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* have operative samples stained by Congo red in search of amyloid, which will be typed by immunochemistry in positive samples, |
* undergo a multimodal imaging search for cardiac involvement, if ATTR is identified, |
* undergo a preoperative complete clinical examination, including collection of medical history, ECG, biochemical tests, and imaging (ultrasound scans of rotator cuff and hip capsule in all participating patients, of the carpal tunnel in patients operated at this site, and MRI + standing profile radiography of the lumbar spine, in patients operated for lumbar stenosis) |
* ATTR positive patients will be proposed to be followed-up by a reference center, with the aim of an early diagnosis of cardiac involvement, allowing efficient mamagement. |
Researchers will assess the frequency of ATTR deposits at each operated site, the frequency or ATTR cardiopathy in ATTR + patients, and will compare demographic, clinical, biochemical, and imaging features in patients with and without ATTR deposits, to guide the indications of pathological examination during these frequent orthopedic surgeries conditions: ATTR Amyloidosis conditions: Cardiopathy conditions: Carpal Tunnel Syndrome conditions: Lumbar Spine Stenosis conditions: Hip Prosthesis conditions: Knee Prosthesis studyType: OBSERVATIONAL observationalModel: CASE_CONTROL timePerspective: CROSS_SECTIONAL count: 150 type: ESTIMATED measure: frequency of ATTR amyloidosis measure: presence of ATTR cardiopathy measure: proportion of wild type and hereditary ATTR measure: Description of preoperative predictors of ATTR measure: Description of preoperative predictors of ATTR measure: preoperative predictors of ATTR sex: ALL minimumAge: 50 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Mutualist Montsouris Institute status: RECRUITING city: Paris zip: 75014 country: France name: Thomas M Bardin, Pr role: CONTACT phone: +33 156616263 email: [email protected] lat: 48.85341 lon: 2.3488 hasResults: False |
<|newrecord|> nctId: NCT06367829 id: WO.24.025 briefTitle: Lubinus SPII Hip Stem Target Trial Emulation (LARGE) acronym: LARGE overallStatus: ENROLLING_BY_INVITATION date: 2024-01-08 date: 2024-07-14 date: 2025-01-08 date: 2024-04-16 date: 2024-04-16 name: JointResearch class: OTHER name: OLVG name: Uppsala University name: Göteborg University name: Leiden University Medical Center briefSummary: The research questions this study aims to answer are as follows: |
Primary research question: |
"Do primary total hip arthroplasties for patients with OA, hip fracture or osteonecrosis with the 150mm Lubinus SPII hip stem have better mortality and stem revision rates than primary total hip arthroplasties with the 130mm hip stem?" |
Secondary aims include: |
* How does line-to-line cementation, compare to undersized cementation in primary total hip arthroplasty for patients with OA, hip fracture, or osteonecrosis when comparing equal size Lubinus SPII hip stems implanted with different cementation techniques? |
* Does the Lubinus SPII 150mm hip stem perform equal to the Lubinus SPII 130mm hip stem in primary total hip arthroplasties for patients with OA, hip fracture or osteonecrosis when comparing patient reported outcome measures? |
To answer these questions, this study has been allowed use of registered data from the LROI (dutch arthroplasty registry) and the SAR (swedish arthroplasty registry). After exclusion of patients who did not meet inclusion criteria between 2007-2020, approximately 110000 patients remain eligible for analysis. conditions: Treatment Outcome studyType: OBSERVATIONAL observationalModel: OTHER timePerspective: OTHER count: 110000 type: ESTIMATED name: Lubinus SPII hip stem 130mm name: Lubinus SPII hip stem 150mm measure: Mortality rate measure: Revision rate measure: NRS pain score measure: Oxford hip score measure: EQ - 5D measure: HOOS - PS measure: Revision rate measure: Mortality rate sex: ALL minimumAge: 5 Years maximumAge: 105 Years stdAges: CHILD stdAges: ADULT stdAges: OLDER_ADULT facility: OLVG city: Amsterdam state: Noord Holland zip: 1090 HM country: Netherlands lat: 52.37403 lon: 4.88969 hasResults: False |
<|newrecord|> nctId: NCT06367816 id: 13509 briefTitle: Brain Recovery With Automated VEntilation acronym: BRAVE overallStatus: RECRUITING date: 2024-04-11 date: 2024-12-31 date: 2024-12-31 date: 2024-04-16 date: 2024-04-16 name: University of Genova class: OTHER briefSummary: Thus far, the closed-loop ventilation mode INTELLiVENT-ASV has been extensively tested in various groups of critically ill patients, and has been shown to be effective and safe in various groups of ventilated patients, including those at risk of acute respiratory distress syndrome (ARDS), patients with ARDS, and patients with chronic obstructive pulmonary disease (COPD). Some of these studies included acute brain injury (ABI) patients, but the effectiveness, efficacy and safety of INTELLiVENT-ASV has never been thoroughly tested in these patients. The current study will investigate the effectiveness in providing both brain- and lung protective ventilation, the safety and the efficacy of a closed-loop ventilation mode (INTELLiVENT-ASV) in acute brain injury patients, using breath-by-breath data. conditions: Brain Injuries, Acute conditions: Respiration, Artificial conditions: Automation studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: PROSPECTIVE count: 20 type: ESTIMATED name: INTELLiVENT name: Conventional ventilation measure: Proportion of breaths in predefined zones of ventilation measure: Proportion of time in predefined zones of ventilation measure: Intracerebral changes assessed by multimodal neuromonitoring available measure: Changes on Electrical Impedence Tomography when available measure: Effectiveness in primary ABI patients vs non primary ABI patients measure: Episodes and time of high maximum airway pressure measure: Episodes and time of high respiratory rate measure: Incidence of severe hypoxemia measure: Incidence of severe hypercapnia measure: Discontinuation of ventilatory mode (yes or no) measure: Percentage of breaths in the predefined 'critical' ventilation zone measure: Incidence of pneumothorax measure: Efficacy on glascow coma scale measure: Duration of ventilation in survivors measure: Ventilator free days measure: Intensive care unit length of stay measure: Hospital length of stay measure: 28-day mortality measure: 90-day mortality measure: Number of alarms measure: Number of manual adjustments sex: ALL minimumAge: 18 Years maximumAge: 105 Years stdAges: ADULT stdAges: OLDER_ADULT facility: UO Clinica Anestesiologica e Terapia Intensiva, IRCCS Ospedale Policlinico San Martino status: RECRUITING city: Genova state: GE zip: 16132 country: Italy name: Denise Battaglini, MD, PhD role: CONTACT phone: +39-0105554970 email: [email protected] name: Lorenzo Ball, MD, PhD role: CONTACT phone: +39-0105554970 email: [email protected] lat: 44.40478 lon: 8.94438 hasResults: False |
<|newrecord|> nctId: NCT06367803 id: DVS010 briefTitle: Cost Analysis of Vascular Surgical Techniques overallStatus: COMPLETED date: 2023-06-01 date: 2023-12-01 date: 2024-03-01 date: 2024-04-16 date: 2024-04-16 name: University Hospital of Limerick class: OTHER briefSummary: Whilst mortality rates and surgical limitations are widely known and understood for each intervention performed, the cost implications, in UHL, are not known. Therefore, it is deemed a matter of interest to understand these costs and weigh them against the mortality rates for each intervention if available. conditions: Critical Limb Ischemia studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: RETROSPECTIVE count: 200 type: ACTUAL measure: A comparative assessment of the cost implications of the surgical modalities used in the treatment of CLTI i.e., revascularisation and amputation. sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: University Hospital Limerick city: Limerick state: Munster country: Ireland lat: 52.66472 lon: -8.62306 hasResults: False |
<|newrecord|> nctId: NCT06367790 id: Bask-Pliomet briefTitle: Plyometry and Tapping in the Functional Improvement of Non-professional Basketball Players overallStatus: NOT_YET_RECRUITING date: 2024-04-15 date: 2024-06-10 date: 2024-07-01 date: 2024-04-16 date: 2024-04-16 name: Universidad Católica San Antonio de Murcia class: OTHER briefSummary: Introduction. In basketball, the lower extremities have the highest prevalence of injury, regardless of gender and professional category. |
