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<|newrecord|> nctId: NCT06274346 id: ahmedU briefTitle: Effect of Retro Walking Versus Isometric Multi-angular Exercises on Pain and Functional Performance in Knee Osteoarthritis in Geriatric Population overallStatus: COMPLETED date: 2023-06-01 date: 2023-11-10 date: 2023-11-30 date: 2024-02-23 date: 2024-02-23 name: Delta University for Science and Technology class: OTHER briefSummary: Osteoarthritis is a leading musculoskeletal cause of disability in elderly persons all over the world and a major cause of physical limitations and reduced quality of life (1). Its onset is around 40 years of age and it is estimated that over 80% of people over 55 have evidence of radiographic changes in the knee due to osteoarthritis. It has been estimated that the incidence has increased by the increase in life expectancy and it has been identified as a frequent cause for health services demand in patients over 65(2).
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The common clinical manifestations of knee OA include pain, stiffness, joint enlargement, crepitus, muscle weakness, deformity, impaired proprioception, reduced joint motion, and disability(3).
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Patients with knee Osteoarthritis seems to develop their own gait pattern and try to unload the affected structures during gait. More over patients with less severe knee osteoarthritis develop a gait pattern that differs from patients with severe osteoarthritis and control group of patients (4).
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Isometric exercises are types of strength training in which the joint angle and muscle length do not change during contraction, and therefore this approach can be advantageous in the early stages of knee rehabilitation in cases where the range of motion is restricted due to pain (13). No physical work is performed during isometric exercise. Intensity and duration combination reflects the energy consumption of an isometric contraction (14). In addition, muscle strength increases in isometric exercise are specific to the angle applied. It was also concluded that isometric exercise performed at different angles should be especially considered as an alternative strength training since it induces the most noticeable and fastest increase in muscle moment (15). A study was conducted to investigate the effects of isometric quadriceps exercise on muscle strength, pain, and function in knee osteoarthritis, it was concluded that isometric quadriceps exercise program showed beneficial effects on quadriceps muscle strength, pain, and functional disability in patients with osteoarthritis of the knee (16).
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Another study was conducted to assess the effectiveness of Isometric exercise and counseling on level of pain among patients with Knee osteoarthritis, the authors concluded that Isometric exercise and counseling program has significantly reduced pain, stiffness and improved physical function and the authors recommended that Isometric exercise and counselling should be adopted as a routine care in the hospitals treating patients with knee osteoarthritis (17) Thus, we hypothesized that a less intensive walking program such as retro walking program could provide an additional benefit more than those experienced by forward walking program in the previous studies. Therefore, the primary aim of the present study was to compare the effect of retro walking versus isometric multiangular exercises group on knee pain and function in geriatric people.
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Materials and Methods
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This randomized controlled experimental trial was carried out at the outpatient clinic of faculty of physical therapy, Delta University for science and technology from June 2023 to November 2023. The aims of the study and the study protocol were explained for each patient before participation in the study. All patients signed an approved informed consent form for participation in this study. Before starting the treatment program, a complete history and physical examination will be taken for all patients.
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Subjects:
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Sixty male and female geriatric patients had chronic knee osteoarthritis were chosen the outpatient clinic of faculty of physical therapy, Delta University for science and technology. In each case, the diagnosis of knee OA was based on the criteria specified by the American College of Rheumatology.
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We recorded the height, weight, and medical history, and lower extremity dominance, level of education, occupation and duration of complaints of each patient. All were evaluated at the beginning of the treatment (week 0), at the endpoint of the treatment (week 4) conditions: Knee Osteoarthritis studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL interventionModelDescription: Patients were randomly assigned into two groups through computer software. We put sixty patients on the software program and the program assigned them randomly. s exercise, straight leg raise, prone knee bending, side lying hip abduction, prone hip extension with 5 seconds hold and a rest interval of 2 seconds for 10 repetitions for each exercise for a period of 4 weeks, 3 days per week was given. Second group was treated by retrowalking exercises in addition to physical therapy interventions including short wave diathermy and strengthening exercise such as static quadriceps exercise, dynamic quadriceps exercise, straight leg raise, prone knee bending, side lying hip abduction, prone hip extension with 5 seconds hold and a rest interval of 2 seconds for 10 repetitions for each exercise for a period of 4 weeks, 3 days per week was given., which were given 3 times/week for 4 consecutive weeks. primaryPurpose: TREATMENT masking: SINGLE maskingDescription: Sixty male and female geriatric patients had chronic knee osteoarthritis were chosen the outpatient clinic of faculty of physical therapy, Delta University for science and technology. education, occupation and duration of complaints of each patient. All were evaluated at the beginning of the treatment (week 0), at the endpoint of the treatment (week 4). whoMasked: PARTICIPANT count: 60 type: ACTUAL name: Multiangular Isometric exercise measure: Pain intensity measure: Functional assessment: sex: ALL minimumAge: 60 Years maximumAge: 90 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Delta University For Science and Technology city: Gamasa state: Almansourah zip: 38733 country: Egypt lat: 31.44112 lon: 31.53675 hasResults: False
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<|newrecord|> nctId: NCT06274333 id: RC.18.1.2024 briefTitle: Adding Dexmedetomidine or Tramadol to Paracetamol- An Effort to Attenuate Catheter Related Bladder Discomfort overallStatus: RECRUITING date: 2024-02-28 date: 2024-05-30 date: 2024-05-30 date: 2024-02-23 date: 2024-03-15 name: Al-Azhar University class: OTHER name: Benha University briefSummary: 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) studyType: INTERVENTIONAL phases: PHASE3 allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: TRIPLE whoMasked: PARTICIPANT whoMasked: INVESTIGATOR whoMasked: OUTCOMES_ASSESSOR count: 60 type: ESTIMATED name: Dexmedetomidine 0.5 mic/kg name: Tramadol 1mg/kg name: Paracetamol 10mg/kg measure: The incidence of catheter-related bladder discomfort (CRBD) measure: Postoperative pain measure: Meperidine requirement measure: Patient satisfaction measure: Surgeon satisfaction sex: MALE minimumAge: 20 Years maximumAge: 50 Years stdAges: ADULT facility: Neveen Kohaf status: RECRUITING city: Cairo zip: 11865 country: Egypt name: Neveen Kohaf, Ph.D role: CONTACT phone: +201069482380 email: [email protected] name: Hany Bauiomy, M.D role: PRINCIPAL_INVESTIGATOR name: Ahmed M. Abosakaya, M.D role: PRINCIPAL_INVESTIGATOR lat: 30.06263 lon: 31.24967 hasResults: False
