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Given the on-going challenges faced by the National Health Service (NHS) in the United Kingdom, such as long waiting times, staff shortages, increased demand for services because of the COVID-19 pandemic, there is an urgent need to develop new ways to support those living with chronic breathlessness. One potential solution is to offer support online, as it is estimated that in the UK, 7 out of every 10 people with chronic breathlessness are internet users.
With the help of patients and NIHR funding the research team lead by Dr Charles Reilly, developed an online breathlessness supportive website called SELF-BREATHE. SELF-BREATHE provides information and self-management tools such as breathing exercises, that patients can do at home themselves.
SELF-BREATHE has been tested as part of its development. SELF-BREATHE is acceptable and valued by patients. But what is unknown is whether SELF-BREATHE improves patients' breathlessness and their life? This is the question this research seeks to answer.
Aims
1. To test if using SELF-BREATHE for six-weeks improves patients' breathlessness, their quality of life and whether SELF-BREATHE should be offered within the NHS
2. To see if patients opt to continue to use SELF-BREATHE after six-weeks and what benefits this may have for patients.
Methods
The research team are undertaking a randomised controlled trial. For this, 246 people living with chronic breathlessness will be recruited in to this study. Each person will be randomly chosen by a computer to continue with their usual care or their usual care plus access to SELF-BREATHE. All study participants will complete questionnaires at the start of the study, thereafter at seven and twelve weeks after randomisation.
These questionnaires will ask patients about 1) their breathlessness and its effect on their life and 2) planned and unplanned hospital visits. At the end of the study, we will compare answers to these questionnaires between the two groups at seven and 12 weeks.
This will tell if SELF-BREATHE improved patients' breathlessness and reduced their need for unplanned hospital visits e.g., A\&E attendances due to breathlessness. conditions: Chronic Obstructive Pulmonary Disease conditions: Bronchiectasis conditions: Interstitial Lung Disease conditions: Lung Cancer conditions: Asthma conditions: Dyspnea conditions: Fibrotic Lung Disease conditions: Chronic Lung Disease studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: SINGLE maskingDescription: A statistician blind whoMasked: INVESTIGATOR count: 246 type: ESTIMATED name: SELF-BREATHE measure: Numerical Rating Scale (NRS) Worst Breathlessness sex: ALL minimumAge: 18 Years maximumAge: 110 Years stdAges: ADULT stdAges: OLDER_ADULT facility: King's College Hospital NHS Foundation Trust city: London zip: MK40 4DG country: United Kingdom name: Charles C Reilly role: CONTACT phone: 00442032998062 email: charles.reilly@nhs.net lat: 51.50853 lon: -0.12574 hasResults: False
<\|newrecord\|> nctId: NCT06326944 id: MS-527-2023 briefTitle: Fascia Transversalis Versus Transversus Abdominis Plane Block for Children Undergoing Inguinal Hernia Surgery overallStatus: RECRUITING date: 2024-01-18 date: 2024-04 date: 2024-05 date: 2024-03-22 date: 2024-03-22 name: Kasr El Aini Hospital class: OTHER briefSummary: Fascia transversalis block in pediatrics undergoing inguinal surgical repair may be simple technique and may give longer effect in reduction of post-operative pain in comparison to transversus abdominis plane block. conditions: Fascia Transversalis Plane Block studyType: INTERVENTIONAL phases: PHASE2 allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: SUPPORTIVE_CARE masking: DOUBLE whoMasked: PARTICIPANT whoMasked: OUTCOMES_ASSESSOR count: 50 type: ESTIMATED name: Ultrasound- guided Fascia Transversalis plane block name: Ultrasound-guided Transversus abdominus plane block name: Fentanyl name: Pethidine name: Acetaminophen measure: Time to First need of analgesia measure: Total Pethidine Consumption measure: Postoperative pain assessment FLACC sex: ALL minimumAge: 1 Year maximumAge: 6 Years stdAges: CHILD facility: Cairo University Hospitals status: RECRUITING city: Giza zip: 11562 country: Egypt name: Maher a Fawzy, MD role: CONTACT phone: 01201730249 email: kasralainirec@kasralainy.edu.eg lat: 30.00808 lon: 31.21093 hasResults: False
<\|newrecord\|> nctId: NCT06326931 id: JE001 briefTitle: Thermal Pulsation Versus Warm Compress Treatment for Meibomian Gland Dysfunction overallStatus: COMPLETED date: 2022-06-24 date: 2023-06-22 date: 2023-06-22 date: 2024-03-22 date: 2024-03-22 name: Jacksoneye class: OTHER briefSummary: This study aimed to assess the treatment outcome differences between a single, in-office bilateral treatment with the thermal pulsation system and twice-daily, 10-minute applications of the warm compress mask at home for 8 weeks. conditions: Meibomian Gland Dysfunction studyType: INTERVENTIONAL phases: PHASE4 allocation: RANDOMIZED interventionModel: PARALLEL interventionModelDescription: Prospective, randomized, controlled clinical trial primaryPurpose: TREATMENT masking: SINGLE maskingDescription: The clinician evaluating MGS score was masked to subject treatment assignment whoMasked: OUTCOMES_ASSESSOR count: 68 type: ACTUAL name: thermal pulsation name: warm compress measure: Change in MGS score for the worse eye measure: Change in MGS score for the worse eye measure: Change in OSDI score measure: Change in OSDI score measure: Incidence of adverse events sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Jacksoneye city: Lake Villa state: Illinois zip: 60046 country: United States lat: 42.41697 lon: -88.07397 hasResults: False
<\|newrecord\|> nctId: NCT06326918 id: RP026 briefTitle: Duodenal Microbiota in Functional Dyspepsia overallStatus: RECRUITING date: 2024-02-12 date: 2024-12-31 date: 2025-06-30 date: 2024-03-22 date: 2024-03-22 name: King Chulalongkorn Memorial Hospital class: OTHER briefSummary: The goal of this observational study is to assess the type of duodenal microbiota and duodenal microbiome in in FD patients compared to control group. The main questions it aims to answer are:
* What are the differences in the type of duodenal microbiota and is there a difference in duodenal microbiome diversity between patients diagnosed with functional dyspepsia (FD) and the control group?
* Are there any significant variations in the composition and diversity of gut microbiota between patients with FD and the control group, considering the method of sample collection (duodenal brushing vs. duodenal biopsy)? conditions: Functional Dyspepsia studyType: OBSERVATIONAL observationalModel: CASE_CONTROL timePerspective: CROSS_SECTIONAL count: 40 type: ESTIMATED name: Duodenal mucosal brushing name: Duodenal mucosal biopsy measure: Specific microbial genus using mucosal brushing measure: Microbiome diversity using mucosal brushing measure: Specific microbial genus using mucosal biopsy measure: Microbiome diversity using mucosal biopsy sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: King Chulalongkorn Memorial Hospital status: RECRUITING city: Bangkok zip: 10330 country: Thailand name: Rapat Pittayanon, MD role: CONTACT phone: +66813132112 email: rapat125@gmail.com name: Chatpol Samuthpongtorn, MD role: CONTACT phone: +66813462108 email: csamuthpongtorn@gmail.com lat: 13.75398 lon: 100.50144 hasResults: False
<\|newrecord\|> nctId: NCT06326905 id: IRB00437750 id: K23DK133677-01A1 type: NIH link: https://reporter.nih.gov/quickSearch/K23DK133677-01A1 briefTitle: CAPABLE Transplant overallStatus: NOT_YET_RECRUITING date: 2024-05-01 date: 2025-09-01 date: 2026-05-01 date: 2024-03-22 date: 2024-03-22 name: Johns Hopkins University class: OTHER name: National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) briefSummary: The purpose of this mixed methods study is to adapt CAPABLE as CAPABLE Transplant to accomplish two things: 1) To resolve barriers to being classified as active on the Kidney Transplant (KT) waitlist and 2) as a surgical prehabilitation intervention targeting the pre-frail/ frail KT waitlist population. It consists of two phases- an open label pilot and a randomized waitlist control trial. conditions: Quality of Life conditions: Depression conditions: End Stage Renal Disease conditions: Disability Physical studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL interventionModelDescription: Waitlist Control Trial primaryPurpose: PREVENTION masking: SINGLE maskingDescription: The assessment collector will be blinded as to whether a participant is in the intervention or waitlist group whoMasked: OUTCOMES_ASSESSOR count: 33 type: ESTIMATED name: CAPABLE Transplant- Open Label Pilot name: CAPABLE Transplant- Randomized Control Trial measure: Waitlist-status as assessed by data obtained by the National Kidney Registry measure: Change in self-efficacy as assessed by the Coping Self-Efficacy Instrument measure: Change in self-efficacy as assessed by the Self-Efficacy of Chronic Disease Management Instrument measure: Change in Pain as assessed by the Brief Pain Inventory measure: Change in Depression as assessed by the Patient Health Questionnaire Depression Scale (PHQ-8) measure: Change in Social engagement as assessed by the Lubben Social Network Scale measure: Change in Social engagement as assessed by the Krause-Borawski-Clark Support Interactions Scale measure: Change in Fatigue/Quality of Life as assessed by the Kidney disease Quality of Life Scale measure: Change in Frailty as assessed by the Fried Frailty Phenotype measure: Change in Health Team Communication as assessed by the CollaboRATE Scale Measure measure: Change in Function as assessed by Lawton & Brody's assessment of Instrumental Activities of Daily Living Scale measure: Change in Function as assessed by the Katz Index of Independence in Activities of Daily Living measure: Acceptability at endpoint of intervention assessed by survey measure: Feasibility as assessed by qualitative questions measure: Fidelity as assessed by percent completion of intervention items sex: ALL minimumAge: 50 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Johns Hopkins School of Nursing city: Baltimore state: Maryland zip: 21205 country: United States name: Samantha Curriero, MPH role: CONTACT phone: 443-699-1220 lat: 39.29038 lon: -76.61219 hasResults: False
