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The first trial in the series will compare a research dissemination tool (infographic) against a plain-language summary comparator. Participants will be randomly assigned to receive the dissemination tool or comparator. Study participants will rate communication tools for (1) information completeness; (2) understandability; and (3) ease of use of format. Our results can be used by researchers and patient organizations who disseminate research results so that they can tailor the way they disseminate results to patient needs. conditions: Scleroderma conditions: Systemic Sclerosis studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL interventionModelDescription: Parallel Assignment primaryPurpose: OTHER masking: NONE count: 488 type: ESTIMATED name: Plain-language summary name: Dissemination Tool (Infographic) measure: Completeness measure: Understandability measure: Ease of use measure: Please to have received results measure: Intention to participate in future studies measure: Open-ended items sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT hasResults: False |
<|newrecord|> nctId: NCT06373250 id: sdilek7 briefTitle: Maternal Consequences of Membrane Stripping overallStatus: RECRUITING date: 2024-04-11 date: 2024-10-11 date: 2024-11-11 date: 2024-04-18 date: 2024-04-18 name: Kocaeli University class: OTHER briefSummary: This study aims to investigate the maternal effects of membrane stripping during vaginal birth. This study was designed as an experimental case-control study. The sample size in the study was determined by Njoku et al in 2023 to assess the effectiveness of membrane stripping applied to participants who had vaginal birth in reducing the incidence of prolonged pregnancy. Calculated based on the study conducted by. The sample size of the study was calculated using G\*Power 3.1.9.2, and the mean and standard deviation of the Bishop score in the relevant article were used to calculate the effect size. Using the mean and standard deviation of the relevant article, the blended effect size was calculated as 0.596. The minimum number of individuals that should be included in the sample of this research was calculated using G\*Power 3.1.9.2, effect size: 0.596, α= 0.05, power: 0.95 (stripping = 70, control = 70) and at least in each group in the sample size. The sample size was set at 70 participants. The research data will be collected by the researcher using the Informed Volunteer Consent Form, Participant Information Form, Bishop Scoring, Visual Analogue Scale, and Birth Satisfaction Scale Short Form, which were created by the researcher within the framework of the literature on the subject. conditions: Maternal Care for Other Abnormalities of Cervix studyType: INTERVENTIONAL phases: NA allocation: NON_RANDOMIZED interventionModel: PARALLEL primaryPurpose: SUPPORTIVE_CARE masking: NONE count: 140 type: ESTIMATED name: Membrane stripping group name: Control group measure: Visual analogue scale evaluation of vaginal examination pain measure: Visual analogue scale evaluation of vaginal examination pain measure: Evaluation of the cervix with Bishop score measure: Evaluation of the amount of bleeding measure: Birth Satisfaction Scale Short Form sex: FEMALE minimumAge: 18 Years maximumAge: 40 Years stdAges: ADULT facility: Kocaeli University status: RECRUITING city: Kocaeli zip: 41380 country: Turkey name: Burcu Ozturk, M.Sc. role: CONTACT email: [email protected] lat: 39.62497 lon: 27.51145 hasResults: False |
<|newrecord|> nctId: NCT06373237 id: INC-IG-2024-001 briefTitle: Outcome of Embryos Transferred After Initial Chaotic Results on PGT-A overallStatus: ACTIVE_NOT_RECRUITING date: 2024-03-26 date: 2024-05 date: 2026-05 date: 2024-04-18 date: 2024-04-18 name: Inception Fertility, LLC class: INDUSTRY name: Igenomix briefSummary: This is a retrospective review of treatment outcomes from fertility clinics in The Prelude Network who have used Igenomix for PGT-A and have transferred embryos with initial chaotic results, regardless if re-biopsy was performed. conditions: Infertility studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: RETROSPECTIVE count: 2000 type: ESTIMATED measure: Frequency of embryo re-biopsy measure: Re-biopsy results measure: Embryo disposition measure: Embryo transfer outcome measure: Pregnancy outcome sex: FEMALE stdAges: CHILD stdAges: ADULT stdAges: OLDER_ADULT facility: Inception Fertility LLC city: Houston state: Texas zip: 77081 country: United States lat: 29.76328 lon: -95.36327 hasResults: False |
<|newrecord|> nctId: NCT06373224 id: 23-037 briefTitle: Cold Saline Irrigation Before Endobronchial Biopsy overallStatus: RECRUITING date: 2023-12-01 date: 2024-12-02 date: 2025-02-02 date: 2024-04-18 date: 2024-04-22 name: TriHealth Inc. class: OTHER briefSummary: Patients undergoing an endobronchial ultrasound and biopsy can experience bleeding during the biopsy. These biopsies are read in real time by pathologists who travel to the endoscopy unit during the procedure. Often, when this happens, the blood contaminates the pathology slides making the slide unreadable. This then requires more biopsies to be performed, thus prolonging the procedure, and increasing anesthesia time. One innovative way to reduce bleeding may be to irrigate the bronchial wall with cold saline, where the biopsy is to be taken, immediately before biopsy, thus causing vasoconstriction and possibly resulting in less blood contamination on the biopsy slides. The current study will evaluate this prophylactic irrigation with saline to control bleeding, thus resulting in a quicker diagnostic result of the biopsies. conditions: Lung Diseases studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: PREVENTION masking: NONE count: 120 type: ESTIMATED name: Flush measure: Incidence of unreadable biopsy slides sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Bethesda North Hospital status: RECRUITING city: Cincinnati state: Ohio zip: 45242 country: United States name: Rachel Baker, PhD, RN role: CONTACT phone: 513-569-6191 email: [email protected] lat: 39.12713 lon: -84.51435 hasResults: False |
<|newrecord|> nctId: NCT06373211 id: APHP230701 id: 2023-506942-22-01 type: OTHER domain: CTIS briefTitle: Early Immunotherapy With Intravenous Immunoglobulin, Cyclophosphamide and Methylprednisolone in Patients With Anti-Hu-associated Paraneoplastic Sensory Neuronopathy acronym: NESPA overallStatus: NOT_YET_RECRUITING date: 2024-06 date: 2027-06 date: 2027-06 date: 2024-04-18 date: 2024-04-18 name: Assistance Publique - Hôpitaux de Paris class: OTHER briefSummary: Paraneoplastic Neurological Syndromes are rare autoimmune complications linked to the presence of systemic cancer. Despite their autoimmune origin, they have historically shown little response to immunotherapy. The reason for this failure is probably related to too late administration of immunotherapy, at a stage where the inflammation has already disappeared and irreversible neuronal loss has occurred. The protocol focuses on patients with anti-Hu antibody sensory neuronopathy. This single arm trial consists of an early immunotherapy combining Intravenous Immunoglobulin (IVIG) for 3 months, cyclophosphamide and methylprednisolone for 6 months, at the rate of 1 cycle per month. The percentage of patients with clinical improvement will be evaluated (ONLS) at 3 months. The tolerance of the treatment will also be evaluated as well as other functional scales at 3 and 6 months. conditions: Paraneoplastic Sensory Neuronopathy studyType: INTERVENTIONAL phases: PHASE2 allocation: NA interventionModel: SINGLE_GROUP primaryPurpose: TREATMENT masking: NONE count: 21 type: ESTIMATED name: Immunoglobulins IV (CLAYRIG) name: Cyclophosphamide IV name: Methylprednisolone IV measure: Percentage of patients with clinical improvement on the ONLS (Overall Neuropathy Limitations Scale) at 3 months measure: Percentage of patients with clinical improvement on the ONLS (Overall Neuropathy Limitations Scale) at 3 and 6 months measure: Percentage of patients with improvement in the ataxic component on the Score of Ataxia scale at 3 and 6 months measure: Percentage of patients with improvement in neuropathic pain on the Numeric Rating Scale (NRS) at 3 and 6 months measure: Percentage of patients with functional improvement on the modified Rankin Score (mRS) at 3 and 6 months measure: Percentage of patients with functional improvement on the Barthel Index (BI) at 3 and 6 months measure: Percentage of patients alive and without tumor progression at 6 months measure: Tolerance to treatment sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Hôpital Pitié-Salpêtrière city: Paris zip: 75013 country: France name: Dimitri Psimaras, MD role: CONTACT email: [email protected] name: Alice LEPRINCE-LAURENGE, MD role: CONTACT email: [email protected] lat: 48.85341 lon: 2.3488 hasResults: False |
<|newrecord|> nctId: NCT06373198 id: 0040/2023-versión 1.0 briefTitle: Implementation of a Re-engagement Program for Hepatitis C Patients Lost to Follow-up in Argentina. overallStatus: NOT_YET_RECRUITING date: 2024-05-01 date: 2024-07-01 date: 2025-01-15 date: 2024-04-18 date: 2024-04-18 name: Hospital El Cruce class: OTHER name: Gilead Sciences briefSummary: Hepatitis C virus (HCV) is a leading cause of morbidity and mortality worldwide. This infection continues to represent a major global public health concern. This is why the introduction of potent antivirals for the treatment of HCV has been one of the major breakthroughs of the current medical era. |
From a public health perspective, HCV prevalence will be eliminated if the available treatment also targets those most likely to transmit the virus. Despite this scientific advance, a systematic review from the U.S. described that of the 43% of patients aware of their HCV diagnosis, only 16% started treatment. Clearly, the long-known barriers to accessing this treatment must be broken down in order to administer these effective antivirals. The World Health Organization (WHO) has set the ambitious goal of eliminating viral hepatitis as a public health threat by 2030. This goal is really difficult to achieve, especially in low and middle-income countries. Particularly in Argentina, there is a need to improve diagnosis, access to care, and treatment of viral hepatitis. The prospect of viral hepatitis elimination in our country is daunting due to the complexity of the health system and the cost of implementing different strategies. The most pragmatic approach would be to break down national elimination targets into smaller targets for individual populations, for which treatment and prevention interventions can be delivered more quickly and efficiently. This concept is known as micro-elimination. Focusing on micro-elimination of viral hepatitis means working to achieve the WHO target in specific subpopulations. Subpopulations known to have a higher prevalence of HCV infection include prisoners, people who inject drugs, and patients requiring hemodialysis, among others. |
