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## Adding Dexmedetomidine or Tramadol to Paracetamol- An Effort to Attenuate Catheter Related Bladder Discomfort - NCT ID: NCT06274333 - Study ID: RC.18.1.2024 - Status: RECRUITING - Start Date: 2024-02-28 - Completion Date: 2024-05-30 - Lead Sponsor: Al-Azhar University ### Study Description The insertion of a urinary catheter in a patient undergoing a surgical procedure, especially urinary interventions, may lead to catheter-related bladder discomfort (CRBD) with varying degrees of severity during the postoperative period. Paracetamol is a drug with proven efficacy for the management of mild and moderate postoperative pain. Tramadol is a centrally acting, synthetic opioid analgesic with weak opioid agonist properties. It inhibits the detrusor activity by inhibition of type-1 muscarinic (M1) and type-3 muscarinic (M3) receptors. Dexmedetomidine, a highly selective α2-adrenergic receptor agonist, with analgesic, sedative, anxiolysis, sympatholytic, and sedative properties, is a very useful associated agent for general anesthesia. ### Conditions - Percutaneous Nephrolithotripsy (PCNL) ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: TREATMENT ### Interventions - Dexmedetomidine 0.5 mic/kg - Tramadol 1mg/kg - Paracetamol 10mg/kg ### Outcomes Primary Outcomes - The incidence of catheter-related bladder discomfort (CRBD) Secondary Outcomes - Postoperative pain - Meperidine requirement - Patient satisfaction - Surgeon satisfaction ### Location - Facility: Neveen Kohaf, Cairo, N/A, 11865, Egypt @@
## Effect of Lipikar Urea 30% Before Actinic Keratoses Treatment - NCT ID: NCT06274320 - Study ID: LRP22002 LIPIKAR UREA 30% - Status: NOT_YET_RECRUITING - Start Date: 2024-04 - Completion Date: 2024-10 - Lead Sponsor: Cosmetique Active International ### Study Description This study is conducted in one center in Germany, in adult subjects having actinic keratoses (grade I or II) lesions on the scalp and meeting specific inclusion/exclusion criteria. The purpose of the study is to evaluate a holistic management (efficacy, tolerability and lesion cosmetic outcomes) of Tolak® treatment. ### Conditions - Actinic Keratoses ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: SUPPORTIVE_CARE ### Interventions - Group A: holistic approach - Group B: Tolak® Standard of use ### Outcomes Primary Outcomes - Change in lesion response rate Secondary Outcomes - Percentage change ### Location - Facility: CentroDerm GmbH, Wuppertal, N/A, N/A, Germany @@
## Efficacy of Transversus Abdominis Plane Block - NCT ID: NCT06274307 - Study ID: IRB-21-10-4045 - Status: RECRUITING - Start Date: 2023-06-22 - Completion Date: 2024-09-01 - Lead Sponsor: Justin Hruska ### Study Description This study aims to assess the efficacy of Transversus Abdominus Plane (TAP) blocks, a well-established anesthetic technique, to decrease the amount of post-operative pain in patients who undergo minimally invasive gynecologic surgeries. During minimally invasive gynecologic surgeries, the abdomen is inflated with pressurized air for visualization purposes and released at the end of the surgery. Traditionally, TAP blocks are performed by injecting long-acting local anesthetic agents under ultrasound guidance into the abdominal wall after abdominal surgery after the air has been emptied from the abdomen for additional anesthetic coverage post-operatively. This study proposes a novel approach: that performing TAP blocks while the abdomen is still insufflated will result in better post-operative pain outcomes as compared to the traditional method. ### Conditions - Anesthesia, Local ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: TREATMENT ### Interventions - Transversus abdominis plane block ### Outcomes Primary Outcomes - Time to perform TAP Block - TAP block attempts - Pain Score Visual Analog Scale (VAS) 0 Hours Post Surgery - Pain Score Visual Analog Scale (VAS) 1 Hours Post Surgery - Pain Score Visual Analog Scale (VAS) 2 Hours Post Surgery - Pain Score Visual Analog Scale (VAS) 4 Hours Post Surgery - Pain Score Visual Analog Scale (VAS) 24 Hours Post Surgery - Postoperative Opioid Consumption - Ease of performing TAP Block-anatomical plane visualization - Ease of performing TAP Block-performance efficacy - Patient satisfaction Secondary Outcomes ### Location - Facility: Detroit Medical Center Detroit Receiving Hospital, Detroit, Michigan, 48201, United States @@
## Pharmacokinetics, Efficacy and Safety of CT-P13 Subcutaneous as Induction Therapy in Patients With Active CD or UC - NCT ID: NCT06274294 - Study ID: 2023/12 - Status: NOT_YET_RECRUITING - Start Date: 2024-03 - Completion Date: 2025-01 - Lead Sponsor: CMC Ambroise Paré ### Study Description The goal of this clinical trial is to compare induction treatment with CT-P13 SC to induction treatment with CT-P13 IV in terms of pharmacokinetics in adult patients with inflammatory bowel disease (IBD) who have been diagnosed for at least 3 months and for whom the physician has decided to initiate treatment with infliximab CT-P13 as part of the standard of care.The main aim of this study is to demonstrate that induction treatment with CT-P13 SC is non-inferior to CT-P13 IV in terms of pharmacokinetics at Week 6. ### Conditions - Inflammatory Bowel Diseases ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: TREATMENT ### Interventions - CT-P13 ### Outcomes Primary Outcomes - Ratio SC/IV Secondary Outcomes - Ctrough at week 24 (non-inferiority) - AUC at week 24 - Clinical response at week 6 and week 24 - IBD disability index at week 6 - Fecal calprotectin at week 24 - Clinical remission at week 6 and week 24 - Presence of antibodies to infliximab at Week 6 and Week 24 - Concentration of C-reactive protein up to week 6 (the samples are collected at weeks 0, 6 and 24) - Adverse events, including injection site reactions and hypersensitivity reactions - TSQM collected at Week 6 and Week 24 ### Location - Facility: N/A, N/A, N/A, N/A, N/A @@
## Digital Telerehabilitation in Functional Motor Disorders - NCT ID: NCT06274281 - Study ID: TOMs_FMD - Status: NOT_YET_RECRUITING - Start Date: 2024-03-01 - Completion Date: 2026-02-01 - Lead Sponsor: Universita di Verona ### Study Description Functional motor disorders (FMDs) are a broad spectrum of functional neurological disorders, including abnormal gait/balance disorders. Patients experience high degrees of disability and distress, equivalent to those suffering from degenerative neurological diseases. Rehabilitation is essential in their management. However, the current systems of rehabilitation delivery face two main challenges. Patients are not receiving the amount and kind of evidence-based rehabilitation they need due to the lack of rehabilitation professionals and experts in the field. The rehabilitation setting is not adequate for the long-term management and monitoring of these patients. Digital medicine is a new field that means "using digital tools to upgrade the practice of medicine to one that is high-definition and far more individualized." It can upgrade rehabilitation practice, addressing the existing critical components towards marked efficiency and productivity. Digital telerehabilitation will increase the accessibility to personalized rehabilitation by expert professionals placing tools to monitor the patient's health by themselves.The increasing development and availability of portable and wearable technologies are rapidly expanding the field of technology-based objective measures (TOMs) in neurological disorders. However, substantial challenges remain in (1) recognizing TOMs relevant to patients and clinicians to provide accurate, objective, and real-time assessment of gait and activity in a real-world setting and (2) their integration into telerehabilitation systems towards a digital rehabilitation transition.This feasibility study provides preliminary data on the integration of a real-time gait and activity analysis by wearable devices in the real world with a digital platform to improve the diagnosis, monitoring, and rehabilitation of patients with FMDs. ### Conditions - Functional Movement Disorder ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: TREATMENT ### Interventions - Digital Telerehabilitation - Usual care ### Outcomes Primary Outcomes - number of patients who accept/refuse the treatment, physiotherapy compliance and falls or event near falling occurred during rehabilitation - Budget issues related to TOMs - Time spent to train patients Secondary Outcomes - Change in the Simplified Functional Movement Disorders Rating Scale (S-FMDRS) score - Multidimensional Fatigue Inventory Scale (MFI-20) score - Change in the Brief Pain Inventory (BPI) score - Change in the Beck Depression Inventory (BDI-II) score - Change in the Beck Anxiety Inventory (BAI) score - Change in the 12-item Short-Form Health Survey (SF-12) score - The EuroQol-5D (EQ-5D) - iMTA Productivity Cost Questionnaire - Change in the Clinical Global Impression (CGI) score - Gait outcome: Gait speed - Gait outcome: Stride length - Gait outcome: Cadence - Balance outcome: CoP trajectory - Balance outcomes: Sway area ### Location - Facility: Department of Neurosciences, Biomedicine and Movement Sciences, University of Verona, Verona, N/A, 37131, Italy @@
## Effect of Sarcopenia on the Occurrence of Toxicity Related to Anti-cancer Treatments - NCT ID: NCT06274268 - Study ID: CHMS23006 - Status: NOT_YET_RECRUITING - Start Date: 2024-04-01 - Completion Date: 2028-05-01 - Lead Sponsor: Centre Hospitalier Metropole Savoie ### Study Description The goal of this clinical trial is to learn about the effect of sarcopenic status on the occurrence of treatment-related toxicity during the first course of anti-cancer treatment in several types of cancers.The main question it aims to answer is :Is sarcopenia a predictive marker for the occurrence of toxicity in the initial phase of cancer treatment?The evaluation will focus on the body composition of the participants, assessed by impedancemetry, and on their muscular performance by standardized physical tests. ### Conditions - Sarcopenia - Oncology - Physical Inactivity - Toxicity Due to Chemotherapy ### Study Design - Type: INTERVENTIONAL - Allocation: NA - Intervention Model: SINGLE_GROUP - Primary Purpose: DIAGNOSTIC ### Interventions - Sarcopenia diagnostic test ### Outcomes Primary Outcomes - Event-free survival according to sarcopenic statut Secondary Outcomes - Event-free survival according to the link between: 1/ the dose/lean mass ratio and 2/ body composition and the occurrence of adverse events linked to treatment. - Progression free-survival - Overall survival - Objective response rate at 6 and 12 months - Number of patients classified as sarcopenic by BIA method and CT method. - Exploratory: Event-free survival during PACLITAXEL protocol - Exploratory: Level of spontaneous activity measurement by accelerometry (m.s-2). - Exploratory: RCB-based objective response rate at 6 and 12 months ### Location - Facility: N/A, N/A, N/A, N/A, N/A @@
## Serum Magnesium Level and Pediatric Migraine - NCT ID: NCT06274255 - Study ID: BalikesirU - Status: NOT_YET_RECRUITING - Start Date: 2024-03-01 - Completion Date: 2024-05-15 - Lead Sponsor: Mersin University ### Study Description Aim: The purpose of this study is to compare serum magnesium levels between patients with migraine and a control group and to examine the relationship between the frequency and duration of attacks in patients with migraine and mean serum magnesium levels.Material-Method: Patients diagnosed presenting to the Balıkesir University Medical Faculty pediatric neurology clinic between 01.09.2019 and 01.04.2023 and diagnosed with migraine were enrolled retrospectively. Patients diagnosed with migraine were included as the study group and healthy children presenting to the pediatric neurology clinic in the same period as the control group. The demographic characteristics (age, sex, and body mass index) of the patient group and their clinical (attack durations and frequencies, symptoms during attacks, and treatments) and laboratory (hemoglobin, hematocrit, platelet, glucose, calcium, magnesium, vitamin D, folate and ferritin levels) characteristics were recorded. ### Conditions - Migraine, Magnesium, Pediatric ### Study Design - Type: OBSERVATIONAL - Allocation: N/A - Intervention Model: N/A - Primary Purpose: N/A ### Interventions ### Outcomes Primary Outcomes - Serum Magnesium Level and Pediatric Migraine Secondary Outcomes - Serum Magnesium Level and Pediatric Migraine ### Location - Facility: Hilal Aydın, Balıkesir, Türkiye, 33343, Turkey @@
## Mixed Natural Prebiotic-Fibers Impact on Stool Frequency and Fecal Microbiota in Constipated Thai Adults - NCT ID: NCT06274242 - Study ID: MU-CIRB 2022/300.0711 - Status: ACTIVE_NOT_RECRUITING - Start Date: 2023-03-10 - Completion Date: 2024-04-19 - Lead Sponsor: Mahidol University ### Study Description Mixed Natural Prebiotic-Fibers Impact on Stool Frequency and Fecal Microbiota in Constipated Thai Adults: A Randomized Clinical Trial. ### Conditions - Constipation ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: TREATMENT ### Interventions - Haruna - Placebo Powder ### Outcomes Primary Outcomes - Change in Stool Frequency - Change in Fecal Microbiota Secondary Outcomes - Change in Stool consistency ### Location - Facility: Mahidol University, Nakhon Pathom, N/A, 73170, Thailand @@
## DivAirCity Social Health Survey - NCT ID: NCT06274229 - Study ID: EA4/252/23 - Status: RECRUITING - Start Date: 2024-02-20 - Completion Date: 2025-12-31 - Lead Sponsor: Charite University, Berlin, Germany ### Study Description To reduce stress among urban residents, the consortium members of the European Council Horizon 2020 research program DivAirCity install different stress reducing, noise reducing and air quality improving means in the five cities of the consortium. This study measures physiological and psychological stress and health factors before and after the implementation of the project (at intervention sites) and compares the change (improvement) to the change in comparable places where no means were installed (control site). ### Conditions - Psychological Stress - Psychological Well-Being - Pollution; Exposure ### Study Design - Type: OBSERVATIONAL - Allocation: N/A - Intervention Model: N/A - Primary Purpose: N/A ### Interventions - Air pollution and noise reducing installations ### Outcomes Primary Outcomes - WHO-5 Well-being Scale Secondary Outcomes - Kessler K6 psychological distress - ASKU questionnaire ### Location - Facility: Charité -- Universitaetsmedizin Berlin, Berlin, N/A, 14109, Germany @@
## The Effect of Vitamin D Supplementation on Dental Implant Osseointegration: A Randomized Controlled Trial - NCT ID: NCT06274216 - Study ID: 4381021ABOS - Status: COMPLETED - Start Date: 2021-09-01 - Completion Date: 2022-04-01 - Lead Sponsor: Ziauddin University ### Study Description Dental implantation is a new technique for the single or more missing tooth replacement. Dental professionals might utilize the findings of this investigation to generate local data and learn more about how vitamin D affects bone metabolism and implant osseo-integration. The long-term success of dental implants would also be enhanced and preserved with the right medical use of vitamin D ### Conditions - Osseointegration Failure of Dental Implant ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: SUPPORTIVE_CARE ### Interventions - Vitamin D3 - Vitamin E 400 ### Outcomes Primary Outcomes - Osseo-integration is measured by evaluating the ISQ value (Implant Stability Quotient, ranging from 1-100) Secondary Outcomes - Evaluation of Mean Change in Serum Vitamin D Levels in Dental Implant Patients with and without Vitamin D Supplementation at a Tertiary Care Hospital ### Location - Facility: Afifa Razi, Karachi, Sindh, 74700, Pakistan @@
## High Dose Vitamin D Supplementation in Children With Sickle Cell Disease - NCT ID: NCT06274203 - Study ID: 10584-2/5-2023 - Status: COMPLETED - Start Date: 2023-05-03 - Completion Date: 2024-02-10 - Lead Sponsor: Zagazig University ### Study Description Suboptimal vitamin D status is well reported in sickle cell disease (SCD) patients and associated with a negative impact on health-related quality of life (HRQL). The investigators enrolled 42 SCD patients and 42 healthy controls, subjects within each group received monthly oral vitamin D3 dose according to the baseline status of vitamin D as follows: sufficient: 100,000 IU, insufficient: 150,000 IU, and deficient: 200,000 IU. The investigators assessed safety and efficacy on normalization of vitamin D level, bone mineral density (BMD), hand grip strength (HGS), and HRQL. ### Conditions - Sickle Cell Disease - Vitamin D Deficiency - Health Related Quality of Life - Hand Grip Strength - Bone Mineral Density ### Study Design - Type: INTERVENTIONAL - Allocation: NA - Intervention Model: SINGLE_GROUP - Primary Purpose: TREATMENT ### Interventions - Vitamin D3 ### Outcomes Primary Outcomes - Serum 25(OH)D level Secondary Outcomes - Bone mineral density (BMD) - Maximum handgrip strength (HGS) - Health related quality of life (HRQL) - Serum concentrations of C reactive protein (CRP) - Serum concentrations of Erythrocyte sedimentation rate (ESR) - Safety reporting of any adverse events - Safety measurements of serum Ca - childhood health assessment - Safety measurements of serum 25(OH)D levels ### Location - Facility: Zagazig university, Zagazig, Sharkia, 44519, Egypt @@
## Personalized Care Pathways for Bowel Symptoms in Rectal Cancer patients_development of E-diary - NCT ID: NCT06274190 - Study ID: S68746 - Status: NOT_YET_RECRUITING - Start Date: 2024-04-29 - Completion Date: 2026-03 - Lead Sponsor: KU Leuven ### Study Description Colorectal cancer is the 2nd and 3rd most common cancer in respectively women and men, of which about 40% is located in the rectum. The gold standard treatment for rectal cancer (RC) is a low anterior resection, combined with chemoradiotherapy. However, this treatment will negatively impact different aspects of bowel function and the patients' quality of life. These bowel symptoms often remain prevalent, even at 12 months after RC treatment. Most assessment tools are however not capable of capturing the full range or therapeutic-related evolution of these bowel symptoms. Consequently, the aim is to develop a validated bowel diary for diagnosing and evaluation of all bowel symptoms. ### Conditions - Rectal Cancer - LARS - Low Anterior Resection Syndrome ### Study Design - Type: INTERVENTIONAL - Allocation: NON_RANDOMIZED - Intervention Model: SINGLE_GROUP - Primary Purpose: SUPPORTIVE_CARE ### Interventions - bowel e-diary ### Outcomes Primary Outcomes - Selection of items for the newly developed bowel diary - Assessment of content validity of the newly developed bowel diary in a post-Delphi patient focus group consisting of 8-12 participants - The usability of the newly developed e-diary, assessed with the System Usability Scale (SUS) in patients after rectal surgery for rectal cancer - The usability of the newly developed e-diary will be evaluated through conversations with patients who have undergone rectal surgery for rectal cancer, after these patients have used the e-diary for seven consecutive days - Construct validity of the newly developed bowel e-diary - Criterion validity of the newly developed bowel e-diary - Test-retest reliability of the newly developed bowel e-diary - Responsiveness of the newly developed bowel e-diary in patients after rectal surgery for rectal cancer. The newly validated e-diary is the primary outcome. Secondary Outcomes ### Location - Facility: N/A, N/A, N/A, N/A, N/A @@
## Evaluation of the BTL-785F Device for Submental Fat Reduction and Neck Rejuvenation - NCT ID: NCT06274177 - Study ID: BTL-785_CTUS1400 - Status: ACTIVE_NOT_RECRUITING - Start Date: 2023-07-26 - Completion Date: 2024-04-01 - Lead Sponsor: BTL Industries Ltd. ### Study Description This study will evaluate the clinical safety and the performance of the BTL-785F system equipped with the BTL-785-7 applicator for non-invasive reduction of submental fat and skin laxity treatment. ### Conditions - Fat Burn ### Study Design - Type: INTERVENTIONAL - Allocation: NA - Intervention Model: SINGLE_GROUP - Primary Purpose: TREATMENT ### Interventions - BTL-785-7 ### Outcomes Primary Outcomes - Submental fat thickness reduction Secondary Outcomes - Incidence of Treatment-related Adverse Events - Change on the Clinician Reported - Submental Fat Rating Scale score - Satisfaction Assessed by the Satisfaction Questionnaire - Change in the submental-cervical angle - Comfort Assessed by Therapy Comfort Questionnaire ### Location - Facility: Precision Skin LLC, Davie, Florida, 33328, United States @@
## Clinical and Molecular Biomarker Studies in RAI1 (Retinoic Acid-Induced 1) -Related Disorders - NCT ID: NCT06274164 - Study ID: H-54820 / RAI1 - Status: RECRUITING - Start Date: 2024-03-13 - Completion Date: 2027-03 - Lead Sponsor: Baylor College of Medicine ### Study Description Currently, there is no clinically available genetic-based treatment for RAI1 (Retinoic Acid-Induced 1) -related disorders other than symptomatic management and there are no established clinical or molecular biomarkers that could be used as measures for the efficacy of therapy in future treatment studies. Biomarkers are measures of what is happening inside the body, shown by the results of laboratory, imaging or other tests.Biomarkers can help doctors and scientists diagnose diseases and health conditions, monitor responses to treatment and see how a person's disease or health condition changes over time.The goal of this observational and laboratory study is to develop clinical, neurophysiology and molecular biomarkers in RAI1-related disorders. The main question\[s\] it aims to answer are:* to characterize the disease features more precisely and analyze the differentiating and overlapping features of RAI1-related disorders (Smith-Magenis syndrome and Potocki-Lupski Syndrome)* to identify clinical, neurophysiology, and laboratory biomarkers that differentiate RAI1-related disorders one from another.Participants will have to complete:* a clinical examination* a blood draw* a skin biopsy (optional)* a sleep studyResearchers will compare patients' blood to control group's blood for biomarker studies. ### Conditions - RAI1 Gene 17P11.2 Deletion+Duplication ### Study Design - Type: OBSERVATIONAL - Allocation: N/A - Intervention Model: N/A - Primary Purpose: N/A ### Interventions - Electroencephalography/Polysomnography (EEG/PSG) - Skin Biopsy - Blood draw ### Outcomes Primary Outcomes - Rate of neurological clinical finding - Rate of electroencephalogram (EEG) and/or sleep abnormalities - Concentration of downstream molecular pathway interactors of RAI1 Secondary Outcomes ### Location - Facility: Texas Children's Hospital, Houston, Texas, 77030, United States @@
## Optimal Treatment of Acute Skeletal Muscle Injury - NCT ID: NCT06274151 - Study ID: H-22038917 - Status: NOT_YET_RECRUITING - Start Date: 2024-02-15 - Completion Date: 2029-12-31 - Lead Sponsor: Bispebjerg