text
stringlengths 0
197k
|
|---|
<|newrecord|> nctId: NCT06264076 id: 686340 id: CIV-NO-23-09-043976 type: OTHER domain: Eudamed CIV ID briefTitle: Ligament Balancing in Total Knee Arthroplasty acronym: BLIS-TKA overallStatus: NOT_YET_RECRUITING date: 2024-03 date: 2025-12-31 date: 2025-12-31 date: 2024-02-16 date: 2024-02-16 name: Oslo University Hospital class: OTHER name: Vestre Viken Hospital Trust briefSummary: The goal of this interventional pilot study is to evaluate if performing ligament balancing on the medial collateral ligament (MCL) in a more systematical manner with a novel instrument can produce more objective and repeatable ligament lengthening in Total Knee Arthroplasty. The main questions it aim to answer are:
|
1. Is it feasible to perform systematic ligament balancing on the MCL using a novel instrument?
|
2. Can a novel instrument for ligament balancing acquire more objective and repeatable results, without risk of injury?
|
Participants must consent prior to the surgery, but inclusion is only done once ligament balancing is indicated during surgery. Patients will be follow-up as standard protocol for Total Knee Arthroplasty patients at the hospital. conditions: Ligament; Laxity, Knee conditions: Knee Osteoarthritis studyType: INTERVENTIONAL phases: NA allocation: NA interventionModel: SINGLE_GROUP interventionModelDescription: Prospective, single-group, non-blind, interventional study primaryPurpose: TREATMENT masking: NONE maskingDescription: Non-blind count: 20 type: ESTIMATED name: A novel instrument for ligament balancing in total knee arthroplasty measure: Is it feasible to perform systematic ligament balancing on the MCL using a novel instrument? measure: MCL-lengthening in millimeters after ligament balancing using the novel instrument measure: Demographic information - height (cm) - and how this parameters affects ligament balancing. measure: Demographic information - weight (kg) - and how this parameters affects ligament balancing. measure: Demographic information - age (years) - and how this parameters affects ligament balancing. measure: Demographic information - sex (biologic, male/ female) - and how this parameters affects ligament balancing. measure: Demographic information - co-morbidities (disease state) - and how this parameters affect ligament balancing. measure: Patient reported outcome measures (PROM) using EQ-5D-5L measure: Patient reported outcome measures (PROM) using FJS-12 measure: Patient reported outcome measures (PROM) using KOOS-12 sex: ALL minimumAge: 40 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Baerum Hospital, Vestre Viken Hospital Trust city: Bærums Verk state: Viken zip: 1346 country: Norway name: Jarle Vik, MD role: CONTACT phone: 004793844926 email: jarle.vik@vestreviken.no lat: 59.94148 lon: 10.50273 facility: Oslo University Hospital, Ullevaal city: Oslo zip: 0450 country: Norway name: Lars HW Engseth, MD role: CONTACT phone: 004741254136 email: laengs@ous-hf.no lat: 59.91273 lon: 10.74609 hasResults: False
|
<|newrecord|> nctId: NCT06264063 id: D-DIST briefTitle: Study of Behavioral Dysfunctions and Related Neuronal Correlates in Patients With Dystonia acronym: D-DIST overallStatus: RECRUITING date: 2024-01-10 date: 2024-03-10 date: 2025-10-10 date: 2024-02-16 date: 2024-02-16 name: IRCCS Centro Neurolesi "Bonino-Pulejo" class: OTHER briefSummary: Dystonias represent hyperkinetic movement disorders characterized by protracted muscle contractions, such as to cause torsional movements and anomalous postures in different parts of the body. Although they occur more often in a focal form (blepharospasm, oromandibular dystonia, cervical dystonia, laryngeal dystonia, attitudinal cramps of the limbs) than segmental (involvement of several contiguous muscle groups, e.g. facial muscles and neck muscles), they are nevertheless capable of significantly influencing the quality of life, with consequent social and health costs. Although described as a predominantly motor disorder, the presence of non-motor symptoms in dystonias associated with alteration of the fronto-striatal circuits is increasingly recognized. Neuroimaging studies have highlighted that the striatum and, more specifically, striatal dopamine, is involved in high cognitive processes such as attention, reward-based learning and decision making. Clinical conditions associated with cortico-striatal circuit dysfunction and abnormal meso-striatal or meso-cortical dopamine transmission also appear to influence temporal estimation, delay discounting, showing an impulsive preference for immediate rewards over delayed gratification.
|
Based on these premises, the present project aims to evaluate the cognitive and affective aspects of dystonias, in line with neuroimaging research documenting structural and functional dysfunctions in the respective brain regions. conditions: Dystonia conditions: Neurologic Disorder conditions: NEUROSCIENCE studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: SCREENING masking: SINGLE whoMasked: PARTICIPANT count: 102 type: ESTIMATED name: control group name: experimental group name: EEG power in alpha band measure: montreal cognitive assessment measure: Beck depression inventory measure: EEG power in alpha band sex: ALL minimumAge: 18 Years maximumAge: 60 Years stdAges: ADULT facility: IRCCS Centro Neurolesi Bonino Pulejo status: RECRUITING city: Messina zip: 98124 country: Italy name: Caterina Formica, PhD, PSY role: CONTACT phone: +3909060128185 email: katia.formica@irccsme.it lat: 38.19394 lon: 15.55256 hasResults: False
|
<|newrecord|> nctId: NCT06264050 id: 2023.04 briefTitle: Psychological Support Group and Its Effects on Mood, Anxiety and Coping acronym: SUPPORT overallStatus: ACTIVE_NOT_RECRUITING date: 2004-01-08 date: 2024-09-08 date: 2025-03-15 date: 2024-02-16 date: 2024-02-16 name: IRCCS San Camillo, Venezia, Italy class: OTHER briefSummary: The aim of this study is to verify the influence that participation in a Psychological Support Group has on anxiety, depression and coping skills in patients admitted to the IRCCS San Camillo Hospital.
|
It is therefore an observational study with a pre-post design on a cohort of patients hospitalized at San Camillo IRCCS who attend the Psychological Support Group.
|
The study consists of verifying whether the therapeutic activity of the Psychological Support Group (GSP) has an influence on the levels of anxiety, mood and coping skills in the patients who attend it. These purposes will be pursued through the administration to each patient at the beginning (pre) and at the end (post) of the period of attendance at the GSP, of validated scales: Stay Y2 (anxiety), BDI II(depressive symptoms), COPE NVD 25 (coping strategies) and the CORE-OM (outcomes of psychological activity). conditions: Coping Strategies conditions: Anxiety conditions: Nurse-Patient Relations conditions: Psychological conditions: Mood Depressed conditions: Rehabilitation conditions: Neurologic Manifestations studyType: INTERVENTIONAL phases: NA allocation: NA interventionModel: SINGLE_GROUP interventionModelDescription: pre post study on a single cohort primaryPurpose: DIAGNOSTIC masking: NONE count: 19 type: ACTUAL name: evalutaion scales measure: The State-Trait Anxiety Inventory (STAI) Y2 measure: The Beck Depression Inventory II (BDI-II) measure: The Clinical Outcomes in Routine Evaluation-Outcome Measure (CORE-OM) measure: The Coping Orientations to Problem Experienced NVI - 25 sex: ALL minimumAge: 18 Years maximumAge: 85 Years stdAges: ADULT stdAges: OLDER_ADULT hasResults: False
|
<|newrecord|> nctId: NCT06264037 id: 2023.03 id: Studio 1574 /IRCCS San Camillo type: OTHER domain: CESC di Venezia e IRCSS San Camillo briefTitle: The Experience in Neurorehabilitation Setting: a Qualitative Study acronym: NURSEXPERIENCE overallStatus: RECRUITING date: 2023-03-15 date: 2024-12-08 date: 2025-03-15 date: 2024-02-16 date: 2024-02-16 name: IRCCS San Camillo, Venezia, Italy class: OTHER briefSummary: In this exploratory qualitative study with a hermeneutic phenomenological approach, we will describe and understand the experience of treatment and hospitalization in hospitalized people suffering from stroke, multiple sclerosis, Parkinson\'s disease and patients post-neurosurgery for oncological causes. Patients will be interviewed in a semi-structured manner and sampling will take place for each of the pathology groups according to the saturation method. conditions: Rehabilitation conditions: Neurologic Disorder conditions: Stroke conditions: Parkinson Disease conditions: Multiple Sclerosis conditions: Neurosurgery studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: PROSPECTIVE count: 40 type: ESTIMATED name: semi structured interview measure: narrative contents sex: ALL stdAges: CHILD stdAges: ADULT stdAges: OLDER_ADULT facility: Alberto Camuccio status: RECRUITING city: Venezia zip: 30126 country: Italy name: Alberto Camuccio, doctor role: CONTACT phone: +39412207516 email: alberto.camuccio@hsancamillo.it name: Enrico Dal Pozzo, doctor role: CONTACT phone: +39412207111 email: enrico.dalpozzo@hsancamillo.it lat: 45.43713 lon: 12.33265 facility: IRCCS San Camillo Department of Neurorehabilitation, Venezia status: RECRUITING city: Venezia zip: 30126 country: Italy name: Alberto Camuccio, doctor role: CONTACT phone: +39412207516 email: alberto.camuccio@hsancamillo.it name: Enrico Dal Pozzo, doctor role: CONTACT phone: +39412207111 email: enrico.dalpozzo@hsancamillo.it lat: 45.43713 lon: 12.33265 facility: IRCCS San Camillo Venezia status: RECRUITING city: Venezia zip: 30126 country: Italy name: Alberto Camuccio, doctor role: CONTACT phone: +39412207516 email: alberto.camuccio@hsancamillo.it name: Enrico Dal Pozzo, doctor role: CONTACT phone: +39412207111 email: enrico.dalpozzo@hsancamillo.it lat: 45.43713 lon: 12.33265 hasResults: False
|
<|newrecord|> nctId: NCT06264024 id: 519516 briefTitle: Simultaneous pHototherapeutic Keratectomy and corneAl Collagen cRosslinking in Eyes With Keratoconus: a Randomized Trial (SHARK) overallStatus: RECRUITING date: 2024-02-12 date: 2025-05-01 date: 2034-02-01 date: 2024-02-16 date: 2024-02-16 name: Oslo University Hospital class: OTHER briefSummary: The goal of this clinical trial is to compare CXL with combined treatment with CXL and t-PTK.