Currently, patient unawareness of HCV infection represents one of the major barriers to treatment. In many cases, the diagnosis of HCV was established many years ago and patients do not seek treatment probably because they do not recognize the urgency of treating this asymptomatic infection. It is our goal, then, to identify the group of individuals who have been diagnosed with HCV infection but are not currently undergoing regular visits with health care professionals. This strategy is now called re-linking to the medical care of patients with chronic HCV. conditions: Hepatitis C Chronic conditions: Hepatitis C studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: PROSPECTIVE count: 800 type: ESTIMATED name: standard of care measure: rate of relinked HCV patients measure: proportion of relinked patients who received antiviral treatment measure: Evaluation and characteristics of the treatment established sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT hasResults: False |
<|newrecord|> nctId: NCT06373185 id: 2023/21 briefTitle: Comparison of the Efficacy of Sacral Espb and Caudal Block for Pain Management After Urogenital Surgeries in Children acronym: SESPB overallStatus: RECRUITING date: 2024-04-22 date: 2024-05 date: 2024-06 date: 2024-04-18 date: 2024-04-23 name: Giresun University class: OTHER briefSummary: The aim of this study was to compare the efficacy of caudal block and sacral espb used as a postoperative analgesia method in urogenital pediatric surgery cases. conditions: Urogenital Diseases conditions: Nerve Block conditions: Pain, Postoperative studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL interventionModelDescription: Randomized controlled double blind study primaryPurpose: TREATMENT masking: DOUBLE maskingDescription: Randomisation using a closed envelope method based on computer-generated random numbers was to assign patients to two equal groups. Group 1 received midline US-guided sacral erector spinae plane block and Group 2 received caudal block. The experienced anesthetist who opened the envelope performed the block according to the group code and patients were followed postoperatively by an anesthetist blinded to which block was performed. Patients were also blinded as to which block was performed. whoMasked: PARTICIPANT whoMasked: OUTCOMES_ASSESSOR count: 60 type: ESTIMATED name: Ultrasound-guided sacral erector spinae plane block name: Ultrasound-guided caudal block measure: Face, Leg, Activity, Cry, Consolability (FLACC) score measure: Analgesic requirement measure: Satisfaction of the patient's parents measure: Satisfaction of the surgeons sex: ALL minimumAge: 1 Year maximumAge: 7 Years stdAges: CHILD facility: Giresun Research and Training Hospital status: RECRUITING city: Gi̇resun state: Central zip: 28100 country: Turkey name: Bilge Olgun Keleş role: CONTACT phone: 05317338805 email: [email protected] name: Dilek Yeniay role: CONTACT phone: 05375521553 email: [email protected] lat: 40.91698 lon: 38.38741 hasResults: False |
<|newrecord|> nctId: NCT06373172 id: 202005-HR-003 briefTitle: Enhancing Clinical Reasoning Competency acronym: Reasoning overallStatus: COMPLETED date: 2020-05-01 date: 2020-06-01 date: 2023-03-01 date: 2024-04-18 date: 2024-04-18 name: Tongmyong University class: OTHER briefSummary: Enhancing Clinical Reasoning Competency for Undergraduate Nursing Students Using Virtual Simulation-based Education based on the Rasch model |
Aims: Clinical reasoning is a core nursing competency that involves analyzing patient-related data and providing appropriate nursing practices. Simulation-based education is effective in improving the clinical reasoning competencies and communication skills of nursing students. This study aimed to verify the effectiveness of virtual simulation-based education. conditions: Clinical Reasoning conditions: Communication conditions: Development, Human studyType: INTERVENTIONAL phases: NA allocation: NA interventionModel: SINGLE_GROUP interventionModelDescription: This quasi-experimental study used a single-group pretest-posttest design to verify the effectiveness of virtual simulation-based education for undergraduate nursing students. primaryPurpose: OTHER masking: NONE count: 37 type: ACTUAL name: virtual simulation-based education program measure: Nurses Clinical Reasoning Scale measure: Communication Skills Scale sex: ALL minimumAge: 20 Years maximumAge: 28 Years stdAges: ADULT facility: Tongmyong Unoversity city: Busan zip: 48520 country: Korea, Republic of lat: 35.10278 lon: 129.04028 hasResults: False |
<|newrecord|> nctId: NCT06373159 id: 22643 briefTitle: An Observational Study to Learn About the Occurrence of Disseminated Intravascular Coagulation Among Adults With Sepsis in Japan overallStatus: ACTIVE_NOT_RECRUITING date: 2024-04-10 date: 2024-09-30 date: 2024-09-30 date: 2024-04-18 date: 2024-04-18 name: Bayer class: INDUSTRY briefSummary: This is an observational study in which data already collected from people with sepsis (blood poisoning) and/or disseminated intravascular coagulation (DIC) are studied. |
In observational studies, only observations are made without participants receiving any advice or changes to their healthcare. |
DIC is a serious blood disorder that can cause clots throughout the body, blocking blood vessels. People who have sepsis or cancer are at a higher risk of developing DIC. |
To find a treatment that works well for people with DIC associated with sepsis, it is important to know about its occurrence, treatments people receive, and their outcomes. Japan is the only country that has officially approved medicines for DIC including a few newer medicines that prevent extensive blood clotting. |
In this study, researchers will assess patient data from a hospital database in Japan. |
The main purpose of this study is to learn more about how many adults develop DIC related to sepsis, thrombocytopenic sepsis (sudden decrease in the number of platelets in the blood), or septic shock (dangerously low blood pressure) in Japan every year. |
To learn about this, researchers will collect the following information: |
* The number of participants who developed DIC 14 days, 21 days and 28 days after their sepsis diagnosis |
* The grading scores given to the participants which are used to assess the likelihood, cause, severity, treatment plan, and outcome of DIC (including scores called JAAM, ISTH, MHLW, and/or SOFA scores) |
* The number of days between diagnosis of sepsis and the beginning of DIC |
Researchers will study the data collected between June 2018 and June 2023. The data will come from TXP Medical, which collects data through the hospital health information system of 7 selected hospitals for this study across Japan. |
In this study, only available data from routine care are collected. conditions: Sepsis conditions: Disseminated Intravascular Coagulation studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: RETROSPECTIVE count: 5740 type: ESTIMATED name: No study intervention measure: Incidence of DIC assessed at 14 days, 21 days and 28 days of the patient follow up measure: Distribution of JAAM DIC score measure: Distribution of ISTH DIC score measure: Distribution of MHLW DIC score measure: Distribution of SOFA score measure: Days from sepsis diagnosis to the onset of DIC measure: Number of participants per clinical characteristics measure: Number of participants per DIC treatment patterns in patients with sepsis-associated DIC following the onset of DIC measure: Incidence rates of clinical outcomes assessed in patients with sepsis-associated DIC measure: Cumulative incidences of clinical outcomes assessed in patients with sepsis-associated DIC measure: Number of participants per clinical characteristics in subgroup of patients who developed sepsis-associated DIC measure: Number of participants per treatment patterns in subgroup of patients who developed sepsis-associated DIC measure: Incidence rates of clinical outcomes in subgroup of patients who developed sepsis-associated DIC measure: Number of participants per clinical characteristics after the onset of DIC in patients with non-sepsis-associated DIC measure: Number of participants per treatment patterns after the onset of DIC in patients with non-sepsis-associated DIC measure: Incidence rates of clinical outcomes after the onset of DIC in patients with non-sepsis-associated DIC sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Bayer city: Tokyo zip: 100-8265 country: Japan lat: 35.6895 lon: 139.69171 hasResults: False |