Hospital ### Study Description Acute muscle strain injuries occur both during sports, in leisure time activities and during manual occupation and represent a major clinical challenge and has societal economic costs. The recovery time is long and a substantial injury recurrence is observed. Despite current best evidence rehabilitation with early mechanical loading, a significant loss of muscle mass, fatty infiltration and formation of scar tissue is reported.Animal models and human in vitro experiments suggest that inflammation is vital in the early period after an injury, however an inhibition of inflammatory processes is beneficial for healing.We investigate here whether a pharmacological inhibition of inflammatory pathways in the 2nd week following a muscle strain injury will provide a better clinical outcome and an advantageous cellular profile than rehabilitative training alone would. ### Conditions - Muscle Strain, Multiple Sites - Inflammation ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: BASIC_SCIENCE ### Interventions - Naproxen 500 Mg - Rehabilitation - Placebo ### Outcomes Primary Outcomes - Effect of anti-inflammatory medicine on cellular profile in skeletal muscle Secondary Outcomes - Functional outcome performance - Functional outcome re-injury rate - Functional outcome Patient Related Outcome Measures (PROM) ### Location - Facility: N/A, N/A, N/A, N/A, N/A @@
## The Enchanting Symphony of Haptonomy's Impact on Attachment and Spousal Harmony for Women Conceiving Through Infertility Treatment - NCT ID: NCT06274138 - Study ID: HAPTONOMY - Status: ENROLLING_BY_INVITATION - Start Date: 2024-03-15 - Completion Date: 2025-03-15 - Lead Sponsor: Baskent University ### Study Description Pregnancies resulting from infertility treatment are considered normal and 'low-risk' in some countries, they often entail significant stress. Prenatal attachment may be experienced differently by parents conceiving through fertility interventions. The rising prevalence of fertility treatments is associated with increased risks such as preterm birth, low birth weight, and perinatal mortality for pregnancies achieved through infertility treatments. Beyond medical implications, post-infertility treatment pregnancies can induce high levels of anxiety and a perception of pregnancy as risky, affecting individuals psychologically. The transition to parenthood after infertility treatment can be psychologically challenging.Healthy prenatal attachment in expectant mothers fosters the development of a healthy role as both mother and father. Maternal bonding is closely tied to a woman's mental health during the prenatal period and her commitment to her baby. Similarly, prenatal bonding with the father sheds light on the emotional connection developing between the father and the unborn child. Active participation in prenatal experiences, such as attending ultrasound appointments or discussing parenting plans, contributes to a stronger sense of attachment for fathers and establishes a positive foundation for future bonding. Supportive partner relationships during pregnancy enhance paternal bonding and emphasize the importance of a collaborative approach to prenatal care for both parents. The prenatal period is critical for fathers to establish an early emotional connection with their unborn children, laying a positive groundwork for postnatal bonding.Various interventions aim to enhance communication between parents and augment prenatal attachment. One such practice is haptonomy-haptotherapy. Haptotherapy focuses on restoring emotional connections, especially with one's own body. It helps individuals recognize their emotional capacities and allows them to experience these capacities through insightful conversations, therapeutic touch, and skill exercises. In the context of pregnancy, haptonomy involves physical contact between the pregnant woman, her partner, and the unborn baby. Advocates of haptonomy believe that this touch-based communication can strengthen the bond between parents and the baby, promote a sense of security, and positively influence the pregnancy experience.Haptonomy is thought to contribute positively to the psychological well-being of women during pregnancy, birth, and the postpartum period, potentially preventing mental health issues and enhancing the health of both mother and baby. It is emphasized that haptonomy is a distinct practice focused on enhancing communication between parents and the baby. Existing literature suggests that haptonomy can increase emotional bonding during the prenatal period and may be effective for parents showing low attachment. Studies indicate that touch communication develops from the second month, involving vibrations for communicating with the fetus, ultimately increasing bonding through haptonomy. Furthermore, haptonomy is reported to enhance both spousal and parental attachment, as demonstrated in a study emphasizing increased attachment for fathers with their partners and children.Despite documented benefits of haptonomy in various patient groups, from cancer patients undergoing chemotherapy to pregnant women and those with chronic pain, limited research exists on haptotherapy for pregnant women. This study aims to investigate the impact of partner-administered haptonomy on prenatal attachment and marital adjustment in pregnant women. Conducted through a randomized controlled experimental design, the study seeks to provide evidence by enhancing prenatal attachments in both mothers and fathers.Research Hypotheses:H0-1: The application of haptonomy by partners has an effect on maternal attachment in pregnant women.H1-1: The application of haptonomy by partners does not have an effect on maternal attachment in pregnant women.H0-2: The application of haptonomy by partners has no effect on paternal attachment in pregnant women.H1-2: The application of haptonomy by partners has an effect on paternal attachment in pregnant women.H0-3: The application of haptonomy by partners has no effect on marital adjustment in pregnant women.H1-3: The application of haptonomy by partners has an effect on marital adjustment in pregnant women. ### Conditions - Infertility ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: SUPPORTIVE_CARE ### Interventions - haptonomy ### Outcomes Primary Outcomes - Marital adjustment score - Prenatal attachment score - Father attachment score Secondary Outcomes ### Location - Facility: Başkent University, Ankara, N/A, N/A, Turkey @@
## Evaluation of Kidney Damage Using NGAL Measurements - NCT ID: NCT06274125 - Study ID: AslıDemircioglu1 - Status: RECRUITING - Start Date: 2023-10-01 - Completion Date: 2024-04 - Lead Sponsor: Ankara City Hospital Bilkent ### Study Description The main objective of this study is to evaluate whether blood NGAL measurement provides superiority over sCr and BUN tests in early diagnosis for assessing renal function in patients undergoing robotic urological surgery. ### Conditions - Prostatectomy - Neutrophil Gelatinase-Associated Lipocalin - Kidney Function Tests ### Study Design - Type: OBSERVATIONAL - Allocation: N/A - Intervention Model: N/A - Primary Purpose: N/A ### Interventions - Robotic-Assisted Laparoscopic Radical Prostatectomy ### Outcomes Primary Outcomes - The main objective of this study is to evaluate whether blood NGAL measurement has superiority over sCr and BUN tests in terms of early diagnosis for assessing kidney function in patients undergoing robotic urologic surgery. Secondary Outcomes - The relationship between demographic parameters such as age, BMI, comorbidities, and ASA classification will be evaluated in relation to the development of AKI. - The evaluation of the relationship between intraabdominal pressure and the development of AKI. - The relationship between intraoperative mean arterial pressure (MAP) and NGAL (Neutrophil Gelatinase-Associated Lipocalin) values. ### Location - Facility: Ankara Bilkent City Hospital, Ankara, Çankaya, 06530, Turkey @@
## Using TMS to Understand Neural Processes of Social Motivation - NCT ID: NCT06274112 - Study ID: 1K23MH135222 - Status: NOT_YET_RECRUITING - Start Date: 2024-09 - Completion Date: 2029-09 - Lead Sponsor: Auburn University ### Study Description The purpose of this study is to use transcranial magnetic stimulation (TMS) to better understand the neural circuits associated with social motivation.Participant includes four study visits each that range from 1.5 - 3.0 hours in duration over approximately a one month period. The first study visit involves answering survey questions, a clinical interview, and computer tasks. The second study visit involves a magnetic resonance imaging (MRI) scan, computer tasks, and a brief TMS protocol. The second and third study visits involve a full session of TMS followed by an MRI scan and computer tasks.Adults in the Auburn/Apelika area who avoid social situations, experience symptoms of depression or social anxiety, and are between 25 years old and 50 years old are eligible to participate. ### Conditions - Social Avoidant Behavior - Major Depressive Disorder - Social Anxiety Disorder ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: CROSSOVER - Primary Purpose: BASIC_SCIENCE ### Interventions - TMS ### Outcomes Primary Outcomes - Social motivation - Neural circuit function Secondary Outcomes ### Location - Facility: N/A, N/A, N/A, N/A, N/A @@
## The Effect of the Care Given to Hemodialysis Patients on Comfort Level and Complaints - NCT ID: NCT06274099 - Study ID: TDK-2023-12649 - Status: NOT_YET_RECRUITING - Start Date: 2024-02 - Completion Date: 2024-12 - Lead Sponsor: Reva Balci Akpinar ### Study Description Kolcaba's comfort theory is a theory used by nurses to increase the comfort of patients. There are limited studies determining that nursing care provided according to this theory contributes to the increase in patients' comfort levels in various patient groups. This study will be carried out in the hemodialysis center of a public hospital located in the city center of Bingöl. Patients in the intervention group receiving hemodialysis treatment will be given nursing care by the researcher for 12 sessions during the sessions in which the patient receives hemodialysis treatment. In order to provide nursing care, nursing diagnoses suitable for the patient group will be determined in advance and the care the patient needs will be given according to these diagnoses.. If necessary, the researcher will add additional diagnoses to the preliminary diagnosis form and provide care.In this research, the individual nursing care needs of the researcher patient will be determined. Individualized caregiving is unique to this study. Individually provided care is expected to increase patient comfort and satisfaction. Increased comfort will help the patient cope more easily with the disease and hemodialysis treatment symptoms. In addition, the results of individual care provided can guide nurses in their care behaviors. By adding this research to the literature, the groundwork will be laid for studies that will provide individual care to patients. It is expected that the results of this research will guide the planning of the research and the provision of individualized care in all patient groups, especially patients receiving hemodialysis treatment. ### Conditions - Hemodialysis Complication - Nurse's Role ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: SUPPORTIVE_CARE ### Interventions - nursing care ### Outcomes Primary Outcomes - General Comfort Scale - Dialysis Symptom Index Secondary Outcomes ### Location - Facility: Ataturk University, Erzurum, Diğerleri, 25200, Turkey @@
## Two-session Catheter-directed Sclerotherapy Using Ethanol for Endometrioma - NCT ID: NCT06274086 - Study ID: S2022-2027-0001 - Status: COMPLETED - Start Date: 2020-06-01 - Completion Date: 2023-03-31 - Lead Sponsor: Asan Medical Center ### Study Description The goal of this clinical trial is to evaluate the safety and clinical outcomes of two-session catheter-directed sclerotherapy (CDS) with 96% ethanol in patients with endometrioma. The main question it aims to answer is:• Is two-session CDS with 96% ethanol safe and effective for treating endometrioma?Participants will:* Receive the first session CDS for endometrioma* Carry the catheter overnight and be monitored in the patient ward* Receive the second session CDS the next day ### Conditions - Sclerotherapy - Endometrioma ### Study Design - Type: INTERVENTIONAL - Allocation: NA - Intervention Model: SINGLE_GROUP - Primary Purpose: TREATMENT ### Interventions - Two-session catheter-directed sclerotherapy ### Outcomes Primary Outcomes - Recurrence Secondary Outcomes ### Location - Facility: Asan Medical Center, Seoul, N/A, 05505, Korea, Republic of @@
## Double-dorsal Versus Single-volar Digital Block - NCT ID: NCT06274073 - Study ID: E2-22-2566 - Status: COMPLETED - Start Date: 2022-10-12 - Completion Date: 2023-09-12 - Lead Sponsor: Ankara City Hospital Bilkent ### Study Description The aim of this study is to compare the traditional dorsal double injection digital block with the palmar single injection technique in the suturing of acute traumatic hand finger lacerations in terms of injection pain score (NRS), anesthesia onset time, and success of anesthesia.It is understood that single injection digital block and double injection digital block techniques do not have significant advantages over each other in terms of pain levels and procedure times.However, the need for rescue anesthesia was evaluated to be lower in the single injection digital block technique. This difference is especially due to measurements in the volar region incisions.According to the results of this study, we think that choosing the single injection digital block technique for volar region incisions is a more rational approach, especially in terms of the data of the need for rescue anesthesia. ### Conditions - Laceration of Skin - Anesthesia, Local - Pain - Nerve Block ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: TREATMENT ### Interventions - Dorsal digital block - Palmar digital block ### Outcomes Primary Outcomes - Anesthesia pain score Secondary Outcomes - Anesthesia onset time ### Location - Facility: Ankara City Hospital Emergency Medicine Department, Ankara, N/A, N/A, Turkey @@
## Project Phakama: Testing Support Strategies to Empower Young Women on PrEP in South Africa - NCT ID: NCT06274060 - Study ID: 135399 - Status: RECRUITING - Start Date: 2024-04-16 - Completion Date: 2025-04 - Lead Sponsor: Johns Hopkins Bloomberg School of Public Health ### Study Description The goal of this trial is to understand which strategies work best to support pre-exposure prophylaxis (PrEP) use among female sex workers (FSW) and adolescent girls and youth women (AGYW) in uMgungundlovu, KwaZulu-Natal, South Africa. Participants will be randomly assigned to receive a combination of up to four support strategies encourage the participants in continuing to use PrEP. The four strategies being tested are: case management, food vouchers, peer support buddies, and community-based PrEP pick-up points. The intention of this trial is to determine which PrEP support strategy or bundle(s) of strategies best promote(s) long-term PrEP use, so that these services can be scaled up to other districts in South Africa. ### Conditions - Pre-exposure Prophylaxis - HIV Infections ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: FACTORIAL - Primary Purpose: PREVENTION ### Interventions - Case management - Food vouchers - PrEP support buddy - Community-based PrEP pickup points ### Outcomes Primary Outcomes - PrEP persistence at 7 months after PrEP initiation - PrEP adherence at 7 months after PrEP initiation among all trial participants Secondary Outcomes - PrEP persistence at 1 month after PrEP initiation - PrEP persistence at 4 months after PrEP initiation - PrEP persistence at 13 months after PrEP initiation - PrEP adherence at 7 months after PrEP initiation among trial participants who provided dried blood spot samples ### Location - Facility: TB HIV Care, Pietermaritzburg, KwaZulu Natal, 3200, South Africa @@
## PROSTATE-IQ: Parallel RandOmized STudy of Personalized Apalutamide Treatment and Evaluation to Improve Quality of Life in Post-Operative Radiation With Androgen Axis Suppression. A Phase III Multi-center Study for Men With Detectable PSA After Prostatectomy for Prostate Cancer. - NCT ID: NCT06274047 - Study ID: 2023-0409 - Status: NOT_YET_RECRUITING - Start Date: 2024-08-31 - Completion Date: 2029-06-30 - Lead Sponsor: M.D. Anderson Cancer Center ### Study Description 1. Personalize treatment for prostate cancer based on how aggressive the disease is and2. Learn if apalutamide-based treatment can help to reduce fatigue and other side effects of treatment in participants who are being treated with radiation therapy for prostate cancer, as compared to standard therapy. ### Conditions - Androgen Axis Suppression - Prostatectomy - Prostate Cancer ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: TREATMENT ### Interventions - Apalutamide - Androgen Deprivation Therapy ### Outcomes Primary Outcomes - Functional Assessment of Chronic Illness Therapy-Fatigue Scale (FACIT-Fatigue) Secondary Outcomes ### Location - Facility: MD Anderson Cancer Center, Houston, Texas, 77030, United States @@
## MUSE-S Headband System for Improving Anxiety and Insomnia Among Breast Cancer Survivors - NCT ID: NCT06274034 - Study ID: 23-006870 - Status: RECRUITING - Start Date: 2024-01-08 - Completion Date: 2025-01-31 - Lead Sponsor: Mayo Clinic ### Study Description This early phase I trial evaluates the feasibility and impact of a meditation headband system (MUSE-S) for breast cancer survivors. Anxiety and insomnia are among the most common distresses in breast cancer survivors during and after chemotherapy, in part due to the side effects of chemotherapy, fear of cancer coming back, progression of the cancer, and uncertainty of the future. These distresses impair patients' well-being and quality of life (QOL) in general, and their cancer treatment adherence and effectiveness in particular. Meditation has been demonstrated to be an effective management tool of stress and anxiety and is given the highest level of evidence (grade A) in the systematic review-based guidelines by the Society of Integrative Medicine. The portable, interactive, electroencephalographic (EEG) Muse headband guided meditation has been shown to improve fatigue, QOL, and stress in newly diagnosed breast cancer patients. The MUSE-S Headband System may decrease anxiety and insomnia among breast cancer survivors. ### Conditions - Breast Carcinoma ### Study Design - Type: INTERVENTIONAL - Allocation: NA - Intervention Model: SINGLE_GROUP - Primary Purpose: SUPPORTIVE_CARE ### Interventions - Electronic Health Record Review - Medical Device Usage and Evaluation - Meditation Therapy - Survey Administration ### Outcomes Primary Outcomes - Frequency of use of meditation - Feasibility of a wearable electroencephalographic (EEG) headband (Muse™ S Headband) - Impact of interactive meditation and sleep support through the Muse-S™ system Secondary Outcomes ### Location - Facility: Mayo Clinic in Rochester, Rochester, Minnesota, 55905, United States @@
## Neuromodulation to Reduce Muscle Stiffness Following Spinal Cord Injury - NCT ID: NCT06274021 - Study ID: UMMC-IRB-2023-125 - Status: NOT_YET_RECRUITING - Start Date: 2024-04-01 - Completion Date: 2025-12-31 - Lead Sponsor: University of Mississippi Medical Center ### Study Description People with spinal cord injuries may experience muscle tightness or uncontrollable spasms. This study is being conducted to investigate whether transcutaneous spinal stimulation can improve these symptoms. Transcutaneous spinal stimulation is a non-surgical intervention by applying electrical currents using skin electrodes over the lower back and belly.The investigators want to see how well the intervention of transcutaneous spinal stimulation performs by testing different levels of stimulation pulse rates. Also, transcutaneous spinal stimulation is compared to muscle relaxants such as baclofen and tizanidine, commonly given to people with spinal cord injuries, to reduce muscle stiffness and spasms. By doing this, the investigators hope to discover if transcutaneous spinal stimulation similarly reduces muscle spasms and stiffness or if combining both methods works best. This could help improve treatment options for people with spinal cord injuries in the future. ### Conditions - Spinal Cord Injuries - Spinal Cord Injury - Spinal Cord Injury Cervical - Spinal Cord Injury Thoracic ### Study Design - Type: INTERVENTIONAL - Allocation: NA - Intervention Model: SEQUENTIAL - Primary Purpose: OTHER ### Interventions - Transcutaneous spinal stimulation at 100 Hz - Transcutaneous spinal stimulation at 50 Hz - Transcutaneous spinal stimulation at 50 Hz and single dose of baclofen - Transcutaneous spinal stimulation at 50 Hz and single dose of tizanidine - Sham transcutaneous spinal stimulation ### Outcomes Primary Outcomes - Change from baseline of posterior root reflexes (PRRs) recruitment curves. - Change from baseline of flexion withdrawal reflex (FWR) response amplitude. - Change from baseline of stretch reflex (SR) response amplitude. - Change from baseline in muscle stiffness as measured by the Modified Ashworth Scale (MAS), - Change from baseline in spasms as measured by the Spinal Cord Assessment Tool for Spastic Reflexes (SCATS). Secondary Outcomes - Change from baseline of posterior root reflexes (PRRs) recruitment curves. - Change from baseline of flexion withdrawal reflex (FWR) response amplitude. - Change from baseline of stretch reflex (SR) response amplitude. ### Location - Facility: Methodist Rehabilitation Center, Jackson, Mississippi, 39216, United States @@
## Exparel vs. ACB With Bupivacaine for ACL Reconstruction - NCT ID: NCT06274008 - Study ID: 230110 - Status: RECRUITING - Start Date: 2023-10-12 - Completion Date: 2024-12-31 - Lead Sponsor: Children's Hospital of Orange County ### Study Description Opioid misuse and addiction among children and adolescents is an increasingly concerning problem. Post-surgical opioid prescriptions for commonly performed surgeries such as anterior cruciate ligament reconstruction (ACLR) increase opioid exposure in young athletes. The purpose of the current study is to determine if extended-release Bupivacaine Liposome Injectable Suspension (Exparel) is effective in decreasing at home narcotic consumption compared to standard Bupivacaine Adductor Canal Block for Anterior Cruciate Ligament (ACL) reconstruction/reconstruction for the surgical treatment of adolescents with ACL tears and concomitant pathology i.e. meniscus / cartilage injury/tear. ### Conditions - ACL Tear - Opioid Misuse - Pain - Anxiety ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: SUPPORTIVE_CARE ### Interventions - Exparel ### Outcomes Primary Outcomes - At-home narcotic consumption by the patients as measured by the medication form completed by parents post discharge Secondary Outcomes - Postoperative pain level of child - Functional disability of child - Parent and child