<\|newrecord\|> nctId: NCT06326892 id: CHR1-101-2024 briefTitle: Natural Orifice Specimen Extraction in Low Rectal Cancer Surgery acronym: NOSES overallStatus: RECRUITING date: 2023-07-31 date: 2024-04-30 date: 2024-10-15 date: 2024-03-22 date: 2024-03-25 name: Istituto Clinico Humanitas class: OTHER briefSummary: This study aims to compare the postoperative outcomes of low rectal cancer patients who underwent surgery with Natural Orifice Specimen Extraction (NOSE) versus traditional Pfannenstiel extraction. conditions: Rectal Cancer conditions: Surgery studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: RETROSPECTIVE count: 350 type: ESTIMATED name: Natural Orifice Specimen Extraction (NOSE) name: Traditional specimen extraction measure: Surgical Site Infections (SSI) measure: Opioid rescue measure: Postoperative pain measure: Postoperative ileus measure: Incisional hernia measure: Overall postoperative complications sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: IRCCS Humanitas Research Hospital status: RECRUITING city: Rozzano state: MI zip: 20089 country: Italy name: Annalisa Maroli, PhD role: CONTACT phone: 02 8224 7776 phoneExt: 0039 email: colorapp@humanitas.it name: Stefano De Zanet, MS role: CONTACT phone: 02 8224 4623 phoneExt: 0039 email: colorapp@humanitas.it lat: 45.38193 lon: 9.1559 hasResults: False
<\|newrecord\|> nctId: NCT06326879 id: 3527 briefTitle: A Comparative Study Between Early Onset Colorectal Cancer and Late Onset Colorectal Cancer Patients acronym: EOrOS overallStatus: RECRUITING date: 2023-11-30 date: 2026-12-31 date: 2027-10-30 date: 2024-03-22 date: 2024-03-25 name: Istituto Clinico Humanitas class: OTHER briefSummary: This study aims to investigate the clinical, socioeconomic, behavioral, genetic, and molecular factors characterizing Early Onset Colorectal Cancer (EOCRC) patients compared with Late Onset Colorectal Cancer (LOCRC) patients conditions: Colorectal Cancer studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: PROSPECTIVE count: 340 type: ESTIMATED name: No intervention measure: Incidence rate ratio of colorectal cancer recurrence measure: Correlation between lifestyle and incidence rate of colorectal cancer recurrence measure: Correlation between genetic profile and incidence rate of colorectal cancer recurrence measure: Correlation between molecular profile and incidence rate of colorectal cancer recurrence measure: Correlation between socioeconomic characteristics and incidence rate of colorectal cancer recurrence sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: IRCCS Humanitas Research Hospital status: RECRUITING city: Rozzano state: MI zip: 20089 country: Italy name: Annalisa Maroli, PhD role: CONTACT phone: 02 8224 7776 phoneExt: 0039 email: colorapp@humanitas.it name: Stefano De Zanet, MS role: CONTACT phone: 02 8224 4623 phoneExt: 0039 email: colorapp@humanitas.it lat: 45.38193 lon: 9.1559 hasResults: False
<\|newrecord\|> nctId: NCT06326866 id: E-74555795-050.04-941208 briefTitle: Otoacoustic Emissions in Different Blood Types overallStatus: COMPLETED date: 2024-02-07 date: 2024-03-12 date: 2024-03-18 date: 2024-03-22 date: 2024-03-26 name: Istanbul University - Cerrahpasa (IUC) class: OTHER briefSummary: The objective of this study is to examine whether ABO and Rhesus (Rh) blood group systems have an association with distortion product otoacoustic emission (DPOAE) and transient otoacoustic emission (TEOAE) amplitudes with the hypothesis of blood groups may affect hearing thresholds. conditions: Hearing Loss, Cochlear studyType: OBSERVATIONAL observationalModel: CASE_ONLY timePerspective: CROSS_SECTIONAL count: 70 type: ACTUAL name: Otoacoustic emissions (non-invasive) measure: Signal to noise ratios sex: ALL minimumAge: 18 Years maximumAge: 26 Years stdAges: ADULT facility: Eyyup KARA city: İstanbul zip: 34107 country: Turkey lat: 41.01384 lon: 28.94966 hasResults: False
<\|newrecord\|> nctId: NCT06326853 id: Adipofisi briefTitle: Neuroendocrine Mechanisms in Adiposity: An Integrated Approach to the Characterization of Potential Pharmacological Novel Targets Based on Experimental and Clinical Models overallStatus: NOT_YET_RECRUITING date: 2024-03 date: 2024-03 date: 2026-12 date: 2024-03-22 date: 2024-03-25 name: IRCCS San Raffaele class: OTHER briefSummary: The goal of this observational study is to evaluate, retrospectively and prospectively, the effect of different hormonal and neuropeptide dysfunctions on the body composition of patients suffering from hypothalamic-pituitary pathologies, and to evaluate the potential beneficial effect of surgical and medical treatments with agonists and antagonists of hypothalamic neuropeptides, currently available, on the development and treatment of adiposity and negative cross-talk between adiposity and muscle/bone tissue conditions: Endocrine Disorders conditions: Adiposity conditions: Pituitary Adenoma conditions: Cushing Syndrome conditions: Acromegaly conditions: Hypopituitarism studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: OTHER count: 200 type: ESTIMATED measure: Rate of patients with BMI greater than 30 with hypothalamic-pituitary pathologies sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT hasResults: False
<\|newrecord\|> nctId: NCT06326840 id: 98107 briefTitle: Clinical Efficacy and Adverse Reactions of Antipsychotic Treatment overallStatus: COMPLETED date: 2010-05-31 date: 2011-06-10 date: 2011-06-10 date: 2024-03-22 date: 2024-03-22 name: Taipei Medical University Hospital class: OTHER name: Taipei Medical University briefSummary: The goal of this clinical trial is to explore the potential of metformin in managing olanzapine-induced metabolic disturbance and hyperprolactinemia in patients with schizophrenia. The main questions it aims to answer are:
1. The effect of metformin on olanzapine-induced metabolic disturbance
2. The effect of metformin on olanzapine-induced hyperprolactinemia
Participants will receive metformin 1500 mg/day for 8 weeks and assessments every 2 weeks. conditions: Metabolic Disturbance conditions: Hyperprolactinemia conditions: Schizophrenia studyType: INTERVENTIONAL phases: NA allocation: NA interventionModel: SINGLE_GROUP primaryPurpose: TREATMENT masking: NONE count: 42 type: ACTUAL name: Metformin measure: Glucose level measure: prolactin level measure: Insulin level measure: low-density lipoprotein cholesterol (LDL-C) level measure: high-density lipoprotein cholesterol (HDL-C) level measure: cholesterol level measure: triglycerides level measure: leptin level measure: Clinical Global Impression scale sex: ALL minimumAge: 18 Years maximumAge: 60 Years stdAges: ADULT facility: Taipei Medical University-Wan Fang Hospital city: Taipei zip: 116 country: Taiwan lat: 25.04776 lon: 121.53185 hasResults: False
<\|newrecord\|> nctId: NCT06326827 id: P231127IBSORTHO briefTitle: In'Oss™ (MBCP® Putty) Ortho overallStatus: NOT_YET_RECRUITING date: 2024-05 date: 2026-05 date: 2026-08 date: 2024-03-22 date: 2024-03-29 name: Advanced Medical Solutions Ltd. class: INDUSTRY briefSummary: Study of the osteoconductive potential of the injectable bone substitute In'Oss™ (MBCP® Putty) in the filling of orthopaedic bone defects to collect Post-Market Clinical Follow-up (PMCF) data for the CE-marked In'Oss™ (MBCP® Putty) device in the orthopaedic trauma surgery conditions: Orthopedic Disorder conditions: Trauma Injury conditions: Extremity Injury studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: PROSPECTIVE count: 100 type: ESTIMATED name: In'Oss™ (MBCP® Putty) measure: Successful bone defect reconstruction in the extremities measure: Evaluation of functional mobility restoration in the extremities with PRO measures measure: Evaluation of patient's pain intensity with VAS pain scale measure: Evaluation of safety of In'Oss measure: Evaluation of device usability sex: ALL minimumAge: 18 Years maximumAge: 85 Years stdAges: ADULT stdAges: OLDER_ADULT hasResults: False
<\|newrecord\|> nctId: NCT06326814 id: TDU16837 id: U1111-1298-7281 type: REGISTRY domain: ICTRP briefTitle: A Study to Test if SAR443809 is Tolerated and Safe When Taken as a Single Dose in Healthy Adults overallStatus: COMPLETED date: 2021-10-11 date: 2023-05-05 date: 2023-05-05 date: 2024-03-22 date: 2024-03-22 name: Sanofi class: INDUSTRY briefSummary: Primary objective
* The tolerability and safety of SAR443809 Secondary
* The PK parameters of SAR443809
* The PD activity of SAR443809
* The immunogenicity of SAR443809 conditions: Paroxysmal Nocturnal Hemoglobinuria studyType: INTERVENTIONAL phases: PHASE1 allocation: RANDOMIZED interventionModel: SEQUENTIAL primaryPurpose: TREATMENT masking: DOUBLE whoMasked: PARTICIPANT whoMasked: INVESTIGATOR count: 54 type: ACTUAL name: Humanized anti-Factor Bb monoclonal antibody name: Placebo measure: Number of participants with adverse events (AEs)/treatment-emergent adverse events (TEAEs) measure: Incidence of potentially Clinical laboratory abnormalities measure: PK parameters of SAR443809 for IV and SC administrations: Maximum plasma concentration observed (Cmax measure: PK parameters of SAR443809 for IV and SC administrations: First time to reach Cmax (tmax measure: PK parameters of SAR443809 for IV and SC administrations: Area under the plasma concentration versus time curve calculated using the trapezoidal method from time zero to tlast (AUClast) measure: PK parameters of SAR443809 for IV and SC administrations: Area under the plasma concentration versus time curve extrapolated to infinity (AUC0-∞) measure: PK parameters of SAR443809 for IV and SC administrations: Terminal half-life associated with the terminal slope (λz) (t1/2z) measure: PK parameters of SAR443809 for IV and SC administrations: Time corresponding to the last concentration above the limit of quantification (Clast tlast) measure: PK parameters of SAR443809 for IV and SC administrations: total body clearance of a drug from the plasma calculated by dividing dose by AUC (CL) measure: PK parameters of SAR443809 for SC administrations: apparent total body clearance of the SC formulation (CL/F) measure: PK parameters of SAR443809 for IV and SC administrations: volume of distribution at steady-state (Vss) measure: PK parameters of SAR443809 for SC administrations: apparent volume of distribution at steady-state (Vss/F) measure: PK parameters of SAR443809 for SC administrations: absolute bioavailability (F) measure: Complement alternative pathway activity (Wieslab AP and alternative pathway hemolytic activity [AH50]) measure: Complement classical pathway activity (Wieslab CP) measure: Incidence of treatment -emergent Anti-SAR443809 antibodies sex: ALL minimumAge: 18 Years maximumAge: 45 Years stdAges: ADULT facility: Parexel International Site Number : 8400002 city: Glendale state: California zip: 91206 country: United States lat: 34.14251 lon: -118.25508 facility: Parexel International Site Number : 8400003 city: Baltimore state: Maryland zip: 21255 country: United States lat: 39.29038 lon: -76.61219 hasResults: False
