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Discussion: This trial is expected to explore the effect of acupuncture on cognitive function, gait performance, and hemodynamic changes in the prefrontal cortices for AD patients. conditions: Alzheimer Disease studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: SINGLE whoMasked: OUTCOMES_ASSESSOR count: 108 type: ESTIMATED name: Acupuncture measure: Three-dimensional gait analysis measure: Cerebral hemodynamics measure: Mini-Mental State Examination measure: Montreal Cognitive Assessment measure: Barthel Index sex: ALL minimumAge: 40 Years maximumAge: 85 Years stdAges: ADULT stdAges: OLDER_ADULT hasResults: False
<\|newrecord\|> nctId: NCT06346262 id: STUDY20230921 briefTitle: Seizure Rescue Medication (RM) as Part of a Comprehensive Epilepsy Self-management Package of Care overallStatus: RECRUITING date: 2024-03-05 date: 2026-01-01 date: 2026-01-01 date: 2024-04-04 date: 2024-04-04 name: Martha Sajatovic class: OTHER briefSummary: This study will be done in two phases. Using stakeholder input (community advisory board (CAB)), the study team will adapt the SMART program to incorporate education and self-management support for use of Rescue Medication (RM) to manage seizure occurrence among Persons With Epilepsy (PWE) who have repetitive seizures. Additional content/support materials, pending input stakeholder might include posters/hand-outs that present information on the use of RM in a way that is engaging and salient to PWE. It is expected that participants will be in Phase 1 for about 3 months and participate in the CAB 2 or 3 times via zoom for 60-90 minutes/meeting. The advisory board will provide input on needed refinement of an adapted version of SMART based on their individual experiences. It is anticipate the total time commitment to be no more than 6 hours over 3 months, spread out over 2-3 meetings with review of materials possible in between meetings.
Phase 2: The investigators will use a 6-month prospective trial design to test engagement with and effects of SMART-RM among approximately 35 adult (≥ 18 years) PWE who have repetitive seizures. conditions: Epilepsy studyType: INTERVENTIONAL phases: PHASE4 allocation: NA interventionModel: SINGLE_GROUP primaryPurpose: PREVENTION masking: NONE count: 43 type: ESTIMATED name: SMART RM name: Valtoco Nasal Product measure: Change in number of seizures as measured by patient report. measure: Change in quality of life as measure by QOLIE-31 measure: Change in functional status as measure by Short-Form Health Survey (SF-36) measure: Change in depressive symptoms as measure by Patient Health Questionnaire (PHQ-9) measure: Change in epilepsy self management as measure by Epilepsy Self-Efficacy Scale (ESES) measure: Change in epilepsy self management as measure by Multidimensional Scale of Perceived Social Support (MSPSS) measure: Change in epilepsy self management as measure by Epilepsy Self-Management Scale (ESMS) measure: Change in epilepsy self management as measure by Epilepsy Stigma Scale (ESS) measure: Change in number of emergency room visit as measure by patient report measure: Change in number of hospitalizations as measure by patient report measure: Change in number of non study outpatient services utilization as measure by patient report sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: University Hospitals Medical Center status: RECRUITING city: Cleveland state: Ohio zip: 44106 country: United States name: Kari M Zimmermann, MA role: CONTACT phone: 216-368-8775 email: kmz24@case.edu lat: 41.4995 lon: -81.69541 hasResults: False
<\|newrecord\|> nctId: NCT06346249 id: 49/2024 briefTitle: Workplace Based Physiotherapy of Elderly-care Workers With Non-specific Neck Pain. overallStatus: RECRUITING date: 2024-03-04 date: 2024-05 date: 2024-05 date: 2024-04-04 date: 2024-04-04 name: Universidad de Extremadura class: OTHER briefSummary: The overall objective of this study is to determine the efficacy of a physical therapy intervention based on manual therapy, therapeutic exercise and application of electrotherapy in healthcare workers with non-specific neck pain. conditions: Neck Pain studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: SINGLE whoMasked: PARTICIPANT count: 60 type: ESTIMATED name: Electrical Stimulation Therapy name: Manual Therapy name: Exercise Therapeutic measure: Changes in Pain measure: Changes Pressure Pain measure: Changes in Disability measure: Changes in Range of Motion measure: General Health. sex: ALL minimumAge: 18 Years maximumAge: 60 Years stdAges: ADULT facility: María de los Ángeles Cardero Durán status: RECRUITING city: Badajoz zip: 06006 country: Spain name: María de los Ángeles Cardero Durán, Doctor role: CONTACT email: mcarderod@unex.es lat: 38.87789 lon: -6.97061 typeAbbrev: ICF hasProtocol: False hasSap: False hasIcf: True label: Informed Consent Form date: 2024-03-27 uploadDate: 2024-04-01T16:35 filename: ICF_000.pdf size: 253582 hasResults: False
<\|newrecord\|> nctId: NCT06346236 id: 69HCL21_0843 id: 401 type: OTHER domain: AGORA HCL briefTitle: Neurodevelopmental Impact of Treatment in Hypothyroxinaemia of Prematurity. acronym: NEO-TYR overallStatus: COMPLETED date: 2020-03-01 date: 2021-07-01 date: 2022-09-01 date: 2024-04-03 date: 2024-04-03 name: Hospices Civils de Lyon class: OTHER briefSummary: Nowadays, taking care of preterm birth is associated with an important increase in survival. This increased survival comes with impairment in neurodevelopmental outcomes in long term evaluation. Thyroid hormones are essentials for brain development, especially for neuronal differentiation. Transient hypothyroxinaemia of prematurity (THOP) is a frequent condition defined by decreased thyroid hormones without the expected rise in thyroid stimulating hormone. Various studies have showed various results regarding the consequences of THOP on neurodevelopment in premature neonates. However, the biggest and most powerful studies agree to say that THOP impair neurodevelopment. On the other hand, only a few studies evaluated the impact of treatment of THOP, and only two focused on treating exclusively the neonates with a biological diagnosis of THOP (Suzumura and co. in 2010 and Nomura and co. in 2014) and their results are inconsistent.
