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<|newrecord|> nctId: NCT06358118 id: 2024-003-KY briefTitle: Buyuan-zhixiao Formula in the Treatment of Elderly Patients With Diabetes and Multiple Metabolic Disorders overallStatus: NOT_YET_RECRUITING date: 2024-05-06 date: 2025-07-01 date: 2025-07-01 date: 2024-04-10 date: 2024-04-10 name: Qing Ni class: OTHER briefSummary: The primary objective of this clinical trial is to assess the clinical efficacy and safety of the Buyuan Zhixiao Formula in treating elderly patients with diabetes and multiple metabolic disorders exhibiting symptoms of renal deficiency and blood stasis. Furthermore, this study aims to intervene in high-risk factors to prevent arteriosclerosis and to investigate the clinical efficacy of the Buyuan Zhixiao Formula in the prevention and treatment of cognitive impairments.
The main questions it aims to answer are:
1. What are the clinical effects of Buyuan Zhixiao Formula, including lowering blood sugar, lowering blood pressure, lowering lipids, and treating obesity?
2. Can Buyuan Zhixiao Formula improve cognitive impairment in diabetes? Researchers compared Buyuan Zhixiao Formula with a placebo (a drug that looks similar but contains only 10% of the active ingredients) to see if the drug Buyuan Zhixiao Formula can treat elderly people with diabetes and multiple metabolic disorders.
Participants will:
1. Take the drug Bu Yuan Zhi XiaoFormula or placebo every day for 6 months；Follow-up for 6 months；
2. Check fasting blood sugar and 2-hour postprandial blood sugar every month; check HbA1c, blood lipids, vascular function, and cognitive impairment serum markers every 3 months;
3. Conduct scores on TCM symptoms, cognitive ability, nutritional status and other scales and adverse events;
4. Urine and serum samples were collected before and after treatment; conditions: Diabete Mellitus conditions: Aging conditions: Metabolic Disorders conditions: Traditional Chinese Medicine conditions: Randomized Controlled Trial studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: TRIPLE whoMasked: PARTICIPANT whoMasked: INVESTIGATOR whoMasked: OUTCOMES_ASSESSOR count: 240 type: ESTIMATED name: Buyuan Zhixiao Formula name: Placebo measure: HbA1c measure: Fasting blood glucose measure: 2-hour postprandial blood glucose measure: blood pressure measure: weight measure: waist circumference measure: BMI measure: Total Cholesterol measure: Triglycerides measure: High density lipoprotein cholesterol measure: Low density lipoprotein cholesterol measure: Ankle-Brachial Index（ABI） measure: Fasting insulin measure: C-peptide measure: insulin resistance index measure: islet β-cell function index measure: lipid Lipid accumulation product measure: visceral adiposity index measure: Measurement Results of Tumor Necrosis Factor-alpha Levels at Different Time Points measure: Concentration Variation of Interleukin-10 measure: Change in Homocysteine Levels measure: Average Concentration of Interleukin-6 measure: Change in Endothelin-1 Levels measure: Average Concentration of Nitric Oxide measure: Concentration Variation of Von Willebrand Factor measure: Measurement Results of Vascular Endothelial Growth Factor Levels at Different Time Points measure: Change in Matrix Metalloproteinase-9 Levels" or "Participants' Matrix Metalloproteinase-9 Concentration measure: Average Concentration of Soluble Intercellular Adhesion Molecule-1 measure: Change in Serum Tau Protein Levels measure: Average Concentration of Aβ40 measure: Average Concentration of Aβ42 measure: Change in Neurofilament Light Chain Protein Levels measure: Carotid Ultrasound; Carotid Intima-Media Thickness. measure: Activities of Daily Living Scale score; Fried Frailty Phenotype Scale; Mini Nutritional Rating Scale; MoCA scale score; Traditional Chinese Medicine Kidney Deficiency and Blood Stasis Syndrome Scale score. measure: Montreal Cognitive Assessment Score measure: Fried Frailty Phenotype Scale measure: Activities of Daily Living Scale score measure: Mini Nutritional Rating Scale measure: Serum and urine metabolomics sex: ALL minimumAge: 65 Years stdAges: OLDER_ADULT facility: China Academy of Chinese Medical Sciences Guang'anmen Hospital city: Beijin state: Beijing zip: 100053 country: China name: Qing Ni, postgraduate role: CONTACT phone: 010-88001245 email: [email protected] name: zhige Wen, postgraduate role: CONTACT phone: 15890643963 email: [email protected] facility: Cangzhou integrative medicine hospital city: Hebei country: China name: zhongyong zhang, postgraduate role: CONTACT phone: 18031783396 email: [email protected] facility: Hohhot Mongolian Traditional Chinese Medicine Hospital city: Neimeng country: China facility: Binzhou Traditional Chinese Medicine Hospital city: Shandong country: China name: lijuan Du, postgraduate role: CONTACT phone: 18800102622 email: [email protected] facility: Yantai Baishi Traditional Chinese Medicine Hospital city: Shandong country: China facility: The First Teaching Hospital of Tianjin University of Traditional Chinese Medicine city: Tianjin country: China name: bin Wang, postgraduate role: CONTACT phone: 13051395068 lat: 39.14222 lon: 117.17667 hasResults: False
<|newrecord|> nctId: NCT06358105 id: id. 6457 briefTitle: Simulator Training to Improve Interventional Cardiologist Skills (STARTERS) Trial acronym: STARTERS overallStatus: NOT_YET_RECRUITING date: 2024-11-15 date: 2024-11-15 date: 2025-11-15 date: 2024-04-10 date: 2024-04-10 name: Fondazione Policlinico Universitario Agostino Gemelli IRCCS class: OTHER briefSummary: The goal of this clinical trial is to learn if simulator-based training will improve interventional cardiology fellows' skills and will improve patient outcomes.
The main questions it aims to answer are:
* Does this training improve specific operative parameters recorded during initial coronary interventions performed as first operators under senior supervision?
* Will major and minor procedural complications be reduced after simulator-based training?
Interventional cardiology fellows in their first year of training will be randomized between standard master-apprentice training or simulator-based training before starting their cath lab period.
They will be supervised during their cath lab period as first operators by senior interventional cardiologists.
During their first 50 procedures performed as supervised first operator, specific procedural data will be collected. conditions: Coronary Artery Disease studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: NONE count: 400 type: ESTIMATED name: Simulator-based training name: Standard training measure: Mean total fluoroscopy radiation time (expressed in seconds) measure: Mean arterial cannulation time (expressed in seconds) measure: Total radiation dose (expressed in cGy*cm2) measure: Total contrast dose (expressed in ml) measure: Failure to achieve arterial cannulation (e.g.: rate of failure for each partecipant) measure: Failure to achieve right coronary cannulation (e.g.: rate of failure for each partecipant) measure: Failure to achieve left coronary cannulation (e.g.: rate of failure for each partecipant) measure: Number of catheters used measure: Any major or minor procedural and clinical complication sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Fondazione Policlinico Univrsitario Agostino Gemelli IRCCS city: Rome zip: 00168 country: Italy lat: 41.89193 lon: 12.51133 hasResults: False
<|newrecord|> nctId: NCT06358092 id: ZSSYXHNK2401 briefTitle: Two-dimensional Shear Wave Elastography for Assessment of Cirrhosis and Portal Hypertension overallStatus: NOT_YET_RECRUITING date: 2024-04-01 date: 2025-01-01 date: 2026-01-01 date: 2024-04-10 date: 2024-04-10 name: Third Affiliated Hospital, Sun Yat-Sen University class: OTHER briefSummary: Exploring and establishing new non-invasive risk stratification techniques for portal hypertension based on E imaging technology for measuring liver and spleen stiffness is an urgent need in this field of research. conditions: Cirrhosis, Liver conditions: Portal Hypertension studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: PROSPECTIVE count: 112 type: ESTIMATED name: Hepatic venous pressure gradient name: Two-Dimensional Shear Wave Elastography measure: the diagnostic performance of liver and spleen stiffness by E imaging technology for clinically significant portal hypertension measure: the diagnostic performance of microvessel imaging of hepatic microcirculation by E imaging technology for clinically significant portal hypertension measure: the difference among left, middle and right hepatic venous pressure gradient sex: ALL minimumAge: 18 Years maximumAge: 75 Years stdAges: ADULT stdAges: OLDER_ADULT hasResults: False
<|newrecord|> nctId: NCT06358079 id: 258 briefTitle: Re-infusion of Unwashed Shed Blood During Off-pump Surgery overallStatus: RECRUITING date: 2024-03-27 date: 2026-03-30 date: 2026-03-30 date: 2024-04-10 date: 2024-04-10 name: Damascus University class: OTHER briefSummary: To assess the efficacy and side-effects of re-infusion of unwashed shed blood during off-pump coronary artery surgery using a novel cardiotomy circuit. conditions: Coronary Artery Disease conditions: Blood Transfusion Complication conditions: Cardiovascular Complication studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL interventionModelDescription: A prospective study involving patients undergoing off-pump coronary artery bypass surgery. Patients will be randomized to two groups; an isolated cardiotomy circuit for re-infusion of unwashed shed blood will be used in group (a) and the conventional no re-infusion technique will be used in group (b). primaryPurpose: TREATMENT masking: SINGLE maskingDescription: Outcome assessor will be blinded to the group type when analyzing data whoMasked: OUTCOMES_ASSESSOR count: 50 type: ESTIMATED name: Re-infusion of unwashed shed blood measure: blood transfusion requirements measure: inflammatory response measure: alveolar/arterial oxygen pressure gradients measure: cost-benefit measure: Neuro-markers measure: myocardial marker CK-MB measure: myocardial marker troponin-I measure: blood loss measure: complement response sex: ALL minimumAge: 40 Years maximumAge: 75 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Damascus University Cardiac Surgery Hospital status: RECRUITING city: Damascus country: Syrian Arab Republic name: Mohammad Bashar Izzat, FRCS role: CONTACT phone: +963943240820 email: [email protected] name: Albaraa Bara, MD role: CONTACT phone: 0934206291 email: [email protected] lat: 33.5102 lon: 36.29128 hasResults: False
