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Participants will be asked to complete surveys at three timepoints, prior to and following child life intervention and about 3.5 months later. During child life interventions, participants will receive resources and support to explain leukemia to their school aged, 3-16-year-old, child (patient or sibling).
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Researchers will compare Intervention and Control Groups to see if parental stress is lower in those who received the storybook in addition to the standard child life intervention versus the standard child life intervention alone. conditions: Leukemia studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: SUPPORTIVE_CARE masking: NONE count: 140 type: ESTIMATED name: "Who is Luke Eemia?" Storybook measure: Parental Stress, prior to and following child life intervention measure: Parent perception of the child's stress measure: Parent's Comfort Explaining Aspects of Leukemia Diagnosis measure: Parent comfort, readiness, and importance, explaining aspects of the diagnosis at the discharge (1-week post baseline). measure: Parental Impression of the Storybook Tool using a Likert scale (1-week post baseline). sex: ALL minimumAge: 3 Years stdAges: CHILD stdAges: ADULT stdAges: OLDER_ADULT facility: Children's Hospital Los Angeles status: RECRUITING city: Los Angeles state: California zip: 90027 country: United States name: Erin Shields, MA role: CONTACT lat: 34.05223 lon: -118.24368 hasResults: False
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<|newrecord|> nctId: NCT06360705 id: CVVD003 briefTitle: StrataMGT for the Treatment of Vulvar Lichen Sclerosus overallStatus: RECRUITING date: 2024-04 date: 2024-09 date: 2024-10 date: 2024-04-11 date: 2024-04-19 name: Center for Vulvovaginal Disorders class: OTHER name: Stratpharma AG briefSummary: This study is designed to evaluate the efficacy and safety of StrataMGT for the treatment of vulvar lichen sclerosus. conditions: Vulvar Lichen Sclerosus studyType: INTERVENTIONAL phases: NA allocation: NA interventionModel: SINGLE_GROUP primaryPurpose: TREATMENT masking: NONE count: 5 type: ESTIMATED name: StrataMGT measure: Histopathologic Inflammation sex: FEMALE minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Centers for Vulvovaginal Disorders status: RECRUITING city: New York state: New York zip: 10036 country: United States name: Andrew Goldstein, MD role: CONTACT phone: 4102790209 email: [email protected] name: Andrew Goldstein, MD role: PRINCIPAL_INVESTIGATOR name: Leia Mitchell, PA-C, MMSc, MSc role: SUB_INVESTIGATOR lat: 40.71427 lon: -74.00597 hasResults: False
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<|newrecord|> nctId: NCT06360692 id: Marta Lluesma Vidal Carden briefTitle: Impact of Nipple Micropigmentation in Mastectomized Women overallStatus: NOT_YET_RECRUITING date: 2024-06-01 date: 2024-10-30 date: 2025-12-31 date: 2024-04-11 date: 2024-04-11 name: Cardenal Herrera University class: OTHER briefSummary: This will be a multicenter prospective descriptive case series study following a cohort.
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The micropigmentation/tattoo procedure will be carried out following the protocol established in each center (see annex x). The present investigation only involves measuring the impact that this technique has on the patients by collecting data in digital format before and after the CAP micropigmentation/tattoo that motivated their visit to the clinical service.
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CAP micropigmentation/tattooing is usually performed between 6 and 12 months after the breast reconstructive surgery has been completed, sufficient time for healing to complete and the breast to stabilize, although it can be performed from 2 months after the intervention. Nurses are responsible for performing micropigmentation/tattooing of the areola and nipple in mastectomized women. conditions: Body Image conditions: Female Sexual Function conditions: Self Esteem conditions: Intimacy With Your Partner studyType: OBSERVATIONAL observationalModel: OTHER timePerspective: PROSPECTIVE count: 30 type: ESTIMATED measure: Body imagen measure: Self-esteem measure: Sexual Function measure: Intimacy with the partner sex: FEMALE minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT hasResults: False
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<|newrecord|> nctId: NCT06360679 id: CIP000004 briefTitle: Clinical Feasibility Study of the BariTon™ System in Obese or Overweight Patients. overallStatus: RECRUITING date: 2024-01-29 date: 2024-10-01 date: 2025-06-01 date: 2024-04-11 date: 2024-04-11 name: BariaTek Medical class: INDUSTRY briefSummary: Safety and efficacy evaluation of the BariTon™, BariaTek Medical gastric restriction and biliodigestive diversion device. conditions: Obesity studyType: INTERVENTIONAL phases: NA allocation: NA interventionModel: SINGLE_GROUP primaryPurpose: TREATMENT masking: NONE count: 10 type: ESTIMATED name: Endoscopic gastric restriction and biliodigestive diversion measure: Safety of the BariTon™ measure: Safety of the BariTon™ measure: Safety of the BariTon™ measure: Safety of the BariTon™ measure: Efficacy of the BariTon™ measure: Efficacy of the BariTon™ measure: Efficacy of the BariTon™ measure: Efficacy of the BariTon™ measure: Efficacy of the BariTon™ measure: Efficacy of the BariTon™ sex: ALL minimumAge: 25 Years maximumAge: 60 Years stdAges: ADULT facility: BMI Clinic Double Bay status: RECRUITING city: Sydney state: New South Wales zip: 2028 country: Australia name: Adrian Sartoretto, Dr role: CONTACT phone: 0290534688 phoneExt: 61 email: [email protected] lat: -33.86785 lon: 151.20732 facility: BMI Clinic Liverpool status: RECRUITING city: Sydney state: New South Wales zip: 2170 country: Australia name: Adrian Sartoretto, Dr role: CONTACT phone: 0290534688 phoneExt: 61 email: [email protected] lat: -33.86785 lon: 151.20732 hasResults: False
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<|newrecord|> nctId: NCT06360666 id: Neurax1 briefTitle: Clinical Outcomes in Adult Patients Undergoing Laparoscopic Surgery Under Neuraxial Anesthesia acronym: NEURAX overallStatus: ENROLLING_BY_INVITATION date: 2022-10-01 date: 2024-01-31 date: 2024-12-31 date: 2024-04-11 date: 2024-04-11 name: Asst Melegnano e Martesana class: OTHER_GOV briefSummary: The goal of this observational study is to learn about postoperative mortality and postoperative length of stay outcomes after abdominal laparoscopic major surgery. The main question it aims to answer is:
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Does general anesthesia lower complications compared to loco-regional anesthesia (keeping the patient spontaneously breathing and sedated) in laparoscopic abdominal major surgery? Participants are followed for neurological sequelae for 90 days following surgery conditions: Mortality conditions: Surgical Complication conditions: Neurological Complication conditions: Respiratory Complication conditions: Cardiovascular Complication conditions: Nephrotoxicity conditions: Metabolic Complication studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: RETROSPECTIVE count: 70 type: ESTIMATED measure: Mortality measure: Morbidity measure: Surgical revisions measure: organ dysfunctions sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: ASST Melegnano e Martesana - Ospedale Vizzolo Predabissi city: Vizzolo Predabissi state: Milan zip: 20070 country: Italy lat: 45.35587 lon: 9.34815 hasResults: False
