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- Measure the impact of the protocol on the proportion of patients with a VAS greater than 3/10 on day one and who did not take the analgesics.
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The participants are divided into two groups. The control group leaves the hospital with instructions and prescriptions. The experimental group leaves the hospital with instructions, analgesics for a maximum of two days with detailed dosages and an explanatory booklet on postoperative pain. conditions: Postoperative Pain conditions: Outpatient Surgery studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: RETROSPECTIVE count: 1423 type: ACTUAL name: Measure the impact of the home analgesia protocol on the proportion of patients with a VAS &gt; 3/10 on day one and who did not take analgesics. measure: Measure the impact of the protocol on the proportion of patients with a pain greater than 3/10 on a Visual Analogue Scale at day one and who did not take the analgesics. measure: Measure the adequacy of post-op analgesics by measuring the proportion of patients with a Visual Analogue Scale < or = 3/10 on day one for each group measure: Measure the impact of the protocol on the occurrence of nausea and vomiting on day one measure: Measure the impact of the protocol on general satisfaction of stay in outpatient surgery on day 7 with a Visual Analogue Scale Satisfaction sex: ALL stdAges: CHILD stdAges: ADULT stdAges: OLDER_ADULT facility: CHU de Liège city: Liège state: Wallonie zip: 4000 country: Belgium lat: 50.63373 lon: 5.56749 hasResults: False
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<|newrecord|> nctId: NCT06268574 id: RIVER-52 briefTitle: Safety and Efficacy of RVU120 for Treatment of Relapsed/Refractory AML acronym: RIVER-52 overallStatus: RECRUITING date: 2024-01-23 date: 2026-02 date: 2026-09 date: 2024-02-20 date: 2024-02-20 name: Ryvu Therapeutics SA class: INDUSTRY briefSummary: The goal of this study is to assess the safety, tolerability, anti-tumor activity (efficacy), pharmacokinetics (PK), and pharmacodynamics (PD) of the agent RVU120 when administered to adult patients with relapsed or refractory acute myeloid leukemia (AML) or relapsed or progressing high-risk myelodysplastic syndrome (HR-MDS) and who have no alternative therapies available. The study consists of two parts. Part 1 will assess the safety and tolerability of the dosages given and the level of anti-tumor activity or clinical response. Based on the results from part 1 the study will continue to enrol patient into Part 2 which will continue to evaluate safety and tolerability and anti-tumor activity in a larger number of patients. conditions: Acute Myeloid Leukemia (AML) conditions: High-risk Myelodysplastic Syndrome studyType: INTERVENTIONAL phases: PHASE2 allocation: NA interventionModel: SINGLE_GROUP interventionModelDescription: Single Group Assignment primaryPurpose: TREATMENT masking: NONE count: 94 type: ESTIMATED name: RVU120 measure: Complete Remission (CR), with and without measurable residual disease (MRD) measure: Overall response rate measure: Duration of response measure: Progression-free survival measure: Overall survival measure: Incidence of Adverse Events (Safety and Tolerability) measure: Percentage of participants bridged to hematopoietic stem cell transplantation measure: Maximum Plasma Concentration (Cmax) measure: Maximum Plasma Concentration (Tmax) measure: Area Under the Concentration Time-Curve (AUC) measure: Impact of treatment on hematological malignancy patient-reported outcomes (HM-PRO) measure: Impact of treatment on health-related quality of life (QOL-E) sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: MTZ Clinical Research status: RECRUITING city: Warszawa state: Mazowieckie Województwo zip: 02-172 country: Poland name: Krzysztof Mądry role: CONTACT phone: +48 22 572 59 59 email: [email protected] name: Krzysztof Mądry, MD role: PRINCIPAL_INVESTIGATOR lat: 52.22977 lon: 21.01178 facility: MICS Centrum Medyczne Toruń status: RECRUITING city: Toruń zip: 87-100 country: Poland name: Dominik Chraniuk role: CONTACT phone: +48 56 300 43 email: [email protected] name: Dominik Chraniuk, MD role: PRINCIPAL_INVESTIGATOR lat: 53.01375 lon: 18.59814 hasResults: False
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<|newrecord|> nctId: NCT06268561 id: IRBN852023/CHUSTE briefTitle: Ozurdex Endophtamitis Cohort, Prognostic Assessment at 12 Months overallStatus: RECRUITING date: 2023-06-05 date: 2024-06 date: 2024-06 date: 2024-02-20 date: 2024-02-20 name: Centre Hospitalier Universitaire de Saint Etienne class: OTHER briefSummary: OZURDEX endophthalmitis is a rare and potentially very serious pathology. Different treatments can be carried out early and change the functional prognosis of the patient. conditions: Endophthalmitis studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: RETROSPECTIVE count: 8 type: ESTIMATED name: Visual acuity analysis name: Intraocular pressure analysis name: Analysis of optical coherence tomography (OCT) images name: Analysis of retinograms measure: Visual acuity measure: IOP measured in mmHg by tonometer and confirmed with Goldman Applanation measure: Tomography measure: Resumption of intravitreal therapy sex: ALL stdAges: CHILD stdAges: ADULT stdAges: OLDER_ADULT facility: CHU Saint Etienne status: RECRUITING city: Saint-Étienne zip: 42000 country: France name: Thibaud GARCIN, MD PhD role: CONTACT phone: (0)477829662 phoneExt: +33 email: [email protected] name: Thibaud GARCIN, MD PhD role: PRINCIPAL_INVESTIGATOR name: Henri PITEAU, resident role: SUB_INVESTIGATOR lat: 45.43389 lon: 4.39 hasResults: False
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<|newrecord|> nctId: NCT06268548 id: P.T.REC/012/004790 briefTitle: Effect of Manual Diaphragmatic Activation on Diaphragm Function in Patients With Gastroesophageal Reflux Disease overallStatus: RECRUITING date: 2023-09-15 date: 2024-02-20 date: 2024-02-27 date: 2024-02-20 date: 2024-02-20 name: Cairo University class: OTHER briefSummary: This study was conducted to investigate Effect of manual diaphragmatic activation on diaphragm function in patients with gastroesophageal reflux disease conditions: Diaphragm Dysfunction studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: SINGLE whoMasked: PARTICIPANT count: 30 type: ESTIMATED name: Manual diaphragmatic activation measure: Diaphragm Excursion sex: ALL minimumAge: 20 Years maximumAge: 50 Years stdAges: ADULT facility: Faculty of physical therapy status: RECRUITING city: Giza zip: 12613 country: Egypt name: Nesreen Ghareb Mohamed, Professor role: CONTACT phone: 01002227242 email: [email protected] lat: 30.00808 lon: 31.21093 hasResults: False
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<|newrecord|> nctId: NCT06268535 id: CaenUH_DL_1 briefTitle: Identification of Anticancer Drugs Associated With Heart Failure: a WHO Pharmacovigilance Database Analysis overallStatus: COMPLETED date: 2022-04-01 date: 2022-05-31 date: 2022-05-31 date: 2024-02-20 date: 2024-02-20 name: University Hospital, Caen class: OTHER briefSummary: Therapeutic advances have significantly improved the survival of patients with cancer. However, these novel therapies are associated with a concomitant increase in the prevalence of toxicity, including cardiovascular complications of cancer therapy.
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Among these adverse drug reactions, heart failure and, more generally, cancer therapy-related cardiac dysfunction are the most concerning cardiovascular complications of cancer therapy, carrying a high morbidity burden and an elevated risk of death.
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Patients with both heart failure and cancer have a worse prognosis when compared with heart failure patients with no history of cancer. It is therefore crucial to enhance the identification of patients at a higher risk of cancer therapy-related cardiac dysfunction both before and during treatment, especially when utilizing cancer therapies with known potential cardiovascular adverse drug reactions.
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The explosion of new anticancer drugs has led to the potential association of these therapies with cardiac dysfunction.
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Using VigiBase, the World Health Organization's (WHO) global pharmacovigilance database, the investigators aimed to assess the relationship between cancer therapy-related cardiac dysfunction and the administration of anti-cancer drugs. conditions: Heart Failure conditions: Cancer, Therapy-Related studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: RETROSPECTIVE count: 3406383 type: ACTUAL name: Cancer therapy with FDA and/or EMA approval on the 31st March 2022 measure: Disproportionality individual case data analysis between heart failure of cardiac dysfunction and cancer therapies measure: Description of the population of patients having a heart failure of cardiac dysfunction event with cancer therapies measure: Description of the pathologies (cancer) for which the incriminated drugs have been prescribed measure: Description of the drug-drug interactions associated with adverse events sex: ALL stdAges: CHILD stdAges: ADULT stdAges: OLDER_ADULT facility: Caen University Hospital city: Caen country: France lat: 49.18585 lon: -0.35912 hasResults: False
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<|newrecord|> nctId: NCT06268522 id: 2023P001582 briefTitle: Adjunctive Mindfulness During Opioid Tapering for patientS With Chronic Pain (The AMOS Study) overallStatus: RECRUITING date: 2024-02 date: 2024-06 date: 2024-06 date: 2024-02-20 date: 2024-02-20 name: Brigham and Women's Hospital class: OTHER briefSummary: This study is a Randomized Controlled Trial exploring the effects of a Mindfulness interventions in reducing pain interference and opioid dose in patients with Chronic Low Back Pain. A total of 200 opioid-using patients with chronic pain, male and female participants will be enrolled, with a need for 160 completers. Patient will be randomly assigned into the Mindfulness-Oriented Recovery Enhancement or the Psychoeducation comparison control group. conditions: Low Back Pain studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL interventionModelDescription: Behavioral primaryPurpose: TREATMENT masking: TRIPLE whoMasked: CARE_PROVIDER whoMasked: INVESTIGATOR whoMasked: OUTCOMES_ASSESSOR count: 200 type: ESTIMATED name: Mindfulness-Oriented Recovery Enhancement: (MORE) group name: Psychoeducation measure: Pain Interference measure: Opioid Dose measure: Pain Intensity measure: Opioid Misuse measure: Opioid Withdrawal measure: Opioid Craving sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Brigham and Women's Hospital status: RECRUITING city: Chestnut Hill state: Massachusetts zip: 02467 country: United States name: Marie Curiel role: CONTACT phone: 617-732-9578 email: [email protected] name: Asimina Lazaridou, PhD role: PRINCIPAL_INVESTIGATOR name: Robert Edwards, PhD role: SUB_INVESTIGATOR lat: 42.33065 lon: -71.16616 hasResults: False
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<|newrecord|> nctId: NCT06268509 id: MONAS briefTitle: Nutrition Optimalization Among Pregnant Women to Improve Maternal and Neonatal Outcome in DKI Jakarta acronym: MONAS overallStatus: RECRUITING date: 2023-04-01 date: 2024-06 date: 2024-08 date: 2024-02-20 date: 2024-02-20 name: Dr Cipto Mangunkusumo General Hospital class: OTHER name: Dinas Kesehatan DKI Jakarta name: Fakultas Kedokteran Universitas Indonesia briefSummary: The goal of this MONAS Study is to learn about comprehensive monitoring and nutritional intervention among pregnant women in order to improve maternal and neonatal outcomes. The main questions it aims to answer are:
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1. Are comprehensive monitoring and nutritional intervention among pregnant women can improve maternal outcomes (maternal death, preterm labour, preeclampsia, intrauterine infection, and bleeding during pregnancy and delivery) compared to standard maternal health services?
