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The goal of this clinical trial is to learn more about the feasibility of offering rTMS as a treatment in the Nicotine Dependence Clinic (NDC) to help daily smokers to quit smoking. The NDC is at the Center for Addiction and Mental Health (CAMH) at 1025 Queen Street West, in Toronto, Canada.
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Participants will be asked to come to CAMH to:
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* Complete surveys and optional interviews to learn more about their opinions and experiences with this treatment
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* Start a treatment course that includes 3 weeks of daily (Monday to Friday) rTMS sessions followed by 3 weeks of weekly rTMS sessions for a total of 6 weeks. Each session lasts about 25 minutes and is provided by an rTMS technician with medical supervision.
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Objectives
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• Learning about the feasibility of rTMS as a treatment option for patients in the NDC will help us improve the treatment when offering it in other clinics, which may help improve smoking quit rates and people's overall health. conditions: Smoking studyType: INTERVENTIONAL phases: PHASE4 allocation: NA interventionModel: SINGLE_GROUP primaryPurpose: TREATMENT masking: NONE count: 40 type: ESTIMATED name: Brainsway H4 deep rTMS coil and Brainsway stimulator system measure: The primary objective of the study is to evaluate the feasibility of implementing rTMS in the Nicotine Dependence Clinic (NDC) at CAMH, in Toronto. This is determine by reach, the extent to which patients are engaging in the rTMS treatment. measure: Identify rates of adoption of rTMS in Nicotine Dependence Clinic measure: Identify contextual determinants of rTMS adoption and reach NDC through a qualitative approach. measure: Evaluate the effectiveness of rTMS on smoking cessation rates in real world patients with common comorbidities seeking treatment at NDC. measure: Explore patient-HCP communication about shared treatment decision-making for rTMS. sex: ALL minimumAge: 18 Years maximumAge: 70 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Center for Addiction and Mental Health (CAMH) status: RECRUITING city: Toronto state: Ontario country: Canada name: Alexandra S, BScH role: CONTACT phone: 416-535-8501 phoneExt: 31551 email: [email protected] lat: 43.70011 lon: -79.4163 hasResults: False
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<|newrecord|> nctId: NCT06346015 id: HX-A-2023050 briefTitle: Gamma Entrainment Stimulation for Cognitive Dysfunction After aSAH acronym: GES-aSAH overallStatus: NOT_YET_RECRUITING date: 2024-04-01 date: 2025-03-31 date: 2025-03-31 date: 2024-04-03 date: 2024-04-03 name: Beijing Tiantan Hospital class: OTHER name: Shanghai Joyingmed Sensory Stimulation Lab briefSummary: The goal of this clinical trial is to Explore and verify whether 40Hz audio and binaural beat 40Hz audio can improve the postoperative cognitive dysfunction seen in patients with aneurysmal subarachnoid hemorrhage. This study is a single-center, prospective, randomized, controlled clinical trial. Patients with aneurysmal subarachnoid hemorrhage were selected and randomized into intervention group (audio adjuvant group) and control group (conventional treatment group). Patients in the intervention group will receive audio therapy after surgery, and patients in the control group will receive usual care. EEG, fMRI and mRS scores were evaluated after 3 months of follow-up. conditions: Subarachnoid Hemorrhage, Aneurysmal conditions: Cognitive Dysfunction studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: SINGLE maskingDescription: The relevant neuroimaging evaluation process is blinded to the evaluator to ensure the objectivity of the evaluation results. whoMasked: OUTCOMES_ASSESSOR count: 60 type: ESTIMATED name: Gamma Entrainment Stimulation measure: Montreal Cognitive Assessment (MoCA) scores < 22 measure: mini-mental state examiniation (MMSE) < 27 measure: modified Rankin Scales (mRS) > 2 measure: electroencephalogram (EEG) indicators measure: functional Magnetic Resonance Imaging (fMRI) indicators measure: Safety indicator sex: ALL minimumAge: 18 Years maximumAge: 75 Years stdAges: ADULT stdAges: OLDER_ADULT hasResults: False
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<|newrecord|> nctId: NCT06346002 id: 2026_e_2017 briefTitle: Impact of a Mindfulness-based Intervention on Well-being and Mental Health of Elementary School Children overallStatus: COMPLETED date: 2017-03-01 date: 2020-03-31 date: 2020-03-31 date: 2024-04-03 date: 2024-04-03 name: Bishop's University class: OTHER briefSummary: Background: Prevention programs for children such as mindfulness-based interventions (MBIs) are often implemented in schools to prevent psychological disorders from emerging and contribute to children' mental health.
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Aim: This study used a randomized cluster design and assessed the impact of a MBI on well-being and mental health of elementary school children's.
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Method: 13 elementary school classrooms were randomly allocated to the experimental condition (7 classrooms, n = 127 students) or the waitlist control condition (6 classrooms, n = 104 students). Participants in the experimental condition received a 10-week MBI. conditions: Mindfulness-based Intervention conditions: Elementary School Children conditions: Mental Health Wellness 1 studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL interventionModelDescription: Randomized cluster trial with a wait-list control primaryPurpose: PREVENTION masking: NONE count: 231 type: ACTUAL name: Mindfulness-based intervention measure: Symptoms of Mental Health Disorders measure: Basic Psychological Needs Satisfaction measure: Process Measure sex: ALL minimumAge: 8 Years maximumAge: 12 Years stdAges: CHILD facility: École primaire Préville city: Saint-Lambert state: Quebec zip: J4S 1M8 country: Canada lat: 45.50008 lon: -73.51028 hasResults: False
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<|newrecord|> nctId: NCT06345989 id: 187157 briefTitle: Time and Cost-implications of Intraoral Scans vs Alginate Impressions: A Randomised Controlled Trial overallStatus: NOT_YET_RECRUITING date: 2024-06 date: 2025-06 date: 2025-12 date: 2024-04-03 date: 2024-04-03 name: University of Sheffield class: OTHER name: Nottingham University Hospitals NHS Trust briefSummary: This research project investigates the time and cost implications of two common techniques in orthodontics: alginate impressions and intraoral scans. Alginate impressions (putty moulds) are a traditional technique that has been used in orthodontic practice for many years. Intraoral scans are a more modern method and are becoming more commonly used in orthodontic practice. Both alginate impressions and intraoral scans are a means of recording a copy of a patient's teeth which aids in record keeping and treatment planning.
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Whilst the majority of the available literature reveals patient preference in favour of intraoral scanning, it remains common practice to use alginate impressions for orthodontic records. Considerations such as time implications, device costs, associated software expenses, and the need for clinician training pose challenges to widespread adoption of intraoral scanning. When comparing chairside time taken for intraoral scans versus alginate impressions, there are varying findings, requiring a thorough investigation.
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The main question being addressed is:
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- Are intraoral scans more time efficient than alginate impressions?
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The secondary question being addressed is:
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- Are intraoral scans more cost effective than alginate impressions?
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This research protocol outlines a clinical trial, evaluating the chairside time and costs associated with intraoral scanning versus alginate impressions. The sample population will be orthodontic patients ages 9 years and above attending the orthodontic department at a district general hospital.
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The outcomes of this study will provide important insights into the practicality and economic viability of intraoral scanning versus alginate impressions in orthodontic settings, thereby informing clinical practices within the United Kingdom. This research contributes to strengthening the evidence base surrounding orthodontic techniques and their implications for patient-centred care. conditions: Chairside Time and Costs Associated With Intraoral Scanning Versus Alginate Impressions studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL interventionModelDescription: Prospective single-centre parallel arm randomised controlled trial, with an allocation ratio of 1:1 to investigate the difference in chairside time and cost of alginate impressions vs intraoral scans. primaryPurpose: HEALTH_SERVICES_RESEARCH masking: SINGLE maskingDescription: Due to the nature of the study, blinding to intervention will not be possible for the participants or clinicians during data acquisition. All data analysis will be carried out blinded using a coded data set. whoMasked: OUTCOMES_ASSESSOR count: 68 type: ESTIMATED name: Alginate impression name: Intraoral scan measure: Chairside time taken for alginate impressions vs intraoral scans. measure: Cost implications of alginate impressions vs intraoral scans. sex: ALL minimumAge: 9 Years maximumAge: 50 Years stdAges: CHILD stdAges: ADULT facility: Queens Medical Centre, Nottingham University Hospitals NHS Trust city: Nottingham state: Nottinghamshire zip: NG7 2UH country: United Kingdom name: Hannah Hook, BDS role: CONTACT phone: 07853993215 email: [email protected] name: Andrew Flett, BDS role: CONTACT email: [email protected] lat: 52.9536 lon: -1.15047 hasResults: False
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<|newrecord|> nctId: NCT06345976 id: RLX_2023_10 briefTitle: Functional Impairment in Albinism acronym: PLAIB overallStatus: NOT_YET_RECRUITING date: 2024-05 date: 2025-05 date: 2025-05 date: 2024-04-03 date: 2024-04-03 name: Fondation Ophtalmologique Adolphe de Rothschild class: NETWORK briefSummary: Albinism is a genetic and hereditary anomaly that affects pigmentation. This pathology is characterized by a deficit in melanin production. In humans, the clinical diagnosis of albinism is based on a number of factors, including :
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* In the integumentary region: fair skin tone, with white hair, eyelashes and eyebrows.
