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<|newrecord|> nctId: NCT06380400 id: 0000-0001-5786-4385 briefTitle: The Effect of Foot Bath on Birth Pain and Birth Comfort overallStatus: RECRUITING date: 2024-02-01 date: 2024-07-30 date: 2024-07-30 date: 2024-04-23 date: 2024-04-23 name: Selcuk University class: OTHER briefSummary: Although childbirth is seen as a natural, happy, meaningful and universal experience, women are often faced with severe pain, discomfort and a sensory state that can be overwhelming. There are two ways to reduce labour pain: pharmacological (drugs) and non-pharmacological (non-drug methods). Non-pharmacological methods, in particular, attempt to relieve pain by addressing emotional, cognitive, behavioural and socio-cultural dimensions. These methods provide relief and reduce the perception of pain. One of the non-pharmacological methods used to reduce labour pain is footbaths. Footbaths are widely used as a nurse/midwife intervention in many countries. Footbathing is a simple technique used to induce a sense of comfort and relaxation. It involves gently immersing the patient's legs and feet (below the knees) in a basin of warm water. Local heat treatments are generally safe and are considered an effective form of complementary medicine. In its simplest form it means "a tool to be part of supportive care, promoting peace, positive emotions, comfort, satisfaction and enjoyment". The mechanisms responsible for the effects of footbathing are not fully understood, but soaking the feet in warm water and stimulating the sense of touch through massage or washing can reduce sympathetic nerve activity, thereby reducing pain and increasing comfort. In other words, reducing pain during labour means providing support and comfort to the woman. This study was designed to evaluate the effect of a foot bath applied in the first stage of labour on labour pain and comfort in nulliparous women. conditions: Parturition studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: SUPPORTIVE_CARE masking: SINGLE whoMasked: PARTICIPANT count: 196 type: ESTIMATED name: Foot bath measure: Visuell analog scale score of the pregnant woman measure: Birth comfort scale score of the pregnant woman sex: FEMALE minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Habibe Bay Ozcalik status: RECRUITING city: Konya zip: 42250 country: Turkey name: Habibe Bay Ozcalik role: CONTACT phone: 05424469343 email: [email protected] lat: 37.87135 lon: 32.48464 hasResults: False |
<|newrecord|> nctId: NCT06380387 id: H-21046543 briefTitle: Whole Body Metabolism in Children Before and After Treatment of CNS Tumor overallStatus: RECRUITING date: 2023-03-23 date: 2025-12 date: 2026-12 date: 2024-04-23 date: 2024-04-23 name: Rigshospitalet, Denmark class: OTHER briefSummary: At the center of pediatric oncology in Copenhagen the investigators experience that the children with brain tumor, more or less have a healthy body with normal skeletal muscle mass and are physical active to the same level as their friends at the same age. The treatment period for brain tumor is approximately two years. After the treatment period, the children are more sedative with less interest in coming out doing physical activities and thus the investigators suspect that they have altered hormonal response, low skeletal muscle mass and perhaps are in risk of developing metabolic syndrome. |
By comparing children with newly diagnosed CNS tumor with children finished treated for CNS tumor, we wish to describe the metabolic path during the approximately two years treatment period these children go through. These results will also be compared with results from healthy controls. |
The investigators aim to include 10 children (aged 6-18 years) with newly diagnosed CNS tumor, 10 children (aged 6-18 years) finished treated for CNS tumor and 10 healthy controls (aged 6-18 years). By using stable isotope technique the investigators will investigate systemic fat, glucose and protein metabolism together with liver protein degradation and glucose production. Furthermore, by using DXA scan the investigators will describe the quality and distribution of skeletal muscle. Lastly, the investigators will determine the skeletal muscle signal pathway and metabolism in skeletal muscle via the Bergström biopsy technique in vastus lateralis. conditions: CNS Tumor, Childhood studyType: INTERVENTIONAL phases: NA allocation: NA interventionModel: SINGLE_GROUP primaryPurpose: BASIC_SCIENCE masking: NONE count: 30 type: ESTIMATED name: Meal measure: Protein breakdown measure: Protein synthesis measure: Phenylalanine concentration measure: Phe oxidation to TYR measure: Whole-body protein synthesis measure: Whole-body protein degradation measure: Netto protein balance measure: Glucose Rate of appearance measure: Total glucose Rate of appearance measure: Total glucose Rate of disappearance measure: Endogenous glucose measure: Oral phenylalanine Rate of appearance measure: Phenylalanine oxidation measure: Rate of Appearance of Palmitate in Plasma measure: Rate of Disappearance of Palmitate measure: Concentration of ketones measure: Glucose measure: Quality of Skeletal Muscle measure: Protein synthesis rate measure: Pain score measure: Life quality score measure: Muscle biopsy measure: Incretins measure: Glucagon measure: Liver parameters ALT, AST, GGT measure: Bilirubin measure: International normalized ratio (INR) measure: LDH measure: Insulin measure: catecholamines measure: Blood pressure measure: Waist- and hip circumference measure: Lipids measure: Concentration of Plasma Amino Acids measure: Concentration of Plasma Glucose measure: Concentration of Plasma Palmitate measure: Concentration of Plasma Free Fatty Acids measure: Level of HbA1c sex: ALL minimumAge: 6 Years maximumAge: 18 Years stdAges: CHILD stdAges: ADULT facility: Department of Pediatrics and Adolescent Medicine and Copenhagen Neuromuscular Center, Rigshospitalet status: RECRUITING city: Copenhagen state: Copenhagen Ø zip: 2100 country: Denmark name: Mette Cathrine Ørngreen, MD, DMSc role: CONTACT phone: 35455935 email: [email protected] name: Mette Cathrine Ørngreen, MD, DMSc role: PRINCIPAL_INVESTIGATOR lat: 55.67594 lon: 12.56553 hasResults: False |
<|newrecord|> nctId: NCT06380374 id: 2024\01 briefTitle: Gamification in Disaster Nursing Education overallStatus: NOT_YET_RECRUITING date: 2024-04-22 date: 2024-07-01 date: 2024-07-22 date: 2024-04-23 date: 2024-04-23 name: Selcuk University class: OTHER briefSummary: This research will be conducted as a randomized controlled study with a parallel design to evaluate the effectiveness of the disaster nursing training program prepared with a gamification strategy based on multiple intelligence theory for final-year public health nursing students. Research hypothesis "H1a: The disaster nursing knowledge level of the students participating in the program, which is prepared with a Gamification Strategy Based on Multiple Intelligence Theory, differs from the control group. H1b: The perception of volunteering towards disaster nursing differs for the students included in the Program Prepared with Gamification Strategy Based on Multiple Intelligence Theory compared to the control group. H1c: The self-efficacy level of students involved in the Program Prepared with Gamification Strategy Based on Multiple Intelligences Theory regarding disaster nursing differs from the control group." conditions: Gamification conditions: Nursing Students conditions: Multiple Intelligence Theory conditions: Disaster Nursing studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: OTHER masking: SINGLE whoMasked: PARTICIPANT count: 72 type: ESTIMATED name: Gamification in Disaster Nursing Education measure: Level of knowledge related to disaster nursing services measure: Volunteer intention to become a disaster nurse measure: Perception of self-efficacy related to disaster nursing sex: ALL stdAges: CHILD stdAges: ADULT stdAges: OLDER_ADULT facility: Selcuk University Faculty of Nursing city: Konya state: Selcuklu zip: 42000 country: Turkey name: Sema Yilmaz Dean, MD role: CONTACT phone: +903322230763 email: [email protected] lat: 37.87135 lon: 32.48464 hasResults: False |
<|newrecord|> nctId: NCT06380361 id: SEN-ONCO-1 briefTitle: InvestigatioN of a Smart Probe for Lung lEsion Characterization Using Impedance Technology acronym: INSPECT overallStatus: NOT_YET_RECRUITING date: 2024-04-20 date: 2025-03-31 date: 2025-04-01 date: 2024-04-23 date: 2024-04-23 name: Sensome class: INDUSTRY briefSummary: The objective of the study is to evaluate the feasibility of the BioSpy System sensor to differentiate tissues that are encountered during bronchoscopic biopsy of endobronchial tumors and peripheral lung nodules and masses. conditions: Lung Cancer studyType: INTERVENTIONAL phases: NA allocation: NA interventionModel: SINGLE_GROUP interventionModelDescription: Patient with suspected lung cancer coming to the hospital for bronchoscopic biopsy will be selected for this trial. primaryPurpose: OTHER masking: NONE maskingDescription: No masking count: 30 type: ESTIMATED name: BioSpy System measure: The ability of BioSpy System to acquire electrophysiological measurements in the relevant tissues during bronchoscopic biopsy. measure: The ability of BioSpy Sysem to differentiate the lesion from healthy tissue measure: The ability of BioSpy Sysem to differentiate various lesion types sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT hasResults: False |