|
The main questions it aims to answer are whether combined treatment can give better visual acuity and if the treatments are equally safe. conditions: Keratoconus studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: NONE count: 81 type: ESTIMATED name: Corneal collagen cross linking (CXL) name: Transepithelial phototherapeutic keratectomy (t-PTK) measure: Visual acuity measure: Risk of progression measure: Visual acuity measure: Visual acuity measure: Visual acuity measure: Visual acuity measure: Visual acuity measure: Risk of progression measure: Risk of progression measure: Risk of progression measure: Risk of progression measure: Risk of progression measure: Depth of demarcation line (OCT) measure: Depth of demarcation line (confocal microscopy) measure: Patient reported outcome measure (PROMs) measure: Patient reported outcome measure (PROMs) measure: Patient reported outcome measure (PROMs) measure: Patient reported pain after surgery sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Department of Ophhtalmology, University of Oslo status: RECRUITING city: Oslo country: Norway name: Olav Kristianslund, MD, PhD role: CONTACT email: olakri@ous-hf.no name: Bjarne L Thorbjørnsen, MD role: CONTACT email: uxtbja@ous-hf.no lat: 59.91273 lon: 10.74609 hasResults: False
|
<|newrecord|> nctId: NCT06264011 id: 2023B0044 briefTitle: Discrimination and Religious Experiences of Adult Muslimahs in Salaat acronym: DREAMS overallStatus: RECRUITING date: 2023-07-13 date: 2024-06 date: 2024-06 date: 2024-02-16 date: 2024-04-26 name: Ohio State University class: OTHER briefSummary: This goal of this clinical trial is to examine the effects of the Muslim prayer (salaat) on physiological arousal among Muslim women. This study aims to measure EEG and HRV during the salaat performance among Muslim women. Using EEG as a measure of physiological relaxation, HRV will be utilized as a measure of stress experienced by Muslim women whose prayer have been understudied in research on the salaat. Thus, the main questions it aims to answer are 1) whether salaat performed by Muslim women influences physiological relaxation similar to what is seen by men, and 2) Evaluate health-related correlates of perceived discrimination among Muslim women.
|
Participants will complete 15 questionnaires. Participants will be connected to a Heart Rate Variability (HRV) monitor as well as a 32-electrode EEG cap. After the baseline data are obtained, all participants will complete both conditions (salaat and counting) but the order of participation in conditions will be randomly assigned. The resting period will again occur between conditions and at the end of the second condition.
|
All participants will pray the Duha prayer, an optional superogatory prayer that typically occurs in the early morning, to control for differences in timing and duration of prayer. The Duha is completed between the dawn and noon prayers and consists of four cycles of prayer as well as Qur'an recitation and supplication throughout the four positions. The salaat condition includes four cycles with four different positions during each cycle (standing with bowing at a 90-degree angle with both hands covering the knees, standing again briefly with arms at the sides, prostrating with forehead, hands, knees, and feet touching the ground, followed by sitting with knees bent under the torso, prostrating, and sitting again). The counting condition will include the same physical component as the salaat condition. This will include 4 cycles of movement through the four different positions (i.e., standing, bowing at a 90-degree angle with both hands covering the knees, standing again briefly with arms at the sides, prostrating with forehead, hands, knees, and feet touching the ground, followed by sitting with knees bent under the torso, prostrating, and a final sitting position in cycles two and four (see Figure 2)). Apart from not including the final sitting position, cycles one and three are identical to cycles two and four (see Figure 2). The counting condition will include replacing Qur'anic recitation and subsequent supplications throughout the prayer by counting "one one-thousand, two one-thousand, three one-thousand, etc." throughout the duration of time typically required to perform the full salaat. During the standing position, counting can last for approximately 30-60 seconds in line with the previous study by Doufesh and colleagues (2012). Thus, the first three cycles of prayer will require approximately 77 seconds each while the final cycle will require around 97 seconds based on the estimates by Doufesh and colleagues (2012), for a total of approximately five and a half minutes. To ensure that participant duration during the counting condition is, on average, equivalent to the salaat condition, an audio recording will be provided with counting aloud during each position. The duration of the counting in the audio recording will be an average of the duration of each position as found in Doufesh and colleagues (2012). A bell sound will be used to indicate when participants should change to the next position. After performance of each condition, participants will return to a comfortable seated position. Participants will complete a questionnaire to rate their mental focus in the condition. Blood pressure will be measured at the end of each condition. While at rest, assessment of blood pressure, HRV, and EEG will be obtained from participants for 5 minutes between each condition and at the end of the study. conditions: Stress, Psychological conditions: Control studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: CROSSOVER interventionModelDescription: There is one intervention (i.e., the prayer condition) and one control condition (i.e., the counting condition). primaryPurpose: SUPPORTIVE_CARE masking: SINGLE maskingDescription: This study uses a cross-sectional, repeated measures, crossover design. All participants will complete both conditions of the study but will be randomized to start in either the salaat or counting conditions. whoMasked: INVESTIGATOR count: 45 type: ESTIMATED name: Salaat name: Sham comparator measure: Relative power alpha measure: High frequency heart rate variability (HF-HRV) measure: The Body Perception Questionnaire Body Awareness Very Short Form (BPQ-VSF) measure: The SF 36-Item Health Survey (SF-36) measure: Modified International Physical Activity Questionnaire - Short Form (IPAQ-SF) measure: Health Care Discrimination Scale (HCDS; Martin, 2015) measure: Perceived Religious Discrimination Scale (PRDS; Rippy & Newman, 2008) measure: The Internalized Islamophobia Scale measure: Muslim Identification Scale (MIS; Verkuyten, 2007) measure: Brief Religious COPE measure: Salaat Frequency Scale measure: The Salaat Index measure: Hijab Frequency Scale sex: FEMALE minimumAge: 18 Years maximumAge: 50 Years stdAges: ADULT facility: The Ohio State University status: RECRUITING city: Columbus state: Ohio zip: 43016 country: United States name: Ihsan Rodriguez, MS role: CONTACT phone: 505-463-5297 email: Rodriguez.919@osu.edu name: Charles Emery, PhD role: CONTACT phone: 43210 email: emery.33@osu.edu name: Charles Emery, PhD role: PRINCIPAL_INVESTIGATOR name: Ihsan Rodriguez, MS role: SUB_INVESTIGATOR lat: 39.96118 lon: -82.99879 hasResults: False
|
<|newrecord|> nctId: NCT06263998 id: HUC1-394 briefTitle: Clinical Study for the Evaluation of Safety and Tolerability of NCP112 Eye Drops overallStatus: NOT_YET_RECRUITING date: 2024-06-03 date: 2025-11-28 date: 2026-01-30 date: 2024-02-16 date: 2024-02-16 name: Huons Co., Ltd. class: INDUSTRY briefSummary: The objective is to evaluate the safety, local tolerability, and pharmacokinetics of NCP112 eye drops through single and multiple dose-escalation ocular administrations in healthy adults. conditions: Xerophthalmia studyType: INTERVENTIONAL phases: PHASE1 allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: DOUBLE whoMasked: PARTICIPANT whoMasked: INVESTIGATOR count: 60 type: ESTIMATED name: NCP112 name: NCP112 Placebo measure: Treatment-Emergent Adverse Events measure: Evaluation of pharmacokinetic profile measure: Evaluation of pharmacokinetic profile sex: ALL minimumAge: 19 Years maximumAge: 50 Years stdAges: ADULT hasResults: False
|
<|newrecord|> nctId: NCT06263985 id: 20214133 briefTitle: Axis(TM) Solvent-dehydrate Dermal Allograft in the Treatment of Pelvic Organ Prolapse. overallStatus: ACTIVE_NOT_RECRUITING date: 2021-11-02 date: 2025-05-30 date: 2025-05-30 date: 2024-02-16 date: 2024-02-16 name: Michigan Institution of Women's Health PC class: OTHER name: Coloplast A/S briefSummary: The goal of this study is to assess improvement in subjects who have undergone Axis Dermis, biologic mesh for pelvic organ prolapse repair. \[describe participant population/health conditions\]. The main question\[s\] it aims to answer are:
|
* Is the leading edge of the prolapse above the hymen
|
* Does subject notice a bulge Participants will undergo Axis Dermis pelvic organ prolapse repair procedure. conditions: Pelvic Organ Prolapse studyType: INTERVENTIONAL phases: PHASE4 allocation: NA interventionModel: SINGLE_GROUP interventionModelDescription: Subjects undergoing the treatment for pelvic organ prolapse with Axis Dermis biologic mesh. primaryPurpose: TREATMENT masking: NONE count: 50 type: ACTUAL name: Axis Dermis biologic mesh repair for pelvic organ prolapse measure: Improvement in function measure: Improvement in Anatomy measure: Assess complications or untoward side effects. sex: FEMALE minimumAge: 21 Years maximumAge: 89 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Advanced Urogynecology of Michigan city: Dearborn state: Michigan zip: 48124 country: United States lat: 42.32226 lon: -83.17631 hasResults: False
|
<|newrecord|> nctId: NCT06263972 id: 0168-21EMC briefTitle: Comparison of the Efficacy of Transcranial Direct Current Stimulation (tDCS) of the Primary Motor Cortex (M1) or the Prefrontal Cortex Combined With Aerobic Activity for Alleviation of Fibromyalgia Symptoms. overallStatus: NOT_YET_RECRUITING date: 2024-03 date: 2026-03 date: 2026-07 date: 2024-02-16 date: 2024-02-16 name: HaEmek Medical Center, Israel class: OTHER name: Technion, Israel Institute of Technology name: Rambam Health Care Campus briefSummary: The goal of this study is to demonstrate the effectiveness of treating fibromyalgia using combination of electrical stimulation with aerobic activity.
