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Do vitamin C and N-acetylcysteine improve the shoulder functional score of participants? Do vitamin C and N-acetylcysteine improve healing of rotator tendon? Researchers will compare vitamin C and N-acetylcysteine to a placebo (a look-alike substance that contains no drug) to see if vitamin C and N-acetylcysteine works to improve shoulder functional score after rotator cuff repair. |
Participants will: |
Take vitamin C and N-acetylcysteine or a placebo every day for 45 days. Visit the OPD three times at 2 week, 6 month and 12 month after surgery for checkups and tests. conditions: Rotator Cuff Tears studyType: INTERVENTIONAL phases: PHASE4 allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: TRIPLE whoMasked: PARTICIPANT whoMasked: CARE_PROVIDER whoMasked: OUTCOMES_ASSESSOR count: 110 type: ESTIMATED name: Ascorbic acid name: N-acetyl cysteine name: placebo measure: ASES score measure: UCLA shoulder scale measure: WORC index measure: Tendon healing at 6 months postoperatively sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT hasResults: False |
<|newrecord|> nctId: NCT06384820 id: R3767-ONC-2330 id: 2023-510514-38-00 type: REGISTRY domain: EU CT Number briefTitle: Study of Cemiplimab Alone or in Combination With Fianlimab and/or Other Experimental Agents in Adult Participants With Peri-operative Stage III/IV Cutaneous Squamous Cell Carcinoma (CSCC) overallStatus: NOT_YET_RECRUITING date: 2024-11-14 date: 2026-06-08 date: 2030-05-06 date: 2024-04-25 date: 2024-04-25 name: Regeneron Pharmaceuticals class: INDUSTRY briefSummary: This study is researching an investigational drug called REGN2810, also known as cemiplimab, when combined with another investigational drug called REGN3767, also known as fianlimab (each individually called a "study drug" or called "study drugs" when combined). The study is focused on a type of skin cancer known as cutaneous squamous cell carcinoma (CSCC). |
The aim of the study is to see if cemiplimab or cemiplimab in combination with fianlimab can eliminate or reduce the number of living cancer cells in tumor(s) if taken before surgery. |
The study is looking at several other research questions, including: |
* Whether taking cemiplimab or cemiplimab in combination with fianlimab before surgery may make it possible to have a less extensive surgery or a different treatment plan after surgery |
* Whether taking cemiplimab or cemiplimab in combination with fianlimab before surgery may make the cancer less likely to come back after surgery |
* What side effects may happen from taking the cemiplimab or cemiplimab in combination with fianlimab |
* How much of the cemiplimab or cemiplimab in combination with fianlimab is in the blood at different times |
* Whether the body makes antibodies against the study drug(s) (which could make the drug(s) less effective or could lead to side effects) conditions: Cutaneous Squamous Cell Carcinoma studyType: INTERVENTIONAL phases: PHASE2 allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: NONE count: 140 type: ESTIMATED name: cemiplimab name: fianlimab measure: Pathological complete response (pCR) rate by blinded independent pathological review (BIPR) measure: pCR rate by local pathological review measure: Major pathological response (MPR) measure: Event-free survival (EFS) measure: Disease free survival (DFS) measure: Objective response rate (ORR) prior to surgery measure: Overall survival (OS) measure: Occurrence of treatment-emergent adverse events (TEAEs) measure: Occurrence of immune-mediated adverse events (imAEs) measure: Occurrence of treatment-related TEAEs measure: Occurrence of adverse event of special interest (AESI) measure: Occurrence of treatment-emergent serious adverse events (SAEs) measure: Occurrence of laboratory abnormalities measure: Occurrence of death due to TEAE measure: Occurrence of interruption of study drug(s) due to TEAEs measure: Occurrence of discontinuation of study drug(s) due to TEAEs measure: Occurrence of cancellation of surgery due to TEAE measure: Occurrence of delay to surgery due to TEAE measure: Concentrations of cemiplimab in serum measure: Concentrations of fianlimab in serum measure: Concentrations of other experimental agents (as applicable) in serum measure: Incidence of anti-drug antibodies (ADA) to cemiplimab measure: Incidence of ADA to fianlimab measure: Incidence of ADA to other experimental agents (as applicable) measure: Titer of ADA to cemiplimab measure: Titer of ADA to fianlimab measure: Titer of ADA to other experimental agents (as applicable) sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT hasResults: False |
<|newrecord|> nctId: NCT06384807 id: BHV1510-101 (PBI-410-101) briefTitle: A Phase 1/2 Study of PBI-410 in Advanced Solid Tumors overallStatus: NOT_YET_RECRUITING date: 2024-04 date: 2028-02 date: 2028-02 date: 2024-04-25 date: 2024-04-25 name: Pyramid Biosciences class: INDUSTRY briefSummary: This is a Phase 1/2, first in human (FIH), open-label, multicenter study of PBI-410 in participants with previously treated, advanced solid tumors. conditions: Solid Tumor studyType: INTERVENTIONAL phases: PHASE1 phases: PHASE2 allocation: NA interventionModel: SEQUENTIAL interventionModelDescription: Dose escalation followed by enrollment in signal-finding cohorts. primaryPurpose: TREATMENT masking: NONE count: 170 type: ESTIMATED name: PBI-410 measure: Phase 1: Number of patients with adverse events (AEs) measure: Phase 1: Recommended dose for expansion (RDE) and maximum tolerated dose (MTD) measure: Phase 2: Objective Response Rate (ORR) measure: Phase 2: Number of patients with AEs measure: Phase 2: Duration of Response (DoR) measure: Phase 1 and 2: Maximum Plasma Concentration (Cmax) of PBI-410 measure: Phase 1 and 2: Area Under the Concentration versus time Curve (AUClast) from the end of infusion to the last measurable concentration of PBI-410 measure: Phase 1 and 2: Area Under the Concentration versus time curve extrapolated to infinity (AUCinf) measure: Phase 1 and 2: Elimination half-life (t1/2) of PBI-410 in plasma measure: Phase 1: ORR measure: Phase 1: Duration of Response (DoR) measure: Phase 1 and 2: Immunogenicity of PBI-410 measure: Phase 2: Disease control rate (DCR) measure: Phase 2: Progression free survival (PFS) measure: Phase 2: Overall survival (OS) sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT hasResults: False |
<|newrecord|> nctId: NCT06384794 id: 2211-VLC-157-MD briefTitle: Study of the ZyMōt Sperm Selection Method and Its Effect on Embryo Ploidy. acronym: ZYMOT2 overallStatus: RECRUITING date: 2023-06-29 date: 2025-07-01 date: 2026-12-31 date: 2024-04-25 date: 2024-04-29 name: Instituto Valenciano de Infertilidad, IVI VALENCIA class: OTHER name: IVI Madrid briefSummary: It has been described that 11% of men with semen values within the normal range established by the World Health Organization (WHO) have sperm DNA fragmentation. This has been associated with a lower fertilization rate, lower embryo development and, therefore, lower reproductive success. Focusing on the study of the integrity of the male genome can provide us information to diagnose infertility in the couple. The use of conventional sperm selection methods such as swim-up or density gradients has been a great advance in the improvement of male fertility. However, these methods use centrifugation in their protocol, a procedure that has been associated with sperm DNA damage. The ZyMōt is a chip based on microfluidic properties that allows the recovery of spermatozoa with lower DNA fragmentation rate without centrifugation of the semen sample. This new sperm selection method maintains all the advantages of conventional techniques, but decreasing DNA fragmentation associates to sperm recoveries techniques eventually improving reproductive rates. This quality would be beneficial for patients with unexplained infertility, recurrent pregnancy loss or clinical varicocele, factors that have been associated with a higher index of DNA fragmentation. However up to date there is evidence-based data supporting such improvement. The main objective of the present project is to evaluate the ZyMōt as a new non-invasive sperm selection device and to see its impact on the euploidy rate, comparing it with a sperm selection technique that is routinely used in the clinic: swim-up. At the same time, the effect that this new chip may have on sperm and other reproductive variables will be analyzed clinically, and molecularly with immunohistochemical and transcriptomic analyses in order to observe the impact of SDF(sperm DNA fragmentation) at the molecular and genomic level in