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Participation requires completing surveys by email, text message, in person, and/or by telephone. Medical tests will also be done to track the health of participants. conditions: Acetabular Labrum Tear studyType: INTERVENTIONAL phases: NA allocation: NA interventionModel: SINGLE_GROUP primaryPurpose: TREATMENT masking: NONE count: 30 type: ESTIMATED name: PRP measure: Pain & Function Improvements measure: Visual Analog Scale (VAS) measure: Harris Hip Scores (HHS) measure: International Hip Outcome Tool (iHOT-12) measure: EQ-5D (EuroQual 5D) sex: ALL minimumAge: 18 Years maximumAge: 40 Years stdAges: ADULT facility: University of Utah - Department of Orthopaedics status: RECRUITING city: Salt Lake City state: Utah zip: 84108 country: United States name: Luke A Johnson, BS role: CONTACT phone: 801-213-3379 email: luke.a.johnson@utah.edu name: Daniel Cushman, MD role: PRINCIPAL_INVESTIGATOR name: Derek Stokes, MD role: SUB_INVESTIGATOR lat: 40.76078 lon: -111.89105 hasResults: False
<\|newrecord\|> nctId: NCT06332339 id: HVTN 313 briefTitle: Clinical Trial to Evaluate the Safety, Tolerability, and Immunogenicity of 16055 NFL Delta Gly4 Env Protein Trimer and Trimer 4571 Combined With 3M-052-AF + Alum Adjuvant and Ad4-Env145NFL Viral Particles as Heterologous Prime-boost Regimens in Adult Participants Without HIV. overallStatus: RECRUITING date: 2024-04-10 date: 2026-11-11 date: 2026-11-11 date: 2024-03-27 date: 2024-04-03 name: National Institute of Allergy and Infectious Diseases (NIAID) class: NIH briefSummary: The goal of this clinical trial is to test 16055 NFL delta Gly4 Env protein trimer and Trimer 4571 combined with 3M-052-AF + Alum adjuvant and Ad4-Env145NFL viral particles as heterologous prime-boost regimens in adult participants without HIV.
The main question\[s\] it aims to answer are:
* Are these vaccine regimens safe and well tolerated?
* Are the prime-boost vaccine regimens that include Ad4-Env145NFL and Trimer 4571 as heterologous boosts going contribute to the development of B-cell and antibody responses?
Participants will attend scheduled study visits to receive their vaccine and will record symptoms on a daily eDiary. conditions: HIV studyType: INTERVENTIONAL phases: PHASE1 allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: PREVENTION masking: NONE count: 50 type: ESTIMATED name: 16055 NFL delta Gly4 trimer name: Trimer 4571 name: Ad4-Env145NFL, 5 x 108 viral particles (vp) measure: Local reactogenicity signs and symptoms measure: Systemic reactogenicity signs and symptoms measure: Number of adverse events (AEs) reported for 30 days after receipt of any study product measure: Number of Serious Adverse Reactions (SAEs) leading to early participant withdrawal or permanent discontinuation measure: Number of Medically Attended Adverse Event (MAAEs) leading to early participant withdrawal or permanent discontinuation measure: Number of Adverse Events of Special Interest (AESIs) that are Potential Immune Mediated Medical Conditions (PIMMCs) leading to early participant withdrawal or permanent discontinuation measure: Number of Adverse Events (AEs) leading to early participant withdrawal or permanent discontinuation measure: Occurrence of serum IgG binding antibodies to vaccine-matched HIV-1 Env trimers and specific epitopes (e.g., CD4 binding site, V2, base of trimer, etc) measure: Magnitude of serum IgG binding antibodies to vaccine-matched HIV-1 Env trimers and specific epitopes (e.g., CD4 binding site, V2, base of trimer, etc.) measure: Response Rate of serum IgG binding antibodies to vaccine-matched HIV-1 Env trimers and specific epitopes (e.g., CD4 binding site, V2, base of trimer, etc.) measure: Occurrence of serum antibody neutralization of the autologous pseudovirus HIV-1 strains (including vaccine-matched deglycosylated 16055, WT 16055, BG505, 1086) measure: Magnitude of serum antibody neutralization of the autologous pseudovirus HIV-1 strains (including vaccine-matched deglycosylated 16055, WT 16055, BG505, 1086) measure: Response Rate of serum antibody neutralization of the autologous pseudovirus HIV-1 strains (including vaccine-matched deglycosylated 16055, WT 16055, BG505, 1086) measure: Occurrence of serum antibody neutralization of HIV-1 strains measure: Magnitude of serum antibody neutralization of HIV-1 strains measure: Response Rate of serum antibody neutralization of HIV-1 strains measure: Flow cytometry analysis of the frequency of Env-specific IgG+ B cells measure: Occurrence of serum IgG binding antibodies as measured by BAMA measure: Magnitude of serum IgG binding antibodies as measured by BAMA measure: Response Rate of serum IgG binding antibodies as measured by BAMA measure: Number of Isolation of CD4bs bnAb specific VH and VL alleles and characteristic mutations measure: Flow cytometry analysis of the frequency of Env-specific IgG+ B cells at 26 weeks and 52 weeks after the fifth vaccination measure: Occurrence of serum IgG binding antibodies measure: Magnitude of serum IgG binding antibodies measure: Response Rate of serum IgG binding antibodies measure: Occurrence of serum antibody neutralization to tier 2 HIV-1 strains measure: Magnitude of serum antibody neutralization to tier 2 HIV-1 strains measure: Response Rate of serum antibody neutralization to tier 2 HIV-1 strains measure: Epitope specific response rates as measured by electron microscopy polyclonal epitope mapping (EMPEM) sex: ALL minimumAge: 18 Years maximumAge: 55 Years stdAges: ADULT facility: Alabama CRS status: NOT_YET_RECRUITING city: Birmingham state: Alabama zip: 35222 country: United States name: Heather Logan, ANP role: CONTACT phone: 205-873-8686 email: heatherlogan@uabmc.edu lat: 33.52066 lon: -86.80249 facility: The Ponce de Leon Center CRS status: NOT_YET_RECRUITING city: Atlanta state: Georgia zip: 30308 country: United States name: Erika Patrick, MSN role: CONTACT phone: 404-616-6313 email: erpatri@emory.edu lat: 33.749 lon: -84.38798 facility: Brigham and Women's Hospital Vaccine CRS (BWH VCRS) status: NOT_YET_RECRUITING city: Boston state: Massachusetts zip: 02115 country: United States name: Jose Licona, MD role: CONTACT phone: 617-525-9433 email: jlicona@partners.org lat: 42.35843 lon: -71.05977 facility: Columbia Partnership for Prevention and Control of HIV/AIDS CTU status: NOT_YET_RECRUITING city: New York state: New York zip: 10032 country: United States name: Mascha Elskamp role: CONTACT phone: 212-305-2201 email: Me2500@cumc.columbia.edu lat: 40.71427 lon: -74.00597 facility: University of Rochester HIV/AIDS CTU status: NOT_YET_RECRUITING city: Rochester state: New York zip: 14642 country: United States name: Catherine Bunce, RN MS, CCRC role: CONTACT phone: 585-275-5871 email: catherine_bunce@urmc.rochester.edu lat: 43.15478 lon: -77.61556 facility: University of Pennsylvania HIV Therapeutics and Prevention Clinical Trials Unit status: RECRUITING city: Philadelphia state: Pennsylvania zip: 19104 country: United States name: Debora Dunbar, MSN, CRNP role: CONTACT phone: 215-746-3713 email: ddunbar@pennmedicine.upenn.edu lat: 39.95233 lon: -75.16379 hasResults: False
<\|newrecord\|> nctId: NCT06332326 id: E-10840098-772.02-4966 briefTitle: Investigation of the Efficacy of Non-Invasive Vagus Nerve Stimulation and Physiotherapy in Unilateral Vestibular Hypofunction Patients overallStatus: RECRUITING date: 2022-10-23 date: 2024-04 date: 2024-05 date: 2024-03-27 date: 2024-03-27 name: Medipol University class: OTHER briefSummary: The purpose of this study: To investigate the effectiveness of non-invasive vagus nerve stimulation and vestibular rehabilitation applications in patients diagnosed with Unilateral Vestibular Hypofunction (UVH). conditions: Vestibular Diseases conditions: Vestibular Vertigo conditions: Vertigo studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL interventionModelDescription: 40 patients diagnosed with UHV were included. Patients were randomized into 2 separate groups (20 people in the vestibular rehabilitation group, 20 people in the vagus nerve stimulation group in addition to vestibular rehabilitation). primaryPurpose: TREATMENT masking: TRIPLE whoMasked: PARTICIPANT whoMasked: INVESTIGATOR whoMasked: OUTCOMES_ASSESSOR count: 40 type: ESTIMATED name: non-invasive vagus nerve stimulation name: vestibular rehabilitation measure: Modified-CTSIB measure: Semitandem test measure: tandem test measure: one-leg standing test measure: Unterberger test measure: VAS Visual Analogue Scale (dizziness severity) measure: Dynamic visual acuity test measure: Dizziness Handicap Inventory Scale measure: Tampa Kinesiophobia Scale measure: Hospital Anxiety and Depression Scale (HAD) sex: ALL minimumAge: 18 Years maximumAge: 50 Years stdAges: ADULT facility: Istanbul Medipol University status: RECRUITING city: Istanbul country: Turkey name: tuğba türk kalkan, MD role: CONTACT phone: +905334956459 email: tugbatrkk@gmail.com name: tugba türk kalkan, MD role: PRINCIPAL_INVESTIGATOR lat: 41.01384 lon: 28.94966 hasResults: False
<\|newrecord\|> nctId: NCT06332313 id: 2023/10/05 briefTitle: Erector Spina Plane Block Volume Comparison overallStatus: NOT_YET_RECRUITING date: 2024-06-12 date: 2024-11-20 date: 2024-12-05 date: 2024-03-27 date: 2024-03-27 name: Kahramanmaras Sutcu Imam University class: OTHER briefSummary: After obtaining ethical committee approval from Kahramanmaras University Anesthesiology and Reanimation Department and Urology Clinic, 60 patients between 18-65 years old who meet ASA I-II classification criteria with body mass index ≤40 will be informed about this study both verbally and in writing prior to their inclusion in this study using a randomization method according to Helsinki Declaration after obtaining their written consent. Patients who cannot give consent due to any reason or have allergy history against local anesthetics or contraindications for peripheral nerve blocks (local infection,coagulopathy etc.) or psychiatric disorders or receiving antipsychotic drugs will be excluded from this study. Routine preoperative evaluation including age, height, and weight measurements will be performed on all patients at pre-anesthesia clinic.
