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Traumatic Brain Injury Patients will be divided into the the control group and observation group evenly. All the patients were provided with routine therapy, while the patients in the observation group were given stellate ganglion block. The swallowing function, and activities of daily living of the two groups of patients before and after treatment were evaluated. conditions: Traumatic Brain Injury studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: QUADRUPLE whoMasked: PARTICIPANT whoMasked: CARE_PROVIDER whoMasked: INVESTIGATOR whoMasked: OUTCOMES_ASSESSOR count: 80 type: ESTIMATED name: Rehabilitation therapy name: Stellate ganglion block name: Lidocaine Hydrochloride measure: Penetration-Aspiration Scale measure: Modified Barthel Index measure: Swallowing duration measure: Functional Oral Intake Scale sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT hasResults: False
<\|newrecord\|> nctId: NCT06304103 id: AND017-MDS-206 briefTitle: A Study of Efficacy and Safety of AND017 in Patients With Myelodysplastic Syndrome overallStatus: NOT_YET_RECRUITING date: 2024-12 date: 2026-12 date: 2027-05 date: 2024-03-12 date: 2024-03-15 name: Kind Pharmaceuticals LLC class: INDUSTRY briefSummary: This is a Phase 2, multicenter, randomized, open-lable study to evaluate the efficacy and safety of luspatercept (ACE-536) for the treatment of anemia due to lower risk Myelodysplastic syndromes (MDS)in patients subjects who are Red blood cell (RBC) non-transfusion dependent (NTD) and low transfusion burden (LTB). conditions: Myelodysplastic Syndromes studyType: INTERVENTIONAL phases: PHASE2 allocation: RANDOMIZED interventionModel: SEQUENTIAL primaryPurpose: TREATMENT masking: NONE count: 63 type: ESTIMATED name: AND017 measure: Percentage of HI-E/RBC-TI responding subjects measure: Mean level and change from baseline in untransfused Hb throughout the first 8 weeks of treatment measure: Mean level and change from baseline in untransfused Hb at each visit throughout the treatment period and measure: Percentage of visits in which untransfused Hb was maintained in this range after reaching two consecutive increases of ≥1.5 g/dL and ≥1.0 g/dL from baseline, respectively, throughout the treatment period measure: Mean time required after two consecutive increases in untransfused Hb ≥1.5 g/dL and ≥1.0 g/dL from baseline, respectively, throughout the treatment period measure: For changes in mean transfusion units throughout the treatment period compared to baseline (mean transfusion units 16 weeks prior to first dose) measure: For LTB cohorts, the average time required to reach first transfusion independence throughout the treatment period measure: Levels of reticulocyte count at each visit and change from baseline measure: Levels of hematocrit at each visit and change from baseline measure: Levels of mean corpuscular volume at each visit and change from baseline measure: Levels of mean corpuscular hemoglobin at each visit and change from baseline sex: ALL minimumAge: 18 Years maximumAge: 75 Years stdAges: ADULT stdAges: OLDER_ADULT hasResults: False
<\|newrecord\|> nctId: NCT06304090 id: SGB-NT briefTitle: Efficacy of Lidocaine Block in Children With Cerebral Palsy and Dysphagia overallStatus: NOT_YET_RECRUITING date: 2024-03 date: 2024-12 date: 2024-12 date: 2024-03-12 date: 2024-03-15 name: Muhammad class: OTHER briefSummary: The goal of this clinical trial is to test the efficacy of stellate ganglion block in children with cerebral palsy and dysphagia. The main question it aims to answer are:
• Can stellate ganglion block improve the dysphagia of children with cerebral palsy? Participants were randomly divided into two groups, all provided with routine therapy. Based on this, the experimental group was given stellate ganglion block. The video fluoroscopic swallowing study was done to test the swallowing function before and after the study. conditions: Cerebral Palsy studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: QUADRUPLE whoMasked: PARTICIPANT whoMasked: CARE_PROVIDER whoMasked: INVESTIGATOR whoMasked: OUTCOMES_ASSESSOR count: 80 type: ESTIMATED name: routine rehabilitation treatment name: Stellate ganglion block name: Lidocaine Hydrochloride measure: Penetration-Aspiration Scale measure: Functional Oral Intake Scale sex: ALL minimumAge: 4 Years maximumAge: 7 Years stdAges: CHILD hasResults: False
<\|newrecord\|> nctId: NCT06304077 id: 2023-01894 id: 000005739 type: REGISTRY domain: Swiss National Clinical Trial Portal (SNCTP) briefTitle: Restorative Environments for Gait Therapy With VR acronym: REGaitVR overallStatus: RECRUITING date: 2024-03-01 date: 2025-02 date: 2025-02 date: 2024-03-12 date: 2024-03-12 name: ETH Zurich class: OTHER briefSummary: The aim of our study is to investigate the effects of landscapes during gait therapy. The investigators will evaluate the impacts of restorative landscapes as they occur in urban, rural and forest environments. Older people will experience those landscapes using virtual reality (VR) goggles during their gait training. The investigators expect the landscapes to have an effect on the following three aspects: (1) stress reduction, (2) restoration of attention and (3) change in gait parameters. For this purpose, volunteers who are currently inpatient in one of our study centers and already participating in gait therapy will be assigned to a group. The control group will receive the standard therapy. The participants of the intervention groups will receive five additional VR training sessions to the standard therapy. In these sessions, the participants will walk through urban, rural and forest landscapes and perform balance improvement exercises. The five training sessions will take place within ten days. Allocation to the control or intervention groups and their landscapes is random. At the start and end of participation, tests defining stress levels and gait parameters are carried out so that comparisons can be made between before and after treatment. The goal of the study is to find out which type of landscape supports restoration and can therefore contribute to greater gait stability. The investigators expect that improved gait stability will be promoted by stress reduction and increased attention induced by the virtual environments. The investigators are investigating the consequences of repeated application of virtual landscapes and the relationship between the effect of the landscape and the preferences and habits of the study participants. conditions: Gait Analysis conditions: Virtual Reality conditions: Attention conditions: Stress studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL interventionModelDescription: This is a randomized, multi-arm (4-arm), open-label pilot controlled trial with an allocation ratio of 1:1:1:1 (per intervention group (urban, rural, forest) : control). The study setup is multicentric (Geriatrische Klinik St. Gallen, Spitäler Schaffhausen, Spital Zollikerberg). primaryPurpose: TREATMENT masking: NONE count: 84 type: ESTIMATED name: Forest name: Urban name: Rural measure: Gait Stability measure: Variability (Gait Parameter) measure: Speed (Gait Parameter) measure: Asymmetry (Gait Parameter) measure: Stance (Gait Parameter) measure: Max. Heel Clearance (Gait Parameter) measure: 1-Minute-Sit-to-Stand Test (1-Min-STST) measure: Perceived Restorativeness Scale (PRS) (Attention Restoration) measure: Perceived Stress Scale (PSS) (Stress Reduction) measure: Skin Conductance Levels (SCL) (Stress Reduction) measure: Non-Specific Skin Conductance Responses (NS-SCRs) (Stress Reduction) measure: Event-related Skin Conductance Responses (ER-SCRs) (Stress Reduction) measure: Standard deviation of all NN (normal-to-normal) intervals (SDNN) (Heart Rate Variability (HRV), Stress Reduction) measure: Root Mean Square of Successive Differences (RMSSD) (Heart Rate Variability (HRV), Stress Reduction) measure: LF/HF-ratio (Heart Rate Variability (HRV), Stress Reduction) measure: Heart Rate change (ΔHR) (Meaning / Valence of Landscapes) measure: Questionnaire / structured interview on landscape preferences and meanings ascribed to landscapes (Meaning / Valence of Landscapes) measure: Gaze patterns measure: Age (Demographic data) measure: Height (Demographic data) measure: Weight (Demographic data) measure: Gender (Demographic data) measure: Education (Demographic data) measure: Diagnosis and reason for gait stability training measure: Time since last fall sex: ALL minimumAge: 65 Years stdAges: OLDER_ADULT facility: Geriatrische Klinik St. Gallen status: NOT_YET_RECRUITING city: St. Gallen state: Saint Gallen zip: 9000 country: Switzerland name: Dzuza Papik role: CONTACT phone: +41 (0)71 243 88 30 email: dzuza.papik@geriatrie-sg.ch lat: 47.42391 lon: 9.37477 facility: Spital Zollikerberg status: RECRUITING city: Zollikerberg state: Zürich zip: 8125 country: Switzerland name: Cor Dekker role: CONTACT phone: +41 (0)44 397 27 11 email: cor.dekker@therapien-zollikerberg.ch lat: 47.3451 lon: 8.60088 facility: Spitäler Schaffhausen status: NOT_YET_RECRUITING city: Schaffhausen zip: 8208 country: Switzerland name: Eliane Hepfer role: CONTACT phone: +41 (0)52 634 83 50 email: eliane.hepfer@spitaeler-sh.ch lat: 47.69732 lon: 8.63493 hasResults: False
<\|newrecord\|> nctId: NCT06304064 id: CAP-1002-DMD-03 briefTitle: Halt cardiomyOPathy progrEssion in Duchenne (HOPE-OLE) acronym: HOPE-OLE overallStatus: COMPLETED date: 2018-06-21 date: 2019-03-06 date: 2019-03-06 date: 2024-03-12 date: 2024-04-24 date: 2024-04-24 name: Capricor Inc. class: INDUSTRY briefSummary: This Phase 2, multi-center, open-label extension trial will provide CAP-1002 to participants who were randomized to the Usual Care treatment group of the HOPE-Duchenne study (NCT02485938) and completed 12 months of follow-up.
The trial will assess the safety and efficacy of two intravenous administrations of CAP-1002, each separated by three months. conditions: Duchenne Muscular Dystrophy studyType: INTERVENTIONAL phases: PHASE2 allocation: NA interventionModel: SINGLE_GROUP primaryPurpose: TREATMENT masking: NONE count: 8 type: ACTUAL name: Allogeneic Cardiosphere-Derived Cells (CAP-1002) measure: Number of Participants Experiencing Acute Respiratory Decompensation measure: Number of Participants With Hypersensitivity Reactions measure: All-cause Mortality measure: Number of Treatment-emergent Adverse Events (TEAEs) Related to Investigational Product or Administration and Serious Adverse Events (SAEs) measure: Number of Participants With Immune Sensitization Syndrome sex: MALE minimumAge: 12 Years stdAges: CHILD stdAges: ADULT stdAges: OLDER_ADULT facility: University of Florida city: Gainesville state: Florida zip: 32610 country: United States lat: 29.65163 lon: -82.32483 facility: Cincinnati Children's Medical Center city: Cincinnati state: Ohio zip: 45229 country: United States lat: 39.12713 lon: -84.51435 typeAbbrev: Prot hasProtocol: True hasSap: False hasIcf: False label: Study Protocol date: 2018-02-12 uploadDate: 2024-03-29T13:28 filename: Prot_000.pdf size: 2102667 typeAbbrev: SAP hasProtocol: False hasSap: True hasIcf: False label: Statistical Analysis Plan date: 2019-03-26 uploadDate: 2024-03-29T13:25 filename: SAP_001.pdf size: 741616 hasResults: True
<\|newrecord\|> nctId: NCT06304051 id: Naochuxue-IOE briefTitle: Effect of Intermittent Oral Enteral Nutrition Tube in Tracheostomized Patients With Intracerebral Hemorrhage overallStatus: COMPLETED date: 2023-01-17 date: 2023-05-10 date: 2023-06-01 date: 2024-03-12 date: 2024-03-12 name: Muhammad class: OTHER briefSummary: This was a multicenter, prospective, randomized controlled clinical trail involved tracheostomized patients with Intracerebral Hemorrhage.
The goal of this clinical trial is to compare the clinical effect of Intermittent Oro-esophageal Tube Feeding vs Nasogastric Tube Feeding in Tracheostomized Patients with Intracerebral Hemorrhage. The main questions it aims to answer are:
Compared to Nasogastric Tube Feeding, can the Intermittent Oro-esophageal Tube Feeding better improve the nutritional status, extubation of tracheostomy tube, pulmonary infection, neurological deficit of Patients with Intracerebral Hemorrhage Compared to Nasogastric Tube Feeding, is the Intermittent Oro-esophageal Tube Feeding safer.