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<|newrecord|> nctId: NCT06360653 id: 76CIVICO2023 briefTitle: a SIngle Center Study of Post-operative STEReotactic RAdiotherapY for Endometrial Cancer acronym: SISTER-RAY overallStatus: NOT_YET_RECRUITING date: 2024-06 date: 2025-06 date: 2026-06 date: 2024-04-11 date: 2024-04-11 name: ARNAS Civico Di Cristina Benfratelli Hospital class: OTHER briefSummary: The primary endpoint of the present prospective study is to assess the outcomes in terms of acute toxicity of post-operative stereotactic radiotherapy for endometrial cancer conditions: Endometrial Cancer studyType: INTERVENTIONAL phases: NA allocation: NA interventionModel: SINGLE_GROUP primaryPurpose: TREATMENT masking: NONE count: 60 type: ESTIMATED name: Stereotactic Post-operative Radiotherapy for Endometrial Cancer measure: Acute G3 or higher Gastrointestinal and Genitourinary Toxicity measure: Late Gastrointestinal and Genitourinary Toxicity measure: Distant Progression Free Survival measure: Local Control measure: Overall Survival measure: Overall Quality of Life sex: FEMALE minimumAge: 18 Years maximumAge: 80 Years stdAges: ADULT stdAges: OLDER_ADULT facility: ARNAS Civico Hospital city: Palermo state: PA zip: 90100 country: Italy name: FRANCESCO CUCCIA, MD role: CONTACT phone: +393334393336 email: [email protected] lat: 38.13205 lon: 13.33561 hasResults: False
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<|newrecord|> nctId: NCT06360640 id: APC148-001 id: 2023-507939-38-00 type: OTHER domain: EU Trial no briefTitle: A First-in-human Trial to Evaluate Safety, Tolerability, and Pharmacokinetics of APC148 in Healthy Adults overallStatus: NOT_YET_RECRUITING date: 2024-06 date: 2025-03 date: 2025-03 date: 2024-04-11 date: 2024-04-11 name: AdjuTec Pharma AS class: INDUSTRY name: CTC Clinical Trial Consultants AB briefSummary: The purpose of this first-in-human trial is to investigate the safety, tolerability, and pharmacokinetics of APC148 after intravenous (IV) infusion of single ascending doses in healthy adults. conditions: Healthy Subjects studyType: INTERVENTIONAL phases: PHASE1 allocation: RANDOMIZED interventionModel: SEQUENTIAL interventionModelDescription: Placebo-controlled, 6 sequential cohorts. primaryPurpose: BASIC_SCIENCE masking: DOUBLE maskingDescription: This is a double-blind trial. whoMasked: PARTICIPANT whoMasked: INVESTIGATOR count: 46 type: ESTIMATED name: APC148 and Placebo measure: Incidence and intensity of adverse events (AEs) measure: Incidence and intensity of serious adverse events (SAEs) measure: Incidence and intensity of infusion-related AEs measure: Time course of local tolerability reactions measure: Changes from baseline in blood pressure measure: Changes from baseline in respiratory rate measure: Changes from baseline in body temperature measure: Changes from baseline in heart rate measure: Changes from baseline in PQ/PR interval measure: Changes from baseline in QRS interval measure: Changes from baseline in QT interval measure: Changes from baseline in QTcF interval measure: Changes from baseline in Clinical Laboratory Profile measure: Changes from baseline in physical examination measure: APC148 plasma concentrations measure: APC148 urine concentrations measure: Pharmacokinetic (PK) parameter in plasma - Area under curve (AUC) 0-24 measure: PK parameter in plasma - AUC0-inf measure: PK parameter in plasma - AUC0-last measure: PK parameter in plasma - Cmax measure: PK parameter in plasma - Tmax measure: PK parameter in plasma - T1/2 measure: PK parameter in plasma - Clearance (CL) measure: PK parameter in plasma - Vz measure: PK parameter in plasma - Vss determination of plasma concentrations will be collected. measure: PK parameters in urine - A(e) measure: PK parameters in urine - fe measure: PK parameter in urine - renal clearance (CLr) sex: ALL minimumAge: 18 Years maximumAge: 60 Years stdAges: ADULT facility: Clinical Trial Consultants AB city: Uppsala country: Sweden name: Erik Rein-Hedin, MD role: PRINCIPAL_INVESTIGATOR lat: 59.85882 lon: 17.63889 hasResults: False
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<|newrecord|> nctId: NCT06360627 id: 2022_D0008 briefTitle: Ultra Low Dose CT and Use of Iomeron 400 in PCD-CT overallStatus: RECRUITING date: 2023-02-20 date: 2027-03-31 date: 2027-12-01 date: 2024-04-11 date: 2024-04-11 name: University of Zurich class: OTHER briefSummary: Evaluation of ultra low dose protocols and Iomeron 400 contrast in PCD-CT conditions: Radiation Exposure conditions: Lung Embolism conditions: Lung Cancer conditions: Pneumonia studyType: INTERVENTIONAL phases: NA allocation: NON_RANDOMIZED interventionModel: PARALLEL primaryPurpose: DIAGNOSTIC masking: NONE count: 100 type: ESTIMATED name: Computed Tomography measure: Dose Reduction by new scanner measure: stable Image Quality in reduced dose scans sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: University Hospital Zurich - Diagnostic Radiology status: RECRUITING city: Zurich zip: 8091 country: Switzerland name: Thomas Frauenfelder, PD MD role: CONTACT phone: 0041442551111 email: [email protected] name: Marga Rominger, Prof MD role: CONTACT phone: 0041442551111 email: [email protected] name: Thomas Frauenfelder, PD MD role: PRINCIPAL_INVESTIGATOR lat: 47.36667 lon: 8.54999 hasResults: False
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<|newrecord|> nctId: NCT06360614 id: 2024s01 briefTitle: The Effect of Hand Massage Applied to Palliative Care Oncology Patients overallStatus: NOT_YET_RECRUITING date: 2024-05-01 date: 2025-05-01 date: 2025-06-01 date: 2024-04-11 date: 2024-04-15 name: murat koç class: OTHER_GOV name: Istanbul Sultanbeyli State Hospital briefSummary: World Health Organization (WHO) palliative care is defined as "an approach that aims to reduce or prevent suffering by early identification, evaluation and treatment of the physical, psychosocial and spiritual problems of patients and families accompanying life-threatening diseases, and thus to increase their quality of life." Palliative care is a multidisciplinary approach that provides appropriate health care for oncology patients, who have a wide variety of medical, functional, social and emotional needs. Pharmacological approaches are generally used in symptom management of palliative care patients. In addition to pharmacological approaches, non-pharmacological approaches are also preferred. Massage is a preferred intervention among professional nursing practices because it is reliable, has no side effects, has a direct effect on patients, and is easy to apply.
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Massage is the stimulation of the skin, subcutaneous tissue, muscles, internal organs, metabolism, circulation and lymph systems for therapeutic purposes through mechanical and neural means. The presence of sufficient mechanoreceptors in the hands, which stimulate painless nerve endings, shows that the hands should be chosen as the appropriate area for massage. Among the effects of hand massage: ensuring the regeneration of cells, facilitating the elimination of accumulated toxins, providing relaxation, helping to reduce pain by facilitating the release of endorphins, helping to increase circulation, regulating respiratory functions, providing stress and anxiety control, creating a state of well-being, strengthening the immune system, increasing general comfort, improving sleep quality. is located. Studies in the literature have found that hand massage reduces anxiety levels, stress and agitation levels, pain levels, and increases comfort and sleep levels. As seen in the literature, the effectiveness of hand massage applied to different sample groups on anxiety, stress, agitation, pain, comfort and sleep parameters was evaluated. There are very few studies evaluating the effectiveness of hand massage applied to oncology patients. In addition, no study has been found that evaluated the effects of hand massage on pain, comfort and sleep in palliative oncology patients, who constitute the majority of palliative care patients. conditions: Hand Massage studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL interventionModelDescription: Before the application, data will be collected and recorded through a face-to-face interview (8-10 minutes) by a nurse who does not know which group the patients are in. Sleep times of patients will be measured with a smart bracelet. At this stage, the same procedure will be continued for the intervention and control groups.
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Hand massage will be applied to the intervention group for 4 weeks, 2 days a week (Monday and Friday), 2 sessions each day. The control group will receive routine monitoring and nursing care for 4 weeks.
