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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: [email protected] name: Bjarne L Thorbjørnsen, MD role: CONTACT email: [email protected] lat: 59.91273 lon: 10.74609 hasResults: False
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<|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.
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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.
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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: [email protected] name: Charles Emery, PhD role: CONTACT phone: 43210 email: [email protected] name: Charles Emery, PhD role: PRINCIPAL_INVESTIGATOR name: Ihsan Rodriguez, MS role: SUB_INVESTIGATOR lat: 39.96118 lon: -82.99879 hasResults: False
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<|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
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<|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:
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* Is the leading edge of the prolapse above the hymen
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* 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
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<|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.
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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
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<|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: [email protected] lat: 39.9075 lon: 116.39723 hasResults: False
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<|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: [email protected] 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: [email protected] name: James LOUGHMAN, Professor role: CONTACT phone: +353868589593 email: [email protected] 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: [email protected] name: Jan Roelof Polling role: CONTACT phone: 010-7040704 email: [email protected] name: Caroline Klaver role: PRINCIPAL_INVESTIGATOR name: Jan Roelof Polling role: SUB_INVESTIGATOR lat: 51.9225 lon: 4.47917 hasResults: False
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<|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: [email protected] name: Dominique Januel role: CONTACT phone: 0143093232 phoneExt: 033 email: [email protected] name: Dominique Januel, Pr role: PRINCIPAL_INVESTIGATOR name: Ilona Arcomano, PhD role: SUB_INVESTIGATOR lat: 48.85373 lon: 2.54903 hasResults: False
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<|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.
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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.
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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.
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Purpose and Background
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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.
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What does taking part involve?
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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.
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Participants can choose the level of involvement that is right for them.
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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.
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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.
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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.
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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.
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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.
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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: [email protected] name: Research Access role: CONTACT email: [email protected] name: Jasmine Wall role: PRINCIPAL_INVESTIGATOR lat: 53.76282 lon: -2.70452 hasResults: False
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<|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
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<|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: [email protected] lat: 41.01384 lon: 28.94966 hasResults: False
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<|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
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<|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.
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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.
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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.
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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: [email protected] 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: [email protected] 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: [email protected] 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: [email protected] 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: [email protected] 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: [email protected] 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: [email protected] 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: [email protected] 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: [email protected] 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: [email protected] 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: [email protected] 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: [email protected] 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: [email protected] 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: [email protected] 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: [email protected] 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: [email protected] 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: [email protected] 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: [email protected] 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: [email protected] 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: [email protected] 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: [email protected] 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: [email protected] 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: [email protected] 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: [email protected] 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: [email protected] name: Maxime GERARD, MD role: PRINCIPAL_INVESTIGATOR lat: 48.85341 lon: 2.3488 hasResults: False
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<|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
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<|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.
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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: [email protected] name: mostafa fayed, bachelor role: CONTACT phone: +201063376252 lat: 31.11174 lon: 30.93991 hasResults: False
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<|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.
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* 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.
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* 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.
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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.
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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
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<|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.
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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: [email protected] lat: 49.9 lon: 2.3 facility: CHU Angers city: Angers country: France name: OBERTI FREDERIC role: CONTACT email: [email protected] 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: [email protected] facility: CHU Jean Minjoz city: Besançon country: France name: WEIL DELPHINE, Dr role: CONTACT email: [email protected] lat: 47.24878 lon: 6.01815 facility: CHU Haut Lévêque city: Bordeaux country: France name: DE LEDINGHEN VICTOR, Dr role: CONTACT email: [email protected] lat: 44.84044 lon: -0.5805 facility: CHU Caen city: Caen country: France name: OLLIVIER-HOURMAND Isabelle, Dr role: CONTACT email: [email protected] 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: [email protected] facility: CHU Clermont Ferrand city: Clermont Ferrand country: France name: ABERGEL ARMAND, Dr role: CONTACT email: [email protected] lat: 45.77966 lon: 3.08628 facility: Hôpital Henri Mondor city: Créteil country: France name: LEROY Vincent, Dr role: CONTACT email: [email protected] lat: 48.78333 lon: 2.46667 facility: Hôpital Francois Mitterrand city: Dijon country: France name: MINELLO Anne, Dr role: CONTACT email: [email protected] lat: 47.31667 lon: 5.01667 facility: CHU Grenoble city: Grenoble country: France name: HILLERET Marie-Noelle, Dr role: CONTACT email: [email protected] 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: [email protected] lat: 46.66667 lon: -1.43333 facility: Hôpital Huriez city: Lille country: France name: LOUVET ALEXANDRE, Dr role: CONTACT email: [email protected] lat: 50.63297 lon: 3.05858 facility: CHU la Croix Rousse city: Lyon country: France name: LEBOSSE FANNY, Dr role: CONTACT email: [email protected] lat: 45.74848 lon: 4.84669 facility: CHU de Montpellier city: Montpellier country: France name: URSIC Jose, Dr role: CONTACT email: [email protected] lat: 43.61092 lon: 3.87723 facility: CHU Hôtel Dieu city: Nantes country: France name: ARCHAMBEAUD Isabelle, Dr role: CONTACT email: [email protected] lat: 47.21725 lon: -1.55336 facility: CHU Avicenne city: Paris country: France name: BLAISE LORAINE, Dr role: CONTACT email: [email protected] lat: 48.85341 lon: 2.3488 facility: CHU Pitié-Salpêtrière city: Paris country: France name: THABUT DOMINIQUE, Dr role: CONTACT email: [email protected] lat: 48.85341 lon: 2.3488 facility: CHU Saint-Antoin city: Paris country: France name: OZENNE Violaine, Dr role: CONTACT email: [email protected] lat: 48.85341 lon: 2.3488 facility: CHU de Reims city: Reims country: France name: BERNARD CHABERT Brigitte, Dr role: CONTACT email: [email protected] lat: 49.25 lon: 4.03333 facility: CHU Pontchaillou city: Rennes country: France name: JEZEQUIEL Caroline, Dr role: CONTACT email: [email protected] lat: 48.11198 lon: -1.67429 facility: Hôpitaux Universitaires de Strasbourg city: Strasbourg country: France name: TRIPON Simona, Dr role: CONTACT email: [email protected] lat: 48.58392 lon: 7.74553 facility: CHU de Toulouse city: Toulouse country: France name: BUREAU Christophe, Dr role: CONTACT email: [email protected] lat: 43.60426 lon: 1.44367 facility: Hôpital Paul Brousse city: Villejuif country: France name: KOUNIS Ilias, Dr role: CONTACT email: [email protected] lat: 48.7939 lon: 2.35992 hasResults: False
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<|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: [email protected] lat: 37.86726 lon: 32.52863 hasResults: False
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<|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.
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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
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<|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
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<|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: [email protected] name: Karina Wijayanti, MD role: CONTACT phone: +6285226207270 email: [email protected] lat: -6.21462 lon: 106.84513 hasResults: False
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<|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: [email protected] name: Adam Hively, MPH role: CONTACT phone: 6142021540 email: [email protected] lat: 38.62727 lon: -90.19789 hasResults: False
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<|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: [email protected] name: Barry Sandler, DO role: PRINCIPAL_INVESTIGATOR lat: 39.64499 lon: -106.5942 hasResults: False
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<|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
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<|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.
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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).
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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.