oocytes with low reparative potential oocytes. conditions: Infertility, Male conditions: Sperm Count, Low studyType: INTERVENTIONAL phases: NA allocation: NON_RANDOMIZED interventionModel: PARALLEL interventionModelDescription: Multicentric, prospective, experimental study. primaryPurpose: DIAGNOSTIC masking: SINGLE maskingDescription: Embryologists performing IVF/ICSI are blinded to the treatment the sample has undergone. All samples are labeled with the patients Identification number. This is a unique code per patient that does not allow identification of which arm the sample belongs to. whoMasked: OUTCOMES_ASSESSOR count: 80 type: ESTIMATED name: Sperm capacitation through the ZyMōt®Sperm Separation Device® name: Swim-up measure: EUPLOIDY RATE measure: MOBILITY RATE measure: VITALITY RATE measure: DNA FRAGMENTATION RATE measure: SPERM RETRIEVAL RATE measure: FERTILIZATION RATE measure: USEFUL BLASTOCYS RATE sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Ivirma Madrid status: RECRUITING city: Madrid zip: 28023 country: Spain name: MONICA TORIBIO role: CONTACT phone: +34 651 79 10 00 email: [email protected] name: Alberto Pacheco, PhD role: SUB_INVESTIGATOR name: Lucía Sánchez, MSc role: SUB_INVESTIGATOR lat: 40.4165 lon: -3.70256 facility: Ivirma Valencia status: RECRUITING city: Valencia zip: 46015 country: Spain name: Maria Jose Delossantos, PhD role: CONTACT phone: 34963050900 email: [email protected] name: Laura Caracena, Mrs role: CONTACT phone: 34963050900 phoneExt: 11054 email: [email protected] name: Maria Jose Delossantos, PhD role: PRINCIPAL_INVESTIGATOR name: José María Delosantos, PhD role: SUB_INVESTIGATOR name: Angel Martín, MSc role: PRINCIPAL_INVESTIGATOR name: David Ortega, MSs role: PRINCIPAL_INVESTIGATOR lat: 39.46975 lon: -0.37739 hasResults: False |
<|newrecord|> nctId: NCT06384781 id: 2130836 id: R61DA059892-01 type: NIH link: https://reporter.nih.gov/quickSearch/R61DA059892-01 briefTitle: Development, Refinement, and Validation of a Peer Support Specialist Checklist for Individuals With Opioid Use Disorder / STAMPS: South Carolina Buprenorphine Treatment Initiation, Adherence, and Retention Utilizing Mobile Health Units and Peer Support Specialists overallStatus: RECRUITING date: 2024-04 date: 2025-01 date: 2025-01 date: 2024-04-25 date: 2024-04-25 name: Prisma Health-Upstate class: OTHER name: Clemson University name: National Institute on Drug Abuse (NIDA) briefSummary: This study seeks to develop a tool to better guide and operationalize peer recovery coaching service delivery specifically for patients with opioid use disorder. This study will entail the initial development, acceptability, and validity of this tool in a sample of both peer support specialists (PSSs) and patients with opioid use disorder (OUD). This checklist will be adapted from ACE model PSS interventions for SUD broadly. Open-ended qualitative research questions regarding PSSs roles and responsibilities, patients' needs for recovery support, and perceptions of the checklist will be administered. Participants (PSSs and individuals with OUD) will also answer survey questions in which they indicate their satisfaction and likely to use the tool with the proposed services offered in the checklist. Outcome measures include satisfaction, perceived use of use, and perceived helpfulness of the checklist. We hypothesize that using both PSS and patient input will result in a validated intervention protocol with demonstrated acceptability using it with patients with OUD. conditions: Opioid Use Disorder studyType: OBSERVATIONAL observationalModel: CASE_CONTROL timePerspective: PROSPECTIVE count: 90 type: ESTIMATED measure: Phase 1: Conceptualization measure: Phase 2: Conceptulization measure: Phase 3: Refinement measure: Phase 4: Validation measure: Phase 5: Preliminary efficacy sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Prisma Addiction Medicine Center - Mobile Health Clinic status: RECRUITING city: Clinton state: South Carolina zip: 29325 country: United States name: Marisol A Miranda, BS role: CONTACT phone: 864-501-9693 email: [email protected] name: Kaileigh A Byrne, PhD role: PRINCIPAL_INVESTIGATOR lat: 34.47263 lon: -81.88066 facility: Prisma - Addiction Medicine Center Mobile Health Clinic status: RECRUITING city: Seneca state: South Carolina zip: 29672 country: United States name: Marisol A Miranda, BS role: CONTACT phone: 864-501-9693 email: [email protected] name: Kaileigh A Byrne, PhD role: PRINCIPAL_INVESTIGATOR lat: 34.68566 lon: -82.9532 hasResults: False |
<|newrecord|> nctId: NCT06384768 id: EBIst id: 1919B012104428 type: OTHER_GRANT domain: TUBITAK briefTitle: Video Training on Pre-Pregnancy Fear of Birth in Male Partners overallStatus: COMPLETED date: 2022-02-01 date: 2022-05-01 date: 2022-08-30 date: 2024-04-25 date: 2024-04-26 name: Istanbul University - Cerrahpasa (IUC) class: OTHER briefSummary: This study aimed to evaluate the effect of an online video training on fears surrounding childbirth given to male partners before the pregnancy of their spouses. The study conducted with 43 male (22 intervention; 21 control) participants. Participants were divided into intervention and control groups. The intervention group was given video training on pregnancy and the birth process. \"Descriptive Information Form\" and the "Male-Childbirth Fear Prior to Pregnancy Scale" was used for data collection. Before the intervention, it was found that the fear level of childbirth was low. The video training given to male partners before the pregnancy of their spouses diminished the fear of birth but did not create a significant difference. These findings support long-term training that includes video tutorials for parents before birth. Interactive, participatory birth preparation training is likely to enhance the training's appeal for male partners. conditions: Fear of Childbirth studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: SUPPORTIVE_CARE masking: NONE count: 43 type: ACTUAL name: Video training measure: Fear of Childbirth sex: MALE stdAges: CHILD stdAges: ADULT stdAges: OLDER_ADULT facility: Istinye University city: Istanbul country: Turkey lat: 41.01384 lon: 28.94966 hasResults: False |
<|newrecord|> nctId: NCT06384755 id: 645788 id: 2022_HE2_409659 type: OTHER_GRANT domain: The Dam Foundation id: 645788 type: OTHER domain: Regional Ethics Committee (REK), South-East Norway briefTitle: Honest Open Proud for Psychotic and Bipolar Disorder in Norway acronym: HOP-NOR overallStatus: RECRUITING date: 2024-04-20 date: 2024-12-31 date: 2026-12-31 date: 2024-04-25 date: 2024-04-25 name: Oslo University Hospital class: OTHER name: University of Oslo briefSummary: The purpose of this pilot study is to evaluate the feasibility, acceptability and efficacy of a Norwegian adaptation of the group-based intervention 'Honest Open Proud' among adults with psychotic and bipolar disorders in an outpatient setting. conditions: Psychotic Disorders conditions: Bipolar Disorder conditions: Disclosure studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: NONE count: 40 type: ESTIMATED name: Honest Open Proud program measure: Stigma Stress Scale (Rüsch, Corrigan, Wassel et al., 2009; Rüsch, Corrigan, Powell et al., 2009) measure: Disclosure Distress (Rüsch et al., 2014a) measure: Warwick and Edinburgh Wellbeing Scale (WEMWBS) (Tennant et al 2007) measure: Satisfaction with life (Lehman, 1988) measure: The Questionnaire about the Process of Recovery - 15 (QPR-15) (Niel et al 2007) measure: Internalised Stigma of Mental Illness Inventory (ISMI-10) (Boyd, Otilingam, & Deforge, 2014) measure: Patient Health Questionnaire-4 (PHQ-9) (Kroenke et al 2009) measure: Generalized Anxiety disorder (GAD-7) (Spitzer et al, 2006) measure: Disclosure measure: Feasibility of HOP program measure: Acceptability of HOP program participants measure: Acceptability of HOP peer facilitators sex: ALL minimumAge: 18 Years maximumAge: 65 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Nydalen DPS, Division of Mental Health and Addiction, Oslo University Hospital status: RECRUITING city: Oslo zip: 0351 country: Norway name: Mari Husa, MD role: CONTACT phone: 0047 95837846 email: [email protected] name: Magnus Engen, PhD role: CONTACT phone: 0047 41004660 email: [email protected] lat: 59.91273 lon: 10.74609 facility: Søndre Oslo DPS, Division of Mental Health and Addiction, Oslo University Hospital status: NOT_YET_RECRUITING city: Oslo zip: 1281 country: Norway name: Hilde Daler, MSc role: CONTACT phone: 0047 23023100 email: [email protected] name: Marit Haram, PhD role: CONTACT phone: 0047 21077000 email: [email protected] lat: 59.91273 lon: 10.74609 hasResults: False |
