Split (1)

train · 22k rows

Record stringlengths 1 197k
<\|newrecord\|> nctId: NCT06343181 id: IEO 1824 briefTitle: A Qualitative Study on Treatment Adherence in Patients With Metastatic Breast Cancer overallStatus: RECRUITING date: 2022-10-03 date: 2024-12-31 date: 2024-12-31 date: 2024-04-02 date: 2024-04-02 name: European Institute of Oncology class: OTHER briefSummary: Qualitative observational study with the aim to explore medication adherence in a sample of patients with metastatic breast cancer.
Patients with metastatic breast cancer receiving or having received oral oncologic therapy, and attending the Division of Medical Senology at the European Institute of Oncology, will be included and enrolled in this research project." conditions: Metastatic Breast Cancer studyType: OBSERVATIONAL observationalModel: CASE_ONLY timePerspective: PROSPECTIVE count: 20 type: ESTIMATED measure: Evaluation of factors influencing patients' adherence to medical therapy sex: FEMALE minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: European Institute of Oncology status: RECRUITING city: Milan country: Italy name: Gabriella Pravettoni role: CONTACT lat: 45.46427 lon: 9.18951 hasResults: False
<\|newrecord\|> nctId: NCT06343168 id: frailty briefTitle: Prevalence of Frailty and Associated Factors in Coronary Artery Bypass Patients overallStatus: COMPLETED date: 2021-02-18 date: 2022-02-18 date: 2022-02-18 date: 2024-04-02 date: 2024-04-02 name: Uşak University class: OTHER briefSummary: This study aimed to determine the prevalence of and factors affecting frailty in patients with coronary artery bypass graft.
The main question it aims to answer are:
What are the prevalence of and factors affecting frailty in patients with coronary artery bypass graft Type of study: descriptive cross-sectional study Participant population: coronary artery bypass grafting patients conditions: Frailty studyType: OBSERVATIONAL observationalModel: OTHER timePerspective: CROSS_SECTIONAL count: 96 type: ACTUAL name: prevalence of frailty measure: Prevalence of frailty measure: Activities of Daily Living measure: Nutritional Assessment measure: Comorbidity measure: Cognitive Assessment sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Usak University city: Usak state: Center zip: 64200 country: Turkey lat: 38.67351 lon: 29.4058 hasResults: False
<\|newrecord\|> nctId: NCT06343155 id: E-10840098-202.3.02-235 briefTitle: Effect of Chronic Low Back Pain Treatment on Temporomandibular Disorder" overallStatus: NOT_YET_RECRUITING date: 2024-04-11 date: 2024-05-27 date: 2024-06-03 date: 2024-04-02 date: 2024-04-03 name: Medipol University class: OTHER briefSummary: According to the information obtained from clinical studies, it has been stated that Temporomandibular Disorder (TMD) is associated with chronic low back pain (LBP). In this study, participants will be divided into two groups. Only Rocabado's exercise will be given to the Rocabado's group (RG), and Rocabado's and therapeutic lumbar exercises will be given to the therapeutic group (TG). Warm-up exercises will be given before starting the exercises with the therapeutic group, and cool-down exercises will be given after the exercises with the therapeutic group. At the end of the sixth week, the effect of therapeutic lumbar exercises on TMD pain and function will be evaluated. conditions: Temporomandibular Disorder conditions: Chronic Low-back Pain studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL interventionModelDescription: There are two groups: Therapeutic group and Rocabado's group. primaryPurpose: TREATMENT masking: NONE count: 40 type: ESTIMATED name: Therapeutic Group name: Rocabado's Group measure: Temporomandibular Joint Range of Motion Measurement (ROM) measure: The Jaw Functional Limitation Scale 20 (JFLS-20) measure: Oral Health Impact Profile - 14 (OHIP-14) measure: The short-form McGill Pain Questionnaire (SF-MPQ) measure: Graded Chronic Pain Scale 2.0 total (GCPS 2.0) measure: Visual Analog Scale sex: ALL minimumAge: 23 Years maximumAge: 65 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Istanbul Medipol University city: Istanbul country: Turkey name: İkra Çakıcı role: CONTACT phone: +90 05426696487 email: ikrabayraktar951@gmail.com lat: 41.01384 lon: 28.94966 hasResults: False
<\|newrecord\|> nctId: NCT06343142 id: 42038 briefTitle: Effects of Time of Day and Nut Intake on Cognitive Performance overallStatus: RECRUITING date: 2024-04-08 date: 2025-02-28 date: 2025-06-30 date: 2024-04-02 date: 2024-04-04 name: Monash University class: OTHER briefSummary: This is a 2 x 2-factor crossover design study to investigate the effects of time of day and nuts on post-meal cognitive performance. conditions: Cognitive Performance studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: CROSSOVER interventionModelDescription: 2 x 2-factor crossover design study primaryPurpose: PREVENTION masking: NONE count: 25 type: ESTIMATED name: Nuts name: Nut-free meal measure: N-back task - accuracy measure: N-back task - matched responses measure: N-back task - false alarm measure: N-back task - reaction time measure: Stroop test - congruent measure: Stroop test - incongruent measure: Stroop test - interference measure: Multitasking - pure blocks measure: Multitasking - mixed blocks measure: Multitasking - mixing cost measure: Satiety - hunger measure: Satiety - fullness measure: Satiety - satisfaction measure: Satiety - eating capacity measure: Satiety index sex: ALL minimumAge: 18 Years maximumAge: 55 Years stdAges: ADULT facility: Department of Nutrition, Dietetics and Food - Monash University status: RECRUITING city: Notting Hill state: Victoria zip: 3168 country: Australia name: Barbara R Cardoso, PhD role: CONTACT phone: +61499840472 email: barbara.cardoso@monash.edu name: Maxine Bonham, PhD role: CONTACT phone: +61418 234 292 email: maxine.bonham@monash.edu lat: -37.905 lon: 145.1427 hasResults: False
<\|newrecord\|> nctId: NCT06343129 id: 3817 briefTitle: Effects of a Whole-food, Plant-based Nutrition Program on BP and Potassium in Subjects With CKD overallStatus: COMPLETED date: 2020-10-26 date: 2022-12-12 date: 2022-12-12 date: 2024-04-02 date: 2024-04-17 name: University of Rochester class: OTHER name: Rochester Lifestyle Medicine Institute briefSummary: The purpose of this study is to determine if an educational program emphasizing a whole food plant based diet favorably impacts blood pressure while not significantly increasing blood potassium levels, by comparing a group of patients receiving the educational program with a control group of patients receiving no specific education. conditions: Chronic Kidney Diseases studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: NONE count: 43 type: ACTUAL name: Dietary education program measure: Mean change in systolic blood pressure measure: Mean change in diastolic blood pressure measure: Mean change in potassium levels measure: Proportion of participants developing hyperkalemia measure: Mean Change in energy/day measure: Mean change in energy/kg of body mass measure: Mean change in total fat measure: Mean change in % calories from fat measure: Mean change in % calories from carbohydrates measure: Mean change in % calories from protein measure: Mean change in Animal protein measure: Mean change in Vegetable protein measure: Mean change in cholesterol measure: Mean change in Total dietary fiber measure: Mean change in Total fiber per 1000 kcal measure: Mean change in calcium measure: Mean change in phosphorous measure: Mean change in magnesium measure: Mean change in sodium measure: Mean change in potassium measure: Mean change in body mass measure: Mean change in body mass index measure: Mean change in sodium measured in blood measure: Mean change in chloride measured in blood measure: Mean change in bicarbonate measured in blood measure: Mean change in blood urea nitrogen (BUN) measured measure: Mean change in creatinine measured in blood measure: Mean change in glucose measured in blood measure: Mean change in calcium measured in blood measure: Mean change in phosphorous measured in blood measure: Mean change in parathyroid hormome (PTH) measured in blood measure: Mean change in albumin measured in blood measure: Mean change in magnesium measured in blood measure: Mean change in erythrocyte sedimentation rate (ESR) measured in blood measure: Mean change in fibroblast growth factor (FGF)-23 measured in blood measure: Mean change in total cholesterol measured in blood measure: Mean change in low density lipoprotein (LDL) measured in blood measure: Mean change in high density lipoprotein (HDL) measured in blood measure: Mean change in triglycerides measured in blood measure: Mean change in 8-isoprostane measured in urine measure: Mean change in symptoms measure: Mean change in effects of kidney disease measure: Mean change in burden of kidney disease measure: Mean change in Medical Outcomes Study Short Form (MOS SF-12) physical composite measure: Mean change in Medical Outcomes Study Short Form (MOS SF-12) mental composite sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Clinical Research Center of the University of Rochester Medical Center city: Rochester state: New York zip: 14642 country: United States lat: 43.15478 lon: -77.61556 facility: University of Rochester Medical Center city: Rochester state: New York zip: 14642 country: United States lat: 43.15478 lon: -77.61556 hasResults: False
<\|newrecord\|> nctId: NCT06343116 id: BPL-Nim-CRC-3001 briefTitle: Nimotuzumab Combined With Trifluridine/Tipiracil in the Treatment of Refractory Metastatic Colorectal Cancer acronym: NOTABLE-308 overallStatus: NOT_YET_RECRUITING date: 2024-04 date: 2027-04 date: 2027-04 date: 2024-04-02 date: 2024-04-02 name: Biotech Pharmaceutical Co., Ltd. class: OTHER briefSummary: This is a randomized, double-blind, placebo-controlled, multicenter study. The main purpose of the study is to evaluate the clinical efficacy and safety of nimotuzumab combined with trifluridine/tipiracil in third-line and beyond for the treatment of metastatic colorectal cancer (mCRC). This study planned to be divided into two parts: Part A and Part B. Part A (safety run-in) with a 3 + 3 study design, which primary endpoint is safety; Part B (main study) with a prospective, randomized, double-blind, placebo-controlled design, which primary endpoint is overall survival (OS). conditions: Refractory Metastatic Colorectal Cancer studyType: INTERVENTIONAL phases: PHASE3 allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: QUADRUPLE whoMasked: PARTICIPANT whoMasked: CARE_PROVIDER whoMasked: INVESTIGATOR whoMasked: OUTCOMES_ASSESSOR count: 420 type: ESTIMATED name: Nimotuzumab injection name: Placebo name: Trifluridine/tipiracil measure: overall survival (OS) measure: dose-limiting toxicity (DLT) measure: Progression free survival (PFS) measure: time to progress (TTP) measure: overall response rate (ORR) measure: disease control rate (DCR) measure: duration of response (DoR) measure: European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire Core 30 (EORTC-QLQ-C30) measure: European Organization for Research and Treatment of Cancer Quality of Life Questionnaire Colorectal Cancer 29 (EORTC-QLQ-CR29) measure: Adverse Events measure: tumor-related markers sex: ALL minimumAge: 18 Years maximumAge: 75 Years stdAges: ADULT stdAges: OLDER_ADULT hasResults: False
<\|newrecord\|> nctId: NCT06343103 id: IEO 1735 briefTitle: Study Evaluating Occupational Exposure to Antineoplastic Drugs acronym: BRIC overallStatus: RECRUITING date: 2022-08-02 date: 2025-12-31 date: 2025-12-31 date: 2024-04-02 date: 2024-04-02 name: European Institute of Oncology class: OTHER briefSummary: The multicenter study involves comparing two groups (an exposed group and a control group). The exposed group is selected from workers who perform their activities in drug handling areas (DH) or units for antineoplastic preparation (UFA), while the control group involves the voluntary participation of non-exposed workers (administrative staff).