Participants will be divided into two groups randomly, with different nutritional support respectively. conditions: Intracerebral Hemorrhage studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: SINGLE whoMasked: OUTCOMES_ASSESSOR count: 118 type: ACTUAL name: Intermittent Oro-esophageal Tube Feeding name: Nasogastric Tube Feeding measure: Number of cases of successful extubation measure: Body mass index measure: Serum albumin level measure: Hemoglobin level measure: Clinical Pulmonary Infection Score sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Hongkong central Hospital city: Hong Kong country: Hong Kong lat: 22.27832 lon: 114.17469 hasResults: False
<\|newrecord\|> nctId: NCT06304038 id: 2018 briefTitle: Cost-consequence Analysis of Influenza Vaccination in a Teaching Hospital in Rome overallStatus: COMPLETED date: 2017-10-16 date: 2018-04-29 date: 2019-11-14 date: 2024-03-12 date: 2024-03-12 name: Fondazione Policlinico Universitario Agostino Gemelli IRCCS class: OTHER briefSummary: Flu vaccination, as well as being effective to prevent seasonal influenza, decreases staff illness and absenteeism and reduces costs resulting from loss of productivity. Despite the effectiveness of flu vaccination, the seasonal coverage among healthcare workers is usually low. The aim of this retrospective observational study is to analyze the vaccination coverage rate among all employees (healthcare workers and administrative staff) of a large teaching hospital in Rome during the 2017-2018 influenza season, to perform a cost-consequence analysis of influenza vaccination (by evaluating the absenteeism due to illness in the epidemic period), and to assess the impact of vaccination in terms of both costs and sick days. conditions: Influenza Vaccine conditions: Cost-Benefit Analysis studyType: OBSERVATIONAL observationalModel: CASE_CONTROL timePerspective: RETROSPECTIVE count: 5483 type: ACTUAL name: Flu Vaccine measure: Effectiveness of the quadrivalent vaccine measure: Economic impact of the quadrivalent vaccine measure: Expected economic savings for each one percentage point increase in vaccination coverage measure: Non-economic incentives for healthcare personnel who decide to vaccinate sex: ALL stdAges: CHILD stdAges: ADULT stdAges: OLDER_ADULT facility: Fondazione Policlinico Universitario "A.Gemelli" IRCCS city: Rome zip: 00168 country: Italy lat: 41.89193 lon: 12.51133 hasResults: False
<\|newrecord\|> nctId: NCT06304025 id: GvHD 01 briefTitle: Sequential Administration of WJ-MSCs for the Treatment of GvHD Refractory to Second Line Treatment acronym: GvHD overallStatus: NOT_YET_RECRUITING date: 2024-06 date: 2025-06 date: 2025-08 date: 2024-03-12 date: 2024-03-12 name: Fundación Oftalmológica de Santander Clínica Carlos Ardila Lulle class: OTHER name: Instituto Distrital de Ciencia, Biotecnología e Innovación en Salud - IDCBIS briefSummary: Hematopoietic stem cell transplantation (HSCT) is the treatment of choice for malignant hemopathies, but highlights the limitations of long-term results due to the high toxicity of the procedure and the development of Graft versus Host Disease (GVHD). Conventional treatments for GVHD have limited success rates, and some patients may be refractory to ruxolitinib, a second-line treatment option. As a result, there is a need to explore alternative immuno-modulatory therapies, such as the use of Wharton's jelly mesenchymal stem cells (WJ-MSCs).
The research question aims to investigate the safety and potential benefits of sequentially infusing thawed or expanding allogeneic WJ-MSCs in the treatment of acute GVHD refractory to second-line treatment in patients from the Colombian population. This pilot clinical study is being conducted to address the unmet need for patients who develop GVHD resistant to ruxolitinib. conditions: Graft Versus Host Disease studyType: INTERVENTIONAL phases: PHASE1 phases: PHASE2 allocation: RANDOMIZED interventionModel: PARALLEL interventionModelDescription: Experimental (pilot clinical study), randomized, blind, and parallel. primaryPurpose: TREATMENT masking: DOUBLE whoMasked: PARTICIPANT whoMasked: CARE_PROVIDER count: 10 type: ESTIMATED name: Wharton's jelly mesenchymal stem cells (WJ-MSCs) measure: Incidence of treatment-emergent adverse events: safety and tolerability measure: Efficacy clinic profile: response of acute GVDH measure: Efficacy clinic profile : duration of response measure: Efficacy clinic profile: decrease in treatments measure: Efficacy biological profile: secretion pattern of soluble factors measure: Efficacy biological profile: cell populations measure: Efficacy biological profile: ocrrelation of the biological markers with the clinical response sex: ALL minimumAge: 18 Years maximumAge: 65 Years stdAges: ADULT stdAges: OLDER_ADULT hasResults: False
<\|newrecord\|> nctId: NCT06304012 id: IOE-TBI lao briefTitle: Effect of Oral Enteral Nutrition on Severe Traumatic Brain Injury overallStatus: COMPLETED date: 2022-06-01 date: 2023-05-17 date: 2023-06-01 date: 2024-03-12 date: 2024-03-12 name: Muhammad class: OTHER briefSummary: This was a multicenter randomized controlled study of 98 severe Traumatic Brain Injury patients with tracheostomy. Patients enrolled were divided randomly into the observation group with Intermittent Oro-esophageal Tube Feeding (n=50) or the control group with Nasogastric tube feeding (n=48) for enteral nutrition support, respectively. Nutritional status, complications, decannulation of tracheostomy tubes and level of consciousness on day 1 and day 28 were recorded and compared. conditions: Traumatic Brain Injury studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: SINGLE whoMasked: OUTCOMES_ASSESSOR count: 104 type: ACTUAL name: Nasogastric tube feeding name: Intermittent Oro-esophageal Tube Feeding name: Rehabilitation therapy measure: Concentration of hemoglobin measure: Concentration of albumin measure: Concentration of prealbumin measure: Nutritional status-body mass index measure: Complications-Pulmonary Infections measure: Complications-Gastroesophageal Reflux measure: Complications- Gastrointestinal Bleeding measure: Complications-Gastric Retention measure: Complications-Diarrhea measure: Complications-Constipation measure: Decannulation of tracheostomy tube-placement duration measure: Level of consciousness sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Jiansheng Hos. city: Yilan country: Taiwan lat: 24.757 lon: 121.753 hasResults: False
<\|newrecord\|> nctId: NCT06303999 id: IOE-Small lao briefTitle: Effect of Oral Enteral Nutrition on Cerebral Small Vessel Disease overallStatus: COMPLETED date: 2023-01-01 date: 2023-06-02 date: 2023-06-15 date: 2024-03-12 date: 2024-03-12 name: Muhammad class: OTHER briefSummary: Nasogastric tube feeding (NGT) has been widely used in cerebral small vessel disease (CSVD) patients with dysphagia but has a significant risk of complications. Intermittent Oro-esophageal Tube Feeding (IOE) is an established enteral nutrition approach that can be used with comprehensive rehabilitation therapy. This study aims to explore the clinical effect of IOE vs. NGT on CSVD Patients with Dysphagia. Compared to NGT, IOE, as an enteral nutrition support mode, in CSVD Patients with Dysphagia who received comprehensive rehabilitation therapy, showed advantages in improvement in dysphagia, nutritional status, ADL, QOL, pneumonia, and adverse events, which should be considered as the preferred approach. conditions: Cerebral Small Vessel Diseases studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: SUPPORTIVE_CARE masking: SINGLE whoMasked: OUTCOMES_ASSESSOR count: 60 type: ACTUAL name: Intermittent Oro-esophageal Tube name: Nasogastric tube measure: Functional Oral Intake Scale measure: Body mass index measure: Serum albumin measure: Hemoglobin measure: Pneumonia measure: Activities of daily living measure: World Health Organization Quality of Life Assessment Instrument Brief Version sex: ALL minimumAge: 40 Years maximumAge: 70 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Huimin Hos. city: Pengfu country: Taiwan lat: 24.98333 lon: 121.41667 hasResults: False
<\|newrecord\|> nctId: NCT06303986 id: NAS-002 briefTitle: Study to Collect Data for Neonatal Abstinence Syndrome (NAS) and Evaluate the Automated Data Collection Process overallStatus: RECRUITING date: 2024-03-18 date: 2024-06-30 date: 2024-06-30 date: 2024-03-12 date: 2024-03-22 name: Rekovar Inc. class: INDUSTRY name: Johns Hopkins University name: Children's Hospital of Orange County name: Children's Hospital Los Angeles name: University of New Mexico briefSummary: Substance abuse during pregnancy is on the rise through both prescribed and illicit use of controlled substances, which has increased neonatal abstinence syndrome (NAS). The prevalence of opioid use during pregnancy has increased by 333% from 2013 to 2014 and continues to rise. Approximately 1 in 3 women were prescribed opioids during pregnancy from 2008 to 2012. In the US, NAS was diagnosed every 25 minutes in 2014. By 2019, it became every 15 minutes. Although there are medication-based interventions for the treatment of NAS, used in up to 80% of opioid-exposed infants, these treatments carry risks of toxicity and drug interactions. Despite the steep medical costs and the risks of treatment, current tools to assess the severity of NAS are subjective and suffer from examiner bias, resulting in poorer clinical outcomes, such as longer lengths of stay in the Neonatal Intensive Care Unit (NICU), for these babies. Studies have shown that continuous vital sign monitoring improves outcomes and decreases the length of stay in general practice. Preliminary machine learning models have been able to predict pharmacological treatment for Neonatal Opioid Withdrawal Syndrome (NOWS). This project will collect physiological and behavioral data of NAS patients to develop an AI algorithm and establish the advantages of continuous monitoring in NAS. The AI algorithm, processed by machine learning, will help predict NAS symptoms, automate scoring, and provide healthcare personnel with predictive analytics to guide suggested treatments. conditions: Neonatal Abstinence Syndrome studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: PROSPECTIVE count: 60 type: ESTIMATED name: Neomonki measure: Training/validation data collection measure: Continuous Monitoring sex: ALL maximumAge: 4 Weeks stdAges: CHILD facility: John Hopkins University status: RECRUITING city: Baltimore state: Maryland zip: 21224 country: United States name: Krystle McConnell, MPH role: CONTACT phone: 410-550-8779 email: kgreen39@jhmi.edu name: Lauren Jansson, MD role: PRINCIPAL_INVESTIGATOR lat: 39.29038 lon: -76.61219 facility: University of New Mexico status: RECRUITING city: Albuquerque state: New Mexico zip: 87106 country: United States name: Sandra S Beauman, MSN, RNC-NIC role: CONTACT phone: 505-272-0363 email: sbeauman@salud.unm.edu name: Jessie R Maxwell, MD, MBA role: PRINCIPAL_INVESTIGATOR lat: 35.08449 lon: -106.65114 typeAbbrev: ICF hasProtocol: False hasSap: False hasIcf: True label: Informed Consent Form date: 2023-03-23 uploadDate: 2024-02-26T15:29 filename: ICF_000.pdf size: 230657 hasResults: False
<\|newrecord\|> nctId: NCT06303973 id: IOE-PRS briefTitle: Effect of Oral Enteral Nutrition in Pierre Robin Syndrome overallStatus: COMPLETED date: 2022-01-10 date: 2023-06-02 date: 2023-06-15 date: 2024-03-12 date: 2024-03-12 name: Muhammad class: OTHER briefSummary: This was a randomized controlled study. The infants enrolled were randomly divided into the IOE group (with Intermittent Oro-Esophageal Tube Feeding, n=25) and the PNG group (with Nasogastric Tube Feeding, n=23), all receiving systemic therapy. Before and after 4-week treatment, pulmonary infection, swallowing function, nutritional status and body weight between the two group were compared. conditions: Pierre Robin Syndrome studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: SUPPORTIVE_CARE masking: SINGLE whoMasked: OUTCOMES_ASSESSOR count: 50 type: ACTUAL name: IOE name: PNG measure: Number of patients diagnosed as the pulmonary infection "Positive". measure: Nutritional status-total protein measure: Nutritional status-hemoglobin measure: Nutritional status-albumin measure: Nutritional status-prealbumin measure: Body weight measure: Swallowing function sex: ALL minimumAge: 1 Month maximumAge: 12 Months stdAges: CHILD facility: Renai Hospital city: Yilan country: Taiwan lat: 24.757 lon: 121.753 hasResults: False
<\|newrecord\|> nctId: NCT06303960 id: Cerebellar DBS for stroke briefTitle: Bilateral or Unilateral Cerebellar Deep Brain Stimulation for Chronic Post-stroke Motor Rehabilitation overallStatus: RECRUITING date: 2024-03-15 date: 2025-03-07 date: 2026-03-07 date: 2024-03-12 date: 2024-03-27 name: Qilu Hospital of Shandong University class: OTHER briefSummary: Upper-extremity impairment after stroke remains a major therapeutic challenge and a target of neuromodulation treatment efforts.In this open-label, randomized phase I trial, we applied deep brain stimulation to the cerebellar dentate nucleus combined with bilateral or unilateral stimulation. We hypothesized that bilateral stimulation was superior to unilateral stimulation as the motor rehabilitation after stroke benefits from both side of cerebellum. conditions: Stroke studyType: INTERVENTIONAL phases: EARLY_PHASE1 allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: DOUBLE whoMasked: PARTICIPANT whoMasked: OUTCOMES_ASSESSOR count: 100 type: ESTIMATED name: Bilateral Cerebellar deep brain stimulation name: Unilateral Cerebellar deep brain stimulation measure: safety and feasibility of bilateral cerebellar DBS measure: FM-UE scores between bilateral and unilateral cerebellar DBS measure: Arm Motor Ability Test (AMAT) bilateral and unilateral cerebellar DBS measure: the Nine-Hole Peg Test between bilateral and unilateral cerebellar DBS measure: the Bilateral Box and Block Test between bilateral and unilateral cerebellar DBS measure: Short Form Health Survey (SF-12) between bilateral and unilateral cerebellar DBS measure: the EuroQol Five Dimensions Questionnaire (EQ-5D) between bilateral and unilateral cerebellar DBS measure: the Beck Depression Inventory or the Beck Anxiety Inventory between bilateral and unilateral cerebellar DBS measure: nerve conduction velocity between bilateral and unilateral cerebellar DBS sex: ALL minimumAge: 30 Years maximumAge: 75 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Chao Zhang status: RECRUITING city: Jinan state: Sichuan zip: 250100 country: China name: chao zhang role: CONTACT phone: +8613969007232 email: chao_zhang@sdu.edu.cn lat: 36.66833 lon: 116.99722 hasResults: False
<\|newrecord\|> nctId: NCT06303947 id: IOE-PKS briefTitle: Effect of Oral Enteral Nutrition Feeding in Parkinson Disease overallStatus: NOT_YET_RECRUITING date: 2024-03 date: 2024-07 date: 2024-07 date: 2024-03-12 date: 2024-03-15 name: Muhammad class: OTHER briefSummary: The goal of this or clinical trial is to explore Intermittent Oro-esophageal Tube Feeding vs. Nasogastric Tube Feeding on nutritional status, dysphagia, and activities of daily living in patients with Parkinson's disease. The main question it aims to answer are:
• Can stellate ganglion block improve the nutritional status, dysphagia, and activities of daily living in patients with Parkinson's disease, better than Nasogastric Tube Feeding.