<|newrecord|> nctId: NCT06384742 id: K23HL157698 type: NIH link: https://reporter.nih.gov/quickSearch/K23HL157698 briefTitle: Shift Worker Intervention for Sleep Health acronym: SWISH overallStatus: NOT_YET_RECRUITING date: 2024-09 date: 2026-09 date: 2027-03 date: 2024-04-25 date: 2024-04-25 name: Oregon State University class: OTHER name: National Heart, Lung, and Blood Institute (NHLBI) briefSummary: The aim of this study is to pilot test a comprehensive, personalized, media-augmented telehealth intervention ("SWISH") designed to improve sleep health among shift workers. conditions: Shift Work Type Circadian Rhythm Sleep Disorder conditions: Insomnia, Psychophysiological studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: DOUBLE maskingDescription: Participants are asked to refrain from mentioning any information about the treatment they receive when interacting with the investigator or outcomes assessors. Participants are asked not to share details of their treatment with other individuals at their workplace. whoMasked: INVESTIGATOR whoMasked: OUTCOMES_ASSESSOR count: 60 type: ESTIMATED name: Shift Worker Intervention for Sleep Health measure: Retention Rate measure: Session Attendance measure: Implementation Assessment Measure measure: Patient Adherence measure: Therapist Fidelity measure: Acceptability of Study Procedures and SWISH measure: Mean 24-hour sleep duration and efficiency measure: Change in Fatigue Severity Scale measure: Change in Epworth Sleepiness Scale measure: Executive functioning measure: PROMIS Sleep Related Impairment measure: PROMIS Sleep Disturbances sex: ALL minimumAge: 18 Years maximumAge: 65 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Oregon State University city: Corvallis state: Oregon zip: 97331-1102 country: United States name: Jessee Dietch, PhD role: CONTACT phone: 541-737-1358 email: [email protected] name: Jessee Dietch, PhD role: PRINCIPAL_INVESTIGATOR lat: 44.56457 lon: -123.26204 hasResults: False |
<|newrecord|> nctId: NCT06384729 id: 123 briefTitle: Effectiveness of the EXOPULSE Mollii Ⓡ Suit in Patients With Multiple Sclerosis overallStatus: RECRUITING date: 2024-04-01 date: 2024-05-01 date: 2024-09-01 date: 2024-04-25 date: 2024-04-25 name: Universidad Europea de Madrid class: OTHER briefSummary: Abstract: |
Background: |
Multiple sclerosis (MS) is a chronic inflammatory demyelinating disease of the central nervous system with unknown etiology, causing a variety of symptoms including impaired balance, coordination, and walking difficulties. The Exopulse Mollii Ⓡ suit is an innovative approach for non-invasive, self-administered electrical stimulation designed to alleviate spasticity and improve motor function in various neurological conditions. |
Objective: |
To determine the effectiveness of the Exopulse Mollii Ⓡ suit in improving motor control in patients with MS. |
Methods: |
A randomized, double-blind clinical trial will be conducted, recruiting patients diagnosed with MS , aged 18 or above, with a Functional Ambulation Category (FAC) score between 2 and 4. Patients will be randomly assigned to two groups receiving either inactive or active Exopulse Mollii Ⓡ treatment for 60 minutes, three times a week, for three weeks. Outcome measures include pain, balance, gait speed, risk of falls, perception of walking difficulties, and quality of life assessed using validated scales. Statistical analysis will be performed using SPSS v.29.0.0.0. |
Results: |
Data on age, sex, weight, and MS-related factors will be collected at baseline. Primary outcomes include changes in pain, balance, and gait speed, while secondary outcomes encompass risk of falls, perception of walking difficulties, and quality of life. Analysis will compare mean differences between groups using appropriate statistical tests. |
Conclusion: |
This study aims to evaluate the efficacy of the Exopulse Mollii Ⓡ suit in enhancing motor function in MS patients. Findings may contribute to the development of novel therapeutic strategies for managing MS-related symptoms and improving patients' quality of life. conditions: Multiple Sclerosis studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: CROSSOVER primaryPurpose: TREATMENT masking: TRIPLE maskingDescription: A randomized, double-blind clinical trial is proposed, in which two researchers will conduct the intervention, and a third researcher will be responsible for programming the suits and attaching the belt to the suit. The data will be analyzed by a fourth researcher. whoMasked: PARTICIPANT whoMasked: CARE_PROVIDER whoMasked: INVESTIGATOR count: 22 type: ESTIMATED name: EXOPULSE Mollii Ⓡ measure: referred pain measure: Balance measure: gait speed and distance measure: fall risk measure: perception of walking difficulties measure: perceived quality of life sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Cecilia Estrada Barranco status: RECRUITING city: Villaviciosa De Odón state: Madrid zip: 28670 country: Spain name: Cecilia Estrada Barranco, PhD role: CONTACT phone: 686166483 email: [email protected] lat: 40.35692 lon: -3.90011 hasResults: False |
<|newrecord|> nctId: NCT06384716 id: CEB briefTitle: Evaluation of the Influence of a Core Muscle Control-Based Rehabilitation Program Patients With Multiple Sclerosis overallStatus: RECRUITING date: 2024-02-19 date: 2024-07-01 date: 2024-09-01 date: 2024-04-25 date: 2024-04-25 name: Universidad Europea de Madrid class: OTHER briefSummary: Given the structural relationship of the CORE as a whole, in this study we propose an intervention based on the global motor control of all the structures that make up the CORE to assess its effectiveness on urinary incontinence, sexual dysfunction and balance, as well as its relationship with respiratory function. According to our hypothesis, a global intervention could also be taken into account during conventional treatment in the future, helping to prevent genitourinary dysfunctions derived from alterations in motor control. conditions: Multiple Sclerosis conditions: Pelvic Floor Disorders conditions: Incontinence, Urinary studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL interventionModelDescription: This is a randomised clinical trial. The research will be conducted in accordance with the framework of application of the Helsinki declaration (21) and the law on Personal Data Protection and guarantee of digital rights (Organic Law 3/2018) . The design of this project will follow the definition of the standard elements of a clinical trial protocol: SPIRIT declaration primaryPurpose: TREATMENT masking: SINGLE whoMasked: INVESTIGATOR count: 32 type: ESTIMATED name: rehabilitation programme based on motor control of core muscles measure: Difference in the percentage of initial and final maximum activity of the pelvic floor muscles. measure: - Differences between the initial and final thickness of the oblique abdominis and transverse oblique muscles by ultrasound. measure: - Differences in the assessment of health-related quality of life before and after the intervention measured with the I-QOL questionnaire. measure: - Differences in the assessment of female UI before and after intervention using the I-CIQ questionnaire measure: - Difference in the percentage of initial and final maximum activity of the paravertebral musculature activity. measure: - Differences between initial and final amplitude of initial and final diaphragmatic excursion by ultrasound. measure: - Difference between initial and final FVC/- Differences between the initial and final peak expired volume (FEV1) measure: differences between peak expiratory pressure (PEM) and minimum initial and end inspiratory pressure (MIP). measure: balance sex: ALL minimumAge: 18 Years maximumAge: 70 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Cecilia Estrada Barranco status: RECRUITING city: Madrid country: Spain name: Cecilia Estrada-Barranco, PhD role: CONTACT phone: 686166483 email: [email protected] name: Esther Delgado, PhD role: CONTACT email: [email protected] lat: 40.4165 lon: -3.70256 hasResults: False |