The control group is selected based on the characteristics of the exposed group to ensure a homogeneous sample in terms of size and characteristics. conditions: Cytotoxicity studyType: INTERVENTIONAL phases: NA allocation: NON_RANDOMIZED interventionModel: PARALLEL primaryPurpose: PREVENTION masking: NONE count: 500 type: ESTIMATED name: Workers exposed name: Workers not exposed measure: Evaluation of the difference in micronuclei frequency sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: IRCCS Ospedale Policlinico San Martino status: RECRUITING city: Genova country: Italy name: Sabrina Beltramini role: CONTACT lat: 44.40478 lon: 8.94438 facility: European Institute of Oncology status: RECRUITING city: Milan country: Italy name: Emanuela Omodeo Salè role: CONTACT lat: 45.46427 lon: 9.18951 facility: Istituto Nazionale Tumori IRCCS "Fondazione G. Pascale" status: RECRUITING city: Napoli country: Italy name: Piera Maiolino role: CONTACT lat: 40.85216 lon: 14.26811 facility: Istituto Oncologico Veneto Irccs status: RECRUITING city: Padova country: Italy name: Nicoletta Rigamonti role: CONTACT lat: 45.40797 lon: 11.88586 facility: Fondazione Policlinico Universitario Campus Bio-Medico status: RECRUITING city: Roma country: Italy name: Andrea Di Mattia role: CONTACT lat: 41.89193 lon: 12.51133 hasResults: False
<\|newrecord\|> nctId: NCT06343090 id: BJGBYY-IIT-LCYJ-2023-003 briefTitle: Clinical Trial of CD19 and CD22 CAR Sequential Therapy Versus Single CD19 CAR Bridging to HSCT for r/r B-ALL Patients overallStatus: RECRUITING date: 2024-04-12 date: 2042-12-01 date: 2043-09-30 date: 2024-04-02 date: 2024-04-18 name: Beijing GoBroad Hospital class: OTHER briefSummary: This is a single-center, open-label, non-randomized, two-arm, non-inferior trial. Patients with r/r B-ALL would be assigned to the CD19 CAR and CD22 CAR T-cell sequential infusion group (Sequential CAR, Arm-1) and the CD19 CAR T-cell infusion bridging to hematopoietic stem cell transplantation group (CAR+HSCT, Arm-2), according their own discretion. Patients would be also allowed to assigned to the CD19 CAR T-cell infusion without consolidation therapies group (Single CAR, additional placebo arm) according their own discretion. The primary objective is to prospectively evaluate and compare the efficacy of CD19 CAR and CD22 CAR T cell sequential infusions and CD19 CAR T-cell infusion bridging to HSCT in the treatment of r/r B-ALL. The primary endpoint is event-free survival of children and adolescent and young adult (AYA) with r/r B-ALL a treated with CD19 CAR and CD22 CAR T-cell sequential infusions and CD19 CAR T-cell infusion bridging to HSCT. A total number of 353 subjects will be enrolled. conditions: B-cell Acute Lymphoblastic Leukemia conditions: Acute Lymphoblastic Leukemia, in Relapse conditions: Refractory Acute Lymphoid Leukemia studyType: INTERVENTIONAL phases: NA allocation: NON_RANDOMIZED interventionModel: PARALLEL interventionModelDescription: a prospective cohort study primaryPurpose: TREATMENT masking: NONE count: 353 type: ESTIMATED name: CD19 CAR T-cell name: CD22 CAR T cells name: hematopoietic stem-cell transplantation measure: EFS in CD19 CAR and CD22 CAR-T sequential infusion (Sequential CAR group) and CD19 CAR T-cell infusion bridging to HSCT (CAR+HSCT group) measure: ORR in Sequential CAR group and CAR+HSCT group measure: DOR in Sequential CAR group and CAR+HSCT group measure: OS in Sequential CAR group and CAR+HSCT group measure: Adverse events (AEs) in Sequential CAR group and CAR+HSCT group measure: Levels of CD19 and CD22 CAR-T cells in Sequential CAR group measure: Levels of CD19 CAR-T cells in CAR+HSCT group measure: Levels of CD19 and CD22 CAR transgene in Sequential CAR group measure: Levels of CD19 CAR transgene in CAR+HSCT group measure: Quantification of B cells in Sequential CAR group and CAR+HSCT group measure: EFS in CD19 CAR T-cell infusion without consolidation therapies (Single CAR group) measure: DOR in Single CAR group measure: OS in Single CAR group measure: ORR in Single CAR group measure: Adverse events (AEs) in Single CAR group measure: Levels of CD19 CAR-T cells in Single CAR group measure: Levels of CD19 CAR transgene in Single CAR group measure: Quantification of B cells in Single CAR group sex: ALL minimumAge: 1 Year maximumAge: 39 Years stdAges: CHILD stdAges: ADULT facility: Beijing GoBroad Hospital status: RECRUITING city: Beijing state: Beijing zip: 102206 country: China name: Tengyu Wang role: CONTACT phone: 86+18333186020 email: tengyu.wang@gohealtharo.com lat: 39.9075 lon: 116.39723 hasResults: False
<\|newrecord\|> nctId: NCT06343077 id: STUDY-22-00106 briefTitle: Intratumoral and Systemic Hiltonol® (Poly-ICLC) in Prostate Cancer Patients on Active Surveillance overallStatus: RECRUITING date: 2024-01-16 date: 2026-12-31 date: 2026-12-31 date: 2024-04-02 date: 2024-04-02 name: Ashutosh Kumar Tewari class: OTHER name: Oncovir, Inc. briefSummary: This is a partially blinded randomized controlled phase II pilot study comparing Poly-ICLC (Hiltonol®) treatment vs no treatment, for prostate cancer participants on active surveillance. conditions: Prostate Cancer Patients on Active Surveillance studyType: INTERVENTIONAL phases: PHASE2 allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: DOUBLE whoMasked: PARTICIPANT whoMasked: OUTCOMES_ASSESSOR count: 114 type: ESTIMATED name: Poly-ICLC intramuscular (IM) injection name: Poly-ICLC, Intertumoral (IT) injection measure: Proportion of subjects without Gleason group upgrade after treatment measure: Proportion of subjects without Gleason group upgrade after treatment measure: Proportion of subjects without Gleason group downgrade after treatment measure: Proportion of subjects without Gleason group downgrade after treatment measure: Number of subjects who experience adverse events per NCI-CTCAE 5.0 measure: Number of subjects who experience adverse events per NCI-CTCAE 5.0 measure: Number of subjects who receive prostate cancer treatment measure: Number of subjects who receive prostate cancer treatment sex: MALE minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Icahn School of Medicine at Mount Sinai (ISMMS) status: RECRUITING city: New York state: New York zip: 10029 country: United States name: Monali Fatterpekar, PhD role: CONTACT email: monali.fatterpekar@mountsinai.org name: Sujit S Nair, PhD role: CONTACT phone: 212-241-7005 email: sujit.nair@mountsinai.org name: Ashutosh K Tewari, MD role: PRINCIPAL_INVESTIGATOR lat: 40.71427 lon: -74.00597 hasResults: False
<\|newrecord\|> nctId: NCT06343064 id: PLB1001/PLB1004-NSCLC-Ib/II-01 briefTitle: Vebreltinib Plus PLB1004 in EGFR-mutated, Advanced NSCLC With MET Amplification or MET Overexpression Following EGFR-TKI overallStatus: RECRUITING date: 2023-06-13 date: 2024-12-31 date: 2025-06-30 date: 2024-04-02 date: 2024-04-02 name: Avistone Biotechnology Co., Ltd. class: INDUSTRY briefSummary: Efficacy and Safety Evaluation of Vebreltinib Plus PLB1004 in EGFR TKI Relapsed MET Amplified or MET Expression in NSCLC conditions: Non-Small-Cell Lung Cancer studyType: INTERVENTIONAL phases: PHASE1 phases: PHASE2 allocation: NON_RANDOMIZED interventionModel: SEQUENTIAL primaryPurpose: TREATMENT masking: NONE count: 156 type: ESTIMATED name: Vebreltinib name: PLB1004 measure: Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability]). measure: Incidence of dose-limiting toxicities (DLT) as defined in the protocol. measure: Overall Response Rate (ORR） measure: Pharmacokinetics of Vebreltinib and PLB1004 : Area under the concentration time curve (AUC) measure: Pharmacokinetics of Vebreltinib and PLB1004: Maximum plasma concentration of the study drug (C-max) measure: Pharmacokinetics of Vebreltinib and PLB1004: Time to maximum plasma concentration of the study drug (T-max) measure: Incidence of Treatment-Emergent Adverse Events sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Shanghai Pulmonary Hospital status: RECRUITING city: Shanghai state: Shanghai zip: 200433 country: China name: Caichun Zhou, PHD role: CONTACT phone: +86-21-65115006 email: caicunzhoudr@163.com lat: 31.22222 lon: 121.45806 hasResults: False
<\|newrecord\|> nctId: NCT06343051 id: STUDY-23-01681 briefTitle: USCOM in Newly Diagnosed FGR Cases acronym: USCOM FGR overallStatus: NOT_YET_RECRUITING date: 2024-06 date: 2026-06 date: 2026-06 date: 2024-04-02 date: 2024-04-02 name: Icahn School of Medicine at Mount Sinai class: OTHER briefSummary: The purpose of this research study is to study the use of an ultrasound measurement system (USCOM) for patients with newly diagnosed fetal growth restriction (FGR). This system uses a technology to measure how much blood is being pumped in and out of the heart, which is important for understanding the heart's function in relation to pregnancy. conditions: Fetal Growth Restriction conditions: USCOM studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: PROSPECTIVE count: 100 type: ESTIMATED name: USCOM measure: Systemic vascular resistance obtained from USCOM sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Mount Sinai Hospital city: New York state: New York zip: 10029 country: United States name: Nicola F Tavella, MPH role: CONTACT phone: 212-241-3888 email: nicola.tavella@mssm.edu name: Rachel J Meislin role: PRINCIPAL_INVESTIGATOR lat: 40.71427 lon: -74.00597 hasResults: False
<\|newrecord\|> nctId: NCT06343038 id: 2023-01868; th23Nicolas briefTitle: Targeted Radionuclide Therapy in Metastatic Prostate Cancer Using a New PSMA Ligand Radiolabelled With Terbium-161 (161Tb-SibuDAB) - Dose Identification/Escalation Phase Ia/b Study acronym: PROGNOSTICS overallStatus: NOT_YET_RECRUITING date: 2024-06 date: 2028-06 date: 2028-06 date: 2024-04-02 date: 2024-04-02 name: University Hospital, Basel, Switzerland class: OTHER briefSummary: Researchers will test a new treatment for prostate cancer. This treatment uses an antibody tagged with a small amount of radioactive material. Researchers believe the new antibody might work better than those used before.
In the first part of the study researchers will compare the new treatment to the old one on prostate cancer patients using very low doses, not strong enough to treat nor to cause strong adverse reactions. Each patient will eventually receive both treatments, but one at a time.
The aim of the second part of the study is to find the best dose of the new treatment for patients. This means finding the dose that offers the most benefits with the fewest side effects.