<|newrecord|> nctId: NCT06380348 id: JMT101-012 briefTitle: JMT101 in Combination With Osimertinib, Versus Cisplatin-pemetrexed in Participants With Locally Advanced or Metastatic Non-small Cell Lung Cancer (NSCLC) Characterized by Epithermal Growth Factor Receptor (EGFR) Exon 20ins Mutations overallStatus: NOT_YET_RECRUITING date: 2024-04-26 date: 2027-03-26 date: 2028-03-26 date: 2024-04-23 date: 2024-04-23 name: Shanghai JMT-Bio Inc. class: INDUSTRY briefSummary: This is a multicenter, randomized, open-label, parallel-controlled phase 3 study. This study aims to evaluate the efficacy and safety of JMT101 combined with Osimertinib compared with Cisplatin combined with pemetrexed in participants with local advanced or metastatic non-small-cell lung cancer harboured EGFR 20ins mutation without prior systemic therapy. |
Primary objective of this study is to assess the efficacy of JMT101 combined with Osimertinib versus Cisplatin combined with pemetrexed using by （Independent Review Center）IRC-assessed Progression Free Survival (PFS) per RECIST 1.1 as primary endpoint. Approximately 398 participants are estimated to be randomized into the study. Participants enrolled will be randomized to JMT101 or Cisplatin chemotherapy in a 1:1 manner, stratified by baseline brain metastasis (with/without) and Eastern Cooperative Oncology Group (ECOG) Performance Status (PS) (0 versus 1). conditions: Local Advanced or Metastatic NSCLC studyType: INTERVENTIONAL phases: PHASE3 allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: NONE count: 398 type: ESTIMATED name: JMT101 Injection name: Osimertinib tablet name: Cisplatin injection name: Pemetrexed injection measure: Progression Free Survival (PFS) as assessed by Independent Review Center (IRC) per RECIST 1.1 measure: Overall Survival (OS) measure: Overall Response Rate (ORR) by IRC per RECIST 1.1 measure: Duration of Response (DoR) by IRC per RECIST 1.1 measure: PFS by investigator per RECIST 1.1 measure: ORR by investigator per RECIST 1.1 measure: DoR by investigator per RECIST 1.1 sex: ALL minimumAge: 18 Years maximumAge: 75 Years stdAges: ADULT stdAges: OLDER_ADULT hasResults: False |
<|newrecord|> nctId: NCT06380335 id: RTX001-01S briefTitle: Study in Patients With Decompensated Liver Cirrhosis acronym: OPAL overallStatus: RECRUITING date: 2023-10-10 date: 2024-12-31 date: 2026-11-03 date: 2024-04-23 date: 2024-04-23 name: Resolution Therapeutics Limited class: NETWORK briefSummary: OPAL is a multicenter observational study, following the natural disease trajectory of participants who have permanent damage to their liver caused by scarring, sometimes also referred to as liver cirrhosis. These participants will also have recently had an acute worsening of their liver disease, which is also known as a hepatic decompensating event, which has resulted in them being admitted to hospital or required them to seek medical attention as an outpatient. conditions: Liver Cirrhosis studyType: OBSERVATIONAL observationalModel: OTHER timePerspective: PROSPECTIVE count: 240 type: ESTIMATED measure: Examine the characteristics of patients admitted to hospital with hepatic decompensation. measure: Examine the characteristics of patients admitted to hospital with hepatic decompensation. measure: Examine the characteristics of patients admitted to hospital with hepatic decompensation. measure: Examine the characteristics of patients admitted to hospital with hepatic decompensation. measure: Examine the characteristics of patients admitted to hospital with hepatic decompensation. measure: Examine the characteristics of patients admitted to hospital with hepatic decompensation. measure: Follow the natural history of patients admitted to hospital with hepatic decompensation. measure: Follow the natural history of patients admitted to hospital with hepatic decompensation. measure: Follow the natural history of patients admitted to hospital with hepatic decompensation. measure: Follow the natural history of patients admitted to hospital with hepatic decompensation. measure: Examine the characteristics and natural history of patients with medically refractory ascites that do not require hospitalisation. measure: Examine the characteristics and natural history of patients with medically refractory ascites that do not require hospitalisation. measure: Examine the characteristics and natural history of patients with medically refractory ascites that do not require hospitalisation. measure: Examine the characteristics and natural history of patients with medically refractory ascites that do not require hospitalisation. measure: Examine the characteristics and natural history of patients with medically refractory ascites that do not require hospitalisation. measure: Examine the characteristics and natural history of patients with medically refractory ascites that do not require hospitalisation. measure: Examine the characteristics and natural history of patients with medically refractory ascites that do not require hospitalisation. measure: Explore clinical and laboratory parameters. measure: Evaluate the effect of disease progression on biomarkers of inflammatory activity sex: ALL minimumAge: 18 Years maximumAge: 75 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Bristol Royal Infirmary status: RECRUITING city: Bristol zip: BS2 8HW country: United Kingdom lat: 51.45523 lon: -2.59665 facility: Royal Infirmary Edinburgh status: RECRUITING city: Edinburgh zip: EH16 4SA country: United Kingdom lat: 55.95206 lon: -3.19648 facility: Royal Liverpool Hospital status: RECRUITING city: Liverpool zip: L7 8XP country: United Kingdom lat: 53.41058 lon: -2.97794 facility: Royal Free Hospital status: RECRUITING city: London zip: NW3 2QG country: United Kingdom lat: 51.50853 lon: -0.12574 facility: King's College Hospital status: RECRUITING city: London zip: SE5 9RS country: United Kingdom lat: 51.50853 lon: -0.12574 facility: St George's Hospital status: RECRUITING city: London zip: SW17 0QT country: United Kingdom lat: 51.50853 lon: -0.12574 facility: St Mary's Hospital status: RECRUITING city: London zip: W2 1NY country: United Kingdom lat: 51.50853 lon: -0.12574 facility: Nottingham University Hospital status: RECRUITING city: Nottingham zip: NG5 1PB country: United Kingdom lat: 52.9536 lon: -1.15047 facility: Sunderland Royal Hospital status: RECRUITING city: Sunderland zip: SR4 7TP country: United Kingdom lat: 54.90465 lon: -1.38222 hasResults: False |
<|newrecord|> nctId: NCT06380322 id: PBRC 2023-034 briefTitle: Military Health and Nutrition Examination Study acronym: MHANES overallStatus: NOT_YET_RECRUITING date: 2024-06-01 date: 2026-12-01 date: 2026-12-01 date: 2024-04-23 date: 2024-04-23 name: Pennington Biomedical Research Center class: OTHER name: U.S. Army Medical Research and Development Command briefSummary: The Military Health and Nutrition Examination Study (MHANES) is a Department of Defense funded study conducted by Pennington Biomedical Research Center and the US Army Research Institute of Environmental Medicine. This cross-sectional study will assess, in a large, diverse sample of Army Service Members (n=600), food and supplement intake, cardiovascular health, body composition, biomarkers of nutritional status, measures of health status, injury prevalence, mental wellbeing, gut microbiome composition, and physical performance outcomes. The proposed study is modeled after the National Health and Nutrition Examination Survey (NHANES) and customized for the Army population. conditions: Hypertension conditions: Type 2 Diabetes conditions: Dyslipidemias conditions: Cardiovascular Diseases studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: CROSS_SECTIONAL count: 600 type: ESTIMATED measure: Dietary intake measure: Dietary quality measure: Depression measure: Anxiety measure: Resilience measure: Posttraumatic stress disorder measure: Self-efficacy measure: Mood measure: Physical activity measure: Physical activity measure: Physical performance measure: Physical injuries measure: Sleep duration and quality measure: Sleep duration and quality measure: Eating behavior (Satiety) measure: Eating behavior (Fast Eating Rate) measure: Eating behavior (Slow Eating Rate) measure: Blood pressure measure: Anthropometric and body composition measures measure: Measures of anemia and iron status, nutrient status, hormone status, stress, cardiometabolic health, and inflammation measure: Albumin, iodine, and other biomarkers of health measure: Gut microbiome composition measure: Prescription and over-the-counter medication and supplement use measure: Resting metabolic rate (RMR) measure: Heart rate variability (HRV) measure: Genomics sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Pennington Biomedical Research Center city: Baton Rouge state: Louisiana zip: 70808 country: United States name: Claire E Berryman, PhD, RD role: CONTACT email: [email protected] lat: 30.45075 lon: -91.15455 hasResults: False |
<|newrecord|> nctId: NCT06380309 id: LY001-I001 briefTitle: A Clinical Study on Evaluating Intravenous Administration of IDOV-SAFE overallStatus: RECRUITING date: 2024-05-06 date: 2025-11-30 date: 2027-10-30 date: 2024-04-23 date: 2024-04-23 name: Peking University class: OTHER briefSummary: Subjects were inoperable Chinese patients with histologically or cytologically confirmed advanced malignant solid tumors (mainly focusing on MSS type colorectal cancer) who had failed standard systemic therapy. |
In the first stage, each subject was given three doses on day 1, day 3 and day 5, and was divided into 4 dose groups, including 1 subject in the first dose group and 3-6 subjects in each of the last three dose groups. The second stage was the dose extension stage, with 2 dose groups, at least 10 subjects were enrolled in the selected group, and the administration method was the same as that of the first stage. There were about 20-60 cases in the two stages. conditions: Advanced Malignant Solid Tumor of Digestive System studyType: INTERVENTIONAL phases: EARLY_PHASE1 allocation: NON_RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: SINGLE whoMasked: INVESTIGATOR count: 60 type: ESTIMATED name: IDOV-SAFE measure: Occurrence of dose-limiting toxicity (DLT) measure: Incidence of adverse events (AE) measure: The level of (non-essential) viral DNA in tumor tissue measure: Tumor markers measure: Anti-vaccinia virus neutralizing antibody test(VV-Nab) measure: Levels of viral DNA in blood measure: Levels of viral DNA in saliva measure: T cell subsets measure: Cytokines measure: ORR measure: DCR measure: DOR measure: PFS measure: OS sex: ALL minimumAge: 18 Years maximumAge: 70 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Beijing Cancer Hospital status: RECRUITING city: Beijing country: China name: Lin Shen role: CONTACT phone: +86 10 8819 6561 email: [email protected] lat: 39.9075 lon: 116.39723 hasResults: False |
<|newrecord|> nctId: NCT06380296 id: 2024-10240 briefTitle: Outcomes of NeoMTA and NeoPUTTY Pulpotomies in Primary Molars overallStatus: NOT_YET_RECRUITING date: 2024-04 date: 2026-09 date: 2027-03 date: 2024-04-23 date: 2024-04-23 name: McGill University Health Centre/Research Institute of the McGill University Health Centre class: OTHER briefSummary: The goal of this clinical trial is to evaluate the outcomes of different medications used for pulpotomies (baby root canal) in children. The main question it aims to answer is: • what are the long-term clinical and radiographic success of pulpotomies in baby teeth using two different medications (NeoMTA and NeoPUTTY) over a 24-month follow-up period? Healthy children aged between 3 and 10 years undergoing dental treatment under general anesthesia who have deep caries lesions approximating or reaching the nerve will be invited to participate in this study. Pulpotomies (baby root canal) will be performed by trained dentists following a protocol. Children will receive pulpotomies either with NeoMTA or NeoPUTTY, two medications indicated for the procedure. Participants will be asked to come for an appointment at 1, 6, 12 and 24 months after the procedure. Researcher will compare the clinical and radiographic performance of pulpotomies (baby root canal) done with both medications. conditions: Pulp Disease, Dental studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: DOUBLE whoMasked: PARTICIPANT whoMasked: OUTCOMES_ASSESSOR count: 50 type: ESTIMATED name: Primary molars pulpotomies with NeoMTA name: Primary molar pulpotomies with NeoPUTTY measure: Success rate of a primary molar pulpotomy measure: Radiographic success of a primary molar pulpotomy sex: ALL minimumAge: 3 Years maximumAge: 10 Years stdAges: CHILD hasResults: False |
<|newrecord|> nctId: NCT06380283 id: 2024-10221 briefTitle: The Feasibility and Clinical Utility of the Use of Virtual Reality for the Management of Pediatric Dental Anxiety overallStatus: RECRUITING date: 2024-03-21 date: 2025-07 date: 2026-01 date: 2024-04-23 date: 2024-04-23 name: McGill University Health Centre/Research Institute of the McGill University Health Centre class: OTHER briefSummary: The use of virtual reality (VR) in pediatric healthcare settings helps to reduce children's pain and anxiety. However, this technology has not been used consistently in pediatric dentistry. Consequently, the goal of this study is to investigate the effectiveness of using a Virtual Reality headset as a distraction technique during dental procedures in children and identify patient and clinician's opinions regarding its use. |
This study incorporates a single-site, randomized clinical trial design with two paralleled study groups. One group will receive dental treatment following regular standard of care of behavior management while the second group will receive dental treatment using a Virtual Reality distraction headset. Patients in both groups will complete a questionnaire to assess their perception of pain and anxiety before and after the intervention, as well as their satisfaction with the dental treatment. The dentist providing the treatment will also report their observations relating to patient behavior during dental treatment. conditions: Children, Only conditions: Dental Anxiety conditions: Behavior studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: OTHER masking: NONE count: 128 type: ESTIMATED name: Virtual reality headset measure: Children's pain perception during dental treatment measure: Children's fear during dental treatment measure: Children's acceptability of virtual reality intervention during dental care measure: Oral health care provider's acceptability of virtual reality during dental care sex: ALL minimumAge: 6 Years maximumAge: 12 Years stdAges: CHILD facility: Division of Dentistry, Montreal Children's Hospital, McGill University Health Centre status: RECRUITING city: Montreal state: Quebec country: Canada name: Beatriz Ferraz dos Santos, DDS, MSc role: CONTACT phone: +1 (514) 412-4400 phoneExt: 23357 email: [email protected] lat: 45.50884 lon: -73.58781 hasResults: False |
<|newrecord|> nctId: NCT06380270 id: LUMHS/B12/Temp/14.04.2024 briefTitle: Safety and Human Tolerance of Oral Probiotic Streptococcus Salivarius K12 overallStatus: NOT_YET_RECRUITING date: 2024-06-01 date: 2024-10-31 date: 2024-12-31 date: 2024-04-23 date: 2024-04-23 name: Liaquat University of Medical & Health Sciences class: OTHER briefSummary: Streptococcus salivarius K12, an oral probiotic strain, has emerged as a promising tool in promoting oral health. Found naturally in the mouth, S. salivarius K12 works by establishing itself in the oral cavity and producing antimicrobial compounds, such as bacteriocins, including salivaricin A2 (SalA2) and the 2,740-Da salivaricin B (SboB) lantibiotics, which inhibit the growth of harmful bacteria including Streptococcus pyogenes. By maintaining a healthy balance of oral microbiota, this probiotic may help prevent common oral health issues such as bad breath, throat infections, and tooth decay. While further research is needed to fully elucidate its mechanisms and efficacy, S. salivarius K12 holds potential as a natural and safe adjunct to oral hygiene practices for promoting overall oral health and hygiene. conditions: Strep Throat studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: PREVENTION masking: DOUBLE whoMasked: PARTICIPANT whoMasked: INVESTIGATOR count: 54 type: ESTIMATED name: Oral probiotic Streptococcus salivarius K12 sachet measure: Effect on oral health physical condition measure: Effect on other physical features measure: Effect on vital signs measure: Effect on vital signs measure: Effect on vital signs measure: Effect on vital signs measure: Effect on blood biochemistry measure: Effect on blood biochemistry measure: Effect on blood biochemistry measure: Effect on blood biochemistry measure: Effect on blood electrolytes balance measure: Effect on hematology measure: Incidence of inflammation measure: Incidence of gastrointestinal side effects measure: Incidence of Adverse events (AEs) sex: ALL minimumAge: 18 Years maximumAge: 60 Years stdAges: ADULT facility: Liaquat University of Medical and Health Sciences city: Jāmshoro zip: 76090 country: Pakistan name: Dr. Amjad Khan, DPhil role: CONTACT phone: 03000506955 email: [email protected] lat: 25.43773 lon: 68.28522 hasResults: False |
<|newrecord|> nctId: NCT06380257 id: ANBA briefTitle: Anorexia Nervosa and Brain in Adolescence overallStatus: NOT_YET_RECRUITING date: 2024-09 date: 2030-08 date: 2030-12 date: 2024-04-23 date: 2024-04-23 name: Kuopio University Hospital class: OTHER briefSummary: Aims of this follow-up study are to investigate effects of anorexia nervosa on brain structure and functions in adolescence. conditions: Anorexia Nervosa studyType: OBSERVATIONAL observationalModel: CASE_CONTROL timePerspective: PROSPECTIVE count: 50 type: ESTIMATED name: Observational study methods measure: Neuroimaging measure: Neuroimaging measure: Psychiatric evaluation measure: Body composition measurement measure: Laboratory tests sex: ALL minimumAge: 16 Years maximumAge: 19 Years stdAges: CHILD stdAges: ADULT hasResults: False |
<|newrecord|> nctId: NCT06380244 id: 1072.6120.136.2023 briefTitle: Opioid-free Anesthesia as an Alternative to General Anesthesia in Abdominal Surgery overallStatus: RECRUITING date: 2024-03-10 date: 2025-12-31 date: 2025-12-31 date: 2024-04-23 date: 2024-04-23 name: Jagiellonian University class: OTHER briefSummary: Due to the increasing number of reports of cancer progression in people undergoing surgery under general anesthesia using opioids, OFA is believed to have a favorable long-term prognostic effect, especially in cancer patients. The opioid-free protocol is also used in postoperative analgesia. It is estimated that up to 75% of surgical patients experience chronic postoperative pain, which has a particularly negative impact on the quality of life. |