In this study, we aim to show that a treatment with L-thyroxine at a dose of 7.5 µg/kg/j for neonates diagnosed with THOP (defined as a level of l-T4 \< 12 pmol/L and a level of TSH \< 15 mUI/L before 15 days of life or \< 85 mUI/L after 15 days of birth) is associated with an increased neurodevelopmental prognosis. conditions: Transient Hypothyroxinemia of Prematurity studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: RETROSPECTIVE count: 373 type: ACTUAL name: L-thyroxine at a dose of 7.5 µg/kg/d for THOP name: THOP without treatment name: NoTHOP measure: Neuro-development judged " abnormal " by the paediatrician during the two years of corrected age's consultation. sex: ALL maximumAge: 2 Weeks stdAges: CHILD facility: HFME city: Bron zip: 69300 country: France lat: 45.73333 lon: 4.91667 facility: CHU Grenoble city: Grenoble zip: 38100 country: France lat: 45.16667 lon: 5.71667 facility: CHU Saint EtienneHopital city: Saint-Étienne zip: 42000 country: France lat: 45.43389 lon: 4.39 hasResults: False
<\|newrecord\|> nctId: NCT06346223 id: HSEARS20230928006 briefTitle: Mindfulness-Based Intervention for Family Caregivers overallStatus: NOT_YET_RECRUITING date: 2024-08 date: 2025-08 date: 2025-08 date: 2024-04-03 date: 2024-04-04 name: The Hong Kong Polytechnic University class: OTHER name: Health and Medical Research Fund briefSummary: The aim of this study is to investigate the efficiency of a single-session mindfulness-based intervention for reducing stress and promoting psychological health in family caregivers of people with dementia. The single-session mindfulness intervention includes one 90-minute group-based session containing different mindfulness practices, psychoeducation and group sharing activities in the single-session mindfulness intervention. A self-practice tool kit with the teaching materials (e.g., recording of guided mindfulness activities) will be provided to the participants for home practice 20 minutes daily through an online platform and the participants will be told to develop the practice as a daily habit.
Participants will be randomly assigned to receive either the mindfulness intervention combined with psychoeducation or psychoeducation alone. Evaluations will be conducted at baseline (0 weeks), immediately post-intervention (8 weeks), and during a follow-up assessment (6 months). Both groups will complete the same assessments at the same time-points. conditions: Caregiving Stress studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL interventionModelDescription: A single-blinded, parallel-group, randomized-controlled trial (RCT) design. primaryPurpose: SUPPORTIVE_CARE masking: SINGLE whoMasked: PARTICIPANT count: 160 type: ESTIMATED name: Mindfulness and psychoeducation name: Psychoeducation measure: Perceived Caregiving Stress in the Family Caregiver measure: Depressive Symptoms in the Family Caregiver measure: Positive Aspect of Caregiving in the Family Caregiver measure: Dyadic Relationship Between the Family Caregiver and the Care Recipient measure: Trait Mindfulness in the Family Caregiver measure: Neuropsychiatric Syndromes in the Care Recipient measure: Feasibility of Eligibility and Enrollment measure: Feasibility of Attendance Rate measure: Feasibility of Adherence to Self-Practice measure: Feasibility of Retention Rate sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT hasResults: False
<\|newrecord\|> nctId: NCT06346210 id: UNT: U1111-1288-2037 briefTitle: Optimal Timing for Tracheostomy in Invasively Mechanically Ventilated COVID-19 Patients overallStatus: COMPLETED date: 2024-04-02 date: 2024-04-02 date: 2024-04-02 date: 2024-04-03 date: 2024-04-10 name: Uppsala University class: OTHER name: Healthcare Region Dalarna briefSummary: Tracheostomy is a medical procedure performed on the front of a persons neck. It is used to create a connection between the persons trachea and a mechanical ventilator instead of using a tube going through the mouth into the trachea, oral intubation. Living with a tracheostomy tube is less stressful compared to oral intubation and facilitate being awake and the start of training on spontaneous ventilation in mechanically ventilated patients. Studies of the timing of tracheostomy are either severely affected by methodological bias of to small to determine an effect. Thus, it is not known what the optimal timing of the tracheostomy is in mechanically ventilated COVID-19 patients. conditions: COVID-19 studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: RETROSPECTIVE count: 4000 type: ACTUAL name: Tracheostomy measure: Ventilator free days alive measure: 60 day mortality sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Uppsala University city: Uppsala country: Sweden lat: 59.85882 lon: 17.63889 hasResults: False