The performance of different prostate cancer diagnostic methods is also in scope of the study. conditions: Castration-resistant Prostate Cancer studyType: INTERVENTIONAL phases: PHASE1 allocation: RANDOMIZED interventionModel: CROSSOVER interventionModelDescription: In Phase Ia:
Radiation dosimetry driven, head-to-head in cross-over design comparison of tumour and critical organ absorbed doses after sequential non-therapeutic injections of 161Tb-SibuDAB and 177Lu-PSMA-I\&T in the same mCRPC patients undergoing standard 177Lu-PSMA-I\&T RLT.
In Phase Ib:
Clinical and radiation dosimetry-based dose escalation study, with a classical 3+3 design, to identify the optimal biologic dose (injected activity) of 161Tb-SibuDAB for safe and effective RLT. primaryPurpose: TREATMENT masking: SINGLE whoMasked: PARTICIPANT count: 25 type: ESTIMATED name: Injection, 161Tb-SibuDAB,1GBq name: Injection, 177Lu-PSMA-I&T, 1GBq name: Injection, 161Tb-SibuDAB, Dose Escalation measure: Phase Ia: Tumour absorbed dose measure: Phase Ib: Identification of the optimal biological dose of 161Tb-SibuDAB for mCRPC RLT measure: Phase Ia: Estimation of critical organ median absorbed doses measure: Phase Ia: Estimation of the median tumour-to-critical organ absorbed dose ratios measure: Phase Ib: Cumulative median tumour and organ absorbed doses after 4 cycles of 161Tb-SibuDAB RLT measure: Phase Ib: Estimation of the "therapy index" for 161Tb-SibuDAB RLT. sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: University Hospital Basel city: Basel zip: 4031 country: Switzerland name: Alin Chirindel, MD role: CONTACT phone: +41 61 328 63 75 email: alin.chirindel@usb.ch name: Guillaume Nicolas, MD role: CONTACT phone: +41 61 265 47 02 email: guillaume.nicolas@usb.ch lat: 47.55839 lon: 7.57327 hasResults: False
<\|newrecord\|> nctId: NCT06343025 id: Hasan Kalyoncu University briefTitle: The Effects of Tai Chi and Pilates for Individuals With Prediabetes overallStatus: NOT_YET_RECRUITING date: 2024-06 date: 2025-06 date: 2025-09 date: 2024-04-02 date: 2024-04-02 name: Nigde Omer Halisdemir University class: OTHER name: Hasan Kalyoncu University briefSummary: The purpose of this study; To investigate the effects of Clinical Pilates and Tai Chi exercises on glycemic control, body composition, balance function and physical activity level in individuals with prediabetes. conditions: PreDiabetes studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL interventionModelDescription: Individuals will be divided into 3 groups: Clinical Pilates group, Tai Chi group and Control group. 3 groups. 3 groups will be measured at the same time and then the exercise part will begin. primaryPurpose: TREATMENT masking: SINGLE maskingDescription: Outcomes ,Assesor, who will make the evaluations in the first week and after 12 weeks, will not know which group the people are in. whoMasked: OUTCOMES_ASSESSOR count: 54 type: ESTIMATED name: Pilates Exercises Group name: Tai Chi Exercises Group measure: Glisemic Control measure: Body Composition measure: Balance measure: Physical Activity Level sex: ALL minimumAge: 18 Years maximumAge: 65 Years stdAges: ADULT stdAges: OLDER_ADULT hasResults: False
<\|newrecord\|> nctId: NCT06343012 id: 0305900 briefTitle: Caring Leadership Intervention Program for First-Line Nurse Managers overallStatus: COMPLETED date: 2022-07-01 date: 2022-12-31 date: 2022-12-31 date: 2024-04-02 date: 2024-04-02 name: Matrouh University class: OTHER briefSummary: Caring leadership can help first-line nurse managers create a healthy environment, resulting in a positive outcome for nurse staff, patients, and healthcare organizations. conditions: Intervention conditions: Behavior studyType: INTERVENTIONAL phases: NA allocation: NON_RANDOMIZED interventionModel: PARALLEL interventionModelDescription: A quasi-experimental study design utilized two groups, study and control groups primaryPurpose: OTHER masking: SINGLE maskingDescription: A quasi-experimental study design utilized two groups, study and control groups. whoMasked: PARTICIPANT count: 60 type: ACTUAL name: Caring leadership Intervention program measure: Questionnaire to measure first-line nurse managers' knowledge measure: Questionnaire to measure the managerial actions of first-line nurse managers measure: Questionnaire to assess nurses' perceived first-line nurse managers' caring behavior measure: questionnaire to measure nurse outcomes sex: ALL stdAges: CHILD stdAges: ADULT stdAges: OLDER_ADULT facility: Faculty of Nursing, Matrouh University city: Marsa Matruh zip: 002 country: Egypt lat: 31.3529 lon: 27.23725 hasResults: False
<\|newrecord\|> nctId: NCT06342999 id: 22-012399 briefTitle: Fetal Aortic Valvuloplasty for Evolving Hypoplastic Left Heart Syndrome overallStatus: NOT_YET_RECRUITING date: 2024-07 date: 2035-07 date: 2035-07 date: 2024-04-02 date: 2024-04-10 name: Mauro H. Schenone class: OTHER briefSummary: The purpose of this research is to investigate the best way to manage evolving hypoplastic left heart syndrome (HLHS). conditions: Hypoplastic Left Heart Syndrome studyType: INTERVENTIONAL phases: NA allocation: NON_RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: NONE count: 80 type: ESTIMATED name: Fetal Aortic Valvuloplasty Procedure name: Emerge Monorail and Over-The-Wire PTCA Dilatation Catheter name: Trek RX and Mini Trek RX Coronary Dilatation Catheter measure: Number of cases in which the procedure was successful measure: Number of cases in which a biventricular repair was achieved measure: Number cases with pulmonary hypertension measure: Number of cases delivered prematurely measure: Number of cases with perinatal death measure: Number of maternal complications sex: FEMALE maximumAge: 45 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
<\|newrecord\|> nctId: NCT06342986 id: 2023LS185 id: P01CA111412 type: NIH link: https://reporter.nih.gov/quickSearch/P01CA111412 briefTitle: Intraperitoneal FT536 in Recurrent Ovarian, Fallopian Tube, and Primary Peritoneal Cancer overallStatus: NOT_YET_RECRUITING date: 2024-08-01 date: 2028-06-30 date: 2029-06-30 date: 2024-04-02 date: 2024-04-26 name: Masonic Cancer Center, University of Minnesota class: OTHER name: National Cancer Institute (NCI) briefSummary: This is a single center Phase I clinical trial of FT536 administered intraperitoneally (IP) 3 times a week for one week for the treatment of recurrent gynecologic cancers. A short course of outpatient lymphodepleting chemotherapy is given prior to the first dose of FT536 to promote adoptive transfer. conditions: Gynecologic Cancer conditions: Ovarian Cancer conditions: Fallopian Tube Cancer conditions: Primary Peritoneal Cavity Cancer studyType: INTERVENTIONAL phases: PHASE1 allocation: NON_RANDOMIZED interventionModel: SEQUENTIAL interventionModelDescription: A minimum of 28 days must separate each Dose Cohort. A minimum of 30 days must separate the 1st and 2nd patient. All patients are assessed for Dose Limiting Toxicity (DLT) primaryPurpose: TREATMENT masking: NONE count: 33 type: ESTIMATED name: FT536 name: Fludarabine name: CY measure: Progression free survival (PFS) measure: Progression free survival (PFS) measure: Overall survival (OS) measure: Overall survival (OS) sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT hasResults: False
<\|newrecord\|> nctId: NCT06342973 id: 5591 briefTitle: Horizontal Ridge Augmentation With Demineralized Bone Allograft Layered With Xenograft - a Case Series overallStatus: RECRUITING date: 2024-03-27 date: 2025-05-30 date: 2025-05-30 date: 2024-04-02 date: 2024-04-02 name: Louisiana State University Health Sciences Center in New Orleans class: OTHER briefSummary: The aim of this case series is to evaluate the outcomes of horizontal ridge augmentation performed using a combination of demineralized freeze-dried bone allograft layered with xenograft bone with a resorbable native collagen membrane. conditions: Alveolar Ridge Deficiency studyType: INTERVENTIONAL phases: PHASE4 allocation: NA interventionModel: SINGLE_GROUP interventionModelDescription: Single group primaryPurpose: TREATMENT masking: NONE count: 15 type: ESTIMATED name: Xenograft and allograft measure: Horizontal bone gain measure: Vital bone percentage measure: Bone shrinkage measure: Surgical complications sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: LSUHSC School of Dentistry status: RECRUITING city: New Orleans state: Louisiana zip: 70119 country: United States name: Eswar Kandaswamy role: CONTACT phone: 504-941-8272 email: ekanda@lsuhsc.edu name: Eswar Kandaswamy, BDS, MS role: PRINCIPAL_INVESTIGATOR name: Vinayak Joshi, BDS, MS, PhD role: SUB_INVESTIGATOR name: Jeanne St Germain, RDH role: SUB_INVESTIGATOR lat: 29.95465 lon: -90.07507 hasResults: False
<\|newrecord\|> nctId: NCT06342960 id: KYV101-003 briefTitle: A Study of Anti-CD19 Chimeric Antigen Receptor T-Cell (CD19 CAR T) Therapy, in Subjects With Refractory Lupus Nephritis (KYSA-3) overallStatus: RECRUITING date: 2022-12-01 date: 2028-10 date: 2029-01 date: 2024-04-02 date: 2024-04-02 name: Kyverna Therapeutics class: INDUSTRY briefSummary: A Study of Anti-CD19 Chimeric Antigen Receptor T Cell Therapy for Subjects With Refractory Lupus Nephritis conditions: Lupus Nephritis conditions: Lupus Nephritis - WHO Class III conditions: Lupus Nephritis - WHO Class IV studyType: INTERVENTIONAL phases: PHASE1 phases: PHASE2 allocation: NA interventionModel: SEQUENTIAL primaryPurpose: TREATMENT masking: NONE count: 32 type: ESTIMATED name: KYV-101 anti-CD19 CAR-T cell therapy name: Standard lymphodepletion regimen measure: Incidence adverse events (AEs) and laboratory abnormalities measure: Frequency of dose limiting toxicities measure: To characterize the pharmacokinetics (PK) measure: To characterize the pharmacodynamics (PD) measure: To characterize the pharmacodynamics (PD) measure: To evaluate disease related biomarkers measure: To evaluate disease related biomarkers measure: To evaluate efficacy measure: To evaluate efficacy measure: To evaluate efficacy measure: To evaluate the immunogenicity (humoral response) of KYV-101 sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: University Hospital Carl Gustav Carus Dresden status: RECRUITING city: Dresden country: Germany name: Study Coordinator role: CONTACT lat: 51.05089 lon: 13.73832 facility: University Hospital Erlangen status: RECRUITING city: Erlangen country: Germany name: Study Coordinator role: CONTACT lat: 49.59099 lon: 11.00783 facility: University Hospital Hamburg-Eppendorf status: RECRUITING city: Hamburg country: Germany name: Study Coordinator role: CONTACT lat: 53.57532 lon: 10.01534 hasResults: False
