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* If there are specific miRNAs that can regulate this immune response and can be considered as suitable biomarkers and therapeutic targets.
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Obese or non-obese participants with periodontitis will receive non-surgical periodontal treatment, consisting of oral health guidance and mechanical periodontal debridement throughout the mouth using an ultrasonic device and manual curettes. Researchers will compare four groups: obese women, non-obese women, obese men, and non-obese men, to clarify the involment of immune response after treatment, considering the coexistence of obesity and potential gender differences. conditions: Periodontal Diseases studyType: OBSERVATIONAL observationalModel: CASE_CONTROL timePerspective: CROSS_SECTIONAL count: 100 type: ESTIMATED name: non-chirurgical periodontal treatment measure: Changes in inflammasome complex activation grade in patients with chronic periodontitis with and without obesity, before and after non-surgical periodontal treatment. measure: Changes in endothelial function in the study population. measure: Changes in endothelial function at molecular level in the study population. measure: Changes in the systemic inflammation status in the study population. measure: Changes in the expression of genes related to inflammatory pathways in PBMC in the study population. measure: Changes in the expression of genes related to oxidative stress levels in PBMC in the study population. measure: Changes in the expression of genes related to cellular respiration in PBMC in the study population. measure: Sequence miRNAs in biological fluids in patients with chronic periodontitis with and without obesity, before and after non-surgical periodontal treatment. measure: Evaluate the distribution and phenotype of different T lymphocyte and monocyte subpopulations in the study population. measure: Changes in the protein expression of autophagy markers in PBMC in the study population. measure: Evaluate autophagy flux in the study population. measure: Evaluate autophagosome formation in the study population. sex: ALL minimumAge: 18 Years maximumAge: 69 Years stdAges: ADULT stdAges: OLDER_ADULT facility: University Hospital Dr Peset status: RECRUITING city: Valencia zip: 46017 country: Spain name: Milagros Rocha Barajas, PhD role: CONTACT phone: 0034 963 189 132 email: [email protected] name: Milagros Rocha Barajas, PhD role: PRINCIPAL_INVESTIGATOR lat: 39.46975 lon: -0.37739 facility: University Hospital Dr. Peset status: RECRUITING city: Valencia zip: 46017 country: Spain name: Milagros Rocha Barajas role: CONTACT phone: 963188875 email: [email protected] lat: 39.46975 lon: -0.37739 hasResults: False
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<|newrecord|> nctId: NCT06261710 id: EA2_253_23 briefTitle: Intrapartum Ultrasound in Labor: Sonography Only, Few Internal Examinations acronym: SOFIE overallStatus: RECRUITING date: 2024-02-27 date: 2029-02-01 date: 2030-02-01 date: 2024-02-15 date: 2024-02-16 name: Larry Hinkson class: OTHER briefSummary: This is a prospective, randomized trial to determine whether the use of sonographic parameters during labor results in less intrapartum infection compared to traditional invasive examination. Other secondary outcomes include maternal satisfaction and overall birth outcomes. conditions: Labor Complication studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: PREVENTION masking: NONE count: 356 type: ESTIMATED name: Sonography in labour measure: Maternal Fever Incidence measure: Maternal Tachycardia Incidence measure: Maternal Leucocytosis measure: Uterine tenderness measure: Fetal Tachycardia measure: Foul-smelling amniotic fluid measure: Average age measure: Maternal weight measure: Maternal height measure: Completed weeks of pregnancy measure: Previous pregnancy measure: Incidence of Vaginal Examinations measure: Incidence of Caesarean section measure: Incidence of Instrumental Delivery measure: Incidence of estimated blood loss >1000 ml measure: Incidence of antibiotics usage measure: Incidence of Neonatal Admission measure: Neonatal weight measure: Maternal Satisfaction Scores measure: Incidence of Chorioamnionitis on Placenta Histologie sex: FEMALE minimumAge: 18 Years maximumAge: 60 Years stdAges: ADULT facility: Charité University Hospital status: RECRUITING city: Berlin country: Germany name: Larry Hinkson, FRCOG role: CONTACT lat: 52.52437 lon: 13.41053 hasResults: False
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<|newrecord|> nctId: NCT06261697 id: P.T.REC/012/004876 briefTitle: Relationship Between Smartphone Addiction and Temporomandibular Joint Disorders Among Adults in Egypt. overallStatus: NOT_YET_RECRUITING date: 2024-02-20 date: 2024-04 date: 2024-06 date: 2024-02-15 date: 2024-02-21 name: Cairo University class: OTHER briefSummary: Cross sectional study to investigate the relation between Smartphone addiction and temporomandibular disorders among youth population in Egypt. An online- based questionnaire study. A 296 participants who are Egyptians with age between18 and 35 years old without prior neck and upper extremity related diseases, orofacial trauma or surgeries, history of rheumatoid arthritis or congenital musculoskeletal problems. An online- based questionnaire will be sent through different social media platforms, it will include three screens, the first includes the consent form, the second includes the demographic data (year of birth, current educational status, gender and geographic information ), and the third page includes questionnaires
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. conditions: Temporomandibular Disorders conditions: Smartphone Addiction studyType: OBSERVATIONAL observationalModel: CASE_CROSSOVER timePerspective: PROSPECTIVE count: 296 type: ESTIMATED name: A web based survey measure: Fonseca Anamnestic Index (FAI) questionnaire measure: Smartphone Addiction Scale-Short version (SAS-SV) questionnaire measure: Patient Health Questionnaire (PHQ) sex: ALL minimumAge: 18 Years maximumAge: 35 Years stdAges: ADULT hasResults: False
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<|newrecord|> nctId: NCT06261684 id: MS-259-2023 briefTitle: Intralesional Acyclovir Versus Cryotherapy in the Treatment of Plantar Warts. A Randomized Controlled Trial. overallStatus: RECRUITING date: 2023-10-01 date: 2024-10-01 date: 2024-10-01 date: 2024-02-15 date: 2024-02-15 name: Cairo University class: OTHER briefSummary: The goal of this prospective randomized controlled study is to study the safety and efficacy of intralesional acyclovir compared to cryotherapy in plantar warts. The main questions needed to be answered are:
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1. Is Intralesional acyclovir safe for plantar warts?
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2. Is Intralesional acyclovir more efficient in treating plantar warts compared to cryotherapy? conditions: Plantar Wart studyType: INTERVENTIONAL phases: PHASE2 phases: PHASE3 allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: DOUBLE whoMasked: INVESTIGATOR whoMasked: OUTCOMES_ASSESSOR count: 92 type: ESTIMATED name: Intralesional Acyclovir name: Cryotherapy measure: Cure rate measure: Recurrence rate measure: Patient satisfaction score measure: Correlation of treatment with number of ipsilateral warts measure: Correlation of treatment with age measure: Correlation of treatment with gender measure: Correlation of treatment with size of the wart sex: ALL minimumAge: 18 Years maximumAge: 70 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Cairo University Hospital status: RECRUITING city: Cairo country: Egypt name: Basant Helal, MRCP role: CONTACT name: Shahira Ramadan, Professor role: PRINCIPAL_INVESTIGATOR name: Yousra Azzazi, Lecturer role: SUB_INVESTIGATOR lat: 30.06263 lon: 31.24967 hasResults: False
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<|newrecord|> nctId: NCT06261671 id: 2312-ABU-028-VF briefTitle: Effect of Antioxydant-enriched Media on Blastocyst Euploidy Rates. acronym: GX overallStatus: NOT_YET_RECRUITING date: 2024-03-01 date: 2024-12-31 date: 2024-12-31 date: 2024-02-15 date: 2024-02-15 name: ART Fertility Clinics LLC class: OTHER briefSummary: One of the most sensible factors in IVF culture conditions is the susceptibility of gametes and embryos to an induced increase in reactive oxidative species (ROS) caused by the artificial environment. This study aims to evaluate the impact of using antioxidant-supplemented media during culture to evaluate embryo ploidy rates in a prospective randomized trial using sibling oocytes. conditions: Infertility conditions: In Vitro Fertilization studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL interventionModelDescription: A randomization list (indicating Gx Media Vitrolife or GT Coopersurgical) will be used to verify to which group the first half of oocytes will be allocated to. In case an odd number of oocytes is present, one extra oocyte is allocated to the group as indicated by the randomization list. primaryPurpose: TREATMENT masking: NONE count: 500 type: ESTIMATED name: antioxidants-enriched culture medium (Gx) measure: Blastocyst ploidy is determined after a biopsy of trophectoderm cells, taken from the blastocyst on day 5, 6 or 7 from development. The following outcomes are possible: • Normal • Abnormal • No result/Inconclusive • Low or high Mosaic measure: Cycle ploidy rate: the number of euploid embryos in the group Blastocyst quality at the time of biopsy based on modified Gardner's criteria. Usable blastocyst rate per group and per day of biopsy (day 5, 6, 7) sex: ALL minimumAge: 18 Years maximumAge: 43 Years stdAges: ADULT hasResults: False
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<|newrecord|> nctId: NCT06261658 id: TESOVA2022 briefTitle: Improving the Quality of Cryopreserved Ovarian Tissue Reimplantation Using Platelet-enriched Autologous Plasma acronym: TESOVA2022 overallStatus: RECRUITING date: 2024-03-01 date: 2024-12-29 date: 2033-12-29 date: 2024-02-15 date: 2024-02-15 name: IRCCS Azienda Ospedaliero-Universitaria di Bologna class: OTHER briefSummary: The study is aimed to evaluate the effects of intraovarian injection of autologous Platelet-enriched Autologous Plasma on the outcomes of orthotopic transplantation of cryopreserved ovarian tissue. conditions: Cryopreservation conditions: Ovary Injury conditions: Infertility, Female conditions: Menopause Ovarian Failure studyType: INTERVENTIONAL phases: NA allocation: NA interventionModel: SINGLE_GROUP primaryPurpose: TREATMENT masking: NONE count: 45 type: ESTIMATED name: Cryopreserved Ovarian Tissue Reimplantation measure: Safety of Cryopreserved ovarian tissue transplantation Using Platelet-enriched Autologous Plasma measure: Effectiveness of Cryopreserved ovarian tissue transplantation Using Platelet-enriched Autologous Plasma sex: FEMALE stdAges: CHILD stdAges: ADULT stdAges: OLDER_ADULT facility: Diego Raimondo status: RECRUITING city: Bologna state: BO zip: 40138 country: Italy name: Diego Raimondo, MD role: CONTACT phone: 0512144389 phoneExt: 0039 email: [email protected] name: Renato Seracchioli, MD role: PRINCIPAL_INVESTIGATOR name: Diego Raimondo, MD role: SUB_INVESTIGATOR name: Rossella Vicenti, PhD role: SUB_INVESTIGATOR name: Valentina Magnani, PhD role: SUB_INVESTIGATOR lat: 44.49381 lon: 11.33875 hasResults: False
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<|newrecord|> nctId: NCT06261645 id: ROTOFUNK_2_2023 briefTitle: Rotofunc - Non-traumatic Shoulder Instability and Total Rotator Cuff Function acronym: ROTOFUNC overallStatus: RECRUITING date: 2023-05-01 date: 2025-12 date: 2026-12 date: 2024-02-15 date: 2024-03-08 name: Sahlgrenska University Hospital, Sweden class: OTHER briefSummary: The goal of this clinical trial is to test the effect of a novel assessment and treatment strategy for young adults with severely disabling non-traumatic shoulder instability. The main question it aims to answer is if this treatment will substantially change the patients shoulder function to a more stable and controllable state and thereby give a higher quality of life. Participants failure in active shoulder muscle function will be assessed and exercises will be selected individually. Patients will be asked to perform the exercises twice per day. At clinical visits to a specialized physiotherapist the exercises will be upgraded to restore full dynamic stability throughout shoulder movement range. The active treatment period will be 4 months. Researchers will compare two groups. One group will start directly after a baseline assessment is fulfilled. The other group will receive the treatment with a delay of 4 months to evaluate if the selected exercises can substantially change the shoulder stability compared to no treatment, the natural course of the condition. conditions: Shoulder Dislocation or Subluxation studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: SEQUENTIAL interventionModelDescription: A 16 week exercise program with specific exercises to restore total rotator cuff function individually selected during clinical physiotherapy visits and performed 2 - 4 times daily.
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In addition, the patient will receive education and guidance in the daily use of the arm to adjust to appropriate load on the shoulder. primaryPurpose: TREATMENT masking: DOUBLE maskingDescription: Investigator: 6 physiotherapists are care providers, responsible for the Intervention . Two independent investigators does not know who is the actual care provider. However, all patients recieve the same intervention.
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Outcome assessor: each participant is given a research code. The results from the assessments are entered in the data base by a research assistant, not involved in the study on any level.
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Individuals are not identifiable. The outcome assessor are planning for all statistics used and is not in other ways involved in the study. whoMasked: INVESTIGATOR whoMasked: OUTCOMES_ASSESSOR count: 100 type: ESTIMATED name: Early Physiotherapist selected active exercises name: Delayed Physiotherapist selected active exercises measure: Neuromuscular control measure: Clinical assessment - Active and passive range of motion measure: Pain at rest measure: Pain during motion measure: Apprehension of instability during motion measure: Patient reported quality-of-life in relation to shoulder function measure: Patient's satisfaction sex: ALL minimumAge: 16 Years maximumAge: 35 Years stdAges: CHILD stdAges: ADULT facility: Sahlgrenska University Hospital/Mölndal, Physiotherapy Dpt status: RECRUITING city: Gothenburg state: Mölndal zip: SE 43180 country: Sweden name: Ingrid K Hultenheim Klintberg, PhD role: CONTACT email: [email protected] lat: 57.70716 lon: 11.96679 hasResults: False
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<|newrecord|> nctId: NCT06261632 id: Hemo-Blood briefTitle: Blood Flow Restriction in Improving Muscle Strength of Patients With Hemophilic Knee Arthropathy overallStatus: ACTIVE_NOT_RECRUITING date: 2024-02-19 date: 2024-07-28 date: 2024-11-01 date: 2024-02-15 date: 2024-02-20 name: Investigación en Hemofilia y Fisioterapia class: NETWORK briefSummary: Background. The main physical sequela of patients with hemophilia is the development of a progressive, degenerative intra-articular lesion, known as hemophilic arthropathy). This sequela is manifested by chronic pain, limited range of motion, axial abnormalities, and periarticular muscle atrophy.
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Objective. To assess the safety and effectiveness of an intervention through blood flow restriction, regarding the frequency of bleeding and the improvement in muscle activation and strength, range of motion, functionality, joint pain, joint status and the perception of quality of life in patients with hemophilic arthropathy. knee and ankle.
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Study design. Randomized, multicenter, single-blind clinical study. Method. 60 patients with hemophilia A and B will be recruited in this study. Patients will be recruited in 6 regions of Spain. The dependent variables will be: bleeding frequency (self-registration), pain (measured with the visual analog scale and pressure algometer), quality of life (SF-36 scale), joint status (Hemophilia Joint Health Score scale), strength (dynamometer) and muscle activation (surface electromyograph), range of motion (goniometer) and functionality (Timed up and go test). Three evaluations will be carried out: pre-treatment, post-treatment and after a follow-up period of 4 weeks.