Patients will be randomized into three groups: Group K, who will receive analgesia with patient-controlled analgesia (PCA) with tramadol only; Group E20, who will receive PCA with 20cc volume of ESP block; and Group E30, who will receive PCA with 30cc volume of ESP block. After standard general anesthesia induction and endotracheal intubation, one of the three analgesic methods will be randomly applied, and the surgery will commence. All patients will receive patient-controlled analgesia. Patients in Group K will not receive any local anesthetic injection. When the patient is transferred to the postoperative care unit, intravenous PCA device will be attached, and pain scores using Visual Analog Scale (VAS), rated from 0 (no pain) to 10 (worst pain ever experienced), at rest and during coughing will be evaluated at 2, 4, 6, 12, 18, and 24 hours postoperatively. The values will be recorded. When the patient experiences pain, analgesic agents will be administered according to the patient-controlled analgesia protocol. The time of first analgesic requirement and total amount of consumed analgesic agent within 24 hours will be recorded. Postoperative QUIPS: Quality Improvement in Postoperative Pain Management questionnaire will be administered, and side effects such as nausea/vomiting or sedation will be noted. Additionally, patient satisfaction regarding these methods and their willingness for repeat surgery or recommendation level on a scale from poor to excellent (very poor/poor/fair/good/excellent)will also be evaluated and recorded conditions: Pain, Postoperative studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: CROSSOVER primaryPurpose: SUPPORTIVE_CARE masking: NONE count: 60 type: ESTIMATED name: erector spina plane block measure: The aim is to observe the difference in tramadol consumption within the first 24 hours after surgery in 3 groups. sex: ALL minimumAge: 18 Years maximumAge: 65 Years stdAges: ADULT stdAges: OLDER_ADULT hasResults: False
<\|newrecord\|> nctId: NCT06332300 id: ADBL-LC-003 briefTitle: An Exploratory Clinical Study of Adebelimumab in Combination With Famitinib and Chemotherapy in Patients With NSCLC overallStatus: RECRUITING date: 2024-02-01 date: 2025-02-01 date: 2026-02-01 date: 2024-03-27 date: 2024-03-27 name: Jiangsu Province Nanjing Brain Hospital class: OTHER briefSummary: This study was a single-arm design to explore the efficacy and safety of Adebelimumab in combination with famitinib and lateral ventricular chemotherapy in patients with floppy meningeal metastases from non-squamous NSCLC who have failed EGFR-TKI therapy, and included patients with pathologically confirmed non-squamous non-small cell lung cancer. conditions: NSCLC studyType: INTERVENTIONAL phases: PHASE2 allocation: NA interventionModel: SINGLE_GROUP primaryPurpose: TREATMENT masking: NONE count: 28 type: ESTIMATED name: Adebelimumab+Famitinib + FOLFIRI+Ariely measure: ORR measure: iPFS measure: iDoR measure: PFS measure: OS sex: ALL minimumAge: 18 Years maximumAge: 75 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Shengcun Fang status: RECRUITING city: Nanjing state: Jiangsu country: China name: Shengcun Fang, PhD role: CONTACT phone: +86 13404163638 email: Fang1984@aliyun.com name: Jian Zhang, Master role: CONTACT phone: +86 13095457871 email: 919939410@qq.com lat: 32.06167 lon: 118.77778 hasResults: False
<\|newrecord\|> nctId: NCT06332287 id: 2023-NSCLC briefTitle: A Study of Trilaciclib Combined With Chemotherapy in the Treatment of Advanced NSCLC With Leptomeningeal Metastasis overallStatus: RECRUITING date: 2023-05-01 date: 2024-11-01 date: 2025-06-01 date: 2024-03-27 date: 2024-03-27 name: Jiangsu Province Nanjing Brain Hospital class: OTHER briefSummary: To observe the efficacy of Trilaciclib combined with lateral ventricular chemotherapy in the treatment of non-small cell lung cancer with leptomeningeal metastasis。 conditions: NSCLC studyType: INTERVENTIONAL phases: PHASE2 allocation: NA interventionModel: SINGLE_GROUP interventionModelDescription: Trilaciclib primaryPurpose: TREATMENT masking: NONE count: 25 type: ESTIMATED name: combination of Trilaciclib and Pemetrexed measure: Duration of severe neutropenia (DSN) measure: Incidence of Treatment-Emergent Adverse Events measure: Incidence of grade 3 and 4 hematologic toxicity measure: Incidence of G-CSF treatment measure: Incidence of platelet transfusion sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Fang Shencun status: RECRUITING city: Suzhou state: Jiangsu zip: 210029 country: China name: fang S cun, M.D. role: CONTACT phone: 83728558 phoneExt: 025 email: fang1984@aliyun.com lat: 31.30408 lon: 120.59538 hasResults: False
<\|newrecord\|> nctId: NCT06332274 id: 2023-503316-33-00 id: 2023/3720 type: OTHER domain: CSET number briefTitle: tislelizUMaB in canceR Patients With molEcuLar residuaL Disease acronym: UMBRELLA overallStatus: NOT_YET_RECRUITING date: 2024-05 date: 2028-05 date: 2029-04 date: 2024-03-27 date: 2024-03-27 name: Gustave Roussy, Cancer Campus, Grand Paris class: OTHER name: BeiGene name: C2i Genomics briefSummary: Numerous studies have shown that even when imaging does not reveal the presence of cancer cells, traces of tumor DNA (i.e. originating from cancer cells) can be detected in the blood of certain patients: this is called molecular residual disease (MRD). When such traces are detected (we speak of MRD+ status), the risk of relapse is much higher than when there is no circulating tumor DNA (MRD - status). Given the success of immunotherapy in treating patients with metastatic disease in a variety of tumor types, there is enormous enthusiasm for expanding the use of immunotherapy to people with cancer at an early stage.
UMBRELLA is a biology-driven trial designed to study the impact of systemic treatment with tislelizumab monotherapy after detection of MRD+ status after completion of surgery and perioperative treatments in patients with cancer of a solid tumor. Residual disease (MRD) will be determined by optimized detection and precise monitoring of circulating tumor DNA, enabling early detection of recurrence and disease monitoring, including in patients without MRD \[MRD(-)\]. conditions: Cancer conditions: Lung Cancer conditions: Colo-rectal Cancer conditions: Pancreas Cancer conditions: Soft Tissue Sarcoma studyType: INTERVENTIONAL phases: PHASE3 allocation: RANDOMIZED interventionModel: PARALLEL interventionModelDescription: This is a double-blinded, randomized, placebo-controlled, multi-center, national, Phase 3 biology-driven trial designed to investigate the impact of systemic treatment with tislelizumab or placebo following detection of MRD minimum 3 months and maximum 4.5 months after completion of curative-intent therapy. primaryPurpose: TREATMENT masking: QUADRUPLE whoMasked: PARTICIPANT whoMasked: CARE_PROVIDER whoMasked: INVESTIGATOR whoMasked: OUTCOMES_ASSESSOR count: 717 type: ESTIMATED name: Tislelizumab name: Blood sampling name: Placebo measure: Efficacy of tislelizumab compared to placebo as measured by DFS (Disease-free survival) measure: Estimation of DFS in subjects without MRD measure: Estimation of overall survival (OS) measure: Percentage of MRD (+) subject's completion of standard curative-intent therapy measure: Time between detection of MRD and detection of relapse at imaging. measure: Percentage of subjects with MRD assessment failure. measure: Estimation of the time to become MRD (-) for MRD(+) patients measure: Evaluation of Health-Related Quality of Life (QLQ) by QLQ-C30 measure: Evaluation of Health-Related Quality of Life (QLQ) by EQ-5D-5L measure: Cost effectiveness analysis: incremental cost measure: Cost effectiveness analysis: QALY measure: Cost effectiveness analysis: ICER sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Gustave Roussy city: Villejuif state: Val De Marne zip: 94800 country: France lat: 48.7939 lon: 2.35992 hasResults: False
<\|newrecord\|> nctId: NCT06332261 id: 2024-BB-01 briefTitle: Standardized Assessment in Depression Treatment in Routine Psychiatric Services overallStatus: ACTIVE_NOT_RECRUITING date: 2024-03-08 date: 2024-04 date: 2024-04 date: 2024-03-27 date: 2024-03-27 name: Karolinska Institutet class: OTHER name: Region Stockholm briefSummary: The goal of this observational study is to evaluate current practices in depression treatment in psychiatric services in Stockholm, Sweden.
The main questions it aims to answer are:
* Are current practices consistent with local clinical guidelines in terms of standardized assessment and the treatments provided?
* What are the present conditions for implementing measurement-based care in depression treatment in this setting?
Data will be collected retrospectively from medical records of patients having received psychological or pharmacological treatment for depression from 2020 to 2023. Frequency of standardized assessments (not scores) using the Montgomery-Åsberg Depression Rating Scale, the Montgomery-Åsberg Depression Rating Scale-Self Assessment, and the Patient Health Questionnaire-9 is collected, together with information on patient, clinician, and treatment characteristics. conditions: Major Depressive Disorder studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: RETROSPECTIVE count: 4000 type: ESTIMATED measure: Montgomery-Åsberg Depression Rating Scale measure: Montgomery-Åsberg Depression Rating Scale-Self Assessment measure: The Patient Health Questionnaire-9 sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Stockholm Health Care Services, Region Stockholm city: Stockholm country: Sweden lat: 59.33258 lon: 18.0649 hasResults: False
<\|newrecord\|> nctId: NCT06332248 id: 2014/1023-31/4 & 2014/274-31/5 briefTitle: Possible Effects of the Dietary Supplement Magnesium Compared to Placebo overallStatus: COMPLETED date: 2014-09-15 date: 2015-05-20 date: 2015-05-28 date: 2024-03-27 date: 2024-03-27 name: Dan Hasson class: OTHER name: Stiftelsen Stressmottagningen name: AFA Insurance briefSummary: The goal of this clinical trial was to investigate possible outcomes of the nutritional supplement magnesium compared to placebo in healthy, working adults. The main questions it aimed to answer were:
* Are there differences in ratings of health, stress, well-being and work environment indicators between individuals intaking 375 mg magnesium (daily for 3 months) compared to placebo?
* Are there differences in hearing, measured with hearing tests between those receiving 375 mg magnesium compared to placebo?
Participants were asked to ingest 375 mg magnesium or placebo daily for 3 months.