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2. Are comprehensive monitoring and nutritional intervention among pregnant women can improve neonatal outcomes (neonatal death, low birth weight, intrauterine growth restriction, and neonatal asphyxia) compared to standard maternal health services?
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Participants in the intervention group will receive:
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* Fetomaternal ultrasound examination each trimester
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* Complete laboratory examination for nutritional panel (complete blood count with reticulocyte profile and iron profile, vitamin D level, zinc level, fatty acid profile, electrophoresis for Thalassemia) as an addition to standard maternal routine laboratory examination
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* Supplements: multivitamin, minerals, vitamin D, fatty acid
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* Intervention regarding any abnormal results of nutritional panel
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* All standard maternal health services according to Indonesian Ministry of Health protocol
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Participants in the control group will receive:
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- All standard maternal health services according to Indonesian Ministry of Health protocol conditions: Pregnancy Complications conditions: Maternal Death conditions: Preeclampsia conditions: Intrauterine Infection conditions: Pregnancy Hemorrhage conditions: Preterm Birth conditions: Neonatal Death conditions: Low; Birthweight, Extremely (999 Grams or Less) conditions: Asphyxia Neonatorum conditions: IUGR studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: PREVENTION masking: NONE count: 245 type: ESTIMATED name: Nutritional panel laboratory examination name: Pregnancy supplements (other than provided by Ministry of Health) name: Fetomaternal ultrasound measure: Composite of poor maternal outcomes measure: Composite of poor neonatal outcomes sex: FEMALE stdAges: CHILD stdAges: ADULT stdAges: OLDER_ADULT facility: Jakarta Primary Care Health Facility (Puskesmas) under Jakarta Health Office status: RECRUITING city: Jakarta country: Indonesia name: Risal, M.D., M.Sc. role: CONTACT email: [email protected] lat: -6.21462 lon: 106.84513 hasResults: False
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<|newrecord|> nctId: NCT06268496 id: LRP23021-A serum briefTitle: Efficacy and Tolerability of the Tested Formula After 3 Months in Treatment of Facial Hyperpigmentation of 3 Origins overallStatus: NOT_YET_RECRUITING date: 2024-03 date: 2024-06 date: 2024-06 date: 2024-02-20 date: 2024-03-05 name: Cosmetique Active International class: INDUSTRY briefSummary: The objective of this study is to evaluate the efficacy, cosmetic acceptability and improvement of the stigmatization of the tested product (2039125 03) used bis in die (BID) for 3 months in adult patients suffering from mild to moderate melasma, or mild to moderate acne induced post-inflammatory hyperpigmentation, or solar lentigo. conditions: Hyperpigmentation studyType: INTERVENTIONAL phases: NA allocation: NON_RANDOMIZED interventionModel: PARALLEL primaryPurpose: OTHER masking: NONE count: 60 type: ESTIMATED name: serum formula 2039125 03 measure: IGA score for patients with melasma or acne induced post-inflammatory hyperpigmentation (PIHP) measure: modified Melasma Area and Severity Index (mMASI) for patients with melasma measure: Post-Acne Hyperpigmentation Index (PAHPI) measure: solar lentigo pigmentation scale measure: colorimetry measurements sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Medcin Instituto da Pele Ltda city: Osasco country: Brazil lat: -23.5325 lon: -46.79167 hasResults: False
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<|newrecord|> nctId: NCT06268483 id: JalUrol id: Policlinico type: OTHER domain: IRCCS Fondazione Ca' Granda Ospedale Maggiore Policlinico briefTitle: Effect of Hyaluronic Acid Oral Supplementation on Sexual and Urinary Symptoms of Women With Recurrent Urinary Tract Infections acronym: JalUrol overallStatus: COMPLETED date: 2022-03-01 date: 2023-03-28 date: 2023-03-28 date: 2024-02-20 date: 2024-02-20 name: Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico class: OTHER briefSummary: Uncomplicated urinary tract infections (UTI) are one of the most common bacterial infections globally, causing a significant proportion of medical consultations in primary and outpatient settings. Recurrent UTI (rUTI) have a detrimental impact on the patient's quality of life, causing a negative effect on women's social relationships, self-esteem, as well as irritability and tiredness. Moreover, several real-life studies have shown that reproductive-aged women with rUTI more frequently experience sexual dysfunction as compared to controls without infections. The glycosaminoglycan layer of the bladder urothelium, mainly composed by chondroitin sulfate (CS) and hyaluronic acid (HA), provides a protective barrier against the penetration of bacteria. A deficiency of this layer facilitates bacterial adherence, leading to recurrent infection. Treatment to restore this layer with intravesical instillation of HA has been proven to reduce the incidence of rUTI episodes. Furthermore, intravesical instillation with HA has been associates with sexual function improvement in women with rUTI and painful bladder . Therefore, in conditions where the glycosaminoglycan layer of the bladder is impaired, such as rUTIs, treatment with HA to restore it appears to have a beneficial effect on urinary and sexual symptoms.
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Recently, a randomized control trial has demonstrated that an oral formulation of HA, CS, quercetin and curcumin was effective in improving urinary symptoms in women undergoing intravesical chemotherapy for bladder cancer. However, there are no studies investigating the impact of the oral administration of HA and CS on the sexual and urinary symptoms of women with rUTI. Since rUTI are highly prevalent in sexually active women and exert a detrimental impact on women's quality of life, sexual and urinary symptoms, the identification of oral treatments that could alleviate these bothersome consequences is of primary clinical importance.
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Therefore we will conduct this randomized, cross-over trial to evaluate the efficacy of an oral preparation of HA, CS, N-Acetylglucosamine and vitamin C in improving sexual and urinary symptoms in a cohort of reproductive-aged women with rUTI.
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Methods:
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Pre-menopausal, sexually active women referred to our center for symptomatic rUTIs. At the time of enrollment, participants were randomized with a 1:1 allocation ratio by means of a computer-generated random list in two groups: intervention (I) and control (C) (Figure 1).
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Inclusion and exclusion criteria We included sexually active, reproductive-aged women with symptomatic rUTIs. Exclusion criteria: younger than 18, if they had used combined hormonal contraception during the previous 6 months; pregnant, breastfeeding or trying to conceive, if they had symptoms of upper UTI, a history of urinary tract anomalies/vesicoureteral reflux, stress urinary incontinence, interstitial cystitis, diabetes, urinary tract stones, neurologic conditions, clinical depression or depressive symptoms.
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All women will be assessed with a thorough medical and sexual history. To psychometrically quantify sexual function impairment all participants completed The Female Sexual Function Index (FSFI) questionnaire at baseline and at each follow up assessment.
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Treatment Protocol Group I: an oral preparation (capsule) of HA 100 mg, CS 400 mg, N-Acetylglucosamine 200 mg and vitamin C 80 mg once a day in the morning plus an oral preparation of cranberry, D-mannose, propolis extract, tumeric and Boswellia twice a day for three months.
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Group C: an oral preparation of cranberry, D-mannose, propolis extract, tumeric and Boswellia twice a day for three months.
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After three months of treatment (follow up 1) all women were evaluated with medical and sexual history. Participants also completed the FSFI and IPSS questionnaires. At this point the treatment was reversed (crossover scheme) for additional three months.
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At 6 months follow up (follow up 2) participants were again investigated with medical and sexual history and the IPSS and FSFI were completed. Figure 2 report the complete study design. Monthly phone calls were performed to check for adherence to treatment.
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Statistics: The sample size consisted of 25 participants in each group, calculated by using the two-sample t-test analysis. Baseline clinical and psychometric scores will be compared between I and C groups. Second, potential differences in FSFI values at 3-6 months follow-up assessment will be evaluated between and within groups. Potential predictors of FSFI improvement will be evaluated. conditions: Urinary Tract Infections, Recurrent studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: CROSSOVER interventionModelDescription: randomized, crossover primaryPurpose: TREATMENT masking: NONE count: 50 type: ACTUAL name: HA 100 mg, CS 400 mg, N-Acetylglucosamine 200 mg and vitamin C 80 mg + cranberry, D-mannose, propolis extract, tumeric and Boswellia name: cranberry, D-mannose, propolis extract, tumeric and Boswellia measure: Improvement in sexual symptoms measure: Improvement in urinary symptoms sex: FEMALE minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: IRCCS Fondazione Ca' Granda Ospedale Maggiore Policlinico city: Milan state: MI zip: 20122 country: Italy lat: 45.46427 lon: 9.18951 hasResults: False
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<|newrecord|> nctId: NCT06268470 id: Chula-ARC 001/18 briefTitle: Antiplatelet Therapy in Chronic Urticaria overallStatus: ACTIVE_NOT_RECRUITING date: 2018-06-01 date: 2024-03-01 date: 2024-05-01 date: 2024-02-20 date: 2024-02-21 name: Chulalongkorn University class: OTHER briefSummary: This study compares the combination of antiplatelets and antihistamine versus antihistamine alone for the treatment of chronic spontaneous urticaria conditions: Chronic Urticaria studyType: INTERVENTIONAL phases: PHASE2 allocation: RANDOMIZED interventionModel: PARALLEL interventionModelDescription: Patients diagnosed with chronic urticaria will be assigned to 2 treatment arms. 1. high dose antihistamine with antiplatelets; and 2. high dose antihistamine alone. primaryPurpose: TREATMENT masking: TRIPLE maskingDescription: Identical capsules whoMasked: PARTICIPANT whoMasked: CARE_PROVIDER whoMasked: INVESTIGATOR count: 12 type: ESTIMATED name: Desloratadine plus cilostazol and dipyridamole name: Desloratadine measure: Weekly urticaria activity score measure: D-dimer levels sex: ALL minimumAge: 18 Years maximumAge: 65 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Faculty of Medicine, Chulalongkorn University city: Bangkok zip: 10330 country: Thailand lat: 13.75398 lon: 100.50144 hasResults: False
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<|newrecord|> nctId: NCT06268457 id: CE-AVEC 789/2023/Oss/IOR briefTitle: Arterial Chemoembolization for the Treatment of Desmoid Fibromatosis acronym: Embodesmo overallStatus: RECRUITING date: 2024-02-20 date: 2027-02-01 date: 2028-02-01 date: 2024-02-20 date: 2024-03-20 name: Istituto Ortopedico Rizzoli class: OTHER briefSummary: Desmoid fibromatoses are rare (1-2 cases/million per year) and locally aggressive mesenchymal tumors. For asymptomatic disease, current guidelines suggest an initial period of active surveillance.