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* Ophthalmological: reduced visual acuity, photophobia, nystagmus, transilluminated blue irises, hypopigmentation of the retina at the back of the eye with fovea plana.
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As treatment options begin to emerge for certain albinism-induced anomalies (including, for example, the depigmentation that causes photophobia), it is desirable to understand what these patients' complaints are, and to gather their views on the emergence of treatments targeting just one of their complaints, namely glare. conditions: Albinism, Ocular studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: PROSPECTIVE count: 50 type: ESTIMATED name: questionnaire measure: To determine whether patients with albinism would be interested in a treatment that could improve their glare without improving their visual acuity. sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT hasResults: False
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<|newrecord|> nctId: NCT06345963 id: HSC-MS-23-1044 briefTitle: Enhancing Brain Connectivity in Schizophrenia Through Neuromodulation (Study 1) overallStatus: NOT_YET_RECRUITING date: 2024-05-01 date: 2029-05-01 date: 2030-05-01 date: 2024-04-03 date: 2024-04-05 name: The University of Texas Health Science Center, Houston class: OTHER briefSummary: Patients with schizophrenia spectrum disorder (SSD) will be exposed to active repetitive transcranial magnetic stimulation (rTMS) from H coil for improving white matter integrity. conditions: Schizophrenia studyType: INTERVENTIONAL phases: NA allocation: NA interventionModel: SINGLE_GROUP primaryPurpose: TREATMENT masking: NONE count: 120 type: ESTIMATED name: active H-coil delivered rTMS measure: brain microstructural integrity from magnetic resonance imaging (MRI) measure: Resting-state functional connectivity (rsFC) from functional MRI measure: Electrophysiological responses measured by mismatch negativity and steady-state auditory evoked potentials from electroencephalography recording (EEG) measure: Cognitive insight, depression, perception, and delusion measured from questionnaires measure: Cognitive functions measured by the MATRICS consensus cognitive battery (MCCB) sex: ALL minimumAge: 18 Years maximumAge: 60 Years stdAges: ADULT facility: The University of Texas Health Science Center, Houston city: Houston state: Texas zip: 77054 country: United States name: Xiaoming Du, PhD role: CONTACT phone: 410-402-6036 email: [email protected] name: Victoria Acosta role: CONTACT phone: 713-486-2740 email: [email protected] lat: 29.76328 lon: -95.36327 hasResults: False
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<|newrecord|> nctId: NCT06345950 id: 2022-04-003 briefTitle: Pharmacokinetics and Safety of a New Micellar Glutathione Formulation overallStatus: COMPLETED date: 2022-06-21 date: 2022-12-31 date: 2023-06-30 date: 2024-04-03 date: 2024-04-03 name: Factors Group of Nutritional Companies Inc. class: INDUSTRY name: Isura briefSummary: This study seeks to determine the short-term effects of daily oral supplementation with a new micellar Glutathione formulation (LipoMicel) on the oral absorption and safety of glutathione in healthy volunteers.
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The primary objective of this study is to evaluate and compare the pharmacokinetics of a novel micellar Glutathione (GSH) formulation with that of a standard formulation as well as a liposomal GSH formulation. The secondary objective is to evaluate the safety of a new micellar GSH formulation with higher bioavailability in human participants over a 30-day study period. conditions: Bioavailability conditions: Safety studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: CROSSOVER interventionModelDescription: Participants are randomly assigned to interventions in a crossover design to assess the pharmacokinetics over 24 hours; subsequently, the safety of one intervention with higher bioavailability is evaluated in an additional single-arm, 30-day trial. primaryPurpose: TREATMENT masking: DOUBLE whoMasked: PARTICIPANT whoMasked: INVESTIGATOR count: 16 type: ACTUAL name: Liposomal Glutathione name: Standard Glutathione name: New Micellar Glutathione (Lipomicel) measure: AUC: the area under the concentration-time curve measure: Cmax: maximum plasma concentration measure: Tmax: the time point of maximum plasma concentration measure: Alanine aminotransferase (ALT) measure: Aspartate aminotransferase (AST) measure: Alkaline phosphatase (ALP) measure: Bilirubin measure: Serum creatinine measure: Blood urea nitrogen (BUN) measure: Glomerular filtration rate (GFR) measure: C-reactive protein (CRP) measure: White blood cell count (WBC) measure: Hemoglobin (Hb) measure: Hematocrit (Hct) measure: Platelet count measure: Fasting blood glucose measure: Total cholesterol measure: Low-density lipoprotein (LDL) cholesterol measure: High-density lipoprotein (HDL) cholesterol measure: Triglycerides sex: ALL minimumAge: 21 Years maximumAge: 65 Years stdAges: ADULT stdAges: OLDER_ADULT facility: ISURA city: Burnaby state: British Columbia zip: V2N 4S9 country: Canada lat: 49.26636 lon: -122.95263 hasResults: False
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<|newrecord|> nctId: NCT06345937 id: REB #44724 briefTitle: Multiple Risk Factor Intervention Trial (Ms. FIT) acronym: MsFIT overallStatus: RECRUITING date: 2024-04-01 date: 2027-08-01 date: 2028-08-01 date: 2024-04-03 date: 2024-04-04 name: University of Toronto class: OTHER name: Canadian Institutes of Health Research (CIHR) briefSummary: This study aims to produce new evidence, specific to women, on the efficacy and mechanisms of exercise and diet for cardiometabolic risk reduction in pre and postmenopausal women. Using a 3-arm randomized controlled trial (RCT) with equal recruitment and stratification by menopausal status to 6 months of: 1) exercise following Health Canada guidelines; 2) the same exercise plus counselling to follow Canada's Dietary Guidelines to improve diet quality; or 3) stretching group, this study will answer the following questions:
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* How does the impact of exercise compare among each of the causal links between physical inactivity and cardiometabolic disease in women?
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* What is the effect modification of adding a diet quality intervention to exercise?
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* What is the effect modification by menopausal status?
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The investigators hypothesize that exercise adaptations will be: 1) largest peripherally, including Matsuda index (primary outcome), Homeostatic Model Assessment of Insulin Resistance (HOMA-IR), arteriovenous oxygen difference (avO2diff), and visceral fat, compared to centrally (stroke volume (SV), endothelial function, aortic stiffness), 2) blunted or absent in post vs premenopause; 3) enhanced by the addition of diet quality which will be essential or additive for Matsuda index, metabolic syndrome, Framingham cardiovascular disease (CVD) risk, cytokines and adipokines, thigh myosteatosis, muscle mass, peak oxygen uptake (VO2peak), 4) enhanced by adding diet quality in more outcomes postmenopause. conditions: Metabolic Disturbance conditions: Sedentary Behavior studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL interventionModelDescription: 3-arm parallel-group randomized controlled trial primaryPurpose: PREVENTION masking: SINGLE maskingDescription: It is not possible to blind participants to their assigned intervention. Care providers are not involved. The outcome assessors for any assessments involving potential for subjectivity in data collection or analysis will be blinded to group assignment. whoMasked: OUTCOMES_ASSESSOR count: 180 type: ESTIMATED name: Behavioural Experimental: guidelines-based physical activity name: Behavioural Experimental: guidelines-based physical activity and healthy eating name: Behavioural: Stretching exercise measure: Insulin resistance measure: Hepatic insulin resistance measure: Metabolic syndrome severity measure: Framingham 10-year risk (%) measure: Cardiorespiratory fitness measure: Heart Rate Recovery measure: Exercise stroke volume & cardiac output measure: Left ventricular ejection fraction measure: Left ventricular mass measure: Arteriovenous Oxygen Difference (avO2diff) measure: Endothelial Function measure: Carotid Intima Media Thickness measure: Central & Peripheral Arterial stiffness measure: Blood Pressure measure: Resting Heart Rate & Heart Rate Variability measure: Thigh Myosteatosis measure: Knee flexion and extension (strength and endurance) measure: Thigh Muscle Volume measure: Biochemical markers of skeletal muscle protein content measure: Biochemical markers of skeletal muscle structure measure: Biochemical markers of skeletal muscle enzyme activity measure: Whole-body fat and fat-free mass measure: Visceral adipose tissue measure: Liver fat fraction measure: Body circumferences measure: Concentration of inflammation biomarkers in blood measure: Lipid panel: high-density lipoprotein (HDL) cholesterol, low-density lipoprotein (LDL) cholesterol, total Cholesterol, Triglycerides measure: Hemoglobin A1c measure: Dietary intake measure: Liver enzymes: alanine transaminase (ALT), aspartate aminotransferase (AST), and albumin measure: Liver fibrosis measure: Aerobic physical activity adherence measure: Resistance exercise adherence measure: Diet quality measure: Health-related quality of life measure: Menopausal symptom presence and severity measure: Psychosocial stress measure: Depression & Anxiety measure: Barriers and self-efficacy for physical activity measure: Physical activity motivation measure: Sleep quality - subjective measure: Sleep quantity and quality - device measured measure: Self-reported physical activity measure: Serum Estradiol measure: Salivary Estradiol measure: Hemoglobin measure: Free fatty acids measure: Body weight measure: Body mass index (BMI) measure: Energy Balance sex: FEMALE minimumAge: 30 Years stdAges: ADULT stdAges: OLDER_ADULT facility: University of Toronto status: RECRUITING city: Toronto state: Ontario zip: M5S 2C9 country: Canada name: Amy A. Kirkham, PhD role: CONTACT phone: 416-946-4069 email: [email protected] name: Jenna B. Gillen, PhD role: CONTACT phone: 416-978-3244 email: [email protected] lat: 43.70011 lon: -79.4163 hasResults: False
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<|newrecord|> nctId: NCT06345924 id: Meraki_Palliative Care briefTitle: Music Therapy for Cancer Patients(Meraki_PC) acronym: Meraki_Cancer overallStatus: RECRUITING date: 2024-03-01 date: 2024-07 date: 2025-07 date: 2024-04-03 date: 2024-04-15 name: University of Valencia class: OTHER briefSummary: The overall aim of the study is to analyse the impact of a music therapy-based treatment on the emotional well-being and quality of life of cancer patients in palliative care (PC). To this end, the effectiveness and efficiency of a music therapy-based treatment to improve adaptation to illness and psychological well-being in this population will be validated and implemented.
