hackint0sh/New-Dataset huggingface dataset:
nctId: NCT06382012 id: 2024-15703 briefTitle: Antiemetic Fosaprepitant To Remedy Nausea and Vomiting acronym: AFTR NV RCT overallStatus: NOT_YET_RECRUITING date: 2024-06 date: 2024-12 date: 2024-12 date: 2024-04-24 date: 2024-04-26 name: Montefiore Medical Center class: OTHER briefSummary: The study team proposes a randomized, double-blind, RCT to address the following goal: to determine the relative efficacy and adverse event profile of fosaprepitant compared to the standard of care antiemetic ondansetron. Fosaprepitant and its active metabolite aprepitant are a relatively new class of antiemetic that exclusively acts in the central nervous system by blocking neurokinin (NK-1) which is a key signaling molecule in the centrally mediated aspects of the vomiting reflex. Currently, fosaprepitant and aprepitant both have only two United Stated Food and Drug Administration (USFDA) approved indications for nausea and vomiting: chemotherapy-induced and postoperative. Neurokinin inhibitors are highly effective and generally well-tolerated. Therefore, this class of medication may be a more appropriate medication for the millions of patients with nausea and vomiting that seek care in EDs. Intravenous fosaprepitant is converted to the active metabolite aprepitant on the order of minutes and is significantly cheaper to procure at this time. The outcome for the efficacy analysis will be no need for additional medication to treat nausea and vomiting within 2 hours of investigational medication administration. The primary outcome for the tolerability analysis will be the development of any new symptom within 2 hours of medication administration. conditions: Nausea and Vomiting conditions: Nausea conditions: Vomiting 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: 250 type: ESTIMATED name: Fosaprepitant 150 mg name: Ondansetron 4 mg measure: Sustained Relief from NV measure: Severity of Nausea measure: Need for rescue antiemetic medication measure: Medication Preference measure: Functional disability measure: Vomiting measure: Hospitalization measure: Fluid Treatment measure: Mean Fluid Volume measure: Length of Stay measure: QTc Interval (QT interval corrected for heart rate) measure: Revisit Rate sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Montefiore Medical Center (Montefiore and Weiler EDs) city: Bronx state: New York zip: 10467 country: United States name: Mustfa K Manzur, MD role: CONTACT phone: 718-920-6626 email: mmanzur@montefiore.org lat: 40.84985 lon: -73.86641 hasResults: False
nctId: NCT06381999 id: M602011083 briefTitle: Validity and Inter-rater Reliability for Early Recognition of Spasticity Using the Decision Tree Tool acronym: I-REFER overallStatus: COMPLETED date: 2023-10-27 date: 2024-02-26 date: 2024-02-26 date: 2024-04-24 date: 2024-04-24 name: Merz Therapeutics GmbH class: INDUSTRY briefSummary: The aim of this study is to investigate the validity and Inter-rater reliability for early recognition of spasticity by nurses and physiotherapists using the decision tree tool. conditions: Post-stroke Spasticity studyType: OBSERVATIONAL observationalModel: CASE_CONTROL timePerspective: CROSS_SECTIONAL count: 73 type: ACTUAL measure: Assessment of the level of agreement between the nurse group and gold-standard group (trained, specialized physicians) in their decision for toxin treatment referral measure: Assessment of the level of agreement between the physiotherapist and/or occupational therapist group and gold-standard group (trained, specialized physicians) in their decision for toxin treatment referral sex: ALL minimumAge: 18 Years maximumAge: 80 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Gailtal-Klinik city: Hermagor zip: 9620 country: Austria lat: 46.62722 lon: 13.36722 hasResults: False
nctId: NCT06381986 id: SHJ002-SJP2 briefTitle: Efficacy and Safety of SHJ002 Ophthalmic Solution in the Treatment of Corneal Erosion in Sjogren's Patients overallStatus: NOT_YET_RECRUITING date: 2024-05 date: 2025-01 date: 2025-02 date: 2024-04-24 date: 2024-04-24 name: Sunhawk Vision Biotech, Inc. class: INDUSTRY briefSummary: The purpose of this study is to measure efficacy and safety with 0.25% SHJ002 sterile ophthalmic solution compared to vehicle in treating corneal erosion in Sjogren's patients.