<|newrecord|> nctId: NCT06384703 id: 201518015 briefTitle: The Relationship Between Microbiota and Coronary Ectasia overallStatus: COMPLETED date: 2020-11-03 date: 2021-04-25 date: 2021-06-18 date: 2024-04-25 date: 2024-04-25 name: Konya Beyhekim Training and Research Hospital class: OTHER_GOV name: Necmettin Erbakan University briefSummary: Introduction: It is now known that the microbiota is far beyond the microbial communities living in certain parts of our body and functions like a metabolic organ. In addition, the microbiota, through its metabolites, is involved in the pathophysiology or progression of a wide range of diseases, from atherosclerotic diseases to metabolic diseases and even neurological diseases. Among these metabolites, trimethylamine n-oxide metabolite has been shown to be particularly effective on atherosclerotic heart diseases. conditions: Coronary Ectasia conditions: Microbial Disease studyType: OBSERVATIONAL observationalModel: CASE_CONTROL timePerspective: PROSPECTIVE count: 2 type: ACTUAL name: Taking blood for kit study measure: death sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Necmettin Erbakan University city: Konya zip: 42050 country: Turkey lat: 37.87135 lon: 32.48464 hasResults: False |
<|newrecord|> nctId: NCT06384690 id: 4331899 briefTitle: Generating Health Evidence From Dietary Supplementation With a Micro-vegetable Blend overallStatus: RECRUITING date: 2024-02-01 date: 2024-11-30 date: 2025-08-31 date: 2024-04-25 date: 2024-04-25 name: University of Exeter class: OTHER name: Advanced Growers Limited name: Ecog Pro Limited briefSummary: Micro-vegetables (MV) are seedlings of larger vegetables. They can be grown quickly and are a concentrated source of micronutrients. MV are thought to have broad health benefits, including many inflammatory conditions. These include metabolic, cardiovascular, and cognitive diseases. This could have important implications for the health of an ageing UK population. Less than a third of British adults consume 5 portions of fruit and vegetables per day; this is the level that reduces risk of morbidity and mortality. Vegetables, including MV may - at least in part - exert their health effects by changing the level and type of bacteria in the mouth and gut. Despite their promise, the MV scientific literature is not yet extensive enough to support definitive health claims. It requires the addition of high-quality studies that are relevant to humans. This study will firstly investigate the anti-inflammatory effects on skeletal muscle and adipose tissue in older adults, using a proteomics approach. Second, this study will assess concentrations of circulating inflammatory markers in the sera collected from participants at baseline and at the conclusion of a 6-week period. Further, this study will describe the effects of six weeks MV consumption on cognition, and the oral and gut microbiome. As the bioactive compounds in the MV are owed to the potential beneficial effects for human health, these will be characterised in sera collected from participants. conditions: Inflammation studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: BASIC_SCIENCE masking: DOUBLE whoMasked: PARTICIPANT whoMasked: INVESTIGATOR count: 30 type: ESTIMATED name: Micro-vegetable blend name: Placebo measure: Tandem Mass Tag (TMT) global proteomics measure: Concentration of broad panel of inflammatory cytokines measure: Concentration of circulating bioactive components measure: Microbiome measure: Simple Reaction Time measure: Digit Vigilance measure: Choice Reaction Time measure: Pattern Separation sex: ALL minimumAge: 60 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Public Health and Sports Sciences, University of Exeter status: RECRUITING city: Exeter state: Devon zip: EX1 2LU country: United Kingdom name: Cealan Henry role: CONTACT email: [email protected] lat: 50.7236 lon: -3.52751 hasResults: False |
<|newrecord|> nctId: NCT06384677 id: 03.03.2023/371 briefTitle: Comparison of Postoperative Analgesia Methods in Patients Undergoing Major Intraabdominal Surgery overallStatus: COMPLETED date: 2023-04-20 date: 2024-02-01 date: 2024-02-01 date: 2024-04-25 date: 2024-04-25 name: Marmara University class: OTHER briefSummary: This study aims to examine the effects of M-TAPA applied for postoperative analgesia in patients who had major intraabdominal surgery on the postoperative pain score, the change in the postoperative total opioid requirement and the side effects. conditions: Abdominal Cancer conditions: Abdomen Disease studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: DIAGNOSTIC masking: NONE count: 43 type: ACTUAL name: M-Tapa Block measure: Opioid Consumption measure: NRS Scores measure: the need for rescue analgesia measure: side effects sex: ALL minimumAge: 18 Years maximumAge: 65 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Marmara University Pendik Research and Training Hospital city: Istanbul country: Turkey lat: 41.01384 lon: 28.94966 hasResults: False |
<|newrecord|> nctId: NCT06384664 id: HUM00241242 briefTitle: Cryoablation Effects on Acute and Chronic Pain After Thoracotomy and Thoracoscopy overallStatus: NOT_YET_RECRUITING date: 2024-04 date: 2027-04 date: 2028-04 date: 2024-04-25 date: 2024-04-25 name: University of Michigan class: OTHER name: AtriCure, Inc. briefSummary: The researchers will compare the common methods of post-surgical pain control, such as epidural or intercostal nerve block with a newer method called cryoablation. The research team is conducting this study to determine if cryoablation provides more effective pain control when compared to an epidural or intercostal nerve block. conditions: Pain, Postoperative conditions: Intrathoracic Procedure studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: SUPPORTIVE_CARE masking: NONE count: 80 type: ESTIMATED name: Atricure's crysoSPHERE probe name: Standard of Care measure: Severity of pain in the peri-operative period measure: Inflammatory cytokine levels as measured by blood samples measure: Inflammatory cytokines (IL-1, IL-6, TNF-a) levels correlations to pain score measure: Peri-operative pain scores between different surgical incisions (posterolateral thoracotomy vs thoracoscopy) measure: Peri-operative nerve function between different surgical incisions (posterolateral thoracotomy vs thoracoscopy) measure: Quality of life score as measured by SF-36 Health questionnaire measure: Cost (including postoperative epidural management, narcotic pain medication, and outpatient pain management) measure: Workflow/time measure: Complications following surgery measure: Length of stay measure: Time to ambulation measure: Chronic Pain medication use through 6 months measure: Chronic pain through 6 months. measure: Chronic pain through 6 months. measure: Chronic pain through 6 months. measure: Incentive spirometry volumes in the peri-operative period (POD 1 and 2) measure: Oxygen requirement measure: Hospital charges and hospital reimbursement by different payors sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: University of Michigan city: Ann Arbor state: Michigan zip: 48109 country: United States name: Shari L Barnett role: CONTACT phone: 734-936-4561 email: [email protected] name: Rishindra Reddy, MD, MBA role: PRINCIPAL_INVESTIGATOR lat: 42.27756 lon: -83.74088 hasResults: False |
<|newrecord|> nctId: NCT06384651 id: PRO00037789 briefTitle: Intraosseous vs. Intravenous Vancomycin Administration in Total Ankle Arthroplasty acronym: IOTAA overallStatus: RECRUITING date: 2023-12-13 date: 2027-04 date: 2027-12 date: 2024-04-25 date: 2024-04-25 name: The Methodist Hospital Research Institute class: OTHER briefSummary: The purpose of this study is to compare two different antibiotic regimens and techniques during total ankle arthroplasty (TAA). |
Primary Objective: Comparable levels of vancomycin will be found in bone, soft tissue, and systemic samples between patient groups. |
Secondary Objective: Compare 30 day and 90 day post-operative complication rates (infection) between the control (standard IV administration of vancomycin) vs the interventional group (intraosseous administration of vancomycin). The investigators hypothesize that there will be no difference in complication (infection) rates between groups. conditions: Infections conditions: Ankle Arthritis studyType: INTERVENTIONAL phases: PHASE4 allocation: RANDOMIZED interventionModel: PARALLEL interventionModelDescription: This study is a prospective, randomized, single-blinded, controlled trial. 20 patients in each treatment arm: 20 patients will be given IV vancomycin, 20 patients will be given IO vancomycin primaryPurpose: TREATMENT masking: DOUBLE maskingDescription: single blind patient is blinded. Surgeon is not blinded. Lab technician measuring tissue concentrations are blinded. Research coordinator is not blinded. whoMasked: PARTICIPANT whoMasked: OUTCOMES_ASSESSOR count: 40 type: ESTIMATED name: Intraosseous Vancomycin Injection name: Intravenous Vancomycin measure: Systemic Sample Vancomycin Tissue Concentration - Start of Case measure: Systemic Sample Vancomycin Tissue Concentration - End of Case measure: Capsule or Synovium Sample Vancomycin Tissue Concentration measure: Distal Tibia Sample Vancomycin Tissue Concentration measure: Talar Bone Sample Vancomycin Tissue Concentration measure: 90 day post-operative wound complication and infection rates sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Houston Methodist Hospital status: RECRUITING city: Houston state: Texas zip: 77030 country: United States name: Thomas C Sullivan, BS role: CONTACT phone: 346-238-1603 email: [email protected] name: Jason S Ahuero, MD role: PRINCIPAL_INVESTIGATOR name: Kevin Varner, MD role: SUB_INVESTIGATOR name: Kwan J Park, MD role: SUB_INVESTIGATOR lat: 29.76328 lon: -95.36327 hasResults: False |