<|newrecord|> nctId: NCT06358066 id: self assembling peptides briefTitle: The Remineralization of Early Enamel Caries in Permanent Teeth overallStatus: NOT_YET_RECRUITING date: 2024-04-06 date: 2024-10-06 date: 2024-12-06 date: 2024-04-10 date: 2024-04-10 name: Tanta University class: OTHER briefSummary: Evaluate clinically the remineralizing potential of self-assembling peptide ( P11-4) fluoride plus in early enamel carious lesions of permanent anterior teeth. conditions: White Spot Lesion studyType: INTERVENTIONAL phases: PHASE1 allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: NONE count: 50 type: ESTIMATED name: diagnodent name: ICDAS 2 measure: measurement of mineral contents of teeth with early carious lesions among 2 arms. quantitatively using the laser fluorescence DIAGNOdent and qualitatively using ICDAS II scoring system measure: measurement of mineral contents of teeth with early carious lesions among 2 arms. quantitatively using the laser fluorescence DIAGNOdent and qualitatively using ICDAS II scoring system sex: ALL minimumAge: 10 Years maximumAge: 14 Years stdAges: CHILD hasResults: False
<|newrecord|> nctId: NCT06358053 id: CRTE7A2-2302C briefTitle: CRTE7A2-01 TCR-T Cells for HPV-16 Positive Advanced Cancers overallStatus: NOT_YET_RECRUITING date: 2024-04-15 date: 2027-12-31 date: 2028-04-30 date: 2024-04-10 date: 2024-04-10 name: Corregene Biotechnology Co., Ltd class: INDUSTRY briefSummary: A single center, open, single arm dose escalation and dose expansion phase I study to evaluate the safety, tolerability, and efficacy of CRTE7A2-01 TCR-T cells in HLA-A\*02:01+ Subjects HPV16 positive advanced cervical, anal, or head and neck cancers. The study will determine RP2D of CRTE7A2-01 TCR-T cell injection. conditions: Cervical Cancer conditions: Anal Cancer conditions: Head and Neck Cancers conditions: Other Solid Tumors studyType: INTERVENTIONAL phases: PHASE1 allocation: NA interventionModel: SINGLE_GROUP primaryPurpose: TREATMENT masking: NONE count: 24 type: ESTIMATED name: CRTE7A2-01 TCR-T cell therapy measure: DLT measure: RP2D measure: cevents (SAEs). measure: Objective Response Rate (ORR) measure: Disease Control Rate (DCR) measure: Duration of Response (DOR) measure: Progression-Free Survival (PFS) measure: Overall Survival(OS) measure: Peripheral blood TCR-T cell copy number sex: ALL minimumAge: 18 Years maximumAge: 65 Years stdAges: ADULT stdAges: OLDER_ADULT hasResults: False
<|newrecord|> nctId: NCT06358040 id: 2023-0328 briefTitle: Opioid Dispenser for Microdiscectomy/Laminectomy overallStatus: NOT_YET_RECRUITING date: 2024-05 date: 2025-05 date: 2025-07 date: 2024-04-10 date: 2024-04-22 name: Hospital for Special Surgery, New York class: OTHER briefSummary: The opioid crisis continues to plague the United States. While great strides have been made nationwide to decrease overprescribing, improvements are still needed to appropriately educate patients on the safe and responsible use, storage and disposal of opioids. Pain after surgery is often treated with opioid medications. Opioid medications can have side effects. Some side effects are relatively minor (constipation, nausea, vomiting), while others are more severe (sedation, abnormal breathing, etc.) and can lead to serious illness or death. Opioid pain medications when used the wrong way may also be addictive. Due to theses side effects, sometimes patients feel uncomfortable about taking these medications, and doctors prescribe them very cautiously. However, when used properly and safely, opioid pain medications are excellent pain relievers.
Addinex, a technology company, has developed a device to help patients take opioids more safely. In this study the investigators aim to enroll a total of 30 patients who undergo spine surgery. Half will be randomly assigned to receive a standard pill bottle with opioids at discharge and will download a mobile app so that they can record their daily pain scores and the number of opioids they take for two weeks after surgery. The other half will receive the new opioid dispenser filled with opioids and a mobile app that generates a passcode that opens that device only at designated times. For this group of patients, every time the patient wants to take an opioid, they need to go to the app, enter their pain score before the app generates a passcode. The investigators will be tracking all study patients' opioid use and pain scores for the two weeks after surgery, will count how many pills they have left over 14 days after their surgery during a live telehealth session, and ask patients how they liked using the device. Results from this study will help understand if the Addinex device could potentially be useful to patients in the future after surgeries as opposed to typical pill bottles. conditions: Opioid Use conditions: Pain, Postoperative conditions: Medical Device conditions: Laminectomy conditions: Diskectomy studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: PREVENTION masking: NONE count: 30 type: ESTIMATED name: Opioid-Dispensing Device name: App name: Standard Opioid Pill Bottle measure: Cumulative Opioid Consumption at Postoperative Day 14 (POD14) measure: NRS pain intensity ratings measure: Patient satisfaction with the app and with the dispensing device measure: Frequency of reported difficulties using the device measure: Frequency of reported difficulties using the app measure: Opioid prescription refill rates measure: Concordance of app data and medication left in the device or pill bottle (medication reconciliation) sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Hospital for Special Surgery city: New York state: New York zip: 10021 country: United States name: William Chan, MEng role: CONTACT phone: 917-260-4788 email: [email protected] name: Alexandra Sideris, PhD role: CONTACT phone: 212-774-2602 email: [email protected] lat: 40.71427 lon: -74.00597 hasResults: False
<|newrecord|> nctId: NCT06358027 id: DokuzEU-ACC-BOtlu-01 briefTitle: Evaluation of the Effects of Different Ventilation Modes Used During Anesthesia Awakening on the Frequency of Postoperative Atelectasis overallStatus: NOT_YET_RECRUITING date: 2024-04-05 date: 2024-04-21 date: 2024-04-30 date: 2024-04-10 date: 2024-04-10 name: Dokuz Eylul University class: OTHER briefSummary: In our study, we aimed to detect atelectasis developing in patients undergoing surgery under general anesthesia using transthoracic lung ultrasonography and to investigate the effect of ventilation methods used during recovery from anesthesia on the formation of postoperative atelectasis. conditions: Atelectasis, Postoperative Pulmonary studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: PROSPECTIVE count: 278 type: ESTIMATED name: lung ultrasound measure: Modified Transthoracic Ultrasound Score sex: ALL minimumAge: 18 Years maximumAge: 80 Years stdAges: ADULT stdAges: OLDER_ADULT hasResults: False
<|newrecord|> nctId: NCT06358014 id: YX2021-02 briefTitle: Assessment of the Improvement in Cognitive Levels of Postmenopausal Depression Patients by Estrogen overallStatus: RECRUITING date: 2023-05-12 date: 2024-12-30 date: 2024-12-30 date: 2024-04-10 date: 2024-04-10 name: Xiao Wang class: OTHER briefSummary: After menopause, there is a certain tendency towards depression, with the risk of developing depression being about 3 to 4 times higher than before menopause. Additionally, postmenopausal women experience varying degrees of cognitive decline, which are closely associated with hormonal changes. Therefore, we should pay more attention to the cognitive levels of postmenopausal depression patients. Increasing evidence suggests that changes in cognitive function during menopause may be related to the effects of estrogen on cognitive function, and estrogen therapy can effectively improve cognitive decline. Estrogen is not only associated with cognitive symptoms after menopause, but estrogen intervention is also an adjunctive treatment for postmenopausal depression symptoms. There is a close relationship between cognitive levels and depression, as depression itself is accompanied by cognitive decline, and early cognitive decline can also manifest depressive symptoms. Therefore, the cognitive levels of postmenopausal depression patients are also worthy of further attention.This study is an 8-week randomized controlled trial. The subjects are patients with postmenopausal depression accompanied by cognitive decline, all of whom have undergone natural menopause for at least one year; with HAMD-17 scores ≥17 points; and MOCA scores ≤26 points. This study aims to recruit patients with postmenopausal depression accompanied by cognitive decline from the outpatient or inpatient departments of Beijing Anding Hospital, Capital Medical University. Patients who meet the inclusion criteria will be randomly assigned to the combination group and the control group using a random number method. The combination group will receive estrogen combined with SSRIs, while the control group will only receive Selective serotonin reuptake inhibitors (SSRIs) intervention. Patients' cognitive function and depressive symptoms will be assessed using scales at baseline, 2 weeks, 4 weeks, and the end of 8 weeks of treatment, and safety evaluations will be conducted. The primary efficacy endpoint is the change in MoCA scores from baseline to the end of the study. Secondary efficacy endpoints include changes in HAMD-17, modified Kupperman Scale, ADL Scale, and hormone levels from baseline to the end of the study. The safety of the study drug will be evaluated through adverse event reporting, clinical laboratory tests, and physical examinations. conditions: Postmenopausal Depression conditions: Estrogen studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL interventionModelDescription: The combination group will receive estrogen combined with Selective serotonin reuptake inhibitors (SSRIs) , while the control group will only receive Selective serotonin reuptake inhibitors (SSRIs) intervention.SSRIs include Citalopram (Celexa) , Escitalopram (Lexapro) ,Fluoxetine (Prozac) ,Paroxetine (Paxil, Pexeva) and Sertraline (Zoloft) primaryPurpose: TREATMENT masking: NONE count: 40 type: ESTIMATED name: Fematon (estradiol/estradiol-norethindrone acetate combination tablet package)+SSRIs name: SSRIs measure: The average change value of MOCA total scores from baseline to 8 weeks of treatment, as assessed by raters, is the primary efficacy endpoint(0-8week). measure: The average change value of HAMD-17 total scores from baseline to 8 weeks of treatment, as assessed by raters, is secondary Outcome Measures measure: The average change value of HAMA total scores from baseline to 8 weeks of treatment, as assessed by raters, is secondary Outcome Measures measure: The average change value of Kupperman total scores from baseline to 8 weeks of treatment, as assessed by raters, is secondary Outcome Measures measure: The average change value of PSQI total scores from baseline to 8 weeks of treatment, as assessed by raters, is secondary Outcome Measures measure: The average change value of ADL total scores from baseline to 8 weeks of treatment, as assessed by raters, is secondary Outcome Measures sex: FEMALE maximumAge: 70 Years stdAges: CHILD stdAges: ADULT stdAges: OLDER_ADULT facility: Beijing Anding Hospital Affiliated to Capital Medical University status: RECRUITING city: Beijing country: China name: xiao wang, prof role: CONTACT phone: +8658303103 email: [email protected] lat: 39.9075 lon: 116.39723 hasResults: False