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Expected results. Observe the safety of blood flow restriction in hemophilia patients. To analyze the efficacy of blood flow restriction in improving muscle strength and activation, range of motion, chronic pain, functionality, and the perception of quality of life in patients with hemophilic knee and ankle arthropathy. conditions: Hemophilia studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: DOUBLE whoMasked: CARE_PROVIDER whoMasked: OUTCOMES_ASSESSOR count: 40 type: ESTIMATED name: Blood flow restriction measure: Change from baseline hemarthrosis after treatment and at four weeks measure: Change from baseline pressure pain threshold after treatment and at four weeks measure: Change from baseline muscle strength after treatment and at four weeks measure: Change from baseline electrical activity of the muscles after treatment and at four weeks measure: Change from baseline range of motion after treatment and at four weeks measure: Change from baseline joint status after treatment and at four weeks measure: Change from baseline functionality after treatment and at four weeks sex: MALE minimumAge: 18 Years maximumAge: 60 Years stdAges: ADULT facility: University of Oviedo city: Oviedo state: Asturias zip: 33006 country: Spain lat: 43.36029 lon: -5.84476 hasResults: False
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<|newrecord|> nctId: NCT06261619 id: 2079951 briefTitle: Superiority Trial Between Sotair® Device Attached to Manual Resuscitator Versus Ventilation Alone overallStatus: RECRUITING date: 2024-02-19 date: 2025-01-31 date: 2025-06-01 date: 2024-02-15 date: 2024-02-20 name: Rhode Island Hospital class: OTHER briefSummary: Effective respiratory ventilation is achieved by moving the right amount of air to and out of the lungs while keeping the pressures at a safe level. A disposable safety device, Adult Sotair®, was created to improve manual ventilation delivery. In this superiority study, the investigators will perform two-group cross over randomized design to test the superiority of the Adult Sotair® device compared to manual ventilation alone. conditions: Airway Management conditions: Respiration, Artificial studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: CROSSOVER interventionModelDescription: Study Design: A superiority trial; a single two-group cross over randomized trial. primaryPurpose: SUPPORTIVE_CARE masking: SINGLE maskingDescription: The care provider will not know the recorded lung function recordings. whoMasked: PARTICIPANT count: 30 type: ESTIMATED name: Adult Sotair Device measure: Peak airway pressure measure: Tidal volume measure: Airflow sex: ALL minimumAge: 18 Years maximumAge: 80 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Rhode Island Hospital status: RECRUITING city: Providence state: Rhode Island zip: 02903 country: United States name: Mark Kendall, MD role: CONTACT phone: 401-444-5172 email: [email protected] lat: 41.82399 lon: -71.41283 hasResults: False
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<|newrecord|> nctId: NCT06261606 id: 4020286 briefTitle: Feasibility of a Multifaceted Program to Reduce Cardiovascular Complications of Air Pollution overallStatus: RECRUITING date: 2024-01-28 date: 2024-03 date: 2024-03 date: 2024-02-15 date: 2024-03-05 name: Parham Sadeghipour class: OTHER briefSummary: The main goal of this clinical trial is to evaluate the feasibility of conducting a large-scale clinical trial testing a program containing several aspects for reducing the effects of air pollution on cardiovascular health (which is named the hybrid program hereafter) in adult patients (18 years or older) with atherosclerotic cardiovascular disease. Furthermore, we seek to answer how much patients adhere to and are satisfied with implementing the hybrid program, and what problems executing this program will bring for patients. conditions: Atherosclerosis conditions: Coronary Artery Disease conditions: Peripheral Arterial Disease conditions: Ischemic Stroke conditions: Carotid Artery Diseases studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL interventionModelDescription: Participants undergo permuted block randomization with block sizes of four via a web-based system will be used for the study, in a 1:1 ratio between the hybrid strategy or control arms. primaryPurpose: OTHER masking: NONE count: 50 type: ESTIMATED name: Hybrid strategy measure: Feasibility of conducting the trial measure: Adherence to the individual components of the hybrid strategy measure: Patient satisfaction with the hybrid strategy measure: Any potential adverse events in intervention and control groups during the 30-day follow-up measure: Change in the health-related quality of life measure: Change in the level of anxiety sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Rajaie Cardiovascular Medical and Research Center status: RECRUITING city: Tehran zip: 1995614331 country: Iran, Islamic Republic of name: Parham Sadeghipour, MD role: CONTACT phone: +98 21 2392 2092 email: [email protected] lat: 35.69439 lon: 51.42151 hasResults: False
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<|newrecord|> nctId: NCT06261593 id: Ankle-Blood briefTitle: Blood Flow Restriction in Improving Muscle Strength of Patients With Hemophilic Ankle Arthropathy overallStatus: RECRUITING date: 2024-04-06 date: 2024-07-03 date: 2024-09-20 date: 2024-02-15 date: 2024-02-20 name: Investigación en Hemofilia y Fisioterapia class: NETWORK briefSummary: Background. The main physical sequela of patients with hemophilia is the development of a progressive, degenerative intra-articular lesion, known as hemophilic arthropathy). This sequela is manifested by chronic pain, limited range of motion, axial abnormalities, and periarticular muscle atrophy.
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Objective. To assess the safety and effectiveness of an intervention through blood flow restriction, regarding the frequency of bleeding and the improvement in muscle activation and strength, range of motion, stability, joint pain, joint status and the perception of quality of life in patients with hemophilic ankle arthropathy.
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Study design. Randomized, multicenter, single-blind clinical study. Method. 32 patients with hemophilia A and B will be recruited in this study. Patients will be recruited in 4 regions of Spain. The dependent variables will be: bleeding frequency (self-registration), pain (measured with the visual analog scale and pressure algometer), quality of life (SF-36 scale), joint status (Hemophilia Joint Health Score scale), strength (dynamometer) and muscle activation (surface electromyograph), range of motion (goniometer) and stability (The Single Leg Stance Test). Three evaluations will be carried out: pre-treatment, post-treatment and after a follow-up period of 4 weeks.
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Expected results. Observe the safety of blood flow restriction in hemophilia patients. To analyze the efficacy of blood flow restriction in improving muscle strength and activation, range of motion, chronic pain, stabilit, and the perception of quality of life in patients with hemophilic ankle arthropathy. conditions: Hemophilia studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: DOUBLE whoMasked: CARE_PROVIDER whoMasked: OUTCOMES_ASSESSOR count: 24 type: ESTIMATED name: Blood flow restriction measure: Change from baseline hemarthrosis after treatment and at 4 weeks measure: Change from baseline pressure pain threshold after treatment and at 4 weeks measure: Change from baseline muscle strength after treatment and at 4 weeks measure: Change from baseline electrical activity of the muscles after treatment and at 4 weeks measure: Change from baseline joint status after treatment and at 4 weeks measure: Change from baseline range of motion after treatment and at four weeks measure: Change from baseline balance after treatment and at four weeks sex: MALE minimumAge: 18 Years maximumAge: 55 Years stdAges: ADULT facility: University of Oviedo status: RECRUITING city: Oviedo state: Asturias zip: 33006 country: Spain name: Rubén Cuesta-Barriuso, PhD role: CONTACT lat: 43.36029 lon: -5.84476 hasResults: False
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<|newrecord|> nctId: NCT06261580 id: TP-CLN-100502 briefTitle: Normal Reference Range Study With the TEG6s Heparin Neutralization Cartridge in Healthy Volunteers overallStatus: COMPLETED date: 2021-07-28 date: 2021-10-25 date: 2021-10-25 date: 2024-02-15 date: 2024-02-15 name: Haemonetics Corporation class: INDUSTRY name: Machaon Diagnostics name: ClinStatDevice briefSummary: This trial holds minimal risk to the trial volunteers and consists of obtaining whole blood via venipuncture to perform coagulation parameter measurements to define a Normal Reference Range.
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Written consent to participate in the study will be obtained prior to volunteer screening per site procedures. conditions: Healthy studyType: OBSERVATIONAL observationalModel: OTHER timePerspective: PROSPECTIVE count: 181 type: ACTUAL name: TEG 6s Citrated K, KH, RTH, and FFH Cartridge name: Clauss Fibrinogen measure: CK-MA TEG Parameter measure: CK-R TEG Parameter measure: CKH-MA TEG Parameter measure: CKH-R TEG Parameter measure: CKH-LY30 TEG Parameter measure: CRTH-MA TEG Parameter measure: CFFH-MA TEG Parameter sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Machaon Diagnostics city: Oakland state: California zip: 94609 country: United States lat: 37.80437 lon: -122.2708 facility: Cardiovascular Research Institute - Loyola University Chicago Health Sciences city: Maywood state: Illinois zip: 60153 country: United States lat: 41.8792 lon: -87.84312 facility: Louisiana Coagulation / Machaon Division city: New Orleans state: Louisiana zip: 70118 country: United States lat: 29.95465 lon: -90.07507 hasResults: False
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<|newrecord|> nctId: NCT06261567 id: D2287R00189 briefTitle: A Retrospective Chart Review to Investigate Clinical Remission in Patients With Severe Asthma Treated With Biologics in the United Kingdom National Health Service acronym: REMISSION UK overallStatus: RECRUITING date: 2024-02-27 date: 2024-09-27 date: 2024-09-27 date: 2024-02-15 date: 2024-04-23 name: AstraZeneca class: INDUSTRY briefSummary: Asthma is a common lung condition that causes occasional breathing difficulties and affects around 5.4 million people in the UK of all ages. Common symptoms can include wheezing when breathing, breathlessness, a tight chest and coughing. However, these symptoms can get worse and lead to an asthma attack which can be fatal.
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There is currently no cure for asthma but there are treatments that can help keep the symptoms under control. The main types of treatment include reliever inhalers used when needed quickly to reverse asthma symptoms for a short time, and preventer inhalers that are used everyday to prevent symptoms for starting. Unfortunately, not all patients are able to control their asthma on these treatments alone. Biologic treatments, also known as monoclonal antibodies, have been introduced to treat certain types of severe asthma over recent years. These specialist treatments use antibodies produced from cells in a laboratory to help reduce inflammation and might offer the possibility of higher levels of disease control including the reduction or absence of symptoms and normal lung function. This higher level of disease control is called remission.
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This study aims to understand whether or not remission is possible in patients with severe asthmas treated with biologics in the NHS. This study will take place a 4 specialist asthma centres in the UK and seeks to include retrospective data from approximately 450 adult patients that were treated with biologics as part of routine care between 01 October 2021 and 30 September 2022. Data will be collected directly from medical records and entered into the study database in a pseudonymised format by members of the direct care team ready for analysis. conditions: Asthma studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: RETROSPECTIVE count: 425 type: ESTIMATED name: Biologic treatment measure: Proportion of patients in clinical remission measure: Number and proportion achieving specific criteria for clinical remission measure: Number and proportion of super-responders measure: Number and proportion of responders measure: Number and proportion of non-responders measure: Age at index measure: Sex measure: Ethnicity measure: Smoking status measure: BMI measure: IMD quintile measure: Comorbidities measure: COVID-19 vaccination status measure: Fractional Exhaled Nitric Oxide (FeNO) measure: Blood eosinophil count (EOS) measure: IgE measure: ACQ-6 measure: AQLQ measure: lung function (FEV1) measure: Rate of exacerbation in prior 12 months measure: Asthma treatments at 6 months measure: Asthma treatments at 12 months measure: Annualised exacerbation rate (AER) measure: mOCS use (proportion with 0 mg/day) measure: ACQ-6 score measure: AQLQ score measure: Lung function (FEV-1) measure: Respiratory infections measure: Annualised exacerbation rate (AER) measure: mOCS use (proportion with 0 mg/day) measure: ACQ-6 score measure: AQLQ score measure: Lung function (FEV-1) measure: Respiratory infections sex: ALL minimumAge: 18 Years maximumAge: 130 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Research Site status: NOT_YET_RECRUITING city: Birmingham country: United Kingdom lat: 52.48142 lon: -1.89983 facility: Research Site status: RECRUITING city: London country: United Kingdom lat: 51.50853 lon: -0.12574 facility: Research Site status: NOT_YET_RECRUITING city: Manchester country: United Kingdom lat: 53.48095 lon: -2.23743 facility: Research Site status: RECRUITING city: Southampton country: United Kingdom lat: 50.90395 lon: -1.40428 hasResults: False
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<|newrecord|> nctId: NCT06261554 id: Low-dose sesame OIT briefTitle: Efficacy and Safety of Low-dose Sesame Oral Immunotherapy in Pediatric Patients overallStatus: RECRUITING date: 2024-03 date: 2026-03-01 date: 2027-03-01 date: 2024-02-15 date: 2024-03-05 name: Medical University of Warsaw class: OTHER briefSummary: It is a randomized, single-center, controlled trial to evaluate the effectiveness of oral immunotherapy with low-dose sesame protein compared with standard treatment (elimination diet) in patients with sesame allergy. conditions: Food Allergy studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: NONE count: 39 type: ESTIMATED name: Dietary Supplement: Low dose OIT measure: Tolerance of sesame measure: Adverse event measure: Laboratory data measure: Basophil activation test measure: Skin prick test (SPT) measure: Desensitization dose sex: ALL minimumAge: 3 Years maximumAge: 17 Years stdAges: CHILD facility: Medical University of Warsaw status: RECRUITING city: Warsaw state: Mazowieckie zip: 02-091 country: Poland name: Katarzyna Grzela, PhD, MD role: CONTACT phone: +48 22 3179431 email: [email protected] lat: 52.22977 lon: 21.01178 hasResults: False
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<|newrecord|> nctId: NCT06261541 id: ABLEexoMS briefTitle: Clinical Investigation to Validate the Safety and Performance of the ABLE Exoskeleton Device for Individuals With Multiple Sclerosis in a Clinical Setting overallStatus: RECRUITING date: 2024-04-08 date: 2024-08-01 date: 2024-08-01 date: 2024-02-15 date: 2024-04-22 name: ABLE Human Motion S.L. class: INDUSTRY name: Fundación Esclerosis Múltiple Madrid (FEMM) briefSummary: The primary objective of the study is to validate the safety and performance of the ABLE Exoskeleton device in people with multiple sclerosis during a 10-session gait training program in a clinical setting. Furthermore, the potential effects of the training on walking, and balance function, general health status, user satisfaction, and quality of life will be assessed. conditions: Multiple Sclerosis studyType: INTERVENTIONAL phases: NA allocation: NA interventionModel: SINGLE_GROUP primaryPurpose: TREATMENT masking: NONE count: 20 type: ESTIMATED name: ABLE Exoskeleton measure: Number and type of device-related Adverse Events measure: Level of Assistance (LoA) to don/doff the device measure: Time taken to don/doff the device measure: Level of Assistance (LoA) to complete therapy activity tasks measure: Time spent upright and time spent walking measure: Number of steps walked measure: Distance walked measure: Timed 25-Feet Walk test (T25FW) measure: Ambulation Index (AI) measure: 6-Minute Walk Test (6MWT) measure: Timed Up-and-Go test (TUG) measure: Trunk Impairment Scale (TIS) measure: Lower extremity muscle strenght measure: Modified Ashworth Scale (MAS) measure: Borg Rating of Perceived Exertion measure: Barthel Index (BI) score measure: Modified Fatigue Impact Scale (MFIS) score measure: Multiple Sclerosis Quality of Life-54 (MSQoL-54) measure: Psychosocial Impact of Assistive Devices Scale (PIADS) score measure: Quebec User Evaluation of Satisfaction with assistive Technology (QUEST 2.0) score sex: ALL minimumAge: 18 Years maximumAge: 70 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Fundación Esclerosis Múltiple Madrid (FEMM) status: RECRUITING city: Madrid country: Spain name: Almudena Chao role: CONTACT phone: 913993245 email: [email protected] name: Kenneth Malpartida role: CONTACT email: [email protected] lat: 40.4165 lon: -3.70256 hasResults: False