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The current scientific evidence regarding the efficacy and safety of the treatment of desmoid fibromatosis by arterial embolization is constituted by several retrospective and prospective studies. Embolization of desmoid tumors alone, without chemotherapy, on the contrary, has been shown to be inefficient. Using Doxorubicin in desmoid fibromatosis is effective but associated with systemic toxicity. Consequently, this drug is reserved for symptomatic, nonresponsive, rapidly growing or life-threatening tumors. The intrinsic hypervascularity of desmoid tissue can be exploited as a conduit to achieve local distribution of Doxorubicin by navigation of a catheter endovascular. conditions: Desmoid studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: PROSPECTIVE count: 20 type: ESTIMATED name: Chemoembolization with Doxorubicin measure: Volume reduction in cm measure: Reduction of pain (VAS score) measure: Reduction of antalgic therapy (mg) measure: Improvement in quality of life (EORTC QLQ-C15-PAL questionnaire) measure: Improvement in quality of life (EORTC QLQ - BM22) sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Istituto Ortopedico Rizzoli status: RECRUITING city: Bologna state: Emilia Romagna zip: 40136 country: Italy name: Giancarlo Facchini, MD role: CONTACT phone: +39 333 650 0944 email: [email protected] lat: 44.49381 lon: 11.33875 hasResults: False
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<|newrecord|> nctId: NCT06268444 id: PI2023_843_0077 briefTitle: Infant Sleep and Exposure to Mixture of Chemical Environmental Pollutants acronym: SOLANGE overallStatus: RECRUITING date: 2024-02-07 date: 2026-02 date: 2026-02 date: 2024-02-20 date: 2024-02-20 name: Centre Hospitalier Universitaire, Amiens class: OTHER briefSummary: During their first year of life, children spend more than half their time sleeping, a function essential to their neurodevelopment. This period of maturation and development of the future adult is considered extremely vulnerable to environmental exposure. During this period, the child\'s diet is mainly provided by breastfeeding, where persistent chemical substances have been found. A cocktail of 19 mostly persistent substances (POPs) present in breast milk has recently been identified as the main contributor to neurodevelopmental risk. However, the reality of their impact on neurophysiological development, in particular on infant sleep, has yet to be assessed.
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In this project, the sleep of children under 6 months of age will be studied using an actimetry watch worn for 7 days by the child, accompanied by a sleep diary. Exposure to environmental pollutants will be assessed by measuring their presence in the infant\'s milk (breastfeeding) and wearing a silicone bracelet to collect air pollutants. A questionnaire on exposure will complement this evaluation. conditions: Newborn conditions: Chemical Pollutants Exposure conditions: Sleep studyType: INTERVENTIONAL phases: NA allocation: NA interventionModel: SINGLE_GROUP primaryPurpose: BASIC_SCIENCE masking: NONE count: 60 type: ESTIMATED name: 7-day actimetry sleep recording name: Determination of environmental pollutants in breast milk name: Measurements of environmental pollutants in indoor air deposited on the bracelet worn by the child name: Continuous recording of the child's temperature for 7 days name: Use of a sleep diary for 7 days name: Parental questionnaire of environmental exposure measure: total sleep time per day in infants using actimetry measure: Concentration of various substances in breast milk measure: concentration of chemical polluants on newborn bracelets measure: Child Temperature level (°C) sex: ALL maximumAge: 6 Months stdAges: CHILD facility: CHRU Amiens status: RECRUITING city: Amiens zip: 80054 country: France name: Karen CHARDON, Pr role: CONTACT phone: 03.22.82.78. 65 email: [email protected] name: Elodie HARAUX, HARAUX role: PRINCIPAL_INVESTIGATOR name: Pierre TOURNEUX, Pr role: SUB_INVESTIGATOR lat: 49.9 lon: 2.3 hasResults: False
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<|newrecord|> nctId: NCT06268431 id: 43084 briefTitle: Oxytocin Rest to Reduce Cesarean Delivery acronym: ORCA overallStatus: RECRUITING date: 2024-02-15 date: 2026-02-15 date: 2026-03-15 date: 2024-02-20 date: 2024-02-20 name: Christiana Care Health Services class: OTHER briefSummary: Prolonged labor is usually managed with continuous oxytocin infusion. "Oxytocin rest" has been proposed as a strategy to resolve protracted labor in patients who have received continuous oxytocin without progress. This strategy involves discontinuing oxytocin then restarting infusion after a period of time, under the theory that washout of the oxytocin receptor will strengthen uterine contractions to improve labor progress. "Oxytocin rest" is performed on labor and delivery units across the United States. Yet, there is no randomized or prospective data to support the practice.
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The purpose of this study is to assess whether oxytocin rest of 60 minutes in patients with prolonged labor reduces risk for cesarean delivery. conditions: Prolonged Labor conditions: Failed Induction conditions: Labor Dystocia studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: NONE count: 350 type: ESTIMATED name: Oxytocin rest measure: Cesarean rate measure: Time to delivery (hours) measure: Time to vaginal delivery (hours) measure: Time to active labor (hours) measure: Duration of active labor (hours) measure: Composite maternal adverse outcome measure: Composite neonatal adverse outcome measure: Labor Agentry Scale score measure: Rate of intraamniotic infection (IAI) measure: Rate of postpartum endometritis measure: Rate of postpartum hemorrhage sex: FEMALE minimumAge: 18 Years maximumAge: 55 Years stdAges: ADULT facility: ChristianaCare Health System status: RECRUITING city: Newark state: Delaware zip: 19718 country: United States name: Teresa C Logue role: CONTACT phone: 302-733-6563 email: [email protected] lat: 39.68372 lon: -75.74966 typeAbbrev: Prot_SAP hasProtocol: True hasSap: True hasIcf: False label: Study Protocol and Statistical Analysis Plan date: 2024-01-21 uploadDate: 2024-02-11T17:37 filename: Prot_SAP_000.pdf size: 239099 hasResults: False
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<|newrecord|> nctId: NCT06268418 id: 2024PI020 briefTitle: Pre-therapeutic 68Ga-PSMA PET AI Based Dose Prediction for 177Lu-PSMA Targeted Radionuclide Therapy acronym: PADL overallStatus: NOT_YET_RECRUITING date: 2024-03-31 date: 2024-06-30 date: 2024-08-30 date: 2024-02-20 date: 2024-02-21 name: Central Hospital, Nancy, France class: OTHER briefSummary: Targeted Radionuclide Therapy (TRT) is a contemporary approach to radiation oncology, aiming to deliver the maximal destructive radiation dose via cancer-targeting radiopharmaceutical. Radioactive ligands for the prostate-specific membrane antigen (PSMA) have emerged for the treatment of metastatic castration-resistant prostate cancer (mCRPC).Normal organ and tumor dose can be assessed by a series of cross-sectional whole-body SPECT scans, however, these require a large amount imaging time and are often not feasible in routine clinical practice.
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An alternative is to generate a 3D time integrated activity (TIA) map per patient based on the PBPK and the pre-therapy imaging conditions: Radionucleide Therapy studyType: OBSERVATIONAL observationalModel: OTHER timePerspective: RETROSPECTIVE count: 46 type: ESTIMATED name: Artificial intelligence measure: Evaluate the prediction of the absorbed dose by Deep Learning approaches for RLT with 177Lu-PSMA, from pre-treatment 68Ga-PSMA.PET/CT images measure: Automatically contour the total tumor metabolic volume on 68Ga-PSMA pretreatment PET images using Deep Learning approaches sex: MALE minimumAge: 18 Years maximumAge: 99 Years stdAges: ADULT stdAges: OLDER_ADULT hasResults: False
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<|newrecord|> nctId: NCT06268405 id: 22-5806 briefTitle: Positron Emission Mammography and Liquid Biopsy in Women With High-risk Breast Screenings overallStatus: RECRUITING date: 2023-09-21 date: 2024-09-21 date: 2024-09-21 date: 2024-02-20 date: 2024-02-20 name: University Health Network, Toronto class: OTHER briefSummary: The goal of this pilot research study is to compare two experimental tests, namely Liquid Biopsy and Positron Emission Mammography (PEM) in women at high risk of breast cancer. The plan for this study is to evaluate if findings from Liquid Biopsy can be matched to images obtained by PEM.
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Liquid Biopsy is a blood test that can detect early tumours in patients with malignancies, while PEM is an imaging tool equipped with a high-resolution camera that uses an injected positron emitting isotope to locate breast tumours. Participation in this study entails a blood draw for Liquid Biopsy test and a PEM imaging exam before undergoing a magnetic resonance imaging (MRI) - guided biopsy for a suspicious breast lesion.
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If correlations between paired samples are observed between imaging using PEM and the Liquid Biopsy data, further studies will be conducted to evaluate if these techniques can help refine screening investigations and ultimately reduce the unnecessary biopsies and anxiety in high-risk populations. conditions: Breast Cancer studyType: INTERVENTIONAL phases: NA allocation: NA interventionModel: SINGLE_GROUP primaryPurpose: SCREENING masking: NONE count: 30 type: ESTIMATED name: Liquid Biopsy name: Positron Emission Mammography (PEM) measure: Correlation of paired samples between Liquid Biopsy data and Positron Emission Mammography (PEM) images sex: FEMALE minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: University Health Network status: RECRUITING city: Toronto state: Ontario zip: M5G 2M9 country: Canada name: Samira Taeb, MSc role: CONTACT phone: 416-946-4501 phoneExt: 5853 email: [email protected] name: Vivianne Freitas role: CONTACT phone: 416-946-2000 phoneExt: 5608 email: [email protected] name: Vivianne Freitas, MD role: PRINCIPAL_INVESTIGATOR lat: 43.70011 lon: -79.4163 hasResults: False
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<|newrecord|> nctId: NCT06268392 id: CT-2023-11-20-001 briefTitle: A Comparative Study of AI Methods for Fetal Diagnostic Accuracy in Ultrasound overallStatus: NOT_YET_RECRUITING date: 2024-02-15 date: 2024-08-01 date: 2024-08-01 date: 2024-02-20 date: 2024-02-22 name: Copenhagen Academy for Medical Education and Simulation class: OTHER name: Slagelse Hospital name: Technical University of Denmark name: Rigshospitalet, Denmark briefSummary: This study serves as a supplemental investigation to the randomized controlled SCAN-AID study (NCT0632187). This study will evaluate and compare the fetal growth estimation outcomes of AI-supported groups, expert sonographers, and control groups using a secondary AI predictive model. conditions: Fetal Growth Retardation conditions: Fetal Macrosomia conditions: Fetal Growth studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: RETROSPECTIVE count: 150 type: ESTIMATED measure: Fetal weight measure: Ultrasound fetal weight estimation sex: FEMALE minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT hasResults: False
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<|newrecord|> nctId: NCT06268379 id: #08-01-03-23 briefTitle: BMA and Dynamic Nomogram for Survival Prediction in Patients With CRC overallStatus: COMPLETED date: 2010-02-15 date: 2021-12-15 date: 2021-12-15 date: 2024-02-20 date: 2024-02-20 name: Cabrini Health class: OTHER briefSummary: This project will examine the outstanding statistical techniques for predicting the survival of patients with colorectal cancer (CRC) (colorectal neoplasia database). The motivating clinical question that led to proposing this project is based on the general assumption that: "Right-sided colorectal cancer (CRC) has worse survival than left-sided CRC." The question is, which aspects of the patient's characteristics are responsible for this difference? This led us to BMA model selection and provide a clinician-friendly online nomogram. conditions: Colon Cancer conditions: Model Disease studyType: OBSERVATIONAL observationalModel: OTHER timePerspective: PROSPECTIVE count: 2475 type: ACTUAL name: Surgery measure: OS measure: RFS sex: ALL minimumAge: 22 Years maximumAge: 101 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Cabrini Health city: Melbourne state: Victoria zip: 3144 country: Australia lat: -37.814 lon: 144.96332 hasResults: False
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<|newrecord|> nctId: NCT06268366 id: UEvansville briefTitle: Effects of Exercise-Based Interventions on Symmio Self-Movement Screen overallStatus: NOT_YET_RECRUITING date: 2024-03-01 date: 2024-08-01 date: 2025-03-01 date: 2024-02-20 date: 2024-02-29 name: University of Evansville class: OTHER briefSummary: Musculoskeletal screening for physical risk factors requires equipment and a trained healthcare or fitness professional to perform and interpret the scoring so that appropriate exercise interventions can be prescribed. However, barriers such as healthcare costs and accessibility, low perceived need to seek medical care, and previous unfavorable evaluation of seeking medical care are associated with healthcare avoidant behaviors. This research aims to explore the effectiveness of the Symmio Self-Screen application to generate specific exercise interventions to address an individual's associated physical risk factors. The ability of the Symmio application to prescribe a targeted exercise program which can reduce asymmetries, improve movement quality, and enhance overall function is unknown. Therefore, the purpose of this study is to determine the effectiveness of the Symmio application in designing individualized exercise interventions which target the unique movement limitations and asymmetries in adults. conditions: Movement Disorders studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: SINGLE maskingDescription: The primary investigators and statisticians will be blinded to the group allocation whoMasked: OUTCOMES_ASSESSOR count: 180 type: ESTIMATED name: Exercise measure: Symmio Self-Movement Screen measure: Global Rating of Change sex: ALL minimumAge: 18 Years maximumAge: 65 Years stdAges: ADULT stdAges: OLDER_ADULT hasResults: False
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<|newrecord|> nctId: NCT06268353 id: 109324-1 briefTitle: Is the Plasma Concentration of CAPGDF15 Increased in Pregnancy? A Pilot Study acronym: CAP overallStatus: NOT_YET_RECRUITING date: 2024-03-15 date: 2026-03-15 date: 2026-03-15 date: 2024-02-20 date: 2024-02-26 name: University of Copenhagen class: OTHER name: Stanford University briefSummary: Background and Purpose During pregnancy, the hormone GDF15 rises between 100-200 times higher than before pregnancy. The significance of this dramatic increase is not clarified, but it has been shown that pregnant women with insufficient increase in GDF15 have a higher risk of spontaneous abortion. CAPGDF15 is a small peptide consisting of 12 amino acids recently found in plasma in both mice and humans, and this peptide is part of the prohormone from which GDF15 is synthesized. Therefore, the assumption is that CAPGDF15 is secreted simultaneously with GDF15. The significance of CAPGDF15 in the organism is completely unknown, except that injection into mice reduces food intake. Therefore, the investigators are interested in investigating whether there is a similar dramatic upregulation of CAPGDF15 as with GDF15 itself. The investigators will not set up a large-scale study without having some prior knowledge of whether this is indeed the case. Therefore, the investigators will conduct a pilot study on 3 pregnant women and 3 control women to examine whether there is any reason to proceed with an actual scientific experiment. Since the increase in GDF15 itself is very large at least100 fold, a pilot study involving only 3 pregnant women and 3 non-pregnant women will be sufficient to gain an impression of whether there is also a significant increase in CAPGDF15. The data will be used to assess whether an actual research project is worth establishing.