<|newrecord|> nctId: NCT06384638 id: coconut periodontitis briefTitle: Coconut Oil in Treatment of Periodontitis overallStatus: COMPLETED date: 2022-02-15 date: 2024-01-16 date: 2024-02-09 date: 2024-04-25 date: 2024-04-25 name: Misr University for Science and Technology class: OTHER briefSummary: Virgin Coconut Oil (VCO) is a vegetable oil extracted from coconut fleshcontains unsaturated fatty acids in the form of oleic acid and linoleic acid and flavonoids which function as anti-inflammatory. Periodontitis is an inflammatory disease of the periodontal tissues with a high prevalence worldwide. The main etiology of plaque periodontitis is biofilm containing colonies of pathogenic microorganisms. The aim of the study is to evaluate and compare the effect of scaling and root debridement alone versus the use of topically applied coconut oil as adjunctive to scaling and root debridement in treatment of Stage II and III Grade B periodontitis. conditions: Periodontal Diseases studyType: INTERVENTIONAL phases: PHASE1 allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: DOUBLE whoMasked: CARE_PROVIDER whoMasked: OUTCOMES_ASSESSOR count: 34 type: ACTUAL name: topical application of coconut oil name: scaling and debridement measure: clinical parameters measure: clinical parameters measure: Biological parameters sex: ALL minimumAge: 35 Years maximumAge: 60 Years stdAges: ADULT facility: Faculty of dentistry at MUST city: Giza zip: 02 country: Egypt lat: 30.00808 lon: 31.21093 hasResults: False |
<|newrecord|> nctId: NCT06384625 id: 361378 briefTitle: Air Pollution Intervention for Cardiovascular Patients overallStatus: NOT_YET_RECRUITING date: 2024-06-01 date: 2025-02-01 date: 2025-02-01 date: 2024-04-25 date: 2024-04-25 name: University of Montana class: OTHER name: Providence Heart Institute briefSummary: This pilot study (n=20) is a prospective evaluation of the implementation of an indoor air pollution intervention among patients who have undergone recent percutaneous coronary intervention procedures. The intervention, called Air Improvement and Real-time Monitoring for Wellness through Interactive Strategies and Education (AIRWISE), is focused on improving indoor air quality through air filtration, education, and behavioral recommendations. All participants will receive the AIRWISE intervention with the objective of evaluating acceptance and use of the individual intervention components. This implementation study will inform the submission of a larger NIH proposal for a randomized trial. The central study hypothesis is that an intervention program with educational strategies and visual behavioral cues will increase knowledge and awareness of air pollution exposures among the participants and lead to improved intervention compliance. conditions: Coronary Heart Disease conditions: Cardiovascular Diseases conditions: Environmental Exposure studyType: INTERVENTIONAL phases: NA allocation: NA interventionModel: SINGLE_GROUP primaryPurpose: OTHER masking: NONE count: 20 type: ESTIMATED name: AIRWISE measure: Evaluate the implementation of an indoor air pollution intervention. measure: Fine particulate matter (PM2.5) measure: Life's Essential 8 sex: ALL minimumAge: 20 Years stdAges: ADULT stdAges: OLDER_ADULT hasResults: False |
<|newrecord|> nctId: NCT06384612 id: Adnan Menderes U briefTitle: The Effect Of The Use Of Pocket Cards In An Undergraduate Nursıng overallStatus: COMPLETED date: 2021-09-13 date: 2022-05-22 date: 2023-07-13 date: 2024-04-25 date: 2024-04-25 name: Aydin Adnan Menderes University class: OTHER briefSummary: The aim of this study is to examine the effect of the use of pocket cards by students taking the "Care of a Child with Special Needs" course on students' self-efficacy perceptions and course success. |
1. H01. There is no difference between the self-efficacy perception scores of the students in the group who use pocket cards in the care of children with special needs course and the students in the group who do not use pocket cards. |
2. H02. There is no significant difference between the course success scores of the students in the group who use pocket cards in the care of children with special needs course and the students in the group who do not use pocket cards. conditions: Student conditions: Self Efficacy studyType: INTERVENTIONAL phases: NA allocation: NON_RANDOMIZED interventionModel: PARALLEL interventionModelDescription: experimental primaryPurpose: OTHER masking: NONE count: 128 type: ACTUAL name: use of pocket cards measure: Self-Efficacy Perception Scale sex: ALL minimumAge: 18 Years maximumAge: 22 Years stdAges: ADULT facility: Bircan Kahraman Berberoğlu city: Efeler state: Aydin zip: 0900 country: Turkey hasResults: False |
<|newrecord|> nctId: NCT06384599 id: CS-190 briefTitle: VT Cryoablation System Post-Market Clinical Follow-up (PMCF) Study overallStatus: NOT_YET_RECRUITING date: 2024-06-01 date: 2026-06-01 date: 2026-06-01 date: 2024-04-25 date: 2024-04-25 name: Adagio Medical class: INDUSTRY briefSummary: The PMCF is a prospective, single-arm, multi-center, controlled study of up to 130 patients designed to collect safety and performance data regarding the use of the Adagio VT Cryoablation System in the treatment of recurrent ventricular tachycardia. conditions: Ventricular Tachycardia studyType: INTERVENTIONAL phases: NA allocation: NA interventionModel: SINGLE_GROUP primaryPurpose: TREATMENT masking: NONE count: 130 type: ESTIMATED name: VT Cryoablation System measure: Primary Performance Endpoint measure: Primary Safety Endpoint measure: Secondary Performance Endpoint measure: Secondary Safety Endpoint sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Essex Cardiothoracic Centre city: Basildon state: Essex zip: SS16 5NL country: United Kingdom name: Neil Srinivasan role: CONTACT lat: 51.56844 lon: 0.45782 hasResults: False |
<|newrecord|> nctId: NCT06384586 id: CD J8855 briefTitle: Investigation of Dietary Supplement Liquid Shot Products on Mental Energy, Cognition (Acuity),and Mood overallStatus: COMPLETED date: 2022-11-17 date: 2022-12-22 date: 2022-12-22 date: 2024-04-25 date: 2024-04-25 name: The Water Street Collective class: INDUSTRY name: HCD Research name: British American Tobacco (Investments) Limited briefSummary: This is a single center, randomized, double blind, placebo-controlled, crossover study to determine the acute effect of a developmental dietary supplement liquid shot product on cognitive task performance and perceived effect measures related to mood and mental energy. The study will be conducted in healthy participants. conditions: Cognition conditions: Mental Fatigue conditions: Mood studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: CROSSOVER primaryPurpose: BASIC_SCIENCE masking: TRIPLE whoMasked: PARTICIPANT whoMasked: INVESTIGATOR whoMasked: OUTCOMES_ASSESSOR count: 45 type: ACTUAL name: Placebo shot name: Functional energy shot measure: Mental energy via Cognitive Demand Battery (CDB) Performance Index; for the functional energy shot versus placebo shot. measure: Mental energy via Cognitive Demand Battery (CDB) Accuracy score for the functional energy shot versus placebo shot. measure: Change in performance on Corsi blocks task for functional energy shot versus placebo measure: Change in performance on Rapid Visual Information Processing (RVIP) for functional energy shot versus placebo measure: Change in performance on Numeric working memory for functional energy shot versus placebo measure: Change in performance on Serial subtraction task for functional energy shot versus placebo measure: Change in Mood via Visual Analogue Scales (VAS) during Cognitive Demand Battery (CDB), for functional energy shot versus placebo measure: Change in physiological state via Profile Of Mood States (POMS) during Cognitive Demand Battery (CDB), for functional energy shot versus placebo sex: ALL minimumAge: 18 Years maximumAge: 30 Years stdAges: ADULT facility: Schlesinger Group New Jersey city: Iselin state: New Jersey zip: 08330 country: United States lat: 40.57538 lon: -74.32237 hasResults: False |