<\|newrecord\|> nctId: NCT06346197 id: ET23-185 briefTitle: Combination of Immune Checkpoint in Locally Advanced or Metastatic MSI/dMMR Esogastric Adenocarcinomas acronym: CIME overallStatus: NOT_YET_RECRUITING date: 2024-05-15 date: 2028-05-15 date: 2028-05-15 date: 2024-04-03 date: 2024-04-03 name: Centre Leon Berard class: OTHER name: Agenus Inc. briefSummary: CIME is a multicenter, randomised, comparative, open-label phase III study aiming to compare the survival of patients suffering from MSI-H/dMMR locally advanced or metastatic oeasogastric adenocarcinoma treated by a bi-immunotherapy (experimental arm) versus standard current treatment (FOLFOX/XELOX + nivolumab : standard arm). conditions: Gastric Cancer conditions: MSI-H conditions: Metastatic Cancer conditions: Advanced Cancer studyType: INTERVENTIONAL phases: PHASE3 allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: NONE count: 124 type: ESTIMATED name: Balstilimab name: Botensilimab name: Folfox Protocol name: XELOX name: Nivolumab measure: Survival of patients measure: Progression free survival measure: Objective response rate measure: Duration of response measure: Adverse Event description as assessed by CTCAE V5.0 measure: EORTC QLQ C30 measure: Gene expression and genomic profile description measure: Gene expression and genomic profile description measure: Number of tumor samples with modification of tumor microenvironment under study treatments measure: Value of Tumor mutational Burden (Mutation/ Megabase) on tumor and blood (circulating tumor DNA) during treatment sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Centre Léon Bérard city: Lyon country: France name: Clélia COUTZAC, MD role: CONTACT email: clelia.coutzac@lyon.unicancer.fr lat: 45.74848 lon: 4.84669 hasResults: False
<\|newrecord\|> nctId: NCT06346184 id: HM-EMMA-101 briefTitle: A Study to Evaluate the Pharmacokinetics and Safety Between HCP2303 and Co-administration of Each Component in Healthy Volunteers overallStatus: NOT_YET_RECRUITING date: 2024-04-30 date: 2024-06-08 date: 2024-06-08 date: 2024-04-03 date: 2024-04-12 name: Hanmi Pharmaceutical Company Limited class: INDUSTRY briefSummary: The purpose of this study is to evaluate the pharmacokinetic characteristics and safety between HCP2303 and co-administration of each component in fasting condition in healthy volunteers. conditions: Healthy studyType: INTERVENTIONAL phases: PHASE1 allocation: RANDOMIZED interventionModel: CROSSOVER primaryPurpose: TREATMENT masking: NONE count: 36 type: ESTIMATED name: HCP2303 name: RLD2302 name: RLD2102 measure: AUCt measure: Cmax measure: AUCinf measure: Tmax measure: t1/2 measure: CL/F measure: Vd/F sex: ALL minimumAge: 19 Years maximumAge: 54 Years stdAges: ADULT facility: Jeonbuk University Hospital city: Jeonju state: Jeollabuk-do country: Korea, Republic of name: Jin A Lee, Researcher role: CONTACT phone: 063-259-3550 name: Min-gul Kim, MD role: PRINCIPAL_INVESTIGATOR lat: 35.82194 lon: 127.14889 hasResults: False
<\|newrecord\|> nctId: NCT06346171 id: 408/06.03.2024 briefTitle: VR Augmented Human Delivered Integrative Psychotherapy for Colonoscopy Procedural Anxiety and Pain acronym: VRIPanx-COL overallStatus: NOT_YET_RECRUITING date: 2024-04-28 date: 2024-08-30 date: 2024-11-30 date: 2024-04-03 date: 2024-04-05 name: Grigore T. Popa University of Medicine and Pharmacy class: OTHER briefSummary: Colonoscopy is an invaluable tool for the diagnosis and management of colon diseases, especially colorectal cancer (CRC) - the third most common cancer worldwide. Its unmatched ability to detect CRC and premalignant growths makes it the gold standard; however, it is not without its challenges. Patients often experience pre-procedure anxiety and discomfort primarily related to anticipated pain, which negatively impacts both the procedure and its outcomes.
Colonoscopy procedural anxiety not only exacerbates the experience of pain, but also may compromise the quality of bowel preparation, augment procedure and recovery room times, and increase the use of sedation, particularly among females, who report greater pre-procedural anxiety, and perceive the procedure to be more painful and harder to endure. This underscores the importance of interventions aimed at mitigating anxiety to improve patient experience and adherence to colonoscopy procedures.
The profound positive corelation between anxiety and pain impact on outcomes of colonoscopy warrants an investigation of comprehensive patient care strategies. A growing body of evidence indicates that non-pharmacologic interventions, such as music therapy and immersive virtual reality (iVR), may effectively reduce anxiety, pain, and enhance overall patient satisfaction.