Researchers compared the group ingesting magnesium with the group ingesting placebo pills to see if there were any differences in for example self-rated health, recovery, wellbeing, etc. conditions: Health Promotion studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL interventionModelDescription: Participants received either 375 mg nutritional supplement magnesium or placebo pill. primaryPurpose: SUPPORTIVE_CARE masking: TRIPLE whoMasked: PARTICIPANT whoMasked: INVESTIGATOR whoMasked: OUTCOMES_ASSESSOR count: 1013 type: ACTUAL name: Magnesium name: Placebo measure: Time x group difference in HealthWatch-11 (questionnaire) measure: Intervention compliance measure 1 (objective, number of pills left) measure: Intervention compliance measure 2 (subjective, marked days in calendar) measure: Time x group difference in Oldenburg Burnout Inventory (questionnaire) measure: Time x group difference in Karolinska Sleep Questionnaire measure: Time x group difference in Pure Tone Audiogram (clinical hearing test) measure: Time x group difference in Speech in noise test (clinical hearing test) measure: Time x group difference in Uncomfortable loudness level (clinical hearing test) measure: Time x group difference in single questionnaire item assessing sick leave measure: Time x group difference in single questionnaire item assessing sickness presenteeism measure: Time x group difference in prevalence of pain (questionnaire) measure: Time x group difference in pain frequency (questionnaire) measure: Time x group difference in pain discomfort (questionnaire) measure: Time x group difference in pain intensity (questionnaire) measure: Time x group difference in functional impairment due to pain (questionnaire) sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT hasResults: False
<\|newrecord\|> nctId: NCT06332235 id: KMUHIRB-F(I)-20220023 briefTitle: Efficacy and Safety of Silodosin in the Treatment of Lower Urinary Tract Symptoms in Taiwanese Population. overallStatus: RECRUITING date: 2022-02-18 date: 2024-09-30 date: 2024-12-31 date: 2024-03-27 date: 2024-03-27 name: Kaohsiung Medical University Chung-Ho Memorial Hospital class: OTHER briefSummary: To evaluate the therapeutic effects and safety of silodosin in the patients of acute brain injury with lower urinary tract symptoms. conditions: Human Trichinellosis studyType: OBSERVATIONAL observationalModel: OTHER timePerspective: PROSPECTIVE count: 70 type: ESTIMATED name: Silodosin 8 mg measure: Assessment criteria Efficacy measure: Assessment criteria Safety measure: Assessment criteria Efficacy sex: ALL minimumAge: 20 Years maximumAge: 100 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Kaohsiung Medical University Chung-Ho Memorial Hospital status: RECRUITING city: Kaohsiung state: Sanmin District zip: 807 country: Taiwan name: Chen Yu Chen, MS role: CONTACT phone: 0911884597 email: jennis7995@hotmail.com lat: 22.61626 lon: 120.31333 hasResults: False
<\|newrecord\|> nctId: NCT06332222 id: 1987 briefTitle: Recovery With Tart Cherry Supplementation Following a Marathon. overallStatus: COMPLETED date: 2023-04-01 date: 2023-10-11 date: 2023-10-11 date: 2024-03-27 date: 2024-03-27 name: Northumbria University class: OTHER name: Iprona Lana SpA briefSummary: The goal of this clinical trial is to compare recovery in healthy, active runners.
The main questions it aimed to answer were whether 7 day supplementation with Vistula TC attenuated:
* muscle function
* inflammation
* soreness following a marathon run.
Participants will either consume a spray-dried tart cherry supplement or a calorie-matched placebo-control for 7 days, and complete a marathon. Participants will perform functional tests, be assessed for their perceptual recovery and markers of inflammation and muscle damage via:
* maximal voluntary contractions
* counter movement jumps
* visual analog scales to assess soreness
* blood samples conditions: Exercise Recovery studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: BASIC_SCIENCE masking: TRIPLE whoMasked: PARTICIPANT whoMasked: INVESTIGATOR whoMasked: OUTCOMES_ASSESSOR count: 35 type: ACTUAL name: Tart Cherry name: Placebo measure: Maximal Voluntary Contraction measure: Counter Movement Jump measure: Active Muscle Soreness measure: Serum Concentration of High-Sensitive C-Reactive Protein measure: Serum Concentration of Creatine Kinase measure: Perceptual Measures sex: ALL minimumAge: 18 Years maximumAge: 65 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Northumbria University city: Newcastle Upon Tyne state: Tyne And Wear zip: NE1 8ST country: United Kingdom lat: 54.97328 lon: -1.61396 hasResults: False
<\|newrecord\|> nctId: NCT06332209 id: Pro00135303 id: U66RH31458 type: OTHER_GRANT domain: Telehealth Center of Excellence briefTitle: Randomized Trial of Tele Vs. Clinic TF-CBT in Puerto Rico overallStatus: NOT_YET_RECRUITING date: 2024-06-01 date: 2025-09-30 date: 2025-09-30 date: 2024-03-27 date: 2024-03-29 name: Medical University of South Carolina class: OTHER briefSummary: The current study will evaluate TF-CBT delivered via tele-health for youth presenting with trauma symptoms via a randomized controlled trial. Goals of the current study are to examine the effectiveness of Tele-TF-CBT delivered by community providers in Puerto Rico in improving youth trauma outcomes. Goals are also to support the feasibility, acceptability, and engagement outcomes of Tele-health delivery. conditions: Post-Traumatic Stress Disorder studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: SINGLE whoMasked: OUTCOMES_ASSESSOR count: 80 type: ESTIMATED name: Trauma Focused Cognitive Behavioral Therapy measure: Traumatic Stress Symptoms measure: Traumatic Stress Symptoms measure: Anxiety and Depression Symptoms measure: Anxiety and Depression Symptoms sex: ALL minimumAge: 7 Years maximumAge: 18 Years stdAges: CHILD stdAges: ADULT hasResults: False
<\|newrecord\|> nctId: NCT06332196 id: L-IEI briefTitle: Immunodeficiency and Cancer: Identification of Congenital Immune System Defects Underlying Paediatric Lymphomas overallStatus: RECRUITING date: 2023-10-18 date: 2025-06-18 date: 2025-10-18 date: 2024-03-27 date: 2024-03-27 name: Meyer Children's Hospital IRCCS class: OTHER briefSummary: Inborn Errors of Immunity (IEI) are a heterogeneous group of disorders characterised not only by an infectious diathesis, but by a wide variety of other clinical manifestations. Lymphoma is one of the most common malignancies in children and may be the first clinical manifestation of IEI, thereby 'hiding' the immune defect and delaying genetic/immunological diagnosis. Lymphomas, especially non-Hodgkin's lymphomas (NHL) are frequently associated with congenital defects of the immune system, in particular diffuse large B-cell lymphoma and Burkitt's lymphoma. Preliminary analyses conducted on 6 patients diagnosed with NHL allowed the identification of genetic variants in genes associated with IEI. In clinical practice, the diagnosis and choice of therapeutic treatment in patients with immunodeficiency-associated lymphoma are decisive and, due to the complex pathophysiology of the disease, it is not always possible to identify the boundary between benign and malignant proliferation. The identification of an undiagnosed immunodeficiency in patients with lymphoma will ensure the opportunity to apply targeted therapies, such as allogeneic haematopoietic stem cell transplantation, instead of standard clinical management based mainly on chemotherapy. The study aims to identify possible congenital defects of immunity, i.e. genetic disorders affecting the immune system, as responsible for the development of haematological malignancies. Through a multidisciplinary approach involving immunological analyses, genetic analyses and a thorough examination of clinical manifestations, we aim to characterise the immunological component underlying the development of paediatric lymphomas. conditions: Immune Deficiency studyType: INTERVENTIONAL phases: NA allocation: NA interventionModel: SINGLE_GROUP interventionModelDescription: Patients diagnosed with non-Hodgkin's lymphoma (NHL) or Hodgkin's lymphoma (HL) aged and patients with previous lymphoma and signs of immunodeficiency primaryPurpose: DIAGNOSTIC masking: NONE count: 50 type: ESTIMATED name: Analysis of biological sample and clinical data measure: To unravel inborn error of immunity behind Lymphoid neoplasm in children measure: Identification of lymphoma-specific biomarkers sex: ALL minimumAge: 1 Day maximumAge: 24 Years stdAges: CHILD stdAges: ADULT facility: AOU Malpighi IRCCS status: ACTIVE_NOT_RECRUITING city: Bologna country: Italy lat: 44.49381 lon: 11.33875 facility: Meyer Children's Hospital IRCCS status: RECRUITING city: Florence country: Italy name: Eleonora Gambineri role: CONTACT email: eleonora.gambineri@meyer.it lat: 43.77925 lon: 11.24626 facility: AOU Pisana status: ACTIVE_NOT_RECRUITING city: Pisa country: Italy lat: 43.70853 lon: 10.4036 facility: Ospedale Pediatrico Bambin Gesù IRCCS status: ACTIVE_NOT_RECRUITING city: Roma country: Italy lat: 41.89193 lon: 12.51133 hasResults: False
<\|newrecord\|> nctId: NCT06332183 id: ECDGWAS briefTitle: GWAS and EWAS in Patients With Erdheim-Chester Disease overallStatus: RECRUITING date: 2019-07-17 date: 2024-07-01 date: 2024-10-01 date: 2024-03-27 date: 2024-03-27 name: Augusto Vaglio class: OTHER briefSummary: Erdheim-Chester Disease (ECD) is a rare form of histiocytosis characterized by the proliferation of blood cells, known as histiocytes, which infiltrate various organs and tissues, often causing irreversible damage. The causes of the condition are still unknown, and although some mutations in genes involved in cell proliferation have been identified, other factors may be involved. Susceptibility to developing rare diseases like ECD is typically associated with genetic factors, including DNA polymorphisms and epigenetic modifications.