<|newrecord|> nctId: NCT06373146 id: 18750 id: I8F-MC-GPIV type: OTHER domain: Eli Lilly and Company briefTitle: A Study of Tirzepatide (LY3298176) Plus Mibavademab Compared With Tirzepatide Alone in Adult Participants With Obesity overallStatus: NOT_YET_RECRUITING date: 2024-05 date: 2025-12 date: 2026-04 date: 2024-04-18 date: 2024-04-23 name: Eli Lilly and Company class: INDUSTRY name: Regeneron Pharmaceuticals briefSummary: The main purpose of this study is to determine if combining tirzepatide with the mibavademab will result in more weight loss in adult participants than tirzepatide alone. The study will last about 72 weeks and may include up to 19 visits. conditions: Obesity studyType: INTERVENTIONAL phases: PHASE2 allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: DOUBLE whoMasked: PARTICIPANT whoMasked: INVESTIGATOR count: 360 type: ESTIMATED name: Tirzepatide name: Mibavademab name: Tirzepatide-Placebo name: Mibavademab-Placebo measure: Mean Percent Change from Baseline in Body Weight measure: Mean Change from Baseline for Percent Change and Absolute Change in Body Weight (kg) measure: Mean Absolute Change from Baseline for Body Weight (kg) measure: Percentage of Participants Who Achieve ≥5% Body Weight Reduction measure: Percentage of Participants Who Achieve ≥10% Body Weight Reduction measure: Percentage of Participants Who Achieve ≥15% Body Weight Reduction measure: Percentage of Participants Who Achieve ≥20 Body Weight Reduction measure: Mean Percent Change from Randomization 2 for Body Weight measure: Mean Change from Randomization 2 for Body Weight (kg) measure: Mean Absolute Change from Randomization 2 for Body Weight (kg) measure: Change from Baseline to Week 24 in CoEQ Scores measure: Change from Baseline to Week 24 in CoEQ Scores measure: Change from Baseline in FCQ-T-r Scores measure: Change from Baseline in FCQ-T-r Scores sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Velocity Clinical Research, Gardena city: Gardena state: California zip: 90247 country: United States name: Mark T. Leibowitz role: PRINCIPAL_INVESTIGATOR lat: 33.88835 lon: -118.30896 facility: Irvine Clinical Research city: Irvine state: California zip: 92614 country: United States name: Elly R Lee role: PRINCIPAL_INVESTIGATOR lat: 33.66946 lon: -117.82311 facility: National Research Institute - Wilshire city: Los Angeles state: California zip: 90057 country: United States name: Juan Pablo Frias role: PRINCIPAL_INVESTIGATOR lat: 34.05223 lon: -118.24368 facility: Velocity Clinical Research, North Hollywood city: North Hollywood state: California zip: 91606 country: United States name: Samuel Penziner role: PRINCIPAL_INVESTIGATOR lat: 34.17223 lon: -118.37897 facility: Velocity Clinical Research, Panorama City city: Panorama City state: California zip: 91402 country: United States name: Maricor Grio role: PRINCIPAL_INVESTIGATOR lat: 34.22473 lon: -118.44981 facility: Velocity Clinical Research, Santa Ana city: Santa Ana state: California zip: 92704 country: United States name: Julie Vu role: PRINCIPAL_INVESTIGATOR lat: 33.74557 lon: -117.86783 facility: Diablo Clinical Research, Inc. city: Walnut Creek state: California zip: 94598 country: United States name: Bonnie S. Kimmel role: PRINCIPAL_INVESTIGATOR lat: 37.90631 lon: -122.06496 facility: Solaris Clinical Research city: Meridian state: Idaho zip: 83646 country: United States name: David J. Butuk role: PRINCIPAL_INVESTIGATOR lat: 43.61211 lon: -116.39151 facility: Tandem Clinical Research city: Marrero state: Louisiana zip: 70072 country: United States name: Adil Fatakia role: PRINCIPAL_INVESTIGATOR lat: 29.89937 lon: -90.10035 facility: Velocity Clinical Research, Metairie city: Metairie state: Louisiana zip: 70006 country: United States name: Scott P Striplin role: PRINCIPAL_INVESTIGATOR lat: 29.98409 lon: -90.15285 facility: Velocity Clinical Research, Norfolk city: Norfolk state: Nebraska zip: 68701 country: United States name: Charles Harold Harper role: PRINCIPAL_INVESTIGATOR lat: 42.02834 lon: -97.417 facility: Lillestol Research city: Fargo state: North Dakota zip: 58104 country: United States name: Michael J Lillestol role: PRINCIPAL_INVESTIGATOR lat: 46.87719 lon: -96.7898 facility: South Texas Clinical Research city: Corpus Christi state: Texas zip: 78404 country: United States name: Lloyd Stegemann role: PRINCIPAL_INVESTIGATOR lat: 27.80058 lon: -97.39638 facility: Dallas Diabetes Research Center city: Dallas state: Texas zip: 75230 country: United States name: Julio Rosenstock role: PRINCIPAL_INVESTIGATOR lat: 32.78306 lon: -96.80667 facility: Northwest Clinical Research Center city: Bellevue state: Washington zip: 98007 country: United States name: Nazia Rahman role: PRINCIPAL_INVESTIGATOR lat: 47.61038 lon: -122.20068 facility: Centro de Investigacion en Artritis y Osteoporosis SC city: Mexicali state: Baja California zip: 21200 country: Mexico name: Francisco Fidencio Cons Molina role: PRINCIPAL_INVESTIGATOR lat: 32.62781 lon: -115.45446 facility: Clínicos Asociados BOCM city: Mexico City state: Distrito Federal zip: 03300 country: Mexico name: Israel Olvera-Alvarez role: PRINCIPAL_INVESTIGATOR lat: 19.42847 lon: -99.12766 facility: Unidad biomedica avanzada monterrey city: Monterrey state: Nuevo León zip: 64460 country: Mexico name: Raymundo Garcia Reza role: PRINCIPAL_INVESTIGATOR lat: 25.67507 lon: -100.31847 facility: Medical Care and Research SA de CV city: Merida state: Yucatán zip: 97070 country: Mexico name: Carlos Eduardo Medina role: PRINCIPAL_INVESTIGATOR lat: 20.97537 lon: -89.61696 facility: Investigacion En Salud Y Metabolismo S.C / Nutricion Clinica / Unidad de Base de Datos city: Chihuahua zip: 31110 country: Mexico name: Luis Alejandro Nevarez role: PRINCIPAL_INVESTIGATOR lat: 28.63528 lon: -106.08889 hasResults: False |
<|newrecord|> nctId: NCT06373133 id: 2024 (82) briefTitle: SHR-8068 Combined With Adbelizumab and BP102 in the Treatment of Advanced Colorectal Cancer overallStatus: NOT_YET_RECRUITING date: 2024-05-01 date: 2026-11-01 date: 2026-11-01 date: 2024-04-18 date: 2024-04-18 name: West China Hospital class: OTHER briefSummary: To evaluate the efficacy and safety of SHR-8068 and Adebrelimab in Combination With Bevacizumabin in the treatment of microsatellite stable (MSS) advanced colorectal cancer. conditions: Colorectal Cancer studyType: INTERVENTIONAL phases: PHASE1 phases: PHASE2 allocation: NA interventionModel: SINGLE_GROUP primaryPurpose: TREATMENT masking: NONE count: 36 type: ESTIMATED name: SHR-8068 name: Adebrelimab name: BP102 measure: Dose-limiting toxicity measure: PFS sex: ALL minimumAge: 18 Years maximumAge: 75 Years stdAges: ADULT stdAges: OLDER_ADULT hasResults: False |
<|newrecord|> nctId: NCT06373120 id: QX20231057-X-1 briefTitle: Interventional Ventricular Assist System for PCI in CHIP Patients acronym: REC-CHIPMCS overallStatus: RECRUITING date: 2024-03-01 date: 2025-03-30 date: 2025-04-30 date: 2024-04-18 date: 2024-04-18 name: Xijing Hospital class: OTHER briefSummary: In patients with complex coronary artery disease (CAD), determining the optimal revascularization strategy (percutaneous coronary intervention (PCI) or coronary artery bypass grafting (CABG) remains a challenge. These high-risk patients pose an extreme surgical risk. However, with the development of new interventional techniques and materials, PCI is a good alternative to CABG and is referred to as complex high-risk indicated PCI (CHIP). |
During CHIP, hemodynamics can deteriorate because of temporary complete coronary occlusion or profound myocardial ischemia. This could result in loss of cardiac output and hemodynamics collapse. Mechanical support during CHIP facilitates native cardiac function by achieving a stable hemodynamic state to withstand repetitive derangements such as ischemia caused by prolonged and repeated balloon inflations, and resume original cardiac function immediately postprocedure or shortly thereafter. |
There are several mechanical circulatory support (MCS) systems available, i.e., intra-aortic balloon counterpulsation (IABP), Impella, TandemHeart, and veno-arterial extracorporeal membrane oxygenation (VA-ECMO). These MCS have been widely studied in patients with acute myocardial infarction (MI) complicated by cardiogenic shock and showed conflicting results. However, studies regarding the use of MCS in the setting of CHIP are much less abundant and no randomized study has compared Impella with VA-ECMO in CHIP patients. |
The aim of the study is to evaluate the effectiveness of interventional ventricular assist system (CorVad) compared to the venoarterial extracorporeal membrane oxygenation (VA-ECMO) system in providing circulatory support for complicated and high-risk patient with indications for PCI. conditions: High-Risk Percutaneous Coronary Intervention (High-risk PCI) conditions: Left Ventricular Assist Devices studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL interventionModelDescription: Prospective, 1:1 randomized, controlled, multicenter trial to assess effectiveness and safety of CorVad compared to VA-ECMO in complicated and high-risk patient with indications for PCI primaryPurpose: TREATMENT masking: SINGLE maskingDescription: A blinded and independent clinical event adjudication committee will adjudicate all primary and secondary outcomes whoMasked: OUTCOMES_ASSESSOR count: 262 type: ESTIMATED name: CorVad name: VA-ECMO measure: Major adverse event measure: All-cause death measure: Stroke measure: Myocardial infarction measure: Revascularization measure: Cardiovascular hospitalization measure: MCS-ARC defined type 3, 4, 5 bleeding measure: Acute kidney injury measure: Serious device-related adverse events measure: Cardiopulmonary resuscitation measure: Hospitalization time measure: Intensive care unit (ICU/CCU) stay time measure: ECMO/Corvad utilization time measure: Hemodynamic disorder measure: Transfusion rate measure: Units of transfusion measure: Device-related composite endpoint (DoCE) measure: Patient-related composite endpoint (PoCE) measure: Net adverse clinical events measure: Cardiac death measure: Ischemic stroke measure: Hemorrhagic stroke measure: Transient ischemic attack measure: Target vessel myocardial infarction measure: Target lesion revascularization measure: Target vessel revascularization measure: Clinically and physiologically driven target lesion revascularization (CPI-TLR) measure: Rehospitalization measure: MCS-ARC type 2 bleeding measure: Puncture complications measure: Aortic valve injury measure: Active Infection measure: ECMO/Corvad setup time measure: Complete revascularization rate measure: Change in left ventricular ejection fraction (LVEF) from baseline measure: Change in New York Heart Association (NYHA) classification from baseline measure: Change in Seattle Angina Questionnaire (SAQ) score from baseline measure: Change in Kansas City Cardiomyopathy Questionnaire (KCCQ) score from baseline measure: Change in 5-level EQ-5D version (EQ-5D-5L) standardized health status scale score from baseline measure: Change in creatinine clearance rate from baseline measure: Stent thrombosis sex: ALL minimumAge: 18 Years maximumAge: 90 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Ling Tao status: RECRUITING city: Xi'an state: Shannxi zip: 710032 country: China name: Chao Gao, M.D., Ph.D. role: CONTACT phone: 86-18629551066 email: [email protected] lat: 34.25833 lon: 108.92861 hasResults: False |