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<|newrecord|> nctId: NCT06274320 id: LRP22002 LIPIKAR UREA 30% briefTitle: Effect of Lipikar Urea 30% Before Actinic Keratoses Treatment overallStatus: NOT_YET_RECRUITING date: 2024-04 date: 2024-10 date: 2024-10 date: 2024-02-23 date: 2024-02-28 name: Cosmetique Active International class: INDUSTRY briefSummary: 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 studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: SUPPORTIVE_CARE masking: TRIPLE whoMasked: CARE_PROVIDER whoMasked: INVESTIGATOR whoMasked: OUTCOMES_ASSESSOR count: 100 type: ESTIMATED name: Group A: holistic approach name: Group B: Tolak® Standard of use measure: Change in lesion response rate measure: Percentage change sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: CentroDerm GmbH city: Wuppertal country: Germany lat: 51.27027 lon: 7.16755 hasResults: False
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<|newrecord|> nctId: NCT06274307 id: IRB-21-10-4045 briefTitle: Efficacy of Transversus Abdominis Plane Block overallStatus: RECRUITING date: 2023-06-22 date: 2024-07-01 date: 2024-09-01 date: 2024-02-23 date: 2024-02-23 name: Justin Hruska class: OTHER briefSummary: 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 studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL interventionModelDescription: The treatment group (Group 1) will have a transversus abdominis plane (TAP) block performed with an insufflated abdomen in the operating room. The control group (Group 2) will receive the traditionally performed standard of care TAP block performed in the post-anesthesia care unit primaryPurpose: TREATMENT masking: DOUBLE maskingDescription: The patient will be unaware of their grouping allotment. The outcomes assessor will be unaware of the patient grouping allotment. whoMasked: PARTICIPANT whoMasked: OUTCOMES_ASSESSOR count: 120 type: ESTIMATED name: Transversus abdominis plane block measure: Time to perform TAP Block measure: TAP block attempts measure: Pain Score Visual Analog Scale (VAS) 0 Hours Post Surgery measure: Pain Score Visual Analog Scale (VAS) 1 Hours Post Surgery measure: Pain Score Visual Analog Scale (VAS) 2 Hours Post Surgery measure: Pain Score Visual Analog Scale (VAS) 4 Hours Post Surgery measure: Pain Score Visual Analog Scale (VAS) 24 Hours Post Surgery measure: Postoperative Opioid Consumption measure: Ease of performing TAP Block-anatomical plane visualization measure: Ease of performing TAP Block-performance efficacy measure: Patient satisfaction sex: FEMALE minimumAge: 18 Years maximumAge: 85 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Detroit Medical Center Detroit Receiving Hospital status: RECRUITING city: Detroit state: Michigan zip: 48201 country: United States name: George M McKelvey, PhD role: CONTACT phone: 313-598-6036 email: [email protected] name: Justin Hruska, M.D. role: PRINCIPAL_INVESTIGATOR lat: 42.33143 lon: -83.04575 facility: Detroit Medical Center, Harper University Hospital status: RECRUITING city: Detroit state: Michigan zip: 48201 country: United States name: George M McKelvey, PhD role: CONTACT phone: 313-598-6036 email: [email protected] name: Justin Hruska, MD role: PRINCIPAL_INVESTIGATOR lat: 42.33143 lon: -83.04575 hasResults: False
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<|newrecord|> nctId: NCT06274294 id: 2023/12 briefTitle: Pharmacokinetics, Efficacy and Safety of CT-P13 Subcutaneous as Induction Therapy in Patients With Active CD or UC acronym: PASSPORT overallStatus: NOT_YET_RECRUITING date: 2024-03 date: 2025-01 date: 2025-01 date: 2024-02-23 date: 2024-02-23 name: CMC Ambroise Paré class: OTHER name: Paris IBD Center name: Celltrion HealthCare France briefSummary: 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.
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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 studyType: INTERVENTIONAL phases: PHASE3 allocation: RANDOMIZED interventionModel: PARALLEL interventionModelDescription: The full sample size comprises 130 patients, with 65 patients allocated to each arm. The arms are defined as follows:
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* Experimental Arm: Patients receive CT-P13 SC at weeks 0, 1, 2, 3, 4, and 6, followed by subcutaneous administration every two weeks until week 24.
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* Control Arm: Patients receive CT-P13 IV at weeks 0 and 2, followed by subcutaneous administration every two weeks until week 24. primaryPurpose: TREATMENT masking: SINGLE whoMasked: PARTICIPANT count: 130 type: ESTIMATED name: CT-P13 measure: Ratio SC/IV measure: Ctrough at week 24 (non-inferiority) measure: AUC at week 24 measure: Clinical response at week 6 and week 24 measure: IBD disability index at week 6 measure: Fecal calprotectin at week 24 measure: Clinical remission at week 6 and week 24 measure: Presence of antibodies to infliximab at Week 6 and Week 24 measure: Concentration of C-reactive protein up to week 6 (the samples are collected at weeks 0, 6 and 24) measure: Adverse events, including injection site reactions and hypersensitivity reactions measure: TSQM collected at Week 6 and Week 24 sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT hasResults: False
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<|newrecord|> nctId: NCT06274281 id: TOMs_FMD briefTitle: Digital Telerehabilitation in Functional Motor Disorders overallStatus: NOT_YET_RECRUITING date: 2024-03-01 date: 2025-02-01 date: 2026-02-01 date: 2024-02-23 date: 2024-02-23 name: Universita di Verona class: OTHER briefSummary: 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.
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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.
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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 studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL interventionModelDescription: This is an experimental single-blind randomized-controlled trial (RCT) with 2-parallel arms comparing the effects between the experimental group (EG) and control group (CG). After screening, a simple randomization list will be generated by a physician using an automated randomization system (alloca-tion ratio 1:1) to assign eligible patients to either the EG or the CG. Group allocation will be kept concealed. primaryPurpose: TREATMENT masking: SINGLE maskingDescription: The outcome assessor will be blinded to the type of intervention performed by the patient. whoMasked: OUTCOMES_ASSESSOR count: 30 type: ESTIMATED name: Digital Telerehabilitation name: Usual care measure: number of patients who accept/refuse the treatment, physiotherapy compliance and falls or event near falling occurred during rehabilitation measure: Budget issues related to TOMs measure: Time spent to train patients measure: Change in the Simplified Functional Movement Disorders Rating Scale (S-FMDRS) score measure: Multidimensional Fatigue Inventory Scale (MFI-20) score measure: Change in the Brief Pain Inventory (BPI) score measure: Change in the Beck Depression Inventory (BDI-II) score measure: Change in the Beck Anxiety Inventory (BAI) score measure: Change in the 12-item Short-Form Health Survey (SF-12) score measure: The EuroQol-5D (EQ-5D) measure: iMTA Productivity Cost Questionnaire measure: Change in the Clinical Global Impression (CGI) score measure: Gait outcome: Gait speed measure: Gait outcome: Stride length measure: Gait outcome: Cadence measure: Balance outcome: CoP trajectory measure: Balance outcomes: Sway area sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Department of Neurosciences, Biomedicine and Movement Sciences, University of Verona city: Verona zip: 37131 country: Italy lat: 45.4299 lon: 10.98444 facility: USD Parkinson's Disease and Movement Disorders Unit city: Verona zip: 37134 country: Italy lat: 45.4299 lon: 10.98444 hasResults: False
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<|newrecord|> nctId: NCT06274268 id: CHMS23006 briefTitle: Effect of Sarcopenia on the Occurrence of Toxicity Related to Anti-cancer Treatments acronym: SARC-ONCO overallStatus: NOT_YET_RECRUITING date: 2024-04-01 date: 2027-05-01 date: 2028-05-01 date: 2024-02-23 date: 2024-02-23 name: Centre Hospitalier Metropole Savoie class: OTHER name: Université Savoie Mont Blanc briefSummary: 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.
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The main question it aims to answer is :
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Is sarcopenia a predictive marker for the occurrence of toxicity in the initial phase of cancer treatment?