<|newrecord|> nctId: NCT06358001 id: 21-07 briefTitle: EchoTip AcuCore Post-Market Clinical Study overallStatus: NOT_YET_RECRUITING date: 2024-06-01 date: 2025-06-01 date: 2025-06-01 date: 2024-04-10 date: 2024-04-10 name: Cook Research Incorporated class: INDUSTRY briefSummary: The purpose of collecting this data is to continue to learn more about the EchoTip AcuCore and the device's ability to produce the desired favorable effect and if there are any undesired outcomes that may be related to the EchoTip AcuCore. conditions: Adenocarcinoma conditions: Neuroendocrine Tumors conditions: Hepatocellular Carcinoma conditions: Cholangiocarcinoma conditions: Malignant Lymphoma conditions: Metastasis conditions: Chronic Pancreatitis conditions: Autoimmune Pancreatitis studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: PROSPECTIVE count: 183 type: ESTIMATED name: EchoTip AcuCore measure: Technical Success sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT hasResults: False
<|newrecord|> nctId: NCT06357988 id: NCI-2024-01149 id: NCI-2024-01149 type: REGISTRY domain: CTRP (Clinical Trial Reporting Program) id: EAY131-T type: OTHER domain: ECOG-ACRIN Cancer Research Group id: EAY131-T type: OTHER domain: CTEP id: U10CA180820 type: NIH link: https://reporter.nih.gov/quickSearch/U10CA180820 briefTitle: Testing GDC-0449 (Vismodegib) as Potentially Targeted Treatment in Cancers With Smoothened or Patched 1 Mutant Tumors (MATCH - Subprotocol T) overallStatus: ACTIVE_NOT_RECRUITING date: 2016-02-24 date: 2024-11-04 date: 2024-11-04 date: 2024-04-10 date: 2024-04-22 name: National Cancer Institute (NCI) class: NIH briefSummary: This phase II MATCH treatment trial tests how well GDC-0449 (vismodegib) works for treating patients with solid tumors, lymphoma, or multiple myeloma that may have spread from where it first started to nearby tissue, lymph nodes, or distant parts of the body (advanced) or that does not respond to treatment (refractory) and who have a smoothened or patched 1 genetic mutation. Vismodegib is a type of medication called a hedgehog signaling pathway antagonist and works by blocks a type of protein involved in tissue growth and repair and may block the growth of cancer cells. conditions: Advanced Lymphoma conditions: Advanced Malignant Solid Neoplasm conditions: Hematopoietic and Lymphatic System Neoplasm conditions: Refractory Lymphoma conditions: Refractory Malignant Solid Neoplasm conditions: Refractory Multiple Myeloma studyType: INTERVENTIONAL phases: PHASE2 allocation: NA interventionModel: SINGLE_GROUP primaryPurpose: TREATMENT masking: NONE count: 35 type: ESTIMATED name: Biopsy name: Biospecimen Collection name: Echocardiography name: Radionuclide Imaging name: Vismodegib measure: Objective response rate (ORR) measure: Overall survival (OS) measure: 6-month progression-free survival (PFS) rate measure: Progression free survival sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: ECOG-ACRIN Cancer Research Group city: Philadelphia state: Pennsylvania zip: 19103 country: United States lat: 39.95233 lon: -75.16379 hasResults: False
<|newrecord|> nctId: NCT06357975 id: NCI-2024-01126 id: NCI-2024-01126 type: REGISTRY domain: CTRP (Clinical Trial Reporting Program) id: EAY131-C1 type: OTHER domain: ECOG-ACRIN Cancer Research Group id: EAY131-C1 type: OTHER domain: CTEP id: U10CA180820 type: NIH link: https://reporter.nih.gov/quickSearch/U10CA180820 briefTitle: Testing Crizotinib as Potentially Targeted Treatment in Cancers With MET Genetic Changes (MATCH - Subprotocol C1) overallStatus: ACTIVE_NOT_RECRUITING date: 2016-05-30 date: 2024-11-15 date: 2024-11-15 date: 2024-04-10 date: 2024-04-22 name: National Cancer Institute (NCI) class: NIH briefSummary: This phase II MATCH treatment trial tests how well crizotinib works in treating patients with solid tumors, lymphoma, or multiple myeloma that may have spread from where it first started to nearby tissue, lymph nodes, or distant parts of the body (advanced) or that does not respond to treatment (refractory) and who have MET gene amplification. Crizotinib is in a class of medications called tyrosine kinase inhibitors. It works by blocking the action of enzymes that cancer cells need to grow and spread. It may also prevent the growth of new blood vessels that tumors need to grow. conditions: Advanced Lymphoma conditions: Advanced Malignant Solid Neoplasm conditions: Refractory Lymphoma conditions: Refractory Malignant Solid Neoplasm conditions: Refractory Multiple Myeloma studyType: INTERVENTIONAL phases: PHASE2 allocation: NA interventionModel: SINGLE_GROUP primaryPurpose: TREATMENT masking: NONE count: 50 type: ESTIMATED name: Biopsy name: Biospecimen Collection name: Crizotinib name: Radiologic Examination measure: Objective response rate (ORR) measure: Overall survival (OS) measure: 6-month progression-free survival (PFS) rate measure: Progression free survival sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: ECOG-ACRIN Cancer Research Group city: Philadelphia state: Pennsylvania zip: 19103 country: United States lat: 39.95233 lon: -75.16379 hasResults: False
<|newrecord|> nctId: NCT06357962 id: CSAPG-40 briefTitle: Semi-permanent Acupuncture Effect on Cervical Ripening overallStatus: NOT_YET_RECRUITING date: 2024-09 date: 2025-09 date: 2025-10 date: 2024-04-10 date: 2024-04-12 name: Consorci Sanitari de l'Alt Penedès i Garraf class: OTHER briefSummary: Cervical ripening is a medical treatment that can cause physical or emotional discomfort in pregnant women and is not without risks. This is a pilot study to assess feasibility and calculate the number of participants necessary for a complete clinical trial. The aim is to evaluate whether acupuncture can reduce the need for treatment (cervical ripening) in pregnant women at low or intermediate risk. Participants will be divided into two groups: one group will receive acupuncture, and the other will receive a simulated treatment of acupuncture. conditions: Pregnancy Complications studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: SUPPORTIVE_CARE masking: DOUBLE whoMasked: PARTICIPANT whoMasked: CARE_PROVIDER count: 30 type: ESTIMATED name: Semi-permanent acupuncture name: Sham of semi-permanent acupuncture measure: Pharmacological induction measure: Change on score of Bishop scale measure: Onset of spontaneous labor measure: Duration of induction period Duration of the induction period Duration of the induction period Duration of the induction period measure: Duration of labor period measure: Satisfaction of pregnants sex: FEMALE maximumAge: 40 Years stdAges: CHILD stdAges: ADULT facility: Consorci Sanitari Alt Penedes i Garraf city: Vilafranca Del Penedès state: Barcelona zip: 08720 country: Spain name: Gloria Villena role: CONTACT phone: +34 938180440 phoneExt: 43197 email: [email protected] name: Noemí Casaponsa role: CONTACT phone: +34 938960025 phoneExt: 43197 email: [email protected] lat: 41.34618 lon: 1.69713 hasResults: False
<|newrecord|> nctId: NCT06357949 id: E2-23-3615 briefTitle: The Effectiveness of High-intensity Laser Therapy on Plantar Flexor Muscle Spasticity in Stroke Patients overallStatus: RECRUITING date: 2024-04-05 date: 2024-09 date: 2024-09 date: 2024-04-10 date: 2024-04-29 name: Hitit University class: OTHER briefSummary: The aim of this study is to investigate the effectiveness of high-intensity laser therapy for treating plantar flexor muscle spasticity in subacute and chronic stroke patients, focusing on its impact on spasticity, joint range of motion, pain, muscle thickness, functional ambulation, and quality of life. conditions: Stroke studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: SINGLE whoMasked: INVESTIGATOR count: 20 type: ESTIMATED name: High-intensity laser name: Sham laser measure: 10-Meter Walk Test measure: Visual analogue scale for pain (VAS- pain) measure: Modified Ashworth Scale measure: Joint Range of Motion (ROM) Measurement measure: Ultrasonography measure: Timed Up and Go test measure: Stroke Specific Quality of Life Scale sex: ALL minimumAge: 18 Years maximumAge: 75 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Ankara Gaziler Physical Therapy and Rehabilitation Training and Research Hospital status: RECRUITING city: Ankara country: Turkey name: Tuğba Atan role: CONTACT phone: +90 312 2911000 phoneExt: 1414 email: [email protected] lat: 39.91987 lon: 32.85427 hasResults: False
<|newrecord|> nctId: NCT06357936 id: CNMT002 briefTitle: Nanofat Grafting as a Method of Treating Critical Limb Ischemia overallStatus: NOT_YET_RECRUITING date: 2024-04-20 date: 2024-11-20 date: 2025-02-20 date: 2024-04-10 date: 2024-04-10 name: Center of New Medical Technologies class: OTHER briefSummary: This clinical trial will investigate nano fat grafting as a method for treating critical limb ischemia. The method involves the collection of adipose tissue under tumescent anesthesia through a separate incision in the anterior abdominal wall, followed by preparation and injection of nano fat into the tissues of the foot and leg without additional drug therapy. The novelty of this method lies in the use of autologous stem cells and growth factors, differing from current treatments like neovasculgen, which is a plasmid DNA-based treatment. The trial aims to assess the safety and effectiveness of nano fat grafting, including pain relief, the frequency of intraoperative complications, increased distance of pain-free walking, limb preservation, and mortality rates.