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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: [email protected] name: Anja C Gysin-Maillart, Ph.D. role: PRINCIPAL_INVESTIGATOR lat: 46.94809 lon: 7.44744 hasResults: False
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<|newrecord|> nctId: NCT06263699 id: S68225 briefTitle: Goniometry and Goniometric Measurement on Standardised Images in Dupuytren's Disease acronym: Goniometry overallStatus: RECRUITING date: 2024-01-29 date: 2025-01-01 date: 2025-01-01 date: 2024-02-16 date: 2024-02-21 name: Universitaire Ziekenhuizen KU Leuven class: OTHER briefSummary: Measuring range of motion (ROM) is essential in detecting musculoskeletal deficits, monitoring the effects of treatment and progression of the disease. In Dupuytren's disease the active and passive extension deficits (AED, PED) of digits 4 and 5 are usually clinically measured using a universal, short arm goniometer which is considered the standard of care. Using the goniometer can be time consuming. Measuring the extension deficit on a standardised picture could improve follow up, since it is a faster and easier process to take a picture and upload it to the patients files. Though this gives rise to the question whether this kind of measurement would be equally accurate and reliable in comparison to regular clinical measurement using a goniometer. conditions: Dupuytren's Disease studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: PROSPECTIVE count: 59 type: ESTIMATED name: ROM measurement of the MCP and PIP joints in digits 4 and 5 measure: Active Extension Deficits (AED) sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Universitaire Ziekenhuizen KU Leuven status: RECRUITING city: Leuven state: Vlaams-Brabant zip: 3000 country: Belgium name: Ilse Degreef, Prof. Dr. role: CONTACT phone: +32 16 33 88 43 email: [email protected] name: Anna Tarasiuk role: CONTACT phone: +32 16 33 88 18 email: [email protected] name: Ilse Degreef, Prof. Dr. role: PRINCIPAL_INVESTIGATOR lat: 50.87959 lon: 4.70093 hasResults: False
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<|newrecord|> nctId: NCT06263686 id: DAN056 briefTitle: Evaluation of the Effects of Routine Intake of Fresh vs- Pasteurized Yoghurt on the Immune System in Healthy Adults acronym: YASI-03 overallStatus: COMPLETED date: 2016-06-01 date: 2016-11-01 date: 2016-12-31 date: 2024-02-16 date: 2024-02-16 name: University of Valladolid class: OTHER name: Danone Institute International name: University of Seville briefSummary: In this study, the purpose was to describe and compare the modulator effects on the immune system of the routine ingestion of fresh vs. pasteurized yoghurt. A unicentral, prospective, randomized, double-blind, parallel group nutritional study for 8 weeks was carried out comparing the ingestion of 125 g (three times a day) of the products in healthy adults. A complete battery of in vitro tests on the activity of immune system, processes and phenomena was performed. conditions: Immune System conditions: Innate Inflammatory Response studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: BASIC_SCIENCE masking: SINGLE whoMasked: CARE_PROVIDER count: 125 type: ACTUAL name: Pasteurised yoghurt name: Fresh yoghurt name: Sterilised yoghurt measure: T-cells measure: IFN-gamma induction measure: IgG sex: ALL minimumAge: 20 Years maximumAge: 70 Years stdAges: ADULT stdAges: OLDER_ADULT hasResults: False
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<|newrecord|> nctId: NCT06263673 id: 23-008183 briefTitle: Anti-Diabetic Medications to Fight PD and LBD overallStatus: RECRUITING date: 2024-04-17 date: 2024-06-30 date: 2024-06-30 date: 2024-02-16 date: 2024-04-17 name: Mayo Clinic class: OTHER briefSummary: The purpose of this study is to test the hypothesis that DPP4 inhibitors and SGLT2 inhibitors are well tolerated and have beneficial neurological effects, specifically for Parkinson's disease and Lewy body dementia. conditions: Lewy Body Dementia conditions: Parkinson Disease studyType: INTERVENTIONAL phases: PHASE4 allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: DOUBLE whoMasked: PARTICIPANT whoMasked: INVESTIGATOR count: 12 type: ESTIMATED name: Sitagliptin name: Dapagliflozin name: Placebo measure: Movement Disorder Society- Unified Parkinson's Disease Rating Scale (MDS-UPDRS) measure: Change in Mini Mental State Examination measure: Glucose measure: Supine blood pressure measure: Standing blood pressure sex: ALL minimumAge: 45 Years maximumAge: 65 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Mayo Clinic Florida status: RECRUITING city: Jacksonville state: Florida zip: 32224 country: United States name: Zoe A Parrales, BS role: CONTACT phone: 904-953-3381 email: [email protected] lat: 30.33218 lon: -81.65565 hasResults: False
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<|newrecord|> nctId: NCT06263660 id: 2022-007 briefTitle: Evaluation of a Keto-Like Supplement on Brain Responses to Emotional Stimuli in Depression overallStatus: RECRUITING date: 2024-01-09 date: 2026-01 date: 2026-01 date: 2024-02-16 date: 2024-02-20 name: Laureate Institute for Brain Research, Inc. class: OTHER briefSummary: This study aims to determine whether a keto-like supplement relative to placebo results in functional brain changes during fMRI tasks evaluating positive and negative valence in individuals with moderate to severe depression. In this double-blind randomized placebo-controlled trial, 75 individuals with a Patient Health Questionnaire (PHQ-9) scale score ≥ 10 (MDD) will be enrolled to participate in an 8-week treatment study to obtain 60 completers. Participants will be randomized with a 1-1 ratio to receive the keto-like supplement (n= 30 completers) or placebo (n=30 completers) taken orally three times per day for 8 weeks. Participants will undergo a 10.5-hour screening/baseline evaluation visit split over 2 days at week 0 including questionnaires, neuroimaging before and after supplement or placebo administration and blood draws, office visits at week 2 (1.5 hours), week 4 (3 hours), week 6 (0.5 hours), week 8 (6 hours), a follow-up visit at week 10 (1.5 hours) and two phone calls between visits (weeks 1 and 3) during which a brief clinical assessment will be obtained (10 minutes each). The total time involved in the study is approximately 23.5 hours. conditions: Depression studyType: INTERVENTIONAL phases: PHASE2 allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: BASIC_SCIENCE masking: QUADRUPLE whoMasked: PARTICIPANT whoMasked: CARE_PROVIDER whoMasked: INVESTIGATOR whoMasked: OUTCOMES_ASSESSOR count: 75 type: ESTIMATED name: Keto-like supplement name: Placebo measure: BOLD response during Monetary Incentive Delay Task measure: BOLD response during Adjective Task sex: ALL minimumAge: 18 Years maximumAge: 65 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Laureate Institute for Brain Research status: RECRUITING city: Tulsa state: Oklahoma zip: 74136 country: United States name: Teresa Victor, PhD role: CONTACT phone: 918-502-5108 email: [email protected] name: Colleen McCallum role: CONTACT phone: 918-502-5180 lat: 36.15398 lon: -95.99277 hasResults: False
