pankajmathur/National_Library_of_Medicine_Studies_data huggingface dataset:
Adherence to Medication in Patients With Acute Decompensated Heart Failure
NCT Number: NCT06459115
Acronym: ADHF-ED
Status: RECRUITING
Study Type: OBSERVATIONAL
Conditions: Acute Decompensated Heart Failure
Sponsor: Universität des Saarlandes
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 100
Study Design: Observational Model: |Time Perspective: p
Start Date: 2023-02-01
Completion Date: 2024-12-31
Locations: Department of Internal Medicine III, Cardiology, Angiology and Intensive Care Medicine, University Hospital Saarland, Saarland University, Homburg, 66421, Germany

Summary:
Every day, patients present to emergency department due to acute heart failure. There are many causes for decompensation. One possible cause is a lack of adherence to heart failure medication (prognosis-improving medications and diuretics). The aim of this study is to directly measure adherence in patients with acute heart failure (gold standard of adherence measurement using liquid chromatography coupled to high-resolution mass spectrometry= LC-HRMS/MS) at the emergency department. Questionnaires are used to investigate possible factors influencing adherence.

Primary Outcome Measures: Adherence to heart failure medication, Directly measured adherence rates (measurement of drug levels or metabolites in body fluids via toxicological analysis) of patients with acute heart failure at the emergency department

Two different definitions of adherence are used:

* If all prescribed drugs/metabolites for the treatment of heart failure were detectable in urine, the patient is "adherend". If 1 or at least 2 prescribed drugs were nondetectable in urine, the patient was classified as "partially adherend" and "non-adherend", respectively.
* A 80% threshold is used. If \>80% of the prescribed heart failure drugs were detectable in urine, the patient was characterized as "adherent." Otherwise, the patient was considered to be "nonadherent.", 1 day (cross-sectional)
Secondary Outcome Measures: Patients-related factor with impact on adherence (anxiety and depression), Measurement of anxiety and depressions via one questionnaire with two subscales (Hospital Anxiety and Depression Scale- German version= HADS-D; Two subscales HADS-A (anxiety) and HADS-D (depression), each with 7 items; this results in two total scores for the HADS-A (anxiety) and HADS-D (depression) scales with value ranges from 0 - 21; higher values indicating depression or anxiety; 0-7 unremarkable, 8-10 suspicious, \>10 conspicuous), 1 day (cross-sectional)|Patients-related factors with impact on adherence (social support), Measurement of social support via one questionnaire (ENRICHD Social Support Instrument German version= ESSI-D; 5 items; total score 5-25; higher values indicating better social support), 1 day (cross-sectional)|Patients-related factor with impact on adherence (dementia), Measurement of dementia via one questionnaire (Demtect; Total score= 0-18; 0-8= Suspected dementia; 9-12= Mild cognitive impairment; 13-18= Cognitive powers appropriate for subject's age), 1 day (cross-sectional)
The Effects of Familiar Toy and Parental Presence Combination on Perioperative Pediatric Anxiety
NCT Number: NCT06459089
Status: RECRUITING
Study Type: OBSERVATIONAL
Conditions: Perioperative Anxiety|Emergence Delirium
Interventions: BEHAVIORAL: Selection of the parent according to children preference|BEHAVIORAL: Bringing the favorite toy of the children that will accompany the child during their perioperative period
Sponsor: Karaman Training and Research Hospital
Sex: ALL
Age: CHILD
Enrollment: 100
Study Design: Observational Model: |Time Perspective: p
Start Date: 2024-06-26
Completion Date: 2024-08-20
Locations: Karaman Training and Research Hospital, Karaman, Turkey

Summary:
This study will evaluate the effect of presence of favorite toy and parent during perioperative period on pediatric anxiety and emergence delirium. Half of the patients patients will be accompanied with their ownselected parent and the other half will be accompanied with their favorite toy in addition to their own selected parent.

Primary Outcome Measures: Modified Yale Preoperative Anxiety Scale (mYPAS) of the children undergoing elective surgery under general anesthesia., The mYPAS will be used to evaluate the anxiety level of children. The mYPAS is an observational measure of preoperative anxiety consisting of 27 items in 5 domains (activity, emotional expressivity, state of arousal, vocalization, and use of parents). The adjusted mYPAS total score ranges from 22.9 to 100, with higher scores indicating greater anxiety., Perioperative period
Secondary Outcome Measures: Evaluation with Pediatric Anesthesia Emergence Delirium Scale (PAED) in the postoperative waiting room, Incidence of post-anesthesia and postoperative delirium Discordant behaviors assessed with Pediatric Anesthesia Emergence Delirium Scale (PAED) with five features, each scored using a 5-point Likert scale, Postoperative 1st day
Intra-articular Allocetra in Osteoarthritis of the 1st Carpo-metacarpal Joint
NCT Number: NCT06459063
Status: RECRUITING
Study Type: INTERVENTIONAL
Phases: PHASE1|PHASE2
Conditions: Osteoarthritis Thumb
Interventions: DRUG: Allocetra - Safety run-in phase|OTHER: Placebo|DRUG: Allocetra - Randomization phase
Sponsor: Kaplan Medical Center
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 46
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: QUADRUPLE (PARTICIPANT, CARE_PROVIDER, INVESTIGATOR, OUTCOMES_ASSESSOR)|Primary Purpose: TREATMENT
Start Date: 2024-06-10
Completion Date: 2025-11
Locations: Kaplan Medical Center, Rehovot, Israel

Summary:
This study is a single center trial to assess the safety and efficacy of intra-articular administration of Allocetra to patients with 1st CMC thumb joint osteoarthritis (OA).