Understanding barriers to colonoscopy compliance, such as fear of cancer diagnosis, the perception of invasiveness, and feelings of embarrassment is paramount to enhancing CRC screening uptake, therefore lowering mortality. conditions: Procedural Anxiety conditions: Procedural Pain studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL interventionModelDescription: The VRIPanx-COL study is an RCT investigating the efficacy of VR-facilitated integrative psychotherapy compared to VR distraction only and NSE-Col. Variance minimisation and propensity score matching are used to ensure that the groups are balanced and to supplement the internal validity of evaluating the efficacy of the intervention. primaryPurpose: TREATMENT masking: TRIPLE maskingDescription: To ensure credible outcomes, robust blinding for participants, care providers, and outcome assessors is vital to minimize bias. Participants will be briefed generally about participating in VR distraction research, with no details on psychotherapy inclusion. Gastroenterologists and outcome assessors remain blinded to intervention types, using standard tools for unbiased outcome evaluation. The principal investigator, aware of the intervention nature, conducts psychotherapy sessions or engages in simple discussion for control arm VR exposure. Another gastroenterologist oversees randomization to maintain blinding. Standardized VR distractions and pre-programmed randomization ensure unbiased participant allocation, reinforcing study validity through meticulous concealment and blinding protocols. whoMasked: PARTICIPANT whoMasked: CARE_PROVIDER whoMasked: OUTCOMES_ASSESSOR count: 36 type: ESTIMATED name: Virtual Reality Integrative Psychotherapy name: Virtual Reality Distraction measure: Reduction in Procedure-Related Anxiety measure: Pain perception measure: Feasibility and Acceptability of VRIP-Col Interventions measure: Qualitative Feedback on VRIP-Col Interventions measure: Trait anxiety measure: Quality of Life impact VRIP-Col sex: ALL minimumAge: 18 Years maximumAge: 65 Years stdAges: ADULT stdAges: OLDER_ADULT facility: University of Medicine and Pharmacy Grigore T Popa city: Iaşi state: Iasi zip: 700115 country: Romania lat: 47.16667 lon: 27.6 hasResults: False
<\|newrecord\|> nctId: NCT06346158 id: 2024-3615 briefTitle: Prediction of Propofol Effect-Site Concentration Associated With Deep Anesthesia acronym: PRESCOD-AI overallStatus: NOT_YET_RECRUITING date: 2024-05 date: 2025-05 date: 2025-05 date: 2024-04-03 date: 2024-04-03 name: Ciusss de L'Est de l'Île de Montréal class: OTHER name: CIUSSS du Nord de l'Ile de Montréal briefSummary: The goal of this observational study is to explore the variability of the concentration at the effect site (Ce) of propofol to reach deep anesthesia (DA) during induction of general anesthesia in adults.
The investigators hypothesized that there is a great variability in this Ce that could be precisely explained by
* Electroencephalographic (EEG) features available prior to induction of anesthesia
* Cognitive performance
* Patients characteristics Participants will undergo preoperative cognitive testing and awake EEG. Then, induction of general anesthesia will be performed using continuous infusion of propofol. The Ce at which Deep anesthesia is observed will be recorded. conditions: Anesthesia studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: PROSPECTIVE count: 110 type: ESTIMATED name: Cognitive testing name: electroencephalogram name: High density electroencephalogram name: General anesthesia measure: Concentration at the effect-site propofol associated with deep anesthesia (CeDA) measure: Coefficient of determination between statistical, spectral, entropic features extracted from the electroencephalogram and the Concentration at the effect-site propofol associated with deep anesthesia measure: Coefficient of determination between multivariable model and the Concentration at the effect-site propofol associated with deep anesthesia measure: Mean absolute error between predicted Concentration at the effect-site propofol associated with deep anesthesia by the machine-learning model and observed Concentration at the effect-site propofol associated with deep anesthesia. measure: Concentration at the effect-site propofol associated with loss of consciousness (CeLOC) sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT hasResults: False
<\|newrecord\|> nctId: NCT06346145 id: MIMS study id: 2023-00453 type: OTHER_GRANT domain: Swdeish research council briefTitle: Impact of Bariatric Surgery on Heart Disease Compared to Standard Care acronym: MIMS overallStatus: NOT_YET_RECRUITING date: 2024-05-01 date: 2028-05-01 date: 2030-05-01 date: 2024-04-03 date: 2024-04-03 name: Danderyd Hospital class: OTHER name: Karolinska Institutet name: The 21 healthcare regions in Sweden briefSummary: Obesity is associated with type 2 diabetes (T2D) and cardiovascular disease (CVD). Metabolic and bariatric surgery (MBS) has in several randomized controlled trials (RCT) been shown to be superior to best medical therapy in the treatment of T2D. In the area of CVD, RCT after MBS are lacking. It was recently demonstrated in a cohort study that MBS in patients with severe obesity and a previous myocardial infarction (MI) was associated with a 50% reduction in the risk of death and new MI. The aim of this proposal is to confirm this in a nationwide RCT. Using the nationwide SWEDEHEART database patients with severe obesity and a previous MI will be identified. They will be contacted and offered participation. After informed consent the patients will be randomized to MBS or optimized care (including visit with a cardiologist and optimization of secondary preventive measures and referral to dietician/physiotherapist). The primary outcome measure is a major cardiovascular adverse event (MACE). Secondary outcome measures include mortality, new MI, stroke, heart failure and atrial fibrillation. Tertiary outcome measures include health related quality of life and surgical complications. Patients will be followed in