The investigators would like to compare pain during the first 48 postoperative hours of patients undergoing abdominal surgery who would be anesthetized with opioids and without opioids (patients would be randomly assigned to a group) (1, 2, 6, 12, 24 and 48 h after operations). A secondary objective will be to measure total oxycodone consumption in the postoperative period in both groups. Other secondary objectives: assessment of postoperative nausea and vomiting (PONV). conditions: Analgesics, Opioid conditions: Anesthesia, Endotracheal conditions: Anesthesia, General studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL interventionModelDescription: Parallel Assignment primaryPurpose: TREATMENT masking: SINGLE whoMasked: INVESTIGATOR count: 100 type: ESTIMATED name: anesthesia without opioids measure: Pain level measure: Total long acting opioid consumption in oxycodone equivalents sex: ALL minimumAge: 18 Years maximumAge: 80 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Jagiellonian University status: RECRUITING city: Kraków state: Malopolskie zip: 31501 country: Poland name: Tomasz Skladzien, phd md role: CONTACT phone: 506602250 phoneExt: 48 email: [email protected] lat: 50.06143 lon: 19.93658 hasResults: False |
<|newrecord|> nctId: NCT06380231 id: IRU-YAZILE-001 briefTitle: Skin-to-skin Contact Between Premature Infant and Mother overallStatus: COMPLETED date: 2019-11-01 date: 2019-12-01 date: 2020-12-01 date: 2024-04-23 date: 2024-04-23 name: Istanbul Rumeli University class: OTHER briefSummary: Aim: To determine the effect of kangaroo mother care (KMC) on perfusion index, heart rate, and oxygen saturation in premature infants who were discharged early and admitted to the neonatal intensive care in the following days. conditions: Kangaroo-mother Care studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: SUPPORTIVE_CARE masking: DOUBLE whoMasked: INVESTIGATOR whoMasked: OUTCOMES_ASSESSOR count: 76 type: ACTUAL name: kangaroo mother care (KMC) measure: power analysis measure: The effect of kangaroo mother care sex: ALL minimumAge: 24 Weeks maximumAge: 37 Weeks stdAges: CHILD facility: TC Istanbul Rumeli University city: Istanbul state: Haliç zip: 34445 country: Turkey lat: 41.01384 lon: 28.94966 hasResults: False |
<|newrecord|> nctId: NCT06380218 id: 2023-A00249-36 briefTitle: Evaluation of Nutritional Prevention Program for Women's Cardiovascular Health on Quality of Life (SAFE) acronym: SAFE overallStatus: RECRUITING date: 2023-07-11 date: 2025-03-01 date: 2025-08-01 date: 2024-04-23 date: 2024-04-23 name: Institut Pasteur de Lille class: OTHER briefSummary: The objective is to evaluate the effect of a nutritional prevention program associated with the consumption of "Primevère margarine" on the quality of life of women at risk of cardiovascular disease after 10 group coaching sessions in nutrition and physical activity. conditions: Healthy Volunteers studyType: INTERVENTIONAL phases: NA allocation: NA interventionModel: SINGLE_GROUP primaryPurpose: PREVENTION masking: NONE count: 50 type: ESTIMATED name: Nutrional and physical activity program measure: Change from baseline on quality of life of women with cardiovascular risk at 3 months after a nutritional prevention program associated with the consumption of "Primevère margarine" measure: Change from baseline on life behaviours at 3 months after a nutritional prevention program associated with the consumption of "Primevère margarine" measure: Change from baseline on well-being at 3 months after a nutritional prevention program associated with the consumption of "Primevère margarine" measure: Change from baseline on stress management at 3 months after a nutritional prevention program associated with the consumption of "Primevère margarine" measure: Change from baseline on food behaviors at 3 months after a nutritional prevention program associated with the consumption of "Primevère margarine" measure: Change from baseline on food behaviors at 3 months after a nutritional prevention program associated with the consumption of "Primevère margarine" measure: Change from baseline on food and physical activity knowledge at 3 months after a nutritional prevention program associated with the consumption of "Primevère margarine" measure: Change from baseline on motivation to change behaviors at 3 months after a nutritional prevention program associated with the consumption of "Primevère margarine" measure: Change from baseline on physical behaviors at 3 months after a nutritional prevention program associated with the consumption of "Primevère margarine" measure: Change from baseline on recovery capacity at 3 months after a nutritional prevention program associated with the consumption of "Primevère margarine" measure: Change from baseline on static balance at 3 months after a nutritional prevention program associated with the consumption of "Primevère margarine" measure: Change from baseline on flexibility at 3 months after a nutritional prevention program associated with the consumption of "Primevère margarine" measure: Change from baseline on handgrip strengh at 3 months after a nutritional prevention program associated with the consumption of "Primevère margarine" measure: Change from baseline on lower limb strengh at 3 months after a nutritional prevention program associated with the consumption of "Primevère margarine" measure: Change from baseline on endurance at 3 months after a nutritional prevention program associated with the consumption of "Primevère margarine" measure: Change from baseline on lipids metabolism at 3 months after a nutritional prevention program associated with the consumption of "Primevère margarine" measure: Change from baseline on glucose metabolism at 3 months after a nutritional prevention program associated with the consumption of "Primevère margarine" measure: Change from baseline on cardiovascular risk at 3 months after a nutritional prevention program measure: Change from baseline on BMI at 3 months after a nutritional prevention program associated with the consumption of "Primevère margarine" measure: Change from baseline on waist circumference at 3 months after a nutritional prevention program associated with the consumption of "Primevère margarine" measure: Change from baseline on body composition at 3 months after a nutritional prevention program associated with the consumption of "Primevère margarine" measure: Change from baseline on systolic and diastolic blood pressure at 3 months after a nutritional prevention program associated with the consumption of "Primevère margarine" measure: Satisfaction of Primevere products sex: FEMALE minimumAge: 40 Years maximumAge: 65 Years stdAges: ADULT stdAges: OLDER_ADULT facility: NutrInvest - Institut Pasteur de Lille status: RECRUITING city: Lille state: Nord zip: 59019 country: France name: Coralie Berthier, PhD role: CONTACT phone: 0320877333 phoneExt: 0033 email: [email protected] name: Bérengère Legendre role: CONTACT phone: 0320877346 phoneExt: 0033 email: [email protected] name: Jean-Michel Lecerf, MD role: PRINCIPAL_INVESTIGATOR lat: 50.63297 lon: 3.05858 hasResults: False |
<|newrecord|> nctId: NCT06380205 id: INCB54707-111 briefTitle: A Study to Evaluate the Drug Interaction Between Povorcitinib and the Oral Contraceptive Levonorgestrel/Ethinyl Estradiol in Healthy Adult Females overallStatus: RECRUITING date: 2024-05-07 date: 2024-06-07 date: 2024-06-07 date: 2024-04-23 date: 2024-04-24 name: Incyte Corporation class: INDUSTRY briefSummary: The purpose of this study is to evaluate the drug interaction between povorcitinib and the oral contraceptive levonorgestrel/ethinyl estradiol in healthy adult females. conditions: Healthy Participants studyType: INTERVENTIONAL phases: PHASE1 allocation: NA interventionModel: SINGLE_GROUP primaryPurpose: TREATMENT masking: NONE count: 24 type: ESTIMATED name: Povorcitinib name: Levonorgestrel/Ethinyl estradiol measure: Levonorgestrel (LNG) concentration in plasma measure: Ethinyl estradiol (EE) concentration in plasma measure: Number of participants with Treatment-emergent Adverse Events (TEAEs) measure: Additional LNG/EE PK parameters in plasma measure: Povorcitinib concentration in plasma sex: FEMALE minimumAge: 18 Years maximumAge: 60 Years stdAges: ADULT facility: Celerion Clinical Research Unit status: RECRUITING city: Tempe state: Arizona zip: 85283 country: United States lat: 33.41477 lon: -111.90931 hasResults: False |
<|newrecord|> nctId: NCT06380192 id: HJ22-DEE-RETRO briefTitle: Developmental and Epileptic Encephalopathy of Genetic Etiology: Natural History Through Reuse of Clinical Data acronym: DEE-RETRO overallStatus: NOT_YET_RECRUITING date: 2024-05-01 date: 2026-03-31 date: 2026-03-31 date: 2024-04-23 date: 2024-04-23 name: Imagine Institute class: OTHER briefSummary: Developmental and Epileptic Encephalopathy (DEE) are a heterogeneous group of neurodevelopmental disorders linked to both epilepsy and its underlying etiology, independently of epileptiform activity. |