SHJ002 is an antisense oligonucleotide to neutralize a specific microRNA. conditions: Corneal Erosion studyType: INTERVENTIONAL phases: PHASE2 allocation: RANDOMIZED interventionModel: PARALLEL interventionModelDescription: Double-Blinded, Parallel, Vehicle-Controlled primaryPurpose: TREATMENT masking: QUADRUPLE maskingDescription: Double-Blinded, Parallel, Vehicle-Controlled whoMasked: PARTICIPANT whoMasked: CARE_PROVIDER whoMasked: INVESTIGATOR whoMasked: OUTCOMES_ASSESSOR count: 122 type: ESTIMATED name: SHJ002 name: Vehicle measure: To assess the efficacy of SHJ002 sterile ophthalmic solution relative to vehicle as measured by corneal fluorescein staining (CFS) score measure: To assess the efficacy of SHJ002 sterile ophthalmic solution relative to the vehicle as measured by central corneal fluorescein staining (cCFS) score measure: To assess the efficacy of SHJ002 sterile ophthalmic solution relative to the vehicle as measured by Visual Analogue Scale (VAS) measure: To assess the efficacy of SHJ002 sterile ophthalmic solution relative to the vehicle as measured by Symptom Assessment in Dry Eye (SANDE) sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Kaohsiung Medical Chung-Ho Memorial Hospital city: Kaohsiung zip: 807 country: Taiwan name: Shiuh-Liang Hsu, MD role: CONTACT phone: +886-73121101 email: shiuhlianghsu@gmail.com name: Shiuh-Liang Hsu, MD role: PRINCIPAL_INVESTIGATOR name: Li-Yi Chiu, MD role: SUB_INVESTIGATOR lat: 22.61626 lon: 120.31333 hasResults: False
nctId: NCT06381973 id: ELTGOL briefTitle: Ventilation Distribution in COPD Patients During Breathing Exercises overallStatus: RECRUITING date: 2024-04-15 date: 2024-08-01 date: 2024-08-01 date: 2024-04-24 date: 2024-04-25 name: William Poncin, PT, PhD class: OTHER briefSummary: ELTGOL (Slow Expiration with the Opened Glottis in the Lateral posture) is an airway clearance technique performed in the lateral decubitus position. This technique focuses on optimizing ventilation of the infralateral lung (when the subject is lying in the lateral posture) to enhance local air-liquid interaction. Previous studies on ventilation differences between the infra- and supralateral lungs were conducted on healthy, young, male subjects, without the application of thoracic or abdominal pressure.
This study aimed to assess ventilation distribution in right lateral recumbency in patients with chronic obstructive pulmonary disease (COPD), as well as healthy individuals, and investigate the impact of thoracic and abdominal manual pressures during ELTGOL on ventilation distribution. conditions: Chronic Obstructive Pulmonary Disease conditions: Healthy studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: CROSSOVER primaryPurpose: TREATMENT masking: SINGLE whoMasked: OUTCOMES_ASSESSOR count: 50 type: ESTIMATED name: ELTGOL_Physio name: ELTGOL_Auto name: PEP name: 1L-Tidal-Breathing name: Spontaneous Breathing measure: Impedance variation using Electrical Impedance Tomography sex: ALL minimumAge: 40 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Cliniques universitaires Saint-Luc status: RECRUITING city: Brussels state: Brussels Capital zip: 1200 country: Belgium name: William Poncin role: CONTACT phone: +320470592032 phoneExt: +320470592032 email: william.poncin@uclouvain.be lat: 50.85045 lon: 4.34878 hasResults: False
nctId: NCT06381947 id: 19092023 briefTitle: Efficacy and Safety of Bempedoic Acid in Association With Anti-PCSK9 and Ezetimibe in Statin-intolerant Patients acronym: BESAFE overallStatus: NOT_YET_RECRUITING date: 2024-05-01 date: 2025-06-30 date: 2025-06-30 date: 2024-04-24 date: 2024-04-24 name: University of Salerno class: OTHER briefSummary: Statin intolerance occurs in up to 15-20% of treated patients. The combined use of Proprotein Convertase Subtilisin/Kexin type 9 (PCSK9) inhibitors with ezetimibe is commonly performed in these patients, and has been associated with an estimated LDL-C reduction of 65-70%. This drug combination may be insufficient to reach the LDL-C target in high- and very-high-risk patients with statin intolerance, also considering the goals recommended by the current international guidelines. Also, PCSK9 inhibitor dosage escalations frequently fail to achieve the target. Doubling the dosage of alirocumab from 75 mg to 150 mg, when administrated as monotherapy, determines a further reduction of only 3,6% of LDL-C serum level. The full dose of Evolocumab (420 mg every two weeks), was approved only in the setting of homozygous familiar hypercholesterolemia.