<\|newrecord\|> nctId: NCT06326801 id: REC/014220 Muhammad Iqbal briefTitle: Resistive Diaphragmatic Breathing Exercise With Pursed Lips Breathing Exercise in Sub-acute Stroke Patients overallStatus: COMPLETED date: 2023-09-01 date: 2024-01-15 date: 2024-01-18 date: 2024-03-22 date: 2024-03-22 name: Riphah International University class: OTHER briefSummary: To determine whether resistive diaphragmatic breathing exercise with pursed lips breathing exercise improve pulmonary function in sub-acute ischemic stroke, To determine whether resistive diaphragmatic breathing exercise with pursed lips breathing exercise improve Trunk Control in sub-acute ischemic stroke, To determine whether resistive diaphragmatic breathing exercise with pursed lips breathing exercise improve Functional Capacity in sub-acute ischemic stroke conditions: Stroke, Ischemic studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: NONE count: 27 type: ACTUAL name: Resistive Diaphragmatic breathing exercise name: Diaphragmatic breathing exercise name: Conventional stroke physiotherapy measure: pulmonary function measure: Trunk Control measure: Functional Capacity sex: ALL minimumAge: 40 Years maximumAge: 65 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Northwest General Hospital, Peshawar; city: Peshawar state: Punjab zip: 44000 country: Pakistan lat: 34.008 lon: 71.57849 hasResults: False
<\|newrecord\|> nctId: NCT06326788 id: 3912 Mehnoor Butt briefTitle: Effects of Moderate Intensity Soleus Push-ups vs Sustained Soleus Push-ups on Lipid Profile Among Young Population overallStatus: RECRUITING date: 2023-10-01 date: 2024-07-28 date: 2024-07-30 date: 2024-03-22 date: 2024-03-22 name: Riphah International University class: OTHER briefSummary: To determine the effects of Short duration moderate intensity soleus push- ups VS Sustained Soleus Push-ups on lipid profile among Young Population. conditions: Health Behavior studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: PREVENTION masking: SINGLE whoMasked: PARTICIPANT count: 33 type: ESTIMATED name: Short Duration Moderate Intensity Soleus Push-ups name: SUSTAINED SOLEUS PUSH-UPS measure: Change in Lipid Profile measure: Adherence to Exercise Protocol sex: ALL minimumAge: 18 Years maximumAge: 26 Years stdAges: ADULT facility: Riphah Rehabilitation Center status: RECRUITING city: Islamabad zip: 46600 country: Pakistan name: Mehnoor Butt, MSPT role: CONTACT phone: 335 5400831 email: mehnoorarshad1109@gmail.com name: Waqar Ahmed Awan, PHD role: CONTACT phone: 333 5348846 email: waqar.ahmed@riphah.edu.pk lat: 33.72148 lon: 73.04329 hasResults: False
<\|newrecord\|> nctId: NCT06326775 id: KY20240311-KS-02 briefTitle: Research on Precision Pharmaceutical Care for Heart Transplant Recipients overallStatus: ACTIVE_NOT_RECRUITING date: 2024-03-12 date: 2026-12 date: 2026-12 date: 2024-03-22 date: 2024-03-22 name: Nanjing First Hospital, Nanjing Medical University class: OTHER name: Wuhan Union Hospital, China name: Changhai Hospital name: Shanghai Zhongshan Hospital briefSummary: Establishing personalized dose prediction and related adverse drug reaction prediction models for immunosuppressive drugs after heart transplantation using multiple methods to construct a precise pharmaceutical service system for heart transplant patients has important research value and clinical significance in improving the safety and effectiveness of medication for patients. conditions: Heart Transplant Patients studyType: OBSERVATIONAL observationalModel: OTHER timePerspective: RETROSPECTIVE count: 500 type: ESTIMATED measure: Steady state whole blood trough concentration of tacrolimus sex: ALL stdAges: CHILD stdAges: ADULT stdAges: OLDER_ADULT facility: Pharmacy Department of Nanjing First Hospital city: Nanjing state: Jiangsu zip: 210006 country: China lat: 32.06167 lon: 118.77778 hasResults: False
<\|newrecord\|> nctId: NCT06326762 id: younes briefTitle: Gap CO2 in Septic Patient to Predict Cardiomyopathy Septic overallStatus: COMPLETED date: 2023-01-01 date: 2023-10-30 date: 2023-10-30 date: 2024-03-22 date: 2024-03-22 name: Mohammed VI University Hospital class: OTHER briefSummary: the investigators included 98 patients admitted for sepsis and septic shock (68.4% men, 31.6% women) with an average age of 60.42 years ± 15.13, ranging from 21 to 96 years. The average length of hospital stay was 7.53 days. The most noted medical histories were diabetes (38.8%), hypertension (28.6%), and renal insufficiency (17.1%). Regarding laboratory findings: the mean white blood cell count was 15,985.16 cells/mm³, the mean C-reactive protein (CRP) level was 227.69 mg/L, and the mean procalcitonin level was 50.43 µg/L. In terms of blood gas analysis: the mean lactate level was 3.67 mmol/L, and the mean PCO2 gap (DELTAPCO2) was 4.85. All our patients were continuously monitored by pulse wave analysis: the mean cardiac output was 5.69 L/min, and the mean cardiac index was 4.14 L/s/m² All our patients underwent an echocardiogram, which is a routine examination in our department and is performed at the patient's bedside. The average left ventricular ejection fraction (LVEF) was 51.73%, and the average subaortic peak velocity (ITV) was 14.66 cm.
Subsequently. the investigators examined the clinical and paraclinical profile of patients with septic cardiomyopathy. the investigators identified 19 patients with this condition, while 79 patients did not exhibit cardiac involvement. The percentage was significantly higher in the population with cardiac involvement, accounting for 28.3%. Among the patients with cardiac involvement, 76.5% had a PCO2 gap (DELTAPCO2) ≥ 6 mmHg, a significantly reduced cardiac output with an average of 3.3 L/min, and a predominantly low cardiac index, with 64.3% having an index \< 2.2 L/min/m². The mortality rate was significantly increased at 73.7%. conditions: Gap co2 conditions: Cardiac Output, Low conditions: Cardiac Defect studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: RETROSPECTIVE count: 98 type: ACTUAL name: comparaison measure: gapCO2 sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: younes Oujidi city: Berkane zip: 9999 country: Morocco lat: 34.92 lon: -2.32 hasResults: False
<\|newrecord\|> nctId: NCT06326749 id: 2024/19 briefTitle: Effectiveness of Modified Graded Motor Imagery Training in Stroke Patients overallStatus: NOT_YET_RECRUITING date: 2024-04-01 date: 2024-11-15 date: 2025-03-15 date: 2024-03-22 date: 2024-03-22 name: Inonu University class: OTHER briefSummary: In the study, movement observation training, Modified Graded Motor Imaging Training, which includes upper extremity functional exercises, and Graded Motor Imaging Training, where the standard protocol is applied, will be used in stroke patients to improve their upper extremity motor functions and daily lives. It is aimed to present it on an evidence-based basis by investigating its effects on Daily Living Activity, quality of life, upper extremity-specific right/left lateralization performance, mental stopwatch performance and motor imagery skills. conditions: Graded Motor Imagery conditions: Stroke conditions: Action Observation Training conditions: Motor Imagery studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: SINGLE whoMasked: PARTICIPANT count: 21 type: ESTIMATED name: Modified Graded Motor Imagery and Conventional Treatment Group name: Graded Motor Imagery and Conventional Treatment Group name: Conventional Treatment Group measure: Fugl-Meyer Upper Extremity Motor Rating Scale measure: Wolf Motor Function Test (WMFT) measure: Modified Barthel Index measure: Stroke-Specific Quality of Life Scale measure: Lateralization Assessment measure: Mental Chronometry Time measure: Kinesthetic and Visual Imagery Questionnaire (KGIA) sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Inonu University city: Malatya zip: 44280 country: Turkey name: Havva ADLI role: CONTACT phone: 05369831133 email: h.adli@hotmail.com name: Kezban BAYRAMLAR, Prof. Dr. role: SUB_INVESTIGATOR lat: 38.35018 lon: 38.31667 hasResults: False
<\|newrecord\|> nctId: NCT06326736 id: 2024NZKY-014-02 briefTitle: Study of Neoantigen mRNA Vaccines in Patients With Resectable Pancreatic Cancer overallStatus: RECRUITING date: 2024-04 date: 2025-12 date: 2026-12 date: 2024-03-22 date: 2024-03-22 name: Jinling Hospital, China class: OTHER name: Jiangsu Synthgene Biotechnology Co.Ltd. briefSummary: The purpose of this study is to evaluate the safety and efficacy of treating pancreatic cancer with surgery to remove cancerour tissue, followed by camrelizumab and a personalized cancer mRNA vaccines. conditions: Pancreatic Cancer studyType: INTERVENTIONAL phases: EARLY_PHASE1 allocation: NA interventionModel: SINGLE_GROUP primaryPurpose: TREATMENT masking: NONE count: 12 type: ESTIMATED name: Surgery name: Camrelizumab name: SJ-Neo006 name: Gemcitabine+Abraxane measure: Incidence of Treatment Emergent Adverse Events (TEAEs) measure: Disease control rate (DCR) sex: ALL minimumAge: 18 Years maximumAge: 75 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Wang Sizhen status: RECRUITING city: Nanjing state: Jiangsu country: China name: wu qiong role: CONTACT phone: 02580863234 lat: 32.06167 lon: 118.77778 hasResults: False
<\|newrecord\|> nctId: NCT06326723 id: SIM0808-101 briefTitle: Investigate the PK, Safety, and Tolerability After Single and Multiple Dose Daridorexant in Chinese Healthy Subjects overallStatus: COMPLETED date: 2023-09-04 date: 2023-12-24 date: 2024-02-05 date: 2024-03-22 date: 2024-03-22 name: Jiangsu Simcere Pharmaceutical Co., Ltd. class: INDUSTRY briefSummary: This clinical study is a single-center, randomized, double-blind, placebo-controlled Phase 1 clinical study to assess the PK characteristics and safety and tolerability of single and multiple dose daridorexant in 32 healthy adult Chinese subjects. conditions: Healthy Volunteer studyType: INTERVENTIONAL phases: PHASE1 allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: QUADRUPLE whoMasked: PARTICIPANT whoMasked: CARE_PROVIDER whoMasked: INVESTIGATOR whoMasked: OUTCOMES_ASSESSOR count: 32 type: ACTUAL name: Daridorexant measure: Pharmacokinetic Endpoints1 measure: Pharmacokinetic Endpoints2 measure: Pharmacokinetic Endpoints3 measure: Pharmacokinetic Endpoints4 measure: Pharmacokinetic Endpoints5 measure: Pharmacokinetic Endpoints6 measure: Pharmacokinetic Endpoints7 measure: Safety Endpoints1 measure: Safety Endpoints2 measure: Safety Endpoints3 measure: Safety Endpoints4 measure: Safety Endpoints5 measure: Safety Endpoints6 measure: Safety Endpoints7 measure: Safety Endpoints8 sex: ALL minimumAge: 18 Years maximumAge: 55 Years stdAges: ADULT facility: Nanjing Drum Tower hospital city: Nanjing state: Jiangsu zip: 210000 country: China lat: 32.06167 lon: 118.77778 hasResults: False
<\|newrecord\|> nctId: NCT06326710 id: P0045122 briefTitle: The 'Outdoor Rehab-Fit' App-based Physical Activity Education Intervention for Frail Older Adults in Hong Kong overallStatus: RECRUITING date: 2024-04-01 date: 2024-10-01 date: 2024-12-31 date: 2024-03-22 date: 2024-04-09 name: The Hong Kong Polytechnic University class: OTHER briefSummary: In recent years, research teams around the world have developed interventions to educate older adults to use outdoor exercise facilities (OEFs) to improve health outcomes like strength, balance, mobility, PA level, and weight. These interventions employed trainers or therapists to instruct, and monitor exercise training for older adults using the public accessible OEFs. Apart from therapist or trainer-led intervention, an Australian research team developed a mobile application, and social support strategies to help participants to use OEFs to enhance their aerobic and resistance-based PA.