<|newrecord|> nctId: NCT06373107 id: 2117651-2 briefTitle: Investigating Effects of High-intensity Gait Training on Gait, Balance and Depression Post-stroke overallStatus: NOT_YET_RECRUITING date: 2024-04-11 date: 2025-10-30 date: 2026-01-31 date: 2024-04-18 date: 2024-04-18 name: Alvernia University class: OTHER name: Lehigh Valley Health Network briefSummary: The purpose of this research is to study the improvements from walking practice that is vigorous enough to keep participants' heart rate over a certain target level during their physical therapy sessions. The investigators want to know about improvements in participants' walking function and mental health after 20 interventions. The study also aims to evaluate if participants' mental health, social support, and health literacy affect their attendance at physical therapy sessions. conditions: Stroke studyType: INTERVENTIONAL phases: NA allocation: NA interventionModel: SINGLE_GROUP primaryPurpose: TREATMENT masking: NONE count: 24 type: ESTIMATED name: High intensity gait training measure: 3-meter backwards walk test measure: 6-minute walk test measure: 10-meter walk test measure: Surface electromyography (EMG) measure: Berg Balance Scale measure: Functional Gait Assessment measure: Borg Rating Scale of Perceived Exertion (RPE) measure: Patient Health Questionnaire (PHQ-9) measure: Rate of patient attendance (Compliance) to physical therapy measure: Newest Vital Sign measure: Multidimensional Scale of Perceived Social Support (MSPSS) sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Lehigh Valley Health Network Outpatient Neurologic Rehab city: Allentown state: Pennsylvania zip: 18104-2310 country: United States name: Sandra M Tremblay, DPT role: CONTACT lat: 40.60843 lon: -75.49018 hasResults: False |
<|newrecord|> nctId: NCT06373094 id: DON102-CTP briefTitle: A Single Dose Escalation Study of HHT201 in Healthy Subjects overallStatus: NOT_YET_RECRUITING date: 2024-06-01 date: 2025-03-31 date: 2025-03-31 date: 2024-04-18 date: 2024-04-18 name: Shanghai Synergy Pharmaceutical Sciences Co., Ltd. class: INDUSTRY briefSummary: The objective of this study is to evaluate the safety and pharmacokinetic profiles of HHT201 in healthy subjects. conditions: Alzheimer Disease studyType: INTERVENTIONAL phases: PHASE1 allocation: NON_RANDOMIZED interventionModel: SEQUENTIAL primaryPurpose: TREATMENT masking: NONE count: 64 type: ESTIMATED name: Donepezil Dihydroxynaphthalate for Injection measure: Adverse events measure: Number of Participants With Abnormal Laboratory Values measure: Number of Participants With Abnormal ECG QT Interval measure: Number of Participants With Abnormal Vital signs measure: Number of Participants With Abnormal Physical examination measure: VAS measure: Cmax of Donepezil measure: Tmax of Donepezil measure: AUC0-t of Donepezil measure: AUC0-∞ of Donepezil measure: t1/2z of Donepezil measure: Vz/F measure: CLz/F sex: ALL minimumAge: 20 Years maximumAge: 59 Years stdAges: ADULT facility: Zhejiang Province Taizhou Hospital Luqiao Hospital (Enze Hospital) (Taizhou Hospital Phase I Center) city: Taizhou state: Zhe Jiang zip: 318000 country: China name: Donqing Lv role: CONTACT phone: 86-0576-85199816 email: [email protected] name: Zhanrong Ye role: CONTACT phone: 86-0576-85199816 email: [email protected] lat: 32.49069 lon: 119.90812 hasResults: False |
<|newrecord|> nctId: NCT06373081 id: CD19-CD3E-CN-A1 briefTitle: Anti-CD19-CD3E-CAR-T Cells in Relapsed/Refractory Autoimmune Disease overallStatus: RECRUITING date: 2024-04-20 date: 2025-04-15 date: 2026-04-15 date: 2024-04-18 date: 2024-04-18 name: Shanghai Changzheng Hospital class: OTHER briefSummary: This is an investigator-initiated trial to evaluate the safety and efficacy of anti-CD19-CD3E-CAR-T cells in the relapse or refractory autoimmune diseases. conditions: Systemic Lupus Erythematosus (SLE) conditions: Sjogren's Syndrome conditions: Systemic Sclerosis conditions: Inflammatory Myopathy conditions: ANCA Associated Vasculitis conditions: Antiphospholipid Syndrome studyType: INTERVENTIONAL phases: NA allocation: NA interventionModel: SINGLE_GROUP primaryPurpose: TREATMENT masking: NONE count: 6 type: ESTIMATED name: Anti-CD19-CD3E-CAR-T cells measure: The incidence of dose-limiting toxicities (DLTs) (Safety) measure: Proportion of patients for whom the desired dose of anti-CD19-CD3E-CAR-T cells can be successfully manufactured measure: Clinical response for relapsed/Refractory SLE measure: Clinical response for Sjögren's Syndrome measure: Clinical response for relapsed/refractory/progressive systemic sclerosis measure: Clinical response for relapsed/refractory/progressive inflammatory myopathy measure: Clinical response for relapsed/refractory anti-neutrophil cytoplasmic antibody (ANCA)-associated vasculitis: measure: Clinical response for relapsed/refractory/Catastrophic Antiphospholipid Syndrome sex: ALL minimumAge: 18 Years maximumAge: 65 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Shanghai ChangZheng hospital status: RECRUITING city: Shanghai zip: 200003 country: China name: Huji Xu role: CONTACT phone: 86021-81885514 email: [email protected] lat: 31.22222 lon: 121.45806 hasResults: False |
<|newrecord|> nctId: NCT06373068 id: Resuscitation Orders ICU briefTitle: Association Between Resuscitation Orders and Mortality in ICU Patients overallStatus: NOT_YET_RECRUITING date: 2024-05 date: 2024-12 date: 2025-03 date: 2024-04-18 date: 2024-04-24 name: Karolinska Institutet class: OTHER briefSummary: The hypothesis of the study is that a resuscitation order other than full code is associated with increased mortality among critically ill patients. By incorporating conventional variables associated with death such as age, sex, and Simplified Acute Physiological Score, as well as including the new Clinical Frailty Scale in a statistical model, the aim is to investigate whether there is still an increased risk of death that remains unexplained. conditions: Critical Illness studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: RETROSPECTIVE count: 1500 type: ESTIMATED name: Resuscitation orders measure: Mortality sex: ALL minimumAge: 16 Years stdAges: CHILD stdAges: ADULT stdAges: OLDER_ADULT hasResults: False |
<|newrecord|> nctId: NCT06373055 id: 4-2023-1232 briefTitle: Prediction of Therapeutic Response to Neoadjuvant Chemotherapy in Muscle Invasive Bladder Cancer Patients Using Spatial Transcriptomics overallStatus: RECRUITING date: 2024-05-01 date: 2033-11 date: 2033-11 date: 2024-04-18 date: 2024-04-18 name: Yonsei University class: OTHER briefSummary: Although neoadjuvant chemotherapy in muscle-invasive bladder cancer has significantly improved oncological outcomes, approximately 50% of patients do not respond to neoadjuvant chemotherapy, which has adverse effects on patients by causing treatment toxicity and surgical delays. Therefore, treatment tailored specifically to the individual patient based on the genetic and/or molecular profile of the patient is urgently needed. Among patients scheduled for neoadjuvant chemotherapy, the investigators should differentiate between patients who will be highly effective with neoadjuvant chemotherapy and those who will not, and preferentially select other treatments including radical cystectomy in the patients with high probability of failure to neoadjuvant chemotherapy. However, there is no standard which patients would benefit from neoadjuvant chemotherapy. This study plans to predict treatment response to neoadjuvant chemotherapy in patients with muscle-invasive bladder cancer by analyzing genetic and molecular profiles of tumor tissues obtained through transurethral bladder tumor resection. conditions: Muscle-invasive Bladder Cancer studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: PROSPECTIVE count: 250 type: ESTIMATED name: neoadjuvant chemotherapy followed by radical cystectomy measure: Identification of responder to neoadjuvant chemotherapy by genetic and molecular profiles measure: overall survival of bladder cancer patients who have undergone neoadjuvant chemotherapy and radical cystectomy measure: cancer-specific survival of bladder cancer patients who have undergone neoadjuvant chemotherapy and radical cystectomy measure: progression-free survival of bladder cancer patients who have undergone neoadjuvant chemotherapy and radical cystectomy measure: recurrence-free survival of bladder cancer patients who have undergone neoadjuvant chemotherapy and radical cystectomy sex: ALL minimumAge: 18 Years maximumAge: 80 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Department of Urology and Urological Science Institute, Yonsei University College of Medicine Seoul, Republic of Korea status: RECRUITING city: Seoul country: Korea, Republic of name: Won Sik Ham role: CONTACT phone: 02-2228-2310 email: [email protected] lat: 37.566 lon: 126.9784 hasResults: False |
<|newrecord|> nctId: NCT06373042 id: ADJUVANT-2 briefTitle: Tirofiban for Successful Endovascular Stroke Thrombectomy acronym: ADJUVANT-2 overallStatus: NOT_YET_RECRUITING date: 2024-07-31 date: 2026-07-31 date: 2026-10-31 date: 2024-04-18 date: 2024-04-18 name: Zhongming Qiu class: OTHER name: The Second Affiliated Hospital of Chongqing Medical University name: Mianyang Central Hospital name: The Second Hospital of Jiaozuo name: Chongzhou People's Hospital name: Xihua People's Hospital name: Xingguo People's Hospital briefSummary: Up to 50% of acute ischemic stroke patients with large vessel occlusion failed to achieve functional independence even after successful reperfusion therapy, a phenomenon that is referred to as "futile recanalization". The mechanism of futile recanalization is complex, and some studies have shown that it may be related to factors such as tissue no reflow, reocclusion, poor status of collateral circulation, hemorrhagic transformation, impaired cerebrovascular autonomic regulation, and low perfusion volume. Several studies suggested that maximizing the improvement of cerebral reperfusion is still the primary goal of acute large vessel occlusive stroke. Structural and functional alterations in the microvascular system may be a major obstacle to reperfusion. In animal models of cerebral ischemia, downstream microvascular thrombosis may occur in the early stage of cerebral ischemia and before vascular recanalization, which is the main factor leading to incomplete reperfusion and affecting the efficacy of endovascular thrombectomy. |