The CLEAR (Cholesterol Lowering via Bempedoic acid, an ACL-Inhibiting Regimen) Harmony trial demonstrated that bempedoic acid in addition to maximally tolerated statin therapy did not lead to a higher incidence of adverse events compared to placebo and significantly lowered LDL-C levels. In the CLEAR Serenity study, bempedoic acid showed a safe and effective profile compared with placebo in patients with statin intolerance. In the CLEAR Tranquility, it provided an oral therapeutic option complementary to ezetimibe in patients intolerant to high-dose statins who required additional LDL-C lowering.
The synergistic effect of bempedoic acid plus PCSK9 inhibitors has been investigated by one phase 2 trial (NCT03193047), which showed a statistical superiority of bempedoic acid plus evolocumab strategy versus placebo plus evolocumab in terms of percent change in LDL-C up to 2 months. To date, no randomized phase 3 clinical trial have evaluated the effect of bempedoic acid in association with anti-PCSK9 and ezetimibe in statin-intolerant patients not attaining the recommended LDL-C target.
The investigators hypothesized that the association of bempedoic acid with PCSK9 inhibitors and ezetimibe may be safe and effective in reducing LDL-C in statin-intolerant patients. conditions: Dyslipidemias conditions: Statin Adverse Reaction conditions: Cardiovascular Diseases conditions: Lipid Metabolism Disorders studyType: INTERVENTIONAL phases: PHASE4 allocation: RANDOMIZED interventionModel: CROSSOVER interventionModelDescription: This is an investigator-initiated, phase 4, open-label, multicentre, 2-way crossover trial primaryPurpose: PREVENTION masking: NONE count: 130 type: ESTIMATED name: Lipid-lowering therapy combination with PCSK9 inhibitors, bempedoic acid and ezetimibe name: Lipid-lowering therapy combination with PCSK9 inhibitors and ezetimibe measure: Mean percentage change in LDL-C after 12 weeks of treatment measure: Mean absolute change from baseline to week 12 in low-density lipoprotein cholesterol measure: Percentage of patients reaching the recommended LDL-C target measure: Changes in plasmatic levels of total cholesterol after 12 weeks of treatment measure: Changes in plasmatic levels of HDL cholesterol after 12 weeks of treatment measure: Changes in plasmatic levels of non-HDL cholesterol after 12 weeks of treatment measure: Changes in plasmatic levels of fasting glucose after 12 weeks of treatment measure: Changes in plasmatic levels of glycated haemoglobin after 12 weeks of treatment measure: Changes in plasmatic levels of fasting insulinemia after 12 weeks of treatment measure: Changes in plasmatic levels of HOMA index after 12 weeks of treatment measure: Changes in plasmatic levels of hs-CRP after 12 weeks of treatment measure: Changes in plasmatic levels of lipoprotein(a) after 12 weeks of treatment measure: Changes in plasmatic levels of apolipoprotein B after 12 weeks of treatment measure: Changes in PCSK9 serum levels before starting the treatment and after 12 weeks of treatment measure: Number of participants with abnormal uric acid level, abnormal AST/ALT level, ALT or AST >3x ULN, and/or unexplained creatine kinase (CK) >3x ULN measure: The number and type of adverse events measure: MACE at 12 and 28 weeks measure: Rehospitalization at 12 and 28 weeks measure: Death at 12 and 28 weeks 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: 2023-05-02 uploadDate: 2024-04-08T09:09 filename: Prot_SAP_000.pdf size: 452473 typeAbbrev: ICF hasProtocol: False hasSap: False hasIcf: True label: Informed Consent Form date: 2023-05-02 uploadDate: 2024-04-08T09:09 filename: ICF_001.pdf size: 193521 hasResults: False
nctId: NCT06381934 id: 2024-00335; kt23ChristCrain4 briefTitle: Validation of New Diagnostic Indices to Simplify Hyponatremia Therapy Assessment in Patients on Thiazide Diuretics overallStatus: NOT_YET_RECRUITING date: 2024-05 date: 2027-04 date: 2027-04 date: 2024-04-24 date: 2024-04-24 name: University Hospital, Basel, Switzerland class: OTHER briefSummary: This study is looking at two new parameters, aSID and ChU, to see if these can help physicians to distinguish between different causes of low sodium levels (hyponatremia) in Patients taking a medicament against high blood pressure (thiazide). Researchers also want to see if using these new parameters to decide on treatment works just