The trial will involve patients with diagnosed occlusive lesions of the femoral-popliteal-tibial segment and chronic ischemia of III-IV degree according to Fontaine and 5-6 categories according to Rutherford, excluding those with contraindications for surgical intervention on the femoral-popliteal-tibial segment, chronic heart failure of III-IV NYHA class, severe liver or kidney failure, among others.
The study design includes preoperative examinations, hospital phase activities including the surgery and post-operative assessments, and follow-up visits at 6 and 12 months post-operation to evaluate the method's safety, complications, and effectiveness based on various parameters like pain, trophic disturbances, and limb ischemia severity.
Statistical methods will involve quantitative data presented as mean ± standard deviation, with qualitative traits compared using the Chi-square test or Fisher's exact test. The planned patient number is 40, aiming to demonstrate the effectiveness and safety of nano fat grafting for critical limb ischemia treatment compared to current treatments. conditions: Limb Ischemia studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: DOUBLE whoMasked: PARTICIPANT whoMasked: OUTCOMES_ASSESSOR count: 40 type: ESTIMATED name: nano-fat grafting in chronic limb ischaemia name: sham comparator measure: Percent of pain absence in experimental group measure: Number of any intraoperative complications measure: Number of any inhospital complications measure: Number of saved limbs measure: Percent change in visual analog pain score (VAS) change sex: ALL minimumAge: 18 Years maximumAge: 80 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Center of New Medical Technologies city: Novosibirsk state: Novosibirsk Region zip: 630090 country: Russian Federation name: Andrey V Ponomarenko, MD role: CONTACT lat: 55.0415 lon: 82.9346 hasResults: False
<|newrecord|> nctId: NCT06357923 id: 23-PP-13 id: 2024-A00321-46 type: OTHER domain: ANSM briefTitle: Study of the Evolution of the Expression of the LAMP-2 Protein During the Advance in Age overallStatus: NOT_YET_RECRUITING date: 2024-05-01 date: 2024-05-02 date: 2026-05-01 date: 2024-04-10 date: 2024-04-10 name: Centre Hospitalier Universitaire de Nice class: OTHER briefSummary: Recruitment on the RAV pole in consultation or day hospital. Competitive recruitment of subjects \> 60 years of age respecting a male/female ratio = 1. conditions: Aging studyType: INTERVENTIONAL phases: NA allocation: NA interventionModel: SINGLE_GROUP primaryPurpose: DIAGNOSTIC masking: NONE count: 100 type: ESTIMATED name: dosage measure: Expression level of LAMP2 (protein and isoform A and B mRNA) measure: Presence of mutation in the "Oncomin Myeloid Reasearch Assay" gene panel targeting approximately 40 Different genes sex: ALL minimumAge: 60 Years maximumAge: 99 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Chu de Nice city: Nice zip: 06003 country: France name: Andrea CICCONE role: CONTACT phone: 0492034702 email: [email protected] name: marion causeret role: CONTACT phone: 0492034702 email: [email protected] name: Andrea CICCONE role: PRINCIPAL_INVESTIGATOR lat: 43.70313 lon: 7.26608 hasResults: False
<|newrecord|> nctId: NCT06357910 id: HM-EMMA-102 briefTitle: A Study to Evaluate the Pharmacokinetics and Safety Between HCP2303 and Co-administration of Each Component in Healthy Volunteers Under Fed Conditions overallStatus: NOT_YET_RECRUITING date: 2024-05-17 date: 2024-06-29 date: 2024-06-29 date: 2024-04-10 date: 2024-04-12 name: Hanmi Pharmaceutical Company Limited class: INDUSTRY briefSummary: The purpose of this study is to evaluate the pharmacokinetic characteristics and safety between HCP2303 and co-administration of each component in fed condition in healthy volunteers. conditions: Healthy studyType: INTERVENTIONAL phases: PHASE1 allocation: RANDOMIZED interventionModel: CROSSOVER primaryPurpose: TREATMENT masking: NONE count: 34 type: ESTIMATED name: HCP2303 name: RLD2302 name: RLD2102 measure: AUCt measure: Cmax measure: AUCinf measure: Tmax measure: t1/2 measure: CL/F measure: Vd/F sex: ALL minimumAge: 19 Years maximumAge: 54 Years stdAges: ADULT facility: Jeonbuk University Hospital city: Jeonju state: Jeollabuk-do country: Korea, Republic of name: Jin A Lee, Researcher role: CONTACT phone: 063-259-3550 name: Min-gul Kim, MD role: PRINCIPAL_INVESTIGATOR lat: 35.82194 lon: 127.14889 hasResults: False
<|newrecord|> nctId: NCT06357897 id: 0093/67 briefTitle: The Efficacy and Palatability of Developed Polyethylene Glycol-based Formula for Children With Functional Constipation overallStatus: NOT_YET_RECRUITING date: 2024-05 date: 2026-05 date: 2026-06 date: 2024-04-10 date: 2024-04-12 name: Chulalongkorn University class: OTHER briefSummary: This study aims to evaluate the efficacy and palatability of a developed polyethylene glycol-based formula compared with the standard polyethylene glycol (PEG) in the treatment of children with functional constipation for 8 weeks. Besides, we also aim to assess the side effects of a developed PEG-based formula as well as evaluate the change of rectal diameter from baseline at each visit between 2 groups. conditions: Functional Constipation studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL interventionModelDescription: Intervention group received PEG-Chula Control group received Forlax primaryPurpose: TREATMENT masking: TRIPLE maskingDescription: The intervention and control were prepared in the similar sachet and was blinded to investigatiors, participants and guardians whoMasked: PARTICIPANT whoMasked: CARE_PROVIDER whoMasked: INVESTIGATOR count: 52 type: ESTIMATED name: Local PEG4000 name: Commercial PEG4000 measure: The frequency of stool measure: Stool consistency assessed by Bristol stool chart measure: Fecal incontinence measure: Rectal diameter measure: Adverse events measure: Palatability of medication assessed by facial Hedonic scale sex: ALL minimumAge: 6 Months maximumAge: 18 Years stdAges: CHILD stdAges: ADULT facility: Faculty of Medicine, Chulalongkorn University city: Bangkok zip: 10330 country: Thailand lat: 13.75398 lon: 100.50144 hasResults: False