Mechanical thrombectomy mainly addressed the occluded large arteries, and does not consider the distal arteries. However, the recanalization of occluded large arteries does not necessarily translate into successful reperfusion of the ischemic tissue supplied by the distal capillaries. Even with complete recanalization, impaired microcirculatory reperfusion may lead to poor clinical outcomes. Therefore, we speculate that at the end of endovascular thrombectomy, microthrombi remain present in the microcirculation of brain tissue in patients with complete or near-complete cerebral angiography, and that microthrombi is more likely to be dissolved than thrombus more proximal to the heart. Therefore, intra-arterial administration of pharmaceutical, such as tirofiban, may be the only possible option to ensure complete reperfusion of ischemic tissue. Tirofiban is a platelet glycoprotein IIb/IIIa receptor antagonist, which has been widely used in acute coronary syndrome, and its role in acute ischemic stroke has attracted more and more attention from stroke experts. Previous studies have suggested that tirofiban can further increase the incidence of successful recanalization, while reducing the reocclusion rate. |
Whether early administration of intraarterial and intravenous tirofiban can further improve the clinical outcomes of patients with large vessel occlusive stroke after successful mechanical thrombectomy remains unclear. conditions: Stroke, Acute Ischemic studyType: INTERVENTIONAL phases: PHASE2 phases: PHASE3 allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: QUADRUPLE whoMasked: PARTICIPANT whoMasked: CARE_PROVIDER whoMasked: INVESTIGATOR whoMasked: OUTCOMES_ASSESSOR count: 712 type: ESTIMATED name: Intraarterial and intravenous tirofiban name: Intraarterial and intravenous placebo measure: Functional independence measure: Recanalization on follow-up CTA or MRA measure: Early neurologic improvement measure: Level of disability measure: Excellent outcome measure: Independent ambulation measure: Health-related quality of life measure: Long-term of disability level measure: Health-related quality of life (long-term) measure: Incidence of symptomatic intracranial hemorrhage (SICH) measure: Radiologic intracranial hemorrhage rate measure: Mortality measure: Incidence of non-hemorrhagic serious adverse events sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT hasResults: False |
<|newrecord|> nctId: NCT06373029 id: 2023PHB211-001(2) briefTitle: Deep-learning Enabled Ultrasound Diagnosis of Anterior Talofibular Ligament Injury overallStatus: NOT_YET_RECRUITING date: 2024-04-20 date: 2024-05-30 date: 2025-12-30 date: 2024-04-18 date: 2024-04-18 name: Peking University People's Hospital class: OTHER briefSummary: Ultrasound (US) is a more cost-effective, accessible, and available imaging technique to assess anterior talofibular ligament (ATFL) injuries compared with magnetic resonance imaging (MRI). However, challenges in using this technique and increasing demand on qualified musculoskeletal (MSK) radiologists delay the diagnosis. The investigators have already developed a deep convolutional network (DCNN) model that automates detailed classification of ATFL injuries. The investigators hope to use the DCNN in real-world clinical setting to test its diagnostic accuracy. conditions: Ultrasound conditions: Anterior Talofibular Ligament conditions: Deep Learning studyType: OBSERVATIONAL observationalModel: OTHER timePerspective: PROSPECTIVE count: 400 type: ESTIMATED name: Ultrasound examination measure: classification of ATFL injury sex: ALL minimumAge: 18 Years maximumAge: 80 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Peking University People's Hospital city: Beijing state: Beijing zip: 100032 country: China lat: 39.9075 lon: 116.39723 hasResults: False |
<|newrecord|> nctId: NCT06373016 id: 2015P000652 id: 2023005 type: OTHER_GRANT domain: Baszucki Foundation briefTitle: Use of Ketosis in Modulating Metabolic Pathways in Bipolar Disorder overallStatus: RECRUITING date: 2024-01-26 date: 2027-02-01 date: 2027-02-01 date: 2024-04-18 date: 2024-04-18 name: Stony Brook University class: OTHER name: Massachusetts General Hospital name: Mclean Hospital briefSummary: The goal of this clinical trial is to test how specific components of diet affect brain function and behavior for individuals with bipolar. The main question it aims to answer is how glucose and ketones each affect the brain's response to risk and reward. Participants will be asked to provide blood (to assess baseline measures of how the body uses energy), and then to receive two MRI scan sessions, on separate days. During each MRI scan session, participants will play three games, from which they can win money, before and after drinking glucose (on one day) or ketones (on the other day). Investigators will compare individuals with and without bipolar to test whether the two groups differ in how their brains use energy, and to test how the brain's use of energy affects behavior. conditions: Bipolar Disorder conditions: Bipolar Disorder Type 1 studyType: INTERVENTIONAL phases: NA allocation: NA interventionModel: SINGLE_GROUP primaryPurpose: BASIC_SCIENCE masking: NONE count: 100 type: ESTIMATED name: Glucose name: Ketones measure: Stabilization of brain networks (general brain functioning) measure: Relative stabilization or destabilization of brain networks in response to metabolic bolus measure: Prefrontal-limbic circuit regulation measure: Cortico-striatal circuit regulation measure: Concentration of neurometabolites measured by Magnetic Resonance Spectroscopy (MRS) sex: ALL minimumAge: 18 Years maximumAge: 45 Years stdAges: ADULT facility: McLean Hospital status: RECRUITING city: Belmont state: Massachusetts zip: 02478 country: United States name: Dost Ongur, MD PhD role: CONTACT phone: 617-855-3922 email: [email protected] name: Virginie-Anne Chouinard, MD role: CONTACT phone: 617-855-3034 email: [email protected] name: Dost Ongur, MD PhD role: PRINCIPAL_INVESTIGATOR lat: 42.39593 lon: -71.17867 facility: Martinos Center for Biomedical Research, Building 149, 13th Street status: RECRUITING city: Charlestown state: Massachusetts zip: 02129 country: United States name: Lilianne Mujica-Parodi, PhD role: CONTACT phone: 631-428-8461 email: [email protected] name: Eva-Maria Ratai, PhD role: CONTACT phone: 781-521-4436 email: [email protected] name: Eva-Maria Ratai, PhD role: PRINCIPAL_INVESTIGATOR lat: 42.37787 lon: -71.062 facility: Laufer Center for Physical and Quantitative Biology , Stony Brook University status: ACTIVE_NOT_RECRUITING city: Stony Brook state: New York zip: 11794 country: United States lat: 40.92565 lon: -73.14094 hasResults: False |
<|newrecord|> nctId: NCT06373003 id: SNAPSITA briefTitle: Negative Antiphospholipid Syndrome: a Multicentric Study acronym: SNAPSITA overallStatus: RECRUITING date: 2024-03-31 date: 2026-03-31 date: 2026-03-31 date: 2024-04-18 date: 2024-04-18 name: Italian Society for Rheumatology class: OTHER briefSummary: Multicentre no-profit, national, (cross-sectional diagnostic) retrospective study, promoted by the Italian Society for Rheumatology. |
The main objective of the study is to assess the diagnostic accuracy of non-criteria aPL (anti-vimentin/cardiolipin and anti-phosphatidylserine/prothrombin) in identifying APS in patients with thrombosis/recurrent adverse pregnancy outcomes. |
The recruited patients have the following criteria: |
(i)Patients fulfilling the classification criteria for antiphospholipid syndrome (seropositive APS, SP-APS) or patients with seronegative APS (SN-APS) or patients with clinical criteria (thrombotic or obstetric) for APS, negative for aPL, but without clinical features highly suggestive of APS; (ii) Age \<65 years; (iii) less than 5 years from the first event to the beginning of the study. conditions: Antiphospholipid Syndrome conditions: Seronegative Antiphospholipid Syndrome studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: RETROSPECTIVE count: 105 type: ESTIMATED name: Diagnostic accuracy measure: Primary endpoint measure: Secondary endpoint_1 measure: Secondary endpoint_2 measure: Secondary endpoint_3 measure: Exploratory Endpoint sex: ALL minimumAge: 18 Years maximumAge: 65 Years stdAges: ADULT stdAges: OLDER_ADULT facility: UOC di Reumatologia - AOU Policlinico Umberto I, "Sapienza" Università di Roma status: RECRUITING city: Roma state: Rome zip: 00185 country: Italy name: Simona Truglia, MD role: CONTACT phone: 06 49974631 email: [email protected] lat: 41.89193 lon: 12.51133 hasResults: False |
<|newrecord|> nctId: NCT06372990 id: 0015338 briefTitle: Rapid T-cell Analysis Test in Patients With Chronic HBV and HBV/HDV Disease acronym: BDTc overallStatus: NOT_YET_RECRUITING date: 2024-04-15 date: 2025-09-30 date: 2026-09-30 date: 2024-04-18 date: 2024-04-18 name: Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico class: OTHER name: Duke-NUS Medical School (Singapore) briefSummary: Prospective, non-pharmacological, single-center, non-profit observational study. |
The study design allows longitudinal evaluation of the immune response during the natural history of the infection and/or treatment, correlating the data with the outcome of the disease and antiviral therapies, which will be collected as study variables from the source documents. |
The study population will be patients suffering from chronic HBV infection with or without HBV-HDV co-infection followed at the Division of Gastroenterology and Hepatology of Fondazione IRCCS Ca' Granda Ospedale Maggiore Policlinico. |
The present study is part of an international cooperation project between the Division of Gastroenterology and Hepatology, Fondazione IRCCS Ca' Granda Ospedale Maggiore Policlinico (Milan, Italy) and the Duke-NUS Medical School, Singapore, financed by a grant (project MAECI-2023-23683653) and divided into two specific Work Packages: |
* WP 1 Milan team (WP1.1 - Clinical and virological phenotyping of CHB and CHD patients; WP1.2 - Clinical evaluation of rapid HBV T cell test in CHB and CHD populations) |