the nationwide metabolic surgery register SOReg, the national inpatient register, national cause of death register, the Swedish prescribed drug register, and the Swedish population register. If positive results these can be included in guidelines for MBS. conditions: Obesity, Morbid conditions: Bariatric Surgery Candidate conditions: Heart Diseases studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: NONE count: 500 type: ESTIMATED name: Bariatric surgery name: Standard care measure: MACE defined as first occurrence of death (all-cause mortality), MI, stroke, myocardial revascularization (not related to MI), hospital admission because of heart failure or atrial fibrillation as a primary ICD diagnosis. measure: Total event rate measure: All-cause mortality measure: Cardiovascular death measure: Remission of type 2 diabetes (T2D) and hypertension measure: Myocardial infarction measure: Stroke measure: Myocardial revascularization (not related to MI) measure: hospital admission because of heart failure as a primary ICD diagnosis. measure: hospital admission because of atrial fibrillation as a primary ICD diagnosis. measure: Safety, i.e., no excess of severe complications (Clavien-Dindo ≥3b (a complication requiring intervention under general anesthesia or resulting in organ failure or death)) and long-term morbidity. measure: Body weight change measure: Change in quality of life measure: All-cause hospitalizations measure: Change in quality of life sex: ALL minimumAge: 18 Years maximumAge: 70 Years stdAges: ADULT stdAges: OLDER_ADULT hasResults: False
<\|newrecord\|> nctId: NCT06346132 id: 2024-00043 CE 4516 briefTitle: Effect of Virtual Reality on Patient's Comfort During Cardiac Electronic Device Implantation. overallStatus: NOT_YET_RECRUITING date: 2024-04-01 date: 2025-12-31 date: 2025-12-31 date: 2024-04-03 date: 2024-04-03 name: Schlotterbeck Hervé class: OTHER briefSummary: The purpose of this study is to assess the effect on patient's comfort of a virtual reality experience during a procedure of cardiac electronic device implantation under local anesthesia. conditions: Virtual Reality conditions: Medical Device conditions: Local Anesthesia conditions: Pain studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: NONE count: 150 type: ESTIMATED name: Virtual reality application measure: Global pain intensity experienced during the procedure. measure: Need for supplementary sedation and/or analgesia during the procedure. measure: Global anxiety intensity experienced during the procedure. measure: Patient's comfort during the procedure assessed by the surgeon and cardiologist. measure: Incidence of motion sickness during the virtual reality experience. measure: Patient's perceived procedure duration. measure: Maximal systolic arterial blood pressure. measure: Incidence of hypotensive or hypoxic events during procedure. measure: Total dose of local anaesthetic used during the procedure. measure: Change in anesthetic strategy during procedure. measure: Interruption of virtual reality experience during the procedure. measure: Intra- and post-procedure complications. measure: Overall patient's comfort and satisfaction experienced during the procedure. sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Istituto CardioCentro city: Lugano state: Ticino zip: 6900 country: Switzerland name: Herve Schlotterbeck, MD role: CONTACT phone: +41918115189 email: herve.schlotterbeck@eoc.ch lat: 46.01008 lon: 8.96004 hasResults: False
<\|newrecord\|> nctId: NCT06346119 id: PI-2023-01 briefTitle: Evaluation of the Impact of Touch Relaxation in Sedated Intubated Patients Hospitalized in Intensive Care at Niort Hospital acronym: ETDR overallStatus: RECRUITING date: 2023-02-27 date: 2024-01-05 date: 2025-12-31 date: 2024-04-03 date: 2024-04-03 name: Centre Hospitalier de Niort class: OTHER briefSummary: This is a randomized prospective study. This objective is the impact of "relaxing touch" on the use of chemical restraint for patients in intensive care from the lifting of sedation until extubation. conditions: Reaction Anxiety conditions: Difficult or Failed Intubation studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL interventionModelDescription: This study will be conducted in two parallel groups. At the inclusion, each patient will be assigned to one of two groups by randomization; one group will receive the "touch" and the second group will not receive it will be the control arm. primaryPurpose: OTHER masking: SINGLE maskingDescription: It's a person external to the care service and to the randomization process will collect the possible prescription of a chemical restraint or the evolution of this chemical restraint by the resuscitator, in order to maintain the blind. whoMasked: OUTCOMES_ASSESSOR count: 72 type: ESTIMATED name: this arm will received relaxing touch (hands, feet, head) during 30 minutes twice a day measure: chemical restraint measure: self-extubations measure: patient discomfort measure: respiratory rate measure: Ratio chemical restraint use measure: cardiac frequency sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Centre Hospitalier de Niort status: RECRUITING city: Niort zip: 79000 country: France lat: 46.32313 lon: -0.45877 hasResults: False
<\|newrecord\|> nctId: NCT06346106 id: 23-0075 briefTitle: The Diagnostic Experience of Male Rett Syndrome overallStatus: RECRUITING date: 2023-05-24 date: 2024-04-30 date: 2024-04-30 date: 2024-04-03 date: 2024-04-03 name: Children's Hospital Colorado class: OTHER name: University of Colorado, Denver name: Vanderbilt University School of Medicine name: University of Alabama at Birmingham name: University of Pennsylvania name: International Rett Syndrome Foundation name: Rocky Mountain Rett Association briefSummary: The Diagnostic Experience of Male Rett Syndrome collects information on the lived experiences of parents or caregivers to boys with Rett Syndrome. Key information examined includes the process of getting a male Rett syndrome diagnosis, your son's systems of care, and your priorities for his health needs.