A recent local in-depth qualitative study discovered that OEFs in Hong Kong attracted frailer older adults (i.e., those who recovered from a major illness or who has chronic diseases), and their caregivers to use OEFs to support and maintain their daily PA behavior. Some used OEFs to complement their formal rehabilitation sessions. It appears that OEFs in Hong Kong serves as an important health maintenance space for frailer older adults in the city to "age in place", yet educational training related to OEFs has been lacking over the years. Signage besides the exercise equipment has been the only education material for users over the years.
A mobile app-based physical activity education intervention will be developed for frail old adults in Hong Kong. The intervention has two components: (1) mobile app; and (2) face-to-face group session that teaches the how to use correctly and safely use OEF in public parks to maintain PA habits.
The main objective of this study is to evaluate the feasibility, acceptability, and pilot effectiveness of the 'Outdoor Rehab-Fit' App-based physical activity education intervention. Primary outcomes include recruitment rate, retention rate, attrition rate, attendance, perceived usefulness of the app. Secondary outcomes include exercise self-efficacy, mental well-being, physical activity level.
This study adopts a mixed-method design with quantitative and qualitative method. This study is a pilot randomized controlled trial, running for 4 months evaluating of the effectiveness of the mHealth intervention. 40 frail older adults will be randomized into (i) mHealth group or (ii) control group.
Quantitative analysis will be adopted to investigate the effectiveness of the 'Outdoor Rehab-Fit' App-based physical activity education intervention on the health outcomes of frail older adults. The qualitative component will consist of semi-structure interviews with the frail older adults to understand the acceptability of the intervention. conditions: Physical Inactivity conditions: Frailty studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: SUPPORTIVE_CARE masking: DOUBLE whoMasked: PARTICIPANT whoMasked: OUTCOMES_ASSESSOR count: 40 type: ESTIMATED name: mHealth name: Health Talk measure: Feasibility outcome: Recruitment rate measure: Feasibility outcome: Intervention completion rate measure: Feasibility outcome: Attrition rate measure: Feasibility outcome: Attendance measure: Acceptability outcome: Perceived Usefulness on Outdoor Rehab-Fit App measure: Acceptability outcome: Participants' views about the barriers and facilitation of the mHealth program measure: Change in Physical activity level (Objective) at 1 month and 3 months measure: Change in Physical activity level (Subjective) at 1 month and 3 months measure: Change in Exercise self-efficacy at 1 month and 3 months measure: Change in Mental well-being at 1 month and 3 months measure: Change in usage of outdoor exercise facilities sex: ALL minimumAge: 55 Years maximumAge: 100 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Department of Rehabilitation Sciences, The Hong Kong Polytechnic University status: RECRUITING city: Hong Kong country: Hong Kong name: Janet Lok Chun Lee, PhD role: CONTACT email: lcjlee@polyu.edu.hk lat: 22.27832 lon: 114.17469 hasResults: False
<\|newrecord\|> nctId: NCT06326697 id: HIK-AZA-2023-01 briefTitle: Bioequivalence of Azacitidine 300 mg Film-Coated Tablets in Adult Patients With Acute Myeloid Leukaemia (AML) overallStatus: NOT_YET_RECRUITING date: 2024-03 date: 2025-01 date: 2025-03 date: 2024-03-22 date: 2024-03-22 name: Hikma Pharmaceuticals LLC class: INDUSTRY briefSummary: A Randomized, Single Oral Dose, Open Label, Two Treatment, Crossover study to investigate the bioequivalence of the Test Product Azacitidine 300 mg Film coated tablets relative to Reference Product Onureg® 300 mg Film Coated Tablets in adult patients with AML under fasting conditions conditions: Acute Myeloid Leukaemia studyType: INTERVENTIONAL phases: PHASE1 allocation: RANDOMIZED interventionModel: CROSSOVER primaryPurpose: OTHER masking: NONE count: 32 type: ESTIMATED name: Azacitidine name: Onureg measure: Cmax measure: AUC0-t measure: AUC0-∞ measure: Kel measure: Tmax measure: T1/2el measure: Adverse Events (AEs) measure: Change in clinical safety labs sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT hasResults: False
<\|newrecord\|> nctId: NCT06326684 id: 88524 briefTitle: Suvorexant and Alcohol overallStatus: NOT_YET_RECRUITING date: 2024-06-15 date: 2027-03-15 date: 2027-03-15 date: 2024-03-22 date: 2024-03-27 name: University of Kentucky class: OTHER name: National Institute on Alcohol Abuse and Alcoholism (NIAAA) briefSummary: This research will translate findings from preclinical research and provide the initial clinical evidence that orexin antagonism reduces motivation for alcohol, as well as other alcohol-associated maladaptive behaviors in people with Alcohol Use Disorder. This study will also provide basic science information about the orexinergic mechanisms underlying the pharmacodynamic effects of alcohol in humans. As such, the outcomes will contribute to our understanding of the clinical neurobiology of Alcohol Use Disorder. Overall, the proposed work seeks to expand the scope of current clinical neuroscience research on alcohol addiction by focusing on orexin, which has strong preclinical evidence supporting its critical role in addiction but remains unstudied in humans. conditions: Alcohol Use Disorder studyType: INTERVENTIONAL phases: EARLY_PHASE1 allocation: RANDOMIZED interventionModel: CROSSOVER primaryPurpose: BASIC_SCIENCE masking: TRIPLE whoMasked: PARTICIPANT whoMasked: CARE_PROVIDER whoMasked: OUTCOMES_ASSESSOR count: 30 type: ESTIMATED name: Alcohol name: Placebo name: Suvorexant name: Suvorexant measure: Reinforcing Effects of Alcohol measure: Craving measure: Mood measure: Alcohol Response measure: Heart rate measure: Blood pressure measure: Breath Alcohol Level measure: Temperature measure: Side Effects measure: Delay Discounting measure: n-back Task measure: Stop-Signal Task Inhibitory Failures measure: Sleep sex: ALL minimumAge: 21 Years maximumAge: 55 Years stdAges: ADULT facility: Psychopharmacology of Addiction Laboratory city: Lexington state: Kentucky zip: 40507 country: United States name: William Walton Stoops role: CONTACT phone: 8592575388 email: william.stoops@uky.edu name: William W Stoops, PhD role: PRINCIPAL_INVESTIGATOR lat: 37.98869 lon: -84.47772 hasResults: False
<\|newrecord\|> nctId: NCT06326671 id: STXA-BE-03 briefTitle: A Trial to Assess the Bioequivalence of Generic Tiotropium Bromide Inhalation Powder and Reference Product in Healthy Adult Participants Under Fasting Conditions (Pilot) overallStatus: ACTIVE_NOT_RECRUITING date: 2024-02-28 date: 2024-03 date: 2024-04 date: 2024-03-22 date: 2024-03-29 name: Chia Tai Tianqing Pharmaceutical Group Co., Ltd. class: INDUSTRY briefSummary: Primary Objective: To evaluate the pharmacokinetics of Tiotropium Bromide Inhalation Powder (Strength:18 mcg; manufactured by Chia Tai Tianqing Pharmaceutical Group Co. Ltd) and reference products Tiotropium Bromide Inhalation Powder (Spiriva®, Handihaler®, Strength: 18mcg, manufactured by Boehringer Ingelheim Pharmaceuticals, Inc) by oral inhalation of single dose in healthy participants under fasting conditions. conditions: Chronic Obstructive Pulmonary Disease studyType: INTERVENTIONAL phases: PHASE1 allocation: RANDOMIZED interventionModel: CROSSOVER primaryPurpose: TREATMENT masking: NONE count: 39 type: ACTUAL name: Tiotropium Bromide Inhalation Powder name: Spiriva HandiHaler measure: Peak concentration (Cmax) measure: Area under the plasma concentration versus time curve (AUC) 0-t measure: Area under the plasma concentration versus time curve (AUC) 0-∞ measure: The time to maximum plasma concentration (Tmax) measure: The elimination half-life (t1/2) measure: Terminal elimination rate constant (Kel) sex: ALL minimumAge: 18 Years maximumAge: 55 Years stdAges: ADULT facility: Henan (Zhengzhou) Zhonghui Cardiovascular Hospital city: Zhengzhou state: Henan zip: 450003 country: China lat: 34.75778 lon: 113.64861 hasResults: False
<\|newrecord\|> nctId: NCT06326658 id: TCM for Frequent AECOPD briefTitle: Bufei Yishen Prescription on Patients With Frequent AECOPD in Stable Stage overallStatus: NOT_YET_RECRUITING date: 2024-04-01 date: 2026-05-01 date: 2026-10-31 date: 2024-03-22 date: 2024-03-22 name: Henan University of Traditional Chinese Medicine class: OTHER name: The First Affiliated Hospital of Henan University of Traditional Chinese Medicine name: The First Affiliated Hospital of Anhui University of Traditional Chinese Medicine briefSummary: To evaluate the clinical efficacy and health economic advantages of Lung Replenishing and Kidney Enhancing Formula for the treatment of patients with frequent acute exacerbations in the stabilized phase. conditions: Chronic Obstructive Pulmonary Disease studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: DOUBLE whoMasked: PARTICIPANT whoMasked: INVESTIGATOR count: 848 type: ESTIMATED name: Bufei Yishen Prescription Granule measure: The number of acute exacerbations measure: The number of AECOPD leading to hospitalization and death measure: Time of onset of the first AECOPD measure: Severity of AECOPD measure: Duration of AECOPD measure: Case fatality rate measure: Lung function measure: Score for clinical signs and symptoms measure: 6-minute walking distance (6MWD) measure: The Chronic Obstructive Pulmonary Patient Self-Assessment Test (CAT) measure: The MOS item short fromhealth survey（SF-36） sex: ALL minimumAge: 40 Years maximumAge: 80 Years stdAges: ADULT stdAges: OLDER_ADULT hasResults: False
<\|newrecord\|> nctId: NCT06326645 id: IRB23-891 briefTitle: Open-Label Pilot Study With Crofelemer in Patients With Short Bowel Syndrome overallStatus: NOT_YET_RECRUITING date: 2024-12-01 date: 2025-12-01 date: 2025-12-01 date: 2024-03-22 date: 2024-03-22 name: Lindsey Russell, MD class: OTHER name: Napo Pharmaceuticals, Inc. briefSummary: The objectives of this study are to evaluate the efficacy and safety of crofelemer treatment in adults affected by Short Bowel Syndrome (SBS) with an ileostomy on parenteral support (PS) in reducing output or PS needs. Crofelemer will be provided as a powder three times daily for 12 weeks and a 4 week follow up. . conditions: Short Bowel Syndrome studyType: INTERVENTIONAL phases: EARLY_PHASE1 allocation: NA interventionModel: SINGLE_GROUP interventionModelDescription: Small exploratory study primaryPurpose: TREATMENT masking: NONE count: 6 type: ESTIMATED name: Crofelemer Oral Product measure: Ostomy output reduction measure: Change in average weekly Parenteral Support (PS) volume measure: Change in SBS-QoL (Short bowel syndrome quality of life) measure: Change in GSRS (Gastrointestinal Symptom Rating Scale) measure: Change in intestinal absorption of fluids and macronutrients with consequent reduction of macronutrient requirements in patients with SBS measure: Change in weekly need for parenteral electrolytes sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Cleveland Clinic Main Campus city: Cleveland state: Ohio zip: 44106 country: United States name: Lindsey A Russell, MD role: CONTACT lat: 41.4995 lon: -81.69541 hasResults: False
<\|newrecord\|> nctId: NCT06326632 id: RHPT/0022/023 briefTitle: Comparative Effectiveness Study of Constant-Load Versus Graded Aerobic Exercise in Obese Children With Bronchial Asthma overallStatus: COMPLETED date: 2022-10-30 date: 2023-12-07 date: 2023-12-07 date: 2024-03-22 date: 2024-03-22 name: Cairo University class: OTHER briefSummary: This study aimed to compare the effect of constant-load aerobic exercise (CL-AE) and graded aerobic exercise (G-AE) on cardiopulmonary fitness, and functional capacity in a cohort of obese children with bronchial asthma (BA).