* WP 2 Singapore team (WP2.1 - Applicability of the rapid T cell assay approach; WP 2.2 - Optimization of the rapid T cell assay protocol) |
The primary objective of the study is to define the prevalence of specific T cell responses in patients with chronic HBV and HBV-HDV infection, through the application of a specific rapid T cell assay. conditions: HBV conditions: HBV/HDV studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: PROSPECTIVE count: 300 type: ESTIMATED measure: Define the prevalence of specific T cell responses in patients with chronic HBV and HBV-HDV infection, through the application of a specific rapid T cell assay measure: Evaluate differences in terms of T cell response in patients with chronic HBV infection vs. HBV-HDV measure: Correlate the T cell response phenotype with the clinical profile (chronic infection vs. chronic hepatitis), disease severity (cirrhosis vs. non-cirrhosis) and response to specific HBV and HBV-HDV therapies measure: Improve the rapid T cell analysis protocol by simplifying the process, reducing analysis time and/or reducing the amount of material (blood) needed sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Foundation IRCCS Ca' Granda Ospedale Maggiore Policlinico, Division of Gastroenterology and Hepatology, Milan, Italy. city: Milano state: MI zip: 20122 country: Italy name: Pietro Lampertico, MD role: CONTACT phone: 0255035432 email: [email protected] lat: 45.46427 lon: 9.18951 hasResults: False |
<|newrecord|> nctId: NCT06372977 id: kappa index in ms briefTitle: Kappa Index Versus Csf Oligoclonal Bands in Diagnosis of ms and Prediction of Disease Activity overallStatus: NOT_YET_RECRUITING date: 2024-05 date: 2025-12 date: 2026-05 date: 2024-04-18 date: 2024-04-18 name: Assiut University class: OTHER briefSummary: To: |
1. Compare the diagnostic performance of cerebrospinal fluid kappa index to that of cerebrospinal fluid IgG oligoclonal bands in differentiating multiple sclerosis from other inflammatory and non-inflammatory neurological diseases . |
2. Assess the role of kappa free light chain and oligoclonal bands in predicting disease activity (conversion from clinical isolated syndrome to multiple sclerosis) conditions: Multiple Sclerosis studyType: OBSERVATIONAL observationalModel: CASE_CONTROL timePerspective: CROSS_SECTIONAL count: 140 type: ESTIMATED name: kappa index measure: Assess the diagnostic performance of CSF k index in differentiating MS from other inflammatory and non-inflammatory neurological diseases . measure: Assess the diagnostic performance of CSF IgG OCBs in differentiating MS from other inflammatory and non-inflammatory neurological diseases . measure: Assess the role of k FLC in predicting disease activity (conversion from CIS to MS) measure: Assess the role of OCBs in predicting disease activity (conversion from CIS to MS) sex: ALL minimumAge: 18 Years maximumAge: 40 Years stdAges: ADULT hasResults: False |
<|newrecord|> nctId: NCT06372964 id: ITI-007-421 briefTitle: Multicenter Study of Lumateperone for the Treatment of Bipolar Depression in Pediatric Patients overallStatus: RECRUITING date: 2024-04 date: 2027-04 date: 2027-05 date: 2024-04-18 date: 2024-04-23 name: Intra-Cellular Therapies, Inc. class: INDUSTRY briefSummary: This is a multicenter, randomized, double-blind, placebo-controlled study in pediatric patients who are experiencing major depressive episodes (MDEs) associated with a primary diagnosis of bipolar I or bipolar II disorder as confirmed by Kiddie Schedule for Affective Disorders and Schizophrenia for School-Age Children-Present and Lifetime Version (K-SADS-PL), according to criteria of the Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition (DSM 5). conditions: Bipolar Depression studyType: INTERVENTIONAL phases: PHASE3 allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: QUADRUPLE whoMasked: PARTICIPANT whoMasked: CARE_PROVIDER whoMasked: INVESTIGATOR whoMasked: OUTCOMES_ASSESSOR count: 384 type: ESTIMATED name: Lumateperone name: Placebo measure: Children's Depression Rating Scale-Revised (CDRS-R) measure: Clinical Global Impression Scale-Severity (CGI-S) sex: ALL minimumAge: 10 Years maximumAge: 17 Years stdAges: CHILD facility: Clinical Site status: NOT_YET_RECRUITING city: Anaheim state: California zip: 92805 country: United States lat: 33.83529 lon: -117.9145 facility: Clinical Site status: NOT_YET_RECRUITING city: Sacramento state: California zip: 95817 country: United States lat: 38.58157 lon: -121.4944 facility: Clinical Site status: NOT_YET_RECRUITING city: San Diego state: California zip: 92103 country: United States lat: 32.71533 lon: -117.15726 facility: Clinical Site status: NOT_YET_RECRUITING city: Colorado Springs state: Colorado zip: 80910 country: United States lat: 38.83388 lon: -104.82136 facility: Clinical Site status: NOT_YET_RECRUITING city: Gainesville state: Florida zip: 32607 country: United States lat: 29.65163 lon: -82.32483 facility: Clinical Site status: NOT_YET_RECRUITING city: Hialeah state: Florida zip: 33012 country: United States lat: 25.8576 lon: -80.27811 facility: Clinical Site status: NOT_YET_RECRUITING city: Miami Lakes state: Florida zip: 33014 country: United States lat: 25.90871 lon: -80.30866 facility: Clinical Site status: NOT_YET_RECRUITING city: Miami Lakes state: Florida zip: 33016 country: United States lat: 25.90871 lon: -80.30866 facility: Clinical Site status: RECRUITING city: Miami Springs state: Florida zip: 33166 country: United States lat: 25.82232 lon: -80.2895 facility: Clinical Site status: RECRUITING city: Orlando state: Florida zip: 32803 country: United States lat: 28.53834 lon: -81.37924 facility: Clinical Site status: NOT_YET_RECRUITING city: Atlanta state: Georgia zip: 30318 country: United States lat: 33.749 lon: -84.38798 facility: Clinical Site status: RECRUITING city: Decatur state: Georgia zip: 30030 country: United States lat: 33.77483 lon: -84.29631 facility: Clinical Site status: RECRUITING city: Lawrenceville state: Georgia zip: 30046 country: United States lat: 33.95621 lon: -83.98796 facility: Clinical Site status: NOT_YET_RECRUITING city: Savannah state: Georgia zip: 31405 country: United States lat: 32.08354 lon: -81.09983 facility: Clinical Site status: NOT_YET_RECRUITING city: Chicago state: Illinois zip: 60611 country: United States lat: 41.85003 lon: -87.65005 facility: Clinical Site status: NOT_YET_RECRUITING city: Indianapolis state: Indiana zip: 46202 country: United States lat: 39.76838 lon: -86.15804 facility: Clinical Site status: NOT_YET_RECRUITING city: Baltimore state: Maryland zip: 21229 country: United States lat: 39.29038 lon: -76.61219 facility: Clinical Site status: NOT_YET_RECRUITING city: Saint Charles state: Missouri zip: 63304 country: United States lat: 38.78394 lon: -90.48123 facility: Clinical Site status: NOT_YET_RECRUITING city: Lincoln state: Nebraska zip: 68526 country: United States lat: 40.8 lon: -96.66696 facility: Clinical Site status: NOT_YET_RECRUITING city: Kinston state: North Carolina zip: 28504 country: United States lat: 35.26266 lon: -77.58164 facility: Clinical Site status: NOT_YET_RECRUITING city: Avon Lake state: Ohio zip: 44012 country: United States lat: 41.50532 lon: -82.0282 facility: Clinical Site status: NOT_YET_RECRUITING city: Cincinnati state: Ohio zip: 45219 country: United States lat: 39.12713 lon: -84.51435 facility: Clinical Site status: NOT_YET_RECRUITING city: Garfield state: Ohio zip: 44125 country: United States facility: Clinical Site status: NOT_YET_RECRUITING city: Oklahoma City state: Oklahoma zip: 73112 country: United States lat: 35.46756 lon: -97.51643 facility: Clinical Site status: NOT_YET_RECRUITING city: Oklahoma City state: Oklahoma zip: 73116 country: United States lat: 35.46756 lon: -97.51643 facility: Clinical Site status: NOT_YET_RECRUITING city: Austin state: Texas zip: 78759 country: United States lat: 30.26715 lon: -97.74306 facility: Clinical Site status: NOT_YET_RECRUITING city: Frisco state: Texas zip: 75034 country: United States lat: 33.15067 lon: -96.82361 facility: Clinical Site status: NOT_YET_RECRUITING city: Houston state: Texas zip: 77089 country: United States lat: 29.76328 lon: -95.36327 facility: Clinical Site status: NOT_YET_RECRUITING city: Houston state: Texas zip: 77090 country: United States lat: 29.76328 lon: -95.36327 facility: Clinical Site status: NOT_YET_RECRUITING city: Bellevue state: Washington zip: 98007 country: United States lat: 47.61038 lon: -122.20068 hasResults: False |
<|newrecord|> nctId: NCT06372951 id: Lung ultrasound in neonate briefTitle: Lung Ultrasound in Neonatal Intensive Care Units overallStatus: NOT_YET_RECRUITING date: 2024-05-01 date: 2026-03 date: 2026-03 date: 2024-04-18 date: 2024-04-18 name: Assiut University class: OTHER briefSummary: Identification of lung diseases causing neonatal respiratory distress by lung ultrasound as a tool that can replace x-ray . conditions: Neonatal Respiratory Distress studyType: OBSERVATIONAL observationalModel: CASE_CONTROL timePerspective: CROSS_SECTIONAL count: 132 type: ESTIMATED name: Ultrasound measure: Identifying causes of neonatal respiratory distress sex: ALL minimumAge: 1 Day maximumAge: 28 Days stdAges: CHILD hasResults: False |
<|newrecord|> nctId: NCT06372938 id: AEŞH-BADEK-2024-43 briefTitle: Role of Inflammatory Markers and Doppler Parameters in Late-Onset Fetal Growth Restriction: A Machine Learning Approach overallStatus: ACTIVE_NOT_RECRUITING date: 2024-01-31 date: 2024-04-30 date: 2024-04-30 date: 2024-04-18 date: 2024-04-18 name: Ankara Etlik City Hospital class: OTHER_GOV briefSummary: Fetal growth restriction (FGR) is a serious complication in pregnancy that can lead to various adverse outcomes. It's classified into early-onset (before 32 weeks) and late-onset (after 32 weeks), with late-onset associated with long-term risks like hypoxemia and developmental delays. The study focuses on the role of inflammation in FGR, introducing new blood markers for better understanding and diagnosis. It also addresses the challenges of using advanced diagnostic tools in low-resource settings and explores the use of machine learning to predict FGR based on inflammatory markers, highlighting the potential of artificial intelligence in overcoming these challenges. conditions: Fetal Growth Restriction conditions: Inflammatory Response studyType: OBSERVATIONAL observationalModel: CASE_CONTROL timePerspective: RETROSPECTIVE count: 240 type: ACTUAL name: Ultrasound measurement name: Laboratory Tests and Inflammatory Markers measure: Evaluation of data measure: Machine learning modeling sex: FEMALE minimumAge: 18 Years maximumAge: 45 Years stdAges: ADULT facility: Etlik City Hospital city: Ankara state: Yenimahalle zip: 06170 country: Turkey lat: 39.91987 lon: 32.85427 hasResults: False |