Participants will be divided into the control group and observation group evenly. All the patients were provided with routine therapy and given nutritional support by Intermittent Oro-esophageal Tube Feeding and Nasogastric Tube Feeding respectively. The nutritional status, swallowing function, and activities of daily living of the two groups of patients before and after treatment were evaluated. conditions: Parkinson Disease studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: SUPPORTIVE_CARE masking: SINGLE whoMasked: OUTCOMES_ASSESSOR count: 80 type: ESTIMATED name: Intermittent Oro-esophageal Tube name: Nasogastric tube name: Comprehensive rehabilitation training measure: Serum albumin level measure: Hemoglobin measure: Modified Barthel Index measure: Functional Oral Intake Scale sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT hasResults: False
<\|newrecord\|> nctId: NCT06303934 id: IOE-NT briefTitle: Oral Enteral Nutrition in Infants With Cerebral Palsy and Dysphagia overallStatus: COMPLETED date: 2022-01-01 date: 2023-06-15 date: 2023-06-30 date: 2024-03-12 date: 2024-03-12 name: Muhammad class: OTHER briefSummary: This was a randomized controlled study including 80 infants with cerebral palsy and dysphagia. The Participants were evenly divided into the observation group (with intermittent oro-esophageal tube feeding, n=40) and the control group (with persistent nasogastric tube feeding , n=40). Nutritional status and physical development, condition of dysphagia, and pneumonia before and after 3-month treatment were compared. conditions: Cerebral Palsy studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: SUPPORTIVE_CARE masking: SINGLE whoMasked: OUTCOMES_ASSESSOR count: 80 type: ACTUAL name: systemic therapy name: Intermittent Oro-Esophageal Tube Feeding name: Persistent Nasogastric Tube Feeding measure: The Oral Motor Assessment Scale measure: Pneumonia measure: Hemoglobin measure: Total Protein measure: Albumin measure: Prealbumin measure: body weight measure: Penetration-Aspiration Scale measure: Functional Oral Intake Scale for Infants measure: Feeding amount sex: ALL minimumAge: 6 Months maximumAge: 12 Months stdAges: CHILD facility: River First Hos. city: Pingdong country: Taiwan lat: 24.46667 lon: 118.41667 hasResults: False
<\|newrecord\|> nctId: NCT06303921 id: 854681 briefTitle: Study of Biodistribution, Metabolism, Excretion and Brain Uptake11C-M503 overallStatus: RECRUITING date: 2024-02-16 date: 2029-02 date: 2029-02 date: 2024-03-12 date: 2024-04-25 name: University of Pennsylvania class: OTHER briefSummary: The current protocol is to determine the biodistribution, metabolism, excretion and brain uptake of 11C-M503. The goal of this radiotracer is to quantify alpha-synuclein that is abnormally deposited in the brain of people with Parkinson's disease (PD). Investigators will compare uptake in participants with PD versus participants with multiple system atrophy (MSA) and progressive supranuclear palsy (PSP), as well as non-Parkinsonism volunteers. This multicenter project funded by an NIH U19 grant, is centered at U Pennsylvania (Penn, Grant PI: Robert Mach) in collaboration with U Pittsburgh (Pitt) (non-clinical site) Yale U, U of California at San Francisco (UCSF) and Washington University in St. Louis (WU). The University of Pennsylvania will act as the sIRB for this multi-center human subjects project and participants will be recruited from all sites. conditions: Tauopathies studyType: INTERVENTIONAL phases: EARLY_PHASE1 allocation: NA interventionModel: SINGLE_GROUP primaryPurpose: DIAGNOSTIC masking: NONE count: 70 type: ESTIMATED name: 11C-M503 PET name: Brain MRI name: Amyloid PET name: Neurological assessments measure: Organ Biodistribution or Dosimetry measure: PET Uptake of Tracer measure: Adverse Events sex: ALL minimumAge: 40 Years maximumAge: 85 Years stdAges: ADULT stdAges: OLDER_ADULT facility: University of Pennsylvania status: RECRUITING city: Philadelphia state: Pennsylvania zip: 19104 country: United States name: Erin Schubert role: CONTACT phone: 215-662-3041 email: erinshu@pennmedicine.upenn.edu name: IIya Nasrallah, MD, PhD role: PRINCIPAL_INVESTIGATOR lat: 39.95233 lon: -75.16379 hasResults: False
<\|newrecord\|> nctId: NCT06303908 id: Commu-PKS briefTitle: How Traditional Chinese Medicine Exercise Improves Parkinson Disease overallStatus: NOT_YET_RECRUITING date: 2024-11 date: 2024-12 date: 2024-12 date: 2024-03-12 date: 2024-03-15 name: Muhammad class: OTHER briefSummary: The goal of this clinical trial is to explore the impact of Simple Gymnastics Training on Limb motor function and mental health in Parkinson's Patients in the Community (≥60 year old) with swallowing disorders. It primarily aims to address two key aspects: 1) the prevalence of Parkinson's Diseases among community-dwelling elderly individuals, and 2) the effects of Simple Gymnastics Training on Limb motor function and mental health in community-dwelling Parkinson's Patients. All patients are required to undergo a continuous three-week (21 days) Simple Gymnastics Training, with weekends off and training conducted only on weekdays. The training will be conducted two sessions per day, lasting 30 minutes each. conditions: Parkinson Disease studyType: INTERVENTIONAL phases: NA allocation: NA interventionModel: SINGLE_GROUP primaryPurpose: TREATMENT masking: NONE count: 300 type: ESTIMATED name: Simple Gymnastics Training measure: Unified Parkinson's Disease Rating Scale measure: The Berg Balance Scale measure: Patient Health Questionnaire-9 measure: Generalized Anxiety Disorder-7 sex: ALL minimumAge: 60 Years stdAges: ADULT stdAges: OLDER_ADULT hasResults: False
<\|newrecord\|> nctId: NCT06303895 id: Acu-PKS-new briefTitle: How Acupuncture Therapy Improves Dysphagia in Parkinson's Patients overallStatus: NOT_YET_RECRUITING date: 2024-03 date: 2024-06 date: 2024-06 date: 2024-03-12 date: 2024-03-13 name: Muhammad class: OTHER briefSummary: This study is focusing on dysphagic participants with Parkinson's disease. The aim of our study is to evaluate the effectiveness of acupuncture therapy as an additional intervention for these participants. Participants were randomly assigned to either the experimental group or the control group, with 56 individuals in each group. Both groups are receiving standard treatment and swallowing rehabilitation training, while the experimental group is also receiving acupuncture therapy. Our study aims to provide valuable insights into the potential benefits of acupuncture in improving swallowing difficulties in Parkinson's disease participants. conditions: Dysphagia studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: SINGLE whoMasked: OUTCOMES_ASSESSOR count: 80 type: ESTIMATED name: Routine rehabilitation training name: Swallowing rehabilitation training name: Acupuncture therapy measure: Penetration-Aspiration Scale-liquid measure: Penetration-Aspiration Scale-paste measure: Swallowing time measure: body mass index measure: Serum Albumin measure: Prealbumin measure: Hemoglobin measure: Swallowing Quality of Life sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT hasResults: False
<\|newrecord\|> nctId: NCT06303882 id: AI-Dysphagia briefTitle: Effect of Computer-based Cognitive Function Training on Cognitive Dysphagia After Stroke overallStatus: NOT_YET_RECRUITING date: 2024-03 date: 2024-06 date: 2024-06 date: 2024-03-12 date: 2024-03-15 name: Muhammad class: OTHER briefSummary: This is a multicenter randomized controlled study. The study recruited stroke patients with mild cognitive impairment and dysphagia who were undergoing inpatient rehabilitation treatment in three hospitals in mainland China as the participants (study subjects). The study duration for each participant was 15 days. The subjects were randomly divided into an experimental group and a control group. During the treatment, all patients received routine rehabilitation treatment. In addition, patients in the control group received conventional cognitive training, while patients in the experimental group received computer-assisted cognitive training. conditions: Dysphagia studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: SINGLE whoMasked: OUTCOMES_ASSESSOR count: 80 type: ESTIMATED name: routine rehabilitation treatment name: Computer-assisted Cognitive Function Training name: conventional cognitive training measure: Montreal Cognitive Assessment measure: The coordination of swallowing measure: Penetration-Aspiration Scale measure: Swallowing duration measure: Swallowing reflex sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT hasResults: False
<\|newrecord\|> nctId: NCT06303869 id: STUDY22070043 briefTitle: Deep Brain Stimulation Motor Ventral Thalamus (VOP/VIM) for Restoration of Speech and Upper-limb Function in People With Subcortical Stroke overallStatus: NOT_YET_RECRUITING date: 2024-05 date: 2029-05 date: 2029-10 date: 2024-03-12 date: 2024-04-03 name: Jorge Gonzalez-Martinez class: OTHER briefSummary: The goal of this study is to verify whether the use of deep brain stimulation can improve motor function of the hand and arm and speech abilities for people following a stroke. Participants will undergo a surgical procedure to implant deep brain stimulation electrode leads. The electrodes will be connected to external stimulators and a series of experiments will be performed to identify the types of movements that the hand and arm can make and how speech abilities are affected by the stimulation. The implant will be removed after less than 30 days. Results of this study will provide the foundation for future studies evaluating the efficacy of a minimally-invasive neuro-technology that can be used in clinical neuro-rehabilitation programs to restore speech and upper limb motor functions in people with subcortical strokes, thereby increasing independence and quality of life. conditions: Stroke conditions: Brain Disease conditions: Central Nervous System Diseases conditions: Nervous System Diseases conditions: Cardiovascular Diseases studyType: INTERVENTIONAL phases: NA allocation: NA interventionModel: SINGLE_GROUP interventionModelDescription: Prospective, non-randomized, open-label, descriptive, experimental. primaryPurpose: BASIC_SCIENCE masking: NONE count: 10 type: ESTIMATED name: Deep Brain Stimulation (DBS) of the Motor Thalamus measure: Adverse Events measure: Discomfort and Pain measure: Dysphagia measure: Hand dexterity measure: Muscle weakness measure: Dexterity of Articulation AMRs measure: Dexterity of Articulation SMRs measure: Intelligibility of Speech measure: Spasticity measure: Range of Motion (ROM) sex: ALL minimumAge: 18 Years maximumAge: 70 Years stdAges: ADULT stdAges: OLDER_ADULT facility: University of Pittsburgh city: Pittsburgh state: Pennsylvania zip: 15213 country: United States name: Cierra Clark, MS role: CONTACT phone: 240-441-4216 email: cic27@pitt.edu lat: 40.44062 lon: -79.99589 hasResults: False
<\|newrecord\|> nctId: NCT06303856 id: ABE-OLDer briefTitle: How Active Breathing Training Improves Dysphagia in Elderly People overallStatus: NOT_YET_RECRUITING date: 2024-03 date: 2024-05 date: 2024-05 date: 2024-03-12 date: 2024-03-13 name: Muhammad class: OTHER briefSummary: The goal of this clinical trial is to explore the impact of Active Breathing Exercises on swallowing function and quality of life in community-dwelling elderly individuals (≥60 year old) with swallowing disorders. It primarily aims to address two key aspects: 1) the prevalence of dysphagia among community-dwelling elderly individuals, and 2) the effects of Active Breathing Exercises on swallowing function and quality of life in community-dwelling elderly individuals with swallowing disorders. All participants enrolled are required to undergo a continuous three-week (21 days) Active Breathing Exercises, with weekends off and training conducted only on weekdays. The training will be conducted two sessions per day, lasting 15-30 minutes each. conditions: Dysphagia studyType: INTERVENTIONAL phases: NA allocation: NA interventionModel: SINGLE_GROUP primaryPurpose: PREVENTION masking: NONE count: 300 type: ESTIMATED name: Active Breathing Exercises measure: Eating Assessment Tool-10 measure: Time consumed in eating measure: Swallowing-Related Quality of Life Questionnaire sex: ALL minimumAge: 60 Years stdAges: ADULT stdAges: OLDER_ADULT hasResults: False
<\|newrecord\|> nctId: NCT06303843 id: 13.04.2023 briefTitle: The Effect of Electric Ride-On Cars Use During Transport to the Operating Theatre overallStatus: COMPLETED date: 2023-05-02 date: 2024-02-15 date: 2024-02-15 date: 2024-03-12 date: 2024-03-12 name: Uşak University class: OTHER briefSummary: The aim of our study was to evaluate the effect of the use of a electric ride-on car during transport to the operating theatre on preoperative anxiety in children undergoing elective ambulatory surgery. As a distraction method, children in the experimental group will be introduced to the operating theatre with a electric ride-on car. Yale Modified Preoperative Anxiety Scale Child Form will be used to evaluate anxiety. The sample size was determined as 118 as a result of power analysis. 59 children will be included in the experimental group and 59 children in the control group.