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<|newrecord|> nctId: NCT06261528 id: STU-2023-1289 briefTitle: Study of Circadian Focused Light Therapy in Progressive Multiple Sclerosis acronym: NO-FATIGUE overallStatus: RECRUITING date: 2024-04-18 date: 2025-05-01 date: 2025-12-01 date: 2024-02-15 date: 2024-04-22 name: University of Texas Southwestern Medical Center class: OTHER name: National Multiple Sclerosis Society name: International Progressive Multiple Sclerosis Alliance briefSummary: The study is being done to determine if treatment with a novel form of light therapy is tolerated in patients with progressive multiple sclerosis. The goal of this trial to establish the safety profile of this light therapy while generating data on its impact on fatigue, as well as its mechanism of action. Fatigue is often a complex symptom in multiple sclerosis, without any FDA-approved direct therapy. Fatigue is traditionally treated with symptom management through a multidisciplinary team. conditions: Progressive Multiple Sclerosis studyType: INTERVENTIONAL phases: PHASE1 allocation: NA interventionModel: SINGLE_GROUP interventionModelDescription: This will be an open label, single arm, single center phase 1 research study designed to generate safety data, biomarker data, and preliminary efficacy data to reduce fatigue in patients with progressive MS, to include PPMS and SPMS primaryPurpose: TREATMENT masking: NONE count: 20 type: ESTIMATED name: Light therapy measure: Treatment Emergent Adverse Events (TEAEs) sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: UT Southwestern Medical Center status: RECRUITING city: Dallas state: Texas zip: 75247 country: United States name: Ana Raicu role: CONTACT phone: 214-645-0292 email: [email protected] name: Ana Raicu role: CONTACT phone: 214-645-0292 name: Peter Sguigna, MD role: PRINCIPAL_INVESTIGATOR name: Benjamin Greenberg, MD role: SUB_INVESTIGATOR lat: 32.78306 lon: -96.80667 hasResults: False
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<|newrecord|> nctId: NCT06261515 id: Perio-gut PRIN briefTitle: Multi-omics Analysis of Oral-gut Microbial Profiles overallStatus: NOT_YET_RECRUITING date: 2024-02-15 date: 2026-01-15 date: 2026-02-15 date: 2024-02-15 date: 2024-02-15 name: University of Turin, Italy class: OTHER briefSummary: Periodontitis is a chronic inflammatory disease of the tooth supporting structures induced by a dysbiosis in the oral and subgingival microenvironment of susceptible patients. The long-term swallowing of high doses of periodontal pathogenic microorganisms could induce a dysbiosis of the intestinal microbiota, favouring the establishment of an 'inflamed' microbiome in terms of composition and/or function. The present project is aimed at a better understanding of the etiopathogenetic correlation between periodontitis and intestinal dysbiosis, and aims to explore the hypothesis that periodontal treatment may influence the multi-omics profile on the oral-gut-systemic axis. 70 patients affected by stage III-IV periodontitis will be recruited, and treated by means of full-mouth scaling and root planing. Salivary, subgingival plaque, plasma and stool samples, together with a complete periodontal charting and a food diary will be collected and compared at baseline and after treatment. Age, gender and BMI-matched healthy individuals will be recruited as controls. conditions: Periodontitis studyType: INTERVENTIONAL phases: NA allocation: NA interventionModel: SINGLE_GROUP primaryPurpose: TREATMENT masking: NONE count: 70 type: ESTIMATED name: Active periodontal treatment measure: Changes in gut microbial profile measured in stool samples measure: Changes in oral microbial profile measured in saliva samples measure: Changes in oral microbial profile measured in subgingival plaque samples measure: Changes in oral-gut metabolome measured in stool samples measure: Changes in oral-gut miRNAome measured in stool samples measure: Metabolic plasma changes sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT hasResults: False
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<|newrecord|> nctId: NCT06261502 id: 2023-4527 id: 275882 type: OTHER domain: Health Canada id: 202010PJT-451514 type: OTHER_GRANT domain: Canadian Institutes of Health Research briefTitle: Effect of CANnabidiol on Anxiety and GABAergic Function in Individuals With Fragile-X Syndrome acronym: CANAX overallStatus: NOT_YET_RECRUITING date: 2024-04-01 date: 2027-05-01 date: 2027-08-01 date: 2024-02-15 date: 2024-02-15 name: Université de Sherbrooke class: OTHER name: Canadian Institutes of Health Research (CIHR) name: Jazz Pharmaceuticals name: Centre de recherche du Centre hospitalier universitaire de Sherbrooke briefSummary: This study focuses on the therapeutic relevance of the endocannabinoid (eCB) system for the treatment of Fragile-X syndrome (FXS), the primary hereditary cause of autism spectrum disorder (ASD). Most individuals with FXS have moderate to severe intellectual disability (ID), and caregivers are mainly concerned about aggressive behavior and anxiety problems. Since FXS individuals have a normal lifespan, the overall lifetime cost for the Canadian society of a single case is estimated at $1.2 to $4.7 millions reaching $18 billions for all FXS cases. There is no cure for FXS, as all clinical trials so far have been unsuccessful.FXS is caused by transcriptional silencing of the Fragile X mental retardation protein (FMR1) gene, making FXS a simple model to study ASD and ID pathophysiological mechanisms. Of those, neuronal hyperexcitability is largely recognized as a core deficit in FXS, and a critical therapeutic target for the disorder. Using transcranial magnetic stimulation (TMS) in FXS patients, our team provided the first direct evidence of Gamma-aminobutyric acid (GABA) receptor a (GABAa) dysfunctions in humans with this disorder and showed that this inhibitory deficit is linked with cortical hyperexcitability (PMID: 31748507). Concurrent lines of evidence suggest that stimulation of the endocannabinoid (eCB) system with the administration of Cannabidiol (CBD) could upregulate GABAergic function and correct inhibitory deficits presumed responsible for the neuropsychiatric phenotype of FXS. CBD has been shown to increase GABA concentration levels in the brains of healthy individuals, an effect that could help correct the hyperexcitability typically found in FXS. Thus, this trial aims to define the therapeutic potential of the eCB system for FXS, by measuring the impacts of oral CBD administration on the principal inhibitory neurotransmitter system of FXS patients, and the severity of the clinical phenotype. conditions: Fragile X Syndrome studyType: INTERVENTIONAL phases: PHASE2 allocation: RANDOMIZED interventionModel: CROSSOVER interventionModelDescription: Randomized, Double-blind, placebo-controlled, single center, cross-over trial primaryPurpose: TREATMENT masking: QUADRUPLE maskingDescription: The randomization and participant code allocation process will be carried out by the Centre de recherche du Centre hospitalier universitaire de Sherbrooke (CRCHUS) pharmacy. The pharmacy will dispense the medication or placebo based on the randomization. The principal investigators, Drs. Lepage and Corbin and the research, as well as the participants and their caregivers, will never be aware of the randomization. To avoid any suspicions on the part of the investigators, Dr. Artuela Çaku, who is not part of the research team, will have access to the laboratory results. In the event of an adverse drug effect, Dr. Çaku may break the code to make a more informed decision for the patient's well-being, such as discontinuing participation or reducing the dose, etc. whoMasked: PARTICIPANT whoMasked: CARE_PROVIDER whoMasked: INVESTIGATOR whoMasked: OUTCOMES_ASSESSOR count: 40 type: ESTIMATED name: CBD Oral Solution name: Placebo measure: Impact of Oral CBD Solution anxiety. measure: Impact of Oral CBD Solution on disruptive behavior measure: Impact of Oral CBD Solution on Behavioral Inhibition measure: Impact of Oral CBD Solution on intracortical inhibition measure: Impact of Oral CBD Solution on intracortical facilitation measure: Impact of Oral CBD Solution on sex: ALL minimumAge: 7 Years maximumAge: 40 Years stdAges: CHILD stdAges: ADULT hasResults: False
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<|newrecord|> nctId: NCT06261489 id: REB23-1128 briefTitle: Cannabis (THC vs. CBD) in Multiple Sclerosis overallStatus: NOT_YET_RECRUITING date: 2024-03 date: 2025-09 date: 2025-12 date: 2024-02-15 date: 2024-02-15 name: University of Calgary class: OTHER name: Multiple Sclerosis Society of Canada briefSummary: The goal of this clinical trial is to examine the effect of Cannabis components, THC and CBD, on cognition and bladder symptoms in people with Multiple Sclerosis (MS).
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Participants will complete questionnaires and cognitive tests. They will be randomly assigned to receive either CBD or THC oil and will take the study drug for 15 weeks. conditions: Multiple Sclerosis studyType: INTERVENTIONAL phases: PHASE2 allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: QUADRUPLE whoMasked: PARTICIPANT whoMasked: CARE_PROVIDER whoMasked: INVESTIGATOR whoMasked: OUTCOMES_ASSESSOR count: 30 type: ESTIMATED name: THC name: CBD measure: Cognitive outcome: The Differential Effect, if any, of THC and CBD in MS Cognition will be measured by Symbol Digit Modality Test (SDMT). measure: NLUTD outcome: The Differential Effect, if any, of THC and CBD on Neurogenic lower urinary tract dysfunction (NLUTD) symptoms will be measured by Neurogenic Bladder Symptom Score (NBSS). measure: Blinding feasibility: The ability to blind the administration of THC vs CBD in PwMS will be evaluated based on participants and investigators report. sex: ALL minimumAge: 18 Years maximumAge: 59 Years stdAges: ADULT hasResults: False
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<|newrecord|> nctId: NCT06261476 id: DYP-Pharm-RP-23 briefTitle: Safety of Ashwagandha (Withania Somnifera) Root Extract overallStatus: RECRUITING date: 2024-02 date: 2024-05 date: 2024-05 date: 2024-02-15 date: 2024-02-15 name: SF Research Institute, Inc. class: NETWORK briefSummary: The primary objective is to evaluate the laboratory safety of Ashwagandha standardized root extract 500 mg capsules in healthy adults over 12-week therapy based on Complete Blood Count, Renal Function Test, Liver Function Test, Lipid Profile and Thyroid Function Test, Fasting blood sugar and HbA1c Test. The secondary objectives are to evaluate the clinical safety of Ashwagandha standardized root extract 500 mg capsules in healthy adults over 12-week therapy and to evaluate the effect of the Ashwagandha standardized root extract 500 mg on Quality of Life (QoL) using the SF-36 tool. conditions: Healthy studyType: INTERVENTIONAL phases: NA allocation: NA interventionModel: SINGLE_GROUP primaryPurpose: OTHER masking: NONE count: 100 type: ESTIMATED name: Ashwagandha (Withnia somnifera) measure: Hemoglobin Test measure: Total Erythrocyte Count measure: Total Leukocyte Count measure: Platelet Count measure: Hematocrit Test measure: Total Cholesterol Test measure: LDL Test measure: HDL Test measure: Triglycerides Test measure: Serum Alkaline Transaminase Test measure: Aspartate Transaminase Test measure: Alkaline Phosphatase Test measure: Bilirubin Test measure: Serum Creatinine Test measure: Blood Urea Nitrogen Test measure: T4 measure: T3 measure: Serum TSH measure: Fasting Blood Sugar measure: HbA1c measure: Adverse Events measure: Quality of Life (SF-36 QoL) sex: ALL minimumAge: 18 Years maximumAge: 65 Years stdAges: ADULT stdAges: OLDER_ADULT facility: SF Research Institute status: RECRUITING city: San Francisco state: California zip: 94127 country: United States name: John Ademola, PhD role: CONTACT phone: 415-549-9362 email: [email protected] lat: 37.77493 lon: -122.41942 hasResults: False
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<|newrecord|> nctId: NCT06261463 id: 2023-0326 id: K01MH128524-01A1 type: NIH link: https://reporter.nih.gov/quickSearch/K01MH128524-01A1 briefTitle: Pilot Trial of a Peer-led Family and Social Strengthening Group Intervention for Refugee Families overallStatus: NOT_YET_RECRUITING date: 2024-03 date: 2025-07 date: 2025-07 date: 2024-02-15 date: 2024-02-15 name: University of Illinois at Chicago class: OTHER name: National Institute of Mental Health (NIMH) briefSummary: The proposed study draws on prior research to evaluate the feasibility, acceptability and explore preliminary effectiveness of Coffee and Family Education and Support, Version (CAFES2) using a pilot randomized type 1 hybrid effectiveness-implementation design. CAFES2 is a peer-led family and social strengthening multiple family group intervention that is designed to respond to multi-level needs of refugee families. Results of the trial will contribute to the emerging evidence base on family-based mental health interventions for refugee and newcomer communities. The trial will also generate new insights regarding implementation strategies needed to promote successful delivery of services by peer providers and the unique role of human-centered design practices for adaptation of mental health and psychosocial interventions. conditions: Depression conditions: Anxiety conditions: PTSD conditions: Family Dynamics conditions: Social Functioning studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL interventionModelDescription: The investigators will conduct a randomized controlled trial with Syrian refugee families (n=74). Half of the families will be randomized to receive CAFES2 and half will be randomized to the enhanced control condition where they will receive ongoing access to services through partner organizations and healthy lifestyle materials. primaryPurpose: PREVENTION masking: SINGLE maskingDescription: The Research Assistants (RAs) who will collect both qualitative and quantitative data will be blind to the condition in which study participants are randomized. whoMasked: OUTCOMES_ASSESSOR count: 74 type: ESTIMATED name: CAFES2 measure: Changes in PTSD symptoms via the PTSD Checklist (adult, exploratory) measure: Changes in adult depression and anxiety via the Hopkins Symptom Checklist (HSCL, adult, exploratory) measure: Changes in youth depression and anxiety via the Hospital Anxiety and Depression Scale (HADS, youth, exploratory) measure: Changes in PTSD in children and youth via the Child Revised Impacted of Events Scale (CRIES, youth, exploratory) measure: Changes in social support via the Medical Outcomes Study Social Support Survey measure: Changes in social interaction via the Duke Social Support Index, social interaction subscale measure: Changes in parenting via the Alabama Parenting Questionnaire (adult and youth) measure: Changes in family communication via the Family Problem Solving Communication Scale measure: Changes in acceptability of the intervention via the Johns Hopkins University Dissemination and Implementation Science Measure measure: Changes in feasibility of the intervention via the Johns Hopkins University Dissemination and Implementation Science Measure sex: ALL minimumAge: 12 Years maximumAge: 45 Years stdAges: CHILD stdAges: ADULT hasResults: False
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<|newrecord|> nctId: NCT06261450 id: 2020-3424 id: 236114 type: OTHER domain: Health Canada id: 202010PJT-451514 type: OTHER_GRANT domain: Canadian Institutes of Health Research briefTitle: Effect of CBD on the Brain overallStatus: NOT_YET_RECRUITING date: 2024-04-01 date: 2027-08-15 date: 2027-08-15 date: 2024-02-15 date: 2024-02-15 name: Université de Sherbrooke class: OTHER name: Canadian Institutes of Health Research (CIHR) name: Jazz Pharmaceuticals name: Centre de recherche du Centre hospitalier universitaire de Sherbrooke briefSummary: This proposal focuses on the therapeutic relevance of the endocannabinoid (eCB) system for the treatment of Fragile-X syndrome (FXS), the primary hereditary cause of autism spectrum disorder (ASD). Although most individuals with FXS have moderate to severe intellectual disability (ID), caregivers are mainly concerned about aggressive behavior and anxiety problems, hallmark features of the condition. Concurrent lines of evidence suggest that targeting the endocannabinoid (eCB) system by administration of cannabidiol (CBD) could upregulate GABAergic functions and correct inhibitory deficits presumed responsible for the neuropsychiatric phenotype of FXS. However, the eCB system and its effect on the brain remains unexplored in FXS patients. This clinical trial aims to define the therapeutic relevance of the eCB system for FXS using a multimodal neuroimaging approach to finely characterize the acute effects of oral CBD on the principal inhibitory neurotransmitter system (GABA) in a large cohort of FXS patients. conditions: Fragile X Syndrome studyType: INTERVENTIONAL phases: PHASE2 allocation: RANDOMIZED interventionModel: CROSSOVER interventionModelDescription: This study is a double-blind-crossover placebo control comparing the acute effect of oral CBD in patients with FXS to controls. primaryPurpose: BASIC_SCIENCE masking: TRIPLE maskingDescription: Randomization and dispensing of active and control will be conducted by the research center pharmacy. whoMasked: PARTICIPANT whoMasked: INVESTIGATOR whoMasked: OUTCOMES_ASSESSOR count: 50 type: ESTIMATED name: CBD Oral Solution (eCBD system Target) name: Placebo measure: Short Intracortical Inhibition measure: Intracortical Facilitation measure: Gaba concentration levels sex: ALL minimumAge: 7 Years maximumAge: 55 Years stdAges: CHILD stdAges: ADULT hasResults: False
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<|newrecord|> nctId: NCT06261437 id: M-11053 id: MO230060 type: OTHER_GRANT domain: Military Operational Medicine Research Program (MOMRP) briefTitle: Effect of Ration Formulations on Warfighter Energy Balance and Physical Performance During a Field Training Exercise overallStatus: NOT_YET_RECRUITING date: 2024-02-22 date: 2024-03-04 date: 2024-03-04 date: 2024-02-15 date: 2024-02-15 name: United States Army Research Institute of Environmental Medicine class: FED briefSummary: The goal of this randomized clinical trial is to determine the effects of consuming the Close Combat Assault Ration (CCAR) compared to the First Strike Ration (FSR) during a 7-day strenuous military training on energy intake and energy balance in healthy, Active Duty Warfighters.