<|newrecord|> nctId: NCT06357884 id: CREC2023.572 briefTitle: Short-term Effect of Podiatric Callus Debridement on Plantar Pressure in Diabetic Neuropathic Patients overallStatus: RECRUITING date: 2024-02-23 date: 2024-04-20 date: 2024-04-30 date: 2024-04-10 date: 2024-04-10 name: Chinese University of Hong Kong class: OTHER name: Princess Margaret Hospital, Hong Kong briefSummary: Diabetes peripheral neuropathy (DPN) affects up to 50% of the diabetes population. In the diabetic neuropathic foot, it commonly manifests as loss of protective sensation, foot deformity and skin dryness. Alongside with day-to-day weightbearing activities, this can lead to formation of callus over plantar pressure points. Studies have proven that callus formation leads to high plantar pressure and increased risk of diabetic foot ulcers. For podiatrists, diabetic foot screening and treatment is our daily practice. Plantar callus are commonly treated by sharp debridement to relief pressure from the hard skin build up and thus reducing the risk of ulceration. However, the effectiveness of callus sharp debridement is not commonly studied in researches. Only a few studies in the past evaluated the effectiveness of callus treatment by different outcome measurements. Among those studies only 2 were specifically done in diabetic patients, in which one reported results of diabetic neuropathic patients. All the available studies used peak plantar pressure only as their pedobarographic outcome measure. In this study, the treatment effect of podiatric sharp debridement of callus in diabetic neuropathic patients will be evaluated using a range of pedobarographic parameters and Foot and Ankle Outcome Score (FAOS) questionnaire. The immediate and short-term (3-4 weeks) effect of sharp debridement in DPN patients with callus could be quantified. Change in loading pattern could also be analysed based on different areas of the foot. conditions: Diabetic Neuropathies conditions: Plantar Callus studyType: INTERVENTIONAL phases: NA allocation: NA interventionModel: SINGLE_GROUP primaryPurpose: TREATMENT masking: NONE count: 16 type: ESTIMATED name: Callus debridement measure: Peak plantar pressure (PPP) (unit: kPa) measure: Pressure time integral (PTI) (unit: kPa*sec) measure: Peak pressure gradient (PPG) (unit: kPa/cm) measure: Forefoot to rearfoot peak pressure ratio (F/R ratio) measure: Foot and Ankle Outcome Score (FAOS) sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Podiatry Department, Princess Margaret Hospital status: RECRUITING city: Hong Kong country: Hong Kong name: Joanne Tze Yan Lai role: CONTACT phone: 29903901 lat: 22.27832 lon: 114.17469 hasResults: False
<|newrecord|> nctId: NCT06357871 id: 2023PI178 briefTitle: Role of Renal Biopsy in the Suspicion of Nephrotoxicity of Immunotherapy (Checkpoint Inhibitors) in Solid Cancer acronym: NEPHROTOX overallStatus: RECRUITING date: 2023-11-28 date: 2025-12-31 date: 2025-12-31 date: 2024-04-10 date: 2024-04-10 name: Central Hospital, Nancy, France class: OTHER name: University Hospital, Strasbourg, France name: CHU de Reims name: Centre Hospitalier Régional Metz-Thionville name: European Georges Pompidou Hospital briefSummary: Checkpoint inhibitors represent a new class of widely used immunotherapy, however with immune-mediated adverse effects, with renal damage estimated at 1.4% and 4.9% depending on the series.
Acute tubulointerstitial nephritis (ATNI) represents the most common type of damage, although there are other types of damage, associated or not with NTIA.
We aim to establish a probability score for the presence of histological NTIA lesions in a patient treated with CPI who presents with acute renal failure in order to guide the nephrologist and oncologist in their management in the event of AKI at the CPI, and determine the usefulness of a PBR to guide the suspension/resumption of immunotherapy +/- associated corticosteroid therapy; avoiding a PBR exposing to a high iatrogenic risk and sometimes impossible. conditions: Chemotherapeutic Toxicity studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: RETROSPECTIVE count: 100 type: ESTIMATED name: No intervention measure: Estimation using a multivariate model of the factors associated with the histological presence of NTIA vs NTA lesions in a patient treated with CPI sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: CHRU de Nancy status: RECRUITING city: Vandoeuvre les nancy zip: 54500 country: France name: Adrien Flahault, MD PhD role: CONTACT phone: 0383858585 email: [email protected] lat: 48.65 lon: 6.18333 hasResults: False
<|newrecord|> nctId: NCT06357858 id: CASE6323 briefTitle: ASTX727 and Nivolumab in Squamous Cell Carcinoma of the Head and Neck overallStatus: NOT_YET_RECRUITING date: 2024-06-01 date: 2025-02-28 date: 2026-02-28 date: 2024-04-10 date: 2024-04-10 name: Case Comprehensive Cancer Center class: OTHER briefSummary: The goal of this clinical trial is to see if the combination of experimental drug ASTX727 and Nivolumab enhances the antitumor immune response in participants will recurrent or metastatic squamous cell carcinoma of the head and neck.
Participants will take a pill called ASTX727 for 4 or 5 days every month followed by an injection of Nivolumab one week after the first dose of study medication. conditions: Recurrent Squamous Cell Carcinoma of the Head and Neck conditions: Metastatic Squamous Cell Carcinoma conditions: Head and Neck Squamous Cell Carcinoma studyType: INTERVENTIONAL phases: PHASE1 allocation: NA interventionModel: SINGLE_GROUP primaryPurpose: TREATMENT masking: NONE count: 15 type: ESTIMATED name: INQOVI (decitabine and cedazuridine) name: Nivolumab measure: Pharmacodynamics Effect of ASTX727 on global DNA methylation status measure: Immunogenicity of ASTX27 in combination with Nivolumab measure: Maximum Tolerated Dose measure: Safety of ASTX measure: Objective Response Rate (ORR) measure: Overall Survival (OS) sex: ALL minimumAge: 19 Years stdAges: ADULT stdAges: OLDER_ADULT facility: University Hospitals Cleveland Medical Center, Case Comprehensive Cancer Center city: Cleveland state: Ohio zip: 44106 country: United States name: Kyunghee Burkitt, DO, PhD role: CONTACT phone: 216-844-0512 email: [email protected] lat: 41.4995 lon: -81.69541 hasResults: False
<|newrecord|> nctId: NCT06357845 id: CASE5Z24 id: 1R21ES036031-01 type: NIH link: https://reporter.nih.gov/quickSearch/1R21ES036031-01 briefTitle: Linking Somatic Mutation Rate With Baseline Exposure in East Palestine overallStatus: NOT_YET_RECRUITING date: 2024-05-01 date: 2025-09-01 date: 2026-01-31 date: 2024-04-10 date: 2024-04-10 name: Case Comprehensive Cancer Center class: OTHER name: National Institutes of Health (NIH) name: National Institute of Environmental Health Sciences (NIEHS) briefSummary: The goal of this study is to This research team is conducting this study to develop methods to measure the biological impact of exposure to the chemicals released following the February 3, 2023 train derailment on residents of East Palestine, Ohio, and surrounding communities. The main question it aims to answer is:
* What biological impact will be measured based on DNA damage?
* In participants who provide a biospecimen, how are biomarker changes related to proximity to the derailment and variations in residents' health histories and behaviors?
Participants will:
* Complete a brief survey asking about experiences related to the February 3, 2023 train derailment, health experiences, and concerns following the derailment, and background information regarding health history.
* Possibly contribute biospecimens such as blood, spit, hair, and/or toenail clippings.
* Receive communication about study updates and future research opportunities.