Objective. To analyse the efficacy of a physiotherapy intervention using a protocol of plyometric exercises and dry needling in non-professional basketball athletes. |
Methods. Randomised clinical study. 20 players will be randomised to an experimental group (plyometric exercises and dry needling of the gastrocnemius muscles) and a control group (plyometric exercises). The intervention will include 8 sessions over 4 weeks. The study variables will be: range of motion in dorsal flexion in loading (Leg Motion®) and unloading (goniometer) and vertical jump (MyJump2®). |
Expected results. An intervention of plyometric exercises and dry needling produces significant differences in range of motion and vertical jump in basketball players, compared to the isolated administration of plyometric exercises. conditions: Basketball Players studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: PREVENTION masking: SINGLE whoMasked: OUTCOMES_ASSESSOR count: 20 type: ESTIMATED name: Experimental group name: Control group measure: Change from baseline range of motion in loaded dorsal flexion after treatment and at 4 weeks measure: Change from baseline range of motion in unloaded dorsal flexion after treatment and at 4 weeks measure: Change from baseline vertical jump after treatment and at 4 weeks sex: MALE minimumAge: 18 Years maximumAge: 30 Years stdAges: ADULT facility: Rubén Cuesta-Barriuso city: Oviedo state: Asturias zip: 33006 country: Spain name: Rubén Cuesta-Barriuso, PhD role: CONTACT phone: 607547274 email: [email protected] lat: 43.36029 lon: -5.84476 hasResults: False |
<|newrecord|> nctId: NCT06367777 id: 2024/14MAR/132 briefTitle: Cervical/Thoracic Neuromodulation and Nociceptive Processing acronym: MICROVOLT2 overallStatus: NOT_YET_RECRUITING date: 2024-05 date: 2024-10 date: 2024-10 date: 2024-04-16 date: 2024-04-16 name: Université Catholique de Louvain class: OTHER briefSummary: Several studies have demonstrated that direct currents delivered through the skin at the level of the low-thoracic spinal cord can influence spinal cord function. In human volunteers, anodal low-thoracic transcutaneous spinal direct current stimulation (tsDCS) alters spinal processing of nociceptive inputs. Whether cervical tsDCS is able to do the same is less well known. In this double-blinded, sham-controlled and cross-over trial, the investigators will compare the effects on the nociceptive processing of healthy volunteers of cervical and low-thoracic tsDCS. conditions: Nociceptive Pain studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: CROSSOVER primaryPurpose: BASIC_SCIENCE masking: QUADRUPLE whoMasked: PARTICIPANT whoMasked: CARE_PROVIDER whoMasked: INVESTIGATOR whoMasked: OUTCOMES_ASSESSOR count: 24 type: ESTIMATED name: cervical a-tsDCS name: thoracic a-tsDCS name: sham tsDCS measure: Change in contact-heat evoked potentials amplitude measure: Change in intensity of perception to contact-heat nociceptive stimuli measure: Change in skin temperature measure: Change in cutaneous blood flow sex: ALL minimumAge: 18 Years maximumAge: 40 Years stdAges: ADULT hasResults: False |
<|newrecord|> nctId: NCT06367764 id: BPS-2022C3-30535 briefTitle: A Comparative Effectiveness Study of PTSD Treatments Among Sexual and Gender Minority Populations acronym: LIFESCAPE overallStatus: NOT_YET_RECRUITING date: 2024-05 date: 2028-06 date: 2028-06 date: 2024-04-16 date: 2024-04-23 name: University of California, San Francisco class: OTHER name: Patient-Centered Outcomes Research Institute name: Stanford University briefSummary: The goal of this clinical trial is see if Cognitive Processing Therapy and STAIR Narrative Therapy work to treat posttraumatic stress disorder (PTSD) among lesbian, gay, bisexual, transgender, queer/questioning, intersex, asexual/aromantic, and all other sexual or gender minority (LGBTQIA+) adults. The main questions it aims to answer are: |
* Do these treatments reduce PTSD symptoms in LGBTQIA+ patients? |
* Do these treatments help improve quality of life and reduce depression in LGBTQIA+ patients? |
* Do stress from stigma and discrimination and drug/alcohol use change the impact of the treatment on PTSD symptoms? |
* Are LGBTQIA+ patients satisfied with these treatments? Do these treatments work differently among different groups within the LGBTQIA+ community? |
* Do LGBTQIA+ patients complete these treatments? |
Study participants will receive one of these two PTSD treatments. Participants will complete assessments before and after receiving treatment. conditions: PTSD studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: SINGLE whoMasked: OUTCOMES_ASSESSOR count: 400 type: ESTIMATED name: Cognitive Processing Therapy name: STAIR Narrative Therapy measure: Change in Posttraumatic Stress Disorder (PTSD) Symptoms Measured by PTSD Checklist for DSM-5 (PCL-5) measure: Change in Depression Measured by Patient Health Questionnaire (PHQ-9) measure: Change in Quality of Life Measured by WHOQOL-BREF: Social Relationships and Environment Scales measure: Patient Satisfaction Measured By Satisfaction with Therapy and Therapist Scale-Revised (STTS-R) measure: Assessing Treatment Dropout Measured by Completion of Less than 8 Sessions measure: Minority Stress Measured by Cultural Assessment of Risk for Suicide (CARS) Minority Stress Subscale - Moderator measure: Substance Use Measured Alcohol and Substance, Smoking, and Substance Involvement Screening Test (ASSIST) - Moderator sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: UCSF Alliance Health Project city: San Francisco state: California zip: 94103 country: United States name: Annesa Flentje, PhD role: CONTACT lat: 37.77493 lon: -122.41942 hasResults: False |
<|newrecord|> nctId: NCT06367751 id: 2024-00358; th23Kasenda briefTitle: Implementation of Liquid Biopsies During Routine Clinical Care in Patients With Advanced Malignancies (LIQPLAT) acronym: LIQPLAT overallStatus: NOT_YET_RECRUITING date: 2024-05 date: 2026-10 date: 2026-10 date: 2024-04-16 date: 2024-04-19 name: University Hospital, Basel, Switzerland class: OTHER name: Research Center for Clinical Neuroimmunology and Neuroscience Basel briefSummary: The goal of this study is to assess the implementation and feasibility of ctDNA measurements from blood samples obtained during routine clinical care of cancer patients in the University Hospital Basel. |
Researchers will compare clinical and patient reported outcomes from the LIQPLAT study with patients who did not receive ctDNA measurements (external comparator from registry AO_2023-00091). |
Blood samples will be drawn from the patients as part of routine care and ctDNA measurements will be performed on these samples. conditions: Advanced Solid Tumor studyType: INTERVENTIONAL phases: NA allocation: NA interventionModel: SINGLE_GROUP interventionModelDescription: This is a trial using routinely collected health care data from an ongoing registry (AO_2023-00091) in cancer patients with advanced solid malignancies receiving first line systemic anti-cancer treatment for advanced disease. All patients will receive routine diagnostics, treatment and follow-up. All patients with a new cancer diagnosis will be assessed for eligibility based on the routinely collected information available in the registry. We will then randomly decide which eligible patients are invited to participate in the trial. If patients accept the invitation and intend to get a measurement of ctDNA, they have to provide written informed consent. The study comprises an external comparator arm with 75 (anticipated) cancer patients, and an active comparator arm with 150 (anticipated) cancer patients. primaryPurpose: OTHER masking: NONE count: 150 type: ESTIMATED name: ctDNA measurement measure: Number and proportion of patients in whom ctDNA was detectable before starting medical anticancer treatment measure: Patients in whom actionable alterations were identified in ctDNA analysis measure: Turn-around time of ctDNA analysis measure: ctDNA kinetics measure: Number of ctDNA testing results that were successfully made available to the molecular tumor board measure: Number of patients being positive for ctDNA and suspicious Clonal Hematopoiesis of Indeterminate Potential measure: Quality of life and physical function measure: Overall survival measure: Survival rate 6 months measure: Survival rate 12 months measure: Time to next treatment line measure: Unplanned hospital admissions and emergency room visits measure: Progression free survival measure: Number of ctDNA analyses with a valid result measure: Patients being referred and recruited to a different interventional clinical trial measure: Tissue biopsies per patient measure: Imaging per patient measure: Blood products per patient measure: Cumulative doses of cancer drug treatments administered sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT hasResults: False |