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In the intervention and control groups, VAS-Pain, General Comfort Scale and Pittsburgh Sleep Quality were assessed by a face-to-face interview by a nurse who did not know which group the patients were in, on the 7th day (Monday), 14th day (Monday) and 28th day (Monday). Index measurement tools will be applied and patients' sleep times will be measured with a smart bracelet. primaryPurpose: SCREENING masking: SINGLE whoMasked: OUTCOMES_ASSESSOR count: 80 type: ESTIMATED name: Hand massage application name: routine monitoring and nursing care measure: İndividual Information Form measure: Patient Follow-up Form measure: General Comfort Scale measure: Pittsburgh Sleep Quality Index measure: Smart Bracelet sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Sultanbeyli State Hospital city: Istanbul zip: 34000 country: Turkey name: Murat Koç role: CONTACT phone: +905436725093 email: [email protected] lat: 41.01384 lon: 28.94966 hasResults: False
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<|newrecord|> nctId: NCT06360601 id: 36264PR589/3/24 briefTitle: Intravenous Labetalol Versus Hydralazine in Preeclampsia overallStatus: ACTIVE_NOT_RECRUITING date: 2024-04-01 date: 2024-09 date: 2024-09 date: 2024-04-11 date: 2024-04-11 name: Tanta University class: OTHER briefSummary: We study the effect of intravenous labetalol versus hydralazine in sever preeclampsia patients on cerebral blood flow and neurological outcome conditions: Preeclampsia Severe studyType: INTERVENTIONAL phases: PHASE1 phases: PHASE2 allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: PREVENTION masking: TRIPLE whoMasked: PARTICIPANT whoMasked: INVESTIGATOR whoMasked: OUTCOMES_ASSESSOR count: 40 type: ESTIMATED name: Labetalol Injection name: HydrALAZINE Injection measure: Cerebral blood flow sex: FEMALE minimumAge: 25 Years maximumAge: 45 Years stdAges: ADULT facility: Faculty of Medicine city: Tanta zip: 3511 country: Egypt lat: 30.78847 lon: 31.00192 hasResults: False
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<|newrecord|> nctId: NCT06360588 id: NCI-2024-01141 id: NCI-2024-01141 type: REGISTRY domain: CTRP (Clinical Trial Reporting Program) id: EAY131-Z1G type: OTHER domain: ECOG-ACRIN Cancer Research Group id: EAY131-Z1G type: OTHER domain: CTEP id: U10CA180820 type: NIH link: https://reporter.nih.gov/quickSearch/U10CA180820 briefTitle: Testing Copanlisib as Potentially Targeting Treatment in Cancers With PTEN Loss (MATCH - Subprotocol Z1G) overallStatus: ACTIVE_NOT_RECRUITING date: 2018-06-19 date: 2024-11-15 date: 2024-11-15 date: 2024-04-11 date: 2024-04-22 name: National Cancer Institute (NCI) class: NIH briefSummary: The phase II MATCH treatment trial tests how well copanlisib works to treat patients with cancer with PTEN loss. Copanlisib may stop the growth of tumor cells and may kill them by blocking some of the enzymes needed for cell growth. conditions: Malignant Solid Neoplasm studyType: INTERVENTIONAL phases: PHASE2 allocation: NA interventionModel: SINGLE_GROUP primaryPurpose: TREATMENT masking: NONE count: 35 type: ESTIMATED name: Biopsy name: Biospecimen Collection name: Copanlisib name: Radiologic Examination measure: Objective response rate (ORR) measure: Overall survival (OS) measure: 6-month progression-free survival (PFS) rate measure: Progression free survival sex: ALL stdAges: CHILD stdAges: ADULT stdAges: OLDER_ADULT facility: ECOG-ACRIN Cancer Research Group city: Philadelphia state: Pennsylvania zip: 19103 country: United States lat: 39.95233 lon: -75.16379 hasResults: False
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<|newrecord|> nctId: NCT06360575 id: NCI-2024-01127 id: NCI-2024-01127 type: REGISTRY domain: CTRP (Clinical Trial Reporting Program) id: EAY131-C2 type: OTHER domain: ECOG-ACRIN Cancer Research Group id: EAY131-C2 type: OTHER domain: CTEP id: U10CA180820 type: NIH link: https://reporter.nih.gov/quickSearch/U10CA180820 briefTitle: Testing Crizotinib as Potentially Targeted Treatment in Cancers With MET Exon 14 Deletion Genetic Changes (MATCH - Subprotocol C2) overallStatus: ACTIVE_NOT_RECRUITING date: 2016-05-30 date: 2024-11-15 date: 2024-11-15 date: 2024-04-11 date: 2024-04-22 name: National Cancer Institute (NCI) class: NIH briefSummary: This phase II MATCH treatment trial tests how well crizotinib works to treat patients with cancers with MET exon 14 deletion genetic changes. Crizotinib is in a group of medications called tyrosine kinase inhibitors. It works by blocking enzymes that cancer cells need to grow and spread. It may also prevent the growth of new blood vessels that tumors need to grow. conditions: Advanced Lymphoma conditions: Advanced Malignant Solid Neoplasm conditions: Refractory Lymphoma conditions: Refractory Malignant Solid Neoplasm conditions: Refractory Multiple Myeloma studyType: INTERVENTIONAL phases: PHASE2 allocation: NA interventionModel: SINGLE_GROUP primaryPurpose: TREATMENT masking: NONE count: 35 type: ESTIMATED name: Biopsy name: Biospecimen Collection name: Crizotinib name: Radiologic Examination measure: Objective response rate (ORR) measure: Overall survival (OS) measure: 6-month progression-free survival (PFS) rate measure: Progression free survival sex: ALL stdAges: CHILD stdAges: ADULT stdAges: OLDER_ADULT facility: ECOG-ACRIN Cancer Research Group city: Philadelphia state: Pennsylvania zip: 19103 country: United States lat: 39.95233 lon: -75.16379 hasResults: False
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<|newrecord|> nctId: NCT06360562 id: 2020P002418 briefTitle: Reconnecting to Ourselves and Others in Virtual Meetings (ROOM) overallStatus: RECRUITING date: 2020-09-15 date: 2025-01-30 date: 2025-04-25 date: 2024-04-11 date: 2024-04-11 name: Massachusetts General Hospital class: OTHER briefSummary: This study aimed to determine the feasibility and acceptability of delivering Resilience Training in multi-user virtual reality. conditions: Mood Disorders conditions: Anxiety Disorders conditions: Psychotic Disorders studyType: INTERVENTIONAL phases: NA allocation: NA interventionModel: SINGLE_GROUP primaryPurpose: TREATMENT masking: NONE count: 174 type: ESTIMATED name: Resilience Training measure: Discomfort with Others measure: Intervention Feasibility and Acceptability measure: Penn Emotion Recognition Test measure: Stop Distance Paradigm measure: Beck Depression Inventory measure: Spielberger State-Trait Anxiety Inventory measure: Prodromal Questionnaire- Brief measure: Connor-Davidson Resilience Scale sex: ALL minimumAge: 14 Years stdAges: CHILD stdAges: ADULT stdAges: OLDER_ADULT facility: Massachusetts General Hospital status: RECRUITING city: Charlestown state: Massachusetts zip: 02129 country: United States name: Daphne J Holt, MD, PhD role: CONTACT phone: 617-726-7618 email: [email protected] name: Nicole DeTore, PhD role: CONTACT phone: 617-726-2065 email: [email protected] lat: 42.37787 lon: -71.062 hasResults: False
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<|newrecord|> nctId: NCT06360549 id: TJ-IRB202403019 briefTitle: Effect of Percutaneous Acupoint Electrical Stimulation on Delirium overallStatus: RECRUITING date: 2024-03-01 date: 2024-12-30 date: 2025-06-30 date: 2024-04-11 date: 2024-04-11 name: Qin Zhang class: OTHER name: National Natural Science Foundation of China briefSummary: This study is a multicenter, prospective, randomized controlled clinical trial that aims to observe the impact of Transcutaneous Electrical Acupoint Stimulation (TEAS) on plasma TK/MMP3 in a randomized controlled setting. The intervention group received percutaneous acupoint electrical stimulation, whereas the control group underwent conventional treatment. The primary objective is to enhance the management of postoperative delirium, specifically focusing on the occurrence and severity of delirium following thoracoscopic pulmonary resection. Additionally, various perioperative inflammatory markers, cognitive function, recovery quality, pain levels, anxiety, sleep patterns, postoperative complications, and overall hospital stay duration were monitored to elucidate the mechanisms through which percutaneous acupoint electrical stimulation improves postoperative delirium. conditions: Delirium, Postoperative studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL interventionModelDescription: The intervention group was percutaneous acupoint electrical stimulation treatment group, and the control group was conventional treatment group.