Translated with DeepL.com (free version) conditions: Anxiety conditions: Preoperative Anxiety conditions: Pediatric Surgery studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: SUPPORTIVE_CARE masking: SINGLE whoMasked: OUTCOMES_ASSESSOR count: 118 type: ACTUAL name: Transfer with an electric ride-on car measure: Perioperative anxiety sex: ALL minimumAge: 2 Years maximumAge: 10 Years stdAges: CHILD facility: Usak University Training and Research Hospital city: Usak zip: 64100 country: Turkey lat: 38.67351 lon: 29.4058 hasResults: False
<\|newrecord\|> nctId: NCT06303830 id: BACA2019 briefTitle: Bariatric Surgery and Cardiovascular Responses to Sodium Nitrate overallStatus: COMPLETED date: 2019-04-16 date: 2020-12-17 date: 2021-10-01 date: 2024-03-12 date: 2024-03-12 name: University of Sao Paulo class: OTHER briefSummary: Inorganic nitrite and nitrate can be reduced to NO and NO-related species such as S-nitrosothiols via the nitrate-nitrite-NO pathway. This is due to the reduction of nitrate to nitrite by the action of bacteria in the mouth and the reduction of nitrite to NO depending on the acidic pH on the stomach or by enzymes with nitrite-reductase activity. The acidic environment of the stomach is very important to the formation of NO and S-nitrosothiols and several studies suggest that changes in gastric pH can affect this conversion. In this context, bariatric surgery, by altering the anatomy of the stomach and increasing gastric pH, can affect the nitrate-nitrite-NO pathway and change the antihypertensive and antioxidant effect of sodium nitrate. conditions: Hypertension studyType: INTERVENTIONAL phases: NA allocation: NON_RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: NONE count: 30 type: ACTUAL name: Sodium nitrate measure: Assess changes in s-nitrosothiols measure: Assess changes in blood pressure measure: Assess changes in endotelial function measure: Assess changes in Vascular stiffness measure: Assess changes in nitrate concentration measure: Assess changes in nitrite concentration sex: FEMALE minimumAge: 18 Years maximumAge: 60 Years stdAges: ADULT facility: Usp - Hospital Das Clínicas Da Faculdade de Medicina de Ribeirão city: Ribeirão Preto state: São Paulo zip: 14.048-900 country: Brazil lat: -21.1775 lon: -47.81028 hasResults: False
<\|newrecord\|> nctId: NCT06303817 id: 1812 briefTitle: Double Knots Versus Triple Knots Facia Closure Method; is There a Difference in Pain Sensation or Cosmetic Satisfaction? overallStatus: COMPLETED date: 2022-03-01 date: 2022-06-01 date: 2023-01-01 date: 2024-03-12 date: 2024-03-12 name: Adana City Training and Research Hospital class: OTHER briefSummary: The study included women who were scheduled for an elective or had an emergency cesarean section. Age, body mass index (BMI), obstetric history, education status, smoking status and C-section indications of the patients were recorded. Patients with a previous suprapubic scar, medical conditions affecting wound healing (such as diabetes or chronic corticosteroid use), those needing a vertical incision (e.g., placenta previa), individuals with postoperative wound infection or under 18 years old were excluded. Data were collected in standardized data form by a research assistant. Pre- and post-surgery treatments and/or interventions were standardized. All patients received antimicrobial prophylaxis with cefazolin before the operation. The abdomen was entered via a transverse suprapubic skin incision and the surgical steps up to the point of facia closure were accomplished in a standard fashion. Technical differences such as blunt and sharp dissection, uterus exteriorization vs in situ, or parietal peritoneum closure were left to the surgeon's discretion. The procedures for facia closure are as follows; in Group I (Double knots group), the edge of the fascia was determined with a Kocher clamp. The fascia was closed starting from the opposite side with a synthetic absorbable multifilament suture in a continuous fashion up to the Kocher clamp and tied the knots with the same single suture (Figure 2; a-b). In Group II (Triple knots group), the edge of the fascia was fixed with the same suture material instead of the Kocher clamp, and the fascia was closed similarly, starting from the opposite corner via the second loop. Then the loops from the first suture were tied to the second suture (Figure 2; c-d). After the incision was irrigated with sterile saline solution, the subcutaneous space was closed if the thickness was 2 cm or more. Skin closure was accomplished with a subcuticular technique using a non-absorbable monofilament suture, which was removed on the 10th day postoperatively. A closed subcutaneous suction drain was not used in any of the patients. Postoperative pain at and around the incision line was measured on the 1st, and 10th days postoperatively on the NRS (Numeric Rating Scale), with "0" being "no pain" and "10" being "the worst pain imaginable." The 1st measurements were made face-to-face, and the 10th-day evaluation was made via telephone interviews by the same research assistant. conditions: Cesarean Section conditions: Pain conditions: Cosmetics Sensitivity studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: OTHER masking: NONE count: 203 type: ACTUAL name: Double knots facia closure method during cesarean section name: Triple knots facia closure method during cesarean section measure: Change from baseline in pain on NRS (Numeric Rating Scale) at 10 days measure: Change from baseline in aesthetic results at 3 months sex: FEMALE minimumAge: 18 Years maximumAge: 45 Years stdAges: ADULT facility: Adana Şehir Eğitim ve Araştırma Hastanesi city: Adana state: Yüreğir zip: 01120 country: Turkey lat: 37.00167 lon: 35.32889 hasResults: False
<\|newrecord\|> nctId: NCT06303804 id: HSC-SPH-23-0837 briefTitle: Prevention of Opioid Misuse and Overdose Deaths Among Hispanic/Latinx Adolescents: A Family-based Perspective overallStatus: NOT_YET_RECRUITING date: 2024-05-01 date: 2024-08-31 date: 2024-08-31 date: 2024-03-12 date: 2024-03-12 name: The University of Texas Health Science Center, Houston class: OTHER briefSummary: The purpose of this study is to develop culturally-competent family-focused educational modules targeting opioid knowledge and attitudes (including targeting safe storage and prevention of accidental opioid overdose in adolescent populations) and examine changes acceptability, knowledge, and attitudes scores conditions: Opioid Misuse studyType: INTERVENTIONAL phases: NA allocation: NA interventionModel: SINGLE_GROUP primaryPurpose: PREVENTION masking: NONE count: 50 type: ESTIMATED name: Educational videos measure: Acceptability of the educational materials presented via the educational videos, including cultural congruence as assessed by a questionnaire measure: Changes in opioid related knowledge as assessed by a questionnaire sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: The University of Texas Health Science Center at Houston city: Houston state: Texas zip: 77030 country: United States name: Alejandra Fernandez, PhD role: CONTACT phone: 972-546-2920 email: Alejandra.Fernandez@uth.tmc.edu lat: 29.76328 lon: -95.36327 hasResults: False
<\|newrecord\|> nctId: NCT06303791 id: 1905517 briefTitle: Digital-based Psychosocial Intervention for Parents of Children With Neurodevelopmental Disorders acronym: INPSYD overallStatus: ACTIVE_NOT_RECRUITING date: 2022-09-07 date: 2024-05 date: 2024-12 date: 2024-03-12 date: 2024-03-12 name: University of Valencia class: OTHER briefSummary: The goal of this clinical trial is to implement a structured psychosocial intervention program with digital support (randomized and with a control group) that will be conducted virtually and synchronously to families of children with autism spectrum disorder (ASD) and families of children with Attention Deficit with hyperactivity Disorder (ADHD). The main questions it aims to answer are:
1. Will the program impact on different variables in the parents' domain (parental stress variables, quality of life/social support and coping skills),
2. Will the program impact on different variables in the children's domain (daily life functioning, social behavioral variables, and executive functioning).
3. Treatment outcomes will be assessed at pre-test, post-test, and 6-month follow-up assessment across intervention and control groups using a battery of measures of parenting stress, coping skills, social support, and children's dysfunctional outcomes
Parents and teachers will complete different questionnaires to see if there are improvements on parent's and children outcomes.
Researchers will compare intervention group and control group to see if there are improvements on parent's domains (parenting stress, coping skills, social support) and children's dysfunctional outcomes (daily life functioning, social behavioral variables, and executive functioning). conditions: Autism Spectrum Disorder conditions: Attention Deficit Hyper Activity studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL interventionModelDescription: To test the proposed objectives, a design will be used with a between-groups factor (type of therapy) and a intra-groups with pre-treatment (T0), post-treatment (T1) and follow-up measurements at 6 months (T2). Participants will be randomly assigned (1:1) to the two conditions; a group that will receive the intervention of the structured psychosocial program with digital support (experimental group) and an active control group. The experimental group will undergo an evaluation prior to the intervention, one immediately after it, and a third follow-up evaluation. In the case of the control group, it will be evaluated through the pretest phases, posttest and follow-up. primaryPurpose: TREATMENT masking: DOUBLE maskingDescription: Families/children who meet the inclusion criteria will be randomly assigned to one of the two conditions (intervention group or control group) using a controlled design. Block randomization will be applied to each of the diagnostic groups (ASD, ADHD) to ensure that participants were of approximately similar size (1:1 ratio) in the treatment and control conditions. After determining the size of each block in the sample (#ASD and #ADHD) the treatment allocation of each individual participant will be done randomly.A blind procedure will be used: participating families will not know the group to which participants will be assigned, and the researchers who will collect and enter the data will also have no knowledge of the condition to which the families will be assigned. whoMasked: PARTICIPANT whoMasked: OUTCOMES_ASSESSOR count: 90 type: ACTUAL name: Digital Psychosocial intervention measure: Parental stress in The Parenting Stress Index - Short Form (PSI-SF) Spanish adaptation measure: Social support: The Social Functional Support Questionnaire Duke-UNC measure: Coping Skills using The Brief COPE measure: Children's social problems using Strengths and Difficulties Questionnaire (SDQ) measure: Daily life executive functioning using the BRIEF measure: Children Sleep problems: using The Sleep Disturbance Scale for Children (SDSC) measure: Behavioral problems using The Weiss Functional Impairment Rating Scale-Parent Form (WFIRS-P) measure: Children Learning Behavior using Learning behavior scale (LBS) sex: ALL minimumAge: 7 Years maximumAge: 11 Years stdAges: CHILD facility: University of Valencia city: Valencia zip: 46010 country: Spain lat: 39.46975 lon: -0.37739 hasResults: False
<\|newrecord\|> nctId: NCT06303778 id: IIR 22-141 id: HX003742-01A1 type: OTHER_GRANT domain: VA HSR&D briefTitle: Combining a Smartphone App With Medications to Manage Heavy Drinking overallStatus: NOT_YET_RECRUITING date: 2024-06-01 date: 2028-06-01 date: 2028-06-01 date: 2024-03-12 date: 2024-03-12 name: VA Office of Research and Development class: FED briefSummary: One in 10 Veterans have an alcohol use disorder. However, few Veterans receive evidenced-based psychosocial interventions or medications to treat alcohol use disorder. Barriers to receiving these treatments include long wait times, stigma, and long distances from treatment facilities. Even fewer Veterans receive psychosocial and medication interventions together, despite clinical practice guidelines recommending both and evidence of better outcomes. Expanding access to these treatments in primary care is a VA priority but delivering psychosocial interventions is difficult in this setting, and medication is often the only option. Smartphone apps that deliver alcohol interventions may improve drinking outcomes and ensure Veterans can receive both treatments in primary care. This study will determine whether medications and an app for alcohol use problems offered to Veterans in primary care results in improved drinking outcomes, compared to Veterans receiving medications only. Study data will inform how to spread the app across the VA nationally. conditions: Alcohol Use Disorder (AUD) studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL interventionModelDescription: Following completion of informed consent and baseline assessments, participants will be randomized in a 1:1 ratio to MAUD+SD-App or MAUD only conditions. primaryPurpose: HEALTH_SERVICES_RESEARCH masking: NONE count: 330 type: ESTIMATED name: Stand Down mobile app name: Standard Care measure: Change in Percent Heavy Drinking Days measure: Semi-structured qualitative interview data from patients, providers, clinical leaders measure: Change in Short Inventory of Problems - Revised version (SIP-R) measure: Change in World Health Organization (WHO) Risk Levels measure: Change in Client Satisfaction Questionnaire (CSQ) Scores measure: Change in Patient Health Questionnaire Depression Screen (PHQ-9) Scores measure: Change in PTSD Checklist for DSM-5 (PCL-5) Scores measure: Change in Veterans RAND 12 Item Health Survey Scores measure: Change in Percent Heavy Drinking Days measure: Change in Short Inventory of Problems - Revised version (SIP-R) measure: Change in World Health Organization (WHO) Risk Levels measure: Change in Patient Health Questionnaire Depression Screen (PHQ-9) Scores measure: Number