|
Participants will be randomly assigned to stimulation in a ratio of 1:1:1. 120 participants (40 in each group). The therapeutic course will include moderate aerobic physical activity (at 60% of the target heart rate adjusted for age) 3 times a week for 4 weeks (a week of adjustment, and 3 weeks of treatment), along with low current electrical stimulation for 3 weeks. conditions: Fibromyalgia conditions: Electric Shock studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: SINGLE whoMasked: PARTICIPANT count: 120 type: ESTIMATED name: Direct Stimulation Prefrontal Cortex name: Shame cortex stimulation name: Direct Stimulation to Motor Cortex name: erobic physical activity measure: Study objectives: • Comparing the effectiveness of direct electric current stimulation between the two stimulus areas Numeric pain rating scale. measure: Study objectives: • Comparing the effectiveness of direct electric current stimulation (tDCS) between the two stimulus areas and in relation Adult sensory profile test Raw score. measure: Study objectives: • Comparing the effectiveness of direct electric current stimulation between the two stimulus areas and in relation to The Montreal Cognitive Assessment (MoCA) score. measure: Study objectives: • Comparing the effectiveness of direct electric current stimulation between the two stimulus areas and in relation to Generalized Anxiety Disorder 7-Item Scale sex: ALL minimumAge: 18 Years maximumAge: 65 Years stdAges: ADULT stdAges: OLDER_ADULT hasResults: False
|
<|newrecord|> nctId: NCT06263959 id: GST-HG131-II-01 briefTitle: A Randomized, Double-blind, Placebo-controlled Phase IIa Clinical Study to Evaluate the Safety and Efficacy of GST-HG131 Tablets in Patients With Chronic Hepatitis B overallStatus: RECRUITING date: 2023-12-29 date: 2024-09-01 date: 2024-11-01 date: 2024-02-16 date: 2024-02-16 name: Fujian Akeylink Biotechnology Co., Ltd. class: INDUSTRY briefSummary: A randomized, double-blind, placebo-controlled Phase IIa clinical study to evaluate the safety and efficacy of GST-HG131 tablets in patients with chronic hepatitis B conditions: Chronic Hepatitis B studyType: INTERVENTIONAL phases: PHASE2 allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: TRIPLE whoMasked: PARTICIPANT whoMasked: CARE_PROVIDER whoMasked: INVESTIGATOR count: 45 type: ESTIMATED name: GST-HG131 name: Placebo to match GST-HG131 measure: Change from Baseline in HBsAg levels measure: Number of participants with adverse events (AEs), serious adverse events (SAEs), and withdrawals due to AEs sex: ALL minimumAge: 35 Years maximumAge: 65 Years stdAges: ADULT stdAges: OLDER_ADULT facility: The Fifth Medical Center of Chinese PLA General Hospital status: RECRUITING city: Beijing country: China name: Tang Yanan role: CONTACT phone: +8613585734994 email: annie_tyn@163.com lat: 39.9075 lon: 116.39723 hasResults: False
|
<|newrecord|> nctId: NCT06263946 id: WS10337 briefTitle: Essilor® Stellest® Lenses Multicentre European Study (SLOMES) acronym: SLOMES overallStatus: RECRUITING date: 2024-03-22 date: 2026-09-30 date: 2026-12-30 date: 2024-02-16 date: 2024-04-03 name: Essilor International class: INDUSTRY briefSummary: The goal of this post-market clinical follow up Study is to demonstrate the efficacy, safety, acceptability, and quality of life implications of Essilor® Stellest® spectacle lenses in slowing myopia progression in European children and adolescents. Participants will receive Essilor® Stellest® at inclusion visit and will be asked for a full time wear (\>12 hours daily) for 24 months. The primary endpoints are the change in axial length and cycloplegic autorefraction from baseline to 24 months compared to expected change based on axial length and refraction centile positions at baseline. conditions: Myopia studyType: INTERVENTIONAL phases: NA allocation: NA interventionModel: SINGLE_GROUP interventionModelDescription: multicentre, European, prospective primaryPurpose: TREATMENT masking: NONE count: 150 type: ESTIMATED name: Essilor® Stellest® spectacle lenses measure: Change in cycloplegic axial length measure: Change in cycloplegic autorefraction measure: Change in refraction progression centile measure: Change in cycloplegic axial length measure: Change in cycloplegic autorefraction measure: Change in refraction measure: Change in axial length measure: Change in choroidal thickness measure: Change in refraction measure: Change in axial length vs atropine measure: Change in choroidal thickness measure: Change in Paediatric Refractive Error Profile (PREP-2) score sex: ALL minimumAge: 6 Years maximumAge: 16 Years stdAges: CHILD facility: Hôpital Fondation Adolphe de Rothschild - Ophthalmology Department status: RECRUITING city: Paris zip: 75019 country: France name: Ramin Tadayoni, Professor role: CONTACT email: rtadayoni@for.paris name: Ramin Tadayoni role: PRINCIPAL_INVESTIGATOR lat: 48.85341 lon: 2.3488 facility: Centre for Eye Research Ireland (CERI) - TU DUBLIN status: RECRUITING city: Dublin zip: D07 H6K8 country: Ireland name: Ian Flitcroft, Professor role: CONTACT email: ian.flitcroft@tudublin.ie name: James LOUGHMAN, Professor role: CONTACT phone: +353868589593 email: james.loughman@tudublin.ie name: Ian Flitcroft, Pr. role: PRINCIPAL_INVESTIGATOR name: James Loughman, Pr. role: SUB_INVESTIGATOR lat: 53.33306 lon: -6.24889 facility: Erasmus Medical Center status: NOT_YET_RECRUITING city: Rotterdam zip: 3015 country: Netherlands name: Caroline Klaver, Professor role: CONTACT email: c.c.w.klaver@erasmusmc.nl name: Jan Roelof Polling role: CONTACT phone: 010-7040704 email: j.polling@erasmusmc.nl name: Caroline Klaver role: PRINCIPAL_INVESTIGATOR name: Jan Roelof Polling role: SUB_INVESTIGATOR lat: 51.9225 lon: 4.47917 hasResults: False
|
<|newrecord|> nctId: NCT06263933 id: 2023-A01804-41 briefTitle: Effect of Experience Sharing and Mutual Assistance on Insight and Recovery During the First Psychotic Episode acronym: DIPEM overallStatus: RECRUITING date: 2023-11-13 date: 2024-11-13 date: 2025-11-13 date: 2024-02-16 date: 2024-02-16 name: Centre hospitalier de Ville-Evrard, France class: OTHER briefSummary: Controlled, prospective, qualitative and quantitative trial. The goal of this trial is to evaluate the mutual assistance early intervention device efficacy and its impact on insight and personal recovery of participants living with a first psychotic episode. This intervention lasts 5 days with 1 session per day of 1 hour 30 minutes. Three evaluations, before the intervention, after intervention and 1 month after the hospitalization's end. conditions: Psychotic Episode studyType: INTERVENTIONAL phases: NA allocation: NON_RANDOMIZED interventionModel: PARALLEL interventionModelDescription: A control group and a intervention group primaryPurpose: SUPPORTIVE_CARE masking: NONE count: 50 type: ESTIMATED name: Insight Scale name: Semi-directional interviews name: routine care name: session of mutual assistance with a mediator psychologist measure: The level of the increasing of The INSIGHT scale measure: The increase of Recovery Scale measure: The semi-structured interview sex: ALL minimumAge: 18 Years maximumAge: 40 Years stdAges: ADULT facility: Etablissement Public de Santé de Ville-Evrard status: RECRUITING city: Neuilly-sur-Marne zip: 93330 country: France name: Rusheenthira Thavaseelan role: CONTACT phone: 0143093232 phoneExt: 033 email: r.thavaseelan@epsve.fr name: Dominique Januel role: CONTACT phone: 0143093232 phoneExt: 033 email: d.januel@epsve.fr name: Dominique Januel, Pr role: PRINCIPAL_INVESTIGATOR name: Ilona Arcomano, PhD role: SUB_INVESTIGATOR lat: 48.85373 lon: 2.54903 hasResults: False
|
<|newrecord|> nctId: NCT06263920 id: 288703 briefTitle: Neurofrailty: A Study of Late-onset Epilepsy and Its Associations overallStatus: RECRUITING date: 2022-05-05 date: 2027-01-12 date: 2027-01-12 date: 2024-02-16 date: 2024-02-16 name: Lancashire Teaching Hospitals NHS Foundation Trust class: OTHER briefSummary: We don't know a great deal about why some people develop seizures in adulthood, but some researchers think that it might tell us something about the brain. A small number of people with first seizure in adulthood go on to experience problems like stroke or dementia later in life. However, stroke and dementia are common diseases, so we don't know whether there is a real association between these conditions. When people develop their first seizure in adult life, this is sometimes called Late-Onset Epilepsy. Through the NeuroFrailty study, we will observe 'brain health' over the years following the onset of a seizure, and I hope that it might give us more information about people with these kinds of seizures.
|
The NeuroFrailty study involves observing people from the time of diagnosis of first seizure. At this time, we will look at investigations such as blood tests, blood pressure, brain scans, alongside other diagnoses which might tell us whether there are differences compared to people without seizures. For some people, we will also look in greater depth at lifestyle including exercise, driving, family planning, and memory assessments.
|
Over the following years, we will look at how things change: for example whether there are changes in memory, new diagnoses, medication changes and how lifestyle has changed. Because there is so little research in this area, it is very difficult to predict what might happen. For example, some people can experience worse memory because of medication side effects; on the other hand, good seizure control following a diagnosis can sometimes lead to improved memory. Over years, it may become clear that some diseases are more likely in people with late-onset epilepsy than in people without such a diagnosis. You will receive a yearly newsletter to keep you updated on everything we learn about late-onset epilepsy.
|
Purpose and Background
|
Most of the time, we do not know why an adult develops epilepsy. Some researchers think there may be a connection between epilepsy which starts in adulthood, and increased risk of stroke or dementia in the future. However, there is very little research or evidence in this area, so we cannot say whether this is true.
|
What does taking part involve?
|
This study is an observational study, which means that the management of participants' seizure disorder will not be affected if they choose to take part in this study. The purpose of this study is to watch participants over the course of several years, to find out more about seizures which start in adulthood.
|
Participants can choose the level of involvement that is right for them.
|
1. LOW involvement. A researcher will check hospital and General Practice (GP records) once or twice per year, for the LIMITED AND SPECIFIC purpose of checking: medications, any new diagnoses, investigations associated with stroke risk (such as cholesterol, blood pressure, heart trace) and any brain scans that have been performed. I will not have access to more detailed information, such as conversations between a participant and their GP.
|
2. HIGH involvement. This involves being contacted by telephone once per year for 15-30 minutes to ask questions assessing memory and enquiring about lifestyle, such as exercise, smoking and alcohol use.
|
3. VERY HIGH involvement. These participants will be contacted for a longer telephone conversation 30-45 minutes once per year about their experience of how epilepsy has affected home life, work and medications.
|
If someone decides in the future that they don't want to be involved, they can withdraw from the study. However, once the study is completely finished, the information will be completely anonymous, which means that I won't be able to find individual's information in order to delete it.
|
Glossary Seizure disorder = any disorder which involved having experienced at least one seizure. First seizure and epilepsy both can be classed as a form of seizure disorder.