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The main questions it aims to answer are:
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* Will consuming the CCAR result in lower energy intake or energy balance compared to consumption of the FSR?
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* Will consuming the CCAR result in lower lower body strength or anaerobic power compared to consuming the FSR?
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* Will those consuming the CCAR report lower ration acceptability or greater gastrointestinal side effects compared to those consuming the FSR?
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Participants will be asked to consume either the CCAR or FSR as the sole nutrition source during a 7-day field training exercise (FTX). The vertical jump test, running-based anaerobic sprint test, and lower-body strength pull will be conducted pre and post the 7-day FTX to assess physical performance. Energy expenditure and intake will be measured by the doubly-labelled water method and dietary logs, respectively. Surveys will be completed to assess ration acceptability and gastrointestinal symptoms.
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Researchers will compare the CCAR and FSR groups to see if their consumption impacted energy intake, energy balance, physical performance, ration acceptance, or gastrointestinal side effects. conditions: Healthy Volunteers studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: BASIC_SCIENCE masking: SINGLE whoMasked: PARTICIPANT count: 60 type: ESTIMATED name: CCAR name: FSR measure: Energy intake measure: Energy expenditure measure: Energy balance measure: Physical performance (vertical jump) measure: Physical performance (peak power) measure: Physical performance (Anaerobic capacity) measure: Physical performance (lower-body strength) measure: Food acceptance scale measure: Gastrointestinal Quality of Life Index measure: Hunger and Satiety Visual Analog Scales sex: ALL stdAges: CHILD stdAges: ADULT stdAges: OLDER_ADULT facility: U.S. Army Research Institute of Environmental Medicine city: Natick state: Massachusetts zip: 01760 country: United States name: USARIEM role: CONTACT phone: 508-206-2200 email: [email protected] name: Michael A Dawson, PhD role: PRINCIPAL_INVESTIGATOR lat: 42.28343 lon: -71.3495 hasResults: False
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<|newrecord|> nctId: NCT06261424 id: 2024-1426 briefTitle: Effects of a Supervised Rehabilitation Program on Disease Severity in Spastic Ataxias overallStatus: NOT_YET_RECRUITING date: 2024-02 date: 2026-04 date: 2027-03 date: 2024-02-15 date: 2024-02-15 name: Université du Québec à Chicoutimi class: OTHER name: McGill University name: Université de Sherbrooke name: Université du Québec a Montréal name: Laval University name: University of Calgary name: Corporation de recherche et d'action sur les maladies héréditaires (CORAMH) name: Cégep de Jonquière name: Centre intégré universitaire de santé et de services sociaux du Saguenay-Lac-St-Jean name: Muscular Dystrophy Canada name: University of Alberta name: Integrated University Health and Social Services Center of the Capitale-Nationale briefSummary: Spastic ataxias are a group of diseases causing symptoms such as walking difficulties and balance impairments that lead to a high risk of falls. No pharmacological treatments exist to treat these diseases. Unfortunately, little effort is made to develop non-pharmacological treatments specific to spastic ataxias despite the detrimental impact of the disease on several aspects of an individual's life and the high cost of falls for society each year. The three objectives of this project are: 1) to determine the effect of a 12-week rehabilitation program on disease severity as compared with usual care for individuals with spastic ataxias; 2) to identify which factors can help (or not) the implementation of the program in the clinical settings ("reel world"); and 3) to explore the cost-benefits of IMPACT \[rehabIlitation prograM for sPAstiC aTaxias\]. The team has developed the program to specifically target symptoms present in these patients and was previously pilot-tested. Based on the results obtained in this pilot project, positive effects are expected concerning the disease severity of participants. The investigators want, with this project, provide to health care professionals an option to offer better-suited services to people living with spastic ataxia worldwide. conditions: ARSACS conditions: SPG7 studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL interventionModelDescription: A multicentre and controlled trial design. primaryPurpose: SUPPORTIVE_CARE masking: SINGLE maskingDescription: All participants will be assessed at their respective neuromuscular clinic (Saguenay, Quebec, Montreal or Calgary) by physiotherapists trained according to standard operating procedures (SOP). These physiotherapists will not be involved in the supervision of the program and will be blinded. whoMasked: CARE_PROVIDER count: 84 type: ESTIMATED name: IMPACT - rehabIlitation prograM for sPAstiC aTaxias measure: Severity of ataxia measure: Medication change measure: Weight measure: height measure: Physical activities measure: Walking speed. measure: Standing balance measure: Balance confidence measure: Sitting balance measure: Activities of Daily Living measure: Muscle tone measure: Life habits measure: Community mobility measure: Plasma measure: DNA measure: Serum measure: RNA measure: Urine measure: Saliva measure: Mobility Life-space measure: Ataxia impact scale measure: Lower limb coordination measure: Peak respiratory flow and cough measure: Fatigue measure: Falls. measure: Patient-reported impression of change. measure: Anxiety and Depression measure: Pain characteristics measure: Functional lower extremity strength measure: Focus group with intervention group participants measure: Focus groups with stakeholders measure: Lower limb muscle activation measure: Quality of life measure: CBA analyses and Willingness to pay measure: Gait's temporal parameters measure: Stance balance measure: Postural balance sex: ALL minimumAge: 16 Years stdAges: CHILD stdAges: ADULT stdAges: OLDER_ADULT facility: CIUSSS de la Capitale-Nationale, Hôpital de Baie-Saint-Paul city: Baie-Saint-Paul state: Quebec zip: G3Z 0K3 country: Canada name: Élise Duchesne, Ph. D. role: CONTACT email: [email protected] name: Jacques Beaulieu, commissaire local aux plaintes role: CONTACT email: [email protected] name: Xavier Rodrigue, M.D. role: SUB_INVESTIGATOR lat: 47.44109 lon: -70.49858 facility: CIUSSS de la Capitale-Nationale, Hôpital de La Malbaie city: La Malbaie state: Quebec zip: G5A 1T1 country: Canada name: Élise Duchesne, Ph. D. role: CONTACT email: [email protected] name: Jacques Beaulieu, commissaire local aux plaintes role: CONTACT email: [email protected] lat: 47.654 lon: -70.15268 facility: CIUSSS du Centre-Sud-de-l'Île-de-Montréal, installation Centre de réadaptation Lucie-Bruneau city: Montréal state: Quebec zip: H2H 2N8 country: Canada name: Élise Duchesne, Ph. D. role: CONTACT email: [email protected] name: Céline Roy, commissaire local aux plaintes role: CONTACT phone: 514-593-3600 email: [email protected] lat: 45.50884 lon: -73.58781 facility: CIUSSS de la Capitale-Nationale, installation IRDPQ city: Québec state: Quebec zip: G1M 2S8 country: Canada name: Élise Duchesne, Ph. D. role: CONTACT phone: 418-590-3552 name: Jacques Beaulieu, commissaire local aux plaintes role: CONTACT email: [email protected] name: Xavier Rodrigue, M.D. role: SUB_INVESTIGATOR lat: 46.81228 lon: -71.21454 facility: Clinique des maladies neuromusculaires du Centre intégré universitaire de santé et de services sociaux (CIUSSS) du Saguenay-Lac-Saint-Jean, installation Hôpital Jonquière city: Saguenay state: Quebec zip: G7X 7X2 country: Canada name: Élise Duchesne role: CONTACT phone: 418-590-3552 email: [email protected] name: Julie Bouchard, commissaire local aux plaintes role: CONTACT phone: 1 877 662-3963 email: [email protected] name: Jean-Denis Brisson, M.D. role: SUB_INVESTIGATOR lat: 48.41675 lon: -71.06573 hasResults: False
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<|newrecord|> nctId: NCT06261411 id: 999430 id: FOU2024-00038 type: REGISTRY domain: Forskning och Utveckling (Region Uppsala) briefTitle: Lung Ultrasound as Alternative to Radiation in Thoracic Surgery acronym: LUS-ART overallStatus: ENROLLING_BY_INVITATION date: 2024-02-12 date: 2025-04-30 date: 2025-04-30 date: 2024-02-15 date: 2024-02-20 name: Uppsala University Hospital class: OTHER briefSummary: This projects aim is to study the effects of substitute conventional chest x-ray with lung ultrasound for patients undergoing thoracic surgery.