This study aims to analyze the entire genome of a large cohort of patients with ECD and healthy controls to determine whether there are polymorphisms and epigenetic variants associated with susceptibility to developing the disease. The study could thus clarify the genetic predisposition to ECD development, provide insights into disease pathogenic mechanisms, and identify proteins or cellular mechanisms potentially targeted by specific treatments. conditions: Erdheim-Chester Disease studyType: OBSERVATIONAL observationalModel: CASE_CONTROL timePerspective: PROSPECTIVE count: 300 type: ESTIMATED name: Presence of polymorphisms measure: Polymorphisms and genetic variants correlated with disease development measure: Methylation in Erdheim-Chester disease measure: Gene expression in Erdheim-Chester disease sex: ALL minimumAge: 1 Year maximumAge: 99 Years stdAges: CHILD stdAges: ADULT stdAges: OLDER_ADULT facility: Hopital Pitié Salpetrière status: RECRUITING city: Paris country: France name: Julien Haroche role: CONTACT lat: 48.85341 lon: 2.3488 facility: Meyer Children's Hospital IRCCS status: RECRUITING city: Florence country: Italy name: Augusto Vaglio role: CONTACT email: augusto.vaglio@meyer.it lat: 43.77925 lon: 11.24626 facility: IRCCS Ospedale San Raffaele status: RECRUITING city: Milano country: Italy name: Lorenzo Dagna role: CONTACT lat: 45.46427 lon: 9.18951 facility: AOU Parma status: RECRUITING city: Parma country: Italy name: Davide Martorana role: CONTACT lat: 44.79935 lon: 10.32618 facility: Genetics Lab, CSIC status: RECRUITING city: Granada country: Spain name: Javier Martin role: CONTACT lat: 37.18817 lon: -3.60667 hasResults: False
<\|newrecord\|> nctId: NCT06332170 id: HS-20093-103 briefTitle: ARTEMIS-101: A Study of HS-20093 Combinations in Patients With Advanced Solid Tumors overallStatus: NOT_YET_RECRUITING date: 2024-05-30 date: 2026-05-30 date: 2028-05-30 date: 2024-03-27 date: 2024-03-27 name: Hansoh BioMedical R&D Company class: INDUSTRY briefSummary: HS-20093 is a fully humanized IgG1 antibody-drug conjugate (ADC) which specifically binds to B7-H3, a target wildly expressed on solid tumor cells. The objectives of this study are to investigate the safety, tolerability, pharmacokinetics and anti-tumor activity of HS-20093 in combination with other anti-cancer agents in patients with advanced solid tumor patients. conditions: Advanced Solid Tumor studyType: INTERVENTIONAL phases: PHASE1 allocation: NON_RANDOMIZED interventionModel: SEQUENTIAL primaryPurpose: TREATMENT masking: NONE count: 610 type: ESTIMATED name: HS-20093 name: Adebrelimab name: Cisplatin/ Carboplatin name: Cetuximab name: Enzalutamide measure: Maximum tolerated dose (MTD) for combination-treatments measure: Incidence and severity of adverse events (AEs) measure: Objective response rate (ORR) determined by investigators measure: Disease control rate (DCR) determined by investigators measure: Duration of response (DoR) determined by investigators measure: Progression-free survival (PFS) determined by investigators according to RECIST 1.1 measure: Overall survival (OS) measure: Radiographic progression-free survival (rPFS) determined by investigators according to RECIST 1.1 and PCWG3 measure: Time to PSA progression (TTPP) measure: Prostate-specific cancer antigen (PSA) response rate measure: Time to first subsequent therapy (TFST) measure: Observed maximum plasma concentration (Cmax) of HS-20093advanced solid tumor measure: Time to reach maximum plasma concentration (Tmax) of HS-20093 measure: Terminal half-life (T1/2) of HS-20093 following the first dose measure: Area under plasma concentration versus time curve from zero to last sampling time (AUC0-t) following the first dose of HS-20093 measure: Percentage of participants with antibodies to HS-20093 in serum sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT hasResults: False
<\|newrecord\|> nctId: NCT06332157 id: 2023-ke-715-1 briefTitle: Postoperative Quality of Recovery After General Anesthesia With Remimazolam overallStatus: NOT_YET_RECRUITING date: 2024-06 date: 2025-12 date: 2025-12 date: 2024-03-27 date: 2024-03-27 name: Beijing Chao Yang Hospital class: OTHER briefSummary: 126 patients undergoing general anesthesia for elective surgery in Beijing Chaoyang Hospital were selected. In the intervention group, anesthesia was induced with remimazolam besylate at a rate of 6mg/min; Anesthesia was maintained with 1.0-2.0mg/min remimazolam besylate by continuous pump. Control group: anesthesia induction, intravenous injection of propofol 2mg/kg; Anesthesia was maintained by continuous pumping of 6-8mg/kg/h propofol. All patients were routinely monitored for vital signs and anesthesia depth after entering the operating room. The patients were followed up after surgery, and the quality of recovery score at 24 hours after surgery was the main study outcome. conditions: Anesthesia Recovery Period studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: DOUBLE whoMasked: PARTICIPANT whoMasked: OUTCOMES_ASSESSOR count: 126 type: ESTIMATED name: Remimazolam besylate name: Propofol Injection Emulsion measure: 15-item quality of recovery scale sex: ALL minimumAge: 18 Years maximumAge: 65 Years stdAges: ADULT stdAges: OLDER_ADULT hasResults: False
<\|newrecord\|> nctId: NCT06332144 id: 1R56DC020208-01A1 type: NIH link: https://reporter.nih.gov/quickSearch/1R56DC020208-01A1 briefTitle: Predicting Language and Literacy Growth in Children With ASD Using Statistical Learning acronym: PLAUSL overallStatus: RECRUITING date: 2024-01-13 date: 2024-08-31 date: 2024-08-31 date: 2024-03-27 date: 2024-03-27 name: Northeastern University class: OTHER name: University of Delaware name: Boston University name: Cornell University briefSummary: The goal of this observational study is to test a reciprocal relationship between statistical learning and the development of language and literacy in first-graders with autism and their non-autistic peers. The main questions it aims to answer are:
1. whether children's statistical learning abilities can predict their long-term improvement of language and literacy skills in school;
2. how children's brains automatically learn patterns from speech and prints;
3. whether children's learning in the lab reflects the language patterns they have learned over the years from their native language.
First-grade students will participate in the study twice across three months.
During Time 1, children will complete
* a battery of language, reading, and cognitive assessments
* a series of computer-based statistical learning games both inside and outside of functional MRI scanner.
During Time 2, children will complete a battery of language and reading assessments to detect the growth in three months.
Researchers will compare the autistic and the non-autistic groups to see if statistical learning plays a similar or different role in predicting children's language and literacy growth. conditions: Autism Spectrum Disorder conditions: Language Development conditions: Literacy studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: PROSPECTIVE count: 50 type: ESTIMATED name: Structural vs. Random sequences of stimuli name: Intact vs. Degraded speech name: Repeating 5-syllable nonwords or 2-syllable nonwords name: Recall letter or syllable strings that either contain highly frequent bigram/trigram items or infrequent items according to English Corpus data. measure: Language Composite Score measure: Reading Composite Score measure: Language/Literacy Disorder Status measure: Neural similarity between language and statistical learning tasks measure: Orthographic statistical sensitivity measure: Phonological statistical sensitivity measure: Linguistic SL composite scores measure: Neural sensitivity to statistical regularities during the statistical learning tasks measure: Neural activation to statistical regularities during the language tasks sex: ALL minimumAge: 72 Months maximumAge: 90 Months stdAges: CHILD facility: Northeastern University status: RECRUITING city: Boston state: Massachusetts zip: 02115 country: United States name: Brynn Siles, BS role: CONTACT phone: 617-830-1530 email: plausl.project@gmail.com name: Zhenghan Qi, MD/PhD role: PRINCIPAL_INVESTIGATOR lat: 42.35843 lon: -71.05977 facility: Boston University status: ENROLLING_BY_INVITATION city: Boston state: Massachusetts zip: 02215 country: United States lat: 42.35843 lon: -71.05977 hasResults: False
<\|newrecord\|> nctId: NCT06332131 id: UPCC07623 briefTitle: Effects of Immune Checkpoint Inhibitors on Coronary Microvasculature overallStatus: NOT_YET_RECRUITING date: 2024-04 date: 2027-04 date: 2027-04 date: 2024-03-27 date: 2024-04-10 name: Abramson Cancer Center at Penn Medicine class: OTHER briefSummary: This is an observational study that includes patients with melanoma who will be treated with adjuvant immune checkpoint inhibitor (ICI) therapy. The investigators will use echocardiograms, blood draws, and PET stress tests to understand how ICI therapy affects the heart and circulatory system. conditions: Melanoma conditions: Coronary Microvascular Dysfunction conditions: Cardiotoxicity studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: PROSPECTIVE count: 25 type: ESTIMATED measure: Incidence of new abnormal myocardial blood flow reserve (MBFR) measure: Incidence of major cardiovascular events measure: Coronary calcium score measure: All cause mortality measure: Cardiovascular specific mortality sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Abramson Cancer Center at University of Pennsylvania city: Philadelphia state: Pennsylvania zip: 19104 country: United States lat: 39.95233 lon: -75.16379 hasResults: False
<\|newrecord\|> nctId: NCT06332118 id: avf ice massage briefTitle: The Effect of Ice Massage on Pain, Ecchymosis, Hematoma and Patient Satisfaction overallStatus: NOT_YET_RECRUITING date: 2024-04-15 date: 2024-05-15 date: 2024-05-30 date: 2024-03-27 date: 2024-04-02 name: Erzurum Technical University class: OTHER briefSummary: The research was planned to measure pain, ecchymosis, hematoma and patient satisfaction with ice massage applied to the fistula before the arteriovenous fistula procedure in hemodialysis patients. Patients who agree to participate in the study will be given ice massage before the procedure and the relevant parameters will be measured. conditions: Hemodialysis Complication studyType: INTERVENTIONAL phases: NA allocation: NA interventionModel: SINGLE_GROUP interventionModelDescription: The research is quasi-experimental and relationship-seeking in a pretest-posttest format. primaryPurpose: PREVENTION masking: NONE count: 35 type: ESTIMATED name: ice massage group measure: Pain score measure: Ecchymosis degree measure: Hematoma degree measure: Patient satisfaction score sex: ALL minimumAge: 18 Years maximumAge: 90 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Ercan Bakır city: Erzurum state: Yakutiye zip: 25010 country: Turkey name: Ercan Bakır, PhD role: CONTACT phone: 05444252111 email: ercan.bakir@erzurum.edu.tr name: Ercan Bakır, PhD role: CONTACT phone: 05443047186 email: e.bakir02@gmail.com lat: 39.90861 lon: 41.27694 facility: Ercan Bakır city: Erzurum state: Yakutiye country: Turkey lat: 39.90861 lon: 41.27694 hasResults: False
<\|newrecord\|> nctId: NCT06332105 id: CUK001 briefTitle: Evaluation of Low Phenylalanine Formulas overallStatus: ACTIVE_NOT_RECRUITING date: 2023-01-30 date: 2025-01 date: 2025-04 date: 2024-03-27 date: 2024-04-15 name: Ajinomoto Co., Inc. class: INDUSTRY name: Birmingham Children's Hospital name: Great Ormond Street Hospital for Children NHS Foundation Trust briefSummary: Ajinomoto Cambrooke has developed a PKU protein substitute that is a proprietary blend of purified Glycomacropeptide (GMP) and essential amino acids, under the brand name Glytactin®. One serving of such Glytactin® products contains 20mg or less of Phenylalanine (Phe). The aim of the proposed study is to use this purified GMP-AA-based protein substitute, with less Phe per gram of protein equivalent than other commercially available products, in children with PKU at 100% of their protein substitute intake and evaluate its efficacy and the change in blood Phe in comparison to Phe-free L-AA-based protein substitutes. conditions: Phenylketonurias studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: CROSSOVER interventionModelDescription: 2-stage, 15-week randomized crossover trial. primaryPurpose: TREATMENT masking: NONE count: 19 type: ESTIMATED name: Glytactin name: L-AA measure: Change in blood Phe in sex: ALL minimumAge: 3 Years maximumAge: 16 Years stdAges: CHILD facility: Birmingham Women and Children's Hospital city: Birmingham state: West Midlands zip: B4 6NH country: United Kingdom lat: 52.48142 lon: -1.89983 facility: Great Ormond Street Hospital for Children city: London zip: WC1N 3JH country: United Kingdom lat: 51.50853 lon: -0.12574 hasResults: False
<\|newrecord\|> nctId: NCT06332092 id: FID-007-003 briefTitle: FID-007 and Cetuximab in Treating Patients With Advanced Head and Neck Squamous Cell Carcinoma acronym: HNSCC overallStatus: RECRUITING date: 2024-04-10 date: 2025-03-31 date: 2025-12-31 date: 2024-03-27 date: 2024-04-17 name: Fulgent Pharma LLC. class: INDUSTRY briefSummary: The goal of this FID-007 Clinical Trial is to compare the efficacy of different dosing regimens of FID-007 in combination with Cetuximab in patients with recurrent or metastatic Head and Neck Squamous Cell Carcinoma (HNSCC). The main questions it aims to answer are: to evaluate the efficacy, and to characterize the safety and tolerability. Eligible participants will be enrolled and randomized to 1 of 2 arms of FID-007 with fixed-dose Cetuximab in each 28-day cycle. conditions: Head and Neck Squamous Cell Carcinoma studyType: INTERVENTIONAL phases: PHASE2 allocation: RANDOMIZED interventionModel: SINGLE_GROUP interventionModelDescription: Two different dosing regimens of FID-007 in combination with fixed-dose Cetuximab primaryPurpose: TREATMENT masking: NONE count: 46 type: ESTIMATED name: FID007 measure: ORR assessed by Response Evaluation Criteria in Solid Tumors (RECIST) measure: BOR assessed by Response Evaluation Criteria in Solid Tumors (RECIST) measure: Duration of Response (DoR) measurement measure: Progression-free Survival (PFS) measurement measure: Overall Survival (OS) measurement measure: Disease Control Rate (DCR) analysis measure: Adverse Events (AEs) graded according to the CTCAE version 5.0 measure: Vital Signs safety assessments measure: Clinical Laboratory safety assessments measure: ECGs safety assessment measure: Area Under the Plasma Concentration Versus Time Curve (AUC) of FID-007 measure: Peak Plasma Concentration (Cmax) measure: Terminal/elimination half-life (t1/2) measure: Clearance (CL) measure: Volume of Distribution (Vd) sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Gabrail Cancer Center Research status: RECRUITING city: Canton state: Ohio zip: 44718 country: United States name: Nashat Gabrail, MD role: CONTACT lat: 40.79895 lon: -81.37845 hasResults: False
<\|newrecord\|> nctId: NCT06332079 id: HAITI 2023-505356-22-00 briefTitle: Holmium-166 TARE in Liver Limited Unresectable Colorectal Cancer Patients acronym: HAITI overallStatus: RECRUITING date: 2024-03-13 date: 2026-11 date: 2027-02 date: 2024-03-27 date: 2024-03-27 name: Gruppo Oncologico del Nord-Ovest class: OTHER briefSummary: The aim of this study is to assess the efficacy of 166Ho-TARE followed by maintenance therapy with fluoropyrimidine and anti-EGFR or bevacizumab in liver-limited unresectable colorectal cancer patients, in terms of progression free rate 9- and 8-months for cohort A and B, respectively. conditions: Colorectal Cancer Metastatic studyType: INTERVENTIONAL phases: PHASE2 allocation: NA interventionModel: SINGLE_GROUP interventionModelDescription: Two cohorts of patients will be included according to the two main prognostic populations in mCRC (left sided, RAS/BRAF wild-type and, right-sided and/or RAS mutated tumors) treated with different maintenance therapy (fluoropyrimidine plus anti-EGFR or bevacizumab).