<|newrecord|> nctId: NCT06384573 id: DIAN-TU-003 id: The Alzheimer's Association type: OTHER_GRANT domain: DIAN-TU-OLE-21-725093 briefTitle: DIAN-TU Amyloid Removal Trial (ART) in Dominantly Inherited Alzheimer's Disease acronym: DIAN-TU overallStatus: NOT_YET_RECRUITING date: 2024-06 date: 2029-11 date: 2029-11 date: 2024-04-25 date: 2024-04-25 name: Washington University School of Medicine class: OTHER name: Alzheimer's Association name: Eisai Inc. briefSummary: This is an open label study to treat dominantly inherited Alzheimer's disease (DIAD) mutation carrier participants from the DIAN-TU-001 gantenerumab Open Label Extension (OLE) period with lecanemab to determine the effects of amyloid removal on age of onset and clinical progression compared to external controls, if amyloid plaque as measured by amyloid PET can be fully removed in DIAD, and the effects of amyloid removal on biomarkers of disease progression. conditions: Alzheimer's Disease conditions: Dementia conditions: Alzheimer's Disease, Familial studyType: INTERVENTIONAL phases: PHASE3 allocation: NA interventionModel: SINGLE_GROUP primaryPurpose: TREATMENT masking: NONE count: 65 type: ESTIMATED name: lecanemab measure: The primary endpoint for the final analysis is the time to recurrent progression of Clinical Dementia Rating - Sum of Boxes (CDR-SB). sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: University of Alabama in Birmingham city: Birmingham state: Alabama zip: 35294 country: United States name: Erik Roberson role: PRINCIPAL_INVESTIGATOR lat: 33.52066 lon: -86.80249 facility: University of California San Diego Medical Center city: La Jolla state: California zip: 92037 country: United States name: Doug Galasko role: PRINCIPAL_INVESTIGATOR lat: 32.84727 lon: -117.2742 facility: Indiana University School of Medicine city: Indianapolis state: Indiana zip: 46202 country: United States name: Jared Brosch role: PRINCIPAL_INVESTIGATOR lat: 39.76838 lon: -86.15804 facility: Washington University in St. Louis city: Saint Louis state: Missouri zip: 63110 country: United States name: Barbara Snider role: PRINCIPAL_INVESTIGATOR lat: 38.62727 lon: -90.19789 facility: University of Pittsburgh city: Pittsburgh state: Pennsylvania zip: 15213 country: United States name: Sarah Berman role: PRINCIPAL_INVESTIGATOR lat: 40.44062 lon: -79.99589 facility: University of Washington city: Seattle state: Washington zip: 98195 country: United States name: Suman Jayadev role: PRINCIPAL_INVESTIGATOR lat: 47.60621 lon: -122.33207 facility: Neuroscience Research Australia city: Randwick state: New South Wales zip: 2031 country: Australia name: William Brooks role: PRINCIPAL_INVESTIGATOR lat: -33.91439 lon: 151.24895 facility: The National Hospital for Neurology and Neurosurgery city: London state: Greater London zip: WC1B 3BG country: United Kingdom name: Catherine Mummery role: CONTACT lat: 51.50853 lon: -0.12574 hasResults: False |
<|newrecord|> nctId: NCT06384560 id: 2023-508707-20-00 briefTitle: Neoadjuvant Triple Treatment for Borderline Resectable Pancreatic Cancer (PREOPANC-5) acronym: PREOPANC-5 overallStatus: NOT_YET_RECRUITING date: 2024-05 date: 2028-03 date: 2028-03 date: 2024-04-25 date: 2024-04-25 name: Amsterdam UMC, location VUmc class: OTHER name: Maastricht University Medical Center name: Erasmus Medical Center name: St. Antonius Hospital briefSummary: Since patients with borderline resectable pancreatic cancer (BRPC) have a limited life expectancy, it is important to improve treatment strategies. Therefore, the objective of this study is to investigate whether neoadjuvant triple treatment chemotherapy, immunotherapy and radiotherapy, followed by surgery and chemotherapy and immunotherapy survival in patients with BRPC. conditions: Borderline Resectable Pancreatic Cancer studyType: INTERVENTIONAL phases: PHASE1 phases: PHASE2 allocation: NA interventionModel: SINGLE_GROUP primaryPurpose: TREATMENT masking: NONE count: 66 type: ESTIMATED name: Pembrolizumab measure: Percentage of patients with progression free survival at 18 months (RECIST 1.1) sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT hasResults: False |
<|newrecord|> nctId: NCT06384547 id: VRDN-001-303 briefTitle: A Randomized, Active Controlled, Safety and Tolerability Study of VRDN-001 in Participants With Thyroid Eye Disease (TED) overallStatus: NOT_YET_RECRUITING date: 2024-04 date: 2025-05 date: 2026-01 date: 2024-04-25 date: 2024-04-25 name: Viridian Therapeutics, Inc. class: INDUSTRY briefSummary: The investigational drug, VRDN-001, is a monoclonal antibody that inhibits the activity of a cell surface receptor called insulin-like growth factor-1 receptor (IGF-1R). Inhibition of IGF-1R may help to reduce the inflammation and associated tissue swelling that occurs in patients with thyroid eye disease (TED). The primary objective of this clinical trial is to evaluate the safety and tolerability of VRDN-001 in patients with TED. conditions: Thyroid Eye Disease studyType: INTERVENTIONAL phases: PHASE3 allocation: RANDOMIZED interventionModel: PARALLEL interventionModelDescription: A randomized, active controlled, safety and tolerability study of VRDN-001, a humanized monoclonal antibody directed against the IGF-1 receptor, in participants with thyroid eye disease (TED) primaryPurpose: TREATMENT masking: DOUBLE whoMasked: PARTICIPANT whoMasked: INVESTIGATOR count: 212 type: ESTIMATED name: VRDN-001 10 mg/kg name: VRDN-001 3 mg/kg measure: Treatment Emergent Adverse Event (TEAE) incidence rate measure: Change from baseline in proptosis in the study eye as measured by exophthalmometer at Week 15 sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: United Medical Research Institute city: Inglewood state: California zip: 90301 country: United States name: James Peace, MD role: CONTACT phone: 310-645-4673 lat: 33.96168 lon: -118.35313 hasResults: False |
<|newrecord|> nctId: NCT06384534 id: PVD_6MWD_SOT briefTitle: Exercise Performance on Ambient Air vs. Low-Flow Oxygen Therapy in Pulmonary Vascular Disease (PVD) overallStatus: NOT_YET_RECRUITING date: 2024-05 date: 2025-05 date: 2025-11 date: 2024-04-25 date: 2024-04-25 name: University of Zurich class: OTHER briefSummary: The investigators aim to study the effect of SOT in Swiss residents with pulmonary vascular diseases (PVD) defined as pulmonary arterial hypertension (PAH) or chronic thromboembolic pulmonary hypertension (CTEPH). conditions: Pulmonary Vascular Disorder conditions: Chronic Thromboembolic Pulmonary Hypertension conditions: Pulmonary Arterial Hypertension studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: CROSSOVER interventionModelDescription: Each participant is its own control primaryPurpose: OTHER masking: NONE count: 28 type: ESTIMATED name: 6-minute walk distance (6MWD) test on ambient air name: 6-minute walk distance test with supplemental oxygen measure: 6-minute walk distance (6MWD) with supplemental oxygen therapy (SOT) vs. ambient air measure: SpO2 at rest and peak 6MWD with SOT vs. ambient air measure: Heart rate at rest and peak 6MWD with SOT vs. ambient air measure: Borg dyspnea scale at rest and peak 6MWD with SOT vs. ambient air measure: Borg leg fatigue scale at rest and peak 6MWD with SOT vs. ambient air measure: Blood pressure at rest and peak 6MWD with SOT vs. ambient air sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: University Hospital Zürich city: Zurich zip: 8091 country: Switzerland name: Silvia Ulrich, Prof. Dr. role: CONTACT phone: 0041 44 255 22 20 email: [email protected] name: Mona Lichtblau, Dr. role: CONTACT phone: +41442552220 email: [email protected] name: Silvia Ulrich, Prof. Dr. role: PRINCIPAL_INVESTIGATOR lat: 47.36667 lon: 8.54999 hasResults: False |
<|newrecord|> nctId: NCT06384521 id: STUDY00000500 briefTitle: Lifestyle MIND- Feasibility for Randomized Wait-list Control Trial acronym: MIND overallStatus: NOT_YET_RECRUITING date: 2024-06 date: 2025-04 date: 2025-05 date: 2024-04-25 date: 2024-04-25 name: The University of Texas Health Science Center at San Antonio class: OTHER briefSummary: The goal of this clinical trial is to examine if it is feasible to randomly assign people into two groups and participate in Lifestyle MIND (Mental Illness and/N' Diabetes) at two different times. Lifestyle MIND is a diabetes lifestyle intervention recently developed for people with serious mental illness (SMI). It is known to be helpful for people with SMI who complete it, but the investigators do not know the effect in comparison to those who do not participate in it. The main questions it aims to answer are: |
* Does Lifestyle MIND improve diabetes control among people with SMI? |