A total of 78 children with BA were randomly assigned to the CL-AE group (n = 26, who underwent moderate-intensity aerobic training with the training load maintained at the same level throughout the entire program, besides the respiratory re-training program), the G-AE group (n = 26, received an intensity- and duration-graded aerobic training in addition to the respiratory re-training program), or the control group (n = 29, who only engaged in a respiratory re-training program). Interventions were administered three times/week for 12 successive weeks.
The cardiopulmonary fitness and functional capacity were evaluated in the three groups before and after the completion of the assigned interventions. conditions: Bronchial Asthma studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL interventionModelDescription: A prospective, three-arm, randomized controlled trial primaryPurpose: TREATMENT masking: SINGLE maskingDescription: A single-blind protocol was adopted. The researcher who collected the data was blind to the allocation of treatment whoMasked: OUTCOMES_ASSESSOR count: 78 type: ACTUAL name: Constant-load Aerobic Exercise name: Graded Aerobic exercise name: Respiratory Re-training measure: Peak oxygen uptake measure: Six-minute walk test measure: Dyspnea measure: Fatigue sex: ALL minimumAge: 8 Years maximumAge: 18 Years stdAges: CHILD stdAges: ADULT facility: Ragab K. Elnaggar city: Al Kharj state: Riyadh country: Saudi Arabia lat: 24.15541 lon: 47.33457 hasResults: False
<\|newrecord\|> nctId: NCT06326619 id: SurvSysT briefTitle: Survival Benefit of Primary Tumour Resection Compared to Systemic Therapy Alone in Stage IV Colorectal Cancer Patients acronym: SurvSysT overallStatus: COMPLETED date: 2012-01-01 date: 2020-12-31 date: 2020-12-31 date: 2024-03-22 date: 2024-03-22 name: Medizinische Hochschule Brandenburg Theodor Fontane class: OTHER name: Clinical-Epidemiological Cancer Registry Brandenburg-Berlin briefSummary: About 20-25 percent of all colorectal cancer patients are diagnosed with International Union Against Cancer (UICC) stage IV disease. The benefit of primary tumor resection in the palliative context is therefore of high concern. However, empirical evidence from randomized and observational studies is inconsistent.
The objective of the present study is to compare the survival of palliative stage IV colorectal cancer patients selected for primary tumor resection and systemic treatment (PTR+SYST) to patients with systemic treatment only (SYST). conditions: Colorectal Cancer conditions: Neoadjuvant Systemic Therapy studyType: OBSERVATIONAL observationalModel: CASE_CONTROL timePerspective: RETROSPECTIVE count: 480 type: ACTUAL name: Primary tumor resection name: Systemic Therapy measure: Survival sex: ALL stdAges: CHILD stdAges: ADULT stdAges: OLDER_ADULT hasResults: False
<\|newrecord\|> nctId: NCT06326606 id: 23-MLS101-101 briefTitle: A Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of MLS101 in Healthy Participants overallStatus: RECRUITING date: 2024-03 date: 2024-09 date: 2024-10 date: 2024-03-22 date: 2024-03-22 name: MycoMedica Life Sciences PBC class: INDUSTRY briefSummary: MLS101 is being developed as a low dose psilocybin, that can be administered to treat various neurological and psychiatric conditions.
The purpose of this clinical trial is to assess how safe and tolerated MLS101 is; to see how MLS101 is distributed and cleared by the body (pharmacokinetics); and to assess the psychedelic effects of MLS101 in healthy adult participants. conditions: Healthy Volunteers studyType: INTERVENTIONAL phases: PHASE1 allocation: RANDOMIZED interventionModel: PARALLEL interventionModelDescription: This is a randomized, double-blind, placebo-controlled, single ascending and multiple dose study to assess the safety, tolerability, and pharmacokinetics of MLS101 in healthy participants. The study consists of 2 parts:
Part 1 - Single Ascending Dose (SAD): 24 participants will be enrolled in 3 sequential dose cohorts and will be randomized to receive a single dose of MLS101 or placebo. Additional cohorts (comprising 8 participants in each cohort) may be enrolled to explore more doses.
Part 2: Multiple Dose study, doses and administration regimens are pending the results from Part 1 primaryPurpose: TREATMENT masking: QUADRUPLE whoMasked: PARTICIPANT whoMasked: CARE_PROVIDER whoMasked: INVESTIGATOR whoMasked: OUTCOMES_ASSESSOR count: 80 type: ESTIMATED name: Psilocybin name: Placebo measure: Incidence, severity, and seriousness of treatment-emergent adverse events (TEAEs) measure: Occurrence of clinically significant changes in physical examination, vital signs, ECGs, clinical laboratory tests, the Columbia-Suicide Severity Rating Scale (C-SSRS). measure: Pharmacokinetics of MLS101: maximum observed serum concentration (Cmax) measure: Pharmacokinetics of MLS10: area under the plasma concentration-time curve (AUC) measure: Pharmacokinetics of MLS101: time corresponding to the occurrence of Cmax (tmax) measure: Pharmacokinetics of MLS101: apparent terminal elimination half-life (t½) measure: Pharmacokinetics of MLS101: apparent total systemic clearance after oral administration (CL/F) measure: Pharmacokinetics of MLS101: apparent volume of distribution during the terminal phase (Vz/F) measure: Sensorial effects of MLS101 measure: Cognitive function sex: ALL minimumAge: 18 Years maximumAge: 65 Years stdAges: ADULT stdAges: OLDER_ADULT facility: CMAX Clinical Research Pty Ltd status: RECRUITING city: Adelaide state: South Australia zip: 5000 country: Australia name: Eloise Spooner role: CONTACT phone: +61 8 7088 7900 email: eloise.spooner@cmax.com.au name: Sepehr Shakib role: PRINCIPAL_INVESTIGATOR lat: -34.92866 lon: 138.59863 hasResults: False
<\|newrecord\|> nctId: NCT06326593 id: P.T.REC/012/005049 briefTitle: Wii Aerobic Training in Inhalation-injury Children Post-thermal Burn overallStatus: RECRUITING date: 2024-02-22 date: 2024-05-25 date: 2024-06-01 date: 2024-03-22 date: 2024-03-22 name: MTI University class: OTHER briefSummary: Inhalation injury is a composite of multiple insults including: supra glottic thermal injury, subglottic airway and alveolar poisoning, and systemic poisoning from absorbed small molecule toxins. These contaminant insults independently affect each of the pulmonary functions as well as having a direct effect on systemic physiology. Further, anatomic characteristics can predispose patients to inhalation injury. For example, an infant will develop airway obstructions much faster than an adult due to reduced airway diameter. Understanding the contributions of each of these pathologies to the patient's disease is critical to managing inhalation injury.
Wii fit aerobic training gives similar results with traditional rehabilitation practices, it causes less energy costs. This suggests that it can be a suitable rehabilitation tool for adult and elderly people with low energy levels. A review showed that video games are safe and feasible in the children with lung complications. Children' balance, aerobic and cognitive functions, quality of life improved and depressive mood decreased. WII aerobic games also make children to communicate better with other family members. conditions: Inhalation Injury studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: DOUBLE whoMasked: INVESTIGATOR whoMasked: OUTCOMES_ASSESSOR count: 80 type: ESTIMATED name: Wii aerobic training name: conservative chest care measure: Forced vital capacity (FVC) measure: forced expiratory volume in 1 second (FEV1) measure: peak expiratory flow (PEF) measure: Upper and lower chest expansion (2nd intercostal space, xiphoid)]) measure: Functional capacity 6-Minute Walk Test (6-MWT) measure: Timed Up and Go test (TUG) sex: ALL minimumAge: 12 Years maximumAge: 17 Years stdAges: CHILD facility: Heba Elfeky status: RECRUITING city: Cairo zip: 6347113 country: Egypt name: ahmed m el fahl, phd role: CONTACT phone: 00201097782441 email: nn_ee_mm_oo@yahoo.com lat: 30.06263 lon: 31.24967 facility: Ahmed Mohamed Ahmed Abdelhady status: RECRUITING city: Cairo country: Egypt name: Ahmed El Fahl, ph.d role: CONTACT lat: 30.06263 lon: 31.24967 hasResults: False
<\|newrecord\|> nctId: NCT06326580 id: MS.22.09.2144 briefTitle: Clinical Prediction Model of Obstructive Sleep Apnea at Mansoura University Hospitals overallStatus: COMPLETED date: 2022-10-20 date: 2023-10-20 date: 2024-02-20 date: 2024-03-22 date: 2024-03-22 name: Mansoura University class: OTHER briefSummary: Obstructive sleep apnea syndrome (OSAS)is a sleep breathing disorder manifested by complete apnea or partial hypopnea obstruction of the upper airway, which often remains undiagnosed and untreated (Kuczynski, W., 2019). These episodes, which should be more than 5 per hour and last at least 10 s, can lead to a sleep fragmentation and hypoxia (Huon, L.-K.A., 2017). OSAS predominantly affects 26% of individuals between 30 and 70 years in the U.S (apnea hypopnea index ≥5 events per hour) (Schwartz, M., 2018).
Obstructive sleep apnea it is increasingly recognized as an independent risk factor for cardiac, neurologic, and perioperative morbidities. Yet this disorder remains undiagnosed in a substantial portion of our population. It is imperative for all physicians to remain vigilant in identifying patients with signs and symptoms consistent with OSA (Park, J. G., 2011).