Primary Outcome Measures: Injection-related reactions, Injection-related reactions occurring during study treatment injection, including injection interruption/discontinuation., Day 0 (Treatment visit).|Treatment emergent adverse events, Treatment emergent adverse events following study treatment injection. Safety assessments beyond 4 weeks following injection will focus on events that are at least possibly related to study treatment., Day 0 to 6 months.
Secondary Outcome Measures: Thumb base pain - NRS, Thumb base pain numerical rating scale (NRS; 0-10)., Screening day to 12 months.|Hand function - FIHOA, Hand function, assessed by Functional Index for Hand Osteoarthritis (FIHOA; 0-30)., Day 0 to 12 months.|Key pinch and grip strength, Key pinch and grip strength - measured with dynamometer., Day 0 to 12 months.
Effects of Isometric Conditioning Activity on Subsequent Jumping Performance in Volleyball Players
NCT Number: NCT06459050
Status: COMPLETED
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Resistance Training
Interventions: OTHER: Dominant Limb Overcoming Isometric Conditioning Activity|OTHER: Non-dominant Limb Overcoming Isometric Conditioning Activity
Sponsor: The Jerzy Kukuczka Academy of Physical Education in Katowice
Collaborators: Charles University, Czech Republic|University School of Physical Education, Krakow, Poland
Sex: MALE
Age: ADULT
Enrollment: 20
Study Design: Allocation: NON_RANDOMIZED|Intervention Model: CROSSOVER|Masking: DOUBLE (PARTICIPANT, OUTCOMES_ASSESSOR)|Primary Purpose: TREATMENT
Start Date: 2023-04-02
Completion Date: 2023-07-03
Locations: The Jerzy Kukuczka Academy of Physcial Education in Katowice, Katowice, Slask, 40-065, Poland

Summary:
The pairing of high-effort exercise, called conditioning activity, with a biomechanically similar high-velocity power movement is considered a valid method to effectively facilitate muscle power adaptations. Research has mainly focused on using this method in exercises performed by both limbs, even though sports tasks are often executed through motion sequences produced by a single limb alternately. However, available studies have focused solely on the dominant leg, leaving it unclear if the effectiveness is similar in both legs and how it transfers between them. Therefore, this study aims to evaluate the immediate effects of the isometric split squat exercise on single-leg drop jump performance in volleyball players, considering their training status.

Primary Outcome Measures: Drop Jump Height, Drop jump height estimated via take-off velocity performed on force plates. Participants performed 2 trials at each time-point., Immediately pre- and at 4th and 8th minute post-completion of conditioning activity.|Drop Jump Contact Time, Drop jump contact time was estimated via time spent on the ground between drop and jump transition performed on force plates. Participants performed 2 trials at each time-point., Immediately pre- and at 4th and 8th minute post-completion of conditioning activity.|Drop Jump Reactive Strength Index, Drop jump reactive strength index was estimated via jump height divided by the contact time performed on force plates. Participants performed 2 trials at each time-point., Immediately pre- and at 4th and 8th minute post-completion of conditioning activity.
Comparison of Salivary Neuropilin-1 (NRP-1), Cotinine and C-Reactive Protein (CRP) Levels With Periodontal Clinical Parameters in Smokers and Non-Smokers With Different Periodontal Diseases
NCT Number: NCT06459037
Status: RECRUITING
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Periodontal Diseases
Interventions: DIAGNOSTIC_TEST: Saliva obtaining
Sponsor: Izmir Katip Celebi University
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 80
Study Design: Allocation: NON_RANDOMIZED|Intervention Model: PARALLEL|Masking: NONE|Primary Purpose: DIAGNOSTIC
Start Date: 2024-05-10
Completion Date: 2025-04-14
Locations: Izmir Katip Çelebi University Department of Periodontology, İzmir, Çiğli, 35640, Turkey

Summary:
In order to determine the pathogenesis of chronic inflammatory diseases, the levels of various cytokines are analysed in tissues and fluids taken from the body. In various publications, the role of the glycoprotein sNRP-1 on inflammatory diseases and the relationship between smoking and periodontal diseases have been investigated. In this study, our aim was to evaluate the levels of this biomarker in the saliva of smokers with systemically healthy periodontitis and non-smokers with systemically healthy periodontitis, gingivitis and periodontal disease and to compare the concentration differences with CRP. Another aim is to show the effect of nicotine exposure rate on all these by measuring cotinine levels. In our study, all oral clinical parameters of 80 patients, including 20 systemically healthy, non-smoking and periodontally healthy patients, 20 patients with gingivitis, 20 patients with periodontitis; 20 systemically healthy, smoking patients with periodontitis, will be measured and saliva samples will be taken from the patients. The sNRP-1, cotinine and CRP levels in the samples will be determined by enzyme-linked immunoassay (ELISA). Then, statistical analyses will be performed and the difference in the levels of biomarkers between the groups will be interpreted. Possible significant differences between the levels of these biomarkers may reveal that sNRP-1 can be used as a diagnostic tool in periodontal diseases or as a guide for treatments to be performed and may reveal a new perspective on the relationship between periodontitis and smoking.