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Inclusion criteria:
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1. Voluntarily sign informed consent;
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2. Age ≥18 years old;
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3. Patients undergoing thoracoscopic pneumonectomy;
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4. ASA Grade I-III; primaryPurpose: TREATMENT masking: QUADRUPLE whoMasked: PARTICIPANT whoMasked: CARE_PROVIDER whoMasked: INVESTIGATOR whoMasked: OUTCOMES_ASSESSOR count: 238 type: ESTIMATED name: Transcutaneous Electrical Acupoint Stimulation measure: Delirium (using the Delirium Rating Scale, DRS) measure: Mini-Mental State Examination (MMSE) sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Guangdong Hospital of Traditional Chinese Medicine status: NOT_YET_RECRUITING city: Guangzhou state: Guangdong zip: 510000 country: China name: Jiemin Deng role: CONTACT phone: 2780 email: [email protected] name: Jiemin Deng role: CONTACT lat: 23.11667 lon: 113.25 facility: Tongji Hospital, Tongji Medical College, Huazhong University of Science and Technology status: RECRUITING city: Wuhan state: Hubei zip: 430030 country: China name: Qin Zhang, phd role: CONTACT phone: 15717154768 email: [email protected] name: Qin Zhang, phd role: PRINCIPAL_INVESTIGATOR lat: 30.58333 lon: 114.26667 hasResults: False
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<|newrecord|> nctId: NCT06360536 id: IRB-300012634 id: P50MD017338 type: NIH link: https://reporter.nih.gov/quickSearch/P50MD017338 briefTitle: Remotely Delivered Resistance Training for Cardiometabolic Health Among Black Women acronym: OVERCOME-IT overallStatus: NOT_YET_RECRUITING date: 2024-09-01 date: 2026-06-01 date: 2026-06-30 date: 2024-04-11 date: 2024-04-11 name: University of Alabama at Birmingham class: OTHER name: National Institute on Minority Health and Health Disparities (NIMHD) briefSummary: The purpose of this study is to collect preliminary data on the feasibility, acceptability, and potential effects of a novel, remotely delivered resistance training program. conditions: Overweight or Obesity conditions: Prediabetes or Diabetes conditions: Prehypertension (Elevated Blood Pressure) or Hypertension conditions: Resistance Training studyType: INTERVENTIONAL phases: NA allocation: NA interventionModel: SINGLE_GROUP primaryPurpose: TREATMENT masking: NONE count: 36 type: ESTIMATED name: Resistance Training measure: Feasibility of recruitment measure: Feasibility of retention measure: Intervention adherence measure: Change in resistance training behaviors measure: Change in blood pressure measure: Change in HbA1C measure: Change in body composition measure: Change in handgrip strength measure: Change in the number of chair stands sex: FEMALE minimumAge: 30 Years maximumAge: 64 Years stdAges: ADULT facility: University of Alabama at Birmingham city: Birmingham state: Alabama zip: 35294 country: United States name: Jackie Grant role: CONTACT phone: 205-975-7108 email: [email protected] name: Amber Kinsey role: CONTACT phone: 205-934-9851 email: [email protected] name: Amber W Kinsey, PhD role: PRINCIPAL_INVESTIGATOR lat: 33.52066 lon: -86.80249 hasResults: False
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<|newrecord|> nctId: NCT06360523 id: CRE-2024.141 briefTitle: To Evaluate an MRI-based Optimized Prostate Cancer Diagnostic Pathway Powered by Artificial Intelligence overallStatus: NOT_YET_RECRUITING date: 2024-05-01 date: 2025-05-31 date: 2025-07-20 date: 2024-04-11 date: 2024-04-11 name: Chinese University of Hong Kong class: OTHER briefSummary: It is a prospective paired-cohort study for diagnostic test evaluation. The study aim to determine the accuracy of AI review and investigate whether AI review could detect MRI visible significant cancer as effective as radiologist review. MRI image of about 102 men recommended for biopsy will be reviewed by an AI model and an experienced radiologist, respectively. AI review (index) and radiologist review (standard) will be blinded to each other, while biopsy urologists will be well-informed of the findings of both AI review and radiologist review and make personalized biopsy plan by combining both findings. The pathological results of MRI-ultrasound fusion biopsy (reference) will serve as the gold standard to assess the diagnostic accuracy. conditions: Prostate Cancer studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: PROSPECTIVE count: 102 type: ESTIMATED name: AI modal measure: Prostate Cancer detection rate of ISUP grade group ≥2 measure: Diagnosis of any grade of prostate cancer sex: MALE minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Prince of Wales Hospital, Chinese University of Hong Kong city: Hong Kong country: Hong Kong lat: 22.27832 lon: 114.17469 hasResults: False
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<|newrecord|> nctId: NCT06360510 id: 44 briefTitle: Comparison of %5 Dextrose and Betamethasone Injections in Patients With Carpal Tunnel Syndrome overallStatus: ACTIVE_NOT_RECRUITING date: 2023-05-05 date: 2024-05-05 date: 2024-05-05 date: 2024-04-11 date: 2024-04-11 name: Gaziler Physical Medicine and Rehabilitation Education and Research Hospital class: OTHER briefSummary: The aim of the study is to compare the effectiveness of ultrasound-guided betamethasone and 5% dextrose injection, which is routinely applied in clinical practice, in patients with mild and moderate carpal tunnel syndrome (CTS). conditions: Carpal Tunnel Syndrome studyType: OBSERVATIONAL observationalModel: OTHER timePerspective: PROSPECTIVE count: 30 type: ACTUAL name: %5 dextrose injection name: betamethasone injection measure: vas measure: boston carpal tunnel syndrome questionnaire measure: median nerve cross sectional area measure: tinnel test positivity measure: phalen test positivity measure: duruöz hand index measure: global evaluation of treatment outcomes sex: ALL minimumAge: 18 Years maximumAge: 75 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Ankara Gaziler Physical Medicine and Rehabilitation Education and Research Hospital city: Ankara country: Turkey lat: 39.91987 lon: 32.85427 hasResults: False
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<|newrecord|> nctId: NCT06360497 id: 202206090070 briefTitle: The Effect of Mindfulness Meditation and Loving-kindness and Compassion Meditation on Psychological Distress overallStatus: COMPLETED date: 2022-06-03 date: 2022-10-09 date: 2022-10-09 date: 2024-04-11 date: 2024-04-11 name: Beijing Normal University class: OTHER briefSummary: The purpose of the study is to explore the effect of of mindfulness meditation and loving-kindness and compassion meditation on psychological distress (i.e., anxiety, depression, stress), and explore the mechanism from the perspective of reinforcement sensitivity theory. conditions: MM Group conditions: LKCM Group conditions: Waitlist Group studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: OTHER masking: NONE count: 152 type: ACTUAL name: mindfulness meditation intervention and loving-kindness and compassion meditation intervention measure: The Depression Anxiety Stress Scale measure: The Philadelphia Mindfulness Scale measure: The Sensitivity to Punishment and Sensitivity to Reward Questionnaire measure: The Emotional Word Lists sex: ALL minimumAge: 18 Years maximumAge: 56 Years stdAges: ADULT facility: Xianglong Zeng city: Beijing state: Beijing zip: 100875 country: China lat: 39.9075 lon: 116.39723 typeAbbrev: Prot_SAP hasProtocol: True hasSap: True hasIcf: False label: Study Protocol and Statistical Analysis Plan date: 2024-03-27 uploadDate: 2024-03-27T06:37 filename: Prot_SAP_000.pdf size: 125410 hasResults: False
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<|newrecord|> nctId: NCT06360484 id: PrevelanceHDVSudan briefTitle: Prevalence and Clinical Characterization of Hepatitis D Virus (HDV) Infection Among Sudanese Patients With Hepatitis B Virus overallStatus: COMPLETED date: 2022-06-01 date: 2022-09-01 date: 2022-09-10 date: 2024-04-11 date: 2024-04-11 name: National Center for Gastroentestinal and Liver Disease class: OTHER briefSummary: Background: Sudan has a high prevalence of hepatitis B surface antigen (HBsAg), exceeding 8%. The prevalence of hepatitis B varies across different regions of Sudan, ranging from 6.8% in central Sudan to as high as 26% in southern Sudan. Hepatitis B virus (HBV) infection can lead to various complications, including cirrhosis, liver failure, and hepatocellular carcinoma (HCC). Hepatitis D virus (HDV) relies on HBV for replication and can accelerate the progression of HBV-related liver diseases, leading to more severe outcomes. This study aims to determine the prevalence of HDV infection among Sudanese patients with HBV-related liver diseases and to investigate the clinical characteristics of patients with HBV/HDV co-infection.
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Design/Method: This descriptive cross-sectional hospital-based study was conducted at Ibn Sina Specialized Hospital in Sudan between June and September 2022. Ninety HBV patients aged 16 years and above were included. Patients were interviewed using a structured questionnaire, and medical histories and examinations were recorded. Investigations included liver function tests, abdominal ultrasounds, and ELISA for Ant-HDV-IgG conditions: Hepatitis B conditions: Hepatitis D conditions: Viral Hepatitis studyType: OBSERVATIONAL observationalModel: CASE_ONLY timePerspective: CROSS_SECTIONAL count: 90 type: ACTUAL name: investigations for Hepatitis D virus measure: the prevalence of hepatitis D infection among Sudanese patients with HBV-related liver diseases. sex: ALL minimumAge: 16 Years stdAges: CHILD stdAges: ADULT stdAges: OLDER_ADULT facility: National Center for Gastrointestinal and Liver Diseases city: Khartoum zip: 15004 country: Sudan lat: 15.55177 lon: 32.53241 hasResults: False
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<|newrecord|> nctId: NCT06360471 id: FS-FMC briefTitle: Fertility Preservation and Pregnancy and Offspring Health Outcomes in Female Cancer overallStatus: RECRUITING date: 2023-10-01 date: 2027-10-01 date: 2032-10-01 date: 2024-04-11 date: 2024-04-16 name: The First Affiliated Hospital with Nanjing Medical University class: OTHER briefSummary: To explore whether there is a significant difference in the cumulative live birth rate and maternal and child health outcomes between cancer patients who undergo or do not undergo fertility preservation before receiving anti-tumor treatment and non-cancer patients who undergo assisted reproductive technology treatment/natural pregnancy.