The test of hypothesis is to design a clinical prediction model of obstructive sleep apnea from collected data of the patients having symptoms of obstructive sleep apnea and the results of their sleep study conditions: Osa Syndrome studyType: OBSERVATIONAL observationalModel: OTHER timePerspective: OTHER count: 1129 type: ACTUAL measure: The recorded data of all patients which include all their symptoms and comorbidities as well as their use of any regular medications will be collected. sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Mansoura University city: Mansoura state: Dakhlia zip: 050 country: Egypt lat: 31.03637 lon: 31.38069 hasResults: False
<\|newrecord\|> nctId: NCT06326567 id: 84032 briefTitle: Comprehensive Connected Cancer Care (C4): Intervention Evaluation overallStatus: RECRUITING date: 2024-02-01 date: 2025-06 date: 2025-06 date: 2024-03-22 date: 2024-03-22 name: Timothy Mullett class: OTHER name: Merck Sharp & Dohme LLC briefSummary: The C4 program aims to provide a multi-level intervention program (Patient Level, Healthcare Team and Healthcare System Level) that improves the coordination of care with supportive/ancillary care providers and community services through the use of patient navigation and a digital needs assessment and a closed-loop referral system and improves patient-centered communication and engagement in care through skills training for the healthcare team and provision of culturally appropriate patient educational tools and resources. The program components incorporate three areas that are critical to improving patient-centered care: coordination of care, patient-centered communication and engagement, and psychosocial care and other supportive services. conditions: Cancer conditions: Health Care Utilization studyType: INTERVENTIONAL phases: NA allocation: NON_RANDOMIZED interventionModel: PARALLEL primaryPurpose: HEALTH_SERVICES_RESEARCH masking: NONE count: 300 type: ESTIMATED name: C4 Program measure: Change in Health Related Quality of Life (FACT-G7) measure: Overall Survival sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: University of Kentucky status: RECRUITING city: Lexington state: Kentucky zip: 40506 country: United States name: Yvonne Taul, RN role: CONTACT phone: 859-323-2354 email: Yvonne.Taul@uky.edu lat: 37.98869 lon: -84.47772 hasResults: False
<\|newrecord\|> nctId: NCT06326554 id: 22-5933 briefTitle: Single Arm Pilot Trial of Virtual and In-person STEP2 acronym: STEP2 overallStatus: NOT_YET_RECRUITING date: 2024-04-01 date: 2025-01-01 date: 2025-01-01 date: 2024-03-22 date: 2024-03-22 name: University Health Network, Toronto class: OTHER briefSummary: The goal of this clinical trial is to assess the feasibility of offering oncology patients a referral to the outpatient palliative care clinic based on virtual symptom screening before oncology clinic appointments, and to qualitatively explore factors patients consider when deciding to accept or defer a visit to this clinic.
Participants will be asked to complete questionnaires assessing quality of life, symptom burden, depression, anxiety, and satisfaction with care at baseline, 2, 4, and 6 months. conditions: Oncology studyType: INTERVENTIONAL phases: NA allocation: NA interventionModel: SINGLE_GROUP interventionModelDescription: Single arm intervention primaryPurpose: SUPPORTIVE_CARE masking: NONE count: 20 type: ESTIMATED name: Virtual and in-person Symptom screening with Targeted Early Palliative care (STEP2) measure: FACIT-PAL 14 measure: FACIT-PAL 14 measure: ESAS-r-CS measure: PHQ-9 measure: FAMCARE-P16 measure: Generalized Anxiety Disorder-7 measure: Patient Global Impression of Change sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT hasResults: False
<\|newrecord\|> nctId: NCT06326541 id: okutan briefTitle: The Effect of Listening to the Holy Quran on Vital Signs in Coma Patients overallStatus: COMPLETED date: 2023-01-05 date: 2023-12-10 date: 2023-12-30 date: 2024-03-22 date: 2024-03-22 name: Bitlis Eren University class: OTHER briefSummary: The aim of this study is to examine the effect of the Holy Quran listened to to coma patients on their vital signs.
Does listening to the Holy Quran have a positive effect on the life values of coma patients? conditions: Sequelae of; Complications Surgical and Medical Care studyType: INTERVENTIONAL phases: NA allocation: NA interventionModel: SINGLE_GROUP interventionModelDescription: single group pretest-posttest primaryPurpose: SUPPORTIVE_CARE masking: NONE count: 72 type: ACTUAL name: music therapy measure: systolic blood pressure- (mmHg) measure: diastolic blood pressure- (mmHg) measure: pulse (number of beats/min) measure: body temperature (degrees Celsius) measure: saturation (%-oxygen saturation) sex: ALL stdAges: CHILD stdAges: ADULT stdAges: OLDER_ADULT facility: Bitlis Eren University city: Bitlis zip: 13100 country: Turkey lat: 38.40115 lon: 42.10784 hasResults: False
<\|newrecord\|> nctId: NCT06326528 id: SGLT2 inhibitors briefTitle: SGLT2 Inhibitors and Perioperative Period overallStatus: NOT_YET_RECRUITING date: 2024-05-01 date: 2025-04-01 date: 2025-10-01 date: 2024-03-22 date: 2024-03-22 name: Assiut University class: OTHER briefSummary: The expanded use of SGLT2 inhibitors motivates us to assess the role of SGLT2 inhibitors in perioperative period on patients who will undergo cardiac surgery in Assiut University. conditions: Perioperative Complication studyType: OBSERVATIONAL observationalModel: CASE_CONTROL timePerspective: PROSPECTIVE count: 100 type: ESTIMATED name: SGLT2 inhibitor measure: Difference of cardiac function by speckle tracing between patients who will receive SGLT2 and patients who not. sex: ALL stdAges: CHILD stdAges: ADULT stdAges: OLDER_ADULT hasResults: False
<\|newrecord\|> nctId: NCT06326515 id: Government College University briefTitle: Cognitive Behavior Therapy for Depression, Stigmatization, Criminogenic Cognition, and Quality of Life Among Patients With Opioid Use Disorder (OUD): A Randomized Control Trial. acronym: CBT with OUD overallStatus: ACTIVE_NOT_RECRUITING date: 2024-01-01 date: 2024-07-20 date: 2024-09-10 date: 2024-03-22 date: 2024-03-22 name: Government College University Faisalabad class: OTHER briefSummary: to investigate the impact of cognitive behavior therapy for psychiatric problems among patients with opioid use disorder with relapse condition.
In this randomize control trail (RCT), N=120 patients with relapse condition would be taken. After enrolment patients' eligibility assessment would be completed and then n=60 patients would be allocated to experimental (n=30) and waitlist control (n=30) through random assignment. Patient's age range would be between 20 to 30 years. conditions: Psychoeducation studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL interventionModelDescription: Randomized control trial design would be used in this study. It would be two arm study and there would be two groups an experimental and wait-list control group. Experimental group will receive intervention and another group would be placed in waitlist. In this research, parallel group design would be used. We will give treatment to all participants in a parallel way. Allocation ratio and framework would be equivalence i.e., treatment group and control group would be equal number of participants primaryPurpose: TREATMENT masking: NONE count: 120 type: ESTIMATED name: psychoeducation name: Stigma Reduction and Relapse Management measure: The Alcohol, Smoking and Substance Involvement Screening Test (ASSIST; Henry-Edwards et al., 2003; Hussain et al., 2022). measure: Criminogenic Cognition Scale (CCS;Tangney, at el, 2012; Jamil & Fatima, 2018): measure: Patient Health Questionnaire (PHQ-9; Robert et al. 1999; Ahmad et al, 2018). measure: Relapse Risk Scale (RRS; Marlatt & Gordon, 1985; Hussain et al., 2016): measure: Perceived Stigma of Addiction Scale measure: Brief Cope Inventory (BCI) measure: World Health Organization Quality-of-Life Scale sex: ALL minimumAge: 20 Years maximumAge: 30 Years stdAges: ADULT facility: Dr Khalid Mahmood city: Faisalābad state: Punjab country: Pakistan lat: 31.41554 lon: 73.08969 hasResults: False
<\|newrecord\|> nctId: NCT06326502 id: 22ETN101-2IND001 briefTitle: A Safety and Efficacy Study of Multiple Tyrosine Kinase Inhibitor Drug (ETN101) in Advanced Hepatocellular Carcinoma overallStatus: RECRUITING date: 2024-02-07 date: 2027-03-07 date: 2027-06-07 date: 2024-03-22 date: 2024-03-27 name: Etnova Therapeutics Corp. class: INDUSTRY briefSummary: ETN101 is a multiple tyrosine kinase inhibitor (mTKI) targeting fms-like tyrosine kinase 3 (FLT3), receptor tyrosine kinase (KIT), vascular endothelial growth factor receptor 2 (VEGFR2), and platelet-derived growth factor receptor beta. Both in vitro and in vivo studies showed that ETN101 treatment/administration inhibited cancer cell survival and proliferation. In animal models, ETN101 had antitumor activity when administered to animals that did not respond to conventional targeted anticancer agents. conditions: Hepatocellular Carcinoma conditions: Advanced Hepatocellular Carcinoma conditions: Liver Cancer studyType: INTERVENTIONAL phases: PHASE1 allocation: NA interventionModel: SINGLE_GROUP primaryPurpose: TREATMENT masking: NONE count: 50 type: ESTIMATED name: ETN101 measure: Dose-limiting Toxicity (DLT) sex: ALL minimumAge: 19 Years maximumAge: 65 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Seoul National University Hospital status: RECRUITING city: Seoul zip: 03080 country: Korea, Republic of lat: 37.566 lon: 126.9784 facility: Severance Hospital status: RECRUITING city: Seoul zip: 03722 country: Korea, Republic of lat: 37.566 lon: 126.9784 hasResults: False
<\|newrecord\|> nctId: NCT06326489 id: 105122023-1/05.12.2023 id: ERP-2023-13520 type: OTHER_GRANT domain: Medtronic briefTitle: Evaluating the Efficacy and Quality of Life Impact of Transitioning to Advanced Hybrid Closed-Loop Insulin Pump Therapy in Romanian Children With Type 1 Diabetes Mellitus overallStatus: RECRUITING date: 2024-03-11 date: 2024-08-30 date: 2024-11-30 date: 2024-03-22 date: 2024-03-26 name: ELIAS Emergency University Hospital class: OTHER briefSummary: The proposed study aims to demonstrate the potential benefits of transitioning T1DM children from predictive low glucose suspend insulin pump therapy to advanced hybrid closed-loop insulin pump therapy in Romania. Primary Outcome: Variations in HbA1c between baseline visit (V1 - 740G) and assessment visit following three months of 780G insulin pump therapy (V2 - 780G).