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Specifically, the implementation of an individualised treatment programme for palliative care patients will be carried out. conditions: Cancer conditions: Palliative Care studyType: INTERVENTIONAL phases: NA allocation: NON_RANDOMIZED interventionModel: PARALLEL primaryPurpose: PREVENTION masking: NONE count: 80 type: ESTIMATED name: MERAKI_PC measure: Change in Anxiety and Depression Symptomatology (T1, T2 and T4) measure: Change in Quality of Life (T1, T2 and T4) measure: Change in emotional distress (T1, T2, T3 and T4) measure: Change in Social Suport (T1 and T4) measure: Change in Resilience (T1 and T4) measure: Change in Spirituality (T1 and T4) measure: Change Knowledge of the disease (T1 and T4) measure: Barthel Index measure: Pfeiffer Short Form Mental State Questionnaire, SPMSQ measure: Charlson Comorbidity Index (CCI) sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Hospital Dr. Moliner status: RECRUITING city: Serra state: Valencia country: Spain name: Miguel Fombuena, PhD role: CONTACT email: [email protected] name: Selene Valero-Moreno, PhD role: SUB_INVESTIGATOR name: Isabel Bellver Vercher role: SUB_INVESTIGATOR name: Ana Alegre Soler role: SUB_INVESTIGATOR name: José Jorge Botella Trellis, Dr. role: SUB_INVESTIGATOR name: Cristina Rocío Espejo Fernández, Dra. role: SUB_INVESTIGATOR name: María Carmen Badía Picazo, Dra. role: SUB_INVESTIGATOR lat: 39.68333 lon: -0.43333 hasResults: False
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<|newrecord|> nctId: NCT06345911 id: NEU-49/899 briefTitle: Do Vacutainers With Animal Characters Reduce Fear and Anxiety? overallStatus: COMPLETED date: 2021-12-01 date: 2022-02-25 date: 2022-03-30 date: 2024-04-03 date: 2024-04-03 name: Burdur Mehmet Akif Ersoy University class: OTHER briefSummary: The study was designed as a randomized controlled experimental research with the purpose of determining the effect of distraction by using vacutainers of three different animal characters. conditions: Procedural Pain conditions: Acute Pain conditions: Fear conditions: Anxiety studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: SUPPORTIVE_CARE masking: NONE count: 180 type: ACTUAL name: Experimental group measure: Children's Fear Scale measure: Wong-Baker FACES Pain Rating Scale sex: ALL minimumAge: 4 Years maximumAge: 7 Years stdAges: CHILD facility: Karaman Education and Research Hospital city: Karaman country: Turkey lat: 37.18111 lon: 33.215 hasResults: False
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<|newrecord|> nctId: NCT06345898 id: 2023-1479 briefTitle: Safety and Efficacy of a Single Subretinal Injection of JWK002 Gene Therapy in Subjects With X-linked Retinoschisis(XLRS) overallStatus: RECRUITING date: 2023-11-17 date: 2026-12-30 date: 2029-12-30 date: 2024-04-03 date: 2024-04-03 name: West China Hospital class: OTHER briefSummary: This trial is to evaluate the safety and efficacy of JWK002 treatment of X-linked retinoschisis(XLRS). This study will enroll subjects aged 5-18 years old to receive a sub-retinal injection of JWK002. conditions: X Linked Retinoschisis studyType: INTERVENTIONAL phases: EARLY_PHASE1 allocation: NON_RANDOMIZED interventionModel: SEQUENTIAL primaryPurpose: TREATMENT masking: SINGLE whoMasked: PARTICIPANT count: 9 type: ESTIMATED name: JWK002 measure: Safety(Participants With Ocular and Non-ocular AEs (Adverse Events) and SAEs (Serious Adverse Events) measure: Best corrected visual acuity (BCVA) measure: Full-field electroretinogram(ff-ERG) measure: Macular structure as assessed by swept source optical coherence tomography measure: Visual field sex: MALE minimumAge: 5 Years maximumAge: 18 Years stdAges: CHILD stdAges: ADULT facility: West China Hospital status: RECRUITING city: Chengdu state: Sichuan zip: 610023 country: China name: Licong Liang role: CONTACT email: [email protected] name: Fang Lu role: CONTACT email: [email protected] lat: 30.66667 lon: 104.06667 hasResults: False
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<|newrecord|> nctId: NCT06345885 id: PROPMHP002 briefTitle: Immunogenicity and Safety of One Dose of HPV Vaccine overallStatus: COMPLETED date: 2023-02-23 date: 2024-01-17 date: 2024-01-17 date: 2024-04-03 date: 2024-04-03 name: Xiamen Innovax Biotech Co., Ltd class: INDUSTRY briefSummary: This study will assess the immunogenicity and safety of one dose of Cecolin and one dose of Gardasil conditions: Human Papillomavirus Vaccines studyType: INTERVENTIONAL phases: PHASE4 allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: PREVENTION masking: NONE count: 200 type: ACTUAL name: HPV vaccine measure: Anti-HPV seropositivity measure: Anti-HPV Seropositivity measure: HPV Antibody Titers measure: Local and Systemic Reactions/Event sex: FEMALE minimumAge: 9 Years maximumAge: 14 Years stdAges: CHILD facility: Fujian Provincial Center for Disease Control and Prevention city: Fuzhou state: Fujian zip: 350012 country: China lat: 26.06139 lon: 119.30611 hasResults: False
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<|newrecord|> nctId: NCT06345872 id: STUDY005883 id: 1R01DA054311 type: NIH link: https://reporter.nih.gov/quickSearch/1R01DA054311 briefTitle: Improving Sleep and Reducing Opioid Use in Individuals With Chronic Pain overallStatus: RECRUITING date: 2024-04 date: 2028-01 date: 2028-07 date: 2024-04-03 date: 2024-04-18 name: University of South Florida class: OTHER name: National Institutes of Health (NIH) name: National Institute on Drug Abuse (NIDA) briefSummary: The goal of this study is to test two behavioral interventions for chronic insomnia in individuals with chronic pain and use prescribed opioid medication to treat their chronic pain. conditions: Chronic Pain conditions: Chronic Insomnia conditions: Opioid Use studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: TRIPLE whoMasked: PARTICIPANT whoMasked: INVESTIGATOR whoMasked: OUTCOMES_ASSESSOR count: 165 type: ESTIMATED name: CBT-I name: Treatment as usual name: Tapered Withdrawal measure: Change in Insomnia Severity Index measure: Change in Pain Intensity - Daily Electronic Sleep Diaries measure: Change in Wake After Sleep Onset - Daily Electronic Sleep Diaries measure: Change in Sleep Onset Latency- Daily Electronic Sleep Diaries measure: Change in Sleep Efficiency- Daily Electronic Sleep Diaries measure: Change in Fatigue - Daily Electronic Sleep Diaries measure: Change in Sleep and Pain Medication - Daily Electronic Sleep Diaries measure: Change in Perceived Stress Scale measure: Change in Peripheral Arousal measure: Change in Neural Imaging: Structural/Functional MRI/Diffusion Weighted Imaging measure: Change in Thermal Pain Response measure: Change in Opioid Use (Quantitative) measure: Change in Opioid Use (Self-Report) measure: Change in Objective Wake After Sleep Onset (Actigraph) measure: Change in Objective Sleep Onset Latency (Actigraph) measure: Change in Objective Sleep Efficiency (Actigraph) measure: Change in Neural Connectivity: Structural/Functional MRI/Diffusion Weighted Imaging measure: Short Inventory of Problems measure: Change in Pain Catastrophizing Scale measure: Change in 36-Item Short Form Survey (SF-36) measure: Change in Depression (Beck Depression Inventory-II) measure: Change in State-Trait Anxiety Inventory (STAI) measure: Medications/Substances Uses and Dosages measure: Change in Subjective Opioid Withdrawal Scale (SOWS) measure: Change in Opioid Cravings Scale measure: Change in NIH Toolbox sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: University of South Florida status: RECRUITING city: Tampa state: Florida zip: 33612 country: United States name: Christina S McCrae, PhD role: CONTACT phone: 813-974-1804 email: [email protected] name: Jasmine L Niazi, MS role: CONTACT phone: (813) 906-0483 email: [email protected] lat: 27.94752 lon: -82.45843 hasResults: False