|
Neurofrailty = A condition whereby a person is at risk of stroke or dementia. conditions: Late Onset Epilepsy conditions: Stroke conditions: Dementia studyType: OBSERVATIONAL observationalModel: CASE_CONTROL timePerspective: PROSPECTIVE count: 360 type: ESTIMATED measure: At the time of onset, do people with late-onset epilepsy have higher prevalence of cerebrovascular disease risk factors compared to a control population? measure: Quality of Life - how of chronic illness is mediated measure: What is the absolute and relative incidence of stroke and dementia in people after the onset of LOE compared to the background population? measure: Which anti-epileptic drugs are used in current practice in LOE, and how are they tolerated? sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Lancashire Teaching Hospitals NHS status: RECRUITING city: Preston state: Lancashire zip: PR2 9HT country: United Kingdom name: Kina Bennett role: CONTACT phone: (+44) 01772 522031 email: kina.bennett@lthtr.nhs.uk name: Research Access role: CONTACT email: research.access@lthtr.nhs.uk name: Jasmine Wall role: PRINCIPAL_INVESTIGATOR lat: 53.76282 lon: -2.70452 hasResults: False
|
<|newrecord|> nctId: NCT06263907 id: stellate ganglion block briefTitle: Stellate Ganglion Block for Prevention of Post Mastectomy Depression acronym: SGB overallStatus: NOT_YET_RECRUITING date: 2024-03-01 date: 2024-12-31 date: 2025-04-30 date: 2024-02-16 date: 2024-02-28 name: Mansoura University class: OTHER briefSummary: Complications after mastectomy include chronic pain and depression. conditions: Mastectomy conditions: Pain, Acute conditions: Pain, Chronic studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL interventionModelDescription: Patients will be randomization into two equal groups using computer-generated random numbers prior to surgery of 70 each; Group S: will receive ipsilateral stellate gangalion block and Group C: will receive no block. primaryPurpose: PREVENTION masking: DOUBLE maskingDescription: The anesthesiologist, who will be responsible for opening the envelope and do the block or not according to the group besides, evaluation of its success and covering the skin over the site of ipsilateral stellate gangalion with sterile dressing in both groups, will not be involved in data collection. whoMasked: PARTICIPANT whoMasked: INVESTIGATOR count: 140 type: ESTIMATED name: Stellate gangalion block measure: incidence of postmastectomy depression measure: incidence of postmastectomy depression measure: the need for postoperative antidepressant measure: acute postoperative pain at the incision site (breast and the axilla) measure: chronic postmastectomy pain at the incision site measure: incidence of nausea and vomiting measure: Functional pain in the ipsilateral shoulder measure: Any complications related to stellate ganglion injection sex: FEMALE minimumAge: 21 Years maximumAge: 65 Years stdAges: ADULT stdAges: OLDER_ADULT hasResults: False
|
<|newrecord|> nctId: NCT06263894 id: MarmaraU-Ebe-ZDY-01 briefTitle: Alexander Technique on Labor Pain and Anxiety overallStatus: RECRUITING date: 2024-02-05 date: 2024-06-01 date: 2024-07-02 date: 2024-02-16 date: 2024-02-20 name: Marmara University class: OTHER name: The Scientific and Technological Research Council of Turkey briefSummary: This study will examine the effect of the Alexander Technique on labor pain and anxiety during labor. This study is designed as a randomized controlled experimental study. The population of the study consists of primiparous pregnant women who applied to Istanbul Provincial Health Directorate Başakşehir Çam and Sakura City Hospital, D-Block Maternity Hospital between November 2023 and May 2024. In calculating the sample size, G\*Power (3.1.9.6) program was used to calculate the sample size with an error of 0.05, effect level of 0.5, power of 95%, and the required sample size for 2 groups was calculated as 34 people for each group with a total of 68 people. conditions: Labor Pain conditions: Anxiety studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL interventionModelDescription: One experimental group and one conventional (control) group primaryPurpose: SUPPORTIVE_CARE masking: DOUBLE maskingDescription: In order to reduce selection bias in determining the experimental and control groups, a computer-assisted randomization program (https://www.randomizer.org) will be used for pregnant women who meet the inclusion criteria. whoMasked: PARTICIPANT whoMasked: OUTCOMES_ASSESSOR count: 68 type: ESTIMATED name: Experimental group measure: Decreasing labor pain measure: Decreasing anxiety sex: FEMALE minimumAge: 18 Years maximumAge: 35 Years stdAges: ADULT facility: Başakşehir Çam and Sakura City Hospital status: RECRUITING city: Istanbul country: Turkey name: Ayşen Özgür role: CONTACT phone: +905393806296 email: aysenozgurr@gmail.com lat: 41.01384 lon: 28.94966 hasResults: False
|
<|newrecord|> nctId: NCT06263881 id: MMH-407-009 briefTitle: Clinical Trial of the Efficacy and Safety of Raphamin in Combined Treatment of Community-acquired Pneumonia overallStatus: RECRUITING date: 2023-12-01 date: 2026-12-31 date: 2026-12-31 date: 2024-02-16 date: 2024-04-19 name: Materia Medica Holding class: INDUSTRY briefSummary: Multicenter double-blind placebo-controlled randomized in parallel groups clinical trial. conditions: Community-acquired Pneumonia conditions: Pneumonia studyType: INTERVENTIONAL phases: PHASE3 allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: QUADRUPLE whoMasked: PARTICIPANT whoMasked: CARE_PROVIDER whoMasked: INVESTIGATOR whoMasked: OUTCOMES_ASSESSOR count: 370 type: ESTIMATED name: Raphamin name: Placebo measure: Percentage of patients with clinical cure at the test of cure (TOC) visit measure: Average duration of antibacterial therapy measure: Proportions of patients with a positive response to the initial course of antibiotic therapy after 48-72 hours measure: Proportion of patients who discontinue antibiotic therapy after 7 days of treatment (based on physician assessment of clinical symptoms). measure: Proportion of patients who required a change in antibiotic 48-72 hours after initiation of therapy. measure: Time until a persistent decrease in body temperature ≤37.2ºС (according to the patient's diary). measure: Proportion of patients who required a second course of antibiotic therapy. measure: Proportion of patients who required hospitalization during 15 days of follow-up. measure: Number of antipyretic drug doses taken during 7 days of the initial course of antibacterial therapy (per patient). measure: Proportion of patients without infiltration on x-ray/CT 14 days after randomization. measure: The Presence of Adverse Events (AEs). measure: Changes in Vital Signs (Blood Pressure measured in mm Hg) measure: Changes in Vital Signs (Pulse Rate (Heart Rate) measured in beats per minute) measure: Changes in Vital Signs (Respiratory Rate (Breathing Rate) measured in breaths per minute) sex: ALL minimumAge: 18 Years maximumAge: 65 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Northern Medical Clinical Center named after N.A. Semashko Federal Medical and Biological Agency status: RECRUITING city: Arkhangelsk zip: 163000 country: Russian Federation name: Vadim Arkhipovsky, PhD, MD role: CONTACT name: Vadim Arkhipovsky, PhD, MD role: PRINCIPAL_INVESTIGATOR lat: 64.5401 lon: 40.5433 facility: Regional Clinical Hospital # 3 status: WITHDRAWN city: Chelyabinsk zip: 454018 country: Russian Federation lat: 55.15402 lon: 61.42915 facility: Ivanovo Clinical Hospital named after Kuvayevs status: RECRUITING city: Ivanovo zip: 153025 country: Russian Federation name: Svetlana Ushakova, PhD, MD role: CONTACT name: Svetlana Ushakova, PhD, MD role: PRINCIPAL_INVESTIGATOR lat: 56.99719 lon: 40.97139 facility: Central City Clinical Hospital status: RECRUITING city: Kaliningrad zip: 236005 country: Russian Federation name: Vladimir Rafalsky, Prof. role: CONTACT name: Vladimir Rafalsky, Prof. role: PRINCIPAL_INVESTIGATOR lat: 54.70649 lon: 20.51095 facility: Kazan State Medical University/Department of Infectious Diseases status: RECRUITING city: Kazan zip: 420012 country: Russian Federation name: Irina Kravchenko, MD, PhD role: CONTACT name: Irina Kravchenko, MD, PhD role: PRINCIPAL_INVESTIGATOR lat: 55.78874 lon: 49.12214 facility: Kuban State Medical University/Department of Infectious Diseases and Phthisiopulmonology status: RECRUITING city: Krasnodar zip: 350063 country: Russian Federation name: Marina Avdeeva, Prof. role: CONTACT name: Marina Avdeeva, Prof. role: PRINCIPAL_INVESTIGATOR lat: 45.04484 lon: 38.97603 facility: Lomonosov Interdistrict Hospital named after. I.N. Yudchenko status: RECRUITING city: Lomonosov zip: 188531 country: Russian Federation name: Svetlana Mosolova, MD role: CONTACT name: Svetlana Mosolova, MD role: PRINCIPAL_INVESTIGATOR lat: 59.90612 lon: 29.77253 facility: Central Research Institute of Epidemiology status: RECRUITING city: Moscow zip: 111123 country: Russian Federation name: Antonina Ploskireva, PhD, MD role: CONTACT name: Antonina Ploskireva, PhD, MD role: PRINCIPAL_INVESTIGATOR lat: 55.75222 lon: 37.61556 facility: Moscow Regional Research Clinical Institute named after. M.F. Vladimirsky status: RECRUITING city: Moscow zip: 129110 country: Russian Federation name: Svetlana Erofeeva, MD, PhD role: CONTACT name: Svetlana Erofeeva, MD, PhD role: PRINCIPAL_INVESTIGATOR lat: 55.75222 lon: 37.61556 facility: Nizhny Novgorod Regional Clinical Hospital named after N.A. Semashko status: RECRUITING city: Nizhny Novgorod zip: 603093 country: Russian Federation name: Vladimir Nosov, MD, PhD role: CONTACT name: Vladimir Nosov, MD, PhD role: PRINCIPAL_INVESTIGATOR lat: 56.32867 lon: 44.00205 facility: LLC "Persona group of companies" status: RECRUITING city: Nizhny Novgorod zip: 603155 country: Russian Federation name: Natalya Eremina, MD, PhD role: CONTACT name: Natalya Eremina, MD, PhD role: PRINCIPAL_INVESTIGATOR lat: 56.32867 lon: 44.00205 facility: LLC "Professor's clinic" status: RECRUITING city: Perm zip: 614070 country: Russian Federation name: Svetlana Teplykh, MD, PhD role: CONTACT name: Svetlana Teplykh, MD, PhD role: PRINCIPAL_INVESTIGATOR lat: 58.01046 lon: 56.25017 facility: LLC "4D Ultrasound Clinic" status: RECRUITING city: Pyatigorsk zip: 357502 country: Russian Federation name: Daria Saenko, MD role: CONTACT name: MD role: CONTACT name: Daria Saenko role: PRINCIPAL_INVESTIGATOR lat: 44.04861 lon: 43.05944 facility: St. Petersburg Research Institute of