Primary Outcome Measures: The total amount of CRP in saliva, The total amount of CRP in saliva, 24 hours after taking the clinical measurements at the first visit|The total amount of Neuropilin-1(NRP-1) in saliva, The total amount of Neuropilin-1(NRP-1) in saliva, 24 hours after taking the clinical measurements at the first visit|The total amount of , Cotinine in saliva, The total amount of , Cotinine in saliva, 24 hours after taking the clinical measurements at the first visit
Disclosure Intervention for People in Treatment for Opioid Use Disorder
NCT Number: NCT06458985
Status: RECRUITING
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Opioid Use Disorder
Interventions: BEHAVIORAL: Disclosing Recovery: A Decision Aid and Toolkit
Sponsor: University of Delaware
Collaborators: National Institute on Drug Abuse (NIDA)|Brandywine Counseling and Community Services
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 480
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: NONE|Primary Purpose: TREATMENT
Start Date: 2024-05-20
Completion Date: 2028-05-01
Locations: Brandywine Counseling & Community Services, Wilmington, Delaware, 19805, United States

Summary:
The goal of this clinical trial is to test a disclosure intervention among people in treatment for opioid use disorder. The main question it aims to answer is whether people who receive a disclosure intervention have better treatment- and recovery-related outcomes one year after receiving the intervention. Participants will complete a brief disclosure intervention designed to help them (1) make key disclosures related to disclosure and (2) build skills to disclose. Researchers will compare results to participants in a waitlist comparator condition, who receive the intervention at the end of the study.

Primary Outcome Measures: Retention in treatment, Whether participants are retained in treatment 1 year after baseline, 1 year|Illicit opioid use, Percentages of drug screens that are positive for illicit opioid use, 1 year
Secondary Outcome Measures: Recovery capital score, Average scores on recovery capital measure (titled: Brief Assessment of Recovery Capital); items are measured on a 1-5 point Likert-type scale, and composite scores range from 1-5. Higher values indicate greater recovery capital., 1 year|Quality of life score, Average scores on quality of life measure (titled: European Health Interview Survey-Quality of Life - 8 item); items are measured on a 1-5 point Likert-type scale, and composite scores range from 1-5. Higher scores indicate greater quality of life., 1 year
Exploratory Trial of a Pediatric Web-Based Care Planning Guide
NCT Number: NCT06458959
Acronym: PROSPECT+
Status: NOT_YET_RECRUITING
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Developmental Disabilities|Developmental Delay
Interventions: BEHAVIORAL: PEM+
Sponsor: University of Illinois at Chicago
Collaborators: Rocky Mountain Human Services
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 223
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: SINGLE (CARE_PROVIDER)|Primary Purpose: SUPPORTIVE_CARE
Start Date: 2024-09-01
Completion Date: 2024-12-30

Summary:
Infants and toddlers with developmental disabilities or delays use early intervention (EI) for rehabilitation services. Yet, poor quality of EI services is pervasive, particularly for racially and ethnically diverse and socially disadvantaged families. A key lever to improve EI quality is family-centered care, an evidence-based approach that is grounded in family engagement for shared decision-making. This project is motivated by the need to give families a smart and connected option for engaging in the design of the EI service plan for their child. This project upgrades and tests an evidence-based and innovative electronic solution that helps families to organize and share their priorities for change and ideas for goal attainment with professionals, so as to ensure fit of the service plan with their needs.

Primary Outcome Measures: Pediatric Rehabilitation Intervention Measure of Engagement - Parent version (PRIME-P), 11-item self-report measure that asks parents what they thought, how they felt, and what they did during their child's therapy session and how the session has affected their overall feelings about the intervention process., baseline, 4 weeks, 3 months
Monitoring Postprandial Blood Glucose and Insulin in Fruit Snacks
NCT Number: NCT06458946
Status: RECRUITING
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Blood Glucose|Blood Insulin
Interventions: DIETARY_SUPPLEMENT: Fruit snack 1|DIETARY_SUPPLEMENT: Fruit snack 2|DIETARY_SUPPLEMENT: Fruit snack 3|DIETARY_SUPPLEMENT: Fruit snack 4|DIETARY_SUPPLEMENT: Fruit snack 5|DIETARY_SUPPLEMENT: Confection control
Sponsor: Ocean Spray Cranberries, Inc.
Sex: ALL
Age: ADULT
Enrollment: 24
Study Design: Allocation: RANDOMIZED|Intervention Model: CROSSOVER|Masking: QUADRUPLE (PARTICIPANT, CARE_PROVIDER, INVESTIGATOR, OUTCOMES_ASSESSOR)|Primary Purpose: TREATMENT
Start Date: 2024-05-22
Completion Date: 2024-10-31
Locations: Biofortis Innovation Services, Addison, Illinois, 60101, United States

Summary:
The goal of this clinical trial is to compare the postprandial glucose and insulin responses after different fruit snacks compared to confection control in a healthy population

Primary Outcome Measures: Blood glucose iAUC - 2 hours, The primary outcome variable will be glucose incremental area under the curve (iAUC) from pre-product consumption to 120 min (iAUC0-120 min), 2 hours
Secondary Outcome Measures: Blood glucose change, Plasma glucose concentration change (Cmax - Cbaseline), 2 hours|blood glucose time to max concentration, Plasma glucose time to Cmax (Tmax), 2 hours|Blood insulin, Serum insulin iAUC, concentration change, time to the max concentration in 2 hours after consumption, 2 hours
Social Facilitation of Emotion Regulation in Adolescence
NCT Number: NCT06458920
Status: RECRUITING
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Emotion Regulation
Interventions: BEHAVIORAL: Social regulation|BEHAVIORAL: Cognitive regulation
Sponsor: University of California, Los Angeles
Collaborators: Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Sex: ALL
Age: CHILD, ADULT
Enrollment: 100
Study Design: Allocation: RANDOMIZED|Intervention Model: CROSSOVER|Masking: NONE|Primary Purpose: BASIC_SCIENCE
Start Date: 2022-10-05
Completion Date: 2025-06-01
Locations: University of California, Los Angeles, Los Angeles, California, 90095, United States