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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 conditions: Oncology conditions: Physical Inactivity conditions: Toxicity Due to Chemotherapy studyType: INTERVENTIONAL phases: NA allocation: NA interventionModel: SINGLE_GROUP interventionModelDescription: Prospective cohort study primaryPurpose: DIAGNOSTIC masking: NONE count: 700 type: ESTIMATED name: Sarcopenia diagnostic test measure: Event-free survival according to sarcopenic statut measure: 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. measure: Progression free-survival measure: Overall survival measure: Objective response rate at 6 and 12 months measure: Number of patients classified as sarcopenic by BIA method and CT method. measure: Exploratory: Event-free survival during PACLITAXEL protocol measure: Exploratory: Level of spontaneous activity measurement by accelerometry (m.s-2). measure: Exploratory: RCB-based objective response rate at 6 and 12 months sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT hasResults: False
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<|newrecord|> nctId: NCT06274255 id: BalikesirU briefTitle: Serum Magnesium Level and Pediatric Migraine acronym: Migraine overallStatus: NOT_YET_RECRUITING date: 2024-03-01 date: 2024-04-10 date: 2024-05-15 date: 2024-02-23 date: 2024-02-23 name: Mersin University class: OTHER briefSummary: 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.
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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 studyType: OBSERVATIONAL observationalModel: CASE_CONTROL timePerspective: CROSS_SECTIONAL count: 60 type: ESTIMATED measure: Serum Magnesium Level and Pediatric Migraine measure: Serum Magnesium Level and Pediatric Migraine sex: ALL minimumAge: 72 Months maximumAge: 18 Years stdAges: CHILD stdAges: ADULT facility: Hilal Aydın city: Balıkesir state: Türkiye zip: 33343 country: Turkey name: Hilal Aydın, assoc. Dr. role: CONTACT phone: +902666121461 email: [email protected] name: Hilal Aydın, assoc. Dr. role: CONTACT phone: +905072607541 email: [email protected] lat: 39.64917 lon: 27.88611 facility: Aysen Orman city: Mersin state: Türkiye zip: 33343 country: Turkey lat: 36.79526 lon: 34.61792 facility: MersinU city: Mersin state: Türkiye zip: 33343 country: Turkey name: Aysen Orman role: CONTACT email: [email protected] name: Aysen Orman role: CONTACT phone: 3242410000 phoneExt: 2646 email: [email protected] lat: 36.79526 lon: 34.61792 facility: Aysen Orman city: Mersin state: Türkiye zip: 38000 country: Turkey name: Aysen Orman, assoc. Dr. role: CONTACT phone: +903242410000 phoneExt: +903242410000 email: [email protected] name: Aysen Orman, assoc. Dr. role: PRINCIPAL_INVESTIGATOR lat: 36.79526 lon: 34.61792 hasResults: False
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<|newrecord|> nctId: NCT06274242 id: MU-CIRB 2022/300.0711 briefTitle: Mixed Natural Prebiotic-Fibers Impact on Stool Frequency and Fecal Microbiota in Constipated Thai Adults overallStatus: ACTIVE_NOT_RECRUITING date: 2023-03-10 date: 2023-07-22 date: 2024-04-19 date: 2024-02-23 date: 2024-02-23 name: Mahidol University class: OTHER briefSummary: Mixed Natural Prebiotic-Fibers Impact on Stool Frequency and Fecal Microbiota in Constipated Thai Adults: A Randomized Clinical Trial. conditions: Constipation studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: SINGLE whoMasked: PARTICIPANT count: 98 type: ACTUAL name: Haruna name: Placebo Powder measure: Change in Stool Frequency measure: Change in Fecal Microbiota measure: Change in Stool consistency sex: ALL minimumAge: 20 Years maximumAge: 60 Years stdAges: ADULT facility: Mahidol University city: Nakhon Pathom zip: 73170 country: Thailand lat: 13.8196 lon: 100.04427 hasResults: False
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<|newrecord|> nctId: NCT06274229 id: EA4/252/23 briefTitle: DivAirCity Social Health Survey acronym: DivAirCitySH overallStatus: RECRUITING date: 2024-02-20 date: 2024-12-31 date: 2025-12-31 date: 2024-02-23 date: 2024-02-23 name: Charite University, Berlin, Germany class: OTHER name: Universitat Politècnica de València name: Universitatea din Bucuresti name: University of Aarhus name: Fondazione C.N.R./Regione Toscana "G. Monasterio", Pisa, Italy name: European Commission briefSummary: 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 conditions: Psychological Well-Being conditions: Pollution; Exposure studyType: OBSERVATIONAL observationalModel: ECOLOGIC_OR_COMMUNITY timePerspective: PROSPECTIVE count: 1000 type: ESTIMATED name: Air pollution and noise reducing installations measure: WHO-5 Well-being Scale measure: Kessler K6 psychological distress measure: ASKU questionnaire measure: Questionnaire for General Physiological Health measure: Questionnaire about feelings of safety and security at the site sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Charité -- Universitaetsmedizin Berlin status: RECRUITING city: Berlin zip: 14109 country: Germany name: Farid I Kandil, PhD role: CONTACT phone: +491605631744 email: [email protected] lat: 52.52437 lon: 13.41053 hasResults: False
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<|newrecord|> nctId: NCT06274216 id: 4381021ABOS briefTitle: The Effect of Vitamin D Supplementation on Dental Implant Osseointegration: A Randomized Controlled Trial overallStatus: COMPLETED date: 2021-09-01 date: 2022-03-30 date: 2022-04-01 date: 2024-02-23 date: 2024-02-23 name: Ziauddin University class: OTHER briefSummary: 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 studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL interventionModelDescription: The research commences through a self-administered questionnaire such as age, gender, weight, height, BMI, smoking habits, sun exposure, and employment status.
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Prior to implant surgery, each participant undergoes a blood test to assess their vitamin D levels.
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Detailed records are maintained concerning the anatomical position (molar, pre-molar, canine, and incisor) and implant site (maxilla and mandible) for every participant.
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Group Formation: The participant pool is stratified into two distinct groups - Group A and Group B. This categorization is essential for implementing and comparing different interventions within the study. Group A undergoes a specific intervention wherein they receive a daily oral dose of 5000 IU of vitamin D3 for a duration of 12 weeks. In contrast, Group B receives a placebo.
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Following the intervention period, the implants are allowed to cure adequately primaryPurpose: SUPPORTIVE_CARE masking: DOUBLE maskingDescription: Groups A and B were created out of all patients who had signed up. Patients in group A received 5000 IU of vitamin D3 orally every day for 12 weeks , whereas patients in group B received a placebo. Patients were blinded to the study medication. The implants were then allowed to cure adequately and submerged for a further three months. Patients were summoned back three months later to un-cover the implant.
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The both groups were compared for the difference of osseo-integration at 3 months, as well as difference of osseo-integration were compared with respect to implant site (maxilla and mandible).