Phthisiopulmonology status: RECRUITING city: Saint Petersburg zip: 191036 country: Russian Federation name: Yana Startseva, MD role: CONTACT name: Yana Startseva, MD role: PRINCIPAL_INVESTIGATOR lat: 59.93863 lon: 30.31413 facility: LLC "Energy of Health" status: RECRUITING city: Saint Petersburg zip: 194156 country: Russian Federation name: Natalya Egorova, MD role: CONTACT name: Natalya Egorova, MD role: PRINCIPAL_INVESTIGATOR lat: 59.93863 lon: 30.31413 facility: City Multidisciplinary Hospital # 2 status: WITHDRAWN city: Saint Petersburg zip: 194354 country: Russian Federation lat: 59.93863 lon: 30.31413 facility: LLC "Medical Clinic" status: RECRUITING city: Saint Petersburg zip: 194356 country: Russian Federation name: Maxim Bushara, MD role: CONTACT name: Maxim Bushara, MD role: PRINCIPAL_INVESTIGATOR lat: 59.93863 lon: 30.31413 facility: LLC "Research Center Eco-Safety" status: WITHDRAWN city: Saint Petersburg zip: 196143 country: Russian Federation lat: 59.93863 lon: 30.31413 facility: LLC "Zvezdnaya Clinic" status: RECRUITING city: Saint Petersburg zip: 196158 country: Russian Federation name: Artem Sergeenko, MD role: CONTACT name: Artem Sergeenko, MD role: PRINCIPAL_INVESTIGATOR lat: 59.93863 lon: 30.31413 facility: City Pokrovskaya Hospital status: RECRUITING city: Saint Petersburg zip: 199106 country: Russian Federation name: Oleg Khmelnitsky, PhD, MD role: CONTACT name: Oleg Khmelnitsky, PhD, MD role: PRINCIPAL_INVESTIGATOR lat: 59.93863 lon: 30.31413 facility: LLC "Meili" status: RECRUITING city: Saint Petersburg zip: 199406 country: Russian Federation name: Irina Nesterovich, PhD, MD role: CONTACT name: Irina Nesterovich, PhD, MD role: PRINCIPAL_INVESTIGATOR lat: 59.93863 lon: 30.31413 facility: Samara State Medical University/Department of General and Clinical Microbiology, Immunology and Allergology status: RECRUITING city: Samara zip: 443099 country: Russian Federation name: Alexander Zhestkov, Prof. role: CONTACT name: Alexander Zhestkov, Prof. role: PRINCIPAL_INVESTIGATOR lat: 53.20007 lon: 50.15 facility: Smolensk State Medical University status: RECRUITING city: Smolensk zip: 214019 country: Russian Federation name: Roman Kozlov, Prof. role: CONTACT name: Roman Kozlov, Prof. role: PRINCIPAL_INVESTIGATOR lat: 54.7818 lon: 32.0401 facility: LLC "Scientific Medical Center of General Therapy and Pharmacology" status: RECRUITING city: Stavropol zip: 355000 country: Russian Federation name: Olga Ukhanova, Prof. role: CONTACT name: Olga Ukhanova, Prof. role: PRINCIPAL_INVESTIGATOR lat: 45.0428 lon: 41.9734 facility: Bashkir State Medical University/Department of Internal Medicine status: RECRUITING city: Ufa zip: 450008 country: Russian Federation name: Khalida Gantseva, Prof. role: CONTACT name: Khalida Gantseva, Prof. role: PRINCIPAL_INVESTIGATOR lat: 54.74306 lon: 55.96779 facility: Regional Clinic Hospital status: RECRUITING city: Vladimir zip: 600023 country: Russian Federation name: Mikhail Smirnov, MD role: CONTACT name: Mikhail Smirnov, MD role: PRINCIPAL_INVESTIGATOR lat: 56.13655 lon: 40.39658 facility: Voronezh Regional Clinical Hospital # 1 status: RECRUITING city: Voronezh zip: 394066 country: Russian Federation name: Natalya Kostina, PhD, MD role: CONTACT name: Natalya Kostina, PhD, MD role: PRINCIPAL_INVESTIGATOR lat: 51.67204 lon: 39.1843 facility: Clinical Hospital # 2 status: RECRUITING city: Yaroslavl zip: 150030 country: Russian Federation name: Andrey Arshinov, Prof. role: CONTACT name: Andrey Arshinov, Prof. role: PRINCIPAL_INVESTIGATOR lat: 57.62987 lon: 39.87368 facility: LLC "Medical Center for Diagnostics and Prevention Plus" status: RECRUITING city: Yaroslavl zip: 150040 country: Russian Federation name: Ekaterina Melnikova, MD, PhD role: CONTACT name: Ekaterina Melnikova, MD, PhD role: PRINCIPAL_INVESTIGATOR lat: 57.62987 lon: 39.87368 hasResults: False
|
<|newrecord|> nctId: NCT06263868 id: 69HCL23_1090 id: 2023-A02313-42 type: OTHER domain: ID-RCB briefTitle: First Observatory of Precocious Puberty. acronym: PAPPEL overallStatus: NOT_YET_RECRUITING date: 2024-03-01 date: 2028-03-01 date: 2028-03-01 date: 2024-02-16 date: 2024-02-20 name: Hospices Civils de Lyon class: OTHER briefSummary: The age of puberty has fluctuated throughout history. Recent data shows an increase in the age of onset of puberty signs, in the United States but also in Europe. A recent Public Health France study published in 2018 reports an increase in the incidence of precocious puberty with geographical heterogeneity. The consequences of these appearances include the early onset of menarche, short adult height and the psychological impact.
|
Due to a lack of studies and additional data, the reasons for this development are difficult to understand. Among current hypotheses, the entanglement with the evolution of our environment is at the forefront: the action of environmental endocrine disruptors and nutritional factors could play a role in the process of early appearance of pubertal signs.
|
The establishment of a national observatory for early and advanced puberty in collaboration with pediatric endocrinologists (on the front line) would allow a reliable and precise field approach, capable of supplementing epidemiological data, which are currently insufficient.
|
The investigators hypothesize that the establishment of an observatory of pubertal advances (early puberty and advanced puberty) in private medicine is possible, with inclusion of at least 75% of eligible patients, and collection of at least 80% of data. conditions: Puberty, Precocious studyType: OBSERVATIONAL observationalModel: CASE_CONTROL timePerspective: PROSPECTIVE count: 3360 type: ESTIMATED measure: Number of recruited patients with at least 80% of the main data collected measure: Missing data rate measure: At least 75% of patients included sex: ALL maximumAge: 11 Years stdAges: CHILD facility: Clinique du Val d'Ouest city: Ecully state: Auvergne-Rhône-Alpes zip: 69130 country: France name: Emilie Doye, MD role: CONTACT phone: 0472118890 phoneExt: 33 email: emilie.doye@chu-lyon.fr name: Emilie Doye, MD role: PRINCIPAL_INVESTIGATOR lat: 45.77726 lon: 4.77481 facility: Clinique du Val d'Ouest city: Ecully state: Auvergne-Rhône-Alpes zip: 69130 country: France name: Emilie Beaufils, MD role: CONTACT phone: 0658187556 phoneExt: 33 email: pediatre.beaufils@gmail.com name: Emilie Beaufils, MD role: PRINCIPAL_INVESTIGATOR lat: 45.77726 lon: 4.77481 facility: Clinique du Val d'Ouest city: Ecully state: Auvergne-Rhône-Alpes zip: 69130 country: France name: Mélanie Daval Cote, MD role: CONTACT phone: 0472193310 phoneExt: 33 email: drdavalcote@yahoo.fr name: Mélanie Daval Cote, MD role: PRINCIPAL_INVESTIGATOR lat: 45.77726 lon: 4.77481 facility: Pediatric practice city: Lyon state: Auvergne-Rhône-Alpes zip: 69006 country: France name: Prisca DEALBERTI, MD role: CONTACT phone: 04 72 83 50 01 phoneExt: 33 email: dr.dealberti@gmail.com name: Prisca DEALBERTI, MD role: PRINCIPAL_INVESTIGATOR lat: 45.74848 lon: 4.84669 facility: Clinique Saint jean city: Lyon state: Auvergne-Rhône-Alpes zip: 69008 country: France name: Aude Mariani Ecochard, MD role: CONTACT phone: 0681560894 phoneExt: 33 email: docteurmariani@yahoo.com name: Aude Mariani Ecochard, MD role: PRINCIPAL_INVESTIGATOR lat: 45.74848 lon: 4.84669 facility: Pediatric practice city: Rennes state: Bretagne zip: 35200 country: France name: Livie CHATELAIS, MD role: CONTACT phone: 02 99 86 77 57 phoneExt: 33 email: lchatelais@yahoo.fr name: Livie CHATELAIS, MD role: PRINCIPAL_INVESTIGATOR lat: 48.11198 lon: -1.67429 facility: Pediatric practice city: Chambray-lès-Tours state: Centre-Val De Loire zip: 37170 country: France name: Caroline HASSELMAN, MD role: CONTACT phone: 02 46 65 07 45 phoneExt: 33 email: chasselmann@mac.com name: Caroline HASSELMAN, MD role: PRINCIPAL_INVESTIGATOR lat: 47.33537 lon: 0.70286 facility: Pediatric practice city: Essey-lès-Nancy state: Grand Est zip: 54270 country: France name: Julie AUGER, MD role: CONTACT phone: 03 83 21 01 11 phoneExt: 33 email: dr.augerjulie@gmail.com name: Julie AUGER, MD role: PRINCIPAL_INVESTIGATOR lat: 48.70179 lon: 6.22425 facility: Pediatric practice city: Levallois-Perret state: Hauts-de-Seine zip: 92300 country: France name: Delphine ZENATY, MD role: CONTACT phone: 01 70 83 61 23 phoneExt: 33 email: delphine.revco@gmail.com name: Delphine ZENATY, MD role: PRINCIPAL_INVESTIGATOR lat: 48.89389 lon: 2.28864 facility: Pediatric practice city: Paris state: Ile-de-France zip: 75116 country: France name: Mélanie AMOUYAL, MD role: CONTACT phone: 01 45 25 70 11 phoneExt: 33 email: dramouyal.endocrinoped@gmail.com name: Mélanie AMOUYAL, MD role: PRINCIPAL_INVESTIGATOR lat: 48.85341 lon: 2.3488 facility: Pediatric practice city: Fondettes state: Indre-et-Loire zip: 37230 country: France name: Myriam BOUILLO, MD role: CONTACT phone: 02 47 66 45 52 phoneExt: 33 email: myriam.bouillo@orange.fr name: Myriam BOUILLO, MD role: PRINCIPAL_INVESTIGATOR lat: 47.4035 lon: 0.59686 facility: Polyclinique Bordeaux rive droite city: Lormont state: Nouvelle-Aquitaine zip: 33310 country: France name: Aurélie LACOSTE RODRIGUE, MD role: CONTACT email: dr.aurelielacoste@free.fr name: Aurélie LACOSTE RODRIGUE, MD role: PRINCIPAL_INVESTIGATOR lat: 44.87495 lon: -0.51782 facility: Pediatric practice city: Pau state: Nouvelle-Aquitaine zip: 64000 country: France name: Catie CESSANS, MD role: CONTACT phone: 06 15 82 62 59 phoneExt: 33 email: pediatre.cessans@gmail.com name: Catie CESSANS, MD role: PRINCIPAL_INVESTIGATOR lat: 43.3 lon: -0.36667 facility: Pediatric Practice city: Pessac state: Nouvelle-Aquitaine zip: 33600 country: France name: Olivier PUEL, MD role: CONTACT phone: 0556453585 phoneExt: 33 email: opuel@free.fr name: Olivier PUEL, MD role: PRINCIPAL_INVESTIGATOR lat: 44.81011 lon: -0.64129 facility: Clinique rive gauche city: Toulouse state: Occitanie zip: 31300 country: France name: Adelaïde DURAND, MD role: CONTACT phone: 05 67 77 51 31 phoneExt: 33 email: dr.durand@cliniquerivegauche.fr name: Adelaïde DURAND, MD role: PRINCIPAL_INVESTIGATOR lat: 43.60426 lon: 1.44367 facility: Pediatric practice city: Saint-Nazaire state: Pays De La Loire zip: 44600 country: France name: Isabelle GUEMAS, MD role: CONTACT phone: 02 40 53 88 91 phoneExt: 33 email: isabelleguemas@gmail.com name: Isabelle GUEMAS, MD role: PRINCIPAL_INVESTIGATOR lat: 47.28333 lon: -2.2 facility: Pediatric practice city: Trélazé state: Pays De La Loire zip: 49800 country: France name: Julie CHEIGNON, MD role: CONTACT phone: 02 41 79 08 09 phoneExt: 33 