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This study is conducted according to the principles of the Declaration of Helsinki regarding experimentation involving human subjects, and written informed consent will be obtained from all participants before enrollment. conditions: Anxiety conditions: Pancreatic Cancer conditions: Pancreatic Cystic Lesions conditions: Stress studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL interventionModelDescription: Graphic novel will be visualized by interventional group before EUS-FNB primaryPurpose: HEALTH_SERVICES_RESEARCH masking: SINGLE whoMasked: CARE_PROVIDER count: 50 type: ESTIMATED name: Graphic novel visualization measure: Anxiety and stress level according to BAI measure: Anxiety and stress level according to mASS-14 sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Irccs - Ismett city: Palermo state: PA zip: 90127 country: Italy name: Giacomo Emanuele Maria Rizzo, MD role: CONTACT phoneExt: +393406602502 email: g.rizzo.gr@gmail.com name: Ilaria Tarantino, MD role: PRINCIPAL_INVESTIGATOR name: Giacomo Emanuele Maria Rizzo, MD role: PRINCIPAL_INVESTIGATOR name: Mario Traina, MD role: PRINCIPAL_INVESTIGATOR lat: 38.13205 lon: 13.33561 hasResults: False
<|newrecord|> nctId: NCT06268093 id: XWTETS briefTitle: The Therapeutic Effect of Thalidomide in Syringomyelia overallStatus: RECRUITING date: 2024-02 date: 2027-02 date: 2028-02 date: 2024-02-20 date: 2024-02-20 name: Xuanwu Hospital, Beijing class: OTHER briefSummary: Purpose: This phase II clinical trial aims to evaluate the indications, therapeutic effects and side effects of thalidomide in refractory syringomyelia.
Primary outcome measure: The primary endpoint is the change of ASIA at week 12. The clinical efficacy is defined as ASIA increase ≥ 1 at week 12, as compared with that before thalidomide usage. conditions: Syringomyelia conditions: Thalidomide studyType: INTERVENTIONAL phases: PHASE2 allocation: NA interventionModel: SINGLE_GROUP primaryPurpose: TREATMENT masking: NONE count: 30 type: ESTIMATED name: Thalidomide measure: ASIA Score measure: syringomyelia remission measure: The evoked electromyographic signal (eEMG) potential measure: Visual Analog Scale (VAS) measure: Klekamp and Sammi syringomyelia scale measure: modified Japanese Orthopaedic Association Scores (mJOA) measure: xuanwu syringomyelia scale measure: Incidence of complications sex: ALL minimumAge: 18 Years maximumAge: 80 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Fengzeng Jian status: RECRUITING city: Beijing state: Beijing City zip: 100032 country: China name: fengzeng jian, md role: CONTACT email: jianfengzeng@xwh.ccmu.edu.cn lat: 39.9075 lon: 116.39723 hasResults: False
<|newrecord|> nctId: NCT06268080 id: A+9317 briefTitle: Depth of Anesthesia on Postoperative Delirium and Cognitive After Surgery acronym: Balanced-2 overallStatus: NOT_YET_RECRUITING date: 2024-03-31 date: 2027-12-31 date: 2028-12-31 date: 2024-02-20 date: 2024-02-20 name: Auckland City Hospital class: OTHER_GOV briefSummary: The goal of this clinical trial (Balanced-2 study) is to compare light to deep general anesthesia using widely available brain monitors, to see if 'light' anesthesia could reduce rates of delirium, cognitive decline, and disability in older adults undergoing major surgery.
Delirium is the most common serious surgical complication, occurring in an estimated one in four older adults undergoing major surgery. Delirium causes significant distress to patients and family, and is associated with prolonged hospital stay, physical disability, progression to dementia-like illnesses, and discharge to long-term care. Between 10 - 30% of adults aged 70 years and above have surgery every year, and preserving brain health and wellbeing is an important priority during this time.
Older adults (aged ≥65 years, or Indigenous, Pasific patients aged ≥55 years) undergoing major surgery with general anesthesia (excluding heart and brain surgery) and able to provide consent will be able to participate. Participants will be randomized to two groups - a lighter general anesthesia group and a deeper general anesthesia group using processed electroencephalography (a brain monitor that provides information on depth of anesthesia using brain waves). The anesthesiologist will titrate anesthetic drugs according to the brain monitor. Participants will be followed up to determine if they experience delirium after surgery, and longer term impact of delirium such as cognitive and physical decline will also be measured.
If found to be effect, this simple, cheap, and widely available treatment could reduce disability, preserve brain health and wellbeing of many older adults undergoing surgery worldwide, and save millions in healthcare dollars. conditions: Delirium, Postoperative conditions: Anesthesia conditions: Surgery-Complications conditions: Cognition Disorder conditions: Delirium conditions: Cognitive Decline studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL interventionModelDescription: Multicentre, prospective, randomized, active control, parallel group, intention to treat, safety and efficacy study. primaryPurpose: PREVENTION masking: TRIPLE maskingDescription: Blinding of procedural anesthesiologist is not possible. Patients, surgeons, and all outcome assessors will be blinded. One unblinded research coordinator at each site will collect pEEG related data points. Other research coordinators will be blinded as to treatment allocation and will collect data relating to primary and secondary outcomes. Clinicians carrying out participant usual care will be able to unblind study allocation if necessary by viewing the patients anesthesia record via password protected, accessing clinician identity logged, Electronic Health Record (EHR). This record will be unavailable for access by other means. whoMasked: PARTICIPANT whoMasked: INVESTIGATOR whoMasked: OUTCOMES_ASSESSOR count: 2766 type: ESTIMATED name: Depth of anesthesia titration using pEEG measure: Incidence of postoperative delirium (POD) measure: Incidence of severe delirium measure: Incidence of new mild and major postoperative neurocognitive disorders measure: Postoperative cognitive decline measure: Functional decline measure: All-cause mortality measure: Duration of delirium measure: Incidence of awareness measure: Adverse and serious adverse events sex: ALL minimumAge: 55 Years stdAges: ADULT stdAges: OLDER_ADULT hasResults: False
<|newrecord|> nctId: NCT06268067 id: Renal uptake at F18 FDG PET/CT briefTitle: Kidney Uptake at F-18 FDG PET/CT Studies and Renal Function Status overallStatus: NOT_YET_RECRUITING date: 2024-03-01 date: 2025-03-01 date: 2025-04-01 date: 2024-02-20 date: 2024-02-20 name: Assiut University class: OTHER briefSummary: Searching for a possible correlation between renal uptake at F-18-FDG PET/CT and renal functional parameters in both normal subjects and patients with CKD. conditions: Renal Uptake at F-18-FDG PET/CT studyType: OBSERVATIONAL observationalModel: CASE_CONTROL timePerspective: PROSPECTIVE count: 97 type: ESTIMATED name: PET/CT measure: significance of renal uptake at F18-FDG PET CT studies measure: Early detection of patients with CKD sex: ALL minimumAge: 19 Years maximumAge: 75 Years stdAges: ADULT stdAges: OLDER_ADULT hasResults: False
<|newrecord|> nctId: NCT06268054 id: DEH113-III-0123 briefTitle: Efficacy and Safety of DEH113 in the Treatment of Menstrual Cramp Pain Associated With Primary Dysmenorrhea acronym: LIBERTÀ overallStatus: NOT_YET_RECRUITING date: 2025-02 date: 2027-02 date: 2027-09 date: 2024-02-20 date: 2024-02-22 name: EMS class: INDUSTRY briefSummary: The purpose of this study if to evaluate the efficacy and safety of DEH113 in the Treatment of Menstrual Cramp Pain Associated With Primary Dysmenorrhea. conditions: Primary Dysmenorrhea studyType: INTERVENTIONAL phases: PHASE3 allocation: RANDOMIZED interventionModel: CROSSOVER primaryPurpose: TREATMENT masking: QUADRUPLE whoMasked: PARTICIPANT whoMasked: CARE_PROVIDER whoMasked: INVESTIGATOR whoMasked: OUTCOMES_ASSESSOR count: 78 type: ESTIMATED name: DEH113 name: Placebo Comparator measure: Sum of Total Pain Relief (TOTPAR) over 0-6 hours post-dose measure: Sum of Total Pain Relief (TOTPAR) over 0-4 and 0-8 hours post-dose measure: Sum of Pain Intensity Difference (SPID) over 4, 6 and 8 hours post-dose. measure: Use of rescue medication measure: Number of additional drug intake measure: Patients' Global Impression of Change (PGIC) measure: Incidence of Adverse Events Associated with DEH113 in the Treatment of Primary Dysmenorrhea sex: FEMALE minimumAge: 16 Years maximumAge: 35 Years stdAges: CHILD stdAges: ADULT hasResults: False