anxiety - Child pain ### Location - Facility: CHOC Children's Hospital, Orange, California, 92868, United States @@
## Telehealth Behavioral Activation for Teens - NCT ID: NCT06273995 - Study ID: H-54233 - Status: RECRUITING - Start Date: 2024-03-01 - Completion Date: 2029-12-01 - Lead Sponsor: Baylor College of Medicine ### Study Description Behavioral activation is one such empirically supported intervention. Derived from cognitive-behavioral therapy, a well-established treatment for depression, behavioral activation uses psychoeducation and skill-building to increase an individual's engagement in valued and enjoyable activities (e.g., socializing with family and friends, exercising, participating in a hobby) in order to improve depressive symptoms. Research has shown that behavioral activation is an effective intervention for depressed youth. Additionally, it has been shown as a promising intervention that can be conducted in a brief, virtual format and can be effectively implemented by both trained clinicians and trained, non-licensed interventionists. This project will provide Behavioral Activation for youth (12-17) experiencing depression or suicidal ideation who are currently enrolled in the Youth Depression Suicide Network study in Texas. ### Conditions - Depression - Suicide and Self-harm - Depression in Adolescence - Depression Mild - Depression Moderate - Depression Severe ### Study Design - Type: INTERVENTIONAL - Allocation: NA - Intervention Model: SINGLE_GROUP - Primary Purpose: TREATMENT ### Interventions - Behavioral Activation ### Outcomes Primary Outcomes - Patient Health Questionnaire 9-modified for adolescents (PHQ-A) - Behavioral Activation for Depression-Short Form (BAD-SF) - Dimensional Anhedonia Rating Scale (DARS) Secondary Outcomes - Strengths and Difficulties Questionnaire (SDQ) - Duke Social Support Index (DSSI) ### Location - Facility: Baylor College of Medicine, Houston, Texas, 77030, United States @@
## Behavioral Telehealth in Low-resource Primary Care Settings for Anxiety and Depression in Youth - NCT ID: NCT06273982 - Study ID: 1R01MH131698 - Status: NOT_YET_RECRUITING - Start Date: 2024-07-01 - Completion Date: 2028-05-31 - Lead Sponsor: San Diego State University ### Study Description The goal of this clinical trial is to test a brief, behavioral telehealth treatment program (STEP-UP) for depression and anxiety in youths (age 8-16 years old). Youths and families will be recruited through participating community health centers and will be randomly assigned to either: (a) receive STEP-UP care from providers at their health center or (b) be referred to care from local community mental health clinicians. Youth and families will be interviewed before treatment starts, 16 weeks later, and 24 weeks later to assess how youth are feeling. The main question the study aims to answer is whether STEP-UP improves youths functioning in daily life, anxiety symptoms, and depression symptoms. Researchers will compare STEP-UP to referral to community treatment-as-usual mental health services to see if STEP-UP is more effective. ### Conditions - Depression, Anxiety ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: TREATMENT ### Interventions - STEP-UP (transdiagnostic behavioral therapy for pediatric anxiety and depression) - ARC (assisted referral to community care) ### Outcomes Primary Outcomes - Children's Global Assessment Scale (CGAS) - Pediatric Anxiety Rating Scale (PARS) - Children's Depression Rating Scale -- Revised (CDRS-R) Secondary Outcomes ### Location - Facility: N/A, N/A, N/A, N/A, N/A @@
## Ultrasonographic Evaluation of Osteopathic Manipulation for Thoracic Outlet Syndrome - NCT ID: NCT06273969 - Study ID: PK20240105- 001 - Status: NOT_YET_RECRUITING - Start Date: 2024-04-01 - Completion Date: 2024-04-24 - Lead Sponsor: A.T. Still University of Health Sciences ### Study Description The purpose of the study is to develop a protocol to assess blood flow in the upper limb vasculature before and after osteopathic manipulative treatment (OMT) using Pulsed-wave Doppler ultrasonography (US). We will assess the subclavian artery and vein at two locations (above and below the clavicle) and the brachial artery and vein (within the axilla) to determine the reproducibility of the blood flow findings at each location and the impact of OMT on the blood flow. Additionally we will qualitatively assess morphological changes of the brachial plexus before and after OMT with US. ### Conditions - Thoracic Outlet Syndrome ### Study Design - Type: INTERVENTIONAL - Allocation: NA - Intervention Model: SINGLE_GROUP - Primary Purpose: TREATMENT ### Interventions - Osteopathic Manipulative Treatment (OMT) ### Outcomes Primary Outcomes - Blood flow changes in the upper extremity. Secondary Outcomes ### Location - Facility: N/A, N/A, N/A, N/A, N/A @@
## Explore the Relationship Between Platelet Count and Bleeding Score in ITP - NCT ID: NCT06273956 - Study ID: bleeding scores in ItP - Status: RECRUITING - Start Date: 2022-04-10 - Completion Date: 2025-12-30 - Lead Sponsor: Assiut University ### Study Description Assessment of bleeding scores in immune thrombocytopenia purpuria to explore the relationship between platelet count and bleeding score in immune thrombocytopenia purpura (ITP) and compare the clinical practicability of bleeding grading systems with adult patients with ITP. ### Conditions - ITP - Immune Thrombocytopenia ### Study Design - Type: OBSERVATIONAL - Allocation: N/A - Intervention Model: N/A - Primary Purpose: N/A ### Interventions ### Outcomes Primary Outcomes - explore the relationship between platelet count and bleeding assessment systems (ITP Bleeding Assessment Tool (ITP -BAT) and ITP Bleeding Scale (IBLS) in Patients with ITP to measure severity of bleeding Secondary Outcomes ### Location - Facility: Aml Sayed Hamed, Assiut, N/A, N/A, Egypt @@
## Impact of Long-acting Injectable Cabotegravir for HIV PrEP in MSM in France. - NCT ID: NCT06273943 - Study ID: ANRS 0410s CABOPrEP - Status: NOT_YET_RECRUITING - Start Date: 2024-04-01 - Completion Date: 2026-10-30 - Lead Sponsor: ANRS, Emerging Infectious Diseases ### Study Description The purpose of this study is to evaluate if offering long-acting injectable cabotegravir (CAB-LA) as an additional HIV prevention choice among oral PrEP-experienced men who have sex with men (MSM) in France can significantly increase the sustained PrEP use over time and the PrEP coverage of at-risk sexual risk behaviors. ### Conditions - Prevention ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: PREVENTION ### Interventions - Cabotegravir Tablets, for oral use. - Cabotegravir Extended-Release Injectable Suspension, for intramuscular use. - Tenofovir disoproxil/Emtricitabine 300mg/200mg fixed-dose combination tablets, for oral use - Rectal Biopsies ### Outcomes Primary Outcomes - Number of protocol visits completed with a documented PrEP prescription aligned with the randomization arm. Secondary Outcomes - Number of protocol visits completed with a documented PrEP prescription aligned with the randomization arm. - Number of participants with missing follow-up visits, temporary PrEP discontinuation, permanent PrEP discontinuation, switching to another PrEP regimen, study discontinuation, lost to follow-up. - Number of participants whose last condomless anal sexual intercourse was not covered by PrEP. - Number of condomless anal sexual intercourse in the month prior to each study visit. - Number of sexual partners in the last 3 months. - Mean PrEP satisfaction score based on study arm. - Number of participants with syphilis, chlamydiae, and/or gonorrhea infection. - Number of participants with Grade 2 or higher clinical or laboratory drug-related adverse events at any time during the study. - Change from baseline in body weight (kg). - Change from baseline in lipids - Change from baseline in the insulin resistance index (HOMA-IR). - Number and severity of injection site reaction. - Cabotegravir concentration in plasma and tenofovir diphosphate and emtricitabine triphosphate concentration in dried blood spots. - Number of participants with new HIV infection. - Number of participants who used psychoactive drugs in the last 3 months - Score of quality of life measured by the EuroQol-5D questionnaire - Depression score assessed with the Center for Epidemiologic Studies Depression Scale (CES-D). - Self-esteem score assessed with the Rosenberg scale. - Number and nature of uses of community peer support and therapeutic patient education. ### Location - Facility: Hôpital Hôtel Dieu, Paris, Ile De France, 75004, France @@
## Reduction of Dentine Hypersensitivity After Use of Different Dentifrices - NCT ID: NCT06273930 - Study ID: AFID - Status: RECRUITING - Start Date: 2024-02-01 - Completion Date: 2024-10-30 - Lead Sponsor: Armed Forces Institute of Dentistry, Pakistan ### Study Description To assess the impact of the use of 5% Calcium Sodium Phosphosilicate or 8% Arginine dentifrices on dentinal hypersensitivity following non-surgical periodontal therapy in patients with periodontitis. ### Conditions - Sensitivity, Tooth ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: PREVENTION ### Interventions - 5% CALCIUM SODIUM PHOSPHOSILICATE - 8% Arginine ### Outcomes Primary Outcomes - To assess the impact on Dentinal hypersensitivity following the use of 5% CSPS or 8% Arginine following non-surgical periodontal therapy in patients with Periodontitis by VAS. - To assess the impact on Dentinal hypersensitivity following the use of 5% CSPS or 8% Arginine following non-surgical periodontal therapy in patients with Periodontitis by Schiff scale. Secondary Outcomes ### Location - Facility: AFID, Rawalpindi, N/A, N/A, Pakistan @@
## Deprescribing Potentially Inappropriate Medications in the Emergency Department for Persons Living With Dementia - NCT ID: NCT06273917 - Study ID: FY23_Pilot2_Dresden - Status: NOT_YET_RECRUITING - Start Date: 2024-03-01 - Completion Date: 2025-01-01 - Lead Sponsor: National Institute on Aging (NIA) ### Study Description Aim 1: To demonstrate the feasibility by determining proportion of completed medication reconciliation, Central Nervous System active Potentially Inappropriate Medication (CNS PIM) use among patients with Alzheimer's Disease and Related Dementias (ADRD) and Mild Cognitive Impairment (MCI) in the emergency department (ED), and communication between ED clinical pharmacists and outpatient prescribers.Aim 2: To demonstrate the feasibility of collecting the primary and secondary outcomes for a subsequent study. The future primary outcome will be reduction in CNS PIMs 90 days after an ED visit. Secondary outcomes will include outpatient follow-up, repeat ED visits, and hospitalizations during the 90 days following an ED visit.Aim 3: To demonstrate the acceptability of the PRIDE intervention to outpatient clinicians using the Acceptability of Intervention Measure and qualitative analysis of responses. ### Conditions - Dementia ### Study Design - Type: INTERVENTIONAL - Allocation: NA - Intervention Model: SINGLE_GROUP - Primary Purpose: HEALTH_SERVICES_RESEARCH ### Interventions - PRIDE ### Outcomes Primary Outcomes - Pharmacist communication of deprescribing recommendation Secondary Outcomes - Medication reconciliation - Medication supply of CNS PIMs - Outpatient follow up - Repeat Emergency Department visits ### Location - Facility: Northwestern Memorial Hospital, Chicago, Illinois, 60611, United States @@
## Modulating Escape Using Focused Ultrasound - NCT ID: NCT06273904 - Study ID: Pro00132631 - Status: NOT_YET_RECRUITING - Start Date: 2024-04 - Completion Date: 2025-12 - Lead Sponsor: Medical University of South Carolina ### Study Description This is a study to find out if a cutting-edge technology called transcranial focused ultrasound (tFUS) can be used to treat how people with anxiety or related concerns cope with emotional situations. tFUS is a brain stimulation technology that causes temporary changes in the activity of deep brain areas without a need for any surgery or other permanent or invasive procedures.This study is recruiting participants who recently started treatment for anxiety or a related concern to come in for 3 visits at the Medical University of South Carolina. At the first visit, participants will do interviews and surveys asking about anxiety and related concerns, and they do tasks where they respond to emotional pictures while brain activity is measured using magnetic resonance imaging (MRI). At the next two visits, participants again do a task where they see and react to emotional images, and this time the task is done once before and again once after receiving tFUS that either actively causes temporary changes (lasting for about an hour) in a targeted brain area or is not active (no changes elicited). At each tFUS visit, responses are measured with sensors worn on the hand, arms, face, and head (these visits do not involve MRI).Each visit in this study is expected to last between 2 - 3 hours. This study is not a treatment study, but it could help improve treatment in the future. Participants in this study are paid for their time. ### Conditions - Anxiety Disorders ### Study Design - Type: INTERVENTIONAL - Allocation: NA - Intervention Model: SINGLE_GROUP - Primary Purpose: BASIC_SCIENCE ### Interventions - Active transcranial focused ultrasound (tFUS) - Sham transcranial focused ultrasound (tFUS) ### Outcomes Primary Outcomes - Change in Fear-Potentiated Startle Reflex Secondary Outcomes - Change in speed to initiate avoidance behavior - Change in Electroencephalography (EEG)-Assessed Contingent Negative Variation During Escape/ Avoidance Preparation - Change in Electroencephalography (EEG)-Assessed N200 During Implicit Approach/ Avoid Bias Assessment - Change in Electroencephalography (EEG)-Assessed Theta-Band Power During Behavioral Tasks - Change in High-Frequency Heart Rate Variability/ Respiratory Sinus Arrhythmia - Change in Task-Based Heart Rate (Beats per Minute) Changes - Change in Task-Based Galvanic Skin Conductance - Change in State Anxiety During Session ### Location - Facility: Medical University of South Carolina, Charleston, South Carolina, 29425, United States @@
## Erythromycin Versus Azithromycin for Preterm Prelabor Rupture of Membranes - NCT ID: NCT06273891 - Study ID: INOVA-2023-58 - Status: RECRUITING - Start Date: 2024-03-08 - Completion Date: 2025-10-01 - Lead Sponsor: Inova Fairfax Hospital ### Study Description The goal of this study is to help identify the best antibiotic treatment for pregnant people when their water breaks prematurely (a condition abbreviated as PPROM). Current practice is to attempt to maintain the pregnancy until at least 34 weeks gestational age, when the risks of prematurity to the baby are lessened. Research shows that antibiotics help the pregnancy last longer, but there have been limited studies about which combination works best. Currently, both azithromycin and erythromycin are accepted antibiotic treatments, in addition to ampicillin and amoxicillin. Participants diagnosed with PPROM will be randomized to receive ampicillin and amoxicillin plus either azithromycin or erythromycin, in addition to the care they would normally receive. Studying these two drugs will help decide the best care for future patients with PPROM. ### Conditions - Premature Rupture of Membrane ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: TREATMENT ### Interventions - Erythromycin - Azithromycin ### Outcomes Primary Outcomes - Latency period Secondary Outcomes ### Location - Facility: Inova Fairfax Medical Campus, Falls Church, Virginia, 22042, United States @@
## From Fetal-maternal Interface Immune Tolerance to Endometrial Cancer Immune Escape: Potential Targets for Immunotherapy - NCT ID: NCT06273878 - Study ID: RS1439/20 - Status: RECRUITING - Start Date: 2023-01-15 - Completion Date: 2025-01-15 - Lead Sponsor: Regina Elena Cancer Institute ### Study Description Non-interventional retro-prospective study on Endometrial tissue samples taken from surgically treated patients. ### Conditions - Endometrial Cancer ### Study Design - Type: OBSERVATIONAL - Allocation: N/A - Intervention Model: N/A - Primary Purpose: N/A ### Interventions ### Outcomes Primary Outcomes - Validate the differential expression of LOX-1 and NALP3 receptors. Secondary Outcomes - Characterize phenotypic alterations. - Evaluate the predictive and/or prognostic value. ### Location - Facility: National Cancer Institute - IFO -, Rome, RM, 00144, Italy @@
## Version Testing of EnzySystem Version A for Hemophilia A - NCT ID: NCT06273865 - Study ID: HEMSTOL77 - Status: NOT_YET_RECRUITING - Start Date: 2024-03-15 - Completion Date: 2024-12-15 - Lead Sponsor: Radboud University Medical Center ### Study Description Background of the study:To measure blood clotting, blood is taken from a vein. This blood is processed in the laboratory and then tested. A new device has been developed that requires only a very small volume of blood (5-10 drops of blood) to perform the laboratory tests. The long-term goal is that this device can be used by a doctor or at home to quickly measure blood clotting. In this research we want to compare this new system with the standard methods - measurement in the laboratory - and evaluate whether the correct value is determined.Objective of the study:The primary objective of this study is to demonstrate that the EnzySystem HemA version A can record thrombin generation TG and quantify FVIII activity levels within a time frame of 60 min in fresh whole blood samples of healthy volunteers and patients with hemophilia A in the Enzyre laboratory (for healthy volunteers) and the Radboudumc (for patients with hemophilia A).Study design:This is a cross-sectional observational study. All participants are asked to fill a questionnaire prior to blood collection. The blood of healthy volunteers will be collected in an office of Enzyre BV, the blood of patients will be collected in the Radboudumc. Blood collection, by venepuncture, will be conducted by a Radboudumc research nurse or physician of the research team in both locations. In total, four blood tubes with citrate as anticoagulant will be drawn (a total of around 11 mL).Study population:The study population consists of 20 healthy volunteers: evenly distributed between male and female; ages spread over the range from 20 to 70 years old; recruited by Enzyre via advertisement. 20 Patients: 5 severe hemophilia A; 5 moderate hemophilia A; 10 mild hemophilia A; recruited from the Hemophilia Treatment Center (HTC) Nijmegen-Eindhoven-Maastricht (NEM) (location Radboudumc).Primary study parameters/outcome of the study:Demonstrate that the EnzySystem HemA version A can record TG and quantitative FVIII activity levels within a time frame of 60 min in fresh blood samples of healthy volunteers and patients with hemophilia A.Secondary study parameters/outcome of the study (if applicable):Secondary study parameters are composed whether the measured values comply with the desired assay specificity and accuracy.Outcomes are analysed for equivalence compared to one-stage FVIII assay, FVIII chromogenic assay, thrombin generation via the Nijmegen Hemostasis Assay, and possibly via the Technoclone assay.Is it possible to measure FVIII activity with the EnzySystem HemA version A in fresh blood samples of healthy volunteers and patients with hemophilia A, compared to the gold standard with;* Precision in the normal range (60-140%): min. 30%* Precision in the low range (3-10%): min. 50%* Limit of Detection range min. 100 % FVIII activity* Limit of Detection low range min. 3 % FVIII activity Is it possible to measure TG with the EnzySystem HemA version A in fresh blood samples of healthy volunteers and patients with hemophilia A, compared to the gold standard with;* Precision in the normal range (60-140%) of control samples: min. 30%* Precision in patient with hemophilia A: min. 50%* Limit of Detection, high range \> 400 nM thrombin activity* Limit of Detection measured with Plasma, low range \< 50 nM thrombinOther study parameters All samples will also be tested for other hemostasis specific parameters as these parameters may affect a proper measurement of both FVIII activity and Thrombin Generation. The following parameters will be measured in plasma obtained from the whole blood vacutainers. Moreover, left over samples (plasma) will eventually be used to develop other coagulation related parameters.