<|newrecord|> nctId: NCT06367738 id: 2024-11-14799 briefTitle: Investigating the Persisting Effects of a Single Dose of Psilocybin on Structural Plasticity in Healthy Older Adults overallStatus: NOT_YET_RECRUITING date: 2025-04-01 date: 2026-12-30 date: 2027-12-30 date: 2024-04-16 date: 2024-04-16 name: University of California, Berkeley class: OTHER briefSummary: We will use cognitive exams, perceptual tasks, brain imaging, peripheral psychophysiology, and surveys to investigate the persisting effects of psilocybin on cognition, predictive coding, and affect in healthy older adults. We will measure changes in these measures by comparing baseline to one-week and one-month post-treatment. Participants will be randomly assigned to receive a dose of psilocybin in a range from microdose to moderate-to-high dose. Dose response will be assessed. Anatomical magnetic resonance imaging (MRI) and diffusion weighted imaging (DWI) will be used to assess changes in brain structure, while functional magnetic resonance imaging (fMRI) will be used to quantify changes in functional brain activity. We will assess whether changes in these brain measures underlie observed changes in cognition, predictive coding and affect. conditions: Aging studyType: INTERVENTIONAL phases: PHASE1 allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: BASIC_SCIENCE masking: TRIPLE whoMasked: PARTICIPANT whoMasked: CARE_PROVIDER whoMasked: INVESTIGATOR count: 40 type: ESTIMATED name: Psilocybin measure: MRI measurements of brain structure measure: Amplitude and pattern of fMRI cortical responses measure: Peripheral psychophysiology measure: Perceptual measurements measure: Cognitive measurements sex: ALL minimumAge: 60 Years maximumAge: 85 Years stdAges: ADULT stdAges: OLDER_ADULT hasResults: False |
<|newrecord|> nctId: NCT06367725 id: 1-10-72-122-23 briefTitle: Pharmacokinetics of Dexamethasone in Childhood ALL and Reduction in Bone Mineral Density overallStatus: RECRUITING date: 2024-04-11 date: 2027-12-30 date: 2030-12-30 date: 2024-04-16 date: 2024-04-16 name: University of Aarhus class: OTHER briefSummary: The goal of this observational study is to learn about, the systemic exposure to dexamethason in childhood acute lymphatic leukemia (ALL). The main questions it aims to answer are: |
* How does the intake of dexamethasone correlate with systemic exposure to dexamethason? |
* Does systemic exposure to dexamethasone correlate with a reduction in bone mineral density? |
Participants will: |
* Continue to receive the best available therapy for ALL in Western Europe. |
* Have blood samples taken from their central line to measure dexamethasone levels. |
* When standard lumbar punctures are done as part of treatment, a sample of cerebrospinal fluid will also be taken to analyze dexamethasone. |
* Visit the clinic four times for a DXA scans to measure bone density and vertebral fracture assessment: within three weeks of starting treatment, six months after starting treatment, one month after finishing treatment, and one year after finishing treatment. Biomarkers related to bone health will also be collected on these days. Additionally, participants will fill out questionnaires to track their daily physical activity levels. conditions: Acute Lymphoblastic Leukemia studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: PROSPECTIVE count: 100 type: ESTIMATED measure: Area Under the Plasma Concentration Curve (AUC) of Dexamethasone measure: Mineral bone density by DXA-scan measure: Vertebral fracture assessment (VFA) by DXA-scan measure: Dexamethasone in cerebrospinal fluid measure: Physical activity questionnaire measure: Biomarkers of bone metabolism sex: ALL minimumAge: 1 Year maximumAge: 17 Years stdAges: CHILD facility: Department of Paediatrics and Adolescent Medicine, Copenhagen University Hospital Rigshospitalet status: NOT_YET_RECRUITING city: Copenhagen state: København Ø zip: 2100 country: Denmark name: Peter EL Pontoppidan, phd role: CONTACT email: [email protected] lat: 55.67594 lon: 12.56553 facility: Department of Paediatrics and Adolescent Medicine, Odense University Hospital status: NOT_YET_RECRUITING city: Odense state: Odense C zip: 5000 country: Denmark name: Peder S Wehner, phd role: CONTACT email: [email protected] lat: 55.39594 lon: 10.38831 facility: Department of Paediatrics and Adolescent Medicine, Aalborg University Hospital status: NOT_YET_RECRUITING city: Aalborg zip: 9000 country: Denmark name: Marianne Olsen, phd role: CONTACT email: [email protected] lat: 57.048 lon: 9.9187 facility: Department of Paediatrics and Adolescent Medicine, Aarhus University Hospital status: RECRUITING city: Aarhus N zip: 8200 country: Denmark name: Karen S Jensen, phd role: CONTACT email: [email protected] name: Birgitte K Albertsen, Professor role: CONTACT lat: 56.15674 lon: 10.21076 hasResults: False |
<|newrecord|> nctId: NCT06367712 id: Ahmed Kassab briefTitle: Letrozole Alone Protocol Versus Using Letrozole and HCG Protocol overallStatus: COMPLETED date: 2022-11-10 date: 2023-11-01 date: 2023-11-10 date: 2024-04-16 date: 2024-04-16 name: Egymedicalpedia class: INDUSTRY briefSummary: Letrozole is a chemical compound, CGS 20267 which is a third-generation, nonsteroidal aromatase inhibitor. |
Letrozole blocks estrogen synthesis by directly affecting the hypothalamic-pituitary-ovarian axis, subsequently, increases gonadotropins which increase pregnancy rates. Possible positive outcomes of aromatase inhibitors over selective estrogen-receptor modulators include a more physiologic hormonal stimulation of the endometrium which increases receptivity, a lower multiple-pregnancy through single follicle growth, a lesser side-effect especially vasomotor and mood symptoms, and more prompt clearance from blood, hence, reducing the probabilities of periconceptional exposure conditions: PCOS (Polycystic Ovary Syndrome) of Bilateral Ovaries studyType: INTERVENTIONAL phases: PHASE1 allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: SINGLE whoMasked: PARTICIPANT count: 132 type: ACTUAL name: Letrozole tablets measure: Pregnancy test sex: FEMALE minimumAge: 18 Years maximumAge: 35 Years stdAges: ADULT facility: Ahmed Maher Teaching Hospital city: Cairo country: Egypt lat: 30.06263 lon: 31.24967 hasResults: False |
<|newrecord|> nctId: NCT06367699 id: H-44821 briefTitle: Conversational Agents to Improve HPV Vaccine Acceptance in Primary Care (ECA-HPV) Clinical Trial overallStatus: NOT_YET_RECRUITING date: 2024-06 date: 2027-09 date: 2027-12 date: 2024-04-16 date: 2024-04-16 name: Tufts Medical Center class: OTHER name: Boston Medical Center name: Northeastern University briefSummary: The objective of this study is to assess the use of and satisfaction with the ECA-HPV intervention over a 16-month period, its ability to increase HPV vaccination, and the comparative effectiveness of clinic notification and adolescent ECA components on these factors. conditions: Human Papilloma Virus studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: HEALTH_SERVICES_RESEARCH masking: NONE count: 1750 type: ESTIMATED name: Usual Care name: ECA-HPV App with Clinic Notification and Adolescent Functions Disabled name: ECA-HPV App with Clinic Notification Function Enabled name: ECA-HPV App with Adolescent Function Enabled name: ECA-HPV App with Clinic Notification and Adolescent Functions Enabled measure: HPV vaccination series completion comparing the control group to the intervention groups measure: HPV vaccination series completion comparing the intervention groups measure: HPV Knowledge measure: HPV Attitudes measure: General Vaccine Attitudes measure: ECA-HPV App Satisfaction measure: Clinic Notification Feature Satisfaction sex: ALL minimumAge: 9 Years maximumAge: 12 Years stdAges: CHILD facility: Boston Medical Center city: Boston state: Massachusetts zip: 02118 country: United States name: Lori Henault, MPH role: CONTACT phone: 617-414-6935 email: [email protected] name: Rebecca Perkins, MD, MSc role: PRINCIPAL_INVESTIGATOR lat: 42.35843 lon: -71.05977 hasResults: False |