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<|newrecord|> nctId: NCT06263647 id: HSC-MS-23-0904 id: UG3NR021232 type: NIH link: https://reporter.nih.gov/quickSearch/UG3NR021232 briefTitle: Incorporation of a Health Equity Approach to Hospital Violence Intervention Programs: The Integration of a Community and Hospital Based Initiatives to Reduce Gun Violence in a Large Metropolitan Area overallStatus: NOT_YET_RECRUITING date: 2025-06-01 date: 2028-02-01 date: 2028-05-01 date: 2024-02-16 date: 2024-02-16 name: The University of Texas Health Science Center, Houston class: OTHER name: National Institute of Nursing Research (NINR) briefSummary: The purpose of this study is to evaluate the effectiveness of Houston-Hospital Violence Intervention Programs (HVIP) in reducing the occurrence of repeat violent events among adults receiving care at Memorial Hermann Hospital in Houston, to determine the impact of the community-engaged Houston-HVIP program on violent re-injury and mental and behavioral health, assess the impact of the Houston-HVIP program on racial and ethnic disparities in those impacted by firearm violence injury and to identify the predictors of implementation success, including dosage, reach, fidelity, and acceptability from the perspective of gun violence victims, health care providers, and community violence intervention specialists conditions: Firearm Injury studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: PREVENTION masking: DOUBLE maskingDescription: Participants will be partially blinded in that they will know some information about the intervention but will not be exposed to the details of the intervention or the intervention manual. whoMasked: PARTICIPANT whoMasked: OUTCOMES_ASSESSOR count: 300 type: ESTIMATED name: Houston-HVIP treatment name: Enhanced Case Management measure: Repeat violent victimization as assessed by the number of participants who return to the hospital system for a violent injury measure: Repeat violent victimization as assessed by the number of participants who are exposed to repeat violence but not admitted to the hospital captured using the Computer-assisted self-interviewing (CASI) instrument measure: Change in post-traumatic stress as assessed by the post-Traumatic Stress Disorder Checklist Version 5(PCL-5) measure: Change in aggression as assessed by the Buss-Perry Aggression Questionnaire (BPAQ) measure: Change in general health as assessed by the 12-item Short Form Health Survey (SF-12) sex: ALL minimumAge: 18 Years maximumAge: 30 Years stdAges: ADULT facility: The University of Texas Health Science Center at Houston city: Houston state: Texas zip: 77030 country: United States name: Sandra McKay, MD role: CONTACT phone: 713-500-5666 email: [email protected] name: Alexander Testa, PhD role: CONTACT phone: (210) 276-9000 email: [email protected] lat: 29.76328 lon: -95.36327 hasResults: False
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<|newrecord|> nctId: NCT06263634 id: 2022-206 briefTitle: Hand Exercises in Psoriatic Arthritis overallStatus: RECRUITING date: 2023-04-05 date: 2024-04-05 date: 2024-05-05 date: 2024-02-16 date: 2024-02-28 name: Akdeniz University class: OTHER briefSummary: This study is a randomized controlled study examining the effects of 8-week hand home exercises on grip strength, functionality, disease activity and quality of life in patients with PsA. Individuals participating in the study will be randomly divided into 2 groups. Individuals in the intervention group will perform home exercises consisting of stretching, mobility and strengthening, 4 days a week for 8 weeks, and the patients' compliance with the exercise will be monitored by phone call once a week. Individuals in the control group are on the waiting list and the same home exercise program will be taught to the patients at the end of the study. conditions: Psoriatic Arthritis conditions: Hand Rheumatism studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL interventionModelDescription: Randomized controlled trial primaryPurpose: TREATMENT masking: NONE count: 34 type: ESTIMATED name: Hand exercises measure: Psoriatic Arthritis Disease Activity Score (DAPSA) measure: Hand grip strength measurement measure: Hand fine grip strength measurement: measure: Nine-Hole Peg Test measure: Duruöz Hand Index measure: Michigan Hand Outcome Questionnaire (MHQ) measure: Hand Functional Index (HFI) measure: Psoriatic Arthritis Quality of Life Questionnaire (PsAQoL) sex: ALL minimumAge: 18 Years maximumAge: 65 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Akdeniz University status: RECRUITING city: Antalya country: Turkey name: Ayse Ayan, MD role: CONTACT phone: +90 242 249 44 00 email: [email protected] lat: 36.90812 lon: 30.69556 hasResults: False
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<|newrecord|> nctId: NCT06263621 id: 855090 briefTitle: Changing Portion Size Descriptions in a Cafeteria overallStatus: ACTIVE_NOT_RECRUITING date: 2024-01-11 date: 2024-05-29 date: 2024-05-29 date: 2024-02-16 date: 2024-02-26 name: University of Pennsylvania class: OTHER name: Restaurant Associates briefSummary: The goal of this this intervention is to test the degree to which a portion size labeling intervention influences consumer selection of smaller portions at two large cafés. The main question it aims to answer is: Do consumers order fewer calories when the portion size label for the smaller entree is called "standard" instead of "small"?
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Participants will order lunch as usual in the two cafes (one intervention, one control) for 5.5 months, and all order items will be recorded in the check-out system. One cafe will receive the labeling intervention, while the other will not. Researchers will compare the average calories per order between the two cafes to see if there are differences. conditions: Food Selection conditions: Obesity conditions: Weight Gain conditions: Food Preferences studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL interventionModelDescription: Entrees are offered in two different portion sizes at two cafes. The cafes were randomized to either receive the "Standard" portion label for the smaller size (Intervention) or the "Small" portion label for the smaller size (Control). The larger portion was labeled "Large." Daily lunch transaction data will be provided by the cafes. primaryPurpose: PREVENTION masking: NONE count: 12000 type: ESTIMATED name: Intervention "Standard" measure: Average kcal per entree sold measure: Number of entrée units purchased measure: Total kcal per transaction measure: Weekly gross sales sex: ALL stdAges: CHILD stdAges: ADULT stdAges: OLDER_ADULT facility: Courtyard Cafe city: Boston state: Massachusetts zip: 02115 country: United States lat: 42.35843 lon: -71.05977 facility: Elements Cafe city: Boston state: Massachusetts zip: 02115 country: United States lat: 42.35843 lon: -71.05977 hasResults: False
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<|newrecord|> nctId: NCT06263608 id: BUN B3002023000204 briefTitle: Structured Testing and Treatment for Obstructive Sleep Apnea in Patients With Atrial Fibrillation acronym: STAROSA overallStatus: RECRUITING date: 2024-02-23 date: 2028-02 date: 2028-02 date: 2024-02-16 date: 2024-03-06 name: University Hospital, Antwerp class: OTHER name: Jessa Hospital name: Hasselt University name: Universiteit Antwerpen briefSummary: The main goal of this prospective pre-post implementation study is to investigate how a structured testing and treatment program for obstructive sleep apnea using the NOX T3s device and a Fitbit smartwatch with the FibriCheck algorithm impacts the proportion of atrial fibrillation (AF) in an AF population.