email: julie.cheignon@wanadoo.fr name: Julie CHEIGNON, MD role: PRINCIPAL_INVESTIGATOR lat: 47.44565 lon: -0.4654 facility: Pediatric practice city: Aix-en-Provence state: Provence-Alpes-Côte d'Azur zip: 13090 country: France name: Céline CASTAINGS-CARLIOZ, MD role: CONTACT phone: 06 20 70 02 99 phoneExt: 33 email: celine.carlioz@yahoo.fr name: Céline CASTAINGS-CARLIOZ, MD role: PRINCIPAL_INVESTIGATOR lat: 43.5283 lon: 5.44973 facility: Pediatric practice city: Marseille state: Provence-Alpes-Côte d'Azur zip: 13008 country: France name: Hélène Bellon, MD role: CONTACT phone: 04 86 97 40 13 phoneExt: 33 email: h.bellon@sfr.fr name: Hélène Bellon, MD role: PRINCIPAL_INVESTIGATOR lat: 43.29551 lon: 5.38958 facility: Pediatric practice city: Nice state: Provence-Alpes-Côte d'Azur zip: 06000 country: France name: Frédérique GASTAUD, MD role: CONTACT phone: 04 93 13 85 17 phoneExt: 33 email: docteurgastaud.frederique@orange.fr name: Frédérique GASTAUD, MD role: PRINCIPAL_INVESTIGATOR lat: 43.70313 lon: 7.26608 facility: Pediatric practice city: Marseille state: Provence-Alpes-Côte-d'Azur zip: 13012 country: France name: Catherine BRUE FABRE role: CONTACT phone: 04 91 49 29 35 phoneExt: 33 email: catherine.brue@gmail.com name: Catherine BRUE FABRE, MD role: PRINCIPAL_INVESTIGATOR lat: 43.29551 lon: 5.38958 facility: Hôpital Femme Mère Enfant, Hospices civils de Lyon city: Bron zip: 69677 country: France name: Emilie Doye, MD role: CONTACT phone: 0472118890 email: emilie.doye@chu-lyon.fr name: Emilie Doye, MD role: PRINCIPAL_INVESTIGATOR lat: 45.73333 lon: 4.91667 facility: Pediatric practice city: Paris state: Île-De-France zip: 75010 country: France name: Capucine VIGNON SAVOYE, MD role: CONTACT phone: 09 80 46 71 19 phoneExt: 33 email: capucinevignon@free.fr name: Capucine VIGNON SAVOYE, MD role: PRINCIPAL_INVESTIGATOR lat: 48.85341 lon: 2.3488 facility: Pediatric practice city: Paris state: Île-De-France zip: 75011 country: France name: Isabelle FLECHTNER, MD role: CONTACT phone: 01 43 55 17 17 phoneExt: 33 email: drflechtner@gmail.com name: Isabelle FLECHTNER, MD role: PRINCIPAL_INVESTIGATOR lat: 48.85341 lon: 2.3488 facility: Pediatric practice city: Paris state: Île-De-France zip: 75017 country: France name: Maxime GERARD, MD role: CONTACT phone: 06 37 63 83 07 phoneExt: 33 email: m.gerard.endocped@gmail.com name: Maxime GERARD, MD role: PRINCIPAL_INVESTIGATOR lat: 48.85341 lon: 2.3488 hasResults: False
|
<|newrecord|> nctId: NCT06263855 id: 24-000352 briefTitle: Effect of Large Language Model in Assisting Discharge Summary Notes Writing for Hospitalized Patients overallStatus: ENROLLING_BY_INVITATION date: 2024-07-01 date: 2024-12-31 date: 2025-04-01 date: 2024-02-16 date: 2024-04-05 name: Mayo Clinic class: OTHER briefSummary: This pilot study aims to assess the feasibility of carrying out a full-scale pragmatic, cluster-randomized controlled trial which will investigate whether discharge summary writing assisted by a large language model (LLM), called CURE (Checker for Unvalidated Response Errors), improves care delivery without adversely impacting patient outcomes. conditions: Large Language Model studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: HEALTH_SERVICES_RESEARCH masking: NONE count: 1015 type: ESTIMATED name: CURE measure: Rate of patient accrual sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Mayo Clinic city: Rochester state: Minnesota zip: 55905 country: United States lat: 44.02163 lon: -92.4699 hasResults: False
|
<|newrecord|> nctId: NCT06263842 id: KFSIRB200-132 briefTitle: Elamrousy Novel Approach of Socket Shield Technique overallStatus: RECRUITING date: 2024-02-10 date: 2025-02-10 date: 2025-02-20 date: 2024-02-16 date: 2024-03-12 name: Kafrelsheikh University class: OTHER briefSummary: The current trial aim was to evaluate clinically and radiographically the changes around dental implants inserted immediately in maxillary anterior esthetic zone using a novel combination of autogenous whole tooth graft (AWTG) with socket shield approach (SSA) and compared this approach to socket shield technique with xenograft.
|
The present study included 63 patients, aged 20 to 45, with teeth that needed to be extracted. After Kafrelsheikh University research ethics committee approval, patients were randomized into 3 groups: group I patients underwent immediate implantation using socket shield protocol, while group II patients underwent the same procedure, but the shield/fixture jumping gap was grafted by xenograft. finally group III was grafted by AWTG that was created using the decoronated crown and the extracted palatal portion of the tooth; and then placed in the peri-implant gap defect. conditions: Implant Complication studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL interventionModelDescription: The present study included 63 participants, aged 20 to 45, with teeth that needed to be extracted. After Kafrelsheikh University research ethics committee approval, patients were randomized into 3 groups: group I patients underwent immediate implantation using SSA protocol without grafting, while group II was grafted by xenograft, but group II was grafted with AWTG was created using the decoronated crown and the extracted palatal portion of the tooth; and then placed in the peri-implant gap defect. Clinically, pink aesthetic score (PES), midfacial mucosal alterations (MFMA), stability quotient of dental implants (SQDI) were observed at baseline, six and twelve months after implantation. Moreover, baseline, 6- and 12-months alterations of radiographic horizontal buccolingual ridge width (HBLRW), facial marginal bone level (FMBL), peri-implant Density of bone (PIDB) and peri-implant vertical bone defect depth (PIVBDD) changes were assessed using cone beam computed tomography (CBCT). primaryPurpose: TREATMENT masking: DOUBLE maskingDescription: neither participant nor the outcome assessor know the group distribution whoMasked: PARTICIPANT whoMasked: OUTCOMES_ASSESSOR count: 63 type: ESTIMATED name: modified Elamrousy approach for socket shield technique name: conventional socket shield name: combined socket shild with xenograft measure: Stability Quotient of dental implant (SQDI) measure: pink esthetic score (PES) measure: Midfacial Mucosal Alterations measure: facial marginal bone level (FMBL) sex: ALL minimumAge: 25 Years maximumAge: 40 Years stdAges: ADULT facility: Walid Elamrousy status: RECRUITING city: Kafr Ash Shaykh zip: 76130 country: Egypt name: walid elamrousy, phd role: CONTACT phone: +201005724781 email: Waled_Hammed@den.kfs.edu.eg name: mostafa fayed, bachelor role: CONTACT phone: +201063376252 lat: 31.11174 lon: 30.93991 hasResults: False
|
<|newrecord|> nctId: NCT06263829 id: 2023-1580 briefTitle: HCV Tappt Adherence Study overallStatus: NOT_YET_RECRUITING date: 2024-07-01 date: 2025-01-01 date: 2025-07-01 date: 2024-02-16 date: 2024-02-16 name: University of Illinois at Chicago class: OTHER name: Synchronyx name: American Society of Health-System Pharmacists briefSummary: The goal of this non-inferiority clinical trial is to evaluate the efficacy of Tappt, a novel digital medication companion solution, among individuals with hepatitis C virus (HCV) who are starting a daily oral medication regimen following standard of care in a clinical pharmacy setting.
|
* The primary aim is to assess the non-inferiority of Tappt with medication adherence, treatment completion, sustained virologic response (SVR) assessment, and SVR achievement rates.
|
* The secondary aim is to assess the efficacy of Tappt at enabling pharmacists to personalize treatment and management decision based on participants' reported barriers to adherence, care, and SVR achievement.
|
Participants will download and utilize the Tappt app to record adherence to oral medication. For the purposes of this study, adherence for participants in the intervention arm will be measured using a modified medication possession ratio (MPR) measure called medication tag scan ratio (MTSR). MTSR is defined as a percentage of the number of times participants scanned their passive tags versus the total of expected tag scans based on that participant's medication regimen and treatment period.
|
Upon study completion, a retrospective matched control will be established for the intervention group. Historic data for the matched control's adherence, treatment completion, SVR assessment, and SVR rates will be compared to the intervention arm. conditions: Hepatitis C studyType: INTERVENTIONAL phases: NA allocation: NON_RANDOMIZED interventionModel: SINGLE_GROUP primaryPurpose: OTHER masking: NONE count: 30 type: ESTIMATED name: Use of Tappt App measure: Medication adherence sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT hasResults: False
|
<|newrecord|> nctId: NCT06263816 id: CARVECIR briefTitle: Effect of Long-term Carvedilol to Prevent Decompensation or Death in Patients With Asymptomatic Child-Pugh A5 to B8 Cirrhosis and Clinically Significant Portal Hypertension: a Multicenter Double-blind Randomized Control Trial acronym: CARVECIR overallStatus: NOT_YET_RECRUITING date: 2024-11-15 date: 2029-10-15 date: 2030-06-15 date: 2024-02-16 date: 2024-02-20 name: University Hospital, Tours class: OTHER name: Centre Hospitalier Universitaire Amiens Picardie name: Centre Hospitalier Universitaire Angers name: Assistance Publique Hopitaux Paris BEAUJON name: Centre Hospitalier Universitaire Caen name: Centre Hospitalier intercommunal de Créteil name: Hospices Civils de Lyon name: Centre Hospitalier Universitaire Grenoble name: Centre Hospitalier Universitaire Haut Lévêque name: Centre Hospitalier Régional Universitaire Lille name: Centre Hospitalier Universitaire Jean Minjoz name: Assistance Publique Hopitaux Paris AVICENNE name: Centre Hospitalier Universitaire Clermont Ferrand name: Assistance Publique Hopitaux Paris LA PITIE SALPETRIERE name: Centre Hospitalier Universitaire Pontchaillou name: Assistance Publique Hopitaux Paris ST ANTOINE name: Assistance Publique Hopitaux Paris PAUL BROUSSE name: University Hospital, Montpellier name: Assistance Publique Hopitaux Paris HENRI MONDOR name: Centre Hospitaliser Départemental de Vendée name: Nantes University Hospital name: Centre Hospitalier Universitaire Dijon name: CHU de Reims name: Hôpitaux Universitaires de Strasbourg name: University Hospital, Toulouse briefSummary: Decompensation of cirrhosis is a turning point in cirrhosis course, as associated with a marked decrease in life expectancy. Thus, prevention of decompensation is crucial.