<|newrecord|> nctId: NCT06367686 id: REK KULMU B 714179 briefTitle: Detecting Systemic Carbon Dioxide Levels With a Novel Biosensor acronym: DISCO overallStatus: NOT_YET_RECRUITING date: 2024-05 date: 2024-12 date: 2024-12 date: 2024-04-16 date: 2024-04-16 name: The Hospital of Vestfold class: OTHER name: Sensocure AS briefSummary: The study is an open, prospective, single center clinical observational pilot investigation. The aim is to compare the carbon dioxide values measured by the IscAlert sensor, which is inserted in proximity to the nasal mucosa. The study wants to investigate if the nasal mucosa application and measurements are feasible, what kind of possible complications such a measurement can cause, and if the measurements can be a surrogate marker for systemic carbon dioxide values. conditions: Hypercapnic Respiratory Failure conditions: Pulmonary Disease, Chronic Obstructive conditions: Neuromuscular Diseases conditions: Obesity Hypoventilation Syndrome (OHS) studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: PROSPECTIVE count: 11 type: ESTIMATED name: IscAlert sensor measure: Partial pressure (level) of carbon dioxide at the nasal mucosa measure: Bleeding measure: Infection measure: Sinusitis measure: Ulceration measure: Pain at sensor insertion site measure: Muscular temperature level measure: Nasal temperature level measure: Temporal temperature level measure: IscAlert functionality measure: Number of pack-years measure: Length of sensor implantation time measure: Peripheral oxygen saturation measure: Arterial partial pressure (level) of carbon dioxide measure: Arterial partial pressure (level) of oxygen measure: Intramuscular partial pressure (level) of carbon dioxide measure: Transcutaneous partial pressure (level) of carbon dioxide measure: Patient-Reported Outcome Measures 1a - discomfort measure: Patient-Reported Outcome Measures 1b - discomfort measure: Patient-Reported Outcome Measures 2a - runny nose measure: Patient-Reported Outcome Measures 2b - runny nose measure: Patient-Reported Outcome Measures 3a - sneezing measure: Patient-Reported Outcome Measures 3b - sneezing measure: Patient-Reported Outcome Measures 3b - Ulceration measure: Patient-Reported Outcome Measures 3a - Ulceration measure: Patient-Reported Outcome Measures 4a - tenderness measure: Patient-Reported Outcome Measures 4b - tenderness measure: Patient-Reported Outcome Measures 5b - bleeding measure: Patient-Reported Outcome Measures 5a - bleeding measure: Patient-Reported Outcome Measures 6a - reduced sense of smell measure: Patient-Reported Outcome Measures 6b - reduced sense of smell measure: Patient-Reported Outcome Measures 7b - reduced sense of taste measure: Patient-Reported Outcome Measures 7a - reduced sense of taste measure: Patient-Reported Outcome Measures 8a - difficulty sleeping measure: Patient-Reported Outcome Measures 8b - easy to wake up while sleeping measure: Patient-Reported Outcome Measures 9 - problems with eating and drinking measure: Patient-Reported Outcome Measures 10 - difficult breathing measure: Patient-Reported Outcome Measures 11a - diagnosed infection in the nose or sinuses measure: Patient-Reported Outcome Measures 11b - diagnosed infection in the nose or sinuses sex: ALL minimumAge: 18 Years maximumAge: 110 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Vestfold Hopsital Trust city: Tønsberg zip: 3103 country: Norway name: Anne-Marie Gabrielsen, MD, PhD role: CONTACT phone: 92485580 phoneExt: +47 email: [email protected] name: Morten Waldvogel-Rønning, MD role: CONTACT phone: 95203195 phoneExt: +47 email: [email protected] name: Morten Waldvogel-Rønning, MD role: SUB_INVESTIGATOR name: Caroline Sahlstrøm, MD role: SUB_INVESTIGATOR lat: 59.26754 lon: 10.40762 hasResults: False |
<|newrecord|> nctId: NCT06367673 id: QH-ZYDC-01 briefTitle: Natural Killer(NK) Cell Therapy Targeting CLL1 or CD33 in Acute Myeloid Leukemia overallStatus: RECRUITING date: 2024-04-30 date: 2026-03-31 date: 2026-08-31 date: 2024-04-16 date: 2024-04-18 name: Zhejiang University class: OTHER name: Hangzhou Qihanjiyin Biotech Co.,Ltd. briefSummary: This is a phase 1, first-in-human (FIH), open-label, multicohort study to evaluate the safety, tolerability and preliminary efficacy of CLL1 or CD33 target Chimeric antigen receptor (CAR) -induced pluripotent stem cells derived NK cells in patients with relapsed/refractory AML conditions: AML, Adult studyType: INTERVENTIONAL phases: PHASE1 allocation: NA interventionModel: SINGLE_GROUP primaryPurpose: TREATMENT masking: NONE count: 24 type: ESTIMATED name: iPSC-NK cells measure: Incidence of Treatment-Emergent Adverse Events sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: the First Affiliated Hospital, School of Medicine, Zhejiang University status: RECRUITING city: Hangzhou state: Zhejiang zip: 321000 country: China name: Yongxian Hu role: CONTACT email: [email protected] lat: 30.29365 lon: 120.16142 hasResults: False |
<|newrecord|> nctId: NCT06367660 id: 98-2024 briefTitle: Comparison Between Hyperbaric Bupivacaine With Fentanyl vs. Hyperbaric Bupivacaine With Dexmedetomidine in Reducing Visceral Pain During Cesarean Delivery Under Spinal Anaesthesia overallStatus: NOT_YET_RECRUITING date: 2024-04 date: 2024-08 date: 2024-09 date: 2024-04-16 date: 2024-04-24 name: Tribhuvan University Teaching Hospital, Institute Of Medicine. class: OTHER briefSummary: In patients undergoing elective LSCS under subarachnoid block, group BF will receive 0.5% hyperbaric bupivacaine 10mg (2ml) with fentanyl 10 mcg (0.2ml) with total of 2.2 ml and group BD will receive 0.5% hyperbaric bupivacaine 10 mg with Dexmedetomidine 5mcg (0.2ml) total volume 2.2ml. Assessment of intraoperative visceral pain will be done by self-reporting of patients, who are previously educated, as poorly localized discomfort or dragging, pulling heaviness or unpleasant feeling or pain with or without nausea and will be categorized according to preformed scale conditions: Visceral Pain studyType: INTERVENTIONAL phases: PHASE4 allocation: RANDOMIZED interventionModel: SEQUENTIAL interventionModelDescription: Research method: Quantitative Type of study: Randomized, interventional, comparative study primaryPurpose: TREATMENT masking: DOUBLE whoMasked: PARTICIPANT whoMasked: INVESTIGATOR count: 168 type: ESTIMATED name: Intrathecal Bupivacaine-Fentanyl and Bupivacaine-Dexmedetomidine measure: Primary outcome measure: Secondary Outcome sex: FEMALE minimumAge: 18 Years maximumAge: 45 Years stdAges: ADULT hasResults: False |
<|newrecord|> nctId: NCT06367647 id: zhujiangjy-20240229 briefTitle: Investigation on the Detection Rate of Pathogenic Viruses in Feces of Parenteral Infected Individuals overallStatus: RECRUITING date: 2024-04-15 date: 2025-10-31 date: 2025-12-31 date: 2024-04-16 date: 2024-04-22 name: Zhujiang Hospital class: OTHER briefSummary: This project is a cross-sectional study. Investigators plan to search and collect 1600 publicly published fecal metagenomic and metatranscriptome data through the Pubmed database, by summarizing and analyzing them to construct an enterovirus database. 200 apparently healthy individuals are planned to be enrolled. At the time of enrollment, fecal specimens of participants will be collected, and their demographic characteristics, disease and medication history, gastrointestinal status, dietary habits, lifestyle habits, and mental health information will be recorded. Another 200 specimens will be collected from patients with parenteral virus infection. The demographic characteristics and pathogen test results of the parenteral virus infected patients will be reviewed and recorded. By virus metagenomic sequencing on fecal specimens, investigators will identify which viruses can be detected in the intestinal tract of apparently healthy people, and to explore whether parenteral infection viruses can be detected in feces. conditions: Virus Infections studyType: OBSERVATIONAL observationalModel: OTHER timePerspective: CROSS_SECTIONAL count: 2000 type: ESTIMATED measure: virus infection checklist measure: general information of apparently healthy individuals by questionnaire measure: Self-Rating Anxiety Scale SAS measure: Self-rating depression scale SDS measure: Pittsburgh sleep quality index PSQI measure: demographic characteristics case information of parenteral virus infected patients sex: ALL minimumAge: 18 Years maximumAge: 75 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Zhujiang hospital of southern medical university status: RECRUITING city: Guangzhou state: Guangdong zip: 510280 country: China name: Yumei Liu, master role: CONTACT phone: +8618810795365 email: [email protected] lat: 23.11667 lon: 113.25 hasResults: False |