* von Willebrand Factor antigen levels* von Willebrand Factor ristocetin activity levels* Prothrombin Fragment 1+2 levels* ADAMTS13 activity* FVIII antigen levels* blood group ### Conditions - Hemophilia A ### Study Design - Type: OBSERVATIONAL - Allocation: N/A - Intervention Model: N/A - Primary Purpose: N/A ### Interventions - Several assays ### Outcomes Primary Outcomes - Time between venipuncture and EnzySystem assay results Secondary Outcomes - Validity of EnzySystem FVIII activity results - Validity of EnzySystem thrombin generation results ### Location - Facility: Radboud university medical center, Nijmegen, N/A, 6525 GA, Netherlands @@
## A Study of the Intratumoral Microdose Administration of PBA-0405 in Patients With Solid Tumors - NCT ID: NCT06273852 - Study ID: PBL-0405-01 - Status: NOT_YET_RECRUITING - Start Date: 2024-03 - Completion Date: 2025-03 - Lead Sponsor: Pure Biologics S.A. ### Study Description This is a multi-center, single arm, open-label, localized pharmacodynamic biomarker Phase 0 trial designed to study the biological effects within the tumor microenvironment of PBA-0405 when administered intratumorally in microdose quantities via the CIVO device. ### Conditions - Head and Neck Squamous Cell Carcinoma - Soft Tissue Sarcoma Adult - Triple Negative Breast Cancer ### Study Design - Type: INTERVENTIONAL - Allocation: NA - Intervention Model: SINGLE_GROUP - Primary Purpose: BASIC_SCIENCE ### Interventions - PBA-0405 ### Outcomes Primary Outcomes - Quantification of Cell Death and Immune Cell Biomarkers by immuno-histochemistry (IHC) and In-Situ Hybridization (ISH) Secondary Outcomes - Number of Patients with Adverse Events ### Location - Facility: N/A, N/A, N/A, N/A, N/A @@
## A Study to Learn How Different Forms of Study Medicine Tafamidis Are Taken Up Into The Blood in Healthy Adults - NCT ID: NCT06273839 - Study ID: B3461114 - Status: ACTIVE_NOT_RECRUITING - Start Date: 2024-02-27 - Completion Date: 2024-05-27 - Lead Sponsor: Pfizer ### Study Description The purpose of this clinical trial is to compare the amount of tafamidis in the blood of healthy adult participants after taking three different forms of tafamidis by mouth. ### Conditions - Healthy ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: CROSSOVER - Primary Purpose: BASIC_SCIENCE ### Interventions - Tafamidis 61 mg free acid tablet (Test 1) - Tafamidis 70 mg free acid tablet (Test 1) - Tafamidis 61 mg free acid capsule (Reference) ### Outcomes Primary Outcomes - Area under the concentration-time curve (AUCinf) - Maximum observed plasma concentration (Cmax) Secondary Outcomes ### Location - Facility: Pfizer Clinical Research Unit - Brussels, Brussels, Bruxelles-capitale, Région DE, B-1070, Belgium @@
## "Colorectal Leakage App" for Early Detection of Anastomotic Leakage After Colorectal Surgeries - NCT ID: NCT06273826 - Study ID: 01 - Status: RECRUITING - Start Date: 2024-01-19 - Completion Date: 2025-05 - Lead Sponsor: National Research Oncology and Transplantology Center, Kazakhstan ### Study Description The aim of this prospective observational study is to evaluate the effectiveness of the mobile application "Colorectal Leakage App" in the early diagnosis of anastomotic leakage after colorectal surgeries at the National Research Oncology Center in Astana, Kazakhstan.Main Questions:1. Development, validation, and implementation of the mobile application "Colorectal Leakage App," based on the Dutch Leakage Score.2. Evaluate the diagnostic effectiveness of the application in detecting anastomotic leakage after colorectal surgeries.3. Determine the frequency of anastomotic leakage after colorectal surgeries performed in the colorectal surgery sector of the National Research Oncology Center in the Astana city.Participants in the study, individuals aged 18 and above undergoing colorectal surgeries, will be monitored by the mobile application "Colorectal Leakage App" in the postoperative period for early identification of anastomotic leakage. ### Conditions - Anastomotic Leak Large Intestine - Anastomotic Leak Rectum ### Study Design - Type: OBSERVATIONAL - Allocation: N/A - Intervention Model: N/A - Primary Purpose: N/A ### Interventions - "Colorectal Leakage App" ### Outcomes Primary Outcomes - Diagnostic effectiveness of "Colorectal Leakage App". - Frequency of anastomotic leakage after colorectal surgeries. Secondary Outcomes - Mortality within 30 days - Delay in the diagnosis of anastomotic leakage - Duration of hospital stay. - Number of days in the ICU. - Number of days between surgery and detection of AL. ### Location - Facility: National Research Oncology Center, Astana, N/A, 010000, Kazakhstan @@
## Treatment of Topical Ketorolac Gel in Acute Gouty Flare - NCT ID: NCT06273813 - Study ID: NOV-1776-CL-101 - Status: NOT_YET_RECRUITING - Start Date: 2024-02 - Completion Date: 2024-12 - Lead Sponsor: Novilla Pharmaceuticals ### Study Description This study will be a phase 1, open-label, bioavailability, safety and PK study of topically applied transcutaneous ketorolac tromethamine gel 12.5% (/w) (NOV-1776) versus intravenous administration of approved ketorolac tromethamine injection, USP (15mg/mL) comparator in healthy volunteers, including an evaluation of safety, tolerability, and efficacy in gout participants with flare-up. ### Conditions - Acute Gouty Arthritis - Acute Pain - Gout Flare ### Study Design - Type: INTERVENTIONAL - Allocation: NA - Intervention Model: SEQUENTIAL - Primary Purpose: TREATMENT ### Interventions - Ketorolac Tromethamine 15 MG/ML - Ketorolac Tromethamine ### Outcomes Primary Outcomes - Number of Participants With Treatment-Related Adverse Events as Assessed by CTCAE v5.0 - Area Under the Plasma Concentration Versus Time Curve (AUC) of topical ketorolac tromethamine Secondary Outcomes ### Location - Facility: Paratus Clinical,, Blacktown, N/A, 2148, Australia @@
## Chemosensitivity During Phases of the Menstrual Cycle in Breast Cancer Patients - NCT ID: NCT06273800 - Study ID: M23CMC - Status: NOT_YET_RECRUITING - Start Date: 2024-04-15 - Completion Date: 2036-07-15 - Lead Sponsor: The Netherlands Cancer Institute ### Study Description This study is a prospective, multicenter study in which a serum sample will be collected at the day of starting neo adjuvant treatment in breast cancer patients ### Conditions - Breast Cancer ### Study Design - Type: INTERVENTIONAL - Allocation: NA - Intervention Model: SINGLE_GROUP - Primary Purpose: DIAGNOSTIC ### Interventions - Blood sample ### Outcomes Primary Outcomes - pCR rate Secondary Outcomes - Radiological reduction on tumor size - Pathological reduction on tumor size - Residual cancer burden (RCB) - Distant recurrence free interval (DRFI) - Recurrence-free interval (RFI) - Overall survival (OS) ### Location - Facility: Antoni van Leeuwenhoek, Amsterdam, Noord-Holland, 1066CX, Netherlands @@
## Effect of Diaphragmatic Release in Sleep Quality During Pregnancy - NCT ID: NCT06273787 - Study ID: Mitu - Status: RECRUITING - Start Date: 2023-11-01 - Completion Date: 2024-03-17 - Lead Sponsor: MTI University ### Study Description Sleep disordered breathing (SDB) is very common during pregnancy, and is most likely explained by hormonal, physiological and physical changes. Maternal obesity, one of the major risk factors for SDB, together with physiological changes in pregnancy may predispose women to develop SDB. SDB has been associated with poor maternal and fetal outcomes. Thus, early identification, diagnosis and treatment of SDB are important in pregnancy. ### Conditions - SLEEP APNEA PREGNANCY ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: TREATMENT ### Interventions - diaphragmatic release ### Outcomes Primary Outcomes - pittshurgh sleep quality index Secondary Outcomes - diaphragmatic excursion assessment ### Location - Facility: MTI, Cairo, N/A, N/A, Egypt @@
## A Study of MK-8189 in Participants With Bipolar I Disorder (MK-8189-020) - NCT ID: NCT06273774 - Study ID: 8189-020 - Status: RECRUITING - Start Date: 2024-04-08 - Completion Date: 2024-09-10 - Lead Sponsor: Merck Sharp & Dohme LLC ### Study Description The goal of this study is to evaluate the safety and tolerability of MK-8189 in participants with stable bipolar I disorder. There will be no hypothesis testing in this study. ### Conditions - Bipolar I Disorder ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: SEQUENTIAL - Primary Purpose: TREATMENT ### Interventions - MK-8189 - Placebo ### Outcomes Primary Outcomes - Number of Participants Who Experience One or More Adverse Events (AEs) - Number of Participants Who Discontinue Study Treatment Due to an AE Secondary Outcomes ### Location - Facility: Hassman Research Institute Marlton Site ( Site 0006), Marlton, New Jersey, 08053, United States @@
## Evaluation of Medication Management Service - NCT ID: NCT06273761 - Study ID: UW 23-550 - Status: RECRUITING - Start Date: 2024-02-06 - Completion Date: 2027-05-01 - Lead Sponsor: The University of Hong Kong ### Study Description Medication management services (MMS) is a pharmacist-led service of optimizing the medication use and health outcomes, by promoting medication safety and enhancing the ability in self-management of health and diseases of patients and their caregivers. Yet, only limited evidence on the implementation of MMS service in Hong Kong is available. The goal of this clinical trial is to evaluate the cost effectiveness and effects of implementing MMS in community pharmacies owned by 8 non-government organizations (NGOs) in Hong Kong on humanistic and clinical outcomes in patients with hypertension and/or type II diabetes mellitus. The clinical trial aims to look into the following aspects:* To evaluate the perception and satisfaction of patients on MMS service* To investigate whether MMS could improve patients' adherence to their medication regimen, health-related quality of life, health outcomes and health service utilization, as well as their ability to understand and cope with their illness and drug-related problems* To identify and categorize the types of drug-related problems identified during MMS* To evaluate the cost-effectiveness of implementing MMS in community pharmaciesMMS services will be rolled out in a total of 8 NGO community pharmacies progressively (2 pharmacies per phase) in 4 successive phases. Participants will complete the questionnaires at the following time points throughout the trial, namely 1) during recruitment, 2) baseline (1 month before MMS), 3) 3 months after MMS begins, 4) 12 months after MMS begins, and 5) 24 months after MMS begins. Researchers will compare the results of questionnaires conducted at different time points to identify the potential changes in the effects of MMS. Furthermore, researchers will link up the electronic health records of the participants and identify the potential changes in the health outcomes and health service utilizations after receiving MMS. ### Conditions - Medication Adherence - Medication Safety - Diabetes Mellitus, Type 2 - Hypertension - Polypharmacy - High Risk Medications ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: SUPPORTIVE_CARE ### Interventions - Medication Management Service (MMS) ### Outcomes Primary Outcomes - Medication adherence Secondary Outcomes - Additional health service utilization - Patient perception and satisfaction - Patient perceived sensitivity to medicines - Social impact - Health-related quality of life - Drug-related problems - Change in costs - Change in effectiveness - Incremental cost effectiveness ratio (ICER) - Beliefs in medicines ### Location - Facility: Aberdeen Kai-Fong Welfare Association A-Lively Community Pharmacy, Hong Kong, N/A, N/A, Hong Kong @@
## RChildUV:Study on Non-infectious Chronic Uveitis in Pediatric Age - NCT ID: NCT06273748 - Study ID: RChildUV - Status: RECRUITING - Start Date: 2022-02-10 - Completion Date: 2032-05-02 - Lead Sponsor: Meyer Children's Hospital IRCCS ### Study Description Uveitis is an inflammatory disease of the uvea, one of the highly vascularized fundamental structures of the eye. It is a rare condition in children, with an incidence in the pediatric population ranging from 2% to 14% of all uveitis cases. The diagnosis and management of patients with uveitis rely on a multidisciplinary approach involving an ophthalmologist, a rheumatologist, and an infectious disease specialist to establish the correct diagnosis and assess the involvement of other organs. In Italy, there is no national or regional registry for non-infectious chronic uveitis as per the Prime Ministerial Decree (DPCM) of March 3, 2017 (Identification of surveillance systems and registries for mortality, tumors, and other diseases). However, many clinical centers adopt data recording systems to evaluate the quality of care and to study diseases and outcomes. The Universitary Hospital Meyer Institute Research Hospital (IRCCS) is a national referral center for managing these pediatric cases of non-infectious chronic uveitis, estimated to constitute 95% of all pediatric uveitis cases ### Conditions - Uveitis ### Study Design - Type: OBSERVATIONAL - Allocation: N/A - Intervention Model: N/A - Primary Purpose: N/A ### Interventions ### Outcomes Primary Outcomes - Describe a population of paediatric patients with chronic non-infectious uveitis - Describe a population of paediatric patients with chronic non-infectious uveitis - Identify any differences between the different forms of uveitis in terms of characteristics and outcomes - Identify risk factors for a more severe course - Frequency achievement of response for each drug according to the definition of response - Time to archieve the response after drug initiation - Achievement of inactive disease on therapy according to the definition of MIWGUC - Time to achieve inactive disease on therapy according to the definition of MIWGUC - Presence and percentages of flares on therapy after achievement of remission on therapy - Time to the first flare on therapy - Time to flare after drug withdrawal Secondary Outcomes ### Location - Facility: Cincinnati Children's Hospital Medical Center, Cincinnati, Ohio, 45207, United States @@
## Prospective Trial: Myocardial Injury After Noncardiac Surgery (MINS) Following Radical Prostatectomy - NCT ID: NCT06273735 - Study ID: 2019-PS-33b - Status: RECRUITING - Start Date: 2023-08-14 - Completion Date: 2026-10 - Lead Sponsor: Martini-Klinik am UKE GmbH ### Study Description The aim of this study is to prospectively analyse the rate of MINS in the standardised radical prostatectomy patient clientele at the Martini-Clinic and to identify risk factors. Pre- and postoperative troponin levels are determined (1st and 2nd postoperative day). The patient's height, weight, age and cardiovascular risk factors (including determination of the Revised Cardiac Risk Index) are recorded in the medical history as well as previous medical and interventional cardiological therapy. Furthermore, the prostate carcinoma-associated tumour and surgical parameters are determined. Clinically significant cardiovascular events during the inpatient stay are also described. Finally, a description of the rate of events, a check for correlation with the Revised Cardiac Risk Index and an identification of risk factors are carried out. ### Conditions - Myocardial Injury ### Study Design - Type: OBSERVATIONAL - Allocation: N/A - Intervention Model: N/A - Primary Purpose: N/A ### Interventions - Pre- and postoperative determination of troponin as part of the study and 24-month FU survey ### Outcomes Primary Outcomes - rate of MINS in standardised open and robot-assisted radical prostatectomy Secondary Outcomes ### Location - Facility: Martini-Klinik am UKE GmbH, Hamburg, N/A, 20246, Germany @@
## D-OCT for Detection and Subtyping of BCC: a Diagnostic Cohort Study - NCT ID: NCT06273722 - Study ID: 2024-0059 - Status: NOT_YET_RECRUITING - Start Date: 2024-04-01 - Completion Date: 2024-12-31 - Lead Sponsor: Maastricht University Medical Center ### Study Description The current gold standard for diagnosing basal cell carcinoma (BCC) is the histopathological examination of biopsy specimen. However, non-invasive imaging modalities such as optical coherence tomography (OCT) may replace biopsy if BCC presence and its subtype can be established with high confidence. Subtype differentiation is crucial; while superficial BCCs (sBCC) can be treated topically, nodular (nBCC) and infiltrative BCCs (iBCC) require excision. Dynamic OCT (D-OCT) is a functionality integrated within the OCT device, enabling the visualization of vascular structures through speckle variance.Descriptive studies have unveiled vascular shapes and patterns associated with BCC and its respective subtypes. These findings suggest that D-OCT could contribute to the accuracy of BCC detection and subtyping. Yet comparative clinical studies between OCT and D-OCT are lacking. In the proposed diagnostic cohort study, we aim to assess whether D-OCT assessment is superior to OCT in terms of accuracy for BCC detection and subtyping. ### Conditions - Basal Cell Carcinoma - Optical Coherence Tomography ### Study Design - Type: OBSERVATIONAL - Allocation: N/A - Intervention Model: N/A - Primary Purpose: N/A ### Interventions - Vivosight Multi-beam Swept-Source Frequency Domain OCT scanner ### Outcomes Primary Outcomes - Diagnostic accuracy for BCC detection on D-OCT assessment Secondary Outcomes - Diagnostic accuracy for BCC subtyping on D-OCT assessment - Diagnostic value of vascular structures and patterns ### Location - Facility: N/A, N/A, N/A, N/A, N/A @@
## Remote Assessment of OCT Scans for BCC Detection - NCT ID: NCT06273709 - Study ID: 2023-3698 - Status: NOT_YET_RECRUITING - Start Date: 2024-03-01 - Completion Date: 2024-12-31 - Lead Sponsor: Maastricht University Medical Center ### Study Description Basal cell carcinoma (BCC) is the most common form of cancer and entails approximately 80% of all cutaneous malignancies. This locally destructive neoplasm is commonly diagnosed by punch biopsy which is considered painful, causes procedural scarring and carries a small risk of infection and re-bleeding associated with invasive procedures. Moreover, awaiting the results of the subsequent histopathological examination causes treatment delay and can be stressful for the patient. The drawbacks of biopsy could be overcome by optical coherence tomography (OCT), a non-invasive diagnostic modality that may replace biopsy in up to 66% of patients. However, OCT assessors are scarce which hinders the implementation of OCT. This problem may be addressed by teledermatology in which remote OCT assessment by an assessor facilitates simultaneous assessment for multiple clinics. Remote OCT assessment withholds the OCT assessor from visually inspecting the lesion. But the effect of visual inspection on the diagnostic accuracy remains unknown and the question arises whether visual inspection is necessary for accurate OCT assessment. In this diagnostic case-control study we will determine whether distant OCT assessment without visual information on the lesion is non-inferior to distant OCT assessment with clinical and dermoscopic photographs (CDP-OCT). ### Conditions - Basal Cell Carcinoma ### Study Design - Type: OBSERVATIONAL - Allocation: N/A - Intervention Model: N/A - Primary Purpose: N/A ### Interventions - Vivosight Multi-beam Swept-Source Frequency Domain OCT scanner ### Outcomes Primary Outcomes - Diagnostic accuracy of high-confidence BCC diagnosis with and without clinical/dermoscopic photographs Secondary Outcomes ### Location - Facility: N/A, N/A, N/A, N/A, N/A @@
## Evaluation of the Acceptability and Safety of the ShangRing Device for Male Circumcision in Shinyanga, Tanzania - NCT ID: NCT06273696 - Study ID: 2019-519 - Status: COMPLETED - Start Date: 2019-05-01 - Completion Date: 2019-07-30 - Lead Sponsor: IntraHealth International ### Study Description The goal of this observational study was to evaluate the safety and acceptability of the ShangRing device for male circumcision among men in Shinyanga, Tanzania. The main question aims to answer both provider acceptability (practicality of device use and placement and removal times) and client acceptability (comfort during placement and removal, experience while wearing the ring, and penile appearance after healing). Participants voluntarily underwent male circumcision using the ShangRing device and before being discharged, were interviewed about their experience. Participants were also interviewed at device removal day (day 7), during a follow-up phone call (day 10), a sample were selected to participate in in-depth interviews (day28), and finally all men were asked to return for a follow-up visit (day 49). ### Conditions - Penile Infection - Penile Haematoma - Penile Bleeding - Deformity ### Study Design - Type: OBSERVATIONAL - Allocation: N/A - Intervention Model: N/A - Primary Purpose: N/A ### Interventions - ShangRing ### Outcomes Primary Outcomes - Number of Adverse Events - Number of Clients with Adverse Events - Descriptions of Adverse Events Secondary Outcomes - Provider Training - Client Follow-up Visit Rate - Client Preference for ShangRing Over Surgical Circumcision - Client Recommendation Rate - Cosmetic Result Acceptability - Client Experience While Performing Routine Activities - Client Discomfort - Provider Ease of Application - Provider Preference - Provider Recommendation - Description of Procedures - Healing rate ### Location - Facility: Kahama District Hospital, Shinyanga, N/A, N/A, Tanzania @@
## Comparison of Two Salpingectomy Techniques for Sterilization at the Time of Cesarean Delivery - NCT ID: NCT06273683 - Study ID: INOVA-2023-145 - Status: RECRUITING - Start Date: 2024-03-11 - Completion Date: 2024-12 - Lead Sponsor: Inova Health Care Services ### Study Description One in three women of reproductive age utilize tubal sterilization for contraception, and sterilization is often requested at time of cesarean delivery. Complete salpingectomy for the purpose of permanent sterilization at the time of cesarean birth is increasingly being performed worldwide.A preferred complete salpingectomy technique for the purpose of sterilization at the time of cesarean delivery has not emerged in current practice. The objective is to compare short-term clinical outcomes and cost of salpingectomy using a hand-held bipolar energy instrument with those of traditional suture ligation. This retrospective cohort study will be conducted from 2017-2023 at a single tertiary care hospital. The investigators hypothesize that bipolar energy instrument use will not significantly improve clinical outcomes. ### Conditions - Permanent Sterilization - Pregnancy Related ### Study Design - Type: OBSERVATIONAL - Allocation: N/A - Intervention Model: N/A - Primary Purpose: N/A ### Interventions - Hand-held bipolar energy instrument - Traditional suture ligation ### Outcomes Primary Outcomes - Change in Hemoglobin levels on postoperative day one Secondary Outcomes - Completion rate of sterilization - Total procedure estimated blood loss - Adjacent organ damage - Need for blood transfusion - Total operative time - ICU admission - Length of hospital stay - Hospital readmission postoperatively - Reoperation rates - Pain score - Surgical site infection - Cost ### Location - Facility: Inova Fairfax Medical campus, Falls Church, Virginia, 22042, United States @@
## Postpartum Initiation of Long-acting Reversible Contraceptives: Knowledge Attitude and Practice Study (KAP) - NCT ID: NCT06273670 - Study ID: 04-2023-200279 - Status: RECRUITING - Start Date: 2023-06-15 - Completion Date: 2025-10 - Lead Sponsor: Assiut University ### Study Description Comparing Knowledge, attitude and Practice of clients and service providers about the regular (6 weeks) versus earlier initiation of LARC, through a structured questionnaire prepared in English and translated to local language i.e. Arabic. ### Conditions - Contraception ### Study Design - Type: OBSERVATIONAL - Allocation: N/A - Intervention Model: N/A - Primary Purpose: N/A ### Interventions - screening and data collection ### Outcomes Primary Outcomes - Clients' knowledge Secondary Outcomes - Clients' attitude - Clients' practice - Providers' knowledge - Providers' attitude - Providers' practice ### Location - Facility: Assiut University, Assiut, N/A, 71515, Egypt @@
## Effects of Medisinstart for Type 2 Diabetes - NCT ID: NCT06273657 - Study ID: Apokus-002 - Status: RECRUITING - Start Date: 2024-02-07 - Completion Date: 2026-02 - Lead Sponsor: Apokus AS ### Study Description Medisinstart is a counseling service in pharmacies where patients who start taking a new medicine receive two follow-up appointments with a pharmacist. The aim of the service is to promote correct medication use and increase patient adherence. The effect of Medisinstart has previously been studied among patients starting a new cardiovascular drug. The aim of the project is to map the effects of Medisinstart among patients starting a new medication for type 2 diabetes. Knowledge about the effects of Medisinstart is important in order to maximize the benefits of the service for patients and society. The project is being conducted as a randomized controlled trial among adult patients starting a new medication for type 2 diabetes. The intervention group receives Medisinstart, while the control group only receives prescription dispensing as normal. Data collection includes HbA1c analysis in blood samples and responses to questionnaires. HbA1c is an established measure of glycemic control. ### Conditions - Type 2 Diabetes ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: SUPPORTIVE_CARE ### Interventions - Medisinstart ### Outcomes Primary Outcomes - HbA1c - HbA1c Secondary Outcomes - Self-reported adherence - Self-reported adherence - Frequency of medication-related problems - Patients' beliefs about their medicines - Diabetes