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<|newrecord|> nctId: NCT06345859 id: UP-23-00467 id: R01MH133842 type: NIH link: https://reporter.nih.gov/quickSearch/R01MH133842 briefTitle: Regulation of Affect and Physiology in Depression acronym: RAPID overallStatus: RECRUITING date: 2024-03-22 date: 2028-04-30 date: 2029-06-30 date: 2024-04-03 date: 2024-04-03 name: University of Southern California class: OTHER name: National Institute of Mental Health (NIMH) briefSummary: Although treatments for depression are effective for many people, not everyone responds to treatment. This lack of treatment response could be due, in part, to the presence of multiple underlying causes of people's depression. This study aims to identify subtypes of depression, based on two factors: how successful people perceive themselves to be at regulating their affect in everyday life; and how much activity in the parasympathetic nervous system increases during moments when people try to regulate. The study involves ambulatory assessment of affect, regulation strategies, and physiological activity in everyday life, in a sample of young adults with remitted major depressive disorder and healthy volunteers. We will study regulation responses in the lab to further determine how subtypes differ in neural, physiological, and behavioral responses. Finally, participants will be randomly assigned to a remote, self-administered biofeedback intervention (vs. control intervention) designed to increase parasympathetic activity and physiological regulation success. While engaging in biofeedback at home for 10 days, participants will simultaneously repeat the ambulatory assessments. This design will allow us to determine the proximal impact of biofeedback on indices of regulation success in everyday life, and whether biofeedback has differential impact on regulation success for different subtypes. conditions: Major Depressive Disorder studyType: INTERVENTIONAL phases: PHASE2 allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: BASIC_SCIENCE masking: DOUBLE whoMasked: INVESTIGATOR whoMasked: OUTCOMES_ASSESSOR count: 252 type: ESTIMATED name: Heart rate variability biofeedback measure: Physiological regulation success measure: Average level of heart rate variability measure: Perceived regulation success sex: ALL minimumAge: 18 Years maximumAge: 27 Years stdAges: ADULT facility: University of Southern California status: RECRUITING city: Los Angeles state: California zip: 90089 country: United States name: Umiemah Farrukh role: CONTACT phone: 213-740-4503 email: [email protected] lat: 34.05223 lon: -118.24368 hasResults: False
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<|newrecord|> nctId: NCT06345846 id: Secondary IOL briefTitle: Stability of Secondary Intraocular Lenses With no Capsular Support overallStatus: ENROLLING_BY_INVITATION date: 2022-12-30 date: 2025-12 date: 2025-12 date: 2024-04-03 date: 2024-04-03 name: Vienna Institute for Research in Ocular Surgery class: OTHER briefSummary: Assessment and differences in the centration, tilt and wobble of two secondary IOLs without capsular support. conditions: Cataract studyType: INTERVENTIONAL phases: NA allocation: NON_RANDOMIZED interventionModel: PARALLEL primaryPurpose: BASIC_SCIENCE masking: NONE count: 82 type: ESTIMATED name: IFIOL name: SFIOL measure: Centration of the IOL measure: Tilt of the IOL sex: ALL minimumAge: 21 Years maximumAge: 100 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Vienna Institute for Research in Ocular Surgery (VIROS), Hanusch Hospital, Vienna city: Vienna zip: 1140 country: Austria lat: 48.20849 lon: 16.37208 hasResults: False
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<|newrecord|> nctId: NCT06345833 id: ENT-2024-32847 briefTitle: Topical and Local TXA in Facelifts - A Randomized Controlled Double Blinded Study overallStatus: NOT_YET_RECRUITING date: 2024-07-01 date: 2026-07-01 date: 2026-07-01 date: 2024-04-03 date: 2024-04-10 name: University of Minnesota class: OTHER briefSummary: Tranexamic acid (TXA) is a fibrinolytic inhibitor which prevents prolonged bleeding by interfering with fibrin clot breakdown by competitively binding to lysine receptors on plasminogen; this prevents the conversion of plasminogen to plasmin. TXA will be applied to a randomly assigned side of the face during facelift surgery. The intervention groups will include 1% TXA mixed with standard local consisting 1/4% lidocaine with 1:100,000 epinephrine, 3% TXA on TXA-soaked pledgets applied for 10 minutes, and 1% TXA with local plus 3% TXA-soaked pledgets. Each treatment arm will be compared to saline in place of TXA on the contralateral side of the face.
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Although TXA has been widely used in surgical fields for decades and is officially recommended by agencies such as ACOG for use during maternal hemorrhage, its current FDA approval only pertains to oral TXA for heavy menstrual bleeding and IV use for patients with hemophilia to prevent or reduce hemorrhage (cite). The main concern with intravenous TXA is the increased risk for the potential formation of blood clots, mainly in patients with clotting disorders, such as Facor V Leiden, and patients on estrogen containing medication. A recent systemic review with metanalysis by Wang et.al contained a total of 2150 patients receiving IV TXA while undergoing plastic surgery concluded that use of IV TXA does not lead to increased adverse events.\[12\] Given the low rate of adverse events while using TXA systemically, this protocol's application of TXA topically and/or locally negates the risk for any potential systemic adverse effects. No systemic adverse effects have been reported in studies examining local TXA in facial plastic surgery to date. conditions: Hemophilia conditions: Hemorrhage conditions: Facelift Surgery studyType: INTERVENTIONAL phases: EARLY_PHASE1 allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: SUPPORTIVE_CARE masking: DOUBLE whoMasked: PARTICIPANT whoMasked: OUTCOMES_ASSESSOR count: 50 type: ESTIMATED name: 1%Tranexamic acid with standard local name: 3% TXA name: 1% TXA with local plus 3% TXA-soaked pledgets measure: Blood loss measure: adverse effects of TXA rates sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT hasResults: False
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<|newrecord|> nctId: NCT06345820 id: Evolux briefTitle: Comparison of Two Non-diffractive Enhanced Monofocal Intraocular Lenses overallStatus: RECRUITING date: 2023-06-28 date: 2025-06 date: 2025-06 date: 2024-04-03 date: 2024-04-04 name: Vienna Institute for Research in Ocular Surgery class: OTHER briefSummary: Comparison of the clinical performance of two enhanced monofocal IOLs with similar design. conditions: Cataract studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: BASIC_SCIENCE masking: DOUBLE whoMasked: PARTICIPANT whoMasked: INVESTIGATOR count: 35 type: ESTIMATED name: Evolux name: Tecnis Eyhance measure: Monocular intermediate visual acuity measure: Monocular distance visual acuity measure: Monocular near visual acuity sex: ALL minimumAge: 21 Years maximumAge: 105 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Vienna Institute for Research in Ocular Surgery (VIROS), Hanusch Hospital, Vienna status: RECRUITING city: Vienna zip: 1140 country: Austria name: Andreas Rotter, MD role: CONTACT phone: 01 91021 phoneExt: 57564 email: [email protected] name: Manuel Ruiss, MSc role: CONTACT phone: 01 91021 phoneExt: 57564 email: [email protected] lat: 48.20849 lon: 16.37208 hasResults: False
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<|newrecord|> nctId: NCT06345807 id: 2023-A02617-38 briefTitle: Innovative Care Pathway in Physical Activity and Behavior Change in Coronary Patients Post-cardiac Rehabilitation acronym: APIC overallStatus: NOT_YET_RECRUITING date: 2024-05 date: 2026-11 date: 2026-11 date: 2024-04-03 date: 2024-04-05 name: Elsan class: OTHER briefSummary: The objective of this 18-month research is to show the effectiveness of an individualized physical activity( PA) compared to standard PA management and voluntary PA, to achieve a change in the behavior of the coronary patient. conditions: Individualised Physical Activity Program conditions: Coronary Patient studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL interventionModelDescription: interventional study, randomized in 3 parallel groups, single center, primaryPurpose: SUPPORTIVE_CARE masking: NONE count: 192 type: ESTIMATED name: Individuals activity programs name: activity program name: no Physical Activity program measure: 6 minutes walk test sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT hasResults: False