* A total of 40 study participants will be recruited to participate in a 90-minute interview. The interviews will be video and audio recorded. conditions: Somatic Mutation studyType: INTERVENTIONAL phases: NA allocation: NA interventionModel: SINGLE_GROUP interventionModelDescription: A cross-sectional study design will be implemented. primaryPurpose: SCREENING masking: NONE count: 500 type: ESTIMATED name: Survey name: Biological specimen collection name: Communications about study updates and future research opportunities name: Qualitative interview measure: Geographic Association of Somatic Mutation Rates measure: Self-reported Symptomology Association of Somatic Mutation Rates sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT hasResults: False
<|newrecord|> nctId: NCT06357832 id: CTP-ACCiTBS-00 briefTitle: New Investigational Stimulation Protocol for Treatment of Major Depression Disorder (MDD) overallStatus: NOT_YET_RECRUITING date: 2024-04-15 date: 2024-10-15 date: 2024-12-15 date: 2024-04-10 date: 2024-04-12 name: Brainsway class: INDUSTRY briefSummary: The BrainsWay Deep Transcranial Magnetic Stimulation (Depp TMS) device is intended for the treatment of depressive episodes in patients suffering from Major Depressive Disorder (MDD). The device technology is based on the application of deep brain TMS by means of repetitive pulse trains at a determined frequency. The purpose of the current study is to evaluate the safety and effectiveness of a new investigational stimulation protocol delivered with the BrainsWay Deep TMS device, for the treatment of MDD, demonstrating that it is non-inferior to the current standard-of-care stimulation protocol, in a randomized, controlled study. conditions: Major Depressive Disorder studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: DOUBLE whoMasked: INVESTIGATOR whoMasked: OUTCOMES_ASSESSOR count: 104 type: ESTIMATED name: Brainsway Deep TMS System measure: Change in Hamilton Depression Rating Scale (HDRS)-21 score in the investigational group measure: Response rate in the investigational group measure: Remission rate in the investigational group measure: Change in Clinical Global Impression-Severity (CGI-S) scores in the investigational group measure: Change in Clinical Global Impression Improvement (CGI-I) scores in the investigational group sex: ALL minimumAge: 22 Years maximumAge: 68 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Novus Neurology city: Tuscaloosa state: Alabama zip: 35401 country: United States name: Timothy Prestley, MD role: CONTACT phone: 205-523-5618 email: [email protected] lat: 33.20984 lon: -87.56917 facility: DTMS Center LLC city: Palm Beach state: Florida zip: 33401 country: United States name: Aron Tendler, MD role: CONTACT phone: 561-749-9999 email: [email protected] lat: 26.70562 lon: -80.03643 facility: Fermata Health city: Brooklyn state: New York zip: 11249 country: United States name: Owen Muir, MD role: CONTACT phone: 929-346-4317 email: [email protected] lat: 40.6501 lon: -73.94958 facility: Complete Mind Care of PA city: Abington state: Pennsylvania zip: 19001 country: United States name: Samson Seplow, MD role: CONTACT phone: 215-254-6000 email: [email protected] lat: 40.12067 lon: -75.11795 facility: ClearPath Psychiatry city: Seattle state: Washington zip: 98105 country: United States name: Molly Davis, MD role: CONTACT phone: 206-486-8150 email: [email protected] lat: 47.60621 lon: -122.33207 facility: PsyCare city: South Charleston state: West Virginia zip: 25303 country: United States lat: 38.36843 lon: -81.69957 hasResults: False
<|newrecord|> nctId: NCT06357819 id: CLS-017A id: HSTAR010 type: OTHER domain: HSTAR Programme id: EZIMOM012 type: OTHER domain: Ezintsha briefTitle: INSTI® HCV (Hepatitis C Virus) Antibody Self-Test Contrived Result Interpretation overallStatus: COMPLETED date: 2023-10-12 date: 2023-12-17 date: 2023-12-17 date: 2024-04-10 date: 2024-04-10 name: bioLytical Laboratories class: INDUSTRY briefSummary: The purpose of this Interpretation Assessment was to document if "lay" people, non-professional and inexperienced in self-testing, were able to successfully perform the steps to use a Hepatitis C Virus (HCV) Self-Test (HCVST) device, without product familiarization \[demonstration\]. conditions: Hepatitis C studyType: OBSERVATIONAL observationalModel: OTHER timePerspective: CROSS_SECTIONAL count: 405 type: ACTUAL name: INSTI HCV Self Test measure: Successful Interpretation of contrived devices sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: bioLytical Laboratories Inc. city: Richmond state: British Columbia zip: V6V 2A2 country: Canada lat: 49.17003 lon: -123.13683 hasResults: False
<|newrecord|> nctId: NCT06357806 id: PIN-CHB-1 briefTitle: The Treatment of PD-1 Antibody Combined With Peg-IFNα in NAs-suppressed CHB Patients overallStatus: NOT_YET_RECRUITING date: 2024-04-01 date: 2025-09-30 date: 2025-09-30 date: 2024-04-10 date: 2024-04-10 name: Beijing 302 Hospital class: OTHER briefSummary: This is a prospective, open-labled, randomized controlled study to assess efficacy and safety of treatment with Sintilimab (PDL-1 antibody) combined Peg-IFNα-2b in CHB patients on stable NAs treatment. conditions: Chronic Hepatitis B studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: NONE count: 45 type: ESTIMATED name: Sintilimab name: Peg-IFNα-2b name: NAs measure: The rate of HBsAg loss at 24 weeks and 48 weeks. measure: Incidence of treatment-emergent adverse events/serious adverse events measure: The rate of HBsAg decline > 1log(IU/ml) at 24 weeks and 48 weeks measure: The rate of HBsAb positive at 24 weeks and 48 weeks. measure: The concentration of HBcrAg at baseline, 12 weeks, 24 weeks and 48 weeks. measure: The concentration of pgRNA at baseline, 12 weeks, 24 weeks and 48 weeks. measure: The concentration of anti-HBc at baseline, 12 weeks, 24 weeks and 48 weeks. measure: Immune response of T cell, B cell, NK cell at baseline, 12 weeks, 24 weeks and 48 weeks. sex: ALL minimumAge: 18 Years maximumAge: 65 Years stdAges: ADULT stdAges: OLDER_ADULT facility: the Fifth Medical Center, Chinese PLA General Hospital city: Beijing state: Beijing zip: 100039 country: China name: Junliang Fu, MD role: CONTACT phone: 010-66933214 email: [email protected] lat: 39.9075 lon: 116.39723 hasResults: False
<|newrecord|> nctId: NCT06357793 id: camsakuraftr briefTitle: Evaluation of Work Productivity and Activities of the Fibromyalgia Patients' Relatives overallStatus: NOT_YET_RECRUITING date: 2024-04-15 date: 2024-11-15 date: 2024-12-15 date: 2024-04-10 date: 2024-04-18 name: Başakşehir Çam & Sakura City Hospital class: OTHER_GOV briefSummary: Patients suffering from fibromyalgia (FM) are challenged by symptoms such as chronic pain, fatigue, sleep disturbance and emotional distress. Patients diagnosed with fibromyalgia can also negatively affect the relatives they live with due to their existing complaints. It is possible that their relatives accompanying them may lose their workforce due to untreated pain complaints and frequent hospital admissions. The main purpose of our study is to examine whether there is any impact on the working life of the people they live with and whether there is a decrease in their work productivity. conditions: Fibromyalgia conditions: Work Productivity conditions: Quality of Life conditions: Pain, Chronic studyType: OBSERVATIONAL observationalModel: CASE_CONTROL timePerspective: CROSS_SECTIONAL count: 122 type: ESTIMATED measure: Work Productivity and Activity of Fibromyalgia Patients' Relatives measure: Quality of life Fibromyalgia Patients' Relatives sex: ALL minimumAge: 18 Years maximumAge: 65 Years stdAges: ADULT stdAges: OLDER_ADULT hasResults: False
<|newrecord|> nctId: NCT06357780 id: 240396837 briefTitle: Closed-loop syncHronization vErsuS convenTional Synchronization in sPontaneously Breathing Adult Nonivasive ventilationPatients acronym: CHESTSPAN overallStatus: NOT_YET_RECRUITING date: 2024-04-08 date: 2024-08-30 date: 2024-12-31 date: 2024-04-10 date: 2024-04-18 name: Başakşehir Çam & Sakura City Hospital class: OTHER_GOV briefSummary: The study is a multicentric prospective randomised cross-over study. It evaluates the compatibility of patients with the device without altering the routine treatment applied. During this evaluation, either the clinician-adjusted values on the device or the standard pre-set values are used to obtain hourly and 30-minute PVA (Patient Ventilator Asynchrony) recordings. These recordings will be analysed offline to identify the settings used and to compare the hourly and 30-minute PVA (Patient Ventilator Asynchrony) values when synchronisation is automatically set. The relationships and differences between these values will be analysed. For this purpose, the IntelliSync+ option, already available on the device, will be used. This software continuously analyses waveform signals at least a hundred times per second. This allows for the immediate detection of patient efforts and the initiation of inspiration and expiration in real time, thereby replacing traditional trigger settings for inspiration and expiration. If the patient is already synchronised with this option, it will then be possible to switch to traditional synchronisation settings for comparison. Statistical analyses will be conducted using SPSS 24.0, JASP (Just Another Statistical Programme), Jamovi ( fork of JASP), or R software. Initially, all numerical and categorical data will be evaluated using descriptive statistical methods. The distributions of numerical variables will be examined using visual (histograms and probability plots) and analytical methods (Kolmogorov-Smirnov/Shapiro-Wilk tests). Mean/SD (standard deviation) or median/interquartile range (IQR) will be used as measures of distribution. For comparing numerical data that follows a normal distribution, the Student-t test will be used, and for non-normally distributed data, the Mann-Whitney U or Wilcoxon signed-rank tests will be employed. PVA (Patient Ventilator Asynchrony) values will be statistically compared. For the analysis of categorical data, the Chi-Square test will be applied. Bayesian analysis may also be used as necessary during the writing of the study. The results obtained will be interpreted and reported by the researchers. Results with a "p" value below 0.05 will be considered statistically significant. conditions: Acute Respiratory Failure conditions: Acute Respiratory Distress Syndrome conditions: Chronic Respiratory Failure studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: CROSSOVER primaryPurpose: TREATMENT masking: SINGLE whoMasked: PARTICIPANT count: 38 type: ESTIMATED name: close-loop synchronization controller with spontaneous mode name: Conventional measure: Asynchrony Index measure: Major Asynchrony index measure: Minor Asynchrony index measure: Dyspnea Scale sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Dr.Suat Seren Chest Diseasees Hospital city: Izmir zip: 35230 country: Turkey name: Cenk Kirakli, professor role: CONTACT lat: 38.41273 lon: 27.13838 hasResults: False
<|newrecord|> nctId: NCT06357767 id: S06GM146079 type: NIH link: https://reporter.nih.gov/quickSearch/S06GM146079 briefTitle: Smoking Cessation Intervention for American Indian Women Experiencing Intimate Partner Violence overallStatus: NOT_YET_RECRUITING date: 2024-05-01 date: 2025-07-31 date: 2026-01-31 date: 2024-04-10 date: 2024-04-22 name: Black Hills Center for American Indian Health class: OTHER name: Yale University briefSummary: The goal of this project is to refine and test a culturally-tailored smoking cessation intervention for American Indian women who have experienced intimate partner violence (IPV). The primary aims of this study are to: (a) use a community-based participatory approach to refine intervention materials and finalize pilot intervention methodology for a culturally tailored, trauma-informed smoking cessation intervention for AI women who have experienced IPV; (b) examine feasibility, acceptability, satisfaction, and preliminary efficacy of the intervention; and (c) explore changes in alcohol and drug use over the course of the intervention.