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Purpose:
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The purpose of conducting this pilot study is to investigate whether there is an upregulation of CAPGDF15 similar to that of the hormone GDF15 during pregnancy. By conducting a pilot study on 3 pregnant women and 3 control women, the investigators will see if this is actually the case before setting up an actual scientific experiment. conditions: Pregnancy Related studyType: INTERVENTIONAL phases: NA allocation: NA interventionModel: SEQUENTIAL interventionModelDescription: Non-pregnant controls and pregnant women primaryPurpose: BASIC_SCIENCE masking: NONE count: 6 type: ESTIMATED name: blood sampling measure: CAPGDF15 levels in plasma sex: FEMALE minimumAge: 18 Years maximumAge: 40 Years stdAges: ADULT hasResults: False
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<|newrecord|> nctId: NCT06268340 id: ABIntl-23-25 briefTitle: Hearing and Structure Preservation Via ECochG acronym: PRESERVE overallStatus: NOT_YET_RECRUITING date: 2024-02-29 date: 2026-06-30 date: 2026-06-30 date: 2024-02-20 date: 2024-02-20 name: Advanced Bionics AG class: INDUSTRY briefSummary: The goal of the study is to determine the benefit of using an ECochG-based corrective action guide during cochlear implant surgery compared to the traditional surgical approach without ECochG surveillance and guidance. conditions: Hearing Loss, Sensorineural conditions: Severe-to-profound Hearing Loss studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: SINGLE whoMasked: PARTICIPANT count: 102 type: ESTIMATED name: ECochG monitored CI surgery incl. corrective action guide name: Routine CI surgery without ECochG monitoring measure: Hearing Preservation measure: Structure Preservation measure: Speech perception measure: Surgeons' feedback sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Universitair Ziekenhuis Gent city: Gent zip: 9000 country: Belgium name: Lara Derycke, Ms role: CONTACT phone: +3293321246 email: [email protected] name: Ingeborg Dhooge, Dr role: PRINCIPAL_INVESTIGATOR name: Freya Swinnen, Dr role: PRINCIPAL_INVESTIGATOR lat: 51.05 lon: 3.71667 facility: Le Centre Hospitalier Régional Universitaire de Tours city: Tours zip: 37000 country: France name: Mme Nollet role: CONTACT email: [email protected] name: David Bakhos, Prof role: PRINCIPAL_INVESTIGATOR name: Mathieu Robier, Mr role: PRINCIPAL_INVESTIGATOR lat: 47.38333 lon: 0.68333 facility: Universitätsklinikum Freiburg Klinik city: Freiburg zip: 79106 country: Germany name: Claudia Greulich, Ms role: CONTACT email: [email protected] name: Antje Aschendorff, Prof role: PRINCIPAL_INVESTIGATOR name: Thomas Wesarg, Dr role: PRINCIPAL_INVESTIGATOR lat: 47.9959 lon: 7.85222 facility: Ospedale Martini city: Torino state: TO zip: 10141 country: Italy name: Diego Di Lisi, Dr role: PRINCIPAL_INVESTIGATOR name: Patrizia Consolino, Dr role: PRINCIPAL_INVESTIGATOR lat: 45.07049 lon: 7.68682 facility: World Hearing Center city: Warsaw state: Nadarzyn zip: 05-830 country: Poland name: Iwona Tomaszewska-Hert, Ms role: CONTACT email: [email protected] name: Piotr Skarżyński, Prof role: PRINCIPAL_INVESTIGATOR name: Adam Walkowiak, Dr role: PRINCIPAL_INVESTIGATOR lat: 52.22977 lon: 21.01178 facility: Cambridge University Hospitals NHS Foundation Trust city: Cambridge state: England zip: CB2 0QQ country: United Kingdom name: Sophie McKenny, Ms role: CONTACT phone: +441223586625 email: [email protected] name: Matthew E Smith, Dr role: PRINCIPAL_INVESTIGATOR name: Patrick Axon, Dr role: PRINCIPAL_INVESTIGATOR lat: 52.2 lon: 0.11667 hasResults: False
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<|newrecord|> nctId: NCT06268327 id: Adjuvant treatment in BC briefTitle: Adding Adjuvant Cisplatin and Gemicitabine Versus Capecitabine in Triple-negative Breast Cancer Patients in Non pCR After Neoadjuvant Standard Chemotherapy overallStatus: NOT_YET_RECRUITING date: 2024-04-30 date: 2025-10-30 date: 2026-10-30 date: 2024-02-20 date: 2024-02-20 name: Assiut University class: OTHER briefSummary: In our study; investigator aim To show efficacy and toxicity of Adjuvant cisplatin and gemcitabine in triple-negative breast cancer patients with non pathologically complete response after neoadjuvant chemotherapy To compare outcome of adjuvant cisplatin and gemcitabine versus capecitabine conditions: Breast Cancer studyType: INTERVENTIONAL phases: PHASE2 phases: PHASE3 allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: NONE count: 30 type: ESTIMATED name: Cisplatin injection and gemcitabine name: Capecitabine tablets measure: Adding adjuvant cisplatin and gemcitabine versus capecitabine in triple-negative Breast cancer patients with non pathologically complete response after neoadjuvant standard chemotherapy measure: Comparison of patients who receive cisplatin and gemcitabine versus capecitabine in Triple negative breast cancer sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT hasResults: False
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<|newrecord|> nctId: NCT06268314 id: hypoalbuminemia in pediatrics. briefTitle: Feeding Pattern and Hypoalbuminemia in Pediatrics With Chronic Kidney Disease. overallStatus: NOT_YET_RECRUITING date: 2024-03-01 date: 2026-03-01 date: 2026-06-01 date: 2024-02-20 date: 2024-03-05 name: Assiut University class: OTHER briefSummary: To determine the impact of feeding pattern on the development of hypoalbuminemia and out come of pediatric patients with chronic kidney disease. conditions: Chronic Kidney Diseases studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: PROSPECTIVE count: 70 type: ESTIMATED measure: Feeding Pattern and Hypoalbuminemia in Pediatrics With Chronic Kidney Disease. sex: ALL minimumAge: 2 Years maximumAge: 16 Years stdAges: CHILD hasResults: False
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<|newrecord|> nctId: NCT06268301 id: TAK-721-1003 briefTitle: A Study to Determine the Effect Food Has on TAK-721 (Budesonide Oral Suspension) in the Body of Healthy Adults overallStatus: COMPLETED date: 2023-02-06 date: 2023-02-17 date: 2023-02-20 date: 2024-02-20 date: 2024-02-20 name: Takeda class: INDUSTRY briefSummary: The main aim of this study is to check what the body of a healthy adult who either fasted or had eaten does to TAK-721 and how TAK-721 is distributed in and removed from the body. Other aims are to learn how safe the treatment with TAK-721 is and how suitable the TAK-721 is for healthy adults who either fasted or had eaten. All participants will receive TAK-721 but half will be assigned by chance to the participant group who are fasting first then getting the high-fat/high-calorie meal later or the group who gets meal first and fasts later. The group assignment will be switched once during the course of the study so that all participants will receive TAK-721 in both a fasted or fed condition. conditions: Healthy Volunteers studyType: INTERVENTIONAL phases: PHASE1 allocation: RANDOMIZED interventionModel: CROSSOVER primaryPurpose: TREATMENT masking: NONE count: 20 type: ACTUAL name: Budesonide measure: Maximum Observed Concentration (Cmax) measure: Area Under the Concentration-time Curve From Time 0 to the Time of the Last Quantifiable Concentration (AUClast) measure: Area Under the Concentration-time Curve From Time 0 to Infinity (AUC∞) measure: Number of Participants who Experience at Least one Treatment Emergent Adverse Event (TEAE) by Severity, Serious Adverse Events (SAE) and Death measure: Number of Participants With Clinically Significant Abnormal Vital Sign Values measure: Number of Participants With Clinically Significant Abnormal Clinical Laboratory Values measure: Area Under the Concentration-time Curve From Time 0 to 12 Hours (AUC0-12) measure: Area Under the Curve From the Last Quantifiable Concentration to Infinity Expressed as a Percentage of AUC∞ (AUCextrap%) measure: Time to First Occurrence of Cmax (tmax) measure: Lag Time to First Quantifiable Concentration (tlag) measure: Terminal Disposition Phase Half-life (t1/2z) measure: Terminal Disposition Phase Rate Constant (λz). measure: Apparent Clearance (CL/F) Calculated Using the Observed Value of the Last Quantifiable Concentration measure: Apparent Volume of Distribution During the Terminal Disposition Phase (Vz/F) Calculated Using the Observed Value of the Last Quantifiable Concentration sex: ALL minimumAge: 19 Years maximumAge: 55 Years stdAges: ADULT facility: Celerion city: Lincoln state: Nebraska zip: 68502 country: United States lat: 40.8 lon: -96.66696 hasResults: False