<\|newrecord\|> nctId: NCT06342947 id: ALG-055009-303 briefTitle: ALG-055009 in Non-cirrhotic Adults With MASH (HERALD) acronym: HERALD overallStatus: RECRUITING date: 2024-04-01 date: 2024-11-25 date: 2024-12-23 date: 2024-04-02 date: 2024-04-25 name: Aligos Therapeutics class: INDUSTRY briefSummary: This is a Phase 2a study to evaluate the safety, tolerability, efficacy, pharmacokinetics, and pharmacodynamics of oral (PO) daily (QD) doses of ALG-055009 (soft gelatin \[softgel\] capsule) for 12 weeks. conditions: NASH conditions: MASH conditions: Metabolic Dysfunction-Associated Steatohepatitis conditions: Nonalcoholic Steatohepatitis studyType: INTERVENTIONAL phases: PHASE2 allocation: RANDOMIZED interventionModel: SINGLE_GROUP primaryPurpose: TREATMENT masking: TRIPLE whoMasked: PARTICIPANT whoMasked: INVESTIGATOR whoMasked: OUTCOMES_ASSESSOR count: 100 type: ESTIMATED name: ALG-055009 name: Placebo measure: Percent relative change from baseline in liver fat content measure: Absolute change from baseline in liver fat content measure: Proportion of subjects with ≥30% relative reduction in liver fat content measure: Proportion of subjects with ≥50% relative reduction in liver fat content measure: Proportion of subjects with ≥70% relative reduction in liver fat content measure: Proportion of subjects with normalization (<5%) in liver fat content measure: Change from baseline (absolute/percent) in lipid/lipoprotein levels measure: Change from baseline (absolute/percent) in SHBG measure: Change from baseline (absolute/percent) alanine aminotransferase (ALT) measure: Change from baseline (absolute/percent) aspartate aminotransferase (AST) measure: Safety and tolerability will be assessed by monitoring TEAEs measure: Safety and tolerability will be assessed by monitoring 12-lead electrocardiograms (ECGs) measure: PK parameters of ALG-055009 in plasma, AUCs measure: PK parameters of ALG-055009 in plasma, Tmax measure: PK parameters of ALG-055009 in plasma, Cmax measure: PK parameters of ALG-055009 in plasma, Cmin sex: ALL minimumAge: 18 Years maximumAge: 75 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Aligos Clinical Study Site 18 status: RECRUITING city: Chandler state: Arizona zip: 85224 country: United States name: Central contact role: CONTACT lat: 33.30616 lon: -111.84125 facility: Aligos Clinical Study Site 15 status: RECRUITING city: Peoria state: Arizona zip: 85301 country: United States name: Central contact role: CONTACT lat: 33.5806 lon: -112.23738 facility: Aligos Clinical Study Site 17 status: RECRUITING city: Tucson state: Arizona zip: 85641 country: United States name: Central contact role: CONTACT lat: 32.22174 lon: -110.92648 facility: Aligos Clinical Study Site 35 status: RECRUITING city: Chula Vista state: California zip: 91902 country: United States name: Central contact role: CONTACT lat: 32.64005 lon: -117.0842 facility: Aligos Clinical Study Site 1 status: RECRUITING city: Lincoln state: California zip: 95648 country: United States name: Central contact role: CONTACT lat: 38.89156 lon: -121.29301 facility: Aligos Clinical Study Site 37 status: RECRUITING city: Poway state: California zip: 92025 country: United States name: Central contact role: CONTACT lat: 32.96282 lon: -117.03586 facility: Aligos Clinical Study Site 10 status: RECRUITING city: Rialto state: California zip: 92316 country: United States name: Central contact role: CONTACT lat: 34.1064 lon: -117.37032 facility: Aligos Clinical Study Site 26 status: RECRUITING city: Bradenton state: Florida zip: 34205 country: United States name: Central contact role: CONTACT lat: 27.49893 lon: -82.57482 facility: Aligos Clinical Study Site 25 status: RECRUITING city: Clearwater state: Florida zip: 33755 country: United States name: Central contact role: CONTACT lat: 27.96585 lon: -82.8001 facility: Aligos Clinical Study Site 39 status: RECRUITING city: Fort Myers state: Florida zip: 33901 country: United States name: Central contact role: CONTACT lat: 26.62168 lon: -81.84059 facility: Aligos Clinical Study Site 2 status: RECRUITING city: Maitland state: Florida zip: 32751, 32794 country: United States name: Central contact role: CONTACT lat: 28.62778 lon: -81.36312 facility: Aligos Clinical Study Site 22 status: RECRUITING city: Ocoee state: Florida zip: 32703 country: United States name: Central contact role: CONTACT lat: 28.56917 lon: -81.54396 facility: Aligos Clinical Study Site 32 status: RECRUITING city: Port Orange state: Florida zip: 32119 country: United States name: Central contact role: CONTACT lat: 29.13832 lon: -80.99561 facility: Aligos Clinical Study Site 38 status: RECRUITING city: Sarasota state: Florida zip: 34230 country: United States name: Central contact role: CONTACT lat: 27.33643 lon: -82.53065 facility: Aligos Clinical Study Site 31 status: RECRUITING city: The Villages state: Florida zip: 32159 country: United States name: Central contact role: CONTACT lat: 28.93408 lon: -81.95994 facility: Aligos Clinical Study Site 3 status: RECRUITING city: Viera state: Florida zip: 32924 country: United States name: Central contact role: CONTACT lat: 28.24696 lon: -80.737 facility: Aligos Clinical Study Site 30 status: RECRUITING city: Winter Park state: Florida zip: 32789 country: United States name: Central contact role: CONTACT lat: 28.6 lon: -81.33924 facility: Aligos Clinical Study Site 23 status: RECRUITING city: Athens state: Georgia zip: 30601 country: United States name: Central contact role: CONTACT lat: 33.96095 lon: -83.37794 facility: Aligos Clinical Study Site 12 status: RECRUITING city: Topeka state: Kansas zip: 66546 country: United States name: Central contact role: CONTACT lat: 39.04833 lon: -95.67804 facility: Aligos Clinical Study Site 29 status: RECRUITING city: Louisville state: Kentucky zip: 40018 country: United States name: Central contact role: CONTACT lat: 38.25424 lon: -85.75941 facility: Aligos Clinical Study Site 24 status: RECRUITING city: Bastrop state: Louisiana zip: 71220 country: United States name: Central contact role: CONTACT lat: 32.75625 lon: -91.87235 facility: Aligos Clinical Study Site 5 status: RECRUITING city: Houma state: Louisiana zip: 70360 country: United States name: Central contact role: CONTACT lat: 29.59577 lon: -90.71953 facility: Aligos Clinical Study Site 4 status: RECRUITING city: Marrero state: Louisiana zip: 70072 country: United States name: Central contact role: CONTACT lat: 29.89937 lon: -90.10035 facility: Aligos Clinical Study Site 6 status: RECRUITING city: Metairie state: Louisiana zip: 70001 country: United States name: Central contact role: CONTACT lat: 29.98409 lon: -90.15285 facility: Aligos Clinical Study Site 14 status: RECRUITING city: Chesterfield state: Michigan zip: 48047 country: United States name: Central contact role: CONTACT lat: 42.66281 lon: -82.84242 facility: Aligos Clinical Study Site 7 status: RECRUITING city: New York state: New York zip: 10001 country: United States name: Central contact role: CONTACT lat: 40.71427 lon: -74.00597 facility: Aligos Clinical Study Site 8 status: RECRUITING city: Morehead City state: North Carolina zip: 28557 country: United States name: Central contact role: CONTACT lat: 34.72294 lon: -76.72604 facility: Aligos Clinical Study Site 21 status: RECRUITING city: Columbus state: Ohio zip: 43004 country: United States name: Central contact role: CONTACT lat: 39.96118 lon: -82.99879 facility: Aligos Clinical Study Site 16 status: RECRUITING city: Westlake state: Ohio zip: 44145 country: United States name: Central contact role: CONTACT lat: 41.45532 lon: -81.91792 facility: Aligos Clinical Study Site 36 status: RECRUITING city: East Greenwich state: Rhode Island zip: 02818 country: United States name: Central contact role: CONTACT lat: 41.66038 lon: -71.45589 facility: Aligos Clinical Study Site 9 status: RECRUITING city: Nashville state: Tennessee zip: 37011 country: United States name: Central contact role: CONTACT lat: 36.16589 lon: -86.78444 facility: Aligos Clinical Study Site 19 status: RECRUITING city: Austin state: Texas zip: 73301 country: United States name: Central contact role: CONTACT lat: 30.26715 lon: -97.74306 facility: Aligos Clinical Study Site 33 status: RECRUITING city: Bellaire state: Texas zip: 77401 country: United States name: Central contact role: CONTACT lat: 29.70579 lon: -95.45883 facility: Aligos Clinical Study Site 27 status: RECRUITING city: Brownsville state: Texas zip: 78520 country: United States name: Central contact role: CONTACT lat: 25.90175 lon: -97.49748 facility: Aligos Clinical Study Site 28 status: RECRUITING city: Edinburg state: Texas zip: 78504 country: United States name: Central contact role: CONTACT lat: 26.30174 lon: -98.16334 facility: Aligos Clinical Study Site 40 status: RECRUITING city: Farmers Branch state: Texas zip: 75006 country: United States name: Central contact role: CONTACT lat: 32.92651 lon: -96.89612 facility: Aligos Clinical Study Site 20 status: RECRUITING city: San Antonio state: Texas zip: 78015 country: United States name: Central contact role: CONTACT lat: 29.42412 lon: -98.49363 facility: Aligos Clinical Study Site 11 status: RECRUITING city: Waco state: Texas zip: 76633 country: United States name: Central contact role: CONTACT lat: 31.54933 lon: -97.14667 facility: Aligos Clinical Study Site 13 status: RECRUITING city: Manassas state: Virginia zip: 20108 country: United States name: Central contact role: CONTACT lat: 38.75095 lon: -77.47527 facility: Aligos Clinical Study Site 34 status: RECRUITING city: Seattle state: Washington zip: 98039 country: United States name: Central contact role: CONTACT lat: 47.60621 lon: -122.33207 hasResults: False
<\|newrecord\|> nctId: NCT06342934 id: INT157/20 briefTitle: Radiomics and Machine Learning in the Diagnosis of Ovarian Masses acronym: Multi-AROMA overallStatus: COMPLETED date: 2020-07-22 date: 2023-12-31 date: 2023-12-31 date: 2024-04-02 date: 2024-04-02 name: Fondazione IRCCS Istituto Nazionale dei Tumori, Milano class: OTHER briefSummary: The correct differential diagnosis between benign and malignant adnexal masses is the main goal of preoperative ultrasound diagnostics and is very important to plan the correct treatment for the patient in terms of surgical team (gynecologist oncologist or benign pathology center), surgical access (laparoscopy / laparotomy) and type of surgery (conservative / demolitive).
Several ultrasound models have been developed to help gynecologists define the risk of malignancy of adnexal masses. In order to use the predictive models, the examiner had to collect certain ultrasound features of the lesion which, integrated with the patient's clinical and / or biochemical characteristics, provided a risk of malignancy of the mass.
Recently radiomics is emerging as an interesting tool to be applied to diagnostic imaging (computed tomography, magnetic resonance and even ultrasound). Radiomics is the evaluation of images through complex software that allows to 'read' the intrinsic characteristics of the tissue identifying aspects that are not visible by subjective interpretation of the operator, in a fully automated and therefore reproducible way.