Enrolled participants will complete an online survey with questions about having a son with Rett Syndrome. The Diagnostic Experience of Male Rett Syndrome study is available to parents or caregivers to boys (alive or passed) with Rett Syndrome. Compensation is not provided. conditions: Rett Syndrome conditions: RTT studyType: OBSERVATIONAL observationalModel: FAMILY_BASED timePerspective: RETROSPECTIVE count: 80 type: ESTIMATED name: Male Rett measure: Diagnostic experiences measure: Attainment of developmental milestones and any regressions measure: QI-disability measure: Parent priorities for care and counseling measure: Parenting experience measure: Information regarding child's death, if applicable measure: Family demographics measure: Systems of supports measure: Healthcare preferences sex: MALE minimumAge: 0 Years maximumAge: 100 Years stdAges: CHILD stdAges: ADULT stdAges: OLDER_ADULT facility: University of Colorado Anschutz Medical Campus status: RECRUITING city: Aurora state: Colorado zip: 80045 country: United States name: Natalia Klamut role: CONTACT phone: 720-277-9095 email: malerettstudy@cuanschutz.edu name: Timothy Benke, MD, PhD role: PRINCIPAL_INVESTIGATOR name: Talia Thompson, PhD role: SUB_INVESTIGATOR lat: 39.72943 lon: -104.83192 hasResults: False
<\|newrecord\|> nctId: NCT06346093 id: CHEC2024-089 briefTitle: Fecal Microbiota Transplantation (FMT) in Patients With Advanced Gastric Cancer overallStatus: NOT_YET_RECRUITING date: 2024-04-15 date: 2026-12-31 date: 2026-12-31 date: 2024-04-03 date: 2024-04-03 name: Xiangyu Kong class: OTHER briefSummary: This study is a randomized, double-blind and placebo-controlled study. The purpose of this study is to evaluate the efficacy and safety of FMT capsules combined with chemotherapy and anti-PD-L1 therapy in the advanced gastric cancer. conditions: Advanced Gastric Cancer studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: DOUBLE whoMasked: PARTICIPANT whoMasked: INVESTIGATOR count: 66 type: ESTIMATED name: Fecal Microbiota Transplantation Capsules name: Placebo measure: Objective response rate (ORR) measure: Rate of Disease Control measure: Progression-free Survival (PFS) measure: Overall Survival (OS) measure: Incidence of Adverse Events Related to Treatment measure: Change in the intestinal microbiome community measure: Quality of life based on the questionnaire measure: Quality of life based on the questionnaire measure: Change in the immunity measure: Marker of nutritional status measure: Marker of nutritional status measure: Marker of nutritional status measure: Body Weight measure: Appetite measure: Marker of nutritional status measure: Marker of nutritional status sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Changhai Hospital city: Shanghai state: Shanghai zip: 200433 country: China lat: 31.22222 lon: 121.45806 hasResults: False
<\|newrecord\|> nctId: NCT06346080 id: s68670 briefTitle: Molecular Analysis for Gastro-Esophageal Cancer: Multicenter Discrete Choice Experiment acronym: MAGECmultiDiCE overallStatus: NOT_YET_RECRUITING date: 2024-08-01 date: 2026-08-01 date: 2026-08-01 date: 2024-04-03 date: 2024-04-03 name: KU Leuven class: OTHER briefSummary: The goal of this survey is to investigate the participants' preference for a specific screening/diagnostic tool to detect and assess gastro-esophageal cancer.
The main question it aims to answer are:
* Which diagnostic modality is preferred by patients and the general population?
* Which features of the diagnostic test are most detrimental in the decision-making for one or the other modality?
* Are geographical differences present in regard to the preference for a diagnostic modality?
Participants will be asked to complete a survey of 20-25min, including a brief intake regarding their socio-economic status. This approach will allow us to correct for confounding factors. conditions: Esophageal Cancer conditions: Gastric Cancer studyType: INTERVENTIONAL phases: NA allocation: NA interventionModel: SINGLE_GROUP interventionModelDescription: A survey will be conducted in a single group of participants from different geographical regions and backgrounds primaryPurpose: OTHER masking: NONE count: 2200 type: ESTIMATED name: Survey measure: The rate of contribution of diagnostic features to the preference of participants measure: The percentage differences in preference of participants between geographical regions measure: Assess the rate patient-level demographics influence the importance of a test feature, expressed as an odds ratio measure: Assess the rate of trade-off demonstrated as odds ratio between cancer-related mortality reduction and costs sex: ALL minimumAge: 18 Years maximumAge: 85 Years stdAges: ADULT stdAges: OLDER_ADULT hasResults: False
<\|newrecord\|> nctId: NCT06346067 id: ERAS-254-02 briefTitle: A Study to Assess Naporafenib (ERAS-254) Administered With Trametinib in Patients With NRAS-mutant Melanoma (SEACRAFT-2) overallStatus: NOT_YET_RECRUITING date: 2024-05 date: 2028-04 date: 2028-12 date: 2024-04-03 date: 2024-04-29 name: Erasca, Inc. class: INDUSTRY briefSummary: Stage 1: To select the optimal dose of naporafenib + trametinib to be studied in Stage 2.