<|newrecord|> nctId: NCT06268041 id: 427659 id: R01HD093694 type: NIH link: https://reporter.nih.gov/quickSearch/R01HD093694 briefTitle: HIT-Stroke Trial 2 acronym: HST2 overallStatus: RECRUITING date: 2024-02-09 date: 2028-01 date: 2028-04 date: 2024-02-20 date: 2024-02-20 name: University of Cincinnati class: OTHER name: Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD) name: University of Kansas Medical Center name: University of Delaware briefSummary: People who had a stroke at least 6 months prior and who still have difficulty with walking will each be randomly assigned to receive either moderate or vigorous intensity walking exercise. Both protocols will be performed individually with a physical therapist for 45 minutes, 3x/week for 12 weeks. Measures including walking function will be assessed at baseline (PRE), after 4, 8 and 12 weeks of training (12WK) and at 3-month follow up (3moPOST), by raters who are unaware of the participant randomization. conditions: Stroke studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: SINGLE whoMasked: OUTCOMES_ASSESSOR count: 156 type: ESTIMATED name: Moderate-Intensity Aerobic Training name: High-Intensity Interval Training measure: 6-Minute Walk Test Distance measure: 6-Minute Walk Test Distance measure: Self-Selected Gait Speed measure: Fastest Gait Speed measure: PROMIS-Fatigue Scale version 8a measure: Aerobic Capacity measure: EuroQol-5D-5L sex: ALL minimumAge: 30 Years maximumAge: 85 Years stdAges: ADULT stdAges: OLDER_ADULT facility: University of Delaware status: RECRUITING city: Newark state: Delaware zip: 19713 country: United States name: Jane Diehl role: CONTACT email: strokestudies@udel.edu name: Darcy Reisman, PT, PhD role: PRINCIPAL_INVESTIGATOR lat: 39.68372 lon: -75.74966 facility: University of Kansas Medical Center status: RECRUITING city: Kansas City state: Kansas zip: 66160 country: United States name: Sasha Moores role: CONTACT phone: 913-588-2697 email: reachlab@kumc.edu name: Sandra Billinger, PT, PhD role: PRINCIPAL_INVESTIGATOR lat: 39.11417 lon: -94.62746 hasResults: False
<|newrecord|> nctId: NCT06268028 id: BELMA TA briefTitle: Discharge Training Given to Primiparous Mothers Who Had a Cesarean Delivery overallStatus: ENROLLING_BY_INVITATION date: 2024-01-10 date: 2024-06-10 date: 2024-11-10 date: 2024-02-20 date: 2024-02-21 name: Aydin Adnan Menderes University class: OTHER briefSummary: This study aimed to determine the effect of discharge training given to primiparous mothers who gave birth by cesarean section on the level of readiness for discharge.
The research is a pre-test-post-test, randomized controlled experimental study. conditions: Education studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: OTHER masking: SINGLE whoMasked: PARTICIPANT count: 70 type: ESTIMATED name: Training measure: A pre-test will be applied to 70 women who constitute the sample of the research. measure: Apost-test will be applied to 70 women who constitute the sample of the research. sex: FEMALE minimumAge: 18 Years maximumAge: 50 Years stdAges: ADULT facility: Aydın Maternity and Child Health Hospital city: Aydın zip: 09010 country: Turkey lat: 37.84501 lon: 27.83963 hasResults: False
<|newrecord|> nctId: NCT06268015 id: Pro00115311 briefTitle: Botensilimab and Balstilimab Optimization in Colorectal Cancer acronym: BBOpCo overallStatus: NOT_YET_RECRUITING date: 2024-07 date: 2028-07 date: 2028-07 date: 2024-02-20 date: 2024-02-22 name: Nicholas DeVito, MD class: OTHER name: Gateway for Cancer Research name: Agenus Inc. briefSummary: This is a single-arm, interventional, pilot clinical trial. Fifteen evaluable patients will have tumor-informed ctDNA testing at baseline and start botensilimab and balstilimab treatment. They will receive botensilimab and balstilimab in 6-week cycles until progression, after which mFOLFOX6 and bevacizumab or panitumumab will be added to the regimen. Subjects will have safety testing at baseline and every two weeks while on study drug. Study treatment with botensilimab and balstilimab, mFOLFOX6, and bevacizumab or panitumumab will be continued until radiographic or clinical progression, toxicity, or patient withdrawal. Subjects will have one safety follow up visit 30 days after the last treatment and will be followed for survival every 12 weeks for up to 2 years. conditions: Colorectal Cancer studyType: INTERVENTIONAL phases: PHASE2 allocation: NA interventionModel: SINGLE_GROUP primaryPurpose: TREATMENT masking: NONE count: 15 type: ESTIMATED name: Botensilimab name: Balstilimab name: Oxaliplatin name: Leucovorin name: Fluorouracil name: Bevacizumab name: Panitumumab measure: Disease control rate based on iRECIST at second restaging scan measure: Proportion of subjects with a best overall response of complete response or partial response according to iRECIST measure: Disease control rate based on RECIST v1.1 at second restaging scan measure: Proportion of subjects with a best overall response of complete response or partial response according to RECIST v1.1 measure: Months of overall survival measure: Months of progression-free survival sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Duke University city: Durham state: North Carolina zip: 27710 country: United States name: Nicholas C. DeVito, MD role: PRINCIPAL_INVESTIGATOR lat: 35.99403 lon: -78.89862 hasResults: False
<|newrecord|> nctId: NCT06268002 id: 5876557033 briefTitle: Effect of Vernonia Cinerea Lozenges as a Smoking Cessation Aid in Patients With Non-communicable Diseases overallStatus: COMPLETED date: 2017-09-01 date: 2021-09-30 date: 2021-12-31 date: 2024-02-20 date: 2024-02-28 name: Chulalongkorn University class: OTHER briefSummary: Vernonia cinerea is an herbal which has been recorded in many Thai herbal formulation and Thai traditional medicine has used this herbal for treating various diseases included hypertension, asthma, fever, hepatitis, kidney stone and smoking cessation. Now aday there are more interest for using Vernonia cinerea as a medication to aid smoker to quit smoking because it is cheaper than other current therapeutic medications. The objective of this study is to evaluate efficacy and safety of Vernonia cinerea lozenge for smoking cessation when compared to placebo. conditions: Smoking Cessation studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL interventionModelDescription: This study was a multicenter randomized, paralleled, double-blind, controlled trial at 5 hospitals and 2 community pharmacies in Thailand primaryPurpose: TREATMENT masking: TRIPLE whoMasked: PARTICIPANT whoMasked: CARE_PROVIDER whoMasked: INVESTIGATOR count: 93 type: ACTUAL name: Vernonia cinerea name: Placebo measure: continuous abstinence rate measure: continuous abstinence rate (CAR) and point prevalence rate sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Krittin Bunditanukul city: Bangkok zip: 10600 country: Thailand lat: 13.75398 lon: 100.50144 hasResults: False
<|newrecord|> nctId: NCT06267989 id: Gothenburg University briefTitle: The Effectiveness of Early Intervention to Correct the Position of PDC:s acronym: PDC overallStatus: RECRUITING date: 2024-02-12 date: 2027-12-30 date: 2027-12-30 date: 2024-02-20 date: 2024-02-21 name: Region Örebro County class: OTHER briefSummary: Approximately 2-3% of children will have problems with one or both of their permanent or 'adult' canine teeth in the upper jaw. These canine teeth sometimes fail to erupt properly, because they are displaced into the roof of the mouth or palate. These are known as palatally displaced canines, PDC, (Brin et al., 1986, Ericson and Kurol, 1987). In addition to failing to erupt, displaced teeth can cause problems, such as damage to the roots or displacement of the neighbouring teeth (Ericson and Kurol, 1988a, Ericson and Kurol, 2000, Falahat et al., 2008).