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Participants in the study will be randomized to either ultrasound or routine chest x-ray as the primary method of diagnosis after having received surgery to their lungs. conditions: Thoracic Surgery conditions: Ultrasonography studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL interventionModelDescription: Case-Control primaryPurpose: DIAGNOSTIC masking: SINGLE maskingDescription: Inter-rater variability will be masked. whoMasked: OUTCOMES_ASSESSOR count: 110 type: ESTIMATED name: Lung Ultrasound measure: Reduction in chest x-ray measure: Re-insertion of chest tube measure: Delayed removal of chest tube measure: Time to chest tube removal measure: Patient Satisfaction measure: Missed Care measure: Inter-rater variability sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Uppsala Akademiska sjukhuset city: Uppsala state: Uppland zip: 751 85 country: Sweden lat: 59.85882 lon: 17.63889 typeAbbrev: Prot hasProtocol: True hasSap: False hasIcf: False label: Study Protocol date: 2024-02-02 uploadDate: 2024-02-07T05:12 filename: Prot_000.pdf size: 806384 typeAbbrev: ICF hasProtocol: False hasSap: False hasIcf: True label: Informed Consent Form date: 2024-02-02 uploadDate: 2024-02-07T05:12 filename: ICF_001.pdf size: 350352 hasResults: False
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<|newrecord|> nctId: NCT06261398 id: 2023H0065 briefTitle: Better Birth Outcomes Through Technology, Education, and Reporting acronym: BETTER overallStatus: RECRUITING date: 2024-02-26 date: 2027-09 date: 2028-03 date: 2024-02-15 date: 2024-02-28 name: Ohio State University class: OTHER name: American Heart Association briefSummary: This is a pragmatic randomized control trial to evaluate the BETTER intervention compared to standard obstetrical care (control) to determine whether it helps to reduce maternal anemia and other adverse pregnancy outcomes. The BETTER intervention includes one motivational interviewing session and bi-weekly text messages to encourage patients to connect with resources that address their social needs, including housing, food, and transportation. Quantitative data will be used to study participant outcomes, including surveys, and electronic health record data. conditions: Pregnancy conditions: Maternal Anemia conditions: Pre-Term Birth conditions: Hypertensive Disorders studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: PREVENTION masking: NONE count: 550 type: ESTIMATED name: BETTER: motivational interviewing and text messaging name: Standard of care measure: Incidence of maternal anemia measure: Incidence of Pre-term birth measure: Incidence of Hypertensive disorders of pregnancy measure: Incidence of infection measure: Incidence of Cesarean Delivery measure: Incidence of Postpartum hemorrhage measure: Incidence Severe maternal morbidity measure: Incidence of maternal mortality measure: Incidence of Small for gestational age birth measure: Incidence of Large for gestational age measure: Incidence of NICU admission measure: Incidence of Perinatal mortality measure: Incidence of Prenatal care visits measure: Incidence of Antepartum admission measure: Length of stay (days) measure: Postpartum re-admission sex: FEMALE minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: The Ohio State University Outpatient Care East status: RECRUITING city: Columbus state: Ohio zip: 43203 country: United States name: William Grobman, MD, MBA role: CONTACT phone: 614-293-4929 email: [email protected] name: Anna Bartholomew, BSN, RN, MPH role: CONTACT phone: 614-685-3229 email: [email protected] lat: 39.96118 lon: -82.99879 facility: McCampbell Hall status: RECRUITING city: Columbus state: Ohio zip: 43210 country: United States name: William Grobman, MD, MBA role: CONTACT phone: 614-293-4929 email: [email protected] name: Anna Bartholomew, BSN, RN, MPH role: CONTACT phone: 614-685-3229 email: [email protected] lat: 39.96118 lon: -82.99879 facility: The Ohio State University Wexner Medical Center OB/GYN Maternal and Fetal Medicine status: RECRUITING city: Columbus state: Ohio zip: 43210 country: United States name: William Grobman, MD, MBA role: CONTACT phone: 614-293-4929 email: [email protected] name: Anna Bartholomew, BSN, RN, MPH role: CONTACT phone: 614-685-3229 email: [email protected] lat: 39.96118 lon: -82.99879 hasResults: False
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<|newrecord|> nctId: NCT06261385 id: typology briefTitle: Development of Typology-based Smoking Relapse Prevention: A Q-methodology and a Pilot Randomized Controlled Trial overallStatus: RECRUITING date: 2024-01-23 date: 2024-10-31 date: 2025-01-31 date: 2024-02-15 date: 2024-02-15 name: The University of Hong Kong class: OTHER name: Health and Medical Research Fund briefSummary: This study aims to develop a typology-based intervention delivered by smoking cessation (SC) counselors to prevent smoking relapse in ex-smokers who recently quit. The two main research questions include (1) Can a typology-based smoking relapse prevention intervention be feasible and accepted by the smokers and SC counselors who deliver the new intervention? (2) What is the preliminary evidence on the efficacy of the typology-based smoking relapse prevention to increase tobacco abstinence in ex-smokers who have recently quit? If the intervention shows at least a small effect size (i.e. risk ratio\>1.3), or the intervention is feasible while modifications can potentially increase the efficacy, a future definitive RCT is warranted. conditions: Smoking Cessation studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: PREVENTION masking: SINGLE maskingDescription: Outcome assessors at the telephone follow-up are blinded to the group allocation. whoMasked: OUTCOMES_ASSESSOR count: 510 type: ESTIMATED name: typology-based intervention measure: self-reported abstinence in the past 30 days at 2-month follow-up measure: iScreen OFD Cotinine Saliva Test Kit (<30ng/ml) biochemical validated tobacco abstinence measure: the difference of the feasibility and acceptability score of the typology-based intervention between the intervention and control group. measure: Time required for the counselling measure: Compliance rate of the SC counsellors in following the intervention protocol measure: Proportion of screened clients who participate in the RCT measure: Dropout rate of the participants who consent to the RCT measure: Satisfaction on the SC counsellors measure: Satisfaction on the e-messages measure: Frequency of reading the e-messages measure: Perceived effectiveness on the intervention measure: Satisfaction on the enrolment procedures measure: Intention to recommend the intervention to other smokers measure: Satisfaction about the intervention from SC counsellor measure: Perceived appropriateness of the intervention length from SC counsellor measure: Satisfaction on the enrolment procedures from SC counsellor measure: Perceived effectiveness of the screening tool from SC counsellor measure: Perceived clients' acceptance of the intervention from SC counsellor measure: Intention to apply this intervention in other clients from SC counsellor sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: LKS Faculty of Medicine status: RECRUITING city: Hong Kong zip: 00 country: Hong Kong name: Derek YT Cheung, PhD role: CONTACT phone: +852 3917 6652 email: [email protected] lat: 22.27832 lon: 114.17469 hasResults: False
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<|newrecord|> nctId: NCT06261372 id: KY2023PJ204 briefTitle: Mindfulness Meditation Combined With Progressive Muscle Relaxation Training for Uremic Sarcopenia overallStatus: COMPLETED date: 2023-08-15 date: 2023-11-15 date: 2023-11-15 date: 2024-02-15 date: 2024-02-15 name: Ningbo Medical Center Lihuili Hospital class: OTHER_GOV briefSummary: To study the effect of mindfulness meditation combined with progressive muscle relaxation training on clinical efficacy and quality of life in maintenance hemodialysis (MHD) patients with sarcopenia. Eligible sarcopenic patients in our hospital were randomly assigned to a control group (n = 24) and an intervention group (n = 25). The control group received conventional dialysis treatment, while the intervention group received mindfulness meditation combined with progressive muscle relaxation training during the interdialysis period in addition to conventional dialysis treatment. The effect of the intervention was evaluated after 12 weeks.To observe whether the combined intervention training can improve the motor ability and quality of life of patients with sarcopenia in a short period of time. conditions: Hemodialysis Patients With Sarcopenia studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: NONE count: 49 type: ACTUAL name: The mindfulness meditation combined with progressive muscle relaxation training . measure: 10 sit-to-stand test in seconds measure: Grip strength in kilograms measure: 6-meter walk test in metre per second measure: KDQOLTM(Kidney Disease Quality of Life short Form) score measure: interleukin-6 (IL-6) measure: high-sensitivity C-reactive protein (hsCRP) measure: albumin(ALB) measure: prealbumin (PA） sex: ALL minimumAge: 18 Years maximumAge: 80 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Li Huili Hospital, Ningbo Medical Center city: Ningbo state: Zhejiang zip: 315046 country: China lat: 29.87819 lon: 121.54945 hasResults: False
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<|newrecord|> nctId: NCT06261359 id: CEND1-202 briefTitle: A Study of CEND-1 With Chemotherapy as First-Line Therapy in Patients With Pancreatic Ductal Adenocarcinoma overallStatus: NOT_YET_RECRUITING date: 2024-02 date: 2025-04 date: 2026-10 date: 2024-02-15 date: 2024-02-15 name: Qilu Pharmaceutical Co., Ltd. class: INDUSTRY briefSummary: The purpose of this study is to evaluate the efficacy and safety of CEND-1 in combination with gemcitabine/nab-paclitaxel versus gemcitabine/nab-paclitaxel and placebo as first-line treatment in patients with Locally Advanced Unresectable or Metastatic Pancreatic Ductal Adenocarcinoma. conditions: Pancreatic Ductal Adenocarcinoma (PDAC) studyType: INTERVENTIONAL phases: PHASE2 allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: QUADRUPLE whoMasked: PARTICIPANT whoMasked: CARE_PROVIDER whoMasked: INVESTIGATOR whoMasked: OUTCOMES_ASSESSOR count: 120 type: ESTIMATED name: CEND-1 name: Gemcitabine name: Nab paclitaxel measure: Objective response rate (ORR) measure: Overall Survival (OS) measure: Progression Free Survival(PFS) measure: 6-month PFS rate measure: Duration Of Response (DOR) measure: Disease Control Rate (DCR) measure: Incidence of AEs, SAEs and treatment-emergent adverse events (TEAEs) sex: ALL minimumAge: 18 Years maximumAge: 80 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Chinese People's Liberation Army (PLA) General Hospital city: Beijing state: Beijing zip: 100000 country: China lat: 39.9075 lon: 116.39723 hasResults: False
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<|newrecord|> nctId: NCT06261346 id: 20230420 briefTitle: Plasma Rich in Growth Factors in Corneal Endothelial Transplantation overallStatus: NOT_YET_RECRUITING date: 2024-05-15 date: 2026-04-30 date: 2026-06-30 date: 2024-02-15 date: 2024-04-02 name: Price Vision Group class: INDUSTRY briefSummary: The purpose of the study is to determine the safety and efficacy of brief intraoperative corneal endothelial graft incubation in plasma rich in growth factors (PRGF) for reducing postoperative endothelial cell loss. Subjects scheduled for endothelial keratoplasty will be enrolled and randomized to have the graft incubated in PRGF or not prior to graft implantation. The main outcome is the percentage central corneal endothelial cell loss 6 months after surgery. conditions: Fuchs' Endothelial Dystrophy conditions: Corneal Edema studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: PREVENTION masking: SINGLE whoMasked: OUTCOMES_ASSESSOR count: 100 type: ESTIMATED name: PRGF measure: Endothelial cell loss at 6 months measure: Corneal endothelial cell density measure: Endothelial cell loss measure: Best corrected visual acuity measure: Re-bubble rate sex: ALL minimumAge: 18 Years maximumAge: 80 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Bascom Palmer Eye Institute city: Miami state: Florida zip: 33136 country: United States name: Alfonso Sabater, MD role: CONTACT phone: 305-326-6326 email: [email protected] lat: 25.77427 lon: -80.19366 facility: Price Vision Group city: Indianapolis state: Indiana zip: 46260 country: United States name: Marianne Price, PhD role: CONTACT phone: 317-814-2990 email: [email protected] lat: 39.76838 lon: -86.15804 hasResults: False
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<|newrecord|> nctId: NCT06261333 id: 23-11519-BO briefTitle: Quality of Life in Patients With Hemorrhagic Telangiectasia overallStatus: ENROLLING_BY_INVITATION date: 2024-01-22 date: 2024-12-31 date: 2025-12-31 date: 2024-02-15 date: 2024-02-15 name: University Hospital, Essen class: OTHER briefSummary: Hereditary Hemorrhagic Telangiectasia (HHT), also known as Osler's disease, is a genetic disorder that leads to abnormal blood vessel formations. It primarily affects blood vessels in the skin, mucous membranes, and internal organs. The disease can be clinically diagnosed using the Curaçao criteria (1. Positive family history of HHT, 2. Recurrent and spontaneous epistaxis, 3. Multiple typical telangiectasias, 4. Organ involvement with vascular malformations, especially in the liver, lungs, gastrointestinal tract, or brain); if a patient meets at least 3 criteria, the diagnosis of HHT can be established.
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Patients with HHT often have telangiectasias on their faces. Additionally, many patients suffer from anemia, which can result in a pale and potentially tired appearance. Patients with HHT may be less satisfied with their appearance due to the aesthetic changes in their faces and may also experience psychosocial impairment. To further investigate this, various validated questionnaires (FACE-Q©, PROMIS-Profile-29+2, EQ5D), as well as routinely collected clinical data (e.g., laboratory values including hemoglobin levels, Curaçao criteria, smoking status, alcohol consumption, and the Epistaxis Severity Score (ESS)) will be used. conditions: Hereditary Hemorrhagic Telangiectasia studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: PROSPECTIVE count: 250 type: ESTIMATED name: Questionnaires measure: Quality of Life and Patient Satisfaction measured using the FACE-Questionnaire sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Departement of Otorhinolaryngology - Head and Neck Surgery University Hospital Essen city: Essen state: NRW zip: 45147 country: Germany lat: 51.45657 lon: 7.01228 hasResults: False
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<|newrecord|> nctId: NCT06261320 id: 2023-506950-18-00 briefTitle: Mesotherapy Treatment of Irritable Bowel Syndrome acronym: MESOCOLO overallStatus: ACTIVE_NOT_RECRUITING date: 2024-02-28 date: 2025-12-31 date: 2026-01-31 date: 2024-02-15 date: 2024-04-05 name: Polyclinique de l'Europe class: OTHER briefSummary: Irritable bowel syndrome (IBS) is a gastrointestinal transit disorder characterized by chronic abdominal pain and impaired transit in the absence of demonstrated organic disease. Considered a non-fatal disease, its effects relate more to quality of life, work production and health care systems.
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Given the complexity of this disease, no treatment has been recognized as standard treatment. The treatment is rather focused on treating the symptoms caused (chronic pain or intestinal transit disorder). In general, therapy is considered individualized and includes lifestyle/diet modifications and pharmaceutical therapy.
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Several published case studies evaluating the effect of mesotherapy on improving the severity of the disease have demonstrated an improvement in the symptoms of this syndrome. Due to the limited number of case studies and the insufficient level of evidence to conclude, our study will therefore be a before-and-after intervention study, to evaluate the effect of four mesotherapy sessions on the treatment of IBS symptoms. conditions: Inflammatory Bowel Diseases studyType: INTERVENTIONAL phases: PHASE2 allocation: NA interventionModel: SINGLE_GROUP primaryPurpose: TREATMENT masking: NONE count: 27 type: ACTUAL name: Mesotherapy with mesocaine, thiocolchicoside, amitriptyline, magnesium pidolate measure: Irritable Bowel Syndrome Symptom Severity Scale(IBS-SSS) measure: Functional Digestive Disorders Quality of Life questionnaire (FDDQL) measure: Pain evaluation measure: Global satisfaction measure: Anxiety evaluation : Questionnaire "Hospital anxiety and depression scale" sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Polyclinique de l'Europe city: Saint-Nazaire zip: 44600 country: France lat: 47.28333 lon: -2.2 hasResults: False
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<|newrecord|> nctId: NCT06261307 id: 13462111 briefTitle: Language Development Deficits and Early Interactive Music Intervention acronym: BusyBaby overallStatus: RECRUITING date: 2024-03-11 date: 2026-03 date: 2027-03 date: 2024-02-15 date: 2024-04-05 name: University of Helsinki class: OTHER name: Folkhälsan Research Center name: Karolinska Institutet name: University of Turku name: University of Jyvaskyla name: Academy of Finland briefSummary: Investigators compare effects of 6-month music versus circus group interventions on language development in infants and toddlers with or without familial risk for dyslexia (anticipated total N=200). Effects of intervention timing, dyslexia risk and genetics, and social-emotional factors on the intervention outcomes are investigated. conditions: Dyslexia, Developmental conditions: Language Development Disorders conditions: Language Development studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL interventionModelDescription: The experimental arm will receive music training and the control arm will receive circus training. primaryPurpose: TREATMENT masking: DOUBLE maskingDescription: A dedicated member of the research team will be in charge of randomization of the participants to the two intervention arms, to ensure blindness of other team members. This member will not act as an outcomes assessor or a care provider.
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The study will be presented to the caregivers as evaluating the effect of hobbies on language development. Therefore, the caregivers should not consider either intervention as the control arm. Both arms are expected to be potentially beneficial for the children's development.