Participants will be asked to participate in the 8-week Healing Within: Smoking Cessation Intervention for American Indian Women Experiencing Intimate Partner Violence, and complete interviews at baseline, end-of-treatment, and three months from the end of treatment. conditions: Smoking Cessation conditions: Cigarette Smoking studyType: INTERVENTIONAL phases: NA allocation: NA interventionModel: SINGLE_GROUP primaryPurpose: TREATMENT masking: NONE count: 48 type: ESTIMATED name: Healing Within: Smoking Cessation Intervention for American Indian Women Experiencing Intimate Partner Violence measure: Trauma-Informed Practice Scales (TIPS) measure: Session Rating Scale (SRS) measure: Group Attitude Scale (GAS) measure: Biochemical verification of smoking status measure: Biochemical verification of smoking status measure: Biochemical verification of smoking status measure: Quit Attempts measure: Quit Attempts measure: Quit Attempts measure: Alcohol Use Disorders Identification Test (AUDIT) measure: Alcohol Use Disorders Identification Test (AUDIT) measure: Alcohol Use Disorders Identification Test (AUDIT) measure: NIDA ASSIST measure: NIDA ASSIST measure: NIDA ASSIST sex: FEMALE minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT hasResults: False
<|newrecord|> nctId: NCT06357754 id: CA082-085 briefTitle: Transgene Assay Testing Service of Tumor Samples From Patients Who Received a Bristol-Myers Squibb Manufactured Gene Modified Cell Therapy and Have a Qualifying Secondary Malignancy overallStatus: RECRUITING date: 2023-10-06 date: 2038-10-06 date: 2038-10-06 date: 2024-04-10 date: 2024-04-10 name: Bristol-Myers Squibb class: INDUSTRY briefSummary: The purpose of this transgene assay testing service is to evaluate the tumor samples for transgene levels in patients who received a Bristol-Myers Squibb manufactured gene modified cellular therapy and have reported a qualifying secondary malignancy. conditions: Non-Hodgkin Lymphoma conditions: Chronic Lymphocytic Leukaemia conditions: Multiple Myeloma studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: PROSPECTIVE count: 50 type: ESTIMATED name: Idecabtagene vicleucel name: Lisocabtagene maraleucel measure: Participant in situ hybridization (ISH) transgene testing results measure: Participant insertion site (ISA) analysis testing results sex: ALL stdAges: CHILD stdAges: ADULT stdAges: OLDER_ADULT facility: CellCarta status: RECRUITING city: Antwerp country: Belgium lat: 51.21989 lon: 4.40346 hasResults: False
<|newrecord|> nctId: NCT06357741 id: 202286 briefTitle: Clinical Study of Desuzumab in the Treatment of Knee Osteoarthritis acronym: CSODITTOKO overallStatus: COMPLETED date: 2023-03-02 date: 2024-02-02 date: 2024-03-10 date: 2024-04-10 date: 2024-04-10 name: Wuhan Union Hospital, China class: OTHER briefSummary: As an activator of inhibiting nuclear factor kB receptor, denosumab affects osteoclast differentiation and development by inhibiting OPG/RANKL-RANK bone regulatory axis pathway. Therefore, denosumab is widely used in the treatment of bone diseases such as osteoporosis. Osteoporosis is closely related to knee osteoarthritis. RANKL-RANK pathway also plays a key role in the pathogenesis of knee osteoarthritis. Therefore, the investigators propose the hypothesis that denosumab can effectively treat knee osteoarthritis. conditions: Knee Osteoarthritis studyType: OBSERVATIONAL observationalModel: OTHER timePerspective: PROSPECTIVE count: 8 type: ACTUAL name: Denosumab measure: Knee pain relief sex: ALL minimumAge: 45 Years maximumAge: 75 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Wuhan Union Hospital city: Wuhan state: Hubei zip: 430000 country: China lat: 30.58333 lon: 114.26667 typeAbbrev: Prot hasProtocol: True hasSap: False hasIcf: False label: Study Protocol date: 2024-04-03 uploadDate: 2024-04-04T11:01 filename: Prot_000.pdf size: 398739 hasResults: False
<|newrecord|> nctId: NCT06357728 id: 2024/2035 briefTitle: Continuous Glucose Monitoring Glycemic cHAracterization During Pregnancy acronym: I-CHAP overallStatus: NOT_YET_RECRUITING date: 2024-04-01 date: 2025-04-01 date: 2025-12-01 date: 2024-04-10 date: 2024-04-10 name: KK Women's and Children's Hospital class: OTHER_GOV briefSummary: Our study named Integrated Continuous glucose monitoring glycemic cHAracterization during Pregnancy in comparison with oral glucose tolerance test (I-CHAP) aims to establish much needed preliminary evidence in our Asian population to show the capabilities of CGM use and its wealth of data for GDM diagnosis. This study aims to test the following aims and hypotheses in a single-armed intervention pilot trial study of pregnant women undergoing the oral glucose tolerance test:
Aim 1. To characterize CGM glucose values with the 3-point blood glucose measured during the OGTT procedure.
The investigators hypothesize that the CGM glucose values at single time points while fasted, and after the 75-g glucose load will be positively correlated with 3-timepoint blood glucose values captured during the OGTT.
Aim 2. To correlate the CGM glucose excursions and CGM-derived metrics (glycaemic variability and glycaemic control) with maternal-fetal outcomes and treatment outcomes.
The investigators hypothesize that higher AUC, glycemic variability and poorer glycaemic control will better distinguish maternal-fetal outcomes and treatment outcomes, compared to the OGTT.
Aim 3. To describe the acceptability of using the Dexcom G6 CGM as a diagnostic tool instead of the OGTT. The investigators hypothesize that a higher proportion of participants will report CGM to be more acceptable than the OGTT for GDM diagnosis. conditions: Gestational Diabetes conditions: Glucose Metabolism Disorders conditions: Metabolic Disease studyType: INTERVENTIONAL phases: NA allocation: NA interventionModel: SINGLE_GROUP interventionModelDescription: All participants will be given a continuous glucose monitoring device to wear for 10 days before during and after the oral glucose tolerance test. primaryPurpose: BASIC_SCIENCE masking: NONE count: 60 type: ESTIMATED name: Continuous glucose monitoring measure: Maternal plasma glucose values measured by oral glucose tolerance test (OGTT) at 0-hour (mmol/L) measure: Maternal plasma glucose values measured by oral glucose tolerance test (OGTT) at 1-hour (mmol/L) measure: Maternal plasma glucose values measured by oral glucose tolerance test (OGTT) at 2-hour (mmol/L) measure: Maternal obstetric outcomes - Pre-eclampsia measure: Maternal obstetric outcomes- Pregnancy-induced hypertension measure: Maternal obstetric outcomes - C-section measure: Neonatal outcomes- Large-for-gestational-age measure: Neonatal outcomes-Birth weigh measure: Neonatal outcomes- Small-for-gestational-age measure: Neonatal outcomes-Pre-term birth measure: Neonatal outcomes-Neonatal hypoglycaemia measure: Types of treatment received for gestational diabetes diagnosis sex: FEMALE minimumAge: 21 Years maximumAge: 45 Years stdAges: ADULT typeAbbrev: Prot_SAP_ICF hasProtocol: True hasSap: True hasIcf: True label: Study Protocol, Statistical Analysis Plan, and Informed Consent Form date: 2024-02-20 uploadDate: 2024-03-18T04:35 filename: Prot_SAP_ICF_000.pdf size: 218503 hasResults: False
<|newrecord|> nctId: NCT06357715 id: 2021/373/HP briefTitle: Effectiveness of Neurodynamic Sliding Mobilisation in the "Slump" Position in Relation to the Perceptible Pain Threshold in Asymptomatic People acronym: SPEAKER 2 overallStatus: NOT_YET_RECRUITING date: 2024-05-01 date: 2024-05-09 date: 2026-05-09 date: 2024-04-10 date: 2024-04-10 name: University Hospital, Rouen class: OTHER briefSummary: According to the French National Health Agency, the use of manual therapy techniques is "possible" \[grade B\] as part of a multimodal combination of treatments for low back pain. These include so-called "neurodynamic" neural mobilisations, which aim in particular to desensitise the pain system and activate descending inhibitory pathways, with effects on pain and function in patients with nerve-related low back pain. Most of the available evidence does not explain the mechanisms involved in neural mobilisation in the slump position. Pain reduction is observed in more areas of the body with sliding techniques than with traction techniques.