It has been suggested that if the primary ('baby' or 'milk') canine is extracted at an appropriate time in a child with a suspected palatally displaced canine, then the displaced tooth might spontaneously correct its position (Ericson and Kurol, 1988b) and the extraction of the baby canine when a clinician suspects that the adult canine is displaced has become accepted clinical practice (Short, 2009). This appears to be on the basis of one report of a series of 35 children who received the intervention and no control group (Ericson and Kurol, 1988b). Two recent systematic reviews have examined the evidence for the effectiveness of removal of the primary canine with the aim of correcting the eruption path of a palatally displaced canine. A recent systematic review published in The Cochrane Library in 2021 (Benson et al., 2021) noted that the evidence for any intervention to correct the eruption path of a displaced permanent canine is weak and further research is required. Numerous problems with the reported studies were identified by both reviews.
Other authors have suggested that using a RME (Rapid Maxillary expansion) or headgrear (EOT) to create sufficient space within the dental arch for the permanent canine tooth will encourage the tooth to erupt (Baccetti et al., 2011). This approach might be less traumatic to a child who may have had no experience of dental treatment, other than routine check-ups. If either or both approaches are shown to be effective then their widespread use would be advantageous to both the child and the healthcare provider, because the need for an operation, under general anaesthetic, to uncover the tooth and extensive brace treatment to straighten the tooth will be avoided. conditions: Ectopic Tooth Eruption conditions: Palatal Expansion Technique conditions: Randomized Clinical Trial studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: PREVENTION masking: SINGLE whoMasked: OUTCOMES_ASSESSOR count: 318 type: ESTIMATED name: Extraction of the primary canine teeth name: Expansion measure: Succeful eruption of the palatally displaced canines into the dental arch measure: Cost effectiveness of the interventions measure: Prevalence and severity of damage to surrounding teeth either due to the unerupted tooth or orthodontic intervention. sex: ALL minimumAge: 10 Years maximumAge: 12 Years stdAges: CHILD facility: Gothenbrug University status: RECRUITING city: Gothenburg country: Sweden name: Farhan Bazargani, DDS, PhD role: CONTACT name: Björn Ludwig, DDS, PhD role: PRINCIPAL_INVESTIGATOR name: Martyn Coborune, DDS, PhD role: PRINCIPAL_INVESTIGATOR lat: 57.70716 lon: 11.96679 hasResults: False
<|newrecord|> nctId: NCT06267976 id: REB23-1003 briefTitle: Validation of the ProSomnus® RPMO2 Device overallStatus: NOT_YET_RECRUITING date: 2024-04-10 date: 2024-05-31 date: 2024-06-30 date: 2024-02-20 date: 2024-04-02 name: ProSomnus Sleep Technologies class: INDUSTRY briefSummary: The purpose of the study is to:
1. Evaluate the SpO2 accuracy of the oximeter component of the ProSomnus RPMO2 Device during non-motion conditions over the range of 70-100% SaO2 by comparison to SaO2 values determined by arterial blood sample specimen analyzed by a CO-oximeter.
2. Evaluate the pulse rate performance simultaneously collected over the SpO2 range. conditions: Healthy studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: PROSPECTIVE count: 15 type: ESTIMATED name: ProSomnus RPMO2 measure: SpO2 accuracy measure: Pulse rate accuracy sex: ALL minimumAge: 18 Years maximumAge: 50 Years stdAges: ADULT facility: University of Calgary city: Calgary state: Alberta zip: T2N4N1 country: Canada name: Brad Hansen role: CONTACT phone: 403-210-8925 email: bhanse@ucalgary.ca lat: 51.05011 lon: -114.08529 hasResults: False
<|newrecord|> nctId: NCT06267963 id: C4391010 id: 2023-507074-40-00 type: REGISTRY domain: CTIS (EU) briefTitle: A Study to Understand What the Body Does to the Study Medicine Called PF-07220060 When Taken by Healthy Adults overallStatus: ACTIVE_NOT_RECRUITING date: 2024-01-31 date: 2024-04-18 date: 2024-04-18 date: 2024-02-20 date: 2024-04-16 name: Pfizer class: INDUSTRY briefSummary: The purpose of this study is to learn about how much PF-07220060 will be taken up and processed by healthy male participants.
The study is seeking for participants who:
* are males aged 18 to 65 years and are healthy.
* have Body mass index (BMI) between 17.5 and 30.5 kilograms/meter2
* have a total body weight of at least 50 kilograms.
The study consists of two groups. In group 1, participants will take one amount of PF-07220060 by mouth. In group 2, participants will take one amount by mouth and one amount as an injection through a vein at the study clinic.
In group 1, participants will stay at the clinic site for up to 15 days. In group 2, the duration of participants' stay depends on the results of group 1.
During their stays, participants will have their blood, urine, and feces collected by the study doctors several times. We will measure the level of PF-07220060 in participants' blood, urine, and feces samples. This will help to know how much the study medicine is getting taken up by the body. At the end of the study, participants will be contacted by phone to check in. Participants will be involved in this study for about 9 weeks from the screening until the follow-up. conditions: Healthy Participants studyType: INTERVENTIONAL phases: PHASE1 allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: BASIC_SCIENCE masking: NONE count: 12 type: ACTUAL name: Oral [14C]PF-07220060 name: Oral PF-07220060 name: IV [14C] PF-07220060 measure: Cumulative recovery (%) of radioactivity in urine and feces (adjusted for vomitus, if any), expressed as a percent of total oral radioactive dose administered. measure: Amount of metabolites of [14C]PF-07220060 in plasma, urine, and feces. measure: Dose normalized AUCinf of intravenous radiolabeled PF-07220060 in plasma (if data permit) measure: The absolute oral bioavailability (F) of PF-07220060 measure: The fraction of PF-07220060 dose absorbed (Fa) measure: Number of participants with treatment emergent clinically significant laboratory abnormalities measure: Number of participants with treatment emergent clinically significant abnormal ECG measurements measure: Number of participants with treatment emergent clinically significant abnormal vital measurements measure: Number of Participants With Treatment-Emergent Adverse Events (AEs) or Serious Adverse Events (SAEs) measure: Number of participants with treatment emergent clinically significant abnormal physical examination sex: MALE minimumAge: 18 Years maximumAge: 65 Years stdAges: ADULT stdAges: OLDER_ADULT facility: PRA Health Sciences city: Groningen zip: 9728 NZ country: Netherlands lat: 53.21917 lon: 6.56667 hasResults: False
<|newrecord|> nctId: NCT06267950 id: PILUO-INFANT briefTitle: Effect of Oral Feeding in Infants With Pierre Robin Syndrome overallStatus: RECRUITING date: 2024-02-29 date: 2024-10 date: 2024-10 date: 2024-02-20 date: 2024-03-06 name: Zeng Changhao class: OTHER briefSummary: This was a randomized controlled study. The infants enrolled were randomly divided into the IOE group (with Intermittent Oro-Esophageal Tube Feeding) and the PNG group (with Nasogastric Tube Feeding), all receiving systemic therapy. Before and after 4-week treatment, pulmonary infection, swallowing function, nutritional status and body weight between the two group were compared. conditions: Pierre Robin Syndrome studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: DOUBLE whoMasked: INVESTIGATOR whoMasked: OUTCOMES_ASSESSOR count: 60 type: ESTIMATED name: systematic therapy name: intermittent oro-esophageal tube feeding name: gastric tube feeding measure: Number of patients diagnosed as the pulmonary infection "Positive" measure: Nutritional status-total protein measure: Nutritional status-hemoglobin measure: Nutritional status-albumin measure: Body weight measure: The Functional Oral Intake Scale for Infants sex: ALL minimumAge: 1 Month maximumAge: 12 Months stdAges: CHILD facility: Hsinchu Rehabilitation Hospital status: RECRUITING city: Xinzhu country: Taiwan name: Haim Liu, Master role: CONTACT lat: 22.46205 lon: 120.47335 hasResults: False
<|newrecord|> nctId: NCT06267937 id: 101 briefTitle: Hip Fractures in Chile: Implications for Public Health Policy and Healthcare Delivery overallStatus: COMPLETED date: 2023-03-10 date: 2023-03-10 date: 2024-01-30 date: 2024-02-20 date: 2024-02-20 name: University of Chile class: OTHER name: Instituto Sistemas Complejos de Ingeniería, Universidad de Chile, Santiago, Chile briefSummary: Hip fractures in individuals aged 60 and above pose significant challenges in terms of morbidity, mortality, and healthcare costs. While countries like the United Kingdom and Australia have optimized their healthcare systems for timely management of hip fractures, the situation in Chile presents distinct challenges due to its mixed healthcare system. This study aims to assess survival rates following hip fractures in Chile and identify associated risk factors using national databases from 2012 to 2018. A comprehensive analysis of 35,520 patients revealed that factors such as age, type of health insurance, access to surgery, and treatment in public hospitals significantly influence mortality rates after hip fractures. The study found that patients with hip fractures experience lower 5-year survival rates compared to the general population, particularly when affiliated with public insurance and treated in public institutions. Modifiable factors like delayed surgery and prolonged hospital stays contribute to increased mortality rates. The findings underscore the urgent need for optimized public health policies and healthcare delivery systems to enhance outcomes for hip fracture patients in Chile.Hip fractures in individuals aged 60 and above pose significant challenges in terms of morbidity, mortality, and healthcare costs. While countries like the United Kingdom and Australia have optimized their healthcare systems for timely management of hip fractures, the situation in Chile presents distinct challenges due to its mixed healthcare system. This study aims to assess survival rates following hip fractures in Chile and identify associated risk factors using national databases from 2012 to 2018. conditions: Hip Fractures studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: RETROSPECTIVE count: 46380 type: ACTUAL name: Access to surgery name: type of intitution measure: survival after hip fracture sex: ALL minimumAge: 60 Years stdAges: ADULT stdAges: OLDER_ADULT facility: hospital Clinico Universidad de Chile city: Santiago state: Region Metropolitana zip: 8380456 country: Chile lat: -33.45694 lon: -70.64827 hasResults: False
<|newrecord|> nctId: NCT06267924 id: Olith10703 briefTitle: SENSE-VM: Safety and Effectiveness of a Novel Medical Device for Symptom Ease in Vestibular Migraines overallStatus: ENROLLING_BY_INVITATION date: 2024-02-28 date: 2024-08-31 date: 2024-09-30 date: 2024-02-20 date: 2024-03-19 name: Otolith Labs class: INDUSTRY name: MCRA briefSummary: The goal of this virtual clinical trial is to compare the effectiveness of two study devices in providing temporary relief to adults aged 18-75 who suffer from symptoms of chronic Vestibular Migraines (VM), also known as Migraine Associated Vertigo.
Participants will be:
* Enrolled up to 50 days; enrollment, 14 days in Baseline Phase (no device), 7 days in Transition Phase, 28 days in Treatment Phase (study device)
* Randomized and stratified into groups based on the referring clinic to be assigned one study device
* Asked to use the study device as instructed by the study coordinator
* Asked to submit daily diaries reporting their symptoms and use of device, and to participate in tele-health visits with study coordinators
* Asked to provide their vertigo diagnosis from their physician
* Compensated for their participation
Researchers will compare the randomized groups to determine which group responds better to which device. conditions: Vestibular Migraine conditions: Migraine Associated Vertigo studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL interventionModelDescription: The proposed clinical trial for the study device will be a randomized, sham-controlled, double-blind study with two-parallel arms (active/sham device). primaryPurpose: TREATMENT masking: DOUBLE whoMasked: PARTICIPANT whoMasked: INVESTIGATOR count: 200 type: ESTIMATED name: Otoband Experimental name: Otoband Sham measure: DHI Change in Scores measure: Number of related adverse events measure: Change in number of vestibular migraine episodes weekly measure: Global Impression of Change (severity of episodes) measure: DHI change from transition to end of study measure: Device responder rate sex: ALL minimumAge: 18 Years maximumAge: 75 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Otolith Labs city: Washington state: District of Columbia zip: 20001 country: United States lat: 38.89511 lon: -77.03637 hasResults: False
<|newrecord|> nctId: NCT06267911 id: 202223-10 id: 160/U/2022 type: OTHER_GRANT domain: Fundació La Marató de TV3 briefTitle: Rehabilitation Gaming System for Intensive Care Units acronym: RGS-ICU overallStatus: NOT_YET_RECRUITING date: 2024-05 date: 2026-04 date: 2026-04 date: 2024-02-20 date: 2024-04-23 name: University of the Balearic Islands class: OTHER name: Corporacion Parc Tauli name: Hospital Son Llatzer name: Fundació La Marató de TV3 briefSummary: Admission to an Intensive Care Unit (ICU) is a potentially traumatic experience for a mentally vulnerable person. Beyond the stress and anxiety associated with the ICU environment and medical procedures, survivors of critical illness are at risk of developing cognitive and psychological sequelae related to Post-Intensive Care Syndrome (PICS). These disorders are associated with high economic, medical and personal costs.