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Participants will wear the NOX T3s respiratory polygraphy device for one night at home. In case of a positive obstructive sleep apnea diagnosis, patients will be referred to the sleep clinic for a polysomnography examination. Patients positively diagnosed with polygraph will be monitored semi-continuously with the Fitbit smartwatch for three months. After the polysomnography examination, the positively diagnosed patients will be monitored semi-continuously for another three months after initiation of treatment (mostly continuous positive airway pressure (CPAP) treatment). Additionally, patients will be administered satisfaction and symptom burden questionnaires twice: right after the polysomnography examination and after the 3-month treatment. conditions: Atrial Fibrillation conditions: Obstructive Sleep Apnea studyType: INTERVENTIONAL phases: NA allocation: NA interventionModel: SINGLE_GROUP primaryPurpose: TREATMENT masking: NONE count: 209 type: ESTIMATED name: (Cardio)Respiratory polygraphy (NOX T3s) name: Polysomnography name: Devices to deliver Continuous Positive Airway Pressure (CPAP), Bilevel Positive Airway Pressure (BiPAP) or Adaptive support ventilation (ASV) name: Fitbit smartwatch measure: AF burden before and after CPAP treatment measure: Obstructive sleep apnea severity agreement between polygraphy and polysomnography measure: False positive rate of polygraphy measure: Total sleep apnea burden measure: CPAP/BiPAP/ASV compliance measure: Sleep score measure: Patients' AF-related symptom burden, assessed by the Leuven ARrhythmia Questionnaire (LARQ) measure: Patients' obstructive sleep apnea-related symptom burden, assessed by the Berlin Questionnaire (BQ) measure: Patients' obstructive sleep apnea-related symptom burden, assessed by the Epworth Sleepiness Scale (ESS) measure: Polygraphy negative patients measure: User-friendliness of the NOX T3s polygraphy device measure: User-friendliness of the Fitbit-based FibriCheck monitoring measure: Uptake rate of the advice to patients to undergo a polysomnography examination measure: Protocol adherence to smartphone heart rhythm measurements measure: The quality of the FibriCheck measurements measure: Number of technical issues sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: University Hospital of Antwerp status: RECRUITING city: Edegem country: Belgium name: Lien Desteghe, MSc PhD role: CONTACT email: [email protected] lat: 51.15662 lon: 4.44504 facility: Jessa Hospital status: RECRUITING city: Hasselt country: Belgium name: Lien Desteghe, MSc PhD role: CONTACT email: [email protected] lat: 50.93106 lon: 5.33781 hasResults: False
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<|newrecord|> nctId: NCT06263595 id: REB23-1754 briefTitle: Semaglutide and Preoperative Residual Gastric Volumes overallStatus: NOT_YET_RECRUITING date: 2024-03-01 date: 2024-12-31 date: 2024-12-31 date: 2024-02-16 date: 2024-02-16 name: University of Calgary class: OTHER name: Alberta Health services briefSummary: Given the pharmacodynamic and pharmacokinetic properties of glucagon-like peptide-1 (GLP-1) agonists, the Canadian Anesthesiologists' Society has recognized that patients on GLP-1 agonists may have an increased aspiration risk due to a 'full stomach,' even after following preoperative fasting guidelines. In other words, safe fasting timelines are not known in individuals taking GLP-1 agonists, as demonstrated by recent case reports of patients who either retained or regurgitated stomach contents despite being adequately fasted.
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To address this gap, we plan to measure preoperative residual gastric volumes with point-of-care ultrasound (POCUS) in patients taking this medication. The priority is to first gather data to identify which patient populations need risk stratification and to then use this data to support the development of specific guidelines that reduce anesthetic complications, such as aspiration pneumonia.
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Our primary objective is to use POCUS preoperatively to assess gastric volumes of fasted patients to demonstrate if there is a clinically significant increase in residual gastric volumes in patients on semaglutide. conditions: Pulmonary Aspiration studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: PROSPECTIVE count: 90 type: ESTIMATED name: gastric antral sonography measure: Number of participants presenting with a full stomach measure: Number of occurrences requiring change in anesthetic management plan measure: Relationship between dose, duration and timing of GLP-1 receptor agonist and gastric volume measure: Relationship between gastric emptying and purpose of GLP-1 receptor agonist administration sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: South Health Campus city: Calgary state: Alberta zip: T3M 1M4 country: Canada name: Joanna J Moser, MD, PhD role: CONTACT phone: 403-956-3883 email: [email protected] lat: 51.05011 lon: -114.08529 hasResults: False
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<|newrecord|> nctId: NCT06263582 id: IGHID12333 briefTitle: Pharmacokinetics of Intravaginal, Self-administered Artesunate Vaginal Pessaries Among Women in Kenya overallStatus: NOT_YET_RECRUITING date: 2024-06 date: 2025-02 date: 2025-02 date: 2024-02-16 date: 2024-02-20 name: UNC Lineberger Comprehensive Cancer Center class: OTHER briefSummary: This study investigates the pharmacokinetics of Artesunate (AS) and dihydroartemisinin (DHA), the active metabolite of Artesunate, following intravaginal use at the dosing and frequency being studied for cervical precancer treatment. A secondary objective is to investigate safety among study participants. conditions: Cervix Cancer conditions: Cervix Intraepithelial Neoplasia Grade 3 conditions: Cervix; Intraepithelial Neoplasia, Grade I conditions: Cervix; Intraepithelial Neoplasia, Grade II studyType: INTERVENTIONAL phases: PHASE1 allocation: NA interventionModel: SINGLE_GROUP primaryPurpose: TREATMENT masking: NONE count: 16 type: ESTIMATED name: Artesunate pessary name: blood draws for pharmacokinetics of the study drug measure: To determine the area under the plasma concentration versus time curve (AUC) of dihydroartemisinin measure: To determine the area under the plasma concentration versus time curve (AUC) of Artesunate (AS) measure: To determine the maximum concentration of Artesunate (AS) measure: To determine the maximum concentration of dihydroartemisinin (DHA) (Cmax) measure: To determine the time to maximum concentration (Tmax) of Artesunate (AS) following five consecutive days measure: To determine the time to maximum concentration (Tmax) of dihydroartemisinin (DHA measure: To determine the half-life (t1/2) of Artesunate (AS) measure: To determine the half-life (t1/2) of dihydroartemisinin (DHA) measure: To determine the apparent clearance (CL/F) of Artesunate (AS) measure: To determine the apparent clearance (CL/F) of dihydroartemisinin (DHA) measure: To determine the volume of distribution (V/F) of Artesunate (AS) measure: To determine the volume of distribution (V/F) of dihydroartemisinin (DHA) measure: Type, frequency, severity, and duration of adverse events sex: FEMALE minimumAge: 18 Years maximumAge: 65 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Lumumba Sub-County Hospital city: Kisumu country: Kenya lat: -0.10221 lon: 34.76171 hasResults: False
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<|newrecord|> nctId: NCT06263569 id: SDB 2023-002 briefTitle: Effectiveness of Total Hip Arthroplasty for Patients With Osteoarthritis, a Target Trial Emulation Study acronym: EAGLE overallStatus: COMPLETED date: 2023-05-24 date: 2023-05-24 date: 2023-05-24 date: 2024-02-16 date: 2024-02-16 name: JointResearch class: OTHER briefSummary: The aim of this study is to assess the effect of total hip arthroplasty on hip disability and pain compared to non-surgery in patients with hip osteoarthritis, using target trial emulation to emulate a randomized controlled trial. conditions: Hip Osteoarthritis studyType: OBSERVATIONAL observationalModel: OTHER timePerspective: OTHER count: 156 type: ACTUAL name: Total hip arthroplasty measure: Hip disability and Osteoarthritis Outcome Score Physical function Short form (HOOS-PS), change score from baseline measure: Numerical Rating Scale (NRS) pain during weight bearing, change score from baseline sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: OLVG city: Amsterdam state: Noord Holland zip: 1090 HM country: Netherlands lat: 52.37403 lon: 4.88969 typeAbbrev: Prot_SAP hasProtocol: True hasSap: True hasIcf: False label: Study Protocol and Statistical Analysis Plan date: 2023-05-17 uploadDate: 2024-02-08T10:36 filename: Prot_SAP_000.pdf size: 949604 hasResults: False
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<|newrecord|> nctId: NCT06263556 id: 2023/389 briefTitle: Effectiveness of TTNS in MS Patients With Lower Urinary Track Symptoms overallStatus: RECRUITING date: 2024-01-17 date: 2024-11-05 date: 2024-12-05 date: 2024-02-16 date: 2024-02-16 name: Bakirkoy Dr. Sadi Konuk Research and Training Hospital class: OTHER_GOV briefSummary: Multiple sclerosis (MS) is the most common inflammatory disease of the central nervous system. It is characterized with demyelinated plaques affecting subcortical, brain stem, and spinal cord nerve fibers. During the course of the disease, with the affection myelinated nerve tracks, lower urinary track symptoms may occur. 50-90% of the MS patients experience lower urinary track symptoms (LUTS) such as urinary incontinence, urgency, nocturia and/or urinary frequency during the at one point of their life.