The creation of a database with retrospective follow-up of a large number of patients on a national scale will enable better knowledge of specific biomarkers, and thus a better classification and understanding of the natural evolution of DEE according to their etiology. This will enable better, more personalized therapeutic management of patients, depending on etiology and the presence or absence of these biomarkers. The investigators will also be able to draw up management recommendations, which are currently non-existent. conditions: Developmental and Epileptic Encephalopathy studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: CROSS_SECTIONAL count: 400 type: ESTIMATED measure: Identification of early diagnostic of a neurodevelopmental trajectory in children with epileptic and developmental encephalopathies measure: Identification of predictive biomarkers of a neurodevelopmental trajectory in children with epileptic and developmental encephalopathies measure: Identification of patient subgroups presenting the identified biomarkers measure: Assessment of patients' quality of life measure: Assessment of age-related adaptive behavior measure: Assessment of behavioral disorders measure: Assessment of autism spectrum disorders sex: ALL maximumAge: 17 Years stdAges: CHILD hasResults: False |
<|newrecord|> nctId: NCT06380179 id: USUHS.2023-126 briefTitle: Photomedicine Project 14: PBMT for Performance Enhancement in SOF acronym: SOF overallStatus: NOT_YET_RECRUITING date: 2024-05 date: 2025-08 date: 2026-01 date: 2024-04-23 date: 2024-04-23 name: Musculoskeletal Injury Rehabilitation Research for Operational Readiness (MIRROR) class: UNKNOWN name: Uniformed Services University (USU) of the Health Sciences name: 1st Special Forces Group (Airborne), United States Army name: United States Army Special Operations Command name: The Geneva Foundation briefSummary: Special Operations Forces (SOF) train continually to maintain peak performance. Thus, they are nearly always in a state of recovery, and in need of noninvasive therapies to address the taxing workload. Photobiomodulation therapy (PBMT) is a noninvasive treatment where a low-level laser is applied to the body to enhance healing, recovery, and performance. Army Tactical Human Optimization Rapid Rehabilitation and Reconditioning (THOR3) provides a consistent avenue for implementation of PBMT as a modality. Studies in athletes have shown performance and recovery benefits with pre-and post-workout focal application of PBMT. While there is less evidence on the potential cognitive/behavioral effects of a systematic application of PBMT, self-reported fatigue has also been found to be significantly lower in groups with focal PBMT application as compared to placebo. Further, PBMT research in healthy military tactical athletes is limited. PBMT may be a promising tool for enhancing physical performance by accelerating musculoskeletal and psychological recovery in the SOF population. The investigators aim to study the physiologic and behavioral effects of PBMT application post-exercise on performance in SOF Operators. |
The Intent: The investigators propose to conduct a single-blinded randomized-control trial with sham control to investigate the effectiveness of providing PBMT post physical training in a SOF population. |
The specific aims of this study are to: |
1. Analyze and describe the physiologic effects, if any, of PBMT application post-exercise in Special Forces Operators undergoing coach-led training. |
2. Analyze and describe the behavioral effects, if any, of PBMT application post-exercise in Special Forces Operators undergoing coach-led training. |
3. Evaluate the overall clinical utility of focal PBMT subsequent to physical training in a US Army SOF, tactical athlete population. conditions: Photobiomodulation Therapy conditions: Photomedicine conditions: Low-Level Laser Therapy conditions: Performance Enhancement conditions: Quadriceps conditions: Special Operations Readiness studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL interventionModelDescription: Approach: Special Operators attending THOR3 coach led training will be invited to participate. After consenting and screening for inclusion/exclusion, participants will be randomized into two groups: 1) sham PBMT and 2) PBMT (applied to quadriceps up to 3 times per week, post coach-led training, taking approximately 5-20 minutes each time). Baseline measurements will include body fat percentage, height, weight and military/demographic information. Metrics for counter movement jump and self-reported delayed muscle onset soreness will be taken at baseline and weekly for three weeks. Isokinetic dynamometer measurements for the lower extremities, and self-reported exertion and fatigue will be taken at baseline and at the 3-week follow-up (post three-week intervention). Oura rings will be assigned at baseline and will continuously measure sleep, heart rate, Sp02, and activity. Activity and pain will also be self-reported throughout the duration of the study. primaryPurpose: TREATMENT masking: SINGLE maskingDescription: In order to facilitate participant blinding to their randomized study group, all participants (regardless of their assigned study group) will be asked to wear blackout glasses and headphones during their treatment. whoMasked: PARTICIPANT count: 116 type: ESTIMATED name: THOR3 training + Photobiomodulation Therapy (PBMT) name: THOR3 training + sham PBMT measure: Countermovement Jump (CMJ) initial baseline: deceleration/concentric impulse measure: Countermovement Jump (CMJ) initial baseline: peak force production measure: Countermovement Jump (CMJ) initial baseline: rate of force production measure: Countermovement Jump (CMJ) initial baseline: unilateral performance comparison measure: Countermovement Jump (CMJ) week 1 follow-up: deceleration/concentric impulse measure: Countermovement Jump (CMJ) week 1 follow-up: peak force production measure: Countermovement Jump (CMJ) week 1 follow-up: rate of force production measure: Countermovement Jump (CMJ) week 1 follow-up: unilateral performance comparison measure: Countermovement Jump (CMJ) week 2 follow-up: deceleration/concentric impulse measure: Countermovement Jump (CMJ) week 2 follow-up: peak force production measure: Countermovement Jump (CMJ) week 2 follow-up: rate of force production measure: Countermovement Jump (CMJ) week 2 follow-up: unilateral performance comparison measure: Countermovement Jump (CMJ) week 3 follow-up: deceleration/concentric impulse measure: Countermovement Jump (CMJ) week 3 follow-up: peak force production measure: Countermovement Jump (CMJ) week 3 follow-up: rate of force production measure: Countermovement Jump (CMJ) week 3 follow-up: unilateral performance comparison measure: Isometric Quadriceps Strength Testing initial baseline measure: Isometric Hamstrings Strength Testing initial baseline measure: Isokinetic Quadriceps Strength Testing initial baseline measure: Isokinetic Hamstrings Strength Testing initial baseline measure: Isometric Quadriceps Strength Testing 3-week follow-up measure: Isometric Hamstrings Strength Testing 3-week follow-up measure: Isokinetic Quadriceps Strength Testing 3-week follow-up measure: Isokinetic Hamstrings Strength Testing 3-week follow-up measure: Defense and Veteran's Pain Rating Scale (DVPRS) initial baseline measure: Defense and Veteran's Pain Rating Scale (DVPRS) daily reports measure: Visual Analog Scale (VAS) initial baseline measure: Visual Analog Scale (VAS) week 1 follow-up measure: Visual Analog Scale (VAS) week 2 follow-up measure: Visual Analog Scale (VAS) week 3 follow-up measure: Borg Modified Rating of Perceived Exertion (RPE) initial baseline measure: Borg Modified Rating of Perceived Exertion (RPE) 3-week follow-up measure: Elloumi fatigue scale initial baseline measure: Elloumi fatigue scale 3-week follow-up measure: Quick Physical Activity Rating scale (QPAR) measure: Oura Ring Sleep Data: sleep metrics - sleep duration measure: Oura Ring Sleep Data: sleep metrics - time in bed measure: Oura Ring Sleep Data: sleep metrics - light sleep length measure: Oura Ring Sleep Data: sleep metrics - rapid eye movement (REM) sleep length measure: Oura Ring Sleep Data: sleep metrics - deep sleep length measure: Oura Ring Sleep Data: sleep metrics - sleep latency measure: Oura Ring Sleep Data: sleep metrics - sleep efficiency score measure: Oura Ring Sleep Data: sleep metrics - sleep quality score measure: Oura Ring Sleep Data: Readiness trends - body temperature changes measure: Oura Ring Sleep Data: Readiness trends - heart rate changes measure: Oura Ring Sleep Data: Readiness trends - heart rate variability (HRV) measure: Oura Ring Sleep Data: Readiness trends - respiration rate measure: Oura Ring Sleep Data: Readiness trends - blood oxygen saturation measure: Oura Ring Sleep Data: Readiness trends - sleep regularity measure: Oura Ring Sleep Data: Readiness trends - readiness score measure: Body Measurements: Height (cm) measure: Body Measurements: Weight (kg/lbs) measure: Body Measurements: Body composition (% body fat) measure: Body Measurements: C1 - proximal thigh circumference (cm) measure: Body Measurements: C2 - distal thigh circumference (cm) measure: Body Measurements: L1 - length of thigh (cm) sex: MALE minimumAge: 18 Years maximumAge: 45 Years stdAges: ADULT typeAbbrev: Prot_SAP hasProtocol: True hasSap: True hasIcf: False label: Study Protocol and Statistical Analysis Plan date: 2024-03-20 uploadDate: 2024-03-29T15:19 filename: Prot_SAP_000.pdf size: 435470 typeAbbrev: ICF hasProtocol: False hasSap: False hasIcf: True label: Informed Consent Form date: 2024-03-19 uploadDate: 2024-03-29T15:20 filename: ICF_001.pdf size: 165533 hasResults: False |
<|newrecord|> nctId: NCT06380166 id: A23-356 briefTitle: Hepatitis C Lab Testing Comparison Study overallStatus: NOT_YET_RECRUITING date: 2024-05 date: 2024-07 date: 2024-09 date: 2024-04-23 date: 2024-04-23 name: HealthPartners Institute class: OTHER briefSummary: Hepatitis C (HCV) HCV antibody assays are the standard of care test used to screen for HCV, but confirmation of acute infection is relegated in the current US guidelines to polymerase chain reaction (PCR) which often takes multiple days and may result in a loss to follow up and treatment, especially in high prevalence populations. HCV core antigen is a new, research use only immunoassay intended for use on the Abbott Alinity i system, an FDA-cleared instrument for clinical chemistry and immunoassay testing. The aim of the study is to evaluate the 48-hour stability of HCV core antigen in fresh serum and plasma specimens collected from individuals with a detectable HCV viral load (HCL VL), as per a recent antibody assay test, under multiple specimen storage conditions mirroring those employed in clinical laboratories. conditions: Hepatitis C studyType: INTERVENTIONAL phases: NA allocation: NA interventionModel: SINGLE_GROUP primaryPurpose: DIAGNOSTIC masking: NONE count: 25 type: ESTIMATED name: Hepatitis C core antigen measure: Serum on the clot stability measure: Serum off the clot stability measure: Plasma on the gel stability measure: Plasma off the gel stability sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT hasResults: False |
<|newrecord|> nctId: NCT06380153 id: HM005PS1S07 briefTitle: To Evaluate the Pharmacokinetics of Hemay005 Tablets in Patients With Renal Impairment overallStatus: NOT_YET_RECRUITING date: 2024-04 date: 2024-12 date: 2024-12 date: 2024-04-23 date: 2024-04-23 name: Ganzhou Hemay Pharmaceutical Co., Ltd class: INDUSTRY briefSummary: The aim of this study was to evaluate the pharmacokinetics of Hemay005 tablets in subjects with mild to moderate renal impairment and normal renal function, and to provide a basis for the formulation of clinical medication regimens for patients with renal impairment. conditions: Psoriasis studyType: INTERVENTIONAL phases: PHASE1 allocation: NON_RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: NONE count: 24 type: ESTIMATED name: Hemay005 measure: Relevant pharmacokinetic parameters，Peak Plasma Concentration（Cmax） measure: Relevant pharmacokinetic parameters，Area under the plasma concentration versus time curve（AUC0-t） measure: Relevant pharmacokinetic parameters，Area under the curve from time 0 extrapolated to infinite time (AUC0-inf) measure: Relevant pharmacokinetic parameters，half-life (T1/2) measure: Relevant pharmacokinetic parameters，clearance (CL/F) measure: Relevant pharmacokinetic parameters，volume of distribution (Vz/F) measure: Relevant pharmacokinetic parameters ，Renal clearance rate（CLr） sex: ALL minimumAge: 18 Years maximumAge: 70 Years stdAges: ADULT stdAges: OLDER_ADULT hasResults: False |
<|newrecord|> nctId: NCT06380140 id: cami3zgmxf3vqyc30ndmdqh6gfjid1 briefTitle: Relationship Between Acute Phase Markers and Post-operative Pain in Open Tension-free Inguinal Hernia Repair: An Observational Study overallStatus: RECRUITING date: 2023-05-03 date: 2024-03-03 date: 2025-12-31 date: 2024-04-23 date: 2024-04-23 name: University of Roma La Sapienza class: OTHER briefSummary: Many patients undergoing inguinal hernia repair are prone to developing acute and chronic post-operative pain. |
The aim of the study is to show a possible correlation between pain and acute phase proteins in order to: |
* predict the severity of pain; |
* select most suitable pain relief therapy for the patient. conditions: Post Operative Pain conditions: Inguinal Hernia studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: PROSPECTIVE count: 71 type: ESTIMATED name: Open Tension-free Inguinal Hernia Repair measure: Relationship Between Post-operative Pain and C Reactive Protein (CRP) in Open Tension-free Inguinal Hernia Repair measure: Relationship Between Post-operative Pain and D-dimer in Open Tension-free Inguinal Hernia Repair measure: Relationship Between Post-operative Pain and Fibrinogen in Open Tension-free Inguinal Hernia Repair measure: Relationship Between Post-operative Pain and white blood cell count in Open Tension-free Inguinal Hernia Repair measure: Relationship Between Post-operative Pain and Neutrophil to Lymphocyte Ratio (NLR) in Open Tension-free Inguinal Hernia Repair sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Augusto Lauro status: RECRUITING city: Roma zip: 000186 country: Italy name: Augusto Lauro role: CONTACT phone: +39 388 8663 879 email: [email protected] lat: 41.89193 lon: 12.51133 typeAbbrev: Prot_SAP hasProtocol: True hasSap: True hasIcf: False label: Study Protocol and Statistical Analysis Plan date: 2023-05-03 uploadDate: 2024-04-18T14:17 filename: Prot_SAP_000.pdf size: 274127 hasResults: False |
<|newrecord|> nctId: NCT06380127 id: CEFADE012021 briefTitle: Feasibility and Effectiveness of Concurrent Exercise Training on Frail Older Adults Living in Nursing Homes overallStatus: COMPLETED date: 2021-10-01 date: 2023-09-30 date: 2023-12-15 date: 2024-04-23 date: 2024-04-24 name: Universidade do Porto class: OTHER briefSummary: The present study is a crossover randomized controlled trial that aims to investigate the effects of concurrent exercise training over usual care on physical performance, muscle strength, and myokines concentrations in frail older adults living in nursing homes.The main questions it aims to answer is: Can a 12-week exercise intervention provide beneficial effects on physical performance, muscle strength and myokines among the most frail participants? Researchers will compare this intervention to usual care. Nursing homes (comprising participants) will be randomly assigned to a sequence of interventions (AB or BA), being A -exercise and B usual care. Participants will be assessed before and after each intervention. conditions: Frailty studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: CROSSOVER interventionModelDescription: The trial will follow a 28-week crossover design: 12 weeks for the first intervention period, a 4-week washout, and another 12 weeks for the second intervention period. Nursing homes (clusters) were randomized into sequences (AB or BA), where intervention A involve concurrent exercise training, and B is usual care. |
Data collection will occurre at four points: baseline, post-first intervention period, post-washout/pre-second intervention period and post-crossover. primaryPurpose: TREATMENT masking: SINGLE whoMasked: OUTCOMES_ASSESSOR count: 46 type: ACTUAL name: Exercise training measure: Change from Baseline on Short Physical Performance Battery (SPBB) measure: Change from Baseline on Handgrip test measure: Change from baseline on isokinetic knee strength measure: Change from Baseline on circulating levels of myostatin measure: Change from Baseline on circulating levels of Decorin sex: ALL minimumAge: 65 Years stdAges: OLDER_ADULT facility: Faculty of Sports, University of Porto city: Porto zip: 4000 country: Portugal lat: 41.14961 lon: -8.61099 hasResults: False |
<|newrecord|> nctId: NCT06380114 id: STUDY00009296 briefTitle: Stand Up 2 HPV: Standing Orders to Improve HPV Vaccination overallStatus: NOT_YET_RECRUITING date: 2024-07 date: 2026-04 date: 2027-11 date: 2024-04-23 date: 2024-04-25 name: University of Rochester class: OTHER name: National Institutes of Health (NIH) briefSummary: Each year in the U.S., ≥20,000 women and 14,000 men are affected by HPV-related cancers, including cervical and oropharyngeal cancer. However, in 2020, only 59% of U.S. adolescents aged 13-17 were up-to-date for HPV vaccination, and rates for 11-12 year olds, the primary target age group for HPV vaccination (when the immune reaction is better and before exposure to HPV infection), are even lower. Standing orders (written protocols that authorize designated members of the healthcare team to vaccinate without first obtaining a patient-specific physician order) have been shown to work in inpatient settings and for adults, but have not been evaluated for HPV vaccine, which some parents consider controversial. Also, the ways in which organizational readiness for change (resources, motivation, staff attributes, leadership support and culture) moderate the effect of standing orders has not been studied. A physician's recommendation is correlated with HPV vaccine acceptance, and the investigators have developed a successful online, interactive, communication education program that will be adapted to train nurses and staff in addition to physicians. The investigators propose testing standing orders for HPV vaccine in an Accountable Care Organization (ACO) in Western New York, and assessing which provider and practice factors moderate the effect of standing orders. Advantages of this setting include a diverse group of rural, urban and suburban practices, and the ACO provides data infrastructure and analytics that allow practices to evaluate vaccination rates in real time. |
Using a 2-arm cluster randomized trial (n=40 practices), the investigators will assess the effectiveness of standing orders (SO) + HPV communication education (intervention arm) relative to HPV communication education alone (control arm) on HPV vaccination for 11-17 year-olds. conditions: Hpv studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: PREVENTION masking: NONE count: 16000 type: ESTIMATED name: Communication name: Standing Orders measure: HPV vaccination sex: ALL minimumAge: 11 Years maximumAge: 17 Years stdAges: CHILD hasResults: False |
<|newrecord|> nctId: NCT06380101 id: NEAAR-LARC briefTitle: Evaluating a Nonessential Amino Acid Restriction (NEAAR) Medical Food With Total Neoadjuvant Therapy for Locally Advanced Rectal Cancer (LARC) acronym: NEAAR-LARC overallStatus: RECRUITING date: 2023-09-08 date: 2024-12 date: 2025-06 date: 2024-04-23 date: 2024-04-23 name: University of South Florida class: OTHER briefSummary: This clinical study aims to assess feasibility, safety, tolerability, and compliance of a Nonessential Amino Acid Restriction (NEAAR) medical food in adult patients with locally advanced rectal cancer during standard of care short course radiotherapy followed by standard of care chemotherapy. conditions: Rectal Cancer studyType: INTERVENTIONAL phases: NA allocation: NA interventionModel: SINGLE_GROUP primaryPurpose: OTHER masking: NONE count: 30 type: ESTIMATED name: NEAAR Medical Food measure: Rate of CTCAE v5.0 non-hematological Grade 3 and higher diarrhea measure: Proportion of clinical complete response 8 weeks post SCRT-TNT with NEAAR medical food defined by the MSK Regression Schema measure: Absolute and relative change from baseline of circulating non-essential amino acids measure: Proportion of clinical complete response at Week 4 post SCRT with NEAAR medical food measure: molecular ctDNA response. sex: ALL minimumAge: 18 Years maximumAge: 100 Years stdAges: ADULT stdAges: OLDER_ADULT facility: University of South Florida status: RECRUITING city: Tampa state: Florida zip: 33606 country: United States name: Jennifer Burgess, MS role: CONTACT phone: 434-806-6445 email: [email protected] name: Veronique Perry, MSHA role: CONTACT phone: 2549873658 email: [email protected] name: Richard Tuli, MD role: PRINCIPAL_INVESTIGATOR lat: 27.94752 lon: -82.45843 hasResults: False |
<|newrecord|> nctId: NCT06380088 id: VEM-DINOGMI-24 briefTitle: Improving Motor Skills: The Role of Music and Encouragement overallStatus: COMPLETED date: 2022-07-01 date: 2023-08-05 date: 2024-03-15 date: 2024-04-23 date: 2024-04-23 name: Universita degli Studi di Genova class: OTHER briefSummary: This study used a randomised crossover design to analyse the effect of three different experimental interventions - i.e. standard conditions, music and verbal encouragement - on performance in an isometric endurance task, comparing results between untrained and trained individuals. The interval between each intervention was set at seven days. The outcome measures are muscle activity and fatigue, assessed by surface electromyography, and task duration. |
Isometric endurance task requires participants to keep their arm flexed at a 90° angle while holding a dumbbell with a supine grip loaded to 80% of 1RM on the dominant side of the body. During execution, the back and head should remain in contact with a vertical wall, with the feet shoulder width apart and firmly planted on the floor. The bar is held with the dominant arm while the other arm remains in a neutral position close to the body. It is imperative to avoid any form of rocking or movement that would make it easier to maintain the position. The test officially begins when the bar is handed to the subject, who is already in the correct position, and ends as soon as the angle of the arm varies by more than five degrees from the starting position. conditions: Healthy studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: CROSSOVER primaryPurpose: OTHER masking: NONE count: 25 type: ACTUAL name: Isometric Task measure: Duration of the task measure: Biceps Brachii muscle fatigue measure: Triceps Brachii muscle fatigue measure: Biceps Brachii activity measure: Triceps Brachii activity sex: ALL minimumAge: 27 Years maximumAge: 40 Years stdAges: ADULT facility: Università degli Studi di Genova city: Genova zip: 16122 country: Italy lat: 44.40478 lon: 8.94438 hasResults: False |
<|newrecord|> nctId: NCT06380075 id: 2024-0480 id: A536000 type: OTHER domain: UW Madison id: SMPH/OPHTHAL&VIS SCI/GEN type: OTHER domain: UW Madison id: Protocol Version 3/22/24 type: OTHER domain: UW Madison briefTitle: COmparison of Clarus and Optos Ultrawide Field Imaging Systems for Inherited Retinal Disease acronym: COCO-IRD overallStatus: NOT_YET_RECRUITING date: 2024-05 date: 2025-05 date: 2025-05 date: 2024-04-23 date: 2024-04-23 name: University of Wisconsin, Madison class: OTHER briefSummary: The goal of this research study is to compare two ultrawide field cameras to the gold standard imaging system to evaluate the back of the eye. The main question it aims to answer is the same results and information can be acquired from all of the cameras for evaluating and monitoring inherited retinal diseases (IRDs). |
Participants will: |
* undergo pupillary dilation |
* have photographs taken of the inside of the eyes using three different cameras conditions: Retinal Disease studyType: INTERVENTIONAL phases: NA allocation: NA interventionModel: SINGLE_GROUP primaryPurpose: OTHER masking: NONE count: 50 type: ESTIMATED name: Spectralis FAF imaging name: Optos imaging name: Clarus imaging measure: Compare FAF retinal patterns by Clarus and standard Spectralis FAF imaging measure: Compare FAF retinal patterns by Optos and standard Spectralis FAF imaging measure: Compare FAF retinal patterns by Clarus and Optos FAF imaging measure: Compare Spectralis FAF imaging to Spectralis OCT imaging measure: Prevalence of FAF retinal pattern changes beyond the standard 30 degress in Clarus and Optos ultrawide field images measure: Prevalence of other autofluorescence abnormalities unique to the IRD across all imaging sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Department of Ophthalmology and Visual Sciences city: Madison state: Wisconsin zip: 53705 country: United States name: Amy Remm role: CONTACT phone: 608-262-3377 email: [email protected] name: Kimberly Stepien, MD role: PRINCIPAL_INVESTIGATOR lat: 43.07305 lon: -89.40123 hasResults: False |
<|newrecord|> nctId: NCT06380062 id: Choline Prostate Cancer briefTitle: Choline Metabolites in People With Prostate Cancer and Those With Benign Hyperplasia overallStatus: COMPLETED date: 2012-01-12 date: 2015-11-30 date: 2015-11-30 date: 2024-04-23 date: 2024-04-25 name: Universität des Saarlandes class: OTHER briefSummary: The aim of this study was to investigate plasma concentrations of one-carbon metabolites and phospholipid classes in participants with primary prostate cancer and those with benign hyperplasia. Moreover, the metabolites were studied in relation to tumor grade and age. conditions: Primary Prostate Urothelial Cancer conditions: Benign Prostatic Hyperplasia studyType: OBSERVATIONAL observationalModel: CASE_CONTROL timePerspective: CROSS_SECTIONAL count: 350 type: ACTUAL name: Plasma concentration of choline measure: Plasma choline concentrations measure: Whole blood choline concentrations measure: Plasma and whole blood folate forms measure: Plasma phospholipids measure: Plasma S-adenosylmethionine concentrations measure: Plasma betaine concentrations measure: Plasma methylmalonic acid concentrations measure: Plasma homocysteine concentrations sex: MALE minimumAge: 50 Years stdAges: ADULT stdAges: OLDER_ADULT facility: University of Saarland city: Homburg state: Saarland zip: 66424 country: Germany lat: 49.32637 lon: 7.33867 hasResults: False |
<|newrecord|> nctId: NCT06380049 id: 0720242110 id: 20240012366 type: OTHER domain: Ministry of Food and Drug Safety briefTitle: Predicting Fall Risk in Stroke Patients Using a Machine Learning Model and Multi-Sensor Data overallStatus: NOT_YET_RECRUITING date: 2024-04-29 date: 2025-04-28 date: 2026-04-28 date: 2024-04-23 date: 2024-04-23 name: Seoul National University Hospital class: OTHER name: Ministry of Trade, Industry & Energy, Republic of Korea briefSummary: The study assesses a machine learning model developed to predict fall risk among stroke patients using multi-sensor signals. This prospective, multicenter, open-label, sponsor-initiated confirmatory trial aims to validate the safety and efficacy of the model which utilizes electromyography (EMG) signals to categorize patients into high-risk or low-risk fall categories. The innovative approach hopes to offer a predictive tool that enhances preventative strategies in clinical settings, potentially reducing fall-related injuries in stroke survivors. conditions: Stroke conditions: Fall studyType: OBSERVATIONAL observationalModel: OTHER timePerspective: CROSS_SECTIONAL count: 90 type: ESTIMATED name: EMG Analysis Software measure: Sensitivity of the Machine Learning Model measure: Specificity of the Machine Learning Model measure: Area Under the Receiver Operating Characteristic Curve measure: Matthews Correlation Coefficient sex: ALL minimumAge: 19 Years stdAges: ADULT stdAges: OLDER_ADULT hasResults: False |