of Participants Receiving VA Outpatient Substance Use Disorder Treatment measure: Number of Participants Receiving VA Emergency Department Services measure: Change in PTSD Checklist for DSM-5 (PCL-5) Scores measure: Change in Veterans RAND 12 Item Health Survey Scores sex: ALL minimumAge: 18 Years maximumAge: 80 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Central Alabama Veterans Health Care System West Campus, Montgomery, AL city: Montgomery state: Alabama zip: 36109 country: United States name: Sebastian Skordallos, PharmD role: CONTACT email: Sebastian.Skordallos@va.gov lat: 32.36681 lon: -86.29997 facility: Phoenix VA Health Care System, Phoenix, AZ city: Phoenix state: Arizona zip: 85012 country: United States name: Courtney Speaks, PharmD role: CONTACT email: Courtney.Speaks@va.gov lat: 33.44838 lon: -112.07404 facility: VA Northern California Health Care System, Mather, CA city: Sacramento state: California zip: 95655-4200 country: United States name: Christine Johnston, PharmD role: CONTACT email: Christine.Johnston2@va.gov lat: 38.58157 lon: -121.4944 facility: Carl Vinson VA Medical Center, Dublin, GA city: Dublin state: Georgia zip: 31021 country: United States name: Deborah Hobbs, PharmD role: CONTACT email: Deborah.Hobbs@va.gov lat: 32.54044 lon: -82.90375 facility: Battle Creek VA Medical Center, Battle Creek, MI city: Battle Creek state: Michigan zip: 49037 country: United States name: Elizabeth Ratti, PharmD role: CONTACT email: Elizabeth.Ratti@va.gov lat: 42.3173 lon: -85.17816 facility: Minneapolis VA Health Care System, Minneapolis, MN city: Minneapolis state: Minnesota zip: 55417-2309 country: United States name: Elizabeth Welch, PharmD role: CONTACT phone: 612-618-8725 email: Elizabeth.Welch@va.gov lat: 44.97997 lon: -93.26384 facility: Kansas City VA Medical Center, Kansas City, MO city: Kansas City state: Missouri zip: 64128-2226 country: United States name: Kyleigh Gould, PharmD role: CONTACT email: Kyleigh.Gould@va.gov lat: 39.09973 lon: -94.57857 facility: Tennessee Valley Healthcare System Nashville Campus, Nashville, TN city: Nashville state: Tennessee zip: 37212-2637 country: United States name: Matthew Phillips, PharmD role: CONTACT email: Matthew.Phillips1@va.gov lat: 36.16589 lon: -86.78444 facility: South Texas Health Care System, San Antonio, TX city: San Antonio state: Texas zip: 78229-4404 country: United States name: Cynthia Mascarenas, PharmD role: CONTACT email: Cynthia.Mascarenas@va.gov lat: 29.42412 lon: -98.49363 facility: VA Salt Lake City Health Care System, Salt Lake City, UT city: Salt Lake City state: Utah zip: 84148-0001 country: United States name: Chad Nelson, PharmD role: CONTACT email: Chad.Nelson@va.gov lat: 40.76078 lon: -111.89105 facility: VA Puget Sound Health Care System Seattle Division, Seattle, WA city: Seattle state: Washington zip: 98108-1532 country: United States name: Thomas S Bundt, FACHE role: CONTACT phone: 253-583-3500 email: thomas.bundt@va.gov name: Susan Perez, BA role: CONTACT phone: (202) 461-6910 email: susan.perez@va.gov name: Eric J. Hawkins, PhD role: PRINCIPAL_INVESTIGATOR lat: 47.60621 lon: -122.33207 hasResults: False
<\|newrecord\|> nctId: NCT06303765 id: 13Nov2023PReDAS Study briefTitle: Evaluating the Practice Resource for Driving After Stroke overallStatus: RECRUITING date: 2024-02-01 date: 2024-07-01 date: 2024-08-31 date: 2024-03-12 date: 2024-04-09 name: Western University, Canada class: OTHER briefSummary: After stroke, individuals must be assessed to determine if they can resume driving. Return to driving is very important to people who have experienced a stroke. Unfortunately, health care providers face challenges in addressing driving after stroke. Common issues include being unsure of the best screening practices, difficulty discussing driving with patients, and challenges making informed recommendations about driving that balance the risk of public safety along with supporting patient goals. Occupational Therapists (OTs) are health care providers that provide screening, assessment, and intervention for driving to individuals who have had a stroke. OTs working in stroke care have highlighted the urgency for evidence-based resources to support practice to address driving with patients. The Practice Resource for Driving After Stroke (PReDAS), is an evidenced-based resource to support the clinical practice of OTs in addressing driving in acute stroke settings. A previous pilot study has demonstrated that the PReDAS is considered useful by both health care providers and patients. Further study is needed to evaluate how the PReDAS can support OTs in addressing driving with patients. The current study proposes to provide the PReDAS as an intervention to OTs working in acute stroke settings to see if the intervention increases OT's self efficacy and clinical reasoning for addressing driving. The study will take repeated measures of self-efficacy and clinical reasoning among participating OTs to determine if the PReDAS intervention supports improved self-efficacy and clinical reasoning. conditions: Stroke, Acute conditions: Driving conditions: Occupational Therapy studyType: INTERVENTIONAL phases: NA allocation: NA interventionModel: SINGLE_GROUP interventionModelDescription: multiple baseline study primaryPurpose: TREATMENT masking: NONE count: 8 type: ESTIMATED name: Practice Resource for Driving After Stroke (PReDAS) measure: clinical reasoning measure: self-efficacy sex: ALL stdAges: CHILD stdAges: ADULT stdAges: OLDER_ADULT facility: Western University status: RECRUITING city: London state: Ontario zip: N6G 1H1 country: Canada name: April K Vander Veen, PhD (c) role: CONTACT phone: 519-661-2111 phoneExt: 89153 email: afrankr2@uwo.ca name: Liliana Alvarez, PhD role: CONTACT phone: 519-661-2111 phoneExt: 88957 email: lalvare2@uwo.ca lat: 42.98339 lon: -81.23304 hasResults: False
<\|newrecord\|> nctId: NCT06303752 id: 260-2021-NQ id: 2022-502659-73 type: EUDRACT_NUMBER briefTitle: Tissue Therapy of Transsphincteric Anal Fistula acronym: REP-PAF overallStatus: NOT_YET_RECRUITING date: 2024-05-01 date: 2027-04-30 date: 2027-04-30 date: 2024-03-12 date: 2024-04-12 name: University of Southern Denmark class: OTHER briefSummary: This clinical study aims to evaluate the outcome of the treatment of complex perianal fistulas (PAF) by the combination of minimal surgical debridement with regenerative cellular therapeutics. conditions: Anal Fistula studyType: INTERVENTIONAL phases: PHASE1 phases: PHASE2 allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: QUADRUPLE whoMasked: PARTICIPANT whoMasked: CARE_PROVIDER whoMasked: INVESTIGATOR whoMasked: OUTCOMES_ASSESSOR count: 75 type: ESTIMATED name: ADRC injection name: ADRC001 injection measure: Healing rate (percentage) measure: QoL measure: Fecal Incontinence measure: Risk factors for recurrence of fistula. measure: Radiological healing. measure: Treatment efficacy. measure: Cellular composition measure: Transplantation-related alloantibodies sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Odense University Hospital city: Odense zip: 5000 country: Denmark name: Karam M Sørensen, Ph.D role: CONTACT phone: +4565415190 email: ouh.a.forskningsenheden@rsyd.dk name: Tina D Hansen role: CONTACT phone: +4565415190 email: ouh.a.forskningsenheden@rsyd.dk lat: 55.39594 lon: 10.38831 hasResults: False
<\|newrecord\|> nctId: NCT06303739 id: 22-1421 briefTitle: Psilocybin-Assisted Therapy in Treatment-Resistant Depression overallStatus: RECRUITING date: 2024-04-19 date: 2025-09 date: 2026-09 date: 2024-03-12 date: 2024-04-23 name: University of North Carolina, Chapel Hill class: OTHER name: Foundation of Hope, North Carolina briefSummary: The goal of this clinical trial is to test how well psilocybin-assisted therapy works in treating people with depression. The main questions this study aims to answer are:
* Does psilocybin with assisted therapy help improve symptoms for people with depression?
* How long do the effects of this treatment last?
Participants will:
* Take part in a couple of screening and preparation visits.
* Be given psilocybin in one or two treatment sessions.
* Attend a series of follow-up sessions over the following year.
* Complete forms and surveys to test how their symptoms have changed and what they thought of their experience.
Researchers will also compare whether one treatment or two treatments help improve symptoms more for participants. conditions: Refractory Depression conditions: Treatment Resistant Depression studyType: INTERVENTIONAL phases: PHASE3 allocation: RANDOMIZED interventionModel: PARALLEL interventionModelDescription: Participants are randomized into one of two groups and will receive either one single treatment of psilocybin-assisted therapy with follow-up therapy and assessments or two treatments spaced two weeks apart with follow-up therapy and assessments. primaryPurpose: TREATMENT masking: SINGLE maskingDescription: Due to the nature of the study and limitations of study staffing, only those conducting assessments and ratings throughout the study will be masked to the treatments. All others, including participants, therapists, investigators, and study coordinator, will not be masked to the number of treatments a participant receives. whoMasked: OUTCOMES_ASSESSOR count: 20 type: ESTIMATED name: psilocybin measure: Change in HAM-D-17 Scores between Baseline and 2 Weeks after Treatment measure: Change in QIDS SR-16 Scores between Baseline and 2 Weeks after Treatment measure: Number of Participants Achieving Remission 2 Weeks after Treatment measure: Number of Participants Achieving Response 2 weeks after treatment measure: Number of Participants Achieving Remission at 6 Weeks measure: Number of Participants Achieving Response at 6 Weeks measure: Number of Participants Achieving Remission at 3 Months measure: Number of Participants Achieving Response at 3 Months measure: Number of Participants Achieving Remission at 6 Months measure: Number of Participants Achieving Response at 6 Months measure: Number of Participants Achieving Remission at 9 Months measure: Number of Participants Achieving Response at 9 Months measure: Number of Participants Achieving Remission at 12 Months measure: Number of Participants Achieving Response at 12 Months measure: Time to Relapse in Participants Who Showed Remission at 2 weeks measure: Time to Relapse in Participants Who Showed Response at 2 Weeks measure: Change in HAM-D-17 Scores between Baseline and 6 Weeks after Treatment measure: Change in HAM-D-17 Scores between Baseline and 3 Months after Treatment measure: Change in HAM-D-17 Scores between Baseline and 6 Months after Treatment measure: Change in HAM-D-17 Scores between Baseline and 9 Months after Treatment measure: Change in HAM-D-17 Scores between Baseline and 12 Months after Treatment measure: Change in QIDS SR-16 Scores between Baseline and 6 Weeks after Treatment measure: Change in QIDS SR-16 Scores between Baseline and 3 Months after Treatment measure: Change in QIDS SR-16 Scores between Baseline and 6 Months after Treatment measure: Change in QIDS SR-16 Scores between Baseline and 9 Months after Treatment measure: Change in QIDS SR-16 Scores between Baseline and 12 Months after Treatment sex: ALL minimumAge: 18 Years maximumAge: 70 Years stdAges: ADULT stdAges: OLDER_ADULT facility: UNC Chapel Hill Medical Center status: RECRUITING city: Chapel Hill state: North Carolina zip: 27514 country: United States name: Mary Pruden, BA role: CONTACT name: Robert K McClure, MD role: PRINCIPAL_INVESTIGATOR name: Amanda Tow, MD, PhD role: SUB_INVESTIGATOR name: Lindley Reynolds, MSW role: SUB_INVESTIGATOR lat: 35.9132 lon: -79.05584 hasResults: False
<\|newrecord\|> nctId: NCT06303726 id: IRP-2021/02-19 briefTitle: Comparison of Single-bundle Versus Double-bundle Anterior Cruciate Ligament Reconstruction overallStatus: ACTIVE_NOT_RECRUITING date: 2022-04-25 date: 2024-04-01 date: 2024-06-25 date: 2024-03-12 date: 2024-03-12 name: University Medical Centre Maribor class: OTHER briefSummary: The goal of this retrospective randomized study is to compare two surgical techniques (single vs. double bundle) of ACL (anterior cruciate ligament) reconstructions in participants with rupture of anterior cruciate ligament without major other injuries of the injured knee (exclusion criteria defined).
The main question it aims to answer are:
* which surgery gives better outcome in patients (short- and long-term results)?
* are there any sings of osteoarthritis in an injured knee compared to a healthy knee?
Participants will be invited to our clinic after 15 years to do clinical and functional exams with x-Ray and magnetic resonance imaging (MRI) of both knees. Subjective exams with different scores (Tegner score, Lysholm score..) were also done. The same exam protocol for participant was used again after two years and fifteen years since surgery. conditions: Anterior Cruciate Ligament Reconstruction studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: SINGLE whoMasked: PARTICIPANT count: 30 type: ACTUAL name: ACL reconstruction single bundle name: ACL reconstruction double bundle measure: IKDC SUBJECTIVE SCORE measure: TEGNER SCORE measure: LYSHOLM SCORE measure: OBJECTIVE PARAMETER: STREENGHT OF FLEXORS AND EXTENSORS measure: OBJECTIVE PARAMETER: AP TRANSLATION (anterior-posterior) sex: ALL stdAges: CHILD stdAges: ADULT stdAges: OLDER_ADULT facility: University Clinical Center Maribor city: Maribor zip: 2000 country: Slovenia lat: 46.55472 lon: 15.64667 hasResults: False
<\|newrecord\|> nctId: NCT06303713 id: 23-693 briefTitle: LuCarbo - a Study of 177Lu-PSMA-617 Plus Carboplatin in Metastatic Castrate-resistant Prostate Cancer overallStatus: NOT_YET_RECRUITING date: 2024-04 date: 2026-07-19 date: 2026-07-19 date: 2024-03-12 date: 2024-03-12 name: Dana-Farber Cancer Institute class: OTHER name: Novartis briefSummary: The purpose of this study is to see whether the combination of a chemotherapy drug, carboplatin, along with the radioligand treatment, 177Lu-PSMA-617, is safe in treating prostate cancer and whether the combination is effective in shrinking or preventing growth of prostate cancer.