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Aim of this study is to determine the effects of transcutaneous tibial nerve stimulation (TTNS) on symptoms and quality of life in MS patients with LUTS. conditions: Multiple Sclerosis conditions: Lower Urinary Tract Symptoms studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL interventionModelDescription: Patients will be randomized and assigned to either group. primaryPurpose: TREATMENT masking: SINGLE whoMasked: PARTICIPANT count: 64 type: ESTIMATED name: Pelvic floor exercises name: Transcutaneous posterior tibial nerve stimulation name: Sham stimulation measure: Incontinence Quality of Life (I-QOL) measure: Post-void residue (PVR) measure: Bladder diary measure: International Consultation on Incontinence Questionnaire Short Form (ICIQ-SF) sex: ALL minimumAge: 18 Years maximumAge: 50 Years stdAges: ADULT facility: Bakirkoy Dr. Sadi Konuk Research and Training Hospital status: RECRUITING city: Istanbul country: Turkey name: Sibel CAGLAR role: CONTACT phone: +905333365651 email: [email protected] name: Arda Can KASAP role: CONTACT phone: +905384590119 email: [email protected] lat: 41.01384 lon: 28.94966 hasResults: False
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<|newrecord|> nctId: NCT06263543 id: 2023-MAH-001 briefTitle: Sequencing Antibody Drug Conjugates in ER+/HER2 LOW MBC acronym: SERIES overallStatus: NOT_YET_RECRUITING date: 2024-04 date: 2026-04 date: 2026-10 date: 2024-02-16 date: 2024-02-16 name: Reshma L. Mahtani, D.O. class: OTHER name: Gilead Sciences briefSummary: The purpose of this research study is to see if the medication sacituzumab govitecan (SG) is effective at the currently approved dose and schedule in people who have previously received trastuzumab deruxtecan (T-DXd) for the treatment of metastatic, hormone receptor positive (HR+)/human epidermal growth factor 2 low (HER2 low) breast cancer. Although SG is approved to treat metastatic HR+/HER2 negative breast cancer, the aim of this study is to determine if SG is still effective specifically in people who have already received T-DXd. conditions: Breast Cancer conditions: Metastatic Breast Cancer conditions: Advanced Breast Cancer conditions: Hormone-receptor-positive Breast Cancer conditions: Human Epidermal Growth Factor 2 Low Breast Cancer studyType: INTERVENTIONAL phases: PHASE2 allocation: NA interventionModel: SINGLE_GROUP primaryPurpose: TREATMENT masking: NONE count: 75 type: ESTIMATED name: Sacituzumab govitecan measure: Overall response rate (ORR) measure: Clinical benefit rate (CBR) measure: Progression-free survival (PFS) measure: Overall survival (OS) measure: Duration of response (DOR) measure: Global Quality of Life measure: Treatment-related Adverse Events (AEs) and Serious Adverse Events (SAEs) measure: Laboratory and Vital Sign Abnormalities measure: Growth Factor Support sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: UCLA Jonsson Comprehensive Cancer Center city: Los Angeles state: California zip: 90404 country: United States name: Aditya Bardia, M.D. role: CONTACT phone: 310-586-2093 email: [email protected] lat: 34.05223 lon: -118.24368 facility: Miami Cancer Institute at Baptist Health, Inc. city: Miami state: Florida zip: 33176 country: United States name: Reshma L Mahtani, D.O. role: CONTACT phone: 786-596-2000 email: [email protected] name: Krystal Fernandez role: CONTACT phone: (786) 596-2000 email: [email protected] lat: 25.77427 lon: -80.19366 facility: Winship Cancer Institute at Emory University city: Atlanta state: Georgia zip: 30322 country: United States name: Kevin Kalinsky, M.D., M.S. role: CONTACT phone: 404-778-0519 email: [email protected] lat: 33.749 lon: -84.38798 hasResults: False
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<|newrecord|> nctId: NCT06263530 id: NU22-03-00182 briefTitle: Prognostic Significance of ctDNA in HL overallStatus: RECRUITING date: 2022-01-02 date: 2023-12-31 date: 2027-12-31 date: 2024-02-16 date: 2024-02-16 name: Interni hematologicka klinika FNKV class: NETWORK name: Charles University, Czech Republic name: General University Hospital, Prague name: University Hospital Olomouc name: University Hospital Hradec Kralove name: University Hospital, Motol briefSummary: Specific somatic mutations using ctDNA will be analyzed in predefined subgroups of cHL (e.g., age \<60 and ≥ 60 years, EBV). These mutations will be correlated with response to the treatment in the first line, in the relapse, during brentuximab vedotin and/or nivolumab treatment. Circulating tumor DNA will be correlated with the extent of tumor mass and chemo/radiotherapy. conditions: Prognostic Cancer Model studyType: OBSERVATIONAL observationalModel: CASE_CONTROL timePerspective: PROSPECTIVE count: 500 type: ESTIMATED measure: Identification of tumor specific mutation profiles at dg. of HL based on ctDNA measure: Quantitative analysis of ctDNA level during the first-line chemotherapy measure: Identification of tumor specific mutation profiles at relapse of classical HL measure: In vitro functional characterization of identified DNA variants and/or mutations sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: University Hospital Hradec Kralove status: RECRUITING city: Hradec Kralove zip: 50005 country: Czechia name: Alice Sykorova, M.D., Ph.D. role: CONTACT phone: +420495 832 866 email: [email protected] lat: 50.20923 lon: 15.83277 facility: University Hospital Olomouc status: RECRUITING city: Olomouc zip: 77520 country: Czechia name: Vit Prochazka, prof. M.D. role: CONTACT phone: +420588 442 878 email: [email protected] lat: 49.59552 lon: 17.25175 facility: University Hospital Kralovske Vinohrady status: RECRUITING city: Praha zip: 10034 country: Czechia name: Heidi Mocikova, M.D., Ph.D. role: CONTACT phone: +420267163554 email: [email protected] name: Katerina Klaskova, Ing. role: CONTACT phone: +420267162880 email: [email protected] lat: 50.08804 lon: 14.42076 facility: Charles University status: ACTIVE_NOT_RECRUITING city: Praha zip: 12108 country: Czechia lat: 50.08804 lon: 14.42076 facility: General University Hospital status: RECRUITING city: Praha zip: 12808 country: Czechia name: Jan Koren, M.D. role: CONTACT phone: +420224962541 email: [email protected] lat: 50.08804 lon: 14.42076 typeAbbrev: Prot_SAP hasProtocol: True hasSap: True hasIcf: False label: Study Protocol and Statistical Analysis Plan date: 2023-11-30 uploadDate: 2024-02-07T11:30 filename: Prot_SAP_000.pdf size: 329948 typeAbbrev: ICF hasProtocol: False hasSap: False hasIcf: True label: Informed Consent Form date: 2023-11-30 uploadDate: 2024-02-07T11:43 filename: ICF_001.pdf size: 82316 hasResults: False
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<|newrecord|> nctId: NCT06263517 id: SPA-S-899-01-21 id: 2021-003124-33 type: EUDRACT_NUMBER briefTitle: Clinical Trial to Assess Efficacy, Tolerability of Rising Doses of Clodronate in Painful Knee Osteoarthritis Patients overallStatus: RECRUITING date: 2023-10-12 date: 2025-07 date: 2025-10 date: 2024-02-16 date: 2024-02-16 name: SPA Società Prodotti Antibiotici S.p.A. class: INDUSTRY name: Pharmaceutical Development and Services briefSummary: The goal of this clinical trial is to to clarify which is the best dose of administration, to select a dose and to confirm the therapeutic efficacy of clodronate in patients with painful knee osteoarthritis (OA). The clinical trial will be divided in two parts.