<|newrecord|> nctId: NCT06380036 id: 003AEstb/EC/01/2022 briefTitle: Two Approaches to Lower the Chances of Recurrence of Anal Fistula After Surgery overallStatus: COMPLETED date: 2022-11-01 date: 2023-10-31 date: 2023-10-31 date: 2024-04-23 date: 2024-04-23 name: Sairah Sadaf class: OTHER_GOV briefSummary: A total of 80 patients with complex fistula in ano of both genders were included. All patients in Group A underwent a loose seton technique. In group B, video-assisted fistula tract surgery (VAAFTS) was performed.Twice daily Sitz baths, analgesics, and stool bulking agents (bran) were used in follow-up care. Repeated examinations were carried out every four weeks and recurrence was noted at the end of three months conditions: Fistula in Ano studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: SINGLE whoMasked: OUTCOMES_ASSESSOR count: 80 type: ACTUAL name: video assisted fistula tract surgery measure: recurrence sex: ALL minimumAge: 18 Years maximumAge: 70 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Sheikh Zayed Medical College city: Rahim yar khan state: Punjab zip: 64200 country: Pakistan lat: 28.41987 lon: 70.30345 hasResults: False |
<|newrecord|> nctId: NCT06380023 id: 2022.354 briefTitle: An Investigation Into the Dispersion Pattern During Coughing and Open Nasopharyngeal Suction Using Various Barrier Devices overallStatus: COMPLETED date: 2022-09-01 date: 2024-03-03 date: 2024-03-03 date: 2024-04-23 date: 2024-04-23 name: North District Hospital class: OTHER name: The Hong Kong Polytechnic University briefSummary: The aim of the study is to examine the air dispersion pattern and the environmental influence of open airway suction in general ward setting. Secondly, the study is aimed at identifying a simple \& practical enclosure device in general ward. Suction will be performed in manikin in supine lying. |
Nasopharyngeal suction will be performed by physiotherapist with working experience more than 1 years. Besides, surgical mask \& enclosure tent will be adopted as the enclosure barrier device in this study. |
Research Question |
1. To assess the extent of the environmental contamination during coughing and simulated airway suction |
2. To measure the air particle count during coughing and simulated open airway suction. |
3. To evaluate how effective the enclosure barrier in reducing the air particle dispersion during open airway suction. conditions: Airway Aspiration studyType: OBSERVATIONAL observationalModel: OTHER timePerspective: PROSPECTIVE count: 13 type: ACTUAL name: Enclosure barrier measure: Air particle count measure: A fluorescent Dye sex: ALL stdAges: CHILD stdAges: ADULT stdAges: OLDER_ADULT facility: North District Hospital city: Hong Kong zip: 000000 country: Hong Kong lat: 22.27832 lon: 114.17469 hasResults: False |
<|newrecord|> nctId: NCT06380010 id: IASO HOSPITAL (ATHENS-GREECE) briefTitle: Mediterranean Diet Intervention in Adolescents With Polycystic Ovary Syndrome overallStatus: COMPLETED date: 2019-12-01 date: 2020-03-31 date: 2020-06-30 date: 2024-04-23 date: 2024-04-23 name: Iaso Maternity Hospital, Athens, Greece class: OTHER name: Harokopio University name: University of Peloponnese briefSummary: The aim of the present randomized controlled study was to examine wether a clinical decision support stystem would increase the adherence to the Mediterranean diet (MD) of adolescent girls, aged 15-17 years, diagnosed with polycystic ovary syndrome. The intervention lasted for 3 months and in total, 40 girls were randomly assigned to either the MD group (n=20) or a Control group receiving general nutritional advice (n=20). Anthropometry, nutritional intake, psychological well-being, and blood markers were analyzed at the begninning and the end of the trial. conditions: Polycystic Ovary Syndrome studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL interventionModelDescription: Recruitment involved adolescents with polycystic ovary syndrome. Participants, who expressed their willingness to take part, attended personal meetings with the appointed dieticians who provided comprehensive explanations on the objectives, methods, and the potential benefits/risks of the study. A leaflet with related information was provided to all patients. Every eligible volunteer, and their guardian, signed a written informed consent and then kept a hard copy of the signed document. All eligible females were recruited in 12/2019 and were randomly allocated in groups of one to either the Control group (CG) or the Intervention group (IG). The IG received a personalized Mediterranean dietary plan, delivered through a clinical decision support system, while the CG received general dietary advice. Every participant had two individual sessions with the assigned dietician, at the beginning and at the trial endpoint, which involved anthropometry, dietary assessment, and blood withdrawal. primaryPurpose: TREATMENT masking: SINGLE maskingDescription: Treatment allocation was not revealed to the appointed statistician until the end of the study and release of the final outcomes. whoMasked: OUTCOMES_ASSESSOR count: 40 type: ACTUAL name: Mediterranean diet group measure: Adherance to the Mediterranean diet measure: Improvement of psychological well-being sex: FEMALE minimumAge: 15 Years maximumAge: 17 Years stdAges: CHILD facility: IASO Hospital city: Athens zip: 15123 country: Greece lat: 37.97945 lon: 23.71622 hasResults: False |
<|newrecord|> nctId: NCT06379997 id: SANTA LUCIA IRCCS briefTitle: Oral Supplementation Compared With Hyaluronic Acid Infiltration in Rotator Cuff Tendinopathies overallStatus: NOT_YET_RECRUITING date: 2024-05-02 date: 2025-11-01 date: 2025-12-31 date: 2024-04-23 date: 2024-04-25 name: I.R.C.C.S. Fondazione Santa Lucia class: OTHER briefSummary: The present study aims to investigate the effectiveness of oral supplementation with a nutraceutical containing Collagen, Hyaluronic Acid, Vitamin C, and Manganese in functional outcome and pain reduction in cases of shoulder rotator cuff tendinopathy compared to a cycle of intra-articular hyaluronic acid injections. |
The project involves the recruitment of 50 adult individuals presenting with shoulder pain and instrumental evidence of rotator cuff tendinopathy. All participants will receive one intra-articular injection of 1 ml of triamcinolone acetonide 40 mg. After the injection, participants will be divided into two groups according to Good Clinical Practice guidelines. One group will begin taking one vial per day for 56 days of an oral supplement containing Hyaluronic Acid, Collagen, Vitamin C, and Manganese (HA-COL) (Tendogenial®, B2Pharma) starting from the day following enrollment (Group 1). The other group will undergo a cycle of 3 intra-articular injections with hyaluronic acid (HA) (Hyalotend®, Fidia) (Group 2). |
The hypothesis is that oral supplementation with HA-COL may have the same efficacy as intra-articular hyaluronic acid treatment in reducing pain and improving shoulder functionality. |
Functional assessments will be conducted by a clinician unaware of the participants' group assignment. The following assessment scales will be used: |
Numeric Rating Scale (NRS) for pain (from 0 to 10), evaluating 3 aspects of pain: 1) pain at rest, 2) nocturnal pain, 3) pain during movement. |
Shoulder Disability Questionnaire (SDQ) for functionality. |
Assessments will be conducted at the following time points: |
T0) Before the administration of corticosteroid intra-articular injection (baseline). |
T1) Seven days after the start of HA-COL intake for Group 1 and before the first intra-articular HA injection for Group 2 (T1, seven days from T0). |
T2) At mid-cycle of oral HA-COL supplementation for Group 1 (28 days of intake) and seven days after the last HA injection for Group 2 (T2, 21 days from T1). |
T3) Follow-up at 28 days from T2, at the end of the 56-day oral treatment cycle for Group 1, and 28 days after the last injection for Group 2 (T3, 56 days from T0). conditions: Tendinitis of Shoulder conditions: Hyaluronic Acid conditions: Dietary Supplements conditions: Shoulder Pain studyType: INTERVENTIONAL phases: NA allocation: NON_RANDOMIZED interventionModel: SEQUENTIAL interventionModelDescription: The enrolling physiatrist, in agreement with the patient and adhering to Good Clinical Practice standards related to safety and clinical-anthropomorphic characteristics, will decide whether to continue the treatment with oral supplements (Group 1 - G1) or with intra-articular hyaluronic acid (Group 2 - G2) primaryPurpose: TREATMENT masking: SINGLE maskingDescription: Both study groups will undergo assessment using pain and functional scales by a clinician who is blinded to the treatment group whoMasked: INVESTIGATOR count: 50 type: ESTIMATED name: Collagen, Hyaluronic Acid, Vitamin C, and Manganese name: Intra-articular infiltration measure: Numeric rating scale (NRS) measure: Shoulder Disability Questionnaire (SDQ) for shoulder functionality sex: ALL minimumAge: 30 Years maximumAge: 80 Years stdAges: ADULT stdAges: OLDER_ADULT hasResults: False |
<|newrecord|> nctId: NCT06379984 id: 855013 briefTitle: Rapid Outpatient Low-dose Initiation of Buprenorphine for OUD With Fentanyl Use acronym: ROLDI overallStatus: NOT_YET_RECRUITING date: 2024-05-01 date: 2025-12-31 date: 2025-12-31 date: 2024-04-23 date: 2024-04-24 name: University of Pennsylvania class: OTHER name: National Institute on Drug Abuse (NIDA) briefSummary: The goal of this clinical trial is to learn if buprenorphine can be started for opioid use disorder with fentanyl use without requiring or precipitating opioid withdrawal. To be eligible, participants must have moderate or severe opioid use disorder and must have fentanyl detected on a urine drug test. |
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