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<|newrecord|> nctId: NCT06345794 id: 27111 id: J5C-MC-FOAG type: OTHER domain: DICE Therapeutics, a wholly owned subsidiary of Eli Lilly and Company briefTitle: A Study to Assess LY4100511 (DC-853) in Healthy Adult Participants overallStatus: NOT_YET_RECRUITING date: 2024-04-03 date: 2024-06-17 date: 2024-06-17 date: 2024-04-03 date: 2024-04-03 name: DICE Therapeutics, Inc., a wholly owned subsidiary of Eli Lilly and Company class: INDUSTRY name: Eli Lilly and Company briefSummary: The main purpose of this study is to assess the effect of multiple doses of itraconazole, fluconazole, and carbamazepine on single dose pharmacokinetic of LY4100511 (DICE-853) in healthy participants. The study will also evaluate the safety and tolerability of LY4100511 (DICE-853) with itraconazole, fluconazole, and carbamazepine. conditions: Healthy studyType: INTERVENTIONAL phases: PHASE1 allocation: NON_RANDOMIZED interventionModel: PARALLEL primaryPurpose: BASIC_SCIENCE masking: NONE count: 50 type: ESTIMATED name: LY4100511 (DC-853) name: Itraconazole name: Fluconazole name: Carbamazepine measure: Pharmacokinetics (PK): Maximum Observed Concentration (Cmax) of LY4100511 (DC-853) measure: PK: PK: Area Under the Concentration Versus Time Curve From Zero to Last Measurable Concentration (AUC[0-t]) of LY4100511 (DC-853) measure: PK: Area Under the Concentration Versus Time Curve From Zero to Infinity (AUC[0-inf]) of LY4100511 (DC-853) sex: ALL minimumAge: 18 Years maximumAge: 55 Years stdAges: ADULT facility: ICON San Antonio Clinical Research Unit city: San Antonio state: Texas zip: 78209 country: United States role: CONTACT phone: 210-283-4500 name: Chinonye Ogbonnaya-Odor role: PRINCIPAL_INVESTIGATOR lat: 29.42412 lon: -98.49363 hasResults: False
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<|newrecord|> nctId: NCT06345781 id: 2174433-1 briefTitle: Abdominal Functional Electrical Stimulation to Improve Bowel Function in Spinal Cord Injury overallStatus: NOT_YET_RECRUITING date: 2024-04 date: 2025-04 date: 2025-05 date: 2024-04-03 date: 2024-04-03 name: Craig Hospital class: OTHER name: Neuroscience Research Australia briefSummary: The primary objective of this study is to gather information about the effectiveness of abdominal FES to improve bowel management time (BMT) for people with chronic SCI. This study will also evaluate whether abdominal FES can improve: 1) bowel-related quality of life, 2) participant-reported bowel function, 3) bowel management strategy, 4) bladder symptoms, and 5) unplanned hospital admissions. In addition, we will also explore participant perspectives and experiences about the stimulation sessions and use of the device. conditions: Spinal Cord Injuries conditions: Neurogenic Bowel studyType: INTERVENTIONAL phases: NA allocation: NA interventionModel: SINGLE_GROUP primaryPurpose: TREATMENT masking: NONE count: 15 type: ESTIMATED name: Abdominal Functional Electrical Stimulation measure: Bowel Management Time (BMT) measure: Bowel Management Strategy measure: Stimulation Dose measure: EuroQoL 5 Dimension 5 Level (EQ-5D-5L) Questionnaire measure: International Spinal Cord Society's (ISCoS) International SCI Bowel Function Basic Data Set Questionnaire measure: Visual Analog Scale (VAS) measure: Neurogenic Bladder Symptom Score (NBSS) measure: Intervention Acceptability measure: Intervention Safety sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Craig Hospital city: Englewood state: Colorado zip: 80113 country: United States lat: 39.64777 lon: -104.98776 hasResults: False
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<|newrecord|> nctId: NCT06345768 id: 147258369 briefTitle: The Effect of the Stress Ball Applied Before Colocystectomy Surgery on Patients' Fear, Stress and Comfort. overallStatus: NOT_YET_RECRUITING date: 2024-04-01 date: 2024-08-01 date: 2024-09-01 date: 2024-04-03 date: 2024-04-03 name: Akdeniz University class: OTHER briefSummary: Cholecystectomy is the most common major abdominal surgical procedure in western countries. Patients may experience fear and anxiety before surgery.
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Stress ball, one of the distraction methods, is an effective method in providing cognitive focus. It is seen that the stress ball method is used to reduce patients' anxiety and pain. Squeezing the stress ball during the surgical procedure allows patients to have direct control over the object, increasing their sense of empowerment. In this way, it has a positive effect on anxiety and patient satisfaction without interfering with the surgical procedure.
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In this study, it is aimed to evaluate the effect of preoperative use of stress ball on patients' fear, stress and comfort in order to determine the effect of stress ball applied before cholecystectomy surgery on patients' surgical fear, stress and comfort. It is thought that the data obtained as a result of the research will provide evidence for the effect of the stress ball, which is a non-pharmacological method used before the procedure, on fear, stress and comfort. conditions: Cholecystitis conditions: Stress conditions: Fear conditions: Comfort studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: PREVENTION masking: NONE count: 90 type: ESTIMATED name: Stress Ball measure: Fear of surgery measure: Fear of surgery measure: Comfort measure: Comfort measure: Stress measure: Stress sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT hasResults: False
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<|newrecord|> nctId: NCT06345755 id: VX23-407-001 briefTitle: A Phase 1 Study to Evaluate Safety, Tolerability, and Pharmacokinetics (PK) of VX-407 in Healthy Participants overallStatus: RECRUITING date: 2024-04 date: 2025-04 date: 2025-04 date: 2024-04-03 date: 2024-04-26 name: Vertex Pharmaceuticals Incorporated class: INDUSTRY briefSummary: The purpose of the study is to evaluate the safety, tolerability, and pharmacokinetic parameters of VX-407 in healthy participants. conditions: Autosomal Dominant Polycystic Kidney Disease (ADPKD) studyType: INTERVENTIONAL phases: PHASE1 allocation: RANDOMIZED interventionModel: SEQUENTIAL primaryPurpose: TREATMENT masking: QUADRUPLE whoMasked: PARTICIPANT whoMasked: CARE_PROVIDER whoMasked: INVESTIGATOR whoMasked: OUTCOMES_ASSESSOR count: 95 type: ESTIMATED name: VX-407 name: Placebo name: Midazolam measure: Part A: Safety and Tolerability as Assessed by Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs) measure: Part B: Safety and Tolerability as Assessed by Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs) measure: Part C: Maximum Observed Plasma Concentration (Cmax) of MDZ in Absence and Presence of VX-407 measure: Part C: Area Under the Concentration Versus Time Curve (AUC) of MDZ in Absence and Presence of VX-407 measure: Part A: Maximum Observed Plasma Concentration (Cmax) of VX-407 measure: Part B: Maximum Observed Plasma Concentration (Cmax) of VX-407 measure: Part A: Area Under the Concentration Versus Time Curve (AUC) of VX-407 measure: Part B: Area Under the Concentration Versus Time Curve (AUC) of VX-407 measure: Part C: Safety and Tolerability as Assessed by Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs) sex: ALL minimumAge: 18 Years maximumAge: 55 Years stdAges: ADULT facility: ICON Lenexa status: RECRUITING city: Lenexa state: Kansas zip: 66219 country: United States lat: 38.95362 lon: -94.73357 hasResults: False
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<|newrecord|> nctId: NCT06345742 id: ATADEK-2023-10/396 briefTitle: The Effect of Parental Participation on Newborn Comfort During Diaper Care overallStatus: RECRUITING date: 2023-12-19 date: 2025-02-01 date: 2025-02-01 date: 2024-04-03 date: 2024-04-03 name: Acibadem University class: OTHER briefSummary: It was aimed to determine the effect of parental participation on newborn comfort during diaper care practice in preterm infants.