Secondary Outcomes: changes in insulin requirements, time in range (TIR) levels, time below range (TBR), coefficient of variation (CV), frequency of severe hypoglycemic and hyperglycemic events requiring hospitalization, and PedsQL SF15 questionnaire scores. conditions: Diabetes Mellitus, Type 1 studyType: INTERVENTIONAL phases: PHASE4 allocation: NA interventionModel: SINGLE_GROUP interventionModelDescription: The study will include 30 children with type 1 diabetes aged seven years and older who use a predictive low glucose suspend insulin pump (740G). Patients eligible for the study will receive a 780G insulin pump for three months. primaryPurpose: TREATMENT masking: NONE count: 30 type: ESTIMATED name: Switching to the Medtronic 780G insulin pump measure: Variations in HbA1c measure: changes in insulin requirements measure: changes in time in range (TIR) levels measure: changes in time below range (TBR) measure: changes in coefficient of variation (CV) measure: changes in frequency of severe hypoglycemic and hyperglycemic events requiring hospitalization measure: changes in The Pediatric Quality of Life Inventory™ 4.0 Short Form 15 Generic Core Scales questionnaire scores sex: ALL minimumAge: 7 Years maximumAge: 17 Years stdAges: CHILD facility: Elias University Emergency Hospital status: RECRUITING city: Bucharest state: Sector 1 zip: 011461 country: Romania name: Sorin Ioacara, MD, PhD role: CONTACT phone: 0040213161600 email: drsorin@yahoo.com lat: 44.43225 lon: 26.10626 hasResults: False
<\|newrecord\|> nctId: NCT06326476 id: IRB-300012699 id: 000544067 type: OTHER domain: University of Alabama at Birmingham briefTitle: A Study to Demonstrate the Safety and Efficacy of Siplizumab in the Treatment of Hidradenitis Suppurativa overallStatus: NOT_YET_RECRUITING date: 2025-01 date: 2025-09-30 date: 2025-12-31 date: 2024-03-22 date: 2024-03-22 name: University of Alabama at Birmingham class: OTHER name: ITB-Med LLC briefSummary: This study is to investigate the efficacy of siplizumab in the treatment of Hidradenitis Suppurativa. conditions: Hidradenitis Suppurativa studyType: INTERVENTIONAL phases: EARLY_PHASE1 allocation: NA interventionModel: SINGLE_GROUP primaryPurpose: TREATMENT masking: NONE count: 12 type: ESTIMATED name: Siplizumab measure: Change in inflammatory lesion counts measure: Change in Hidradenitis Suppurativa Clinical Response (HiSCR) measure: Change in Hurley Stage measure: Change in Dermatology Life Quality Index (DLQI) scores measure: Improvement in Visual Analogue Scale (VAS) pain scores measure: Change in Lesion Counts sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT hasResults: False
<\|newrecord\|> nctId: NCT06326463 id: DIRECT70 id: NCI-2024-03240 type: OTHER domain: NCI Clinical Trial Registration Program briefTitle: CAR T-cell Therapy Directed to CD70 for Pediatric Patients With Hematological Malignancies overallStatus: NOT_YET_RECRUITING date: 2024-05 date: 2030-07-01 date: 2031-07-01 date: 2024-03-22 date: 2024-04-12 name: St. Jude Children's Research Hospital class: OTHER briefSummary: The study participant has one of the following blood cancers: acute myelogenous leukemia (AML)/myelodysplastic syndrome (MDS), acute lymphoblastic leukemia (B-ALL, T-ALL) or Lymphoma. Your cancer has been difficult to treat (refractory) or has come back after treatment (relapse).
Primary Objective
To determine the safety and maximum tolerated dose of intravenous infusions of escalating doses of CD70-CAR T cells in patients (≤21 years) with recurrent/refractory CD70+ hematological malignancies after lymphodepleting chemotherapy.
Secondary Objectives
To evaluate the antileukemic activity of CD70-CAR T cells. We will determine the anti- leukemic activity of the CD70-CAR T cells in the bone marrow and in the treatment of extramedullary disease. conditions: Hematologic Malignancy conditions: ALL, Childhood conditions: AML, Childhood conditions: Lymphoma conditions: MDS studyType: INTERVENTIONAL phases: PHASE1 allocation: NA interventionModel: SINGLE_GROUP primaryPurpose: TREATMENT masking: NONE count: 24 type: ESTIMATED name: Fludarabine name: Cyclophosphamide name: CD70-CAR T cell infusion (Autologous) name: Mesna measure: Maximum tolerated dose of CD70-CAR T cells sex: ALL maximumAge: 21 Years stdAges: CHILD stdAges: ADULT facility: St. Jude Children's Research Hospital city: Memphis state: Tennessee zip: 38105 country: United States name: Swati Naik, MD role: CONTACT phone: 866-278-5833 email: referralinfo@stjude.org lat: 35.14953 lon: -90.04898 hasResults: False
<\|newrecord\|> nctId: NCT06326450 id: 74626 briefTitle: Traditional In-Person Vs. Remote AR Clinical Simulation acronym: AR Brazil overallStatus: NOT_YET_RECRUITING date: 2024-06-01 date: 2025-05-31 date: 2025-05-31 date: 2024-03-22 date: 2024-04-12 name: Stanford University class: OTHER briefSummary: This is a non-inferiority, international, controlled trial that aims to evaluate the progression of physicians and residents through an Advanced Cardiac Life Support (ACLS) clinical simulated scenario. The study's primary objective is to compare the performance outcomes between two groups: participants in the traditional in-person simulation and those immersed in the Augmented Reality (AR) scenario conditions: Educational Problems studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: SUPPORTIVE_CARE masking: NONE count: 20 type: ESTIMATED name: Augmented Reality Headset measure: Progression through the ACLS clinical simulation demonstrated by NTS and TS measure: Demonstration of NTS during ACLS scenario measure: Evaluation of the AR system's usability measure: Exploration of perceptions, attitudes, and opinions of the AR simulation participants sex: ALL minimumAge: 18 Years maximumAge: 99 Years stdAges: ADULT stdAges: OLDER_ADULT hasResults: False
<\|newrecord\|> nctId: NCT06326437 id: 1223 briefTitle: Dyadic Intervention for Psychological Distress of Patients With Colorectal Cancer and Their Spouses overallStatus: NOT_YET_RECRUITING date: 2024-04-01 date: 2024-06-01 date: 2024-07-01 date: 2024-03-22 date: 2024-03-22 name: Sun Yat-sen University class: OTHER briefSummary: The overall aim of the study is to evaluate the preliminary effect and feasibility of a dyadic intervention on mutuality, psychological strengths (i.e., illness cognition and dyadic coping), psychological distress, and QoL outcomes of patients with colorectal cancer and spouses. The colorectal cancer couples will be randomly allocated to the intervention group to receive a 6-week dyadic intervention, or to the control group to receive the usual care provided by the clinical team in the hospital. conditions: Colorectal Cancer studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: SUPPORTIVE_CARE masking: DOUBLE whoMasked: INVESTIGATOR whoMasked: OUTCOMES_ASSESSOR count: 30 type: ESTIMATED name: 6-week dyadic intervention measure: the Kessler psychological distress scale-10 measure: The Illness Cognition Questionnaire measure: Dyadic Coping Inventory measure: European Organization for Research and Treatment of Cancer, Quality of Life Questionnaire-Core 30 measure: Locke-Wallace Marital Adjustment Scale sex: ALL minimumAge: 20 Years maximumAge: 59 Years stdAges: ADULT facility: The Sixth Affiliated Hospital of Sun Yat-sen University city: Guangzhou state: Guangdong zip: 510000 country: China name: Qian Sun role: CONTACT phone: +86 15616167998 email: sunq68@mail2.sysu.edu.cn lat: 23.11667 lon: 113.25 hasResults: False
<\|newrecord\|> nctId: NCT06326424 id: 2023H0085 briefTitle: Delirium Identification in Older Patients With Alzheimer's and Other Related Dementias In the Emergency Department acronym: DELIRIUM overallStatus: NOT_YET_RECRUITING date: 2024-04-10 date: 2025-03-01 date: 2025-03-01 date: 2024-03-22 date: 2024-03-22 name: Ohio State University class: OTHER briefSummary: Delirium is highly prevalent and very bad for patients with dementia. Delirium is a dangerous medical condition that occurs in 6-38% of older Emergency Department patients and 70% of ICU patients. A person who develops delirium in the ED or hospital has a 12 times higher odds of being newly diagnosed with dementia in the next year compared to a similar patient who does not become delirious. Delirium is especially dangerous for persons living with Alzheimer Disease and Related Dementias (AD/ADRD). Persons living with ADRD have an almost 50% chance of developing delirium in the hospital.
Clinicians are bad at recognizing delirium. A recent systematic review led by the Geriatric Emergency Care Applied Research network (NIH funded) found that current delirium screening tools are at most 64% sensitive, meaning that physicians can identify some phenotypes of delirium well, but cannot easily rule out delirium in acutely ill older patients.
The investigators propose integrating wrist biosensors into the emergency management of older adults with dementia. The investigators will monitor heart rate variability, movement, and electrodermal activity (electrical activity of at the level of the skin) to determine if an array of biosensors more sensitive to delirium than current verbal screening tools. conditions: Delirium conditions: Dementia conditions: Hospital Acquired Condition studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: PROSPECTIVE count: 60 type: ESTIMATED name: Empatica EmbracePlus measure: Proportion of participants who develop delirium measure: Intervention Acceptability measure: Biosensor data usability measure: Correlation of biosensor array data with clinical delirium sex: ALL minimumAge: 65 Years stdAges: OLDER_ADULT facility: The Ohio State University Wexner Medical Center city: Columbus state: Ohio zip: 43210 country: United States lat: 39.96118 lon: -82.99879 hasResults: False
<\|newrecord\|> nctId: NCT06326411 id: NST-628-001 briefTitle: A Study to Investigate the Safety and Efficacy of NST-628 Oral Tablets in Subjects With Solid Tumors acronym: NST-628 overallStatus: RECRUITING date: 2024-03 date: 2028-11 date: 2029-11 date: 2024-03-22 date: 2024-03-27 name: Nested Therapeutics, Inc class: INDUSTRY briefSummary: This is a two-part Phase 1, open label, multi-center, single arm, non-randomized, multiple dose, safety, pharmacokinetic (PK) and preliminary efficacy study of single agent NST-628 in adult patients with MAPK pathway mutated/dependent advanced solid tumors who have exhausted standard treatment options. conditions: Oncology conditions: MEK Mutation conditions: RAF Gene Mutation conditions: Ras (KRAS or NRAS) Gene Mutation conditions: Melanoma conditions: NSCLC conditions: Glioma conditions: Solid Tumor, Adult conditions: MAPK Pathway Gene Mutation studyType: INTERVENTIONAL phases: PHASE1 allocation: NA interventionModel: SEQUENTIAL primaryPurpose: TREATMENT masking: NONE count: 230 type: ESTIMATED name: NST-628 measure: Part A and B: Evaluate the safety of NST-628 in patients with advanced solid tumors measure: Part A: Determine the recommended dose for expansion of NST-628 measure: Part B: Evaluate objective tumor response rate measure: Part A: Evaluate objective tumor response rate measure: Part A and B: Evaluate progression free survival (PFS) measure: Part A and B: Evaluate overall survival (OS) measure: Part A and B: Characterize the pharmacokinetics of NST-628 sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Scientia Clinical Research, Ltd status: RECRUITING city: Rand state: New South Wales zip: 2031 country: Australia name: Shiena Lemin role: CONTACT phone: +61 2 9382 5800 email: ethics@scientiaclinicalresearch.com.au name: Charlotte Lemech, MD role: PRINCIPAL_INVESTIGATOR lat: -35.60079 lon: 146.62354 facility: Southern Oncology Research Unit status: NOT_YET_RECRUITING city: Adelaide zip: 5042 country: Australia name: Meggan O'Riley role: CONTACT email: Meggan.ORiley@socru.org.au name: Ganessan Kichenadasse, MD role: PRINCIPAL_INVESTIGATOR lat: -34.92866 lon: 138.59863 hasResults: False
<\|newrecord\|> nctId: NCT06326398 id: 3D moulage briefTitle: The Effect of Using 3D Printers and Moulage on Improving Stoma Care overallStatus: NOT_YET_RECRUITING date: 2024-04-01 date: 2024-05-01 date: 2024-10-01 date: 2024-03-22 date: 2024-03-25 name: Namik Kemal University class: OTHER name: TÜBİTAK briefSummary: When studies in the literature are examined, there are studies in which various methods are applied to students' stoma care knowledge and skills. Additionally, it is seen that there are studies using moulage or 3D printers as simulation applications in nursing education. However, there is no study on high-reality simulation application using 3D printer and moulage technique together.nIn this research, the effect of the stoma created with a 3D printer in a high-reality simulation on the stoma care knowledge and skills, satisfaction and self-confidence of nursing students will be examined by using the moulage technique. In addition, this application will be compared with nursing students' stoma care practices in the stoma model, which is classified as low-reality simulation. We think that our project will be unique in this field, as it uses current technological methods together in this planned research and is different from similar studies. conditions: Stoma Colostomy studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: OTHER masking: SINGLE whoMasked: OUTCOMES_ASSESSOR count: 76 type: ESTIMATED name: Stoma Care measure: Knowledge Level Evaluation Form Regarding Stoma Care measure: Stoma Care Skill Grading Key measure: Student Satisfaction and Self-Confidence Scale in Learning sex: ALL minimumAge: 18 Years maximumAge: 22 Years stdAges: ADULT hasResults: False
<\|newrecord\|> nctId: NCT06326385 id: 53244021 briefTitle: Machine Learning Predictive Models for Sepsis Risk in ICU Patients With Intracerebral Hemorrhage overallStatus: NOT_YET_RECRUITING date: 2024-03-30 date: 2024-05-01 date: 2024-05-30 date: 2024-03-22 date: 2024-03-25 name: Xiangya Hospital of Central South University class: OTHER briefSummary: Patients with intracerebral hemorrhage (ICH) in the intensive care unit (ICU) are at heightened risk of developing sepsis, significantly increasing mortality and healthcare burden. Currently, there is a lack of effective tools for the early prediction of sepsis in ICH patients within the ICU. This study aims to develop a reliable predictive model using machine learning techniques to assist clinicians in the early identification of patients at high risk and to facilitate timely intervention.