Summary:
The goal of this project is to test whether regulating emotions with help from a friend is more effective and long-lasting in adolescents than regulating alone, and to characterize age-related differences in the neural mechanisms supporting social versus cognitive emotion regulation. Participants will complete a psychology experiment while undergoing fMRI scanning.

Primary Outcome Measures: Negative affect, Participant's self-reported negative affect on 1-4 scale (1=not bad at all, 4=very bad) during experiment, 1 day
Research on Building and Application of Internet-based Home Pre-rehabilitation Model for Lung Surgery Patients.
NCT Number: NCT06458894
Status: NOT_YET_RECRUITING
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Lung Cancer
Interventions: BEHAVIORAL: Prerehabilitation
Sponsor: The Fourth Affiliated Hospital of Zhejiang University School of Medicine
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 100
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: DOUBLE (PARTICIPANT, CARE_PROVIDER)|Primary Purpose: SUPPORTIVE_CARE
Start Date: 2024-06-24
Completion Date: 2026-12-26

Summary:
This study, based on the Internet platform, involving family caregivers in preoperative management, not only promotes patient compliance with preoperative rehabilitation exercise, but also provides multi-way rehabilitation measures for elderly patients with limited mobility or medical difficulties, and also provides new ideas for other specialties。

Primary Outcome Measures: Time to the first ambulation after surgery, Patients can complete the time of walking at the bed, and unplanned extubation, 3 Weeks after intervention|Dwelling time of chest drain and chest drainage flow, The duration of the postoperative chest drain and the chest on postoperative day 1 and postoperative day 2 were recorded Lead the flow, Two days after the intervention
Secondary Outcome Measures: Lung function index, Pulmonary function test was performed with the pulmonary function detector on the day of the patient and 30 days after surgery Guide the patient to do inhale or exhale with maximum effort, make three consecutive measurements, and record the best results, including Forced expiratory volume at second 1, 30 Days after intervention
EFFICACY OF A MIXTURE OF SIMETHICONE AND TYNDALLIZED BACILLUS COAGULANS IN INFANT COLIC: A PILOT STUDY
NCT Number: NCT06458881
Status: COMPLETED
Study Type: OBSERVATIONAL
Conditions: Infant Colic
Interventions: COMBINATION_PRODUCT: Mixture of Simethicone and Tyndallized Bacillus Coagulans
Sponsor: Federico II University
Sex: ALL
Age: CHILD
Enrollment: 42
Study Design: Observational Model: |Time Perspective: p
Start Date: 2023-07-01
Completion Date: 2024-02-28
Locations: Marina Russo, Napoli, 80121, Italy

Summary:
: A pilot study was conducted on a group of 41 infants with diagnosis of Infant Colic according to Rome IV criteria. We administered to all the enrolled infants a mixture of Tyndallized bacillus coagulans and Simethicone for 28 days. The primary outcome was the mean infant crying duration at 28th day. The secondary outcome was the improvement in the quality of sleep and infants' and parents' quality of life

Primary Outcome Measures: The primary endpoint was the infant crying duration at 28 days., reatment success was defined as at least 50% reduction in crying time from baseline to day 28 postintervention.
An Open-label Controlled Trial: Effectiveness of Balneotherapy in Palmoplantar Psoriasis and Contact Dermatitis.
NCT Number: NCT06458868
Status: COMPLETED
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Psoriasis|Contact Dermatitis of Hand
Interventions: OTHER: salt water or tap water before UVA
Sponsor: Sifa Okulu - Independent Research Center of Dermatology and Venereology
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 68
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: NONE|Primary Purpose: TREATMENT
Start Date: 2014-06-01
Completion Date: 2023-10-01
Locations: Sifa Okulu Independent Center of Dermatological Research, Altinordu, Ordu, 52100, Turkey

Summary:
Patients who had an indication for phototherapy were included in this study. The treatment was used as a monotherapy protocol.

The standard protocol for bathing PUVA involved applying 0.01% bath psoralen for 15 minutes, while the tap water group only received a tap water bath for 15 minutes and the salt water group received 3% salted (NaCl) water before UVA treatment.

Primary Outcome Measures: Disease Severity Reduction, At least %50 reduction of the disease severity with the intervention groups at 36th week of the treatment, Disease Severity
Secondary Outcome Measures: Improvevement in the Quality of Life, statistically significant improvement in the quality of life of the patients compared to the beginning of the study at the 36the week of the treatment, Qol
Postoperative Pain Protocol Limiting Narcotics for Laparoscopic Hand-assisted Donor Nephrectomy
NCT Number: NCT06458842
Status: TERMINATED
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Narcotic Use|Renal Transplant Donor of Left Kidney
Interventions: DRUG: Ketamine|OTHER: Placebo
Sponsor: Stony Brook University
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 56
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: QUADRUPLE (PARTICIPANT, CARE_PROVIDER, INVESTIGATOR, OUTCOMES_ASSESSOR)|Primary Purpose: TREATMENT
Start Date: 2014-05-23
Completion Date: 2019-10-11

Summary:
Kidney donors represent healthy patients and their anticipated postoperative course should be uncomplicated and brief. This study looks to optimize the perioperative pain regimen of laparoscopic donor nephrectomy patients by minimizing or eliminating narcotics from the immediate post-operative period. Current postoperative standard of care after donor nephrectomy require narcotic analgesics. While narcotics are potent pain medications, they are often associated with complications including nausea, vomiting and dysfunction of the gastrointestinal tract causing prolonged complications.