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This study will be conducted in the Clinical Center of Reproductive Medicine, First Affiliated Hospital of Nanjing Medical University. 2800 women diagnosed with malignant cancers who has desire to reproduce will be enrolled in this study.
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Statistical analysis of the data will be performed. conditions: Fertility Issues conditions: Cancer studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: PROSPECTIVE count: 2800 type: ESTIMATED name: fertility preservation measure: 5-year cumulative live birth rate measure: Ovarian function(AMH levels) measure: Ovarian function(AFC counts) measure: Newborn malformation rate measure: Tumor recurrence rate measure: Tumor survival rate sex: FEMALE minimumAge: 20 Years maximumAge: 40 Years stdAges: ADULT facility: Clinical Center of Reproductive Medicine of First Affiliated Hospital with Nanjing Medical University status: RECRUITING city: Nanjing state: Jiangsu zip: 210000 country: China name: Xiang Ma, MD. PHD role: CONTACT phone: +8618001581878 email: [email protected] name: Nan Lu role: CONTACT phone: +8615950476023 email: [email protected] lat: 32.06167 lon: 118.77778 hasResults: False
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<|newrecord|> nctId: NCT06360458 id: MRCTA,ECFAH of FMU[2024]368 briefTitle: Methylprednisolone Adjunctive to Endovascular Treatment for Stroke overallStatus: NOT_YET_RECRUITING date: 2024-05-01 date: 2025-05-01 date: 2028-03-01 date: 2024-04-11 date: 2024-04-11 name: Wan-Jin Chen class: OTHER briefSummary: The efficacy and safety of methylprednisolone in acute ischemic stroke patients with large infarct cores (ASPECTS score \< 6) due to anterior circulation large vessel occlusion have not been clearly established. This is a multi-center, randomized, double-blind, placebo-controlled trial to investigate early combination therapy with methylprednisolone for reperfusion in acute large core infarction. conditions: Acute Ischemic Stroke studyType: INTERVENTIONAL phases: PHASE3 allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: QUADRUPLE whoMasked: PARTICIPANT whoMasked: CARE_PROVIDER whoMasked: INVESTIGATOR whoMasked: OUTCOMES_ASSESSOR count: 735 type: ESTIMATED name: Methylprednisolone measure: Mortality at 90 days sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT hasResults: False
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<|newrecord|> nctId: NCT06360445 id: HD1912BE202201 briefTitle: Bioequivalence Study of Olaparib Tablets Under Fasting and Fed Conditions in Healthy Subjects overallStatus: COMPLETED date: 2022-05-26 date: 2022-08-21 date: 2022-08-21 date: 2024-04-11 date: 2024-04-11 name: CSPC Ouyi Pharmaceutical Co., Ltd. class: INDUSTRY briefSummary: This Study is a Randomized, Open-Label, 2-formulation, Single-Dose, 2-Period Crossover Bioequivalence Study with a washout period of 7 days. During each session, the subjects were administered a single dose of 100 mg Olaparib Tablets (Test formulation or reference formulation ) under Fasting conditions or 150mg Olaparib Tablets (Test formulation or reference formulation ) under Fasting and Fed conditions. Venous blood samples were collected at pre-dose (0 h), and up to 72 h post dose. This study was to evaluate the bioequivalence and safety of the test formulation and the reference formulation of Olaparib Tablets in healthy subjects. conditions: Healthy Participants studyType: INTERVENTIONAL phases: PHASE1 allocation: RANDOMIZED interventionModel: CROSSOVER interventionModelDescription: 2-period Crossover Assignment primaryPurpose: TREATMENT masking: NONE maskingDescription: Open label count: 102 type: ACTUAL name: Olaparib Tablet test formulation 100mg name: Olaparib Tablet reference formulation 100mg name: Olaparib Tablet test formulation 150mg name: Olaparib Tablet reference formulation 150mg measure: Cmax Description: Maximum observed plasma concentration measure: AUC0-∞ Description: Area under the plasma concentration time curve from time zero extrapolated to infinite time measure: AUC0-t Description: Area under the plasma concentration time curve from time zero to the time of the last quantifiable concentration measure: Time of maximum observed plasma concentration (Tmax) measure: Terminal elimination half-life (T1/2) measure: Apparent total body clearance (Cl/F) measure: Apparent volume of distribution (V/F) measure: Number of participants with Adverse Events sex: MALE minimumAge: 18 Years maximumAge: 50 Years stdAges: ADULT facility: Beijing Friendship Hospital, Capital Medical University city: Beijing state: Beijing zip: 100050 country: China lat: 39.9075 lon: 116.39723 hasResults: False
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<|newrecord|> nctId: NCT06360432 id: HSEARS20240214001 briefTitle: Effects of the EatWelLog App on Diet Management for Older Adults With Sarcopenic Obesity overallStatus: NOT_YET_RECRUITING date: 2024-04-08 date: 2024-10-31 date: 2025-04-30 date: 2024-04-11 date: 2024-04-11 name: The Hong Kong Polytechnic University class: OTHER briefSummary: Sarcopenic obesity, characterised by concurrent reduced muscle mass and excess body fat, affects 11% of older adults worldwide, rising to 23% in those over 75. Considering the negative synergistic impact on health, promoting muscle mass gains while reducing fat mass remains a significant challenge, necessitating urgent and effective intervention strategies for managing SO. Exercise and nutrition are the primary interventions recommended for SO.
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This project aims to evaluate the effects of the EatWellLog App developed by the investigators' team for local older adults, in improving:
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* their sarcopenic obesity status, measured by all four diagnostic criteria, including grip strength, muscle mass, physical performance and body fat mass (primary outcome), and,
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* nutritional self-efficacy, nutritional status, dietary quality, health-related quality of life, and adherence to diet and exercise regimens (secondary outcomes), by enhancing the self-management abilities and longer-term adherence to daily diet management among participants in the M-health group using the App, compared to the control group.
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The EatWellLog App, designed for older adults with SO, incorporating Klasnja and Pratt's five-strategy framework for mobile health (mHealth) applications development to facilitate health behavioural change. This App supports users with SO in managing daily diets that promote gradual weight loss and muscle mass preservation, adhering to the dietary regimen for this population.
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Forty older adults with SO will be recruited from local community health centres and then randomized to either m-health or control groups. Both groups will receive an 8-week supervised programme separately. The programme consists of personalised dietary modification programme and group-based exercise training which have been tested and used in the investigators' pilot and General Research Fund (GRF) project. Additionally, only the m-health group will be instructed to use the App for daily diet self-management.