|
The usefulness of carvedilol to prevent decompensation of cirrhosis in patients with TE-LSM ≥ 25 kPa as a surrogate marker for clinically significant portal hypertension, has never been evaluated in a clinical trial. conditions: Asymptomatic Cirrhosis conditions: Clinically Significant Portal Hypertension studyType: INTERVENTIONAL phases: PHASE3 allocation: RANDOMIZED interventionModel: PARALLEL interventionModelDescription: This study will be a national multicentric, phase III, superiority double-blinded randomized controlled trial with two parallel arms: carvedilol versus placebo. The primary end-point will be assessed by the local investigator (hepatologist), blinded of the randomization arm primaryPurpose: TREATMENT masking: TRIPLE whoMasked: PARTICIPANT whoMasked: INVESTIGATOR whoMasked: OUTCOMES_ASSESSOR count: 290 type: ESTIMATED name: Experimental group: Patients will be treated with carvedilol. name: Control group: Patients will receive a placebo. measure: To evaluate the effect of low dose carvedilol (<=12.5 mg per day) versus placebo on the occurrence of decompensation of cirrhosis or liver-related death at 36 months sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: CHU Amiens Picardie city: Amiens country: France name: NGUYEN KHAC Eric, Dr role: CONTACT email: nguyen-khac.eric@chu-amiens.fr lat: 49.9 lon: 2.3 facility: CHU Angers city: Angers country: France name: OBERTI FREDERIC role: CONTACT email: froberti@chu-angers.fr lat: 47.46667 lon: -0.55 facility: CHU Beaujon city: Assistance Publique Hôpitaux De Paris country: France name: RAUTOU PIERRE EMMANUEL, Dr role: CONTACT email: pierre-emmanuel.rautou@aphp.fr facility: CHU Jean Minjoz city: Besançon country: France name: WEIL DELPHINE, Dr role: CONTACT email: dweil@chu-besancon.fr lat: 47.24878 lon: 6.01815 facility: CHU Haut Lévêque city: Bordeaux country: France name: DE LEDINGHEN VICTOR, Dr role: CONTACT email: victor.deledinghen@chu-bordeaux.fr lat: 44.84044 lon: -0.5805 facility: CHU Caen city: Caen country: France name: OLLIVIER-HOURMAND Isabelle, Dr role: CONTACT email: ollivierhourmand-i@chu-Caen.fr lat: 49.18585 lon: -0.35912 facility: CH intercommunal de Créteil city: CH Intercommunal De Créteil country: France name: ROSA ISABELLE, dR role: CONTACT email: isabelle.rosa@chi-creteil.fr facility: CHU Clermont Ferrand city: Clermont Ferrand country: France name: ABERGEL ARMAND, Dr role: CONTACT email: aabergel@chu-clermontferrand.fr lat: 45.77966 lon: 3.08628 facility: Hôpital Henri Mondor city: Créteil country: France name: LEROY Vincent, Dr role: CONTACT email: vincent.leroy2@aphp.fr lat: 48.78333 lon: 2.46667 facility: Hôpital Francois Mitterrand city: Dijon country: France name: MINELLO Anne, Dr role: CONTACT email: anne.minello@chu-dijon.fr lat: 47.31667 lon: 5.01667 facility: CHU Grenoble city: Grenoble country: France name: HILLERET Marie-Noelle, Dr role: CONTACT email: mnhilleret@chu-grenoble.fr lat: 45.16667 lon: 5.71667 facility: Centre Hospitalier départemental de Vendée city: La Roche-sur-Yon country: France name: LAGIN Ludovic, Dr role: CONTACT email: ludovic.lagin@ght85.fr lat: 46.66667 lon: -1.43333 facility: Hôpital Huriez city: Lille country: France name: LOUVET ALEXANDRE, Dr role: CONTACT email: alexandre.louvet@chru-lille.fr lat: 50.63297 lon: 3.05858 facility: CHU la Croix Rousse city: Lyon country: France name: LEBOSSE FANNY, Dr role: CONTACT email: fanny.lebosse@chu-lyon.fr lat: 45.74848 lon: 4.84669 facility: CHU de Montpellier city: Montpellier country: France name: URSIC Jose, Dr role: CONTACT email: jose.ursicbedoya@chu-montpellier.fr lat: 43.61092 lon: 3.87723 facility: CHU Hôtel Dieu city: Nantes country: France name: ARCHAMBEAUD Isabelle, Dr role: CONTACT email: isabelle.archambeaud@chu-nantes.fr lat: 47.21725 lon: -1.55336 facility: CHU Avicenne city: Paris country: France name: BLAISE LORAINE, Dr role: CONTACT email: lorraine.blaise@aphp.fr lat: 48.85341 lon: 2.3488 facility: CHU Pitié-Salpêtrière city: Paris country: France name: THABUT DOMINIQUE, Dr role: CONTACT email: dominique.thabut@aphp.fr lat: 48.85341 lon: 2.3488 facility: CHU Saint-Antoin city: Paris country: France name: OZENNE Violaine, Dr role: CONTACT email: violaine.ozenne@aphp.fr lat: 48.85341 lon: 2.3488 facility: CHU de Reims city: Reims country: France name: BERNARD CHABERT Brigitte, Dr role: CONTACT email: bbernard-chabert@chu-reims.fr lat: 49.25 lon: 4.03333 facility: CHU Pontchaillou city: Rennes country: France name: JEZEQUIEL Caroline, Dr role: CONTACT email: caroline.jezequiel@chu-rennes.fr lat: 48.11198 lon: -1.67429 facility: Hôpitaux Universitaires de Strasbourg city: Strasbourg country: France name: TRIPON Simona, Dr role: CONTACT email: simona.tripon@chru-strasbourg.fr lat: 48.58392 lon: 7.74553 facility: CHU de Toulouse city: Toulouse country: France name: BUREAU Christophe, Dr role: CONTACT email: bureau.c@chu-toulouse.fr lat: 43.60426 lon: 1.44367 facility: Hôpital Paul Brousse city: Villejuif country: France name: KOUNIS Ilias, Dr role: CONTACT email: ilias.kounis@aphp.fr lat: 48.7939 lon: 2.35992 hasResults: False
|
<|newrecord|> nctId: NCT06263803 id: Karataymusic briefTitle: The Effect of Listening to Music on Chronic Low Back Pain overallStatus: RECRUITING date: 2024-02-01 date: 2024-04-01 date: 2024-04-15 date: 2024-02-16 date: 2024-02-16 name: KTO Karatay University class: OTHER briefSummary: The effects of passive music listening on pain, anxiety and quality of life in patients with chronic low back pain in addition to physical therapy will be examined. conditions: Pain, Chronic studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: SINGLE maskingDescription: single whoMasked: PARTICIPANT count: 60 type: ESTIMATED name: Music listening, classic physical therapy measure: Beck anxiety inventory measure: Visual Analogue Scale measure: Short From-36 sex: ALL minimumAge: 30 Years maximumAge: 50 Years stdAges: ADULT facility: Mustafa Savaş Torlak status: RECRUITING city: Karatay state: Eyalet/Yerleşke zip: 42000 country: Turkey name: Mustafa S Torlak role: CONTACT phone: +905373660138 email: mustafa.savas.torlak@karatay.edu.tr lat: 37.86726 lon: 32.52863 hasResults: False
|
<|newrecord|> nctId: NCT06263790 id: NEOUNIPD1(2024) briefTitle: Intubating Laryngeal Mask vs Direct Laryngoscopy: a Crossover Randomized Controlled Preterm Manikin Trial overallStatus: NOT_YET_RECRUITING date: 2024-03 date: 2024-03 date: 2024-03 date: 2024-02-16 date: 2024-02-16 name: University Hospital Padova class: OTHER briefSummary: The study aims to compare the success and time of intubation through an intubating laryngeal mask vs. direct laryngoscopy in a manikin simulating a term infant. In addition, we will assess the operator's opinion on the procedure.