Self-Management - Diabetes Treatment Satisfaction ### Location - Facility: Apotek 1 Andslimoen, Bardufoss, N/A, 9325, Norway @@
## Clinical Research on Acute Intermittent Porphyria and the Use of Carbohydrate-Rich Diet as a Treatment - NCT ID: NCT06273644 - Study ID: HNF1719-24 - Status: RECRUITING - Start Date: 2024-01-27 - Completion Date: 2037-12-31 - Lead Sponsor: Nordlandssykehuset HF ### Study Description The main aim of this clinical trial is to learn about the effect of carbohydrate-rich diet as a treatment for AIP (acute intermittent porphyria).Aim: Investigate the diet's impact on tissue and serum glucose, plasma insulin, cytokine levels, amino acids, and gut microbiota in AIP, and their correlation with PBG (Porphobilinogen).Aim: Assess the diet's effect on AIP symptoms and health status in AIP. Aim: Measure the effect of a high-carbohydrate diet on mitochondrial activity in AIP Aim: Map and detect potential mutations in mitochondrial genomic DNA in AIP Aim: Discover new markers in AIP through RNA sequencing and machine learning.Participants will follow two diet plans, a 4-week intervention with 60-65 E% carbohydrates and a 4 week intervention with 40-45 E% carbohydrates. ### Conditions - Porphyria, Acute Intermittent ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: CROSSOVER - Primary Purpose: TREATMENT ### Interventions - Carbohydrates ### Outcomes Primary Outcomes - Change in Urine Porphobilinogen/creatinine - Urine Porphobilinogen/creatinine concentration, percentage change of repeated measurements Secondary Outcomes - Number of Hospitalizations,sick leaves, and doctor visits due to AIP - Health status - Plasma Glucose level - Interstitial fluid glucose level - Number of hypoglycemic events - Amino acid profile - Plasma insulin, glucose, c-peptide - HOMA score - HbA1c - Cytokines in plasma - Intestinal microbiota composition - Physical activity - Blood pressure - Body composition, metabolic age - Mitochondrial oxygen consumption rate - ALAS1mRNA - Urine-ALA/creatinine & urine-porphyrins - Mitochondrial function-related genes ### Location - Facility: Nordland Hospital Trust, Bodø, Nordland, 8092, Norway @@
## Effect of Changes in Carbohydrate Intake on Glucose Control in Patients With Type 1 Diabetes - NCT ID: NCT06273631 - Study ID: 2022-SR-481 - Status: NOT_YET_RECRUITING - Start Date: 2024-04-01 - Completion Date: 2025-12-31 - Lead Sponsor: Yang Tao ### Study Description The blood glucose fluctuates greatly in T1DM patients, especially in the middle and late stages of the disease, and carbohydrate (CHO) is the main determinant of postprandial glucose response (PGR). Based on the previous investigation to understand how nutritional habits affect blood glucose control, we will conduct dietary intervention studies in T1DM patients to explore whether the adjustment of dietary pattern is beneficial to blood glucose control, and further explore the relevant mechanism through the detection of related metabolic indicators. ### Conditions - Type 1 Diabetes - Diet Intervention - Glucose Control ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: TREATMENT ### Interventions - multiple-diverse carbohydrate diet - middle carbohydrate diet ### Outcomes Primary Outcomes - Change of time in range (TIR) Secondary Outcomes - Change of coefficient of variation of blood glucose（CV） - Change of mean amplitude of glycemic excursions（MAGE） - Change in large amplitude of glycemic excursions (LAGE) from baseline - Change in GA（glycosylated albumin）from baseline - Change in HbA1c from baseline - Change in 1,5-anhydroglucitol (1,5-AG) from baseline - Change in time above range(TAR) from baseline - Change in time below range(TBR) from baseline - Change in total insulin dose from baseline - Change in blood lipids from baseline - Change in body weight from baseline - Change in Incidence of hypoglycemic events from baseline - Change in gut microbiota from baseline - Change in metabolomics from baseline - Change in autoimmunity from baseline ### Location - Facility: N/A, N/A, N/A, N/A, N/A @@
## iLookOut Micro-learning to Improve Knowledge Retention - NCT ID: NCT06273618 - Study ID: iLO-ML-23396 - Status: NOT_YET_RECRUITING - Start Date: 2024-04-15 - Completion Date: 2027-02 - Lead Sponsor: Milton S. Hershey Medical Center ### Study Description This project investigates whether a multi-faceted strategy involving iLookOut's evidence-based Core Training plus an innovative follow-up Micro-Learning can promote knowledge retention and change behavior among early childhood professionals (ECPs) with regard to child abuse and its reporting. Additionally, this study will evaluate if non-ECPs experience similar improvements and retention of knowledge and changes in behavior as do ECPs. ### Conditions - Knowledge - Attitudes - Practice ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: OTHER ### Interventions - Micro-Learning ### Outcomes Primary Outcomes - Change in knowledge about child maltreatment and its reporting as assessed by validated iLookOut knowledge test - Change in behavior regarding child maltreatment and its reporting as measured by self-report questionnaire Secondary Outcomes - Comparison of early childhood professionals vs. non-early childhood professionals ### Location - Facility: Penn State College of Medicine, Hershey, Pennsylvania, 17033, United States @@
## The Egg Up Trial - Testing a New Treatment Pathway for Infants With Newly Diagnosed Egg Allergy - NCT ID: NCT06273605 - Study ID: 102828 - Status: RECRUITING - Start Date: 2024-04-09 - Completion Date: 2025-08-30 - Lead Sponsor: Murdoch Childrens Research Institute ### Study Description The goal of this study is to test the safety and feasibility of a change in management approach for infants with newly diagnosed egg allergy. Infants with newly diagnosed egg allergy will have egg introduced via a gradual and graded home based approach known as an "egg ladder" supervised by a dietitian. The main questions this study aims to answer are how safe and feasible are home-based dietitian-led "egg ladders" as a treatment pathway to achieve tolerance of egg for newly diagnosed infants with egg allergy. ### Conditions - Food Allergy - Food Allergy in Infants ### Study Design - Type: INTERVENTIONAL - Allocation: NA - Intervention Model: SINGLE_GROUP - Primary Purpose: TREATMENT ### Interventions - Egg Ladder ### Outcomes Primary Outcomes - Number and severity of adverse events related to baked egg ingestion (step 1) while following the home-based egg ladder protocol as collected via parent questionnaire and medical history. - Number and severity of adverse events related to ingestion of well cooked egg as an ingredient (step 2) while following the home-based egg ladder protocol as collected via parent questionnaire and medical history. - Number and severity of adverse events related ingestion of well cooked whole egg (step 3) while following the home-based egg ladder protocol as collected via parent questionnaire and medical history. - Number and severity of adverse events related to ingestion of lightly cooked whole egg (step 4) while following the home-based egg ladder protocol as collected via parent questionnaire and medical history. - Number and severity of adverse events related to raw egg ingestion (step 5) while following the home-based egg ladder protocol as collected via parent questionnaire and medical history. - Feasibility of the home-based, egg ladder protocol to achieve egg allergy resolution 12 months from egg allergy diagnosis Secondary Outcomes - Change from baseline (diagnosis) in parent reported Quality of Life scores using the Food Allergy Quality of Life Questionnaire (FAQLQ-PF) to study completion (12 months from diagnosis) - Change from baseline (diagnosis) in parental anxiety scores measured using the Impairment Measure for Parental Food Allergy - Associated Anxiety and Coping Tool (IMPAACT) to study completion (12 months from diagnosis) - Heath care costs ### Location - Facility: Murdoch Children's Research Institute (MCRI), Melbourne, Victoria, 3052, Australia @@
## The Impact of a Plant-based Meat Meal Versus an Animal Meat Meal on Erectile Function in Healthy Men. - NCT ID: NCT06273592 - Study ID: 2023-15558 - Status: NOT_YET_RECRUITING - Start Date: 2024-04 - Completion Date: 2026-04 - Lead Sponsor: Montefiore Medical Center ### Study Description The goal of this study is to determine whether erectile function is differentially impacted by a single plant-based meat meal versus a single animal meat meal in healthy men with normal erectile function. ### Conditions - Erectile Dysfunction ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: CROSSOVER - Primary Purpose: PREVENTION ### Interventions - Animal-based meal - Plant-based meat meal ### Outcomes Primary Outcomes - Percent of time with ≥70% erection during overnight sleep after 1 meal Secondary Outcomes - Erection events per hour during overnight sleep after 1 meal - Tumescence events per hour during overnight sleep after 1 meal. ### Location - Facility: N/A, N/A, N/A, N/A, N/A @@
## Efficiency of Verbal Intelligent Tutor Instruction in Neurosurgical Simulation - NCT ID: NCT06273579 - Study ID: 2010-270, NEU-09-042-Trial 5 - Status: NOT_YET_RECRUITING - Start Date: 2024-03 - Completion Date: 2024-12 - Lead Sponsor: McGill University ### Study Description At the Neurosurgical Simulation and Artificial Intelligence Learning Centre, we seek to provide surgical trainees with innovative technologies that allow them to improve their surgical technical skills in risk-free environments, potentially improving patient operative outcomes. The Intelligent Continuous Expertise Monitoring System (ICEMS), a deep learning application that assesses and trains neurosurgical technical skill and provides continuous intraoperative feedback, is one such technology that may improve surgical education.In this randomized controlled trial, medical students from four Quebec universities will be blinded and randomized to one of three groups (one control and two experimental). Group 1 (control) will be provided with verbal AI tutor feedback based on the ICEMS error detection. Group 2 will be tutored by a human instructor who will receive ICEMS error data and deliver verbal instruction identical to that which the AI tutor delivers. Group 3 will be tutored by a human instructor who will be provided with ICEMS data but may deliver feedback as they feel is appropriate to correct the error.The aim of this study is to determine how the method of delivery of verbal surgical error instruction influences trainee response to instruction and overall surgical performance. Evaluating trainee responses to AI instructor verbal feedback as compared to feedback from human instructors will allow for further development, testing, and optimization of the ICEMS and other AI tutoring systems. ### Conditions - Surgical Education ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: HEALTH_SERVICES_RESEARCH ### Interventions - Experimental Group - Verbal expert instructor feedback in AI's words - Experimental Group - Verbal expert instructor feedback in expert's own words ### Outcomes Primary Outcomes - Response to instruction - Average Intelligent Continuous Expertise Monitoring System (ICEMS) expertise score - Objective Structured Assessment of Technical Skills (OSATS) global rating Secondary Outcomes - Difference in the strength of emotions elicited - Difference in cognitive load ### Location - Facility: Neurosurgical Simulation and Artificial Intelligence Learning Centre, Montréal, Quebec, H2X 4B3, Canada @@
## French Validation of the AdT-Physio Scale - NCT ID: NCT06273566 - Study ID: 20230202 - Status: NOT_YET_RECRUITING - Start Date: 2024-04-01 - Completion Date: 2025-07-31 - Lead Sponsor: Pole Sante Grace de Dieu ### Study Description The goal of this observational study is to translate and validate the Adt-Physio scale in French, and to validate on a large number of patients the French translation of the Adt-Physio scale as a tool for evaluating adherence and perception of the intervention of a physiotherapist in patients with cystic fibrosis.participants will have to answer the French trans-AdT scale, the Brief Cope and GSES questionnaire. ### Conditions - Cystic Fibrosis ### Study Design - Type: OBSERVATIONAL - Allocation: N/A - Intervention Model: N/A - Primary Purpose: N/A ### Interventions - Questionnaire ### Outcomes Primary Outcomes - AdT-Physio scale (Adherence to Treatment of Physiotherapy scale) Secondary Outcomes ### Location - Facility: PSLA GDD, Caen, N/A, 14000, France @@
## A Study in Subjects With Human Papillomavirus 16 or 18 Associated Cervical Intraepithelial Neoplasia Grade 2 or 3 - NCT ID: NCT06273553 - Study ID: RG002-A1201 - Status: NOT_YET_RECRUITING - Start Date: 2024-03 - Completion Date: 2027-12 - Lead Sponsor: RinuaGene Biotechnology Co., Ltd. ### Study Description The purpose of this study is to to evaluate the safety, tolerability, immunogenicity, and efficacy of RG002 Injection in subjects with HPV16/18 associated Cervical Intraepithelial Neoplasia Grade 2 or 3(CIN2/3). ### Conditions - Human Papillomavirus Associated Intraepithelial Neoplasia - Cervical Intraepithelial Neoplasia Grade 2/3 - Human Papillomavirus Type 16 Infection - Human Papillomavirus Type 18 Infection ### Study Design - Type: INTERVENTIONAL - Allocation: NA - Intervention Model: SINGLE_GROUP - Primary Purpose: TREATMENT ### Interventions - RG002 injection ### Outcomes Primary Outcomes - Part A: Safety and Tolerability of RG002 Injection, measured by the incidence of adverse events - Part A: Maximum tolerated dose (MTD) and/or RP2D of RG002 Injection - Part B: Primary efficacy of RG002 Injection, measured by the proportion of subjects with histopathological regression Secondary Outcomes - Part A: Preliminary efficacy of RG002 Injection,measured by proportion of subjects with histopathological regression - Part A: Preliminary efficacy of RG002 Injection,measured by proportion of subjects with clearance of HPV16/18 - Part A: Preliminary efficacy of RG002 Injection,measured by proportion of subjects with histopathological regression and clearance of HPV16/18 - Part A and B: Immunogenicity of RG002 Injection,measured by the level of cellular immune response - Part A and B: Immunogenicity of RG002 Injection,measured by the proportion of T lymphocytes - Part A and B: Immunogenicity of RG002 Injection,measured by the expression of cytokines in serum - Part A and B: Immunogenicity of RG002 Injection,measured by the serum levels of anti-HPV16 and anti-HPV18 IgG antibodies. - Part A and B: Exposure level of RG002 Injection, measured by mRNA - Part A and B: Exposure level of RG002 Injection, measured by cationic lipids - Part A and B: Anti-drug antibody (ADA) to polyethylene glycol (PEG) of RG002 injection, measured by the serum titer of anti-PEG IgG and anti-PEG IgM - Part B: Secondary efficacy, measured by proportion of subjects with histopathological regression - Part B: Secondary efficacy, measured by proportion of subjects with clearance of HPV16/18 - Part B: Secondary efficacy, measured by proportion of subjects with histopathological regression and clearance of HPV16/18 - Part B: Safety and tolerability of RG002 Injection, measured by the incidence of adverse events - Part B: Optionally assess the biomarker of RG002 Injection, measured by the level of potential biomarkers and the level of infiltrating T cells and myeloid cells in the lesions. ### Location - Facility: N/A, N/A, N/A, N/A, N/A @@
## Phase1, STP7 Cocaine Drug-Drug Interaction Study - NCT ID: NCT06273540 - Study ID: STA-P7-C001 - Status: RECRUITING - Start Date: 2024-04-15 - Completion Date: 2024-09-30 - Lead Sponsor: Stalicla SA ### Study Description This is a double-blind, placebo-controlled, parallel group study to compare the effects of STP7 (mavoglurant) vs placebo control on i.v. cocaine's physiological and subjective effects in non-treatment seeking, cocaine-experienced males or females participants between 18 and 59 years of age.The primary objective of this study is to determine if there are clinically meaningful interactions between oral STP7 (mavoglurant) treatment concurrent with 20 and 40 mg i.v. cocaine infusions by measuring adverse events and cardiovascular responses including heart rate, blood pressure, and electrocardiogram (including corrected QT interval).The secondary objectives are:* To evaluate whether administration of STP7 (mavoglurant) alters the pharmacokinetics of cocaine and/or its major metabolite, benzoylecgonine.* To determine the pharmacokinetic of STP7 (mavoglurant) administered at a dose of 200 mg twice a day.* To evaluate whether STP7 (mavoglurant) treatment alters the subjective effects of cocaine measured by Visual Analog Scales (VAS) and Brief Substance Craving Scale (BSCS). ### Conditions - Cocaine Use Disorder ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: TREATMENT ### Interventions - STP7 (mavoglurant) or Placebo ### Outcomes Primary Outcomes - Incidence of Treatment-Emergent Adverse Events. - Heart Rate response following the STP7 treatment with the cocaine infusion. - Heart Rate response following the STP7 treatment with the cocaine infusion. - Blood Pressure (diastolic) response following the STP7 treatment with the cocaine infusion . - Blood Pressure (diastolic) response following the STP7 treatment with the cocaine infusion. - Blood Pressure (systolic) response following the STP7 treatment with the cocaine infusion. - Blood Pressure (systolic) response following the STP7 treatment with the cocaine infusion. - ECG changes (HR) following the STP7 treatment with the cocaine infusion. - ECG changes (RR) following the STP7 treatment with the cocaine infusion. - ECG changes (PR) following the STP7 treatment with the cocaine infusion. - ECG changes (QRS) following the STP7 treatment with the cocaine infusion. - ECG changes (QT) following the STP7 treatment with the cocaine infusion. - ECG changes (HR) following the STP7 treatment with the cocaine infusion. - ECG changes (RR) following the STP7 treatment with the cocaine infusion. - ECG changes (PR) following the STP7 treatment with the cocaine infusion. - ECG changes (QRS) following the STP7 treatment with the cocaine infusion. - ECG changes (QT) following the STP7 treatment with the cocaine infusion. Secondary Outcomes - Pharmacokinetics: Maximum Plasma Concentration [Cmax] of cocaine. - Pharmacokinetics: Maximum Plasma Concentration [Cmax] of benzoylecgonine. - Pharmacokinetics: Maximum Plasma Concentration [Cmax] of STP7. - Pharmacokinetics: Maximum Plasma Concentration [Cmax] of STP7. - Pharmacokinetics: time to maximum plasma concentration [Tmax] of cocaine. - Pharmacokinetics: time to maximum plasma concentration [Tmax] of benzoylecgonine. - Pharmacokinetics: time to maximum plasma concentration [Tmax] of STP7. - Pharmacokinetics: time to maximum plasma concentration [Tmax] of STP7. - Pharmacokinetics: area under the concentration-time curve from time 0 to time t of cocaine. - Pharmacokinetics: area under the concentration-time curve from time 0 to time t of benzoylecgonine. - Pharmacokinetics: area under the concentration-time curve from time 0 to time of STP7. - Pharmacokinetics: area under the concentration-time curve from time 0 to time of STP7. - Pharmacokinetics: area under the concentration-time curve from time 0 to 12 hours post-dose of cocaine. - Pharmacokinetics: area under the concentration-time curve from time 0 to 12 hours post-dose of benzoylecgonine. - Pharmacokinetics: area under the concentration-time curve from time 0 to 12 hours post-dose of STP7. - Pharmacokinetics: area under the concentration-time curve from time 0 to 12 hours post-dose of STP7. - Pharmacokinetics: area under the concentration-time curve from time 0 to time infinity post-dose of cocaine. - Pharmacokinetics: area under the concentration-time curve from time 0 to time infinity post-dose of benzoylecgonine. - Pharmacokinetics: area under the concentration-time curve from time 0 to time infinity post-dose of STP7. - Pharmacokinetics: area under the concentration-time curve from time 0 to time infinity post-dose of STP7. - Pharmacokinetics: trough plasma concentration (Ctrough) of cocaine. - Pharmacokinetics: trough plasma concentration (Ctrough) of benzoylecgonine. - Pharmacokinetics: trough plasma concentration (Ctrough) of STP7. - Pharmacokinetics: trough plasma concentration (Ctrough) of STP7. - Pharmacokinetics: terminal rate constant of cocaine. - Pharmacokinetics: terminal rate constant of benzoylecgonine. - Pharmacokinetics: terminal rate constant of STP7. - Pharmacokinetics: terminal rate constant of STP7. - Pharmacokinetics: half-life of cocaine. - Pharmacokinetics: half-life of benzoylecgonine. - Pharmacokinetics: half-life of STP7. - Pharmacokinetics: half-life of STP7. - Pharmacokinetics: clearance of cocaine. - Pharmacokinetics: clearance of benzoylecgonine. - Pharmacokinetics: clearance of STP7. - Pharmacokinetics: clearance of STP7. - Pharmacokinetics: Clearance from plasma after oral administration of cocaine. - Pharmacokinetics: Clearance of benzoylecgonine from plasma after oral administration (CL/F) of cocaine. - Pharmacokinetics: Clearance from plasma after oral administration (CL/F) of STP7. - Pharmacokinetics: Clearance from plasma after oral administration (CL/F) of STP7. - Visual evaluation of the STP7 on the subjective effects of cocaine at screening - Visual evaluation of the STP7 on the subjective effects of cocaine at baseline and during treatment - Craving evaluation of the STP7 on the subjective effects of cocaine. ### Location - Facility: Altasciences Clinical Kansas, Overland Park, Kansas, 66212, United States @@
## Enhancing Transdiagnostic Mechanisms of Cognitive Dyscontrol (R33) - NCT ID: NCT06273527 - Study ID: 808681 - Status: NOT_YET_RECRUITING - Start Date: 2024-11 - Completion Date: 2027-06 - Lead Sponsor: University of California, San Diego ### Study Description The proposed project aims to test the cognitive and neural effects of a cognitive training in a sample of individuals seeking treatment for anxiety, depression, or traumatic stress symptoms. Participants will be randomly assigned to one of two groups. Group 1 will receive a computer-based program that is designed as a cognitive training intervention and Group 2 will receive a similar computer-based exercise that researchers think will be less effective in training thinking skills (also known as a control or sham condition). Participants will be compared on cognitive performance and brain response during cognitive tasks from baseline to post-treatment. ### Conditions - Anxiety Disorders - Depression - Post Traumatic Stress Disorder ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: TREATMENT ### Interventions - COGENT - Sham Program ### Outcomes Primary Outcomes - Change in cognitive performance Secondary Outcomes - Reading Span Blood Oxygen Level Dependent (BOLD) Response - Neuropsychological Performance - Repetitive Negative Thinking (RNT) ### Location - Facility: UC San Diego, San Diego, California, 92037, United States @@
## Comparison the Effects of TECAR With Dry Needling in the Treatment of