The Medical Information Mart for Intensive Care (MIMIC) IV database (version 2.2) is an international online repository for critical care expertise. This database contains patient-related information collected from the ICUs of Beth Israel Deaconess Medical Center between 2008 and 2019. It includes a vast dataset of 299,712 hospital admissions and 73,181 intensive care unit patients.
The eICU Collaborative Research Database (eICU-CRD) comprises data from over 200,000 ICU admissions for 139,367 unique patients across 208 US hospitals between 2014 and 2015, providing a valuable resource for critical care research.
This study aims to establish and validate multiple machine learning models to predict the onset of sepsis in ICU patients with ICH and to identify the model with the optimal predictive performance. conditions: Intracerebral Hemorrhage conditions: Sepsis studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: RETROSPECTIVE count: 1800 type: ESTIMATED name: no intervention measure: Occurrence of sepsis sex: ALL minimumAge: 18 Years maximumAge: 89 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Le Zhang city: Changsha state: Hunan zip: 410008 country: China name: Le Zhang role: CONTACT phone: 13973187150 email: zlzdzlzd@csu.edu.cn name: Ye Li role: CONTACT phone: 19967131289 email: 17670516318@163.com lat: 28.19874 lon: 112.97087 hasResults: False
<\|newrecord\|> nctId: NCT06326372 id: Delirium briefTitle: The Effect of Intraoperative Hyperoxemia on Postoperative Delirium in Geriatric Patients overallStatus: NOT_YET_RECRUITING date: 2024-03-20 date: 2024-06-20 date: 2024-07-01 date: 2024-03-22 date: 2024-03-28 name: Tepecik Training and Research Hospital class: OTHER briefSummary: Oxygen therapy is the most common treatment modality for patients with hypoxemia, but target values for normoxemia are not clearly defined. Therefore, iatrogenic hyperoxemia is a very common situation. Even though there are many side effects reported related to hyperoxemia and hyperoxemia is shown to be related to worse outcome than expected; clinicians still observe hyperoxemia frequently.
Oxygen reserve index (ORi™) (Masimo Corp., Irvine, USA) can guide clinicians in detection of hyperoxia. ORi is a parameter which can evaluate partial pressure of oxygen (PaO2) rating from 0 to 1. There are growing evidences in ORi that it might be helpful to reduce hyperoxia in general anesthesia. Continuous ORi monitoring can be used for detecting and preventing hyperoxia. The ability to perform FiO2 titration with ORi may be an appropriate monitoring management to prevent the harmful effects of hyperoxia.In this study, in patients who underwent major abdominal surgery; It was aimed to investigate the effectiveness of ORi-guided FiO2 titration in preventing hyperoxia. conditions: Hyperoxia conditions: Delirium in Old Age studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: PROSPECTIVE count: 60 type: ESTIMATED name: control name: ORi+SpO2 measure: Correlation of FiO2 and ORi value measure: Correlation of ORi and Delirium measure: Correlation of FiO2 and delirium sex: ALL minimumAge: 65 Years stdAges: OLDER_ADULT facility: Aykut Saritaş city: İ̇zmi̇r zip: 35640 country: Turkey lat: 38.41273 lon: 27.13838 hasResults: False
<\|newrecord\|> nctId: NCT06326359 id: Soh-Med-24-02-03MD briefTitle: Autologous Stromal Vascular Fraction in Treatment of Male Androgenic Alopecia overallStatus: NOT_YET_RECRUITING date: 2024-03 date: 2024-10 date: 2026-10 date: 2024-03-22 date: 2024-03-22 name: Sohag University class: OTHER briefSummary: Evaluation of Safety and efficacy of autologous stromal vascular fraction derived from denovo versus platelet rich plasma enhanced donner site in treatment of male androgenic alopecia conditions: Androgenic Alopecia studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: SINGLE whoMasked: OUTCOMES_ASSESSOR count: 40 type: ESTIMATED name: autologous stromal vascular fraction measure: hair density measure: hair shaft thickness sex: MALE minimumAge: 18 Years maximumAge: 55 Years stdAges: ADULT hasResults: False
<\|newrecord\|> nctId: NCT06326346 id: AMC2401 briefTitle: GIST Oral Paclitaxel(Liporaxel) overallStatus: NOT_YET_RECRUITING date: 2024-06-01 date: 2027-03-31 date: 2027-03-31 date: 2024-03-22 date: 2024-03-27 name: Asan Medical Center class: OTHER briefSummary: The purpose of this study is to evaluate safety and efficacy of Liporaxel for patients with GIST who failed on prior standard treatments, including imatinib, sunitinib, and regorafenib, and with low P-glycoprotein expression. conditions: Gastrointestinal Stromal Tumors studyType: INTERVENTIONAL phases: PHASE2 allocation: NA interventionModel: SINGLE_GROUP primaryPurpose: TREATMENT masking: NONE count: 28 type: ESTIMATED name: Liporaxel measure: 16 week disease control rate measure: Progression-free survival measure: Overall survival measure: Objective response rate measure: Adverse event assessed by NCI-CTCAE Version 5.0 sex: ALL minimumAge: 20 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Asan Medical Center, University of Ulsan College of Medicine city: Seoul state: Songpagu zip: 138-736 country: Korea, Republic of name: Min-Hee Ryu, MD, PhD role: CONTACT phone: 82-2-3010-5936 email: miniryu@amc.seoul.kr name: Hyung-Don Kim, MD, PhD role: CONTACT phone: 82-2-3010-0236 email: kimhdmd@amc.seoul.kr lat: 37.566 lon: 126.9784 hasResults: False
<\|newrecord\|> nctId: NCT06326333 id: E.Kurul-E2-24-6176 briefTitle: Combination of Parasternal and Serratus Anterior Plane Block in Coronary Artery Bypass Graft Surgery overallStatus: COMPLETED date: 2024-02-07 date: 2024-03-27 date: 2024-04-18 date: 2024-03-22 date: 2024-04-22 name: Ankara City Hospital Bilkent class: OTHER briefSummary: Postoperative analgesia is a critical risk factor for the development of pulmonary and cardiovascular complications in coronary artery bypass graft (CABG) surgery. If patients with high pain levels cannot breathe effectively, it may lead to atelectasis, cardiac ischemia, and arrhythmias. This prolongs the time it takes for patients to be discharged and increases the frequency of postoperative pulmonary complications and postoperative morbidity.
In addition to intravenous medications, various neuraxial and peripheral nerve blocks can be used in cardiac surgery. In recent years, neuraxial anesthesia has been avoided due to the use of intraoperative high-dose heparin. As an alternative, peripheral nerve blocks have recently gained popularity. Parasternal block (PSB) and serratus anterior plane block (SAPB) are very superficial and easy to reach. Recently, in the literature, the number of cases performed with these blocks under ultrasound guidance and the number of randomized controlled prospective studies have increased.
With this study, it was aimed to observe the analgesic effects on both the sternum and the drain site by applying PSB and SAPB applications simultaneously in the postoperative analgesia of CABG patients. conditions: Parasternal Block conditions: Serratus Anterior Plane Block conditions: Acute Pain conditions: Postoperative Analgesia conditions: Cardiac Surgery studyType: INTERVENTIONAL phases: NA allocation: NA interventionModel: SINGLE_GROUP primaryPurpose: TREATMENT masking: NONE count: 20 type: ACTUAL name: Combined parasternal block and serratus anterior plane block measure: Pain Scores measure: Pain Scores measure: Pain Scores measure: Pain Scores measure: Pain Scores measure: Remifentanyl Consumption sex: ALL minimumAge: 18 Years maximumAge: 80 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Ankara City Hospital city: Çankaya state: Ankara zip: 06290 country: Turkey lat: 39.9179 lon: 32.86268 hasResults: False
<\|newrecord\|> nctId: NCT06326320 id: E.Kurul-E2-24-6175 briefTitle: Combined SAPB in MICS overallStatus: RECRUITING date: 2024-02-07 date: 2024-05-07 date: 2024-05-17 date: 2024-03-22 date: 2024-03-25 name: Ankara City Hospital Bilkent class: OTHER briefSummary: Minimally invasive cardiac surgery (MICS) has begun to be performed frequently in recent years. Compared to sternotomy, MISC reduces the risk of mediastinitis, leaves a more aesthetic scar, facilitates postoperative rehabilitation, and shortens the hospital stay. MICS requires a thoracic incision in the right 4th or 5th intercostal space. This incision causes intense and long-lasting pain in the postoperative period. Pain is exacerbated by breathing movements, coughing, and respiratory physiotherapy.
Postoperative analgesia is a critical risk factor for the development of pulmonary and cardiovascular complications in any type of cardiothoracic surgery. If patients with high pain levels cannot breathe effectively, it may lead to atelectasis, cardiac ischemia, and arrhythmias. This prolongs the time it takes for patients to be discharged and increases the frequency of postoperative pulmonary complications and postoperative morbidity.

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