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Outcomes assessors will be unaware of the intervention arm and risk status (dyslexia risk vs no risk) of the children; caregivers will be reminded not to mention these to the researcher. Person in charge of randomization keeps track of violations of outcome assessor blindness. whoMasked: PARTICIPANT whoMasked: OUTCOMES_ASSESSOR count: 200 type: ESTIMATED name: Music intervention name: Circus intervention measure: Infant-Toddler Checklist (ITC) measure: MacArthur-Bates Communicative Development Inventory (MCDI) 8-16mo measure: Mismatch response (MMR) speech, amplitude measure: Mismatch response (MMR) speech, latency measure: Mismatch response (MMR) speech, laterality measure: Obligatory event-related potential (ERP) speech, amplitude measure: Obligatory event-related potential (ERP) speech, latency measure: Obligatory event-related potential (ERP) speech, laterality measure: Infant-Toddler Checklist (ITC) follow-up measure: MacArthur-Bates Communicative Development Inventory (MCDI) 16-30mo follow-up measure: Mismatch response (MMR) speech, amplitude follow-up measure: Mismatch response (MMR) speech, latency follow-up measure: Mismatch response (MMR) speech, laterality follow-up measure: Obligatory event-related potential (ERP) speech, amplitude follow-up measure: Obligatory event-related potential (ERP) speech, latency follow-up measure: Obligatory event-related potential (ERP) speech, laterality follow-up measure: Reynell Developmental Language Scales III (RDLS-III) measure: Infant Behavior Questionnaire Revised short form (IBQ-R-sf) measure: Early Childhood Behavior Questionnaire short form (ECBQ-sf) measure: Parenting Stress Index Short Form (PSI-sf) measure: Brief Infant-Toddler Social Emotional Assessment (BITSEA) measure: Parental dyslexia status (dyslexia - no dyslexia) measure: Allele groupings for dyslexia susceptibility genes measure: Gross and fine motor development measure: Bayley Scales III Motor scale measure: Mismatch response (MMR) music, amplitude measure: Mismatch response (MMR) music, latency measure: Mismatch response (MMR) music, laterality measure: Obligatory event-related potential (ERP) music, amplitude measure: Obligatory event-related potential (ERP) music, latency measure: Obligatory event-related potential (ERP) music, laterality measure: Music test scores (three parts of MMBB-MB) measure: Music-related activities measure: Musical background of parents measure: Home literacy measure: Multilingualism measure: Screen time sex: ALL minimumAge: 8 Months maximumAge: 12 Months stdAges: CHILD facility: University of Helsinki status: RECRUITING city: Helsinki zip: 00014 country: Finland name: Paula Virtala, PhD role: CONTACT phone: +358408446907 email: [email protected] lat: 60.16952 lon: 24.93545 hasResults: False
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<|newrecord|> nctId: NCT06261294 id: CPIP-LUN-A001 briefTitle: OncoSweep Cancer Spotlight and Spectrum Product Line overallStatus: RECRUITING date: 2023-05-23 date: 2025-03-20 date: 2026-03-20 date: 2024-02-15 date: 2024-02-15 name: Pharus Taiwan, Inc. class: INDUSTRY briefSummary: CONQUER cancer study: To collect blood samples from cancer and non-cancer participants for development and validation of the 'OncoSweep Cancer Spotlight and Spectrum Product Line' conditions: Lung Cancer studyType: OBSERVATIONAL observationalModel: CASE_CONTROL timePerspective: PROSPECTIVE count: 800 type: ESTIMATED name: OncoSweep Lung Spotligh measure: To differentiate lung cancer signals from non-cancer signals based on analysis of OncoSweep Lung Spotlight. sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Mackay Memorial Hospital status: RECRUITING city: Taipei state: Zhongshan Dist zip: 104217 country: Taiwan name: Sheng-Hsiung Yang role: CONTACT phone: +886 2 2543-3535 email: [email protected] lat: 25.04776 lon: 121.53185 hasResults: False
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<|newrecord|> nctId: NCT06261281 id: TBI cancel briefTitle: Effect of Intermittent Oro-esophageal Tube Feeding on Severe Traumatic Brain Injury Patient acronym: IOE-TBI overallStatus: WITHDRAWN date: 2024-02-10 date: 2024-07-10 date: 2024-07-10 date: 2024-02-15 date: 2024-03-06 name: Zeng Changhao class: OTHER briefSummary: This was a multicenter randomized controlled study of 98 severe Traumatic Brain Injury patients with tracheostomy. Patients enrolled were divided randomly into the observation group with Intermittent Oro-esophageal Tube Feeding or the control group with Nasogastric tube feeding for enteral nutrition support, respectively. Nutritional status, complications, decannulation of tracheostomy tubes and level of consciousness on day 1 and day 28 were recorded and compared. conditions: Traumatic Brain Injury studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: DOUBLE whoMasked: INVESTIGATOR whoMasked: OUTCOMES_ASSESSOR count: 0 type: ACTUAL name: Rehabilitation therapy name: Intermittent Oro-esophageal Tube Feeding name: Nasogastric tube feeding measure: Concentration of hemoglobin measure: Concentration of albumin measure: Concentration of prealbumin measure: Nutritional status-body mass index measure: Decannulation of tracheostomy tube-placement duration measure: Decannulation of tracheostomy tube-Successful removal measure: Level of consciousness measure: Feeding Amount sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Zheng Da yi Yuan Hospital city: Zhengzhou state: Henan zip: 450000 country: China lat: 34.75778 lon: 113.64861 hasResults: False
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<|newrecord|> nctId: NCT06261268 id: Strip vs FGG briefTitle: Strip Graft w/ Xenogeneic Matrix vs Free Gingival Graft for the Augmentation of Peri-implant Keratinized Mucosa overallStatus: RECRUITING date: 2024-01-29 date: 2024-12-15 date: 2025-07-15 date: 2024-02-15 date: 2024-02-15 name: Universidad Complutense de Madrid class: OTHER briefSummary: The primary objective of this study is to compare changes in peri-implant keratinized mucosa (PIKM) following the application of apically repositioned flap (ARF) using a combination of a Strip graft and a Xenogeneic matrix, or with a free gingival graft (FGG), in implants in the second stage with \<2 mm of PIKM.
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Additionally, as a secondary objective, the investigators compare postoperative blood supply in both recipient and donor sites based on the type of graft obtained. Meanwhile, the investigators evaluate differences between the two groups concerning microcirculation values (perfusion units, PU), soft tissue thickness (STT), volume change, vestibular depth, as well as clinical, aesthetic, and patient-reported outcome measures (PROMS). conditions: Peri-Implantational Loss conditions: Surgical Wound conditions: Healing Surgical Wounds conditions: Thin-gingiva studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL interventionModelDescription: A randomized controlled equivalence clinical trial will be performed, with two parallel groups, a 1:1 allocation ratio, and a 12-month follow-up. primaryPurpose: TREATMENT masking: SINGLE whoMasked: OUTCOMES_ASSESSOR count: 48 type: ESTIMATED name: Strip graft with Mucograft name: Free gingival graft measure: Changes in peri-implant keratinized mucosa width (mm) measure: Vascularization (in Laser Speckle perfusion units [LSPU]) measure: Changes in soft tissue thickness (STT) (mm) measure: Vestibule depth (VD) (mm) measure: Probing pocket depth (PPD) (mm) measure: Dehiscence (mm) measure: Full-mouth plaque score (FMPS) measure: Volumetric changes measure: Patient reported outcome measures (PROMS) measure: Esthetic analysis measure: Intra-surgical parameters measure: Intra-surgical time measure: Demographic data measure: Anamnesis data measure: Smoking habit measure: Full-mouth bleeding score (FMBS) (%) sex: ALL minimumAge: 18 Years maximumAge: 80 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Complutense University status: RECRUITING city: Madrid zip: 28040 country: Spain name: Mariano Sanz Alonso role: CONTACT phone: 913942021 email: [email protected] name: Andrea Dobos, DMD role: SUB_INVESTIGATOR name: David Palombo, DMD role: SUB_INVESTIGATOR lat: 40.4165 lon: -3.70256 hasResults: False
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<|newrecord|> nctId: NCT06261255 id: ATT_CS briefTitle: Autotransplantation and Enamel Matrix Derivatives Case Series acronym: ATTCS overallStatus: COMPLETED date: 2020-06-01 date: 2023-09-01 date: 2023-12-01 date: 2024-02-15 date: 2024-02-15 name: Universidad Complutense de Madrid class: OTHER briefSummary: The goal of this prospective case series is to compare the adjunctive use of enamel matrix derivatives in the treatment of tooth autotransplantation in terms of clinical attachment level.
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The main question it aims to answer is:
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- What is the benefit, in terms of clinical attachment level, of using enamel matrix derivatives adjunctive to tooth autotransplantation?
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Participants will be subjected to a digitally protocol of tooth autotransplantation.Only one group (test) is assessed. It will be supplemented with the application of enamel matrix derivatives before the placement of the transplanted tooth into the surgically produced alveolus. conditions: Tooth Loss studyType: INTERVENTIONAL phases: NA allocation: NA interventionModel: SINGLE_GROUP interventionModelDescription: This clinical investigation is a single-center, prospective case series study and is reported in compliance with the Preferred Reporting of Case Series in Surgery (PROCESS) guidelines. The study was conducted at the Department of Periodontology of the University Complutense of Madrid between March 2021 and September 2023. primaryPurpose: TREATMENT masking: NONE count: 14 type: ACTUAL name: ATT + EMD measure: Clinical attachment level (CAL) sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Universidad Complutense de Madrid city: Madrid zip: 28003 country: Spain lat: 40.4165 lon: -3.70256 facility: Universidad Complutense Madrid city: Madrid country: Spain lat: 40.4165 lon: -3.70256 hasResults: False
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<|newrecord|> nctId: NCT06261242 id: TWM-C-2201 briefTitle: Tripod-Fix Vertebral Body Augmentation System in Osteoporotic Vertebral Compression Fractures Treatment overallStatus: RECRUITING date: 2023-06-16 date: 2025-02-28 date: 2025-07-31 date: 2024-02-15 date: 2024-02-16 name: National Cheng-Kung University Hospital class: OTHER briefSummary: This study is to evaluate the safety and effectiveness of the Tripod-Fix with Tecres Mendec® Spine HV System to treat subjects with osteoporotic vertebral compression fractures. conditions: Osteoporotic Vertebral Compression Fractures studyType: INTERVENTIONAL phases: NA allocation: NA interventionModel: SINGLE_GROUP primaryPurpose: TREATMENT masking: NONE count: 12 type: ESTIMATED name: Tripod-Fix Vertebral Body Augmentation System (Tripod-Fix) measure: Proportion of participants with study success sex: ALL minimumAge: 50 Years stdAges: ADULT stdAges: OLDER_ADULT facility: National Cheng Kung University Hospital Department of Orthopedics status: RECRUITING city: Tainan zip: 704 country: Taiwan name: Susan Guo role: CONTACT phone: +8666-2353535 phoneExt: 3690 name: Cheng-Li Lin role: PRINCIPAL_INVESTIGATOR lat: 22.99083 lon: 120.21333 hasResults: False
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<|newrecord|> nctId: NCT06261229 id: MURA2022/230 briefTitle: The Effectiveness of Intermittent Fasting and Behavioral Economics Intervention on Weight Control in Obese Patients overallStatus: ENROLLING_BY_INVITATION date: 2022-04-18 date: 2024-06-30 date: 2024-06-30 date: 2024-02-15 date: 2024-04-05 name: Mahidol University class: OTHER name: Health Systems Research Institute briefSummary: This study is a parallel randomized controlled trial (RCT). To determine the effect of intermittent fasting, intermittent fasting with behavioral economics, and intensive lifestyle modification on nutritional status; the differences between HOMA-IR, body weight change, and body composition in obese people.
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Each participant will be randomized to receive the intervention (intermittent fasting, intermittent fasting with behavioral economics, or intensive lifestyle modification.
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The study protocol will be explained to the eligible participant and informed written consent will be obtained.
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The total sample size will be 123 participants. Blood and urine samples will be collected at baseline and each follow-up visit including 1-month, 2-months, 6-month, and 12-months, respectively for further study to find out the mechanisms of weight loss, weight regain, and the improvement in the metabolic disease. conditions: Intermittent Fasting conditions: Weight Loss conditions: Behavioral Economic conditions: Obese conditions: HOMA-IR studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: SINGLE whoMasked: OUTCOMES_ASSESSOR count: 123 type: ESTIMATED name: Intermittent fasting name: Intermittent fasting + Behavioral economic name: Intensive Lifestyle Modification measure: HOMR-IR (index) measure: Body mass index (kg/m^2) measure: FBS (mg/dl) measure: HbA1C (%) measure: Albumin (g/L) measure: Creatinine (mg/dL) measure: Alanine transaminase (ALT) U/L measure: Aspartate transaminase (AST) U/L measure: Uric acid (mg/dL) measure: Total cholesterol (mg/dL) measure: HDL-C (mg/dL) measure: LDL-C (mg/dL) measure: Triglycerides (mg/dL) measure: Blood Urea Nitrogen (BUN) (mg/dL) measure: Urine albumin-creatinine ratio (UACR) (mg/g) measure: Energy from food (kilocalories) sex: ALL minimumAge: 18 Years maximumAge: 65 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Mahidol University city: Ratchathewi state: Bangkok zip: 10400 country: Thailand lat: 13.759 lon: 100.53358 hasResults: False
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<|newrecord|> nctId: NCT06261216 id: 01/2023/LPA-wtATTR/NVNS briefTitle: Association Between Lifetime Physical Activity and Exercise and the Development of Wild-type Transthyretin Amyloid Cardiomyopathy overallStatus: RECRUITING date: 2024-02 date: 2025-02 date: 2025-02 date: 2024-02-15 date: 2024-02-15 name: Medical University of Graz class: OTHER name: Medical University Innsbruck briefSummary: The aim of this study is to investigate the association between increased lifetime physical activity and the development of wild-type transthyretin amyloid cardiomyopathy. conditions: Amyloid Cardiomyopathy conditions: Wild Type ATTR Amyloidosis studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: PROSPECTIVE count: 252 type: ESTIMATED name: Interview measure: Association between lifetime physical activity and disease development measure: Association between lifetime athletic activity and disease development sex: ALL minimumAge: 60 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Medical University of Graz status: RECRUITING city: Graz country: Austria name: PI role: CONTACT phone: 0043 316 385 30173 email: [email protected] name: Nicolas Verheyen, MD PhD role: PRINCIPAL_INVESTIGATOR name: Nora Schwegel, MD role: SUB_INVESTIGATOR lat: 47.06667 lon: 15.45 hasResults: False
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<|newrecord|> nctId: NCT06261203 id: Hany Hosny briefTitle: Low Dose Aspirin for Prevention of Early Pregnancy Loss overallStatus: RECRUITING date: 2023-07-01 date: 2025-07-01 date: 2025-07-15 date: 2024-02-15 date: 2024-02-15 name: Egymedicalpedia class: INDUSTRY briefSummary: Preeclampsia is a pregnancy-specific, multisystem disorder affecting 3% to 8% of pregnancies and remains a significant cause of maternal and neonatal morbidity and mortality worldwide.