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H1: Parental participation during infant diaper care practice in preterm infants has an effect on newborn comfort.
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H2: There is a difference in the effect of parent diaper care practice and the participation of the mother or father on newborn comfort in preterm infants.
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H3: There is a difference between the stress levels of parents before the application of infant diaper care in preterm infants. conditions: Preterm studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: SUPPORTIVE_CARE masking: NONE count: 105 type: ESTIMATED name: No parental participation name: Mother participation name: Father participation measure: Level of Parental Stress measure: Change in Level of Comfort sex: ALL minimumAge: 1 Day maximumAge: 28 Days stdAges: CHILD facility: Acıbadem University status: RECRUITING city: İstanbul state: Ataşehir zip: 34750 country: Turkey name: Tuğba Türker, Nurse role: CONTACT email: [email protected] lat: 41.01384 lon: 28.94966 hasResults: False
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<|newrecord|> nctId: NCT06345729 id: 1084-004 id: MK-1084-004 type: OTHER domain: Merck id: U1111-1296-8093 type: OTHER domain: UTN id: 2023-507776-42 type: REGISTRY domain: EU CT briefTitle: A Study of MK-1084 Plus Pembrolizumab (MK-3475) in Participants With KRAS G12C Mutant, Metastatic Non-small Cell Lung Cancer (NSCLC) With Programmed Cell Death Ligand 1 (PD-L1) Tumor Proportion Score (TPS) ≥50% (MK-1084-004) overallStatus: NOT_YET_RECRUITING date: 2024-04-26 date: 2029-02-19 date: 2031-02-18 date: 2024-04-03 date: 2024-04-09 name: Merck Sharp & Dohme LLC class: INDUSTRY briefSummary: This is a study evaluating the efficacy and safety of MK-1084 with pembrolizumab as first-line treatment in participants with metastatic non-small cell lung cancer (NSCLC) with identified Kirsten rat sarcoma viral oncogene homolog G12C (KRAS G12C) mutation and programmed cell death ligand 1 (PD-L1) tumor proportion score (TPS) ≥50%. There are two primary study hypotheses:
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Hypothesis 1: Combination of MK-1084 and pembrolizumab is superior to placebo plus pembrolizumab with respect to progression free survival (PFS) per Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1) by blinded independent central review (BICR).
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Hypothesis 2: Combination of MK-1084 plus pembrolizumab is superior to placebo plus pembrolizumab with respect to overall survival (OS). conditions: Non-small Cell Lung Cancer studyType: INTERVENTIONAL phases: PHASE3 allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: TRIPLE whoMasked: PARTICIPANT whoMasked: INVESTIGATOR whoMasked: OUTCOMES_ASSESSOR count: 600 type: ESTIMATED name: MK-1084 name: Placebo name: Pembrolizumab measure: Progression-Free Survival (PFS) measure: Overall Survival (OS) measure: Objective Response Rate (ORR) measure: Duration of Response (DOR) measure: Number of Participants Who Experience One or More Adverse Event (AEs) measure: Number of Participants Who Discontinue Study Treatment Due to an Adverse Event (AE) measure: Change from Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-Core 30 (EORTC QLQ-C30) Global Health Status (Item 29) and Quality of Life (Item 30) Combined Score measure: Change from Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-Core 30 (EORTC QLQ-C30) Physical Functioning (Items 1-5) Score measure: Change from Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-Core 30 (EORTC QLQ-C30) Role Functioning (Items 6 and 7) Score measure: Change from Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-Core 30 (EORTC QLQ-C30) Dyspnea (Item 8) Score measure: Change from Baseline in European Organization for Research and Treatment of Cancer Quality of Life Lung Cancer-Specific Questionnaire Module (EORTC QLQ-C13) Cough (Item 31) Score measure: Change from Baseline in European Organization for Research and Treatment of Cancer Quality of Life Lung Cancer-Specific Questionnaire Module (EORTC QLQ-LC13) Chest pain (Item 40) Score measure: Time to Deterioration (TTD) in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-Core 30 (EORTC QLQ-C30) Global Health Status (Item 29) and Quality of Life (Item 30) Combined Score measure: Time to Deterioration (TTD) in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-Core 30 (EORTC QLQ-C30) Physical Functioning (Items 1-5) Score measure: Time to Deterioration (TTD) in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-Core 30 (EORTC QLQ-C30) Role Functioning (Items 6 and 7) Score measure: Time to Deterioration (TTD) in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-Core 30 (EORTC QLQ-C30) Dyspnea (Item 8) Score measure: Time to Deterioration (TTD) in European Organization for Research and Treatment of Cancer Quality of Life Lung Cancer-Specific Questionnaire Module (EORTC QLQ-C13) Cough (Item 31) Score measure: Time to Deterioration (TTD) in European Organization for Research and Treatment of Cancer Quality of Life Lung Cancer-Specific Questionnaire Module (EORTC QLQ-C13) Chest pain (Item 40) Score sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT hasResults: False
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<|newrecord|> nctId: NCT06345716 id: renal colic 2024 briefTitle: Paracetamol-Tramadol and Paracetamol-caffeine Versus Placebo in the Emergency Discharge Treatment of Renal Colic acronym: RC overallStatus: NOT_YET_RECRUITING date: 2024-04-10 date: 2025-03-15 date: 2025-11-30 date: 2024-04-03 date: 2024-04-03 name: University of Monastir class: OTHER briefSummary: This is a prospective, randomized, single-blind study. Patients included in the study after successful treatment of the acute attack were randomized upon discharge from the Emergency Department into three groups: oral paracetamol-tramadol group, oral paracetamol-caffeine group and oral placebo group. conditions: Renal Colic studyType: INTERVENTIONAL phases: PHASE2 allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: SINGLE whoMasked: PARTICIPANT count: 1500 type: ESTIMATED name: paracétamol tramadol name: Paracétamol cafeine name: Placebo measure: Pain recurrence measure: Painful recurrence measure: number of patient who revist the ED for residual pain measure: Adverse effects sex: ALL minimumAge: 18 Years maximumAge: 99 Years stdAges: ADULT stdAges: OLDER_ADULT hasResults: False
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<|newrecord|> nctId: NCT06345703 id: NeuShen Therapeutics briefTitle: First-into-human Study of NS-136 in Healthy Subjects overallStatus: NOT_YET_RECRUITING date: 2024-04 date: 2024-11 date: 2025-02 date: 2024-04-03 date: 2024-04-03 name: NeuShen Therapeutics class: INDUSTRY briefSummary: The goal of this clinical trial is to exlplore the profile of NS-136 in health conditions. The main questions it aims to answer are:
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* Is NS-136 safe and tolerable in heathy subjects under tested dosing regimen?