Myofascial Trigger Points - NCT ID: NCT06273514 - Study ID: TECAR and DN intervention - Status: COMPLETED - Start Date: 2020-12-01 - Completion Date: 2022-12-31 - Lead Sponsor: Medical University of Silesia ### Study Description The aim of the study is to assess the effectiveness of dry needling (DN) and capacitive and resistive transfer of energy (TECAR) therapy in the treatment of myofascial trigger points (MTrPs) as well comparison of their efficacy.Research hypothesis:Capacitive and resistive energy transfer therapy is comparable to dry needling therapy for the treatment of myofascial trigger points.It is estimated that the presence of trigger points is the main cause of pain in 30-85% of patients visiting primary health care facilities and pain management clinics. The presence of trigger points may significantly affect the patient's functional status and daily functioning. Recently, diagnostic criteria and methods of treating trigger points have evolved significantly. However, the usefulness of different imaging methods in the diagnosis of trigger points has not yet been established. Despite numerous studies, the long-term effectiveness of the dry needling method is still unknown. Furthermore, there is no available research on the short- and long-term effectiveness of capacitive and resistive energy transfer therapy in the treatment of trigger points.Therefore, the objectives of the work were:Determination and comparison of the short- and long-term effects of capacitive and resistive energy transfer therapy and the dry needling technique of myofascial trigger points located in the upper trapezius muscle (UT) on the strength, neck range of motion and pain intensity within this muscle.The study is planned to include a group of 26 men aged 25 to 45 who suffer from pain caused by the presence of myofascial trigger points in the upper trapezius muscle. The subjects will be divided into two groups of equal number of people. The first group will undergo therapy using the dry needling technique, while the second group will undergo capacitive and resistive energy transfer therapy.In order to determine the immediate effects of capacitive and resistive energy transfer therapy and dry needling techniques, measurements of muscle strength, the intensity of pain in the upper trapezius muscle and neck range of motion will be performed before and after each therapeutic session (2 session in 2 weeks are planed). In turn, to determine the long-term effects of capacitive and resistive energy transfer therapy and dry needling, the next above-mentioned measurements will be performed four weeks after the end of first therapy. ### Conditions - Myofascial Pain Syndrome of Neck - Myofascial Trigger Point Syndrome - Myofascial Trigger Point Pain ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: TREATMENT ### Interventions - TECAR - Dry needling ### Outcomes Primary Outcomes - Pain - Pressure pain threshold (PPT) - Pain - numerical rating scale (NRS) Secondary Outcomes - Muscle strength - Cervical spine range of motion (ROM) ### Location - Facility: Medical fit, Ruda Śląska, Śląsk, 41-717, Poland @@
## MRI and Magnetometer-guided Sentinel Lymph Node Detection in Vulvar Cancer - NCT ID: NCT06273501 - Study ID: D-NR 2022-02876-01 - Status: ENROLLING_BY_INVITATION - Start Date: 2022-03-24 - Completion Date: 2024-12-31 - Lead Sponsor: Sahlgrenska University Hospital, Sweden ### Study Description The aim of the feasibility study is to evaluate whether SPIO-MRI and a magnetometer could be a potential substitute to the routine dual technique in pre-and intraoperative SLN localization. Secondary, to explore if SPIO-MRI could predict lymph node status in comparison to histopathological analysis. ### Conditions - Vulvar Cancer - Lymph Node Metastasis ### Study Design - Type: INTERVENTIONAL - Allocation: NA - Intervention Model: SINGLE_GROUP - Primary Purpose: DIAGNOSTIC ### Interventions - Magtrace ### Outcomes Primary Outcomes - Sentinel lymph node identification Secondary Outcomes ### Location - Facility: Department of Obstetrics and gynecology, Gothenburg, N/A, 41345, Sweden @@
## The Role of Auricular Point Diagnosis and Treatment in ERAS During TKA - NCT ID: NCT06273488 - Study ID: EXZL20240002 - Status: RECRUITING - Start Date: 2024-03-23 - Completion Date: 2024-12-01 - Lead Sponsor: Peking Union Medical College ### Study Description To further improve the surgical outcomes of patients undergoing total knee arthroplasty (TKA). This study aims to use ear acupoint therapy to address the following clinical issues: 1 The degree of postoperative inflammation and edema in the patient; 2. Patient pain; 3. Patient functional recovery. 4. Surgical scar repair for patients; 5. Patient perioperative anxiety and postoperative satisfaction. Exploring the safety and effectiveness of ear acupoint therapy in the postoperative application of TKA, leveraging the advantages of suitable traditional Chinese medicine techniques in simplicity, convenience, effectiveness, and cost-effectiveness, and further improving the ERAS Chinese and Western medicine collaborative plan for TKA. ### Conditions - Auriculotherapy - Arthroplasty, Replacement, Knee - Enhanced Recovery After Surgery ### Study Design - Type: OBSERVATIONAL - Allocation: N/A - Intervention Model: N/A - Primary Purpose: N/A ### Interventions - Auriculotherapy ### Outcomes Primary Outcomes - Range of motion(ROM) Secondary Outcomes - Visual Analogue Pain Scale (VAS) - Self-Assessment Survey for Anxiety（SAS） - Acupoint electrical measurement value(AE) - Vancouver Scar Assessment Scale（VSS） - Dosage of painkillers - Hospital stay - HSS knee joint scoring - Thigh circumference(knee joint circumference) - Kine siphobia (TSK) score - C-reactive protein (CRP) - Erythrocyte Sedimentation Rate(ESR) - Postoperative satisfaction - Expenses during hospitalization - Demand rate and satisfaction rate of auricular point diagnosis and treatment - Adverse events related to auricular acupuncture diagnosis and treatment - Affected limb drainage volume - Preoperative Anxiety Scale (PAS-7) score - Total number of pain pump uses (presses) ### Location - Facility: Peking Union Medical College Hospital, Beijing, Beijing, 100000, China @@
## Robot-Assisted Training Versus Standard Training in Ischemic Stroke - NCT ID: NCT06273475 - Study ID: OUH RoboRehab - Status: RECRUITING - Start Date: 2024-05-01 - Completion Date: 2027-02-01 - Lead Sponsor: Odense University Hospital ### Study Description The aim of this randomised controlled trial (RCT) nested in a prospective cohort, is to investigate the superior effect of late-phase robot-assisted versus standard training on motor function, physical function, fatigue, and quality of life in a moderately-to-severely impaired chronic stroke population following subacute rehabilitation.The main hypothesis of the study is:Robot-assisted training has a superior effect on motor function (Fugl-Meyer Lower Extremity Assessment; primary outcome), physical function, fatigue, and quality of life in moderately-to-severely impaired chronic stroke-affected individuals in comparison to standard training. ### Conditions - Stroke - Ischemic Stroke ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: TREATMENT ### Interventions - Robot-assisted Training - Standard Training ### Outcomes Primary Outcomes - Fugl-Meyer Lower Extremity Assessment of Motor Function Secondary Outcomes - Modified Rankin Scale Score (between-group change) - Functional Ambulation Category (between-group change) - Berg Balance Scale (between-group change) - Barthel-100 Index (between-group change) - Global Rating of Change (between-group change) - International Physical Activity Questionnaire - Short Form (between-group change) - Fatigue Severity Scale 7 (between-group change) - EQ-5D-5L Quality of Life (between-group change) - Hand-grip strength (between-group change) - Gait speed (between-group change) ### Location - Facility: Rigshospitalet and Herlev Gentofte Hospital, Copenhagen, N/A, N/A, Denmark @@
## Palmitoylethanolamide for Chronic Inflammatory Pain Conditions - NCT ID: NCT06273462 - Study ID: NMCSD.2024.0006 - Status: NOT_YET_RECRUITING - Start Date: 2024-03-01 - Completion Date: 2025-05-30 - Lead Sponsor: Navy Medical Center San Diego ### Study Description The goal of this clinical trial is to evaluate if a supplement called palmitoylethanolamide (PEA) is effective in reducing the pain in patients with chronic inflammatory pain conditions. The main question the trial aims to answer is if PEA works better at treating a patients pain and improving their function better than a placebo.Participants will be divided into two equal groups and asked to take either PEA or a placebo for 8 weeks. ### Conditions - Chronic Pain ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: TREATMENT ### Interventions - Palmitoylethanolamide 600mg twice a day - placebo ### Outcomes Primary Outcomes - Pain Level Secondary Outcomes - Pain interference and function - Pain Catastrophizing Scale (PCS) - Patient Reported Outcome Measurement Information System (PROMIS) (Pain interference, Social satisfaction; Physical function) ### Location - Facility: Naval Medical Center San Diego, San Diego, California, 92118, United States @@
## A Smart Digital Workflow Towards High Precision and Through-Put Production for Removable Partial Dentures - NCT ID: NCT06273449 - Study ID: 385/2023 - Status: RECRUITING - Start Date: 2022-12-29 - Completion Date: 2024-08-30 - Lead Sponsor: National Dental Centre, Singapore ### Study Description Tooth loss is a major chronic problem in dentistry and edentulous elderly endures poorer quality of life worldwide. Removable partial dentures (RPDs) are the most widely accepted and cost-effective treatment for patients to restore oral functions. RPDs contain three components including the metal framework, denture base and acrylic teeth. Conventionally, RPD fabrication involves tedious clinical and dental laboratory procedures and is time consuming, labour-intensive, and often imprecise, therefore incapable of meeting the growing demands of RPD by an ageing population. The challenges to achieve a high quality and high-throughput RPD service lie in three aspects: 1) accuracy in capturing oral profile; 2) immediate oral information analysis and device design, and 3) automation in production. ### Conditions - Partial-edentulism ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: SEQUENTIAL - Primary Purpose: SUPPORTIVE_CARE ### Interventions - Group 3 - 3D Printed Removable Partial Denture - Group 2 - 3D Printed Removable Partial Denture ### Outcomes Primary Outcomes - Evaluation of Precision in Fabricated Metal Frameworks Across Three Workflows - Comparison of Patient Satisfaction with RPD Prostheses Fabricated Using Three Workflows - Comparison of Fabrication Cost and Time Across Three Workflows Secondary Outcomes ### Location - Facility: National Dental Centre Singapore, Singapore, N/A, 168938, Singapore @@
## Healing, Equity, Advocacy and Respect for Mamas - NCT ID: NCT06273436 - Study ID: Pro00130902 - Status: NOT_YET_RECRUITING - Start Date: 2024-04-29 - Completion Date: 2028-11-30 - Lead Sponsor: Medical University of South Carolina ### Study Description The goal of the proposed research is to test the comparative effectiveness of AIM safety bundles for post-partum women delivered in-person vs. via text/phone to improve early detection of and timely care for complications during the first six weeks postpartum for women experiencing significant health disparities. ### Conditions - Postpartum Complication ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: PREVENTION ### Interventions - H.E.A.R. for Mamas ### Outcomes Primary Outcomes - Emergency Department (ED) visits within six weeks postpartum Secondary Outcomes - Patient Reported Outcomes (PROs) ### Location - Facility: N/A, N/A, N/A, N/A, N/A @@
## Feasibility Evaluation of a Dance Fitness Program - NCT ID: NCT06273423 - Study ID: OULA for Postpartum Depression - Status: NOT_YET_RECRUITING - Start Date: 2024-10 - Completion Date: 2025-06 - Lead Sponsor: Montana State University ### Study Description The objective of this pilot project is to assess the feasibility, acceptability, and mental health impact of OULA for women with postpartum depression (PPD). ### Conditions - Postpartum Depression ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: OTHER ### Interventions - OULA, Mind-body Physical Activity ### Outcomes Primary Outcomes - Feasibility and acceptability Secondary Outcomes - Changes in postpartum depression - Changes in postpartum anxiety ### Location - Facility: N/A, N/A, N/A, N/A, N/A @@
## Clinical Performance of An Alkasite Based Restorative Material With And Without Adhesive - NCT ID: NCT06273410 - Study ID: 0453-6/2022 - Status: COMPLETED - Start Date: 2022-10-13 - Completion Date: 2023-11-28 - Lead Sponsor: Hams Hamed Abdelrahman ### Study Description Despite significant advances in composite materials, they are still perceived as technique-sensitive and exhibit failure related to excessive wear and polymerization shrinkage. Cention N is a recently introduced alkasite restorative that contains special reactive fillers. Its application in restorative dentistry may be significant, promoting remineralization of carious lesions \& reduction of polymerization shrinkage. The study will aim to compare the clinical performance of Cention N (with and without adhesive) and composite resin (Filtek Bulk Fill) in class I restorations using FDI criteria. Thirty-six class I cavities will be selected and equally allocated into 3 groups: Group I (n=12): (Cention N with adhesive), Group II (n=12): (Cention N without adhesive) \& Group III (n=12): composite resin (Filtek Bulk Fill) in class I cavities. Patients will be followed up at 1 week 3, 6, and 12 months and evaluated using the FDI criteria. Postoperative sensitivity, staining, and recurrent caries will be evaluated in this clinical trial. ### Conditions - Dental Restoration Failure ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: TREATMENT ### Interventions - Cention N - Cention N + Adhesive - Bulk Fill Composite ### Outcomes Primary Outcomes - Change in pain sensitivity - Change in occurrence of recurrent caries - Change in occurrence of marginal stains Secondary Outcomes ### Location - Facility: Alexandria Faculty of Dentistry, Alexandria, N/A, N/A, Egypt @@
## Acetazolamide or Metolazone in Acute Heart Failure - NCT ID: NCT06273397 - Study ID: ACME-AHF - Status: NOT_YET_RECRUITING - Start Date: 2024-05-01 - Completion Date: 2027-05-01 - Lead Sponsor: Clinica Alemana de Santiago ### Study Description Impact of Acute Heart Failure:According to the World Health Organization (WHO), approximately 26 million people suffer from Heart Failure (HF), with a mortality rate of up to 50% within five years of diagnosis. Acute Heart Failure (AHF) exacerbations, leading to hospitalization, are common and represent the primary cause of hospital admissions in those over 65. Effective decongestion during hospitalization is crucial, as failure to achieve it doubles the risk of rehospitalization and mortality, incurring significant healthcare costs.Use of Diuretics in Acute Heart Failure:Diuretics, particularly loop diuretics like furosemide, are a cornerstone in managing AHF by inducing natriuresis and achieving decongestion. Clinical experience supports their use, though limited clinical trials exist. Pharmacological concepts guide their administration, emphasizing intravenous delivery in high doses and adjusting subsequent doses based on decongestive efficacy. Additionally, sequential tubular blockade with other diuretics like metolazone and acetazolamide is explored to enhance decongestion.Use of Metolazone and Acetazolamide:Sequential tubular blockade, using metolazone and acetazolamide in conjunction with furosemide, aims to achieve rapid and effective decongestion. While metolazone targets the distal tubule, inhibiting sodium-chloride channels, acetazolamide affects proximal tubular function. Studies like ADVOR (acetazolamide) and CLOROTIC (thiazide-like diuretic) demonstrate the potential benefits of combining these diuretics for quicker decongestion but with potential risks (in the case of Hydrochlorothiazide).Outcomes Measured by Major Studies:Recent studies assessing decongestion in AHF reveal a lack of uniformity in outcome selection. The primary focus should be on reducing rehospitalizations and post-discharge mortality by achieving effective decongestion. The ADVOR study, using a simple congestion score based on clinical and imaging criteria, underscores the importance of reaching a congestion score of 0 or 1 promptly.Congestion Monitoring:Monitoring diuretic treatment solely based on clinical aspects may not capture subclinical congestion, necessitating biochemical and imaging parameters. The ACME-AHF trial proposes a diagnostic score integrating clinical and imaging aspects to evaluate congestion status. Secondary outcomes include cumulative diuresis, weight loss, diuretic efficiency, and natriuresis, with a focus on natriuresis as a reliable physiological parameter for decongestion.Aim of the study:The ACME-AHF trial is designed to compare the efficacy and safety of two diuretic combination strategies: acetazolamide with furosemide and metolazone with furosemide. The primary objective is to relieve congestion, assessed using a congestion score, within the first three days of treatment during an hospitalization for acute heart failure. ### Conditions - Heart Failure Acute - Decompensated Heart Failure ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: TREATMENT ### Interventions - Acetazolamide 250 MG - Metolazone 2.5 MG - Furosemide Injection ### Outcomes Primary Outcomes - Treatment success Secondary Outcomes - Mortality - Worsening Heart Failure - Cumulative 24-hour Natriuresis - Cumulative weight loss - Subclinical congestion - Change in Hematocrit value - Change in NT-proBNP concentration - Change in CA125 value ### Location - Facility: N/A, N/A, N/A, N/A, N/A @@
## Diagnostic Performance of CIM for Helicobacter Pylori Infection in Patients With Peptic Ulcer Bleeding - NCT ID: NCT06273384 - Study ID: Si 062/2023 - Status: NOT_YET_RECRUITING - Start Date: 2024-03-01 - Completion Date: 2024-12-31 - Lead Sponsor: Mahidol University ### Study Description The goal of this cross-sectional study is to evaluate the efficacy of current infection marker (CIM) method for H. pylori detection. The main questions it aims to answer are:* To evaluate the efficacy of CIM method for H. pylori detection compared to rapid urease test(RUT), histopathology, polymerase chain reaction (PCR), and urea breath test (UBT) in patients who presented with upper gastrointestinal hemorrhage from peptic ulcer, and their sensitivity, specificity, accuracy, positive predictive value (PPV), negative predictive value (NPV), positive likelihood ratio, and negative likelihood ratio.* To evaluate the advantages of CIM method for H. pylori detection comparing to RUT, histopathology, PCR, and UBT in patients who presented with upper gastrointestinal hemorrhage from peptic ulcer as net reclassification index (NRI).* To study the associated factors in false negative value of H. pylori detection methods with CIM, RUT, histopathology, PCR, and UBT. ### Conditions - Helicobacter Pylori Infection - Peptic Ulcer Hemorrhage ### Study Design - Type: OBSERVATIONAL - Allocation: N/A - Intervention Model: N/A - Primary Purpose: N/A ### Interventions ### Outcomes Primary Outcomes - The efficacy of CIM method for H. pylori detection Secondary Outcomes - The advantages of CIM method for H. pylori detection ### Location - Facility: Faculty of Medicine Siriraj Hospital, Mahidol University, Bangkok Noi, Bangkok, 10700, Thailand @@
## Tolerance and Growth Outcomes in Children Diagnosed With Cow's Milk Protein Allergy and Prescribed an Extensively Hydrolyzed Casein Formula (Damira 2000©) in Spain - NCT ID: NCT06273371 - Study ID: DELISA2023 - Status: COMPLETED - Start Date: 2023-12-12 - Completion Date: 2023-12-21 - Lead Sponsor: Lactalis ### Study Description Damira 2000© is a 100% extensive casein hydrolysate (eHCF). It is formulated to help reverse growth retardation as a result of cow's milk proteins allergy (CMPA), to be well tolerated and to help improve symptoms.Damira 2000 is indicated for allergy/intolerance to cow's milk proteins, atopic dermatitis secondary to CMPA, intestinal malabsorption processes and prevention of allergy/intolerance to cow's milk proteins.The study aimed at evaluating the tolerance of Damira 2000 in a cohort of children with CMPA. ### Conditions - Cow's Milk Protein Allergy ### Study Design - Type: OBSERVATIONAL - Allocation: N/A - Intervention Model: N/A - Primary Purpose: N/A ### Interventions - Damira 2000 Infant formula ### Outcomes Primary Outcomes - Tolerance Secondary Outcomes - Weight - Height - Weight for height and BMI - Head circumference ### Location - Facility: Hospital Quirónsalud de Córdoba, Córdoba, Andalucia, N/A, Spain @@
## Preoperative Sleep Quality and Postoperative Delirium - NCT ID: NCT06273358 - Study ID: Study Sleep Quality - Status: COMPLETED - Start Date: 2023-08-01 - Completion Date: 2024-01-27 - Lead Sponsor: Konya City Hospital ### Study Description Background: Delirium is a neurocognitive illness that has lately been connected to sleep difficulties. It is a stressful condition. is still not fully understood. A poor sleep burden and its progress were investigated in this study to determine their correlations with the risk of delirium following surgical procedures.Methods: Between August 1st and December 5th, 2023, 124 patients undergoing non-cardiac general anesthesia (mean age 63.68 ± 8.81 years \[SD\]; range 46-82 years) reported on their sleep characteristics. PSQI, 1- sleep duration, 2- sleep disturbance, 3- sleep latency, 4- daytime dysfunction resulting from sleepiness, 5- sleep efficiency, 6- overall sleep quality, and 7- usage of sleep medications were among these sleep characteristics. Seven component scores, ranging from 0 (no difficulty) to 3 (extreme difficulty), are obtained while assessing the PSQI. The global score ranges from 0 to 21 and is calculated by adding the component scores. Higher scores indicate poorer sleep quality. A three-day median follow-up time was used to analyze hospitalization records to gather data on new-onset delirium (n = 26). Approximately 124 people on average, with a mean. ### Conditions - PREOPERATIVE SLEEP QUALITY ON POSTOPERATIVE DELIRIUM ### Study Design - Type: OBSERVATIONAL - Allocation: N/A - Intervention Model: N/A - Primary Purpose: N/A ### Interventions ### Outcomes Primary Outcomes - Sleep quality and delirium index Secondary Outcomes - Preop. and postop. sleep quality index ### Location - Facility: Yasin Tire, Konya, Meram, 42140, Turkey @@
## OLIGOS: Impact of Treatment on Primary Tumour in Patients With Newly Diagnosed Oligometastatic Neoplasia of the Prostate - NCT ID: NCT06273345 - Study ID: IOV-PR-1-2022-OLIGOS - Status: RECRUITING - Start Date: 2023-01-23 - Completion Date: 2025-01 - Lead Sponsor: Istituto Oncologico Veneto IRCCS ### Study Description The