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The World Health Organization estimates that approximately 76,000 maternal deaths annually are attributed to preeclampsia, accounting for 16% of global maternal mortality, with the majority occurring in low- and middle-income countries conditions: Pre-Eclampsia studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL interventionModelDescription: The The study's findings have the potential to clarify aspirin's role in preventing adverse pregnancy outcomes related to placental dysfunction and improve the management of women at risk of placental-mediated complications. primaryPurpose: PREVENTION masking: DOUBLE whoMasked: PARTICIPANT whoMasked: OUTCOMES_ASSESSOR count: 250 type: ESTIMATED name: Aspirin measure: Prevention of pregnancy loss sex: FEMALE minimumAge: 18 Years maximumAge: 40 Years stdAges: ADULT facility: Assuit University hospitals status: RECRUITING city: Asyūţ state: Assuit country: Egypt name: Mohamed Nagy, Lecturer role: CONTACT phone: 01096655458 email: [email protected] name: Abdelrahman Mahmoud, Assist.Prof. role: PRINCIPAL_INVESTIGATOR lat: 27.18096 lon: 31.18368 hasResults: False
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<|newrecord|> nctId: NCT06261190 id: H-2308-182-1463 briefTitle: Active Surveillance for Low-risk Papillary Thyroid Carcinoma acronym: MAeSTroⅡ overallStatus: NOT_YET_RECRUITING date: 2024-03-04 date: 2029-12-31 date: 2032-12-31 date: 2024-02-15 date: 2024-02-26 name: National Cancer Center, Korea class: OTHER_GOV name: Seoul National University Bundang Hospital name: SMG-SNU Boramae Medical Center name: Seoul National University Hospital briefSummary: This study is an observational cohort study targeting patients with low-risk Papillary thyroid cancer who opted for active surveillance or immediate surgery based on a sufficient understanding of the treatment options. The primary objective of the study is to evaluate progression free survival of the patients with low-risk Papillary thyroid cancer who choose active surveillance, in other words, to observe the natural course of low-risk Papillary thyroid cancer. conditions: Thyroid Cancer conditions: Papillary Thyroid Carcinoma studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: PROSPECTIVE count: 499 type: ESTIMATED measure: Progression free survival of the patients with low-risk Papillary Thyroid Cancer who choose Active Surveillance measure: Disease progression measure: Rate of Participants in the Active Surveillance Group that change to surgery without disease progression measure: Comparison of Quality of Life between the Active Surveillance group and immediate surgery group measure: Measure of Anxiety and Depression measure: Measure of Satisfaction with the treatment measure: Factors influencing patients' decisions regarding disease management sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: National Cancer Center city: Goyang-si country: Korea, Republic of name: Eun Kyung Lee role: PRINCIPAL_INVESTIGATOR lat: 37.65639 lon: 126.835 facility: Seoul National University Bundang Hospital city: Seongnam country: Korea, Republic of name: Jae Hoon Moon role: PRINCIPAL_INVESTIGATOR lat: 37.43861 lon: 127.13778 facility: Seoul National University Hospital city: Seoul country: Korea, Republic of name: Young Joo Park role: PRINCIPAL_INVESTIGATOR lat: 37.566 lon: 126.9784 facility: SMC-SNU Boramae Medical Center city: Seoul country: Korea, Republic of name: Ka Hi Lee role: PRINCIPAL_INVESTIGATOR lat: 37.566 lon: 126.9784 hasResults: False
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<|newrecord|> nctId: NCT06261177 id: 22-175 briefTitle: Take-home Functional Electrical Stimulation for MDD overallStatus: ACTIVE_NOT_RECRUITING date: 2023-12-04 date: 2024-12 date: 2025-03 date: 2024-02-15 date: 2024-02-15 name: Unity Health Toronto class: OTHER briefSummary: The purpose of this study is to learn whether Functional Electrical Stimulation (FES) of the facial muscles is effective in treating major depressive disorder (MDD) and to develop a model for take-home delivery. conditions: MDD studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: TRIPLE maskingDescription: Double-blind whoMasked: PARTICIPANT whoMasked: INVESTIGATOR whoMasked: OUTCOMES_ASSESSOR count: 20 type: ACTUAL name: Functional Electrical Stimulation (FES) name: Sham FES measure: Feasibility of the FES for MDD measure: Tolerability and safety of the FES for MDD measure: Improvement in symptoms of depression-17-item Hamilton Depression Rating Scale (HAM-D-17) measure: Improvement in symptoms of depression-16-Item Quick Inventory of Depressive Symptomatology-Self Report (QIDS-SR-16) measure: Improvement in symptoms of anxiety- General Anxiety Disorder (GAD-7) measure: Improvement in well-being-World Health Organization-5 Well-Being Index (WHO-5) measure: Improvement in sleep quality- Pittsburgh Sleep Quality Index (PSQI) sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: St. Michael's Hospital city: Toronto state: Ontario country: Canada lat: 43.70011 lon: -79.4163 hasResults: False
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<|newrecord|> nctId: NCT06261164 id: 01-19-373- 2/23 briefTitle: Population Pharmacokinetic Model of Amikacin and Vancomycin in Critically Ill Patients overallStatus: RECRUITING date: 2024-01-31 date: 2024-12-31 date: 2025-01-31 date: 2024-02-15 date: 2024-02-15 name: University Clinical Centre of Republic of Srpska class: OTHER briefSummary: The object of the scientific research is the characterization of the pharmacokinetic profile and the investigation of factors of pharmacokinetic variability of amikacin and vacnomycin in critically ill patients with a diagnosis of sepsis-like condition (SIRS), hospital-acquired sepsis and/or septic shock and who are on extracorporeal therapy with Cytosorb® and Oxiris® adsorbents. conditions: Sepsis studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: PROSPECTIVE count: 20 type: ESTIMATED name: Cytosorb® and Oxiris® adsorbents measure: Development of population pharmacokinetic model sex: ALL stdAges: CHILD stdAges: ADULT stdAges: OLDER_ADULT facility: Department of Medical Intensive Care Medicine status: RECRUITING city: Banja Luka zip: 78000 country: Bosnia and Herzegovina name: Nikolina Spiric, MPharm role: CONTACT phone: +38751342295 email: [email protected] name: Pedja Kovacevic, Prof. role: SUB_INVESTIGATOR lat: 44.77842 lon: 17.19386 hasResults: False
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<|newrecord|> nctId: NCT06261151 id: Zhongshan-HHY-03 briefTitle: Preoperative Nutritional Status Associated With Delayed Discharge in Elderly Patients Undergoing Gastrectomy overallStatus: NOT_YET_RECRUITING date: 2024-03-01 date: 2024-12-31 date: 2025-03-31 date: 2024-02-15 date: 2024-02-15 name: Shanghai Zhongshan Hospital class: OTHER briefSummary: Gastric cancer (GC) remains the 5th most common cancer worldwide and had the second- highest mortality rate in China. The population of elder patients with GC has been increasing because of the high prevalence of H. pylori infection and increasing life expectancy. Elderly GC patients face several challenges during treatment, such as comorbidities, organ dysfunction, immunosuppression, and delayed recovery. Advanced age is associated with a higher rate of postoperative complications shortly after surgical treatment, and lower 5-year overall survival as long-term outcome.
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In China, the prevalence of malnutrition in hospitalized patients is around 12.6% to 46.19%. Malnutrition is one of the great risk factors of adverse clinical outcomes in elderly patients with GC. The nutritional status at the time of diagnosis was independently associated with postoperative complications, overall survival, and disease-free survival. The condition can be caused by mechanical obstruction of the digestive tract or anorexia-cachexia syndrome, leading to insufficient protein or energy intake and absorption disorder. Nutrition screening, assessment, and intervention are important steps in nutritional management.
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Previous studies mostly focused on hospitalized internal medical patients. Only a few studies focused on surgical patients regardless of age. Therefore, in this retrospective study, we are going to investigate the nutritional status and perioperative nutritional support of geriatric surgical patients with GC, and provide a basis for implementing an effective nutritional intervention. conditions: Preoperative Nutritional Status and Risk Factors Associated With Elderly Patients Undergoing Gastrectomy studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: RETROSPECTIVE count: 1000 type: ESTIMATED name: Clinical data collection measure: The preoperative nutritional status of elderly patients underwent gastrectomy sex: ALL minimumAge: 60 Years maximumAge: 90 Years stdAges: ADULT stdAges: OLDER_ADULT hasResults: False
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<|newrecord|> nctId: NCT06261138 id: RSR-HCC-2019-001 briefTitle: Survival Analysis: TACE vs. Combination Therapy in HCC overallStatus: COMPLETED date: 2019-02-01 date: 2023-03-31 date: 2023-10-31 date: 2024-02-15 date: 2024-02-15 name: Zhejiang University class: OTHER briefSummary: This retrospective observational study aimed to assess potential improvements associated with systemic therapies in patients receiving transarterial chemoembolization (TACE) for initially unresectable HCC. conditions: Hepatocellular Carcinoma studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: RETROSPECTIVE count: 279 type: ACTUAL name: Transarterial chemoembolization name: Systemic treatment measure: Progression Free Survival (PFS) per mRECIST measure: 12 months PFS rate measure: Overall survival (OS) measure: Objective Response Rate (ORR) per mRECIST measure: Disease Control Rate (DCR) per mRECIST measure: Adverse events (AEs) sex: ALL minimumAge: 18 Years maximumAge: 75 Years stdAges: ADULT stdAges: OLDER_ADULT facility: First Affiliated Hospital, Medical College of Zhejiang University city: Hangzhou state: Zhejiang zip: 310003 country: China lat: 30.29365 lon: 120.16142 hasResults: False
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<|newrecord|> nctId: NCT06261125 id: SL-B2023-718 briefTitle: Combination of SBRT, PD-L1 Inhibitor, and Lenvatinib in Hepatocellular Carcinoma (HSBRT2401) acronym: HSBRT2401 overallStatus: RECRUITING date: 2024-03-10 date: 2026-06-30 date: 2028-06-30 date: 2024-02-15 date: 2024-03-12 name: Mian XI class: OTHER briefSummary: Abdominal lymph node metastasis (LNM) is one of the major modes of extrahepatic metastasis in hepatocellular carcinoma (HCC). Immunotherapy targeting the PD-1/PD-L1 checkpoints combined with targeted therapy is the standard treatment for HCC with abdominal LNM, but the outcome remains very poor, with an objective response rate of 5% to 30%. Previous studies have demonstrated that stereotactic body radiotherapy (SBRT) is an effective local treatment for HCC with abdominal LNM, with a high response rate of 60% to 80%. However, intrahepatic dissemination and distant metastasis remains the major recurrence pattern after SBRT in these patients, suggesting radiotherapy should be combined with systematic treatment. Recently, the combination of immunotherapy with SBRT has shown promising activity in HCC. The aim of this study was to investigate the efficacy and safety of SBRT followed by adebrelimab (an anti-PD-L1 antibody) and lenvatinib in HCC patients with portal abdominal LNM. conditions: Hepatocellular Carcinoma studyType: INTERVENTIONAL phases: PHASE2 allocation: NON_RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: NONE count: 60 type: ESTIMATED name: Stereotactic body radiotherapy name: Adebrelimab name: Lenvatinib measure: Progression-free survival (PFS) measure: Overall survival (OS) measure: Overall response rate (ORR) measure: Disease control rate (DCR) measure: Duration of response (DOR) measure: Treatment-related adverse events measure: Correlation between serum cytokines and overall survival and immune-related adverse events sex: ALL minimumAge: 18 Years maximumAge: 75 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Mian Xi status: RECRUITING city: Guangzhou state: Guangdong zip: 510060 country: China name: Mian Xi, MD role: CONTACT phone: +862087343385 email: [email protected] name: Mian Xi, MD role: PRINCIPAL_INVESTIGATOR lat: 23.11667 lon: 113.25 hasResults: False
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<|newrecord|> nctId: NCT06261112 id: B.30.2.ATA.01.11/285 briefTitle: The Effect of Using a Kaleidoscope on Fear and Pain in Children overallStatus: RECRUITING date: 2022-05-07 date: 2024-05-01 date: 2024-05-01 date: 2024-02-15 date: 2024-02-15 name: Mihriban Culha class: OTHER briefSummary: The research was conducted in randomized controlled experimental type between May 2022 and December2023. The universe of the research consisted of children and their parents who were diagnosed with a fracture, applied to the Orthopedic outpatient clinic and Emergency department of the Erzurum Ataturk University Health Research and Application Center and referred to the Orthopedic clinic, and decided to undergo a cast procedure for treatment. The sample of the research consisted of a total of 70 children and their parents, including 35 control groups and 35 kaleidoscope groups, who met the research criteria from this universe. The children in the kaleidoscope group were shown the kaleidoscope. No intervention other than routine application was applied to the control group. "Introductory Information Form", "Wong-Baker Facial Expressions Rating Scale and Child Fear Scale were used in the collection of data. conditions: Fracture; Complication Orthopedic Procedure studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL interventionModelDescription: Parallel Assigment primaryPurpose: SUPPORTIVE_CARE masking: SINGLE maskingDescription: single /investigatör) whoMasked: INVESTIGATOR count: 70 type: ESTIMATED name: kaleidescope measure: Child Fear Scale (CFS) measure: Facial Expressions Rating Scale sex: ALL minimumAge: 6 Years maximumAge: 12 Years stdAges: CHILD facility: Ataturk University status: RECRUITING city: Erzurum zip: 25240 country: Turkey name: Mihriban ÇULHA role: CONTACT phone: 05070926243 email: [email protected] lat: 39.90861 lon: 41.27694 hasResults: False
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<|newrecord|> nctId: NCT06261099 id: 037 briefTitle: Telerehabilitation-Based Early Upper Extremity Training in Stroke Patients overallStatus: RECRUITING date: 2024-02-08 date: 2025-02-27 date: 2025-11-27 date: 2024-02-15 date: 2024-02-15 name: Suleyman Demirel University class: OTHER briefSummary: Telerehabilitation method, which is an alternative to face-to-face rehabilitation practices for stroke patients who need intensive, regular and long-term rehabilitation in the early period, has been popularly used in recent years. Telerehabilitation is a practice in which the patient participates in the treatment via digital media without the need for the patient to come to the clinic. conditions: Stroke, Acute studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: CROSSOVER interventionModelDescription: prospective double-blind, randomized controlled trial primaryPurpose: TREATMENT masking: QUADRUPLE maskingDescription: Sealed envelopes will be prepared in advance for randomization and will be marked with numbers 1 and 2, indicating whether they are a study group or a control group. Randomization will be done by a third party unaware of the study content. Randomization order tracking will be done with sequentially numbered containers. Patients participating in the study will be blinded to which treatment group they will be included in. whoMasked: PARTICIPANT whoMasked: CARE_PROVIDER whoMasked: INVESTIGATOR whoMasked: OUTCOMES_ASSESSOR count: 40 type: ESTIMATED name: control + working group measure: Mini Mental Test measure: Fugl Meyer Motor Function Scale measure: Laser-pointer Assisted Angle Reproduction Test measure: Modified Barthel Index measure: Reaching Performance Scale sex: ALL minimumAge: 30 Years maximumAge: 65 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Güler Ertuğrul status: RECRUITING city: Kocaeli state: İ̇zmi̇t country: Turkey name: GÜLER ERTUĞRUL role: CONTACT phone: +90 531 950 05 90 email: [email protected] lat: 39.62497 lon: 27.51145 facility: Suleyman Demirel University status: RECRUITING city: Isparta state: Merkez country: Turkey name: MEHMET DURAY role: CONTACT phone: +90 506 473 11 65 email: [email protected] lat: 37.76444 lon: 30.55222 hasResults: False
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<|newrecord|> nctId: NCT06261086 id: soh-med-24-01-06MS briefTitle: Evaluation of Pyroptosis-related Indicators in the Pathogenesis of Vitiligo:Across-sectional Comparative Study overallStatus: NOT_YET_RECRUITING date: 2024-02-24 date: 2024-08-24 date: 2024-08-24 date: 2024-02-15 date: 2024-02-15 name: Sohag University class: OTHER briefSummary: Vitiligo is an acquired pigmentary disorder on skin and/or mucosae, which is characterized by death of melanocytes (MCs), affecting 0.5%-2% of the population worldwide (1). It doesn't affect the health of patients but it has marked social pressure and greatly interfere with their quality of life (2,3). It presents with well circumscribed milky white patches that occur secondary to destruction of melanocyte, it may appear at any age and affect both sexes equally.