The investigators seek to evaluate a peri-operative pain regimen limiting the usage of narcotics. This incorporates a perioperative analgesic course utilizing combination of an intravenous non-steroidal anti-inflammatory drug (NSAID), intravenous acetaminophen, and intravenous ketamine. All three have been demonstrated to be effective for the control of perioperative pain while decreasing narcotics use.

Prior to surgery, participants will be consented and randomly assigned to receive the standard of care perioperative pain management using intravenous narcotics as a patient-controlled analgesia (PCA) by itself plus placebo or along with the new protocol. The study will demonstrate it the new protocol will limit or eliminate the need for narcotics as a patient-controlled dose during the postoperative period.

Upon discharge from the hospital, patients will be followed in clinic and via home questionnaires annually for 5 years to evaluate satisfaction, renal function and quality of life.

Primary Outcome Measures: Length of hospital stay, length of stay after surgery, number of days immediately after the surgery
Secondary Outcome Measures: post surgical complication rates, 30 day|postoperative renal function (serum creatinine), up to 2 years after intervention|amount of narcotic pain medication use, starting immediately after the surgery, during the inpatient time period|postoperative nausea, number of patients reporting postoperative nausea during inpatient time period|return of bowel function (passage of flatus), the number of days after surgery at which return of bowel function is achieved|date of postoperative ambulation, reported during inpatient time period
Non-Invasive Distractor During Knee Arthroscopy
NCT Number: NCT06458816
Status: NOT_YET_RECRUITING
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Knee Arthritis|Knee Arthropathy
Interventions: DEVICE: Non-Invasive Knee Joint Distraction|PROCEDURE: Manual Joint Distraction
Sponsor: The Taylor Collaboration
Collaborators: Wilma Chan Highland Hospital Campus
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 14
Study Design: Allocation: NON_RANDOMIZED|Intervention Model: SINGLE_GROUP|Masking: NONE|Primary Purpose: DEVICE_FEASIBILITY
Start Date: 2024-06
Completion Date: 2025-01

Summary:
Patients will be prospectively recruited for knee joint distraction who are undergoing knee arthroscopy. Patient demographics, operative factors, and rates of medical comorbidities will be collected and evaluated. Intraoperative arthroscopic images will be evaluated by the attending Orthopaedic surgeon with standard and testing mechanism and a measuring device will be used to measure the distance between the femur and tibia in the medial and lateral compartments.

Primary Outcome Measures: Medial Knee Joint Distraction Distance measured in millimeters (mm) during arthroscopy using a reference probe, with manual distraction vs non-invasive distractor, intraoperative|Lateral Knee Joint Distraction Distance measured in millimeters (mm) during arthroscopy using a reference probe, with manual distraction vs non-invasive distractor, intraoperative
Secondary Outcome Measures: Pre and Post operative pain scores, VAS, preoperative and within 1 year after knee arthroscopy
Efficacy and Safety of Eltrombopag for Refractory Thrombocytopenia Associated With Connective Tissue Disease
NCT Number: NCT06458803
Status: COMPLETED
Study Type: OBSERVATIONAL
Conditions: Refractory Thrombocytopenia|Connective Tissue Diseases
Interventions: DRUG: Eltrombopag
Sponsor: Tongji Hospital
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 52
Study Design: Observational Model: |Time Perspective: p
Start Date: 2013-05-06
Completion Date: 2023-11-19

Summary:
Immune thrombocytopenia (ITP) is a haemorrhagic disorder often associated with CTD. Corticosteroids are the first-line treatment for CTD-associated thrombocytopenia, but not all patients respond well. Eltrombopag is an oral, small molecule thrombopoietin receptor agonist. It interacts with the transmembrane domain of the thrombopoietin receptor and stimulates platelet production. This study is designed to evaluate the efficacy and safety of eltrombopag in patients with refractory CTD-ITP. It is a single-centre, retrospective, observational study involving a cohort of 52 patients diagnosed with CTD-RITP who received eltrombopag between 2013 and 2023. Follow-up data will be systematically collected and analysed to evaluate the therapeutic efficacy and safety of the drug. The study will provide valuable insight into the benefit of eltrombopag in CTD-RITP by reviewing baseline characteristics and performing subsequent clinical assessments to determine drug response and adverse events.