Radiomics applied to artificial intelligence for the creation of predictive models represents an interesting tool to overcome the limitations of previous models, at least partly dependent on the operator's experience.
Among the serous ovarian cancer, those with BRCA gene mutation represent an interesting subgroup and are characterized by a different pathophysiological history than wild type tumors due to greater chemosensitivity and the possibility of targeted treatment with antiangiogenic drugs and PARP-inhibitors.
The application of radiomics to preoperative ultrasound images could identify BRCA mutated tumors before surgical planning (radiogenomic analysis) and allow a personalized treatment.
The aim of the study is to validate a predictive model to define the risk of malignancy of adnexal masses that the investigators developed at the Fondazione IRCCS Istituto Nazionale dei Tumori di Milano.
The model, based on the integration of radiomics and artificial intelligence, uses complex software capable of 'reading' the ultrasound images in a completely automatic way and is able to estimate the risk of malignancy of the mass.
If the patient decide to participate in the clinical study, the patient will undergo transvaginal ultrasound (eventually supplemented by transabdominal ultrasound in case of large adnexal masses, if the patients are virgo or if the patients will refuse transvaginal approach for any reason). This exam is part of the routine preoperative evaluation for adnexal pathology and therefore the patients don't have to undergo any additional clinical, biochemical or imaging examination, according to national and international guidelines.
Thereafter, the images stored during the preoperative ultrasound will be exported in anonymous format from the ultrasound system, and sent to the coordinating center (Fondazione IRCCS Istituto Nazionale dei Tumori di Milano). There, images will be submet to radiomic analysis through the application of a dedicated software; that will allow to evaluate the intrinsic characteristics of the tissue according to different parameters (shape, intensity, grade of heterogeneity and many others) of the 'pixels' (gray dots) that constitute the ultrasound image.
This analysis, once validated, will provide clinicians an additional tool to identify malignant adnexal masses prior to surgery.
If the final histological diagnosis is of serous epithelial ovarian cancer, through the use of the same radiomics software described above the investigators will try to identify the intrinsic characteristics of the tissue associated with the presence or absence of the BRCA 1 or 2 mutation conditions: Ovarian Cysts conditions: Ovarian Cancer studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: PROSPECTIVE count: 1000 type: ACTUAL name: Ultrasound measure: Diagnosis of malignant ovarian tumor sex: FEMALE minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Fondazione IRCCS Istituto Nazionale dei Tumori di Milano city: Milano state: Lombardia zip: 20133 country: Italy lat: 45.46427 lon: 9.18951 hasResults: False
<\|newrecord\|> nctId: NCT06342921 id: ADC189-2022-01 briefTitle: ADC189 Tablets on Influenza A Virus Infection/Influenza B Virus Infection acronym: ADC overallStatus: RECRUITING date: 2022-12-07 date: 2024-06-30 date: 2024-06-30 date: 2024-04-02 date: 2024-04-02 name: Jiaxing AnDiCon Biotech Co.,Ltd class: INDUSTRY briefSummary: The goal of this Phase II/III study is to investigate the safty and efficacy of ADC189 tablets in adolescents and adults with influenza A virus infection/influenza B virus infection.
The main aim to answer:
* Phase II study is to evaluate the efficacy of ADC189 tablets in the treatment of adult influenza subjects and determine the optimal therapeutic dose by analyzing the time of virus titer turning to negative. All the results will be used to design the Phase III study.
* Phase III study is to evaluate the efficacy of ADC189 tablets by analyzing the duration of remission of all influenza symptoms in adolescents and adults subjects with influenza.
Participants will be taken ADC189 teblets/Placebo once, and be observed by 22 days.
Phase II study has 3 groups: 15 mg ADC189; 45 mg ADC189; and Placebo; Phase III study has 2 groups: 45 mg ADC189; and Placebo. conditions: Safety Issues conditions: Effect of Drug studyType: INTERVENTIONAL phases: PHASE2 phases: PHASE3 allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: QUADRUPLE whoMasked: PARTICIPANT whoMasked: CARE_PROVIDER whoMasked: INVESTIGATOR whoMasked: OUTCOMES_ASSESSOR count: 675 type: ESTIMATED name: 15 mg ADC189 name: 45 mg ADC189 name: Placebo measure: the severity of influenza measure: the safety of study drug sex: ALL minimumAge: 12 Years maximumAge: 65 Years stdAges: CHILD stdAges: ADULT stdAges: OLDER_ADULT facility: Rui Jin Hospital status: RECRUITING city: Shanghai state: Shanghai country: China name: Haili Liu, Dr role: CONTACT phone: +862134188900 email: rjhfbgs@rjh.com.cn lat: 31.22222 lon: 121.45806 hasResults: False
<\|newrecord\|> nctId: NCT06342908 id: 23-001700 id: NCI-2024-00210 type: REGISTRY domain: CTRP (Clinical Trial Reporting Program) briefTitle: A Vaccine (Neoantigen-Targeted ppDC) for the Treatment of H3 G34-mutant Diffuse Hemispheric Glioma overallStatus: NOT_YET_RECRUITING date: 2024-05-08 date: 2027-03-08 date: 2028-01-09 date: 2024-04-02 date: 2024-04-02 name: Jonsson Comprehensive Cancer Center class: OTHER briefSummary: This phase I trial tests the safety and side effects, and best dose of a vaccine (neoantigen-target ppDC) in treating patients with H3 G34-mutant diffuse hemispheric glioma. Vaccines made from the patient's own white blood cells and peptide-pulsed dendritic cells may help the body build an effective immune response to kill tumor cells. Giving neoantigen-targeted ppDC may be safe, tolerable and/or effective in treating patients with diffuse hemispheric glioma with a H3 G34 mutation. conditions: Diffuse Hemispheric Glioma, H3 G34-Mutant studyType: INTERVENTIONAL phases: PHASE1 allocation: NA interventionModel: SINGLE_GROUP primaryPurpose: TREATMENT masking: NONE count: 6 type: ESTIMATED name: Biospecimen Collection name: Dendritic Cell Therapy name: Leukapheresis name: Magnetic Resonance Imaging name: Poly ICLC measure: Incidence of regimen-limiting toxicities measure: Significant increase in gamma-interferon (IFN) gene expression signature measure: Significant clonal T cell expansion measure: Targets of clonal cytotoxic T cell expansion measure: Pro-inflammatory phenotypic changes in immune cell populations measure: Changes in immune cell subset expansion and contraction in T cell and myeloid-derived cell populations measure: Changes of immune cell markers profile in T cell and myeloid-derived cell populations sex: ALL minimumAge: 18 Years maximumAge: 50 Years stdAges: ADULT facility: UCLA / Jonsson Comprehensive Cancer Center city: Los Angeles state: California zip: 90095 country: United States name: Sichen C. Li role: CONTACT phone: 310-592-9091 email: sichenli@mednet.ucla.edu name: Anthony C. Wang, MD role: PRINCIPAL_INVESTIGATOR lat: 34.05223 lon: -118.24368 hasResults: False
<\|newrecord\|> nctId: NCT06342895 id: 2020_1113 id: 2022-A00103-40 type: OTHER domain: ID-RCB number, ANSM briefTitle: Interpretation and Optimization of Nutrition in the Intensive Care Units acronym: IONIC overallStatus: RECRUITING date: 2024-04-10 date: 2025-04 date: 2025-09 date: 2024-04-02 date: 2024-04-25 name: Dim3 class: INDUSTRY name: Baxter Healthcare Corporation name: University Hospital, Lille briefSummary: Despite recommendations, inadequate nutritional intake in intensive care unit (ICU) patients remains frequent and can lead to complications such as infections, increased length of stay, prolonged weaning from ventilation, increased long-term mortality, and decreased quality of life after intensive care. Studies have shown that patients only receive up to 50-60% of prescribed calories and proteins due to many factors leading to nutritional support interruptions such as ICU procedures, physical therapy, transport for imaging or invasive procedures outside the ICU, and nutrition intolerance.
Furthermore, this discrepancy between prescribed and delivered nutrition may go largely unnoticed, due to issues concerning inadequate manual or automated monitoring of delivered nutrition. A joint "Call to Action" by ASPEN, the Academy of Nutrition and Dietetics, and the American Society of Health-System Pharmacists stated that parenteral nutrition errors and their contributing factors could be prevented by improving the functionality of in-house Clinical Decision Support Systems and the interfaces between electronic health records (EHRs), automated preparation devices and pharmacy systems.
Nutrow® is a software package designed to support nutritional management based on the calculation of recommended calorie and protein requirements, real-time calculation and monitoring of calorie and protein prescriptions, real-time calculation and monitoring of calories and protein truly delivered to patients, and information feedback to prescribers. Feedim® is a Medical Device Data System (MDDS), designed by Dim3, which transmits information from enteral feeding pumps to third-party software, such as Nutrow®.
The aim of the study is to assess whether the joint use of Nutrow-Feedim improves the achievement of nutritional objectives in ICU patients prior to oral intake by reducing the discrepancy between prescribed and delivered calories and protein. conditions: Nutritional Support studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL interventionModelDescription: Usual use of standard clinical and biological information related to nutritional support as available through the ICU electronic health record (i.e. without any calculated information on recommended, prescribed, or received calories and protein, only information on prescribed products and volumes as collected by and presented in the ICU EHR) In this arm, participants, investigators, and healthcare professionals will be blinded to real-time enteral feed volumes that will be collected by the Feedim medical device and transmitted to the electronic study case report form. primaryPurpose: SUPPORTIVE_CARE masking: NONE count: 144 type: ESTIMATED name: Nutritional support prescription and delivery monitoring feedback name: Usual care measure: Mean total daily calories delivered/prescribed ratio (percent) measure: Mean total daily protein delivered/prescribed ratio (%) measure: Mean total daily calories delivered/recommended ratio (percent) measure: Mean total daily protein delivered/recommended ratio (percent) measure: Nutritional support duration (days) measure: Time to initiation of nutritional support (days) measure: Weight (Kg) measure: Day 28 mortality rate measure: ICU length-of-stay (days) measure: Days on ventilator (days) sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: University Hospital Lille status: RECRUITING city: Lille zip: 59037 country: France name: Eric KIPNIS, MD, PhD role: CONTACT phone: +33 (0)3 20 44 59 62 email: eric.kipnis@chu-lille.fr lat: 50.63297 lon: 3.05858 hasResults: False
<\|newrecord\|> nctId: NCT06342882 id: GO 19/833- A briefTitle: Dysphagia Severity and Functional Independence Level overallStatus: COMPLETED date: 2020-01-01 date: 2024-01-01 date: 2024-02-01 date: 2024-04-02 date: 2024-04-02 name: Atılım University class: OTHER briefSummary: Functional independence is the ability of a person to perform daily life activities safely without any restriction, as much as possible. The functional independence depends on physical, social, cognitive and psychological abilities of the person. Therefore, full functional independence requires the harmony of all these parameters.
Dysphagia can be seen in more than 50% of neurological patients, and it is called neurogenic dysphagia. Muscle weakness, tonus changes, sensory loss and coordination problems occur in these patients. Pain and fatigue are also frequently observe. These patients have problems with fine and gross motor movements, and thereby mobility and transfer activities become difficult. Life-threatening complications such as pulmonary problems, malnutrition and dehydration accompany when patients have dysphagia. Both neurological and dysphagia-related problems negatively affect the physical, psychological, emotional and cognitive functions of patients. Neurological patients with dysphagia may have more serious clinical situations due to more affected vital functions such as pulmonary functions and feeding.