<|newrecord|> nctId: NCT06367634 id: TEO-TSUL-2301 briefTitle: TEOSYAL® PureSense ULTRA DEEP Versus Restylane® Lidocaine for the Correction of Moderate to Severe Nasolabial Folds in Chinese Adults overallStatus: RECRUITING date: 2024-01-19 date: 2025-01 date: 2026-02 date: 2024-04-16 date: 2024-04-16 name: Teoxane SA class: INDUSTRY briefSummary: This is a prospective, multi-center, randomized, controlled, subject- and evaluator-blinded clinical investigation to demonstrate non-inferiority of TEOSYAL® PureSense ULTRA DEEP compared to Restylane® Lidocaine for the correction of moderate to severe NLF in Chinese adults. |
Eligible subjects will be enrolled and randomized either to the treatment group or control group in a 1:1 ratio on Day 0. Each subject assigned to the treatment group will receive TEOSYAL® PureSense ULTRA DEEP in both NLFs, whereas subjects assigned to the control group will receive Restylane® Lidocaine. |
The treating investigator will administer the corresponding product in both NLFs of the subject on Day 0. |
All subjects will return to the site at 4, 12, 24, 36, and 52 weeks after the last treatment for effectiveness and safety assessment. All subjects will receive a safety phone call 7 days after the initial treatment at baseline, and after the touch-up treatment, if applicable. conditions: Nasolabial Folds studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: DOUBLE maskingDescription: Blinded-Live evaluator whoMasked: PARTICIPANT whoMasked: OUTCOMES_ASSESSOR count: 390 type: ESTIMATED name: injection in NLF measure: WSRS grading sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Guangdong Second Provincial General Hospital status: RECRUITING city: Guangzhou country: China lat: 23.11667 lon: 113.25 hasResults: False |
<|newrecord|> nctId: NCT06367621 id: CLS-015C briefTitle: Retrospective Study of iStatis Syphilis Ab Test (POC) overallStatus: ACTIVE_NOT_RECRUITING date: 2023-11-15 date: 2024-04-15 date: 2024-04-15 date: 2024-04-16 date: 2024-04-16 name: bioLytical Laboratories class: INDUSTRY briefSummary: The purpose of this retrospective clinical trial is to establish the clinical performance of the iStatis Syphilis AbTest. The data will be used to demonstrate the product is safe and effective for its intended use. The data obtained will be used in the application for CE certification under In Vitro Diagnostic Medical Device Regulation (IVDR) and World Health Organization (WHO) prequalification. conditions: Syphilis conditions: Syphilis Infection studyType: OBSERVATIONAL observationalModel: OTHER timePerspective: CROSS_SECTIONAL count: 1500 type: ACTUAL name: iStatis Syphilis Antibody Test measure: Sensitivity and specificity of the iStatis Syphilis Ab Test sex: ALL minimumAge: 15 Years stdAges: CHILD stdAges: ADULT stdAges: OLDER_ADULT facility: Epicentre Health Research city: Hillcrest state: KwaZulu Natal zip: 3650 country: South Africa hasResults: False |
<|newrecord|> nctId: NCT06367608 id: HP-00104695 briefTitle: MRgFUS Pallidotomy for the Treatment of Task Specific Focal Hand Dystonia (TSFD) acronym: FUS Dystonia overallStatus: NOT_YET_RECRUITING date: 2024-06 date: 2027-06 date: 2028-06 date: 2024-04-16 date: 2024-04-25 name: University of Maryland, Baltimore class: OTHER name: Focused Ultrasound Foundation name: InSightec briefSummary: The purpose of this study is to assess the safety and effectiveness of MRI-guided focused ultrasound (MRgFUS) for treating task specific focal hand dystonias (TSFD). TSFD is a type of dystonia that affects hand movements during specific tasks such as writing, playing instruments or typing, often causing involuntarily movements or cramping. conditions: Task-Specific Focal Dystonia studyType: INTERVENTIONAL phases: NA allocation: NA interventionModel: SINGLE_GROUP primaryPurpose: DEVICE_FEASIBILITY masking: NONE count: 10 type: ESTIMATED name: ExAblate Transcranial treatment measure: Incidence of Treatment related adverse events measure: Change in dystonia intensity measure: Change in patient's perception of quality of life measure: Change in patient's perception of the effect of the procedure sex: ALL minimumAge: 21 Years maximumAge: 75 Years stdAges: ADULT stdAges: OLDER_ADULT facility: University of Maryland Medical Center city: Baltimore state: Maryland zip: 21201 country: United States name: Kaitlyn Henry, MS role: CONTACT phone: 410-328-0939 email: [email protected] name: Rayne Noyes, BS role: CONTACT email: [email protected] lat: 39.29038 lon: -76.61219 hasResults: False |
<|newrecord|> nctId: NCT06367595 id: Intrathecal MgSO4 briefTitle: Effect of Intrathecal Magnesium Sulfate Versus Intravenous Magnesium Sulfate on Postoperative Pain After Abdominal Hysterectomy overallStatus: NOT_YET_RECRUITING date: 2024-04 date: 2026-10 date: 2026-11 date: 2024-04-16 date: 2024-04-16 name: Assiut University class: OTHER briefSummary: The present study aims to compare the effect of adding IV magnesium sulfate versus magnesium sulfate to intrathecal hyperbaric bupivacaine in total abdominal hysterectomy regarding the duration of postoperative analgesia, hemodynamic stability, and complications. conditions: Abdominal Hysterectomy studyType: INTERVENTIONAL phases: PHASE2 allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: PREVENTION masking: DOUBLE whoMasked: PARTICIPANT whoMasked: CARE_PROVIDER count: 90 type: ESTIMATED name: Magnesium sulfate measure: effect on postoperative pain after abdominal hysterectomy using visual analog score measure: sedation by Ramsay sedation scale measure: time of the first opioid request measure: Mean arterial blood pressures (MAP) measure: Heart rate (HR) sex: FEMALE minimumAge: 40 Years maximumAge: 65 Years stdAges: ADULT stdAges: OLDER_ADULT hasResults: False |
<|newrecord|> nctId: NCT06367582 id: CV01-TK-SPINE briefTitle: SPINE BONE CEMENTS OUTCOMES overallStatus: RECRUITING date: 2019-09-04 date: 2029-09-04 date: 2039-09-30 date: 2024-04-16 date: 2024-04-16 name: Teknimed class: INDUSTRY briefSummary: A Post-Market Clinical Follow-Up (PMCF) Study to collect clinical data on safety and performance of all TEKNIMED Spine range of products: SPINEFIX, HIGH V+, OPACITY+ and F20 bone cements and mixing and injection systems, and all their private labels. |
TEKNIMED bone cements are legacy products, some marketed for more than 10 years. Their performance and safety have already been demonstrated by Post-Market Surveillance and previous clinical studies. The current Post-Market Clinical Follow-Up study aims to confirm these claims by collecting data in a "real-life" setting. |