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Participants will be assessed on a variety of outcomes immediately after the 8-week supervised programme (T1), which will be compared to the baseline (T0). To explore the possible long-term effects of the intervention, other measurements will be conducted at 3-(T2) and 6-(T3) months after the supervised programme, which will be compared with those conducted at T0. conditions: Sarcopenic Obesity studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL interventionModelDescription: A two-arm, assessor-blinded, parallel design pilot randomized control trial (RCT) consisting of a M-health and a control group will be adopted to evaluate the effectiveness of the EatWellLog App in improving older adults' sarcopenic obesity (SO) status and other SO-related parameters by enhancing the self-management abilities and longer-term adherence to daily diet management among participants in the M-health group using the App, compared to the control group. primaryPurpose: TREATMENT masking: SINGLE maskingDescription: An independent assessor who is blinded to the group allocations will assess the participants' outcomes. whoMasked: OUTCOMES_ASSESSOR count: 40 type: ESTIMATED name: Dietary modification program name: Exercise training name: The EatWellLog App measure: Changes of muscle strength measure: Changes of muscle mass measure: Changes of body mass index measure: Changes of waist circumference measure: Changes of fat mass measure: The Short Physical Performance Battery (SPPB) scale measure: Mini Nutritional Assessment (MNA) Short-form measure: Health Action Process Approach (HAPA) Nutrition Self-efficacy Scale measure: Dietary Quality Index-International (DQI-I) measure: EuroQoL 5D (EQ-5D) measure: Diet Adherence measure: Exercise Adherence sex: ALL minimumAge: 65 Years stdAges: OLDER_ADULT facility: The Hong Kong Polytechnic University city: Hong Kong country: Hong Kong name: Amy Cheung, MA role: CONTACT phone: +852 27664145 email: [email protected] lat: 22.27832 lon: 114.17469 hasResults: False
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<|newrecord|> nctId: NCT06360419 id: SOL-MDD-301 briefTitle: Progressing TAAR-1, Dopamine, and Norepinephrine in Depression Using Solriamfetol acronym: PARADIGM overallStatus: RECRUITING date: 2024-03-18 date: 2025-12 date: 2025-12 date: 2024-04-11 date: 2024-04-11 name: Axsome Therapeutics, Inc. class: INDUSTRY briefSummary: PARADIGM (Progressing TAAR-1, Dopamine, and Norepinephrine in Depression Using Solriamfetol) is a Phase 3, randomized, double-blind, placebo-controlled, multicenter trial to assess the safety and efficacy of solriamfetol for the treatment of major depressive disorder (MDD) in adults. conditions: Major Depressive Disorder studyType: INTERVENTIONAL phases: PHASE3 allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: TRIPLE whoMasked: PARTICIPANT whoMasked: CARE_PROVIDER whoMasked: INVESTIGATOR count: 300 type: ESTIMATED name: Solriamfetol 300 mg name: Placebo measure: Montgomery-Åsberg Depression Rating Scale (MADRS) measure: Incidence of treatment-emergent adverse events sex: ALL minimumAge: 18 Years maximumAge: 65 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Clinical Research Site status: RECRUITING city: Encino state: California zip: 91316 country: United States lat: 34.15917 lon: -118.50119 facility: Clinical Research Site status: RECRUITING city: Lemon Grove state: California zip: 91945 country: United States lat: 32.74255 lon: -117.03142 facility: Clinical Research Site status: RECRUITING city: Oceanside state: California zip: 92056 country: United States lat: 33.19587 lon: -117.37948 facility: Clinical Research Site status: RECRUITING city: Redlands state: California zip: 92374 country: United States lat: 34.05557 lon: -117.18254 facility: Clinical Research Site status: RECRUITING city: Riverside state: California zip: 92506 country: United States lat: 33.95335 lon: -117.39616 facility: Clinical Research Site status: RECRUITING city: Sherman Oaks state: California zip: 91403 country: United States lat: 34.15112 lon: -118.44925 facility: Clinical Research Site status: RECRUITING city: Upland state: California zip: 91786 country: United States lat: 34.09751 lon: -117.64839 facility: Clinical Research Site status: RECRUITING city: Cromwell state: Connecticut zip: 06416 country: United States lat: 41.5951 lon: -72.64537 facility: Clinical Research Site status: RECRUITING city: Hialeah state: Florida zip: 33012 country: United States lat: 25.8576 lon: -80.27811 facility: Clinical Research Site status: RECRUITING city: Jacksonville state: Florida zip: 32256 country: United States lat: 30.33218 lon: -81.65565 facility: Clinical Research Site status: RECRUITING city: Orlando state: Florida zip: 32801 country: United States lat: 28.53834 lon: -81.37924 facility: Clinical Research Site status: RECRUITING city: Orlando state: Florida zip: 32806 country: United States lat: 28.53834 lon: -81.37924 facility: Clinical Research Site status: RECRUITING city: Orlando state: Florida zip: 32807 country: United States lat: 28.53834 lon: -81.37924 facility: Clinical Research Site status: RECRUITING city: Chicago state: Illinois zip: 60634 country: United States lat: 41.85003 lon: -87.65005 facility: Clinical Research Site status: RECRUITING city: Boston state: Massachusetts zip: 02131 country: United States lat: 42.35843 lon: -71.05977 facility: Clinical Research Site status: RECRUITING city: Saint Charles state: Missouri zip: 63304 country: United States lat: 38.78394 lon: -90.48123 facility: Clinical Research Site status: RECRUITING city: Las Vegas state: Nevada zip: 89102 country: United States lat: 36.17497 lon: -115.13722 facility: Clinical Research Site status: RECRUITING city: Brooklyn state: New York zip: 11235 country: United States lat: 40.6501 lon: -73.94958 facility: Clinical Research Site status: RECRUITING city: Rochester state: New York zip: 14609 country: United States lat: 43.15478 lon: -77.61556 facility: Clinical Research Site status: RECRUITING city: Hickory state: North Carolina zip: 28601 country: United States lat: 35.73319 lon: -81.3412 facility: Clinical Research Site status: RECRUITING city: Oklahoma City state: Oklahoma zip: 73118 country: United States lat: 35.46756 lon: -97.51643 facility: Clinical Research Site status: RECRUITING city: Media state: Pennsylvania zip: 19063 country: United States lat: 39.91678 lon: -75.38769 facility: Clinical Research Site status: RECRUITING city: Memphis state: Tennessee zip: 38119 country: United States lat: 35.14953 lon: -90.04898 facility: Clinical Research Site status: RECRUITING city: Wichita Falls state: Texas zip: 76309 country: United States lat: 33.91371 lon: -98.49339 facility: Clinical Research Site status: RECRUITING city: Everett state: Washington zip: 98201 country: United States lat: 47.97898 lon: -122.20208 hasResults: False
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<|newrecord|> nctId: NCT06360406 id: D1346R00009 briefTitle: Real-World Treatment Study of Koselugo (Selumetinib) overallStatus: NOT_YET_RECRUITING date: 2024-06-01 date: 2031-09-30 date: 2031-09-30 date: 2024-04-11 date: 2024-04-11 name: AstraZeneca class: INDUSTRY briefSummary: As part of a post-approval commitment, the Korean health authority requests a study to characterize safety and effectiveness in patients treated with Koselugo (Selumetinib), an oral selective inhibitor of MAPK kinase (MEK) 1 and 2, by physicians in routine clinical practice settings. This study is designed to assess the known safety profile or identify previously unsuspected adverse reactions and evaluate the effectiveness of Koselugo under conditions of routine daily medical practice in Korea.
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This study will provide information on the Korean patient population that is treated with the study drug. conditions: Neurofibromatosis 1 conditions: Neurofibroma, Plexiform studyType: OBSERVATIONAL observationalModel: CASE_ONLY timePerspective: OTHER count: 150 type: ESTIMATED measure: Adverse events (AEs) rate measure: Physeal dysplasia occurance rate measure: Descriptive analysis with the physician qualitative assessments by overall disease status of NF-1 and status of clinically significant PNs, respectively. - Improving - Progression - Stable sex: ALL minimumAge: 3 Years maximumAge: 18 Years stdAges: CHILD stdAges: ADULT hasResults: False
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<|newrecord|> nctId: NCT06360393 id: 17384 briefTitle: Inhaler Adherence and Inhalation Technique Assessed by a Smart Spacer in Patients With Severe Asthma on Biologics acronym: OUTERSPACE-3 overallStatus: NOT_YET_RECRUITING date: 2024-05 date: 2026-02 date: 2026-05 date: 2024-04-11 date: 2024-04-17 name: University Medical Center Groningen class: OTHER name: Trudell Medical International briefSummary: Severe refractory asthma affects about 3.5% of asthma patients, often necessitating biologic therapy in addition to standard treatment. However, little is understood about maintenance and reliever inhalation medication adherence in these cases which might impact overall biologic response. Objectively monitoring inhalation medication adherence remains a significant challenge. The Smart AeroChamber® device, capable of measuring adherence and inhalation technique, is untested in severe asthma patients on biologics, presenting a potentially cost-effective solution to monitor adherence and better understand treatment response.
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This study aims to assess the feasibility of the Smart AeroChamber® device in severe asthma patients on biologic therapy, with objectives to:
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1. Evaluate inhalation medication adherence patterns and inhaler technique, and comparing that adherence data with traditional measures e.g. the Test of Adherence to Inhalers (TAI), and an inhalation technique checklist.
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2. Investigate the association between inhaled medication adherence and clinical outcomes such as exacerbations, short-acting beta-agonists (SABA) use, oral corticosteroids use (OCS), Fractional Exhaled Nitric Oxide (FeNO), blood eosinophil count, and Asthma Control Questionnaire (ACQ) scores.
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3. Assess patient and healthcare provider satisfaction and usability of the Smart AeroChamber® device.
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The study design is prospective and observational, with a sample size of 110 adult patients diagnosed with severe asthma using biologic therapy. Participants will be followed for 12 months, during which they will receive Smart AeroChamber® devices. These devices will measure medication adherence and inhaler technique, and undergo assessments of clinical outcomes at regular intervals. Usability and satisfaction will also be evaluated using the Systems Usability Scale (SUS) in patients and healthcare professionals.