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<|newrecord|> nctId: NCT06268288 id: 22-011492 briefTitle: Non-invasive Vagal Neurostimulation (nVNS) in Adolescents With Postural Orthostatic Tachycardia Syndrome (POTS) overallStatus: NOT_YET_RECRUITING date: 2024-02-12 date: 2024-07-22 date: 2024-12-22 date: 2024-02-20 date: 2024-02-20 name: Mayo Clinic class: OTHER briefSummary: The purpose of this study is to determine if nVNS will decrease autonomic symptom intensity (COMPASS-31 and Child Functional Disability Inventory) in adolescent patients with postural orthostatic tachycardia syndrome (POTS) in comparison to standard recovery STEPS management. conditions: Postural Tachycardia Syndrome conditions: Autonomic Dysfunction conditions: Postural Orthostatic Tachycardia Syndrome conditions: POTS - Postural Orthostatic Tachycardia Syndrome studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL interventionModelDescription: Half of the patient population will be randomized to standard management only. The other half of the population will be randomized to standard management plus use of the vagal nerve stimulator primaryPurpose: TREATMENT masking: SINGLE whoMasked: OUTCOMES_ASSESSOR count: 40 type: ESTIMATED name: GammaCore intervention name: STEPS management protocol measure: The change in COMPASS-31 scores between individuals in both arms of the study measure: The change in Child Functional Disability Inventory scores between individuals in both arms of the study measure: The change in heart rate increase in head up tilt table tests in individuals in both arms of the study measure: Does nVNS influence headache frequency in adolescent patients with POTS measure: Does nVNS influence ability to increase exercise duration in adolescent patients with POTS measure: Does use of nVNS influence degree of depression in adolescent patients with POTS sex: ALL minimumAge: 12 Years maximumAge: 19 Years stdAges: CHILD stdAges: ADULT facility: Mayo Clinic in Rochester city: Rochester state: Minnesota zip: 55905 country: United States lat: 44.02163 lon: -92.4699 hasResults: False
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<|newrecord|> nctId: NCT06268275 id: HE651314 briefTitle: Comparison of Effects of Scalp Block and Intravenous Esmolol on Hemodynamic Response Following the Skull Pins Application for Elective Supratentorial Craniotomy overallStatus: COMPLETED date: 2022-09-19 date: 2024-02-01 date: 2024-02-13 date: 2024-02-20 date: 2024-02-20 name: Khon Kaen University class: OTHER briefSummary: The goal of this clinical trial is to compare hemodynamic response (MAP, SBP, DBP and HR) between scalp block and intravenous esmolol while skull pins application in patients undergoing elective supratentorial craniotomy under general anesthesia. conditions: Hemodynamic Instability studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL interventionModelDescription: RCT primaryPurpose: PREVENTION masking: TRIPLE whoMasked: PARTICIPANT whoMasked: CARE_PROVIDER whoMasked: OUTCOMES_ASSESSOR count: 90 type: ACTUAL name: Scalp block name: Esmolol measure: MAP measure: SBP measure: DBP measure: HR measure: BIS measure: Cumulative postoperative opioids consumption measure: Postoperative adverse events sex: ALL minimumAge: 18 Years maximumAge: 65 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Khon Kaen University city: Khon Kaen state: Naimuang, Muang zip: 40002 country: Thailand lat: 16.44671 lon: 102.833 hasResults: False
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<|newrecord|> nctId: NCT06268262 id: XYFY2023-KL045-01 briefTitle: Surgical-imaging Research on Obesity (SIRO) overallStatus: RECRUITING date: 2023-03-01 date: 2026-12 date: 2028-12 date: 2024-02-20 date: 2024-03-15 name: The Affiliated Hospital of Xuzhou Medical University class: OTHER briefSummary: The global obesity epidemic is well established, and is an important public health issue. The previous researches had applied the clues that obesity is a kind of systemic disease. The investigators hypothesized that a serious alteration of the body systems will occur after bariatric surgery, which may shed light on the mechanisms of obesity. Thus, the research aims to combine the imaging and surgery to investigate the alterations of the body that induced by obese and alterations after surgery. conditions: Overweight and Obesity studyType: OBSERVATIONAL observationalModel: CASE_CONTROL timePerspective: PROSPECTIVE count: 200 type: ESTIMATED measure: Imaging parameters of obesity measure: Imaging parameters of obesity measure: Imaging parameters of obesity measure: Neurotransmitter, inflammatory factors and hormones related to obesity in blood sample measure: Neurotransmitter, inflammatory factors and hormones relating to obesity in blood sample measure: Neurotransmitter, inflammatory factors and hormones related to obesity in blood sample measure: Genetic information from venous blood sample, biopsied liver tissue, biopsied fat tissue, and gastric tissue sex: ALL minimumAge: 18 Years maximumAge: 65 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Affiliated Hospital of Xuzhou Medical University status: RECRUITING city: Xuzhou state: Jiangsu zip: 221000 country: China name: Kai Liu, M.D/Ph.D role: CONTACT phone: +86-15920157720 email: [email protected] lat: 34.18045 lon: 117.15707 hasResults: False
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<|newrecord|> nctId: NCT06268249 id: TJ-IRB20231224 briefTitle: Ulinastatin Improves Post-Cardiac Surgery Cognitive Dysfunction overallStatus: COMPLETED date: 2015-01-01 date: 2022-12-30 date: 2023-12-30 date: 2024-02-20 date: 2024-02-20 name: Qin Zhang class: OTHER briefSummary: This study is a retrospective, observational study that aims to include patients undergoing cardiac surgery. 1. Evaluate the preventive effect of ursodeoxycholic acid on post-cardiac surgery cognitive dysfunction over the past eight years. 2. Utilize the pre-existing preoperative and postoperative 24-hour plasma samples from previous studies to measure the levels of glycocalyx and its related regulatory factors. 3. Assess the clinical correlation between the measured parameters and patient outcomes. conditions: Cardiac Complication studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: RETROSPECTIVE count: 7065 type: ACTUAL name: Ulinastatin measure: POCD - Postoperative Cognitive Dysfunction measure: Survival time sex: ALL minimumAge: 18 Years maximumAge: 80 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Tongji Hospital, Tongji Medical College, Huazhong University of Science and Technology city: Wuhan state: Hubei zip: 430030 country: China lat: 30.58333 lon: 114.26667 hasResults: False
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<|newrecord|> nctId: NCT06268236 id: BF2023-252 briefTitle: Electro-acupuncture to Treat Disorder of Consciousness overallStatus: RECRUITING date: 2024-01-01 date: 2026-01-31 date: 2026-01-31 date: 2024-02-20 date: 2024-02-20 name: The Second Affiliated Hospital, Guangzhou University of Traditional Chinese Medicine class: OTHER briefSummary: With the rapid development of life support technology, more and more people can survive severe brain injury. Some survivors regain consciousness after a period of coma, however, many patients develop prolonged disorders of consciousness (DOC), which poses a therapeutic challenge for clinicians and a heavy burden for their families. The investigators design an Electro-acupuncture to treat disorder of consciousness (AcuDoc) trial with the aim of validating the clinical effect of electroacupuncture in treating DOC and exploring its therapeutic mechanisms by integrating EEG, neuroimaging, evoked potential tests, and behavioral assessments. conditions: Disorder of Consciousness conditions: Electroacupuncture studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: TRIPLE whoMasked: PARTICIPANT whoMasked: CARE_PROVIDER whoMasked: OUTCOMES_ASSESSOR count: 50 type: ESTIMATED name: Electroacupuncture name: Sham electroacupuncture measure: Coma Recovery Scale - Revised score measure: phase locking value measure: amplitude of low-frequency fluctuation measure: Amide proton transfer-weighted signal measure: f value measure: neurite density index measure: latency value of N20 measure: latency between III and V potentials measure: Glasgow Outcome Scale-Extended score measure: Glasgow Outcome Scale-Extended score measure: brain-computer interface accuracy sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: The Second Affiliated Hospital of Guangzhou University of Chinese Medicine status: RECRUITING city: Guangzhou state: Guangdong zip: 510120 country: China name: Fang Yuan, PhD role: CONTACT phone: +86-20-81887233 email: [email protected] lat: 23.11667 lon: 113.25 hasResults: False
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<|newrecord|> nctId: NCT06268223 id: 2023/315 briefTitle: Home-Based Action Observation Training for Chewing and Swallowing Function overallStatus: RECRUITING date: 2023-10-13 date: 2024-05-01 date: 2024-07-01 date: 2024-02-20 date: 2024-02-20 name: Ondokuz Mayıs University class: OTHER name: Hacettepe University briefSummary: The goal of this clinical trial is to investigate the effects of home-based Action Observation Training (AOT) applied together with Functional Chewing Training (FuCT) on chewing and swallowing functions and feeding behavior in children with Cerebral Palsy (CP) who have chewing disorders. The main questions it aims to answer are:
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* Is the application of Home-Based AOT together with FuCT effective on chewing function in children with CP?
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* Is the application of Home-Based AOT together with FuCT effective on swallowing function in children with CP?