The study is a retrospective and prospective global, single arm, non-controlled, multicentric, prospective observational study. Patients will be followed as per local standard medical care of the sites. conditions: Vertebral Fracture conditions: Compression Fracture conditions: Osteoporotic Fractures studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: OTHER count: 500 type: ESTIMATED name: Vertebroplasty (VP) name: Kyphoplasty (KP) name: Pedicular Screw Augmentation (PSA) measure: Alleviation of Pain measure: Restoration of quality of life measure: Patient satisfaction measure: Stabilization of vertebrae measure: Adverse events measure: Antalgic Consumption sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: CHU HautePierre status: RECRUITING city: Strasbourg state: Bas-Rhin zip: 67200 country: France name: Vincent LAMAS, MD role: CONTACT email: [email protected] name: Vincent LAMAS, MD role: PRINCIPAL_INVESTIGATOR lat: 48.58392 lon: 7.74553 facility: Pôle Rachis Hôpital Privé d'Eure et Loir status: RECRUITING city: Mainvilliers state: Eure Et Loir zip: 28300 country: France name: Jean MEYBLUM, MD role: CONTACT email: [email protected] name: Jean MEYBLUM, MD role: PRINCIPAL_INVESTIGATOR lat: 48.45003 lon: 1.45607 facility: Hôpital Toulouse Purpan status: RECRUITING city: Toulouse state: Haute Garonne zip: 31130 country: France name: Marie FARUCH, MD role: CONTACT email: [email protected] name: Marie FARUCH, MD role: PRINCIPAL_INVESTIGATOR lat: 43.60426 lon: 1.44367 facility: Pôle Sud Santé status: RECRUITING city: Le Mans state: Sarthe zip: 72100 country: France name: Alexandru NITULESCU, MD role: CONTACT email: [email protected] name: Alexandru NITULESCU, MD role: PRINCIPAL_INVESTIGATOR lat: 48.0 lon: 0.2 facility: Centre Hospitalier Métropole Savoie status: RECRUITING city: Chambéry state: Savoie zip: 73000 country: France name: Cristian VASILE, MD role: CONTACT email: [email protected] name: Cristian VASILE, MD role: PRINCIPAL_INVESTIGATOR lat: 45.56667 lon: 5.93333 facility: Hospitale Cruz Vermelha Portuguesa status: RECRUITING city: Lisbonne zip: 1549-008 country: Portugal name: Miguel CORDEIRO, MD role: CONTACT phone: 914655121 email: [email protected] name: Miguel CORDEIRO, MD role: PRINCIPAL_INVESTIGATOR lat: 38.71667 lon: -9.13333 facility: Clínica Teknon Instituto de neurociencias status: RECRUITING city: Barcelona zip: 08022 country: Spain name: Daniel CRUZ MIRANDA, MD role: CONTACT email: [email protected] name: David BOSCH GARCIA, MD role: PRINCIPAL_INVESTIGATOR lat: 41.38879 lon: 2.15899 facility: Hospital Neurotraumatologico status: RECRUITING city: Granada zip: 18013 country: Spain name: Fernando RUIZ SANTIAGO, MD role: CONTACT email: [email protected] name: Fernando RUIZ SANTIAGO, MD role: PRINCIPAL_INVESTIGATOR lat: 37.18817 lon: -3.60667 facility: Hospital Clínico Universitario Virgen de la Arrixaca status: RECRUITING city: Murcia zip: 30120 country: Spain name: Gonzalo DE PACO TUDELA, MD role: CONTACT email: [email protected] name: Gonzalo DE PACO TUDELA, MD role: PRINCIPAL_INVESTIGATOR lat: 37.98704 lon: -1.13004 facility: Fundacio Assistencial Mutua de Terrassa - Edifici Estació status: RECRUITING city: Terrassa zip: 08222 country: Spain name: David BOSCH GARCIA, MD role: CONTACT email: [email protected] name: David BOSCH GARCIA role: PRINCIPAL_INVESTIGATOR lat: 41.56667 lon: 2.01667 facility: Hospital de Zafra status: RECRUITING city: Zafra zip: 06300 country: Spain name: Félix PANTA ANTON, MD role: CONTACT email: [email protected] name: Félix PANTA ANTON, MD role: PRINCIPAL_INVESTIGATOR lat: 38.41667 lon: -6.41667 facility: Institute of Traumatology and Orthopaedics status: RECRUITING city: Kiev zip: 1601 country: Ukraine name: Andrii SHEVCHUK, MD role: CONTACT email: [email protected] name: Andrii SHEVCHUK, MD role: PRINCIPAL_INVESTIGATOR lat: 50.45466 lon: 30.5238 hasResults: False |
<|newrecord|> nctId: NCT06367569 id: 2012//375 briefTitle: Evaluation of MRI of the Pineal Gland in Retinoblastoma acronym: TRbFU overallStatus: COMPLETED date: 2012-10-01 date: 2023-09-01 date: 2023-09-01 date: 2024-04-16 date: 2024-04-16 name: Amsterdam UMC, location VUmc class: OTHER briefSummary: Rationale: Currently baseline brain MRI (magnetic resonance imaging) with extended follow-up of pineal cysts is systematically performed in all new retinoblastoma (Rb) patients, because children with hereditary retinoblastoma have an increased risk of primitive neuroectodermal tumors (PNET) that are histopathologically identical to the retinal tumors (1). The prevalence of developing a PNET in combination with unilateral or bilateral hereditary Rb is 5-15% (2). Treatment is difficult and the prognosis is poor as only few survivors are reported. Only patients with small asymptomatic PNETs (\<15 mm) are potentially curable. |
Objective: The main objective of this prospective multicenter study is to evaluate the current strategy of baseline MRI screening of the brain in newly diagnosed retinoblastoma patients, with extended follow-up of selected patients with simple and complicated pineal cysts. |
Study design: The investigators propose a prospective cohort study (part of a larger multicenter study) to investigate the diagnostic accuracy and survival of baseline MRI screening of the pineal gland in new patients with retinoblastoma, with extended follow-up of selected patients with pineal cysts for early detection of pineoblastoma. |
Study population: Within the European Retinoblastoma Imaging Collaboration (ERIC) about 150 new retinoblastoma patients are diagnosed every year. About 10 percent of all new retinoblastoma patients will be diagnosed at the VUmc. According to our sample size calculations the investigators will need 334 Rb patients. |
Main study parameters/endpoints: The primary endpoint of the study is pineoblastoma or supra- / parasellar PNET on MRI (index test). Because a gold standard will not be available, tumor cells in cerebrospinal fluid, histopathological confirmation, clinical disease progression during follow-up, and/or follow-up MRI diagnostics will be used as a composite reference standard in case of a positive index test and clinical diagnosis of pineoblastoma or supra- / parasellar PNET within one year of the last MRI will be used as a composite reference standard in case of a negative index test. conditions: Retinoblastoma studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: PROSPECTIVE count: 607 type: ACTUAL name: Screening for trilateral retinoblastoma with MRI measure: Diagnostic accuracy of the screening measure: Survival analysis of trilateral retinoblastoma patients sex: ALL minimumAge: 0 Years maximumAge: 18 Years stdAges: CHILD stdAges: ADULT facility: VU University Medical Center city: Amsterdam state: Noord-Holland zip: 1081 HV country: Netherlands lat: 52.37403 lon: 4.88969 hasResults: False |
<|newrecord|> nctId: NCT06367556 id: 4542 briefTitle: Emotion and Symptom-Focused Engagement (EASE) for Caregivers acronym: EASE overallStatus: NOT_YET_RECRUITING date: 2024-06-01 date: 2027-10-01 date: 2028-10-01 date: 2024-04-16 date: 2024-04-16 name: University Health Network, Toronto class: OTHER name: The Hospital for Sick Children name: Canadian Institutes of Health Research (CIHR) briefSummary: The goal of this two-site phase III randomized controlled trial is to evaluate the effectiveness of a novel psychotherapeutic intervention called Emotion and Symptom-focused Engagement (EASE) in parents caring for a child or adolescent with cancer. The main question it aims to answer is: |
- Does EASE reduce traumatic stress symptom severity (primary outcome)? |
To do so, researchers will compare parents receiving EASE to usual care. Participants in both groups will complete questionnaires package at enrolment, and 4, 8, and 12 weeks, and 6 months after enrolment. They will also be invited to participate in optional qualitative interviews to better understand their experience. conditions: Trauma and Stressor Related Disorders conditions: Pediatric Cancer conditions: Caregiver Burden studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: SUPPORTIVE_CARE masking: SINGLE maskingDescription: Quantitative outcome assessors and data analysts will be blinded to participant treatment group. Blinding is not possible for trial participants, intervention providers, or pediatric oncology teams, as assignment cannot be hidden from these individuals. whoMasked: OUTCOMES_ASSESSOR count: 306 type: ESTIMATED name: EASE measure: Posttraumatic Stress Disorder Checklist for DSM-5 [PCL-5] measure: SF-36v2 Health Survey measure: Patient Health Questionnaire [PHQ-9] measure: Caregiving Health Engagement Scale [CHE-s] measure: Family Adaptability and Cohesion Evaluation Scales III [FACES-III] measure: Clinical Evaluation Questionnaire [CEQ] measure: Family Satisfaction with End-of-Life Care Tool, 10-item version [FAMCARE-10] measure: Traditional Masculinity-Femininity Scale [TMF] measure: Caregiver Reaction Assessment Scale [CRA] measure: ENRICHD Social Support Instrument [ESSI] measure: Experiences in Close Relationships Scale [ECR-16] measure: Hope of Improvement subscale of the Therapy Expectation and Evaluation Scale [PATHEVH] sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT hasResults: False |