Dysphagia-induced malnutrition adversely affects many systems, including the musculoskeletal system. In a study conducted in the elderly with dysphagia, atrophy in the total muscle mass and swallowing muscles, and increase in intramuscular adipose tissue were reported as a result of malnutrition. Decreases in the muscle mass may negatively affect the functional independence of patients with dysphagia. Other studies in geriatric population have shown that swallowing function is associated with hand grip strength and quadriceps muscle strength, which are indicators of functional independence in activities of daily living (ADL). These studies also suggest that dysphagia may be associated with functional independence in geriatric group. Therefore, functional independence may also reduce in patients with neurogenic dysphagia. However, there is no study investigating the relationship between dysphagia severity and the functional independence levels in patients with neurological diseases. Therefore, the investigators aimed to investigate the relationship between dysphagia severity and functional independence level in patients with neurological diseases. conditions: Dysphagia conditions: Neurologic Disorder studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: CROSS_SECTIONAL count: 30 type: ACTUAL name: dysphagia assessment name: functional independence level measure: dysphagia severity measure: functional independence sex: ALL minimumAge: 18 Years maximumAge: 65 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Atılım Uiveristy city: Ankara state: Incek zip: 06830 country: Turkey lat: 39.91987 lon: 32.85427 hasResults: False
<\|newrecord\|> nctId: NCT06342869 id: 690 briefTitle: Comparison of the Effects of Lidocaine and Articaine Used for Buccal Infiltration and Supplemental Palatinal Infiltration Anesthesia in Teeth With Irreversible Pulpitis overallStatus: COMPLETED date: 2022-04-01 date: 2022-10-01 date: 2022-12-01 date: 2024-04-02 date: 2024-04-02 name: Akdeniz University class: OTHER briefSummary: Objective: The aim of this study was to compare the effects of articaine or lidocaine in buccal infiltration or palatal infiltration in addition to buccal infiltration in maxillary first or second molars with irreversible pulpitis.
Method: Among the patients who applied to Akdeniz University Faculty of Dentistry Endodontic Clinic for the treatment of maxillary molars with irreversible pulpitis, 80 volunteers who met the criteria were included in the study. Eighty patients were divided into 4 groups (n = 20). 1. group buccal infiltration with 4% articaine containing 1:100,000 epinephrine, 2. group buccal infiltration with 2% lidocaine containing 80,000 epinephrine, 3. group buccal and palatinal infiltration with 4% articaine containing 1:100,000 epinephrine, 4.group buccal and palatinal infiltration with 2% lidocaine containing 80.000 epinephrine. Pain during the endodontic procedure was determined and recorded according to the Heft Parker visual analog scale. conditions: Fist and Second Molars With ırreversible Pulpitis studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: SINGLE_GROUP primaryPurpose: TREATMENT masking: DOUBLE whoMasked: PARTICIPANT whoMasked: INVESTIGATOR count: 80 type: ACTUAL name: Anesthesia measure: Assessment of complementary palatinal anesthesia with VAS sex: ALL minimumAge: 18 Years maximumAge: 65 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Akdeniz University city: Antalya zip: 07070 country: Turkey lat: 36.90812 lon: 30.69556 hasResults: False
<\|newrecord\|> nctId: NCT06342856 id: idiopathic infertility briefTitle: Evaluation of Treatment With Coenzyme Q10 and L-Carnitine on Semen Parameters in Infertile Men With Idiopathic Oligoasthenoteratospermia acronym: infertility overallStatus: RECRUITING date: 2023-06-15 date: 2024-06-01 date: 2024-07-01 date: 2024-04-02 date: 2024-04-02 name: Ain Shams University class: OTHER briefSummary: Evaluation of treatment with Coenzyme Q10 and L-Carnitine on Semen Parameters in Infertile men with Idiopathic Oligoasthenoteratospermia conditions: Infertility Unexplained conditions: Oligospermia studyType: INTERVENTIONAL phases: EARLY_PHASE1 allocation: RANDOMIZED interventionModel: CROSSOVER primaryPurpose: TREATMENT masking: NONE count: 120 type: ESTIMATED name: co enzyme Q10 , L- Carnitine measure: Changes in Semen analysis parameters compared to baseline measure: Serum hormone levels ([FSH], [LH], testosterone, and prolactin) levels compared to baseline and Cost analysis sex: MALE stdAges: CHILD stdAges: ADULT stdAges: OLDER_ADULT facility: Ain Shams University status: RECRUITING city: Cairo zip: 002 country: Egypt name: ahmed ma maher, lecturer role: CONTACT phone: 01013340534 email: drwaleedabdelhamid@gmail.com lat: 30.06263 lon: 31.24967 hasResults: False
<\|newrecord\|> nctId: NCT06342843 id: SPLAsH id: NL81395.075.22 type: OTHER domain: CCMO briefTitle: Direct Superior Approach Versus PosteroLateral Approach in Total Hip Arthroplasty (SPLAsH) acronym: SPLAsH overallStatus: RECRUITING date: 2024-02-13 date: 2026-08-30 date: 2026-11-30 date: 2024-04-02 date: 2024-04-02 name: Isala class: OTHER briefSummary: This study will compare postoperative pain, health related quality of life (HRQoL), function, rehabilitation, urinary incontinence, muscle atrophy and component positioning in total hip arthroplasty (THA) using the posterolateral approach (PLA) or the direct superior approach (DSA). In addition, the CT images will be used to validate a new metal artefact reduction technique. conditions: Osteoarthritis, Hip studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL interventionModelDescription: multicenter, prospective, double blinded, randomized controlled intervention study primaryPurpose: TREATMENT masking: DOUBLE whoMasked: PARTICIPANT whoMasked: INVESTIGATOR count: 211 type: ESTIMATED name: Total Hip Arthroplasty measure: Hip disability and Osteoarthritis Outcome Score - Physical Function Short Form measure: Numeric Rating Scale (NRS) measure: Short Form-12 (SF-12) measure: Hip disability and Osteoarthritis Outcome Score (HOOS) measure: Euro Quality of Life (EQ-5D) measure: Global Rating of Change scale measure: Timed Up and Go test (TUG test) measure: 40 meter self-paced walk test for hip osteoarthritis measure: Stair climb test measure: Step count application on iPhone measure: Muscle atrophy by using Computer Tomography (CT) scanner measure: Computer Tomography (CT) image with orthopedic metal artefact reduction (O-MAR) measure: Postoperative cup position on Computer Tomography (CT) image measure: Comparing definite cup position with preoperative planned cup position measure: Comparing definite component position with surgeon's perioperative estimation of component position measure: overall image quality measure: image diagnostic confidence measure: metal artifacts on images measure: Incontinence Severity Index (ISI) measure: Urinary Distress Inventory, Short Form (UDI-6) measure: Patient Global Impression of Severity (PGIS) measure: Incontinence Impact Questionnaire Short Form (IIQ-7) measure: Incontinence after Total Hip Arthroplasty sex: ALL minimumAge: 18 Years maximumAge: 99 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Amphia status: NOT_YET_RECRUITING city: Breda state: Brabant zip: 4818CK country: Netherlands name: Stefan BT Bolder, MD role: CONTACT lat: 51.58656 lon: 4.77596 facility: Medisch Centrum Leeuwarden status: NOT_YET_RECRUITING city: Leeuwarden state: Friesland zip: 8934AD country: Netherlands name: Wierd Zijlstra, MD/PhD role: CONTACT lat: 53.20139 lon: 5.80859 facility: Isala status: RECRUITING city: Zwolle state: Overijssel zip: 8000 GK country: Netherlands name: Diederik de Boer, MSc. role: CONTACT phone: 00316248117 email: die.de.boer@isala.nl name: Roelina Munnik, PhD role: CONTACT phone: 00316245375 email: r.munnik@isala.nl name: Harmen Ettema, MD/PhD role: PRINCIPAL_INVESTIGATOR lat: 52.5125 lon: 6.09444 hasResults: False
<\|newrecord\|> nctId: NCT06342830 id: End 20-05 P briefTitle: Comparing the Effect of Different Intracanal Dressing on Failed Root Canal Treated Cases on Periapical Healing overallStatus: NOT_YET_RECRUITING date: 2024-04 date: 2024-12 date: 2025-05 date: 2024-04-02 date: 2024-04-08 name: Ain Shams University class: OTHER briefSummary: The goal of this clinical trial is to compare the effects of different intracanal medication between endodontic retreatment visits in previously failed root canal treatment patients (single root canal anteriors or premolars teeth). The main question it aims to answer are:
* Is natural and synthetic intracanal Medicament effective in reducing or complete healing of Periapical lesions or not? the researchers will compare the effect of different intracanal dressing including:
* nanocurcumin gel
* curcumin gel
* ciprofloxacin +ibuprofen gel
* calcium hydroxide Paste as control group in between the endodontic retreatment visits to see if these medicaments work well on periapical lesion healing this outcome measured by Cone beam CT at base and after 6 months follow up periods conditions: Periapical Disease studyType: INTERVENTIONAL phases: PHASE2 allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: DOUBLE whoMasked: PARTICIPANT whoMasked: INVESTIGATOR count: 80 type: ESTIMATED name: nanocurcumin gel name: Curcumin Gel name: Ciprofloxacin 500 mg +ibuprofen 400mg name: Metapaste [calcium hydroxide paste (control group)] measure: healing of periapical lesion measure: antibacterial effect (CFU) measure: Interappointment Pain sex: ALL minimumAge: 20 Years maximumAge: 60 Years stdAges: ADULT facility: faculty of dentistry, Ain shams university city: Cairo zip: 11512 country: Egypt name: Rawda Baghdady role: CONTACT phone: 01142361074 email: RawdaBaghdady@dent.asu.edu.eg name: sarah H Fahmy role: CONTACT phone: 01005267999 name: Rawda M Baghdady, PHD student role: PRINCIPAL_INVESTIGATOR lat: 30.06263 lon: 31.24967 typeAbbrev: Prot_SAP hasProtocol: True hasSap: True hasIcf: False label: Study Protocol and Statistical Analysis Plan date: 2020-09-20 uploadDate: 2024-03-01T05:02 filename: Prot_SAP_000.pdf size: 719008 typeAbbrev: ICF hasProtocol: False hasSap: False hasIcf: True label: Informed Consent Form date: 2020-09-20 uploadDate: 2024-03-01T05:04 filename: ICF_001.pdf size: 284949 hasResults: False
<\|newrecord\|> nctId: NCT06342817 id: UFFS briefTitle: Effects of Meditation on Sleep Quality of Medical Students overallStatus: RECRUITING date: 2023-10-18 date: 2024-06-30 date: 2024-06-30 date: 2024-04-02 date: 2024-04-02 name: Universidade Federal da Fronteira Sul class: OTHER briefSummary: The objective of the study is to evaluate the effect of an 8-week online mindfulness-based meditation program on quality sleep status of undergraduate students medicine in the city of Passo Fundo/RS and Chapecó/SC In addition to sleep quality, secondary outcomes such as mindfulness, symptoms of depression, stress, anxiety and burnout will also be assessed conditions: Sleep Disorder studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL interventionModelDescription: Those students interested in participating in the study will leave their contact details (telephone and email) to the research coordinator, to whom it will be sent an online questionnaire containing the inclusion and exclusion criteria, and the free consent form through the Google forms platform. Collection instruments will only be made available after fulfilling the inclusion criteria and absence of exclusion criteria and agreement with the consent form. Responders will be randomly randomized 1:1 and subsequently communicated whether they will participate in the intervention group or the control group. primaryPurpose: SUPPORTIVE_CARE masking: NONE maskingDescription: Responders will be randomly randomized 1:1 and subsequently communicated whether they will participate in the intervention group or the control group. count: 136 type: ESTIMATED name: online mindfulness based meditation program measure: Change in the quality of sleep of medical students on weeks 5, 9 and 17 by the PSQI and ESE measure: Change in the awareness of medical students on weeks 5, 9 and 17 by the MAAS measure: Change in the depression, anxiety and stress symptoms of medical students on weeks 5, 9 and 17 by the DASS-21 measure: Change in the burnout symptoms of medical students on weeks 5, 9 and 17 by CBI-S sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Universidade Federal Da Fronteira Sul status: RECRUITING city: Passo Fundo state: RS zip: 99010200 country: Brazil name: Tiago T Simon, MD role: CONTACT phone: +5554991843384 email: tiago.teixeira@uffs.edu.br lat: -28.26278 lon: -52.40667 hasResults: False
<\|newrecord\|> nctId: NCT06342804 id: GIB-01-02-2023 briefTitle: Food Effect on the Bioavailability of 4-MUST, Tablets, 128 mg overallStatus: RECRUITING date: 2024-03-19 date: 2024-12-31 date: 2024-12-31 date: 2024-04-02 date: 2024-04-02 name: Valenta Pharm JSC class: INDUSTRY briefSummary: Primary objective of the study: evaluation of the effect of food intake on the bioavailability of 4-MUST, tablets, 128 mg (Valenta Pharm JSC) after a single oral administration on an empty stomach and after a meal, at a dose of 256 mg (two tablets).