This trial aims to evaluate the efficacy of an innovative neuropsychological e-health intervention for early cognitive stimulation and psychological support of people in critical care, i.e. the Rehabilitation Gaming System for Intensive Care Units (RGS-ICU) intervention, in improving comfort during ICU admission and cognition and mental health three and 12 months after ICU discharge. The RGS-ICU intervention, applied as an adjunct to standard ICU care, is based on non-immersive virtual reality techniques and has been specifically designed and developed to suit the needs of people in critical care and the characteristics of the ICU environment. To ensure the safety of the intervention, participants' physiological parameters will be automatically recorded by advanced continuous monitoring systems as part of standard ICU care.
The investigadors hypothesize that the cognitive stimulation and psychological support protocols of the RGS-ICU intervention, applied as an adjunct to standard ICU care, in addition to being safe for people in critical care units, will improve comfort during ICU admission and cognitive and mental health outcomes after ICU discharge, compared to receiving standard ICU care alone.
The findings derived from this trial may contribute to establish a novel and superior paradigm of human-centered ICU care to improve the comfort of people admitted to the ICU. This achievement could also have a relevant impact on medical and economic costs during ICU admission, and on functionality and health-related quality of life after ICU discharge associated with the reduction of cognitive and psychological sequelae linked to PICS.
The RGS-ICU intervention has been designed at Corporacion Parc Taulí with the collaboration of the University of the Balearic Islands and has been developed by Eodyne Systems S.L., a company dedicated to the development of science-based technological solutions for intervention, monitoring, diagnosis, and prognosis in stroke and other brain disorders. conditions: Critical Illness studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: NONE count: 80 type: ESTIMATED name: Cognitive stimulation and psychological support (RGS-ICU) measure: Attention performance measure: Working memory performance measure: Learning/memory performance measure: Executive function performance measure: Processing speed performance measure: Incidence of Treatment-Emergent Adverse Events [Safety] measure: Dyspnea intensity measure: Pain intensity measure: Worry intensity measure: Sadness intensity measure: Comfort experienced measure: Anxiety symptoms measure: Symptoms of depression measure: Symptoms of post-traumatic stress disorder measure: Subjective cognition measure: Functionality measure: Health-related quality of life sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: University of the Balearic Islands city: Palma De Mallorca state: Balearic Islands zip: 07122 country: Spain name: Guillem Navarra-Ventura, PhD role: CONTACT phone: +34971259888 email: g.navarra@uib.es lat: 39.56939 lon: 2.65024 facility: Hospital Universitari Son Llàtzer city: Palma De Mallorca state: Balearic Islands zip: 07198 country: Spain name: Gemma Rialp, MD, PhD role: CONTACT phone: +34871202000 email: grialp@ssib.es lat: 39.56939 lon: 2.65024 facility: Corporacion Parc Tauli city: Sabadell state: Catalonia zip: 08208 country: Spain name: Sol Fernández-Gonzalo, PhD role: CONTACT phone: +34937236673 email: msfernandez@tauli.cat lat: 41.54329 lon: 2.10942 hasResults: False
<|newrecord|> nctId: NCT06267898 id: EBMT- 842205547 briefTitle: Non Interventional Study on Iron Toxicity After First Allo-transplant in MDS/CMML overallStatus: COMPLETED date: 2009-11-01 date: 2015-01-29 date: 2015-05-21 date: 2024-02-20 date: 2024-02-20 name: European Society for Blood and Marrow Transplantation class: NETWORK name: Novartis briefSummary: Stem cell transplantation and blood product transfusions are standard of care for Myelodysplastic Syndromes (MDS). Several studies have shown changes in serum ferritin and non-transferrin-bound iron (NTBI) in patients undergoing stem cell transplantation. A large proportion of MDS patients are at risk for organ damage from tissue siderosis, due to the development of iron overload.
Toxic effects of iron may play an important role in the complications associated with HSCT. Iron chelation therapy may reduce the acute and chronic treatment-related toxicity by removing excess of iron, iron radicals and reactive oxygen species (ROS).
There is little information about the efficacy and safety of iron chelation in MDS patients. This audit wants to evaluate the effect of iron toxicity on treatment-related mortality in untreated, adult MDS or CMML patients during and after treatment with myeloablative conditioning (MAC) and reduced intensity conditioning (RIC) allo-HSCT, by prospectively collecting data from 200 MDS or CMML patients from 2009 onwards. conditions: MDS conditions: CMML studyType: OBSERVATIONAL observationalModel: CASE_ONLY timePerspective: PROSPECTIVE count: 222 type: ACTUAL measure: non-relapse mortality (treatment related mortality). measure: treatment-related toxic effects measure: relapse rate measure: event-free survival measure: overall survival sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Antwerp University Hospital (UZA) city: Antwerp zip: 2650 country: Belgium lat: 51.21989 lon: 4.40346 facility: University Hospital Gasthuisberg city: Leuven zip: 3000 country: Belgium lat: 50.87959 lon: 4.70093 facility: University of Liege city: Liege zip: 4000 country: Belgium lat: 50.63373 lon: 5.56749 facility: Charles University Hospital city: Pilsen zip: 304 60 country: Czechia lat: 49.74747 lon: 13.37759 facility: University Hospital city: Essen zip: 45122 country: Germany lat: 51.45657 lon: 7.01228 facility: University Hospital Leipzig city: Leipzig zip: 04103 country: Germany lat: 51.33962 lon: 12.37129 hasResults: False
<|newrecord|> nctId: NCT06267885 id: Children NOF fracture fixation briefTitle: Fixation of Fracture Neck of Femur in Children overallStatus: NOT_YET_RECRUITING date: 2024-03 date: 2026-02 date: 2026-03 date: 2024-02-20 date: 2024-02-20 name: Assiut University class: OTHER briefSummary: Find the best way for fixation of fracture neck of femur in children either by cannulated screws or wagner's technique conditions: Fracture Neck of Femur studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: TRIPLE whoMasked: PARTICIPANT whoMasked: INVESTIGATOR whoMasked: OUTCOMES_ASSESSOR count: 42 type: ESTIMATED name: Cannulated screws vs wagner's technique measure: The better method for fixation of fracture neck of femur sex: ALL minimumAge: 1 Year maximumAge: 14 Years stdAges: CHILD facility: Assiut university city: Assiut country: Egypt name: Mina Maged role: CONTACT lat: 27.18096 lon: 31.18368 hasResults: False
<|newrecord|> nctId: NCT06267872 id: HVTN 309 briefTitle: A Clinical Trial in Adult Participants Without HIV and in Overall Good Health to Evaluate the Safety and Immunogenicity of CD4BS CH505M5 Pr-NP1 Followed by CH505 TF chTrimer Boost Both Adjuvanted With Either Lipid Nanoparticles (LNPs) or 3M-052-AF + Alum overallStatus: NOT_YET_RECRUITING date: 2024-05-31 date: 2025-12-12 date: 2026-07-11 date: 2024-02-20 date: 2024-02-20 name: National Institute of Allergy and Infectious Diseases (NIAID) class: NIH name: National Institutes of Health (NIH) name: Department of Health and Human Services name: Duke University name: Access to Advanced Health Institute (AAHI) briefSummary: This is a multicenter, open-label, phase 1 clinical trial to test two human immunodeficiency virus (HIV) vaccines with two adjuvants. An adjuvant is an ingredient used with some vaccines that may help people make an immune response. HIV is the virus that causes acquired immunodeficiency syndrome (AIDS).