A total of 23 patients will be enrolled in each cohort. primaryPurpose: TREATMENT masking: NONE count: 46 type: ESTIMATED name: 166Holmium TARE name: Cetuximab name: Panitumumab name: 5-Fluorouracil name: Bevacizumab name: Capecitabine measure: Progression-free survival (PFS) Rate measure: Overall Toxicity rate measure: Grade 3/ Grade 4 Toxicity rate measure: Post-treatment Disease Control Rate (DCR) measure: Progression free survival measure: Overall Survival measure: Dose-response relationships measure: Quality of Life (QoL) assessed using the EORTC QLQ-CR29 questionnaire measure: Quality of Life (QoL) assessed using the EORTC QLQ-CR30 questionnaire measure: Quality of Life (QoL) assessed using the EuroQol EQ-5D questionnaire sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Azienda Ospedaliero Universitaria Pisana status: RECRUITING city: Pisa zip: 56126 country: Italy name: Beatrice Borelli, MD, PhD role: CONTACT phone: +39050992192 email: b.borelli89@gmail.com name: Gianluca Masi, MD role: PRINCIPAL_INVESTIGATOR name: Beatrice Borelli, MD, PhD role: SUB_INVESTIGATOR lat: 43.70853 lon: 10.4036 hasResults: False
<\|newrecord\|> nctId: NCT06332066 id: 0046-24-COM briefTitle: Oxytocin Administration to Therapists and Its Effects on Patient-perceived Attunement and Responsiveness overallStatus: NOT_YET_RECRUITING date: 2024-05-01 date: 2024-05-30 date: 2024-06-30 date: 2024-03-27 date: 2024-03-27 name: Shalvata Mental Health Center class: OTHER name: Clalit Health Services briefSummary: In recent years there is a great interest in the possible role of Oxytocin (OT) as a facilitator for enhancing psychotherapeutic processes in patients with mental illnesses. Specific studies explored OT administration to patients, and the effect on psychotherapy on interaction within the therapeutic dyad. Nonetheless, studies exploring OT's effects of the therapists' side of the therapeutic dyad on the psychotherapy session and outcome, have not been conducted. The current study aims to assess the effect of OT administration to the therapists of psychiatric outpatients, on treatment process and outcome and specifically on the patient and therapist experience of the attunement and responsiveness toward the patient in the therapeutic encounter. Twenty staff members from Teradion Mental health Clinic of Clalit Health Services will be recruited, as well as 100 patients treated by these staff members. Therapists agreeing to participate will receive OT and PLC in a random order, at the same day they are seeing the same patients and the consecutive week. Patients agreeing to participate will complete a demographic questionnaire and all study measures, and will be scheduled to perform two consecutive research sessions with their therapists. The therapist will receive either OT or PLC in each of these two sessions, and right after the session the patients will complete the assessment scales. Multilevel models will be performed by the investigators to assess the effects of OT administration in therapists receiving OT versus receiving placebo. This research will be performed in accordance with ethical principles of Helsinki WMA Declaration. This study is the first to assess the effectiveness of hormonal augmentation for therapists and its influence on therapeutic process with patients suffering from acute distress in the public mental health domain. conditions: Mental Health Therapists studyType: INTERVENTIONAL phases: PHASE1 allocation: RANDOMIZED interventionModel: SEQUENTIAL primaryPurpose: TREATMENT masking: TRIPLE whoMasked: PARTICIPANT whoMasked: CARE_PROVIDER whoMasked: OUTCOMES_ASSESSOR count: 20 type: ESTIMATED name: Oxytocin nasal spray measure: Attunement and Responsiveness towards patients measure: Attachment with Therapist measure: Working Alliance with Therapist measure: Patient Symptoms sex: ALL minimumAge: 18 Years maximumAge: 99 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Mental Health Clinic, Teradion city: Misgav country: Israel name: Ayelet Nir,, M.A. role: CONTACT phone: 972-4-6025050 email: ayeletni1@clalit.org.il name: Galit role: CONTACT phone: 972-4-6026050 lat: 32.86017 lon: 35.26165 hasResults: False
<\|newrecord\|> nctId: NCT06332053 id: SY-5007-I-03 briefTitle: A Study to Evaluate the Effect of Itraconazole and Rifampicin on the Pharmacokinetics of SY-5007 in Healthy Subjects overallStatus: NOT_YET_RECRUITING date: 2024-04-01 date: 2024-06-01 date: 2024-06-01 date: 2024-03-27 date: 2024-03-27 name: Shouyao Holdings (Beijing) Co. LTD class: OTHER briefSummary: This study is a single-center, open-lable and fixed sequence test conducted in healthy subjects to evaluate the pharmacokinetic effects of Itraconazole and Rifampicin on a single dose of SY-5007 Oral administration. It is planned to enroll 28 healthy subjects and assign them to two parallel test groups, Group A (SY-5007 combined with Itraconazole) and Group B (SY-5007 combined with Rifampicin). conditions: Healthy Subjects studyType: INTERVENTIONAL phases: PHASE1 allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: NONE count: 28 type: ESTIMATED name: SY-5007 name: Itraconazole name: SY-5007 name: Rifampin measure: Cmax for SY-5007 measure: Tmax for SY-5007 measure: AUC0-t for SY-5007 measure: AUC0-∞ for SY-5007 measure: t½ for SY-5007 measure: CL/F for SY-5007 measure: Vz/F for SY-5007 measure: Safety of SY-5007 sex: MALE minimumAge: 18 Years maximumAge: 45 Years stdAges: ADULT facility: West China Hospital of Sichuan University city: Chengdu state: Sichuan zip: 610041 country: China name: Li Zheng role: CONTACT phone: 86-28-85423655 email: zhengli@wchscu.cn lat: 30.66667 lon: 104.06667 hasResults: False
<\|newrecord\|> nctId: NCT06332040 id: 22-500-243-50-35 briefTitle: Gentamicin Bladder Instillation on CAUTI overallStatus: RECRUITING date: 2023-10-09 date: 2026-10-08 date: 2026-10-08 date: 2024-03-26 date: 2024-03-26 name: St. Joseph's Hospital and Medical Center, Phoenix class: OTHER briefSummary: Urinary tract infections in catheterized patients is an unacceptable complication and has been termed a 'never event' by the Center for Medicare \& Medicaid Services (CMS); however there is not consensus among clinicians on how to best prevent CAUTIs. We propose a prospective randomized controlled trial to test the efficacy of prophylactic gentamicin bladder irrigation in elimination of CAUTIs. conditions: Catheter Infection studyType: INTERVENTIONAL phases: PHASE4 allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: PREVENTION masking: QUADRUPLE whoMasked: PARTICIPANT whoMasked: CARE_PROVIDER whoMasked: INVESTIGATOR whoMasked: OUTCOMES_ASSESSOR count: 400 type: ESTIMATED name: Gentamicin measure: CAUTI as primary outcome sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: St. Jpseph's Hospital and Medical Center status: RECRUITING city: Phoenix state: Arizona zip: 85013 country: United States name: Kristina Kupanoff, PhD role: CONTACT phone: 602-406-5192 email: Kristina.Kupanoff@Commonspirit.org lat: 33.44838 lon: -112.07404 hasResults: False
<\|newrecord\|> nctId: NCT06332027 id: Soh-Med-24-03-03MD briefTitle: Accuracy of Hystro-Salpingo-Foam-Sonography (HYFOSY) as Tubal Patency Test in Comparison to Laparoscopy in Infertile Patients overallStatus: NOT_YET_RECRUITING date: 2024-04-01 date: 2025-04-01 date: 2025-04-01 date: 2024-03-26 date: 2024-03-26 name: Sohag University class: OTHER briefSummary: Tubal patency testing is an essential part of female subfertility evaluation . Tubal abnormalities are seen in 30-40% of female subfertility patients . Laparoscopy with chromopertubation is considered to be the gold standard diagnostic procedure .
Laparoscopy is an invasive test, with a risk of intra-abdominal bleeding, visceral damage, and risks related to general anaesthesia.
Traditionally, Hysterosalpingography(HSG) is a less invasive less expensive first-step alternative, which has been used for decades with disadvantages such as radiation exposure, discomfort, or even abdominal pain.
Hysterosalpingo-Contrast Sonography (HyCoSy) was introduced as an alternative using either contrast media or saline. The accuracy of HyCoSy is comparable to that of HSG and LSC being reference standards for tubal patency testing.However, hyperechogenic contrast media such as Echovist_ (Schering AG, Berlin) and SonoVue_ (Bracco, Milan)are either no longer available or not licensed for tubal patency testing.