Additional aim of the study: evaluation of pharmacokinetic parameters, safety and tolerability of 4-MUST, tablets, 128 mg (Valenta Pharm JSC) in healthy volunteers after a single oral administration on an empty stomach and after a meal, at a dose of 256 mg (two tablets). conditions: Cholecystitis studyType: INTERVENTIONAL phases: PHASE1 allocation: RANDOMIZED interventionModel: CROSSOVER primaryPurpose: OTHER masking: NONE count: 24 type: ESTIMATED name: 4-MUST, 2 tablets, fasted name: 4-MUST, 2 tablets, after meals measure: Pharmacokinetics - Cmax measure: Pharmacokinetics - tmax measure: Pharmacokinetics - AUC0-t measure: Pharmacokinetics - AUC0-inf measure: Pharmacokinetics - AUC ratio measure: Pharmacokinetics - t1/2 measure: Pharmacokinetics - kel measure: Pharmacokinetics - MRT measure: Pharmacokinetics - Vd measure: Pharmacokinetics - Cmax/AUC0-t measure: Pharmacokinetics - f' measure: Pharmacokinetics - f'' measure: Bioavailability - ratio of Cmax measure: Bioavailability - ratio of AUC0-t measure: Bioavailability - ratio of AUC0-inf measure: Adverse event type measure: Adverse event frequency measure: Adverse event severety measure: Drop-outs associated with adverse events sex: ALL minimumAge: 18 Years maximumAge: 45 Years stdAges: ADULT facility: Federal Budgetary Institution of Science "North-Western Scientific Center for Hygiene and Public Health" status: RECRUITING city: Saint Petersburg zip: 191036 country: Russian Federation name: Elena S Shalukho, MD role: CONTACT phone: +7 (903) 099 57 86 email: elena.shalukho@yandex.ru lat: 59.93863 lon: 30.31413 hasResults: False
<\|newrecord\|> nctId: NCT06342791 id: 004349 briefTitle: Effect of Laser Acupuncture on Menstrual Back Pain overallStatus: RECRUITING date: 2024-02-20 date: 2024-05-20 date: 2024-06-20 date: 2024-04-02 date: 2024-04-02 name: Cairo University class: OTHER briefSummary: effect of laser acupuncture on menstrual back pain conditions: Laser Acupuncture conditions: Low Back Pain conditions: Menstruation studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL interventionModelDescription: two groups primaryPurpose: TREATMENT masking: SINGLE maskingDescription: laser acupuncture whoMasked: PARTICIPANT count: 32 type: ESTIMATED name: laser acupuncture measure: back Pain intensity during menstruation measure: pain threshold measure: Ability to perform daily activities measure: back Pain intensity during menstruation measure: pain threshold measure: Ability to perform daily activities sex: FEMALE minimumAge: 20 Years maximumAge: 30 Years stdAges: ADULT facility: Faculty of physical therapy cairo university status: RECRUITING city: Cairo zip: 37617692 country: Egypt name: Mai Ali Galal El sayed role: CONTACT phone: 01152457470 email: Princessmai828@gmail.com lat: 30.06263 lon: 31.24967 hasResults: False
<\|newrecord\|> nctId: NCT06342778 id: DIP-05-02-2023 briefTitle: Pharmacokinetics and Bioequivalence of Doxylamine+Pyridoxine and Diclectin overallStatus: RECRUITING date: 2024-02-27 date: 2024-12-31 date: 2024-12-31 date: 2024-04-02 date: 2024-04-02 name: Valenta Pharm JSC class: INDUSTRY briefSummary: Comparative study of pharmacokinetics and bioequivalence of the study drug Doxylamine + Pyridoxine, enteric-soluble, film-coated tablets, 10 mg + 10 mg (Valenta Pharm JSC, Russia), and reference drug Diclectin, delayed-release tablets, 10 mg + 10 mg (registration certificate holder - Tzamal Bio-Pharma, Israel, manufacturer - Duchesnay Inc, Canada) in healthy volunteers after meals conditions: Nausea studyType: INTERVENTIONAL phases: PHASE1 allocation: RANDOMIZED interventionModel: CROSSOVER primaryPurpose: OTHER masking: NONE count: 28 type: ESTIMATED name: Doxylamine + Pyridoxine name: Diclectin measure: Pharmacokinetics - Cmax measure: Pharmacokinetics - tmax measure: Pharmacokinetics - AUC0-t measure: Pharmacokinetics - AUC0-inf measure: Pharmacokinetics - AUCextr measure: Pharmacokinetics - t1/2 measure: Pharmacokinetics - kel measure: Pharmacokinetics - MRT measure: Bioequivalence - ratio of Cmax measure: Bioequivalence - ratio of AUC0-t measure: Bioequivalence - ratio of AUC0-inf measure: Adverse event type measure: Adverse event frequency measure: Adverse event severety sex: FEMALE minimumAge: 18 Years maximumAge: 49 Years stdAges: ADULT facility: GBOU VPO "Yaroslavl State Medical University" of Ministry of Health of Russian Federation status: RECRUITING city: Yaroslavl zip: 150000 country: Russian Federation name: Sergey M Noskov, Prof. role: CONTACT phone: +7-4852-242332 email: Noskov-SM@mail.ru lat: 57.62987 lon: 39.87368 hasResults: False
<\|newrecord\|> nctId: NCT06342765 id: SV009 briefTitle: Safety and Performance of the SpineVision Posterior Fixation Systems in Thoracolumbar Spinal Treatment acronym: FixedD3 overallStatus: RECRUITING date: 2022-09-22 date: 2028-05-30 date: 2028-05-30 date: 2024-04-02 date: 2024-04-03 name: SpineVision class: INDUSTRY name: Slb Pharma briefSummary: The goal of this observational study is to confirm the safety and performance of the three (3) Spinevision posterior fixations systems Lumis®, Plus® and Ulis® , in the treatment of patient suffering from thoracolumbar spinal degenerative pathologies, or degenerative disc disease (disease that occurs when the spinal disk break down) associated pathologies.
Part of their standard of care, participants will be questioned on their back and leg pains, their disability and if they have encountered any adverse effects since the Spinevision posterior fixation system implant surgery. Those data will be collected up to twenty four (24) months after the Spinevision posterior fixation system implant surgery. conditions: Intervertebral Disc Degeneration studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: OTHER count: 330 type: ESTIMATED name: Pedicle fixation surgery measure: Incidence of serious and non-serious device- and/or procedure-related adverse events measure: Change of the Oswestry Disability Index (ODI) measure: Fusion success measure: Change of the Oswestry Disability Index (ODI) measure: Change of the back and leg Visual Analogue Score (VAS) measure: Incidence of revision surgery at implant site sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: DOSCEA Pôle Rachis status: RECRUITING city: Bayonne zip: 64100 country: France name: Jean Bernard role: CONTACT email: secretariatdoscea@outlook.fr lat: 43.48333 lon: -1.48333 facility: Clinique du dos Bordeaux-Terrefort status: RECRUITING city: Bruges zip: 33520 country: France name: Louis Boissière, Doctor role: CONTACT email: boissierelouis@gmail.com lat: 44.87981 lon: -0.61219 facility: Orthéo Neurochirurgie status: RECRUITING city: Saint-Étienne zip: 42199 country: France name: Benjamin Pommier, Doctor role: CONTACT email: benjamin.pommier@neurochirurgie.fr lat: 45.43389 lon: 4.39 hasResults: False
<\|newrecord\|> nctId: NCT06342752 id: 6007 briefTitle: The Role of VOCs, Airway Mucins and Airway Microbiome in Bronchopulmonary Dysplasia acronym: INFANCY overallStatus: NOT_YET_RECRUITING date: 2024-04 date: 2026-09 date: 2027-09 date: 2024-04-02 date: 2024-04-02 name: University Hospital, Antwerp class: OTHER briefSummary: Bronchopulmonary dysplasia (BPD), the most common respiratory complication of extremely preterm birth, significantly impacts healthcare with high morbidity and mortality rates.
Despite the well-established primordial role of inflammation and oxidative stress in the development of BPD, clinical practice does not incorporate the testing for biomarkers associated with the development of BPD. The diagnosis of BPD based on required respiratory support at 36 weeks PML, stresses the need for an early prediction tool which could identify patients with high levels of these biomarkers. This on its turn, could also improve treatment approaches in clinical practice which are currently mostly supportive or non-specific and do not target underlying pathophysiologic pathways.
Secondly, mucin expression aim to play a rol in other respiratory diseases, whereas in BPD only the potential role of MUC1 was explored.
Thirdly, the composition of the airway microbial composition of an infant is assumed to be influenced by different factors. From early on in pregnancy the airway microbiome of the infant is formed, offering a protective role against pathologies. On the other hand, the role of the airway microbiome in the development of BPD remains unclear and needs to be elucidated.
The threefold aim of this study is as follows:
I. The development of a non-invasive breath test that allows early detection of bronchopulmonary dysplasia, using the potential of VOCs in exhaled breath as biomarkers for inflammation and oxidative stress.
II. The exploration of the composition and diversity of the airway microbiome in infants with BPD, their association with exhaled VOCs and the exploration of the placental and vaginal microbiome.
III. The detection of potential alterations in airway mucin expression in BPD patients.
Through this comprehensive approach, we seek to gain a deeper understanding of how these mutual associations may contribute to the later development of BPD.