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The main questions it aims to answer are:
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* in Phase II, to assess the safety and tolerability of different escalating doses of intra articular (IA) clodronate
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* in Phase II, to set a defined therapeutic dose (DTD) to be used in Phase III
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* in Phase III, to assess the safety and tolerability of different escalating doses of IA clodronate to confirm and extensively evaluate the therapeutic efficacy and safety of the clodronate DTD in patients with knee OA conditions: Osteoarthritis of Knee studyType: INTERVENTIONAL phases: PHASE2 phases: PHASE3 allocation: RANDOMIZED interventionModel: PARALLEL interventionModelDescription: Adaptative, multicenter, randomized, double-blind, parallel-group, placebo controlled primaryPurpose: TREATMENT masking: QUADRUPLE maskingDescription: Randomization list will be performed with Proc Plan procedure by SAS ® Software (release 9.4 or later) software using the block randomization method with block size of 4.
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Subjects eligible at Baseline will be randomly allocated to receive 2, 5, 10 /2ml or placebo according to the balanced randomization list. whoMasked: PARTICIPANT whoMasked: CARE_PROVIDER whoMasked: INVESTIGATOR whoMasked: OUTCOMES_ASSESSOR count: 296 type: ESTIMATED name: Clodronate name: Clodronate name: Clodronate name: Placebo measure: Efficacy: VAS Reduction measure: VAS mean changes measure: VAS mean changes observed 120 minutes after IA measure: Lequesne Algofunctional Index mean changes measure: WOMAC mean changes measure: Range of motion mean changes measure: Paracetamol consumption measure: SAE Reporting measure: AE Reporting measure: Clinical signs of intolerance Recording sex: ALL minimumAge: 50 Years maximumAge: 75 Years stdAges: ADULT stdAges: OLDER_ADULT facility: IRCCS Istituti Clinici Maugeri status: RECRUITING city: Castel Goffredo state: Mantova zip: 46042 country: Italy name: Lul Abdi-Ali role: CONTACT lat: 45.29403 lon: 10.473 facility: Ospedale San Pellegrino status: RECRUITING city: Castiglione delle Stiviere state: Mantova zip: 46043 country: Italy name: Paolo Roberto Ferrari role: CONTACT lat: 45.3902 lon: 10.48619 facility: Ospedale Civile Servizio di Riabilitazione Funzionale status: RECRUITING city: Volta Mantovana state: Mantova zip: 46049 country: Italy name: Luisa Selletti role: CONTACT lat: 45.32192 lon: 10.65891 facility: Azienda Ospedaliera Universitaria San Luigi Gonzaga status: NOT_YET_RECRUITING city: Orbassano state: Torino zip: 10043 country: Italy name: Filippo Castoldi role: CONTACT lat: 45.00547 lon: 7.53813 facility: Centro Riabilitativo Polifunzionale Teresio Borsalino status: RECRUITING city: Alessandria zip: 15122 country: Italy name: Marco Invernizzi role: CONTACT lat: 44.90924 lon: 8.61007 facility: IRCCS Ospedale Policlinico San Martino status: RECRUITING city: Genova zip: 16132 country: Italy name: Matteo Formica role: CONTACT lat: 44.40478 lon: 8.94438 facility: Ospedale Israelitico status: RECRUITING city: Roma zip: 00148 country: Italy name: Maria Chiara Meloni role: CONTACT lat: 41.89193 lon: 12.51133 facility: Ospedale San Pietro status: RECRUITING city: Rome zip: 00189 country: Italy name: Alberto Migliore role: CONTACT lat: 41.89193 lon: 12.51133 facility: Ospedale San Paolo status: NOT_YET_RECRUITING city: Savona zip: 17100 country: Italy name: Danilo Chiapale role: CONTACT lat: 44.30905 lon: 8.47715 facility: Azienda Ospedaliero Universitaria Senese status: RECRUITING city: Siena zip: 53100 country: Italy name: Bruno Frediani role: CONTACT lat: 43.31822 lon: 11.33064 facility: Ospedale Policlinico "G.B. Rossi" Borgo Roma status: RECRUITING city: Verona zip: 37134 country: Italy name: Luca Dalle Carbonare role: CONTACT lat: 45.4299 lon: 10.98444 hasResults: False
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<|newrecord|> nctId: NCT06263504 id: DM001 briefTitle: The Influence of Complex Correction of Dental and Musculoskeletal Systems on the Frequency of Relapses of Functional Disorders in Patients With Dental Pathologies. overallStatus: NOT_YET_RECRUITING date: 2024-03-10 date: 2025-06-15 date: 2025-10-15 date: 2024-02-16 date: 2024-02-26 name: NMSI DENTMASTER class: OTHER briefSummary: In influence of complex correction of dental and musculoskeletal systems on the frequency of relapses of functional disorders in patients with somatic pathologies: a randomized pilot study there will be two groups: Group 1 (control group): Patients in this group will receive standard treatment aimed solely at correcting malocclusions or restoring the integrity of the dentition without interfering with the musculoskeletal system.
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Group 2 (experimental group): Patients will receive comprehensive treatment, including not only dental correction of bite or restoration of the integrity of the dentition, but also correction of disorders of the musculoskeletal system.
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The endpoints will be :
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Primary endpoint:
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• Frequency of relapses and repeated requests for correction of disorders bite or restoration of the integrity of the dentition within 12 months after treatment.
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Secondary endpoints:
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* Change in pain intensity measured by visual analog scale (VAS).
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* Improvement of functional indicators of the temporomandibular joint, including range of motion.