Hysterosalpingo-Foam Sonography (HyFoSy) was developed as an alternative for contrast HyCoSy and was introduced in 2010 as a first-line office tubal patency test.Foam is used in the HyFoSy technique to visualize the fallopian tubes and is created by rigorously mixing 5mlExEm_-gel (containing hydroxyethyl cellulose and glycerol,IQMedical Ventures BV, Rotterdam, TheNetherlands) with 5ml purified ExEm_-water.
The ExEm_-foam is sufficiently fluid to pass the fallopian tubes and in the mean time sufficiently stable to show echogenicity for at least five minutes, which is an advantage over saline. In a review on safety aspects and side effects of ExEm-gel it was considered to be appropriate and safe for tubal patency testing.
In 2017, HyLiFoSy combined with power Doppler (PD)(HyLiFoSy-PD) technique was described as a possibly less painful and easier to detect on ultrasound alternativeto HyFoSy and HyCoSy, which can be used whenever the contrast media used with both are either unavailable or is relatively expensive Ultrasound-based tubal patency tests include hysterosalpingo-contrast sonography (HyCoSy), hysterosalpingo-foam sonography (HyFoSy), and hysterosalpingo-lidocaine-foam sonography (HyLiFoSy)and have shown a high detection rate of tubal obstruction and good reproducibility with concordances from 83.8 to 100% with HSG, and from 78.1 to96.91% with lap-and-dye test.
In addition, they allow for a single comprehensive assessment of the uterus and the fallopian tubes and it can be performed by the same specialist who indicates it, in the clinician's own office with it consequently being time efficient. Finally, some studies have shown an increase in the rate of post-procedure gestation. conditions: Infertility, Female studyType: INTERVENTIONAL phases: NA allocation: NA interventionModel: SINGLE_GROUP primaryPurpose: DIAGNOSTIC masking: NONE count: 122 type: ESTIMATED name: Hystro-Salpingo-Foam-Sonography (HYFOSY) measure: the accuracy of HyFoSy in the assessment of tubal patency sex: FEMALE minimumAge: 18 Years maximumAge: 40 Years stdAges: ADULT facility: Sohag University Hospital city: Sohag country: Egypt name: Magdy M Amin, Professor role: CONTACT lat: 26.55695 lon: 31.69478 hasResults: False
<\|newrecord\|> nctId: NCT06332014 id: 20210123 briefTitle: Evaluation of Efficacy and Safety of Prolia in Subjects of Male Osteoporosis in Mainland China overallStatus: NOT_YET_RECRUITING date: 2024-07-31 date: 2026-07-29 date: 2026-07-29 date: 2024-03-26 date: 2024-03-26 name: Amgen class: INDUSTRY briefSummary: The primary objective of this study is to evaluate the efficacy of Prolia on lumbar spine BMD at 12 months. conditions: Osteoporosis studyType: INTERVENTIONAL phases: PHASE4 allocation: NA interventionModel: SINGLE_GROUP primaryPurpose: TREATMENT masking: NONE count: 100 type: ESTIMATED name: Prolia measure: Percent change from baseline in bone mineral density (BMD) of lumbar spine at month 12 measure: Percent change from baseline in serum C-terminal telopeptide (CTx) at month 3, 6, 9, and 12 measure: Percent change from baseline in serum procollagen Type 1 N-Telopeptide (P1NP) at month 3, 6, 9, and 12 measure: Percent change from baseline in total hip and femoral neck BMD at month 6 and 12 measure: Percent change from baseline in lumbar spine BMD at month 6 measure: Number of participants with adverse events (AE) sex: MALE minimumAge: 30 Years maximumAge: 90 Years stdAges: ADULT stdAges: OLDER_ADULT hasResults: False
<\|newrecord\|> nctId: NCT06332001 id: IEO 1403 briefTitle: Evaluation of a Music and Interaction Intervention on Patient Distress During Whole Body Magnetic Resonance overallStatus: RECRUITING date: 2020-12-31 date: 2024-12-31 date: 2024-12-31 date: 2024-03-26 date: 2024-03-26 name: European Institute of Oncology class: OTHER briefSummary: This is a randomized controlled trial for the evaluation of the acceptability of Whole-Body-Magnetic Resonance Imaging (WB-MRI) based on music and comunication intervention compared to a standard care condition.
Subjects will be randomized into two groups: the experimental group or arm that receives the music and interaction interventions, and the control group or arm that receives a standard care condition. conditions: Neoplasm Malignant studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: PROSPECTIVE count: 200 type: ESTIMATED name: Experimental Group name: Control Group measure: Acceptability of WB-MRI based on music and comunication intervention compared to a standard care condition. measure: Measure the level of patient's distress pre and post WB-MRI in the two groups using Distress Thermometer (V2.2020) sex: ALL stdAges: CHILD stdAges: ADULT stdAges: OLDER_ADULT facility: IEO Istituto Europeo di Oncologia status: RECRUITING city: Milan zip: 20141 country: Italy name: Giuseppe Petralia role: CONTACT email: giuseppe.petralia@ieo.it lat: 45.46427 lon: 9.18951 hasResults: False
<\|newrecord\|> nctId: NCT06331988 id: IEO 1341 briefTitle: Microbiome, Immune-system and Tumor Interaction in Colorectal Cancer acronym: MITICO overallStatus: RECRUITING date: 2022-07-21 date: 2026-07-31 date: 2029-07-31 date: 2024-03-26 date: 2024-03-27 name: European Institute of Oncology class: OTHER briefSummary: Colorectal cancers represent the second leading cause of cancer-related death in the United States Western world. In Italy they represent the second most frequent neoplasm (49,000 cases in 2019). Despite the advancement of surgical techniques and medical therapy programs systemic, it is estimated that approximately 40-50% of colorectal cancers recur after being treated for a limited loco-regional disease. Patients who develop metastases throughout their history clinic have a 5-year overall survival of just over 10%.
Adjuvant systemic chemotherapy can reduce the risk of disease recurrence in patients with colorectal adenocarcinomas, however, the standard drugs used to date for this use (fluoropyrimidines and oxaliplatin) have not undergone substantial changes in the last 20 years or so.
A crucial point is the need to have more precise information regarding risk factors above all biomolecular to base therapeutic choices.
It has now become urgent to overcome the T-tumor N-node M- metastasis (TNM) staging, to have more modern knowledge on the factors capable of impacting significantly on the prognosis, influence the real risk of disease recurrence, Identify new prognostic categories and subcategories, therefore being able to predict the clinical benefit of treatments that can be more targeted, personalized and effective. In this panorama it has developed in recent years an ever-growing literature also regarding the role of bacterial flora intestinal (microbiota) in patients with colorectal cancer. In particular, recent discoveries have highlighted the immunoregulatory role of the microbiota in the anti-tumor response. This study aims of evaluating how the molecular characteristics of the tumor, of the infiltrating immune system cells and of the associated intestinal microbiota correlate with the development of colorectal cancer, its progression and response to treatments. conditions: Colorectal Cancer studyType: OBSERVATIONAL observationalModel: CASE_ONLY timePerspective: PROSPECTIVE count: 320 type: ESTIMATED measure: Relapse free survival measure: Overall survival sex: ALL minimumAge: 18 Years maximumAge: 75 Years stdAges: ADULT stdAges: OLDER_ADULT facility: European Institute of Oncology status: RECRUITING city: Milan zip: 20141 country: Italy name: Davide Ciardiello, MD role: PRINCIPAL_INVESTIGATOR lat: 45.46427 lon: 9.18951 hasResults: False
<\|newrecord\|> nctId: NCT06331975 id: IEO 0836 briefTitle: Radiomics and Radiogenomics of Non-small Cell Lung Cancer overallStatus: COMPLETED date: 2018-06-12 date: 2023-01-31 date: 2023-09-14 date: 2024-03-26 date: 2024-03-26 name: European Institute of Oncology class: OTHER briefSummary: In this study, the radiomic characteristics and a broad range of genetic aberrations in lung adenocarcinomas will be evaluated. Investigators will assess changes in the radiomic and genetic profiles during targeted therapies in a subset of patients harboring treatable mutations. Patients undergoing targeted therapies will also be evaluated for variations in genomic profile and radiomic signature during follow-up conditions: Non Small Cell Lung Cancer studyType: INTERVENTIONAL phases: NA allocation: NA interventionModel: SINGLE_GROUP primaryPurpose: DIAGNOSTIC masking: NONE count: 91 type: ACTUAL name: Radiomic signature measure: Evaluation of the association between the status of Epidermal Growth Factor Receptor (EGFR), Anaplastic Lymphoma Kinase (ALK), Kirsten Rat Sarcoma Virus (KRAS) and nodal status measure: Evaluation of the association between the status of EGFR, ALK, KRAS and overall survival (OS) measure: Evaluation of the association between the status of EGFR, ALK, KRAS and disease free survival (DFS) sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: European Institute of Oncology city: Milan country: Italy lat: 45.46427 lon: 9.18951 hasResults: False
<\|newrecord\|> nctId: NCT06331962 id: B-ER-112-010 briefTitle: Digestive Tract Cancer and CIPN overallStatus: RECRUITING date: 2023-05-19 date: 2025-07-31 date: 2025-07-31 date: 2024-03-26 date: 2024-03-26 name: National Cheng-Kung University Hospital class: OTHER name: National Cheng Kung University briefSummary: According to the incidence rate of cancer, the digestive tract cancer accounts for two of the top ten cancers. It also accounts for half of the top ten causes of cancer death. Chemotherapy remains one of the most common forms of cancer treatment, and chemotherapy-induced peripheral neuropathy (CIPN) is one of the common adverse effects of cancer treatment in cancer survivors. To date, there is no exercise guideline established for patients with CIPN; therefore, CIPN remains quite threatening to cancer survivors. Due to limited studies on effects of exercise on improvement of CIPN symptoms in patients with digestive tract cancers, this study aims to investigate the effects of exercise and different intervention delivery modes (remote home exercise and exercise under supervision) at different time points on the CIPN symptoms, body inflammatory index, physical function, and quality of life of gastrointestinal cancer survivors with chemotherapy-induced peripheral neuropathy. conditions: Digestive Tract Cancer conditions: Chemotherapy-induced Peripheral Neuropathy conditions: Remote Exercise studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: NONE count: 90 type: ESTIMATED name: remote home-based exercise therapy group name: supervised exercise therapy group name: regular care group measure: Basic information measure: gene measure: body height measure: body weight measure: body mass index measure: blood data measure: Questionnaire of Quality of Life measure: Questionnaire of Chemotherapy-Induced Peripheral Neuropathy measure: Muscle Strength measure: Dynamic Balance measure: Sensation Test measure: Cardiovascular Endurance sex: ALL minimumAge: 20 Years maximumAge: 80 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Department of Physical Therapy, National Cheng-Kung University status: RECRUITING city: Tainan zip: 701 country: Taiwan name: Cheng-Feng Lin, Ph.D role: CONTACT lat: 22.99083 lon: 120.21333 hasResults: False