* Will the effect of Lifestyle MIND be sustained 10 weeks after program completion? |
* From the provider's perspective, what are the barriers of achieving optimal diabetes treatment outcomes for patients with SMI? |
Researchers will compare outcomes of participants in the intervention with those in the wait-list control arm, to see if there will be significant differences in blood glucose level, compliance of diabetes self-management, time staying active, number of emergency department (ED) visits and psychiatric hospitalization, and subjective well-being. conditions: Type 2 Diabetes Mellitus conditions: Serious Mental Illness conditions: Schizophrenia conditions: Major Depression conditions: Bipolar Disorder studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: FACTORIAL primaryPurpose: TREATMENT masking: SINGLE whoMasked: OUTCOMES_ASSESSOR count: 20 type: ESTIMATED name: Lifestyle MIND measure: Hemoglobin A1c (HbA1c) measure: Summary of Diabetes Self-Care Activities (SDSCA) Questionnaire measure: Hours of Active and Sedentary Behavior measure: Number of emergency department (ED) visits and psychiatric hospitalizations measure: Satisfaction with Life Scale (SWLS) sex: ALL minimumAge: 18 Years maximumAge: 65 Years stdAges: ADULT stdAges: OLDER_ADULT facility: University of Texas Health Science Center at San Antonio city: San Antonio state: Texas zip: 78229 country: United States name: Chinyu Wu, PhD role: CONTACT phone: 210-567-8890 email: [email protected] name: Chinyu Wu, PhD role: PRINCIPAL_INVESTIGATOR name: Bradley Tragord, ScD role: SUB_INVESTIGATOR lat: 29.42412 lon: -98.49363 hasResults: False |
<|newrecord|> nctId: NCT06384508 id: NL83340.058.23 briefTitle: Decrease Trauma-related Shame With Virtual Reality: The Effectiveness of SHINE-VR acronym: SHINE-VR overallStatus: NOT_YET_RECRUITING date: 2024-04-20 date: 2024-10-31 date: 2024-10-31 date: 2024-04-25 date: 2024-04-25 name: Universiteit Leiden class: OTHER name: University of Amsterdam briefSummary: Suffering from PTSD in childhood can have detrimental formative consequences. Researchers have been eager to develop effective interventions and to enhance treatment motivation since the introduction of the diagnosis of PTSD in the DSM. With evolving understanding of the disorder, its definition and criteria have changed over the course of time. The most recent change involves the addition of the criterium D of negative affects or emotions in relation to PTSD, the feeling of shame amongst others. Individuals experiencing interpersonal trauma, such as sexual abuse, are at high-risk developing trauma-related shame, which in turn can impact the course and effectiveness of PTSD treatment. Shame-inducing situations are typically being avoided, and the feelings are not disclosed to peers and other people. Hence, acknowledging and sharing feelings of shame as well as practicing self-compassion have been proposed to reduce the impact of that negative self-conscious emotion. These aspects get partially tackled in evidence-based trauma therapies, however, there appears to be a need for a more specific trauma-related shame intervention in addition to existing treatments. Recent research has focused on developing such interventions for adults and has reported positive effects. |
To our knowledge, there is no intervention specifically tackling trauma-related shame in adolescents. Virtual Reality (VR) is a promising tool for such an intervention. Findings suggest that including VR in a treatment results in high treatment satisfaction and that it is highly motivating for its users, which is a crucial component for treatment success. |
The goal of this study is to test the effectiveness of a short-term VR shame intervention (SHINE-VR) for adolescents suffering from PTSD after having experienced sexual abuse. The primary objectives of this study to assess the effect of SHINE-VR on trauma-related shame, self-compassion, and PTSD symptom reduction, to investigate whether treatment motivation, an increase in self-compassion, and a decrease in trauma-related shame are associated with PTSD symptom reduction, and the evaluation of SHINE-VR by assessing the feasibility of the intervention. conditions: Shame studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL interventionModelDescription: Single Case Experimental Design (ABC) with two different baseline lengths primaryPurpose: TREATMENT masking: SINGLE maskingDescription: The participants are unaware of different baseline lengths whoMasked: PARTICIPANT count: 10 type: ESTIMATED name: SHINE-VR measure: Trauma-related shame measure: Self-compassion measure: PTSD symptoms measure: Treatment motivation sex: ALL minimumAge: 12 Years maximumAge: 17 Years stdAges: CHILD facility: iMindU Practice for Child, Adolescent and Adult Psychiatry city: Leiden state: South Holland zip: 2311 EX country: Netherlands name: Marie-Jose van Hoof, MD PhD role: CONTACT name: Marie-Jose van Hoof, MD PHD role: PRINCIPAL_INVESTIGATOR lat: 52.15833 lon: 4.49306 facility: LEVVEL city: Amsterdam country: Netherlands name: Ramon Lindauer, Prof. Dr. role: CONTACT lat: 52.37403 lon: 4.88969 hasResults: False |
<|newrecord|> nctId: NCT06384495 id: STUDY00021475 briefTitle: How Does Cerebellar tDCS Alter Intracortical Inhibition Over Time? overallStatus: NOT_YET_RECRUITING date: 2024-08-15 date: 2025-03-31 date: 2025-03-31 date: 2024-04-25 date: 2024-04-25 name: University of Minnesota class: OTHER briefSummary: Combining cortical tDCS with behavioral interventions has been shown to have beneficial outcomes in individuals post-stroke. However, cerebellar tDCS is a fairly new approach for individuals with unilateral cortical stroke and there has not been reports of duration of effect of tDCS applied to the cerebellum in this population. |
Information gained from this study will serve to fill knowledge gaps on the duration of effect of cerebellar tDCS and the effects of polarity. |
The purpose of this study is to determine the duration of effect of ventro-lateral cerebellar transcranial direct current stimulation (tDCS) in healthy adults through cortical excitability (CE), cognitive, language and motor assessment measures. Primary aim: Compare baseline CE from left motor cortex of first dorsal interosseous (FDI) and orbicularis oris (OO) areas to CE post cerebellar tDCS at 15 minutes, 45 minutes and 75 minutes. Single-pulse and paired-pulse transcranial magnetic stimulation (TMS) will be used to measure and compare stimulus response curve (S/R curve), cortical silent period (CSP) and short-interval intracortical inhibition (SICI) in the hand area and facial area of the left primary motor cortex at each time point. |
Secondary aim: Compare baseline performance on cognition, motor learning and language tasks to performance at 15, 45 and 75 minutes after receiving tDCS. Digit Symbol Substitution Test (DSST), Serial Reaction Time Test (SRTT) and Lexical Decision tasks will be presented via a computer interface. conditions: Stroke studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: SUPPORTIVE_CARE masking: DOUBLE whoMasked: PARTICIPANT whoMasked: OUTCOMES_ASSESSOR count: 30 type: ESTIMATED name: REAL-A name: REAL-C name: SHAM measure: stimulus/response curve (S/R Curve) measure: Cortical Silent Period (CSP) measure: Short-interval Intracortical Inhibition (SICI). measure: Digit Symbol Substitution Test (DSST) measure: Serial Reaction Time Test (SRTT) measure: Lexical Decision Task sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT hasResults: False |
<|newrecord|> nctId: NCT06384482 id: SNC115-DLL3 CART-101 briefTitle: SNC115 Injections in Patients With Recurrent/Refractory Small Cell Lung Cancer and Lung Large Cell Neuroendocrine Carcinoma overallStatus: RECRUITING date: 2024-04-30 date: 2025-04-30 date: 2025-12-30 date: 2024-04-25 date: 2024-04-25 name: Shanghai Simnova Biotechnology Co.,Ltd. class: INDUSTRY name: Shanghai Chest Hospital briefSummary: This study is a FIH dose escalation clinical study, with single arm, open label and design, in order to observe the preliminary safety and Pharmacokinetic of SNC115 Injection in participants with Recurrent/refractory small cell lung cancer and Lung large cell neuroendocrine carcinoma. conditions: Recurrent/Refractory Small Cell Lung Cancer Lung Large Cell Neuroendocrine Carcinoma studyType: INTERVENTIONAL phases: PHASE1 allocation: NA interventionModel: SINGLE_GROUP primaryPurpose: TREATMENT masking: NONE count: 35 type: ESTIMATED name: SNC115 injection measure: Safety of SNC115 Injection measure: Safety of SNC115 Injection measure: -Efficacy of SNC115 Injection measure: -Efficacy of SNC115 Injection measure: -Efficacy of SNC115 Injection measure: -Efficacy of SNC115 Injection measure: -Efficacy of SNC115 Injection measure: -Efficacy of SNC115 Injection measure: -PK characteristic of SNC115 Injection. measure: -PK characteristic of SNC115 Injection. measure: PK characteristic of SNC115 Injection. measure: PK characteristic of SNC115 Injection. measure: PK characteristic of SNC115 Injection. measure: PK characteristic of SNC115 Injection. sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Shanghai Chest Hospital status: RECRUITING city: Shanghai state: Shanghai zip: 200030 country: China name: Hua Zhong, MD/PhD role: CONTACT phone: 021-22200000 email: [email protected]; [email protected] lat: 31.22222 lon: 121.45806 hasResults: False |