The names of the study drugs used in this research study are:
* Carboplatin (A type of chemotherapy)
* 177Lu-PSMA-617 (A type of radioligand therapy) conditions: Prostate Cancer conditions: Metastatic Prostate Cancer conditions: Metastatic Castration-resistant Prostate Cancer studyType: INTERVENTIONAL phases: PHASE1 allocation: NON_RANDOMIZED interventionModel: SEQUENTIAL primaryPurpose: TREATMENT masking: NONE count: 37 type: ESTIMATED name: Carboplatin name: 177Lu-PSMA-617 measure: Maximum tolerated dose (MTD) or the Recommended Phase 2 dose (RP2D) of carboplatin administered in combination with 177Lu-PSMA-617 measure: PSA response rate (PSA reduction by ≥50% from baseline). measure: Overall Response Rate (ORR) measure: Radiographic Progression-Free Survival (rPFS) measure: Overall Survival (OS) sex: MALE minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Beth Israel Deaconess Medical Center city: Boston state: Massachusetts zip: 02215 country: United States name: Daniel Fein, MD role: CONTACT phone: 617-667-2100 email: dfein@bidmc.harvard.edu name: Daniel Fein, MD role: PRINCIPAL_INVESTIGATOR lat: 42.35843 lon: -71.05977 facility: Brigham and Women's Hospital city: Boston state: Massachusetts zip: 02215 country: United States name: Praful Ravi, MB BCHir, MRCP role: CONTACT phone: 617-632-3466 email: Praful_Ravi@DFCI.HARVARD.EDU name: Praful Ravi, MB BCHir, MRCP role: PRINCIPAL_INVESTIGATOR lat: 42.35843 lon: -71.05977 facility: Dana-Farber Cancer Institute city: Boston state: Massachusetts zip: 02215 country: United States name: Praful Ravi, MB BChir, MRCP role: CONTACT phone: 617-632-3466 email: praful_ravi@dfci.harvard.edu name: Praful Ravi, MB BCHir, MRCP role: PRINCIPAL_INVESTIGATOR lat: 42.35843 lon: -71.05977 hasResults: False
<\|newrecord\|> nctId: NCT06303700 id: Quality of life briefTitle: Dyspnea, Risk of Falling and Quality of Life in Adolescents, Youth and Geriatric Groups overallStatus: COMPLETED date: 2022-05-10 date: 2024-01-31 date: 2024-01-31 date: 2024-03-12 date: 2024-03-12 name: Amira Hussin Hussin Mohammed class: OTHER briefSummary: To assess the correlation between aspects of the dyspnea scale (indicating poor functionality), the fall efficacy scale (indicating a higher fear of falling), and all aspects of the SF36 (indicating quality of life) in 3 age groups: adolescents, youth, and geriatrics. conditions: Public Health studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: CROSS_SECTIONAL count: 604 type: ACTUAL measure: the severity of dyspnea measure: the level of fear of falling through daily life activities measure: quality of life and public health sex: ALL minimumAge: 12 Years maximumAge: 80 Years stdAges: CHILD stdAges: ADULT stdAges: OLDER_ADULT facility: Amira Hussin Mohammed city: Gamasa zip: 35712 country: Egypt lat: 31.44112 lon: 31.53675 hasResults: False
<\|newrecord\|> nctId: NCT06303687 id: STUDY00003496 briefTitle: VR-PAT and fNIRS to Identify CNS Biomarkers of Pain overallStatus: ENROLLING_BY_INVITATION date: 2024-03 date: 2024-06 date: 2024-06 date: 2024-03-12 date: 2024-03-12 name: Nationwide Children's Hospital class: OTHER briefSummary: This study aims to use functional near-infrared spectroscopy (fNIRS) to identify and quantify pain biomarkers during burn dressing changes and pain relief induced by virtual reality (VR). conditions: Acute Pain conditions: Pediatric ALL conditions: Procedural Pain conditions: Burns studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: CROSSOVER interventionModelDescription: Participants will be randomly assigned to either the intervention (fNIRS and VR-PAT) or the control (fNIRS and standard of care) at the first research dressing change and will then crossover to the alternative group for the second laser procedure. primaryPurpose: DIAGNOSTIC masking: NONE count: 4 type: ESTIMATED name: VR-PAT measure: Change in brain activity measure: Procedural pain during burn dressing changes measure: Change in procedural anxiety measure: Self-reported VR experience sex: ALL minimumAge: 6 Years maximumAge: 17 Years stdAges: CHILD facility: Nationwide Children's Hospital city: Columbus state: Ohio zip: 43205 country: United States lat: 39.96118 lon: -82.99879 hasResults: False
<\|newrecord\|> nctId: NCT06303674 id: 301CER22 id: PID2021-123357OA-I00 type: OTHER_GRANT domain: Ministry of Science and Innovation - Spanish State Research Agency - European Regional Development Fund briefTitle: Effects of Brain Breaks on Educational Achievement in Laboratory Settings: The Break4Brain Project overallStatus: ACTIVE_NOT_RECRUITING date: 2023-02-27 date: 2024-07 date: 2025-09 date: 2024-03-12 date: 2024-03-12 name: University of the Balearic Islands class: OTHER name: Ministry of Science and Innovation name: European Regional Development Fund name: Spanish State Research Agency briefSummary: Advancement in teaching methods, together with the frenetic change in the lifestyles of the school population, provides a unique opportunity to advance scientific knowledge. The current project, called "The Break4Brain Project", aims to examine the acute (transient) effects of physical activity on brain function, cognition, and academic performance in children with and without Attention Deficit Hyperactivity Disorder (ADHD). Specifically, a total of 60 children between 10 and 12 years old will be included with (n=30) and without (n=30) ADHD. The study will use an intra-subject design of isolated conditions with four measurement moments where the children will perform three different experimental conditions lasting 10 minutes, which will be randomized in a counterbalanced manner. These experimental conditions will be based on physical activity engaging cognitively, physical activity without engaging cognitively, and cognitively engaging control condition. This project could have a significant impact in the educational field, since, if brain function, cognition, and academic performance prove to be favorably stimulated, acutely, by physical activity through active breaks, these could be prescribed as an effective teaching strategy for children with and without ADHD in the school setting. conditions: ADHD studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: CROSSOVER interventionModelDescription: The design of the study is a within-participants crossover pretest-posttest comparison design under laboratory settings will be used. In this design, all participants will engage in all experimental conditions (on separate days), with the order of the experimental conditions being counterbalanced across participants and outcomes assessed following each experimental condition. primaryPurpose: TREATMENT masking: DOUBLE whoMasked: PARTICIPANT whoMasked: OUTCOMES_ASSESSOR count: 60 type: ESTIMATED name: Physical activity with engaging cognitively name: Physical activity without engaging cognitively measure: Academic achievement measure: Inhibition measure: Working memory measure: Sustained attention measure: Brain function measure: Physical fitness and body composition measure: Physical activity levels and sleep measure: Self-reported sedentary patterns measure: Motor proficiency measure: Biological maturation measure: ADHD symptoms measure: IQ measure: Socioeconomic levels measure: Educational levels sex: ALL minimumAge: 10 Years maximumAge: 12 Years stdAges: CHILD facility: University of the Balearic Islands city: Palma state: Balearic Islands zip: 07122 country: Spain lat: 39.56939 lon: 2.65024 hasResults: False
<\|newrecord\|> nctId: NCT06303661 id: 74001323.3.0000.5544 briefTitle: Non-ablative Radiofrequency and Low Intensity Shock Wave Therapy in Fibrotic Plaque in Men With Peyronie's Disease overallStatus: RECRUITING date: 2024-01-08 date: 2025-12 date: 2026-06 date: 2024-03-12 date: 2024-03-12 name: Centro de Atenção ao Assoalho Pélvico class: OTHER briefSummary: The goal of this one arm clinical trial is to evaluate the safety and describe the clinical response of non-ablative radiofrequency treatment associated with shockwave therapy in men with Peyronie's disease. The main question\[s\] it aims to answer are: • is the treatment safe? • is there any clinical response to the proposed treatment? Participants will respond to five validated questionnaires: International Index of Erectile Dysfunction (IIEF-5), Medical Outcomes Study 36 - Item Short - Form Health Survey (SF-36), Peyronie's Disease Questionnaire (PDQ), Scale Hospital for Anxiety and Depression (SHAD) and the Erection Quality Questionnaire (EQQ); will undergo a physical assessment that includes palpation of the fibrotic plaque on the penis, pharmacological induction of erection, and assessment of the size of the fibrotic plaque through ultrasound. Every five sessions, the participant's degree of satisfaction will be measured using a 5-point Likert scale, as well as the evolution of symptoms will also be observed, using a 10-point Visual Analogue Scale (VAS) and penile pain, if present. The entire evaluation protocol will be applied before (pre-test), after treatment (post-test) and 1 month after the end of treatment. Volunteers will be monitored by telephone to verify the long-term response after 3, 6, 9 and 12 months of completed treatment in relation to the Likert scale and VAS. The treatments they'll be given are • of monopolar non-ablative radiofrequency associated with • low-intensity shock wave therapy. conditions: Peyronie Disease studyType: INTERVENTIONAL phases: NA allocation: NA interventionModel: SINGLE_GROUP interventionModelDescription: Combination of two therapies with conservative devices is proposed. primaryPurpose: TREATMENT masking: NONE count: 10 type: ESTIMATED name: Non-ablative Radiofrequency name: Low-intensity Shock Wave Therapy measure: It is estimated that non-ablative RF associated with low-intensity SWT in patients with Peyronie Disease is a safe technique that leads to a satisfactory clinical response in relation to sexual function. measure: It is estimated that non-ablative RF associated with low-intensity SWT in patients with Peyronie Disease is a safe technique that leads to a satisfactory clinical response in relation to pain. measure: It is estimated that non-ablative RF associated with low-intensity SWT in patients with Peyronie Disease is a safe technique that leads to a satisfactory clinical response in relation to penile erection. measure: It is estimated that non-ablative RF associated with low-intensity SWT in patients with Peyronie Disease is a technique that promotes a positive impact on quality of life and psycho-emotional aspects of anxiety and depression. measure: It is estimated that non-ablative RF associated with low-intensity SWT in patients with Peyronie Disease is a technique that promotes a positive impact on psycho-emotional aspects of anxiety and depression. sex: MALE minimumAge: 18 Years maximumAge: 80 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Centro de Atenção ao Assoalho Pelvico status: RECRUITING city: Salvador state: Ba zip: 40.290-000 country: Brazil name: Patricia V Lordelo, Phd role: CONTACT phone: +5571988592400 email: pvslordelo@hotmail.com name: Carlos Mamede, Phd role: SUB_INVESTIGATOR name: Patricia V Lordelo, Phd role: PRINCIPAL_INVESTIGATOR lat: -12.97111 lon: -38.51083 hasResults: False
<\|newrecord\|> nctId: NCT06303648 id: TSND201-PK-101 briefTitle: A Single, Ascending Dose Evaluation of the Safety, Pharmacokinetics of Methylone in Healthy Subjects overallStatus: RECRUITING date: 2024-03-20 date: 2024-05-04 date: 2024-05-11 date: 2024-03-12 date: 2024-04-16 name: Transcend Therapeutics class: INDUSTRY briefSummary: This is an open-label, single, ascending dose study evaluating the PK and safety of methylone in healthy subjects. conditions: Post Traumatic Stress Disorder studyType: INTERVENTIONAL phases: PHASE1 allocation: NON_RANDOMIZED interventionModel: SEQUENTIAL interventionModelDescription: Subjects will be enrolled into one of four cohorts. The study will begin enrolling Cohort 1. primaryPurpose: TREATMENT masking: NONE count: 24 type: ESTIMATED name: Methylone measure: Cmax: Maximum Observed Plasma Concentration for methylone measure: AUC: Area under the plasma concentration-time curve for methylone measure: Incidence and frequency of adverse events measure: Change overtime in Visual Analog Scales sex: ALL minimumAge: 25 Years maximumAge: 55 Years stdAges: ADULT facility: CMAX Clinical Research status: RECRUITING city: Adelaide state: South Australia zip: 5000 country: Australia name: Research Team role: CONTACT lat: -34.92866 lon: 138.59863 hasResults: False
<\|newrecord\|> nctId: NCT06303635 id: UFRJvac-1 briefTitle: Safety of UFRJvac, Trivalent COVID-19 Vaccine acronym: UFRJvac-1 overallStatus: NOT_YET_RECRUITING date: 2024-06-24 date: 2025-10-16 date: 2025-11-25 date: 2024-03-12 date: 2024-03-12 name: Azidus Brasil class: INDUSTRY name: Universidade Federal do Rio de Janeiro briefSummary: Phase I study to evaluate the safety and immunogenicity of the vaccine booster with the trivalent UFRJvac COVID-19 vaccine. conditions: Healthy People studyType: OBSERVATIONAL observationalModel: OTHER timePerspective: PROSPECTIVE count: 156 type: ESTIMATED measure: Evaluate the safety and reactogenicity of the UFRJvac COVID-19 vaccine booster measure: Evaluate the safety and reactogenicity of the vaccine booster with the trivalent UFRJvac COVID-19 measure: Evaluate the humoral immunogenicity of the vaccine booster with the trivalent UFRJvac COVID-19 measure: Evaluate the humoral immunogenicity of the vaccine booster the trivalent UFRJvac COVID-19 measure: Evaluate the humoral immunogenicity of the vaccine booster with the trivalent UFRJvac measure: Evaluate the humoral immunogenicity of the vaccine booster trivalent UFRJvac measure: Evaluate the cellular immunogenicity of the vaccine booster with the trivalent UFRJvac COVID-19 sex: ALL minimumAge: 18 Years maximumAge: 65 Years stdAges: ADULT stdAges: OLDER_ADULT hasResults: False
<\|newrecord\|> nctId: NCT06303622 id: CRE-2023.610 briefTitle: Comparing MRI-Ultrasound Fusion and Cognitive-guided Biopsy for the Detection of csPCa: the PROFUSION Trial overallStatus: NOT_YET_RECRUITING date: 2024-06-01 date: 2026-12-31 date: 2027-03-31 date: 2024-03-12 date: 2024-04-10 name: Chinese University of Hong Kong class: OTHER briefSummary: This study is an international multicentre RCT to compare the linically significant prostate cancer (csPCa) detection of cognitive-guided and MRI-USG guided biopsies in men with suspicious MRI lesion. conditions: Prostate Cancer studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: DIAGNOSTIC masking: NONE count: 1250 type: ESTIMATED name: MRI-USG fusion approach name: Cognitive-guided approach measure: Proportion of men with clinically significant Prostate cancer(csPCa) measure: Proportion of men with a diagnosis of csPCa in MRI lesions with maximal size ≤10mm versus >10mm measure: Proportion of men with a diagnosis of csPCa in prostate size of ≤50ml vs >50m measure: The proportion of men with a diagnosis of csPCa only in targeted biopsy measure: Proportion of men with a diagnosis of csPCa only in systemic biopsy measure: Proportion of men with a diagnosis of clinically insignificant PCa, measure: Procedure time measure: Pain score on a scale of 0-10 taken after biopsy measure: Proportion of men with post-biopsy adverse events within 30 days after biopsy sex: MALE minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Prince of Wales Hospital city: Hong Kong country: Hong Kong lat: 22.27832 lon: 114.17469 hasResults: False