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Additionally, change in vitamin D levels were also assessed pre-operatively and post-operatively at 3 months. whoMasked: PARTICIPANT whoMasked: CARE_PROVIDER count: 100 type: ACTUAL name: Vitamin D3 name: Vitamin E 400 measure: Osseo-integration is measured by evaluating the ISQ value (Implant Stability Quotient, ranging from 1-100) measure: Evaluation of Mean Change in Serum Vitamin D Levels in Dental Implant Patients with and without Vitamin D Supplementation at a Tertiary Care Hospital sex: ALL minimumAge: 18 Years maximumAge: 45 Years stdAges: ADULT facility: Afifa Razi city: Karachi state: Sindh zip: 74700 country: Pakistan lat: 24.8608 lon: 67.0104 hasResults: False
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<|newrecord|> nctId: NCT06274203 id: 10584-2/5-2023 briefTitle: High Dose Vitamin D Supplementation in Children With Sickle Cell Disease overallStatus: COMPLETED date: 2023-05-03 date: 2024-01-30 date: 2024-02-10 date: 2024-02-23 date: 2024-02-23 name: Zagazig University class: OTHER_GOV briefSummary: 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 conditions: Vitamin D Deficiency conditions: Health Related Quality of Life conditions: Hand Grip Strength conditions: Bone Mineral Density studyType: INTERVENTIONAL phases: NA allocation: NA interventionModel: SINGLE_GROUP primaryPurpose: TREATMENT masking: NONE count: 75 type: ACTUAL name: Vitamin D3 measure: Serum 25(OH)D level measure: Bone mineral density (BMD) measure: Maximum handgrip strength (HGS) measure: Health related quality of life (HRQL) measure: Serum concentrations of C reactive protein (CRP) measure: Serum concentrations of Erythrocyte sedimentation rate (ESR) measure: Safety reporting of any adverse events measure: Safety measurements of serum Ca measure: childhood health assessment measure: Safety measurements of serum 25(OH)D levels sex: ALL maximumAge: 18 Years stdAges: CHILD stdAges: ADULT facility: Zagazig university city: Zagazig state: Sharkia zip: 44519 country: Egypt lat: 30.58768 lon: 31.502 hasResults: False
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<|newrecord|> nctId: NCT06274190 id: S68746 briefTitle: Personalized Care Pathways for Bowel Symptoms in Rectal Cancer patients_development of E-diary acronym: Treatable overallStatus: NOT_YET_RECRUITING date: 2024-04-29 date: 2025-10 date: 2026-03 date: 2024-02-23 date: 2024-04-08 name: KU Leuven class: OTHER name: Universitaire Ziekenhuizen KU Leuven briefSummary: 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 conditions: LARS - Low Anterior Resection Syndrome studyType: INTERVENTIONAL phases: NA allocation: NON_RANDOMIZED interventionModel: SINGLE_GROUP primaryPurpose: SUPPORTIVE_CARE masking: NONE count: 118 type: ESTIMATED name: bowel e-diary measure: Selection of items for the newly developed bowel diary measure: Assessment of content validity of the newly developed bowel diary in a post-Delphi patient focus group consisting of 8-12 participants measure: The usability of the newly developed e-diary, assessed with the System Usability Scale (SUS) in patients after rectal surgery for rectal cancer measure: 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 measure: Construct validity of the newly developed bowel e-diary measure: Criterion validity of the newly developed bowel e-diary measure: Test-retest reliability of the newly developed bowel e-diary measure: 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. sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT hasResults: False
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<|newrecord|> nctId: NCT06274177 id: BTL-785_CTUS1400 briefTitle: Evaluation of the BTL-785F Device for Submental Fat Reduction and Neck Rejuvenation overallStatus: ACTIVE_NOT_RECRUITING date: 2023-07-26 date: 2024-04-01 date: 2024-04-01 date: 2024-02-23 date: 2024-02-23 name: BTL Industries Ltd. class: INDUSTRY briefSummary: 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 studyType: INTERVENTIONAL phases: NA allocation: NA interventionModel: SINGLE_GROUP primaryPurpose: TREATMENT masking: NONE count: 37 type: ACTUAL name: BTL-785-7 measure: Submental fat thickness reduction measure: Incidence of Treatment-related Adverse Events measure: Change on the Clinician Reported - Submental Fat Rating Scale score measure: Satisfaction Assessed by the Satisfaction Questionnaire measure: Change in the submental-cervical angle measure: Comfort Assessed by Therapy Comfort Questionnaire sex: ALL minimumAge: 21 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Precision Skin LLC city: Davie state: Florida zip: 33328 country: United States lat: 26.06287 lon: -80.2331 facility: Chicago Cosmetic and Dermatologic Research city: Chicago state: Illinois zip: 60654 country: United States lat: 41.85003 lon: -87.65005 facility: New Jersey Plastic Surgery (NJPS) city: Montclair state: New Jersey zip: 07042 country: United States lat: 40.82593 lon: -74.20903 facility: Gentile Facial Plastic and Aesthetic Laser Center city: Youngstown state: Ohio zip: 44512 country: United States lat: 41.09978 lon: -80.64952 hasResults: False
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<|newrecord|> nctId: NCT06274164 id: H-54820 / RAI1 briefTitle: Clinical and Molecular Biomarker Studies in RAI1 (Retinoic Acid-Induced 1) -Related Disorders overallStatus: RECRUITING date: 2024-03-13 date: 2027-03 date: 2027-03 date: 2024-02-23 date: 2024-04-01 name: Baylor College of Medicine class: OTHER name: Doris Duke Charitable Foundation briefSummary: 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.
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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.
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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:
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* 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)
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* to identify clinical, neurophysiology, and laboratory biomarkers that differentiate RAI1-related disorders one from another.
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Participants will have to complete:
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* a clinical examination
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* a blood draw
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* a skin biopsy (optional)
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* a sleep study
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Researchers will compare patients' blood to control group's blood for biomarker studies. conditions: RAI1 Gene 17P11.2 Deletion+Duplication studyType: OBSERVATIONAL observationalModel: CASE_CONTROL timePerspective: PROSPECTIVE count: 90 type: ESTIMATED name: Electroencephalography/Polysomnography (EEG/PSG) name: Skin Biopsy name: Blood draw measure: Rate of neurological clinical finding measure: Rate of electroencephalogram (EEG) and/or sleep abnormalities measure: Concentration of downstream molecular pathway interactors of RAI1 sex: ALL minimumAge: 1 Month maximumAge: 80 Years stdAges: CHILD stdAges: ADULT stdAges: OLDER_ADULT facility: Texas Children's Hospital status: RECRUITING city: Houston state: Texas zip: 77030 country: United States name: Davut Pehlivan, MD role: CONTACT phone: 713-798-6970 email: [email protected] lat: 29.76328 lon: -95.36327 hasResults: False
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<|newrecord|> nctId: NCT06274151 id: H-22038917 briefTitle: Optimal Treatment of Acute Skeletal Muscle Injury overallStatus: NOT_YET_RECRUITING date: 2024-02-15 date: 2025-07-31 date: 2029-12-31 date: 2024-02-23 date: 2024-02-23 name: Bispebjerg Hospital class: OTHER briefSummary: 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.
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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.