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* Is the application of Home-Based AOT together with FuCT effective on feeding behavior in children with CP? Within the scope of the study, children with CP will be divided into two groups as the study group and the control group. All groups will implement FuCT routines, comprising 5 sets per day, 5 days a week, for 12 weeks. Additionally, the study group will be included in an AOT program, conducted via telerehabilitation, for 1 set per day, 3 days a week, for 12 weeks, with the guidance of a physiotherapist. All children with CP will be evaluated at the beginning, after 6 weeks, and at the end of the study. conditions: Cerebral Palsy conditions: Chewing Disease conditions: Action Obervation Training studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: DOUBLE whoMasked: PARTICIPANT whoMasked: OUTCOMES_ASSESSOR count: 20 type: ESTIMATED name: Chewing Exercise Training measure: Karaduman Chewing Performance Scale measure: Turkish version of the Mastication Observation and Evaluation Instrument measure: Test of Masticating and Swallowing Solids in Children measure: Nutrient consistency according toInternational Dysphagia Diet Standardisation Initiative measure: The Pediatric version of the Eating Assessment Tool measure: Dysphagia Disorder Survey measure: Behavioral Pediatrics Feeding Assessment Scale sex: ALL minimumAge: 6 Years maximumAge: 18 Years stdAges: CHILD stdAges: ADULT facility: Seda Nur Kemer,PT, MSc,PhD Candidate, Lecturer status: RECRUITING city: Samsun state: Atakum zip: 55200 country: Turkey name: Seda Nur Kemer, 1 role: CONTACT phone: +9005467861866 email: [email protected] lat: 41.27976 lon: 36.3361 hasResults: False
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<|newrecord|> nctId: NCT06268210 id: 4-2023-1546 briefTitle: Neoadjuvant Lazertinib With or Without Chemotherapy for Patients With EGFR-mutated Resectable Non-small Cell Lung Cancer acronym: NeoLazer overallStatus: NOT_YET_RECRUITING date: 2024-03 date: 2026-06 date: 2028-06 date: 2024-02-20 date: 2024-02-20 name: Yonsei University class: OTHER briefSummary: In the randomized, multicenter Phase II clinical trial, we aim to evaluate the efficacy and safety of Lazertinib monotherapy or the combination of Lazertinib and cytotoxic chemotherapy as neoadjuvant therapy in patients with resectable, treatment-naive EGFR-mutant (exon 19 deletion or exon 21 L858R) non-small cell lung cancer, ranging from clinical stage IB to IIIB. The study is designed to assess the impact on pathological response, as well as effectiveness and safety considerations. conditions: Non-small Cell Lung Cancer studyType: INTERVENTIONAL phases: PHASE2 allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: NONE count: 160 type: ESTIMATED name: Lazertinib+Pemetrexed+Carboplatin name: Lazertinib measure: Primary pathological response measure: Surgical Resection Methods (Segmentectomy or Lobectomy) measure: Pathologic Complete Response measure: Objective Response Rate measure: Event-Free Survival measure: Disease-Free Survival measure: Overall Survival measure: Number of patients with Adverse events according to CTCAE v5.0 sex: ALL minimumAge: 20 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Severance hospital city: Seoul country: Korea, Republic of name: Hye Ryun Kim role: CONTACT phone: 82-2-2228-8125 email: [email protected] lat: 37.566 lon: 126.9784 hasResults: False
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<|newrecord|> nctId: NCT06268197 id: IRB23-0329 briefTitle: Interoception-Based Yoga for Chronic Pain overallStatus: RECRUITING date: 2024-02-16 date: 2024-12-30 date: 2024-12-30 date: 2024-02-20 date: 2024-02-20 name: University of Illinois at Urbana-Champaign class: OTHER briefSummary: The purpose of this research is to examine the feasibility and acceptability of an interoception-based yoga program for chronic pain. Interoception involves your ability to feel sensations in your body (such as your heartbeat or muscle tension) as well as how you think about and interpret those sensations. Interoception may be an important component of chronic pain and the research team is studying whether yoga can change how you feel, think about, and interpret sensations in your body. conditions: Chronic Pain studyType: INTERVENTIONAL phases: NA allocation: NA interventionModel: SINGLE_GROUP primaryPurpose: TREATMENT masking: NONE count: 32 type: ESTIMATED name: Yoga Intervention measure: Feasibility measure: Acceptability measure: Interoceptive Sensibility measure: PROMIS Pain Interference measure: Interoceptive Accuracy measure: Mindfulness measure: PROMIS Pain Intensity measure: Quality of Life measure: Spiritual Wellbeing measure: Pain Impact sex: ALL minimumAge: 18 Years maximumAge: 64 Years stdAges: ADULT facility: University of Illinois Urbana-Champaign status: RECRUITING city: Urbana state: Illinois zip: 61801 country: United States name: Project Coordinator role: CONTACT phone: 217-265-0741 email: [email protected] name: Neha P Gothe, PhD role: PRINCIPAL_INVESTIGATOR name: Steven Petruzzello, PhD role: SUB_INVESTIGATOR lat: 40.11059 lon: -88.20727 hasResults: False
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<|newrecord|> nctId: NCT06268184 id: omega3 in oxidative stress briefTitle: Effect of Omega 3 on Oxidative Stress and Nutritional Status of Children on Regular Dialysis overallStatus: RECRUITING date: 2021-10-04 date: 2024-03-01 date: 2024-04-01 date: 2024-02-20 date: 2024-02-20 name: Tanta University class: OTHER briefSummary: evaluaion the effects of oral omega-3 supplementation on nutritional status and oxidative stress in pediatric patients with end stage renal disease on regular hemodialysis conditions: Oxidative Stress studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL interventionModelDescription: group 1: 30 children with ESRD receive omega 3 supplementation group 2:15 children with ESRD receive lpacebo primaryPurpose: SUPPORTIVE_CARE masking: SINGLE whoMasked: PARTICIPANT count: 45 type: ESTIMATED name: D3 LAB SYRUP name: placebo capsule measure: decrease oxidative stress measure: increase antioxidant activity measure: improvement of nutritional status assessed by anthropometric measurements. measure: mid upper arm circumference in centimeters measure: triceps skin fold thickness in millimeter's measure: improvement of nutritional status assessed by Bioelectrical Inbody Analysis(BIA) measure: improvement of nutritional status assessed by Bioelectrical Inbody Analysis(BIA) measure: improvement of nutritional status assessed by Bioelectrical Inbody Analysis(BIA) measure: improvement of nutritional status assessed by Bioelectrical Inbody Analysis(BIA) measure: improvement of nutritional status assessed by Bioelectrical Inbody Analysis(BIA) measure: improvement of nutritional status assessed by laboratory investigations. measure: s. ionized calcium level measure: s.phosphorus level measure: alkaline phosphatase level measure: parathormone hormone level measure: 25(oh)vitamin D level sex: ALL minimumAge: 6 Years maximumAge: 18 Years stdAges: CHILD stdAges: ADULT facility: Faculty of Medicine status: RECRUITING city: Tanta state: Gharbia country: Egypt name: Noha sayed ahmed, M.Sc role: CONTACT phone: 01016919217 phoneExt: 01097722167 email: [email protected] name: rasha gamal elshafaay, MD role: CONTACT phone: 01227405988 phoneExt: 01114277784 email: [email protected] lat: 30.78847 lon: 31.00192 hasResults: False
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<|newrecord|> nctId: NCT06268171 id: 2023_0214 id: 2023-A02390-45 type: OTHER domain: ANSM briefTitle: Ultrasound Assessment of Rectus Femoris Cross-sectionnal Area Following Lung Transplantation acronym: EchoSS-TP overallStatus: NOT_YET_RECRUITING date: 2024-03-04 date: 2025-09-04 date: 2025-11-05 date: 2024-02-20 date: 2024-02-20 name: Hopital Foch class: OTHER briefSummary: In France, the profile of patients receiving lung transplants has changed in recent years, mainly due to the advent of treatment for cystic fibrosis. This progress has led to an evolution in the patient profile, with an increase in cases of pulmonary fibrosis or COPD, and an increase in the average age of patients. In these older patients, sarcopenia, a condition characterized by loss of muscle mass, is a major concern, as it exacerbates morbidity and mortality.
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After transplantation, patients are at risk of developing neuromyopathy due to their hospitalization in intensive care. There is currently no effective preventive treatment for this condition, underlining the need for early rehabilitation strategies. The combination of sarcopenia and neuromyopathy diminishes their functional capabilities on discharge from the ICU.
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Muscle ultrasound, a simple, non-invasive technique, is already used to assess muscle function in intensive care patients. This study aims to evaluate the use of ultrasound to measure muscle loss in lung transplant patients, in particular by examining the rectus femoris muscle. Objectives include observing variations in the surface area of the rectus femoris muscle before and after transplantation, identifying factors influencing this variation, and exploring its relationship with post-transplant morbidity.
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In summary, this study seeks to better understand muscle loss in lung transplant patients using ultrasound, in order to identify risk factors and guide the development of post-transplant rehabilitation strategies. conditions: Lung Transplant conditions: Physiotherapy conditions: Sarcopenia studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: PROSPECTIVE count: 42 type: ESTIMATED name: ultrasound measurement of the cross-sectional area of the rectus femoris measure: Evaluation of the change at D7 in the cross-sectional area of the rectus femoris following lung transplantation measure: Measure change in CSA-RF at D7 according to LT pattern measure: Evaluate the relationship between length of stay in intensive care unit and variation in CSA-RF at D7 measure: Determine the relationship between CSA-RF at D-1 and Body Mass Index sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT hasResults: False
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<|newrecord|> nctId: NCT06268158 id: 2023/45 briefTitle: The Effect of Eye Mask and Music on Sleep Quality and Delirium in Patients Monitored in Intensive Care Unit overallStatus: RECRUITING date: 2023-04-01 date: 2024-04-01 date: 2024-06-01 date: 2024-02-20 date: 2024-02-20 name: TC Erciyes University class: OTHER briefSummary: After abdominal surgery, most patients experience problems such as respiratory complications, surgical wound infection, cardiac problems, renal failure, delirium, and insomnia, along with surgical trauma and underlying comorbidities. Postoperative delirium (POD) is an adverse postoperative complication that can occur in patients of all ages, from children to the elderly. Effective non-pharmacological treatment approaches for delirium include using an orientation board, calendar, clock, ensuring hydration, improving sleep quality, therapeutic activities, providing companionship of family members, and building private rooms. This study will be conducted as a randomized controlled and experimental study to determine the effect of eye patch and music on sleep quality and delirium in patients followed after abdominal surgery in the surgical intensive care unit.
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It was planned to include a total of 34 patients who underwent abdominal surgery, 17 in the experimental group and 17 in the control group.
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During the data collection phase, the Patient Information Form, Richard-Campbell Sleep Scale, Nursing Delirium Screening Scale and Richmond Agitation-Sedation Scale, will be used. conditions: Abdominal Surgery studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: PREVENTION masking: NONE count: 34 type: ESTIMATED name: Eye patch measure: Richard-Campbell Sleep Scale measure: Nursing Delirium Screening Scale measure: Richmond Agitation-Sedation Scale sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Erciyes University status: RECRUITING city: Kayseri state: Talas zip: 38080 country: Turkey name: Yeliz Sürme, PhD role: CONTACT phone: +0905532051130 email: [email protected] name: Tuğçe TOPAL role: CONTACT phone: +9005075698312 email: [email protected] name: Tuğçe TOPAL, Msn role: PRINCIPAL_INVESTIGATOR name: Yeliz SÜRME, PhD role: PRINCIPAL_INVESTIGATOR lat: 38.73222 lon: 35.48528 hasResults: False
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<|newrecord|> nctId: NCT06268145 id: EC0006 briefTitle: ECC5004 RBA FE Study in Healthy Participants overallStatus: RECRUITING date: 2024-02-06 date: 2024-03-30 date: 2024-03-30 date: 2024-02-20 date: 2024-02-20 name: Eccogene class: INDUSTRY briefSummary: This study is a Phase 1, open-label, randomized, single dose, fixed sequence, crossover study designed to compare the relative bioavailability of 50 mg ECC5004 current tablet formulation (F1) and 50 mg ECC5004 new tablet formulation (F2) under fasted and fed conditions in healthy participants conditions: Type 2 Diabetes Mellitus studyType: INTERVENTIONAL phases: PHASE1 allocation: RANDOMIZED interventionModel: CROSSOVER primaryPurpose: TREATMENT masking: NONE count: 14 type: ESTIMATED name: ECC5004 measure: ECC5004 PK parameters: AUC0-tlast measure: ECC5004 PK parameters: AUC0-inf measure: ECC5004 PK parameters: Cmax measure: ECC5004 PK parameters: tmax measure: Number of participants with adverse events, with abnormal laboratory test results, abnormal ECGs, abnormal vital signs, and abnormal physical examinations measure: ECC5004 PK parameters: AUC0-tau measure: ECC5004 PK parameters: AUC 0-24 measure: ECC5004 PK parameters: tlag measure: ECC5004 PK parameters: t1/2 measure: ECC5004 PK parameters: CL/F measure: ECC5004 PK parameters: AUC(extr) sex: ALL minimumAge: 18 Years maximumAge: 65 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Eccogene Investigational Site status: RECRUITING city: Anaheim state: California zip: 92801 country: United States name: Eccogene role: CONTACT lat: 33.83529 lon: -117.9145 hasResults: False
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<|newrecord|> nctId: NCT06268132 id: MLS90 briefTitle: Longevity in Russia overallStatus: RECRUITING date: 2019-12-25 date: 2024-12-31 date: 2025-12-31 date: 2024-02-20 date: 2024-02-22 name: Center for Strategic Planning, of the Federal Medical and Biological Agency class: OTHER name: Pirogov Russian National Research Medical University briefSummary: This is an observational cohort study of long-living adults (participants aged 90 and above) from the Central Federal District of Russia.