Primary Outcome Measures: platelet counts of 52 patients from baseline after taking eltrombopag (Therapeutic effects-for refractory CTD-related ITP), Platelet counts are measured to determine remission status (CTD-RITP). Partial remission is defined as platelet counts ≥ 50 × 10\^9/L, and complete remission is defined as platelet counts ≥ 100 × 10\^9/L., Baseline, post-intervention week 4, post-intervention week 8, post-intervention week 12, post-intervention week 24
Secondary Outcome Measures: changes in disease activity index (Systemic Lupus Erythematosus Disease Activity Index 2000 for SLE patients and EULAR Sjögren's Syndrome Disease Activity Index 2000 for pSS patients) from baseline after taking Eltrombopag, Disease activities are measured in SLE patients by the SLEDAI (systemic lupus erythematosus disease activity index 2000) and in SS patients by the ESSDAI (EULAR Sjögren's syndrome disease activity index 2000), which indicate patients' remission from treatment. For Systemic Lupus Erythematosus Disease Activity Index 2000, the minimum score is 0 and the maximum score is 105. With a score of 5 or more, the disease is considered active. For EULAR Sjögren's Syndrome Disease Activity Index 2000, the minimum score is 0 and the maximum score is 51. With a score of 5 or more, the disease is considered active. The lower the disease activity, the more effective Eltrombopag is., Baseline, post-intervention week 4, post-intervention week 8, post-intervention week 12, post-intervention week 24
Sexual Dysfunction Check-up in Premenopausal Breast Cancer Survivors Taking Endocrine Therapy: A Cross-Sectional Study
NCT Number: NCT06458764
Acronym: SEXCHECK
Status: RECRUITING
Study Type: OBSERVATIONAL
Conditions: Breast Cancer Female|Sexual Dysfunction|Premenopausal Breast Cancer
Interventions: OTHER: Questionnaire
Sponsor: Candiolo Cancer Institute - IRCCS
Sex: FEMALE
Age: ADULT
Enrollment: 150
Study Design: Observational Model: |Time Perspective: p
Start Date: 2023-05-01
Completion Date: 2025-03-01
Locations: IRCCS Candiolo Cancer Center, Torino, TO, 10060, Italy

Summary:
Primary objectives:

* To estimate Sexual Dysfunction (SD) incidence in premenopausal breast cancer patients treated by surgery and taking endocrine therapy.
* To detect the presence of SD-related distress in the population, as a determining factor in the maintenance of a good quality of life.

Secondary objectives:

* To describe SD characteristics determining the most frequently reported symptoms and correlations with type of surgery or therapeutic regimens.
* Collect baseline data for subsequent randomized trials involving practical interventions with the aim to reduce SD prevalence in this population.

Primary Outcome Measures: Sexual Dysfunction (SD) incidence, To estimate Sexual Dysfunction (SD) incidence (physiological parameter) in premenopausal breast cancer patients treated by surgery and taking endocrine therapy., 6 months|SD-related distress, To detect the presence of SD-related distress (physiological parameter) in the population, as a determining factor in the maintenance of a good quality of life., 6 months
Secondary Outcome Measures: SD characteristics, To describe SD characteristics determining the most frequently reported symptoms and correlations with type of surgery or therapeutic regimens., 6 months|Collect baseline data, Collect baseline data for subsequent randomized trials involving practical interventions with the aim to reduce SD prevalence in this population., 6 months
Electrophysiological Study of Berrettini Anastomosis
NCT Number: NCT06458751
Status: COMPLETED
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Electrophysiologic Study|Hand Anastomosis
Interventions: OTHER: electrophysiological study|DEVICE: electromyograph
Sponsor: Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico
Sex: ALL
Age: ADULT
Enrollment: 30
Study Design: Allocation: NA|Intervention Model: SINGLE_GROUP|Masking: NONE|Primary Purpose: BASIC_SCIENCE
Start Date: 2024-01-25
Completion Date: 2024-03-15
Locations: Pediatric Emergency Department Clinica de Marchi, Foundation IRCCS Ca' Granda, Ospedale Maggiore Policlinico, Milan, Italy

Summary:
The common opinion that sensory supply of digit 5 (D5) and medial half of digit 4 (D4) of the hand is by ulnar nerve, while the lateral half of D4 and the remaining digits is by median nerve is an oversimplification of a complex topic. Indeed, the literature demonstrated that both the median and ulnar nerves display a number of deviations to the traditionally taught branching patterns.

The aim of our study was to investigate the physiological role of median and ulnar nerves in the sensory supply of D4.

Primary Outcome Measures: analysis of the sensory potential (UV amplitude in MSEC) recorded on both sides of the IV finger of the hand by stimulation of the median nerve and the ulnar one, immediately after the procedure|analysis of the sensory potential ( latency in MSEC) recorded on both sides of the IV finger of the hand by stimulation of the median nerve and the ulnar one, immediately after the procedure
Clinical Evaluation of a New Printable Denture Base Material
NCT Number: NCT06458738
Status: RECRUITING
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Edentulous Mouth
Interventions: DEVICE: Printable denture base material
Sponsor: Ivoclar Vivadent AG
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 22
Study Design: Allocation: NA|Intervention Model: SINGLE_GROUP|Masking: NONE|Primary Purpose: TREATMENT
Start Date: 2024-07
Completion Date: 2029-12
Locations: Ivoclar Vivadent AG, Schaan, 9494, Liechtenstein

Summary:
This clinical investigation is conducted to prove the long-term clinical performance of a new printable denture base material. The aim of this study is to assess the failure rate, the quality and functionality of the full dentures made with the printable denture base material over an investigational period of 5 years.