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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 conditions: Inflammation studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: BASIC_SCIENCE masking: TRIPLE whoMasked: PARTICIPANT whoMasked: CARE_PROVIDER whoMasked: OUTCOMES_ASSESSOR count: 20 type: ESTIMATED name: Naproxen 500 Mg name: Rehabilitation name: Placebo measure: Effect of anti-inflammatory medicine on cellular profile in skeletal muscle measure: Functional outcome performance measure: Functional outcome re-injury rate measure: Functional outcome Patient Related Outcome Measures (PROM) sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT hasResults: False
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<|newrecord|> nctId: NCT06274138 id: HAPTONOMY briefTitle: The Enchanting Symphony of Haptonomy's Impact on Attachment and Spousal Harmony for Women Conceiving Through Infertility Treatment overallStatus: ENROLLING_BY_INVITATION date: 2024-03-15 date: 2024-03-30 date: 2025-03-15 date: 2024-02-23 date: 2024-03-05 name: Baskent University class: OTHER briefSummary: 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.
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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.
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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.
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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.
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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.
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Research Hypotheses:
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H0-1: The application of haptonomy by partners has an effect on maternal attachment in pregnant women.
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H1-1: The application of haptonomy by partners does not have an effect on maternal attachment in pregnant women.
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H0-2: The application of haptonomy by partners has no effect on paternal attachment in pregnant women.
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H1-2: The application of haptonomy by partners has an effect on paternal attachment in pregnant women.
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H0-3: The application of haptonomy by partners has no effect on marital adjustment in pregnant women.
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H1-3: The application of haptonomy by partners has an effect on marital adjustment in pregnant women. conditions: Infertility studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: SUPPORTIVE_CARE masking: DOUBLE whoMasked: PARTICIPANT whoMasked: OUTCOMES_ASSESSOR count: 76 type: ESTIMATED name: haptonomy measure: Marital adjustment score measure: Prenatal attachment score measure: Father attachment score sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Başkent University city: Ankara country: Turkey lat: 39.91987 lon: 32.85427 hasResults: False
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<|newrecord|> nctId: NCT06274125 id: AslıDemircioglu1 briefTitle: Evaluation of Kidney Damage Using NGAL Measurements overallStatus: RECRUITING date: 2023-10-01 date: 2024-03 date: 2024-04 date: 2024-02-23 date: 2024-02-23 name: Ankara City Hospital Bilkent class: OTHER briefSummary: 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 conditions: Neutrophil Gelatinase-Associated Lipocalin conditions: Kidney Function Tests studyType: OBSERVATIONAL observationalModel: CASE_CONTROL timePerspective: PROSPECTIVE count: 55 type: ESTIMATED name: Robotic-Assisted Laparoscopic Radical Prostatectomy measure: 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. measure: The relationship between demographic parameters such as age, BMI, comorbidities, and ASA classification will be evaluated in relation to the development of AKI. measure: The evaluation of the relationship between intraabdominal pressure and the development of AKI. measure: The relationship between intraoperative mean arterial pressure (MAP) and NGAL (Neutrophil Gelatinase-Associated Lipocalin) values. sex: MALE minimumAge: 18 Years maximumAge: 80 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Ankara Bilkent City Hospital status: RECRUITING city: Ankara state: Çankaya zip: 06530 country: Turkey lat: 39.91987 lon: 32.85427 hasResults: False
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<|newrecord|> nctId: NCT06274112 id: 1K23MH135222 briefTitle: Using TMS to Understand Neural Processes of Social Motivation overallStatus: NOT_YET_RECRUITING date: 2024-09 date: 2029-09 date: 2029-09 date: 2024-02-23 date: 2024-02-23 name: Auburn University class: OTHER briefSummary: The purpose of this study is to use transcranial magnetic stimulation (TMS) to better understand the neural circuits associated with social motivation.
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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.
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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 conditions: Major Depressive Disorder conditions: Social Anxiety Disorder studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: CROSSOVER interventionModelDescription: All participants will receive each dose of TMS in a counterbalanced order (AB or BA) primaryPurpose: BASIC_SCIENCE masking: SINGLE whoMasked: PARTICIPANT count: 40 type: ESTIMATED name: TMS measure: Social motivation measure: Neural circuit function sex: ALL minimumAge: 25 Years maximumAge: 50 Years stdAges: ADULT hasResults: False
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<|newrecord|> nctId: NCT06274099 id: TDK-2023-12649 briefTitle: The Effect of the Care Given to Hemodialysis Patients on Comfort Level and Complaints overallStatus: NOT_YET_RECRUITING date: 2024-02 date: 2024-03 date: 2024-12 date: 2024-02-23 date: 2024-02-23 name: Reva Balci Akpinar class: OTHER name: Atatürk University briefSummary: 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.
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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 conditions: Nurse's Role studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL interventionModelDescription: pretest posttest randomized controlled trial primaryPurpose: SUPPORTIVE_CARE masking: DOUBLE whoMasked: INVESTIGATOR whoMasked: OUTCOMES_ASSESSOR count: 70 type: ESTIMATED name: nursing care measure: General Comfort Scale measure: Dialysis Symptom Index sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Ataturk University city: Erzurum state: Diğerleri zip: 25200 country: Turkey name: REVA BALCI AKPINAR, PROF. DR role: CONTACT phone: +904422312214 email: [email protected] name: RUKIYE DEMİR DIKMEN role: SUB_INVESTIGATOR lat: 39.90861 lon: 41.27694 facility: Ataturk University city: Erzurum state: Diğerleri zip: 25200 country: Turkey name: REVA BALCI AKPINAR, PROF. DR role: CONTACT phone: +904422312214 email: [email protected] lat: 39.90861 lon: 41.27694 hasResults: False
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<|newrecord|> nctId: NCT06274086 id: S2022-2027-0001 briefTitle: Two-session Catheter-directed Sclerotherapy Using Ethanol for Endometrioma overallStatus: COMPLETED date: 2020-06-01 date: 2023-03-31 date: 2023-03-31 date: 2024-02-23 date: 2024-02-23 name: Asan Medical Center class: OTHER briefSummary: 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:
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• Is two-session CDS with 96% ethanol safe and effective for treating endometrioma?
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Participants will:
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* Receive the first session CDS for endometrioma
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* Carry the catheter overnight and be monitored in the patient ward
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* Receive the second session CDS the next day conditions: Sclerotherapy conditions: Endometrioma studyType: INTERVENTIONAL phases: NA allocation: NA interventionModel: SINGLE_GROUP primaryPurpose: TREATMENT masking: NONE count: 22 type: ACTUAL name: Two-session catheter-directed sclerotherapy measure: Recurrence sex: FEMALE minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Asan Medical Center city: Seoul zip: 05505 country: Korea, Republic of lat: 37.566 lon: 126.9784 hasResults: False
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<|newrecord|> nctId: NCT06274073 id: E2-22-2566 briefTitle: Double-dorsal Versus Single-volar Digital Block overallStatus: COMPLETED date: 2022-10-12 date: 2023-07-12 date: 2023-09-12 date: 2024-02-23 date: 2024-02-23 name: Ankara City Hospital Bilkent class: OTHER briefSummary: 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.
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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.
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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.