<\|newrecord\|> nctId: NCT06303609 id: 61102222.5.0000.5544 briefTitle: Effects of Non-ablative Radiofrequency on Female Genito-pelvic Pain Disorder acronym: Pelvic Pain overallStatus: NOT_YET_RECRUITING date: 2024-04-20 date: 2026-06-20 date: 2026-07-20 date: 2024-03-12 date: 2024-03-18 name: Centro de Atenção ao Assoalho Pélvico class: OTHER briefSummary: The goal of this randomized clinical trial is to verify the response of genito-pelvic pain disorders in women associated with inability to penetrate to the treatment with non-ablative radiofrequency. The main question it aims to answer is: Does non-ablative radiofrequency have a positive effect on the symptoms of genito-pelvic pain disorders associated with inability to penetrate? Before starting the intervention and at one week, one-, three- and six months after the end of the study, participants will be evaluated with 03 questionnaires (Female Sexual Function Index, Sexual Quality of Life and Perceived Stress Scale-10) and will score the visual analogue scale the level of pain with the penetration (from 0 to 10); participants will then undergo digital evaluation of the pelvic floor muscles, using vaginal dilators and electromyographic evaluation. After being randomized, participants will be divided into the Experimental Group and the Sham Group, being submitted to • the use of non-ablative radiofrequency in the anal and urogenital triangles, • the positioning of the vaginal dilator at the end of each session • and participants will be instructed to use the vaginal dilator at home daily. The researchers will compare the groups in relation to the ability to penetrate with reduced vaginal pain, sexual function, quality of sexual life and the correlation between pelvic muscle activity and perceived stress. conditions: Pelvic Pain studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: DOUBLE whoMasked: PARTICIPANT whoMasked: INVESTIGATOR count: 56 type: ESTIMATED name: nonablative radiofrequency name: Vaginal dilator name: Sham nonablative radiofrequency measure: Penetration capacity with reduced vaginal pain measure: Sexual function measure: Quality of sexual life measure: Stress perception sex: FEMALE minimumAge: 18 Years maximumAge: 45 Years stdAges: ADULT hasResults: False
<\|newrecord\|> nctId: NCT06303596 id: Hippotherapy in Schizophrenia briefTitle: Hippotherapy in Patients With Schizophrenia overallStatus: NOT_YET_RECRUITING date: 2024-03-20 date: 2024-08-01 date: 2024-10-01 date: 2024-03-12 date: 2024-03-12 name: Erzurum Technical University class: OTHER briefSummary: This study will determine the efficacy of hippotherapy (horseback-riding) program, as an adjuvant to standard psychiatric treatment, on the outcomes of patients with schizophrenia. A randomized controlled trial is conducted in a Community Mental Health Center. All participants are randomized into two groups (experimental and control groups) using blocked randomization. All participants received the standard psychiatric treatment, while the experimental group is additionally provided with a 16-session hippotherapy program for 8 weeks. All participants will be evaluated using the Positive and Negative Syndrome Scale, State-Trait Anxiety Inventory, Quality of Life Scale, UCLA Loneliness Scale at both baseline and after the intervention. conditions: Equine-Assisted Therapy conditions: Schizophrenia studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: SUPPORTIVE_CARE masking: SINGLE maskingDescription: The evaluator who collects the data is blinded to the allocation of groups. whoMasked: OUTCOMES_ASSESSOR count: 88 type: ESTIMATED name: Hippotherapy name: Standard psychiatric treatment measure: The Positive and Negative Syndrome Scale (PANSS) measure: State-Trait Anxiety Inventory (STAI) measure: The Quality of Life Scale (QLS) measure: UCLA Loneliness Scale sex: ALL minimumAge: 19 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Erzurum Technical University, Erzurum Community Mental Health Center city: Erzurum zip: 25010 country: Turkey name: Musa Eymir, Ph.D., PT, Assist. Prof. role: CONTACT phone: +904424445388-2733 email: musa.eymir@erzurum.edu.tr lat: 39.90861 lon: 41.27694 hasResults: False
<\|newrecord\|> nctId: NCT06303583 id: IRB- 2022-213 briefTitle: Neoadjuvant Chemoradiotherapy Followed by Sequential Immunotherapy for Thoracic Esophageal Squamous Cell Carcinoma acronym: CRIS overallStatus: ENROLLING_BY_INVITATION date: 2022-06-01 date: 2024-08-31 date: 2026-12-31 date: 2024-03-12 date: 2024-03-12 name: Qiu Guoqin class: OTHER briefSummary: The purpose of study is to investigate the safety and efficacy of sequential immunotherapy with neoadjuvant chemoradiotherapy for esophageal cancer conditions: Esophageal Squamous Cell Carcinoma studyType: INTERVENTIONAL phases: PHASE1 phases: PHASE2 allocation: NA interventionModel: SINGLE_GROUP primaryPurpose: TREATMENT masking: NONE count: 30 type: ESTIMATED name: paclitaxel name: carboplatin name: tislelizumab name: radiotherapy measure: Complete pathological response rate measure: R0 resection rate measure: 2-year Disease-free survival rate measure: 2-year overall survival rate measure: Safety will be analyzed through the incidence of adverse events, serious adverse events sex: ALL minimumAge: 18 Years maximumAge: 75 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Zhejiang Cancer Hospital city: Hangzhou state: Zhejiang zip: 310000 country: China lat: 30.29365 lon: 120.16142 hasResults: False
<\|newrecord\|> nctId: NCT06303570 id: CBL-0202DD briefTitle: A Study to Evaluate the Efficacy and Safety of CBL-514 Compared to Placebo in Participants With Dercum's Disease Lipomas overallStatus: NOT_YET_RECRUITING date: 2024-06-28 date: 2025-05-23 date: 2025-05-23 date: 2024-03-12 date: 2024-03-12 name: Caliway Biopharmaceuticals Co., Ltd. class: INDUSTRY briefSummary: This is a single-blind, placebo-controlled, randomized phase 2 study to evaluate the efficacy and safety of CBL-514 injections in participants with Dercum's Disease lipomas. conditions: Dercum's Disease studyType: INTERVENTIONAL phases: PHASE2 allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: SINGLE whoMasked: PARTICIPANT count: 30 type: ESTIMATED name: CBL-514 injection name: 0.9% Sodium chloride measure: To estimate the treatment effect, as measured by Complete Response (CR), between CBL-514 and placebo at Week 12 in participants with Dercum's disease (DD). measure: To estimate the treatment effect, as measured by pain, between CBL-514 and placebo at Week 12 in participants with DD. measure: To estimate the treatment effect, as measured by CR, between CBL-514 and placebo, at Weeks 4, 8, 16, 20, and 24. measure: To estimate the treatment effect, as measured by CR, between CBL-514 and placebo, at Weeks 4, 8, 16, 20, and 24. measure: To estimate the treatment effect, as measured by CR, between CBL-514 and placebo, at Weeks 4, 8, 16, 20, and 24. measure: To estimate the treatment effect, as measured by CR, between CBL-514 and placebo, at Weeks 4, 8, 16, 20, and 24. measure: To estimate the treatment effect, as measured by CR, between CBL-514 and placebo, at Weeks 4, 8, 16, 20, and 24. measure: To estimate the treatment effect, as measured by partial response, between CBL-514 and placebo, at Weeks 4, 8, 12, 16, 20, and 24. measure: To estimate the treatment effect, as measured by partial response, between CBL-514 and placebo, at Weeks 4, 8, 12, 16, 20, and 24. measure: To estimate the treatment effect, as measured by partial response, between CBL-514 and placebo, at Weeks 4, 8, 12, 16, 20, and 24. measure: To estimate the treatment effect, as measured by partial response, between CBL-514 and placebo, at Weeks 4, 8, 12, 16, 20, and 24. measure: To evaluate the treatment effect, as measured by change in volume, between CBL-514 and placebo, at Weeks 4, 8, 12, 16, 20, and 24. measure: To evaluate the treatment effect, as measured by pain, between CBL-514 and placebo, at Weeks 4, 8, 12, 16, 20, and 24. measure: To evaluate the treatment effect, as measured by pain, between CBL-514 and placebo, at Weeks 4, 8, 12, 16, 20, and 24. measure: To evaluate the incidence of adverse events of special interests (AESI) as defined in the protocol. measure: To evaluate the incidence of clinically significant abnormal findings as defined in the protocol as defined in the protocol. sex: ALL minimumAge: 18 Years maximumAge: 64 Years stdAges: ADULT hasResults: False
<\|newrecord\|> nctId: NCT06303557 id: AEŞH-EK1-2023-797 briefTitle: Effect of ESPB on Intraoperative Remifentanil Consumption overallStatus: RECRUITING date: 2024-01-31 date: 2024-11-30 date: 2024-12-30 date: 2024-03-12 date: 2024-03-12 name: Atatürk Chest Diseases and Chest Surgery Training and Research Hospital class: OTHER briefSummary: In recent years, regional anesthesia techniques have also been frequently applied to patients for pain relief. Erector spinae plane block (ESPB), is among the regional anesthesia techniques frequently used in lumbar spine surgery.
General anesthesia (GA) is the main method of anesthesia for lumbar spine surgery. However, GA can only inhibit the projection system of the cortical limbic system or hypothalamic cortex. GA cannot completely block the transmission of peripheral noxious stimulus to the central nervous system and cannot effectively inhibit the intraoperative stress response. With the addition of peripheral blocks such as ESPB, lower remifantanil consumption, and more stable hemodynamics are expected by providing preemptive analgesia in patients.
As a result of all these; it was aimed to compare the intraoperative remifantanil consumption of patients who underwent preoperative ESPB in patients who will undergo lumbar spine surgery resection under GA with those who underwent postoperative ESPB. conditions: Lumbar Spine Surgery conditions: Erector Spinae Plane Block conditions: Remifentanil Consumption studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: DOUBLE whoMasked: PARTICIPANT whoMasked: OUTCOMES_ASSESSOR count: 60 type: ESTIMATED name: Preoperative Erector Spinae Plane Block name: Postperative Erector Spinae Plane Block measure: Intraoperative remifentanil consumption measure: Mean arterial pressure measure: Heart rate measure: Pain scores sex: ALL minimumAge: 18 Years maximumAge: 65 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Ankara Etlik City Hospital status: RECRUITING city: Yenimahalle state: Ankara zip: 06170 country: Turkey name: Musa Zengin, Associate Professor role: CONTACT phone: 00905307716235 email: musazengin@gmail.com name: Deniz Çolak, MD role: CONTACT phone: 00905386519710 email: doctordenizcolak@outlook.com hasResults: False
<\|newrecord\|> nctId: NCT06303544 id: R01HL168853 type: NIH link: https://reporter.nih.gov/quickSearch/R01HL168853 briefTitle: More Outside Your Door: A Diet/Physical Activity Intervention to Decrease Risk of Obesity in Alaska Native Preschoolers acronym: MOYD overallStatus: NOT_YET_RECRUITING date: 2024-08-01 date: 2027-06-30 date: 2028-05-30 date: 2024-03-12 date: 2024-03-12 name: Alaska Native Tribal Health Consortium class: OTHER name: Washington State University name: University of Alaska Anchorage briefSummary: The preschool age is a crucial period of growth and an optimal time to begin to establish healthy eating and physical activity habits leading to better food and activity choices into adulthood, thereby minimizing risk for obesity-related diseases and decreasing the cardiometabolic disparities in this Indigenous population. More Outside Your Door is a multi-level, randomized, stepped-wedge intervention trial designed to reduce the disparity of childhood obesity in Yup'ik Alaska Native children by increasing the proportion of nutrient-dense traditional and traditional-like foods offered and increasing physical activity, particularly outdoor activities related to traditional Yup'ik subsistence and lifestyle practices. This 5-year intervention trial targeting 3-5 year olds is conducted in partnership with Rural Action Community Action Program Head Start programs in 12 rural Alaskan communities, where each site is assigned annually to a wedge group to receive either a community-altered culturally-tailored 8-month traditional foods and activities curriculum intervention or the standard regional Head Start program intervention. conditions: Child Obesity studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: SEQUENTIAL interventionModelDescription: Wedge design using repeated cross sectional samples of Head Start preschool students primaryPurpose: OTHER masking: NONE count: 450 type: ESTIMATED name: Wedge 1 measure: BMI measure: Physical activity measure: Outdoor time measure: Sleep quality measure: Fingernail nitrogen & carbon stable isotope ratios sex: ALL minimumAge: 3 Years maximumAge: 5 Years stdAges: CHILD facility: Alaska Native Tribal Health Consortium city: Anchorage state: Alaska zip: 99508 country: United States lat: 61.21806 lon: -149.90028 hasResults: False
<\|newrecord\|> nctId: NCT06303531 id: Efficacious Iron briefTitle: Efficacious Iron for Iron Deficiency Anemia in Adults Aged ≥18 Years overallStatus: ENROLLING_BY_INVITATION date: 2024-02-24 date: 2025-02 date: 2025-02 date: 2024-03-12 date: 2024-03-25 name: Dr. Anil K. Gupta Medicine Professional Corporation class: NETWORK briefSummary: Iron deficiency anemia (IDA) is a widespread condition affecting many people globally. Despite the many cases of IDA, there are few studies that compare the effectiveness of different types of iron supplements with a greater emphasis on the cost of supplements and their tolerability. This study aims to conduct a comparison between different iron supplements to determine the superiority of the iron supplements Ferrous Ascorbate (EBMfer) and Ferrous Fumarate (Eurofer) over polysaccharide iron (FeraMax). This comparison will be conducted by determining the change in hemoglobin levels for participants in this trial over a 3-month period. conditions: Iron Deficiency Anemia studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: NONE count: 111 type: ESTIMATED name: Ferrous Fumarate name: Polysaccharide Iron name: Ferrous Ascorbate measure: Change in Hemoglobin Levels measure: Change in Serum Ferritin measure: Tolerability of Study Medication - Discontinuation Rate sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Albion Finch Medical Centre city: Etobicoke state: Ontario zip: M9V 4B4 country: Canada lat: 43.65421 lon: -79.56711 hasResults: False
<\|newrecord\|> nctId: NCT06303518 id: H23-03546 briefTitle: End Tidal Carbon Dioxide Concentration and Depth of Anesthesia in Children overallStatus: NOT_YET_RECRUITING date: 2024-05 date: 2024-12-31 date: 2024-12-31 date: 2024-03-12 date: 2024-03-12 name: University of British Columbia class: OTHER briefSummary: Carbon Dioxide (CO2) is a by-product of metabolism and is removed from the body when we breathe out. High levels of CO2 can affect the nervous system and cause us to be sleepy or sedated. Research suggests that high levels of CO2 may benefit patients who are asleep under anesthesia, such as by reducing infection rates, nausea, or recovery from anesthesia . CO2 may also reduce pain signals or the medication required to keep patients asleep during anesthesia; this has not been researched in children.