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* Improved quality of life, assessed using the OHRQoL (Oral Health Related Quality) scale All endpoints will be evaluated within 12 months. conditions: Malocclusion conditions: Musculoskeletal Disorder studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: NONE count: 40 type: ESTIMATED name: at correcting malocclusions or restoring the integrity of the dentition name: comprehensive treatment, including not only dental correction of bite or restoration of the integrity of the dentition, but also correction of disorders of the musculoskeletal system. measure: Frequency of relapses and repeated requests for correction of disorders bite or restoration of the integrity of the dentition. measure: Change in pain intensity measured by visual analog scale (VAS). measure: Changes in functional parameters of the temporomandibular joint, including range of motion. joint, including range of motion. measure: Improved quality of life, assessed using the OHRQoL (Oral Health Related Quality) scale sex: ALL minimumAge: 18 Years maximumAge: 50 Years stdAges: ADULT facility: Nmsi Dentmaster city: Novosibirsk state: Novosibirsk Region zip: 630090 country: Russian Federation name: Tatiana A Gatilova role: CONTACT phone: 952939919 phoneExt: +7 email: [email protected] name: Anastasia V Semivolova role: PRINCIPAL_INVESTIGATOR lat: 55.0415 lon: 82.9346 hasResults: False
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<|newrecord|> nctId: NCT06263491 id: 2023-0413 id: NCI-2024-01325 type: OTHER domain: NCI-CTRP Clinical Registry briefTitle: Phase II Study of Pirtobrutinib, Rituximab (PR) in Previously Untreated Low and Intermediate Risk MCL (Mantle Cell Lymphoma) Patients overallStatus: NOT_YET_RECRUITING date: 2024-08-31 date: 2025-03-01 date: 2027-03-01 date: 2024-02-16 date: 2024-03-01 name: M.D. Anderson Cancer Center class: OTHER briefSummary: To learn if the chemotherapy-free combination of pirtobrutinib (also called LOXO-305) and rituximab can help provide long term remission in low and intermediate risk MCL. conditions: Mantle Cell Lymphoma studyType: INTERVENTIONAL phases: PHASE2 allocation: NON_RANDOMIZED interventionModel: SINGLE_GROUP primaryPurpose: TREATMENT masking: NONE count: 50 type: ESTIMATED name: Rituximab name: Pirtobrutinib measure: Safety and adverse events (AEs) sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: MD Anderson Cancer Center city: Houston state: Texas zip: 77030 country: United States name: Preetesh Jain, MBBS, MD, DM, PhD role: CONTACT phone: (713) 563-8786 email: [email protected] name: Preetesh Jain, MBBS, MD, DM, PhD role: PRINCIPAL_INVESTIGATOR lat: 29.76328 lon: -95.36327 hasResults: False
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<|newrecord|> nctId: NCT06263478 id: INCA34176-358 briefTitle: A Study to Evaluate the Efficacy, Safety, and Pharmacokinetics of Axatilimab Monotherapy in Japanese Participants With Recurrent or Refractory Active Chronic Graft-Versus-Host Disease overallStatus: NOT_YET_RECRUITING date: 2024-06-30 date: 2025-12-31 date: 2025-12-31 date: 2024-02-16 date: 2024-02-16 name: Incyte Biosciences Japan GK class: INDUSTRY briefSummary: This study will be conducted to determine the clinical efficacy of axatilimab in Japanese participants with chronic graft-versus-host disease (cGVHD). conditions: Chronic Graft-versus-host-disease studyType: INTERVENTIONAL phases: PHASE3 allocation: NA interventionModel: SINGLE_GROUP primaryPurpose: TREATMENT masking: NONE count: 20 type: ESTIMATED name: INCA034176 measure: Overall Response Rate in the First 6 Cycles measure: Proportion of participants with a ≥ 7-point improvement in modified Lee symptom scale (mLSS) score measure: Overall Response Rate measure: Duration of Response measure: Organ-specific Response Rate measure: Percent reduction in average daily dose (or equivalent) of corticosteroids measure: Proportion of participants who discontinue corticosteroid use measure: Number of participants with Treatment-emergent Adverse Events (TEAEs) measure: Change from baseline in Karnofsky/Lansky performance status measure: Axatilimab pharmacokinetic (PK) in Plasma measure: Number of Participants with Anti-Drug Antibody (ADA) sex: ALL minimumAge: 6 Years stdAges: CHILD stdAges: ADULT stdAges: OLDER_ADULT hasResults: False
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<|newrecord|> nctId: NCT06263465 id: CALM briefTitle: Precision Vaginal Microbiome Transplantation in Women With Bacterial Vaginosis overallStatus: RECRUITING date: 2024-03-11 date: 2025-07-01 date: 2025-12-31 date: 2024-02-16 date: 2024-03-13 name: Zhujiang Hospital class: OTHER name: ZhuHai Hospital briefSummary: The aim of this study was to explore the efficacy and safety of a new vaginal microbiome transplantation technique, using Lactobacillus cispatus from healthy donors as a treatment of bacterial vaginosis. conditions: Bacterial Vaginosis studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: OTHER masking: DOUBLE whoMasked: PARTICIPANT whoMasked: INVESTIGATOR count: 120 type: ESTIMATED name: Lactobacillus cispatus name: placebo measure: BV recurrence rate measure: vaginal secretions 16s rRNA gene sequencing measure: BV recurrence rate sex: FEMALE minimumAge: 18 Years maximumAge: 55 Years stdAges: ADULT facility: Zhuhai People'S Hospital status: RECRUITING city: Zhuhai state: Guangdong zip: 519050 country: China name: Jingya WU, Doctor role: CONTACT phone: +8615902057821 lat: 22.27694 lon: 113.56778 hasResults: False
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<|newrecord|> nctId: NCT06263452 id: 23-2768 id: 1R01HL157422-01 type: NIH link: https://reporter.nih.gov/quickSearch/1R01HL157422-01 briefTitle: Beta-Blocker Influences on Inflammatory and Neural Responses to Stress overallStatus: NOT_YET_RECRUITING date: 2024-03 date: 2026-03 date: 2026-03 date: 2024-02-16 date: 2024-03-06 name: University of North Carolina, Chapel Hill class: OTHER name: National Heart, Lung, and Blood Institute (NHLBI) name: University of California, Los Angeles name: Dartmouth College briefSummary: The purpose of this study is to map the neural and molecular mechanisms underlying psychological stress-induced changes in inflammation which could reveal new targets for intervention to reduce the risk of cardiovascular disease. conditions: Cardiovascular Disease studyType: INTERVENTIONAL phases: PHASE4 allocation: RANDOMIZED interventionModel: PARALLEL interventionModelDescription: Subjects (n = 60 per condition, N = 120) will either take a one-time, 40mg dose of propranolol or an encapsulated placebo. primaryPurpose: BASIC_SCIENCE masking: TRIPLE maskingDescription: This is a double blind, randomized, placebo-controlled mechanistic clinical trial. The Investigational Drug Service will randomly assign patients to the experimental group (propranolol) or the placebo group. Research staff who have direct contact with the participant will be blind to their condition. whoMasked: PARTICIPANT whoMasked: CARE_PROVIDER whoMasked: INVESTIGATOR count: 120 type: ESTIMATED name: Propranolol name: Placebo measure: Change in levels of pro-inflammatory cytokine interleukin-6 in response to social stress measure: Change in levels of inflammatory gene expression in response to social stress sex: ALL minimumAge: 18 Years maximumAge: 30 Years stdAges: ADULT facility: Social Neuroscience and Health Laboratory city: Chapel Hill state: North Carolina zip: 27514 country: United States name: Keely A Muscatell, PhD role: CONTACT phone: 916-495-7661 email: [email protected] name: Jessica R Cohen, PhD role: SUB_INVESTIGATOR name: Kristen A Lindquist, PhD role: SUB_INVESTIGATOR name: Samantha E Meltzer-Brody, MD, MPH role: SUB_INVESTIGATOR lat: 35.9132 lon: -79.05584 hasResults: False
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<|newrecord|> nctId: NCT06263439 id: RNI 2023 MIRAND id: 2023-A00585-40 type: OTHER domain: ANSM briefTitle: Surveillance of HFMD in Pediatric Outpatients acronym: PMB overallStatus: RECRUITING date: 2023-06-20 date: 2028-06-20 date: 2028-06-20 date: 2024-02-16 date: 2024-02-16 name: University Hospital, Clermont-Ferrand class: OTHER briefSummary: The aims of this prospective multicentric study is to determine the types of enteroviruses (EVs) responsible for hand, foot and mouth disease (HFMD) or herpangina in children seen within an ambulatory setting :