Primary Outcome Measures: rate of failures leading to replacement of denture, number of dentures, 5 years
Secondary Outcome Measures: functional (e.g. retention) properties of the dentures, Evaluated according to adapted FDI criteria (grade 1-4). Lower scores mean a better outcome., 5 years|biological (e.g. plaque accumulation) properties of the dentures, Evaluated according to adapted FDI criteria (grade 1-4). Lower scores mean a better outcome., 5 years|aesthetic (e.g. surface staining) properties of the dentures, Evaluated according to adapted FDI criteria (grade 1-4). Lower scores mean a better outcome., 5 years
Assessment of DW-MRI Measures : Reproducibility and Repeatability in Pelvic Imaging on MR-Linac With Healthy Volunteers
NCT Number: NCT06458725
Acronym: PILLAR
Status: NOT_YET_RECRUITING
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Rectum Cancer|Pelvic Cancer
Interventions: DEVICE: Magnetic Resonance Imaging (MRI)
Sponsor: Jules Bordet Institute
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 30
Study Design: Allocation: NA|Intervention Model: SINGLE_GROUP|Masking: NONE|Primary Purpose: OTHER
Start Date: 2024-06-13
Completion Date: 2024-11

Summary:
This study evaluates the reliability of functional MRI measurements in pelvic disease through quantifying repeatability and reproducibility, using healthy volunteers. The aim is to provide insights into the consistency of results across sessions and observers, informing the trustworthiness of functional MRI in assessing pelvic disease and particularly rectal cancers and guiding protocol optimization.

Primary Outcome Measures: Assess the repeatability coefficient (RC) (percentage), Quantitative assessment of the Repeatability Coefficient for functional MRI sequences in rectal tissue, expressed as a percentage., Day 1 and Day 10-17|Assess the reproducibility coefficient (RDC) (percentage), Comparative analysis of Repeatability Coefficient values obtained from distinct MRI devices, providing insights into device-specific variations., Day 1 and Day 10-17
Secondary Outcome Measures: Percentage of variation between the different calculation Methods for Repeatability Coefficient., Comparative evaluation of different calculation methods for the Repeatability Coefficient, highlighting the consistency and discrepancies among methods., Day 1 and Day 10-17|Percentage of variation across various pelvic organs for Repeatability Coefficient., Exploration of Repeatability Coefficients in different pelvic organs, providing insights into the variability of repeatability across distinct anatomical structures., Day 1 and Day 10-17
Other Outcome Measures: Percentage of variation based on sequence types for the Repeatability Coefficients., Comparative assessment of Repeatability Coefficients across different types of functional MRI sequences, elucidating the impact of sequence variations on repeatability., Day 1 and Day 10-17
Study to Assess Safety, Tolerability and Activity of DSB2455 in Participants With Advanced Malignancies
NCT Number: NCT06458712
Status: NOT_YET_RECRUITING
Study Type: INTERVENTIONAL
Phases: PHASE1
Conditions: Advanced Malignancies With Homologous Recombination Deficiency (HRD) (Breast, Ovarian, mCRPC, Brain Metastases)
Interventions: DRUG: DSB2455
Sponsor: Duke Street Bio Ltd
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 90
Study Design: Allocation: NA|Intervention Model: SEQUENTIAL|Masking: NONE|Primary Purpose: TREATMENT
Start Date: 2024-09
Completion Date: 2028-08

Summary:
Open label, multi-centre, Phase Ia/b adaptive design study with an initial 2-stage inter-participant Dose Escalation Phase followed by a Dose Expansion Phase.

Primary Outcome Measures: Number of patients demonstrating dose limiting toxicities and SAEs, Number of patients demonstrating dose limiting toxicities and SAEs, Through study completion, an average of 1 year|Number of patients exhibiting reduction in tumor size., Objective Response Rate (ORR), Through study completion, an average of 1 year
Management Of Stoma In Patients Younger Than 3 Months Old
NCT Number: NCT06458699
Acronym: STOMP
Status: ACTIVE_NOT_RECRUITING
Study Type: OBSERVATIONAL
Conditions: Stoma Colostomy|Stoma Ileostomy|Neonatal Disease
Sponsor: University Hospital, Clermont-Ferrand
Sex: ALL
Age: CHILD
Enrollment: 82
Study Design: Observational Model: |Time Perspective: p
Start Date: 2024-05-30
Completion Date: 2024-07-15
Locations: Clermont-Ferrand University Hospital, Clermont-Ferrand, Auvergne, 63000, France

Summary:
Indications for jejunostomy, ileostomy or colostomy vary in the neonatal population. The most common etiologies are congenital anomalies, such as anorectal malformations, intestinal atresia or Hirschsprung's disease, but also acquired conditions, such as enterocolitis or intestinal perforation. The aim of these stomas is to divert stool in the event of intestinal obstruction or risk of fecal contamination.

Depending on the indication and the type of stoma used, the post-operative follow-up, such as resumption of intestinal transit and feeding, secondary closure of the stoma or not, and the duration and cost of hospitalization differ.

The aim of this study is to compare these differences in order to extract an optimal management strategy, in the light of what is reported in the international scientific literature.