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* What is the pharmacokinectic profile of NS-136 in healthy subjects under tested dosing regimen? conditions: Healthy Subjects studyType: INTERVENTIONAL phases: PHASE1 allocation: RANDOMIZED interventionModel: SEQUENTIAL interventionModelDescription: The trial consists of three parts: the first part is a single ascending dose (SAD) study, the second part is a multiple ascending dose (MAD) study, and the third part is food effect (FE) study. The first two parts (SAD and MAD) will be randomized, double-blind, single or multiple ascending dose and placebo-controlled study designs. The third part (FE) will be a randomized, open-label, two-period, crossover study design. To evaluate the safety, tolerability, pharmacokinetic profile, and the effect of food on the PK profile of NS-136 in healthy subjects and to determine the maximum tolerated dose (MTD) primaryPurpose: TREATMENT masking: TRIPLE whoMasked: PARTICIPANT whoMasked: CARE_PROVIDER whoMasked: INVESTIGATOR count: 60 type: ESTIMATED name: Placebo name: NS-136 tablet measure: Number of Participants with Treatment-Related Adverse Events measure: Main pharmacokinetic parameters measure: Main pharmacokinetic parameters measure: Main pharmacokinetic parameters measure: Main pharmacokinetic parameters measure: Main pharmacokinetic parameters measure: Main pharmacokinetic parameters sex: ALL minimumAge: 18 Years maximumAge: 65 Years stdAges: ADULT stdAges: OLDER_ADULT facility: CMAX Clinical Research Pty Ltd city: Adelaide state: South Australia zip: 5000 country: Australia name: Study Services Director role: CONTACT phone: +61 08 7088 7900 email: [email protected] lat: -34.92866 lon: 138.59863 hasResults: False
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<|newrecord|> nctId: NCT06345690 id: VIA-2023-003 briefTitle: VIA Disc NP Registry 3.0 overallStatus: RECRUITING date: 2024-02-27 date: 2027-01-01 date: 2027-01-01 date: 2024-04-03 date: 2024-04-03 name: VIVEX Biologics, Inc. class: INDUSTRY name: Moxie Clinical briefSummary: Registry is to observe and trend patterns of care and outcomes for patients treated with VIA Disc NP. conditions: Discogenic Pain conditions: Back Pain conditions: Back Pain, Low studyType: OBSERVATIONAL observationalModel: CASE_ONLY timePerspective: PROSPECTIVE count: 500 type: ESTIMATED name: VIA Disc NP measure: Numeric Pain Rating Scale (NPRS) measure: Oswestry Disability Index (ODI) measure: Patient Satisfaction measure: Pain Medication sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: The Denver Spine & Pain Institute status: RECRUITING city: Greenwood Village state: Colorado zip: 80111 country: United States name: Josephine Steinbrecher role: CONTACT email: [email protected] name: Scott Bainbridge, M.D. role: PRINCIPAL_INVESTIGATOR lat: 39.61721 lon: -104.95081 facility: The Orthopedic Institute status: RECRUITING city: Gainesville state: Florida zip: 32605 country: United States name: Carole Newell role: CONTACT email: [email protected] name: Ajay Antony, M.D. role: PRINCIPAL_INVESTIGATOR lat: 29.65163 lon: -82.32483 facility: Interventional Pain Specialists - Pain Clinic status: RECRUITING city: Opelousas state: Louisiana zip: 70570 country: United States name: Lisa Briggs role: CONTACT email: [email protected] name: Albert Gros, M.D. role: PRINCIPAL_INVESTIGATOR lat: 30.53353 lon: -92.08151 facility: Premier Pain Solutions status: RECRUITING city: Asheville state: North Carolina zip: 28803 country: United States name: Courtney Musser role: CONTACT email: [email protected] name: Javid Baksh, M.D. role: PRINCIPAL_INVESTIGATOR lat: 35.60095 lon: -82.55402 facility: Crystal Coast Pain Management status: RECRUITING city: New Bern state: North Carolina zip: 28560 country: United States name: Amy Harum role: CONTACT email: [email protected] name: Kirk Harum, M.D. role: PRINCIPAL_INVESTIGATOR lat: 35.10849 lon: -77.04411 hasResults: False
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<|newrecord|> nctId: NCT06345677 id: ViXe-CLP-0002 briefTitle: Clinical Trial for the Assessment of Safety, Usability and Efficacy of the Vixe Combination for OAB in Female Subjects acronym: XAVIER overallStatus: COMPLETED date: 2023-06-09 date: 2024-02-01 date: 2024-02-01 date: 2024-04-03 date: 2024-04-09 name: Vensica Therapeutics Ltd. class: INDUSTRY name: Blueclinical, Ltd. briefSummary: The goal of this interventional clinical trial is to assess the safety, usability and initial efficacy of Xeomin and Vibe combination (ViXe) compared to placebo + sham in female subjects with idiopathic Overactive Bladder. The main question\[s\] it aims to answer are: • The rate of device and drug related serious adverse events during treatment and throughout the follow up period • Investigator, subject and technician satisfaction from treatment, and • Assess the initial efficacy of the drug-device combination compared to placebo-sham combination. Participants will be treated a single time with the ViXe combination and will be followed up for a period of 12 weeks, during which they will visit the clinic after 2, 6 and 12 weeks. Participants will complete a 3-day voiding diary prior to the 6- and 12-week FU visit. conditions: Overactive Bladder studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: TRIPLE whoMasked: PARTICIPANT whoMasked: CARE_PROVIDER whoMasked: INVESTIGATOR count: 48 type: ACTUAL name: ViXe Xombination name: Placebo + Sham measure: Adverse Events Rate measure: Usability and ease-of-use perception by investigator, subject and technician measure: Daily Urgency Urinary Incontinence measure: Total Daily Episodes measure: Urinary Urgency measure: Voiding Leaks measure: Quality of Life Queationnsaire measure: Nocturia sex: FEMALE minimumAge: 18 Years maximumAge: 80 Years stdAges: ADULT stdAges: OLDER_ADULT facility: CHUC city: Coimbra country: Portugal lat: 40.20564 lon: -8.41955 facility: HSOG city: Guimarães country: Portugal lat: 41.44443 lon: -8.29619 facility: CHLN city: Lisboa country: Portugal lat: 38.71667 lon: -9.13333 facility: CHUSJ city: Porto country: Portugal lat: 41.14961 lon: -8.61099 facility: Hospital Lusíadas city: Porto country: Portugal lat: 41.14961 lon: -8.61099 facility: Hospital Prelada city: Porto country: Portugal lat: 41.14961 lon: -8.61099 facility: Hospital Luz Setúbal city: Setúbal country: Portugal lat: 38.5244 lon: -8.8882 facility: CHVNG city: Vila Nova De Gaia country: Portugal lat: 41.13363 lon: -8.61742 hasResults: False
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<|newrecord|> nctId: NCT06345664 id: 548/2022BO1 briefTitle: Interdisciplinary E-health Based Follow-up of Preterm Born Children acronym: NeoUp overallStatus: RECRUITING date: 2023-03-01 date: 2024-10 date: 2024-12 date: 2024-04-03 date: 2024-04-08 name: University Hospital Tuebingen class: OTHER briefSummary: The aim of the study is to assess mental and somatic symptoms of preterm born children at the ages of 2, 5 and 10 by a multidisciplinary team and to evaluate an app that screens for these symptoms. Furthermore, there will be an evaluation of an intervention by our multidisciplinary team that provides recommendations for further treatment and diagnostic procedures of the children. conditions: Preterm Birth studyType: INTERVENTIONAL phases: NA allocation: NA interventionModel: SINGLE_GROUP primaryPurpose: SUPPORTIVE_CARE masking: NONE count: 90 type: ESTIMATED name: Diagnostics and intervention recommendations measure: Bayley Scales of Infant and Toddler Development measure: Wechsler Intelligence Scale for Children (WISC-V) measure: Children's Sleep Habit Questionnaire (CSHQ-DE 4-10) measure: Sleep Self Report (SSR) measure: Somatics measure: Child Behavior Checklist (CBCL) measure: Youth Self Report (YSR) measure: Diagnostic-system for mental illness for children and adolescents - III (DISYPS-III SCREEN FBB and SBB) measure: KIDSCREEN-27 (The KIDSCREEN) measure: Parent's Stress Inventory (EBI) measure: App-questions measure: Postexperimental questionnaire measure: Demographic data measure: Actigraphy measurement measure: Video of a sleeping sequence measure: Sleep cartoon for children measure: Kiddie-Sads-Present and Lifetime Version (K-SADS PL) measure: Self efficacy dealing with social situations (WIRKSOZ) measure: Group interviews sex: ALL minimumAge: 2 Years maximumAge: 10 Years stdAges: CHILD facility: University Hospital Tuebingen status: RECRUITING city: Tuebingen zip: 72076 country: Germany name: Annette Conzelmann, Prof. Dr. role: CONTACT name: Axel Franz, Prof. Dr. role: PRINCIPAL_INVESTIGATOR name: Mirja Quante, Dr. role: PRINCIPAL_INVESTIGATOR name: Andrea Bevot, Dr. role: PRINCIPAL_INVESTIGATOR name: Anna Haigis role: SUB_INVESTIGATOR name: Dorothee Fütterer, Dr. role: SUB_INVESTIGATOR name: Annette Conzelmann, Prof. Dr. role: PRINCIPAL_INVESTIGATOR name: Tobias Renner, Prof. Dr. role: PRINCIPAL_INVESTIGATOR lat: 48.52266 lon: 9.05222 hasResults: False
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<|newrecord|> nctId: NCT06345651 id: 2023-03, Version 7 briefTitle: Brain Oscillation-synchronized Stimulation of the Frontal Cortex in Major Depressive Disorder acronym: BOSSFRONT2 overallStatus: RECRUITING date: 2023-09-01 date: 2025-08 date: 2025-08 date: 2024-04-03 date: 2024-04-03 name: University Hospital Tuebingen class: OTHER briefSummary: Major depressive disorder (MDD) is a common severe psychiatric disease with enormous socioeconomic costs for the patient and society alike. Current pharmacological treatments are ineffective in a substantial fraction of patients and are accompanied by unwanted side effects. Using a novel non-invasive brain stimulation method to specifically target and modulate dysfunctional brain oscillations with high spatial and temporal precision this study will investigate the efficacy of EEG-triggered transcranial magnetic stimulation to alleviate de-pressive symptomatology in patients with MDD in a double-blind randomized controlled pilot clinical trial. conditions: Major Depressive Disorder studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL interventionModelDescription: The study is a single-site randomized standard TMS therapy-controlled double-blind paral-lel-group design clinical trial. primaryPurpose: TREATMENT masking: TRIPLE maskingDescription: In both conditions the identical setup is used consisting of Neuronavigation, EEG and TMS. Only in the experimental condition the treatment will be EEG-informed. In the control condition the treatment will be applied indepentently of the EEG signal. whoMasked: PARTICIPANT whoMasked: INVESTIGATOR whoMasked: OUTCOMES_ASSESSOR count: 30 type: ESTIMATED name: Transcranial Magnetic Stimulation measure: Montgomery-Åsberg Depression Rating Scale (MADRS) measure: MADRS (Montgomery-Åsberg Depression Rating Scale) 4 weeks after intervention measure: HDRS-17 (Hamilton Depression Rating Scale-17) measure: BDI-2 (Beck Depression Inventory-2) measure: IDS-30 (Inventory of depressive symptoms-30) measure: Response Rate measure: Remission Rate sex: ALL minimumAge: 18 Years maximumAge: 65 Years stdAges: ADULT stdAges: OLDER_ADULT facility: University Hospital Tuebingen status: RECRUITING city: Tuebingen state: Baden-Wuerttemberg zip: 72076 country: Germany name: Anne Lieb, Dr. role: CONTACT phone: +4970712980483 email: [email protected] name: Andreas J. Fallgatter, Prof. role: PRINCIPAL_INVESTIGATOR name: Ulf Ziemann, Prof. role: PRINCIPAL_INVESTIGATOR name: Julia Becker-Sadzio, Dr. role: SUB_INVESTIGATOR name: Anne Lieb, Dr. role: PRINCIPAL_INVESTIGATOR lat: 48.52266 lon: 9.05222 hasResults: False
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<|newrecord|> nctId: NCT06345638 id: 854343 briefTitle: Sex Hormones and Inflammatory Biomarkers in Patients With Sickle Cell Disease overallStatus: ENROLLING_BY_INVITATION date: 2024-03-01 date: 2025-04-30 date: 2025-05-31 date: 2024-04-03 date: 2024-04-03 name: University of Pennsylvania class: OTHER briefSummary: This study aims to characterize sex differences in the pathophysiology of vaso-occlusive crises (VOC) occurring among individuals with sickle cell disease (SCD).