About 42 people will take part in the HVTN 309 clinical trial. This clinical trial will take place at multiple sites in the US and South Africa and the clinical trial is divided into 3 parts: Part A, Part B and Part C. About 3 people will participate in Part A of this study. After results from Part A are reviewed, it will be determined whether or not Part B and Part C of the clinical trial will proceed. conditions: HIV studyType: INTERVENTIONAL phases: PHASE1 allocation: RANDOMIZED interventionModel: SEQUENTIAL primaryPurpose: PREVENTION masking: NONE count: 42 type: ESTIMATED name: CD4BS CH505M5 Pr-NP1 name: CH505TF chTrimer name: 3M-052-AF (labeled as AP 60-702) name: Aluminum Hydroxide Suspension (Alum) name: ACU-026-001-1 (labeled as empty LNP) measure: Frequency of local reactogenicity signs and symptoms after receipt of any study vaccine measure: Frequency of systemic reactogenicity signs and symptoms after receipt of any study vaccine measure: Number of serious adverse events (SAEs) leading to early participant withdrawal or permanent discontinuation measure: Number of medically attended adverse events (MAAEs) leading to early participant withdrawal or permanent discontinuation measure: Number of adverse events of special interest (AESIs) leading to early participant withdrawal or permanent discontinuation measure: Number of adverse events (AEs) leading to early participant withdrawal or permanent discontinuation measure: Part C only: Frequency of the CD4BS and CH505M5, G458Y, GNT1-specific, N280D KO IgG+ memory B cells, as assessed by flow cytometry measure: Part C only: Response rate of serum Ab neutralization of vaccine-matched tier 2 HIV-1 strains as measured by TZM-bl assay measure: Part C only: Magnitude of serum Ab neutralization of vaccine-matched tier 2 HIV-1 strains as measured by TZM-bl assay measure: Parts B and C: Response rate of serum IgG binding Abs to autologous and heterologous HIV Env stabilized trimers, as assessed by binding antibody multiplex assay (BAMA) measure: Parts B and C: Magnitude of serum IgG binding Abs to autologous and heterologous HIV Env stabilized trimers, as assessed by binding antibody multiplex assay (BAMA) measure: Part B only: Response rate of serum Ab neutralization of vaccine-matched tier 2 HIV-1 strains as measured by the TZM-bl assay measure: Part B only: Magnitude of serum Ab neutralization of vaccine-matched tier 2 HIV-1 strains as measured by the TZM-bl assay measure: Parts B and C: Response rate of differential serum Ab neutralization of precursor detection virus and corresponding epitope KO virus, as measured by TZM-bl assay measure: Parts B and C: Magnitude of differential serum Ab neutralization of precursor detection virus and corresponding epitope KO virus, as measured by TZM-bl assay measure: Parts B and C: Response rate of serum Ab neutralization of heterologous HIV-1 strains, as measured by TZM-bl assay measure: Parts B and C: Magnitude of serum Ab neutralization of heterologous HIV-1 strains, as measured by TZM-bl assay measure: Parts B and C: Response rate of CD4+ and CD8+ T-cell responses, as measured by flow cytometry measure: Parts B and C: Magnitude of CD4+ and CD8+ T-cell responses, as measured by flow cytometry measure: Part B only: Frequency of the CD4BS and CH505M5, G458Y, GNT1-specific, N280D KO IgG+ memory B cells, as assessed by flow cytometry sex: ALL minimumAge: 18 Years maximumAge: 55 Years stdAges: ADULT facility: Alabama CRS (Site ID: 31788) city: Birmingham state: Alabama zip: 35222 country: United States name: Heather Logan, A.N.P. role: CONTACT phone: 205-873-8686 email: heatherlogan@uabmc.edu lat: 33.52066 lon: -86.80249 facility: The Ponce de Leon Center CRS (Site ID: 5802) city: Atlanta state: Georgia zip: 30308 country: United States name: Ericka Patrick, M.S.N role: CONTACT phone: 404-616-6313 email: erpatri@emory.edu lat: 33.749 lon: -84.38798 facility: Vanderbilt Vaccine (VV) CRS (Site ID: 30352) city: Nashville state: Tennessee zip: 37232 country: United States name: Shonda E. Sumner, B.S.N. role: CONTACT phone: 615-343-6906 email: Shonda.sumner@vumc.org lat: 36.16589 lon: -86.78444 facility: Setshaba Research Centre CRS (Site ID: 31829) city: Soshanguve state: Gauteng zip: 0152 country: South Africa name: Magdeline K. Molapo role: CONTACT phone: 27-12-7992422 email: KMolapo@setshaba.org.za facility: Isipingo CRS (Site ID: 31635) city: Isipingo state: Kwa Zulu Natal zip: 4110 country: South Africa name: Girisha Kistnasami, B.Sc., D.P.M. role: CONTACT phone: 27-31-2423600 email: girisha.kistnasami@mrc.ac.za lat: -29.98639 lon: 30.91853 facility: Klerksdorp CRS (Site ID: 30325) city: Klerksdorp state: North West Province zip: 2571 country: South Africa name: Olebogeng Jonkane role: CONTACT phone: None Listed email: ojonkane@auruminstitute.org lat: -26.85213 lon: 26.66672 hasResults: False
<|newrecord|> nctId: NCT06267859 id: No. 2 of 2023/11/7 briefTitle: Development of Methods for Effective Treatment and Improvement of Common Somatic Diseases in Children overallStatus: RECRUITING date: 2023-11-08 date: 2033-12-30 date: 2034-01-30 date: 2024-02-20 date: 2024-02-28 name: Tashkent Pediatric Medical Institute class: OTHER briefSummary: The goal of the clinical study is to clarify the course of common congenital, infectious, and non-infectious diseases in children living in Uzbekistan, and to develop methods for their treatment and rehabilitation.