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The study seeks to determine the genetic and cellular and molecular determinants of healthy longevity and to assess the impact of lifestyle and socioeconomic and environmental factors on healthy longevity.
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The study is expected to result in the development of a panel of markers of healthy longevity and/or a model of healthy aging based on the analysis of all factors under consideration. conditions: LONGEVITY 1 conditions: Frailty conditions: Aging conditions: Age-related Cognitive Decline conditions: Aging Disorder studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: PROSPECTIVE count: 4000 type: ESTIMATED measure: Mortality among long-living adults measure: Morbidity among long-living adults measure: Aging phenotypes measure: Social, economic, and medical- history-related determinants measure: Genetic determinants measure: Epigenetic determinants measure: Metagenomic determinants sex: ALL minimumAge: 90 Years stdAges: OLDER_ADULT facility: RUSSIAN CLINICAL AND RESEARCH CENTER OF GERONTOLOGY, Pirogov Russian National Research Medical University of the Ministry of Healthcare of the Russian Federation status: RECRUITING city: Moscow zip: 129226 country: Russian Federation name: Irina D. Strazhesko, M.D., Ph.D role: CONTACT phone: +7 (499) 187-64-67 email: [email protected] lat: 55.75222 lon: 37.61556 hasResults: False
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<|newrecord|> nctId: NCT06268119 id: MustafaKU-SBF-GKS-01 briefTitle: Effectiveness of Delirium Care Protocol After Cardiac Surgery overallStatus: COMPLETED date: 2023-03-06 date: 2023-05-15 date: 2023-05-22 date: 2024-02-20 date: 2024-02-20 name: Gonul Kara Soylemez class: OTHER briefSummary: This study was conducted as a quasi-experimental study to determine the effectiveness of the postoperative delirium prevention, diagnosis and intervention protocol in patients monitored in the intensive care unit after cardiac surgery. conditions: Delirium, Postoperative studyType: INTERVENTIONAL phases: NA allocation: NON_RANDOMIZED interventionModel: PARALLEL interventionModelDescription: The control group received standard care. The intervention group received care in line with postoperative delirium prevention, diagnosis, and intervention. primaryPurpose: PREVENTION masking: NONE count: 64 type: ACTUAL name: training nurses and caring for patients to prevent, diagnose, and intervene in postoperative delirium. measure: Confusion Assessment Scale in the Intensive Care Unit (CAM-ICU) measure: Glasgow Coma Scale (GCS) measure: Richmond Agitation-Sedation Scale (RASS) measure: Information Assessment Form for Postoperative Delirium (Pretest-Posttest) sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Antalya Training and Research Hospital city: Antalya state: Center zip: 07000 country: Turkey lat: 36.90812 lon: 30.69556 hasResults: False
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<|newrecord|> nctId: NCT06268106 id: IRB N/A briefTitle: Graphic Novel for Patients Undergoing EUS-FNB overallStatus: NOT_YET_RECRUITING date: 2024-03-01 date: 2024-07-30 date: 2024-08-01 date: 2024-02-20 date: 2024-02-20 name: The Mediterranean Institute for Transplantation and Advanced Specialized Therapies class: OTHER briefSummary: Endoscopy with endoscopic ultrasound (EUS) is a primary technique for diagnosing and treating severe pancreatic disorders. However, the procedure can cause fear and anxiety in patients, especially when a biopsy is involved. Graphic medicine, a form of visual storytelling that explores narratives of healthcare, is being used to alleviate this anxiety.
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This is a prospective single-center interventional pilot study with the aim to evaluate the impact of a novel graphic on the stress and behaviors of patients with pancreatic lesions undergoing EUS-FNB. The study will run for six months with the aim to enroll patients to llok for differences in the anxiety and stress levels.
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Enrolled patients will be randomly allocated to the test or control group, with the test group receiving a graphic novel to read while waiting for the procedure. Post-procedure, patients will complete the Beck Anxiety Inventory (BAI) and a modified version of the Depression Anxiety Stress Scales-21 (mDASS-21), now named mASS-14 (modified Anxiety Stress Scales-14), to assess anxiety and stress levels.
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This study is conducted according to the principles of the Declaration of Helsinki regarding experimentation involving human subjects, and written informed consent will be obtained from all participants before enrollment. conditions: Anxiety conditions: Pancreatic Cancer conditions: Pancreatic Cystic Lesions conditions: Stress studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL interventionModelDescription: Graphic novel will be visualized by interventional group before EUS-FNB primaryPurpose: HEALTH_SERVICES_RESEARCH masking: SINGLE whoMasked: CARE_PROVIDER count: 50 type: ESTIMATED name: Graphic novel visualization measure: Anxiety and stress level according to BAI measure: Anxiety and stress level according to mASS-14 sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Irccs - Ismett city: Palermo state: PA zip: 90127 country: Italy name: Giacomo Emanuele Maria Rizzo, MD role: CONTACT phoneExt: +393406602502 email: [email protected] name: Ilaria Tarantino, MD role: PRINCIPAL_INVESTIGATOR name: Giacomo Emanuele Maria Rizzo, MD role: PRINCIPAL_INVESTIGATOR name: Mario Traina, MD role: PRINCIPAL_INVESTIGATOR lat: 38.13205 lon: 13.33561 hasResults: False
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<|newrecord|> nctId: NCT06268093 id: XWTETS briefTitle: The Therapeutic Effect of Thalidomide in Syringomyelia overallStatus: RECRUITING date: 2024-02 date: 2027-02 date: 2028-02 date: 2024-02-20 date: 2024-02-20 name: Xuanwu Hospital, Beijing class: OTHER briefSummary: Purpose: This phase II clinical trial aims to evaluate the indications, therapeutic effects and side effects of thalidomide in refractory syringomyelia.
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Primary outcome measure: The primary endpoint is the change of ASIA at week 12. The clinical efficacy is defined as ASIA increase ≥ 1 at week 12, as compared with that before thalidomide usage. conditions: Syringomyelia conditions: Thalidomide studyType: INTERVENTIONAL phases: PHASE2 allocation: NA interventionModel: SINGLE_GROUP primaryPurpose: TREATMENT masking: NONE count: 30 type: ESTIMATED name: Thalidomide measure: ASIA Score measure: syringomyelia remission measure: The evoked electromyographic signal (eEMG) potential measure: Visual Analog Scale (VAS) measure: Klekamp and Sammi syringomyelia scale measure: modified Japanese Orthopaedic Association Scores (mJOA) measure: xuanwu syringomyelia scale measure: Incidence of complications sex: ALL minimumAge: 18 Years maximumAge: 80 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Fengzeng Jian status: RECRUITING city: Beijing state: Beijing City zip: 100032 country: China name: fengzeng jian, md role: CONTACT email: [email protected] lat: 39.9075 lon: 116.39723 hasResults: False
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<|newrecord|> nctId: NCT06268080 id: A+9317 briefTitle: Depth of Anesthesia on Postoperative Delirium and Cognitive After Surgery acronym: Balanced-2 overallStatus: NOT_YET_RECRUITING date: 2024-03-31 date: 2027-12-31 date: 2028-12-31 date: 2024-02-20 date: 2024-02-20 name: Auckland City Hospital class: OTHER_GOV briefSummary: The goal of this clinical trial (Balanced-2 study) is to compare light to deep general anesthesia using widely available brain monitors, to see if 'light' anesthesia could reduce rates of delirium, cognitive decline, and disability in older adults undergoing major surgery.
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Delirium is the most common serious surgical complication, occurring in an estimated one in four older adults undergoing major surgery. Delirium causes significant distress to patients and family, and is associated with prolonged hospital stay, physical disability, progression to dementia-like illnesses, and discharge to long-term care. Between 10 - 30% of adults aged 70 years and above have surgery every year, and preserving brain health and wellbeing is an important priority during this time.
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Older adults (aged ≥65 years, or Indigenous, Pasific patients aged ≥55 years) undergoing major surgery with general anesthesia (excluding heart and brain surgery) and able to provide consent will be able to participate. Participants will be randomized to two groups - a lighter general anesthesia group and a deeper general anesthesia group using processed electroencephalography (a brain monitor that provides information on depth of anesthesia using brain waves). The anesthesiologist will titrate anesthetic drugs according to the brain monitor. Participants will be followed up to determine if they experience delirium after surgery, and longer term impact of delirium such as cognitive and physical decline will also be measured.