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* The study will compare CRP and other biomarkers between females with SCD in the follicular phase of the menstrual cycle and males with SCD.
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* The study will explore potential sex differences in biomarker changes between females and males with SCD during and following resolution of VOC.
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* The study will compare neutrophil and platelet adhesion to the endothelium and real time fibrin deposition in the blood. conditions: Sickle Cell Disease conditions: Vaso-occlusive Crisis studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: PROSPECTIVE count: 40 type: ESTIMATED measure: C-reactive protein level sex: ALL minimumAge: 18 Years maximumAge: 45 Years stdAges: ADULT facility: Penn Medicine University City city: Philadelphia state: Pennsylvania zip: 19104 country: United States lat: 39.95233 lon: -75.16379 facility: Pennsylvania Hospital city: Philadelphia state: Pennsylvania zip: 19107 country: United States lat: 39.95233 lon: -75.16379 facility: Hospital of the University of Pennsylvania city: Philadelphia state: Pennsylvania zip: 19143 country: United States lat: 39.95233 lon: -75.16379 hasResults: False
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<|newrecord|> nctId: NCT06345625 id: 6012 briefTitle: Gait and Postural Balance Analysis During Head-motion Perturbed Standing and Walking in Older Adults acronym: BALANCAR overallStatus: RECRUITING date: 2024-04-15 date: 2027-01 date: 2028-01 date: 2024-04-03 date: 2024-04-16 name: Universiteit Antwerpen class: OTHER briefSummary: The main aim of this study is to unravel the biomechanics of postural balance reactions during head-motion perturbed standing and walking in older adults who fall, while integrating the influence of frailty, sensory functioning and cognitive processing. conditions: Aged conditions: Accidental Fall conditions: Postural Balance conditions: Gait studyType: OBSERVATIONAL observationalModel: CASE_CONTROL timePerspective: PROSPECTIVE count: 100 type: ESTIMATED name: Cognition name: Sensory function name: Frailty name: Biomechanical movement analysis name: Screening name: Follow up measure: Spatio-temporal parameters of gait measure: Foot placement estimator measure: Onset latency measure: Peak amplitude measure: Fixation duration measure: Gain measure: Latency measure: Fall characteristics measure: Multisensory integration measure: Digit symbol substitution test measure: Trail making test measure: Go/No Go test measure: Head Repositioning Accuracy measure: Fly test measure: Fly test measure: vHIT measure: fHIT measure: Frailty measure: Age measure: Gender measure: Medical history measure: Fall history sex: ALL minimumAge: 65 Years maximumAge: 100 Years stdAges: OLDER_ADULT facility: University of Antwerp status: RECRUITING city: Antwerp zip: 2160 country: Belgium name: Ann Hallemans, PhD role: CONTACT phone: +32 3 265 29 12 email: [email protected] name: PhD role: CONTACT lat: 51.21989 lon: 4.40346 hasResults: False
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<|newrecord|> nctId: NCT06345612 id: Hypoxia-Exercise-DiabetesT1 briefTitle: Impact of Eccentric Training in Hypoxia With Creatine on Metabolic Control and VO2max in Patients With Type 1 Diabetes overallStatus: RECRUITING date: 2023-11-15 date: 2025-06 date: 2025-07 date: 2024-04-03 date: 2024-04-03 name: Silesian Centre for Heart Diseases class: OTHER briefSummary: Exercise plays an important role in treatment of diabetes. In recent years exercise training in normobaric hypoxia is used in training programs for athletes and in rehabilitation and also commercially. The aim of the study is to assess the impact of eccentric training conducted in conditions of normobaric hypoxia or normoxia and creatine supplementation on metabolic control: profile and stability of glucose concentration, HbA1c value, hypoglycemia and insulin demand, as well as the level of muscle strength, VO2max and anthropometric parameters conditions: Type 1 Diabetes studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: NONE count: 28 type: ESTIMATED name: hypoxia name: normoxia name: creatine supplementation name: no creatine supplementation measure: Metabolic control of diabetes measure: Time in range measure: Time below range measure: Maximum oxygen consumption (VO2max) sex: MALE minimumAge: 20 Years maximumAge: 45 Years stdAges: ADULT facility: Department of Internal Diseases, Diabetology and Cardiometabolic Disorders, School of Medicine with the Division of Dentistry in Zabrze, Medical University of Silesia in Katowice, Poland status: RECRUITING city: Zabrze state: Silesia zip: 41-800 country: Poland name: Marta Wróbel, PhD role: CONTACT phone: 48606873060 email: [email protected] lat: 50.32492 lon: 18.78576 hasResults: False
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<|newrecord|> nctId: NCT06345599 id: LK2023100 briefTitle: PRaG Therapy in Combination With Locally Advanced Pancreatic Ductal Adenocarcinoma (PDAC) (NeoPRAG Study) overallStatus: NOT_YET_RECRUITING date: 2024-05-01 date: 2027-01-10 date: 2027-01-10 date: 2024-04-03 date: 2024-04-03 name: Second Affiliated Hospital of Soochow University class: OTHER briefSummary: The goal of this clinical trial is to learn about Phase I+Phase II Clinical Study of PRaG Therapy in Combination With Chemotherapy (AG Regimen) for Neoadjuvant Treatment of Locally Advanced Pancreatic Ductal Adenocarcinoma (PDAC) (NeoPRAG Study).The main question it aims to answer is to investigate the safety and efficacy of the PRaG treatment modality combined with chemotherapy neoadjuvant therapy for locally advanced pancreatic cancer. conditions: Pancreatic Ductal Adenocarcinoma studyType: INTERVENTIONAL phases: PHASE1 phases: PHASE2 allocation: NA interventionModel: SINGLE_GROUP primaryPurpose: TREATMENT masking: NONE count: 66 type: ESTIMATED name: Radiotherapy name: Immunotherapy:Granulocyte macrophage-colony stimulating factor(GM-CSF)、Cadumilimab name: Chemotherapy:Albumin-bound paclitaxel、Gemcitabine measure: Adverse events measure: Serious adverse events measure: 1-year overall survival measure: Objective response rate measure: Disease control rate measure: Overall survival measure: R0 resection rate measure: Progression free survival sex: ALL minimumAge: 18 Years maximumAge: 75 Years stdAges: ADULT stdAges: OLDER_ADULT typeAbbrev: Prot_SAP hasProtocol: True hasSap: True hasIcf: False label: Study Protocol and Statistical Analysis Plan date: 2023-09-22 uploadDate: 2024-03-26T10:41 filename: Prot_SAP_000.pdf size: 1237855 typeAbbrev: ICF hasProtocol: False hasSap: False hasIcf: True label: Informed Consent Form date: 2023-11-27 uploadDate: 2024-03-26T10:44 filename: ICF_001.pdf size: 376918 hasResults: False
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