<|newrecord|> nctId: NCT06384469 id: 98984697615 briefTitle: The Impact of Rhinoplasty Approach and Used Autologous Cartilage Grafts on the Nasal Skin-soft Tissue Envelope Metabolism overallStatus: NOT_YET_RECRUITING date: 2025-01-02 date: 2026-01-02 date: 2026-09-01 date: 2024-04-25 date: 2024-04-29 name: University Hospital "Sestre Milosrdnice" class: OTHER briefSummary: This is a prospective observation cohort investigation. Patients, that is participants, undergoing primary functional rhinoplasty will be evaluated in terms of measuring capillary blood lactic acid concentration in the nasal skin-soft tissue envelope immediately after the procedure and 7 days after the procedure. |
The aim of our study is to test whether or not different rhinoplasty approaches and volume of the used autologous cartilage grafts impact the nasal skin-soft tissue metabolism. conditions: Rhinoplasty conditions: Nasal Skin-soft Tissue Envelope Metabolism conditions: Lactic Acid conditions: Autologous Cartilage Grafting studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: PROSPECTIVE count: 100 type: ESTIMATED measure: Difference of capillary blood lactic acid concentration in the nasal skin-soft tissue envelope depending on the rhinoplasty approach measure: Correlation between the used autologous cartilage graft volume and lactic acid concentration in the nasal skin-soft tissue envelope sex: ALL minimumAge: 18 Years maximumAge: 80 Years stdAges: ADULT stdAges: OLDER_ADULT hasResults: False |
<|newrecord|> nctId: NCT06384456 id: 23-5708 briefTitle: Topical TRanexamic Acid vs. Placebo on Acute Postoperative Pain Following DRF Fixation acronym: TRADR overallStatus: NOT_YET_RECRUITING date: 2024-08 date: 2026-06 date: 2026-09 date: 2024-04-25 date: 2024-04-26 name: University Health Network, Toronto class: OTHER briefSummary: The goal of this study is to find out whether the use of topical tranexamic acid (TXA) into the surgical wound will result in less post-operative pain, less pain killer use, and better post-operative use of the wrist in people undergoing surgery for a wrist fracture compared to not using topical TXA (placebo). conditions: Distal Radius Fractures studyType: INTERVENTIONAL phases: PHASE4 allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: QUADRUPLE whoMasked: PARTICIPANT whoMasked: CARE_PROVIDER whoMasked: INVESTIGATOR whoMasked: OUTCOMES_ASSESSOR count: 90 type: ESTIMATED name: Topical TRanexamic Acid name: Placebo measure: acute post-op pain measure: opioid use measure: persistent pain measure: unscheduled hand-related procedures measure: Patient reported function sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Toronto Western Hospital city: Toronto state: Ontario country: Canada name: Ryan Paul, MD role: CONTACT email: [email protected] lat: 43.70011 lon: -79.4163 hasResults: False |
<|newrecord|> nctId: NCT06384443 id: 01001099646 briefTitle: Proton Pump Inhibitors in Cirrhotic Patients overallStatus: COMPLETED date: 2020-10-01 date: 2024-03-01 date: 2024-03-01 date: 2024-04-25 date: 2024-04-25 name: National Liver Institute, Egypt class: OTHER briefSummary: Proton pump inhibitors (PPIs) inappropriate use, in patients with cirrhosis, presents a significant clinical challenge. This study evaluates overprescription and misuse of PPIs in cirrhotic patients. The patterns of use of PPIs will be classified into two groups based on adherence to the proven indications: Group A: Inappropriate use of PPI, Group B: Appropriate use of PPI. We will estimate the prevalence of PPI misuse in cirrhotics and correlate it with different factors. conditions: Proton Pump Inhibitor Adverse Reaction conditions: Liver Cirrhosis studyType: OBSERVATIONAL observationalModel: OTHER timePerspective: CROSS_SECTIONAL count: 1000 type: ACTUAL measure: Inappropriate use of PPIs measure: Predictors for inappropriate use of PPIs sex: ALL minimumAge: 18 Years maximumAge: 70 Years stdAges: ADULT stdAges: OLDER_ADULT facility: National Liver institute - Menoufia University city: Shibīn Al Kawm state: Menoufia zip: 32511 country: Egypt lat: 30.55258 lon: 31.00904 hasResults: False |
<|newrecord|> nctId: NCT06384430 id: MuğlaSKU-NKO briefTitle: Subacromial Impingement Syndrome overallStatus: RECRUITING date: 2024-04-01 date: 2024-08-31 date: 2024-09-01 date: 2024-04-25 date: 2024-04-25 name: Muğla Sıtkı Koçman University class: OTHER briefSummary: Subacromial impingement syndrome is a common shoulder pain disorder. In this study, among the patients who applied to the Physical Medicine and Rehabilitation outpatient clinic of Muğla Training and Research Hospital and were diagnosed with subacromial impingement by anamnesis and clinical tests, inclusion criteria (being between 18-70 years of age, positivity for subacromial impingement syndrome in clinical evaluation (Neer's test, Hawkins Kennedy, supraspinatus palpation test)) and exclusion criteria (under 18 years of age, over 70 years of age, rheumatologic disease diagnosis, symptomatic shoulder osteoarthritis, shoulder instability; shoulder pain in active, passive cervical spine movements, previous shoulder surgery, those with adhesive capsulitis findings (\>50% passive range of motion restriction in 2 planes or full-thickness rotator cuff tear detected on ultrasound), those who received physiotherapy or intra-articular injections in the last 3 months, those with type 2 diabetes or hypothyroidism) will be included in the study. Demographic data of the patients will then be recorded. DASH (Disabilities of the Arm, Shoulder and Hand) and Constant Murley scores will be calculated. 4 years of musculoskeletal ultrasound experience will be recorded by a radiologist using ultrasound (Siemens® V8, LA2-14A probe) in modified Crass position (positioning with the palm of the examined side on the posterior iliac wing) by measuring subacromial bursa thickness, supraspinatus tendon thickness, acromiohumeral distance, supraspinatus tendon thickness/acromiohumeral distance ratio. Demographic data of the patients will then be recorded. DASH (Disabilities of the Arm, Shoulder and Hand) and Constant Murley scores will be calculated. conditions: To Show the Relationship Between Ultrasound Parameters and Shoulder Functional Tests studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: CROSS_SECTIONAL count: 70 type: ESTIMATED name: Shoulder functional tests and ultrasound measure: subacromial bursa thickness measure: supraspinatus tendon thickness measure: acromiohumeral distance sex: ALL minimumAge: 18 Years maximumAge: 70 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Mugla Egitim Arastima status: RECRUITING city: Mugla country: Turkey name: Nihal KARAYER OZGUL, 1 role: CONTACT lat: 37.21807 lon: 28.3665 hasResults: False |
<|newrecord|> nctId: NCT06384417 id: STUDY00024858 briefTitle: Using an End-of-life Conversation Game to Engage Patients With Cancer in Advance Care Planning: Phase 2 overallStatus: NOT_YET_RECRUITING date: 2024-06 date: 2025-02 date: 2026-12 date: 2024-04-25 date: 2024-04-25 name: Milton S. Hershey Medical Center class: OTHER briefSummary: The goal of this clinical trial is to explore feasibility, acceptability, and effectiveness of end-of-life conversation game "Hello" as a tool to help individuals with various solid cancer types (including: breast, gastro-intestinal, lung, melanoma, head and neck, and/or genito-urinary cancers) treated at Penn State Health clinics and their loved ones perform advance care planning (ACP). The main questions it aims to answer are: |
What modifications and/or adaptations are necessary to Hello for use in cancer populations? |
What impact does participation in Hello event have on health care usage (e.g., number of hospitalizations, ICU admissions, emergency department visits, etc.)? How feasible is it to randomize participants to play either Hello for Cancer or Table Topics? |
Participants will: |
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