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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 conditions: Anesthesia, Local conditions: Pain conditions: Nerve Block studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL interventionModelDescription: Two parallel groups (two digital block techniques) primaryPurpose: TREATMENT masking: SINGLE whoMasked: OUTCOMES_ASSESSOR count: 160 type: ACTUAL name: Dorsal digital block name: Palmar digital block measure: Anesthesia pain score measure: Anesthesia onset time sex: ALL minimumAge: 18 Years maximumAge: 65 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Ankara City Hospital Emergency Medicine Department city: Ankara country: Turkey lat: 39.91987 lon: 32.85427 hasResults: False
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<|newrecord|> nctId: NCT06274060 id: 135399 id: R01MH121161 type: NIH link: https://reporter.nih.gov/quickSearch/R01MH121161 id: IRB00012628 type: OTHER domain: JHSPH IRB briefTitle: Project Phakama: Testing Support Strategies to Empower Young Women on PrEP in South Africa overallStatus: RECRUITING date: 2024-04-16 date: 2025-04 date: 2025-04 date: 2024-02-23 date: 2024-04-19 name: Johns Hopkins Bloomberg School of Public Health class: OTHER name: TB/HIV Care name: Unity Health Toronto name: National Institute of Mental Health (NIMH) briefSummary: 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 conditions: HIV Infections studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: FACTORIAL interventionModelDescription: This fractional factorial design includes four strategies resulting in 16 trial arms/conditions. The design compares results in arms with and without each of the strategies, but is not fully powered to test every combination of strategies.Thus, each strategy will be received by half of the participants, though the combinations of strategies will vary. primaryPurpose: PREVENTION masking: NONE count: 304 type: ESTIMATED name: Case management name: Food vouchers name: PrEP support buddy name: Community-based PrEP pickup points measure: PrEP persistence at 7 months after PrEP initiation measure: PrEP adherence at 7 months after PrEP initiation among all trial participants measure: PrEP persistence at 1 month after PrEP initiation measure: PrEP persistence at 4 months after PrEP initiation measure: PrEP persistence at 13 months after PrEP initiation measure: PrEP adherence at 7 months after PrEP initiation among trial participants who provided dried blood spot samples sex: FEMALE minimumAge: 16 Years stdAges: CHILD stdAges: ADULT stdAges: OLDER_ADULT facility: TB HIV Care status: RECRUITING city: Pietermaritzburg state: KwaZulu Natal zip: 3200 country: South Africa name: Chitra Singh, MSocSci role: CONTACT phone: +27721516828 email: [email protected] name: Joel Steingo, MBChB, MPH role: CONTACT phone: +27833009377 email: [email protected] name: Harry Hausler, MD, PhD, MPH role: PRINCIPAL_INVESTIGATOR name: Mfezi Mcingana, BA role: SUB_INVESTIGATOR name: Jenny Mcloughlin, RN role: SUB_INVESTIGATOR name: Joel Steingo, MBChB, MPH role: SUB_INVESTIGATOR lat: -29.61679 lon: 30.39278 hasResults: False
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<|newrecord|> nctId: NCT06274047 id: 2023-0409 id: NCI-2024-01553 type: OTHER domain: NCI-CTRP Clinical Registry briefTitle: 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. overallStatus: NOT_YET_RECRUITING date: 2024-08-31 date: 2027-06-30 date: 2029-06-30 date: 2024-02-23 date: 2024-03-28 name: M.D. Anderson Cancer Center class: OTHER name: Janssen Scientific Affairs, LLC briefSummary: 1. Personalize treatment for prostate cancer based on how aggressive the disease is and
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2. 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 conditions: Prostatectomy conditions: Prostate Cancer studyType: INTERVENTIONAL phases: PHASE3 allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: NONE count: 120 type: ESTIMATED name: Apalutamide name: Androgen Deprivation Therapy measure: Functional Assessment of Chronic Illness Therapy-Fatigue Scale (FACIT-Fatigue) sex: MALE minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: MD Anderson Cancer Center city: Houston state: Texas zip: 77030 country: United States name: Karen Hoffman, MD role: CONTACT phone: 713-563-2339 email: [email protected] name: Karen Hoffman, MD role: PRINCIPAL_INVESTIGATOR lat: 29.76328 lon: -95.36327 hasResults: False
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<|newrecord|> nctId: NCT06274034 id: 23-006870 id: NCI-2024-01019 type: REGISTRY domain: CTRP (Clinical Trial Reporting Program) id: 23-006870 type: OTHER domain: Mayo Clinic Institutional Review Board briefTitle: MUSE-S Headband System for Improving Anxiety and Insomnia Among Breast Cancer Survivors overallStatus: RECRUITING date: 2024-01-08 date: 2025-01-31 date: 2025-01-31 date: 2024-02-23 date: 2024-02-23 name: Mayo Clinic class: OTHER briefSummary: 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 studyType: INTERVENTIONAL phases: EARLY_PHASE1 allocation: NA interventionModel: SINGLE_GROUP primaryPurpose: SUPPORTIVE_CARE masking: NONE count: 40 type: ESTIMATED name: Electronic Health Record Review name: Medical Device Usage and Evaluation name: Meditation Therapy name: Survey Administration measure: Frequency of use of meditation measure: Feasibility of a wearable electroencephalographic (EEG) headband (Muse™ S Headband) measure: Impact of interactive meditation and sleep support through the Muse-S™ system sex: FEMALE minimumAge: 18 Years maximumAge: 80 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Mayo Clinic in Rochester status: RECRUITING city: Rochester state: Minnesota zip: 55905 country: United States name: Clinical Trials Referral Office role: CONTACT phone: 855-776-0015 email: [email protected] name: Stacy D. D'Andre, M.D. role: PRINCIPAL_INVESTIGATOR lat: 44.02163 lon: -92.4699 hasResults: False
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<|newrecord|> nctId: NCT06274021 id: UMMC-IRB-2023-125 briefTitle: Neuromodulation to Reduce Muscle Stiffness Following Spinal Cord Injury overallStatus: NOT_YET_RECRUITING date: 2024-04-01 date: 2025-12-31 date: 2025-12-31 date: 2024-02-23 date: 2024-03-25 name: University of Mississippi Medical Center class: OTHER name: Methodist Rehabilitation Center name: The Craig H. Neilsen Foundation briefSummary: 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.