In total 140 preterm infants, including 70 BPD patients and 70 preterm controls, born below 30 weeks' gestation at the Antwerp University Hospital will be included. conditions: Bronchopulmonary Dysplasia studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: PROSPECTIVE count: 140 type: ESTIMATED name: Breath test name: Throat swabs name: Placental samples name: Vaginal swab name: Endotracheal aspirates measure: Exhaled breath Volatile Organic Compounds (VOCs) measure: Airway mucin profiles measure: Airway microbial profiles measure: Placental headspace VOCs measure: Placental microbiome measure: Vaginal microbiome measure: Follow-up structural lung imaging measure: Hypercapnia sex: ALL minimumAge: 0 Days maximumAge: 3 Days stdAges: CHILD hasResults: False
<\|newrecord\|> nctId: NCT06342739 id: IEO 1595 briefTitle: Verbal Synchrony, Satisfaction and Decision-making in Face-to-face Consultations overallStatus: RECRUITING date: 2022-03-23 date: 2024-12-31 date: 2024-12-31 date: 2024-04-02 date: 2024-04-02 name: European Institute of Oncology class: OTHER briefSummary: Eligible participants will be: benign thyroid nodules patients, to be involved in a consultation with their endocrinologist and/or surgeon and/or radiologist, in order to discuss treatment options related to benign thyroid nodules. conditions: Thyroid Nodule studyType: OBSERVATIONAL observationalModel: CASE_ONLY timePerspective: PROSPECTIVE count: 60 type: ESTIMATED measure: Evaluation of predictive power of verbal synchrony established between patient and physician during the consultation on patients' satisfaction sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: European Institute of Oncology status: RECRUITING city: Milan country: Italy name: Gabriella Pravettoni role: CONTACT lat: 45.46427 lon: 9.18951 hasResults: False
<\|newrecord\|> nctId: NCT06342726 id: 2024/714469 briefTitle: The Effect of Active External Rewarming on Rewarming Rate in Simulated Prehospital Accidental Hypothermia overallStatus: RECRUITING date: 2024-05-28 date: 2024-06-02 date: 2024-06-02 date: 2024-04-02 date: 2024-04-02 name: Haukeland University Hospital class: OTHER briefSummary: In this study, we aim to compare the effect of active external rewarming to passive rewarming in healthy research participants on core temperature.
The participants will be cooled to a core temperature of 35 degress C, the rewarmed using 2 different scenarios. Scenario 1 will be with passive rewarming, scenario 2 with active rewarming. Shivering will be pharmacologically inhibited using Buspirone and Meperidine. conditions: Accidental Hypothermia studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: CROSSOVER interventionModelDescription: The study will use a crossover design on where research participants will undergo repetitions of the same scenario with different interventions in order to serve as their own control. The research participants will be healthy volunteers providing both oral and written consent.
Before the start of experiment, the research participant will be cooled in an ice cave wearing wet clothing and with 2-3 m/s wind to a core temperature of 35.0 °C using the established protocol for inhibition of shivering. The maximum cooling time will be 2 hours (120 minutes). The order of interventions will be randomized.
When the research subjects reach the target temperature of 35.0°C or the maximum cooling time of 2 hours, they will be subjected to one of the two scenarios listed below, with a rewarming phase of maximum 60 minutes. primaryPurpose: TREATMENT masking: TRIPLE whoMasked: PARTICIPANT whoMasked: INVESTIGATOR whoMasked: OUTCOMES_ASSESSOR count: 12 type: ESTIMATED name: PAX Warming Blanket name: Passive insulation measure: Core body temperature sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Haukeland University Hospital status: RECRUITING city: Bergen zip: 5021 country: Norway name: Sigurd Mydske, MD role: CONTACT phone: 90659586 email: sigurd.mydske@norskluftambulanse.no name: Øyvind Thomassen, MD, PhD role: CONTACT phone: 977 18 721 email: oyvind.thomassen1@helse-bergen.no lat: 60.39299 lon: 5.32415 hasResults: False
<\|newrecord\|> nctId: NCT06342713 id: BGB-45035-101 briefTitle: A Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of Single- and Multiple-Ascending Doses and Food Effect of BGB-45035 overallStatus: NOT_YET_RECRUITING date: 2024-05-28 date: 2025-04-30 date: 2025-04-30 date: 2024-04-02 date: 2024-04-02 name: BeiGene class: INDUSTRY briefSummary: This study is the first-in-human (FIH) study for BGB-45035. The study will evaluate the safety, tolerability, pharmacokinetics, and pharmacodynamics of BGB-45035 with both a single dose and multiple doses administered at different dose levels in healthy participants.
Study details include:
* The study duration will be up to 16 months.
* The treatment duration will be up to 14 days.
* Safety follow-up 30 days after last dose of study drug. conditions: Healthy Participants conditions: Healthy Subjects conditions: Healthy Volunteers conditions: Autoimmune Diseases conditions: Healthy Adult Participants studyType: INTERVENTIONAL phases: PHASE1 allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: DOUBLE maskingDescription: The cohorts in Part A, B, and C will be double-blinded, while the food effect study in Part D will be open-label whoMasked: PARTICIPANT whoMasked: CARE_PROVIDER count: 92 type: ESTIMATED name: BGB-45035 name: Placebo measure: Number of Participants Experiencing Adverse Events (AEs) measure: Number of participants with clinically significant changes from baseline in clinical laboratory values measure: Number of participants with clinically significant changes from baseline in vital signs measure: Number of participants with clinically significant changes from baseline in cardiac conduction intervals measure: Area under the plasma concentration time curve from time zero to last quantifiable time(AUClast) measure: Area under the plasma concentration time curve from time zero to infinite time (AUCinf) measure: Area under the plasma concentration time curve from time zero to end of dosing interval (AUCtau) measure: Maximum observed plasma concentration (Cmax) measure: Time to maximum plasma concentration (Tmax) measure: Trough plasma concentration (Ctrough) measure: Half life (t½) measure: Apparent systemic clearance (CL/F) measure: Apparent volume of distribution (Vz/F) measure: Accumulation Ratios sex: ALL minimumAge: 18 Years maximumAge: 55 Years stdAges: ADULT hasResults: False
<\|newrecord\|> nctId: NCT06342700 id: PKM18138 id: U1111-1299-1906 type: REGISTRY domain: ICTRP briefTitle: A Food Effect and Relative Bioavailability Study of Rilzabrutinib in Healthy Participants overallStatus: RECRUITING date: 2024-03-25 date: 2024-04-29 date: 2024-04-29 date: 2024-04-02 date: 2024-04-11 name: Sanofi class: INDUSTRY briefSummary: This is a cross-over, Phase 1, 4-arm study. The purpose of this study is to measure the relative bioavailability and food effect of crystalline formulation rilzabrutinib and amorphous formulation rilzabrutinib in healthy male and female participants aged 18 to 55 years of age.
The total study duration per participant is expected to be up to 36 days, including:
* Screening: up to 4 weeks
* Treatment periods: once successfully screened, enrolled participants will be randomized to 1 of 4 treatment sequences with 4 single dose treatment periods.
* Washout: One day washout is planned after each treatment period hence providing 2 days between doses.
* Safety follow-up: participants will be asked to participate in an end-of-study safety assessment upon discharge from the clinical study unit, ie, on Day 8 of the study. conditions: Autoimmune Disorder conditions: Healthy Volunteers studyType: INTERVENTIONAL phases: PHASE1 allocation: RANDOMIZED interventionModel: CROSSOVER primaryPurpose: BASIC_SCIENCE masking: NONE count: 28 type: ESTIMATED name: Rilzabrutinib crystalline form name: Rilzabrutinib amorphous form measure: Relative bioavailability as assessed by rilzabrutinib Cmax following administration of the test and reference formulations in the fasted state measure: Relative bioavailability as assessed by rilzabrutinib AUClast following administration of the test and reference formulations in the fasted state measure: Relative bioavailability as assessed by rilzabrutinib AUC following administration of the test and reference formulations in the fasted state measure: Relative bioavailability as assessed by rilzabrutinib Cmax following administration of the test and reference formulations in the fed state measure: Relative bioavailability as assessed by rilzabrutinib AUClast following administration of the test and reference formulations in the fed state measure: Relative bioavailability as assessed by rilzabrutinib AUC following administration of the test and reference formulations in the fed state measure: Food effects as assessed by rilzabrutinib Cmax following administration of the test and reference formulations under the fed versus fasted state measure: Food effects as assessed by rilzabrutinib AUClast following administration of the test and reference formulations under the fed versus fasted state measure: Food effects as assessed by rilzabrutinib AUC following administration of the test and reference formulations under the fed versus fasted state measure: Number of participants with adverse events, treatment-emergent adverse events, serious adverse events and adverse events of special interest sex: ALL minimumAge: 18 Years maximumAge: 55 Years stdAges: ADULT facility: Nucleus Network Site Number : 8400001 status: RECRUITING city: Saint Paul state: Minnesota zip: 55114 country: United States lat: 44.94441 lon: -93.09327 hasResults: False
<\|newrecord\|> nctId: NCT06342687 id: JagiellonianU 1 briefTitle: Compliance With ERAS and Five Year Survival After Colorectal Cancer Treatment overallStatus: COMPLETED date: 2018-01-01 date: 2022-12-31 date: 2023-12-31 date: 2024-04-02 date: 2024-04-02 name: Jagiellonian University class: OTHER briefSummary: The Enhanced Recovery after Surgery (ERAS) protocol has transformed perioperative care, representing a significant paradigm shift in managing colorectal cancer patients. While the immediate benefits of Enhanced Recovery After Surgery (ERAS) in expediting postoperative recovery are well-documented and widely acknowledged, it is essential to investigate its long-term implications, particularly its influence on survival rates. The aim of this study will be to analyse the impact of compliance with the ERAS protocol on long- term outcomes after laparoscopic colorectal resection. conditions: Colorectal Cancer conditions: ERAS studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: RETROSPECTIVE count: 468 type: ACTUAL name: High compliance with ERAS protocol measure: Post operative 5 year survival rate sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Jagiellonian University Medical College city: Kraków state: Małopolskie zip: 31-008 country: Poland lat: 50.06143 lon: 19.93658 hasResults: False
<\|newrecord\|> nctId: NCT06342674 id: Nejla CANBULAT ŞAHİNER briefTitle: Effect of Breast Milk Circadian Properties on Infant's Growth Parameters and Absorption of Nutrients acronym: The overallStatus: NOT_YET_RECRUITING date: 2024-04-01 date: 2024-04-01 date: 2025-07-31 date: 2024-04-02 date: 2024-04-02 name: Sakarya University class: OTHER briefSummary: The most ideal method for providing breast milk is breastfeeding. However, it may be necessary to express breast milk for reasons such as the newborn being in an intensive care unit, the mother being hospitalized for any reason, or the mother starting to work. The content of breast milk varies according to gestational age and stages of lactation. However, it varies from day to day depending on the infant's needs. In recent literature, it is emphasized that the content of breast milk (carbohydrates, fats, proteins, vitamins, trace elements, etc.) varies according to circadian variation. In the literature review, no national or international study was found indicating whether the circadian properties of breast milk have an effect on the infant's growth parameters. This study was designed as a randomized controlled experimental study to determine the effect of the circadian properties of breast milk on the growth parameters of the infant and the absorption levels of nutrients by the baby in preterm newborns.

Subsets and Splits

No community queries yet

The top public SQL queries from the community will appear here once available.