<|newrecord|> nctId: NCT06372925 id: CKJX839A1CN04 id: CKJX839A1CN04 type: OTHER domain: Novartis briefTitle: Intravascular Imaging Study of the Effect of Inclisiran on Plaque in Patients With Acute Myocardial Infarction acronym: V-ACCELERATE overallStatus: NOT_YET_RECRUITING date: 2024-07-23 date: 2026-06-24 date: 2026-06-24 date: 2024-04-18 date: 2024-04-18 name: Novartis Pharmaceuticals class: INDUSTRY briefSummary: This study is to evaluate the effect of Inclisiran on coronary atherosclerosis using intravascular ultrasound (IVUS) and optical coherence tomography (OCT) in patients with acute myocardial infarction and elevated low-density lipoprotein cholesterol (LDL-C). conditions: Plaque, Atherosclerotic studyType: INTERVENTIONAL phases: PHASE4 allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: SINGLE maskingDescription: IVUS/OCT will be conducted in local lab and blinded analyzed to Independent Review Committee(IRC). whoMasked: OUTCOMES_ASSESSOR count: 318 type: ESTIMATED name: atorvastatin name: IVUS/OCT name: inclisiran measure: Change in percent atheroma volume (PAV) measure: Change in minimum fibrous cap thickness (FCT) measure: Change in mean minimum FCT of all images measure: Change in normalized total atheroma volume (NTAV) measure: Proportion of participants with progression, regression, or no change in PAV measure: Change in LDL-C measure: Change in TC measure: Change in HDL-C measure: Change in non-HDL-C measure: Change in ApoB measure: Change in ApoA1 measure: Change in Lp(a) measure: Change in TG measure: Proportion of participants with LDL-C target attainment sex: ALL minimumAge: 18 Years maximumAge: 75 Years stdAges: ADULT stdAges: OLDER_ADULT hasResults: False |
<|newrecord|> nctId: NCT06372912 id: Complications-Bariatric-TJ briefTitle: Early Postoperative Complications in Patients Undergoing Bariatric Surgery overallStatus: RECRUITING date: 2024-04-01 date: 2024-12-31 date: 2024-12-31 date: 2024-04-18 date: 2024-04-18 name: Instituto Mexicano del Seguro Social class: OTHER_GOV briefSummary: This study examined immediate postoperative complications in patients undergoing various bariatric surgeries, aiming to evaluate the safety and efficacy of these interventions. Conducted at specialized high-volume bariatric surgery centers in Tijuana, Mexico. Predominantly female patients with severe obesity underwent procedures like sleeve gastrectomy and Roux-en-Y gastric bypass. Immediate complications were rare, occurring in only 0.38% of patients, with bleeding being the most common issue. Surgical reintervention within 48 hours was required in 0.33% of cases. The study's low complication rate suggests that surgeon expertise is crucial in minimizing risks and improving postoperative outcomes in bariatric surgery. conditions: Bariatric Surgery Candidate conditions: Complication,Postoperative studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: RETROSPECTIVE count: 3000 type: ESTIMATED name: Sleeve gastrectomy, Roux-en-Y gastric bypass, mini-gastric bypass, SADIS, intragastric balloon insertion, and gastric band placement are bariatric surgeries. measure: Rate of Postoperative Complications measure: Long-term Weight Loss Efficacy sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Elias Ortiz & Company Mexico Weight Loss Specialists. Ernesto Sarmiento 2308, Tijuana 22046, Baja California, Mexico. status: RECRUITING city: Tijuana state: Baja California zip: 22046 country: Mexico name: José a Guzmán Barba, MD, PhD role: CONTACT phone: 3471043237 email: • [email protected] lat: 32.5027 lon: -117.00371 hasResults: False |
<|newrecord|> nctId: NCT06372899 id: 855140 id: R01CA290541-01A1 type: NIH link: https://reporter.nih.gov/quickSearch/R01CA290541-01A1 briefTitle: Alternative Nicotine Delivery Systems as Potential Harm Reduction Tools for Persistent Cigarette Smokers overallStatus: NOT_YET_RECRUITING date: 2024-04 date: 2027-11 date: 2028-03-31 date: 2024-04-18 date: 2024-04-19 name: University of Pennsylvania class: OTHER name: National Cancer Institute (NCI) briefSummary: This between-subjects study aims to evaluate whether e-cigarettes (ECIGS) versus oral nicotine pouches (ONPS) more readily substitute for combustible cigarettes among 200 cigarette smokers. After measuring baseline cigarette smoking rate, participants will be randomized to ECIGS or ONPS and be instructed to switch (versus smoking cigarettes) over a 6-week period. Relative reductions in biomarkers of exposure will be measured. ECIG- and ONP-associated subjective reward and the reinforcing value of ECIGS and ONPS relative to combustible cigarettes will be assessed as mechanisms. conditions: E-cigarette Use conditions: Cigarette Smoking conditions: Harm Reduction conditions: Tobacco Use studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: BASIC_SCIENCE masking: NONE count: 200 type: ESTIMATED name: E-cigarettes name: Oral nicotine pouches measure: Cigarette Consumption measure: Cigarette Smoking Across Follow-Up measure: Biomarkers of Exposure: Carbon Monoxide (CO) measure: Biomarkers of Exposure: Mean mid-expiratory forced expiratory flow (FEF25% - 75%) measure: Biomarkers of Exposure: 4-(methylnitrosamino)-1-(3-pyridyl)-1-butanol (NNAL) measure: Biomarkers of Exposure:1-hydroxypyrene (1-HOP) sex: ALL minimumAge: 21 Years stdAges: ADULT stdAges: OLDER_ADULT hasResults: False |
<|newrecord|> nctId: NCT06372886 id: 2402-147-1516 briefTitle: Clinical Outcomes of Preservation Versus Resection of Portal/Superior Mesenteric Vein During Pancreaticoduodenectomy in Pancreatic Cancer Patients Who Respond to Neoadjuvant Treatment overallStatus: COMPLETED date: 2012-01-01 date: 2022-01-01 date: 2024-03-01 date: 2024-04-18 date: 2024-04-18 name: Seoul National University Hospital class: OTHER briefSummary: 1. There is a lack of evidence on the need to perform portal/superior mesenteric vein (PV/SMV) resection routinely in pancreatic ductal adenocarcinoma (PDAC) patients with venous involvement who responded to neoadjuvant treatment (NAT). |
2. There is no significant differences in R0 rate, 5-year overall survival and recurrence-free survival between the PV/SMV preservation (PVP) group and PV/SMV resection (PVR) group. |
3. PVP group showed significantly better 5-year PV/SMV stenosis free survival than the PVR group. |
4. We propose that if dissection is possible and there is a high likelihood of achieving R0 resection after NAT, routine PVR may be unnecessary in PDAC patients with venous involvement. conditions: Pancreatic Head Cancer Patients Who Underwent Surgery After Neoadjuvant Treatment studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: RETROSPECTIVE count: 264 type: ACTUAL name: portal/superior vein resection measure: 5-year overall survival measure: 5-year portal/superior mesenteric vein stenosis free survival sex: ALL maximumAge: 79 Years stdAges: CHILD stdAges: ADULT stdAges: OLDER_ADULT hasResults: False |
<|newrecord|> nctId: NCT06372873 id: 2023PHB211-001 briefTitle: Deep-learning For Ultrasound Classification of Anterior Talofibular Ligament Injury overallStatus: ACTIVE_NOT_RECRUITING date: 2024-04-01 date: 2024-04-30 date: 2025-05-30 date: 2024-04-18 date: 2024-04-23 name: Peking University People's Hospital class: OTHER briefSummary: Ultrasound (US) is a more cost-effective, accessible, and available imaging technique to assess anterior talofibular ligament (ATFL) injuries compared with magnetic resonance imaging (MRI). However, challenges in using this technique and increasing demand on qualified musculoskeletal (MSK) radiologists delay the diagnosis. Using datasets from multiple clinical centers, the investigators aimed to develop and validate a deep convolutional network (DCNN) model that automates classification of ATFL injuries using US images with the goal of providing interpretable assistance to radiologists and facilitating a more accurate diagnosis of ATFL injuries. |
The investigators collected US images of ATFL injuries which had arthroscopic surgery results as reference standard form 13 hospitals across China;Then the investigators divided the images into training dataset, internal validation dataset, and external validation dataset in a ratio of 8:1:1; the investigators chose an optimal DCNN model to test its diagnostic performance of the model, including the diagnostic accuracy, sensitivity, specificity, F1 score. At last, the investigators compared the diagnostic performance of the model with 12 radiologists at different levels of expertise. conditions: Deep Learning conditions: Ultrasound conditions: Anterior Talofibular Ligament studyType: OBSERVATIONAL observationalModel: OTHER timePerspective: RETROSPECTIVE count: 3000 type: ESTIMATED name: re-evaluate by two senior radiologists in our medical center measure: To evaluate whether the US images are in consensus with the ATFL injury classification of the reference standard sex: ALL minimumAge: 18 Years maximumAge: 80 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Peking University People's Hospital city: Beijing state: Beijing zip: 100032 country: China lat: 39.9075 lon: 116.39723 hasResults: False |