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If found to be effect, this simple, cheap, and widely available treatment could reduce disability, preserve brain health and wellbeing of many older adults undergoing surgery worldwide, and save millions in healthcare dollars. conditions: Delirium, Postoperative conditions: Anesthesia conditions: Surgery-Complications conditions: Cognition Disorder conditions: Delirium conditions: Cognitive Decline studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL interventionModelDescription: Multicentre, prospective, randomized, active control, parallel group, intention to treat, safety and efficacy study. primaryPurpose: PREVENTION masking: TRIPLE maskingDescription: Blinding of procedural anesthesiologist is not possible. Patients, surgeons, and all outcome assessors will be blinded. One unblinded research coordinator at each site will collect pEEG related data points. Other research coordinators will be blinded as to treatment allocation and will collect data relating to primary and secondary outcomes. Clinicians carrying out participant usual care will be able to unblind study allocation if necessary by viewing the patients anesthesia record via password protected, accessing clinician identity logged, Electronic Health Record (EHR). This record will be unavailable for access by other means. whoMasked: PARTICIPANT whoMasked: INVESTIGATOR whoMasked: OUTCOMES_ASSESSOR count: 2766 type: ESTIMATED name: Depth of anesthesia titration using pEEG measure: Incidence of postoperative delirium (POD) measure: Incidence of severe delirium measure: Incidence of new mild and major postoperative neurocognitive disorders measure: Postoperative cognitive decline measure: Functional decline measure: All-cause mortality measure: Duration of delirium measure: Incidence of awareness measure: Adverse and serious adverse events sex: ALL minimumAge: 55 Years stdAges: ADULT stdAges: OLDER_ADULT hasResults: False
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<|newrecord|> nctId: NCT06268067 id: Renal uptake at F18 FDG PET/CT briefTitle: Kidney Uptake at F-18 FDG PET/CT Studies and Renal Function Status overallStatus: NOT_YET_RECRUITING date: 2024-03-01 date: 2025-03-01 date: 2025-04-01 date: 2024-02-20 date: 2024-02-20 name: Assiut University class: OTHER briefSummary: Searching for a possible correlation between renal uptake at F-18-FDG PET/CT and renal functional parameters in both normal subjects and patients with CKD. conditions: Renal Uptake at F-18-FDG PET/CT studyType: OBSERVATIONAL observationalModel: CASE_CONTROL timePerspective: PROSPECTIVE count: 97 type: ESTIMATED name: PET/CT measure: significance of renal uptake at F18-FDG PET CT studies measure: Early detection of patients with CKD sex: ALL minimumAge: 19 Years maximumAge: 75 Years stdAges: ADULT stdAges: OLDER_ADULT hasResults: False
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<|newrecord|> nctId: NCT06268054 id: DEH113-III-0123 briefTitle: Efficacy and Safety of DEH113 in the Treatment of Menstrual Cramp Pain Associated With Primary Dysmenorrhea acronym: LIBERTÀ overallStatus: NOT_YET_RECRUITING date: 2025-02 date: 2027-02 date: 2027-09 date: 2024-02-20 date: 2024-02-22 name: EMS class: INDUSTRY briefSummary: The purpose of this study if to evaluate the efficacy and safety of DEH113 in the Treatment of Menstrual Cramp Pain Associated With Primary Dysmenorrhea. conditions: Primary Dysmenorrhea studyType: INTERVENTIONAL phases: PHASE3 allocation: RANDOMIZED interventionModel: CROSSOVER primaryPurpose: TREATMENT masking: QUADRUPLE whoMasked: PARTICIPANT whoMasked: CARE_PROVIDER whoMasked: INVESTIGATOR whoMasked: OUTCOMES_ASSESSOR count: 78 type: ESTIMATED name: DEH113 name: Placebo Comparator measure: Sum of Total Pain Relief (TOTPAR) over 0-6 hours post-dose measure: Sum of Total Pain Relief (TOTPAR) over 0-4 and 0-8 hours post-dose measure: Sum of Pain Intensity Difference (SPID) over 4, 6 and 8 hours post-dose. measure: Use of rescue medication measure: Number of additional drug intake measure: Patients' Global Impression of Change (PGIC) measure: Incidence of Adverse Events Associated with DEH113 in the Treatment of Primary Dysmenorrhea sex: FEMALE minimumAge: 16 Years maximumAge: 35 Years stdAges: CHILD stdAges: ADULT hasResults: False
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<|newrecord|> nctId: NCT06268041 id: 427659 id: R01HD093694 type: NIH link: https://reporter.nih.gov/quickSearch/R01HD093694 briefTitle: HIT-Stroke Trial 2 acronym: HST2 overallStatus: RECRUITING date: 2024-02-09 date: 2028-01 date: 2028-04 date: 2024-02-20 date: 2024-02-20 name: University of Cincinnati class: OTHER name: Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD) name: University of Kansas Medical Center name: University of Delaware briefSummary: People who had a stroke at least 6 months prior and who still have difficulty with walking will each be randomly assigned to receive either moderate or vigorous intensity walking exercise. Both protocols will be performed individually with a physical therapist for 45 minutes, 3x/week for 12 weeks. Measures including walking function will be assessed at baseline (PRE), after 4, 8 and 12 weeks of training (12WK) and at 3-month follow up (3moPOST), by raters who are unaware of the participant randomization. conditions: Stroke studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: SINGLE whoMasked: OUTCOMES_ASSESSOR count: 156 type: ESTIMATED name: Moderate-Intensity Aerobic Training name: High-Intensity Interval Training measure: 6-Minute Walk Test Distance measure: 6-Minute Walk Test Distance measure: Self-Selected Gait Speed measure: Fastest Gait Speed measure: PROMIS-Fatigue Scale version 8a measure: Aerobic Capacity measure: EuroQol-5D-5L sex: ALL minimumAge: 30 Years maximumAge: 85 Years stdAges: ADULT stdAges: OLDER_ADULT facility: University of Delaware status: RECRUITING city: Newark state: Delaware zip: 19713 country: United States name: Jane Diehl role: CONTACT email: [email protected] name: Darcy Reisman, PT, PhD role: PRINCIPAL_INVESTIGATOR lat: 39.68372 lon: -75.74966 facility: University of Kansas Medical Center status: RECRUITING city: Kansas City state: Kansas zip: 66160 country: United States name: Sasha Moores role: CONTACT phone: 913-588-2697 email: [email protected] name: Sandra Billinger, PT, PhD role: PRINCIPAL_INVESTIGATOR lat: 39.11417 lon: -94.62746 hasResults: False
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<|newrecord|> nctId: NCT06268028 id: BELMA TA briefTitle: Discharge Training Given to Primiparous Mothers Who Had a Cesarean Delivery overallStatus: ENROLLING_BY_INVITATION date: 2024-01-10 date: 2024-06-10 date: 2024-11-10 date: 2024-02-20 date: 2024-02-21 name: Aydin Adnan Menderes University class: OTHER briefSummary: This study aimed to determine the effect of discharge training given to primiparous mothers who gave birth by cesarean section on the level of readiness for discharge.
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The research is a pre-test-post-test, randomized controlled experimental study. conditions: Education studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: OTHER masking: SINGLE whoMasked: PARTICIPANT count: 70 type: ESTIMATED name: Training measure: A pre-test will be applied to 70 women who constitute the sample of the research. measure: Apost-test will be applied to 70 women who constitute the sample of the research. sex: FEMALE minimumAge: 18 Years maximumAge: 50 Years stdAges: ADULT facility: Aydın Maternity and Child Health Hospital city: Aydın zip: 09010 country: Turkey lat: 37.84501 lon: 27.83963 hasResults: False
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<|newrecord|> nctId: NCT06268015 id: Pro00115311 briefTitle: Botensilimab and Balstilimab Optimization in Colorectal Cancer acronym: BBOpCo overallStatus: NOT_YET_RECRUITING date: 2024-07 date: 2028-07 date: 2028-07 date: 2024-02-20 date: 2024-02-22 name: Nicholas DeVito, MD class: OTHER name: Gateway for Cancer Research name: Agenus Inc. briefSummary: This is a single-arm, interventional, pilot clinical trial. Fifteen evaluable patients will have tumor-informed ctDNA testing at baseline and start botensilimab and balstilimab treatment. They will receive botensilimab and balstilimab in 6-week cycles until progression, after which mFOLFOX6 and bevacizumab or panitumumab will be added to the regimen. Subjects will have safety testing at baseline and every two weeks while on study drug. Study treatment with botensilimab and balstilimab, mFOLFOX6, and bevacizumab or panitumumab will be continued until radiographic or clinical progression, toxicity, or patient withdrawal. Subjects will have one safety follow up visit 30 days after the last treatment and will be followed for survival every 12 weeks for up to 2 years. conditions: Colorectal Cancer studyType: INTERVENTIONAL phases: PHASE2 allocation: NA interventionModel: SINGLE_GROUP primaryPurpose: TREATMENT masking: NONE count: 15 type: ESTIMATED name: Botensilimab name: Balstilimab name: Oxaliplatin name: Leucovorin name: Fluorouracil name: Bevacizumab name: Panitumumab measure: Disease control rate based on iRECIST at second restaging scan measure: Proportion of subjects with a best overall response of complete response or partial response according to iRECIST measure: Disease control rate based on RECIST v1.1 at second restaging scan measure: Proportion of subjects with a best overall response of complete response or partial response according to RECIST v1.1 measure: Months of overall survival measure: Months of progression-free survival sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Duke University city: Durham state: North Carolina zip: 27710 country: United States name: Nicholas C. DeVito, MD role: PRINCIPAL_INVESTIGATOR lat: 35.99403 lon: -78.89862 hasResults: False
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<|newrecord|> nctId: NCT06268002 id: 5876557033 briefTitle: Effect of Vernonia Cinerea Lozenges as a Smoking Cessation Aid in Patients With Non-communicable Diseases overallStatus: COMPLETED date: 2017-09-01 date: 2021-09-30 date: 2021-12-31 date: 2024-02-20 date: 2024-02-28 name: Chulalongkorn University class: OTHER briefSummary: Vernonia cinerea is an herbal which has been recorded in many Thai herbal formulation and Thai traditional medicine has used this herbal for treating various diseases included hypertension, asthma, fever, hepatitis, kidney stone and smoking cessation. Now aday there are more interest for using Vernonia cinerea as a medication to aid smoker to quit smoking because it is cheaper than other current therapeutic medications. The objective of this study is to evaluate efficacy and safety of Vernonia cinerea lozenge for smoking cessation when compared to placebo. conditions: Smoking Cessation studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL interventionModelDescription: This study was a multicenter randomized, paralleled, double-blind, controlled trial at 5 hospitals and 2 community pharmacies in Thailand primaryPurpose: TREATMENT masking: TRIPLE whoMasked: PARTICIPANT whoMasked: CARE_PROVIDER whoMasked: INVESTIGATOR count: 93 type: ACTUAL name: Vernonia cinerea name: Placebo measure: continuous abstinence rate measure: continuous abstinence rate (CAR) and point prevalence rate sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Krittin Bunditanukul city: Bangkok zip: 10600 country: Thailand lat: 13.75398 lon: 100.50144 hasResults: False
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<|newrecord|> nctId: NCT06267989 id: Gothenburg University briefTitle: The Effectiveness of Early Intervention to Correct the Position of PDC:s acronym: PDC overallStatus: RECRUITING date: 2024-02-12 date: 2027-12-30 date: 2027-12-30 date: 2024-02-20 date: 2024-02-21 name: Region Örebro County class: OTHER briefSummary: Approximately 2-3% of children will have problems with one or both of their permanent or 'adult' canine teeth in the upper jaw. These canine teeth sometimes fail to erupt properly, because they are displaced into the roof of the mouth or palate. These are known as palatally displaced canines, PDC, (Brin et al., 1986, Ericson and Kurol, 1987). In addition to failing to erupt, displaced teeth can cause problems, such as damage to the roots or displacement of the neighbouring teeth (Ericson and Kurol, 1988a, Ericson and Kurol, 2000, Falahat et al., 2008).
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It has been suggested that if the primary ('baby' or 'milk') canine is extracted at an appropriate time in a child with a suspected palatally displaced canine, then the displaced tooth might spontaneously correct its position (Ericson and Kurol, 1988b) and the extraction of the baby canine when a clinician suspects that the adult canine is displaced has become accepted clinical practice (Short, 2009). This appears to be on the basis of one report of a series of 35 children who received the intervention and no control group (Ericson and Kurol, 1988b). Two recent systematic reviews have examined the evidence for the effectiveness of removal of the primary canine with the aim of correcting the eruption path of a palatally displaced canine. A recent systematic review published in The Cochrane Library in 2021 (Benson et al., 2021) noted that the evidence for any intervention to correct the eruption path of a displaced permanent canine is weak and further research is required. Numerous problems with the reported studies were identified by both reviews.
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