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The study will be conducted across five severe asthma clinics in the Netherlands. Data analysis will involve comparing the inhalation medication adherence data with traditional measures for adherence and inhalation technique, assessing clinical outcomes, and evaluating usability and satisfaction. The findings from this study will provide insights into the feasibility and effectiveness of using digital devices like the Smart AeroChamber® to support medication adherence and possibly improve outcomes in patients with severe asthma on biologic therapy. conditions: Asthma studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: PROSPECTIVE count: 110 type: ESTIMATED name: Smart spacer measure: Comparative analysis of smart spacer medication adherence and inhaler technique against Test of Adherence to Inhalers (TAI-12) measure: Comparison of smart spacer medication adherence patterns (adherence and inhaler technique) with inhaler checklist examined by pulmonologist or pulmonary nurse measure: Assessing the association of smart spacer assessed adherence with annual exacerbation rate measure: Assessing the association of smart spacer assessed adherence with reliever inhaler use (e.g. SABA) measure: Assess the association of smart spacer assessed adherence with oral corticosteroids use measure: Assess the association of smart spacer assessed adherence with FeNO results measure: Assess the association of smart spacer assessed adherence with blood eosinophils measure: Assess the association of smart spacer assessed adherence with asthma control (ACQ-6) measure: Assess the association of smart spacer assessed adherence with spirometry results measure: Assess usability and patient satisfaction using the System Usability Scale measure: Assess usability and healthcare provider satisfaction using the System Usability Scale sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Medisch Centrum Leeuwarden city: Leeuwarden state: Friesland zip: 8934AD country: Netherlands name: Akke-Nynke van der Meer, MD, PhD role: CONTACT phone: +31 58 286 3875 email: [email protected] lat: 53.20139 lon: 5.80859 facility: Isala city: Zwolle state: Overijssel zip: 8025AB country: Netherlands name: Niels Patberg, MD role: CONTACT email: [email protected] lat: 52.5125 lon: 6.09444 facility: Stichting Sint Franciscus Vlietland Groep city: Rotterdam state: Zuid-Holland zip: 3118JH country: Netherlands name: Yasemin Türk, MD, PhD role: CONTACT phone: +31 10 461 6161 email: [email protected] lat: 51.9225 lon: 4.47917 facility: University Medical Center Groningen city: Groningen zip: 9713GZ country: Netherlands name: Maarten van den Berge, MD, PhD role: CONTACT phone: +31 6 24450194 email: [email protected] name: Titia Klemmeier, RN role: SUB_INVESTIGATOR name: Huib Kerstjens, MD, PhD role: SUB_INVESTIGATOR lat: 53.21917 lon: 6.56667 facility: Foundation Martini Hospital city: Groningen zip: 9728NT country: Netherlands name: Marjolein J van Es, MD, PhD role: CONTACT phone: +31 50 524 5245 email: [email protected] lat: 53.21917 lon: 6.56667 hasResults: False
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<|newrecord|> nctId: NCT06360380 id: AQP-CLP-004 briefTitle: Reducing Fluid Overload in Heart Failure Patients Using a Non-invasive, Renal Independent System acronym: REFORM-HF overallStatus: NOT_YET_RECRUITING date: 2024-07-03 date: 2024-11-03 date: 2024-12-29 date: 2024-04-11 date: 2024-04-11 name: AquaPass Medical Ltd. class: INDUSTRY briefSummary: The REFORM-HF study aims to test a new technology, AquaPass, designed to assist patients experiencing symptoms of fluid overload due to Heart Failure.
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Patients will wear a lightweight suit that helps remove excess fluids through their sweat.
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We want to see if AquaPass can remove an additional 500mL of fluids during treatment, alongside patients' regular medications like diuretics.
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Participants will select if to be treated at their home or in the outpatient clinic. conditions: Chronic Heart Failure conditions: CKD Stage 3 studyType: INTERVENTIONAL phases: NA allocation: NON_RANDOMIZED interventionModel: CROSSOVER interventionModelDescription: A prospective, multicenter, single-arm, within-patient-controlled, pivotal trial, enrolling patients with decompensated heart failure and/or CKD stage 2-3 inadequately responding to current medical treatment, indicated by persistent or worsening congestion despite a daily dose of ≥40 mg furosemide or equivalent. primaryPurpose: TREATMENT masking: NONE count: 40 type: ESTIMATED name: AquaPass System measure: AquaPass Performance Evaluation measure: AquaPass Safety Evaluation sex: ALL minimumAge: 21 Years maximumAge: 80 Years stdAges: ADULT stdAges: OLDER_ADULT hasResults: False
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<|newrecord|> nctId: NCT06360367 id: 2023-00060 briefTitle: mHealth to Improve Diet Quality Among Early Adolescents in SNAP-Ed in Hawaii overallStatus: RECRUITING date: 2024-04-23 date: 2024-10-22 date: 2024-10-22 date: 2024-04-11 date: 2024-04-12 name: University of Hawaii class: OTHER name: United States Department of Agriculture (USDA) name: Pennington Biomedical Research Center briefSummary: The goal of this 8-week clinical trial is to learn whether the PortionSize Ed mobile app helps to improve healthy eating habits among early adolescents in the Hawai'i-Food and Lifeskills for Youth (HI-FLY) program.
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PortionSize Ed is a dietary assessment and nutrition education mobile app, that provides real-time feedback on adherence to tailored dietary recommendations. HI-FLY is a healthy lifestyle program delivered in schools throughout Hawaii. PortionSize Ed also contains educational videos.
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Participants in this study will be randomly assigned to either the HI-FLY only group (HI-FLY), where they will receive the standard HI-FLY program or to the HI-FLY + PortionSize Ed app (HI-FLY + PSEd) group where they will receive the standard HI-FLY program and a study iPhone with the PortionSize Ed app for the 8-week study. This will allow us to evaluate the effect of the PortionSize Ed app among early adolescents in HI-FLY. conditions: Diet, Healthy studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: PREVENTION masking: NONE count: 60 type: ESTIMATED name: HI-FLY Curriculum name: HI-FLY Curriculum + PortionSize Ed app measure: Feasibility- Study enrollment measure: Acceptability- User Satisfaction Survey (USS) scores and qualitative responses measure: Acceptability- Computer System Usability Questionnaire (CSUQ) scores measure: Acceptability- PortionSize Ed app usage data measure: Acceptability- Reason for study drop out measure: Efficacy- Change in total Healthy Eating Index-2020 (HEI-2020) total score measure: Efficacy- Change in HEI-2020 component scores measure: Efficacy- Change in healthy eating behavior scores from the Nutrition Education Survey measure: Feasibility- Study Attrition measure: Change in body weight sex: ALL minimumAge: 11 Years maximumAge: 14 Years stdAges: CHILD facility: University of Hawaii at Manoa status: RECRUITING city: Honolulu state: Hawaii zip: 96822 country: United States name: Chloe P Lozano, PhD role: CONTACT phone: 808-956-7095 email: [email protected] lat: 21.30694 lon: -157.85833 hasResults: False
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<|newrecord|> nctId: NCT06360354 id: 20230223 briefTitle: A Study Evaluating AMG 193 in Combination With Other Therapies in Participants With Advanced Gastrointestinal, Biliary Tract, or Pancreatic Cancers With Homozygous Methylthioadenosine Phosphorylase (MTAP)-Deletion overallStatus: RECRUITING date: 2024-05-01 date: 2026-06-30 date: 2028-06-29 date: 2024-04-11 date: 2024-04-22 name: Amgen class: INDUSTRY briefSummary: The study aims to determine maximum tolerated dose (MTD) or recommended combination dose of the MTA-cooperative PRMT5 inhibitor AMG 193 administered in combination with other therapies in adult participants with metastatic or locally advanced methylthioadenosine phosphorylase (MTAP)-deleted gastrointestinal, biliary tract, or pancreatic cancers. The study also aims to determine the safety profile of AMG 193 administered in combination with other therapies in adult participants with metastatic or locally advanced MTAP-deleted gastrointestinal, biliary tract, or pancreatic cancers. conditions: Advanced Gastrointestinal, Biliary Tract, and Pancreatic Cancers studyType: INTERVENTIONAL phases: PHASE1 allocation: NON_RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: NONE count: 282 type: ESTIMATED name: AMG 193 name: Gemcitabine name: Nab-paclitaxel name: Cisplatin name: Pembrolizumab name: Modified FOLFIRINOX measure: Number of Participants Experiencing Dose Limiting Toxicities (DLT) measure: Number of Participants Experiencing Treatment Emergent Adverse Events (TEAE) measure: Number of Participants Experiencing Serious Adverse Events (SAE) measure: Objective Response (OR) per Response Evaluation Criteria in Solid Tumors (RECIST v1.1) measure: Disease Control (DC) per RECIST v1.1 measure: Duration of Response (DOR) per RECIST v1.1 measure: Time to Response (TTR) per RECIST v1.1 measure: Overall Survival (OS) per RECIST v1.1 measure: Progression-free Survival (PFS) per RECIST v1.1 measure: Maximum Plasma Concentration (Cmax) of AMG193 measure: Time to Maximum Plasma Concentration (tmax) of AMG193 measure: Area Under the Plasma Concentration-time Curve (AUC) of AMG 193 sex: ALL minimumAge: 18 Years maximumAge: 100 Years stdAges: ADULT stdAges: OLDER_ADULT facility: City of Hope National Medical Center status: RECRUITING city: Duarte state: California zip: 91010 country: United States lat: 34.13945 lon: -117.97729 hasResults: False