as well, or better, than the current standard treatments. conditions: Thiazide Associated Hyponatremia studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: NONE count: 136 type: ESTIMATED name: Standard Care name: aSID/ChU Guided Therapy measure: Serum Sodium Level measure: Descriptive analyses: Changes in aSID in relation to changes in serum sodium levels measure: Descriptive analyses: Changes in ChU in relation to changes in serum sodium levels measure: Diagnostic performance analyses of: aSID and ChU measure: Diagnostic performance analyses of: aSID measured in blood gas analysis measure: Diagnostic performance analyses of: clinical volume status assessment measure: Diagnostic performance analyses of: not-invasive instrumental volume status assessment measure: Diagnostic performance analyses of: other hormones such as aldosterone, renin, arginine-vasopressin sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: University Hospital Basel city: Basel zip: 4031 country: Switzerland name: Laura Potasso, Dr. med. sc. role: CONTACT phone: +41 61 328 58 76 email: laura.potasso@usb.ch name: Mirjam Christ-Crain, Prof. Dr. med. role: CONTACT phone: +41 61 328 70 80 email: mirjam.christ-crain@usb.ch name: Laura Potasso, Dr. med. sc. role: PRINCIPAL_INVESTIGATOR name: Mirjam Christ-Crain, Prof. Dr. med. role: SUB_INVESTIGATOR lat: 47.55839 lon: 7.57327 hasResults: False
nctId: NCT06381921 id: B2023-0046 briefTitle: Objective Integrated Multimodal Electrophysiological Index for the Quantification of Visceral Pain acronym: OIME overallStatus: NOT_YET_RECRUITING date: 2025-05-01 date: 2027-10-31 date: 2029-02-28 date: 2024-04-24 date: 2024-04-24 name: University of Connecticut class: OTHER name: Yale University briefSummary: The objectives of the study are to 1) Conduct telemetric biosignals (EDA, ECG, and EMG) recording in healthy controls and IBS participants experiencing cutaneous and visceral pain; and 2) Validate the OIME index as a biomarker for quantifying pain in IBS participants and its capability to assess the treatment of IBS pain via an ambulatory trial. conditions: Abdominal Pain studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL interventionModelDescription: randomized controlled ambulatory trial primaryPurpose: DIAGNOSTIC masking: NONE count: 120 type: ESTIMATED name: IBS-PPSM intervention measure: Pain intensity and interference measure: IBS-related symptoms measure: Electrodermal activity (EDA) measure: Electrocardiogram (ECG) measure: Electromyogram (EMG) measure: Objective integrated multimodal electrophysiological index sex: ALL minimumAge: 18 Years maximumAge: 50 Years stdAges: ADULT hasResults: False
nctId: NCT06381895 id: SYSKY-2023-467-01 briefTitle: The Efficacy of Radiomics to Predict Tumor Microenvironment Markers and Comprehensive Therapy for Bladder Cancer overallStatus: COMPLETED date: 2023-05-30 date: 2024-02-01 date: 2024-02-20 date: 2024-04-24 date: 2024-04-24 name: Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University class: OTHER briefSummary: The aim of this study was to develop an radiomic model based on CT images to evaluate markers of the bladder cancer microenvironment, such as TSR,TIL, and IP. Secondly, the association of the radiomic model with clinical outcomes and immunotherapy response was investigated. conditions: Bladder Cancer conditions: Radiomics conditions: Immunotherapy studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: RETROSPECTIVE count: 1200 type: ACTUAL measure: Tumour-infiltrating lymphocytes (TIL) measure: overall survival measure: cancer-specific survival sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Sun Yat-sen Memorial Hospital city: Guangzhou state: Guangdong country: China lat: 23.11667 lon: 113.25 hasResults: False
nctId: NCT06381882 id: MiPac briefTitle: The Role of the Human Microbiome in Patients After Pancreatic Resection. acronym: MiPac overallStatus: NOT_YET_RECRUITING date: 2024-05-01 date: 2026-05-01 date: 2026-11-01 date: 2024-04-24 date: 2024-04-24 name: St. Antonius Hospital class: OTHER briefSummary: The goal of this observational study is to classify patients that undergo pancreatic resection for presumed pancreatic or periampullary malignancy into high and low risk groups for postoperative complications based on longitudinal saliva, rectal/faecal, tumor, blood and/or bile microbiome profiles.