The main questions it aims to answer:
* Analysis of common congenital diseases among children;
* Analysis of commonly diagnosed bronchopulmonary and cardiovascular diseases among children;
* Based on the results of the primary research, common diseases among children will be identified;
* Analysis of existing treatment methods and their effectiveness;
* Development of modern methods of treatment and rehabilitation of children. conditions: Respiratory Diseases conditions: Congenital Heart Defects studyType: INTERVENTIONAL phases: EARLY_PHASE1 allocation: RANDOMIZED interventionModel: PARALLEL interventionModelDescription: identification of children from the group of "frequently ill children" primaryPurpose: SUPPORTIVE_CARE masking: SINGLE maskingDescription: working with children from the "frequently ill children" group whoMasked: PARTICIPANT count: 110 type: ESTIMATED name: The use of a combination of microelements and vitamins against the background of physiotherapy measure: Working with archival documentation. measure: Formation of a group of patients to study immunity and the antioxidant system in venous blood. measure: Clinical scientific research. measure: Clinical trial evaluation. sex: ALL minimumAge: 3 Days maximumAge: 15 Years stdAges: CHILD facility: Turdieva Shokhida Tolkunovna status: RECRUITING city: Tashkent state: Yunus-obad District zip: 100140 country: Uzbekistan name: Shokhida T Turdieva, M.D., D.Sc. role: CONTACT phone: +998935872570 email: Shohidahon69@mail.ru name: Kholida B Abdurashidova role: CONTACT phone: +998935092934 email: otdel.nayka@mail.ru name: Gulmira R Nasirova, Ph.D. role: SUB_INVESTIGATOR lat: 41.26465 lon: 69.21627 hasResults: False
<|newrecord|> nctId: NCT06267846 id: NBI-1070770-MDD2029 briefTitle: A Study to Evaluate the Efficacy and Safety of NBI-1070770 in Adults With Major Depressive Disorder overallStatus: RECRUITING date: 2024-03-20 date: 2025-09 date: 2025-12 date: 2024-02-20 date: 2024-04-12 name: Neurocrine Biosciences class: INDUSTRY briefSummary: To evaluate the efficacy, safety, and tolerability of NBI-1070770 compared to placebo on improving symptoms of depression in participants with major depressive disorder (MDD). conditions: Major Depressive Disorder studyType: INTERVENTIONAL phases: PHASE2 allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: TRIPLE whoMasked: PARTICIPANT whoMasked: CARE_PROVIDER whoMasked: INVESTIGATOR count: 72 type: ESTIMATED name: NBI-1070770 name: Placebo measure: Change in Total Montgomery-Åsberg Depression Rating Scale (MADRS) Score from Baseline to Day 5 measure: Change in Total MADRS Score from Baseline at Postbaseline Timepoints sex: ALL minimumAge: 18 Years maximumAge: 65 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Neurocrine Clinical Site status: RECRUITING city: Little Rock state: Arkansas zip: 72211 country: United States lat: 34.74648 lon: -92.28959 facility: Neurocrine Clinical Site status: RECRUITING city: Rogers state: Arkansas zip: 72758 country: United States lat: 36.33202 lon: -94.11854 facility: Neurocrine Clinical Site status: RECRUITING city: Lemon Grove state: California zip: 91945 country: United States lat: 32.74255 lon: -117.03142 facility: Neurocrine Clinical Site status: RECRUITING city: Long Beach state: California zip: 90806 country: United States lat: 33.76696 lon: -118.18923 facility: Neurocrine Clinical Site status: RECRUITING city: Hollywood state: Florida zip: 33024 country: United States lat: 26.0112 lon: -80.14949 facility: Neurocrine Clinical Site status: RECRUITING city: Decatur state: Georgia zip: 30030 country: United States lat: 33.77483 lon: -84.29631 facility: Neurocrine Clinical Site status: RECRUITING city: Savannah state: Georgia zip: 31405 country: United States lat: 32.08354 lon: -81.09983 facility: Neurocrine Clinical Site status: RECRUITING city: Gaithersburg state: Maryland zip: 20877 country: United States lat: 39.14344 lon: -77.20137 facility: Neurocrine Clinical Site status: RECRUITING city: North Canton state: Ohio zip: 44730 country: United States lat: 40.87589 lon: -81.40234 facility: Neurocrine Clinical Site status: RECRUITING city: Houston state: Texas zip: 77008 country: United States lat: 29.76328 lon: -95.36327 hasResults: False
<|newrecord|> nctId: NCT06267833 id: MSKUSBFFTR01 briefTitle: The Effect of Trunk and Upper Extremity Exercises Added to the Otago Exercise Program acronym: Otago Exercise overallStatus: NOT_YET_RECRUITING date: 2024-09-01 date: 2026-01-01 date: 2026-06-01 date: 2024-02-20 date: 2024-02-20 name: Muğla Sıtkı Koçman University class: OTHER briefSummary: This study is designed to investigate the effect of adding trunk and upper extremity exercises in traditional and mobile game formats to the Otago exercise program on balance performance, fall risk, and fear in older adults. A randomized controlled, cross-sectional, single-blind (evaluator) study will be conducted with 36 older adults aged 65 and older enrolled at Muğla Sıtkı Koçman University (MSKÜ) Elderly Studies Application and Research Center. Participants will be divided into three randomized groups: control group (12 individuals receiving the Otago exercise program), study group 1 (12 individuals receiving additional trunk and upper extremity exercises with traditional methods added to the Otago exercise program), and study group 2 (12 individuals receiving additional trunk and upper extremity exercises with mobile game method added to the Otago exercise program). Participant demographics informations will be recorded in Form 1. Participants' cognitive functions , levels of independence in activities of daily living, fall risk , and fear of falling will be evaluated. Balance performance will be assessed using the Mini Balance Evaluation Systems Test (Mini-BESTest), portable computerized kinetic balance measurement (SportKAT 650-TS), "5 Times Sit-to-Stand" and "Four-Stage Balance Test" from the Otago Exercise Program. Participants' body sway will be assessed simultaneously with the second part of the Mini-BESTest using a mobile application. All assessments will be conducted by a researcher blinded to the exercises, both before and after the exercises, in a one-on-one face-to-face setting. In the exercise protocol, a personalized, home-based, 30-minute Otago exercise program consisting of strength, balance, and walking exercises performed three times a week will be implemented for 8 weeks with home visits and telerehabilitation sessions (via Videoconferencing) under the supervision of the responsible researcher. In addition to the Otago exercise program, trunk and upper extremity exercises (totaling 45 minutes) will be implemented in study group 1 using traditional methods and in study group 2 using the mobile game method. Telerehabilitation sessions will be conducted via an Android-based tablet if the study is supported by Tübitak 1002 A Rapid Support Module. Individual smartphones of participants will be used if the study is not supported. All questionnaires, scales, and tests used in the initial assessments will be repeated at the end of the 8-week exercise protocol for all participants. conditions: Geriatrics conditions: Balance conditions: Exercise conditions: Fall Prevention studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: PREVENTION masking: SINGLE whoMasked: OUTCOMES_ASSESSOR count: 36 type: ESTIMATED name: exercise measure: Mini BESTest measure: Functional Reach Test measure: International Falls Efficacy Scale sex: ALL minimumAge: 65 Years stdAges: OLDER_ADULT hasResults: False
<|newrecord|> nctId: NCT06267820 id: 2010 briefTitle: Postoperative Pain Control by Adding Ketorolac to Bupivacaine in Transversus Abdominis Plane Block in Children overallStatus: COMPLETED date: 2023-06-01 date: 2023-12-01 date: 2023-12-10 date: 2024-02-20 date: 2024-02-20 name: Sohag University class: OTHER briefSummary: Control of of pain in children is fundamental. TAP block is associated with less side effects compared with other neuraxial techniques especially when done under ultrasound guidance.