Primary Outcome Measures: Postoperative medical complications, infections, sepsis, dehydration, hydroelectrolytic disorders, through study completion, an average of 1 year|Postoperative surgical complications, disunion, surgical scar,, through study completion, an average of 1 year
Secondary Outcome Measures: Length of stay, time of hospitalization, through study completion, an average of 1 year|Hospitalization costs, costs by department and overall costs, through study completion, an average of 1 year
Other Outcome Measures: Redo, Necessity to remake the stoma, through study completion, an average of 1 year
Effect of Vitamin D Supplementation on Mental Health: An Exploratory Study on A University Students Suffering From Vitamin D Deficiency
NCT Number: NCT06458686
Status: NOT_YET_RECRUITING
Study Type: INTERVENTIONAL
Phases: PHASE1|PHASE2
Conditions: Psychiatric Disorder
Interventions: DRUG: Vit D|OTHER: Placebo
Sponsor: German University in Cairo
Collaborators: Prof. Mohamed Hassan Solayman, Clinical pharmacy Department, German University in Cairo|Prof. May Ahmed Shawki, Clinical Pharmacy Department, Ain Shams University, Egypt
Sex: ALL
Age: ADULT
Enrollment: 70
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: NONE|Primary Purpose: TREATMENT
Start Date: 2024-06-30
Completion Date: 2026-09-30

Summary:
University students are susceptible to psychological burdens such as depressive symptoms, anxiety, and stress which might have been linked to vitamin D deficiency. Low serum vitamin D level is well recognized around the world. Vitamin D has been reported to modulate several neurological pathways in the brain that control psychological function. As a result, the purpose of this study is to evaluate the effect of vitamin D supplementation on the presence of depressive symptoms, anxiety, and stress in university students. The study will include two phases. The first phase is a cross-sectional phase assessing the prevalence vitamin D deficiency in addition to psychological symptoms. The second phase is a randomized controlled clinical trial that aims to assess the effect of vitamin D supplementation on the prevalent psychological symptoms and its impact on the academic performance among university students. The study will look at the relationship between mental health and vitamin D deficiency, as well as how it will affect academic performance of university students.

Primary Outcome Measures: Evaluation of the correlation between vitamin D deficiency and presence and severity of anxiety, stress and depressive symptoms., Evaluation of the correlation between vitamin D deficiency and presence and severity of anxiety, stress and depressive symptoms., 3 months
LinkPositively+ A Mobile Health App Delivered Intervention to Improve HIV Care Outcomes Among Black Women Affected by Mental Health and Violence
NCT Number: NCT06458660
Acronym: LPP Plus
Status: RECRUITING
Study Type: INTERVENTIONAL
Phases: NA
Conditions: HIV/AIDS|Mental Health Issue
Interventions: BEHAVIORAL: LPP+: Mindfulness Meditation Delivered|BEHAVIORAL: LP
Sponsor: Guiding Right, Inc.
Collaborators: University of California, San Diego
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 60
Study Design: Allocation: RANDOMIZED|Intervention Model: SINGLE_GROUP|Masking: NONE|Primary Purpose: PREVENTION
Start Date: 2024-04-12
Completion Date: 2025-01-15
Locations: Guiding Right, Inc., Oklahoma City, Oklahoma, 73111, United States|New Hope Wellness Center, Oklahoma City, Oklahoma, 73112, United States|Guiding Right, Inc., Tulsa, Oklahoma, 74135, United States

Summary:
The investigative team will conduct a 2-arm randomized control trial to examine the preliminary effect of LinkPositively+ (LPP) an enhanced version of LinkPositively (LP) mobile app on improved HIV care outcomes including improved retention in HIV care, ART adherence, and viral suppression using hair sample analysis and passive electronic, medical record review, and secondarily, self-reported increased social support via activation of social support networks (i.e., assessed by utilization), self-efficacy, and utilization of ancillary support services at baseline, 3- and 6-month post enrollment. Black women living with HIV (WLHA) with a lifetime history of interpersonal violence, who have been linked to care but may have fallen out of care in the past year will be randomized 1:1 to either the LP arm or the LPP arm.

Primary Outcome Measures: Preliminary effect of LPP+ to improve HIV care outcomes, The study aims to examine the preliminary effect of LPP+; mindfulness meditation plus PN plus LP app (e.g., social networking platform, education and self-care tips, resource locator, and ART self-monitoring and reminders) to improve HIV care outcomes including improved retention in HIV care, ART adherence, and viral suppression using empirical hair sample analysis (ART adherence) and passive electronic health medical review (viral suppression)., 3- and 6-month Post Baseline
The Effect of Video Streaming With Virtual Reality Before Coronary Angiography
NCT Number: NCT06458647
Status: NOT_YET_RECRUITING
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Anxiety|Comfort|Patient Satisfaction
Interventions: OTHER: Video Streaming with Virtual Reality
Sponsor: TC Erciyes University
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 74
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: NONE|Primary Purpose: SUPPORTIVE_CARE
Start Date: 2024-07-01
Completion Date: 2024-12-15

Summary:
This study was planned as a randomized controlled experimental study to examine the effects of virtual reality video on anxiety, comfort and patient satisfaction before coronary angiography. Data will be collected using the Descriptive Characteristics Questionnaire, State-Trait Anxiety Inventory, Early Postoperative Comfort Scale, Visual Analog Scale (VAS) for patient satisfaction and pain, Vital Signs Follow-up Form and Complication Follow-up Form.

Primary Outcome Measures: Anxiety, This inventory, which consists of a total of 40 items, is analyzed in two separate sections: The first part is the State Anxiety Inventory, which consists of 20 items, and the individual answers this section with his/her current feelings. The second part is the Trait Anxiety Inventory, which also consists of 20 items, and the individual answers this section with the feelings they have felt in the last 7 days., 30 minutes after angiography|Comfort, The scale, which is based on the concept of comfort, consists of a total of 24 items, 12 of which question the comfort status of the individual before and after the surgical intervention, 12 of which question positive and 12 of which question negative experiences., 30 minutes after angiography|Patient satisfaction, Patients will be asked to rate their satisfaction with the intervention on a 10-point scale., 30 minutes after angiography