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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 conditions: Spinal Cord Injury conditions: Spinal Cord Injury Cervical conditions: Spinal Cord Injury Thoracic studyType: INTERVENTIONAL phases: EARLY_PHASE1 allocation: NA interventionModel: SEQUENTIAL interventionModelDescription: This study employs a crossover design, wherein each participant is systematically administered a sequence of five distinct interventions randomly. This approach ensures that every participant receives each intervention in a unique sequence. The design facilitates within-subject comparisons by minimizing inter-individual variability, as each participant effectively serves as their own control across the study phases. The random assignment of intervention sequences aims to balance potential carryover effects and period effects. primaryPurpose: OTHER masking: NONE maskingDescription: The participants and assessors are kept unaware of which intervention is being administered. For this, the study drugs are designed to be visually identical for all participants, and the intervention and sham stimulation configuration is set without the assessor being present in the room. count: 16 type: ESTIMATED name: Transcutaneous spinal stimulation at 100 Hz name: Transcutaneous spinal stimulation at 50 Hz name: Transcutaneous spinal stimulation at 50 Hz and single dose of baclofen name: Transcutaneous spinal stimulation at 50 Hz and single dose of tizanidine name: Sham transcutaneous spinal stimulation measure: Change from baseline of posterior root reflexes (PRRs) recruitment curves. measure: Change from baseline of flexion withdrawal reflex (FWR) response amplitude. measure: Change from baseline of stretch reflex (SR) response amplitude. measure: Change from baseline in muscle stiffness as measured by the Modified Ashworth Scale (MAS), measure: Change from baseline in spasms as measured by the Spinal Cord Assessment Tool for Spastic Reflexes (SCATS). measure: Change from baseline of posterior root reflexes (PRRs) recruitment curves. measure: Change from baseline of flexion withdrawal reflex (FWR) response amplitude. measure: Change from baseline of stretch reflex (SR) response amplitude. sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Methodist Rehabilitation Center city: Jackson state: Mississippi zip: 39216 country: United States name: Dobrivoje S Stokic, MD, DSc role: CONTACT phone: 601-364-3314 email: [email protected] lat: 32.29876 lon: -90.18481 facility: University of Mississippi Medical Center city: Jackson state: Mississippi zip: 39216 country: United States name: Matthias J Krenn, PhD role: CONTACT phone: 601-364-3413 email: [email protected] lat: 32.29876 lon: -90.18481 hasResults: False
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<|newrecord|> nctId: NCT06274008 id: 230110 briefTitle: Exparel vs. ACB With Bupivacaine for ACL Reconstruction overallStatus: RECRUITING date: 2023-10-12 date: 2024-10-30 date: 2024-12-31 date: 2024-02-23 date: 2024-02-23 name: Children's Hospital of Orange County class: OTHER briefSummary: 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 conditions: Opioid Misuse conditions: Pain conditions: Anxiety studyType: INTERVENTIONAL phases: PHASE1 allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: SUPPORTIVE_CARE masking: DOUBLE whoMasked: PARTICIPANT whoMasked: INVESTIGATOR count: 96 type: ESTIMATED name: Exparel measure: At-home narcotic consumption by the patients as measured by the medication form completed by parents post discharge measure: Postoperative pain level of child measure: Functional disability of child measure: Parent and child anxiety measure: Child pain sex: ALL minimumAge: 7 Years maximumAge: 17 Years stdAges: CHILD facility: CHOC Children's Hospital status: RECRUITING city: Orange state: California zip: 92868 country: United States name: Haydee Cortes role: CONTACT phone: 714-456-2837 email: [email protected] name: Kiran Athreya role: CONTACT phone: 9493064857 email: [email protected] name: John Schlechter, DO role: PRINCIPAL_INVESTIGATOR name: Zeev N. Kain, MD role: SUB_INVESTIGATOR lat: 33.78779 lon: -117.85311 hasResults: False
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<|newrecord|> nctId: NCT06273995 id: H-54233 briefTitle: Telehealth Behavioral Activation for Teens overallStatus: RECRUITING date: 2024-03-01 date: 2029-03-01 date: 2029-12-01 date: 2024-02-23 date: 2024-03-19 name: Baylor College of Medicine class: OTHER name: University of Texas briefSummary: 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 conditions: Suicide and Self-harm conditions: Depression in Adolescence conditions: Depression Mild conditions: Depression Moderate conditions: Depression Severe studyType: INTERVENTIONAL phases: NA allocation: NA interventionModel: SINGLE_GROUP interventionModelDescription: Single group, open-label behavioral activation primaryPurpose: TREATMENT masking: NONE count: 250 type: ESTIMATED name: Behavioral Activation measure: Patient Health Questionnaire 9-modified for adolescents (PHQ-A) measure: Behavioral Activation for Depression-Short Form (BAD-SF) measure: Dimensional Anhedonia Rating Scale (DARS) measure: Strengths and Difficulties Questionnaire (SDQ) measure: Duke Social Support Index (DSSI) sex: ALL minimumAge: 12 Years maximumAge: 18 Years stdAges: CHILD stdAges: ADULT facility: Baylor College of Medicine status: RECRUITING city: Houston state: Texas zip: 77030 country: United States name: Eric Storch, Ph.D. role: CONTACT phone: 713-798-3080 email: [email protected] lat: 29.76328 lon: -95.36327 hasResults: False
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<|newrecord|> nctId: NCT06273982 id: 1R01MH131698 type: NIH link: https://reporter.nih.gov/quickSearch/1R01MH131698 briefTitle: Behavioral Telehealth in Low-resource Primary Care Settings for Anxiety and Depression in Youth acronym: STEP-UP overallStatus: NOT_YET_RECRUITING date: 2024-07-01 date: 2028-05-31 date: 2028-05-31 date: 2024-02-23 date: 2024-02-23 name: San Diego State University class: OTHER name: Kaiser Permanente name: OCHIN, Inc. briefSummary: 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 studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: SINGLE whoMasked: OUTCOMES_ASSESSOR count: 220 type: ESTIMATED name: STEP-UP (transdiagnostic behavioral therapy for pediatric anxiety and depression) name: ARC (assisted referral to community care) measure: Children's Global Assessment Scale (CGAS) measure: Pediatric Anxiety Rating Scale (PARS) measure: Children's Depression Rating Scale -- Revised (CDRS-R) sex: ALL minimumAge: 8 Years maximumAge: 16 Years stdAges: CHILD hasResults: False
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<|newrecord|> nctId: NCT06273969 id: PK20240105- 001 briefTitle: Ultrasonographic Evaluation of Osteopathic Manipulation for Thoracic Outlet Syndrome acronym: TOS overallStatus: NOT_YET_RECRUITING date: 2024-04-01 date: 2024-04-24 date: 2024-04-24 date: 2024-02-23 date: 2024-02-23 name: A.T. Still University of Health Sciences class: OTHER briefSummary: 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 studyType: INTERVENTIONAL phases: NA allocation: NA interventionModel: SINGLE_GROUP interventionModelDescription: Twelve consented male and/or female volunteers between the ages of 18 and 65 with intermittent tingling and/or numbness in one or both hands that has occurred with two weeks of the start date of the study will be evaluated using pulsed-wave doppler ultrasonography (US) and then treated with osteopathic manipulative treatment (OMT).
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US examination of the thoracic outlet will be performed using a Mindray-6 ultrasound machine and will include 4 views/positions with the subject in a seated position.