To identify the dynamics of the microbiome, as well as the possibly related short-term and long-term complications, multiple samples at different timepoints are needed from the patients. conditions: Pancreas Cancer conditions: Pancreas Neoplasm conditions: Pancreas Adenocarcinoma conditions: Periampullary Cancer conditions: Periampullary Carcinoma conditions: Microbial Colonization studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: PROSPECTIVE count: 200 type: ESTIMATED name: Pancreatic resection measure: Risk stratification postoperative complications measure: Long time oncological outcomes - site of recurrence measure: Long time oncological outcomes - disease free survival measure: Long time oncological outcomes - overall survival measure: Complications neoadjuvant chemotherapy measure: Complications adjuvant chemotherapy measure: Response to neoadjuvant chemotherapy measure: Complications bile duct drainage measure: Postoperative endocrine insufficiency measure: Postoperative exocrine insufficiency sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT hasResults: False
nctId: NCT06381869 id: CRNHA 2018-2 briefTitle: Bioavailability of Pea Protein in Young and Old Volunteers acronym: NUTRALYS overallStatus: COMPLETED date: 2019-01-10 date: 2019-06-13 date: 2019-06-13 date: 2024-04-24 date: 2024-04-24 name: Roquette Freres class: INDUSTRY name: CRNH Auvergne name: Université d'Auvergne briefSummary: The aim of this study done in healthy, non-malnourished young and elderly subjects, is to measure the bioavailability of protein intake and the variation of metabolic markers following consumption of pea protein " NUTRALYS ® S85 plus" or a reference protein brought in water either alone or at the end of a standardized meal. conditions: Healthy Male Volunteers studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: CROSSOVER primaryPurpose: OTHER masking: NONE count: 30 type: ACTUAL name: Pea protein (NUTRALYS ® S85 plus) in water name: Pea protein (NUTRALYS ® S85 plus) within meal name: Whey protein in water name: Whey protein within meal measure: Leucine blood concentration measure: Essential amino acids blood concentration (µmol/L) measure: Non essential amino acid blood concentration (µmol/L) measure: Blood glucose concentration (g/L) measure: Blood insulin concentration (μIU/ml) measure: Blood lipid profile (glycerol concentration in mg/l and non-esterified fatty acids concentration in mg/l) measure: Blood inflammatory profile (TNF-α blood concentration in pg/ml and IL-6 blood concentration in pg/ml) sex: MALE minimumAge: 18 Years maximumAge: 85 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Unité d'Exploration en Nutrition Centre de Recherche en Nutrition Humaine d'Auvergne city: Clermont-Ferrand zip: 63009 country: France lat: 45.77966 lon: 3.08628 hasResults: False
nctId: NCT06381856 id: EPM_2024-00227-01 briefTitle: Improving Participation of Autistic Children and Adolescents in the Habilitation Process acronym: IMPAC overallStatus: NOT_YET_RECRUITING date: 2024-09 date: 2025-05 date: 2025-12 date: 2024-04-24 date: 2024-04-24 name: Region Örebro County class: OTHER briefSummary: This project aims to explore the impact of a survey-based and a meeting-based needs assessment models on 7 to 17 year old autistic children's participation in the needs assessment process at the initial reception when enrolled at a Child and Youth Habilitation Centre. conditions: Autism Spectrum Disorders studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: PROSPECTIVE count: 120 type: ESTIMATED measure: The child's involvement measure: The Mental Health Continuum - Short Form measure: The "Your child's strengths, abilities and special needs"-questionnaire. measure: The collaboration with the neuropsychiatric team questionnaire measure: Cantril ladder measure: Individual interviews measure: Type and number of goals in the childrens' individual habilitation plans sex: ALL minimumAge: 7 Years maximumAge: 17 Years stdAges: CHILD facility: University Health Care Research Center city: Örebro zip: 70182 country: Sweden lat: 59.27412 lon: 15.2066 hasResults: False
nctId: NCT06381843 id: WSKCT004 briefTitle: A Clinical Study to Evaluate the Safety and Immunogenicity of the Recombinant COVID-19 Vaccine (Sf9 Cell) as a Booster overallStatus: COMPLETED date: 2022-08-02 date: 2023-03-29 date: 2023-12-30 date: 2024-04-24 date: 2024-04-25 name: WestVac Biopharma Co., Ltd. class: INDUSTRY name: West China Hospital briefSummary: A observer-blind, randomized, controlled, investigator-initiated clinical trial to evaluate the safety and immunogenicity of a booster vaccination with Recombinant COVID-19 vaccine (Sf9 Cell) in a population aged 18-60 years old who have completed 3 doses vaccination with COVID-19 Vaccine (Vero Cell), Inactivated ≥ 6 months at least 6 months prior to enrolment. The study uses a non-inferiority design to compare between schedules with Recombinant COVID-19 Vaccine (Sf9 Cell) versus COVID-19 Vaccine (Vero Cell) Inactivated as the booster dose. Participants, laboratory and analysing statisticians will remain blind to treatment allocation.