During general anesthesia, anesthesiologists keep patients asleep with anesthetic gases or by giving medications into a vein. These drugs can depress breathing; therefore, an anesthesiologist will control breathing (ventilation) with an artificial airway such as an endotracheal tube. Changes in ventilation can alter the amount of CO2 removed from the body. The anesthesiologist may also monitor a patient's level of consciousness using a 'Depth of Anesthesia Monitor' such as the Bispectral Index (BIS), which analyzes a patient's brain activity and generates a number to tell the anesthesiologist how asleep they are.
The investigator's study will test if different levels of CO2 during intravenous anesthesia are linked with different levels of sedation or sleepiness in children, as measured by BIS. If so, this could reduce the amount of anesthetic medication the child receives. Other benefits may be decreased medication costs, fewer side effects, and a positive environmental impact by using less disposable anesthesia equipment. conditions: Anesthesia conditions: Hypercapnia conditions: Hypocapnia studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: CROSSOVER interventionModelDescription: The investigators plan to conduct a randomized, prospective, crossover trial. The six arms will be as below:
1. Normal ETCO2 -\> High Normal ETCO2 -\> Low Normal ETCO2
2. Normal ETCO2 -\> Low Normal ETCO2 -\> High Normal ETCO2
3. High Normal ETCO2 -\> Low Normal ETCO2 -\> Normal ETCO2
4. High Normal ETCO2 -\> Normal ETCO2 -\> Low Normal ETCO2
5. Low Normal ETCO2 -\> High Normal ETCO2 -\> Normal ETCO2
6. Low Normal ETCO2 -\> Normal ETCO2 -\> High Normal ETCO2 primaryPurpose: OTHER masking: SINGLE maskingDescription: The anesthesiologist will be blinded to the BIS reading and will continue to provide anesthesia according to the protocol. The BIS numerical value in the OR will be covered, but the waveform will be visible to assess signal quality. The anesthesiologist providing care to the patient will not be involved in data collection or analysis whoMasked: CARE_PROVIDER count: 100 type: ESTIMATED name: High normal ETCO2: ETCO2 50 mmHg (+/- 3mmHg) name: Normal ETCO2: ETCO2 40 mmHg (+/- 3mmHg) name: Low Normal ETCO2: ETCO2 30 mmHg (+/- 3mmHg) measure: To determine the effect of end-tidal carbon dioxide concentration (EtCO2) on the depth of anesthesia in children, as measured by BIS. measure: Patient movement as detected clinically by the surgical or anesthetic team. sex: ALL minimumAge: 3 Years maximumAge: 11 Years stdAges: CHILD hasResults: False
<\|newrecord\|> nctId: NCT06303505 id: NAPISTAR 1-01 id: 2024-511074-80 type: EUDRACT_NUMBER briefTitle: FiH Study to Investigate Safety, PK and Efficacy of the NaPi2b ADC TUB-040 in Patients With PROC or r/r Adenocarcinoma NSCLC acronym: NAPISTAR1-01 overallStatus: NOT_YET_RECRUITING date: 2024-05 date: 2027-01 date: 2027-01 date: 2024-03-12 date: 2024-03-12 name: Tubulis GmbH class: INDUSTRY briefSummary: The purpose of this multicentric, open label trial (NAPISTAR 1-01) is to evaluate the safety/tolerability, pharmacokinetics and preliminary efficacy of TUB-040 and to find the best dose of TUB-040 in patients with ovarian cancer and Non Small Cell Lung Cancer. TUB-040 is an antibody-drug-conjugate which delivers a topoisomerase I inhibitor to tumor cells which overexpress the target NaPi2b. The study consists of two parts: In dose escalation, ovarian cancer patients and lung cancer patients receive increasing doses of TUB-040 until the maximal tolerated dose is found. In dose optimization, at least two doses are compared with each other to determine which dose is optimal for patients.
TUB-040 is given IV every 3 weeks until the disease progresses or the patient has to stop due to side effects. conditions: Ovarian Cancer conditions: Non-small Cell Lung Cancer studyType: INTERVENTIONAL phases: PHASE1 phases: PHASE2 allocation: NON_RANDOMIZED interventionModel: SEQUENTIAL primaryPurpose: TREATMENT masking: NONE count: 100 type: ESTIMATED name: TUB-040 measure: Determination of MTD measure: Maximum plasma/serum concentration (Cmax) measure: Through plasma/serum concentration (Cmin) measure: The time taken to reach the maximum concentration (Tmax) measure: Area Under Curve (AUC) measure: Half life (T1/2) measure: Determination of immunogenicity measure: Determination of efficacy sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Christ Hospital city: Cincinnati state: Ohio zip: 45219 country: United States name: Alexander Starodub role: CONTACT name: Alexander Starodub, MD role: PRINCIPAL_INVESTIGATOR lat: 39.12713 lon: -84.51435 hasResults: False
<\|newrecord\|> nctId: NCT06303492 id: CTO 4096 briefTitle: Aspiration Risk Assessment by Gastric Ultrasound in eMErgency Surgery and ANesThetic Decision-making: The ARGUMENT Study overallStatus: NOT_YET_RECRUITING date: 2024-05 date: 2025-12 date: 2026-04 date: 2024-03-12 date: 2024-03-12 name: Samuel Lunenfeld Research Institute, Mount Sinai Hospital class: OTHER briefSummary: Pulmonary aspiration of gastric contents is a serious patient safety problem accounting for 50% of anesthesia-related mortality. The risk is higher in patients undergoing emergency surgery as the gastric content is uncertain which poses a challenge to anesthetic decision-making. Standard clinical assessment to identify at-risk patients primarily relies on preoperative fasting guidelines and is not adequate for patients undergoing emergency surgeries. Point-of-care gastric ultrasound (GUS) has emerged as an accurate bedside tool providing information regarding the type and volume of gastric contents. When GUS was added to standard clinical assessment, anesthetic management plan changed in 71% of adult elective and 37% of pediatric emergency surgical procedures. Such data is lacking in adult patients undergoing emergency surgeries. The investigators propose a multicentre mixed-method study to evaluate the impact of GUS on aspiration risk assessment and subsequent Anesthetic Plan before emergency surgeries. The evidence from this study will improve patient safety by accurately identifying patients at risk of aspiration and tailoring anesthetic techniques and airway management to prevent pulmonary aspiration in patients undergoing emergency surgeries. conditions: Pulmonary Aspiration conditions: Emergency Surgery studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: DIAGNOSTIC masking: DOUBLE whoMasked: CARE_PROVIDER whoMasked: OUTCOMES_ASSESSOR count: 142 type: ESTIMATED name: GUS measure: Proportion of change in Anesthetic Plan measure: Percentage change in the three-category risk assessment before and after GUS sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT hasResults: False
<\|newrecord\|> nctId: NCT06303479 id: Voldyne_Tele briefTitle: The Effect of Telerehabilitation-Based Respiratory Exercise Programs on Lung Capacity overallStatus: NOT_YET_RECRUITING date: 2024-04 date: 2024-05 date: 2024-09-29 date: 2024-03-12 date: 2024-03-12 name: Saglik Bilimleri Universitesi class: OTHER briefSummary: It is a prospective randomized controlled trial. In this project, it is aimed to examine the effect of telerehabilitation-based instrumental and noninstrumental respiratory exercise program on lung capacities. For this reason;
* Contributing to the literature by comparing the effect of breathing exercises with and without instruments on lung capacities,
* It is aimed to be a resource for the effective use of respiratory exercise, which has a high effect on lung capacities, in treatment.
In addition, with the data obtained, it is aimed to decide and apply the exercise that is more effective in the treatment of respiratory diseases quickly.
Socio-demographic data will be questioned by using the Demographic Data Form; participants, age, gender, height, weight, marital status, smoking and alcohol use, presence of disease, whether they are included in a different exercise program, dyspnea, severe nausea and vomiting. The cases will be randomized into two groups: non-instrumented breathing exercises group and instrumented breathing exercises group. The physical activity status of the individuals participating in the study will be questioned using the International Physical Activity Questionnaire-Short Form (IPAQ-SF) at the beginning and end of the study. Pulmonary Function Test (PFT) will be used to measure the lung capacity of the participants.
Instrumented breathing exercises will be performed for 8 weeks, 2 days a week with the telerehabilitation program, 3 days a week as a home program, 5 days a week in total, starting with 1 set of 15 repetitions and the program will progress with progression. Diaphragmatic breathing and thoracic extension exercises will be applied as non-instrumented breathing exercises. For 8 weeks, 2 days a week with telerehabilitation method, 3 days a week as a home program, 5 days a week in total, 1 set of 10 repetitions for each exercise and the program will progress with progression. At the end of 8 weeks, all evaluations of the participants in both groups will be repeated. conditions: Breathing Exercises conditions: Telerehabilitation studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: HEALTH_SERVICES_RESEARCH masking: NONE count: 26 type: ESTIMATED name: Non-Instrumental breathing exercise group name: Instrumental breathing exercise group measure: Pulmonary Function Test for FEV1 measure: Pulmonary Function Test for PEF measure: Pulmonary Function Test for FEV1/FVC measure: Pulmonary Function Test for FVC measure: International Physical Activity Questionnaire-Short Form (IPAQ-SF) sex: ALL minimumAge: 18 Years maximumAge: 30 Years stdAges: ADULT facility: University of Health Sciences city: Istanbul country: Turkey name: Esra PEHLİVAN, Assoc. Dr. role: CONTACT phone: +90 212 409 02 00 email: esra.pehlivan@sbu.edu.tr name: Esra PEHLİVAN, Assoc. Prof. role: PRINCIPAL_INVESTIGATOR name: Fatma Nur AYYILDIZ, Student role: SUB_INVESTIGATOR name: Beyzanur YEŞİLYURT, Student role: SUB_INVESTIGATOR name: Mustafa ÇÖRTÜK, Prof. Dr. role: SUB_INVESTIGATOR name: Fulya KARAAHMETOĞLU, PhD (c) role: SUB_INVESTIGATOR lat: 41.01384 lon: 28.94966 hasResults: False
<\|newrecord\|> nctId: NCT06303466 id: R-23053109 briefTitle: Real World Evidence Study of Danish Fabry Patients acronym: RWE-FABRY overallStatus: ACTIVE_NOT_RECRUITING date: 2023-08-01 date: 2024-08-01 date: 2024-12-31 date: 2024-03-12 date: 2024-03-12 name: Caroline Michaela Kistorp class: OTHER name: Amicus Therapeutics name: Rigshospitalet, Denmark briefSummary: Fabry is a rare X-linked metabolic lysosomal disorder caused by deficiency in the enzyme α-galactosidase A (alpha-Gal A) by mutations in the GLA gene, encoding the alpha-Gal A enzyme, which catalyses glycosphingolipids, namely globotriaosylceramide (Gb3). Reduced or absent alpha-Gal A activity leads to accumulation of Gb3 in various organs as well as cellular dysfunction and inflammation causing phsyical symptoms and eventual organ failure. Treatment has been available since 2001 for Fabry patients - first enzyme replacement therapy and since 2016, an oral chaperone therapy, Migalastat. Although the initial trials of Migalastat had some both short and extended outcome treatment comparisons, the overall evidence of clinical efficacy is based on too small numbers considering the heterogeneity of the Fabry patient population as well as the very slow progression of the disease. Though the body of real-world evidence is growing, there is a need for more publications of real-world long-term data on clinical outcomes with a focus on treatment with Migalastat.
Research Question:
Is the incidence and prevalence of Fabry associated clinical events (FACEs) (cardiac, renal, and cerebrovascular) associated with sex, genotype, phenotype at time of diagnosis, biomarkers, and Fabry specific therapy?
Objectives:
* To investigate time to first Fabry associated clinical events (FACE) (cardiac, renal, and cerebrovascular) with particular focus on Migalastat clinical outcomes and treatment outcomes preceding Migalastat therapy.

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