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The following intervention will consist of four osteopathic manipulation techniques (OMT) being performed that target the somatic dysfunctions associated with TOS. These techniques include: 1) Direct Thoracic Inlet Myofascial Release (TIMFR); 2) Direct Muscle Energy for the Scalene Muscles; 3) Direct Muscle Energy for the Pectoralis Muscles; and 4) Supraclavicular Fascial Release. primaryPurpose: TREATMENT masking: NONE count: 12 type: ESTIMATED name: Osteopathic Manipulative Treatment (OMT) measure: Blood flow changes in the upper extremity. sex: ALL minimumAge: 18 Years maximumAge: 65 Years stdAges: ADULT stdAges: OLDER_ADULT hasResults: False
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<|newrecord|> nctId: NCT06273956 id: bleeding scores in ItP briefTitle: Explore the Relationship Between Platelet Count and Bleeding Score in ITP overallStatus: RECRUITING date: 2022-04-10 date: 2025-10-10 date: 2025-12-30 date: 2024-02-23 date: 2024-02-23 name: Assiut University class: OTHER briefSummary: 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 studyType: OBSERVATIONAL observationalModel: OTHER timePerspective: CROSS_SECTIONAL count: 100 type: ESTIMATED measure: 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 sex: ALL minimumAge: 18 Years maximumAge: 60 Years stdAges: ADULT facility: Aml Sayed Hamed status: RECRUITING city: Assiut country: Egypt name: Rania Mohammed Mahmoud Hafez, professor role: CONTACT phone: +201000019198 email: [email protected] name: Yousreyia Abdel Rahman Ahmed, professor role: CONTACT phone: +201223971307 email: [email protected] lat: 27.18096 lon: 31.18368 hasResults: False
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<|newrecord|> nctId: NCT06273943 id: ANRS 0410s CABOPrEP id: 2024-510678-25 type: EUDRACT_NUMBER briefTitle: Impact of Long-acting Injectable Cabotegravir for HIV PrEP in MSM in France. acronym: CABOPrEP overallStatus: NOT_YET_RECRUITING date: 2024-04-01 date: 2025-10-30 date: 2026-10-30 date: 2024-02-23 date: 2024-02-23 name: ANRS, Emerging Infectious Diseases class: OTHER_GOV briefSummary: 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 studyType: INTERVENTIONAL phases: PHASE3 allocation: RANDOMIZED interventionModel: PARALLEL interventionModelDescription: Participants will be randomly assigned in a 1:1 ratio to remain on their current oral PrEP regimen with daily and/or on-demand TDF/FTC (Control arm) or to switch to a CAB-LA based PrEP (Intervention arm). primaryPurpose: PREVENTION masking: NONE count: 322 type: ESTIMATED name: Cabotegravir Tablets, for oral use. name: Cabotegravir Extended-Release Injectable Suspension, for intramuscular use. name: Tenofovir disoproxil/Emtricitabine 300mg/200mg fixed-dose combination tablets, for oral use name: Rectal Biopsies measure: Number of protocol visits completed with a documented PrEP prescription aligned with the randomization arm. measure: Number of protocol visits completed with a documented PrEP prescription aligned with the randomization arm. measure: 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. measure: Number of participants whose last condomless anal sexual intercourse was not covered by PrEP. measure: Number of condomless anal sexual intercourse in the month prior to each study visit. measure: Number of sexual partners in the last 3 months. measure: Mean PrEP satisfaction score based on study arm. measure: Number of participants with syphilis, chlamydiae, and/or gonorrhea infection. measure: Number of participants with Grade 2 or higher clinical or laboratory drug-related adverse events at any time during the study. measure: Change from baseline in body weight (kg). measure: Change from baseline in lipids measure: Change from baseline in the insulin resistance index (HOMA-IR). measure: Number and severity of injection site reaction. measure: Cabotegravir concentration in plasma and tenofovir diphosphate and emtricitabine triphosphate concentration in dried blood spots. measure: Number of participants with new HIV infection. measure: Number of participants who used psychoactive drugs in the last 3 months measure: Score of quality of life measured by the EuroQol-5D questionnaire measure: Depression score assessed with the Center for Epidemiologic Studies Depression Scale (CES-D). measure: Self-esteem score assessed with the Rosenberg scale. measure: Number and nature of uses of community peer support and therapeutic patient education. sex: MALE minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Hôpital Hôtel Dieu city: Paris state: Ile De France zip: 75004 country: France lat: 48.85341 lon: 2.3488 facility: Hôpital Lariboisière city: Paris state: Ile De France zip: 75010 country: France lat: 48.85341 lon: 2.3488 facility: Hôpital Saint Louis city: Paris state: Ile De France zip: 75010 country: France lat: 48.85341 lon: 2.3488 facility: Hôpital Saint Antoine city: Paris state: Ile De France zip: 75012 country: France lat: 48.85341 lon: 2.3488 facility: Hôpital La Pitié Salpêtrière city: Paris state: Ile De France zip: 75013 country: France lat: 48.85341 lon: 2.3488 facility: Hôpital Necker city: Paris state: Ile De France zip: 75015 country: France lat: 48.85341 lon: 2.3488 facility: Hôpital Bichat city: Paris state: Ile De France zip: 75018 country: France lat: 48.85341 lon: 2.3488 facility: Hôpital Tenon city: Paris state: Ile De France zip: 75020 country: France lat: 48.85341 lon: 2.3488 hasResults: False
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<|newrecord|> nctId: NCT06273930 id: AFID briefTitle: Reduction of Dentine Hypersensitivity After Use of Different Dentifrices acronym: Dentrifices overallStatus: RECRUITING date: 2024-02-01 date: 2024-10-15 date: 2024-10-30 date: 2024-02-23 date: 2024-02-23 name: Armed Forces Institute of Dentistry, Pakistan class: OTHER briefSummary: 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 studyType: INTERVENTIONAL phases: PHASE1 allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: PREVENTION masking: QUADRUPLE whoMasked: PARTICIPANT whoMasked: CARE_PROVIDER whoMasked: INVESTIGATOR whoMasked: OUTCOMES_ASSESSOR count: 87 type: ESTIMATED name: 5% CALCIUM SODIUM PHOSPHOSILICATE name: 8% Arginine measure: 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. measure: 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. sex: ALL minimumAge: 30 Years maximumAge: 65 Years stdAges: ADULT stdAges: OLDER_ADULT facility: AFID status: RECRUITING city: Rawalpindi country: Pakistan name: Muhammad J Iqbal role: CONTACT lat: 33.6007 lon: 73.0679 hasResults: False
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<|newrecord|> nctId: NCT06273917 id: FY23_Pilot2_Dresden briefTitle: Deprescribing Potentially Inappropriate Medications in the Emergency Department for Persons Living With Dementia acronym: IMPACT overallStatus: NOT_YET_RECRUITING date: 2024-03-01 date: 2024-10-01 date: 2025-01-01 date: 2024-02-23 date: 2024-02-23 name: National Institute on Aging (NIA) class: NIH name: Brown University briefSummary: 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.
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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.
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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 studyType: INTERVENTIONAL phases: NA allocation: NA interventionModel: SINGLE_GROUP primaryPurpose: HEALTH_SERVICES_RESEARCH masking: NONE count: 290 type: ESTIMATED name: PRIDE measure: Pharmacist communication of deprescribing recommendation measure: Medication reconciliation measure: Medication supply of CNS PIMs measure: Outpatient follow up measure: Repeat Emergency Department visits sex: ALL minimumAge: 18 Years maximumAge: 120 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Northwestern Memorial Hospital city: Chicago state: Illinois zip: 60611 country: United States name: Scott Dresden, Dr. role: CONTACT phone: 312-926-6494 email: [email protected] name: Anuva Fellner role: CONTACT phone: 312-926-8816 email: [email protected] lat: 41.85003 lon: -87.65005 facility: Northwestern Medicine Lake Forest Hospital city: Lake Forest state: Illinois zip: 60045 country: United States name: Timothy Loftus role: CONTACT phone: 312-926-6612 email: [email protected] lat: 42.25863 lon: -87.84063 facility: Northwestern Medicine Palos Hospital city: Palos Heights state: Illinois zip: 60463 country: United States name: JiHun Lee, DO role: CONTACT phone: 708-923-5811 email: [email protected] lat: 41.66809 lon: -87.79644 hasResults: False
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<|newrecord|> nctId: NCT06273904 id: Pro00132631 briefTitle: Modulating Escape Using Focused Ultrasound overallStatus: NOT_YET_RECRUITING date: 2024-04 date: 2025-09 date: 2025-12 date: 2024-02-23 date: 2024-02-23 name: Medical University of South Carolina class: OTHER briefSummary: 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.
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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).
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