|
This is an unblinded, randomized, controlled, crossover (AB/BA) pilot trial of intubation procedure through intubating laryngeal mask vs direct laryngoscopy in a manikin simulating a term newborn. conditions: Neonatal Disease conditions: Intubation; Difficult or Failed studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: CROSSOVER primaryPurpose: TREATMENT masking: NONE count: 50 type: ESTIMATED name: Intubating laryngeal mask name: Direct laryngoscopy measure: Success at the first attempt measure: Time of device positioning measure: Participant's opinion on difficulty of the procedure sex: ALL minimumAge: 25 Years maximumAge: 65 Years stdAges: ADULT stdAges: OLDER_ADULT hasResults: False
|
<|newrecord|> nctId: NCT06263777 id: P.T.REC/012/004142 briefTitle: Early Detection of Children With Developmental Disabilities in Assiut Governorate overallStatus: COMPLETED date: 2021-01-01 date: 2021-03-15 date: 2021-09-30 date: 2024-02-16 date: 2024-02-16 name: Beni-Suef University class: OTHER briefSummary: The study aimed to determine the effectiveness of a designed training program for nurses toward early detection of developmental disabilities among children (0-3 years). conditions: Developmental Disability conditions: Development Delay conditions: Motor Delay conditions: Down Syndrome conditions: Autism Spectrum Disorder studyType: INTERVENTIONAL phases: NA allocation: NA interventionModel: SINGLE_GROUP primaryPurpose: HEALTH_SERVICES_RESEARCH masking: NONE count: 21 type: ACTUAL name: Nurses training program on early detection of disability measure: Questionnaire of Screening and referral knowledge measure: Questionnaire of Disability Perception measure: questionnaire about Monitoring Practices measure: Follow up sex: FEMALE stdAges: CHILD stdAges: ADULT stdAges: OLDER_ADULT facility: Tayseer Saber Abdeldayem city: Banī Suwayf state: Beni-Suef zip: 62521 country: Egypt lat: 29.07441 lon: 31.09785 hasResults: False
|
<|newrecord|> nctId: NCT06263764 id: 23-11-1954 briefTitle: The Effect of Listening to Qur'an Recital on Quality of Life in Systemic Lupus Erythematosus Patients overallStatus: RECRUITING date: 2024-02-12 date: 2024-06-30 date: 2024-07-31 date: 2024-02-16 date: 2024-02-16 name: Indonesia University class: OTHER briefSummary: The goal of this quasi-experimental study is to evaluate the effect of listening to the Qur'an recital on quality of life among systemic lupus erythematosus patients. There will be intervention and control groups. Before the intervention, the quality of life of participants will be assessed using the Lupus-QoL questionnaire. After the baseline assessment, participants in the intervention group will be asked to listen to a Qur'an recital by Surah Ar-Rahman using an MP3 player twice a day for a minimum of 15 minutes each for 40 days. The control group will not receive any specific intervention and will continue with their usual routine. After the 40-day intervention period, the quality of life of participants in both groups will be assessed using the Lupus-QoL questionnaire. The results will be analyzed to determine if there is a significant improvement in quality of life. Besides, potential confounding factors such as SLE clinical manifestations, disease activity, pharmacologic treatment regimen, anxiety/depression, comorbidities, age, and economic status will also be collected before and after intervention to evaluate its effect on the quality of life. conditions: Quality of Life studyType: INTERVENTIONAL phases: NA allocation: NON_RANDOMIZED interventionModel: PARALLEL primaryPurpose: SUPPORTIVE_CARE masking: DOUBLE whoMasked: PARTICIPANT whoMasked: CARE_PROVIDER count: 70 type: ESTIMATED name: Listening to Qur'an Recital measure: Difference in Quality of Life Pre and Post Intervention sex: FEMALE minimumAge: 18 Years maximumAge: 65 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Faculty of Medicine Universitas Indonesia -Cipto Mangunkusumo Hospital, Jakarta, Indonesia status: RECRUITING city: Jakarta zip: 10430 country: Indonesia name: Alvina Widhani, PhD role: CONTACT phone: +6281905910034 email: alvina.widhani@gmail.com name: Karina Wijayanti, MD role: CONTACT phone: +6285226207270 email: karinawija@gmail.com lat: -6.21462 lon: 106.84513 hasResults: False
|
<|newrecord|> nctId: NCT06263751 id: 202401096 id: 24FIM1268045 type: OTHER_GRANT domain: American Heart Association briefTitle: Comparing the Effectiveness of Two Produce Prescription Approaches On Fruit and Vegetable Intake and Food Security, While Exploring Implementation Outcomes Such as Reach, Implementation, Sustainability, and Cost acronym: NutriConnect overallStatus: RECRUITING date: 2024-03-25 date: 2025-03 date: 2025-06 date: 2024-02-16 date: 2024-03-27 name: Washington University School of Medicine class: OTHER name: Schnuck Markets, Inc. name: BJC HealthCare briefSummary: The produce prescription program is one type of food is medicine (FIM) programs, where healthcare providers "prescribe" fruits and vegetables (F\&V) to patients with low household incomes, experience food insecurity, and one or more diet-related diseases. NutriConnect seeks to compare the effectiveness of two produce prescription approaches on F\&V intake and food security: credit to Rewards account (NutriConnect Credit) vs. produce box delivery (NutriConnect Delivery), while exploring implementation outcomes such as reach, sustainability, implementation, and cost. conditions: Food Insecurity studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL interventionModelDescription: 240 patients will be randomized to three arms: "usual care," NutriConnect Credit, and NutriConnect Delivery with equivalent monetary value to credit. The interventions will last 6 months. primaryPurpose: HEALTH_SERVICES_RESEARCH masking: SINGLE maskingDescription: Due to the open study design, the NutriConnect team will not be able to have either patient or research coordinator/Schnucks intervention delivers blinded on group assignment. However, the assignment will be hidden from research faculty, the study biostatistician, and study analyst. whoMasked: OUTCOMES_ASSESSOR count: 240 type: ESTIMATED name: Product prescription program- NutriConnect Credit name: Product prescription program- NutriConnect Delivery measure: change in F&V intake measure: Household food insecurity measure: Self-reported health status sex: ALL minimumAge: 18 Years maximumAge: 99 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Barnes Jewish Hospital status: RECRUITING city: Saint Louis state: Missouri zip: 63110 country: United States name: Jing Li, MD, DrPH, MS role: CONTACT phone: 314-273-9386 email: l.jing@wustl.edu name: Adam Hively, MPH role: CONTACT phone: 6142021540 email: adamh@wustl.edu lat: 38.62727 lon: -90.19789 hasResults: False
|
<|newrecord|> nctId: NCT06263738 id: 2024-248 briefTitle: Cold and Heat Investigation to Lower Levels of Depression acronym: CHILL'D overallStatus: NOT_YET_RECRUITING date: 2024-05-01 date: 2027-04-01 date: 2027-04-01 date: 2024-02-16 date: 2024-03-28 name: Vail Health Behavioral Health class: OTHER name: Steadman Philippon Research Institute briefSummary: This study will recruit 112 medically healthy adults (aged 18-65) currently experiencing depressive symptoms to be randomized to receive either a single Whole Body Hyperthermia (heat therapy) treatment or a Whole Body Hyperthermia treatment followed by a cold water plunge. Participants will complete a baseline assessment of their depressive symptoms as well as 1-week and 2-week post-treatment followup assessments. conditions: Depression conditions: Mood Disorders studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL interventionModelDescription: Participants who meet inclusion/exclusion criteria will be stratified by use of antidepressant medication and randomized with a 1-to-1 allocation to receive a single session of WBH or a single session of WBH followed immediately by cold plunge (WBH+cold). primaryPurpose: TREATMENT masking: DOUBLE maskingDescription: The primary outcome data will be collected by trained raters blinded to participant group assignment and study visit number. The randomization list will be prepared by an unblinded study statistician and administered by study personnel with no other involvement in study activities. The participant will be blinded to their treatment assignment until the end of the WBH treatment, at which point they will be directed to either complete a cool-down period in the sauna device or proceed to the cold plunge. whoMasked: PARTICIPANT whoMasked: OUTCOMES_ASSESSOR count: 112 type: ESTIMATED name: Whole Body Hyperthermia name: Cold Water Plunge measure: Montgomery-Åsberg Depression Rating Scale (MADRS) measure: Warwick Edinburgh Mental Well-Being Scale (WEMWBS) measure: Patient Reported Outcome Measure Information System (PROMIS) 8A - Anxiety measure: Sheehan Disability Scale (SDS) measure: Quality of Life Enjoyment & Satisfaction Questionnaire Short Form (Q-LES-Q SF) sex: ALL minimumAge: 18 Years maximumAge: 65 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Vail Health Behavioral Health Innovation Center city: Edwards state: Colorado zip: 81632 country: United States name: Study Coordinator role: CONTACT phone: 970-445-2489 email: BHIC@vailhealth.org name: Barry Sandler, DO role: PRINCIPAL_INVESTIGATOR lat: 39.64499 lon: -106.5942 hasResults: False
|
<|newrecord|> nctId: NCT06263725 id: ALyster briefTitle: Protein Restriction (PR) for Weight Loss acronym: PR overallStatus: COMPLETED date: 2021-10-01 date: 2023-12-31 date: 2023-12-31 date: 2024-02-16 date: 2024-02-16 name: University of Copenhagen class: OTHER briefSummary: Prolonged dietary protein restriction has been shown to increase energy expenditure in mice simultaneously with an increase in plasma FGF21 levels. In overfeeding studies, a protein-restricted diet reduces weight gain in both mice and humans compared with normal and high-protein diets. Further, in energy balance studies, when lean men are provided with a protein-restricted diet for five weeks, an increase in energy intake was necessary to obtain their body weight. However, whether the effect of a protein-restricted diet is the same when consumed by overweight to obese men has divergent results in both mice and humans. conditions: Diet, Healthy, Body Weight studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: BASIC_SCIENCE masking: NONE count: 15 type: ACTUAL name: Restricted dietary protein name: Habitual diet measure: Body weight measure: FGF21 sex: MALE minimumAge: 25 Years maximumAge: 45 Years stdAges: ADULT facility: University of Copenhagen city: Copenhagen zip: 2100 country: Denmark lat: 55.67594 lon: 12.56553 hasResults: False
|
<|newrecord|> nctId: NCT06263712 id: 2021-02504 (Project 2) briefTitle: Differences Between Suicide Attempters and Suicide Ideators. Influence of the Brief Therapy Attempted Suicide Short Intervention Program (ASSIP) on Neuropsychological Correlates and Psychological Process Factors - Project 2 acronym: NePsyAssip HT overallStatus: RECRUITING date: 2024-03-25 date: 2026-12 date: 2026-12 date: 2024-02-16 date: 2024-03-27 name: University of Bern class: OTHER briefSummary: The present study consists of 3 projects in total and aims to investigate the (neuro-) psychological patterns from suicidal ideation to suicidal behavior as well as the effects and feasibility of ASSIP Home Treatment.
|
The overall aim of project 2 is to investigate how the (neuro-) psychological patterns are modulated by the Attempted Suicide Short Intervention Program (ASSIP). Therefore, suicide attempters participating in this project 2 will be randomly assigned to either the intervention group ASSIP or a standard care plus resource interview (STAR) group. The ASSIP and STAR interventions take place at the University Hospital of Psychiatry and Psychotherapy Bern (Switzerland).
|
At the end of the assessment in project 1 participants who reported a history of past suicide attempt (SUAT) will be informed about project 2.
|
Only if participants agreed to take part in project 2 and have signed the informed consent, they are randomized into two conditions: The ASSIP intervention (ASSIP) versus standard of care plus resource interview (STAR). Participants of both groups will be assessed again 4 weeks and 12 months after their first baseline assessment of project 1. conditions: Inhibitory Control conditions: Self Efficacy conditions: Suicide Ideation conditions: Suicide, Attempted conditions: Locus of Control conditions: Process Factors conditions: Movement Synchrony studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: NONE count: 156 type: ESTIMATED name: Attempted Suicide Short Intervention Program (ASSIP) name: Standard of care plus resource interview group (STAR) measure: Differences in Inhibitory Control measure: Differences in Inhibitory Control measure: Differences in Inhibitory Control measure: Movement analyses measure: Selective Attention and Interference Control measure: General Sense of Self-Efficacy measure: Locus of control measure: Psychological Pain measure: Suicidal ideation and behavior measure: Suicidal ideation measure: Mental abilities like attention, working memory and visuomotor speed as well as mental flexibility measure: Sociodemographic data measure: Diagnostic and Statistical Manual 5 (DSM-V) and International Classification of Diseases 10 (ICD-10) psychiatric disorders measure: Depressive symptoms measure: Loneliness measure: Therapeutic Alliance measure: Therapeutic change measure: Therapeutic outcomes measure: Adherence and Competence measure: Physiologically Experienced Emotional Distress and Arousal measure: Ecological Momentary Assesment measure: Attention and Concentration Abilities measure: Dissociative Experience measure: Motivational Incongruence measure: Motivational Goals measure: Suicide-Related Coping sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: University Hospital of Psychiatry and Psychotherapy, University of Bern status: RECRUITING city: Bern zip: 3008 country: Switzerland name: Anja C Gysin-Maillart, Ph.D. role: CONTACT phone: 0041 31 632 88 11 email: anja.gysin-maillart@unibe.ch name: Anja C Gysin-Maillart, Ph.D. role: PRINCIPAL_INVESTIGATOR lat: 46.94809 lon: 7.44744 hasResults: False
|
Subsets and Splits
No community queries yet
The top public SQL queries from the community will appear here once available.