Ketorolac has analgesic effect comparable to morphine. Children were arranged randomly into two equal groups, forty-five children in each.
Group (K) (n= 45): received ultrasound guided TAP block with bupivacaine 0.25% (0.5 ml/kg) and ketorolac (0.5 mg/kg).
Group (T) (n =45): received ultrasound guided TAP block with bupivacaine 0.25% (0.5 ml/kg) conditions: Postoperative Pain, Acute studyType: INTERVENTIONAL phases: PHASE2 allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: HEALTH_SERVICES_RESEARCH masking: QUADRUPLE whoMasked: PARTICIPANT whoMasked: CARE_PROVIDER whoMasked: INVESTIGATOR whoMasked: OUTCOMES_ASSESSOR count: 90 type: ACTUAL name: Bupivacain name: Ketorolac measure: 1st analgesic requirement measure: Number of patients who requested analgesia measure: heart rate measure: Total rescue analgesia measure: Satisfaction of the parents regarding their children analgesia measure: Number of children in each group who required analgesia in the first 24 h postoperatively measure: blood pressure sex: ALL minimumAge: 6 Years maximumAge: 12 Years stdAges: CHILD facility: Fouad Ibrahim Soliman city: Sohag zip: 52514 country: Egypt lat: 26.55695 lon: 31.69478 hasResults: False
<|newrecord|> nctId: NCT06267807 id: 114369 id: NL84520.091.23 type: OTHER domain: Protocol ID METC briefTitle: Lymphatic Phenotype in Noonan Syndrome Spectrum Disorders acronym: LENS overallStatus: RECRUITING date: 2024-03-27 date: 2025-03-13 date: 2025-06-01 date: 2024-02-20 date: 2024-02-20 name: Radboud University Medical Center class: OTHER briefSummary: To get a better insight into the central conducting lymphatic system in adult volunteers with Noonan Syndrome (NS) without clinical symptoms or signs of lymphatic disease compared to NS and CardioFacioCutaan syndrome patients with severe lymphatic disease conditions: Lymphatic System Disorders Congenital conditions: Lymphatic Diseases conditions: Noonan Syndrome conditions: Lymphatic Disease studyType: INTERVENTIONAL phases: NA allocation: NA interventionModel: SINGLE_GROUP primaryPurpose: DIAGNOSTIC masking: NONE count: 15 type: ESTIMATED name: Dynamic contrast-enhanced lymphangiography measure: Central lymphatic system anatomy and flow descriptive parameters. measure: Diameter Thoracic duct measure: Lymph flow velocity measure: Demographics age measure: Demographics gender measure: Demographics measure: Demographics weight measure: Demographics clinical history measure: Demographics genetic background sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Radboudumc status: RECRUITING city: Nijmegen state: Gelderland zip: 6500 HB country: Netherlands name: Lotte ER Kleimeier, Msc role: CONTACT phone: 024036106873 email: lotte.kleimeier@radboudumc.nl lat: 51.8425 lon: 5.85278 hasResults: False
<|newrecord|> nctId: NCT06267794 id: ODISEA Study briefTitle: Prolonged Release Pirfenidone Versus Placebo in Compensated Cirrhosis. acronym: ODISEA overallStatus: COMPLETED date: 2015-06-26 date: 2021-12-30 date: 2023-03-24 date: 2024-02-20 date: 2024-02-20 name: Jorge L Poo class: OTHER briefSummary: This will be a multicenter, double-blind clinical trial to evaluate the safety and efficacy of two doses of prolonged release pirfenidone, compared against placebo plus conventional therapy in patients with compensated liver cirrhosis. The study will be conducted in compliance with International Standard good clinical practices (GCPs) and the Declaration of Helsinki. The protocol is approved by a local Institutional Review Board and registered in clinical trials.gov. conditions: Liver Fibrosis conditions: Cirrhosis, Liver conditions: Chronic Liver Disease studyType: INTERVENTIONAL phases: PHASE2 allocation: RANDOMIZED interventionModel: PARALLEL interventionModelDescription: Double blind, placebo-controlled multicenter study primaryPurpose: TREATMENT masking: TRIPLE maskingDescription: Placebo will be identical to medication.
Methods to assign treatment:
Before assigning numbers to subjects, the researcher must confirm that the inclusion criteria have been met, that none of the exclusion criteria apply, that written and signed informed consent has been obtained, that the evaluations of the scrutiny (of admission) and that the required laboratory results are available and meet the admission criteria. To do this, the centers will be assisted with a check list format that contains all the selection criteria.
The person responsible for the medication at the research site will contact the Randomization center, where the treatment will be assigned to the patient. whoMasked: PARTICIPANT whoMasked: CARE_PROVIDER whoMasked: INVESTIGATOR count: 180 type: ACTUAL name: Pirfenidone 1200 mg name: Pirfenidone 1800 mg name: Placebo measure: Change in liver fibrosis measure: Clinical side effects measure: Improvement in Child Pugh score measure: Improvement in MELD score measure: Improvement in bilirrubin and albumin measure: Improvement in prothrombin time measure: Improvement in liver enzymes measure: Improvement in EuroQol Visual analog scales measure: Improvement in EuroQol five dimensions Scale measure: Improvement in modified fatigue impact scale (MFIS) sex: ALL minimumAge: 18 Years maximumAge: 80 Years stdAges: ADULT stdAges: OLDER_ADULT hasResults: False
<|newrecord|> nctId: NCT06267781 id: TRANSPLANT-PRO briefTitle: RRMS: Disease PROgression and Myeloid Profiling After Bone Marrow TRANSPLANTation and Second Line Therapies acronym: TRANSPLANTPRO overallStatus: RECRUITING date: 2022-09-02 date: 2027-09-02 date: 2027-09-02 date: 2024-02-20 date: 2024-02-20 name: IRCCS San Raffaele class: OTHER briefSummary: To study whether highly effective therapies can halt disease progression in people with multiple sclerosis by modulating the peripheral myeloid landscape. conditions: Multiple Sclerosis studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: PROSPECTIVE count: 30 type: ESTIMATED measure: Number of fading/disappearing paramagnetic rim lesions (PRLs) measure: Surrogate biomarkers of disease progression (MSFC) measure: Surrogate biomarkers of disease progression (sNfL) measure: Surrogate biomarkers of disease progression (RNFL) measure: Surrogate biomarkers of disease progression (cortical lesions) measure: Surrogate biomarkers of disease progression (atrophy) measure: Changes in myeloid landscape sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: IRCCS San Raffaele status: RECRUITING city: Milan zip: 20132 country: Italy name: Massimo Filippi, MD role: CONTACT phone: 00390226433054 email: filippi.massimo@hsr.it name: Anna A. Bellini, MD role: CONTACT phone: 00390226432154 email: bellini.anna@hsr.it lat: 45.46427 lon: 9.18951 typeAbbrev: Prot_SAP hasProtocol: True hasSap: True hasIcf: False label: Study Protocol and Statistical Analysis Plan date: 2022-05-03 uploadDate: 2024-02-15T03:19 filename: Prot_SAP_000.pdf size: 10630791 hasResults: False