<|newrecord|> nctId: NCT06367543 id: AZ 117/22 briefTitle: Guideline-recommended Basic Parameter Adherence in Neurocritical Care Patients acronym: NORMONICU overallStatus: ACTIVE_NOT_RECRUITING date: 2022-11-30 date: 2024-02-29 date: 2024-12-31 date: 2024-04-16 date: 2024-04-16 name: University of Giessen class: OTHER name: University of Leipzig name: University of Wuerzburg name: Technical University of Munich name: Heidelberg University name: University of Cologne name: University of Mannheim name: University Hospital, Essen briefSummary: The aim of the planned study project is to assess the current situation regarding the treatment of patients with severe stroke at the neuro-critical care unit. Specifically, determination of whether the target parameters recommended in the guidelines for temperature, systolic blood pressure, mean arterial blood pressure, blood glucose, arterial oxygen partial pressure and arterial carbon dioxide partial pressure had to be maintained. From the planned data analysis, the need for the introduction of cerebrovascular bundles can be derived and planned. conditions: Stroke studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: RETROSPECTIVE count: 474 type: ACTUAL name: Time in therapeutic range of vital parameters measure: Time in Therapy range measure: Acute measures measure: Invasive measures performed in the course of the Stay measure: Duration of ventilation measure: Deceased on Intensive Care. measure: NIHSS (National Institutes of Health Stroke Scale). sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Universitätsklinikum Gießen city: Gießen state: Hessen zip: 35392 country: Germany lat: 50.58727 lon: 8.67554 hasResults: False |
<|newrecord|> nctId: NCT06367530 id: GS-TRIO-2024 briefTitle: Trilateral Retinoblastoma: Incidence and Outcomes acronym: GS-TRIO overallStatus: RECRUITING date: 2024-01-01 date: 2027-12-31 date: 2029-12-31 date: 2024-04-16 date: 2024-04-16 name: Amsterdam UMC, location VUmc class: OTHER briefSummary: Patients with heritable retinoblastoma are at risk to develop an intracranial brain tumor, which is often fatal. The investigators intend to look at the incidence and survival of trilateral retinoblastoma (which is a brain tumor that can either be located in the pineal gland or elsewhere in the brain) in retinoblastoma patients globally. All retinoblastoma patients from participating centers will be included. The investigators hypothesize that the apparent incidence of trilateral retinoblastoma (especially the usually later diagnosed pineal trilateral retinoblastoma) in low-income countries will be lower because of low chances of surviving the ocular tumors at about 50% and also because of possible under-diagnosis. Therefore, as retinoblastoma care improves in low-income countries the incidence of (pineal) trilateral retinoblastoma might go up. Knowledge about incidence and survival can help improve health practices in parts of the world where this might be needed. Therefore this global study firstly aims 1) to evaluate survival after trilateral retinoblastoma and factors influencing survival and 2) to evaluate incidence of trilateral retinoblastoma by country income level. The study will run from 2024 through 2027. conditions: Trilateral Retinoblastoma conditions: Retinoblastoma studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: PROSPECTIVE count: 4351 type: ESTIMATED name: Incidence and survival of trilateral retinoblastoma and the differences globally measure: Number of participants (retinoblastoma patients) that will be diagnosed with trilateral retinoblastoma (incidence) measure: Overall and event-free survival after being diagnosed with trilateral retinoblastoma sex: ALL stdAges: CHILD stdAges: ADULT stdAges: OLDER_ADULT facility: Amsterdam UMC status: RECRUITING city: Amsterdam state: Noord-Holland zip: 1082HV country: Netherlands name: Pim de Graaf, MD PhD role: CONTACT phone: 800-555-5555 email: [email protected] lat: 52.37403 lon: 4.88969 hasResults: False |
<|newrecord|> nctId: NCT06367517 id: KB/114/2022 briefTitle: Tocilizumab in Corticosteroid-Resistant Graves' Orbitopathy (Thyroid Eye Disease) overallStatus: RECRUITING date: 2021-05-20 date: 2025-05-20 date: 2026-05-20 date: 2024-04-16 date: 2024-04-16 name: Medical University of Warsaw class: OTHER briefSummary: The aim of this study is to evaluate the efficacy and safety of Tocilizumab as second/third line treatment in patients with Active Moderate-to-Severe Corticosteroid-Resistant Thyroid Eye Disease. conditions: Orbitopathy, Graves conditions: Thyroid Eye Disease conditions: Ophthalmopathy studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: PROSPECTIVE count: 30 type: ESTIMATED name: Tocilizumab measure: Disease improvement measure: Improvement of quality of life measure: Disease inactivation measure: Proportion of patients achieving response in specific GO signs and symptoms measure: Number of participants with treatment-related adverse events as assessed by CTCAE v5.0 measure: Decrease in concentration of thyrotropin receptor antibodies measure: Decrease in levels of proinflammatory cytokines measure: Number of the rehabilitative surgeries performed after immunosuppressive therapy measure: The rate of disease relapse measure: Decrease in proptosis by at least 2 mm assessed using magnetic resonance imaging (MRI) sex: ALL minimumAge: 18 Years maximumAge: 80 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Department of Internal Medicine and Endocrinology, Medical University of Warsaw status: RECRUITING city: Warsaw zip: 02-097 country: Poland name: Tomasz Bednarczuk, MD, PHD role: CONTACT email: [email protected] name: Joanna Rymuza, MD, PHD role: CONTACT email: [email protected] name: Tomasz Bednarczuk, MD, PHD role: PRINCIPAL_INVESTIGATOR name: Joanna Rymuza, MD, PHD role: SUB_INVESTIGATOR name: Aleksander Kuś, MD, PHD role: SUB_INVESTIGATOR lat: 52.22977 lon: 21.01178 hasResults: False |
<|newrecord|> nctId: NCT06367504 id: DB/230904/DBMF/CDI briefTitle: A Study to Assess the Effect of Doctor's Biome Medical Food in Individuals With Clostridium Difficile Infection overallStatus: NOT_YET_RECRUITING date: 2024-05-01 date: 2024-12-15 date: 2024-12-30 date: 2024-04-16 date: 2024-04-16 name: Vedic Lifesciences Pvt. Ltd. class: INDUSTRY briefSummary: A randomized, double-blind, placebo-controlled, pilot clinical study to assess the effect of Doctor's Biome Medical Food (DBMF) in individuals with Clostridium difficile infection (CDI) conditions: Clostridium Difficile Infection studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL interventionModelDescription: Randomized, parallel group, double-blind, placebo-controlled trial primaryPurpose: OTHER masking: QUADRUPLE whoMasked: PARTICIPANT whoMasked: CARE_PROVIDER whoMasked: INVESTIGATOR whoMasked: OUTCOMES_ASSESSOR count: 20 type: ESTIMATED name: DBMF name: Placebo measure: To evaluate the effect of Investigational product on the duration of Clostridium difficile diarrhea in comparison to placebo. measure: To assess the impact of the Investigational product on Number of CDI diarrhea episodes presence of Clostridium difficile in stool samples as assessed by C. difficile toxins A & B - CARD. measure: To assess the impact of the Investigational product on Change in the frequency of watery stools from Bristol Stool Form Scale (BSFS) score type 7 as compared to placebo. measure: To assess the impact of the Investigational product on Number of non-CDI diarrhea episodes as compared to placebo measure: To assess the impact of the Investigational product on Number of SOC medication consumed (antibiotics therapy) throughout the intervention period as compared to placebo. measure: To assess the impact of the Investigational product on Average number of days of consumption of SOC (antibiotics therapy) as compared to placebo. sex: ALL minimumAge: 30 Years maximumAge: 75 Years stdAges: ADULT stdAges: OLDER_ADULT facility: AIMS Hospital city: Dombivali state: Maharashtra zip: 421203 country: India name: Dr Sandeep Kardian, MBBS MD role: CONTACT phone: 870364574 email: [email protected] lat: 19.21667 lon: 73.08333 facility: Stress Test Clinic city: Mumbai state: Maharashtra zip: 400059 country: India name: Dr Ramesh Dargad, MBBS MS role: CONTACT phone: 9820152828 email: [email protected] lat: 19.07283 lon: 72.88261 facility: Nobel Hospital city: Pune state: Maharashtra zip: 411013 country: India name: Dr Pramod Katare, MBBS MD role: CONTACT phone: 8830793201 email: [email protected] lat: 18.51957 lon: 73.85535 facility: Gleneagles Hospital city: Hyderabad state: Telangana zip: 500004 country: India name: Dr G S Sameer Kumar, MBBS MD role: CONTACT phone: 8860031692 email: [email protected] lat: 17.38405 lon: 78.45636 hasResults: False |
<|newrecord|> nctId: NCT06367491 id: IRST100.12 briefTitle: National Database of Bone Metastases acronym: BDMO overallStatus: RECRUITING date: 2013-10-08 date: 2030-01-01 date: 2030-01-01 date: 2024-04-16 date: 2024-04-16 name: Istituto Scientifico Romagnolo per lo Studio e la cura dei Tumori class: OTHER briefSummary: BDMO is an Italian multicentre, observational, prospective study that collects data from all patients with bone metastases referred to each participating centre, using an on-line software 'tailor-made' for data collection. conditions: Bone Metastases studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: PROSPECTIVE count: 800 type: ESTIMATED name: Registration in a database measure: The establishment of a National Bone Metastasis Database at the IRCCS IRST measure: Evaluation of clinical factors related to the primary tumor and metastases measure: Evaluation of clinical factors related to the primary tumor and metastases measure: Evaluation of clinical factors related to the primary tumor and metastases measure: Impact of treatment on skeletal events (SRE) measure: Analysis of overall efficiency of the mono- and multidisciplinary pathway on skeletal events (SRE) measure: Evaluation of biological factors related to the primary tumour and metastases sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: A.U.S.L. Imola status: RECRUITING city: Imola state: Bologna country: Italy name: Antonio Maestri, MD role: CONTACT lat: 44.35916 lon: 11.7132 facility: Istituto Scientifico Romagnolo per lo Studio e la Cura dei Tumori (IRST) status: RECRUITING city: Meldola state: FC zip: 47014 country: Italy name: Nicoletta Ranallo, MD role: CONTACT phone: 0543739100 email: [email protected] name: Nicoletta Ranallo, MD role: SUB_INVESTIGATOR lat: 44.12775 lon: 12.0626 facility: Osp. "Sacro Cuore di Gesù" status: NOT_YET_RECRUITING city: Gallipoli state: Lecce country: Italy name: Rosachiara Forcignanò, MD role: CONTACT lat: 40.05594 lon: 17.99088 facility: Osp. S. Vincenzo - ASP Messina status: RECRUITING city: Taormina state: Messina country: Italy name: Francesco Ferrarù, MD role: CONTACT lat: 37.85358 lon: 15.28851 facility: Osp. Ramazzini di Carpi - AUSL Modena status: RECRUITING city: Carpi state: Modena country: Italy name: Fabrizio Artioli, MD role: CONTACT lat: 44.78237 lon: 10.8777 facility: P.O. "S. Maria delle Grazie" status: RECRUITING city: Pozzuoli state: Napoli country: Italy name: Gaetano Facchini, MD role: CONTACT lat: 40.84394 lon: 14.0952 facility: Osp. degli Infermi status: RECRUITING city: Faenza state: Ravenna country: Italy name: Enrico Campadelli, MD role: CONTACT lat: 44.29007 lon: 11.87948 facility: Ospedale Umberto I status: RECRUITING city: Lugo state: Ravenna country: Italy name: Enrico Campadelli, MD role: CONTACT lat: 44.42137 lon: 11.91094 facility: Istituto Neurotraumatologico Italiano (INI) status: RECRUITING city: Grottaferrata state: Roma country: Italy name: Gaetano Lanzetta, MD role: CONTACT lat: 41.78664 lon: 12.67144 facility: A.O.U. Ospedali Riuniti status: RECRUITING city: Ancona country: Italy name: Rosanna Berardi, MD role: CONTACT lat: 43.5942 lon: 13.50337 facility: Centro di Riferimento Oncologico - IRCCS CRO status: RECRUITING city: Aviano country: Italy name: Alessandro Del Conto, MD role: CONTACT lat: 46.07056 lon: 12.59472 facility: A.O.U.C. Policlinico di Bari Osp."Giovanni XXIII" status: RECRUITING city: Bari country: Italy name: Stefania Succi, MD role: CONTACT lat: 41.11148 lon: 16.8554 facility: A.O. "S. Pio" status: RECRUITING city: Benevento country: Italy name: Vincenzo Ricci, MD role: CONTACT lat: 41.1307 lon: 14.77816 facility: IRCCS Ist. Ortopedico Rizzoli status: RECRUITING city: Bologna country: Italy name: Toni Ibrahim, MD role: CONTACT lat: 44.49381 lon: 11.33875 facility: ASST Spedali Civili di Brescia status: RECRUITING city: Brescia country: Italy name: Rebecca Pedersini, MD role: CONTACT lat: 45.53558 lon: 10.21472 facility: A.O. S. Croce e Carle status: RECRUITING city: Cuneo country: Italy name: Marcella Occelli, MD role: CONTACT lat: 44.39071 lon: 7.54828 facility: A.O.U. "Arcispedale S. Anna" - AUSL Ferrara status: RECRUITING city: Ferrara country: Italy name: Antonio Frassoldati, MD role: CONTACT lat: 44.83804 lon: 11.62057 facility: Ospedale Civile di Legnano - ASST Ovest Milanese status: RECRUITING city: Legnano country: Italy name: Elena Farè, MD role: CONTACT lat: 45.59788 lon: 8.91506 facility: Fond. IRCCS Istituto Nazionale dei Tumori - INT status: RECRUITING city: Milano country: Italy name: Valentina Guadalupi, MD role: CONTACT lat: 45.46427 lon: 9.18951 facility: A.O.R.N. "A. Cardarelli" status: RECRUITING city: Napoli country: Italy name: Ferdinando Riccardi, MD role: CONTACT lat: 40.85216 lon: 14.26811 facility: Istituto Oncologico Veneto status: RECRUITING city: Padova country: Italy name: Marco Maruzzo, MD role: CONTACT lat: 45.40797 lon: 11.88586 facility: Fond. IRCCS Policlinico San Matteo status: RECRUITING city: Pavia country: Italy name: Elisa Ferraris, MD role: CONTACT lat: 45.19205 lon: 9.15917 facility: Osp. Guglielmo da Saliceto status: RECRUITING city: Piacenza country: Italy name: Luigi Cavanna, MD role: CONTACT lat: 45.05242 lon: 9.69342 facility: Osp. S. Maria delle Croci status: RECRUITING city: Ravenna country: Italy name: Enrico Campadelli, MD role: CONTACT lat: 44.41344 lon: 12.20121 facility: IRCCS Arcispedale S. Maria Nuova - A.O. Reggio Emilia status: RECRUITING city: Reggio Emilia country: Italy name: Maria Banzi, MD role: CONTACT lat: 44.69825 lon: 10.63125 facility: Ospedale degli Infermi status: RECRUITING city: Rimini country: Italy name: Manuela Fantini, MD role: CONTACT lat: 44.05755 lon: 12.56528 facility: IRCCS Fond. Policlinico "A. Gemelli" - U.O.C. Oncologia Medica status: RECRUITING city: Roma country: Italy name: Emilio Bria, MD role: CONTACT lat: 41.89193 lon: 12.51133 facility: IRCCS Fond. Policlinico "A. Gemelli" - U.O.S. Senologia Medica / U.O.C. Ginecologia oncologica status: RECRUITING city: Roma country: Italy name: Alessandra Fabi, MD role: CONTACT lat: 41.89193 lon: 12.51133 facility: Ospedale di Treviglio - Caravaggio ASST Bergamo Ovest status: RECRUITING city: Treviglio country: Italy name: Andrea Luciani, MD role: CONTACT lat: 45.52081 lon: 9.59102 facility: A.O.U.I. Verona status: RECRUITING city: Verona country: Italy name: Jessica Menis, MD role: CONTACT lat: 45.4299 lon: 10.98444 hasResults: False |
<|newrecord|> nctId: NCT06367478 id: SPEMG briefTitle: Evaluation of Nerve Conduction Study acronym: SPEMG overallStatus: ACTIVE_NOT_RECRUITING date: 2021-08-01 date: 2021-10-22 date: 2024-10-22 date: 2024-04-16 date: 2024-04-16 name: Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico class: OTHER briefSummary: the investigators study different modality to obtain nerve evoked reponses. They use different parameters of acquisition and stimulation and they compare amplitude and latency of nerve conduction response conditions: Nerve Condition conditions: Health, Subjective studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: PROSPECTIVE count: 125 type: ACTUAL measure: best amplitude of nerve conduction study sex: ALL minimumAge: 18 Years maximumAge: 50 Years stdAges: ADULT facility: Fondazione IRCCS Cà Granda Ospedale Maggiore Policlinico of Milan city: Milan zip: 20122 country: Italy lat: 45.46427 lon: 9.18951 hasResults: False |
<|newrecord|> nctId: NCT06367465 id: 202308056 briefTitle: Feasibility and Acceptability of HCV Treatment in Pregnancy overallStatus: RECRUITING date: 2024-02-01 date: 2026-02-28 date: 2026-02-28 date: 2024-04-16 date: 2024-04-16 name: Washington University School of Medicine class: OTHER briefSummary: Pregnant adults over the age of 18 who are seen in the Washington University obstetrics and gynecology, maternal fetal medicine or infectious diseases clinic or admitted to BJH with hepatitis C virus infection who have a history of past or current drug use |
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