proposed study consists of a multicentre prospective observational study involving patients with oligometastatic prostatic neoplasia defined according to CHAARTED criteria.The aim of the study is the creation of a registry including patients with newly diagnosed OMPCa, belonging to the main urological centres in the Triveneto region, in order to evaluate the oncological outcomes and the impact on the quality of life of local treatment of the primary neoplasm (surgical or radiotherapy) in addition to systemic hormonal treatment (ADT as monotherapy or in combination with Docetaxel/androgen receptor signal inhibitors (ARTA)).The above criteria define 'high metastatic volume' disease with the following parameters* ≥ 4 bone metastases, including at least one outside the spine and pelvis* Presence of visceral metastases Consequently, patients included in the study should not have the above-mentioned characteristics. ### Conditions - Oligometastatic Prostate Carcinoma ### Study Design - Type: OBSERVATIONAL - Allocation: N/A - Intervention Model: N/A - Primary Purpose: N/A ### Interventions ### Outcomes Primary Outcomes - Overall survival (OS) Secondary Outcomes - Cancer-specific survival - CRPCa development - Radiological progression-free survival - Quality of life assessment - Quality of life assessment - Complications ### Location - Facility: Ospedale di Bressanone, Bressanone, Bolzano, N/A, Italy @@
## Assessment of the Artifical Intelligence Assisted Registration Versus Conventional Point Based Registration on Cone Beam-computed Tomography (CBCT) With Heavy Metal Artifacts - NCT ID: NCT06273332 - Study ID: AI surgery protocol - Status: ACTIVE_NOT_RECRUITING - Start Date: 2023-12-20 - Completion Date: 2024-02-25 - Lead Sponsor: Ain Shams University ### Study Description Our study investigates the accuracy and duration needed for 3D model registration using artifical intelligence (AI) assistance compared to conventional point-based registration. Manual segmentation of all cone beam computed tomography (CBCT) scans will be performed before the registration procedure. ### Conditions - Registration Accuracy ### Study Design - Type: INTERVENTIONAL - Allocation: NON_RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: OTHER ### Interventions - AI-assisted registration - Point-based registration ### Outcomes Primary Outcomes - Registration accuracy Secondary Outcomes - Duration for registration ### Location - Facility: Private maxillofacial digital lab, Cairo, N/A, N/A, Egypt @@
## The Effect of Oxygen Application With Double Nasal Cannula on Respiratory Complications - NCT ID: NCT06273319 - Study ID: 010656 - Status: NOT_YET_RECRUITING - Start Date: 2024-03-15 - Completion Date: 2024-06-01 - Lead Sponsor: Inonu University ### Study Description To compare desaturation and respiratory complications by applying oxygen therapy with double nasal cannula to patients who are planned to undergo gastrointestinal endoscopy. ### Conditions - Gastric Disease - Gastric Distress ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: TREATMENT ### Interventions - OXYGEN THERAPY ### Outcomes Primary Outcomes - Determination of the amount of oxygen to prevent the peripheral oxygen saturation of the patients from falling below 95% Secondary Outcomes ### Location - Facility: Inonu universitesi, Malatya, N/A, 44050, Turkey @@
## Towards Telemonitoring in Immune-Mediated Inflammatory Diseases: Implementation of a Mixed Attention Model (IMIDOC) - NCT ID: NCT06273306 - Study ID: HULP.PI-4519 - Status: NOT_YET_RECRUITING - Start Date: 2024-03-15 - Completion Date: 2026-12-31 - Lead Sponsor: Instituto de Investigación Hospital Universitario La Paz ### Study Description The main objective is to evaluate the implementation of a hybrid care model called the mixed attention model (MAM) in clinical practice and to evaluate whether its implementation improves clinical outcomes compared to conventional follow-up.This is a multicenter prospective observational study involving 360 patients with rheumatoid arthritis (RA) and Spondylarthritis (SpA) from five Spanish Hospitals. Patients will be followed-up by the MAM protocol, which is a care model that incorporates the use of digital tool consisting of a mobile application (App) that patients can use at home and that professionals can review asynchronously to detect incidents and to follow their patients; clinical evolution between face-to-face visits. Another group of patients, whose follow-up will be conducted in accordance with a traditional face-to-face care model, will be assessed as the control group. Sociodemographic characteristics, treatments, laboratory parameters, assessment of tender and swollen joints, visual analogue scale for pain and electronic patient reported outcome reports (ePROs) will be collected for all subjects. In the MAM group, these items will be self-assessed both by the mobile App and during face-to-face visits with rheumatologist, who will do the same for patients included in the traditional care model. Patients will be able to report any incidence related to their disease or treatment through the mobile App. ### Conditions - Telemedicine - Telehealth - eHealth - Rheumatic Diseases - Arthritis, Rheumatoid - Spondylarthritis ### Study Design - Type: INTERVENTIONAL - Allocation: NON_RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: HEALTH_SERVICES_RESEARCH ### Interventions - IMIDOC ### Outcomes Primary Outcomes - To assess the primary objective, composite endpoints that consider the viability, adherence and degree of satisfaction of the MAM are included Secondary Outcomes - To identify features associated with adherence to follow-up through the MAM. ### Location - Facility: N/A, N/A, N/A, N/A, N/A @@
## Postprocedural Contrast Mediated FFR Plus Intracoronary Infusion of Nitroglycerin in Multivessel Patients (PROMETEUS TRIAL) - NCT ID: NCT06273293 - Study ID: EPIC35-PROMETEUS - Status: NOT_YET_RECRUITING - Start Date: 2024-03-20 - Completion Date: 2026-01-20 - Lead Sponsor: Fundación EPIC ### Study Description the use of pressure wires is the standar of care to evaluate angiographically intermediate coronary lesions, however, limitations in the management of these type of lesions continue to be a challenge for the interventional cardiologist. The use of FFR has some limitations such as the use of adenosine due to its cost, adverse effects (e.g. transient atrioventricular block, angina, headache, etc.), time consuming and some relative contraindications for its use. In this sense, in recent years new rest indices (iFR, RFR, dPR) and hyperemic indices without adenosine (cFFR-NTG, Pd/Pa-NTG or cFFR) have been developed, demonstrating an improvement in terms of outcomes with its use, so they can also be used as a tool to guide us to plan our strategy. These new indices, particularly the cFFR-NTG, are simpler, at least as safe and have an excellent correlation with the FFR with adenosine in the assessment of intermediate coronary lesions.In recent years, functional assessment after intervention has also been increasingly implemented, which, like intracoronary imaging, can make us change our attitude and correlate with the prognosis. The lower implementation of this practice, especially in multivessel patients, may result from having to lose the position of the wire to check equalization, difficulty in crossing the wire, wear/breakage of the material after diagnosis (2-3 vessels), use more time and contrast, etc. These problems could be reduced, at least partially, with the use of the workhorse coronary guidewire pressure microcatheter to measure post-PCI functional assessment. Although the usefulness of post-PCI FFR has been demonstrated, there is no clearly established cut-off value (0.84-0.96) and it seems that in reality the values are a continuum of risk so that the higher the value, the better the prognosis . Furthermore, other simpler indices such as rest or hyperemic indices without adenosine have not been correlated with FFR in post-PCI.The purpose of this study is to evaluate the correlation between cFFR-NTG and other indices taking FFR as a reference in multivessel patients after undergoing intervention. Establish cut-off points and correlate it with adverse cardiovascular events (MACE) in a 1-year clinical follow-up. ### Conditions - Coronary Disease ### Study Design - Type: INTERVENTIONAL - Allocation: NA - Intervention Model: SINGLE_GROUP - Primary Purpose: DIAGNOSTIC ### Interventions - Fractional Flow Reserve ### Outcomes Primary Outcomes - Agreement between cFFR+NTG and FFR - SAFETY: MACE Secondary Outcomes - Agreement between Pd/Pa or dPR and FFR - Cut-off point for cFFR+NTG post-ICP - Evaluate the change in strategy that the measurement of FFR values ≤0.90 post-PCI - Cardiac death - Cardiovascular death - Acute myocardial infarction of the lesion treated/functionally evaluated - Acute myocardial infarction from any lesion - Need for revascularization of the lesion treated/functionally evaluated - Need for revascularization of any lesion ### Location - Facility: N/A, N/A, N/A, N/A, N/A @@
## Renal-based Optimization of QUADruple Therapy in Patients With Heart Failure With Reduced Ejection Fraction. - NCT ID: NCT06273280 - Study ID: Z-2023025 - Status: ACTIVE_NOT_RECRUITING - Start Date: 2024-02-14 - Completion Date: 2026-03 - Lead Sponsor: Ziekenhuis Oost-Limburg ### Study Description The goal of this clinical trial is to evaluate guideline-directed medical therapy (GDMT) up-titration in patients with heart failure with reduced ejection fraction.The main question it aims to answer is the improvement in prescription rate and dose uptitration of quadruple GDMT in patients with HFrEF, assessed by a weighed composite score.Participants will be randomized towards control (standard of care, SOC) or intervention group.Researchers will compare SOC with protocol-based up-titration to see if the protocolized optimization improves prescription rate of GDMT. ### Conditions - Heart Failure - Heart Failure With Reduced Ejection Fraction ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: TREATMENT ### Interventions - SOC - Protocolized up-titration ### Outcomes Primary Outcomes - Weighed composite score of maximal guideline-directed medical therapy Secondary Outcomes - All-cause mortality and heart failure hospitalizations - Change in NTproBNP - Change in renal function ### Location - Facility: Ziekenhuis Oost-Limburg AV, Genk, Limburg, 3600, Belgium @@
## Initiating Pediatric Palliative Care in ACT Group 4 - NCT ID: NCT06273267 - Study ID: APHP231232 - Status: NOT_YET_RECRUITING - Start Date: 2024-02 - Completion Date: 2024-08 - Lead Sponsor: Assistance Publique - Hôpitaux de Paris ### Study Description Due to the wide range of diagnoses encountered in pediatric palliative care, the Association for Children's Palliative Care (ACT) and the Royal College of Paediatrics and Child Health (RCPCH) have developed a classification of life-limiting illnesses, based on support models.This classification includes four groups. ACT 4 category is made up of children with a serious incurable non-progressive neurological disease (for example: anoxic ischemia, cerebral palsy, traumatic or infectious brain injuries).Although data relating to specific ACT groups are scarce, experience from clinical practice suggests that the needs and use of Pediatric palliative care resources are different across the four categories.The specific history of ACT-4 patients suggests that pediatric palliative care may be required early on in the history of the disease but effective intervention varies greatly from one patient to another. Tthis study aims to better understand the optimal timing for introducing a PPC team into the care pathway for these children. The study also aims to describe the care trajectory over the first year of PPC intervention. ### Conditions - Encephalopathy - Cerebral Palsy - Cerebral Malformation - Traumatic Head Injury ### Study Design - Type: OBSERVATIONAL - Allocation: N/A - Intervention Model: N/A - Primary Purpose: N/A ### Interventions - Collection of data from the patient's medical file ### Outcomes Primary Outcomes - Description of first pediatric palliative care intervention Secondary Outcomes - Description of the patient situation - Timing of pediatric palliative care intervention ### Location - Facility: Hôpital Necker-Enfants Malades, Paris, N/A, 75015, France @@
## A Bioequivalence Study of Sacubitril/Valsartan Film-coated Tablets Under Fasting Conditions - NCT ID: NCT06273254 - Study ID: SCVL-TFZ-1009 - Status: NOT_YET_RECRUITING - Start Date: 2024-04 - Completion Date: 2024-09 - Lead Sponsor: Viatris Inc. ### Study Description Primary objective is to is to evaluate the bioequivalence of two formulations ### Conditions - Bioequivalence Study ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: CROSSOVER - Primary Purpose: HEALTH_SERVICES_RESEARCH ### Interventions - Sacubitril and Valsartan Tablets 49mg/51mg - Entresto® (Sacubitril and Valsartan Tablets 49mg/51mg) ### Outcomes Primary Outcomes - Cmax - AUC Secondary Outcomes - tmax - t1/2 - λz - AUC0-t/AUC0-∞ - residual area ### Location - Facility: Medica Innova Co Ltd, Bangkok, N/A, 10310, Thailand @@
## Impact of Food Intake on Berberine Kinetics - NCT ID: NCT06273241 - Study ID: IPHA-2024-009 - Status: NOT_YET_RECRUITING - Start Date: 2024-03-04 - Completion Date: 2024-09-30 - Lead Sponsor: University Medicine Greifswald ### Study Description The influence of genetic variants of the CYP2D6 enzyme and the Organic Cation Transporter 1 on the kinetics of berberine (BERKI-1) has recently been studied. A significant sex difference was observed. These results lead to the BERKI-2 study, investigating the influence of the female hormonal cycle on berberine kinetics. In this study, women took a single berberine dose once in the first and once in the second half of their menstrual cycle, men served as a control group ingesting a single berberine dose. Contrary to our expectations, the previously observed sex difference could not be confirmed.In both BERKI-1 and 2 studies, the plasma concentration curve exhibited two peaks. The first after about 2-3 h, and the second after approximately 5 h of berberine intake. All participants took a single dose of Berberine under fasting conditions in the morning and 4 h after berberine intake, they ate a meal. Shortly after meal intake, the plasma concentration curve peaked again BERKI-3 will investigate the impact of food intake on berberine bioavailability and the kinetic properties. Given the suspected influence of berberine on glycemic control, we will also measure insulin and glucose after the meal at noon.As in BERKI-1 and 2, time dependent blood and urine samples will be collected after a single berberine dose. One By measuring berberine metabolites by Liquid Chromatography and Mass-spec One dose will be taken in the fasted condition and the other two after a light or high caloric meal, respectively.24 heathy volunteers with an equal ratio of man and women will be enrolled. ### Conditions - Pharmacokinetic Study in Healthy Volunteers ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: CROSSOVER - Primary Purpose: TREATMENT ### Interventions - food intake ### Outcomes Primary Outcomes - Berberine plasma concentration fasted vs fed Secondary Outcomes - Berberine plasma concentrations light vs heavy meal ### Location - Facility: University Medicine Greifswald, Institute of Pharmacology, Greifswald, Mecklenburg-Vorpommern, 17487, Germany @@
## Parenting Young Children in Pediatrics - NCT ID: NCT06273228 - Study ID: STUDY00000788 - Status: RECRUITING - Start Date: 2023-09-27 - Completion Date: 2024-10-01 - Lead Sponsor: University of Oregon ### Study Description Research suggests that one in eight children in the U.S. currently lives with a parent with a substance use disorder. Parents who misuse substances are at increased risk of using harsh and other negative parenting practices with their young children, who are more likely to face challenges with emotional and behavioral regulation and subsequently misuse substances themselves. There is thus an urgent need for evidence-based interventions to promote positive parenting skills in parents who misuse substances. Interventions must be convenient, non-stigmatizing, and accessible to parents with problematic substance use, who frequently face barriers to engaging with healthcare systems. Pediatric primary care is an ideal setting to offer a brief intervention for maladaptive parenting behaviors associated with parental substance use, as the vast majority of children under 5 access pediatric primary care at least annually and parents generally report high levels of trust in their child's pediatrician.The Family Check-Up (FCU) Online app, which was created specifically to promote positive parenting skills in parents with past or current substance misuse, is ideal for delivery to parents with pre-school age children in a pediatric primary care setting as it is brief, convenient, and delivered in a self-directed format that parents favor. The main objective of this pilot study is to test the feasibility and acceptability of the FCU-Online, a brief, app-based parenting intervention, for parents reporting lifetime problematic substance use in a pediatric primary care setting.In this study, investigators will partner with pediatric primary care providers to recruit parent participants, then evaluate feasibility and acceptability by systematically assessing parents' engagement with the FCU Online app. Engagement data from the app includes time spent in app overall and in each module, activities completed, and which modules were accessed. Investigators will also administer a consumer satisfaction survey, which will ask parents to report on their perceptions of the app (e.g., helpfulness, useability, and effects on parenting). To assess engagement in telehealth coaching sessions, investigators will use the following variables: number of telehealth sessions completed, length of session, content of sessions, and coaches' ratings of participant engagement in the session and barriers to using the app. Coaches will also rate participant engagement on a 3-point scale from "low" to "high." Lastly, investigators will conduct qualitative interviews with a sub-sample of participants to solicit additional feedback on the acceptability of the FCU Online, focusing particularly on the perception of acceptability within an integrated primary care context and stigma associated with endorsing substance use in this setting.A second aim of this study is to assess pediatric healthcare providers' perceptions and attitudes regarding the fit of the FCU Online with their practice settings as well as potential barriers to implementation. Through semi-structured focus groups and qualitative interviews with pediatric healthcare providers, investigators will assess provider- and practice-level factors that may facilitate or impede the implementation of the FCU Online in pediatric primary care settings. ### Conditions - Parenting - Parent-Child Relations - Substance Use Disorders - Stress - Depression - Anxiety - Parenting Self-efficacy - Pediatrics ### Study Design - Type: INTERVENTIONAL - Allocation: NA - Intervention Model: SINGLE_GROUP - Primary Purpose: HEALTH_SERVICES_RESEARCH ### Interventions - Family Check-Up Online ### Outcomes Primary Outcomes - change from baseline in parenting skills - change from baseline in parenting efficacy - change from baseline in parent executive functioning - change from baseline in child social-emotional behavior - change from baseline in family conflict - change from baseline in parental substance use - change from baseline in parental depression - change from baseline in parental anxiety - change from baseline in parental stress - change from baseline in parental impact of negative life events Secondary Outcomes ### Location - Facility: Prevention Science Institute, University of Oregon, Eugene, Oregon, 97403, United States @@
## Evaluation of the Pharmacokinetics of Microdose Midazolam, Dabigatran, Pitavastatin, Atorvastatin and Rosuvastatin in Diabetic Patients - NCT ID: NCT06273215 - Study ID: DCTC-IIR202217 - Status: RECRUITING - Start Date: 2023-03-05 - Completion Date: 2025-12-31 - Lead Sponsor: Peking University Third Hospital ### Study Description 1.To explore the functional changes of P-gp, CYP3A4, OATP1B and BCRP in Diabetic patients (including the non-obese T2DM, obese T2DM, elderly T2DM, and T1DM). ### Conditions - Diabetes ### Study Design - Type: INTERVENTIONAL - Allocation: NON_RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: BASIC_SCIENCE ### Interventions - The combinations of 10 µg midazolam, 375 µg dabigatran etexilate, 10 µg pitavastatin, 50 µg rosuvastatin, and 100 µg atorvastatin were administered to diabetic patients on an empty stomach. ### Outcomes Primary Outcomes - Pharmacokinetics of study drug Secondary Outcomes - Concentration of endogenous markers of CYP3A and OATP - Genotype of OATP and BCRP ### Location - Facility: Peking University Third Hospital, Beijing, Beijing, 100191, China @@
## Ultrasound Monitoring of Muscle Thickness in Premature Patients - NCT ID: NCT06273202 - Study ID: 6257 - Status: NOT_YET_RECRUITING - Start Date: 2024-02 - Completion Date: 2025-01 - Lead Sponsor: Fondazione Policlinico Universitario Agostino Gemelli IRCCS ### Study Description The goal of this interventional study is to investigate through musculoskeletal ultrasonography how the thickness and muscle trophism in infants aged 28 to 35 weeks undergoing infant massage compared with a group of infants with similar characteristics not subjected to treatment.The main questions it aims to answer are:* To assess by musculoskeletal ultrasound the impact of infant massage on muscle thickness muscle. Specifically, changes in muscle thickness and trophism of the quadriceps femoris.