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* to detect an EV-A71 epidemic or another type associated with atypical forms of the disease at an early stage
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* to describe and compare the epidemiological, demographic, clinical and virological characteristics of these infections between the different types of EV. conditions: Hand, Foot and Mouth Disease conditions: Herpangina conditions: Enterovirus Infections studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: PROSPECTIVE count: 3000 type: ESTIMATED name: Throat/buccal swab sample measure: Prevalence of different types of Enteroviruses measure: Clinical characteristics of HFMD/Herpangina according to the different types of enteroviruses sex: ALL maximumAge: 10 Years stdAges: CHILD facility: CHU de Clermont-Ferrand status: RECRUITING city: Clermont-Ferrand zip: 63000 country: France name: Lise Laclautre role: CONTACT email: [email protected] name: Audrey Mirand role: PRINCIPAL_INVESTIGATOR lat: 45.77966 lon: 3.08628 hasResults: False
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<|newrecord|> nctId: NCT06263426 id: IRB00387066 id: U01AI177211 type: NIH link: https://reporter.nih.gov/quickSearch/U01AI177211 briefTitle: Kidney Transplantation From Donors With HIV: Impact on Rejection and Long-Term Outcomes (Expanding HOPE Kidney) overallStatus: NOT_YET_RECRUITING date: 2024-04 date: 2028-09 date: 2029-09 date: 2024-02-16 date: 2024-02-16 name: Johns Hopkins University class: OTHER name: National Institute of Allergy and Infectious Diseases (NIAID) briefSummary: This research is being done to better understand rejection in transplant recipients with HIV who receive kidneys from donors with vs without HIV. conditions: Hiv studyType: INTERVENTIONAL phases: NA allocation: NON_RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: NONE count: 200 type: ESTIMATED name: HIV D+/R+ name: HIV D-/R+ measure: Cumulative incidence of death and allograft rejection. measure: Participant survival measure: Graft survival measure: Type and severity of graft rejection measure: Time to first rejection measure: Rate of rejection events over time measure: Graft function over time measured by eGFR trajectory measure: Incidence of HIV viremia post-transplant measure: Incidence of new antiretroviral drug resistance and/or X4 tropic virus posttransplant measure: Incidence of bacterial, fungal, viral, and other opportunistic infections posttransplant measure: Incidence of surgical and vascular transplant complications post-transplant measure: Incidence and causes of chronic kidney disease post-transplant measure: Incidence of post-transplant malignancies measure: Incidence of de novo donor specific antibody (DSA) sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: University of Alabama at Birmingham city: Birmingham state: Alabama zip: 35294 country: United States name: Shikha Mehta, MD role: CONTACT email: [email protected] name: Shikha Mehta, MD role: PRINCIPAL_INVESTIGATOR lat: 33.52066 lon: -86.80249 facility: University of California, Los Angeles city: Los Angeles state: California zip: 90095 country: United States name: Joanna Schaenman, MD, PhD role: CONTACT email: [email protected] name: Joanna Schaenman, MD, PhD role: PRINCIPAL_INVESTIGATOR lat: 34.05223 lon: -118.24368 facility: University of California, San Diego city: San Diego state: California zip: 92037 country: United States name: Saima Aslam, MBBS role: CONTACT email: [email protected] name: Saima Aslam, MBBS role: PRINCIPAL_INVESTIGATOR lat: 32.71533 lon: -117.15726 facility: University of California, San Francisco city: San Francisco state: California zip: 94143 country: United States name: Garrett Roll, MD role: CONTACT email: [email protected] name: Garrett Roll, MD role: PRINCIPAL_INVESTIGATOR lat: 37.77493 lon: -122.41942 facility: Yale School of Medicine city: New Haven state: Connecticut zip: 06510 country: United States name: Maricar Malinis, MD role: CONTACT email: [email protected] name: Maricar Malinis, MD role: PRINCIPAL_INVESTIGATOR lat: 41.30815 lon: -72.92816 facility: Rush University Medical Center city: Chicago state: Illinois zip: 60612 country: United States name: Carlos Santos, MD role: CONTACT email: [email protected] name: Carlos Santos, MD role: PRINCIPAL_INVESTIGATOR lat: 41.85003 lon: -87.65005 facility: Ochsner Clinic Foundation city: New Orleans state: Louisiana zip: 70121 country: United States name: Jonathan Hand, MD role: CONTACT email: [email protected] name: Jonathan Hand, MD role: PRINCIPAL_INVESTIGATOR lat: 29.95465 lon: -90.07507 facility: Johns Hopkins University city: Baltimore state: Maryland zip: 21205 country: United States name: Christine Durand, MD role: CONTACT email: [email protected] name: Christine Durand, MD role: PRINCIPAL_INVESTIGATOR lat: 39.29038 lon: -76.61219 facility: Massachusetts General Hospital city: Boston state: Massachusetts zip: 02114 country: United States name: Nahel Elias, MD role: CONTACT email: [email protected] name: Nahel Elias, MD role: PRINCIPAL_INVESTIGATOR lat: 42.35843 lon: -71.05977 facility: New York University city: New York state: New York zip: 10016 country: United States name: Sapna Mehta, MD role: CONTACT email: [email protected] name: Sapna Mehta, MD role: PRINCIPAL_INVESTIGATOR lat: 40.71427 lon: -74.00597 facility: Icahn School of Medicine at Mt. Sinai city: New York state: New York zip: 10029 country: United States name: Sander Florman, MD role: CONTACT email: [email protected] name: Sander Florman, MD role: PRINCIPAL_INVESTIGATOR lat: 40.71427 lon: -74.00597 facility: Columbia University city: New York state: New York zip: 10032 country: United States name: Marcus Pereira, MD role: CONTACT name: Marcus Pereira, MD role: PRINCIPAL_INVESTIGATOR lat: 40.71427 lon: -74.00597 facility: Weill Cornell Medical Center city: New York state: New York zip: 10065 country: United States name: Catherine Small, MD role: CONTACT email: [email protected] name: Catherine Small, MD role: PRINCIPAL_INVESTIGATOR lat: 40.71427 lon: -74.00597 facility: University of Pittsburgh Medical Center city: Pittsburgh state: Pennsylvania zip: 15213 country: United States name: Ghady Haidar, MD role: CONTACT email: [email protected] name: Ghady Haidar, MD role: PRINCIPAL_INVESTIGATOR lat: 40.44062 lon: -79.99589 hasResults: False
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<|newrecord|> nctId: NCT06263413 id: 24.12.2266-GHM briefTitle: Clinical Workflow Optimization Using Artificial Intelligence for Dermatological Conditions acronym: IDEI_2023 overallStatus: RECRUITING date: 2024-01-15 date: 2024-06-30 date: 2024-09-30 date: 2024-02-16 date: 2024-03-19 name: AI Labs Group S.L class: INDUSTRY name: Instituto de Dermatología Integral (IDEI) briefSummary: Artificial intelligence (AI) based on imaging holds tremendous potential to enhance visual diagnostic accuracy in the medical field. Amid the COVID-19 pandemic, limited access to in-person healthcare services drove shifts in medical care, hastening the adoption of telemedicine. In this context, AI usage for triage and decision support may be crucial for professionals to manage workload and improve performance. In dermatology, pigmented lesions, acne, and alopecia are three recurring pathology groups with high demand in dermatological centers. Both triage, clinical evaluation, and patient follow-up require in-person resources and specialist dedication. Employing tools like AI can benefit these professionals in reducing such processes and optimizing workload.
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Advancements in image recognition and interpretation, as well as in artificial intelligence, have spurred innovations in diagnosing various pathologies, including skin conditions. Computer-Aided Diagnosis (CAD) systems and other algorithm-based technologies have demonstrated the ability to classify lesion images with a competency comparable to that of an expert physician.
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