<\|newrecord\|> nctId: NCT06331949 id: TR TOKAT02 briefTitle: Video Supported Training on Non-Stress Test Application to Pregnant Women overallStatus: NOT_YET_RECRUITING date: 2024-04-01 date: 2024-11-01 date: 2024-11-01 date: 2024-03-26 date: 2024-03-26 name: Hilal Özbek class: OTHER briefSummary: Women go through many practices during their pregnancy. These practices, along with ignorance, create stress in the mother. However, performing the procedures for the first time may increase the mother's stress level. Stress during pregnancy also affects prenatal attachment. Non-Stress Test (NST) Application is a test applied to pregnant women starting from the 28th week of pregnancy and provides information about the baby's well-being and uterine contractions. There is a gap in the literature regarding education for pregnant women undergoing NST regarding stress levels and prenatal attachment. With this study, stress levels and prenatal attachment levels in pregnant women will be determined during NST, which is frequently applied during pregnancy. Additionally, the effects of midwifery care in this process will be realized. In this way, solutions will be produced for problems that may arise. A better quality of midwifery care will be provided conditions: First Pregnancy studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: SUPPORTIVE_CARE masking: SINGLE whoMasked: PARTICIPANT count: 74 type: ESTIMATED name: video assisted training measure: State-Trait Anxiety Scale measure: Prenatal Attachment Inventory (PAI) measure: State-Trait Anxiety Scale measure: Prenatal Attachment Inventory (PAI) measure: State-Trait Anxiety Scale measure: Prenatal Attachment Inventory (PAI) sex: FEMALE minimumAge: 18 Years maximumAge: 49 Years stdAges: ADULT hasResults: False
<\|newrecord\|> nctId: NCT06331936 id: Shenzhen Project briefTitle: Improving Emotional Regulation Skills of Children in Difficulty in Shenzhen overallStatus: RECRUITING date: 2024-01-06 date: 2024-06 date: 2024-09 date: 2024-03-26 date: 2024-03-26 name: City University of Hong Kong class: OTHER name: International Social Service Hong Kong Branch briefSummary: The study aims to 1) improve the emotional regulation strategies of children in difficulty in Shenzhen, and 2) develop and publish a set of evidence-based intervention manuals for professional use. Based on the intervention manual design of the researchers' previous study conducted in Hong Kong, the current research revised the intervention manual to adapt to the context of mainland China. This study adopts a randomized wait-list control trial design. The researchers aim to recruit 200 children in difficulty aged 8 to 14 as participants and randomly assign them to an experimental and a wait-list control group with a ratio of 3:2. Each participant will attend four sessions of intervention and one booster session, and each session requires around 1.5 to 2 hours to complete. The participants will complete assessments before the first session of the intervention (T1), immediately after the fourth session of the intervention (T2), and one month after the completion of the intervention (T3). A qualitative assessment will also be conducted after the booster session. conditions: Emotion Regulation conditions: Parent-Child Relations conditions: Happiness conditions: Positive Affect studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL interventionModelDescription: Children will be randomly assigned to two groups: intervention and waitlist control groups. Children in the waitlist control group will receive experimental intervention after treatment for the experimental group finishes. primaryPurpose: PREVENTION masking: SINGLE maskingDescription: At the recruitment phase, the participants and the social workers who lead the intervention will not know which arm the participants will be assigned. A cluster of approximately 10 participants formed a group based on their attendance date in the intervention program. This group will be randomly assigned to one of the two intervention arms through pre-prepared randomization list calculated by random allocation software. whoMasked: PARTICIPANT count: 200 type: ESTIMATED name: Emotion regulation measure: 10-item Emotional Management Strategy Questionnaire measure: 10-item Positive and Negative Affect Schedule measure: Patient Health Questionnaire-9 measure: Generalized Anxiety Disorder Scale measure: Subjective Happiness Scale measure: Connor-Davidson Resilience Scale 10-Item measure: Child-Parent Relationship Scale measure: Family Harmony Scale sex: ALL minimumAge: 8 Years maximumAge: 14 Years stdAges: CHILD facility: City University of Hong Kong status: RECRUITING city: Hong Kong country: China name: Nancy Xiaonan YU, Ph.D. role: CONTACT phone: (852)34429436 email: nancy.yu@cityu.edu.hk lat: 22.39407 lon: 114.13737 hasResults: False
<\|newrecord\|> nctId: NCT06331923 id: U1111-1305-0484 briefTitle: Assessing the Effectiveness of Continuous Glucose Monitoring in Enhancing Surgical Outcomes for Diabetic Patients overallStatus: RECRUITING date: 2024-04-12 date: 2025-10-31 date: 2025-12-31 date: 2024-03-26 date: 2024-04-16 name: Beijing Tsinghua Chang Gung Hospital class: OTHER name: Peking University International Hospital name: Wang Jing Hospital name: ZhuHai Hospital name: Beijing Hospital name: Siyang County Hospital of Traditional Chinese Medicine name: Second Hospital of Shanxi Medical University name: Henan Provincial Chest Hospital name: Fuzhou First Hospital name: Pinggu Hospital of Beijing Traditional Chinese Medicine Hospital name: The First Affiliated Hospital of Anhui University of Chinese Medicine name: The First Affiliated Hospital of Zhengzhou University name: Mindong Hospital of Ningde name: The Fifth Hospital of Xiamen name: People's Hospital of Ningxia Hui Autonomous Region name: The First People's Hospital of Changzhou name: The Fifth hospital of Deyang name: Suzhou Municipal Hospital name: Tang-Du Hospital name: Yiyang Central Hospital name: First Affiliated Hospital of Xinjiang Medical University name: Peng Ding Shan Shi Zhong Yi Yi Yuan name: Yueyang Central Hospital name: The First People's Hospital of Lianyungang name: Haimen District Traditional Chinese Medicine Hospital name: The 910th Hospital name: The Second Affiliated Hospital of Zhejiang Chinese Medical University name: Beijing Tiantan Hospital name: Affiliated Hospital of Jiangsu University name: Liaocheng People's Hospital name: Beijing Chao Yang Hospital name: Jilin City Hospital of Chemical Industry name: Creen Hospital-465 name: Wuhan Central Hospital name: Air Force Military Medical University, China name: Shanghai Tong Ren Hospital name: Beijing Anzhen Hospital name: Emergency General Hospital name: Beijing Tongren Hospital name: Civil Aviation General Hospital name: Peking University Shougang Hospital name: The First Affiliated Hospital of Anhui Medical University name: Chinese PLA Central Hospital briefSummary: The goal of this multi-center, pragmatic, randomized controlled trial is to assess the effectiveness of continuous glucose monitoring (CGM) compared with conventional monitoring in enhancing surgical outcomes for diabetic patients. The main questions it aims to answer are:
* To assess the effectiveness of CGM compared with conventional monitoring in reducing the comprehensive complication index (CCI) for patients with diabetes or impaired glucose tolerance (IGT) within 30 days after surgery.
* To analyze the impact of different age groups, types of surgery, preoperative levels of HbA1c, and preoperative 24h glycemic variations on the improvement of surgical outcomes under the CGM model.
Participants will receive CGM prescribed by the attending physician for at least 6 hours before surgery. Glucose monitoring should be continued until the 7th day after surgery or discharge.
The investigators will compare conventional monitoring group to see if CGM could reduce the CCIs for patients with diabetes or impaired glucose tolerance within 30 days after surgery. conditions: Comprehensive Complication Index studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: SINGLE whoMasked: OUTCOMES_ASSESSOR count: 10168 type: ESTIMATED name: Continuous glucose monitoring (CGM) device measure: Comprehensive complication index measure: Postoperative complications measure: Morality measure: The length of the stay in the intensive care unit measure: The length of hospital stay measure: The overall hospitalization cost measure: Perioperative glucose level sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Zhifeng Gao status: RECRUITING city: Beijing state: Beijing zip: 102218 country: China name: Zhifeng Gao, MD role: CONTACT phone: 18756235568 email: btchgzf@hotmail.com lat: 39.9075 lon: 116.39723 hasResults: False
<\|newrecord\|> nctId: NCT06331910 id: TITNCUES briefTitle: Efficacy and Safety of Topical Insulin for Neurotrophic Corneal Ulcers overallStatus: NOT_YET_RECRUITING date: 2024-04-01 date: 2025-04-01 date: 2025-05-01 date: 2024-03-26 date: 2024-03-26 name: Assiut University class: OTHER briefSummary: To evaluate Safety and efficacy of topical insulin in treatment of neurotrophic corneal ulcers conditions: Neurotrophic Keratopathy studyType: INTERVENTIONAL phases: PHASE4 allocation: NA interventionModel: SINGLE_GROUP primaryPurpose: TREATMENT masking: NONE count: 14 type: ESTIMATED name: insulin eye drops measure: Decrease in ulcer size and the increase in visual acuity . sex: ALL minimumAge: 18 Years maximumAge: 60 Years stdAges: ADULT hasResults: False
<\|newrecord\|> nctId: NCT06331897 id: Bronchial asthma briefTitle: Bronchial Asthma & Its Exacerbation overallStatus: NOT_YET_RECRUITING date: 2025-01-01 date: 2026-01-01 date: 2026-06-01 date: 2024-03-26 date: 2024-03-26 name: Assiut University class: OTHER briefSummary: Our goals is to assess :
1¬_ the role of spirometer in case of asthma exacerbation 2_hematological parameters (N/L ratio \& platelet indices \&CRP )in asthma exacerbation for diagnosing and classifying asthma severity and its exacerbation conditions: Bronchial Asthma studyType: OBSERVATIONAL observationalModel: OTHER timePerspective: PROSPECTIVE count: 50 type: ESTIMATED measure: Assessment of Broncial asthma & its exacerbation : the utility of laboratory investigation , chest imaging , pulmonary function tests sex: ALL minimumAge: 2 Years maximumAge: 18 Years stdAges: CHILD stdAges: ADULT hasResults: False
<\|newrecord\|> nctId: NCT06331884 id: PCZ_Phase1 briefTitle: Phase 1 Study to Evaluate Safety, Tolerability and Pharmacokinetics/-Dynamics of AK1967 (Procizumab) overallStatus: RECRUITING date: 2024-03-07 date: 2024-07-31 date: 2024-07-31 date: 2024-03-26 date: 2024-03-26 name: 4TEEN4 Pharmaceuticals GmbH class: INDUSTRY briefSummary: Dipeptidyl peptidase 3 (DPP3) is a protease involved in the degradation of several cardiovascular mediators. During cardiogenic shock, upregulation of the vasoconstrictive molecule angiotensin II is a physiologic and potentially life-saving response aimed at maintaining adequate tissue perfusion. As circulating (c)DPP3 is able to effectively cleave angiotensin II, it may represent a novel factor contributing to hemodynamic instability during cardiogenic shock.