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It can affect ethnic groups and people of all skin types with no predilection (4).
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Clinically, several types of vitiligo are distinguished according to the distribution of the achromic lesions. One or more lesions in a dermatomal pattern are characteristic for segmental vitiligo (SV) while this segmental distribution is absent in non-segmental vitiligo (NSV). The latter variety includes both the focal type and the generalized type (5). Numerous previous studies tried to illustrate the pathogenesis behind the disease, but the exact pathophysiology is still not fully understood. It is a multifactorial disease. Factors include, neural theory, oxidative stress theory, autoimmune hypothesis, intrinsic theory, melanocytorrhagy hypothesis (6). Many theories tried to explain the mechanisms of MC destruction in vitiligo. Apoptosis is one of the most widely studied cell death pathways. In addition, the other two forms of cell death, conventional necrosis and autophagy seem to be involved in the death of vitiligo MCs under certain situations. Moreover, new types of regulated cell death including necroptosis, pyroptosis, and ferroptosis may also participate in the pathogenesis (7). Pyroptosis is a highly inflammatory form of necrosis cell death NCD regulated mainly by caspase-1, which is initiated following large supramolecular complex ermed inflammasome activation (8). The inflammasome-activated Caspases then cleave the pyroptosis-inducing protein Gasdermin D (GSDMD), which forms a pore in the plasma membrane and causes cell lysis as well as the secretion of IL-1β typically (9). Another study suggests that inflammasome activation could be a useful marker for assessing disease progression of vitiligo (10). However, the link between vitiligo and inflammasome activation is still unclear. The inflammasome regulates cell death and inflammation via activation of caspase-1 (11). The activation of caspase-1 promotes the secretion of proinflammatory cytokines IL-1β and IL-18, as well as the initiation of pyroptosis (12). So, evaluation of pyroptosis-related indicators (GASDM-D, IL 1β \& IL-18) may help understanding the obscure inflammasome pathway involvement in the pathogenesis of Vitiligo. conditions: Vitiligo studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: DIAGNOSTIC masking: NONE count: 90 type: ESTIMATED name: evaluate serum levels pyroptosis-related indicators (GASDM-D, IL 1β & IL-18) measure: GASDM-D measure: IL 1β measure: IL-18 sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT hasResults: False
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<|newrecord|> nctId: NCT06261073 id: Soh-Med-24-01-08MS briefTitle: Evaluation of Serum and Tissue Cathepsin L in Non-segmental Vitiligo Patients overallStatus: NOT_YET_RECRUITING date: 2024-03-15 date: 2025-03-01 date: 2025-03-01 date: 2024-02-15 date: 2024-02-15 name: Sohag University class: OTHER briefSummary: Introduction Vitiligo is an autoimmune disease of the skin that targets pigment producing melanocytes and results in patches of depigmentation that are visible as white spots (Frisoli et al., 2020) Vitiligo is a relatively common acquired pigmentation disorder that can cause significant psychological stress (Leung AKC et al., 2021). The disease affects both genders equally, it can appear at any age, and the average age of onset is somewhat variable in different geographic (Majumder et al, 1993), with an estimated prevalence of 0.5-2% of the population in both adults and children worldwide (Krüger et al, 2012).
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Vitiligo results in white macules and patches on the body. Initial lesions occur most frequently on the hands, forearms, feet, and face, favoring a periocular or perioral distribution (Ahmed jan N et al., 2023). Vitiligo lesions are classified into 2 major categories: segmental vitiligo (SV) and non-segmental vitiligo (NSV) (Relke et al ., 2019). Segmental vitiligo is characterized by its early onset, rapid stabilization, and unilateral distribution (Van Geel et al., 2017). Non-segmental vitiligo comprises of generalized (vitiligo vulgaris), acrofacial, mucosal (multifocal), and universal vitiligo (Kovacevic et al., 2016). Non-segmental vitiligo (NSV) is the most common form of vitiligo (Benzekri et al., 2013). Multiple mechanisms are involved in melanocyte disappearance, namely genetic predisposition, environmental triggers, metabolic abnormalities, impaired renewal, and altered inflammatory and immune responses (Boniface K et al ., 2018).
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The results of some studies indicate a frequent association of vitiligo with autoimmune diseases. A number of studies have established a higher prevalence of autoimmune endocrine diseases in women, as well as in non-segmental vitiligo patients and in cases of family history of vitiligo and/or other autoimmune diseases. In addition, it was shown that the prevalence of endocrine diseases increases with increasing area of depigmentation (Troshina EA et al., 2020). Autoimmunity in vitiligo is driven by the IFN-γ-CXCL10 cytokine signaling pathway. Activated melanocyte-specific CD8+ T cells secrete IFN-γ, which signals through the IFN-γ receptor (IFN-γR) to activate JAK1/2 and STAT1. This induces the production of CXCL9 and CXCL10, which signal through their receptor CXCR3 to recruit more auto-reactive T cells to the epidermis, resulting in widespread melanocyte destruction (Harris JE et al., 2017).
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The lysosomal cysteine proteinases of the papain family are involved in lysosomal bulk proteolysis, major histocompatibility complex class II-mediated antigen presentation, pro-hormone processing, and extracellular matrix remodeling. conditions: Vitiligo studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: DIAGNOSTIC masking: NONE count: 40 type: ESTIMATED name: blood sample and tissue biopsy measure: Cathepsin L sex: ALL minimumAge: 18 Years maximumAge: 50 Years stdAges: ADULT hasResults: False
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<|newrecord|> nctId: NCT06261060 id: 2023-0918 id: NCI-2024-01333 type: OTHER domain: NCI-CTRP Clinical Registry briefTitle: Low-Dose Sirolimus to Increase Hematopoietic Function in Patients With RUNX1 Familial Platelet Disorder overallStatus: NOT_YET_RECRUITING date: 2024-08-31 date: 2026-06-11 date: 2028-06-11 date: 2024-02-15 date: 2024-03-07 name: M.D. Anderson Cancer Center class: OTHER briefSummary: To learn about the safety and effects of low-dose sirolimus in participants with RUNX1-FPD. conditions: Familial Platelet Disorder conditions: Hematopoietic studyType: INTERVENTIONAL phases: PHASE2 allocation: NA interventionModel: SINGLE_GROUP primaryPurpose: TREATMENT masking: NONE count: 6 type: ESTIMATED name: Sirolimus measure: Safety and adverse events (AEs) sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: MD Anderson Cancer Center city: Houston state: Texas zip: 77030 country: United States name: Courtney DiNardo, MD role: CONTACT phone: 713-794-1141 email: [email protected] name: Courtney DiNardo, MD role: PRINCIPAL_INVESTIGATOR lat: 29.76328 lon: -95.36327 hasResults: False
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<|newrecord|> nctId: NCT06261047 id: SDZLEC2023-389-02 briefTitle: Radiotherapy Delays Second-line Drug Therapy for Oligo Progressive Primary Liver Cancer overallStatus: RECRUITING date: 2024-01-01 date: 2026-01-01 date: 2026-01-01 date: 2024-02-15 date: 2024-02-15 name: Shandong Cancer Hospital and Institute class: OTHER briefSummary: Recent years have seen significant advancements in the treatment landscape of advanced hepatocellular carcinoma (HCC), with the emergence of targeted and immunotherapy strategies reshaping first-line therapy. Sorafenib, a multi-targeted tyrosine kinase inhibitor, initially set the standard, followed by approvals for lenvatinib, regorafenib, cabozantinib, and ramucirumab. Immunotherapy, particularly combinations like atezolizumab with bevacizumab, has shown superior efficacy over sorafenib. Despite these advances, second-line therapies offer limited progression-free survival (mPFS: 2-3 months), necessitating new approaches. Radiotherapy, bolstered by technological advancements, has shown promise. Techniques like stereotactic body radiotherapy (SBRT) combined with PD-1 inhibitors achieve significant response rates and survival benefits. Combining radiotherapy with targeted immunotherapy has also demonstrated improved outcomes. Radiotherapy, especially in oligometastatic HCC, is increasingly favored due to its ability to enhance local control without increasing toxicity. These developments underscore the evolving landscape of HCC treatment towards personalized and multimodal approaches. conditions: Hepatocellular Carcinoma conditions: Radiotherapy studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: PROSPECTIVE count: 36 type: ESTIMATED name: radiotherapy measure: Progression free survival measure: Overall response rate measure: Overall survial measure: Disease control rate measure: Duration of control sex: ALL minimumAge: 18 Years maximumAge: 75 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Jinbo Yue status: RECRUITING city: Jinan state: Shandong zip: 250000 country: China name: jinbo yue role: CONTACT phone: +86053167626442 email: [email protected] lat: 36.66833 lon: 116.99722 hasResults: False
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<|newrecord|> nctId: NCT06261034 id: 23-008765 id: 8K12AR084222-15 type: NIH link: https://reporter.nih.gov/quickSearch/8K12AR084222-15 briefTitle: A Study of Sex Differences in Neurocirculatory Control overallStatus: NOT_YET_RECRUITING date: 2024-05 date: 2027-03 date: 2027-03 date: 2024-02-15 date: 2024-04-10 name: Mayo Clinic class: OTHER name: National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS) briefSummary: The purpose of this study is to investigate potential sex differences in neurocirculatory control of blood pressure in patients with untreated obstructive sleep apnea (OSA). conditions: Obstructive Sleep Apnea studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: CROSS_SECTIONAL count: 60 type: ESTIMATED measure: Blood pressure measure: Arterial stiffness measure: Endothelial function measure: Sympathetic nerve burst frequency measure: Sympathetic nerve burst incidence measure: Sympathetic nerve burst amplitude (AU) measure: Total muscle sympathetic nerve activity (MSNA) measure: Cerebral autoregulation measure: Sympathetic action potentials per burst measure: Sympathetic action potential clusters per burst measure: Sympathetic action potential conduction latency of each cluster measure: Immune function measure: Urinary Extracellular Vesicle Presence and Content measure: Plasma Extracellular Vesicle Presence and Content sex: ALL minimumAge: 20 Years maximumAge: 70 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Mayo Clinic in Rochester city: Rochester state: Minnesota zip: 55905 country: United States name: Joshua Bock, PhD role: CONTACT phone: 507-422-0768 email: [email protected] name: Ian Greenlund, PhD role: CONTACT phone: (507) 422-3411 email: [email protected] name: Virend Somers, MD, PhD role: PRINCIPAL_INVESTIGATOR lat: 44.02163 lon: -92.4699 hasResults: False
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<|newrecord|> nctId: NCT06261021 id: INNO-6051 briefTitle: Study to Evaluate the Efficacy of Ruxolitinib 1.5% Cream in Adult Subjects With Discoid Lupus Erythematosus overallStatus: RECRUITING date: 2024-04-19 date: 2025-02 date: 2025-02 date: 2024-02-15 date: 2024-04-25 name: Innovaderm Research Inc. class: OTHER briefSummary: This study is a single-blind, intraindividual study to evaluate the efficacy of ruxolitinib 1.5 % cream in adult subjects with discoid lupus erythematosus. conditions: Discoid Lupus Erythematosus studyType: INTERVENTIONAL phases: PHASE2 allocation: RANDOMIZED interventionModel: PARALLEL interventionModelDescription: Intra-individual primaryPurpose: TREATMENT masking: SINGLE maskingDescription: This study will be single-blinded. Only the efficacy assessor will be blinded in this study (for subjects with randomized areas). The assessor will only assess efficacy and will not have any other interactions with the subject. whoMasked: OUTCOMES_ASSESSOR count: 20 type: ESTIMATED name: Ruxolitinib 1.5% cream name: Application without occlusion in Area 1 name: Application under occlusion at night in Area 2 name: Application under occlusion at night in Area 1 name: Application without occlusion in Area 2 measure: Change from baseline in target lesion CLASI-A score measure: Change from baseline in target lesion CLASI-A score measure: Proportion of subjects with an erythema score of 0 (absent) measure: Change from baseline in target lesion SADDLE-A measure: Proportion of subjects with a target lesion CLA-IGA score of 0 (clear) or 1 (almost clear) measure: Dermatology Life Quality Index (DLQI) measure: Cutaneous Lupus Erythematosus Quality of Life (CLEQol) measure: Numeric Rating Scale(NRS) sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Innovaderm Research Inc. status: RECRUITING city: Montréal state: Quebec zip: H2X 2V1 country: Canada name: Fareheen Chowdhury, MSc role: CONTACT phone: 514-521-4285 phoneExt: 341 email: [email protected] name: Robert Bissonnette role: PRINCIPAL_INVESTIGATOR lat: 45.50884 lon: -73.58781 hasResults: False
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<|newrecord|> nctId: NCT06261008 id: 2023.553 briefTitle: Interactive Telehealth Intervention to Increase Longitudinal Adherence to Repeat Faecal Immunochemical Test Screening overallStatus: NOT_YET_RECRUITING date: 2024-03-15 date: 2025-03-26 date: 2026-06-26 date: 2024-02-15 date: 2024-02-16 name: Chinese University of Hong Kong class: OTHER briefSummary: In Hong Kong, Colorectal cancer ranks second in both cancer incidence and mortality. The government-subsidized population-based CRC screening program (the Program) was launched for asymptomatic individuals aged 50-75 years to undergo biennial FIT screenings. A subsidized follow-up colonoscopy is offered to participants with positive FIT results. Participants are advised to repeat the FIT screening 2 years after receiving a negative result. An automated noninteractive short message service (SMS) text reminder, used by the Program as standard care (SC), is delivered to participants who are due for repeat FIT. According to unpublished data, despite SC, only 34% of participants adhere to biennial repeat FIT in the CRC screening program. Nonadherence to repeat FIT screening is caused by forgetfulness and is associated with an individual's psychological health behaviour. conditions: CRC, Colorectal Cancer studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL interventionModelDescription: Patient will be randomized into either standard care or telehealth intervention group primaryPurpose: HEALTH_SERVICES_RESEARCH masking: NONE maskingDescription: There will no masking count: 370 type: ESTIMATED name: TI group measure: adherence rate measure: the number of days to repeat FIT measure: costs incurred in each study arm measure: uptake rate in positive FIT measure: detection rate in positive FIT measure: qualitative factors associated with repeat FIT adherence sex: ALL minimumAge: 50 Years maximumAge: 75 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Centre of Digestive Health, Prince of Wales Hospital city: Hong Kong country: Hong Kong lat: 22.27832 lon: 114.17469 hasResults: False
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