<|newrecord|> nctId: NCT06372860 id: RKS2018350 id: 3P20GM144269-02S2 type: NIH link: https://reporter.nih.gov/quickSearch/3P20GM144269-02S2 briefTitle: DPP Feasibility Study of Breastfeeding - eMOMS 2.0 overallStatus: NOT_YET_RECRUITING date: 2024-04 date: 2024-12 date: 2025-02 date: 2024-04-18 date: 2024-04-18 name: University of Kansas Medical Center class: OTHER name: Ascension Health name: National Institute of General Medical Sciences (NIGMS) briefSummary: The purpose of this study is to investigate the impact of a comprehensive intervention that combines breastfeeding support with a diabetes prevention-based program (DPP) on postpartum weight retention and lactation duration among women with pre-pregnancy overweight or obesity. This intervention, named eMOMS, is delivered by a certified health coach via a mobile health (mHealth) application. conditions: Overweight or Obesity conditions: Pregnancy studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: NONE count: 50 type: ESTIMATED name: Diabetes Prevention Program name: Breastfeeding name: Usual Care measure: Maternal weight measure: Maternal body mass index (BMI) measure: Initiation of Lactation measure: Duration of Lactation measure: Type of Infant Feeding measure: Recruitment Rate measure: Retention Rate measure: Research Engagement measure: Mobile Application Usage measure: Health Coach Interaction sex: FEMALE minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT typeAbbrev: Prot_SAP hasProtocol: True hasSap: True hasIcf: False label: Study Protocol and Statistical Analysis Plan date: 2024-02-07 uploadDate: 2024-04-09T16:15 filename: Prot_SAP_000.pdf size: 1164859 hasResults: False |
<|newrecord|> nctId: NCT06372847 id: Project ID 6214 briefTitle: DISE-HNS Effect Study acronym: DISE-HNS overallStatus: NOT_YET_RECRUITING date: 2024-04-23 date: 2028-03-31 date: 2028-03-31 date: 2024-04-18 date: 2024-04-18 name: University Hospital, Antwerp class: OTHER briefSummary: The purpose of this study is to assess the site, pattern and degree of upper airway collapse before and during hypoglossal nerve stimulation (HNS) treatment using clinical standard drug-induced sleep endoscopy (DISE) and using a novel, non-invasive method predicting site of collapse from raw polysomnography (PSG) data. |
Furthermore, outcomes will be compared between responders and non-responders. conditions: Obstructive Sleep Apnea studyType: INTERVENTIONAL phases: NA allocation: NA interventionModel: SINGLE_GROUP interventionModelDescription: Before-and-after study primaryPurpose: BASIC_SCIENCE masking: NONE count: 58 type: ESTIMATED name: Hypoglossal nerve stimulation implant name: Polysomnography name: Drug-induced sleep endoscopy (DISE) measure: Δ%area-of-collapse at the level of the lateral walls measure: Δ%area-of-collapse at the level of the palate, tongue base and epiglottis measure: Δ%area-of-collapse at each possible site of upper airway collapse (palate, lateral walls, tongue base, epiglottis) in responders and non-responders measure: DISE-score during baseline DISE and during one-year follow-up DISE. measure: Non-invasive site and pattern of collapse sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT typeAbbrev: Prot_SAP hasProtocol: True hasSap: True hasIcf: False label: Study Protocol and Statistical Analysis Plan date: 2024-02-29 uploadDate: 2024-04-04T04:58 filename: Prot_SAP_000.pdf size: 425782 typeAbbrev: ICF hasProtocol: False hasSap: False hasIcf: True label: Informed Consent Form date: 2024-02-29 uploadDate: 2024-04-04T04:58 filename: ICF_001.pdf size: 336420 hasResults: False |
<|newrecord|> nctId: NCT06372834 id: B202205178 briefTitle: Adjuvant Accelerated piTBS for Reducing Suicidal Ideation in TRD Patients: A Randomized, Sham-controlled Trial overallStatus: RECRUITING date: 2022-11-07 date: 2024-12-31 date: 2024-12-31 date: 2024-04-18 date: 2024-04-18 name: Tri-Service General Hospital class: OTHER briefSummary: In this double-blind, randomized, sham-controlled trial, we aimed to examine the effect of accelerated piTBS on suicide risk in a group of treatment-resistant patients with MDD (i.e., TRD), using an extensive suicide assessment scale the primary outcome. We hypothesized that this intensified treatment protocol would be safe in TRD patients with suicide ideations and would result in significant decreases in suicide risk in the active treatment condition as compared to the sham condition. conditions: Major Depressive Disorder conditions: Treatment-Resistant Depression conditions: Suicide Ideations studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: QUADRUPLE whoMasked: PARTICIPANT whoMasked: CARE_PROVIDER whoMasked: INVESTIGATOR whoMasked: OUTCOMES_ASSESSOR count: 100 type: ESTIMATED name: piTBS being delivered using the Magstim Rapid2 stimulator measure: The change over time in the score of Beck Scale for Suicide Ideation (BSS) (from baseline to the timepoints at 1 week after piTBS, at the end of piTBS, and at 1, 2, and 4 weeks after piTBS). measure: The change over time in the score of Snaith-Hamilton Pleasure Scale (SHAPS) (from baseline to the timepoints at 1 week after piTBS, at the end of piTBS, and at 1, 2, and 4 weeks after piTBS). measure: The change over time in the score of Beck Hopelessness Scale (BHS) (from baseline to the timepoints at 1 week after piTBS, at the end of piTBS, and at 1, 2, and 4 weeks after piTBS). measure: The change over time in the score of Montgomery-Å sberg Depression Rating Scale (MADRS) (from baseline to the timepoints at 1 week after piTBS, at the end of piTBS, and at 1, 2, and 4 weeks after piTBS). measure: The change over time in the score of 17-item Hamilton Depression Rating Scale (HDRS) (from baseline to the timepoints at 1 week after piTBS, at the end of piTBS, and at 1, 2, and 4 weeks after piTBS). measure: The change over time in the score of Hamilton Anxiety Rating Scale (HAM-A) (from baseline to the timepoints at 1 week after piTBS, at the end of piTBS, and at 1, 2, and 4 weeks after piTBS). measure: The change over time in the score of Young Mania Rating Scale (YMRS) (from baseline to the timepoints at 1 week after piTBS, at the end of piTBS, and at 1, 2, and 4 weeks after piTBS). measure: The changes over time in the results of Wisconsin Card Sorting Test (WCST) (from baseline to the timepoint at the end of piTBS). measure: The changes over time in the results of Color Trails Test (CTT) (from baseline to the timepoint at the end of piTBS). measure: The changes over time in the results of Stroop Color Word Test (SCWT) (from baseline to the timepoint at the end of piTBS). measure: The changes over time in the results of indices of heart rate variability (HRV) (from baseline to the timepoint at the end of piTBS) and the HRV indices during each piTBS session. measure: The changes over time in EEG absolute power and lag phase synchronization in the frontal electrodes in the delta, theta, alpha, beta and gamma range (from baseline to the end of piTBS). measure: The changes over time in high density near infrared spectroscopy (from baseline to the end of piTBS). measure: The changes over time in the results of Digit Symbol Substitution Test (DSST) (from baseline to the timepoint at the end of piTBS). sex: ALL minimumAge: 20 Years maximumAge: 65 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Tri-service general hospital status: RECRUITING city: Taipei zip: 114 country: Taiwan name: Hsin-An Chang, M.D. role: CONTACT phone: 011-886-2-8792-3311 phoneExt: 17389 email: [email protected] name: Hsin-An Chang, M.D. role: PRINCIPAL_INVESTIGATOR lat: 25.04776 lon: 121.53185 hasResults: False |
<|newrecord|> nctId: NCT06372821 id: 158160 briefTitle: A Trial Evaluating the Effect of NIO752 on Tau Synthesis Measured by a Process Known as SILK acronym: NIO-SILK overallStatus: NOT_YET_RECRUITING date: 2024-05 date: 2025-02 date: 2025-08 date: 2024-04-18 date: 2024-04-18 name: University College, London class: OTHER name: Washington University School of Medicine name: University of Washington name: Alzheimer's Association name: Sigrid Rausing Trust briefSummary: This study will assess if drug (NIO752) reduces production of a protein, tau, by the brain. Normally tau maintains the internal skeleton of nerve cells. In Alzheimer's disease (AD) it builds up in the brain, causing damage. Abnormal tau proteins cling to each other forming 'tangles' inside nerve cells, which interfere with how the nerve cells work, and eventually die. This is what causes the symptoms of dementia. It is thought that NIO752 reduces production of tau. conditions: Alzheimer Disease conditions: Autosomal Dominant Alzheimer Disease Due to Mutation of Presenilin 1 (Disorder) conditions: Autosomal Dominant Alzheimer Disease Due to Mutation of Presenilin 2 (Disorder) conditions: Autosomal Dominant Alzheimer Disease Due to Mutation of Amyloid Precursor Protein (Disorder) studyType: INTERVENTIONAL phases: PHASE1 allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: TRIPLE whoMasked: PARTICIPANT whoMasked: CARE_PROVIDER whoMasked: INVESTIGATOR count: 10 type: ESTIMATED name: NIO752 name: Placebo measure: Tau synthesis rate inhibition in individuals with sporadic AD and ADAD measure: Compare efficacy of knockdown of tau production in sporadic AD and ADAD by measuring the synthesis rate of tau by determining the ratio of labelled to unlabeled tau (tracer to tracee ratio) in serial cerebrospinal fluid samples. measure: Number of participants with adverse events [safety and tolerability] measure: Comparison of number of Adverse Events reported between participants receiving one dose of NIO752 versus those receiving two doses of NIO752. measure: Compare rates of tau synthesis and clearance in sporadic AD and ADAD measure: Determine CSF tau concentration to tau production relationships in humans sex: ALL minimumAge: 21 Years maximumAge: 80 Years stdAges: ADULT stdAges: OLDER_ADULT hasResults: False |
<|newrecord|> nctId: NCT06372808 id: 2022/118 briefTitle: The Effect of Plyometric Training in Freestyle Adolescent Wrestlers overallStatus: RECRUITING date: 2023-10-01 date: 2024-06-18 date: 2024-09-15 date: 2024-04-18 date: 2024-04-19 name: Hasan Kalyoncu University class: OTHER briefSummary: This study aims to determine the effect of plyometric exercises on physical fitness parameters in freestyle adolescent wrestlers. conditions: Physical Fitness conditions: Power studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: SINGLE whoMasked: PARTICIPANT count: 40 type: ESTIMATED name: The Plyometric Exercise name: The Regular Training measure: Change from Baseline in Strength at 8 weeks measure: Change from Baseline in Endurance at 8 weeks measure: Change from Baseline in Agility at 8 weeks measure: Change from Baseline in Wrestling Performance at 8 weeks sex: ALL minimumAge: 10 Years maximumAge: 15 Years stdAges: CHILD facility: Batipark Sports Hall status: RECRUITING city: Kahramanmaraş zip: 46050 country: Turkey name: Talha Gökçe, PT role: CONTACT phone: +905065624802 email: [email protected] lat: 37.5847 lon: 36.92641 hasResults: False |
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