text
stringlengths 0
197k
|
|---|
Pairs of experienced psychotherapists trained in one of the therapy protocols will deliver the interventions in an online group setting. whoMasked: PARTICIPANT count: 276 type: ESTIMATED name: Psychoeducation and cognitive modules name: Behavioral module: Starting on Time and Planning Realistically name: Behavioral module: Working Time Restriction measure: Change in Polish version of the Pure Procrastination Scale (PPS) measure: Change in Polish version of the Aitken Procrastination Inventory (API) measure: Change in Polish version of the Patient Health Questionnaire (PHQ-9) measure: Change in Polish version of the Generalized Anxiety Disorder Questionnaire-7 (GAD-7) measure: Percentage of completion of a particular project that the participant decided to work on during the training (e.g. a thesis, an essay, a report). measure: Change in Polish version of the Sensitivity to Punishment and Sensitivity to Reward Questionnaire - Short Form (SPSRQ-SF) measure: Change in Polish version of the Multidimensional-Multiattributional Causality Scale (MMCS) measure: Change in Polish version of the Performance Failure Appraisal Inventory (PFAI) measure: Change in Polish version of the Difficulties in Emotion Regulation questionnaire (DERS) measure: Change in Polish version of the Motivation Diagnostic Test (MDT) measure: Change in Polish version of the Zimbardo Time Perspective Inventory measure: Change in Polish version of the Metacognitive Beliefs about Procrastination Questionnaire (MBPQ) measure: Change in Polish version of the Impulsivity Scale (UPPS-P) measure: Change in Polish version of the Self-control Scale (NAS-50) measure: Change in Polish version of the Procrastination Diagnostic Criteria Questionnaires (PDCQ) measure: Change in Polish version of Positive and Negative Affect Schedule (PANAS) in relation to a project that the participant decided to work on during the training (e.g. a thesis, an essay, a report) measure: Polish version of the Group Session Rating Scale (GSRS) measure: Several items concerning homework compliance (cf. Kazantzis et al., 2005). measure: Polish version of the Credibility Expectancy Questionnaire (CEQ) measure: Polish version of the Negative Effects Questionnaire (NEQ) measure: Polish version of the Client Satisfaction Questionnaire (CSQ) measure: fMRI measurements measure: Electroencephalography (EEG) measurements sex: ALL minimumAge: 18 Years maximumAge: 26 Years stdAges: ADULT facility: Nencki Institute of Experimental Biology, Polish Academy of Sciences status: RECRUITING city: Warsaw zip: 02-093 country: Poland name: Marek Wypych, Phd, DSc role: CONTACT email: [email protected] lat: 52.22977 lon: 21.01178 hasResults: False
|
<|newrecord|> nctId: NCT06357351 id: VISTA in gingival recession briefTitle: Comparison of Using Collagen Membrane and A-PRF Using VISTA Technique in Gingival Recession Treatment overallStatus: ACTIVE_NOT_RECRUITING date: 2022-07-01 date: 2024-04 date: 2024-05 date: 2024-04-10 date: 2024-04-10 name: Mansoura University class: OTHER briefSummary: To assess the efficacy of minimally invasive Vestibular Incision Subperiosteal Tunnel Access (VISTA) with collagen membrane and Advanced Platelet-rich Fibrin (A-PRF) in the treatment of multiple buccal gingival recession type 1(RT1) Cairo Classification. conditions: Gingival Recession studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: DOUBLE whoMasked: PARTICIPANT whoMasked: OUTCOMES_ASSESSOR count: 24 type: ACTUAL name: vestibular incision sub periosteal tunnel access ( VISTA) technique. measure: Measuring the recession width in millimeter measure: Measuring the recession depth in millimeter measure: Measuring the width of keratinized gingiva in millimeter measure: Mean of root coverage measure: Measuring the probing depth measure: Measuring the plaque index measure: Measuring the gingival index measure: Clinical attachment level sex: ALL minimumAge: 18 Years maximumAge: 50 Years stdAges: ADULT facility: Mansoura university city: Mansoura country: Egypt lat: 31.03637 lon: 31.38069 hasResults: False
|
<|newrecord|> nctId: NCT06357338 id: Soh-Med-24-03-15MS briefTitle: Differential Expression and Potential Value of c-MYC in Non-Invasive and Invasive Mammary Carcinoma overallStatus: ENROLLING_BY_INVITATION date: 2024-03-19 date: 2025-04-01 date: 2026-04-01 date: 2024-04-10 date: 2024-04-10 name: Marwa Mahmoud Hassan class: OTHER name: Qena Oncology Center briefSummary: Retrospective observational study to evaluate c-MYC expression in non invasive and invasive mammry carcinoma conditions: Invasive Breast Cancer studyType: OBSERVATIONAL observationalModel: CASE_ONLY timePerspective: RETROSPECTIVE count: 70 type: ESTIMATED name: no intervention measure: role of c-MYC in breast cancer sex: FEMALE minimumAge: 15 Years stdAges: CHILD stdAges: ADULT stdAges: OLDER_ADULT facility: Sohag university city: Sohag country: Egypt lat: 26.55695 lon: 31.69478 hasResults: False
|
<|newrecord|> nctId: NCT06357325 id: E-74555795-050.01.04-52290 briefTitle: 2023 Problems Faced by Women Earthquake Survivors in Kahramanmaraş overallStatus: COMPLETED date: 2023-06-22 date: 2023-09-30 date: 2023-12-01 date: 2024-04-10 date: 2024-04-10 name: Maltepe University class: OTHER briefSummary: Objective:
|
This study was conducted to evaluate the opinions of earthquake victims about the problems affecting women's health physically and psychosocially after the 2023 Kahramanmaraş earthquake.
|
Method:
|
The study was designed in a qualitative type (semi-structured). The population of the study consisted of women affected by the 2023 Kahramanmaraş-Pazarcık earthquake. 15 women were interviewed. conditions: Psychosocial Problem conditions: Nurse-Patient Relations conditions: Disaster; Personality conditions: Gender studyType: OBSERVATIONAL observationalModel: CASE_ONLY timePerspective: CROSS_SECTIONAL count: 15 type: ACTUAL name: a qualitative study. measure: Personal Information Form measure: A semi-structured interview form measure: consists of questions about changes experienced after the earthquake sex: FEMALE minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Ozeninam city: Istanbul state: Maltepe zip: 34857 country: Turkey lat: 41.01384 lon: 28.94966 hasResults: False
|
<|newrecord|> nctId: NCT06357312 id: 2023/11P briefTitle: Influence of Static Distal Locking of a Short Proximal Femoral Nail overallStatus: RECRUITING date: 2024-04-01 date: 2024-04-01 date: 2024-04-01 date: 2024-04-10 date: 2024-04-10 name: Elda University Hospital class: OTHER briefSummary: Prospective, comparative, randomized, double-blind study to evaluate the outcomes of trochanteric nailing in unstable hip fractures with and without a distal interlocking screw. conditions: Hip Fracture studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL interventionModelDescription: Prospective, comparative, randomized and double-blind study primaryPurpose: TREATMENT masking: DOUBLE maskingDescription: Blinding of the patient included in the study and the investigator evaluating the results whoMasked: PARTICIPANT whoMasked: OUTCOMES_ASSESSOR count: 200 type: ESTIMATED name: hip trochanteric nail measure: Evaluation of functional status using the Barthel index measure: Postoperative mechanical complications measure: Parker mobility scale sex: ALL minimumAge: 50 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Elda University Hospital status: RECRUITING city: Elda state: Comunidad Valenciana zip: 03600 country: Spain name: FRANCISCO ANTONIO MIRALLES MUÑOZ role: CONTACT phone: 651552115 email: [email protected] lat: 38.47783 lon: -0.79157 hasResults: False
|
<|newrecord|> nctId: NCT06357299 id: Pro00115060 briefTitle: Assessing Better Bottles for Babies acronym: AB3 overallStatus: NOT_YET_RECRUITING date: 2024-07-01 date: 2026-02-01 date: 2026-02-01 date: 2024-04-10 date: 2024-04-17 name: Duke University class: OTHER name: National Institutes of Health (NIH) briefSummary: This study will use a 2 x 2 factorial design to test impact of two intervention strategies (bottle size and bottle opacity) on infant weight gain. conditions: Pediatric Obesity conditions: Weight Gain Trajectory conditions: Infant Obesity studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: FACTORIAL interventionModelDescription: 2x2 factorial design primaryPurpose: TREATMENT masking: NONE count: 76 type: ESTIMATED name: Small Bottle Size name: Standard Bottle Size name: Clear Bottle name: Opaque Bottle measure: Conditional weight gain z-score changes (CWGz) measure: Formula volume per feed measure: Caregiver sensitivity to cues as measured by the Nursing Child Assessment Feeding Scale (NCAFS) sex: ALL minimumAge: 3 Days maximumAge: 1 Month stdAges: CHILD hasResults: False
|
<|newrecord|> nctId: NCT06357286 id: IRB0148156 briefTitle: Income Volatility and Mental Health, Pilot Study overallStatus: NOT_YET_RECRUITING date: 2024-05-01 date: 2024-09-10 date: 2024-10-10 date: 2024-04-10 date: 2024-04-10 name: Cornell University class: OTHER briefSummary: Income instability is a defining aspect of the lives of the poor, who also disproportionately suffer from poor mental and physical health. Our research is the first to assess the causal effects of predictable and unpredictable income instability on the psychological and physical health of the poor. It will advance the scientific knowledge on the effects of economic instability as well as our understanding of health disparities. conditions: Depression studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: OTHER masking: NONE count: 400 type: ESTIMATED name: Work opportunities measure: Depression sex: FEMALE minimumAge: 18 Years maximumAge: 65 Years stdAges: ADULT stdAges: OLDER_ADULT hasResults: False
|
<|newrecord|> nctId: NCT06357273 id: WhiteTeaAY briefTitle: The Effect of White Tea Consumption on Obesity overallStatus: COMPLETED date: 2023-07-01 date: 2023-11-01 date: 2023-12-15 date: 2024-04-10 date: 2024-04-10 name: Recep Tayyip Erdogan University class: OTHER briefSummary: Obesity is an increasing global public health issue. In general, tea consumption have been shown to offer benefit to obese patients. However, the potential of white tea (WT) to treat and protect from the adverse effects of obesity have not been addressed so far. The aim of this study was to examine the efficacy and impact WT consumption highest in catechins on levels of anthropometric and biochemical values in obese patients. conditions: Obesity conditions: Obesity; Endocrine conditions: Obesity Adult Onset studyType: OBSERVATIONAL observationalModel: CASE_CONTROL timePerspective: PROSPECTIVE count: 91 type: ACTUAL measure: Weight loss measure: Waist Circumference measure: Body Mass Index measure: Tumor Necrosis Factor - alpha measure: Total cholesterol measure: Low-Density Lipoprotein cholesterol measure: High-Density Lipoprotein cholesterol sex: ALL minimumAge: 18 Years maximumAge: 65 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Recep Tayyip Erdogan University city: Rize zip: 53100 country: Turkey lat: 41.02083 lon: 40.52194 hasResults: False
|
<|newrecord|> nctId: NCT06357260 id: Shifa OMR briefTitle: Pregabalin as an add-on Therapy to Carbamazepine in Trigeminal Neuralgia Patients overallStatus: NOT_YET_RECRUITING date: 2024-04 date: 2025-02 date: 2025-03 date: 2024-04-10 date: 2024-04-10 name: Postgraduate Institute of Dental Sciences Rohtak class: OTHER briefSummary: Trigeminal neuralgia is a very painful condition associated with paroxysmal severe episodes of pain. Carbamazepine has been the first line of drug for Trigeminal Neuralgia. However, there are several adverse effects linked with Carbamazepine like drowsiness, accommodation disorders, hepatitis, derangement in hepatic enzymes, renal dysfunction. Pregabalin which is an established drug in neuropathic pain has better pharmacokinetic nature which allows for easy management and rapid dose escalation to therapeutic doses. There have been only few trials evaluating efficacy of Pregabalin in classical trigeminal neuralgia. Thus, the present study is designed to evaluate the efficacy of Pregabalin as an add-on therapy to carbamazepine in patients suffering from Trigeminal Neuralgia. In present trial 50 patients fulfilling the exclusion and inclusion criteria will be recruited in two arms that is test group and the control group. The test group will be prescribed carbamazepine along with fixed dose of Pregabalin 75mg twice daily while the control group will be prescribed carbamazepine only. The dose of carbamazepine will be titrated in both groups as per patients need. The outcome regarding pain relief, quality of life and adverse effects and mean dose of carbamazepine required in both groups will be evaluated. conditions: Trigeminal Neuralgia studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL interventionModelDescription: Test group-1 will be administered carbamazepine+pregabalin with fixed dose of pregabalin 75mg BD and carbamazepine being titrated as per patients's need and follow up done after 1 week with subsequent follow up at 2,4,6 and 8 weeks.
|
control group all the armamentarium and procedure will remain same except that dose titration of carbamazepine is done till patient is relieved of pain. primaryPurpose: TREATMENT masking: SINGLE whoMasked: OUTCOMES_ASSESSOR count: 50 type: ESTIMATED name: Pregabalin and Carbamazepine name: Carbamazepine measure: VAS score measure: Brief pain inventory ● Brief pain inventory assessment of pain. ● Brief pain inventory assessment of pain. Brief pain inventory measure: Patient Global Impression of change(PGI) measure: mean dose of carbamazepine measure: Liverpool scale sex: ALL minimumAge: 25 Years maximumAge: 80 Years stdAges: ADULT stdAges: OLDER_ADULT facility: PGIDS city: Rohtak state: Haryana zip: 124001 country: India name: DR. Lavina Arya, MDS role: CONTACT phone: 09212795285 email: [email protected] name: Dr. Ambika Gupta, MDS role: CONTACT phone: 09315903300 email: [email protected] name: Shifa Akhtar, MDS role: PRINCIPAL_INVESTIGATOR lat: 28.89447 lon: 76.58917 hasResults: False
|
<|newrecord|> nctId: NCT06357247 id: HM20027093 briefTitle: The Effect of SRS on Hemiplegia in Stroke Survivors overallStatus: RECRUITING date: 2024-03-04 date: 2024-08 date: 2024-08 date: 2024-04-10 date: 2024-04-10 name: Virginia Commonwealth University class: OTHER briefSummary: Strokes are one of the leading causes of long term disability and death in the United States. A stroke occurs when the blood supply to the brain is blocked, damaging parts of the brain. Many stroke survivors have difficulty completing dexterous hand movements and manipulating objects due brain damage in the sensorimotor cortex. Damage to these areas can cause decreased motor movements and tactile sensation on the affected side. Research shows that tactile sensation is necessary for maintaining grip, grading grip forces and decreasing object slippage. Therefore, it is important to address tactile sensation with motor performance during stroke rehabilitation to improve performance outcomes among stroke survivors. conditions: Stroke studyType: INTERVENTIONAL phases: NA allocation: NA interventionModel: SINGLE_GROUP primaryPurpose: DEVICE_FEASIBILITY masking: NONE count: 20 type: ESTIMATED name: Sensory Threshold name: Nine Hole Peg Test name: Semmes Weinstein Monofilament Assessment measure: Scores on ease of use, duration of wear, and preference related to wearing a stochastic resonance device at home in chronic stroke patients measure: Optimal level of stochastic resonance vibration sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Virginia Commonwealth University status: RECRUITING city: Richmond state: Virginia zip: 232398 country: United States name: Virginia Chu role: CONTACT phone: 804-828-1564 email: [email protected] lat: 37.55376 lon: -77.46026 hasResults: False
|
<|newrecord|> nctId: NCT06357234 id: APRE-2023 briefTitle: Aprepitant Treatment to Prevent Postoperative Nausea and Vomiting in Children Undergoing Scoliosis Surgery overallStatus: NOT_YET_RECRUITING date: 2024-06 date: 2026-03 date: 2026-04 date: 2024-04-10 date: 2024-04-10 name: IWK Health Centre class: OTHER briefSummary: This research trial will measure how useful Aprepitant is in preventing nausea and vomiting in children having surgery to correct scoliosis (curvature of the spine). conditions: Spinal Fusion conditions: Nausea and Vomiting, Postoperative conditions: Anesthesia studyType: INTERVENTIONAL phases: PHASE2 allocation: RANDOMIZED interventionModel: PARALLEL interventionModelDescription: This is a randomized double-blind placebo controlled study primaryPurpose: PREVENTION masking: QUADRUPLE maskingDescription: Treatment arm of participants will be masked until data collection is complete. whoMasked: PARTICIPANT whoMasked: CARE_PROVIDER whoMasked: INVESTIGATOR whoMasked: OUTCOMES_ASSESSOR count: 100 type: ESTIMATED name: Aprepitant name: Placebo measure: Anti-Nausea Rescue Medication measure: Anti-nausea rescue medication administered by post-operative day measure: Emesis (Yes/No) measure: Baxter Retching Faces score measure: Pain score measure: Headache (yes/no) measure: Flatus (yes/no) measure: Bowel Motility (yes/no) measure: Sensation of Itch measure: Treatment of emergent adverse events sex: ALL minimumAge: 8 Years maximumAge: 19 Years stdAges: CHILD stdAges: ADULT hasResults: False
|
<|newrecord|> nctId: NCT06357221 id: GLI.04.US.SL.035 briefTitle: A Study to Assess Efficacy and Tolerability of Topical Skincare Products on Psoriasis Patients overallStatus: RECRUITING date: 2024-04-08 date: 2024-07-31 date: 2024-07-31 date: 2024-04-10 date: 2024-04-10 name: Galderma R&D class: INDUSTRY briefSummary: Subjects having mild-to-severe plaque psoriasis, with active target lesion plaques, and currently on or starting a prescription treatment for plaque psoriasis will apply a topical skincare regimen to one side of the body. Evaluations of the regimen's efficacy will be conducted at 2 weeks, 4 weeks, and 8 weeks post-baseline. conditions: Plaque Psoriasis conditions: Psoriasis studyType: INTERVENTIONAL phases: PHASE4 allocation: NA interventionModel: SINGLE_GROUP primaryPurpose: TREATMENT masking: NONE count: 50 type: ESTIMATED name: Cetaphil measure: Change in psoriatic Body Surface Area compared to baseline measure: Change in target lesion severity compared to baseline measure: Change of Physician Global Assessment compared to baseline measure: Change in skin quality measured by macroscopic imaging measure: Subject treatment satisfaction measure: Incidence of psoratic irritation [tolerability assessment] measure: Subject Quality of Life Satisfaction sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Southeast Dermatology Specialists, LLC status: NOT_YET_RECRUITING city: Columbus state: Georgia zip: 31904 country: United States name: George F Hougeir, MD role: CONTACT phone: 706-568-2700 email: [email protected] name: Moriah Hibbard role: CONTACT email: [email protected] name: George F Hougeir, MD role: PRINCIPAL_INVESTIGATOR lat: 32.46098 lon: -84.98771 facility: Southeast Dermatology Specialists, LLC status: NOT_YET_RECRUITING city: Douglasville state: Georgia zip: 30135 country: United States name: George F Hougeir, MD role: CONTACT phone: 678-702-3376 email: [email protected] name: Moriah Hibbard role: CONTACT email: [email protected] name: George F Hougeir, MD role: PRINCIPAL_INVESTIGATOR lat: 33.7515 lon: -84.74771 facility: Dermatology Consulting Services status: RECRUITING city: High Point state: North Carolina zip: 27262 country: United States name: Zoe D Draelos, MD role: CONTACT phone: 336-841-2040 email: [email protected] name: Crystal Williams role: CONTACT email: [email protected] name: Zoe D Draelos, MD role: PRINCIPAL_INVESTIGATOR lat: 35.95569 lon: -80.00532 hasResults: False
|
<|newrecord|> nctId: NCT06357208 id: 23-AOI-06 id: 2023-A02687-38 type: OTHER domain: ANSM briefTitle: IMPACT OF BREATH CONTROL AND RETENTION ON PATIENT STRESS. E.S IN MEDICALLY ASSISTED REPRODUCTION BREATH HOLD TO BREATH BETTER PROGRAM acronym: BHBB overallStatus: NOT_YET_RECRUITING date: 2024-05-01 date: 2025-06-01 date: 2025-12-01 date: 2024-04-10 date: 2024-04-10 name: Centre Hospitalier Universitaire de Nice class: OTHER briefSummary: we propose for patient in the course of Medically Assisted Reproduction a study with to arm: one arm active "Breathing Control and Retention" and the other arm control conditions: Reproductive Disorder studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: SUPPORTIVE_CARE masking: NONE count: 30 type: ESTIMATED name: Breathing Control and Retention measure: Rate of stressed patients measure: STAI Y-A (anxiety state) scale sex: ALL minimumAge: 18 Years maximumAge: 65 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Chu de Nice city: Nice zip: 06003 country: France name: Valérie BENOIT role: CONTACT phone: 0492034702 email: [email protected] name: marion causeret role: CONTACT phone: 0492034702 email: [email protected] name: Valérie BENOIT role: PRINCIPAL_INVESTIGATOR lat: 43.70313 lon: 7.26608 hasResults: False
|
<|newrecord|> nctId: NCT06357195 id: 2024H0075 briefTitle: DIAMOND-Lewy Guidelines for Antipsychotic Use in Older Patients overallStatus: NOT_YET_RECRUITING date: 2024-04-01 date: 2024-10-01 date: 2024-10-01 date: 2024-04-10 date: 2024-04-10 name: Ohio State University class: OTHER briefSummary: The goal of this observational study is to learn about current practices for the acute neuropsychiatric management of older adults during emergency department (ED) visits. Researchers will compare current standard of care practices with implemented guideline practice to see if standardized medication guidelines help reduce the usage of antipsychotics and/or benzodiazepines during acute presentations. The main questions this study aims to answer are:
|
* How many older adults are receiving antipsychotics or benzodiazepines during emergency department visits?
|
* Why are older adults receiving antipsychotics or benzodiazepines during emergency department visits?
|
* How many older adults who receive antipsychotics or benzodiazepines during emergency department visits have an underlying cognitive or movement disorder?
|
* What effects does administration of antipsychotics or benzodiazepines during emergency department visits have on patient outcomes in older adults and adults with neurocognitive disorders?
|
* Does implementation of standardized medication guidelines help reduce the usage of antipsychotics and/or benzodiazepines during acute presentations? conditions: Emergency Psychiatric conditions: Cognition Disorder conditions: Movement Disorders conditions: Antipsychotics and Neuroleptics Toxicity conditions: Dementia With Lewy Bodies conditions: Alteration in Mental Status conditions: Behavior conditions: Aging studyType: OBSERVATIONAL observationalModel: OTHER timePerspective: CROSS_SECTIONAL count: 1000 type: ESTIMATED measure: Antipsychotic/Benzodiazepine measure: Clinical Indication measure: Length of Stay measure: Disposition measure: Code Status sex: ALL minimumAge: 54 Years stdAges: ADULT stdAges: OLDER_ADULT hasResults: False
|
<|newrecord|> nctId: NCT06357182 id: STUDY00026136 id: NCI-2024-01262 type: REGISTRY domain: CTRP (Clinical Trial Reporting Program) id: STUDY00026136 type: OTHER domain: OHSU Knight Cancer Institute briefTitle: Iadademstat in Combination With Azacitidine and Venetoclax in Treating Newly Diagnosed Acute Myeloid Leukemia overallStatus: NOT_YET_RECRUITING date: 2024-05-08 date: 2026-03-08 date: 2026-05-29 date: 2024-04-10 date: 2024-04-10 name: OHSU Knight Cancer Institute class: OTHER name: Oregon Health and Science University name: Oryzon Genomics S.A. briefSummary: This phase I trial tests the safety, side effects, and best dose of iadademstat when given together with azacitidine and venetoclax in treating patients with newly diagnosed acute myeloid leukemia (AML). Iadademstat inhibits the LSD1 protein and may lead to inhibition of cell growth in LSD1-overexpressing cancer cells. Chemotherapy drugs, such as azacitidine, work in different ways to stop the growth of cancer cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Venetoclax is in a class of medications called B-cell lymphoma-2 (Bcl-2) inhibitors. It may stop the growth of cancer cells by blocking Bcl-2, a protein needed for cancer cell survival. Giving iadademstat with azacitidine and venetoclax may be safe, tolerable and/or effective in treating patients with newly diagnosed AML who cannot undergo intensive chemotherapy. conditions: Acute Myeloid Leukemia conditions: Myelodysplastic Syndrome/Acute Myeloid Leukemia studyType: INTERVENTIONAL phases: PHASE1 allocation: NON_RANDOMIZED interventionModel: SEQUENTIAL interventionModelDescription: The treatment plan starts with a 7 day monotherapy lead-in (Cycle 0 \[C0\]) and then proceeds to combination therapy in 28 day cycles. Disease will be assessed pre-treatment (Screening/Baseline), at the end of monotherapy, in C1 (and C2, if response is not observed in C1), and at the end of alternating cycles, thereafter. A disease assessment will also be conducted within 30 days of the last dose of IADA. Participants that do not achieve response after up to 2 cycles of the triplet regimen will be taken off treatment. primaryPurpose: TREATMENT masking: NONE count: 24 type: ESTIMATED name: Azacitidine name: Biospecimen Collection name: Bone Marrow Biopsy name: Echocardiography name: Iadademstat name: Multigated Acquisition Scan name: Questionnaire Administration name: Venetoclax measure: Incidence of dose-limiting toxicities (DLTs) within specific iadademstat (IADA) dose levels measure: Percentage of efficacy-evaluable participants achieving composite complete remission (cCR) measure: Percentage of efficacy-evaluable participants achieving an overall response (ORR) measure: Incidence of treatment-emergent grade ≥ 3 adverse events (AEs) sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: OHSU Knight Cancer Institute city: Portland state: Oregon zip: 97239 country: United States name: Curtis A. Lachowiez role: CONTACT phone: 503-494-5058 email: [email protected] name: Curtis A. Lachowiez role: PRINCIPAL_INVESTIGATOR lat: 45.52345 lon: -122.67621 hasResults: False
|
<|newrecord|> nctId: NCT06357169 id: Venus Glow briefTitle: Mechanical Intervention on the Scalp Microbiome: Setting the Stage for the Future Management of Cicatricial Alopecias overallStatus: COMPLETED date: 2023-01-13 date: 2023-06-30 date: 2024-01-13 date: 2024-04-10 date: 2024-04-10 name: University of Minnesota class: OTHER briefSummary: The objective of this study is to assess the effect of standardized scalp care, specifically mechanical cleansing with the Venus Glow™ Device and water, on the scalp microbiome. This study also seeks to characterize the microbiome of the normal, healthy scalp, thereby providing a baseline for which the scalp affected by hair and scalp disease can be compared. conditions: Lichen Planopilaris of Scalp conditions: Alopecia Areata studyType: INTERVENTIONAL phases: NA allocation: NA interventionModel: SINGLE_GROUP primaryPurpose: SUPPORTIVE_CARE masking: NONE count: 40 type: ACTUAL name: Venus Glow measure: scalp microbiome composition measure: scalp health sex: ALL minimumAge: 18 Years maximumAge: 35 Years stdAges: ADULT facility: University of Minnesota city: Minneapolis state: Minnesota zip: 55455 country: United States lat: 44.97997 lon: -93.26384 hasResults: False
|
<|newrecord|> nctId: NCT06357156 id: ORAD-621 briefTitle: Evaluating the Topographic and Quantitative Differences of the Mandibular Symphysis Area Between Males and Females Egyptians Using CBCT Scans: a Cross-sectional Study overallStatus: NOT_YET_RECRUITING date: 2024-06-01 date: 2025-01-30 date: 2025-03-30 date: 2024-04-10 date: 2024-04-10 name: Cairo University class: OTHER briefSummary: Retrospective Data Analysis will be performed after the CBCT images are pooled from the computer database.
|
* Exposure parameters of the scans will vary depending on patients' sizes (according to the manufacturer's recommendations).
|
* Images showing lower anterior mandibular teeth with 0.2 -0.4 voxel sizes will be reviewed.
|
* The topography and the quantity of the mandibular symphysis area will be assessed through the different planes: sagittal, coronal and axial cuts as well as assessing the prevalence of MIC and its distance from inferior border of the mandible if detected. Correlation of results according to gender and age (3 age sub-groups per gender:18-35, 36- 55, 56-75).
|
* CBCT images will be interpreted by oral and maxillofacial radiologist; blinded from demographic data of the patients.
|
* radiologist (Principle investigator) will evaluate the images for assessing the topography and quantity of bone in symphysial area through measuring dimensions of mandibular symphysis. Then will re-evaluate twice with a time lag of two weeks between the two reading sessions. The assistant supervisor will evaluate percentage of the scans. Any disagreement will be solved by consensus between the two observers.
|
* The measurements will be carried out by the principle observer (PY) and will be repeated 2 weeks later for intra-observer reliability assessment.
|
* Mandibular scans will be collected from planmeca machine, with 0.2-0.4 voxel size to be viewed on Romexis software to do the measurements of mandibular symphysis. Vertical height will be measured from the apices of anterior teeth to inferior border of the mandible from the sagittal and coronal cuts with the orientation lines parallel to the buccal cortical plate. Also, the sagittal cuts will be used to determine the depth of the labial bone, from the apices of anterior teeth the labial cortical plate with the orientation lines parallel to the buccal cortical plate (Safi, Yaser et al.,2021) Whilst horizontal dimension (width) will be measured along the outer surface of the labial cortical bone, which is determined from the inter-foraminal distance. 3D slicer software will be used for this curved measurement on the axial plane, since Romexis software can only do the linear and angular measurements (Lee , Kim et al, 2014).
|
Also, the sagittal reformatted cuts will be used for the determination of the topography of bone in symphysial area; either class I, II or III (Jussara Constantino, et al., 2018) Radiographs showing the different topographic types Radiograph A: Type I, B: Type II and C: Type III
|
• Through scrolling in sagittal, coronal cuts and the reformatted panoramic view the prevalence of mandibular incisive nerve will be detected (Borghesi, Andrea et al., 2022).
|
After collecting the whole data, statistically will be correlated to the age and gender. conditions: Mandibular Symphysis, Block Bone Graft, Mandibular Incisive Canal, and CBCT studyType: OBSERVATIONAL observationalModel: OTHER timePerspective: CROSS_SECTIONAL count: 222 type: ESTIMATED name: CBCT measure: Effect of gender on the mean height of basal bone in the symphysial area measure: Effect of gender on quantity of the bone in symphysial area: *depth of the bone *width of the bone measure: Effect of gender on topography of the bone in symphysial area measure: Effect of age on quantity of the bone in the symphysial area measure: Effect of age on topography of the bone in symphysial area measure: Prevalence of mandibular incisive canal sex: ALL minimumAge: 18 Years maximumAge: 75 Years stdAges: ADULT stdAges: OLDER_ADULT hasResults: False
|
<|newrecord|> nctId: NCT06357143 id: REMOVE briefTitle: Efficacy of Early Multimodal Physiotherapy in Patients With Reverse Shoulder Prosthesis overallStatus: NOT_YET_RECRUITING date: 2025-01 date: 2026-06 date: 2027-12 date: 2024-04-10 date: 2024-04-10 name: University of Malaga class: OTHER briefSummary: The present study try to evaluate the effectivenness of an early intervention program based on multimodal physiotherapy and focused on therapeutic exercise to improve the results of patients with a reverse shoulder phrostesis. This trial will be a randomized controlled trial with parallel groups, and outcomes variables will include psychometric properties through the use of specific questionnaries, and laboratory variables such as strength with a dynamometer, range of movement with a goniometer, muscle mass with an ultrasound, and kinematic parameters with inertial sensors. This study aims to develop an original intervention program in order to try to establish new protocols in the management of these patients. conditions: Shoulder Fractures conditions: Prosthesis User studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: DOUBLE whoMasked: INVESTIGATOR whoMasked: OUTCOMES_ASSESSOR count: 40 type: ESTIMATED name: REMOVE name: CONTROL measure: Functionality measure: Muscle mass measure: Kinematics measure: Strength measure: Range of movement sex: ALL minimumAge: 18 Years maximumAge: 75 Years stdAges: ADULT stdAges: OLDER_ADULT hasResults: False
|
<|newrecord|> nctId: NCT06357130 id: CHUBX 2023/75 briefTitle: Gynaecological Care for Transgender People in France in 2024. acronym: GyneTrans overallStatus: NOT_YET_RECRUITING date: 2024-04 date: 2026-04 date: 2026-04 date: 2024-04-10 date: 2024-04-29 name: University Hospital, Bordeaux class: OTHER briefSummary: To date, the transgender population, still poorly characterized, tends to increase. The impact of gender-affirming hormone therapy (GAHT) in this population remains poorly understood, and few data are published on the gynecological repercussions of such therapy. A recent literature review by a French team suggests gynecological follow-up procedures for transgender people. conditions: Transgender Management Care studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: PROSPECTIVE count: 500 type: ESTIMATED name: Questionnaire measure: Percentage of people aware of gynaecological recommendations. measure: Percentage of people aware of cancer risks measure: Percentage of people aware of contraception in transgender male population measure: Percentage of people aware of fertility and the impact of hormone treatments measure: Percentage of people aware of gynaecological repercussions of masculinizing hormone treatment in transgender male population sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Hopital Haut-Lévêque city: Pessac zip: 33604 country: France name: Virginie GROUTHIER, MD role: CONTACT phone: 05.57.65.60.78 phoneExt: +33 email: [email protected] name: Clara GUINARD role: CONTACT phone: 05.57.65.60.78 phoneExt: +33 email: [email protected] lat: 44.81011 lon: -0.64129 hasResults: False
|
<|newrecord|> nctId: NCT06357117 id: A01263 briefTitle: Extent of Intrahepatic Infiltration of Perihilar Cholangiocarcinoma overallStatus: COMPLETED date: 2018-04-13 date: 2021-12-22 date: 2021-12-22 date: 2024-04-10 date: 2024-04-11 name: Beijing Tsinghua Chang Gung Hospital class: OTHER briefSummary: The extent of intrahepatic infiltration of perihilar cholangiocarcinoma (PHCC) remains unclear. This research aimed to explore the pattern and extent of intrahepatic infiltration of PHCC to guide surgical treatment and pathological research. This prospective study included 62 participants diagnosed with PHCC who underwent major hepatectomy. A whole-mount digital liver pathology system (WDLPS) for hepatectomy specimens greater than 10 × 10 cm was used to panoramically assess the intrahepatic infiltration extent of PHCC. conditions: Perihilar Cholangiocarcinoma studyType: OBSERVATIONAL observationalModel: CASE_CONTROL timePerspective: PROSPECTIVE count: 62 type: ACTUAL measure: Relapse-free survival (RFS). measure: Overall survival (OS). sex: ALL minimumAge: 44 Years maximumAge: 81 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Beijing Tsinghua Chang Gung Hospital city: Beijing state: Beijing zip: 102218 country: China lat: 39.9075 lon: 116.39723 hasResults: False
|
<|newrecord|> nctId: NCT06357104 id: SCI-CT-0001 briefTitle: Detoxification From the Lipid Tract overallStatus: COMPLETED date: 2024-02-26 date: 2024-03-14 date: 2024-03-20 date: 2024-04-10 date: 2024-04-10 name: Pachankis, Yang I., M.D. class: INDIV name: First Affiliated Hospital of Chongqing Medical University briefSummary: Apart from electroencephalogram biofeedback and electrical brain stimulation adopted for maintenance treatment, the study utilizes ultra-low frequency transcranial magnetic stimulation (ULF-TMS) for initial γ-aminobutyric acid (GABA) stimulation. The cocktail therapy starts after the primary efficacy endpoint, and concomitant therapy is adopted throughout the study. conditions: COVID-19 Vaccine Adverse Reaction studyType: INTERVENTIONAL phases: PHASE4 allocation: NA interventionModel: SINGLE_GROUP primaryPurpose: TREATMENT masking: NONE count: 1 type: ACTUAL name: electroencephalogram biofeedback name: electrical brain stimulation name: ultra-low frequency transcranial magnetic stimulation name: Sertraline Hydrochloride name: Clonazepam name: Alprazolam name: Metoprolol name: Olanzapine name: Pravastatin Sodium 20 MG name: Sacubitril Valsartan Sodium Hydrate measure: Changes in Leukocyte and Components' Quantities measure: Changes in Leukocyte Components' Ratios measure: Quantity Changes in Megakaryocyte-Erythroid Progenitor measure: Changes in Hemoglobin Distribution measure: Changes in Mean Corpuscular Hemoglobin measure: Changes in Hematocrit measure: Changes in Plateletcrit measure: Red cell Distribution Width Coefficient of Variation measure: Changes in Particulate Matter Sizes measure: Changes in Total Lipid Quantities measure: Changes in Apolipoproteina measure: Changes in Lipoprotein (a) measure: Blood Pressure Changes measure: Heart Rate Changes sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Residential Address city: Chongqing state: Chongqing zip: 402762 country: China lat: 29.56278 lon: 106.55278 typeAbbrev: Prot_ICF hasProtocol: True hasSap: False hasIcf: True label: Study Protocol and Informed Consent Form date: 2024-03-07 uploadDate: 2024-03-15T00:02 filename: Prot_ICF_000.pdf size: 479591 hasResults: False
|
<|newrecord|> nctId: NCT06357091 id: 1097/2023 ACL-Shark Screw® briefTitle: ACL Reconstruction With Shark Screw® or Biocomposite-interference Screws overallStatus: NOT_YET_RECRUITING date: 2024-06-01 date: 2031-06-01 date: 2031-06-01 date: 2024-04-10 date: 2024-04-25 name: Bezirkskrankenhaus Schwaz class: OTHER briefSummary: The goal of this clinical trial is to compare the outcome of 2 different screws for Anterior cruciate ligament reconstruction. The main question is if the human allogeneic cortical bone screw reduces tunnel widening in comparison to conventional treatment with a biocomposite screw. Additional the re-rupture rate will be evaluated and knee scores will be recorded before surgery and after surgery. Participants will have MRI before and after surgery, 3, 6, 12, and 24 months after surgery and Computertomography after surgery, 3, 6 and 24 months after surgery. Questionnaires (Knee-scores) will be recorded before surgery, 6, 12, 24 months after surgery.
|
the investigators hope that with the human cortical bone screw the tunnel widening is reduced and the re-rupture rate is low conditions: Anterior Cruciate Ligament Rupture conditions: Anterior Cruciate Ligament Reconstruction conditions: Anterior Cruciate Ligament Injury studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: SINGLE whoMasked: PARTICIPANT count: 80 type: ESTIMATED name: ACL reconstruction with Shark Screw ACL® name: ACL reconstruction with biocomposite screw (Mecta) measure: bone tunnel widening will be measured by CT and/or MRI and measured in mm measure: International Knee Documentation Committee (IKDC) Scores measure: Knee Injury and Osteoarthritis Outcome Score (KOOS) Scores measure: Lysholm Knee Score measure: Tegner Activity Score sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Bezirkskrankenhaus Schwaz Betriebsgesellschaft m.b.H. city: Schwaz state: Tirol zip: 6130 country: Austria name: Alexander Rofner-Moretti, MD role: CONTACT phone: +435242 phoneExt: 600 email: [email protected] name: Markus Reichkendler, MD role: CONTACT phone: +435242 phoneExt: 600 email: [email protected] lat: 47.35169 lon: 11.71014 facility: Bezirkskrankenhaus Schwaz Betriebsgesellschaft m.b.H city: Schwaz state: Tirol zip: 6130 country: Austria name: Alexander Rofner-Moretti, MD role: CONTACT phone: +435242600 email: [email protected] name: Markus Reichkendler, MD role: CONTACT phone: +435242600 email: [email protected] name: Alexander Rofner-Moretti, MD role: PRINCIPAL_INVESTIGATOR name: Markus Reichkendler, MD role: SUB_INVESTIGATOR name: Boris Tirala, MD role: SUB_INVESTIGATOR name: Martin Wallner, MD role: SUB_INVESTIGATOR name: Lukas Pöhl, MD role: SUB_INVESTIGATOR name: Samuel Dolling, MD role: SUB_INVESTIGATOR name: Edith Reches, MD role: SUB_INVESTIGATOR name: Clemens Lottersberger, MD role: SUB_INVESTIGATOR lat: 47.35169 lon: 11.71014 hasResults: False
|
<|newrecord|> nctId: NCT06357078 id: AmasyaU-NU-679 briefTitle: Art Therapy and Caregivers Stress overallStatus: RECRUITING date: 2024-01-02 date: 2024-06-28 date: 2024-07-31 date: 2024-04-10 date: 2024-04-16 name: Amasya University class: OTHER briefSummary: This research will be conducted to determine the effect of art therapy on the stress, anxiety and well-being of caregivers in the palliative care service. conditions: Caregiver Stress Syndrome studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: SUPPORTIVE_CARE masking: NONE count: 52 type: ESTIMATED name: Art Therapy measure: Distress Thermometer measure: The State Anxiety Inventory measure: Personal Well-Being Index sex: ALL minimumAge: 18 Years maximumAge: 80 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Neşe Uysal status: RECRUITING city: Amasya zip: 0500 country: Turkey name: Neşe Uysal role: CONTACT phone: (90)3582181767 email: [email protected] lat: 40.65333 lon: 35.83306 hasResults: False
|
<|newrecord|> nctId: NCT06357065 id: UCatolicaMaule id: 11240343 type: OTHER_GRANT domain: ANID Chile briefTitle: Active Transport Educational Program Based on the Ecological Model on Improving the Physical and Mental Health: MOV-ES Project acronym: MOV-ES overallStatus: NOT_YET_RECRUITING date: 2024-04-01 date: 2025-12-20 date: 2026-12-20 date: 2024-04-10 date: 2024-04-10 name: Universidad Católica del Maule class: OTHER briefSummary: The epidemic of physical inactivity affects the entire world and is responsible for more than 5 million deaths per year. The call of the United Nations, through the 2030 Agenda and the Sustainable Development Goals, encourages the creation of favorable environments for physical activity based on the ecological model of physical activity. Given this context, active transportation can be an accessible, economical, and sustainable method to increase daily physical activity. The rate of school children who use active transport has decreased, being replaced by motorized transport, causing congestion and high levels of pollution in cities. In the Chilean context, there are studies of active transportation in the Chilean population; however, they are scarce in the school population and none of them is an intervention study, demonstrating the incipient development of this area in the country. The benefits of promoting active transportation not only favor the lifestyles of school children but also include additional co-benefits such as the improvement of mental health and better academic performance, in addition to the reduction of exhaust and greenhouse gas emissions.
|
Objectives. This proposal consists of three phases with the following objectives: Phase I: i) to synthesize the evidence about interventions aimed at estimating the effect on health of active transport in the secondary students; and ii), using qualitative techniques, to explore, from the basis of grounded theory, barriers and facilitators perceived by professors, students and parents about the development and implementation of the MOV-ES intervention. Phase II. Pilot and feasibility trial: a) to test the effect of MOV-ES intervention on improving body composition (body fat percentage and muscle mass), physical fitness (aerobic capacity and muscular strength), executive function and mental fitness (mood disorders, cognitive functioning) in the secondary students; and b), to examine the acceptability by professors, parents and students of the intervention by using ad hoc questionnaires. Phase III: to test the effectiveness of the MOV-ES intervention on physical activity, physical fitness, cognition and mental health through a cluster randomized controlled trial.
|
Expected results: This project will give rise to the following master\'s and doctoral theses, with their corresponding articles of high scientific impact: 1) Barriers and facilitators of teachers, parents and students for active transport from a qualitative approach; 2) Association between the built environment, urban features, and active transportation in high school students, 3) Effectiveness of an active transportation educational intervention on physical fitness and body composition, 4) Effectiveness of an active transportation educational intervention on the cognition of schoolchildren. It is expected that the results of the MOV-ES Project will transcend the physical health of schoolchildren and will have an impact on the school community, especially by decongesting the school environment. Through these results, the Ministry of Education, regional DAEM, municipalities, and educational establishments will be able to propose public policies that favor the practice of physical activity and the acquisition of healthy habits at school age. All of the above is based on quality indicators proposed by the Education Quality Agency. conditions: Physical Inactivity in Children studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL interventionModelDescription: Study design, setting: This is a cluster randomized field trial aimed to evaluate the previously tested MOV-ES intervention.
|
Population: First year of high school students in a city in south-central Chile. Three secondary schools in the urban area of Talca (1 public, 1 private subsidized, and 1 private non-subsidized) with at least three classes per school year will be randomly selected. This methodological option was adopted because, in Chile, school administration is associated with the socioeconomic level of families. primaryPurpose: PREVENTION masking: SINGLE maskingDescription: Randomization and blinding procedures: We invited 6 first-year high school classes to participate and, using a computer-generated procedure, will be randomized to the IG and to CG. The participants will be informed of the result of randomization after they agreed to participate in the study. The nature of the intervention makes its blinding infeasible. whoMasked: INVESTIGATOR count: 180 type: ESTIMATED name: Active transport educational program based on the ecological model measure: Body composition change (fat mass) by bioimpedance at 16 weeks measure: Change from Body Composition (fat-free mass) by bioimpedance at 16 weeks measure: Changes in Executive Function (inhibition) at 16 weeks measure: Changes in Executive Function (cognitive flexibility) at 16 weeks measure: Changes in executive function (working memory) at 16 weeks measure: Change from Anthropometric measurements at 16 weeks measure: Changes in objective physical activity at 16 week measure: Change from Physical Fitness (Aptitud cardiorrespiratoria (VO2 máx) at 16 weeks measure: Change from Physical Fitness (lower body strength) at 16 weeks measure: Change from Physical-Functional Fitness (strenght on the upper body) at 16 weeks measure: Change from mental health (depression) at 16 weeks measure: Change from mental health (Anxiety) at 16 weeks measure: Change from mental health (Stress) at 16 weeks measure: Changes in overall academic performance once the intervention is completed measure: Changes in health-related quality of life at 16 weeks measure: Changes in the Perception of urban environmental characteristics at 16 weeks measure: Changes in physical activity barriers at 16 weeks measure: Changes in adherence to physical activity at 16 weeks measure: Changes in the form of Transportation to and from School (Active Transportation) at 16 weeks. measure: Sociodemographic evaluations of parents measure: Parents' perception of urban environmental characteristics measure: Parents' perception of physical fitness sex: ALL minimumAge: 14 Years stdAges: CHILD stdAges: ADULT stdAges: OLDER_ADULT hasResults: False
|
<|newrecord|> nctId: NCT06357052 id: 2701 briefTitle: The Study of Lithogenesis Processes in Patients With Non-alcoholic Fatty Liver Disease (NAFLD) acronym: LINA overallStatus: COMPLETED date: 2019-07-19 date: 2022-04-30 date: 2022-11-30 date: 2024-04-10 date: 2024-04-10 name: Fondazione Policlinico Universitario Agostino Gemelli IRCCS class: OTHER briefSummary: Non-alcoholic fatty liver disease (NAFLD) is the most common cause of chronic liver disease, ranging from pure steatosis to non-alcoholic steatohepatitis and ultimately to liver cirrhosis. In order to study the association between NAFLD and nephrolithiasis while minimizing the confounding effect of metabolic syndrome, we investigated the impact of different degrees of NAFLD severity on potential risk factors for stone formation. conditions: NAFLD conditions: Urinary Lithiasis studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: CROSS_SECTIONAL count: 42 type: ACTUAL measure: the analysis of the correlation between the degree of severity of NAFLD And urinary lithogenic profilecharacterized by reduced urinary magnesium and altered urinary ammonium excretion. sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Fondazione Policlinico A.Gemelli IRCCS city: Roma zip: 00168 country: Italy lat: 41.89193 lon: 12.51133 hasResults: False
|
<|newrecord|> nctId: NCT06357039 id: 09.2023.422 id: 2220124 type: OTHER_GRANT domain: Scientific and Technological Research Council of Türkiye (TÜBİTAK) id: 1065371 type: OTHER_GRANT domain: Small and Medium Enterprises Development Organization (KOSGEB) briefTitle: Validation Study of Sleep Tracking Devices overallStatus: COMPLETED date: 2023-03-21 date: 2023-05-31 date: 2023-07-17 date: 2024-04-10 date: 2024-04-25 name: PNAPS Health Informatics and Space Technologies Inc. class: OTHER name: Analog Devices briefSummary: In this study, a two-part recursive convolutional neural networks model was developed, extracting features for each epoch window independently from before and after sleep onset (epoch encoder), and then trained in the context of long-term relationships in the sleep process (sequence encoder), using an approach similar to human expert classification based on information from single-channel forehead EEG and PPG (IR, Green, Red). The classification is based on guidelines from the American Academy of Sleep Medicine and calculated six parameters: total sleep duration (TST), wake (W), N1, N2, N3, and REM.
|
The validation study of the developed model and the device was conducted at the Sleep Disorders Centre of the Istanbul Medical Faculty using concurrent polysomnographic data from 305 male and female patients aged 18 to 65 years. conditions: Sleep conditions: Sleep Disorder studyType: OBSERVATIONAL observationalModel: OTHER timePerspective: CROSS_SECTIONAL count: 305 type: ACTUAL name: Sleep tracking device measure: Sleep Stages Classification Accuracy measure: Interoception analysis from PPG data collected from facial skin sex: ALL minimumAge: 18 Years maximumAge: 65 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Pnaps Health Informatics and Space Technologies Inc city: Istanbul state: Başıbüyük, Maltepe zip: 34854 country: Turkey lat: 41.01384 lon: 28.94966 typeAbbrev: Prot hasProtocol: True hasSap: False hasIcf: False label: Study Protocol date: 2023-03-09 uploadDate: 2024-04-04T08:32 filename: Prot_000.pdf size: 55944 typeAbbrev: ICF hasProtocol: False hasSap: False hasIcf: True label: Informed Consent Form date: 2023-03-09 uploadDate: 2024-04-04T04:55 filename: ICF_001.pdf size: 78393 hasResults: False
|
<|newrecord|> nctId: NCT06357026 id: Phitys I -2024 briefTitle: Phitys I™ Percutaneous Left Ventricular Assist System Study overallStatus: NOT_YET_RECRUITING date: 2024-04-01 date: 2025-05-01 date: 2026-04-01 date: 2024-04-10 date: 2024-04-10 name: Shanghai NewMed Medical Co., Ltd. class: INDUSTRY name: Shanghai Phigine Medical Technology Co., Ltd. briefSummary: The primary purpose of this clinical trial is to evaluate the safety and efficacy of the percutaneous left ventricular assist system versus intra-aortic balloon pump (IABP) for Circulatory Support during High-risk PCI. conditions: Coronary Artery Disease studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: NONE count: 344 type: ESTIMATED name: Percutaneous Ventricular Assist System（Phigine Medical） name: intra-aortic balloon pump (IABP) measure: Incidence of freedom from major adverse cardiovascular and cerebrovascular events (MACCE) measure: Incidence of death measure: Incidence of myocardial infarction measure: Incidence of stroke measure: Incidence of target vessel revascularization measure: Incidence of need for cardiac operation or thoracic or abdominal vascular operation or vascular operation for limb ischemia measure: Incidence of acute kidney injury measure: Incidence of cardiopulmonary resuscitation or ventricular arrhythmia requiring cardioversion measure: Incidence of increasing in aortic insufficiency by more than one grade measure: Incidence of severe hypotension measure: Incidence of failure to achieve angiographic success measure: Incidence of freedom from major adverse cardiovascular and cerebrovascular events (MACCE) measure: Hemodynamic support success rate during PCI procedure measure: Technical success rate measure: Procedural success rate measure: Change in LVEF compared to baseline measure: Improvement in cardiac function measure: Evaluation of Experimental device performance sex: ALL minimumAge: 18 Years maximumAge: 90 Years stdAges: ADULT stdAges: OLDER_ADULT facility: The Second Hospital of Jilin University city: Jilin state: Changchun country: China name: Bin Liu role: CONTACT lat: 43.85083 lon: 126.56028 facility: The First Affiliated Hospital of Harbin Medical University city: Harbin state: Heilongjiang country: China name: Yue Li role: CONTACT lat: 45.75 lon: 126.65 facility: Henan Provincial Chest Hospital city: Zhengzhou state: Henan country: China name: Yiqiang Yuan role: CONTACT lat: 34.75778 lon: 113.64861 facility: Renmin Hospital of Wuhan University city: Wuhan state: Hubei country: China name: Hong Jiang role: CONTACT lat: 30.58333 lon: 114.26667 facility: The Second Xiangya Hospital of Central South University city: Changsha state: Hunan country: China name: Shenghua Zhou role: CONTACT lat: 28.19874 lon: 112.97087 facility: General Hospital of Northern Theater Command city: Shenyang state: Liaoning country: China name: Yaling Han role: CONTACT lat: 41.79222 lon: 123.43278 facility: Xinhua Hospital Affiliated to Shanghai Jiao Tong University School of Medicine city: Shanghai state: Shanghai country: China name: Li Zhang role: CONTACT lat: 31.22222 lon: 121.45806 facility: West China Hospital, Sichuan University city: Chengdu state: Sichuan country: China name: Mao Chen role: CONTACT lat: 30.66667 lon: 104.06667 hasResults: False
|
<|newrecord|> nctId: NCT06357013 id: 2023-40 briefTitle: Postoperative Analgesia in Bilateral Knee Arthroplasties overallStatus: ACTIVE_NOT_RECRUITING date: 2024-01-01 date: 2024-05-01 date: 2024-05-30 date: 2024-04-10 date: 2024-04-10 name: Kocaeli City Hospital class: OTHER_GOV briefSummary: To observationally compare the analgesic efficacy of LIA and S-FICB techniques and to record the pain scores of patients who underwent bilateral knee operations in the postoperative period. conditions: Knee Arthroplasty, Total conditions: Peripheral Nerve Block conditions: Pain, Postoperative studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: PROSPECTIVE count: 60 type: ESTIMATED name: Bilateral Suprainguinal fascia iliaca compartment block name: Local infiltration analgesia measure: Suprainguinal fascia iliaca compartment block (S-FICB) produces adequate analgesic effect in knee arthroplasty. sex: ALL minimumAge: 18 Years maximumAge: 75 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Kocaeli City Hospital city: Kocaeli country: Turkey lat: 39.62497 lon: 27.51145 hasResults: False
|
<|newrecord|> nctId: NCT06357000 id: Time from PCI to surgery briefTitle: Time From PCI to Cancer Surgery and Cardiovascular and Oncologic Outcomes overallStatus: COMPLETED date: 2008-01-01 date: 2018-12-31 date: 2018-12-31 date: 2024-04-10 date: 2024-04-10 name: Samsung Medical Center class: OTHER briefSummary: To evaluate the association between time from PCI to cancer surgery and cardiovascular and oncologic outcomes in early-stage cancer patients, A retrospective, population-based cohort study was conducted using data from the Korean National Health Insurance Service (K-NHIS) database. conditions: Coronary Artery Disease conditions: Cancer studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: RETROSPECTIVE count: 3621 type: ACTUAL measure: Occurence of Bleeding measure: Occurence of Spontaneous myocardial infarction measure: Occurence of Repeat revascularization measure: Occurence of Cancer recurrence measure: Occurence of All cause death sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT hasResults: False
|
<|newrecord|> nctId: NCT06356987 id: 0002 briefTitle: Comparison of Laparoscopic Herniotomy and Open Herniotomy in Children acronym: Herniotomy overallStatus: COMPLETED date: 2021-06-01 date: 2021-12-31 date: 2021-12-31 date: 2024-04-10 date: 2024-04-12 name: King Edward Medical University class: OTHER briefSummary: All patients of age 6 month to 12 years with inguinal hernia were included in study.
|
Data was collected on detailed proforma regarding age, sex, side ,operative time, cosmesis , and postoperative complications conditions: Inguinal Hernia studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL interventionModelDescription: 66 patients with inguinal hernia were randomly divided into two groups (A and B) primaryPurpose: TREATMENT masking: NONE maskingDescription: 66 patients (33 patients in each group) of laparoscopic extraperitoneal closure and open herniotomy each count: 66 type: ACTUAL name: Herniotomy measure: Operative time measure: Recurrence sex: ALL minimumAge: 6 Months maximumAge: 12 Years stdAges: CHILD facility: Muhammad Sharif city: Lahore state: Punjab zip: 53711 country: Pakistan lat: 31.558 lon: 74.35071 hasResults: False
|
<|newrecord|> nctId: NCT06356974 id: STROgHAT briefTitle: Stop Transmission of Gambiense Human African Trypanosomiasis (STROgHAT) acronym: STROgHAT overallStatus: NOT_YET_RECRUITING date: 2024-04-08 date: 2026-12-30 date: 2027-12-30 date: 2024-04-10 date: 2024-04-10 name: Drugs for Neglected Diseases class: OTHER name: Institute of Tropical Medicine, Belgium name: Institut de Recherche pour le Developpement name: Institut National de Recherche Biomédicale. Kinshasa, République Démocratique du Congo name: Ministry of Public Health, Democratic Republic of the Congo briefSummary: This protocol describes both the epidemiological study which aims at assessing whether over a three-year period a zero prevalence can be achieved when implementing a screen \& treat approach with acoziborole, as well as a nested clinical study aimed at generating further evidence on safety of acoziborole in gambiense human African trypanosomiasis (gHAT) seropositives individuals. The overall coordinator will be ITM. ITM will be fully responsible for the epidemiological study (study Part A), including cost effectiveness and evaluation of diagnostic tests. DNDi will be the legal sponsor of the nested safety clinical study (study Part B) and will ensure compliance with regulatory requirements and good clinical practices (GCP) for this part of the study.
|
The investigators hypothesize that by systematically screening the populations of all endemic villages in a well-defined HAT focus and by expanding gHAT treatment to all seropositives, that it will be able to arrive at a zero prevalence over a three-year period.
|
The objectives are to evaluate whether a strategy based on widened treatment for all parasitologically negative seropositive gHAT suspects with acoziborole can lead to interruption of transmission of T.b.gambiense in a mainland focus and to assess the safety of acoziborole in gHAT seropositve individuals and parasitologically negative. conditions: Human African Trypanosomiasis studyType: INTERVENTIONAL phases: PHASE3 allocation: NA interventionModel: SINGLE_GROUP interventionModelDescription: one-arm, open label, non-randomized, multicentre, phase IIIb study primaryPurpose: TREATMENT masking: NONE count: 2500 type: ESTIMATED name: Treatment of seropositive individuals (positive serology test, but parasitology not confirmed) measure: Interruption of transmission of T.b. gambiense measure: Assessment of safety measure: Economic evaluation measure: assessment of the performance of several diagnostic tests sex: ALL minimumAge: 11 Years stdAges: CHILD stdAges: ADULT stdAges: OLDER_ADULT hasResults: False
|
<|newrecord|> nctId: NCT06356961 id: 2022Z4BB82 id: 2022Z4BB82 type: OTHER_GRANT domain: Decreto Direttoriale n. 901 SH4(MUR-PRIN 2022) briefTitle: Routine Outcome Monitoring and Feedback Informed Therapy in Italy acronym: FIT-ITALY overallStatus: NOT_YET_RECRUITING date: 2024-04-15 date: 2024-12-31 date: 2025-10-05 date: 2024-04-10 date: 2024-04-10 name: University of Bergamo class: OTHER name: University of Palermo name: Politecnico di Milano name: Leiden University name: University of Ottawa name: University of Sheffield name: Brigham Young University briefSummary: The research project OutProFeed - Italy: Routine outcome monitoring and feedback informed therapy in Italy: 1st Italian RCT large population study, represents the first Italian randomised controlled trial (RCT) to evaluate the effectiveness of feedback-informed psychotherapy (FIT) to improve patients mental health outcomes and psychotherapy processes through the use of the digital platform Mindy.
|
The following project was awarded PRIN 2022 funding by the Ministry of University and Research (MUR). This project has the University of Bergamo as lead partner, with the auxiliary participation of the University of Palermo and the Polytechnic University of Milan.
|
Given the innovative-experimental nature of the following research project, a digital platform -Mindy- will be used, which allows the recruited professionals (once registered) an all-round management of all the professional activities inherent to the psychologist/psychotherapist profession (informed consent, online therapy, administration of psychometric instruments, etc.) and which also facilitates the administration of psychometric instruments. ) and which also facilitates data collection, subsequent analysis and Routine Outcome Monitoring (ROM) and Feedback Informed Therapy (FIT) procedures with ad hoc charts and digital tools, in accordance with the guidelines dictated by the GDPR regulations on health and clinical data. Each therapist involved in the project, after having received guidance on the procedures and after having been instructed to use the platform will involve 5 new patients in the following project. The only inclusion criteria for patients are the following:
|
I) Being of legal age II) Not having a diagnosis of psychosis and/or neurocognitive disorders III) Consent to participate in the following research project IV) Being a new patient (new or less than three sessions carried out) We will randomly assign the previously recruited psychotherapists and their patients to one of three conditions: (1) treatment as usual (TAU) in which therapists and patients proceed with psychotherapy as they normally would without receiving any initial training and using only Mindy as a simplified digital folder (2) process and outcome monitoring (OPM) in which patients will complete process and outcome measures related to each psychotherapy session therapists will receive basic feedback without Clinical Support Tools on these measures, they will use the Mindy platform as a medical record and will not receive specific training on FIT (3) process and outcome monitoring with feedback (OPM-F) where patients will complete process and outcome measures related to each session and therapists will receive feedback on the patient progress and experiences of the therapeutic alliance with specific training on feedback informed therapy (FIT) and will use the Mindy platform with all feedback and Clinical Support Tools information, They will also receive monthly supervision/coaching (for three months) to complete the FIT and ROM training on-going, with practical discussion of the most difficult clinical cases and possible solutions to be implemented in therapy.
|
Recruitment of therapists will take place with the strategic participation of a pool of MIUR-recognised Schools of Specialisation in Psychotherapy (https://www.miur.it/ElencoSSPWeb/).
|
Professionals qualified to practise as psychologists who are in their third year of the Schools of Psychotherapy will be selected, as well as therapists who already have a regular diploma of specialisation in psychotherapy recognised by the MIUR (https://www.miur.it/ElencoSSPWeb/), and who are in active practice. There will be no restrictions on the type of psychotherapy used by the professionals who will be recruited (the only criterion for inclusion is that it must be psychotherapy for a mental health issue). Therapists will not be aware of the randomisation procedure to reduce bias (Zelen design). Specifically, for the following research project we will use data from a maximum of 15 sessions (endpoints) carried out by all therapists of the 3 groups with the Clinical Support System only for the therapists of the group (OPM-F) who, as previously mentioned, will receive ad hoc training; furthermore, various instruments (described in the special section Instruments) will be compiled through the functional use of Mindy and in detail (cadence, purpose and research hypotheses) in the complete protocol in the next section. Finally, through the administration of special questionnaires, factors indicative of therapists aptitude and competences for the use of digital tools in professional practice will be collected in order to obtain statistical clusters that can be used as independent or control variables. conditions: Feedback, Psychological studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: SINGLE whoMasked: PARTICIPANT count: 180 type: ESTIMATED name: (Feedback Informed Therapy) with Clinical Support Tools and ah hoc training name: Feedback and ROM (basic) measure: Change from baseline in Symptom severity (GAD7-PHQ9) in OPM-F,OPM and TAU conditions at T2 (up to 6 months), and follow up (3 months) measure: Clinical Outcomes in Routine Evaluation-10 (Change in Session by session) measure: Working Alliance Inventory-Short Revised-Client (Change in session by session) measure: Impact of Usability of MINDY platform with Post-Study System Usability Questionnaire (PSSUQ) and Net Promoter Score (NPS) on patient outcomes measure: Change from baseline of The Reflective Functioning Questionnaire (RFQ)-7 sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: University of Bergamo (DSUS) city: Bergamo state: Ita (bg) zip: 24125 country: Italy lat: 45.69601 lon: 9.66721 hasResults: False
|
<|newrecord|> nctId: NCT06356948 id: H23-02918 briefTitle: Rate of Tranexamic Acid Administration on Blood Pressure (RateTXA) Study. acronym: RateTXA overallStatus: RECRUITING date: 2024-03-30 date: 2027-07-30 date: 2027-12-30 date: 2024-04-10 date: 2024-04-10 name: University of British Columbia class: OTHER briefSummary: Tranexamic acid is a well-established treatment for post-partum hemorrhage. This study aims to examine the effect of tranexamic acid administration rates on blood pressure changes over 1 minute compared to 10 minutes in healthy pregnant patients scheduled for cesarean delivery. conditions: Healthy Participants studyType: INTERVENTIONAL phases: PHASE4 allocation: RANDOMIZED interventionModel: PARALLEL interventionModelDescription: prospective, randomized, double-blind, non-inferiority trial.
|
Arm 1: Intravenous infusion of TXA 1g (10 mL) administered over 1 minute. Arm 2: Intravenous infusion of TXA 1g (10 mL) administered over 10 minutes primaryPurpose: PREVENTION masking: TRIPLE maskingDescription: An anesthesiologist or anesthesia assistant not involved in the study will draw up TXA and labelling them based on the randomization. whoMasked: PARTICIPANT whoMasked: CARE_PROVIDER whoMasked: INVESTIGATOR count: 110 type: ESTIMATED name: Tranexamic Acid (TXA) measure: Change in systolic blood pressure from baseline over 15 minutes post-TXA administration between groups. measure: Incidence of nausea measure: Incidence of vomiting measure: Incidence of hypotension measure: Incidence of hypertension measure: Incidence of central nervous system side effects sex: FEMALE minimumAge: 19 Years stdAges: ADULT stdAges: OLDER_ADULT facility: BC Women's Hospital status: RECRUITING city: Vancouver state: British Columbia zip: V6H3N1 country: Canada name: Aislynn Sharrock, BA (Hons.) role: CONTACT phone: 604-875-2158 phoneExt: 6335 email: [email protected] name: Anton Chau, MD MMSc role: PRINCIPAL_INVESTIGATOR name: Simon Wydall, MBBS MSc role: SUB_INVESTIGATOR name: Juliana Barrera, MD MSc role: SUB_INVESTIGATOR lat: 49.24966 lon: -123.11934 hasResults: False
|
<|newrecord|> nctId: NCT06356935 id: HP2024 briefTitle: Effects of Heavy-load Resistance Training overallStatus: COMPLETED date: 2023-03-17 date: 2023-08-03 date: 2023-08-03 date: 2024-04-10 date: 2024-04-10 name: University of Southern Denmark class: OTHER name: Team Denmark briefSummary: The study aims to investigate effects of 8-weeks of heavy-load resistance training on mechanical muscle function and functional performance in elite female team handball players from the Danish Women's Handball League. Players will be randomly assigned to either a resistance training group (RT) or serves as training-as-usual controls (CON). conditions: Healthy studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL interventionModelDescription: Randomized controlled trial primaryPurpose: TREATMENT masking: NONE count: 60 type: ACTUAL name: RT name: CON measure: Explosive muscle strength measure: Acceleration capacity measure: Agility performance measure: Jump ability sex: FEMALE minimumAge: 18 Years maximumAge: 35 Years stdAges: ADULT facility: University of Southern Denmark city: Odense zip: 5230 country: Denmark lat: 55.39594 lon: 10.38831 hasResults: False
|
<|newrecord|> nctId: NCT06356922 id: RC20_0123 briefTitle: Study Assessing RLT Using [177Lu]Lu-PentixaTher for Relapsed/Refractory CXCR4+ Acute Leukemia. acronym: PENTILULA overallStatus: NOT_YET_RECRUITING date: 2024-05-15 date: 2027-05-15 date: 2027-05-15 date: 2024-04-10 date: 2024-04-11 name: Nantes University Hospital class: OTHER briefSummary: CXCR4 inhibition may represent a new therapeutic strategy in acute leukemia (AL) patients, not only by increasing chemosensitivity but also by preventing relapse of the disease by disruption of the interaction of residual leukemic cells with the bone marrow niche. Radiolabeled CXCR4 ligands have been developed for PET imaging (68Ga-PentixaFor; INN: Gallium (68Ga) boclatixafortide) and radioligand therapy (RLT) (\[177Lu\]Lu-PentixaTher/\[90Y\]Y-PentixaTher). \[177Lu\]Lu and \[90Y\]Y-PentixaTher have been tested in three multiple myeloma patients in named-patient use with a remarkable efficacy in 2 patients (Herrmann, 2016). Moreover, feasibility of CXCR4 PET imaging in AML was reported, providing a framework for future theranostic approaches targeting the CXCR4/CXCL12-defined leukemia-initiating cell niche (Herhaus, 2016).
|
Here a Phase I/II study to determine maximal tolerated dose (MTD) of a RLT using \[177Lu\]Lu-PentixaTher in relapsed/refractory AL was designed. This will be a standard phase I/II 3+3 dose escalation study. Five dose levels will be tested, so 6 to 21 patients have to be included in the study. conditions: Acute Leukemia studyType: INTERVENTIONAL phases: PHASE1 phases: PHASE2 allocation: NA interventionModel: SINGLE_GROUP primaryPurpose: TREATMENT masking: NONE count: 21 type: ESTIMATED name: Experimental drug [177Lu]Lu-PentixaTher measure: Safety of RLT using one injection of [177Lu]Lu-PentixaTher measure: Tolerance measure: Overall response rate measure: Complete response rate measure: Overall survival measure: Leukemia-free survival measure: Minimal residual disease measure: Whole-body biodistribution measure: Serum uptake measure: Radiation dosimetry measure: Renal safety measure: Renal safety measure: Renal safety measure: Renal safety measure: Correlation between different cytokines and toxicity measure: Factors associated response measure: Exploratory outcome measure = Identification of biological biomarkers sex: ALL minimumAge: 18 Years maximumAge: 100 Years stdAges: ADULT stdAges: OLDER_ADULT facility: CHU de Bordeaux city: Bordeaux state: Gironde zip: 33604 country: France name: DUMAS Pierre-Yves role: CONTACT name: [email protected] role: CONTACT lat: 44.84044 lon: -0.5805 facility: CHU de Nantes city: Nantes state: Loire-Atlantique zip: 44000 country: France name: Patrice CHEVALLIER role: CONTACT phone: 00332 40 08 39 94 email: [email protected] lat: 47.21725 lon: -1.55336 facility: CHU d'Angers city: Angers state: Maine Et Loire zip: 49100 country: France name: HUNAULT Mathilde role: CONTACT email: [email protected] lat: 47.46667 lon: -0.55 facility: CHU de Clermont-Ferrand city: Clermont-Ferrand state: Puy De Dôme zip: 63000 country: France name: MOLUCON Cécile role: CONTACT email: [email protected] lat: 45.77966 lon: 3.08628 hasResults: False
|
<|newrecord|> nctId: NCT06356909 id: SUPREMEneo briefTitle: Study of PREMEdication Before Laryngoscopy in Neonates in France acronym: SUPREMEneo overallStatus: RECRUITING date: 2024-03-11 date: 2024-04-07 date: 2024-04-07 date: 2024-04-10 date: 2024-04-10 name: Centre Hospitalier Intercommunal Creteil class: OTHER briefSummary: This study is a national prospective survey on practices of premedication before laryngoscopy in neonates. The survey will evaluate adequation to the French best practice guidelines to improve their dissemination and to identify current practices of premedication before laryngoscopy in neonates in French units (agents, dosing, efficacy, safety) conditions: Neonatal Respiratory Distress studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: PROSPECTIVE count: 900 type: ESTIMATED name: Survey of sedo-analgesia practices before laryngoscopy measure: Proportion of patients who received a 1st sequence of sedo-analgesia consistent with best practice guidelines during laryngoscopy or laryngeal mask placement measure: Molecules used for sedo-analgesia measure: Cumulative doses of sedo-analgesia used measure: Questionnaire for the operator describing reasons for non-compliance with best practice guidelines measure: Numeric rating scale for pain (by operator and assistant) measure: TRACHEA score (Tonus, Reactivity, Awareness & Conditions of intubation to Help in Endotracheal intubation Assessment) measure: Side effects related to the premedication sex: ALL minimumAge: 20 Weeks maximumAge: 44 Weeks stdAges: CHILD facility: Centre Hospitalier Intercommunal de Creteil status: RECRUITING city: Creteil zip: 94000 country: France name: Manon TAUZIN, MD role: CONTACT phone: 0157023458 email: [email protected] lat: 48.78333 lon: 2.46667 hasResults: False
|
<|newrecord|> nctId: NCT06356896 id: 2023/034 briefTitle: The Effect of Diaphragmatic Breathing Exercise on Symptom Severity, Sleep Quality and Anxiety in CABG Patients. overallStatus: RECRUITING date: 2024-03-01 date: 2024-09-01 date: 2024-09-01 date: 2024-04-10 date: 2024-04-10 name: KTO Karatay University class: OTHER briefSummary: Coronary artery bypass surgery (CABC) is a commonly performed surgical procedure for the treatment of blockages in the heart vessels. This surgical intervention aims to improve the blood circulation of the patients' heart muscle. However, after CABC, patients may experience symptoms arising from the effect of the operation. These symptoms include shortness of breath, chest pain, sleep problems and a general feeling of restlessness. These symptoms occur as a result of the operation and can limit patients' daily activities, negatively affect their quality of life, and make the rehabilitation process difficult. Diaphragmatic breathing exercise can be an effective strategy for managing symptoms after CABC. This exercise involves deep and controlled breathing and aims to strengthen respiratory muscles, increase lung capacity and improve respiratory efficiency. Diaphragmatic breathing exercise helps breathing occur more efficiently by reducing the movement of the chest wall and can reduce patients' breathing difficulties. Diaphragmatic breathing exercise provides relaxation in the body by calming the sympathetic nervous system and can reduce stress during the sleep process. In this way, patients can experience a deeper and more restful sleep and feel more energetic when they wake up. At the same time, diaphragmatic breathing exercise improves mental state and reduces the effects of stress by providing focus and mental relaxation. This thesis study aims to investigate the effect of diaphragmatic breathing exercise applied to patients undergoing CABC on symptom severity, sleep quality and anxiety. The importance of this study is that it has great potential for managing symptoms after CABC and improving patients' quality of life. Diaphragmatic breathing exercise is expected to be effective in reducing symptoms after CABC, allowing patients to improve their respiratory functions and general health status. Additionally, investigating the effects of this exercise on patients' sleep quality and anxiety may help nurses adopt a more holistic approach in healthcare delivery. conditions: Coronary Artery conditions: Anxiety conditions: Symptom conditions: Sleep studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL interventionModelDescription: Adult patients will be divided into two groups: experimental and control groups. Diaphragmatic breathing exercise will be explained to the patients in the experimental group in the preoperative period. In the preoperative period, the sleep, anxiety and symptom levels of the experimental and control groups will be evaluated.In the post-operative period, the experimental group was reminded to do diaphragmatic breathing exercises on the 2nd, 3rd and 4th days.On the 5th post-operative day, sleep, anxiety and symptom severity of the experimental and control groups will be evaluated. primaryPurpose: HEALTH_SERVICES_RESEARCH masking: SINGLE maskingDescription: Single (Participant) Single Blinded whoMasked: PARTICIPANT count: 70 type: ESTIMATED name: diaphragmatic breathing exercise measure: cardiovascular surgery symptom inventory measure: richards champbell sleep quality scale measure: state anxiety inventory measure: Personal information form sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Konya City Hospital status: RECRUITING city: Konya state: Karatay zip: 42020 country: Turkey name: Serap SAYAR, PhD role: CONTACT phone: 05059102994 email: [email protected] name: Havva Nur YALICI, Nurse role: CONTACT phone: 05413386593 email: [email protected] lat: 37.87135 lon: 32.48464 hasResults: False
|
<|newrecord|> nctId: NCT06356883 id: 2024-4938 briefTitle: Intraarterial Carboplatin + Caelyx Compared to Intraarterial Carboplatin + Etoposide Phosphate for Progressing Glioblastoma overallStatus: RECRUITING date: 2024-04 date: 2027-04 date: 2028-04 date: 2024-04-10 date: 2024-04-10 name: Université de Sherbrooke class: OTHER briefSummary: The standard of care for glioblastoma (GBM) treatment involves maximal resection followed by concomitant radiotherapy and temozolomide. Progression-free survival (PFS) with this treatment is only 6.9 months and relapse is inevitable. At relapse, there is no consensus regarding the optimal therapeutic strategy. The rationale behind the fact that limited chemotherapy agents are available in the treatment of malignant gliomas is related to the blood-brain barrier (BBB), which impedes drug entry to the brain. Intraarterial (IA) chemotherapy allows to circumvent this. Using IA delivery of carboplatin, can produce responses in 70% of patients for a median PFS of 5 months. Median survival from study entry was 11 months, whereas the overall survival (OS) 23 months. How can the OS and PFS be improved? By combining chemotherapeutic agents with different mechanisms of action.
|
Study design: In this phase II trial, treatment will be offered at relapse. Surgery will be performed for cytoreduction if it is warranted, followed with a combination IA carboplatin + IA Cealyx (liposomal doxorubicin) or IA carboplatin + IA etoposide phosphate. Toxicity will be assessed according to the NCIC common toxicity criteria. Treatment will consist in either IA carboplatin (400 mg/m\^2) + IA Cealyx (30 mg/m\^2) or IA carboplatin (400 mg/m\^2) + IA etoposide phosphate (400 mg/m\^2) every 4-6 weeks (1 cycle). Up to twelve cycles will be offered.
|
Subsets and Splits
No community queries yet
The top public SQL queries from the community will appear here once available.