Stage 2: To compare progression free survival (PFS) and overall survival (OS) for patients with NRAS-mutant (NRASm) melanoma who are randomized to receive the combination of naporafenib + trametinib to that of patients who are randomized to physician's choice of therapy (dacarbazine, temozolomide, or trametinib monotherapy). conditions: Advanced or Metastatic NRAS-mutant Melanoma studyType: INTERVENTIONAL phases: PHASE3 allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: NONE count: 470 type: ESTIMATED name: Naporafenib name: Dacarbazine name: Temozolomide name: Trametinib measure: Stage 1:To select the optimal dose of naporafenib + trametinib to be studied in Stage 2 measure: Stage 1:To select the optimal dose of naporafenib + trametinib to be studied in Stage 2 measure: Stage 1:To select the optimal dose of naporafenib + trametinib to be studied in Stage 2 measure: Stage 1:To select the optimal dose of naporafenib + trametinib to be studied in Stage 2 measure: Stage 1:To select the optimal dose of naporafenib + trametinib to be studied in Stage 2 measure: Stage 2: To compare PFS and OS for patients who are randomized to receive the combination of naporafenib + trametinib to that of patients who receive physician's choice of therapy (dacarbazine, temozolomide, or trametinib monotherapy) measure: Adverse Events measure: Duration of Response (DOR) measure: Time to Response (TTR) measure: Disease Control Rate (DCR) measure: Overall Response Rate (ORR) measure: Plasma concentration (Cmax):Stage 1 only measure: Area under the curve (AUC):Stage 1 only measure: Quality of Life: To assess disease and treatment-related QOL in patients with NRASm melanoma. measure: Duration of Response (DOR) for CNS disease in participants measure: Overall Response Rate (ORR) for CNS disease in participants measure: Disease Control Rate (DCR) for CNS disease in participants sex: ALL minimumAge: 18 Years maximumAge: 99 Years stdAges: ADULT stdAges: OLDER_ADULT facility: SCRI Oncology Partners (formerly Tennessee Oncology) city: Nashville state: Tennessee zip: 37203 country: United States lat: 36.16589 lon: -86.78444 hasResults: False
<\|newrecord\|> nctId: NCT06346054 id: s68669 briefTitle: Molecular Assessment for Gastro-Esophageal Cancer acronym: MAGEC overallStatus: NOT_YET_RECRUITING date: 2024-07-01 date: 2029-07-01 date: 2029-07-01 date: 2024-04-03 date: 2024-04-03 name: KU Leuven class: OTHER briefSummary: The goal of this minimally invasive interventional study is to learn if oncometabolic biomarkers, detected in the exhaled breath and blood can identify early-stage gastro-oesophageal cancer in patient at risk for gastro-oesophageal cancer.
The main questions this study aims to answer:
Are oncometabolites proficient and reproducible enough to function as diagnostic biomarkers? Can these biomarkers identify early-stage gastro-esophageal cancer? Researchers will compare participants with gastro-oesophageal cancer to healthy controls and participants with Barrett's esophagus to detect meaningful differences between the groups.