In this cross-over, randomised controlled trial, we therefore hypothesise that the neurodynamic sliding technique in the slump position acts on mechanisms linked to central pain modulation processes conditions: Voluntary studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: CROSSOVER primaryPurpose: TREATMENT masking: SINGLE maskingDescription: the second physiotherapist who evaluate the pressure pain whoMasked: OUTCOMES_ASSESSOR count: 54 type: ESTIMATED name: "slump"position name: no" slump" position measure: Difference in pressure at the moment when the volunteer indicates that the sensation of pressure becomes pain sex: ALL minimumAge: 30 Years maximumAge: 65 Years stdAges: ADULT stdAges: OLDER_ADULT hasResults: False
<|newrecord|> nctId: NCT06357702 id: 81313 id: K23DE031807 type: NIH link: https://reporter.nih.gov/quickSearch/K23DE031807 briefTitle: K23- Physical Self Regulation vs Placebo overallStatus: RECRUITING date: 2024-04-04 date: 2028-06-01 date: 2028-08-31 date: 2024-04-10 date: 2024-04-15 name: Ian Boggero, PhD class: OTHER name: National Institute of Dental and Craniofacial Research (NIDCR) briefSummary: This study will use a between-person design. Participants will be treatment-seeking patients with chronic masticatory muscle pain. Participants who are eligible for the study and consent to participate will be randomly assigned to receive a brief behavioral intervention for chronic orofacial pain called Physical Self-Regulation or a control intervention. Interventions will be administered via telehealth in both arms. Both interventions will consist of 2 50-minute sessions scheduled approximately two weeks apart. Participants will be contacted two weeks and three months after completing the interventions to provide additional follow-up data. Investigators hypothesize that both PSR-TH and the control intervention will demonstrate strong feasibility (i.e., recruitment of at least 1 participant per week, \>75% retention, \>95% interventionist fidelity, and adequate acceptability, credibility, and burden). Investigators also hypothesize that specific biopsychosocial variables will moderate PSR-TH-related changes in outcomes, and that PSR-TH-related changes in perceived control over pain, self-efficacy, coping, parafunctional habits, and relaxation will mediate treatment effects. conditions: Temporomandibular Disorder studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: NONE count: 104 type: ESTIMATED name: Physical Self Regulation Telehealth name: Psycho-education Telehealth measure: Change in pain intensity measure: Change in pain interference measure: Change in quality of life measure: Recruitment rate measure: Retention rate measure: Interventionist Fidelity Session 1 measure: Interventionist Fidelity Session 2 measure: Treatment Acceptability measure: Treatment Credibility measure: Research Burden measure: Treatment Satisfaction sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: University of Kentucky status: RECRUITING city: Lexington state: Kentucky zip: 40506 country: United States name: Ian Boggero, Ph.D. role: CONTACT phone: 859-562-3291 email: [email protected] lat: 37.98869 lon: -84.47772 hasResults: False
<|newrecord|> nctId: NCT06357689 id: REC ID 6 briefTitle: Association of SNPs in Long Intergenic Noncoding RNA 00511 (LINC00511) With Breast Cancer Among the Egyptian Population overallStatus: COMPLETED date: 2021-10-24 date: 2023-03-11 date: 2023-04-29 date: 2024-04-10 date: 2024-04-10 name: Ain Shams University class: OTHER name: British University In Egypt briefSummary: Long non-coding RNAs (lncRNAs) play an important role in different types of cancer, including breast cancer, through regulation of gene expression and epigenetic signatures. Genetic variations such as single nucleotide polymorphisms (SNPs) in lncRNAs have been found to be associated with cancer. Our aim was to provide information about the role of LINC00511 SNPs (rs11657109 or rs17780195 or rs9906859, rs4432291 and rs1558535) in breast cancer susceptibility in the Egyptian population. conditions: Breast Cancer studyType: OBSERVATIONAL observationalModel: CASE_CONTROL timePerspective: RETROSPECTIVE count: 417 type: ACTUAL measure: Investigating the relationship of the genotypes of each SNP of the LINC00511 SNPs (rs11657109 or rs17780195 or rs9906859 or rs4432291 and rs1558535) with either increased or decreased risk of breast cancer or no effect in the Egyptian population measure: Finding out the association between LINC00511 SNPs (rs11657109 or rs17780195 or rs9906859 or rs4432291 and rs1558535) and Estrogen receptor measure: Finding out the association between LINC00511 SNPs (rs11657109 or rs17780195 or rs9906859 or rs4432291 and rs1558535) and Progesterone receptor measure: Finding out the association between LINC00511 SNPs (rs11657109 or rs17780195 or rs9906859 or rs4432291 and rs1558535) and HER2 status measure: Finding out the association between LINC00511 SNPs (rs11657109 or rs17780195 or rs9906859 or rs4432291 and rs1558535) and tumor stage measure: Finding out the association between LINC00511 SNPs (rs11657109 or rs17780195 or rs9906859 or rs4432291 and rs1558535) and tumor grade measure: Finding out the association between LINC00511 SNPs (rs11657109 or rs17780195 or rs9906859 or rs4432291 and rs1558535) and lymph node metastasis sex: FEMALE minimumAge: 20 Years maximumAge: 70 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Faculty of pharmacy, Ain Shams University, Advanced Biochemisrty Research Lab city: Cairo country: Egypt lat: 30.06263 lon: 31.24967 facility: Faculty of Pharmacy, The British University in Egypt, Pharmacology and Biochemistry Research lab city: Cairo country: Egypt lat: 30.06263 lon: 31.24967 hasResults: False
<|newrecord|> nctId: NCT06357676 id: STUDY00025355 id: NCI-2024-01208 type: REGISTRY domain: CTRP (Clinical Trial Reporting Program) id: STUDY00025355 type: OTHER domain: OHSU Knight Cancer Institute briefTitle: Glofitamab Plus Ibrutinib With Obinutuzumab for the Treatment of Patients With Mantle Cell Lymphoma overallStatus: NOT_YET_RECRUITING date: 2024-05-01 date: 2027-05-01 date: 2029-05-01 date: 2024-04-10 date: 2024-04-10 name: OHSU Knight Cancer Institute class: OTHER name: Oregon Health and Science University name: Genentech, Inc. briefSummary: This phase IB/II trial tests the safety, side effects and effectiveness of glofitamab plus ibrutinib with obinutuzumab for the treatment of patients with mantle cell lymphoma (MCL). Glofitamab is in a class of medications called bispecific monoclonal antibodies. It works by killing cancer cells. A monoclonal antibody is a type of protein that can bind to certain targets in the body, such as molecules that cause the body to make an immune response (antigens). In the body, glofitamab binds to a receptor called CD3 on T-cells (a type of immune cells) and a receptor called CD20 on B-cells, a receptor that is often over-expressed on the surface of cancerous B-cells. When glofitamab binds to CD3 and CD20 receptors, it causes an immune response against the CD20-expressing cancerous B-cells. Ibrutinib is in a class of medications called kinase inhibitors. It works by blocking the action of the abnormal protein that signals cancer cells to multiply. This helps stop the spread of cancer cells. Obinutuzumab is a monoclonal antibody that may interfere with the ability of cancer cells to grow and spread. Glofitamab plus ibrutinib with obinutuzumab may be safe tolerable and/or effective in treating patients with MCL. conditions: Mantle Cell Lymphoma studyType: INTERVENTIONAL phases: PHASE1 phases: PHASE2 allocation: NA interventionModel: SINGLE_GROUP primaryPurpose: TREATMENT masking: NONE count: 27 type: ESTIMATED name: Biospecimen Collection name: Bone Marrow Biopsy name: Computed Tomography name: Echocardiography name: FDG-Positron Emission Tomography name: Glofitamab name: Ibrutinib name: Magnetic Resonance Imaging name: Obinutuzumab measure: Incidence of dose-limiting toxicities (DLT) measure: Proportion of participants who achieve a complete response (CR) measure: Incidence of grade 3 or above adverse events (AEs) measure: Proportion of patients treated with tocilizumab (TCZ) measure: Number of doses of TCZ per participant measure: Objective response rate (ORR) measure: Progression-free survival (PFS) measure: Duration of response (DOR) measure: Duration of complete response (DOCR) sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: OHSU Knight Cancer Institute city: Portland state: Oregon zip: 97239 country: United States name: Knight Cancer Clinical Trials Hotline role: CONTACT phone: 503-494-1080 email: [email protected] name: Stephen E. Spurgeon role: PRINCIPAL_INVESTIGATOR lat: 45.52345 lon: -122.67621 hasResults: False
<|newrecord|> nctId: NCT06357663 id: Pro00071128 briefTitle: Subtle Energy Transmission and Tao Calligraphy Mindfulness in Telomere Length in Peripheral Blood Leukocytes overallStatus: ACTIVE_NOT_RECRUITING date: 2023-06-15 date: 2025-12-31 date: 2025-12-31 date: 2024-04-10 date: 2024-04-16 name: Sha Research Foundation class: OTHER briefSummary: Effect of Subtle Energy Transmission and Tao Calligraphy Mindfulness Practice on Telomere Length in Peripheral Blood Leukocytes A Follow-up Pilot Study
The goal of this Pilot clinical trial is to learn if a Subtle Energy Transmission and Tao Calligraphy Mindfulness Practice works to increase Telomere Length in Peripheral Blood Leukocytes in adults. The main questions it aims to answer are: