (ORR) after Chemotherapy, 1 year
Secondary Outcome Measures: CR, The secondary endpoints is the complete remission (CR) rate after Chemotherapy, 1 year|CRi, The secondary endpoints is the complete remission with incomplete blood count recovery (CRi) rate after Chemotherapy, 1 year|PR, The secondary endpoints is the partial remission (PR) rate after Chemotherapy, 1 year|OS, The secondary endpoints is the overall survival (OS), 2 year
CMOP±R in the Treatment of Untreated Non-Hodgkin's Lymphoma
NCT Number: NCT06486337
Status: NOT_YET_RECRUITING
Study Type: INTERVENTIONAL
Phases: PHASE2
Conditions: NHL
Interventions: DRUG: CMOP±R
Sponsor: The First Affiliated Hospital of Soochow University
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 197
Study Design: Allocation: NA|Intervention Model: SINGLE_GROUP|Masking: NONE|Primary Purpose: TREATMENT
Start Date: 2024-07-10
Completion Date: 2027-08-31

Summary:
This is a prospective, single arm, multicenter study to evaluate the safety and efficacy of CMOP±R in patients with newly diagnosed non-Hodgkin's lymphoma.

Primary Outcome Measures: Complete Response Rate (CRR), Response is assessed according to the 2014 lugano criteria.Percentage of participants with complete response was determined on 2014 Lugano criteria., 3 years
Secondary Outcome Measures: Overall Response Rate (ORR), Response is assessed according to the 2014 lugano criteria.The total percentage of patients with complete response（CR ）and partial response（PR)., 3 years|Progression-Free-Survival (PFS), From the time subjects were enrolled to the time of disease progression (in any way) or death from any cause.Progression-free survival (PFS) was analyzed using Kaplan-Meier method, and 95% bilateral confidence intervals were calculated., 3 years|Duration of Response (DOR), The time between meeting the criteria for treatment effectiveness (first recorded complete or partial response) and the first clear recurrence or progression.Duration of response (DoR) was analyzed using Kaplan-Meier method, and 95% bilateral confidence intervals were calculated., 3 years|Overall survival (OS), From the date of inclusion to date of death, irrespective of cause.Overall survival (OS) was analyzed using Kaplan-Meier method, and 95% bilateral confidence intervals were calculated., 3 years|Progression of disease within 2 years(POD24), The rate of patients with disease progression within 24 months of receiving first-line treatment at the start of enrollment., 3 years|Treatment-emergent adverse events (TEAEs), The safety of the drug was evaluated by NCI-CTC AE 5.0 standard.Hematologic and non-hematologic toxicity.To identify the incidence of TEAEs with NCI-CTC AE 5.0 standard., From the initiation of the first dose to 28 days after the last dose|Changes in cardiac safety indicators, The change value of LVEF% from baseline, and its mean, median, standard deviation, maximum and minimum values were statistically described., 3 years