Participants will provide a breath and blood sample during their routine standard of care visits. conditions: Esophageal Cancer conditions: Gastric Cancer conditions: Barrett Esophagus studyType: INTERVENTIONAL phases: NA allocation: NON_RANDOMIZED interventionModel: PARALLEL interventionModelDescription: Participants with gastro-esophageal cancer, participants with Barrett's esophagus and Healthy controls will be monitored in parallel to identify oncometabolic biomarkers related to cancer primaryPurpose: DIAGNOSTIC masking: NONE count: 1000 type: ESTIMATED name: Breath analysis name: Blood analysis measure: Identification of the concentrations of oncometabolites measure: Assessment of incidence of early-stage cancer measure: Assessment of incidence of therapy response measure: Assessment of percentage change of therapy response measure: Assessment of incidence of recurrence sex: ALL minimumAge: 18 Years maximumAge: 100 Years stdAges: ADULT stdAges: OLDER_ADULT hasResults: False
<\|newrecord\|> nctId: NCT06346041 id: HJG-IDOV-SAFE-LYSW briefTitle: Safety and Efficacy of Intravenous IDOV-SAFETM in Patients With Advanced Solid Tumors overallStatus: NOT_YET_RECRUITING date: 2024-04-01 date: 2024-12-31 date: 2026-04-01 date: 2024-04-03 date: 2024-04-03 name: Cancer Institute and Hospital, Chinese Academy of Medical Sciences class: OTHER briefSummary: This is an open-label, dose escalation, phase I study to evaluate safety tolerability, MTD or MFD, pharmacokinetic profile, immunogenicity, and pharmacodynamic profile of IDOV-SAFETM in patients with advanced solid tumors. conditions: Neoplasms studyType: INTERVENTIONAL phases: EARLY_PHASE1 allocation: NA interventionModel: SEQUENTIAL primaryPurpose: TREATMENT masking: NONE count: 19 type: ESTIMATED name: Oncolytic Virus injection(IDOV-SAFETM) measure: Dose Limiting Toxicities (DLT) measure: Incidence of adverse events and severe adverse events measure: MTD/MFD measure: The Pharmacokinetics characteristics of IDOV-SAFETM((biological distribution and viral expulsion)) measure: Immunogenicity of IDOV-SAFETM measure: ORR measure: DCR measure: DOR measure: PFS measure: OS sex: ALL minimumAge: 18 Years maximumAge: 75 Years stdAges: ADULT stdAges: OLDER_ADULT hasResults: False
<\|newrecord\|> nctId: NCT06346028 id: 2023/086 briefTitle: Implementation of Transcranial Magnetic Stimulation for Smoking Cessation overallStatus: RECRUITING date: 2024-03-30 date: 2025-06-30 date: 2025-06-30 date: 2024-04-03 date: 2024-04-03 name: Centre for Addiction and Mental Health class: OTHER briefSummary: Repetitive transcranial magnetic stimulation (rTMS) is an alternative non-invasive treatment to help people quit smoking. rTMS uses a magnetic field to stimulate regions of the brain that are involved in addiction. The two brain regions that are stimulated are the insula and the dorsolateral prefrontal cortex, which are involved in drug craving and decision-making, respectively.
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.
Participants will be asked to come to CAMH to:
* Complete surveys and optional interviews to learn more about their opinions and experiences with this treatment
* 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.
Objectives
• 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: rtms.smoking@camh.ca lat: 43.70011 lon: -79.4163 hasResults: False
<\|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
<\|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.
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.
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
<\|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.
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.
The main question being addressed is:
- Are intraoral scans more time efficient than alginate impressions?
The secondary question being addressed is:
- Are intraoral scans more cost effective than alginate impressions?
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.
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: hannah.hook@nuh.nhs.uk name: Andrew Flett, BDS role: CONTACT email: andrew.flett@nuh.nhs.uk lat: 52.9536 lon: -1.15047 hasResults: False
<\|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 :
* In the integumentary region: fair skin tone, with white hair, eyelashes and eyebrows.
* Ophthalmological: reduced visual acuity, photophobia, nystagmus, transilluminated blue irises, hypopigmentation of the retina at the back of the eye with fovea plana.
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
<\|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: Xiaoming.Du@uth.tmc.edu name: Victoria Acosta role: CONTACT phone: 713-486-2740 email: Victoria.Acosta@uth.tmc.edu lat: 29.76328 lon: -95.36327 hasResults: False
<\|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.
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
<\|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:
* How does the impact of exercise compare among each of the causal links between physical inactivity and cardiometabolic disease in women?
* What is the effect modification of adding a diet quality intervention to exercise?
* What is the effect modification by menopausal status?
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: amy.kirkham@utoronto.ca name: Jenna B. Gillen, PhD role: CONTACT phone: 416-978-3244 email: jenna.gillen@utoronto.ca lat: 43.70011 lon: -79.4163 hasResults: False
<\|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.
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: fombuena_mig@gva.es 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
<\|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
<\|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: 932968425@qq.com name: Fang Lu role: CONTACT email: lufang@wchscu.cn lat: 30.66667 lon: 104.06667 hasResults: False
<\|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
<\|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: christinamccrae@usf.edu name: Jasmine L Niazi, MS role: CONTACT phone: (813) 906-0483 email: jlniazi@usf.edu lat: 27.94752 lon: -82.45843 hasResults: False
<\|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: carlab@usc.edu lat: 34.05223 lon: -118.24368 hasResults: False
<\|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
<\|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.
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
<\|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: office@viros.at name: Manuel Ruiss, MSc role: CONTACT phone: 01 91021 phoneExt: 57564 email: office@viros.at lat: 48.20849 lon: 16.37208 hasResults: False
<\|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
<\|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
<\|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
<\|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.
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.
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
<\|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
<\|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.
H1: Parental participation during infant diaper care practice in preterm infants has an effect on newborn comfort.
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.
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: tugba.turker@live.acibadem.edu.tr lat: 41.01384 lon: 28.94966 hasResults: False
<\|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:
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).
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
<\|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
<\|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:
* Is NS-136 safe and tolerable in heathy subjects under tested dosing regimen?
* 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: cmax@cmax.com.au lat: -34.92866 lon: 138.59863 hasResults: False
<\|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: josephine@denverpaininstitute.com 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: cnewell@toi-health.com 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: lisa@ipspain.org 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: courtney@premierpainnc.com 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: aharum@crystalcoastpm.com name: Kirk Harum, M.D. role: PRINCIPAL_INVESTIGATOR lat: 35.10849 lon: -77.04411 hasResults: False

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