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<|newrecord|> nctId: NCT06360341 id: 202301946 briefTitle: Emergency Department Digital Pain Self-Management Intervention to Improve Acute Low Back Pain Outcomes overallStatus: NOT_YET_RECRUITING date: 2024-04-15 date: 2024-12-31 date: 2025-01-01 date: 2024-04-11 date: 2024-04-11 name: University of Florida class: OTHER briefSummary: The proposed study aims to evaluate a pilot emergency department (ED) digital pain self-management intervention (EDPSI) focused on improving self-efficacy, knowledge, and skills, thus reducing the transition from acute to chronic low back pain in ED patients discharged with axial acute low back pain (aLBP). The proposed research has significant potential to improve self-efficacy (the confidence in one's ability to manage their condition) which is one of the most potent factors for improved health outcomes. conditions: Low Back Pain, Mechanical conditions: Acute Pain studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL interventionModelDescription: Individuals in the pilot randomized controlled trial (RCT) intervention will be randomized to either the intervention or routine discharge care (RC) using REDCap randomizer and assigned to RC or Emergency Department Digital Pain Self-Management Intervention (EDPSI) + RC. primaryPurpose: TREATMENT masking: NONE maskingDescription: Randomization to RC or Intervention group will not be masked to the Principal Investigator (PI), co-PI, or to participants. count: 30 type: ESTIMATED name: Emergency Department Digital Pain Self-Management Intervention (EDPSI) name: Routine Discharge Care measure: Improving Self-Management Health Outcomes sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: UF Health Shand's Adult Emergency Department city: Gainesville state: Florida zip: 32608 country: United States name: Alexandria A Carey, MSN, MBA-HC role: CONTACT phone: 661-607-1702 email: [email protected] name: Angela R Starkweather, PhD role: CONTACT phone: (352) 273-6323 email: [email protected] lat: 29.65163 lon: -82.32483 hasResults: False
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<|newrecord|> nctId: NCT06360328 id: 033-2024 briefTitle: Success Rates of Video- vs. Direct Laryngoscopy for Endotracheal Intubation in Anesthesiology Residents: A Randomized Controlled Trial" (The JuniorDoc-VL-Trial) acronym: JuniorDoc-VL overallStatus: RECRUITING date: 2024-04-01 date: 2027-04-01 date: 2027-08-01 date: 2024-04-11 date: 2024-04-15 name: University Hospital Heidelberg class: OTHER briefSummary: Securing the airway through endotracheal intubation (ETI) is a fundamental skill for anaesthetists. It is used during surgery, in the intensive care unit, during periprocedural anaesthesia and in emergency medicine. The clinical relevance of airway management is demonstrated in particular by the fact that the main cause of serious anaesthesia-related complications lies in the area of airway management. increasing technological developments in recent years (e.g. video laryngoscopy \[VL\]) aim to reduce the complication rate in the area of airway management. however, there are currently a large number of VLs available, which differ massively in their application. Therefore, it is essential to systematically collect data and develop structured training in airway management, taking into account current technological developments.While endotracheal intubation is traditionally performed with a direct laryngoscope, indirect video laryngoscopy, with chip-based camera technology at its tip, has been introduced across the board in recent years and is now part of standard clinical and preclinical equipment. Doctors in advanced training are trained with a focus on direct laryngoscopy; the use of and training in indirect video laryngoscopy does not follow any standards; in addition, the decision as to which method of securing the airway is chosen has so far been the responsibility of the individual doctor in anaesthesiology, although there is a tendency for the VL to be associated with a higher success rate in the first intubation attempt, the so-called "first-pass success".The main aim of this clinical prospective, randomised controlled trial is to train anaesthetists in advanced training in conventional direct laryngoscopy on the one hand and indirect video laryngoscopy (VL) on the other, with a focus on tracking the progress of their skills after 200 intubations with regard to first-pass success. conditions: Intubation Complication conditions: Intubation studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL interventionModelDescription: Control group = direct laryngoscopy Intervention group = video laryngoscopy primaryPurpose: TREATMENT masking: NONE count: 30 type: ESTIMATED name: video laryngoscopy measure: Rate of Successful tracheal intubation on the first attempt (First-Pass-Success). measure: Number of complications such as desaturation below 90% Oxygen saturation level (SpO2), regurgitation, dental or soft tissue trauma. measure: Specify the number of attempts made during laryngoscopy. measure: Compare the level of training with intubation success. measure: Mention any failures or transitions to other rescue techniques. measure: Specify the use of Optimal External Laryngeal Manipulation (OELM) techniques such as backward, upward and rightward pressure (BURP) Cricoid Pressure (CP) or adjustment of the participant's head and neck position. measure: When using VL, record the occurrence of fogging. measure: Assess the glottic view using the Cormack-Lehane-Score (I - IV). (I = good view) measure: assess the glottic view using the Percentage of Glottic Opening Score (POGO) (0%-100%). (0%= no view, 100% best view) sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Medical Faculty Heidelberg, Department of Anesthesiology, Heidelberg University, status: RECRUITING city: Heidelberg state: Baden-Wuerttemberg zip: 69120 country: Germany name: Davut Deniz Uzun, MD role: CONTACT phone: 0049 62215639349 email: [email protected] name: Felix Schmitt, MD role: CONTACT phone: 0049 62215639421 email: [email protected] lat: 49.40768 lon: 8.69079 hasResults: False
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<|newrecord|> nctId: NCT06360315 id: 202201265 briefTitle: Impact of a Letter Encouraging Pneumococcal Vaccination on the 1-year Vaccination Rate in Heart Failure Patients With a Primary Care Physician overallStatus: ACTIVE_NOT_RECRUITING date: 2023-01-02 date: 2024-04 date: 2024-06 date: 2024-04-11 date: 2024-04-11 name: University Hospital, Montpellier class: OTHER briefSummary: Heart failure affects more than 1.5 million people in France, resulting in over 70,000 deaths and more than 165,000 hospitalizations each year. Viral and bacterial infections are frequently associated with episodes of acute heart failure in patients with chronic heart failure (CHF). Lower respiratory tract infections, such as influenza and pneumococcus, are common causes of hospitalization for decompensated heart failure, leading to increased morbidity and mortality. Studies have shown that pneumococcal vaccination can reduce the risks of heart attack or stroke in patients with heart failure. However, despite vaccination recommendations, coverage rates remain low, especially for pneumococcus. In this study, we will evaluate the impact of an incentive letter for pneumococcal vaccination on one-year hospitalization rate in patients with heart failure. conditions: Chronic Heart Failure studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: PREVENTION masking: NONE count: 12000 type: ESTIMATED name: Incentive letter for pneumococcal vaccination to the patient and to the GP measure: 1-year Pneumococcus vaccination rate measure: 1-year all-cause hospital admission rate measure: 1-year specific hospital admission rate measure: 1-year all-cause mortality rate sex: ALL minimumAge: 45 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Montpellier University Hospital city: Montpellier zip: 34090 country: France lat: 43.61092 lon: 3.87723 hasResults: False
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<|newrecord|> nctId: NCT06360302 id: RECHMPL22_0505 briefTitle: Plasma Biomarkers of Muscle Metabolism During Exercise to the Assessment of Insulin Resistance in CKD Dialysis Patients acronym: KREBSome-IRC overallStatus: NOT_YET_RECRUITING date: 2024-05-01 date: 2026-05-01 date: 2026-05-01 date: 2024-04-11 date: 2024-04-11 name: University Hospital, Montpellier class: OTHER briefSummary: This prospective, multicenter, cross-sectional, repeated-measures comparative study compared functional and biochemical response profiles to exercise between 2 groups of chronically ill patients (chronic renal failure dialysis patients and patients with metabolic syndrome) and a group of healthy subjects.
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The hypothesis is that the addition of plasma metabolic intermediates associated with energy disorders linked to insulin resistance, will improve the sensitivity of the assessment of muscle oxidative metabolism abnormalities, as reported in exercise intolerant subjects.
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In this way, the metabolomics approach during exercise would provide a biological and functional "signature" of insulin resistance of muscular origin, discriminating between insulin-resistant patients, healthy control subjects and dialysis patients, with an exercise metabolic profile approaching that observed in insulin-resistant patients. A better understanding of metabolic abnormalities could guide muscle rehabilitation.
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Participants will be asked to perform an exercise test, with several blood samples taken at different exercise intensities.
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