* Potential effects on spontaneous motility and stature-ponderal growth of infants. In addition, the discomfort and behavioral status of the infant before and after massage will be investigated infant.Patients included in the study will be randomized according to a random sequence with a 1:1 ratio into theexperimental group (GS) or the control group (GC). Patients in the GS will perform therapy with infant massage in addition to the usual rehabilitation therapies as specified by the program individual habilitative, to which patients in the control group will be subjected exclusively control.Infant massage will be performed three times a day (10 minutes per session) until they reach the 35th week of post-conceptional age (35+6) by the two departmental physical therapists (ADP and ADV).Ultrasound will be performed at the time of randomization (T0) and then 1 time per week until the 35th week by two operators (SN and VA); at the same time, the circumference of the thigh subjected to ultrasound examination. A 12Hz linear ultrasound probe will be used, applied perpendicular to the skin. The infant will be placed supine, with the thigh extended, in a neutral position; excessive compression will be avoided by applying a generous amount of gel. At the midpoint of the thigh, the thickness of the quadriceps muscle will be calculated by measuring the distance between the cortex of the femur and the most superficial muscle fascia. The average of at least 2 measurements will be then calculated. The Heckmatt scale will be used to assess the echogenicity of muscle and bone. In addition, at time T0 and at week 35 the following data will be collected: weeks gestational age, weight at birth and at the end of treatment, rectal temperature, blood gas parameters if present. ### Conditions - Prematurity ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: TREATMENT ### Interventions - Infant Massage ### Outcomes Primary Outcomes - Quadriceps femuri thickness - Quadriceps femuri trophism Secondary Outcomes - To valuate the discomfort/behavioral status of the infant. - To valuate the potential effects on spontaneous motility. - To evaluate differences in ponderal growth. ### Location - Facility: N/A, N/A, N/A, N/A, N/A @@
## Ultrasonic Bone Scalpel in BSSO - NCT ID: NCT06273189 - Study ID: 2017/558 - Status: COMPLETED - Start Date: 2018-12-15 - Completion Date: 2021-12-15 - Lead Sponsor: TC Erciyes University ### Study Description The conventional saw compared with the piezo surgery in BSSO to evaluate cutting time, surgery duration, amount of bleeding. The purpose of this study was to answers following clinical questions: Is ultrasonic bonescalpel effective osteotomy like conventional bur in BSSO? and 2) Does it reduce operative parameter like bleeding, duration, lingual split pattern? 3) Does it reduce postoperative morbidity after BSSO. ### Conditions - Maxillofacial Abnormalities ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: TREATMENT ### Interventions - Conventional - Bone Scalpel ### Outcomes Primary Outcomes - Cutting Time - neurosensory disturbance Secondary Outcomes - The length of the procedure - The splitting time - The pattern of the split - postoperative edema ### Location - Facility: Selin Çelebi, Kayseri, Melikgazi, 38039, Turkey @@
## The RECMAP-study: Resection With or Without Intraoperative Mapping for Recurrent Glioblastoma - NCT ID: NCT06273176 - Study ID: MEC-2020-0812 - Status: RECRUITING - Start Date: 2023-01-01 - Completion Date: 2028-01-01 - Lead Sponsor: Erasmus Medical Center ### Study Description Resection of glioblastoma in or near functional brain tissue is challenging because of the proximity of important structures to the tumor site. To pursue maximal resection in a safe manner, mapping methods have been developed to test for motor and language function during the operation. Previous evidence suggests that these techniques are beneficial for maximum safe resection in newly diagnosed grade 2-4 astrocytoma, grade 2-3 oligodendroglioma, and recently, glioblastoma. However, their effects in recurrent glioblastoma are still poorly understood. The aim of this study, therefore, is to compare the effects of awake mapping and asleep mapping with no mapping in resections for recurrent glioblastoma.This study is an international, multicenter, prospective 3-arm cohort study of observational nature. Recurrent glioblastoma patients will be operated with mapping or no mapping techniques with a 1:1 ratio. Primary endpoints are: 1) proportion of patients with NIHSS (National Institute of Health Stroke Scale) deterioration at 6 weeks, 3 months, and 6 months after surgery and 2) residual tumor volume of the contrast-enhancing and non-contrast-enhancing part as assessed by a neuroradiologist on postoperative contrast MRI scans. Secondary endpoints are: 1) overall survival (OS), 2) progression-free survival (PFS), 4) health-related quality of life (HRQoL) at 6 weeks, 3 months, and 6 months after surgery, and 4) frequency and severity of Serious Adverse Events (SAEs) in each arm. Estimated total duration of the study is 5 years. Patient inclusion is 4 years, follow-up is 1 year.The study will be carried out by the centers affiliated with the European and North American Consortium and Registry for Intraoperative Mapping (ENCRAM). ### Conditions - Glioblastoma, IDH-wildtype - Glioblastoma - Glioblastoma Multiforme of Brain - Astrocytoma, Malignant - Brain Neoplasms - Brain Neoplasms, Adult, Malignant - Brain Neoplasms, Adult - Recurrent Adult Brain Tumor - Recurrent Glioblastoma ### Study Design - Type: OBSERVATIONAL - Allocation: N/A - Intervention Model: N/A - Primary Purpose: N/A ### Interventions - Awake mapping under local anesthesia - Asleep mapping under general anesthesia - Resection under general anesthesia without mapping ### Outcomes Primary Outcomes - Residual volume - Neurological morbidity at 6 weeks Secondary Outcomes - Overall survival - Progression-free survival - Onco-functional outcome (OFO) - Serious Adverse Events - Neurological morbidity at 3 months - Neurological morbidity at 6 months - Overall functioning at 6 weeks - Overall functioning at 3 months - Overall functioning at 6 months - Quality of life at 6 weeks (EORTC QLQ C30) - Quality of life at 3 months (EORTC QLQ C30) - Quality of life at 6 months (EORTC QLQ C30) - Quality of life at 6 weeks (EORTC QLQ BN20) - Quality of life at 3 months (EORTC QLQ BN20) - Quality of life at 6 months (EORTC QLQ BN20) - Quality of life at 6 weeks (EQ-5D) - Quality of life at 3 months (EQ-5D) - Quality of life at 6 months (EQ-5D) ### Location - Facility: University of California, San Francisco, San Francisco, California, 94143, United States @@
## Identifying Strategies to Curtail Weight Regain After GLP-1 Receptor Agonist Treatment Cessation - NCT ID: NCT06273163 - Study ID: STU-2023-1168 - Status: RECRUITING - Start Date: 2024-03-05 - Completion Date: 2024-12-31 - Lead Sponsor: University of Texas Southwestern Medical Center ### Study Description Longitudinal studies show there is a steep increase in weight regain in the first 3-4 months after stopping GLP-1 receptor agonist medications (GLP-1s) and most patients regain most of their weight within a year. Insurers now question the utility of GLP-1s for weight loss as they are hesitant to cover these costs long-term (\~$833 per person per month). Some patients would also prefer not to take these medications in perpetuity and are likely to struggle with lifelong adherence. These challenges present an opportunity to test alternative interventions, such as meal replacements and behavioral treatments, to support weight maintenance after successful weight loss with GLP-1s. This regimen would allow patients to benefit from significant weight loss in the first year of taking GLP-1s and use more cost effective and sustainable strategies for long-term maintenance. ### Conditions - Obesity ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: SUPPORTIVE_CARE ### Interventions - Medically tailored meals - Noom® - Usual care ### Outcomes Primary Outcomes - Intervention Adherence - Intervention Satisfaction Secondary Outcomes - Percent weight loss maintained - Diet quality ### Location - Facility: UT Southwestern Medical Center, Dallas, Texas, 75390, United States @@
## Dentatorubral-pallidoluysian Atrophy Natural History and Biomarkers Study - NCT ID: NCT06273150 - Study ID: 142048 - Status: RECRUITING - Start Date: 2022-05-01 - Completion Date: 2026-04 - Lead Sponsor: University College, London ### Study Description DRPLA Natural History and Biomarkers Study (DRPLA NHBS) is a prospective observational study that will lay the foundation for clinical trials in DRPLA. The aims of this project are:* To characterize the natural history of DRPLA in both juvenile- and adult-onset patients and study different modalities of biomarkers in this condition.* To identify genetic factors and biomarkers that could predict disease progression.* To provide a platform to support the design and conduct of clinical trials.This study has three arms:1. Adult Participants: this arm of the study will require participants to be 16 years old or over to participate.2. Pediatric Participants: this arm of the study will require participants to be under 16 years old to participate.3. Remote Participants: patients that cannot or do not wish to travel to one of the study sites can participate in this arm of the study, irrespective of their age.Participants will have an annual visit for three years (baseline visit and two follow-up visits, three visits in total). Subjects who complete the whole protocol will be assessed on two consecutive days to reduce patient burden.This project will allow for a better understanding of DRPLA and its course, and therefore allow for future clinical trials on this condition to be more precisely and effectively conducted. ### Conditions - Dentatorubral-Pallidoluysian Atrophy ### Study Design - Type: OBSERVATIONAL - Allocation: N/A - Intervention Model: N/A - Primary Purpose: N/A ### Interventions - Positive genetic test for pathological expansion in ATN1 ### Outcomes Primary Outcomes - Scale for the assessment and rating of ataxia (SARA) - Brain atrophy - Neurofilament plasma concentration (NfL) Secondary Outcomes - Inventory of non-ataxia signs (INAS) - Upper limb function test AIM-S - Redenlab DRPLA specific speech battery - Clinical Assessment of Dysphagia in Neurodegeneration (CADN) - Tau plasma concentration - Glial fibrillary acidic protein (GFAP) concentration - Ubiquitin carboxyterminal hydrolase L1 (UCH-L1) concentration ### Location - Facility: NYU Grossman School of Medicine, New York, New York, 10017, United States @@
## Positive Affect Treatment for Adolescents With Early Life Adversity - NCT ID: NCT06273137 - Study ID: 2963 - Status: RECRUITING - Start Date: 2024-02-03 - Completion Date: 2026-10-16 - Lead Sponsor: University of California, Irvine ### Study Description Youth exposed to early life adversity (ELA) are known to be at greater risk for depression and suicidality and account for almost half of the youth suffering from psychiatric diseases today. Youth exposed to ELA consistently report symptoms of anhedonia as well as dysregulated positive affect. The present project will test the efficacy of PAT in a sample of ELA-exposed adolescents in order to determine whether PAT increases positive affect, and subsequently symptoms of depression. For this pilot, the investigators will recruit 22 adolescents exposed to two or more childhood adversities (ACEs) who do not currently have major depressive disorder, and randomize them (1:1) to either participate in PAT or a waitlist control condition. At study enrollment, then 4-, 8, and 12-months thereafter the investigators will measure positive affect and depressive symptoms (including anhedonia). The results of this study will be used to inform whether PAT has the potential to prevent major depressive episodes among adversity-exposed youth. ### Conditions - Depression ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: CROSSOVER - Primary Purpose: PREVENTION ### Interventions - Positive affect treatment ### Outcomes Primary Outcomes - Positive affect Secondary Outcomes - depressive symptoms - total - depressive symptoms - anhedonia subscale - Systemic inflammation - C-reactive protein (CRP) - Inflammatory gene expression ### Location - Facility: University of California Irvine, Irvine, California, 92617, United States @@
## Investigational Extended Wear Insulin Infusion Set in People With Type 1 Diabetes - NCT ID: NCT06273124 - Study ID: 150-1261-00 - Status: RECRUITING - Start Date: 2024-03-07 - Completion Date: 2025-01-15 - Lead Sponsor: Tandem Diabetes Care, Inc. ### Study Description The purpose of this study is to collect clinical data to support a 7-day wear of the Extended Wear Infusion Set (EWIS).Participants will be asked to:1. Wear the EWIS for up to 7 consecutive days for 12 consecutive wear periods2. Perform blood glucose and ketone measurements if continuous glucose meter is ≥250mg/dL for one hour ### Conditions - Type1diabetes ### Study Design - Type: INTERVENTIONAL - Allocation: NA - Intervention Model: SINGLE_GROUP - Primary Purpose: TREATMENT ### Interventions - SteadiSet Extended Wear Infusion Set ### Outcomes Primary Outcomes - Primary Outcome Measure - Primary Outcome Secondary Outcomes ### Location - Facility: Hoag Memorial Hospital Presbyterian, Newport Beach, California, 92663, United States @@
## Topical Simvastatin for Treating Infantile Hemangioma - NCT ID: NCT06273111 - Study ID: 73840 - Status: NOT_YET_RECRUITING - Start Date: 2024-04-01 - Completion Date: 2025-12-31 - Lead Sponsor: Joyce Teng ### Study Description This is a 24-week, open-label pilot study to evaluate the safety and preliminary efficacy of 5% simvastatin ointment in treating 12 children with superficial IH.The primary objective:To evaluate the safety and tolerability of topical treatment with 5% simvastatin ointment for superficial IH over 24 weeks.The secondary objective:1.1 To evaluate the efficacy of 5% simvastatin ointment when topical treatment is administered twice daily for 24 weeks. Evaluation is performed at each clinic visit via investigator global assessment (IGA) based on standardized 3D digital photography and hemangioma activity score (HAS).1.2 To evaluate the impact of 5% simvastatin ointment on quality of life using the IH-QoL questionnaire. ### Conditions - Hemangioma Skin ### Study Design - Type: INTERVENTIONAL - Allocation: NA - Intervention Model: SINGLE_GROUP - Primary Purpose: TREATMENT ### Interventions - 5% simvastatin ointment ### Outcomes Primary Outcomes - Number of Participants with Treatment-Related Adverse Events Secondary Outcomes - Percentage of participants achieved a 50% HAS reduction at week 12 compared to baseline - Percentage of participants achieved a 75% HAS reduction from baseline by the end of the study (week 24) compared to baseline. - Percentage of targeted hemangiomas with complete or nearly complete resolution (IGA 0 or 1), defined as a minimal degree of telangiectasia, skin thickening, and no definitive palpable cutaneous texture changes. - Percentage of targeted hemangiomas that are stabilized (no noticeable change to baseline) or continue to progress. - Percentage of participants with a significant improvement in quality-of-life, defined as > 50% reduction in the IH-QoL questionnaire score from baseline to week 24. ### Location - Facility: Stanford University, Palo Alto, California, 94304, United States @@
## School-Based Bladder Health Intervention - NCT ID: NCT06273098 - Study ID: 73162 - Status: WITHDRAWN - Start Date: 2028-01-01 - Completion Date: 2033-12-31 - Lead Sponsor: Stanford University ### Study Description The aim of this study is to promote healthy bladder behaviors among school children. We hypothesize that a combination of bladder health education and awareness events, additional resources such as a water station to support healthy bladder behaviors, and tailored changes to classroom bathroom policies can promote healthy bladder behaviors among school children. ### Conditions - Urinary Dysfunction - Lower Urinary Tract Symptoms - Urinary Tract Infections - Urinary Tract Infections in Children ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: HEALTH_SERVICES_RESEARCH ### Interventions - Bladder Health Education ### Outcomes Primary Outcomes - Bathroom use - Symptom score - Urine volume Secondary Outcomes ### Location - Facility: Stanford Hospital and Clinics, Palo Alto, California, 94304, United States @@
## Intensive Education Versus Usual Education of Patients for Improving Guideline Directed Medical Therapy (GDMT) Prescription in Heart Failure With Reduced Ejection Fraction - NCT ID: NCT06273085 - Study ID: MOD00016877 - Status: RECRUITING - Start Date: 2024-02-01 - Completion Date: 2025-02 - Lead Sponsor: Medstar Health Baltimore ### Study Description The goal of this randomized clinical trial is to test the effect of patient education on extent of use of guideline directed medical treatment (GDMT) of heart failure with reduced ejection fraction. The main question that our study aims to answer is if patient education can improve the adherence to GDMT in heart failure with reduced ejection fraction. Participants will receive educations about GDMT benefits in 1,3 and 5 months after discharge from hospital. ### Conditions - Heart Failure - Patient Acceptance of Health Care ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: TREATMENT ### Interventions - Patient education ### Outcomes Primary Outcomes - Change in GDMT score Secondary Outcomes - Heart Failure hospitalization - cardiovascular death/Left Ventricular Assist Device implantation/Cardiac Transplant - Number of GDMT classes of medications in use ### Location - Facility: Medstar Union Memorial Hospital, Baltimore, Maryland, 21218, United States @@
## Metformin IN Asthma for Overweight and Obese Individuals (MINA) - NCT ID: NCT06273072 - Study ID: IRB00409080 - Status: NOT_YET_RECRUITING - Start Date: 2024-05-01 - Completion Date: 2028-12-31 - Lead Sponsor: Johns Hopkins University ### Study Description This is a randomized clinical trial of metformin among overweight or obese adults with not well-controlled asthma despite maintenance inhaler therapy. ### Conditions - Asthma - Asthma Chronic - Overweight and Obesity ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: TREATMENT ### Interventions - Metformin hydrochloride extended-release tablets - Visually identical placebo Metformin hydrochloride extended-release tablets ### Outcomes Primary Outcomes - Number of completed telemedicine visits - Adherence to study drug - Retention rate Secondary Outcomes - Asthma control as assessed by the Asthma Control Test (ACT) score - Change in Asthma exacerbations rate - Pre-bronchodilator lung function - Fractional exhaled nitric oxide (FeNO) - Airways hyperresponsiveness ### Location - Facility: N/A, N/A, N/A, N/A, N/A @@
## Genomic Study of Young-Onset Diabetes Mellitus - NCT ID: NCT06273059 - Study ID: 22-07-0717 - Status: RECRUITING - Start Date: 2022-09-12 - Completion Date: 2024-12-12 - Lead Sponsor: Indonesia University ### Study Description Diabetes Mellitus (DM) has been a major contributor to health burden in Indonesia and currently its burden still continues to rise. This is a result of increasing DM prevalence in the country as well as high rates of chronic complications from DM. Findings in Indonesia show that there is a high proportion of young people with diabetes, and also a high risk of therapeutic failure and complications from DM occurring in the younger population.Young-onset DM has a wide clinical spectrum, including autoimmune DM, polygenic DM, and monogenic DM such as Mature Onset Diabetes of the Young (MODY). Identification and proper diagnosis of young-onset DM spectrum is crucial to treatment outcomes, as certain spectrums, such as some subtypes of MODY, may benefit from cost-efficient alternatives with better outcomes.However, proper diagnosis of young-onset DM in Indonesia is still a great challenge, as currently some examinations, including genetic testing, has not yet been feasibly done in the country. With current advances in genomics, genetic testing may prove to be fundamental in providing optimal and personalized treatment and care for DM patients.This study is a pilot project aimed to initiate genomic research in young-onset DM patients in Indonesia. In the short term, this study aims to identify genetic variants that may be able to increase diagnostic accuracy of the young-onset DM spectrum. In the long term, this study aims to identify new genetic variants of young-onset DM. The study also aims to identify genetic variants associated with risks of chronic complications. ### Conditions - Genomic - Diabetes Mellitus - MODY ### Study Design - Type: OBSERVATIONAL - Allocation: N/A - Intervention Model: N/A - Primary Purpose: N/A ### Interventions ### Outcomes Primary Outcomes - The overall objective of this study is to identify and describe genetic variation of young-onset DM in Indonesia. Secondary Outcomes - To describe the proportion of MODY in young-onset DM - To describe genetic variation of MODY in Indonesia. - To describe genetic variation in young-onset DM with diabetic complications in various systems: ### Location - Facility: Cipto Mangunkusumo Hospital, Jakarta Pusat, DKI Jakarta, 10430, Indonesia @@
## Treatment of Fecal Incontinence and Functional Defecation Disorders Using Non-instrumental Biofeedback - NCT ID: NCT06273046 - Study ID: PR(AG)614/2023 - Status: RECRUITING - Start Date: 2024-04-19 - Completion Date: 2025-12-31 - Lead Sponsor: Hospital Universitari Vall d'Hebron Research Institute ### Study Description Background. Rehabilitation and re-education using instrumental anorectal biofeedback are the main treatment of anorectal functional disorders producing incontinence and outlet obstructed defecation. These treatments imply intubation of patient and several sessions of treatment leading to high consumption of resources and costs.Hypothesis. A cognitive intervention based on original audiovisual programs developed specifically for the management of anorectal functional disorders is effective in correcting anorectal function disorders that cause fecal incontinence and evacuation disorders.Aim. To prove in two different protocols (fecal incontinence and dyssinergic defecation) the efficacy of specifically developed non-instrumental biofeedback techniques.Selection criteria. Patients with fecal incontinence and altered sphincter function and patients with outlet obstructed evacuation referred for biofeedback treatment.Intervention. In separate studies (incontinence and dyssynergic defecation) patients will be randomized into biofeedback and placebo groups. One session of either biofeedback or placebo intervention will be performed at the beginning of the intervention period and patients will be instructed to performed the assigned daily treatment at home. A visit for outcome assessment will be performed at 3 months in incontinence study and at 4 weeks in the dyssinergic defecation study. In addition, in the incontinence study a phone call will be performed after 6 months of the beginning of the study to evaluate treatment outcome.Biofeedback: patients will be taught to control anal and abdominal muscular activity by providing instructions using original video supports. Patients will be instructed to perform the same exercises daily at home in scheduled times.Placebo: a pill of placebo containing 0.3 g glucose will be administered every day at home. ### Conditions - Fecal Incontinence - Outlet Dysfunction Constipation ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: TREATMENT ### Interventions - Biofeedback - Placebo ### Outcomes Primary Outcomes - Fecal incontinence study: Number of anal leaks - Dyssinergic defecation study: Number of bowel movements Secondary Outcomes - Incontinence study: Wexner scale - Incontinence study: Quality of life - Incontinence study: anxiety and depression - Incontinence study: Anal sphincter function - Dyssinergic defecation study: sensation of outlet obstructed evacuation - Dyssinergic defecation study: Wexner scale - Dyssinergic defecation study: Quality of life - Dyssinergic defecation study: anxiety and depression - Dyssinergic defecation study: defecatory maneuvers ### Location - Facility: Hospital Vall d'Hebron, Barcelona, N/A, N/A, Spain @@