Recently, a cDPP3-antagonizing antibody called AK1967 (commonly referred to as Procizumab) has been developed. In animal models of cardiogenic- and septic shock, inhibition of cDPP3 by AK1967 resulted in improved cardiac function and survival. Furthermore, AK1967 has shown an excellent safety record in different preclinical studies. In the current study the safety, tolerability and pharmacokinetics/-dynamics of AK1967 will be investigated in healthy male subjects. conditions: Safety and Tolerability studyType: INTERVENTIONAL phases: PHASE1 allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: QUADRUPLE whoMasked: PARTICIPANT whoMasked: CARE_PROVIDER whoMasked: INVESTIGATOR whoMasked: OUTCOMES_ASSESSOR count: 24 type: ESTIMATED name: AK1967 (Procizumab) name: Placebo measure: Reported number of adverse events from baseline (start of Procizumab administration) up until the last follow-up visit after Procizumab administration sex: MALE minimumAge: 18 Years maximumAge: 35 Years stdAges: ADULT facility: Radboud University Medical Center status: RECRUITING city: Nijmegen state: Gelderland zip: 6525 country: Netherlands name: Peter Pickkers, MD, PhD role: CONTACT lat: 51.8425 lon: 5.85278 hasResults: False
<\|newrecord\|> nctId: NCT06331871 id: 2004202111621 briefTitle: Effectiveness of US-PENS for Patients With Post-surgical Shoulder Pain overallStatus: RECRUITING date: 2024-02-01 date: 2025-10-30 date: 2025-10-30 date: 2024-03-26 date: 2024-03-26 name: Universidad Rey Juan Carlos class: OTHER briefSummary: The aim of this clinical trial was to demonstrate the effectiveness of the application of ultrasound-guided percutaneous nerve stimulation (US-PENS) directed at the axillary nerve and the suprascapular nerve, in patients with post-surgical shoulder pain.
This is a randomized, longitudinal, prospective and quasi-experimental clinical trial in which a total of 70 patients divided into two groups; physiotherapy protocol group (n=35) and experimental group to which the same protocol was practiced and a US-PENS session was added (n=35).
The intervention and follow-up period of the participants took place over 12 weeks. conditions: Ultrasound-Guided Percutaneous Electrical Nerve Stimulation studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL interventionModelDescription: 70 patients with shoulder pain undergoing arthroscopic surgery were recruited. They were divided into two groups at random; physiotherapy protocol group (n=35) and experimental group to which the same protocol was practiced and two sessions of ultrasound-guided percutaneous nerve stimulation (US-PENS) were added (n=35). primaryPurpose: TREATMENT masking: NONE count: 70 type: ESTIMATED name: Ultrasound Guied Percutaneus Electrical Nerve Stimulation (US-PENS) and Manual physiotherapy protocol based on available evidence. name: Manual physiotherapy protocol based on available evidence. measure: The Numeric Pain Rating Scale (NPRS) measure: Disabilities of the Arm, Shoulder and Hand (DASH) measure: The Shoulder Pain and Disability Index (SPADI) measure: GONIOMETRY measure: DINAMOMETRY measure: PAIN THRESHOLD ON PRESSURE sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Clinica Cemtro status: RECRUITING city: Madrid zip: 28049 country: Spain name: MARIO J ABRIL SERVÁN role: CONTACT phone: +34636707810 email: MASERVAN@HOTMAIL.COM name: FERNANDO GARCÍA SANZ role: CONTACT phone: +34917355757 email: fisioterapiaclub@clinicacemtro.com name: MARIO J ABRIL SERVÁN role: PRINCIPAL_INVESTIGATOR name: ADRIÁN CASES role: SUB_INVESTIGATOR lat: 40.4165 lon: -3.70256 hasResults: False
<\|newrecord\|> nctId: NCT06331858 id: KutahyaHSU-DRGOKPINARDROMER-43 briefTitle: The Effect of Adding Instrumented Hip Concentric Abductor Strengthening Exercise in Knee Osteoarthritis overallStatus: RECRUITING date: 2023-09-20 date: 2024-03-29 date: 2024-03-29 date: 2024-03-26 date: 2024-03-26 name: Kutahya Health Sciences University class: OTHER briefSummary: The aim of this study was to investigate the effectiveness of adding hip device-assisted concentric abductor strengthening (HDACAS) program to knee device-assisted concentric flexor-extensor strengthening (KDACFES) program on pain, function, physical performance, quality of life and gait parameters in patients with knee osteoarthritis (OA). conditions: Knee Osteoarthritis conditions: Pain conditions: Physical Disability studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL interventionModelDescription: 1. STUDY GROUP
2. CONTROL GROUP primaryPurpose: TREATMENT masking: DOUBLE maskingDescription: Before and after the treatment, all patients were evaluated by a blind evaluator in terms of physical examination, pain and functionality, physical performance, quality of life and gait parameters. whoMasked: INVESTIGATOR whoMasked: OUTCOMES_ASSESSOR count: 60 type: ESTIMATED name: hip device-assisted concentric abductor strengthening (HDACAS) name: knee device-assisted concentric flexor-extensor strengthening (KDACFES) measure: Western Ontario and McMaster Universities (WOMAC) measure: The Lequesne Algofunctional index measure: TIME UP AND GO TEST measure: 30 SECOND CHAIR TEST measure: 40 METER SELF PACED WALK TEST measure: SIX MINUTES WALK TEST measure: STAIR CLIMB TEST measure: Visual Analog Scale (VAS) measure: Mini Osteoarthritis Knee and Hip Quality of Life Scale sex: ALL minimumAge: 45 Years maximumAge: 70 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Kutahya Health Sciences University status: RECRUITING city: Kutahya zip: 43100 country: Turkey name: Hasan Huseyin Gokpinar, Ass. Prof. role: CONTACT phone: +905052842222 email: hasanhuseyin.gokpinar@ksbu.edu.tr name: Ömer Özyümlü role: CONTACT phone: +905442024671 email: omer.ozyumlu@gmail.com lat: 39.42417 lon: 29.98333 facility: Kutahya Health Sciences University status: RECRUITING city: Kutahya zip: 43100 country: Turkey name: Hasan Huseyin Gokpinar, Ass. Prof. role: CONTACT phone: +905052842222 email: hasanhuseyin.gokpinar@ksbu.edu.tr lat: 39.42417 lon: 29.98333 hasResults: False
<\|newrecord\|> nctId: NCT06331845 id: NPC012 briefTitle: Stop and go Strategy as First-line Treatment for Widely Metastatic Nasopharyngeal Carcinoma overallStatus: NOT_YET_RECRUITING date: 2024-05-01 date: 2026-05-01 date: 2028-05-01 date: 2024-03-26 date: 2024-03-26 name: Fujian Cancer Hospital class: OTHER_GOV briefSummary: This study aimed to investigate the value of a novel strategy of intermittent systematic chemotherapy (ISC) in widely metastatic nasopharyngeal carcinoma (wmNPC) patients who achieve objective response after systematic chemotherapy (SC). conditions: Metastatic Nasopharyngeal Carcinoma conditions: Intermittent Systematic Chemotherapy studyType: INTERVENTIONAL phases: PHASE2 allocation: NA interventionModel: SINGLE_GROUP primaryPurpose: TREATMENT masking: NONE count: 39 type: ESTIMATED name: Gemcitabine name: Cisplatin name: Paclitaxel protein-bound name: Capecitabine name: Tislelizumab measure: progression-free survival measure: progression-free survival 2 measure: overall survival sex: ALL minimumAge: 18 Years maximumAge: 70 Years stdAges: ADULT stdAges: OLDER_ADULT hasResults: False
<\|newrecord\|> nctId: NCT06331832 id: 2323-EAP id: 2021-002339-44 type: EUDRACT_NUMBER briefTitle: Expanded Access of Imvotamab (IGM-2323) in Patients With R/R NHL overallStatus: NO_LONGER_AVAILABLE date: 2024-03-26 date: 2024-03-26 name: IGM Biosciences, Inc. class: INDUSTRY briefSummary: Expanded Access of Imvotamab (IGM-2323) in Patients with Relapsed/Refractory Non-Hodgkin Lymphomas from IGM-2323-001 clinical trial. conditions: Relapsed/Refractory Non-Hodgkin Lymphomas studyType: EXPANDED_ACCESS name: IGM2323 sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Sir Charles Gairdner Hospital city: Nedlands state: Western Australia country: Australia lat: -31.98184 lon: 115.8073 facility: Samsung Medical Center city: Seoul state: Gangnam-gu country: Korea, Republic of lat: 37.566 lon: 126.9784 facility: START-Madrid Centro Integral Oncologico Clara Campal city: Madrid country: Spain lat: 40.4165 lon: -3.70256 hasResults: False
<\|newrecord\|> nctId: NCT06331819 id: 7-3-2024 briefTitle: Clinical Association Between Obstructive Sleep Apnea, Facial Pigmentation, and Vasovagal Symptoms. acronym: VasOSA overallStatus: RECRUITING date: 2024-03-10 date: 2025-01-01 date: 2025-03-01 date: 2024-03-26 date: 2024-03-26 name: Jordan Collaborating Cardiology Group class: OTHER briefSummary: The goal of this prospective cohort study is to study patients referred for sleep study by in-lab polysomnography in the Jordan University Hospital and the Jordan Hospital. The main aims are:
* To prospectively obtain demographic and clinical information of patients referred for a sleep study.
* To determine the diagnostic value of facial discoloration as potential marker for obstructive sleep apnea to increase detection rate for the condition.
* To establish a correlation between obstructive sleep apnea and vasovagal symptoms with resulting increased smoking tendency and study the effect of treatment on the disorders.
* To determine the association between timing of appearance of obstructive sleep apnea symptoms and initiation of smoking. conditions: Obstructive Sleep Apnea conditions: Vasovagal Syncope conditions: Smoking conditions: Acanthosis Nigricans studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: PROSPECTIVE count: 200 type: ESTIMATED name: In-lab polysomnography name: Continuous positive airway pressure measure: Clinical association between obstructive sleep apnea and presence of facial pigmentation measure: Clinical association between obstructive sleep apnea and severity of facial pigmentation measure: Relation between obstructive sleep apnea and vasovagal symptoms measure: Relation between obstructive sleep apnea and resulting smoking tendency due to vasovagal symptoms measure: Relation between obstructive sleep apnea and the effect of treatment on facial discolouration measure: Relation between obstructive sleep apnea and the effect of treatment on vasovagal symptoms measure: Relation between obstructive sleep apnea and the effect of treatment on smoking habits sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: The University of Jordan status: RECRUITING city: Amman zip: 11942 country: Jordan name: Asma Btoosh, MD role: CONTACT phone: 00962797684137 email: asmaalbtoosh@gmail.com name: Rand M Zaqqa role: PRINCIPAL_INVESTIGATOR name: Ayah M Zaqqa, MD role: PRINCIPAL_INVESTIGATOR name: Maisa Mansoor, MD role: PRINCIPAL_INVESTIGATOR name: Asma Btoosh, MD role: PRINCIPAL_INVESTIGATOR name: Salah Salah role: SUB_INVESTIGATOR lat: 31.95522 lon: 35.94503 typeAbbrev: Prot hasProtocol: True hasSap: False hasIcf: False label: Study Protocol date: 2024-03-07 uploadDate: 2024-03-07T14:03 filename: Prot_000.pdf size: 82683 hasResults: False

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